Neogen Care Corp

“Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This Standard is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence) failed to provide infection control education to the family and/or caregiver for one of fourteen sampled patients (Patient 23). This failure had the potential to expose Patient 23 and the family member/caregiver to increased risk of infection and injury. During a review of Patient 23’s Home Health Certification and Plan of Care for the certification period of 6/24/2026 to 8/22/2026 (also known as POC, a detailed, written document outlining the services and support an individual needs to meet their healthcare goals), the POC indicated the HHA admitted Patient 23 on 6/24/2026 with diagnoses that included unspecified systolic heart failure (a type of heart failure that occurs when the heart muscle is too weak to contract), weakness, type 2 Diabetes Mellitus (a disorder characterized by difficulty in blood sugar control and poor wound healing), and gastrointestinal hemorrhage (bleeding that occurs in the digestive tract). The POC indicated that Patient 23 was to receive one Skilled Nurse (SN, a licensed nurse in general) visit per week for two weeks, effective 6/24/2026. The SN was to perform teachings regarding management of diabetes mellitus, hypertension, edema (swelling caused by fluid retention), congestive heart failure (a chronic condition in which the heart cannot pump blood effectively to meet the body’s needs, often leading to fluid buildup in the lungs, legs, and other tissues), and chronic kidney disease (a chronic condition where the kidneys gradually lose their ability to filter blood and maintain overall body balance) and perform assessment at each visit and notify the physician for changes in condition or significant findings. The DME (durable medical equipment, medically necessary items designed for long-term use at home) and supplies section of the POC indicated the following DME and supplies for Patient 23: Wheelchair, sterile gloves, tape, gauze pads, diabetic supplies, syringe, exam gloves, needles, walker, sharps container, and alcohol pads. During a concurrent observation and interview on 7/9/2026 at 11:50 a.m. with RN 1 with FM 1, while on a joint home visit with Registered Nurse 1 (RN 1) at Patient 23’s residence, FM 1 stated she was Patient 23’s primary caregiver and administered Patient 23’s medication. FM 1 stated that she checked Patient 23’s blood glucose twice a day, once in the morning before breakfast, and once after lunch. Patient 23 had a continuous glucose monitoring (CGM) device (a wearable medical technology that measures blood glucose levels in real time throughout the day and night); however, FM 1 stated that she also used the glucometer (a small, portable device used to measure the amount of glucose in a drop of blood) daily because she (FM 1) felt the CGM reading was not always accurate. The surveyor observed glucometer, a pack of test strips, and lancets at Patient 23’s residence. When FM 1 was asked where she disposed the used lancet after using the glucometer, FM 1 stated that she would dispose them in the trash can. FM 1 stated there was no sharps container at the residence. FM 1 stated the HHA did not provide them with a sharps container. During an interview with RN 1 during the joint home visit, RN 1 stated the HHA did not provide sharps container for any patient. RN 1 stated that it was the patient’s responsibility to obtain a sharps container. RN 1 stated that Patient 23 and FM 1 could be exposed to the used lancet disposed of in a regular trash can, which put them at risk for injury and infection caused by bloodborne pathogens. During a review of the agency’s policy and procedure (P & P), titled, “Contaminated Waste Disposal,” revised November 2021, the P & P indicated the following: Personnel will teach patients and family/caregivers proper contaminated waste disposal.Needles and razor blades should be placed in a puncture-proof container and labeled as contaminated waste when 3/4 full. Puncture-proof containers should be bagged, secured, and returned to the office for disposal.”

“Immediate reporting of abuse by all staff CFR(s): 484.50(e)(2) Any HHA staff (whether employed directly or under arrangements) in the normal course of providing services to patients, who identifies, notices, or recognizes incidences or circumstances of mistreatment, neglect, verbal, mental, sexual, and/or physical abuse, including injuries of unknown source, or misappropriation of patient property, must report these findings immediately to the HHA and other appropriate authorities in accordance with state law. This Element is not met as evidenced by: Based on interviews and record review, the home health agency (HHA, an organization that provides skilled nursing services and therapeutic services to patients in their residence) failed to ensure an appropriate discharge from home health services for one of 14 sampled patients (Patient 32). This failure had the potential to result in an interruption of Physician ordered skilled physical therapy (PT) services, decline in Patient 32’s functional status, increased risk for falls, delayed achievement of rehabilitation goals, and adverse outcomes (a negative, harmful, or unintended result that happens after a medical treatment, test, or action). Findings: A. During a review of Patient 32’s electronic medical record title,” Home Health Certification and Plan of Care” documentation indicated Patient 32 was admitted to the HHA with a start of care (SOC) date of 1/20/2026, with diagnoses of Parkinson disease (a progressive neurological sort of affecting movement, balance, and coordination), weakness, and difficulty walking. During continued review of Patient 32’s “Home Health Certification and Plan of Care” indicated physician orders for physical therapy services 1 visit per week for four weeks to evaluate Patient 32 and provide therapeutic exercises, gait training, transfer training, home safety instructions, fall prevention education, and establish of a home exercise program. Further review of Patient 32’s “Home Health Certification and Plan of Care” documentation indicated physician orders for physical therapy (PT) visit one (1) time per week, effective 1/20/2026. Documentation included establishing and teaching home exercise program with the caregiver, with a short-term goal date of 2/14/2026, and discharge from therapy when goals were met or the Patient reached maximum rehabilitation potential. During a review of Patient 32’s document titled, “Physical Therapy Evaluation,” dated 1/20/2023, the documentation indicated the physical therapist evaluated Patient 32 on 1/20/2026 and identified deficits in strength, balance, gait, and functional mobility. Further review of the same documentation indicated skilled physical therapy services were necessary to address the patient’s impairments and achieve the established treatment goals in accordance with the physician’s orders. During a telephone interview with patient 32’s Caregiver 5(CG 5), CG 5 stated the physical therapist evaluated Patient 32 on 1/20/2026, in their residence and informed Patient 32 and CG 5 that the physician order physical therapy visits would be provided and created a plan for 3 more visits. CG 5 stated, later that same day (1/20/2026), a staff from the HHA contacted CG 5 and informed them that Patient 32 was being discharged for home health services. CG5 stated Patient 32 never received the physician-ordered ongoing physical therapy visits following the initial evaluation. During review of Patient 32’s the document title “Start of Care Orders” dated 1/20/2026, the documentation indicated physical therapy services were ordered one visit per week for four weeks to establish and teach a home exercise program, provide therapeutic exercises, home safety instructions, fall prevention education, gait training and transfer training. The Soc order indicated to discharge Patient 32 when goals are met or reaches his highest potential. The above findings indicated the HHA failed to ensure Patient 32 was discharged based on assessment that the patients’ goals had been achieved, the patient condition no longer required skilled physical therapy services, and the physician directed plan of care had been completed. The HHA failed to ensure the clinical record contained documentation supporting discontinuation of physician ordered physical therapy services before discharging Patient 32 from home health services. During review a Patient 32’s Outcome and Assessment Information Set (Oasis) dated 1/20/2026, documented, “the patient remains homebound due to poor balance, weakness, and an increased risk for falls”. Documentation further indicated “the patients balance was very poor if he released his Walker, making ballast testing unsafe. Patient 32’s Oasis documented” the patient responded well to the clinical examination, demonstrated a continued need for physical therapy services, and the patient agreed with the proposed plan of care”. During a continued review of Patient 32’s the document titled, “Outcome and Assessment Information Set (OASIS), documentation indicated Patient 32 remained homebound due to weakness, impaired balance, and an increased risk for falls and continued to require skilled physical therapy intervention. During review of the document titled “Discharge Summary,” dated 1/23/2026, documentation indicated the Goal Summary and Outcome section were blank and contained no evidence Patient 32 had achieved the established physical therapy goals or no longer required skilled therapy services before discharge. During a review of the document titled, “Discharge Home Health Order,” documentation indicated Patient 32 was discharged from home health services effective 1/23/2026. Continued review of the document indicated Patient 32 and that Patient 32 had been redirected to Community Agency Division (CAD, a department with the general acute care hospital (GACH), responsible for coordinating referrals and monitoring patients receiving home health services). Patient 32’s HHA,” Discharge Home Health Order, contained no evidence supporting that Patient 32 had met the discharge criteria or that the physician ordered course of physical therapy had been completed before discharge. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 7/14/2026, 3:45 p.m., in the HHA, The DPCS stated Patient 32 should have received an additional physical therapy reassessment before discharge to determine whether Patient 32 had met the established therapy goals or continued to require skilled physical therapy services. The DPCS acknowledge the discharge should not have occurred without reassessment. During an interview with the administrator on 7/20/26 at 11:30 AM, the administrators stated CAD refers to the community agency division, and department with the general acute care hospital, responsible for coordinating referrals and monitoring patients receiving home health services. When asked whether CAD had a physician responsible for authorizing patient discharges from the home health agency, the administrator stated there was no physician assigned to CAD. The above findings indicated the HHA failed to ensure physician order physical therapy services were administered only in accordance with the order of a physician or allowed practitioner by discontinuing physician ordered therapy services and implementing Patient 32’s discharge without document and its physician authorization. These deficient practices have the potential to place patient 32 at risk for interruption of medically necessary rehabilitation services, functional decline, falls, delayed recovery and other adverse health outcomes”

“Therapy services determine eligibility CFR(s): 484.55(b)(3) When physical therapy, speech-language pathology, or occupational therapy is the only service ordered by the physician or allowed practitioner, a physical therapist, speech-language pathologist or occupational therapist may complete the comprehensive assessment, and for Medicare patients, determine eligibility for the Medicare home health benefit, including homebound status. For Medicare patients, the occupational therapist may complete the comprehensive assessment when occupational therapy is ordered with another qualifying rehabilitation therapy service (speech-language pathology or physical therapy) that establishes program eligibility. This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes rather than in a traditional healthcare facility setting) failed to ensure that an Occupational Therapy comprehensive assessment was completed within five (5) days of the referral date for one of 14 sampled patients (Patient 27). This failure had the potential to delay Patient 27’s identification of functional deficits, safety concerns, rehabilitation needs, and increased risk for falls or injury. Findings: During a review of Patient 27’s clinical record titled “Patient Information,” the record indicated that Patient 27 had a Start of Care (SOC) date of 4/22/2025, with a primary diagnosis of sialolithiasis (salivary stones that form in salivary glands causing swelling and/or pain) and antiphospholipid syndrome (disorder in which the body’s immune system mistakenly attacks healthy tissues and organs). During a review of Patient 27’s Home Health Certification and Plan of Care (POC) for the certification period of 4/22/2025 to 6/20/2025 indicated a frequency order for Physical Therapy visits for once a week for one week and twice a week for three weeks, and Skilled Nursing (SN) evaluation for wound care, and OT for evaluation. During a concurrent interview and record review on 7/21/2026 at 12:22 p.m. with the Director of Patient Care Services (DPCS), Patient 27’s General Acute Care Hospital (GACH2) order titled “Referral Home Health Care,” dated 6/6/2025 was reviewed. The order indicated an HHA request for a Registered Nurse (RN) referral for disease management and medication management, and OT for Activities of Daily Living (ADL) training. The DPCS stated and confirmed that Patient 27’s referral for home health Skilled nursing and Occupational Therapy indicated a start date of services from 6/6/2025. The DPCS stated when other home health services are added for patients, then the evaluation visit should be done within 5 days of the order date according to the agency policy. During a concurrent interview and record review on 7/21/2026 at 12:27 p.m. with the DPCS, Patient 27’s EMR for the certification period of 4/22/2025 to 6/20/2025 was reviewed. Patient 27’s EMR indicated an Occupational Therapy evaluation dated 6/18/2025. The DPCS stated and confirmed that the Occupational therapy home visit was done on 6/18/2025 and was conducted 12 days after the referral order date and was considered a late visit. The DPCS stated the occupational therapy evaluation was completed way past the agency’s policy and should have been done within 5 days of the referral date. The DPCS stated and confirmed that Patient 27’s EMR did not indicate a documented order for delay of care stating why the occupational therapy evaluation visit was conducted a late visit. The DPCS stated that referral orders are physician orders and if physician orders are not followed then the patient’s specific treatment plan of care is not being provided. During a review of the HHA’s Policy and Procedure (P&P) titled Admission Criteria and Process with a revised date of November 2021, the P&P indicated that all initial evaluations should be performed no later than 5 calendar days from the start of care date or date when additional discipline was ordered if not ordered in the home health referral. The P&P indicated that if the evaluation cannot be =done within 5 days then the physician must be notified. During a review of the HHA’s Policy and Procedure (P&P) titled Intake Process with a revised date of November 2021, the P&P indicated that all secondary discipline evaluation orders will be performed within 5 days from order date received. The P&P indicated that if the evaluation is not performed within 5 days, the physician will be notified and reason for delay of evaluation will be documented in the patient record.”

“Patient’s needs CFR(s): 484.55(c)(4) The patient’s medical, nursing, rehabilitative, social, and discharge planning needs; This Element is not met as evidenced by: Based on observation, interviews, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure complete and accurate comprehensive assessment of the needs of one of 14 sampled patients (Patient 33) by failing to identify the need for a glucometer (portable device used to measure the amount of sugar in the blood) for Patient 33. This failure had the potential to result in a decline in Patient 33’s health condition and delayed wound healing due to unmonitored blood sugar (BS, level of sugar in the blood) levels. Findings: During a review of Patient 33’s undated clinical record, titled “Patient Information,” the ‘Patient Information” indicated Patient 33’s start of care (SOC) date of 6/23/2026 with medical diagnoses including encounter for change or removal of nonsurgical wound dressing (wound that did not come from surgery and requires management by a medical professional) and stage 2 pressure sore (shallow open ulcer) of the sacral region (shield-shaped bone at the base of the spine). During a review of Patient 33’s “Patient Medication Record,” as of 7/9/2026, for the certification period from 6/23/2026 to 8/21/2026, the “Patient Medication Record” indicated the following active order with start date of 6/23/2026: Glucometer – check your BS regularly before meals or as directed. During a review of Patient 33’s “Home Health Certification and Plan of Care (POC),” for the certification period from 6/23/2026 to 8/21/2026, the POC indicated Patient 33 had a secondary diagnosis of type 2 diabetes mellitus (DMII, long-term health condition where the body resists insulin [hormone made by the pancreas to regulate BS] or does not make enough of it, leading to high BS). The POC indicated Patient 33 required supplies including diabetic supplies, needles, and sharps container. The POC indicated Orders and Treatments included Skilled Nurse (SN) to do the following: 1. Perform caregiver teaching on: -Management of DMII -Importance of self-monitoring BS as ordered or instructed by the physician -Need to notify Patient 33’s physician if the fasting BS (measure of BS, no after at least 8 hours without food) and/or random BS (measure of BS at any time of day, regardless of food intake) is greater than 250 milligrams per deciliter (mg/dL, unit of measurement of concentration of BS in a specific volume of blood) or less than 70 mg/dL. 2. Assess Patient 33/Patient 33’s caregivers’ compliance with the use of the glucometer and diabetic management. During a review of Patient 33’s “Patient Communication,” dated 7/4/2026 (eleven days after Patient 33 was admitted to the HHA), the “Patient Communication” indicated Customer Relations Officer (CRO, non-clinical support staff from overseas who was contracted by the HHA) 2 called Patient 33’s primary care physician office’s hotline staff to request an order from the PCP for a glucometer for Patient 33. During a concurrent observation and interview on 7/9/2026 at 10:48 a.m. with Registered Nurse (RN) 3, while on a joint home visit at Patient 33’s Board and Care Residential Facility (BCRF), in the presence of Patient 33’s caregivers (CG 3 and CG 4), Patient 33 was observed lying in bed, awake, alert, calm, nonverbal, and with no evidence of pain. RN 3 stated CG 3 and CG 4 have not been able to check Patient 33’s BS because Patient 33 did not have a glucometer at the BCRF. RN 3 stated she (RN 3) requested the glucometer about a week ago. During an interview on 7/9/2026 at 11:40 a.m., CG 3 stated when RN 3 admitted Patient 33 to the HHA “about 2 weeks ago,” RN 3 did not inform CG 3 and/or CG 4 regarding the need to check Patient 33’s BS and did not ask if Patient 33 had a glucometer in the BCRF. CG 3 stated he (CG 3) called RN 3 “about a week ago” to inform RN 3 regarding Patient 33’s family member inquiring about Patient 33’s BS but Patient 33 had no glucometer in the BCRF at the time. During a concurrent interview and record review on 7/13/2026 at 2:51 p.m., with the Director of Patient Care Services (DPCS), Patient 33’s Outcome and Assessment Information Set (OASIS-E2 Start of Care), dated 6/23/2026, RN – Skilled Nursing Visit notes, dated 6/25/2026, 6/29/2026, 7/1/2026, 7/6/2026, 7/8/2026, and 7/9/2026, Patient Medication Record, physician orders, and POC were reviewed. The DPCS stated there was no documented evidence that RN 3 assessed Patient 33’s need for a glucometer upon Patient 33’s admission to the HHA. The DPCS stated there was no documented evidence of a follow-up regarding the request for Patient 33’s glucometer submitted on 7/4/2026. The DPCS stated part of Patient 33’s comprehensive assessment must include assessing the devices needed by the patient and putting in the request for the physician’s order for a glucometer. The DPCS stated if there are issues with ordering the glucometer, the HHA must discuss with the family, Patient 33’s financial situation and the costs of obtaining a glucometer and offer medical social worker (MSW) assistance, if needed. The DPCS stated Patient 33’s BS must be checked and recorded regularly to determine if the current treatment plan is adequate for Patient 33’s goals. The DPCS stated if Patient 33’s BS is not well-controlled and is not monitored as ordered by the physician, it can lead to Patient 33’s decline in health condition, including delayed wound healing. During a review the HHA’s policy and procedures (P&P), titled “Initial and Comprehensive Assessment,” dated 11/2021, the P&P indicated the following: A comprehensive patient assessment must be completed within five calendar days of the patient’s start of care.All baseline data to be used in measuring the patient’s progress towards goals and other relevant information will be documented in the patient’s clinical record, including at least the following information, if applicable:-a physical assessment, including blood pressure, temperature, pulse, respiration, skin, pain status, height/weight, nutritional status, and other relevant data related to pertinent findings -equipment presently in the home and potentially needed by the patient -specific, individualized patient needs and problems pertinent to the care being provided. 3. The comprehensive assessment should determine any information that may be used to demonstrate the patient’s progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the organization.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to: 1. Obtain a physician order prior to providing occupational therapy services for lymphatic mobilization (a gentle, rhythmic stretching of the skin that encourages the natural flow of lymph fluid, helping to reduce swelling, relieve inflammation, and support immune function) for one of 14 sampled patients (Patient 27). Occupational Therapist 1 (OT1) performed treatments without a physician’s order on 6/18/2025 during a home visit, including: a. OT1 inspected a lump in Patient 27’s left armpit. OT1 then performed a lymphatic massage using a “digging” technique and a tool she (OT1) described as being used to move lymph fluid out of the body. b. OT1 performed lymphatic massage on Patient 27’s bicep (large, two-headed muscle located on the front of the upper arm between the shoulder and the elbow), on the left chest close to Patient 27’s Peripherally Inserted Central Catheter line (PICC line, a long thin flexible tube inserted into a vein in the upper arm and threaded to a large vein near the heart), and behind Patient 27 left knee. 2. Obtain a physician order to continue skilled nursing services for Patient 28; the HHA provided ongoing skilled nursing care without a current physician‑approved plan of care for the certification period. 3. Obtain a physician order to discontinue physical therapy services for Patient 32; the HHA discontinued physician‑ordered physical therapy without documented physician authorization. These failures resulted in Patient 27 being admitted to a General Acute Care Hospital (GACH2) on 7/2/2025 for complaints of intense pain of the left armpit. Patient 27 required hospitalization from 7/2/2025 to 7/11/2025 for a left septic shoulder (a serious bacterial or fungal infection of the left shoulder joint or surrounding fluid-filled sacs), secondary to an infected PICC line. Patient 28 and Patient 32 had the potential to compromise physician‑directed care, interrupt medically necessary treatment, and place Patient 28 and Patient 32 at risk for adverse health outcomes due to the provision or discontinuation of services without appropriate physician oversight. On 7/20/2026 at 4:28 p.m., while onsite at the agency, the Department called an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause serious injury, harm, impairment, or death to a patient) in the presence of the HHA’s Administrator (ADM) and Director of Patient Care Services (DPCS), related to the HHA’s failure to obtain a physician order prior to providing occupational services for lymphatic mobilization for one of 14 sampled patients (Patient 27). On 7/21/2026, the HHA was unable to submit an IJ Removal Plan (IJRP, a plan that identifies all actions the facility will take to immediately address the noncompliance that has resulted in the IJ situation). On 7/21/2026 at 3 p.m., the Department completed the survey tasks and conducted an exit conference while onsite with the HHA’s ADM and DPCS with the IJ situation not removed. B. During a review of Patient 28’s electronic medical record titled” Home Health Certification and Plan of Care” on 7/14/2026 at ???, documentation indicated Patient 28 was admitted to the home health agency with diagnoses including an encounter for change or removal or nonsurgical wound dressing (Ongoing skilled nursing services to assess, treat, and manage wound care), unspecified open wound of the left lower leg, subsequent encounter(continued treatment and monitoring of a healing open wound to prevent complications and promote healing ),hypertensive heart and chronic kidney disease with heart failure in stage 1 to 4 chronic kidney disease heart disease (late stage chronic kidney disease caused by long standing hypertension, requiring ongoing monitoring and management), and type 2 diabetes mellitus with diabetic chronic kidney disease ( diabetes complicated by chronic kidney disease requiring skilled monitoring to reduce the risk of delayed wound healing, infection, and further decline in kidney functions). During a continued review of patient 28 electronic medical record documentation indicated the only Home Health Certification and Plan of Care available covered the certification period of 3/24/2026 to 5/23/2026. Patient 28 “Home Health Certification and Plan of Care” contained no evidence a current home health certification and plan of care had been completed for the current certification. During review a Patient 28’s”Episode Manager” documentation indicated the Recertification Assessment, Home Health certification and Plan of Care, and medication profile for the current certification were each identified as “Not Started.” During a review of the document titled Physicians Notice of Extension of Services, dated 7/82026, indicated physician order for 10 Registered nurse (RN) visits and 25 Licensed Vocational Nurse (LVN) visits, but skilled nursing visits ordered three times per week. During review of Patient 28’s “Missed Visit” form , dated 7/6/2026, documentation stated no need for visit in parentheses documentation contained no evidence that miss visit was rescheduled, another qualified nurse completed the physician ordered visit, or the physician was notified that the ordered visits was not provided. During the concurrent home visit conducted on 7/16/26 at 10 a.m., with RN 3, at Patient 28’s residence. Observation indicated multiple areas of scaling, dry flaky skin, scattered blisters, and wounds involving the toe, plantar surface, ankles, and bilateral lower extremities from the needs down. During an interview with RN 3 conducted at Patient 28’s residence on 7/16/2026 at 11:15 a.m., RN 3 stated Patient 28 had chronic blisters affecting both lower extremities that develop frequently and varied in size, appearance, and severity. RN 3 stated the blisters could develop daily and extended from Patients 28’s knees to the toes on both lower extremities. RN 3 stated each skilled nurse visit required a comprehensive assessment because the treatment depended on the condition of the wounds at the time of the visit. Rn 3 stated the blisters frequently ruptured, causing wounds, new blisters develop between visits, and different wound care treatments were often required based on the nursing assessment. Rn 3 stated Patient 28 required skilled nursing visits at least three times a week to monitor the wounds, assess for changes, and provide the appropriate wound treatment. During an interview with family caregiver 1 (FCG1)on 7/16/2026 at 11:25 a.m., FCG 1 stated the home health agency frequently cancels Patient 28’s nursing visits, his medications were documented in Patient 28’s HHA record book, by FCG 1 and not the skilled nurses providing care, the HHA scheduled Patient 28’s skilled nurse visit on days when the skilled nurses scheduled day off , and physician ordered visits were missed. During the concurrent record review and interview with the Director of Patient Care Services( DPCS) on 7/14/ 2026 at 3:30 p.m.,, while reviewing Patient 28’s forms, titled, Episode Manger, , Recertification Assessment, and Medical Profile, The DPCS stated those documents should have been completed before continuing services and acknowledged the home health agency continue providing skilled nursing services to Patient 28 without a current physician approved orders for the current certification. The above findings indicated the home health agency failed to ensure skilled nursing services were administered only in accordance with the order of a physician or allowed practitioner by continuing physician order services without current physician authorization, placing Patient 28 at risk for delayed wound assessment, inappropriate treatment, infection, worsening skin integrity, hospitalization, and other adverse health outcomes. B. During a review of Patient 32’s electronic medical record, titled “Home Health Certification and Plan of Care” indicated Patient 32 was admitted to the home health agency (HHA)with a start of care date of 1/20/2026, for the certification period of 1/20/2026 to 3/20/2025, with diagnoses of Parkinsons disease (A progressive neurological disorder that affects movement, balance, coordination, and muscle control, weakness(decrease muscle strength that impairs mobility, transfers, and the ability to safely perform activities of daily living, and difficulty walking(an impairment and ambulation that increases the risk for falls and requires skilled therapeutic interventions to improve mobility and safety). During a telephone interview with patient 32’s caregiver 5, she stated that on 1/20/2026 the home health agencies physical therapist came out to their residence to evaluate Patient 32 for physical therapy services and created a plan for 3 more visits. However, Patient 32 and CG 5 received a call from staff at the HHA the evening of 1/20/2026, discharging Patient 28 from services and they never received the physician ordered service and no explanation or reason regarding the PT services were not being continued. During a review of Patient 32’s “Home Health Certification and Plan of Care” documentation indicated physician orders for physical therapy(PT) visit one (1) time per week , effective 1/20/2026. Documentation included establishing and teaching home exercise program with the caregiver , with a short-term goal date of 2/14/2026, and discharge from therapy when goals were met or the Patient reached maximum rehabilitation potential. During review of the document title “Start of Care Orders” dated 1/202026, the documentation indicated physical therapy services were ordered one visit per week for four weeks to establish and teach a home exercise program, provide therapeutic exercises, home safety instructions, fall prevention education, gait training and transfer training. During review a patient 32’s Outcome and Assessment Information Set( Oasis) dated 1/220026, documented, “the patient remains homebound due to poor balance, weakness, and an increased risk for falls”. Documentation further indicated “the patients balance was very poor if he released his Walker, making ballast testing unsafe. Patient 32’s Oasis documented” the patient responded well to the clinical examination, demonstrated a continued need for physical therapy services, and the patient agreed with the proposed plan of care”. During review of the document titled “Discharge Summary” dated 1/20/2026, indicated the goal summary and outcome sections were blank, and contained no evidence the physician ordered physical therapy goals have been achieved or that Patient 32 had reached maximum rehabilitation potential before discharge. Continued review of the document indicated Patient 32 was discharged from the home health agency effective 1/23/2026 and that “Patient has been redirected to CAD., hence discharged from home health services”. Patient 32’s Discharge order form contained no evidence that discharge was authorized by a physician. During a concurrent record review and interview with the director of patient care services GPCS on 7/14/2026, while reviewing patient 33 electronical medical record, the DPCS stated patient 32 should have received a reevaluation by another physical therapist before discharge because there may have been a conflict between the treating physical therapist and family. The DBCS dated another physician physical therapist should have completed the reassessment to ensure Patient 32 discharge was safe and acknowledge that patient 32 was not discharged safely. During an interview with the administrator on 7/20/26 at 11:30 AM, the administrators stated CAD refers to the community agency division, and department with the general acute care hospital, responsible for coordinating referrals and monitoring patients receiving home health services. When asked whether CAD had a physician responsible for authorizing patient discharges from the home health agency, the administrator stated there was no physician assigned to CAD. The above findings indicated the HHA failed to ensure physician order physical therapy services were administered only in accordance with the order of a physician or allowed practitioner by discontinuing physician ordered therapy services and implementing Patient 32’s discharge without document and its physician authorization. These deficient practices have the potential to place patient 32 at risk for interruption of medically necessary rehabilitation services, functional decline, falls, delayed recovery and other adverse health outcomes. Findings: During a review of Patient 27’s clinical record titled “Patient Information,” the record indicated that Patient 27 had a Start of Care (SOC) date of 4/22/2025, with a primary diagnosis of sialolithiasis (salivary stones that form in salivary glands causing swelling and/or pain) and antiphospholipid syndrome (an autoimmune disorder in which the immune system produces antibodies that attack normal blood proteins, causing the blood to clot easily). During a review of Patient 27’s SOC order dated 4/22/2025, the order indicated that Occupational Therapy (OT) was authorized for an evaluation (a comprehensive assessment by a licensed therapist to determine how an injury, illness, or disability affects the ability to perform everyday tasks). During a review of Patient 27’s GACH2 order titled “Referral Home Health Care,” dated 6/6/2025, the order indicated an HHA request for OT for Activities of Daily Living (ADL) training. During a review of Patient 27’s clinical record from GACH2 titled “Internal Medicine Discharge Summary,” dated 7/11/2025, the record indicated Patient 27 was admitted to GACH2 on 7/2/2025 for left septic shoulder related to an infected PICC line, status post removal, and was discharged on 7/11/2025. The record indicated admission treatment included status post orthopedic incision and drainage (where a surgeon opens and cleans an infected area or fluid collection near a cone, joint, or soft tissue) performed twice, PICC line removal, and intravenous (IV-into a vein) antibiotics (medication to treat infection) for a total duration of four weeks. During an interview on 7/16/2026 at 2:09 p.m. with Patient 27, Patient 27 stated she (Patient 27) received a visit from OT1 on 6/18/2025. Patient 27 stated that OT1 introduced herself (OT1) as a physician and performed a full body assessment. Patient 27 stated that OT1 asked her (Patient 27) about a lump in her (Patient 27) left armpit. Patient 27 stated that OT1 insisted she (OT1) could help her (Patient 27) with the lump and “take care of it,” Patient 27 stated that OT1 then lifted Patient 27’s left arm and performed lymphatic massage on the lump. Patient 27 stated OT1 performed the massage with a digging technique and used a tool she (OT1) described as being used to move “lymph fluid” out of Patient 27’s body. Patient 27 stated she (Patient 27) asked OT1 to stop on three separate occasions. For the first instance, Patient 27 stated OT1’s digging technique caused pain deep in her (Patient 27) armpit, and OT1 informed her (Patient 27) it would not improve unless she (Patient 27) allowed the treatment. Patient 27 stated she (Patient 27) asked OT1 to stop again when OT1 continued lymphatic massage to her (Patient 27) bicep and left chest near her PICC line. Patient 27 stated she (Patient 27) stopped OT1 a third time when OT1 performed lymphatic massage behind her (Patient 27) left knee, where she had recently undergone surgery. Patient 27 stated she (Patient 27) never provided consent (permission) for any lymphatic massage. During an interview on 7/16/2026 at 2:30 p.m. with Patient 27, Patient 27 stated after OT1’s home visit she (Patient 27) began experiencing pain in her left shoulder, loss of sensation from the waistline down, and urinary incontinence. Patient 27 stated she (Patient 27) went to the emergency department twice between 6/19/2025 and 7/2/2025 following OT1’s home visit. Patient 27 stated she (Patient 27) was eventually admitted for emergency surgery from 7/2/2025 to 7/11/2025 for a left septic shoulder secondary to an infected PICC line. During an interview on 7/17/2026 at 12 p.m. with OT1, OT1 stated she (OT1) would not provide any statements regarding Patient 27. During a concurrent interview and record review on 7/17/2026 at 3:50 p.m. with the Director of Patient Care Services (DPCS), reviewed the HHA’s clinical record titled “Home Health Incident Investigation Report,” dated 7/1/2025. The report completed by the HHA Rehab Clinical Manager, indicated that Patient 27 submitted the complaint on 6/29/2025 about OT1’s 6/18/2025 home visit. The DPCS stated that documentation indicated that OT1 justified performing light lymphatic mobilization by stating the purpose was to “enhance movement and stamina,” claiming it was within her (OT1) scope of practice, and stating it had been used successfully on other HHA patients. The DPCS stated OT1’s justification was not accurate and clarified that treatments such as lymphatic mobilization would require a physician’s order. During a concurrent interview and record review on 7/17/2025 at 4 p.m. with the DPCS, reviewed Patient 27’s GACH2 order titled “Referral Home Health Care,” dated 6/6/2025. The referral indicated RN services for disease and medication management, and OT for ADL training. The DPCS stated the order did not specify for lymphatic massage or mobilization. The DPCS stated that for an Occupational Therapist to perform lymphatic massage or mobilization, there must be a physician’s order specifying the treatment. The DPCS stated it was important for the therapist to provide only those treatments ordered by the physician to adhere to the patient’s treatment plan, support recovery, and prevent injury or harm. During a review of the HHA’s policy titled “Verification of Physician Orders,” undated, the policy indicated: 1. Orders must be obtained from a licensed physician for care and services provided to home health patients.”

“Communication with all physicians CFR(s): 484.60(d)(1) Standard: Coordination of Care. The HHA must: (1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, agency providing skilled nursing and other therapeutic services to a patient’s personal residence) failed to ensure communication with all physicians for three of fourteen sampled patients (Patient 25, Patient 26, and Patient 28) as follows: 1.The physician did not sign the plan of care (POC, a detailed, written document outlining the services and support an individual needs to meet their healthcare goals) for Patient 26, and Patient 28. 2. The change of Skilled Nurse (SN, a licensed nurse) visit frequency by the agency was not communicated with the physician for Patient 25 and Patient 28. These failures had placed Patient 25, Patient 26 and Patient 28 at increased risk for adverse outcomes such as worsening clinical conditions, unmet medical needs, delayed wound assessment, inappropriate treatment frequency, unsafe monitoring, and avoidable complications. During a review of Patient 28 electronic medical record on 7/14/2026 at 2:18 p.m., the document titled” Home Health Certification and Plan of Care” indicated that Patient 28 was admitted to the home health agency (HHA an organization either public or private that offers skilled medical care and therapies to patients in their homes these agencies help those recovering from surgery or managing chronic conditions providing professional medical oversight) with physician ordered skilled nursing services for wound care and assessment three times a week. During a review of Patient 28’s document titled “Patient Communication” dated 5/8/2026, on 7/14/2026, at 2:34 p.m., the document stated” Please notify the MD patient has new blisters forming on foot and leg.” The communication further indicated that the information was to be relayed to the podiatrist. The document was completed by the Customer Relations Officer (CRO- the HHA’s offshore Support Team Representative. The clinical record lacked evidence that the physician was notified of Patient 28’s worsening condition, lacked documentation of physicians’ recommendation, and lacked evidence that Patient 28’s plan of care was revised following the identified change in condition. During a concurrent home visit conducted with Patient 28 on 7/6/2026 at 10:00 a.m., observations indicated multiple areas of dry scaling skin with scattered blisters and wounds involving the toes plantar surface of both feet ankles and bilateral lower extremities. During an interview with RN 3 conducted at Patient 28’s residence on 7/16/2026 at 11:15 a.m., RN 3 stated Patient 28 had chronic blisters affecting both lower extremities that develop frequently and varied in size, appearance, and severity. RN 3 stated the blisters could develop daily and extended from Patients 28’s knees to the toes on both lower extremities. RN 3 stated each skilled nurse visit required a comprehensive assessment because the treatment depended on the condition of the wounds at the time of the visit. Rn 3 stated the blisters frequently ruptured, causing wounds, new blisters develop between visits, and different wound care treatments were often required based on the nursing assessment. Rn 3 stated Patient 28 required skilled nursing visits at least three times a week to monitor the wounds, assess for changes, and provide the appropriate wound treatment. During an interview with Patient 28’s caregiver on 7/16/2026 at around 11:25 a.m., the caregiver stated the agency had ongoing problems with visiting patient 28 as ordered, medications were not consistently documented in the home record, and there were concerns regarding the continuity of nursing services. During an interview with the director of patient care services(DPCS) on 7/14/26 at 3:33 PM, the DPCS stated significant changes in Patient 28’s condition should be communicated to the physician promptly, physician orders should be obtained when warranted, and the clinical records should reflect the physician’s notification and any resulting orders or revision to Patient 28’s plan of care. The HHA failed to ensure timely physician notification, failed to obtain and document physician direction following a significant change in Patient 28’s condition, and failed to document implementation of physician directed interventions. 1a. During a review of Patient 26’s Home Health Certification and Plan of Care (POC) for the certification period of 5/7/2026 to 7/5/2026, the POC indicated Patient 26’s start of care (SOC) date was 5/7/2026, with diagnoses that included COPD with exacerbation (a flare-up or episode when your breathing is worse than usual), and chronic (long term) respiratory failure (condition that happens when your lungs cannot get enough oxygen into your blood), with hypoxia (the body’s tissues don’t get enough oxygen). The POC indicated Patient 26 was to receive one Skilled Nurse (SN) visit per week for two weeks, effective 5/7/2026, for management of chronic hypoxemic respiratory failure, COPD, gastroesophageal reflux disease (GERD, stomach acid flows back up into the esophagus and causes heartburn), and oxygen. The SN was also to report changes in condition to the physician. The POC was not signed by the physician. During a concurrent interview and record review with the Director of Patient Care Services (DPCS) on 7/15/2026 at 3:31 p.m., the DPCS reviewed Patient 26’s POC for the certification period of 5/7/2026 to 7/5/2026. The DPCS confirmed there was no physician signature on Patient 26’s POC for the certification period of 5/7/2026 to 7/5/2026. The DPCS stated the physician had 30 days from 5/7/2026 to sign the POC. The DPCS stated the physician needed to sign the POC because the physician was the one overseeing the care of the patient. The DPCS stated that signing the POC indicated the physician was in agreement with the patient’s POC. The DPCS stated, “The POC is based on the physician’s orders.” The DPCS stated that if the physician did not sign the POC, the HHA would not know if the physician agreed with the interventions, goals, or frequency planned for the patient. During a review of the agency’s policy and procedure (P & P), titled, Care Planning Process,” revised November 2021, the P & P indicated the plan of care would be based upon the physician’s (or other authorized licensed independent practitioner’s) orders and will encompass the equipment, supplies, and services required to meet the patient’s needs. 2a. During a review of Patient 25’s Home Health Certification and Plan of Care (POC) for the certification period of 6/25/2026 to 8/23/2026, the POC indicated the HHA admitted Patient 25 on 6/25/2026 with diagnoses that included idiopathic (unknown cause) normal pressure hydrocephalus (a neurological condition in older adults characterized by abnormal gait and cognitive impairment) and chronic kidney disease (a condition where the kidneys are damaged and gradually lose their ability to filter blood and remove waste). The POC indicated that Patient 25 was to receive SN visit once a week for one week, then twice a week for one week, and then once a week for one week, starting 6/25/2026. During a review of RN – Skilled Nursing Visit, dated 7/13/2026, for Patient 25, the RN – Skilled Nursing Visit indicated that on 7/13/2026 Patient 25 had developed stage 2 pressure ulcers (open wounds caused by prolonged, unrelieved pressure) on the left buttock and sacrum. The RN – Skilled Nursing Visit indicated RN 4 performed the following wound treatment: Cleansed with normal saline (NS, a sterile solution used to clean wounds), patted dry, and covered with Mepilex foam dressing (a type of dressing). The RN- Skilled Nursing Visit did not indicate if the physician was notified about the new stage 2 pressure ulcers. The RN – Skilled Nursing Visit did not indicate who ordered the wound treatment that RN 4 did for the pressure ulcers. During a review of Patient Communication, dated 7/13/2026, for Patient 25, the Patient Communication indicated that Customer Relation Officer 1 (CRO 1) relayed a message to the physician’s office that Patient 25’s stage 1 pressure sore (earliest stage of pressure ulcer where the skin remains intact, but might show persistent redness) on the sacrum had now opened and became stage 2. CRO 1 documented as follows: Wound treatment recommendation: Please with NS, pat dry, apply zinc oxide barrier cream (a topical treatment that creates a protective layer on the skin) to surrounding skin, cover with Mepilex foam dressing. CRO 1 did not indicate who recommended the wound treatment. During a review of Patient 25’s clinical records from Medical Office 1 (MO 1), dated 7/13/2026, the records indicated that Patient 25’s nurse reported about the stage 2 pressure ulcer. The clinical records from MO 1 had an “Order Questions” section that indicated the wound care for an open wound on the sacrum as follows: “Cleanse with normal saline, protect surrounding skin with zinc oxide barrier cream, cover with Mepilex foam dressing, three times a week for 2 weeks, then re-evaluate.” During a review of the HHA’s untitled document for Patient 25, dated 7/19/2026, the document indicated that SN visit frequency for Patient 25 was extended to two visits per week for two weeks, effective from the week of 7/19/2026 to continue plan of care and achieve goals. The document was signed by RN 4. During a concurrent interview and record review with the Director of Patient Care Services (DPCS) on 7/21/2026 at 12:01 p.m., the DPCS reviewed Patient 25’s POC for the certification period of 6/25/2026 to 8/23/2026, RN – Skilled Nursing Visit, dated 7/13/2026, Patient Communication, dated 7/13/2026, clinical records from MO 1, dated 7/13/2026, and the HHA’s untitled document, dated 7/19/2026. The DPCS stated Patient 25’s physician from MO 1 ordered the wound treatment for the stage 2 pressure ulcer on the sacrum as follows: “Cleanse with normal saline, protect surrounding skin with zinc oxide barrier cream, cover with Mepilex foam dressing, three times a week for 2 weeks, then re-evaluate.” The DPCS stated the HHA’s untitled document, dated 7/19/2026, was a physician order for Patient 25. The DPCS stated the physician order was to extend the SN services and increased the frequency to 2 (two) times a week to perform the wound care for Patient 25. The DPCS stated that the recommendation from the physician, based on the clinical records from MO 1 on 7/13/2026, was to do the wound care three times a week. The DPCS stated there was documentation if the RN communicated with physician from MO 1 regarding changing the wound care from 3 times a week to 2 times a week. The DPCS stated that she (DPCS) did not know the reason for SN the frequency decrease. The DPCS stated that it was very important to make the physician aware the HHA was providing less visits for the wound care than what the physician recommended. On 7/21/2026, at 12:35 p.m., RN 4 did not respond to the surveyor’s request for an interview. During a review of the HHA’s P & P, titled, “Physician Participation in Plan of Care,” revised November 2021, the P & P indicated that a physician (or other authorized licensed independent practitioner) would direct the care of every home health care patient admitted for service. The attending physician (or other authorized licensed independent practitioner) would sign the plan of care/treatment within 30 days of the start of care. During a review of the HHA’s policy and procedure (P & P), titled, “Monitoring Patient’s Response/Reporting to Physician,” revised November 2021, the P & P indicated that clinicians would establish and maintain ongoing communication with the physician (or other authorized licensed independent practitioner) to ensure safe and appropriate care for the patient. All conferences or attempts to communicate with physician (or other authorized licensed independent practitioner) would be documented in the clinical record.”

“Integrate all orders CFR(s): 484.60(d)(2) Integrate orders from all physicians or allowed practitioners involved in the plan of care to assure the coordination of all services and interventions provided to the patient. This Element is not met as evidenced by: Based on observation, interviews, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure the HHA team communicated with the physician and/or followed up with the physician timely regarding the medications of one of 14 sampled patients (Patient 35) upon Patient 35’s admission to the HHA by failing to: 1. Verify the indications for the physician-ordered guaifenesin (medication to relieve chest congestion by thinning mucus in the airways to make coughs more productive), 2. Follow up with the physician regarding Patient 35’s noncompliance with the aspirin (medication to prevent blood clots) order reported on 6/30/2026, and 3. Clarify the safe administration route for Patient 35’s medications. This failure had the potential to result in Patient 35’s decline in health related to increased aspiration risks (possibility that food, liquid, saliva, or stomach contents will enter the airway or lungs instead of the food pipe) and medication ineffectiveness due to noncompliance with the treatment plan. Findings: During a review of General Acute Care Hospital (GACH) 1’s referral notes for Patient 35, section titled “Internal Medicine History and Physical,” dated 6/24/2026, the referral notes indicated patient 35 had cancer of the colon (large intestine) and underwent major surgical procedure to remove the right part of the colon. The referral notes indicated Patient 35 had a recent diagnosis of palatine squamous cell carcinoma (type of cancer that starts in the lining of the palatine tonsil [oval-shaped mass of lymphoid tissue at the back of the throat]) and on chemotherapy and radiation. The referral notes indicated Patient 35 had a new gastrostomy tube (GT, medical device placed through the skin of the abdomen directly into the stomach to deliver food, liquids, and medications when eating by mouth are not safe or possible due to swallowing disorders or specific cancers) placed. During a review of GACH 1’s “Referral Home Health Care Order,” dated 6/27/2026, the “Referral Home Health Care Order” indicated HHA RN must reinforce gastrostomy care and feedings. During a review of Patient 35’s undated clinical record, titled “Patient Information,” the ‘Patient Information” indicated Patient 35’s start of care (SOC) date of 6/30/2026 with diagnoses including encounter for attention to gastrostomy (requiring routine care, maintenance, and management of an existing GT) and dysphagia (difficulty swallowing). During a review of Patient 35’s “Outcome and Assessment Information Set (OASIS-E2 Start of Care),” dated 6/30/2026, the “OASIS-E2 Start of Care” indicated the following: Patient 35 had “palatine squamous cell carcinoma and recently underwent G-tube placement due to inability to eat and drink.”On Patient 35’s feeding or eating: Current ability to feed self-meals and snacks safely (refers only to the process of eating, chewing, and swallowing, no preparing the food to be eaten), Patient 35 was “unable to take in nutrients orally and is fed nutrients through a nasogastric tube or gastrostomy.”On Drug Regimen Review (evaluation of the patient’s medications to identify and resolve potential side effects, interactions, duplicate therapies, or ineffective treatments), RN 3 documented there were no issues found during a complete drug regimen review to identify potential clinically significant medication issues. Medication review and reconciliation was done with “no discrepancies with medications.” During a review of Patient 35’s “Home Health Certification and Plan of Care (POC),” for certification date from 6/29/2026 to 8/27/2026, the POC indicated the following: SN frequency order of once a week for 2 weeks, effective 6/30/2026.Medication orders included the following:a. Cholecalciferol (vitamin D supplement) 25 microgram (mcg, unit of measurement of weight) – take 1 capsule by mouth daily as supplement b. Aspirin (medication to prevent blood clots) 81 milligram (mg, unit of measurement of weight) enteric-coated tablet, delayed release – take 1 tablet by mouth daily c. Olanzapine (antipsychotic medication to help calm acute agitation [medical or psychiatric emergency characterized by extreme arousal, inner tension, and excessive motor activity]) 5 mg – take 1 tablet by mouth daily at bedtime on days 2 through 4 of each chemotherapy cycle for agitation -Prochlorperazine maleate (medication to treat severe nausea [uneasy feeling in the stomach that creates an urge to throw up] and vomiting) 10 mg – take 1 tablet by mouth as needed for nausea -Hydrocodone-acetaminophen (Norco, combination opioid medication to treat moderate to severe pain) 10-325 mg – take 1 tablet by mouth every 4 hours as needed for moderate to severe pain (4-10 out of 10 on the pain scale) -Guaifenesin (medication to relieve chest congestion by thinning mucus in the airways to make coughs more productive) oral 100 mg/5 milliliters (ml, unit of measurement of volume) – take 10 ml via GT every six (6) hours as needed for congestion, cough, cold, and allergy. -Lidocaine Viscous hydrochloride (prescription liquid medicine used to numb painful sores and/or inflammation inside the mouth and throat) Mouth/Throat 2% – Mix 10 ml of Viscous Lidocaine with 10 ml of Mylanta (liquid antacid to treat heartburn) over the counter, swish and swallow four times a day as needed for mouth or throat pain. 3. SN interventions included: -SN to perform teachings regarding management of disease. -SN to teach rehospitalization prevention, medication management, pain management, and safety prevention measures. -SN to instruct on aspiration prevention measures. -SN to educate patient/caregiver regarding current medications, such as medication name, dose, frequency, and purpose of medications. During a review of Patient 35’s “Patient Communication,” dated 6/30/2026, the “Patient Communication” indicated Patient 35 was “not taking aspirin, no indication why; he just does not want to.” During a concurrent observation and interview on 7/9/2026 at 9:08 a.m., while on a joint home visit at Patient 35’s room in his home, with Registered Nurse (RN) 3, Patient 35 was observed awake, alert, oriented, lying in bed with GT feeding infusing at 50 milliliter per hour. Patient 35 stated he currently takes the aspirin and cholecalciferol by mouth, while olanzapine and prochlorperazine via GT per recommendation of Patient 35’s specialist. RN 3 verified Patient 35 did not have the medication bottles or pack for Norco and guaifenesin as ordered by the physician. During an interview on 7/9/2026 at 10 a.m., Patient 35 stated he did not pick up the prescription for guaifenesin and RN 3 did not explain why it was ordered by the physician, but Patient 35 stated he requested from his primary care physician a medication to loosen his mucus/secretions. Patient 35 stated he did not need Norco for pain, because the Lidocaine Viscous hydrochloride for mouth or throat pain was effective in decreasing throat pain from 6 out of 10 to 2 out of 10 on a pain scale. During a concurrent interview and record review of Patient 35’s electronic medical records (EMRs) on 7/13/2026 at 2:51 p.m., with the Director of Patient Care Services (DPCS), Patient 35’s referral, orders, nursing notes, and POC were reviewed. The DPCS stated RN 3 must review and update the medication list upon every home visit, starting from the SOC, and communicate with Patient 35’s physician any discrepancies between the physician’s order and what Patient 35 was taking. The DPCS stated there was no documented evidence the HHA team communicated with Patient 35’s primary care physician upon Patient 35’s admission to the HHA and/or followed up with the physician timely to clarify the indication/s for guaifenesin, report Patient 35’s noncompliance with the aspirin, and verify the safe route for the administration of Patient 35’s medications. The DPCS stated this had the potential to cause a decline in Patient 35’s health due to RN 3 not assessing the effectiveness of the medication ordered by the physician. The DPCS stated that due to Patient 35’s diagnoses and condition, it was important to individualize Patient 35’s care and ensure medication safety to prevent complications, such as aspiration. During a review of the HHA’s policy and procedures (P&P),” Monitoring Patient’s Response/Reporting to Physician,” dated 11/2021, the P&P indicated the following: Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient.During each home visit, the clinician will monitor the patient’s response to care against the established goals including, but not limited to, care interventions and treatments, medications, and teaching.The patient’s physician will be contacted when any of the following occur:-changes in the patient’s expected response to treatment or medications -when there is any problem implementing the plan of care 4. Based on communication with the physician, a verbal order will be obtained for any change in the plan of care and communicated to all appropriate team members to ensure that care is provided according to the revised plan of care.”

“Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This Element is not met as evidenced by: Based on interviews and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to coordinate care to ensure physical therapy (PT, treatment to preserve, enhance, restore movement and physical function impaired by disease, injury, or disability) was provided as ordered by the physician for one of 14 sampled patients (Patient 34). This failure had the potential to result in Patient 34’s functional decline, decreased ROM, decreased activity tolerance (lack of energy to complete daily tasks), development of contractures (permanent tightening of muscles/tendons/skin/nearby tissues that cause joints to stiffen/shorten and lose normal movement), increased pain, impaired balance, and higher risk for falls due to the delayed/missed treatments. Findings: During a review of Patient 34’s undated clinical record, titled “Patient Information,” the ‘Patient Information” indicated Patient 34’s start of care (SOC) date of 5/26/2026 with medical diagnoses including bilateral primary osteoarthritis of knee (protective cartilage wears away in both knees, causing pain, stiffness, and reduced mobility) and type 2 diabetes mellitus (long-term health condition where the body resists insulin [hormone made by the pancreas to regulate blood sugar (BS)] or does not make enough of it, leading to high BS) with diabetic polyneuropathy (nerve damage caused by long-term high BS). During a review of Patient 34’s physician’s order, titled “Post Hospital Order,” dated 6/9/2026, for the certification period from 5/26/2026 to 7/24/2026, the “Post Hospital Order” indicated Patient 34’s resumption of care date of 6/9/2026 with the Skilled Nurse (SN) frequency order of once a week for 2 weeks, effective 6/9/2026, and an order for PT evaluation. The “Post Hospital Order” indicated Patient 34’s responsible party (RP 34) made medical decisions for Patient 34. During a review of Patient 34’s PT Initial Evaluation (PT Eval), dated 6/15/2026, the PT Eval indicated Patient 34 presented with “pain, range of motion (ROM, full potential of movement of a joint), posture (position in which a person holds the body when standing, sitting, or lying down), strength, endurance (ability to keep doing something difficult, unpleasant, or painful for a long time), balance, flexibility (ability of the joint/s to move through an unrestricted, pain-free ROM), bed mobility (way a person moves around in a bed), transfer (safely moving the body from one surface to another), and gait (manner of walking) impairments limiting her functional mobility (person’s ability to move around safely and independently in his/her daily environment) and her ability to perform her activities of daily living (ADLs) safely and independently.” The PT Eval indicated Patient 34 had good rehabilitation potential. During a review of Patient 34’s physician’s order, titled “Therapy Order,” dated 6/15/2026, the physician’s order indicated a frequency of PT home visits of twice a week for 3 weeks, starting the week of 6/15/2026. During a review of Patient 34’s physician’s order, titled “Referral Home Health Care,” dated 6/23/2026, the “Referral Home Health Care” indicated Patient 34 was referred to the HHA for PT services to evaluate and treat, provide functional mobility training and Durable Medical Equipment (DME, reusable home-use gear ordered by the physician to treat an injury or illness) assessment/training. The “Referral Home Health Care” indicated the physician’s recommendation to resume HHA physical therapy, “intensive care program (longer and/or more frequent therapy sessions)” for more PT. During a telephone interview on 7/13/2026 at 12:55 p.m., RP 34 stated she was “extremely frustrated” with the HHA because Patient 34 did not receive PT as ordered by the physician for three weeks from 6/16/2026 to 7/8/2026. RP 34 stated PT 2 conducted the PT Initial Eval on 6/15/2026 when the HHA resumed care for Patient 34 after Patient 34 was hospitalized. RP 34 stated PT 3 conducted Patient 34’s PT visit on 7/9/2026 after RP 34 attempted to reach out to the HHA multiple times regarding Patient 34’s missed PT visits and ultimately spoke with Customer Relations Officer (CRO, non-clinical staff contracted by the HHA to be part of the Overseas Support Team) 1 from the HHA. RP 34 stated CRO 1 checked the HHA’s staff database and determined that PT 2 was not from the same HHA. During a telephone interview on 7/14/2026 at 12:26 p.m., CRO 1 stated PT 1 reached out to the HHA-Overseas Support Team (OST) on 6/15/2026. CRO 1 stated two members of the HHA-OST attempted to speak with RP 34 on 6/16/2026 to clarify if Patient 34 was receiving care from another HHA due to the PT visit on 7/15/2026. CRO 1 stated there were no notes regarding PT visits for Patient 34 until RP 34 called the HHA on 7/6/2026 inquiring about Patient 34’s PT visits. CRO 1 stated PT visits resumed on 7/9/2026. CRO 1 stated the HHA Clinical Supervisor directly communicates with the Contracted Rehab Agency (CRA) 1. CRO 1 stated the HHA-OST did not receive any communication notes regarding a scheduled PT visit from CRA 1 for Patient 34. During a telephone interview on 7/14/2026 at 1:12 p.m., PT 1 stated she (PT 1) conducted the PT Evaluation on 5/27/2026 (prior to Patient 34’s hospitalization). PT 1 stated she reached out to the HHA on 6/15/2026 to clarify if PT 1 needed to resume Patient 34’s care, but the HHA-OST informed her that Patient 34 was under the care of another HHA (unknown). PT 1 stated she did not know the outcome of her inquiry on 6/15/2026 because of PT 1’s time off from work. During a concurrent interview and record review of Patient 34’s electronic medical records (EMRs) on 7/14/2026 at 2:39 p.m., with Clinical Manager (CM) 3, nursing notes, rehab notes, orders, care plans, and patient communication were reviewed. CM 3 stated there was no documented evidence regarding who, why, and when CRA 1 was contacted by the HHA. CM 3 stated if a PT from CRA 1 conducted the PT evaluation, CRA 1 must schedule and conduct the succeeding PT visits as recommended and ordered by the physician. CM 3 stated there was no documented evidence regarding coordination of PT visits. CM 3 stated the HHA-OST was supposed to monitor and schedule PT visits. CM 3 stated if PT visits were not provided as ordered, Patient 34 was placed at an increased risk for functional decline, decreased ROM, decreased activity tolerance (lack of energy to complete daily tasks), development of contractures (permanent tightening of muscles/tendons/skin/nearby tissues that cause joints to stiffen/shorten and lose normal movement), increased pain, impaired balance, and higher risk for falls. During a review of the HHA’s P&P, titled “Care/Service Coordination,” dated 11/2021, the P&P indicated the following: The purpose of the P&P is to ensure the coordination of services for each patient and to minimize the potential for missed, conflicting, or duplicated services. Each admitted patient will be assigned a Case Manager to facilitate communication about changes in the patient status among assigned personnel. Timely and ongoing communication is the responsibility of each team member and will be appropriate to the needs and abilities of the patient and relevant to the care/service provided. The name of the Case Manager will be clearly documented on the clinical record. Care coordination will include, but not be limited to: -Regularly occurring telephone or email communication among team members -Timely documentation of coordination of care activities -Integration of services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. -Written evidence of care coordination may be found in the plan of care/service, case conference summary forms, clinical notes in the patient’s clinical record or interdisciplinary group meeting notes. -All organization personnel involved in patient care/service, including those providing contracted services, will have access to the plan of care/service and all other relevant patient information to ensure coordination and continuity.”

“Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This Element is not met as evidenced by: Based on observation, interviews, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure Registered Nurse (RN) 3 provide patient education to the caregivers (CG 3 and CG 4) of one of 14 sampled patients (Patient 33) regarding the blood pressure (BP, force of blood against the artery walls) and blood sugar (BS, level of sugar in the blood) parameters (measurable values or guidelines used to check a patient’s health or set treatment limits) to ensure timely reporting Patient 33’s physician. This failure had the potential to result in a decline in Patient 33’s health condition and delayed wound healing due to unmonitored BS and BP levels. Findings: During a review of Patient 33’s undated clinical record, titled “Patient Information,” the ‘Patient Information” indicated Patient 33’s start of care (SOC) date of 6/23/2026 with medical diagnoses including encounter for change or removal of nonsurgical wound dressing (wound that did not come from surgery and requires management by a medical professional) and stage 2 pressure sore (shallow open ulcer) of the sacral region (shield-shaped bone at the base of the spine). During a review of Patient 33’s “Patient Medication Record,” as of 7/9/2026, for the certification period from 6/23/2026 to 8/21/2026, the “Patient Medication Record” indicated the following active orders with start date of 6/23/2026: Lisinopril (medication to treat high BP) 10 milligrams (mg, unit of measurement of weight) – take 1 tablet by mouth daily to control BP and/or prevent strokes and help the heart and kidneysGlucometer – check your BS regularly before meals or as directed.During a review of Patient 33’s “Home Health Certification and Plan of Care (POC),” for the certification period from 6/23/2026 to 8/21/2026, the POC indicated a Skilled Nurse (SN) frequency order of twice a week for one week and three times a week for three weeks, effective 6/23/2026. The POC indicated Patient 33 had secondary diagnoses of type 2 diabetes mellitus (long-term health condition where the body resists insulin [hormone made by the pancreas to regulate BS] or does not make enough of it, leading to high BS), essential hypertension (high BP with no known single cause), personal history of transient ischemic attack (temporary block of blood flow to the brain) and cerebral infarction without residual effects (death of a person’s brain tissue caused by a blocked blood vessel without lasting physical or mental disabilities). The POC indicated Orders and Treatments included SN to do the following: 1. Perform caregiver teaching on: -Management of DMII, hypertension, and stroke (medical emergency that occurs when blood flow to part of the brain stops because of blocked or ruptured blood vessel) -Importance of self-monitoring BS as ordered or instructed by the physician -Monitoring BP daily especially before administering medication -Need to notify Patient 33’s physician if the fasting BS (measure of BS, no after at least 8 hours without food) and/or random BS (measure of BS at any time of day, regardless of food intake) is greater than 250 milligrams per deciliter (mg/dL, unit of measurement of concentration of BS in a specific volume of blood) or less than 70 mg/dL. -Need to notify Patient 33’s physician if systolic BP is greater than 160 mmHg or less than 95 mmHg -Need to notify Patient 33’s physician if diastolic BP is greater than 100 mmHg or less than 50 mmHg 2. Assess Patient 33/Patient 33’s caregivers’ compliance with the use of the glucometer and diabetic management. During a concurrent observation and interview on 7/9/2026 at 10:48 a.m. with Registered Nurse (RN) 3, while on a joint home visit at Patient 33’s Board and Care Residential Facility (BCRF), in the presence of Patient 33’s caregiver (CG 3), Patient 33 was observed lying in bed, awake, alert, calm, nonverbal, and with no evidence of pain. RN 3 stated CG 3 and CG 4 have not been able to check Patient 33’s BS because Patient 33 did not have a glucometer at the BCRF. RN 3 stated she (RN 3) requested the glucometer about a week ago. During an interview on 7/9/2026 at 11:40 a.m., CG 3 stated when RN 3 admitted Patient 33 to the HHA “about 2 weeks ago,” RN 3 did not inform CG 3 and/or CG 4 regarding the need to check Patient 33’s BS and did not ask if Patient 33 had a glucometer in the BCRF. CG 3 stated he (CG 3) called RN 3 “about a week ago” to inform RN 3 regarding Patient 33’s family member inquiring about Patient 33’s BS at that time but Patient 33 had no glucometer in the BCRF. CG 3 stated RN 3 did not instruct him (CG 3) and CG 4, Patient 33’s caregivers at the BCRF, regarding the BP and BS parameters and the need to notify the physician if the BP and/or BS values are outside of the ordered parameters. CG 3 stated RN 3 provided a copy of the POC on 7/9/2026 but did not discuss the contents of the POC. During a concurrent interview and record review on 7/13/2026 at 2:51 p.m., with the Director of Patient Care Services (DPCS), Patient 33’s Outcome and Assessment Information Set (OASIS-E2 Start of Care), dated 6/23/2026, RN – Skilled Nursing Visit notes, dated 6/25/2026, 6/29/2026, 7/1/2026, 7/6/2026, 7/8/2026, and 7/9/2026, Patient Medication Record, physician orders, and POC were reviewed. The DPCS stated Patient 33’s BCRF caregivers must be educated regarding the BP and BS parameters to ensure proper monitoring, coordinate care, and report patient condition to the physician timely. The DPCS stated Patient 33’s BP and BS must be checked and recorded regularly to determine if the current treatment plan is adequate for Patient 33’s goals. The DPCS stated if the BP and BS are not well-controlled and are not monitored as ordered by the physician, it can lead to Patient 33’s decline in health condition, including delayed wound healing. During a review the HHA’s policy and procedures (P&P), titled “Care Planning Process,” dated 11/2021, the P&P indicated the following: All clinicians will consider the conclusions of initial and ongoing assessments in their care planning process, including but not limited to:-Individualized patient needs and resultant problems related to care, functional status, and family/caregiver support system -clinical drug monitoring, as appropriate -patient and caregiver education and training the organization will provide specific to the patient’s care needs 2. The organization must provide the provide the patient and caregiver with a copy of written instructions outlining: - patient medication schedule/instructions -any other pertinent instruction related to the patient’s care and treatments that the organization will provide, specific to the patient’s care needs”

“Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency’s (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence) Registered Nurse (RN 2) failed to communicate with the physician regarding one of fourteen sampled patient’s poorly managed condition at discharge (Patient 26). This failure had the potential to result in unsafe discharge for Patient 26 and result to worsening conditions and rehospitalization. Findings: During a review of Patient 26’s Home Health Certification and Plan of Care (POC, a detailed, written document outlining the services and support an individual needs to meet their healthcare goals) for the certification period of 5/7/2026 to 7/5/2026, the POC indicated Patient 26’s start of care (SOC) date was 5/7/2026, with diagnoses that included COPD with exacerbation (a flare-up or episode when your breathing is worse than usual), and chronic (long term) respiratory failure (condition that happens when your lungs cannot get enough oxygen into your blood), with hypoxia (the body’s tissues don’t get enough oxygen). The POC indicated Patient 26 was to receive one Skilled Nurse (SN) visit per week for two weeks, effective 5/7/2026, for management of chronic hypoxemic respiratory failure, COPD, gastroesophageal reflux disease (GERD, stomach acid flows back up into the esophagus and causes heartburn), and oxygen. The SN was also to report changes in condition to the physician. During a review of Patient 26’s records from General Acute Care Hospital 1 (GACH 1, a licensed medical facility providing 24-hour inpatient care), dated 5/6/2026, the GACH 1 records indicated that Patient 26 had hospitalizations from 2/4/2026 to 2/5/26, from 3/6/2026 to 3/8/2026, and from 5/1/2026 to 5/6/2026 for COPD exacerbation. During a review of Patient 26’s Outcome and Assessment Information Set (OASIS is a standardized, CMS-mandated data collection tool used by Medicare-certified home health agencies to assess adult patient conditions, functional status, and health needs), Start of Care (SOC, the time when a patient begins receiving skilled services at home) assessment dated 5/7/2026, the assessment indicated that Patient 26 had wheezes and shortness of breath, requiring continuous oxygen at 2 liters per minute. During a telephone interview with Patient 26’s family member (FM 2) on 7/15/2026 at 2:51 p.m., FM 2 stated that she (FM 2) was the primary caregiver for Patient 26 and Patient 26 lived with her. FM 2 stated that Patient 26 was only seen by a home health nurse once in May 2026. FM 2 stated that after Patient 26 was discharged from Hospital 1 on 5/6/2026, a home health nurse came the following day. FM 2 stated the doctor (unknown) wanted Patient 26 to be able to manage her COPD better so that she wouldn’t have frequent hospitalizations and to improve her mobility. FM 2 stated that according to the nurse (unknown), Patient 26 was going to receive nursing visits and physical therapy from the HHA, but there was no nurse or physical therapist (a licensed healthcare professional who specializes in improving human movement, managing pain, and restoring physical function) from the agency came after 5/6/2026. FM 2 stated, “a couple of weeks later, approximately 5/25/2026, we (Patient 26 and FM2) were told the HHA had to discharge Patient 26.” FM 2 stated Patient 26 was currently being hospitalized again on 7/15/2026 for COPD exacerbation. FM 2 stated that Patient 26 had not received the home health services for SN visit of once a week for two weeks effective 5/7/2026, as ordered and as per plan of care. During a telephone interview with RN 2 on 7/16/2026 at 11:22 a.m., RN 2 stated she (RN2) admitted Patient 26 to the HHA on 5/7/2026. RN 2 stated after assessing Patient 26, she (RN2) recommended Patient 26 for SN visits once a week and physical therapy evaluation. RN 2 stated she (RN2) was never assigned to do follow-up visits for Patient 26 after the start of care on 5/7/2026. RN 2 stated, “about two weeks after Patient 26’s admission, the HHA assigned me (RN2) to discharge her (Patient 26).” RN 2 stated Patient 26’s family member told her (RN 2) that there had been no nurse or physical therapist who visited Patient 26. RN 2 stated that Patient 26 had never received any services from the home health as written in her individualized plan of care. RN 2 stated when she (RN2) assessed Patient 26 for discharge, on 5/25/2026. RN 2 stated Patient 26’s COPD was poorly managed. When RN 2 was asked if she notified Patient 26’s physician her assessment of Patient 26 on 5/25/2026, RN 2 stated that she notified the HHA on APP 2 (an electronic messaging tool). Per RN 2, the HHA staff used APP 2 for their internal communication. RN 2 stated she did not know if a Clinical Supervisor relayed the message that she (RN 2) left on APP 2 to Patient 26’s physician. RN 2 stated that she did not follow-up with the HHA after she left the message on APP 2 on 5/25/2026. RN 2 stated she never saw Patient 26 after 5/25/2026. During a concurrent interview and record review with the Director of Patient Care Services (DPCS) on 7/16/2026 at 12:49 p.m., the DPCS reviewed Patient 26’s POC for the certification period of 5/7/2026 to 7/5/2026, nursing notes for the month of May 2026, and Outcome and Assessment Information Set (OASIS is a standardized, CMS-mandated data collection tool used by Medicare-certified home health agencies to assess adult patient conditions, functional status, and health needs)-Discharge assessment, dated 5/25/2026. The DPCS stated that she did not see any visits done for Patient 26 per POC for the certification period of 5/7/2026 to 7/5/2026. The DPCS stated the OASIS Discharge assessment was incomplete. The DPCS stated the RN should have made a recommendation to continue the care if Patient 26 still had home health needs upon her assessment. Per DPCS, the clinical supervisor would follow up with that recommendation. The DPCS stated the lack of communication between the HHA’s SN and the physician resulted in an unsafe discharge for Patient 26. During a review of the HHA’s policy and procedure (P & P), titled, “Care/Service Coordination,” revised November 2021, the P & P indicated During a review of the HHA’s policy and procedure (P & P), titled, “Monitoring Patient’s Response/Reporting to Physician,” revised November 2021, the P & P indicated the following: Clinicians will monitor, document, and report the patient’s response to care and treatment provided on each home visit. Progress of goals will be measured at regular intervals. Clinicians will establish and maintain ongoing communication with the physician (or other authorized licensed independent practitioners) to ensure safe and appropriate care for the patient. The P&P indicated: 3. The patient’s physician (or other authorized licensed independent practitioner) will be contacted when any of the following occur: I. Patient is to be discharged from the organization, or a specific service is to be discontinued.”

“Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient’s discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This Element is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes rather than in a traditional healthcare facility setting) failed to ensure a discharge summary was completed for two of 14 sampled patients (Patient 26, Patient 27, and Patient 32). This failure had the potential to compromise continuity of care for Patient 26, Patient 27, and Patient 32 by preventing other healthcare providers from receiving essential information needed to safely assume responsibility for the patients’ follow‑up treatment, increasing the risk for unmet medical needs, inappropriate care planning, medication or treatment errors, delays in necessary interventions, and avoidable adverse health outcomes. During a record review of patient 32’s electronic medical record title, ”Home Health Certification and Plan of Care” on 7/14/26 at 10:00 a.m., documentation indicated Patient 32 was admitted to the home health agency(HHA) with a start of care (SOC) date of 1/20/2026, with diagnoses of Parkinson disease (a progressive neurological sort of affecting movement, balance, and coordination), weakness(a decreased muscle strength affecting mobility, and difficulty walking(impaired ambulation and increases the risk of falls. During continued review of Patient 32’s “Home Health Certification and Plan of Care” indicated physician orders for physical therapy services 1 visit per week for four weeks to evaluate Patient 32 and provide therapeutic exercises, gait training, transfer training, home safety instructions, fall prevention education, and establish of a home exercise program. Further review of Patient 32’s “Home Health Certification and Plan of Care” documentation indicated physician orders for physical therapy(PT) visit one (1) time per week , effective 1/20/2026. Documentation included establishing and teaching home exercise program with the caregiver , with a short-term goal date of 2/14/2026, and discharge from therapy when goals were met or the Patient reached maximum rehabilitation potential. During a review of Patient 32’s document titled, “ Physical Therapy Evaluation,” dated 1/20/2023, the documentation indicated the physical therapist evaluated Patient 32 on 1/20/2026 and identified deficits in strength, balance, gait, and functional mobility. Further review of the same documentation indicated skilled physical therapy services were necessary to address the patient’s impairments and achieve the established treatment goals in accordance with the physician’s orders. During a telephone interview with patient 32’s Caregiver 5(CG 5),CG 5 stated the physical therapist evaluated Patient 32 on 1/20/2026, in their residence and informed Patient 32 and CG 5 that the physician order physical therapy visits would be provided and created a plan for 3 more visits. CG 5 stated, later that same day(1/20/2026), a staff from the HHA contacted the CG 5 and informed them that Patient 32 was being discharged for home health services. CG5 stated Patient 32 never received the physician-ordered ongoing physical therapy visits following the initial evaluation. During review of Patient 32’s the document title “Start of Care Orders” dated 1/20/2026, the documentation indicated physical therapy services were ordered one visit per week for four weeks to establish and teach a home exercise program, provide therapeutic exercises, home safety instructions, fall prevention education, gait training and transfer training. The Soc order indicated to discharge Patient 32 when goals are met or reaches his highest potential. The above findings indicated the HHA failed to ensure Patient 32 was discharged based on assessment that the patients’ goals had been achieved, the patient condition no longer required skilled physical therapy services, and the physician directed plan of care had been completed. The HHA failed to ensure the clinical record contained documentation supporting discontinuation of physician ordered physical therapy services before discharging Patient 32 from home health services. During review a Patient 32’s Outcome and Assessment Information Set( Oasis) dated 1/20/2026, documented, “the patient remains homebound due to poor balance, weakness, and an increased risk for falls”. Documentation further indicated “the patients balance was very poor if he released his Walker, making ballast testing unsafe. Patient 32’s Oasis documented” the patient responded well to the clinical examination, demonstrated a continued need for physical therapy services, and the patient agreed with the proposed plan of care”. During a continued review of Patient 32’s the document titled, “Outcome and Assessment Information Set (OASIS), documentation indicated Patient 32 remained homebound due to weakness, impaired balance, and an increased risk for falls and continued to require skilled physical therapy intervention. During review of the document titled “Discharge Summary,” dated 1/23/2026,documentation indicated the Goal Summary and Outcome section were blank and contained no evidence Patient 32 had achieved the established physical therapy goals or no longer required skilled therapy services before discharge. During a review of the document titled, “Discharge Home Health Order,” documentation indicated Patient 32 was discharged from home health services effective 1/23/2026. Continued review of the document indicated Patient 32 and that Patient 32 had been redirected to Community Agency Division (CAD, a department with the general acute care hospital(GACH), responsible for coordinating referrals and monitoring patients receiving home health services). Findings: During a review of Patient 27’s clinical record titled “Patient Information,” the record indicated that Patient 27 had a Start of Care (SOC) date of 4/22/2025, with a primary diagnosis of sialolithiasis (salivary stones that form in salivary glands causing swelling and/or pain) and antiphospholipid syndrome (an autoimmune disorder in which the immune system produces antibodies that attack normal blood proteins, causing the blood to clot easily). During a review of Patient 27’s Home Health Certification and Plan of Care (POC) for the certification period of 4/22/2025 to 6/20/2025 indicated a frequency order for Physical Therapy visits for once a week for one week and twice a week for three weeks, and Skilled Nursing (SN) evaluation for wound care, and OT for evaluation. During a review of Patient 27’s order titled Discharge Order dated 6/20/2025, the order indicated the discharge service was OT, with an effective date of 6/20/2025 and reason of “Patient declined further OT services, hence discharged from OT.” The order indicated it was signed by Occupational Therapist (OT1) with a date of 6/20/2025. During a review of Patient 27’s Electronic Medical Record (EMR) under section “OT” (Occupational Therapy), it indicated a task titled “Discharge Summary (OT)” for target date of 6/20/2025. The task was in red font color and under status indicated “not Started” and there was not no option to view it. During a concurrent interview and record review on 7/21/2026 at 12:30 p.m. with the Director of Patient Care Services (DPCS), Patient 27’s EMR section OT was reviewed. Patient 27’s EMR section “OT” it indicated a task titled “Discharge (DC) Summary (OT)” for target date of 6/20/2025. The task was in red color and under status indicated “not Started” and there was not no option to view it. The DPCS stated and confirmed that the Discharge Summary task was not started or completed and that is why it was in red font color and not viewable. The DPCS stated that although there was a discharge order, the Occupational Therapist should have completed a DC summary as well. The DPCS stated that a negative outcome of not completing a DC summary could have been an unsafe discharge for the patient with a potential to be readmitted for home health services. The DPCS stated that in the case of Patient 27, it could have declined her health causing dependence with ADL’s and her independence compromised. During a review of the HHA’s Policy and Procedure (P&P) titled Discharge Summary with a revised date of November 2021, the P&P indicated that when a patient is discharged from a service and from the organization, they will have a written DC summary completed and field in the clinical records. The P&P indicated that each clinician providing care will complete a DC summary when discipline is discharged and may include: the date of DC, date physician and patient informed, reason for DC, status of problems identified at admission and during care, progress towards goals/desired outcomes, treatment preferences, overall status of the patient and summary of care/services provided. The P&P further indicated that the DC summary will be completed within 72 hours of discharge from services, a copy of the DC summary will be provided to the patient’s primary doctor or other healthcare provider responsible for the patient, and the organization will audit for completeness of the patient’s clinical record within 30 days of last home visit and DC date. a. During a review of Patient 26’s Home Health Certification and Plan of Care (POC, a detailed, written document outlining the services and support an individual needs to meet their healthcare goals) for the certification period of 5/7/2026 to 7/5/2026, the POC indicated Patient 26 had a start of care (SOC) date of 5/7/2026, with diagnoses that included COPD with exacerbation and chronic respiratory failure with hypoxia (a long-term condition where the lungs cannot adequately transfer oxygen into the bloodstream). The POC indicated that Patient 26 was to receive one Skilled Nurse (SN) visit per week for two weeks, effective 5/7/2026, for management of chronic hypoxemic respiratory failure, COPD, gastroesophageal reflux disease (GERD, a condition where stomach acid flows back up into the esophagus [a muscular tube that connects the throat to the stomach] and causes heartburn) and oxygen. The SN was also to report changes in condition to the physician. During a review of Patient 26’s Outcome and Assessment Information Set (OASIS is a standardized, CMS-mandated data collection tool used by Medicare-certified home health agencies to assess adult patient conditions, functional status, and health needs)-Discharge Assessment, dated 5/25/2026, the OASIS-Discharge assessment was not completed. During a telephone interview with Patient 26’s family member (FM 2) on 7/15/2026 at 2:51 p.m., FM 2 stated that she (FM 2) was the primary caregiver for Patient 26 and Patient 26 lived with her. FM 2 stated that Patient 26 was only seen by a home health nurse once in May 2026. FM 2 stated that after Patient 26 was discharged from General Acute Care Hospital 1 (GACH 1) on 5/6/2026, a home health nurse came the following day. FM 2 stated, “a couple of weeks later, approximately 5/25/2026, we (Patient 26 and FM2) were told the HHA had to discharge Patient 26.” During a concurrent interview and record review with the Director of Patient Care Services (DPCS) on 7/16/2026 at 12:49 p.m., the DPCS reviewed Patient 26’s POC for the certification period of 5/7/2026 to 7/5/2026, OASIS- Discharge Assessment, dated 5/25/2026, and all communication notes. The DPCSD stated there was no physician order for discharge and no discharge summary done for Patient 26. The DPCSD stated that physician order for discharge was necessary because the physician was the one referring the patient to the HHA and was involved in the patient’s care. The DPCSD stated the HHA needed to make sure the doctor was aware that the patient would no longer be under the HHA’s service. The DPCS stated that Patient 26’s OASIS- Discharge Assessment, dated 5/25/2026, indicated 13 (thirteen) goals were not met. The DPCSD also stated that discharge summary had instructions for the patient such as to follow-up with the primary physician, any change of condition to report to the physician, medication teaching, and when to call 911. Per DPCSD, if discharge summary was not provided, the patient might not know what to do after discharge, which could affect their health.”

“Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient’s eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This Condition is not met as evidenced by: Based on observation, interviews, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure the Condition of Participation (CoP, refer to the requirements that healthcare organizations must meet to participate in federal healthcare programs) regarding Comprehensive Assessment of Patients was met as follows: 1. The HHA failed to ensure the clinician conducted the initial assessment visit for three of 20 sampled patients (Patient 7, Patient 14, & Patient 19) within 48 hours of the referral and/or of the patient’s return home. This failure had the potential to result in the patients’ decline in health due to delayed wound healing, increased infection risks, and/or rehospitalization related to the delay of assessment of the patients’ needs. (Refer to G514) 2. The HHA failed to ensure the comprehensive assessment was completed within five days for one of 20 sampled patients (Patient 2). This failure had the potential to cause a delay in the care delivery or incorrect treatments provided to the patients that could lead to hospitalization and distress. (Refer to G520) 3. The HHA failed to ensure the comprehensive assessment accurately reflected the condition of two of 20 sampled patients (Patient 7 and Patient 13) in order to develop and implement an individualized plan of care (CMS-485, patient-specific document that summarizes the patient’s health condition, specific care needs, current treatments, and disciplines involved) to address the patients’ needs. This failure had the potential to cause a delay in the care delivery or incorrect treatments provided to the patients that could lead to hospitalization and distress. (Refer to G528) 4. The HHA failed to maintain an accurate review of all the current medications/treatments for seven of 20 sampled patients (Patient 2, Patient 3, Patient 5, Patient 6, Patient 7, Patient 8, and Patient 14). This failure had the potential to place the patients at risk for medication errors and serious adverse effects, such as heart problems, that could lead to stroke (medical emergency when blood flow to the brain is interrupted or reduced) and hospitalization. (Refer to G536) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Comprehensive Patient Assessment to ensure the highest quality health care is provided to patients assessed to receive home health services. 1. The HHA failed to ensure the clinician conducted the initial assessment visit within 48 hours of the referral and/or of the patient’s return home for three of 20 sampled patients (Patient 7, Patient 14, and Patient 19). This failure had the potential to result in a decline in the health status of Patient 7, Patient 14, and Patient 19, including delayed wound healing, increased risk of infection, and rehospitalization. (Refer to G514). 2. Based on interview and record review, the HHA failed to ensure completion of the comprehensive assessment for three of 20 sampled patients (Patient 7, Patient 9, and Patient 14) within five calendar days after the start of care. This failure had the potential to result in delayed or missed care, placing patients at increased risk of unmet care needs, hospitalization, and distress. (Refer to G520). 3. The HHA failed to maintain an accurate review of all the current medications and treatments for five of 20 sampled patients (Patient 2, Patient 3, Patient 7, Patient 8, and Patient 14). This failure placed Patient 2, Patient 3, Patient 7, Patient 8, and Patient 14 at risk for medication errors, ineffective drug therapy, and serious adverse effects (an undesired, harmful response to a medication or treatment) such as heart problems, that could lead to stroke (medical emergency when blood flow to the brain is interrupted or reduced) and hospitalization. (Refer to G536). 4. The HHA failed to ensure accurate and complete assessment of the tracheostomy (surgical opening in the trachea [windpipe] for breathing) site of one of 20 sampled patients (Patient 13) during the discharge home visit on 4/28/2026. This failure had the potential to cause a decline in the patients’ decline in health due to a delay in the care and service delivery related to inaccurate and incomplete assessment. (Refer to G544). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Comprehensive Patient Assessment to ensure the highest quality health care is provided to patients assessed to receive home health services.”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure the Condition of Participation (CoP-a set of minimum professional standards all home health agencies must meet to participate in Medicare [federal health insurance for anyone age 65 and older, and some people under 65 with certain disabilities or conditions] and Medicaid [a joint federal and state program that provides health coverage for some people with limited income and resources] government programs) for Care planning, coordination, and quality of care was met as follows: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to ensure the Condition of Participation (CoP-a set of minimum professional standards all home health agencies must meet to participate in Medicare [federal health insurance for anyone age 65 and older, and some people under 65 with certain disabilities or conditions] and Medicaid [a joint federal and state program that provides health coverage for some people with limited income and resources] government programs) for Care planning, coordination, and quality of care was met as follows: 1. The HHA failed to ensure a detailed, individualized plan of care (POC) for one of 22 sampled patients (Patient 7) when Patient 7’s POC did not include skilled nursing interventions for bladder and bowel incontinence (involuntary and accidental leakage of urine or stool). This failure resulted in Patient 7 developing deep tissue injuries (DTI- localized damage to the skin and underlying soft tissue), pressure injuries (localized, pressure-related damage to the skin and/or underlying tissue usually over a bony prominence), and potential to result in emotional distress by not completing the POC required elements. (Refer to G574) 2. The HHA failed to record the physician orders on the date they were received in the POC for two of 22 sampled patient (Patient 2, and Patient 7). This deficient practice had the potential to result in a disruption of coordination of care by causing a delay of services or no services provided to Patients 2 and 7 that would have caused a decline in their health and well-being. (Refer to G576) 3. The Home Health Agency failed to follow their policy and procedures on obtaining verbal orders for one of 22 sampled patients (Patient 3). This failure had the potential to cause a decline in Patient 3’s health due to inaccurate care and services provided related to incorrect physician orders. (Refer to G584) 4. The HHA failed to promptly alert and/or follow up with the physician of Changes in condition for two of 22 sampled patient (Patient 3 and Patient 6). This deficient practice had the potential to result in Patient 3 and Patient 6’s rapid decline in health and possible hospitalization due to delays in notifying the physician. (Refer to G590) 5. The HHA failed to ensure the POC was revised and updated for two of 22 sampled patients (Patient 2 and Patient 3), to reflect Patient 1’s change in wound treatment and Patient 3’s new high blood pressure problem, goal, interventions and outcomes. This failure had the potential to delay wound healing for Patient 2 and increase the risk of stroke or hospitalization for Patient 3. (Refer to G592) The cumulative effect of these systemic failures resulted in the Home Health Agency’s inability to comply with the Condition of Participation for Care Planning, Coordination of Services, and Quality of Care, thereby failing to ensure safe, effective, and coordinated services for patients receiving home health care.”

“Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This Condition is not met as evidenced by: Based on observation, interviews, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure the Condition of Participation (CoP, refer to the requirements that healthcare organizations must meet to participate in federal healthcare programs) for Skilled Professional Services was met as follows: 1. The HHA failed to ensure the interdisciplinary team (a group of professionals from different fields who collaborate closely, combining their unique skills and perspectives to achieve a common goal or solve a complex problem) coordinated care for one of 20 sampled patients (Patient 3) by failing to: a. Ensure to coordinate with the Registered Nurse Clinical Supervisor (RNCS) to initiate a skilled nursing assessment after Physical Therapist (PT) 2 and Occupational Therapist (OT) 1 identified multiple episodes of high systolic blood pressure (SBP, maximum pressure on the artery walls when the heart beats and pumps blood into the body, ) above 160 millimeters of mercury (mmHg, unit of measurement of pressure. Normal reference range for adult less than 120 mmHg). b. Report to interdisciplinary team that Patient 3 was not taking the ordered hydrochlorothiazide (medication to treat high blood pressure) and was taking over‑the‑counter Tylenol (medication to treat pain), which was not listed on Patient 3’s medication profile (a comprehensive, up-to-date record of every medicine a person takes). These failures placed Patient 3 at increased risk for unrelieved pain, heart problems, stroke, and hospitalization. (Refer to G706). 2. The HHA failed to follow the physician orders for two of 20 sampled patients (Patient 13 and Patient 21) by failing to: a. Ensure Patient 13 was evaluated by a Speech Therapist (ST) as ordered by the physician. b. Ensure Patient 21’s intravenous (IV, into the vein) antibiotics (medication to treat bacterial infections) was provided as ordered by the physician. These failures had the potential to result in worsening symptoms, delayed treatment, increased risk of complications, preventable deterioration of the underlying condition, and possible rehospitalization. For Patient 13, the lack of a Speech Therapist evaluation could result in unaddressed swallowing difficulties, aspiration risk, nutritional decline, or communication deficits. For Patient 21, delays in IV antibiotic administration could result in progression of infection, sepsis, extended illness, or the need for emergent medical intervention. (Refer to G710). 3. The HHA failed to ensure that the skilled nurses submit completed skilled visit notes for one of 20 sampled patients (Patient 12). This failure placed Patient 12 at increased risk to compromised safety, deterioration in health condition, and complications related to the underlying heart condition. (Refer to G716) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Skilled Professional Services to ensure the highest quality of health care is provided to patients assessed to receive home health services.”

“Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This Condition is not met as evidenced by: Based on observation, interviews, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure the Condition of Participation (CoP, refer to the requirements that healthcare organizations must meet to participate in federal healthcare programs) for Organization and Administration of Services was met as follows: 1. The HHA Administrator failed to ensure an accurate list of active patients was maintained and updated whenever a patient was admitted or discharged, to include one of 20 sampled patients (Patient 19) and ensure care was provided to all patients with physician orders to receive home health services. This failure had the potential to delay needed care and services, resulting in a decline in patient health. (Refer to G948) 2. The HHA failed to ensure the Clinical Managers managed the staff assignment for two of 20 sampled patients (Patient 13 and Patient 19) to ensure the admission physician orders were completed as ordered. This failure had the potential to prevent patients from receiving timely, necessary care and services to address their immediate needs. (Refer to G960) 3. The HHA failed to ensure the Clinical Manager/s coordinated care for one of 20 sampled patients (Patient 3) to schedule a Skilled Nurse (SN) evaluation and follow up with the physician to address multiple episodes of high blood pressure (BP, pressure of the blood against the arteries with the normal adult BP less than 120/80 millimeters of mercury [mmHg, unit of measurement of pressure]) and medication discrepancies regarding hydrochlorothiazide (medication to treat high BP) and Tylenol (medication to treat pain). This failure had the potential to result in Patient 3 not receiving the immediate care needs and services related to the lack of oversight and continuity of care, which could lead to a decline in the patient’s health and well-being. (Refer to G962) 4. The HHA failed to ensure the Clinical Manager reviewed the referral for one of 20 sampled patients (Patient 13) to ensure that all the required home health services were ordered and/or clarified with the physician. This failure had the potential to result in Patient 13 not receiving the immediate care needs and services related to the lack of oversight and continuity of care, which could lead to a decline in the patient’s health and well-being. (Refer to G964) 5. The HHA failed to ensure the Clinical Manager provided oversight to ensure the medication needs of one of 20 sampled patients (Patient 3) was continually assessed. Patient 3’s Communication Note dated 5/4/2026 stated, “Supervisory Medication Reconciliation Done,” yet no Skilled Nurse visit occurred on that date to address documented medication discrepancies, and audit logs showed entries were made by offshore non‑clinical Quality Assurance staff. This failure had the potential to place the patient at risk for medication errors, ineffective drug therapy, and serious adverse effects, including heart complications, stroke, and hospitalization. (Refer to G966) The cumulative effect of these systemic failures resulted in the Home Health Agency’s inability to comply with the Condition of Participation for Organization and Administration of Services, thereby failing to ensure coordinated, safe, and effective care for patients receiving home health services.”

“Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This Condition is not met as evidenced by: Based on observation, interview and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure the Condition of Participation (CoP, refers to the requirements that healthcare organizations must meet to participate in federal healthcare programs) for Clinical Records was met as follows: 1. The HHA failed to ensure complete and accurate documentation on the clinical records for two of 20 sampled patients (Patient 13 and Patient 3) by failing to: a. Ensure complete and accurate documentation of the Registered Nurse (RN) assessment of the tracheostomy (surgically created opening in the trachea [windpipe] for breathing) after Responsible Party (RP) 13 reported redness to the tracheostomy site during the discharge home visit on 4/28/2026. b. Ensure documentation of a revised individualized plan of care (POC) for Patient 3. These failures had the potential to result in a decline of the patients’ health status and well-being related to the inconsistent or delayed delivery of care and services to the patient to address the patients’ immediate care needs. (Refer to G1012). 2. The HHA failed to ensure that clinical record entries were appropriately authenticated, dated, and timed, as required for nine of 20 sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 7, Patient 9, Patient 12, Patient 14 and Patient 19. This failure was evidenced by: a. Clinical record entries for six of 20 sampled patients (Patient 2, Patient 3, Patient 4, Patient 12, Patient 17, and Patient 19) were missing the required authentication (verifying that the documentation was completed by the authorized individual who provided the service typically by a signature, date and time when the entry was completed), as they were not signed by the professional who authored them. b. Clinical record entries for six of 20 sampled patients (Patient 1, Patient 2, Patient 7, Patient 9, Patient 12, and Patient 14) were entered late and backdated (the practice of entering a date on a document, clinical record, or order that is earlier than the actual date the entry was created or signed) indicating dates earlier than the actual date of entry or signature. c. Orders for delayed start of care for two of 20 sampled patients (Patient 7 and Patient 19) did not accurately reflect the clinician’s communication resulting in inaccurate documentation. d. Orders for three of 20 sampled patients (Patient 1, Patient 12, and Patient 14) were not signed within the HHA’s required 72‑hour timeframe, resulting in untimely authentication. These failures had the potential to adversely impact on the quality of patient care, and contributes to worsening of patients conditions, avoidable complications and preventable emergency department visits or hospitalizations. (Refer to G1024). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Clinical Records to ensure the highest quality of health care is provided to patients assessed to receive home health services.”

“Policies/Procedures-Volunteers and Staffing CFR(s): 484.102(b)(5) §403.748(b)(6), §416.54(b)(5), §418.113(b)(4), §441.184(b)(6), §460.84(b)(7), §482.15(b)(6), §483.73(b)(6), §483.475(b)(6), §484.102(b)(5), §485.68(b)(4), §485.542(b)(6), §485.625(b)(6), §485.727(b)(4), §485.920(b)(5), §491.12(b)(4), §494.62(b)(5). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] (6) [or (4), (5), or (7) as noted above] The use of volunteers in an emergency or other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. *[For RNHCIs at §403.748(b):] Policies and procedures. (6) The use of volunteers in an emergency and other emergency staffing strategies to address surge needs during an emergency. *[For Hospice at §418.113(b):] Policies and procedures. (4) The use of hospice employees in an emergency and other emergency staffing strategies, including the process and role for integration of State and Federally designated health care professionals to address surge needs during an emergency. This Standard is not met as evidenced by: Based on interview and record review the HHA (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to implement emergency preparedness policies and procedures in accordance with federal regulations for two of 20 sampled patients (Patient 7 and Patient 8). This failure placed the patients at risk in the event of an emergency or natural disaster. a. During a review of Patient 7’s clinical record titled “Patient Profile,” (admission record, summary of patient’s basic information) undated, the clinical record indicated a referral date of 4/16/2026 with documented diagnoses including hypothyroidism (insufficient production of thyroid hormones, resulting in a slowed metabolism) and shortness of breath (SOB- the sensation of being unable to get enough air during breathing). During a review of Patient 7’s clinical record titled “OASIS (Outcome and Assessment Information Set, a federally mandated, multi-purpose assessment instrument for home health care)-E2 Start of Care,” dated 4/21/2026, the clinical record indicated Registered Nurse 1 (RN 1) assessed the patient’s emergency category level (three categories for triaging patient care in the event the emergency management plan is implemented) as category 1, high (patients who cannot safely forgo care and require home health intervention regardless of other conditions). During a concurrent interview and record review on 5/12/2026 at 11:18 AM with RN 5, RN 5 conducted Patient 7’s skilled nursing visit and reviewed the patient’s HHA Patient Booklet (a booklet provided by the HHA that explains the home health benefit, patient rights and responsibilities, covered services, care coordination, quality measures, and resources for questions or concerns). The inside front cover- where the patient’s emergency preparedness plan is documented - was incomplete. RN 5 stated that the field for the patient’s emergency category level had been left blank. RN 5 stated that she believed the patient’s emergency category level was category 2 (patients with recent exacerbation of disease process; patients requiring moderate level of skilled care that should be provided that day; patients with essentially untrained family/caregivers not prepared to provide needed care). Further stating that she did not know what relocation or evacuation information should be provided to patients. b. During a review of Patient 8’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date of 4/30/2026 with documented diagnoses including hypo-osmolarity (the concentration of solutes [like salt and proteins] in body fluids is abnormally low compared to water), hyponatremia (low sodium concentration), and hypomagnesemia (low magnesium concentration). During a review of Patient 8’s clinical record titled “OASIS-E2 Start of Care (PT- Physical Therapist),” dated 4/30/2026, the clinical record indicated Physical Therapist 5 (PT 5) assessed the patient’s emergency category level as category 2. During a concurrent interview and record review on 5/12/2026 at 12:41 PM with RN 5, RN 5 conducted Patient 8’s skilled nursing visit and reviewed the patient’s HHA Patient Booklet. The inside front cover- where the patient’s emergency preparedness plan is documented - was incomplete. RN 5 stated that the field for the patient’s emergency category level had been left blank. RN 5 stated that the HHA Patient Booklet provides only general guidance on family disaster planning and emergency preparedness. The information is not patient-specific because it does not reflect resources near the patient’s residence or their individual care needs. RN 5 stated that the emergency evacuation plan must consider patients’ functional abilities to ensure safe evacuation during emergencies. During an interview on 5/13/2026 at 2 PM with the HHA’s Director of Patient Care Services Designee (DPCS Designee), the DPCS Designee stated that the visiting clinician must complete the emergency preparedness plan located on the inside front cover of the HHA Patient Booklet during the start of care visit. This includes determining the patient’s emergency category level, identifying their medical supply and equipment needs, completing the patient’s emergency contact information, and providing evacuation information to the patient and/or caregiver. During an interview on 5/19/2026 at 12:05 PM with Licensed Vocational Nurse 1 (LVN 1), LVN 1 stated, “I do not get any in-services or trainings for emergency preparedness in this company.” During an interview on 5/21/2026 at 10:45 AM with Physical Therapist 1 (PT 1), PT 1 stated that he completes a general emergency preparedness plan for all patients, but it is not individualized to the patients’ functional, medical, transportation needs, or caregiver availability. He does not provide patients with information about specific evacuation locations. During a concurrent interview and record review on 5/21/2026 at 11:52 AM with the HHA’s Director of Patient Care Services (DPCS), the HHA’s emergency preparedness binder was reviewed. The emergency preparedness binder did not contain a hard-copy, current patient list with contact information or the emergency category level for each patient. The DPCS stated that the emergency preparedness binder contained all emergency management plans. The HHA relies on access to electronic medical records to access patient information such as their phone number and emergency category level. In an emergency, online systems may fail, preventing staff from accessing patient contact information and making it difficult to determine the patients’ condition, location, and needs. During a concurrent interview and record review on 5/21/2026 at 12:13 PM with the HHA’s Administrator (ADM), the HHA’s emergency preparedness binder was reviewed against the HHA’s policy and procedure (P&P) titled, “Emergency Management Plan,” undated, the following discrepancies were identified: - The emergency plan did not contain a hard-copy, current patient list with contact information or the emergency category level for each patient. - The communication plan did not include names and contact information for patients’ physicians or entities providing services under arrangement. - The communication plan did not specify timeframe requirements for on-duty and off-duty staff to check in with the HHA’s designated individual. - The emergency plan was undated and did not show when it was last reviewed or updated. The ADM stated that maintaining an updated and comprehensive emergency plan was essential to ensure all staff understood their roles during an emergency and safeguarded patient safety. Further stating that the plan also ensured required medical and non-medical supplies were available to patients in their place of residence and that the medical team remained informed of the patients’ condition following an emergency. During a review of HHA’s P&P, titled “Emergency Management Plan,” undated, the P&P indicated to establish a plan which allows for the continuation of services in the event of a disaster affecting the organization or community: -Individualized plans for patients during a natural or man-made disaster will be included as part of the comprehensive patient assessment. -The HHA educates patients and their families in emergency preparedness at the time of admission including where they can go to shelter and what is required by the shelter. -During the comprehensive assessment, the patient will be placed in one of three categories for triaging patient care in the event the emergency management plan is implemented. -The HHA maintains a hard-copy of a current patient list including contact information and categories identified for each patient in the event there is a power failure. -The communication plan will include names and contact information for patients’ physicians, staff, entities providing services under arrangement, and volunteers. -The communication plan will include a timeframe for on-duty and off-duty staff to check in with the HHA’s designated individual. -Initial training in emergency preparedness policies and procedures and their assigned emergency response roles to all new and existing staff, individuals providing services under arrangement, and volunteers. -Training is provided at least every two years, and staff will be able to demonstrate knowledge of emergency procedures after receiving the training. -HHA leadership will provide orientation and annually thereafter of all personnel regarding participation in the emergency management plan. -The HHA shall review and update the emergency preparedness plan every two years. -The HHA shall maintain written documentation of the emergency management plan for at least four years. During a review of HHA’s P&P, titled “Initial and Comprehensive Assessment,” revised on November 2021, the P&P indicated during the initial and comprehensive assessment all baseline data will be documented in the clinical record including an evaluation of the home environment and assessment of emergency preparedness of the patient.”

“Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient’s condition warrants due to a major decline or improvement in the patient’s health status, but not less frequently than- This Standard is not met as evidenced by: Based on interviews and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure accurate and complete assessment of the tracheostomy (surgical opening in the trachea [windpipe] for breathing) site of one of 20 sampled patients (Patient 13) during the discharge home visit on 4/28/2026. This failure had the potential to cause a decline in the patients’ decline in health due to a delay in the care and service delivery related to inaccurate and incomplete assessment. Findings: During a review of Patient 13’s medical record, titled “Patient Information,” the “Patient Information” indicated the Start of Care (SOC) date of 4/21/2026 with the primary diagnosis of malignant neoplasm of the thyroid gland (thyroid cancer) and secondary diagnosis of tracheostomy status.During a review of Patient 13’s “Skilled Nursing Visit (SNV) with (W/) Discharge Summary,” dated 4/28/2026, the “SNV W/ Discharge Summary” indicated Patient 13 had a tracheostomy, decreased secretions (substances produced and released by cells, glands, or tissues in living organisms), and improving with stable respiratory (refers to breathing or the organs or body structures involved in breathing) status. The “SNV W/ Discharge Summary” indicated Patient 13’s skin was warm and dry, and the surgical incision (tracheostomy site) was “healing well with no signs and symptoms of infection.” During an interview on 5/11/2026 at 2:08 p.m., Responsible Party (RP) 13 stated he reported to Registered Nurse (RN) 7 the redness noted on Patient 13’s surgical site on the last home visit (4/28/2026). RP 13 stated RN 7 did not notify the physician about the redness, so RP 13 took Patient 13 to the physician directly to have the tracheostomy site assessed about 2-3 days after RN 7’s last home visit (4/28/2026). RP 13 stated the physician confirmed the tracheostomy site was infected and prescribed three antibiotics for Patient 13. During an interview on 5/11/2026 at 4:20 p.m., RN 7 stated RP 13 reported redness to Patient 13’s tracheostomy site on the last home visit (4/28/2026). RN 7 stated Patient 13’s tracheostomy site had “slight redness” but was resolving with some scabbing (body’s natural defense for sealing a broken skin while tissue heals underneath). RN 7 stated she did not report RP 13’s report of “slight redness” to any HHA supervisor or staff. During a concurrent interview and record review on 5/14/2026 at 1:13 p.m. with the Rehabilitation Supervisor (RS) and Registered Nurse Clinical Supervisor (RNCS), Patient 13’s electronic health records were reviewed. RNCS stated there was no documented evidence that “slight redness” was noted. RNCS stated there were no photos taken of the tracheostomy site to support the skin assessment. RNCS stated there was no documented evidence that RN 7 notified the physician about the redness to the tracheostomy site. RNCS stated inaccurate and incomplete assessment of the tracheostomy site could lead to an infection of the tracheostomy site that could further lead to sepsis (body’s extreme, life-threatening response to an infection). RNCS stated Patient 13 had an infection because Patient 13’s “Patient Communication,” dated 5/1/2026, indicated the physician ordered three antibiotics (medication to treat bacterial infections): mupirocin external ointment 2% apply to affected areas twice a day, Ciprofloxacin 500 milligrams (mg, unit of measurement of weight) 1 tablet by mouth twice a day for 10 days, and Clindamycin 300 mg 1 capsule by mouth four times a day for 10 days. During a review of the HHA’s undated policy and procedures (P&P), titled “Ongoing Assessments,” the P&P indicated the following: 1. During each home visit, the appropriate clinician must re-evaluate the patient according to the problems identified during the initial visit and thereafter. 2. Re-assessments should focus on patient’s response to care and changes in patient condition. 3. The clinician must report changes in condition and clinical issues to the physician. Based on the findings of the reassessment, change/verbal orders must be generated and forwarded to the physician, as needed. In addition, during a review of the HHA’s undated policy and procedures (P&P), titled “Monitoring Patient’s Response/Reporting to Physician,” the P&P indicated the following: 1. Clinicians must establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient. 2. During each home visit, the clinician must monitor the patient’s response to care against the established goals, including but not limited to: care interventions and treatments, medications, and teaching.”

“Disclosure of ownership and management info. CFR(s): 484.100(a) The HHA must comply with the requirements of part 420 subpart C, of this chapter. The HHA also must disclose the following information to the state survey agency at the time of the HHA’s initial request for certification, for each survey, and at the time of any change in ownership or management: (1) The names and addresses of all persons with an ownership or controlling interest in the HHA as defined in §420.201, §420.202, and §420.206 of this chapter. (2) The name and address of each person who is an officer, a director, an agent, or a managing employee of the HHA as defined in §420.20l, §420.202, and §420.206 of this chapter. (3) The name and business address of the corporation, association, or other company that is responsible for the management of the HHA, and the names and addresses of the chief executive officer and the chairperson of the board of directors of that corporation, association, or other company responsible for the management of the HHA. This Standard is not met as evidenced by: Based on interviews and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to provide documented evidence that the HHA notified the Department in writing regarding the change in the Director of Patient Care Services (DPCS) within 10 days of the change. This failure had the potential to cause in the delay of communication with the HHA due to not updating the point of contact. Findings: During a review of the California Department of Public Health online database on 5/7/2026 at 10:32 a.m., the Director of Patient Care Services (DPCS) from 3/25/2024 to present was DPCS 2 (previous DPCS). During a concurrent interview and record review on 5/7/2026 at 12:54 p.m. with the DPCS designee, the HHA’s current organizational chart was reviewed. The DPCS designee stated the current DPCS was DPCS 1, but the DPCS designee was unable to state when DPCS 1 took over the position. During a review of the HHA’s details on the Department’s electronic licensing management system (ELMS), the ELMS indicated there were no applications received regarding a change in the DPCS. During a concurrent interview and record review on 5/19/2026 at 10:41 a.m. with the Administrator, DPCS 1’s appointment letter, dated 6/1/2025 was reviewed. The Administrator stated DPCS 1 accepted the offer to promote to DPCS on 6/1/2025. The Administrator stated the HHA sent the application regarding the changes in the DPCS to the Department, but there was no documented evidence that the application was mailed. The Administrator stated not updating the Department could cause a delay in the communication with the HHA due to the point of contact not being updated. During a review of the HHA’s Job Description for the Administrator/Executive Director, dated 11/2021, the Job Description indicated the essential job functions/responsibilities included complying with the applicable laws and regulations and ensuring the accuracy of public information materials and activities. A review of the California Code of Regulations, Title 22, Division 5, Chapter 6, Article 2. Section 74667, titled “Report Of Changes,” indicated that the licensee shall, within 10 days, notify the Department in writing of the Change of Director of Patient Care Services including the name and mailing address of the Director of Patient Care Services, the date the Director of Patient Care Services assumed office and a brief description of qualifications and background of the Director of Patient Care Services.”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on observation, interview and record review, the HHA (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure that clinical record entries were appropriately authenticated, dated, and timed, as required for nine of 20 sampled patients (Patient 1, Patient 2, Patient 3, Patient 4, Patient 7, Patient 9, Patient 12, Patient 14 and Patient 19. This failure was evidenced by: 1. Clinical record entries for six of 20 sampled patients (Patient 2, Patient 3, Patient 4, Patient 12, Patient 17, and Patient 19) were missing the required authentication (verifying that the documentation was completed by the authorized individual who provided the service typically by a signature, date and time when the entry was completed), as they were not signed by the professional who authored them. 2. Clinical record entries for six of 20 sampled patients (Patient 1, Patient 2, Patient 7, Patient 9, Patient 12, and Patient 14) were entered late and backdated (the practice of entering a date on a document, clinical record, or order that is earlier than the actual date the entry was created or signed) indicating dates earlier than the actual date of entry or signature. 3. Orders for delayed start of care for two of 20 sampled patients (Patient 7 and Patient 19) did not accurately reflect the clinician’s communication resulting in inaccurate documentation. 4. Orders for three of 20 sampled patients (Patient 1, Patient 12, and Patient 14) were not signed within the HHA’s required 72‑hour timeframe, resulting in untimely authentication. These failures had the potential to adversely impact on the quality of patient care, and contributes to worsening of patients conditions, avoidable complications and preventable emergency department visits or hospitalizations. a3. During a review of Patient 3’s undated medical record, titled “Patient Information,” the “Patient Information” indicated the start of care (SOC) date of 4/30/2026 with a primary diagnosis of Alzheimer’s disease (progressive brain disorder that affects memory, mental skills, and the ability to carry out simply daily tasks). During a review of Patient 3’s Physician Order, dated and signed by the Director of Patient Care Services (DPCS) on 5/4/2026, the Physician Order indicated the new medications included: hydrochlorothiazide (medication to treat high blood pressure [BP, pressure of blood against the arteries]) 25 mg 1 tablet by mouth daily for BP (started on 5/4/2026). During a concurrent observation and interview on 5/8/2026 at 11:58 a.m., while on a joint home visit with Physical Therapist (PT) 2 in Patient 3’s living room with RP 4, Patient 3 was alert, confused, and sitting on the couch in the living room. Patient 3 complained of 6 out of 10 pain on the left groin with occasional grimacing during exercise with PT 2. Patient 3’s blood pressure readings were 180/90 mmHg and 200/90 mmHg. RP 4 stated Patient 3’s Primary Care Physician (PCP) was aware of Patient 3’s high BP readings and Patient 3 has an upcoming appointment with the PCP in four days. RP 4 stated Patient 3 refused to take her morning medications, including BP medication. PT 2 provided teaching regarding the importance of taking her BP medication. Patient 3 eventually took the morning medications, including the BP medication, after multiple attempts of PT 2 and RP 4 to convince Patient 3 to take her morning medications. Patient 3’s medication bottles and Patient 3’s Patient Medication Record were also reviewed. Per RP 3, Patient 3 had stopped taking hydrochlorothiazide 25 mg 1 tablet by mouth daily for blood pressure about 6 months ago per physician’s advice. During a review of Patient 3’s “Patient Communication,” dated 5/11/2026, the “Patient Communication” indicated Occupational Therapist (OT) 1 reported Patient 3’s elevated BP readings of 174/67 millimeters of mercury (mmHg, unit of measurement of pressure) and 158/64 mmHg and Patient 3 not taking the hydrochlorothiazide (medication to treat high BP) to the physician via the hospital’s designated hotline. During a review of Patient 3’s audit details on “Patient Communication,” dated 5/11/2026, the audit details indicated Offshore Non-Clinical Quality Assurance (ONCQA) 1 and ONCQA 3 completed the form on 5/12/2026 and OT 1 signed the form on 5/12/2026. During a review of Patient 3’s “Physician Order,” dated 5/11/2026, the “Physician Order” indicated OT 1 obtained a verbal order with the “order read back and verified with ordering provider.” The “Physician Order” indicated Patient 3 was not taking hydrochlorothiazide for BP. During a review of Patient 3’s audit details on “Physician Order,” dated 5/11/2026, the audit details indicated ONCQA 2 and ONCQA 4 created and updated the “task details” on 5/12/2026 and OT 1 signed the form on 5/12/2026. During an interview on 5/20/2026 at 12:09 p.m., OT 1 stated she did not speak with the physician and/or obtain a verbal order regarding Patient 3’s elevated BP and hydrochlorothiazide from the physician. OT 1 stated she did not document on the “Patient Communication,” dated 5/11/2026, or “Physician Order,” dated 5/11/2026 because OT 1 only documented on the Patient 3’s Visit Note. During a concurrent interview and record review on 5/14/2026 at 11:48 a.m. with the Rehabilitation Supervisor (RS) and Registered Nurse Clinical Supervisor (RNCS), Patient 3’s medical records were reviewed. The RS stated there was no documented evidence that PT 2 and/or OT 1 requested a skilled nurse (SN) consult to review the effectiveness of the BP medication and follow up with the physician regarding the high BP readings. The RNCS stated it was important to request an SN consult to further evaluate the causes of high BP, such diet noncompliance (high sodium intake could lead to a higher BP), medication noncompliance, uncontrolled pain or stress, or PT exercises, and obtain a physician order if a change in the BP medication was necessary. The RNCS stated there was no documented evidence an RN followed up with the physician regarding the high BP readings and to clarify the hydrochlorothiazide order. The RNCS stated a BP uncontrolled by BP medications could lead to more heart problems, stroke, and hospitalization. During a concurrent interview and record review on 5/21/2026 at 3:03 p.m. with the Director of Patient Care Services (DPCS), Patient 3’s physician orders were reviewed. The DPCS stated there was no documented evidence regarding the response of Patient 3’s physician and the “verbal order” provided to OT 1 regarding Patient 3’s high BP and Patient 3 not taking hydrochlorothiazide as listed on Patient 3’s medication profile. During a review of the HHA’s undated policy and procedures (P&P), titled “Verification of Physician Orders,” the P&P indicated the following: Orders must be obtained from a licensed physician for care and services to be provided to home health patients.Verbal orders must be spoken to, taken, and documented only by professional, licensed home health personnel (Registered Nurse or qualified therapist). Orders received via text message would not be accepted.A qualified individual must review each order or prescription before care is provided.An order or prescription must be verified when there is a question or discrepancy in the order/prescription and when the order is communicated by someone other than the physician or his/her agent. The order or prescription reviewed may be the original order, a facsimile copy, if permitted by law, or the direct transcription of a verbal order.All telephone orders must be received and processed in accordance with state and federal laws and regulations.Orders must be documented on a form provided by the HHA, dated and signed by the professional receiving the order. a4. During a review of Patient 4’s undated medical record, titled “Patient Information,” the “Patient Information” indicated the SOC date of 5/5/2026 with a primary diagnosis of “Encounter for change or removal of nonsurgical wound dressing (wound not caused by surgery that requires a healthcare provider to assess, clean, and replace the wound dressing).” During a concurrent interview and record review on 5/21/2026 at 12:09 p.m. with the Director of Patient Care Services (DPCS), Patient 4’s “Patient Communication,” dated 5/7/2026, was reviewed. The DPCS stated Patient 4’s “Patient Communication,” dated 5/7/2026, the “Patient Communication” was not signed. The DPCS stated all clinical notes must be signed and dated by the author of the note to ensure accuracy and validity of the note through proper authentication (process of verifying a user to ensure they are who they claim to be) and verification of the communication details. a6. During a review of Patient 17’s undated medical record, titled “Patient Information,” the “Patient Information” indicated SOC date of 4/1/2026 with a primary diagnosis of type 2 diabetes mellitus (chronic condition where the body resists insulin or cannot produce enough of it, causing blood sugar levels to rise) with diabetic polyneuropathy (nerve damage caused by long-term high blood sugar). During a concurrent interview and record review on 5/21/2026 at 12:09 p.m. with the Director of Patient Care Services (DPCS), Patient 17’s “Patient Communication,” dated 4/2/2026, and “Patient Communication,” dated 4/4/2026, were reviewed. The DPCS stated Patient 17’s “Patient Communication,” dated 4/2/2026 ,and “Patient Communication,” dated 4/4/2026 were not signed. The DPCS stated all clinical notes must be signed and dated by the author of the note to ensure accuracy and validity of the note through proper authentication (process of verifying a user to ensure they are who they claim to be) and verification of the communication details. c3. During a review of Patient 19’s undated medical record, titled “Patient Information,” the “Patient Information” indicated Patient 19’s SOC date of 5/6/2026 with a primary diagnosis of “Encounter for change or removal of surgical wound dressing (routine change or removal of a surgical wound dressing)” and a secondary diagnosis of “open wound of left upper arm.” The “Patient Information” indicated Patient 19’s referral date of 5/1/2026. During a review of Patient 19’s referral document from General Acute Care Hospital (GACH) 1, dated 4/30/2026, the referral document indicated Patient 19’s anticipated discharge date was 4/30/2026 with home health. The referral document indicated Patient 19 required Registered Nurse (RN) services to provide wound care as Patient 19 would be discharged home with a small chest tube drain (external, portable drainage collection device attached to a chest tube [flexible, hollow plastic tube inserted through the chest wall into the space around the lungs] to safely remove trapped air, blood, or fluid to allow the lungs to fully expand). The referral indicated per thoracic surgery (team of surgeons who specialize on the operative treatment of organs inside the chest, including the lungs, esophagus [food pipe], trachea [windpipe], and chest wall), Patient 19 required dressing changes every 3 days around the chest tube and to use a 4x4 drain gauze (sterile [free of germs], highly absorbent materials that prevent wound infections by managing exudates [fluids that may seep from wounds or surgical areas]) and tape to reinforce the dressing. The referral also indicated per thoracic surgery, Patient 19’s new chest tube drain might need to be exchanged if it fills up. During a review of Patient 19’s “SOC Delay Order,” dated 5/4/2026, the “SOC Delay Order” indicated the verbal order was obtained with “order read back and verified with ordering provider.” The “SOC Delay Order” indicated the reason for a delayed visit was “tried calling the patient to schedule the SOC visit, but the call remain unanswered.” During a review of Patient 19’s “SOC Delay Order,” dated 5/5/2026, the “SOC Delay Order” indicated the verbal order was obtained with “order read back and verified with ordering provider.” The “SOC Delay Order” indicated the reason for delayed visit was “patient reported a leaking issue and was instructed to go to urgent care or the emergency room (ER) due the leaking condition as home care was not appropriate at this time.” During a review of Patient 19’s “SOC Delay Order,” dated 5/6/2026, the “SOC Delay Order” indicated the verbal order was obtained with “order read back and verified with ordering provider.” The “SOC Delay Order” indicated Patient 19 agreed to do SOC on 5/6/2026. During a review of Patient 19’s Start of Care Order, dated 5/6/2026, the “Start of Care Order” indicated the following orders: Skilled Nurse (SN) frequency of home visits to Patient 19 was twice a week for three weeks.SN to perform chest tube draining using sterile technique and infection control measures using agency policy and procedures and to teach chest tube care and management.SN to perform wound care using infection control measures and standard precautions to the left axilla: Cleanse with normal saline (NS, salt solution to clean the wound), pat dry, apply drain sponge/gauze, secure with tape dressing, and change every 3 days.SN to perform wound care the chest tube site: cleanse with NS, pat dry, apply drain sponge/gauze, secure with tape dressing, and change every 3 days.SN to provide teaching regarding monitoring for signs and symptoms of infection and to report to the physician or SN.SN to provide teaching regarding deep breathing exercises and energy conservation techniques to prevent shortness of breath (SOB) and new Atrium Express Mini 500 Mobile Dry Seal Draine that may need to be exchanged if it fills up.During an interview on 5/18/2026 at 2:02 p.m., Patient 19 stated he had been diagnosed with Stage 4 lung cancer (cancer has spread from where it started in the lung to distant parts of the body, such as the brain, bones, or liver) for which the physician placed a PleurX catheter (small, flexible, tunneled silicone tube placed in the chest or abdomen to intermittently drain recurring fluid buildup in the lungs to relieve shortness of breath [SOB]). Patient 19 stated he was hospitalized from 4/15/2026 to 4/30/2026 due to an infection of the PleurX catheter. Patient 19 stated the physician removed the PleurX catheter, made an incision, removed a part of his rib to wash out the pus or bacteria, and inserted a chest tube. Patient 19 stated he was administered intravenous (IV, into the vein) antibiotics for 10 days. Patient 19 stated his last wound care was done on the date of his discharge from GACH 1 on 4/30/2026. Patient 19 stated GACH 1 stated the HHA would call Patient 19 within 24 hours of discharge from GACH 1 to schedule a nurse home visit to “come in and replace the bandages of the wound, make sure there is no infection, … and put in another chest tube drain, if needed.” Patient 19 stated the HHA might have called, but he was unable to answer the phone call because he “was taking a lot of medications at the time.” Patient 19 stated he might have received a nurse visit on 5/3/2026, but he was unable to recall the name of the HHA nurse. Patient 19 was unable to recall the date when he went back to GACH 1 for the exchange of chest tube drain related to the leaking chest tube. During an interview on 5/18/2026 at 3:26 p.m., RN 8 stated the HHA received Patient 19’s referral on 5/1/2026. RN 8 stated Patient 19 was originally assigned to a different nurse. RN 8 stated there was no nurse available to see Patient 19 on 5/2/2026 and 5/3/2026. RN 8 stated she was “too busy” conducting home visits for the other patients on 5/4/2026, and no nurse was able to conduct a home visit on Patient 19 on 5/4/2026. RN 8 stated Patient 19 was assigned to RN 8 on 5/5/2026, but RN 8 was unable to visit Patient 19 because the HHA staff (unable to identify) advised Patient 19 to go to the ER to address the leaking chest tube. RN 8 stated she conducted the first home visit for Patient 19 on 5/6/2026. During a concurrent interview and record review of Patient 19’s medical records on 5/21/2026 at 12:46 p.m., with the Director of Patient Care Services (DPCS), Patient 19’s electronic health records (EHRs) and Scheduling and Care Coordination Platform (SCCP) details were reviewed. The DPCS stated the following: -Patient 19’s referral date was 5/1/2026, so the expected SOC date was no later than 5/3/2026. -The RN must conduct the initial assessment within 48 hours of the referral date to assess Patient 19’s needs, including ordering of supplies and evaluating the caregiver needs. -There was no documented evidence that an RN called Patient 19 to schedule the SOC visit on or before 5/3/2026. The DPCS stated there was no documented evidence that an RN conducted an SOC visit on 5/3/2026. -There was no documented evidence that an RN was assigned to visit and/or called Patient 19 to schedule a visit on 5/4/2026. -Patient 19 reported a leaking chest tube to the HHA on 5/5/2026, and the Non-Clinical Offshore Staff 1 (NCOS 1) called Patient 19 on 5/5/2026 to advise Patient 19 to go to the ER per “Supervisor’s” instructions. The DPCS was unable to provide documented evidence of the communication details with the “supervisor” who provided the instructions. -The SOC visit and initial assessment were conducted on 5/6/2026. The DPCS stated the delay of care placed Patient 19 at increased risks for delayed wound healing, development of an infection of the wound, and rehospitalization. During a review of the HHA’s undated policy and procedures (P&P), titled “Verification of Physician Orders,” the P&P indicated the following: Orders must be obtained from a licensed physician for care and services to be provided to home health patients.Verbal orders must be spoken to, taken, and documented only by professional, licensed home health personnel (Registered Nurse or qualified therapist). Orders received via text message would not be accepted.A qualified individual must review each order or prescription before care is provided.An order or prescription must be verified when there is a question or discrepancy in the order/prescription and when the order is communicated by someone other than the physician or his/her agent. The order or prescription reviewed may be the original order, a facsimile copy, if permitted by law, or the direct transcription of a verbal order.All telephone orders must be received and processed in accordance with state and federal laws and regulations.Orders must be documented on a form provided by the HHA, dated and signed by the professional receiving the order.b.3.During a review of Patient 7’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date of 4/21/2026 with documented diagnoses including hypothyroidism (insufficient production of thyroid hormones, resulting in a slowed metabolism) and shortness of breath (SOB- the sensation of being unable to get enough air during breathing). During a review of Patient 7’s clinical record titled “OASIS (Outcome and Assessment Information Set, a federally mandated, multi-purpose assessment instrument for home health care)-E2 Start of Care,” dated 4/21/2026, the clinical record indicated Registered Nurse 1 (RN 1) signed the form on 4/21/2026. The clinical record did not indicate the entry was submitted as a late entry or as an addendum. During a concurrent interview and record review on 5/22/2026 at 12:10 PM with the Agency’s Director of Patient Care Services (DPCS), Patient 7’s clinical record titled “Task Details (an electronic medical record (EMR) form indicating who and when a document was created, updated, or revised) Patient 7 OASIS-E2 Start of Care,” undated, was reviewed. The clinical record indicated: - RN 1 initially signed the form on 4/29/2026, and not 4/21/2026 as indicated on Patient 7’s clinical record titled “OASIS-E2 Start of Care,” dated 4/21/2026. - Patient 7’s “OASIS-E2 Start of Care,” dated 4/21/2026, had been reopened and updated by Quality Assurance Staff 1 (QA Staff 1), QA Staff 2 and QA Staff 3 several times between 4/30/2026 to 5/11/2026. - RN 1’s most recent signature on the form was 5/11/2026, and not 4/21/2026 as indicated on Patient 7’s clinical record titled “OASIS-E2 Start of Care,” dated 4/21/2026. The DPCS stated that the OASIS must include the date the form was signed. If the form is edited or entered as a late entry, the documentation must clearly indicate this, and the signature date must reflect the date the form was signed after the changes were completed. During a review of HHA’s P&P, titled “Initial and Comprehensive Assessment,” revised on November 2021, the P&P indicated: -A comprehensive assessment will be completed within 5 calendar days of the patient’s start of care. -The assessment will be patient-specific and comprehensive and will include the exact use of the current versions of the Outcome and Assessment Information Set (OASIS). b.4.During a review of Patient 9’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date 4/3/2026 with documented diagnoses including encounter for adjustment and management of ventricular assist device (a surgically implanted mechanical pump that supports the heart circulate blood) and bacteremia (the presence of bacteria in the bloodstream). During a review of Patient 9’s clinical record titled “OASIS-E2 Start of Care,” dated 4/3/2026, the clinical record indicated RN 10 signed the form on 4/3/2026. The clinical record did not indicate the entry was submitted as a late entry or as an addendum. During a concurrent interview and record review on 5/22/2026 at 12:30 PM with the Agency’s DPCS, Patient 9’s clinical record titled “Task Details Patient 9 OASIS-E2 Start of Care,” undated, was reviewed. The clinical record indicated: - RN 10 initially signed the form on 5/8/2026, and not 4/3/2026 as indicated on Patient 9’s clinical record titled “OASIS-E2 Start of Care,” dated 4/3/2026. - Patient 9’s “OASIS-E2 Start of Care,” dated 4/3/2026, had been reopened and updated by QA Staff 4, QA Staff 5, QA Staff 6, QA Staff 7, QA Staff 8, and QA Staff 9 several times between 4/5/2026 to 5/11/2026. - RN 10’s most recent signature on the form was 5/11/2026, and not 4/21/2026 as indicated on Patient 9’s clinical record titled “OASIS-E2 Start of Care,” dated 4/3/2026. The DPCS stated that the OASIS must include the date the form was signed. If the form is edited or entered as a late entry, the documentation must clearly indicate this, and the signature date must reflect the date the form was signed after the changes were completed. During a review of HHA’s P&P, titled “Initial and Comprehensive Assessment,” revised on November 2021, the P&P indicated: -A comprehensive assessment will be completed within 5 calendar days of the patient’s start of care. -The assessment will be patient-specific and comprehensive and will include the exact use of the current versions of the Outcome and Assessment Information Set (OASIS). b.6.During a review of Patient 14’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date of 3/10/2026 with documented diagnoses including encounter for change or removal of nonsurgical wound dressing (a medical visit specifically for changing or removing a wound dressing that was not applied in a surgical setting) and surgical site infection following procedure (an infection occurring at the location of a surgical incision or internal area involved in surgery). During a review of Patient 14’s clinical record titled “OASIS-E1 Start of Care,” dated 3/10/2026, the clinical record indicated RN 11 signed the form on 3/10/2026. The clinical record did not indicate the entry was submitted as a late entry or as an addendum. During a concurrent interview and record review on 5/22/2026 at 12:44 PM with the Agency’s DPCS, Patient 14’s clinical record titled “Task Details Patient 14 OASIS-E1 Start of Care,” undated, was reviewed. The clinical record indicated: - RN 11 signed the form on 5/11/2026, and not 3/10/2026 as indicated on Patient 14’s clinical record titled “OASIS-E1 Start of Care,” dated 3/10/2026. - Patient 14’s “OASIS-E1 Start of Care,” dated 3/10/2026, had been reopened and updated by QA Staff 3, QA Staff 5, QA Staff 6, QA Staff 8, QA Staff 10, QA Staff 11, QA Staff 12, and QA Staff 13 several times between 3/11/2026 to 5/11/2026. The DPCS stated that the OASIS must include the date the form was signed. If the form is edited or entered as a late entry, the documentation must clearly indicate this, and the signature date must reflect the date the form was signed after the changes were completed. During a review of HHA’s P&P, titled “Assembly of Clinical Record,” revised on November 2021, the P&P indicated all patient care documented will be submitted by the staff member within 72 hours from the time care was provided. During a review of HHA’s P&P, titled “Quality Assurance (QA) Review of Clinical Records,” undated, the P&P indicated: - Clinical records will be reviewed through the QA process to support documentation accuracy, regulatory compliance, and consistency with patient care provided. - QA staff shall review documentation and when deficiencies, omissions, inconsistencies, or corrections are identified, the documentation shall be returned to the clinician responsible for correction. Following correction by the clinician, the documentation shall be resubmitted for QA review. - The clinician must sign and review the clinical record to finalize and close the record. - The clinician must complete clinical records accurately, timely, and in accordance with home health regulations. - QA staff are not permitted to make corrections, additions, completions, or substantive changes on behalf of a clinician. Documentation corrections must be made by the clinician who created the clinical record or by the appropriate responsible clinician. During a review of HHA’s P&P, titled “Initial and Comprehensive Assessment,” revised on November 2021, the P&P indicated: -A comprehensive assessment will be completed within 5 calendar days of the patient’s start of care. -The assessment will be patient-specific and comprehensive and will include the exact use of the current versions of the Outcome and Assessment Information Set (OASIS). c.1.During a review of Patient 7’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date of 4/21/2026 with documented diagnoses including hypothyroidism and SOB. During a review of Patient 7’s clinical record titled “Patient Profile,” undated, the clinical record included contact information for Responsible Party 1 (RP 1) and did not include contact information for the patient’s family members. During an interview on 5/14/2026 at 12:21 PM with RP 1, RP 1 stated that she did not speak with HHA staff on 4/20/2026 to schedule the start of care visit on 4/21/2026. RP 1 stated that she did not speak with HHA staff on 4/28/2026 to report that Patient 7 would not be available for a visit during the week of 4/26/2026 to 5/2/2026. During a concurrent interview and record review on 5/14/2026 at 1:16 PM with RN 1, Patient 7’s physician order titled “SOC (start of care) Delay Order,” dated 4/18/2026 and 4/19/2026 were reviewed. The physician orders indicated a verbal order with read back (a safety practice in which the person receiving a verbal or telephone order repeats the order back to the provider to confirm that it was heard and recorded correctly) was obtained from Patient 7’s physician, and that RN 1attempted to contact Patient 7’s Family Member 1 (FM 1) to schedule the start of care visit but was unable to make contact. RN 1 stated that he did not attempt to contact FM 1 on 4/18/2026 or 4/19/2026 and that the patient’s clinical record did not contain FM 1’s phone number. During a concurrent interview and record review on 5/14/2026 at 1:16 PM with RN 1, Patient 7’s physician order titled “SOC Delay Order,” dated 4/20/2026 was reviewed. The physician order indicated a verbal order with read back was obtained from Patient 7’s physician, and that RN 1 contacted RP 1 to schedule the start of care visit for 4/21/2026. RN 1 stated that he did not attempt to contact RP 1 on 4/20/2026 and that his first communication with RP 1 occurred on 4/21/2026 during the start of care visit. RN 1 requested to continue the interview on 5/15/2026 between 11: 30 – 11:45 AM. During an interview on 5/15/2026 at 11:32 AM, a call was placed to RN 1. RN 1 did not answer, and a voicemail was left requesting a return call. During an interview on 5/15/2026 at 12:22 PM with Caregiver 1 (CG 1), CG 1 stated she was the caregiver assigned to care for Patient 7 on 4/28/2026. CG 1 stated that she did not speak with HHA staff on 4/28/2026 to report that Patient 7 would not be available for a visit during the week of 4/26/2026 to 5/2/2026. During a concurrent interview and record review on 5/22/2026 at 12:10 PM with the Agency’s Director of Patient Care Services (DPCS), Patient 7’s clinical record titled “Task Details (an electronic medical record (EMR) form indicating who and when a document was created, updated, or revised) Patient 7 SOC Delay Order,” for visit date 4/18/2026, 4/19/2026, and 4/20/2026 were reviewed. The clinical record indicated that the order documentation was created on 5/8/2026. The DPCS stated RN 1 signed the physician orders on 5/11/2026 and backdated the orders as 4/18/2026, 4/19/2026, and 4/20/2026 respectively. The physician orders did not accurately reflect the signature date. During a review of HHA’s P&P, titled “Assembly of Clinical Record,” revised on November 2021, the P&P indicated all patient care documented will be submitted by the staff member within 72 hours from the time care was provided. During a review of HHA’s P&P, titled “Verification of Physician Orders,” revised on November 2021, the P&P indicated: - orders will be obtained from a licensed physician for care and services to be provided to home health patients. - verbal orders will be spoken to, taken and documented only by professional, licensed home health personnel (RN or qualified therapist). - a qualified individual will review each order before care is provided. - orders will be documented on a form provided by the HHA, dated and signed by the professional receiving the order. d.3.During a review of Patient 14’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date of 3/10/2026 with documented diagnoses including encounter for change or removal of nonsurgical wound dressing and surgical site infection following procedure. During a review of Patient 14’s clinical record titled “Physician Order,” dated 3/11/2026, the clinical record indicated the following medication orders were received from Patient 14’s physician by RN 11: -New medication: Santyl external ointment (medication applied to the skin used to remove dead, damaged tissue from chronic skin ulcers and severe burns) 250 units/ gram (g- unit of measurement). Apply to affected areas daily or as directed for wound care. -Discontinued medication: oxycodone (pain medication used to treat moderate-to-severe pain) 5 milligram tablet. Take 1 tablet by mouth every 6 hours as needed for moderate pain (4-6/10 - characterized as pain level 4 – 6 on a 0 – 10 pain scale, with 0 being no pain at all and 10 being the absolute worst pain imaginable). During a review of Patient 14’s clinical record titled “Physician Order,” dated 3/13/2026, the clinical record indicated the following medication orders were received from Patient 14’s physician by RN 11: -New medication: diclofenac sodium external gel (medication applied to the skin used to temporarily relieve joint pain) 1%. Apply 2 g to affected areas twice daily as needed for pain. -Discontinued medication: lidocaine-prilocaine external cream (medication applied to the skin used to temporarily numb the skin) 2.5 -2.5%. Apply to dialysis access one hour before dialysis for pain. During a review of Patient 14’s clinical record titled “Physician Order,” dated 3/18/2026, the clinical record indicated the following new medication order was received from Patient 14’s physician by RN 11: - ofloxacin ophthalmic solution (antibiotic eye drop used to treat bacterial eye infections) 0.3%. Instill 1 drop in affected eyes 4 times a day to prevent eye infection. Start 3 days prior to surgery (started on 3/17/2026). During an interview on 5/13/2025 at 1:45 PM with the Agency’s Director of Patient Care Services Designee (DPCS Designee), the DPCS Designee stated that all physician orders must be signed by the receiving nurse within 24 hours of receiving the order. During a concurrent interview and record review on 5/22/2026 at 12:44 PM with the Agency’s DPCS, Patient 14’s “Task Details Patient 14 Physician Order,” for visit date 3/11/2026, 3/13/2026, and 3/18/2026 were reviewed. The clinical record indicated that the order documentation was created on 5/8/2026 and 5/9/2026, and RN 11 signed the physician orders on 5/11/2026. The DPCS stated that entering medication orders two months after they were received placed Patient 14 at increased risk of medication administration errors and potential adverse drug interactions. During a review of HHA’s P&P, titled “Assembly of Clinical Record,” revised on November 2021, the P&P indicated all patient care documented will be submitted by the staff member within 72 hours from the time care was provided. During a review of HHA’s P&P, titled “Verification of Physician Orders,” revised on November 2021, the P&P indicated: - orders will be obtained from a licensed physician for care and services to be provided to home health patients. - verbal orders will be spoken to, taken and documented only by professional, licensed home health personnel (RN or qualified therapist). - a qualified individual will review each order before care is provided. - orders will be documented on a form provided by the HHA, dated and signed by the professional receiving the order. a1. During a review of Patient 2’s Patient Information sheet, the sheet indicated a Start of Care (SOC) date of 4/14/2026 with a primary diagnosis of fracture unspecified of one femur (the thigh bone), subsequent encounter for closure fracture with routine healing. During a review of Patient 2’s clinical record titled Home Health Certification and Plan of Care (POC) for the certification period from 4/14/2026 to 6/12/2026, the POC indicated Skilled Nurse (SN) visit frequency order of three times a week for two weeks then re-evaluate, and Physical Therapy (PT) once a week for one week, two times a week for one week, and once a week for one week. During a review of Patient 2’s clinical record titled SN Evaluation dated 4/22/2025, the SN Evaluation indicated that as of 5/11/2026 there was no evidence of an electronic signature from the DPCSD, who was the clinician who documented the evaluation form. During a review of Patient 2’s clinical record titled RN skilled nursing visit dated 4/24/2026, the record indicated there was no documented evidence of an electronic signature from the visiting nurse who documented it. During a concurrent interview and record review on 5/15/2026 at 12:18 p.m. with the Director of Patient Care Services (DPCS), Patient 2’s clinical record titled SN Evaluation dated 4/22/2026 and Electronic Medical Record (EMR) were reviewed. Patient 2’s SN Evaluation assessment indicated that as of 5/11/2026 there was no evidence of an electronic signature from the DPCSD, who was the clinician who documented the form. The DPCS stated and confirmed that the SN evaluation assessment form as of 5/11/2026 was missing the DPCSD’s signature. The DPCS stated that home visit notes should be documented, signed and dated by the clinician within 72 hours of the visit date. The DPCS stated that as of 5/15/2026 Patient 2’s EMR indicated that the SN evaluation assessment now had an electronic signature from the DPCSD with the date of 4/22/2026. The DPCS stated that the nurse should not have been allowed by the EMR to sign the document 72 hours past the previous date, but instead she should have submitted her signature with real time and date. The DPCS stated that the importance of clinicians submitting and signing their assessments within the 72-hour time frame is to verify and validate what they documented. During a concurrent interview and record review on 5/15/2026 at 12:21 p.m. with the DPCS, Patient 2’s RN skilled nursing visit dated 4/24/2026 was reviewed. The DPCS stated and confirmed that patient 2’s visit note was missing the signature of the visiting nurse and stated the visiting nurse was the DPCSD. The DPCS stated that the visit note should have been completed, signed and submitted within 72 hours of the visit date. The DPCS stated that the importance of the nurse signing the visit note is to verify what they encountered and documented is correct and they validate it. The DPCS stated a visit note that is not signed is incomplete. During a review of Patient 2’s Electronic Medical Record (EMR), the EMR indicated, under comm tab, indicated patient communication notes dated 4/15/2026, 4/30/2026, 5/1/2026, 5/5/2026, and 5/7/2026. During a concurrent interview and record review on 5/15/2026 at 12:41 p.m. with the Director of Patient Care Services (DPCS), Patient 2’s EMR patient communication notes dated 4/15/2026, 4/30/2026, 5/1/2026, 5/5/2026, and 5/7/2026 were reviewed. Patient 2’s patient communication note indicated the following; Patient communication note dated 4/15/2026 did not have documented evidence of an electronic signature from the clinician, Patient communication note dated 4/30/2026 did not have documented evidence of an electronic signature from the clinician, Patient communication note dated 5/1/2026 did not have documented evidence of an electronic signature from the clinician, communication note dated 5/5/2026 did not have documented evidence of an electronic signature from the clinician, communication note dated 5/7/2026 did not have documented evidence of an electronic signature from the clinician. The DPCS stated and confirmed that Patient 2’s communication notes dated 4/15/2026, 4/30/2026, 5/1/2026, 5/5/2026, and 5/7/2026 were missing a signature and date from the clinician who documented it. The DPCS stated that in the EMR comm section next to the date of the communication note, the clinicians name assigned to the note is indicated. The DPCS stated that proper practice was that the clinician who documented the note should sign and date it within 72 hours of the date to validate the information. The DPCS stated a communication note is like an order, if they are not signed then it means the clinician is not agreeing or validating what was documented. a4. During a review of Patient 12’s Patient Information sheet, the sheet indicated a Start of Care (SOC) date of 4/30/2026 with a primary diagnosis of encounter for adjustment and management of Ventricular assistive device (A mechanical pump implanted in the chest to help a weakened heart pump blood throughout the body that is often used for patients waiting for a heart transplant or as a long-term treatment). During a review of Patient 12’s clinical record titled Home Health Certification and Plan of Care (POC) for the certification period from 4/30/2026 to 6/28/2026, the POC indicated a Skilled Nurse (SN) visit frequency order of two times a week for one week, and five times a week for one week effective 4/30/2026. The POC indicated there was no documentation evidence of an electronic signature from the perspective nurse who documented the POC. During a review of Patient 12’s clinical record titled RN skilled nursing visit dated 5/2/2026, the record indicated there was no documentation of the registered nurse’s electronic signature and date. During a review of Patient 12’s clinical record titled RN skilled nursing visit dated 5/8/2026, the record indicated there was no documentation of the registered nurse’s electronic signature and date. During a concurrent interview and record review on 5/15/2026 at 12:58 p.m. with the Director of Patient Care Services (DPCS), Patient 12’s RN Skilled nursing visit notes dated 5/2/2026 and 5/8/2026 were reviewed. Patient 12’s RN skilled nursing visit dated 5/2/2026 And 5/8/2026 indicated there was no documentation of the registered nurse’s electronic signature and date. The DPCS stated and confirmed that Patient 12’s RN skilled nursing visit note dated 5/2/2026 and 5/8/2026 did not have evidence of the nurse’s signature and date. The DPCS stated that the nursing visit notes were considered incomplete because a completed documented visit note includes the clinician’s signature and date. The DPCS stated that it was important to complete all documentation with the clinician’s signature and date to validate the visit, the documented assessment findings of the patient, and any teaching/counseling provided about medications or care. During a concurrent interview and record review on 5/15/2026 at 1:05 p.m. with the Director of Patient Care Services (DPCS), Patient 12’s POC for the certification period from 4/30/2026 to 6/28/2026 was reviewed. The POC indicated there was no documentation evidence of an electronic signature from the perspective nurse who documented the POC. The DPCS stated and confirmed that Patient 12’s POC was not signed by the nurse who documented it. The DPCS stated that the POC should have been completed and signed by the start of care nurse within 24 hours from the start of care visit date. The DPCS stated that the importance of the nurse signing the completed POC is to show validation of the documented patient’s problems and their goals and interventions for them. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 4/30/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/1/2026 was created 5/12/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/2/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/6/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/7/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/9/2026 was created 5/11/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/12/2026 was created 5/13/2026 with no evidence of an electronic signature of the author. During a concurrent interview and record review on 5/15/2026 at 1:14 p.m. with the DPCS, Patient 12’s patient communication notes dated 4/30/2026, 5/1/2026, 5/2/2026, 5/6/2026, 5/7/2026, 5/9/2026, and 5/12/2026 were reviewed. The DPCS stated and confirmed that Patient 12’s communication notes dated 4/30/2026, 5/1/2026, 5/2/2026, 5/6/2026, 5/7/2026, 5/9/2026, and 5/12/2026 were not submitted on the date it indicated and were backdated. The DPCS stated the authors of the communication notes were staff from a contracted company the agency works with, that assist in quality assurance. The DPCS stated that those staff members should have signed the patient communication note with their credentials because they were the ones documenting it. The DPCS stated the importance of the communication notes being signed and dated by the staff the documented it was to be able to trace them back if any questions or concerns arise. b1. During a review of Patient 1’s Patient Information sheet, the sheet indicated a Start of Care (SOC) date of 4/18/2026 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. During a review of Patient 1’s clinical record titled Home Health Certification and Plan of Care (POC) for the certification period from 4/18/2026 to 6/16/2026, the POC indicated Skilled Nurse visit frequency order of one time a week for one week, three times a week for one week and two times a week for one week effective 4/18/2026. During a review of Patient 1’s medical record audit log titled Task Details, it indicated a physician order dated 4/18/2026 was created on 5/7/2026 and signed by the registered nurse on 5/7/2026. During a review of Patient 1’s medical record audit log titled Task Details, it indicated a physician order dated 5/8/2026 was created on 5/11/2026 and signed by the Director of Patient Care Services Designee (DPCSD) on 5/11/2026. During a review of Patient 1’s medical record audit log titled Task Details, it indicated a physician order dated 5/8/2026 was created on 5/11/2026 and signed by the registered nurse on 5/11/2026. During a review of Patient 1’s Electronic Medical Record (EMR) on 5/8/2026, the EMR indicated, under comm tab, that there were no documented or submitted communication notes. During a review of Patient 1’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/7/2026 was created on 5/11/2026 and signed by the registered nurse on 5/11/2026. During a review of Patient 1’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/8/2026 was created on 5/11/2026 and signed by the registered nurse. During a concurrent interview record review on 5/19/2026 at 1:16 p.m. with the Administrator (ADM) Patient 1’s EMR was reviewed. Patient 1’s EMR audit trail titled Task details, indicated a patient communication note dated 5/7/2025 was created on 5/11/2026 and signed by the registered nurse on 5/11/2026, and a patient communication note dated 5/8/2026 that was created on 5/11/2026 and signed by the registered nurse on 5/11/2026. The ADM stated and confirmed that the patient communication notes dated 5/7/2026 and 5/8/2026 were backdated. The ADM stated that it was not the agency’s practice to backdate but instead the clinicians were to document in real time when the information or action happened or have documented it as a late entry. During a concurrent interview and record review on 5/20/2026 at 3:04 p.m. with the Director of Patient Care Services (DPCS) Patient 1’s Electronic Medical Record (EMR) Audit was reviewed. Patient 1’s EMR audit titled Task details indicated patient communication notes dated 5/7/2026 and 5/8/2026 were on 5/11/2026 and signed by a registered nurse on 5/11/2026. The DPCS stated and confirmed that the patient communication notes dated 5/7/2026 and 5/8/2026 were both backdated by the clinician. The DPCS stated the nurse should not have backdated and instead the nurse should have documented in real time and date, or if the documentation was late then inside of the note the nurse should have specified that it was a late entry and for what date and time. During a concurrent interview and record review on 5/20/2026 at 3:10 p.m. With the DPCS, Patient 1’s EMR Audit was reviewed. Patient 1’s EMR audit titled Task details indicated; A physician order dated 4/18/2026 that was created 5/7/2026 and signed by the registered nurse on 5/7/2026, A frequency change order dated 5/8/2026 that was created on 5/11/2026 and signed by the registered nurse on 5/11/2026, A physician order dated 5/8/2026 that was created on 5/11/2026 and signed by the registered nurse on 5/11/2026. The DPCS stated and confirmed that Patient 1’s start of care order dated 4/18/2026 was documented and created 14 days after the order date, the physician order dated 4/18/2026 was documented and created 19 days after the order date, and the frequency change order and physician order dated 5/8/2026 were documented and created 3 days after the order date. The DPCS stated that the orders were submitted late. The DPCS stated that when nurses receive orders from a physician, they are to document them and sign them within 24 hours of the order date. The DPCS stated if the nurse does not document the order within the 24 hours, then the order should be entered as a late entry or addendum. The DPCS stated that any new or change in orders should not only be reflected under orders but also in the Plan of Care (POC) as an addendum to the plan of care. b2. During a review of Patient 2’s Patient Information sheet, the sheet indicated a Start of Care (SOC) date of 4/14/2026 with a primary diagnosis of fracture unspecified of one femur (the thigh bone), subsequent encounter for closure fracture with routine healing. During a review of Patient 2’s clinical record titled Home Health Certification and Plan of Care (POC) for the certification period from 4/14/2026 to 6/12/2026, the POC indicated Skilled Nurse (SN) visit frequency order of three times a week for two weeks then re-evaluate, and Physical Therapy (PT) once a week for one week, two times a week for one week, and once a week for one week. During a review of Patient 2’s medical record audit log titled Task Details, it indicated a Start of Care delay order dated 4/11/2026 was created on 5/8/2026 and signed by the Physical Therapist 1 (PT1) on 5/8/2026. During a review of Patient 2’s medical record audit log titled Task Details, it indicated a Start of Care delay order dated 4/12/2026 was created on 5/8/2026 and signed by the Physical Therapist 1 (PT1) on 5/8/2026. During a review of Patient 2’s medical record audit log titled Task Details, it indicated a Start of Care delay order dated 4/13/2026 was created on 5/8/2026 and signed by the Physical Therapist 1 (PT1) on 5/8/2026. During a review of Patient 2’s medical record audit log titled Task Details, it indicated a physician order dated 4/27/2026 was created on 5/8/2026 and signed by the DPCSD on 5/8/2026. During a review of Patient 2’s medical record audit log titled Task Details, it indicated a physician order dated 4/29/2026 was created on 5/8/2026 and signed by the DPCSD on 5/8/2026. During a review of Patient 2’s medical record audit log titled Task Details, it indicated a physician order dated 5/4/2026 was created on 5/11/2026 and signed by the DPCSD on 5/11/2026. During a concurrent interview record review on 5/19/2026 at 12:54 p.m. with the Administrator (ADM) Patient 2’s EMR was reviewed. Patient 2’s EMR audit trail titled Task details, indicated a Start of Care delay order dated 4/11/2026 was created and signed by PT1 on 5/8/2026, Start of Care delay order dated 4/12/2026 was created and signed by PT1 on 5/8/2026, start of Care delay order dated 4/13/2026 was created and signed by PT1 on 5/8/2026, physician order dated 4/27/2026 was created and signed by the DPCSD on 5/8/2026, physician order dated 4/29/2026 was created and signed by the DPCSD on 5/8/2026, and a physician order dated 5/4/2026 was created and signed by the DPCSD on 5/11/2026. The ADM stated and confirmed that Patient 2’s orders dated 4/11/2026, 4/12/2026, 4/13/2026, 4/27/2026, 4/29/2026, and 5/4/2026 were backdated and submitted late. The ADM stated that it was not the agency’s practice to backdate any orders or documentation. The ADM stated that the clinician should have transcribed the orders in real time when received, and if the clinician was unable to document the order at the time received then make a late entry notice inside the order. During a concurrent interview and record review on 5/20/2026 at 2:53 p.m. with the DPCS, Patient 2’s order audits titled Task details dated 4/11/2026, 4/12/2026, 4/13/2026, 4/27/2026, 4/29/2026, and 5/4/2026 were reviewed. The DPCS stated and confirmed that the order dated 4/11/2026 was backdated and submitted 27 days late, order dated 4/12/2026 was backdated and submitted 26 days late, order dated 4/13/2026 was backdated and submitted 25 days late, order dated 4/27/2026 was backdated and submitted 11 days late, order dated 4/29/2026 was backdated and submitted 9 days late, and order dated 5/4/2026 was backdated and submitted 7 days late. The DPCS stated it was not proper practice of the HHA to backdate any orders or documentation. The DPCS stated that the proper practice of transcribing orders was to document them right away within 24 hours in the EMR, and sign and date to verify that that clinician was the one who received the order, verify the order details are correct and make it an active order. b5. During a review of Patient 12’s Patient Information sheet, the sheet indicated a Start of Care (SOC) date of 4/30/2026 with a primary diagnosis of encounter for adjustment and management of Ventricular assistive device (A mechanical pump implanted in the chest to help a weakened heart pump blood throughout the body that is often used for patients waiting for a heart transplant or as a long-term treatment). During a review of Patient 12’s clinical record titled Home Health Certification and Plan of Care (POC) for the certification period from 4/30/2026 to 6/28/2026, the POC indicated a Skilled Nurse (SN) visit frequency order of two times a week for one week, and five times a week for one week effective 4/30/2026. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a physician order dated 5/4/2026 was created on 5/8/2026 and signed by the registered nurse on 5/8/2026. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a plan of care addendum order dated 5/6/2026 was created on 5/11/2026 and signed by the registered nurse on 5/11/2026. During a concurrent interview and record review on 5/15/2026 at 12:53 p.m. with the DPCS, Patient 12’s orders dated 4/30/2026, 5/4/2026, and 5/6/2026 were reviewed. The DPCS stated that Patient 12’s order dated 5/4/2026 was signed late and it should have been signed within 72 hours of the order date. The DPCS stated the order dated 5/6/2026 was also a late order entry as it was not signed by the nurse within 72 hours of the order date. The DPCS stated it was important that all transcribed physician orders were signed by the entering nurse to make the validate the order is ready to be acted out. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 4/30/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/1/2026 was created 5/12/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/2/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/6/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/7/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/9/2026 was created 5/11/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/12/2026 was created 5/13/2026 with no evidence of an electronic signature of the author. During a concurrent interview and record review on 5/15/2026 at 1:14 p.m. with the DPCS, Patient 12’s patient communication notes dated 4/30/2026, 5/1/2026, 5/2/2026, 5/6/2026, 5/7/2026, 5/9/2026, and 5/12/2026 were reviewed. The DPCS stated and confirmed that Patient 12’s communication notes dated 4/30/2026, 5/1/2026, 5/2/2026, 5/6/2026, 5/7/2026, 5/9/2026, and 5/12/2026 were not submitted on the date it indicated and were backdated. The DPCS stated the authors of the communication notes were staff from a contracted company the agency works with, that assist in quality assurance. The DPCS stated that those staff members should have signed the patient communication note with their credentials because they were the ones documenting it. The DPCS stated the importance of the communication notes being signed and dated by the staff the documented it was to be able to trace them back if any questions or concerns arise. During an interview on 5/15/2026 at 1:55 p.m. with the ADM, the ADM stated that she contacted the agency’s Quality Assurance (QA) nurse in regards to Patient documents were being entered late and backdated. The ADM stated that the QA nurse told her she did review the sampled patients chart because of survey going on, and if she noticed any incomplete or unsigned documents she (QA nurse) contacted the nurses and asked them to go back into the EMR and edit what was necessary. The ADM stated the QA nurse should have not prompted the nurses to do that but instead should of had them add an addendum, late entry note or sign in real time. During an interview on 5/20/2026 at 2:25 p.m. with the QA nurse, the QA nurse stated she did start reviewing the sample patients charts for discrepancies because of the survey happening. The QA stated if she noticed incomplete or unsigned documents she contacted some nurses to have them correct it, but she did not explain to them to not back date. c1. During a review of Patient 1’s Patient Information sheet, the sheet indicated a Start of Care (SOC) date of 4/18/2026 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. During a review of Patient 1’s clinical record titled Home Health Certification and Plan of Care (POC) for the certification period from 4/18/2026 to 6/16/2026, the POC indicated Skilled Nurse visit frequency order of one time a week for one week, three times a week for one week and two times a week for one week effective 4/18/2026. During a review of Patient 1’s medical record audit log titled Task Details, it indicated a Start of care order dated 4/18/2026 was signed by the registered nurse on 5/2/2026. During a concurrent interview and record review on 5/20/2026 at 3:10 p.m. With the DPCS, Patient 1’s EMR Audit was reviewed. Patient 1’s EMR audit titled Task details indicated; a start of care order dated 4/18/2026 that was signed by the Registered Nurse on 5/2/2026. The DPCS stated and confirmed that Patient 1’s start of care order dated 4/18/2026 was documented and created 14 days after the order date. The DPCS stated that the order was considered a late submission because it was not signed. The DPCS stated that when nurses receive orders from a physician, they are to document them and sign them within 24 hours of the order date. The DPCS stated if the nurse does not document the order within the 24 hours, then the order should be entered as a late entry or addendum. c2. During a review of Patient 12’s Patient Information sheet, the sheet indicated a Start of Care (SOC) date of 4/30/2026 with a primary diagnosis of encounter for adjustment and management of Ventricular assistive device (A mechanical pump implanted in the chest to help a weakened heart pump blood throughout the body that is often used for patients waiting for a heart transplant or as a long-term treatment). During a review of Patient 12’s clinical record titled Home Health Certification and Plan of Care (POC) for the certification period from 4/30/2026 to 6/28/2026, the POC indicated a Skilled Nurse (SN) visit frequency order of two times a week for one week, and five times a week for one week effective 4/30/2026. The POC indicated there was no documentation evidence of an electronic signature from the perspective nurse who documented the POC. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Start of care order dated 4/30/2026 was signed by the registered nurse on 5/8/2026. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a physician order dated 5/4/2026 was created on 5/8/2026 and signed by the registered nurse on 5/8/2026. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a plan of care addendum order dated 5/6/2026 was created on 5/11/2026 and signed by the registered nurse on 5/11/2026. During a concurrent interview and record review on 5/15/2026 at 12:53 p.m. with the DPCS, Patient 12’s orders dated 4/30/2026, 5/4/2026, and 5/6/2026 were reviewed. The DPCS stated that Patient 12’s order dated 5/4/2026 was signed late and it should have been signed within 72 hours of the order date. The DPCS stated the order dated 5/6/2026 was also a late order entry as it was not signed by the nurse within 72 hours of the order date. The DPCS stated it was important that all transcribed physician orders were signed by the entering nurse to make the validate the order is ready to be acted out. 6 a. The HHA failed to maintain accurate active patient census and discharges to ensure patients admitted to the agency were tracked and received physician-ordered services for 2 of 22 sampled patients ( Patient 20 and Patient 21) and resulted in the agency’s inability to identify whether physician-ordered services were provided, delayed, or not furnished as ordered. This Failure has the potential to place patient at risk for missed treatments, delayed care, worsening medical conditions, hospitalizations, and adverse health outcomes. Dring a complaint validation survey allegations were received that patients were not being seen for initial assessment on a timely basis if all, and that physician-ordered treatments were not being provided, were delayed, or patients were discharged without receiving ordered wound care or intravenous therapy, On 5/20/2026 at 11 a.m., the Administrator (ADM), Director of Patient Care Services (DPCS) and Registered Nurse Clinical Supervisor (RN clinical supervisor ), were requested to provide the active patient census and discharge list. Review of the active patient census and discharge list provided by the agency on 5/20/2026, at 1:55p.m., indicated Patient 20 and Patient 21 were not listed as active patients and were not listed on the discharge census. On 5/21/2026, the Administrator (ADM), Director of Patient Care Services (DPCS) and Registered Nurse Clinical Supervisor (RN clinical supervisor ), were requested to provide the active patient census and discharge list and stated it was the same as the list given on 5/20/2026. a. During a review of Patient 20’s , Electronic Medical Record titled, “Referral Form (an official medical document used by primary care physician to legally authorize and order n skilled nursing ,physical therapy, or other in-home medical services for a patient)”, dated 5/2/2026, the form indicated the HHA’s registered nurse (RN) was to provide Intravenous (IV, within the vein) Infusion of Nafcillian, IV piggyback (a penicillin-based antibiotic used to treat severely deep-seated bacterial infections such as endocarditis , bacteremia ,or bone infections ), 2 grams every 4 hours between from 4/28/2026 to 6/8/2026 via PICC (Peripherally inserted central catheter- a thin flexible tube inserted in the upper arm and guided into a large vein above the right side of the heart to deliver used for long term intravenous treatments, nutrition, to prevent frequent needle sticks) with HHA IV administration. The referral form indicated to start IV services from 5/3/2026 to 6/8/2026. During a record review of Patient 20’s “Notice of Authorization of Services Form (a document used by healthcare providers and insurance plans like Medicare or Medicaid to formally approve or outline the scope of Home Care Services a patient will receive including type of visits, frequency, and duration of care)”, dated 5/2/2026, the form indicated patient was admitted to the home health agency (HHA), with a start of care (SOC) date of 5/2/2026, with diagnoses which included Orthopedic aftercare (the medical therapy, treatment and patient received following and orthopedic procedure), Bacterial Arthritis [a serious within the joint that requires urgent medical attention] infection), of left knee, and endocarditis (a serious heart infection often caused by bacterial/fungal infections that causes inflammation of the hearts interlining, enter the blood stream, traveling to the heart, attaching to damage valves and destroying the heart tissue). The Notice of Authorization form indicated the RN to visit one time for Nursing assessment/Evaluation, and RN Home Care Per Diem for 6 visits. The “Notice of Authorization and Service” form, the form indicated an approved request for “Priority Next Day IV POD (an infusion pump that is wearable and allows patient to move around their homes while receiving continuous or intermittent treatments). During a record review of Patient 20’s Start of Care Order, dated 5/3/2026, the order indicated skilled nurse frequency daily three days and then two times a week for six weeks. Skilled nurse to perform PICC site assessment and (routine) dressing change; RN IV site assessment every visit. During an interview on 5/19/2026 at 1:30 p.m., RN 2 stated FM 1 told her that she had not seen any HHA staff since 5/3/2026 when Patient 20 was admitted. RN 2 stated that she was informed by the RN Clinical Supervisor on 5/5/2026 to go see Patient 20 and hang the IV antibiotics. During an interview with the DPCS on 5/20/2026 at 1:30 p.m. the DPCS she did not know at the time and would have to further review and investigate to see what the reason Patient 20 had not received the ordered skilled nursing visits and intravenous antibiotic therapy as ordered by Patient 20’s physician. The DPCS stated she and another RN supervisor were responsible to oversee the HHA staff providing services to the patients in northern and southern California. and that they pick random patients medical records to review. The DPCS stated the HHA is looking for more RN supervisors to oversee the care provided to the patients by the HHA staff. During an interview on 5/21/2026 at 1:20 p.m., with RN Clinical Supervisor, the RN Clinical Supervisor stated there was no documentation that indicated the IV medication was provided. The RN Clinical Supervisor stated it was important for Patient 20 to get IV antibiotic therapy to prevent the patient becoming septic, decline in his health and possible rehospitalization. 6 b, During a concurrent medical record review with the Administrator on 05/20/2026 at 2:00 p.m., Patient 21’s document titled “Referral Home Health Care Order,” dated 04/24/2026, indicated a referral for routine home health services due to Aftercare Following Hospitalization (care required following an inpatient stay) and Pneumonia (infection causing inflammation of the lungs, impairing oxygen exchange). The Start of Care (SOC) date was listed as 04/24/2026. During record review, the OASIS assessment dated 04/28/2026 indicated the patient met criteria for admission. Review of the HHA’s SOC order dated 04/28/2026 indicated Patient 21 was admitted to the HHA on 04/28/2026. During record review of Patient 20’s clinical record titled “OASIS‑E2 Start of Care,” dated 04/28/2026, the document indicated Registered Nurse 2 (RN2) signed the form on 04/28/2026. No additional clinical notes were present in Patient 21’s medical record to show that services were provided following admission. Patient 21 was not listed on the active census or discharge list. During an interview with the Administrator and DPCS on 05/21/2026 at approximately 4:30 p.m., both stated they did not know why Patient 20 and Patient 21 were not included on the active or discharge lists. When asked whether they could verify that the active and discharge lists were accurate, both responded they did not know and stated they would need to investigate the issue. The failures identified had the potential to result in missed or delayed physician‑ordered treatments, including wound care and intravenous therapy. , Findings: 1a. During a review of Patient 2’s Patient Information sheet, the sheet indicated Patient 2 had a start of care (SOC) date of 4/14/2026 with a primary diagnosis of unspecified femur (thigh bone) fracture, subsequent encounter for a closed fracture with routine healing. During a review of Patient 2’s clinical record titled Home Health Certification and Plan of Care (POC) for the certification period from 4/14/2026 to 6/12/2026, the POC indicated Skilled Nurse (SN) visit frequency order of three times a week for two weeks then followed by a re evaluation, and Physical Therapy (PT) visits ordered as once weekly for one week, twice weekly for one week, and once weekly for one week. During a review of Patient 2’s clinical record titled SN Evaluation, dated 4/22/2025, the SN Evaluation indicated that as of 5/11/2026 there was no documented signature from the Director of Patient Care Services Designee (DPCSD), the clinician who documented the evaluation form. During a review of Patient 2’s clinical record titled Registered Nurse (RN) skilled nursing visit dated 4/24/2026, the record indicated there was no documented evidence of signature from the visiting nurse who documented it. During a concurrent interview and record review on 5/15/2026 at 12:18 p.m. with the Director of Patient Care Services (DPCS), Patient 2’s clinical record titled SN Evaluation dated 4/22/2026 and Electronic Medical Record (EMR) were reviewed. Patient 2’s SN Evaluation assessment indicated that as of 5/11/2026 there was no signature from the clinician who documented the form. The DPCS stated and confirmed that the SN evaluation assessment form as of 5/11/2026 was missing the DPCSD’s signature, the clinician who documented the form. The DPCS stated that home visit notes should be documented, signed and dated by the clinician within 72 hours of the visit date. The DPCS stated that, as of May 15, 2026, Patient 2’s EMR reflected that the SN Evaluation assessment had been electronically signed by the DPCSD with a signature date of 4/22/2026. The DPCS explained that the EMR system should not have permitted the nurse to sign the document more than 72 hours after the visit date and that the signature should have reflected the actual date and time it was entered. The DPCS stated that the requirement for clinicians to complete and sign their assessments within the 72 hour timeframe ensures verification and validation of the documentation submitted. During a concurrent interview and record review on 5/15/2026 at 12:21 p.m. with the DPCS, Patient 2’s RN skilled nursing visit dated 4/24/2026 was reviewed. The DPCS stated and confirmed that Patient 2’s visit note lacked the signature of the visiting nurse, who she identified the visiting nurse was the DPCSD. The DPCS stated that the visit note should have been completed, signed, and submitted within 72 hours of the visit date. The DPCS stated that the purpose of the nurse’s signature is to verify that the information documented accurately reflects the care provided and to validate the completeness and authenticity of the clinical record. The DPCS stated that a visit note that is not signed is considered incomplete. During a review of Patient 2’s Electronic Medical Record (EMR), the EMR indicated, under comm tab, indicated patient communication notes dated 4/15/2026, 4/30/2026, 5/1/2026, 5/5/2026, and 5/7/2026. During a concurrent interview and record review on 5/15/2026 at 12:41 p.m. with the DPCS, Patient 2’s Electronic Medical Record (EMR) patient communication notes dated 4/15/2026, 4/30/2026, 5/1/2026, 5/5/2026, and 5/7/2026 were reviewed with the DPCS. The DPCS stated and confirmed that Patient 2’s communication notes dated 4/15/2026, 4/30/2026, 5/1/2026, 5/5/2026, and 5/7/2026 were missing both the signature and the date of the clinician who documented them. Patient 2’s patient communication note indicated the following: -Patient communication note dated 4/15/2026 did not have documented evidence of an electronic signature from the clinician. -Patient communication note dated 4/30/2026 did not have documented evidence of an electronic signature from the clinician. -Patient communication note dated 5/1/2026 did not have documented evidence of an electronic signature from the clinician. -Patient communication note dated 5/5/2026 did not have documented evidence of an electronic signature from the clinician. -Patient communication note dated 5/7/2026 did not have documented evidence of an electronic signature from the clinician. During an interview on 5/15/2026 at 12:41 p.m., The DPCS stated that in the EMR communication section, the clinician’s name assigned to each note appears next to the date of the entry. The DPCS stated that proper practice requires clinicians to sign and date communication notes within 72 hours of the documented event to validate the accuracy of the information. The DPCS further stated that a communication notes functions similarly to an order; and if it is not signed, it indicates that the clinician has not agreed to or validated what was documented. 1b. During a review of Patient 3’s undated medical record, titled “Patient Information,” the “Patient Information” indicated Patient 3 had a SOC date of 4/30/2026 with a primary diagnosis of Alzheimer’s disease (progressive brain disorder that affects memory, mental skills, and the ability to carry out simply daily tasks). During a review of Patient 3’s Physician Order, dated and signed by the DPCS on 5/4/2026, the Physician Order indicated the new medications included: hydrochlorothiazide (medication to treat high blood pressure [BP, pressure of blood against the arteries]) 25 mg 1 tablet by mouth daily for BP (started on 5/4/2026). During a concurrent observation and interview on 5/8/2026 at 11:58 a.m., while on a joint home visit with Physical Therapist (PT) 2 in Patient 3’s living room with Responsible Party (4), Patient 3 was alert but confused, and seated on the couch. Patient 3 complained of left groin pain rated six out of ten and demonstrated occasional grimacing during exercise with PT 2. Blood pressure readings obtained were 180/90 mmHg (millimeters of mercury, unit of measurement) and 200/90 mmHg. RP 4 stated Patient 3’s Primary Care Physician (PCP) was aware of Patient 3’s high BP readings and Patient 3 have an upcoming appointment with the PCP in four days. RP 4 stated Patient 3 refused to take her morning medications, including BP medication. PT 2 provided teaching regarding the importance of taking her BP medication. Patient 3 eventually took the morning medications, including the BP medication, after multiple attempts of PT 2 and RP 4 to convince Patient 3 to take her morning medications. Patient 3’s medication bottles and Patient 3’s Patient Medication Record were also reviewed. Per RP 3, Patient 3 had stopped taking hydrochlorothiazide 25 mg 1 tablet by mouth daily for blood pressure about six (6) months ago per physician’s advice. During a review of Patient 3’s “Patient Communication,” dated 5/11/2026, the “Patient Communication” indicated Occupational Therapist (OT) 1 reported Patient 3’s elevated BP readings of 174/67 mmHg and 158/64 mmHg and Patient 3 not taking the hydrochlorothiazide (medication to treat high BP) to the physician via the hospital’s designated hotline. During a review of Patient 3’s audit details on “Patient Communication,” dated 5/11/2026, the audit details indicated that Offshore Non-Clinical Quality Assurance (ONCQA) 1 and ONCQA 3 completed the form on 5/12/2026 and that OT 1 signed the form on 5/12/2026. During a review of Patient 3’s “Physician Order” dated 5/11/2026, the “Physician Order” indicated that OT 1 obtained a verbal order with “order read back and verified with ordering provider.” The “Physician Order” indicated that Patient 3 was not taking hydrochlorothiazide. During a review of Patient 3’s audit details for the 5/11/2026 “Physician Order,” the audit trails indicated ONCQA 2 and ONCQA 4 created and updated the “task details” on 5/12/2026 and OT 1 signed the form on 5/12/2026. During an interview on 5/20/2026 at 12:09 p.m., OT 1 stated she did not speak with the physician and did not obtain a verbal order regarding Patient 3’s elevated BP or hydrochlorothiazide from the physician. OT 1 stated she did not document on the “Patient Communication,” dated 5/11/2026, or “Physician Order,” dated 5/11/2026 because OT 1 only documented on the Patient 3’s Visit Note. During a concurrent interview and record review on 5/14/2026 at 11:48 a.m. with the Rehabilitation Supervisor (RS) and Registered Nurse Clinical Supervisor (RNCS), Patient 3’s medical records were reviewed. The RS stated there was no documented evidence that PT 2 and/or OT 1 requested a skilled nurse (SN) consultation to review the effectiveness of the BP medication and follow up with the physician regarding the high BP readings. The RNCS stated it was important to request an SN consult to further evaluate the causes of high BP, such diet noncompliance (high sodium intake could lead to a higher BP), medication noncompliance, uncontrolled pain or stress, or PT exercises, and obtain a physician order if a change in the BP medication was necessary. The RNCS stated there was no documented evidence an RN followed up with the physician regarding the high BP readings and to clarify the hydrochlorothiazide order. The RNCS stated a BP uncontrolled by BP medications could lead to more heart problems, stroke, and hospitalization. During a concurrent interview and record review on 5/21/2026 at 3:03 p.m. with the DPCS, Patient 3’s physician orders were reviewed. The DPCS stated there was no documented evidence regarding the response of Patient 3’s physician and the “verbal order” reportedly provided to OT 1 regarding Patient 3’s high BP and Patient 3 not taking hydrochlorothiazide as listed on Patient 3’s medication profile. During a review of the HHA’s undated policy and procedures (P&P), titled “Verification of Physician Orders,” the P&P indicated the following: 1.Orders must be obtained from a licensed physician for care and services to be provided to home health patients. 2.Verbal orders must be spoken to, taken, and documented only by professional, licensed home health personnel (Registered Nurse or qualified therapist). Orders received via text message would not be accepted. 3.A qualified individual must review each order or prescription before care is provided. 4.An order or prescription must be verified when there is a question or discrepancy in the order/prescription and when the order is communicated by someone other than the physician or his/her agent. The order or prescription reviewed may be the original order, a facsimile copy, if permitted by law, or the direct transcription of a verbal order. 5.All telephone orders must be received and processed in accordance with state and federal laws and regulations. 6.Orders must be documented on a form provided by the HHA, dated and signed by the professional receiving the order. 1c. During a review of Patient 4’s undated medical record, titled “Patient Information,” the “Patient Information” indicated Patient 4 had a SOC date of 5/5/2026 with a primary diagnosis of “Encounter for change or removal of nonsurgical wound dressing (wound not caused by surgery that requires a healthcare provider to assess, clean, and replace the wound dressing).” During a concurrent interview and record review on 5/21/2026 at 12:09 p.m. with the DPCS, Patient 4’s “Patient Communication,” dated 5/7/2026, was reviewed. The DPCS stated Patient 4’s “Patient Communication,” dated 5/7/2026, the “Patient Communication” was not signed. The DPCS stated all clinical notes must be signed and dated by the author of the note to ensure accuracy and validity of the note through proper authentication and verification of the communication details. 1d. During a review of Patient 12’s Patient Information sheet, the sheet indicated Patient 12 had a Start of Care (SOC) date of 4/30/2026 with a primary diagnosis of encounter for adjustment and management of Ventricular assistive device (a mechanical pump implanted in the chest to help a weakened heart pump blood throughout the body that is often used for patients waiting for a heart transplant or as a long-term treatment). During a review of Patient 12’s clinical record titled Home Health Certification and Plan of Care (POC) for the certification period from 4/30/2026 to 6/28/2026, the POC indicated a SN visit frequency order of two times a week for one week, and five times a week for one week effective 4/30/2026. The POC did not contain documentation of a signature from the nurse who completed the POC. During a review of Patient 12’s medical record titled RN skilled nursing visit dated 5/2/2026 and 5/8/2026, the records lacked authentication and did not include the signature of the RN who completed the skilled nursing visit, date and time when the entry was completed and the credential of the clinician. During a concurrent interview and record review on 5/15/2026 at 12:58 p.m. with the DPCS, Patient 12’s RN Skilled nursing visit notes dated 5/2/2026 and 5/8/2026 were reviewed. Patient 12’s RN skilled nursing visit dated 5/2/2026 And 5/8/2026 indicated there was no documentation of the registered nurse’s electronic signature and date. The DPCS stated and confirmed that Patient 12’s RN skilled nursing visit note dated 5/2/2026 and 5/8/2026 did not have evidence of the nurse’s signature and date. The DPCS stated that the nursing visit notes were considered incomplete because a completed documented visit note should include the clinician’s signature and date. The DPCS stated that completing all documentation with the clinician’s signature and date is essential to validate the visit, the assessment findings, and any teaching or counseling provided regarding medications or care. During a concurrent interview and record review on 5/15/2026 at 1:05 p.m. with the DPCS, Patient 12’s POC for the certification period from 4/30/2026 to 6/28/2026 was reviewed. The POC lacked documentation of an electronic signature from the nurse who completed the POC. The DPCS stated and confirmed that Patient 12’s POC was not signed by the nurse who documented the POC. The DPCS stated that the POC should have been completed and signed by the start of care nurse within 24 hours from the start of care visit date. The DPCS stated that the nurse’s signature is essential to validate the documented patient problems, goals, and planned interventions. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 4/30/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/1/2026 was created 5/12/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/2/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/6/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/7/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/9/2026 was created 5/11/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/12/2026 was created 5/13/2026 with no evidence of an electronic signature of the author. During a concurrent interview and record review on 5/15/2026 at 1:14 p.m. with the DPCS, Patient 12’s patient communication notes dated 4/30/2026, 5/1/2026, 5/2/2026, 5/6/2026, 5/7/2026, 5/9/2026, and 5/12/2026 were reviewed. The DPCS stated and confirmed that Patient 12’s communication notes dated 4/30/2026, 5/1/2026, 5/2/2026, 5/6/2026, 5/7/2026, 5/9/2026, and 5/12/2026 were not submitted on the date it indicated and were backdated. The DPCS stated the authors of the communication notes were staff from a contracted company the agency works with that assist in quality assurance. The DPCS stated that those staff members should have signed the patient communication note with their credentials because they were the ones documenting it. The DPCS stated the importance of the communication notes being signed and dated by the staff the documented it was to be able to trace them back if any questions or concerns arise. 1e. During a review of Patient 17’s undated medical record, titled “Patient Information,” the “Patient Information” indicated SOC date of 4/1/2026 with a primary diagnosis of type 2 diabetes mellitus (chronic condition where the body resists insulin or cannot produce enough of it, causing blood sugar levels to rise) with diabetic polyneuropathy (nerve damage caused by long-term high blood sugar). During a concurrent interview and record review on 5/21/2026 at 12:09 p.m. with the DPCS, Patient 17’s “Patient Communication,” dated 4/2/2026, and “Patient Communication,” dated 4/4/2026, were reviewed. The DPCS stated Patient 17’s “Patient Communication,” dated 4/2/2026, and “Patient Communication,” dated 4/4/2026 were not signed. The DPCS stated all clinical notes must be signed and dated by the author of the note to ensure accuracy and validity of the note through proper authentication and verification of the communication details. 1f. During a review of Patient 19’s undated medical record, titled “Patient Information,” the “Patient Information” indicated Patient 19’s SOC date of 5/6/2026 with a primary diagnosis of “Encounter for change or removal of surgical wound dressing (routine change or removal of a surgical wound dressing) and a secondary diagnosis of “open wound of left upper arm.” The “Patient Information” indicated Patient 19’s referral date of 5/1/2026. During a review of Patient 19’s referral document from General Acute Care Hospital (GACH) 1, dated 4/30/2026, the referral document indicated Patient 19’s anticipated discharge date was 4/30/2026 with home health. The referral document indicated Patient 19 required Registered Nurse (RN) services to provide wound care as Patient 19 would be discharged home with a small chest tube drain (external, portable drainage collection device attached to a chest tube [flexible, hollow plastic tube inserted through the chest wall into the space around the lungs] to safely remove trapped air, blood, or fluid to allow the lungs to fully expand). The referral indicated per thoracic surgery (team of surgeons who specialize on the operative treatment of organs inside the chest, including the lungs, esophagus [food pipe], trachea [windpipe], and chest wall), Patient 19 required dressing changes every 3 days around the chest tube and to use a 4x4 drain gauze (sterile [free of germs], highly absorbent materials that prevent wound infections by managing exudates [fluids that may seep from wounds or surgical areas]) and tape to reinforce the dressing. The referral also indicated per thoracic surgery, Patient 19’s new chest tube drain might need to be exchanged if it fills up. During a review of Patient 19’s “SOC Delay Order,” dated 5/4/2026, the “SOC Delay Order” indicated the verbal order was obtained with “order read back and verified with ordering provider.” The “SOC Delay Order” indicated the reason for a delayed visit was “tried calling the patient to schedule the SOC visit, but the call remain unanswered.” During a review of Patient 19’s “SOC Delay Order,” dated 5/5/2026, the “SOC Delay Order” indicated the verbal order was obtained with “order read back and verified with ordering provider.” The “SOC Delay Order” indicated the reason for delayed visit was “patient reported a leaking issue and was instructed to go to urgent care or the emergency room (ER) due the leaking condition as home care was not appropriate at this time.” During a review of Patient 19’s “SOC Delay Order,” dated 5/6/2026, the “SOC Delay Order” indicated the verbal order was obtained with “order read back and verified with ordering provider.” The “SOC Delay Order” indicated Patient 19 agreed to do SOC on 5/6/2026. During a review of Patient 19’s Start of Care Order, dated 5/6/2026, the “Start of Care Order” indicated the following orders: -Skilled Nurse (SN) frequency of home visits to Patient 19 was twice a week for three weeks. -SN to perform chest tube draining using sterile technique and infection control measures using agency policy and procedures and to teach chest tube care and management. -SN to perform wound care using infection control measures and standard precautions to the left axilla: Cleanse with normal saline (NS, salt solution to clean the wound), pat dry, apply drain sponge/gauze, secure with tape dressing, and change every 3 days. -SN to perform wound care the chest tube site: cleanse with NS, pat dry, apply drain sponge/gauze, secure with tape dressing, and change every 3 days. -SN to provide teaching regarding monitoring for signs and symptoms of infection and to report to the physician or SN. -SN to provide teaching regarding deep breathing exercises and energy conservation techniques to prevent shortness of breath (SOB) and new Atrium Express Mini 500 Mobile Dry Seal Draine that may need to be exchanged if it fills up. During an interview on 5/18/2026 at 2:02 p.m., Patient 19 stated he had been diagnosed with Stage 4 lung cancer (cancer has spread from where it started in the lung to distant parts of the body, such as the brain, bones, or liver) for which the physician placed a PleurX catheter (small, flexible, tunneled silicone tube placed in the chest or abdomen to intermittently drain recurring fluid buildup in the lungs to relieve SOB). Patient 19 stated he was hospitalized from 4/15/2026 to 4/30/2026 due to an infection of the PleurX catheter. Patient 19 stated the physician removed the PleurX catheter, made an incision, removed a part of his rib to wash out the pus or bacteria, and inserted a chest tube. Patient 19 stated he was administered intravenous (IV, into the vein) antibiotics (medication that kills or inhibits the growth of bacteria, used to treat bacterial infections) for 10 days. Patient 19 stated his last wound care was done on the date of his discharge from GACH 1 on 4/30/2026. Patient 19 stated GACH 1 stated the HHA would call Patient 19 within 24 hours of discharge from GACH 1 to schedule a nurse home visit to “come in and replace the bandages of the wound, make sure there is no infection, … and put in another chest tube drain, if needed.” Patient 19 stated the HHA might have called, but he was unable to answer the phone call because he “was taking a lot of medications at the time.” Patient 19 stated he might have received a nurse visit on 5/3/2026, but he was unable to recall the name of the HHA nurse. Patient 19 was unable to recall the date when he went back to GACH 1 for the exchange of chest tube drain related to the leaking chest tube. During an interview on 5/18/2026 at 3:26 p.m., RN 8 stated the HHA received Patient 19’s referral on 5/1/2026. RN 8 stated Patient 19 was originally assigned to a different nurse. RN 8 stated there was no nurse available to see Patient 19 on 5/2/2026 and 5/3/2026. RN 8 stated she was “too busy” conducting home visits for the other patients on 5/4/2026, and no nurse was able to conduct a home visit on Patient 19 on 5/4/2026. RN 8 stated Patient 19 was assigned to RN 8 on 5/5/2026, but RN 8 was unable to visit Patient 19 because the HHA staff (unable to identify) advised Patient 19 to go to the ER to address the leaking chest tube. RN 8 stated she conducted the first home visit for Patient 19 on 5/6/2026. During a concurrent interview and record review of Patient 19’s medical records on 5/21/2026 at 12:46 p.m., with the DPCS, Patient 19’s electronic health records (EHRs) and Scheduling and Care Coordination Platform (SCCP) details were reviewed. The DPCS stated the following: -Patient 19’s referral date was 5/1/2026, so the expected SOC date was no later than 5/3/2026. -The RN must conduct the initial assessment within 48 hours of the referral date to assess Patient 19’s needs, including ordering supplies and evaluating the caregiver needs. -There was no documented evidence that an RN called Patient 19 to schedule the SOC visit on or before 5/3/2026. The DPCS stated there was no documented evidence that an RN conducted an SOC visit on 5/3/2026. -There was no documented evidence that an RN was assigned to visit and/or called Patient 19 to schedule a visit on 5/4/2026. -Patient 19 reported a leaking chest tube to the HHA on 5/5/2026, and the Non-Clinical Offshore Staff 1 (NCOS 1) called Patient 19 on 5/5/2026 to advise Patient 19 to go to the ER per “Supervisor’s” instructions. The DPCS was unable to provide documented evidence of the communication details with the “supervisor” who provided the instructions. -The SOC visit and initial assessment were conducted on 5/6/2026. The DPCS stated the delay of care placed Patient 19 at increased risks for delayed wound healing, development of an infection of the wound, and rehospitalization. During a review of the HHA’s undated policy and procedures (P&P), titled “Verification of Physician Orders,” the P&P indicated the following: Orders must be obtained from a licensed physician for care and services to be provided to home health patients. Verbal orders must be spoken to, taken, and documented only by professional, licensed home health personnel (Registered Nurse or qualified therapist). Orders received via text message would not be accepted. A qualified individual must review each order or prescription before care is provided. An order or prescription must be verified when there is a question or discrepancy in the order/prescription and when the order is communicated by someone other than the physician or his/her agent. The order or prescription reviewed may be the original order, a facsimile copy, if permitted by law, or the direct transcription of a verbal order. All telephone orders must be received and processed in accordance with state and federal laws and regulations. Orders must be documented on a form provided by the HHA, dated and signed by the professional receiving the order. 2a. During a review of Patient 1’s Patient Information sheet, the sheet indicated a Start of Care (SOC) date of 4/18/2026 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. During a review of Patient 1’s clinical record titled Home Health Certification and Plan of Care (POC) for the certification period from 4/18/2026 to 6/16/2026, the POC indicated Skilled Nurse visit frequency order of one time a week for one week, three times a week for one week and two times a week for one week effective 4/18/2026. During a review of Patient 1’s medical record audit log titled Task Details, it indicated a physician order dated 4/18/2026 was created on 5/7/2026 and signed by the registered nurse on 5/7/2026. During a review of Patient 1’s medical record audit log titled Task Details, it indicated a physician order dated 5/8/2026 was created on 5/11/2026 and signed by the DPCSD on 5/11/2026. During a review of Patient 1’s medical record audit log titled Task Details, it indicated a physician order dated 5/8/2026 was created on 5/11/2026 and signed by the registered nurse on 5/11/2026. During a review of Patient 1’s Electronic Medical Record (EMR) on 5/8/2026, the EMR indicated, under comm tab, that there were no documented or submitted communication notes. During a review of Patient 1’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/7/2026 was created on 5/11/2026 and signed by the registered nurse on 5/11/2026. During a review of Patient 1’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/8/2026 was created on 5/11/2026 and signed by the registered nurse. During a concurrent interview record review on 5/19/2026 at 1:16 p.m. with the Administrator (ADM) Patient 1’s EMR was reviewed. Patient 1’s EMR audit trail titled Task details, indicated a patient communication note dated 5/7/2025 was created on 5/11/2026 and signed by the registered nurse on 5/11/2026, and a patient communication note dated 5/8/2026 that was created on 5/11/2026 and signed by the registered nurse on 5/11/2026. The ADM stated and confirmed that the patient communication notes dated 5/7/2026 and 5/8/2026 were backdated. The ADM stated that it was not the agency’s practice to backdate but instead the clinicians were to document in real time when the information or action happened or have documented it as a late entry. During a concurrent interview and record review on 5/20/2026 at 3:04 p.m. with the DPCS Patient 1’s Electronic Medical Record (EMR) Audit was reviewed. Patient 1’s EMR audit titled Task details indicated patient communication notes dated 5/7/2026 and 5/8/2026 were on 5/11/2026 and signed by a registered nurse on 5/11/2026. The DPCS stated and confirmed that the patient communication notes dated 5/7/2026 and 5/8/2026 were both backdated by the clinician. The DPCS stated the nurse should not have backdated and instead the nurse should have documented in real time and date, or if the documentation was late then inside of the note the nurse should have specified that it was a late entry and for what date and time. During a concurrent interview and record review on 5/20/2026 at 3:10 p.m. With the DPCS, Patient 1’s EMR Audit was reviewed. Patient 1’s EMR audit titled Task details indicated; A physician order dated 4/18/2026 that was created 5/7/2026 and signed by the registered nurse on 5/7/2026, A frequency change order dated 5/8/2026 that was created on 5/11/2026 and signed by the registered nurse on 5/11/2026, A physician order dated 5/8/2026 that was created on 5/11/2026 and signed by the registered nurse on 5/11/2026. The DPCS stated and confirmed that Patient 1’s start of care order dated 4/18/2026 was documented and created 14 days after the order date, the physician order dated 4/18/2026 was documented and created 19 days after the order date, and the frequency change order and physician order dated 5/8/2026 were documented and created 3 days after the order date. The DPCS stated that the orders were submitted late. The DPCS stated that when nurses receive orders from a physician, they are to document them and sign them within 24 hours of the order date. The DPCS stated if the nurse does not document the order within the 24 hours, then the order should be entered as a late entry or addendum. The DPCS stated that any new or change in orders should not only be reflected under orders but also in the Plan of Care (POC) as an addendum to the plan of care. 2b. During a review of Patient 2’s Patient Information sheet, the sheet indicated a Start of Care (SOC) date of 4/14/2026 with a primary diagnosis of fracture unspecified of one femur (the thigh bone), subsequent encounter for closure fracture with routine healing. During a review of Patient 2’s clinical record titled Home Health Certification and Plan of Care (POC) for the certification period from 4/14/2026 to 6/12/2026, the POC indicated Skilled Nurse (SN) visit frequency order of three times a week for two weeks then re-evaluate, and Physical Therapy (PT) once a week for one week, two times a week for one week, and once a week for one week. During a review of Patient 2’s medical record audit log titled Task Details, it indicated a Start of Care delay order dated 4/11/2026 was created on 5/8/2026 and signed by the Physical Therapist 1 (PT1) on 5/8/2026. During a review of Patient 2’s medical record audit log titled Task Details, it indicated a Start of Care delay order dated 4/12/2026 was created on 5/8/2026 and signed by the Physical Therapist 1 (PT1) on 5/8/2026. During a review of Patient 2’s medical record audit log titled Task Details, it indicated a Start of Care delay order dated 4/13/2026 was created on 5/8/2026 and signed by the Physical Therapist 1 (PT1) on 5/8/2026. During a review of Patient 2’s medical record audit log titled Task Details, it indicated a physician order dated 4/27/2026 was created on 5/8/2026 and signed by the DPCSD on 5/8/2026. During a review of Patient 2’s medical record audit log titled Task Details, it indicated a physician order dated 4/29/2026 was created on 5/8/2026 and signed by the DPCSD on 5/8/2026. During a review of Patient 2’s medical record audit log titled Task Details, it indicated a physician order dated 5/4/2026 was created on 5/11/2026 and signed by the DPCSD on 5/11/2026. During a concurrent interview record review on 5/19/2026 at 12:54 p.m. with the Administrator (ADM) Patient 2’s EMR was reviewed. Patient 2’s EMR audit trail titled Task details, indicated a Start of Care delay order dated 4/11/2026 was created and signed by PT1 on 5/8/2026, Start of Care delay order dated 4/12/2026 was created and signed by PT1 on 5/8/2026, start of Care delay order dated 4/13/2026 was created and signed by PT1 on 5/8/2026, physician order dated 4/27/2026 was created and signed by the DPCSD on 5/8/2026, physician order dated 4/29/2026 was created and signed by the DPCSD on 5/8/2026, and a physician order dated 5/4/2026 was created and signed by the DPCSD on 5/11/2026. The ADM stated and confirmed that Patient 2’s orders dated 4/11/2026, 4/12/2026, 4/13/2026, 4/27/2026, 4/29/2026, and 5/4/2026 were backdated and submitted late. The ADM stated that it was not the agency’s practice to backdate any orders or documentation. The ADM stated that the clinician should have transcribed the orders in real time when received, and if the clinician was unable to document the order at the time received then make a late entry notice inside the order. During a concurrent interview and record review on 5/20/2026 at 2:53 p.m. with the DPCS, Patient 2’s order audits titled Task details dated 4/11/2026, 4/12/2026, 4/13/2026, 4/27/2026, 4/29/2026, and 5/4/2026 were reviewed. The DPCS stated and confirmed that the order dated 4/11/2026 was backdated and submitted 27 days late, order dated 4/12/2026 was backdated and submitted 26 days late, order dated 4/13/2026 was backdated and submitted 25 days late, order dated 4/27/2026 was backdated and submitted 11 days late, order dated 4/29/2026 was backdated and submitted 9 days late, order dated 5/4/2026 was backdated and submitted 7 days late. The DPCS stated it was not proper practice of the HHA to backdate any orders or documentation. The DPCS stated that the proper practice of transcribing orders was to document them right away within 24 hours in the EMR, and sign and date to verify that that clinician was the one who received the order, verify the order details are correct and make it an active order. 2c. During a review of Patient 7’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date of 4/21/2026 with documented diagnoses including hypothyroidism (insufficient production of thyroid hormones, resulting in a slowed metabolism) and shortness of breath (SOB- the sensation of being unable to get enough air during breathing). During a review of Patient 7’s clinical record titled “OASIS (Outcome and Assessment Information Set, a federally mandated, multi-purpose assessment instrument for home health care)-E2 Start of Care,” dated 4/21/2026, the clinical record indicated Registered Nurse 1 (RN 1) signed the form on 4/21/2026. The clinical record did not indicate the entry was submitted as a late entry or as an addendum. During a concurrent interview and record review on 5/22/2026 at 12:10 PM with the DPCS, Patient 7’s clinical record titled “Task Details (an electronic medical record (EMR) form indicating who and when a document was created, updated, or revised) Patient 7 OASIS-E2 Start of Care,” undated, was reviewed. The clinical record indicated: - RN 1 initially signed the form on 4/29/2026, and not 4/21/2026 as indicated on Patient 7’s clinical record titled “OASIS-E2 Start of Care,” dated 4/21/2026. - Patient 7’s “OASIS-E2 Start of Care,” dated 4/21/2026, had been reopened and updated by Quality Assurance Staff 1 (QA Staff 1), QA Staff 2 and QA Staff 3 several times between 4/30/2026 to 5/11/2026. - RN 1’s most recent signature on the form was 5/11/2026, and not 4/21/2026 as indicated on Patient 7’s clinical record titled “OASIS-E2 Start of Care,” dated 4/21/2026. The DPCS stated that the OASIS must include the date the form was signed. If the form is edited or entered as a late entry, the documentation must clearly indicate this, and the signature date must reflect the date the form was signed after the changes were completed. During a review of HHA’s P&P, titled “Initial and Comprehensive Assessment,” revised on November 2021, the P&P indicated: -A comprehensive assessment will be completed within 5 calendar days of the patient’s start of care. -The assessment will be patient-specific and comprehensive and will include the exact use of the current versions of the Outcome and Assessment Information Set (OASIS). 2d. During a review of Patient 9’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date 4/3/2026 with documented diagnoses including encounter for adjustment and management of ventricular assist device (a surgically implanted mechanical pump that supports the heart circulate blood) and bacteremia (the presence of bacteria in the bloodstream). During a review of Patient 9’s clinical record titled “OASIS-E2 Start of Care,” dated 4/3/2026, the clinical record indicated RN 10 signed the form on 4/3/2026. The clinical record did not indicate the entry was submitted as a late entry or as an addendum. During a concurrent interview and record review on 5/22/2026 at 12:30 PM with the Agency’s DPCS, Patient 9’s clinical record titled “Task Details Patient 9 OASIS-E2 Start of Care,” undated, was reviewed. The clinical record indicated: - RN 10 initially signed the form on 5/8/2026, and not 4/3/2026 as indicated on Patient 9’s clinical record titled “OASIS-E2 Start of Care,” dated 4/3/2026. - Patient 9’s “OASIS-E2 Start of Care,” dated 4/3/2026, had been reopened and updated by QA Staff 4, QA Staff 5, QA Staff 6, QA Staff 7, QA Staff 8, and QA Staff 9 several times between 4/5/2026 to 5/11/2026. - RN 10’s most recent signature on the form was 5/11/2026, and not 4/21/2026 as indicated on Patient 9’s clinical record titled “OASIS-E2 Start of Care,” dated 4/3/2026. The DPCS stated that the OASIS must include the date the form was signed. If the form is edited or entered as a late entry, the documentation must clearly indicate this, and the signature date must reflect the date the form was signed after the changes were completed. During a review of HHA’s P&P, titled “Initial and Comprehensive Assessment,” revised on November 2021, the P&P indicated: -A comprehensive assessment will be completed within 5 calendar days of the patient’s start of care. -The assessment will be patient-specific and comprehensive and will include the exact use of the current versions of the Outcome and Assessment Information Set (OASIS). 2e. During a review of Patient 12’s Patient Information sheet, the sheet indicated Patient 12 had SOC date of 4/30/2026 with a primary diagnosis of encounter for adjustment and management of ventricular assistive device. During a review of Patient 12’s clinical record titled Home Health Certification and POC for the certification period from 4/30/2026 to 6/28/2026, the POC indicated a SN visit frequency order of two times a week for one week, and five times a week for one week effective 4/30/2026. The POC did not contain documentation of a signature from the nurse who completed the POC. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a physician order dated 5/4/2026 was created on 5/8/2026 and signed by the registered nurse on 5/8/2026. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a plan of care addendum order dated 5/6/2026 was created on 5/11/2026 and signed by the registered nurse on 5/11/2026. During a concurrent interview and record review on 5/15/2026 at 12:53 p.m. with the DPCS, Patient 12’s orders dated 4/30/2026, 5/4/2026, and 5/6/2026 were reviewed. The DPCS stated that Patient 12’s order dated 5/4/2026 was signed late and it should have been signed within 72 hours of the order date. The DPCS stated the order dated 5/6/2026 was also a late order entry as it was not signed by the nurse within 72 hours of the order date. The DPCS stated it was important that all transcribed physician orders were signed by the entering nurse to make the validate the order is ready to be acted out. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 4/30/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/1/2026 was created 5/12/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/2/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/6/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/7/2026 was created 5/8/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/9/2026 was created 5/11/2026 with no evidence of an electronic signature of the author. During a review of Patient 12’s medical record audit log titled Task Details, it indicated a Patient communication note dated 5/12/2026 was created 5/13/2026 with no evidence of an electronic signature of the author. During a concurrent interview and record review on 5/15/2026 at 1:14 p.m. with the DPCS, Patient 12’s patient communication notes dated 4/30/2026, 5/1/2026, 5/2/2026, 5/6/2026, 5/7/2026, 5/9/2026, and 5/12/2026 were reviewed. The DPCS stated and confirmed that Patient 12’s communication notes dated 4/30/2026, 5/1/2026, 5/2/2026, 5/6/2026, 5/7/2026, 5/9/2026, and 5/12/2026 were not submitted on the date it indicated and were backdated. The DPCS stated the authors of the communication notes were staff from a contracted company the agency works with that assist in quality assurance. The DPCS stated that those staff members should have signed the patient communication note with their credentials because they were the ones documenting it. The DPCS stated the importance of the communication notes being signed and dated by the staff the documented it was to be able to trace them back if any questions or concerns arise. During an interview on 5/15/2026 at 1:55 p.m. with the ADM, the ADM stated that she contacted the agency’s Quality Assurance (QA) nurse in regard to Patient documents being entered late and backdated. The ADM stated that the QA nurse told her she did review the sampled patient’s chart because of survey going on, and if she noticed any incomplete or unsigned documents she (QA nurse) contacted the nurses and asked them to go back into the EMR and edit what was necessary. The ADM stated the QA nurse should not have prompted the nurses to do that but instead should have had them add an addendum, late entry notes or sign in real time. During an interview on 5/20/2026 at 2:25 p.m. with the QA nurse, the QA nurse stated she did start reviewing the sample patients charts for discrepancies because of the survey happening. The QA stated if she noticed incomplete or unsigned documents, she contacted some nurses to have them correct it, but she did not explain to them to not back date. 2f. During a review of Patient 14’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date of 3/10/2026 with documented diagnoses including encounter for change or removal of nonsurgical wound dressing (a medical visit specifically for changing or removing a wound dressing that was not applied in a surgical setting) and surgical site infection following procedure (an infection occurring at the location of a surgical incision or internal area involved in surgery). During a review of Patient 14’s clinical record titled “OASIS-E1 Start of Care,” dated 3/10/2026, the clinical record indicated RN 11 signed the form on 3/10/2026. The clinical record did not indicate the entry was submitted as a late entry or as an addendum. During a concurrent interview and record review on 5/22/2026 at 12:44 PM with the Agency’s DPCS, Patient 14’s clinical record titled “Task Details Patient 14 OASIS-E1 Start of Care,” undated, was reviewed. The clinical record indicated: - RN 11 signed the form on 5/11/2026, and not 3/10/2026 as indicated on Patient 14’s clinical record titled “OASIS-E1 Start of Care,” dated 3/10/2026. - Patient 14’s “OASIS-E1 Start of Care,” dated 3/10/2026, had been reopened and updated by QA Staff 3, QA Staff 5, QA Staff 6, QA Staff 8, QA Staff 10, QA Staff 11, QA Staff 12, and QA Staff 13 several times between 3/11/2026 to 5/11/2026. The DPCS stated that the OASIS must include the date the form was signed. If the form is edited or entered as a late entry, the documentation must clearly indicate this, and the signature date must reflect the date the form was signed after the changes were completed. During a review of HHA’s P&P, titled “Assembly of Clinical Record,” revised on November 2021, the P&P indicated all patient care documented will be submitted by the staff member within 72 hours from the time care was provided. During a review of HHA’s P&P, titled “Quality Assurance (QA) Review of Clinical Records,” undated, the P&P indicated: - Clinical records will be reviewed through the QA process to support documentation accuracy, regulatory compliance, and consistency with patient care provided. - QA staff should review documentation and when deficiencies, omissions, inconsistencies, or corrections are identified, the documentation shall be returned to the clinician responsible for correction. Following correction by the clinician, the documentation shall be resubmitted for QA review. - The clinician must sign and review the clinical record to finalize and close the record. - The clinician must complete clinical records accurately, timely, and in accordance with home health regulations. - QA staff are not permitted to make corrections, additions, completions, or substantive changes on behalf of a clinician. Documentation corrections must be made by the clinician who created the clinical record or by the appropriate responsible clinician. During a review of HHA’s P&P, titled “Initial and Comprehensive Assessment,” revised on November 2021, the P&P indicated: -A comprehensive assessment will be completed within 5 calendar days of the patient’s start of care. -The assessment will be patient-specific and comprehensive and will include the exact use of the current versions of the Outcome and Assessment Information Set (OASIS). 3a. During a review of Patient 7’s clinical record titled “Patient Profile,” undated, the clinical record indicated Patient 7 had a start of care date of 4/21/2026 with documented diagnoses including hypothyroidism and SOB. During a review of Patient 7’s clinical record titled “Patient Profile,” undated, the clinical record included contact information for Responsible Party (RP) 1 and did not include contact information for Family Member (FM 1). During an interview on 5/14/2026 at 12:21 PM with RP 1, RP 1 stated that she did not speak with HHA staff on 4/20/2026 to schedule the start of care visit on 4/21/2026. RP 1 stated that she did not speak with HHA staff on 4/28/2026. to report that Patient 7 would not be available for a visit during the week of 4/26/2026 to 5/2/2026. During a concurrent interview and record review on 5/14/2026 at 1:16 PM with RN 1, Patient 7’s physician order titled “SOC Delay Order,” dated 4/18/2026 and 4/19/2026 were reviewed. The physician orders indicated a verbal order with read back (a safety practice in which the person receiving a verbal or telephone order repeats the order back to the provider to confirm that it was heard and recorded correctly) was obtained from Patient 7’s physician, and that RN 1attempted to contact Patient 7’s Family Member 1 (FM 1) to schedule the start of care visit but was unable to make contact. RN 1 stated that he did not attempt to contact FM 1 on 4/18/2026 or 4/19/2026 and that the patient’s clinical record did not contain FM 1’s phone number. During a concurrent interview and record review on 5/14/2026 at 1:16 PM with RN 1, Patient 7’s physician order titled “SOC Delay Order,” dated 4/20/2026 was reviewed. The physician order indicated a verbal order with read back was obtained from Patient 7’s physician, and that RN 1 contacted RP 1 to schedule the start of care visit for 4/21/2026. RN 1 stated that he did not attempt to contact RP 1 on 4/20/2026 and that his first communication with RP 1 occurred on 4/21/2026 during the start of care visit. RN 1 requested to continue the interview on 5/15/2026 between 11: 30 – 11:45 AM. During an interview on 5/15/2026 at 11:32 AM, a call was placed to RN 1. RN 1 did not answer, and a voicemail was left requesting a return call. During an interview on 5/15/2026 at 12:22 PM with Caregiver 1 (CG 1), CG 1 stated she was the caregiver assigned to care for Patient 7 on 4/28/2026. CG 1 stated that she did not speak with HHA staff on 4/28/2026 to report that Patient 7 would not be available for a visit during the week of 4/26/2026 to 5/2/2026. During a concurrent interview and record review on 5/22/2026 at 12:10 PM with the DPCS, Patient 7’s clinical record titled “Task Details (an electronic medical record (EMR) form indicating who and when a document was created, updated, or revised) Patient 7 SOC Delay Order,” for visit date 4/18/2026, 4/19/2026, and 4/20/2026 were reviewed. The clinical record indicated that the order documentation was created on 5/8/2026. The DPCS stated RN 1 signed the physician orders on 5/11/2026 and backdated the orders as 4/18/2026, 4/19/2026, and 4/20/2026 respectively. The physician orders did not accurately reflect the signature date. During a review of HHA’s P&P, titled “Assembly of Clinical Record,” revised on November 2021, the P&P indicated all patient care documented will be submitted by the staff member within 72 hours from the time care was provided. During a review of HHA’s P&P, titled “Verification of Physician Orders,” revised on November 2021, the P&P indicated: - Orders will be obtained from a licensed physician for care and services to be provided to home health patients. - Verbal orders will be spoken to, taken and documented only by professional, licensed home health personnel (RN or qualified therapist). - A qualified individual will review each order before care is provided. - Orders will be documented on a form provided by the HHA, dated and signed by the professional receiving the order. 3b. During a review of Patient 19’s undated medical record, titled “Patient Information,” the “Patient Information” indicated Patient 19’s SOC date of 5/6/2026 with a primary diagnosis of “Encounter for change or removal of surgical wound dressing (routine change or removal of a surgical wound dressing)” and a secondary diagnosis of “open wound of left upper arm.” The “Patient Information” indicated Patient 19’s referral date of 5/1/2026. During a review of Patient 19’s referral document from General Acute Care Hospital (GACH) 1, dated 4/30/2026, the referral document indicated Patient 19’s anticipated discharge date was 4/30/2026 with home health. The referral document indicated Patient 19 required Registered Nurse (RN) services to provide wound care as Patient 19 would be discharged home with a small chest tube drain (external, portable drainage collection device attached to a chest tube [flexible, hollow plastic tube inserted through the chest wall into the space around the lungs] to safely remove trapped air, blood, or fluid to allow the lungs to fully expand). The referral indicated per thoracic surgery (team of surgeons who specialize on the operative treatment of organs inside the chest, including the lungs, esophagus [food pipe], trachea [windpipe], and chest wall), Patient 19 required dressing changes every 3 days around the chest tube and to use a 4x4 drain gauze (sterile [free of germs], highly absorbent materials that prevent wound infections by managing exudates [fluids that may seep from wounds or surgical areas]) and tape to reinforce the dressing. The referral also indicated per thoracic surgery, Patient 19’s new chest tube drain might need to be exchanged if it fills up. During a review of Patient 19’s “SOC Delay Order,” dated 5/4/2026, the “SOC Delay Order” indicated the verbal order was obtained with “order read back and verified with ordering provider.” The “SOC Delay Order” indicated the reason for a delayed visit was “tried calling the patient to schedule the SOC visit, but the call remain unanswered.” During a review of Patient 19’s “SOC Delay Order,” dated 5/5/2026, the “SOC Delay Order” indicated the verbal order was obtained with “order read back and verified with ordering provider.” The “SOC Delay Order” indicated the reason for delayed visit was “patient reported a leaking issue and was instructed to go to urgent care or the emergency room (ER) due the leaking condition as home care was not appropriate at this time.” During a review of Patient 19’s “SOC Delay Order,” dated 5/6/2026, the “SOC Delay Order” indicated the verbal order was obtained with “order read back and verified with ordering provider.” The “SOC Delay Order” indicated Patient 19 agreed to do SOC on 5/6/2026. During a review of Patient 19’s Start of Care Order, dated 5/6/2026, the “Start of Care Order” indicated the following orders: 1.Skilled Nurse (SN) frequency of home visits to Patient 19 was twice a week for three weeks. 2.SN to perform chest tube draining using sterile technique and infection control measures using agency policy and procedures and to teach chest tube care and management. 3.SN to perform wound care using infection control measures and standard precautions to the left axilla: Cleanse with normal saline (NS, salt solution to clean the wound), pat dry, apply drain sponge/gauze, secure with tape dressing, and change every 3 days. 4.SN to perform wound care the chest tube site: cleanse with NS, pat dry, apply drain sponge/gauze, secure with tape dressing, and change every 3 days. 5.SN to provide teaching regarding monitoring for signs and symptoms of infection and to report to the physician or SN. 6.SN to provide teaching regarding deep breathing exercises and energy conservation techniques to prevent shortness of breath (SOB) and new Atrium Express Mini 500 Mobile Dry Seal Draine that may need to be exchanged if it fills up. During an interview on 5/18/2026 at 2:02 p.m., Patient 19 stated he had been diagnosed with Stage 4 lung cancer (cancer has spread from where it started in the lung to distant parts of the body, such as the brain, bones, or liver) for which the physician placed a PleurX catheter (small, flexible, tunneled silicone tube placed in the chest or abdomen to intermittently drain recurring fluid buildup in the lungs to relieve shortness of breath [SOB]). Patient 19 stated he was hospitalized from 4/15/2026 to 4/30/2026 due to an infection of the PleurX catheter. Patient 19 stated the physician removed the PleurX catheter, made an incision, removed a part of his rib to wash out the pus or bacteria, and inserted a chest tube. Patient 19 stated he was administered intravenous (IV, into the vein) antibiotics for 10 days. Patient 19 stated his last wound care was done on the date of his discharge from GACH 1 on 4/30/2026. Patient 19 stated GACH 1 stated the HHA would call Patient 19 within 24 hours of discharge from GACH 1 to schedule a nurse home visit to “come in and replace the bandages of the wound, make sure there is no infection, … and put in another chest tube drain, if needed.” Patient 19 stated the HHA might have called, but he was unable to answer the phone call because he “was taking a lot of medications at the time.” Patient 19 stated he might have received a nurse visit on 5/3/2026, but he was unable to recall the name of the HHA nurse. Patient 19 was unable to recall the date when he went back to GACH 1 for the exchange of chest tube drain related to the leaking chest tube. During an interview on 5/18/2026 at 3:26 p.m., RN 8 stated the HHA received Patient 19’s referral on 5/1/2026. RN 8 stated Patient 19 was originally assigned to a different nurse. RN 8 stated there was no nurse available to see Patient 19 on 5/2/2026 and 5/3/2026. RN 8 stated she was “too busy” conducting home visits for the other patients on 5/4/2026, and no nurse was able to conduct a home visit on Patient 19 on 5/4/2026. RN 8 stated Patient 19 was assigned to RN 8 on 5/5/2026, but RN 8 was unable to visit Patient 19 because the HHA staff (unable to identify) advised Patient 19 to go to the ER to address the leaking chest tube. RN 8 stated she conducted the first home visit for Patient 19 on 5/6/2026. During a concurrent interview and record review of Patient 19’s medical records on 5/21/2026 at 12:46 p.m., with the Director of Patient Care Services (DPCS), Patient 19’s electronic health records (EHRs) and Scheduling and Care Coordination Platform (SCCP) details were reviewed. The DPCS stated the following: -Patient 19’s referral date was 5/1/2026, so the expected SOC date was no later than 5/3/2026. -The RN must conduct the initial assessment within 48 hours of the referral date to assess Patient 19’s needs, including ordering of supplies and evaluating the caregiver needs. -There was no documented evidence that an RN called Patient 19 to schedule the SOC visit on or before 5/3/2026. The DPCS stated there was no documented evidence that an RN conducted an SOC visit on 5/3/2026. -There was no documented evidence that an RN was assigned to visit and/or called Patient 19 to schedule a visit on 5/4/2026. -Patient 19 reported a leaking chest tube to the HHA on 5/5/2026, and the Non-Clinical Offshore Staff 1 (NCOS 1) called Patient 19 on 5/5/2026 to advise Patient 19 to go to the ER per “Supervisor’s” instructions. The DPCS was unable to provide documented evidence of the communication details with the “supervisor” who provided the instructions. -The SOC visit and initial assessment were conducted on 5/6/2026. The DPCS stated the delay of care placed Patient 19 at increased risks for delayed wound healing, development of an infection of the wound, and rehospitalization. During a review of the HHA’s undated policy and procedures (P&P), titled “Verification of Physician Orders,” the P&P indicated the following: -Orders must be obtained from a licensed physician for care and services to be provided to home health patients. -.Verbal orders must be spoken to, taken, and documented only by professional, licensed home health personnel (Registered Nurse or qualified therapist). Orders received via text message would not be accepted. -A qualified individual must review each order or prescription before care is provided. -An order or prescription must be verified when there is a question or discrepancy in the order/prescription and when the order is communicated by someone other than the physician or his/her agent. The order or prescription reviewed may be the original order, a facsimile copy, if permitted by law, or the direct transcription of a verbal order. 5.All telephone orders must be received and processed in accordance with state and federal laws and regulations. 6.Orders must be documented on a form provided by the HHA, dated and signed by the professional receiving the order. 4a. During a review of Patient 1’s Patient Information sheet, the sheet indicated a Start of Care (SOC) date of 4/18/2026 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. During a review of Patient 1’s clinical record titled Home Health Certificatio… [TRUNCATED: text continues]”

“Make complaints to the HHA CFR(s): 484.50(c)(3) Make complaints to the HHA regarding treatment or care that is (or fails to be) furnished, and the lack of respect for property and/or person by anyone who is furnishing services on behalf of the HHA; This Element is not met as evidenced by: Based on interview and record review, the home health agency failed to ensure that patients and their representatives were able to effectively exercise their rights to voice complaints regarding treatment and care that was not provided, followed up on, and resolved in accordance with agency policy for 1 of twenty sampled patients (Patient 20). This deficient practice placed Patient 20 at risk for continued delays in physician‑ordered treatment, with the potential for progression of infection, hospitalization, and other adverse health outcomes. During a review of Patient 20’s , Electronic Medical Record titled, “Referral Form (an official medical document used by primary care physician to legally authorize and order n skilled nursing ,physical therapy, or other in-home medical services for a patient)”, dated 5/2/2026, the form indicated the HHA’s registered nurse (RN) was to provide Intravenous (IV, within the vein) Infusion of Nafcillian, IV piggyback (a penicillin-based antibiotic used to treat severely deep-seated bacterial infections such as endocarditis , bacteremia ,or bone infections ), 2 grams every 4 hours between from 4/28/2026 to 6/8/2026 via PICC (Peripherally inserted central catheter- a thin flexible tube inserted in the upper arm and guided into a large vein above the right side of the heart to deliver used for long term intravenous treatments, nutrition, to prevent frequent needle sticks) with HHA IV administration. The referral form indicated to start IV services from 5/3/2026 to 6/8/2026. During a record review of Patient 20’s “Notice of Authorization of Services Form (a document used by healthcare providers and insurance plans like Medicare or Medicaid to formally approve or outline the scope of Home Care Services a patient will receive including type of visits, frequency, and duration of care)”, dated 5/2/2026, the form indicated patient was admitted to the home health agency (HHA), with a start of care (SOC) date of 5/2/2026, with diagnoses which included Orthopedic aftercare (the medical therapy, treatment and patient received following and orthopedic procedure), Bacterial Arthritis [a serious within the joint that requires urgent medical attention] infection), of left knee, and endocarditis (a serious heart infection often caused by bacterial/fungal infections that causes inflammation of the hearts interlining, enter the blood stream, traveling to the heart, attaching to damage valves and destroying the heart tissue). The Notice of Authorization form indicated the RN to visit one time for Nursing assessment/Evaluation, and RN Home Care Per Diem for 6 visits. The “Notice of Authorization and Service” form, the form indicated an approved request for “Priority Next Day IV POD (an infusion pump that is wearable and allows patient to move around their homes while receiving continuous or intermittent treatments). During a telephone interview with Family Member (FM 1) on 5/20/2026 at 10:30 a.m., FM1 stated Patient 20 was seen one time by an RN however, no agency staff returned to administer the ordered intravenous antibiotic therapy. FM1 stated she made multiple attempts to contact HHA’s RN Clinical Supervisor regarding the missed nursing visits for Patient 20’s IV antibiotic therapy. FM 1 stated there was no call back or follow up from the RN Clinical Supervisor. FM 1 stated on 5/6/2026, RN 2 came to visit Patient 20 unannounced to provide follow up IV services and FM 1 told RN 2 that no HHA staff had come to visit Patient 20 since he was admitted. During an interview on 5/19/2026 at 1:30 p.m., RN 2 stated FM 1 told her that she had not seen any HHA staff since 5/3/2026 when Patient 20 was admitted. RN 2 stated that she was informed by the RN Clinical Supervisor on 5/5/2026 to go see Patient 20 and hang the IV antibiotics. During an interview with the DPCS on 5/20/2026 at 1:30 p.m. the DPCS was unable to explain why Patient 20 had not received the ordered skilled nursing visits and intravenous antibiotic therapy as ordered by Patient 20’s physician. The DPCS stated she and another RN supervisor were responsible to oversee the HHA staff providing services to the patients in northern and southern California. and that they pick random patients medical records to review. The DPCS stated the HHA is looking for more RN supervisors to oversee the care provided to the patients by the HHA staff. During a concurrent record review of Patient 20’s EMR with the administrator on 5/21/2026, at 11:00 a.m., the EMR was reviewed. The administrator stated there were no skilled nursing visit notes, medication administration records, missed visit documentation, physician notification records, or any evidence that the order intravenous Nafcillin therapy had been administered by agency staff. The administrator stated she would have to check with the DPCS to see what happened. During an interview with the Administrator on 5/22/2026 at 12 p.m., the Administrator was not able to provide the HHA complaint log for review. The Administrator stated that there was no investigation performed for FM 1 complaint about Patient 20’s missed visit and delay of IV antibiotic therapy. During a review of the HHA’s Policy and Procedure titled, Bill Of Rights, undated, the policy indicated the following: Each patient will be an active, informed participant in his/her plan of care. To ensure this process, the patient will be empowered with certain rights and responsibilities as described B. Voice grievances regarding treatment or care that is (or fails to be) furnished, or regarding the lack of respect for property by anyone who is furnishing services on behalf of the organization and must not be subjected to discrimination or reprisal for doing so. C. Receive an investigation by the organization of complaints made by the patient or the patient’s family or guardian regarding treatment or care that is (or fails to be) furnished, or regarding lack of respect for the patient’s property by anyone furnishing services. D. Be informed in advance about care to be furnished and of any changes in the care to be furnished. During a review of the HHA’s Policy and Procedure titled Complaint/Grievance Process, dated 11/2021, the policy indicated the following: -Any difference of opinion, dispute, or controversy between a patient or family/caregiver or patient representative and Neogen Care concerning any aspect of services or the application of policies or procedures will be considered a grievance. -The Executive Director/Administrator will be informed of situations that may become detrimental to good patient relations, and will be committed to maintaining a consistently high level of patient relations. This grievance procedure will be included in the Bill of Rights document given to each patient upon admission. -The organization staff member receiving the complaint will discuss, verbally and in writing, the grievance with a supervisor within five (5) days of the alleged grievance. The supervisor will investigate the grievance within five (5) days after receipt of such grievance and will make every effort to resolve the grievance to the patient’s satisfaction. Response to the patient regarding the complaint will occur within ten (10) days of receipt.”

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on observation, interviews, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure the clinician conducted the initial assessment visit within 48 hours of the referral and/or of the patient’s return home for three of 20 sampled patients (Patient 7, Patient 14, and Patient 19). This failure had the potential to result in a decline in the health status of Patient 7, Patient 14, and Patient 19, including delayed wound healing, increased risk of infection, and rehospitalization. c. During a review of Patient 19’s undated medical record, titled “Patient Information,” the “Patient Information” indicated Patient 19’s SOC date of 5/6/2026 with a primary diagnosis of “Encounter for change or removal of surgical wound dressing (routine change or removal of a surgical wound dressing)” and a secondary diagnosis of “open wound of left upper arm.” The “Patient Information” indicated Patient 19’s referral date of 5/1/2026. During a review of Patient 19’s referral document from General Acute Care Hospital (GACH) 1, dated 4/30/2026, the referral document indicated Patient 19’s anticipated discharge date was 4/30/2026 with home health. The referral document indicated Patient 19 required Registered Nurse (RN) services to provide wound care as Patient 19 would be discharged home with a small chest tube drain (external, portable drainage collection device attached to a chest tube [flexible, hollow plastic tube inserted through the chest wall into the space around the lungs] to safely remove trapped air, blood, or fluid to allow the lungs to fully expand). The referral indicated per thoracic surgery (team of surgeons who specialize on the operative treatment of organs inside the chest, including the lungs, esophagus [food pipe], trachea [windpipe], and chest wall), Patient 19 required dressing changes every 3 days around the chest tube and to use a 4x4 drain gauze (sterile [free of germs], highly absorbent materials that prevent wound infections by managing exudates [fluids that may seep from wounds or surgical areas]) and tape to reinforce the dressing. The referral also indicated per thoracic surgery, Patient 19’s new chest tube drain might need to be exchanged if it fills up. During a review of Patient 19’s “SOC Delay Order,” dated 5/4/2026, the “SOC Delay Order” indicated the verbal order was obtained with “order read back and verified with ordering provider.” The “SOC Delay Order” indicated the reason for a delayed visit was “tried calling the patient to schedule the SOC visit, but the call remain unanswered.” During a review of Patient 19’s “SOC Delay Order,” dated 5/5/2026, the “SOC Delay Order” indicated the verbal order was obtained with “order read back and verified with ordering provider.” The “SOC Delay Order” indicated the reason for delayed visit was “patient reported a leaking issue and was instructed to go to urgent care or the emergency room (ER) due the leaking condition as home care was not appropriate at this time.” During a review of Patient 19’s “SOC Delay Order,” dated 5/6/2026, the “SOC Delay Order” indicated the verbal order was obtained with “order read back and verified with ordering provider.” The “SOC Delay Order” indicated Patient 19 agreed to do SOC on 5/6/2026. During a review of Patient 19’s Start of Care Order, dated 5/6/2026, the “Start of Care Order” indicated the following orders: Skilled Nurse (SN) frequency of home visits to Patient 19 was twice a week for three weeks.SN to perform chest tube draining using sterile technique and infection control measures using agency policy and procedures and to teach chest tube care and management.SN to perform wound care using infection control measures and standard precautions to the left axilla: Cleanse with normal saline (NS, salt solution to clean the wound), pat dry, apply drain sponge/gauze, secure with tape dressing, and change every 3 days.SN to perform wound care the chest tube site: cleanse with NS, pat dry, apply drain sponge/gauze, secure with tape dressing, and change every 3 days.SN to provide teaching regarding monitoring for signs and symptoms of infection and to report to the physician or SN.SN to provide teaching regarding deep breathing exercises and energy conservation techniques to prevent shortness of breath (SOB) and new Atrium Express Mini 500 Mobile Dry Seal Draine that may need to be exchanged if it fills up.During an interview on 5/18/2026 at 2:02 p.m., Patient 19 stated he had been diagnosed with Stage 4 lung cancer (cancer has spread from where it started in the lung to distant parts of the body, such as the brain, bones, or liver) for which the physician placed a PleurX catheter (small, flexible, tunneled silicone tube placed in the chest or abdomen to intermittently drain recurring fluid buildup in the lungs to relieve shortness of breath [SOB]). Patient 19 stated he was hospitalized from 4/15/2026 to 4/30/2026 due to an infection of the PleurX catheter. Patient 19 stated the physician removed the PleurX catheter, made an incision, removed a part of his rib to wash out the pus or bacteria, and inserted a chest tube. Patient 19 stated he was administered intravenous (IV, into the vein) antibiotics for 10 days. Patient 19 stated his last wound care was done on the date of his discharge from GACH 1 on 4/30/2026. Patient 19 stated GACH 1 stated the HHA would call Patient 19 within 24 hours of discharge from GACH 1 to schedule a nurse home visit to “come in and replace the bandages of the wound, make sure there is no infection, … and put in another chest tube drain, if needed.” Patient 19 stated the HHA might have called, but he was unable to answer the phone call because he “was taking a lot of medications at the time.” Patient 19 stated he might have received a nurse visit on 5/3/2026, but he was unable to recall the name of the HHA nurse. Patient 19 was unable to recall the date when he went back to GACH 1 for the exchange of chest tube drain related to the leaking chest tube. During an interview on 5/18/2026 at 3:26 p.m., RN 8 stated the HHA received Patient 19’s referral on 5/1/2026. RN 8 stated Patient 19 was originally assigned to a different nurse. RN 8 stated there was no nurse available to see Patient 19 on 5/2/2026 and 5/3/2026. RN 8 stated she was “too busy” conducting home visits for the other patients on 5/4/2026, and no nurse was able to conduct a home visit on Patient 19 on 5/4/2026. RN 8 stated Patient 19 was assigned to RN 8 on 5/5/2026, but RN 8 was unable to visit Patient 19 because the HHA staff (unable to identify) advised Patient 19 to go to the ER to address the leaking chest tube. RN 8 stated she conducted the first home visit for Patient 19 on 5/6/2026. During a concurrent interview and record review of Patient 19’s medical records on 5/21/2026 at 12:46 p.m., with the Director of Patient Care Services (DPCS), Patient 19’s electronic health records (EHRs) and Scheduling and Care Coordination Platform (SCCP) details were reviewed. The DPCS stated the following: -Patient 19’s referral date was 5/1/2026, so the expected SOC date was no later than 5/3/2026. -The RN must conduct the initial assessment within 48 hours of the referral date to assess Patient 19’s needs, including ordering of supplies and evaluating the caregiver needs. -There was no documented evidence that an RN called Patient 19 to schedule the SOC visit on or before 5/3/2026. The DPCS stated there was no documented evidence that an RN conducted an SOC visit on 5/3/2026. -There was no documented evidence that an RN was assigned to visit and/or called Patient 19 to schedule a visit on 5/4/2026. -Patient 19 reported a leaking chest tube to the HHA on 5/5/2026, and the Non-Clinical Offshore Staff 1 (NCOS 1) called Patient 19 on 5/5/2026 to advise Patient 19 to go to the ER per “Supervisor’s” instructions. The DPCS was unable to provide documented evidence of the communication details with the “supervisor” who provided the instructions. -The SOC visit and initial assessment were conducted on 5/6/2026. The DPCS stated the delay of care placed Patient 19 at increased risks for delayed wound healing, development of an infection of the wound, and rehospitalization. During a review of the HHA’s undated policy and procedures (P&P), titled “Intake Process,” the P&P indicated the following: The HHA must only accept those patients whose needs can be met by the services the HHA provides.Upon acceptance of the referral, the Clinical Supervisor/Nursing Supervisor must assign personnel and schedule an initial assessment visit. The initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of a patient’s return home, or on the SOC date ordered by the physician.If the service cannot be provided, intake personnel must give the caller the names of other agencies that can provide the required services. A log must be maintained on all patients that cannot be serviced.In addition, during a review of the HHA’s undated policy and procedures (P&P), titled “Initial and Comprehensive Assessment,” the P&P indicated the following: The initial assessment and comprehensive assessment must be conducted by a registered nurse unless rehabilitation therapy is the only requested service for that patient.During the initial and comprehensive patient assessment, all baseline data to be used in measuring the patient’s progress towards goals and other relevant information must be documented in the patient’s clinical record. a. During a review of Patient 7’s clinical record titled “Patient Profile,” (admission record, summary of patient’s basic information) undated, the clinical record indicated a referral date of 4/16/2026 with documented diagnoses including hypothyroidism (insufficient production of thyroid hormones, resulting in a slowed metabolism) and shortness of breath (SOB- the sensation of being unable to get enough air during breathing). During a review of Patient 7’s clinical record titled “OASIS (Outcome and Assessment Information Set, a federally mandated, multi-purpose assessment instrument for home health care)-E2 Start of Care,” dated 4/21/2026, the clinical record indicated Patient 7’s initial assessment visit was conducted on 4/21/2026, five days after the referral date, by Registered Nurse 1 (RN 1). During an interview on 5/13/2026 at 1:11 PM with the Agency’s Director of Patient Care Services Designee (DPCS Designee), the DPCS Designee stated that the initial assessment visit must be completed within 48 hours of the referral date. During a concurrent interview and record review on 5/19/2026 at 2:07 PM with the Agency’s Director of Patient Care Services (DPCS), Patient 7’s clinical record titled, “Notice of Authorization of Services,” dated 5/12/2026 was reviewed. The clinical record indicated home health services were valid from 4/16/2026 – 5/15/2026. The DPCS stated that Patient 7 was accepted by the Agency on 4/16/2026 and the initial assessment visit should have been completed by 4/18/2026 to ensure the patient received the physician ordered home health services, including medication review to confirm accurate medication administration, medication availability, and to provide medication therapy intended for symptom management and prevention of disease progression. During an interview on 5/22/2026 at 10:12 AM with the Agency’s DPCS, the DPCS stated there was no documented evidence demonstrating a clinician requested a delay order for Patient 7’s initial assessment visit. During a review of HHA’s policy and procedure (P&P), titled “Intake Process,” revised on November 2021, the P&P indicated the Clinical Supervisor/Nursing Supervisor will assign personnel and schedule an initial assessment visit. The initial assessment visit will be performed either within 48 hours of the referral, or within 48 hours of a patient’s return home, or on the start of care date ordered by the physician. During a review of HHA’s P&P, titled “Initial and Comprehensive Assessment,” revised on November 2021, the P&P indicated: -An initial patient assessment will be performed and documented in the patient’s clinical record by a registered nurse. -The initial patient assessment must be performed either within 48 hours of the referral, or within 48 hours of a patient’s return home, or on the start of care date ordered by the physician. b. During a review of Patient 14’s clinical record titled “Patient Profile,” undated, the clinical record indicated a referral date of 1/29/2026 with documented diagnoses including encounter for change or removal of nonsurgical wound dressing (a medical visit specifically for changing or removing a wound dressing that was not applied in a surgical setting) and surgical site infection following procedure (an infection occurring at the location of a surgical incision or internal area involved in surgery). During a review of Patient 14’s clinical record titled “Start of Care Order,” dated 3/10/2026, the clinical record indicated Patient 14 was admitted to the Agency on 3/10/2026. The skilled nursing visit frequency was three times a week for four weeks for wound care, medication management, and management of diabetes mellitus (DM-a disorder characterized by difficulty in blood sugar control and poor wound healing), hypertension (HTN-high blood pressure), atrial fibrillation (a type of irregular heartbeat), anemia (a condition in which the blood lacks a sufficient amount of healthy red blood cells), and end stage renal disease (ESDR-irreversible kidney failure). During a concurrent interview and record review on 5/19/2026 at 2:20 PM with the Agency’s DPCS, Patient 14’s clinical record titled “Order,” dated 3/4/2026 was reviewed. The clinical record indicated an order for home health services for wound care. The DPCS stated that the Agency accepted the referral on 3/7/2026. During a concurrent interview and record review on 5/19/2026 at 2:23 PM with the Agency’s DPCS, Patient 14’s clinical record titled “ED (Emergency Department) to Hosp- (Hospital) Admission,” dated 3/3/2026 was reviewed. The clinical record indicated Patient 14 was discharged from the hospital on 3/7/2026. The DPCS stated that the initial assessment visit should have been completed within 48 hours of discharge and no later than 3/9/2026. During a concurrent interview and record review on 5/19/2026 at 2:27 PM with the Agency’s DPCS, Patient 14’s clinical record titled “Patient Profile,” undated was reviewed. The clinical record indicated a referral date of 1/29/2026 and a start of care date of 3/10/2026. The DPCS stated that the referral date shown was from a previous home health referral and had not been updated for the current one. Patient 14’s first visit on 3/10/2026 did not meet the required 48-hour timeframe for completing the initial visit assessment. During a concurrent interview and record review on 5/19/2026 at 2:43 PM with the Agency’s DPCS, Patient 14’s electronic medical record (EMR) titled “Orders,” (section of the EMR containing physician orders) was reviewed. The EMR did not include documented evidence of physician orders indicating a delay in the initial assessment visit. The DPCS stated the delayed initial assessment visit had potential to result in wound infection and delayed wound healing for Patient 14. During a review of HHA’s P&P, titled “Intake Process,” revised on November 2021, the P&P indicated the Clinical Supervisor/Nursing Supervisor will assign personnel and schedule an initial assessment visit. The initial assessment visit will be performed either within 48 hours of the referral, or within 48 hours of a patient’s return home, or on the start of care date ordered by the physician. During a review of HHA’s P&P, titled “Initial and Comprehensive Assessment,” revised on November 2021, the P&P indicated: -An initial patient assessment will be performed and documented in the patient’s clinical record by a registered nurse. -The initial patient assessment must be performed either within 48 hours of the referral, or within 48 hours of a patient’s return home, or on the start of care date ordered by the physician.”

“5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care. This Element is not met as evidenced by: Based on interviews and record review, the HHA failed to ensure completion of the comprehensive assessment for three of 20 sampled patients (Patient 7, Patient 9, and Patient 14) within 5 calendar days after the start of care. This failure had the potential to result in delayed or missed care, placing patients at increased risk of unmet care needs, hospitalization, and distress. a. During a review of Patient 7’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date of 4/21/2026 with documented diagnoses including hypothyroidism (a condition in which the thyroid gland does not produce enough thyroid hormone, leading to fatigue, weight gain, and slowed metabolism) and SOB (shortness of breath; a symptom of difficult or labored breathing). During a review of Patient 7’s clinical record titled “OASIS (Outcome and Assessment Information Set- a federally mandated, multi-purpose assessment instrument for home health care)-E2 Start of Care,” dated 4/21/2026, the clinical record indicated Patient 7’s initial comprehensive assessment visit was conducted on 4/21/2026 by Registered Nurse 1 (RN 1). During an interview on 5/20/2026 at 1:03 PM with the HHA’s Quality Assurance Director (QA Nurse), the QA Nurse stated that the OASIS form must be completed within 5 calendar days after the start of care. During an interview on 5/20/2026 at 3:43 PM with the HHA’s QA Nurse, the QA Nurse stated that the OASIS form cannot be reopened after 5 days from the start of care. The form may be exported (the transmission of the complete patient assessment data to the Centers for Medicare and Medicaid Services) up to 30 days after the start of care, discharge, or resumption of care date, but the comprehensive assessment data must be completed, documented, and signed within 5 days of the visit. During a concurrent interview and record review on 5/22/2026 at 12:10 PM with the HHA’s Director of Patient Care Services (DPCS), Patient 7’s clinical record titled “Task Details (an electronic medical record (EMR) form indicating who and when a document was created, updated, or revised) Patient 7 OASIS-E2 Start of Care,” undated, was reviewed. The clinical record indicated RN 1 initially submitted the OASIS form with a signature on 4/26/2026, the OASIS form was reopened and updated by Quality Assurance Staff 1 (QA Staff 1), QA Staff 2 and QA Staff 3 several times between 4/30/2026 to 5/11/2026 before RN 1 resubmitted the OASIS form with signature on 5/11/2026. The DPCS stated the OASIS form had been reopened and modified multiple times after the initial 5-day completion window following the start of care, potentially resulting in a delay in patient care. b. During a review of Patient 9’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date 4/3/2026 with documented diagnoses including encounter for adjustment and management of ventricular assist device (a surgically implanted mechanical pump that supports the heart circulate blood) and bacteremia (the presence of bacteria in the bloodstream). During a review of Patient 9’s clinical record titled “OASIS-E2 Start of Care,” dated 4/3/2026, the clinical record indicated Patient 9’s initial comprehensive assessment visit was conducted on 4/3/2026 by RN 10. During an interview on 5/20/2026 at 1:03 PM with the HHA’s QA Nurse, the QA Nurse stated that the OASIS form must be completed within 5 calendar days after the start of care. During an interview on 5/20/2026 at 3:43 PM with the HHA’s QA Nurse, the QA Nurse stated that the OASIS form cannot be reopened after 5 days from the start of care. The form may be exported up to 30 days after the start of care, discharge, or resumption of care date, but the comprehensive assessment data must be completed, documented, and signed within 5 days of the visit. During a concurrent interview and record review on 5/22/2026 at 12:30 PM with the HHA’s DPCS, Patient 9’s clinical record titled “Task Details Patient 9 OASIS-E2 Start of Care,” undated, was reviewed. The clinical record indicated the OASIS form was reopened and updated by QA Staff 4, QA Staff 5, QA Staff 6, QA Staff 7, QA Staff 8, and QA Staff 9 several times between 4/5/2026 to 5/11/2026 before RN 10 signed the OASIS form on 5/11/2026. The DPCS stated the OASIS form had been reopened and modified multiple times after the initial 5-day completion window following the start of care, potentially resulting in a delay in patient care. c. During a review of Patient 14’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date of 3/10/2026 with documented diagnoses including encounter for change or removal of nonsurgical wound dressing and surgical site infection following procedure. During a review of Patient 14’s clinical record titled “OASIS-E1 Start of Care,” dated 3/10/2026, the clinical record indicated Patient 14’s initial comprehensive assessment visit was conducted on 3/10/2026 by RN 11. During an interview on 5/20/2026 at 1:03 PM with the HHA’s QA Nurse, the QA Nurse stated that the OASIS form must be completed within 5 calendar days after the start of care. During an interview on 5/20/2026 at 3:43 PM with the HHA’s QA Nurse, the QA Nurse stated that the OASIS form cannot be reopened after 5 days from the start of care. The form may be exported up to 30 days after the start of care, discharge, or resumption of care date, but the comprehensive assessment data must be completed, documented, and signed within 5 days of the visit. During a concurrent interview and record review on 5/22/2026 at 12:44 PM with the HHA’s DPCS, Patient 14’s clinical record titled “Task Details Patient 14 OASIS-E1 Start of Care,” undated, was reviewed. The clinical record indicated the OASIS form was reopened and updated by QA Staff 3, QA Staff 5, QA Staff 6, QA Staff 8, QA Staff 10, QA Staff 11, QA Staff 12, and QA Staff 13 several times between 3/11/2026 to 5/11/2026 before RN 11 signed the OASIS form on 5/11/2026. The DPCS stated the OASIS form had been reopened and modified multiple times after the initial 5-day completion window following the start of care, potentially resulting in a delay in patient care. During a review of HHA’s P&P, titled “Initial and Comprehensive Assessment,” revised on November 2021, the P&P indicated: -A comprehensive assessment will be completed within 5 calendar days of the patient’s start of care. -The assessment will be patient-specific and comprehensive and will include the exact use of the current versions of the Outcome and Assessment Information Set (OASIS). -The OASIS data will be collected during the comprehensive assessment. -A plan of care will be developed utilizing the information gathered during the comprehensive assessment. During a review of HHA’s P&P, titled “Quality Assurance (QA) Review of Clinical Records,” undated, the P&P indicated: - Clinical records will be reviewed through the QA process to support documentation accuracy, regulatory compliance, and consistency with patient care provided. - QA staff shall review documentation and when deficiencies, omissions, inconsistencies, or corrections are identified, the documentation shall be returned to the clinician responsible for correction. Following correction by the clinician, the documentation shall be resubmitted for QA review. - The clinician must sign and review the clinical record to finalize and close the record. - The clinician must complete clinical records accurately, timely, and in accordance with home health regulations. - QA staff are not permitted to make corrections, additions, completions, or substantive changes on behalf of a clinician. Documentation corrections must be made by the clinician who created the clinical record or by the appropriate responsible clinician.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, interviews, and record review, the Home Health Agency ((HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to maintain an accurate review of all the current medications and treatments for five of 20 sampled patients (Patient 2, Patient 3, Patient 7, Patient 8, and Patient 14). This failure placed Patient 2, Patient 3, Patient 7, Patient 8, and Patient 14 at risk for medication errors, ineffective drug therapy, and serious adverse effects (an undesired, harmful response to a medication or treatment) such as heart problems, that could lead to stroke (medical emergency when blood flow to the brain is interrupted or reduced) and hospitalization. e. During a review of Patient 7’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date of 4/21/2026 with documented diagnoses including hypothyroidism and SOB. During a review of Patient 7’s clinical record titled “OASIS (Outcome and Assessment Information Set- a federally mandated, multi-purpose assessment instrument for home health care)-E2 Start of Care,” dated 4/21/2026, the clinical record indicated Registered Nurse 1 (RN 1) reviewed and reconciled all the patient’s medications and provided a medication list on 4/21/2026. During a review of Patient 7’s clinical record titled “Medication Profile,” for the certification period 4/21/2026 – 6/19/2026, the clinical record indicated the following medication orders: - Latanoprost ophthalmic (liquid eye drop medication used to lower high pressure inside the eyes) 0.005 % solution. Instill 1 drop in both eyes at bedtime for glaucoma (eyes pressure increases that lead to permanent vision loss and blindness). Start date 4/21/2026. - Acetaminophen (medication used to relieve pain and lower fever) 650 milligram (mg- unit of measurement) rectal suppository (medications inserted into the rectum). Insert 1 suppository rectally every 4 hours as needed for fever over 100.4 degrees Fahrenheit (F, unit of measurement). Start date 4/21/2026. - Morphine sulfate (medication used to relieve severe pain) 20 mg/5 milliliter (mL- unit of measurement) solution. Take 0.1 mL by mouth every hour as needed for severe pain (characterized as pain level 7 – 10 on a 0 – 10 pain scale, with 0 being no pain at all and 10 being the absolute worst pain imaginable). Start date 4/21/2026. - Lorazepam (medication used for short-term relief of anxiety disorders) 0.5 mg tablet. Take 1 tablet by mouth every 4 hours as needed for anxiety and depressed mood. Start date 4/21/2026. - Hyoscyamine sulfate (medication used to decrease oral and respiratory secretions) 0.125 mg tablet. Dissolve 1 tablet under the tongue every 4 hours as needed for congestion. Start date 4/21/2026. - Haloperidol lactate (medication used to treat mental health and behavioral conditions) 2 mg/mL solution. Take 0.5 mL by mouth every hour as needed for agitation or nausea. Start date 4/21/2026. - Bisacodyl (medication used to relieve constipation) 10 mg rectal suppository. Insert 1 suppository rectally daily as needed for constipation if sennosides (naturally derived compounds used for treatment of constipation) and bisacodyl are ineffective. Hold for loose stool. Start date 4/21/2026. - Amlodipine besylate (medication used to lower blood pressure and prevent chest pain) 2.5 mg tablet. Take 1 tablet by mouth daily for blood pressure. Start date 4/21/2026. During a concurrent observation and interview on 5/12/2026 at 11:01 AM, RN 5 was observed in Patient 7’s residence conducting the medication reconciliation (a formal process of creating the most accurate list of a patient’s current medications and comparing it to the medications the patient is taking or should be taking to identify and resolve discrepancies). A box containing all the patient’s medication was made available for review. Patient 7’s latanoprost ophthalmic 0.005 % solution, acetaminophen 650 mg rectal suppository, morphine sulfate 20 mg/5 mL solution, lorazepam 0.5 mg tablet, hyoscyamine sulfate 0.125 mg tablet, haloperidol lactate 2 mg/mL solution, and bisacodyl 10 mg rectal suppository were missing from Patient 7’s medications available on hand. Patient 7’s amlodipine besylate 2.5 mg tablet did not include parameters for administration (specific, measurable guidelines, clinical limits, and physiological conditions that dictate whether, how, and when a medication should be safely given). RN 5 stated that she completed a medication reconciliation on 5/8/2026 when she assumed Patient 7’s care and noted the medications were not available for administration. RN 5 further stated that the amlodipine prescription label and medication profile did not include any administration parameters. During an interview on 5/13/2026 at 1:11 PM with the Agency’s Director of Patient Care Services Designee (DPCS Designee), the DPCS Designee stated medication reconciliation was done by comparing the medication list received at referral with the medications the patient had on hand. During an interview on 5/13/2026 at 3:20 PM with the Agency’s Registered Nurse Clinical Supervisor (RN Clinical Supervisor), RN Clinical Supervisor stated medication reconciliation includes a review of parameters for medication administration. During an interview on 5/19/2026 at 12:22 PM with the Agency’s Director of Patient Care Services (DPCS), DPCS stated that as needed medications (taken only when specific symptoms or circumstances arise and symptom relief is required) were not required to be available for administration in the patient’s residence because they could expire. Instead, the medications were ordered from the pharmacy when the patient’s condition required them. The DPCS stated this practice could result in medications not being available for administration when needed by Patient 7. During an interview on 5/19/2026 at 1:07 PM with the Agency’s DPCS, the DPCS stated that amlodipine without parameters for administration could result in medication administration errors and Patient 7’s experiencing adverse effects such as low blood pressure, dizziness, lethargy (a state of feeling deeply exhausted, sluggish, and unmotivated), weakness, and falls. During the interview on 5/19/2026 at 1:07 PM, the DPCS stated if pain medications are not available for administration, Patient 7 could experience increased heart rate and blood pressure, feel miserable, and have uncontrolled pain. During the interview on 5/19/2026 at 1:07 PM, the DPCS stated if medications used to treat anxiety, mental health and behavioral conditions were not available for administration, Patient 7 could experience increased heart rate, high blood pressure, and uncontrolled anxiety. During a review of HHA’s P&P, titled “Initial and Comprehensive Assessment,” revised on November 2021, the P&P indicated during the initial and comprehensive patient assessment, all baseline data to be used in measuring the patient’s progress towards goals and other relevant information will be documented in the patient’s clinical record including: a review of current medication use, including prescription, over-the-counter medications, and herbal medications, and identifying drug interactions, duplicative drug therapy, potential adverse effects and drug interactions, ineffective drug therapy, significant side effects and noncompliance with therapy. During a review of HHA’s P&P, titled “Initial and Comprehensive Assessment,” revised on November 2021, the P&P indicated during the initial and comprehensive patient assessment, all baseline data to be used in measuring the patient’s progress towards goals and other relevant information will be documented in the patient’s clinical record including, review of medication history, including prescription, over-the-counter medications and herbal medications, and identifying drug interactions, duplicative drug therapy, potential adverse effects and drug reactions, ineffective drug therapy, significant side effects and noncompliance with therapy. During a review of HHA’s P&P, titled “Medication Profile,” revised on November 2023, the P&P indicated: -Upon admission, the admitting clinician will initiate a medication profile to document the current medication regimen. -A drug regimen review will be performed at the time of admission and when updates to the comprehensive assessment are performed. The review will identify drug/food interactions, potential adverse events and drug reactions, ineffective drug therapy, and noncompliance with drug therapy. -Each patient will receive appropriate written material for specific medications he/she is receiving. The material shall contain information on any special instructions when taking the specific medication. f. During a review of Patient 8’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date of 4/30/2026 with documented diagnoses including hypo-osmolarity (the concentration of solutes [like salt and proteins] in body fluids is abnormally low compared to water), hyponatremia (low sodium concentration), and hypomagnesemia (low magnesium concentration). During a review of Patient 8’s clinical record titled “Medication Profile,” for the certification period 4/30/2026 – 6/28/2026, the clinical record indicated the following medication order: -Carvedilol (medication used to lower blood pressure, slow heart rate, and relax blood vessels) 12.5 mg tablet. Take 1 tablet by mouth twice a day with meals to control blood pressure. Start date 4/30/2026. During a concurrent observation and interview on 5/12/2026 at 12:48 PM, RN 5 was observed in Patient 8’s residence conducting the medication reconciliation. Patient 8’s carvedilol 12.5 mg tablet did not include parameters for administration. RN 5 stated that that the carvedilol prescription label and medication profile did not include any administration parameters. During an interview on 5/13/2026 at 1:11 PM with the Agency’s DPCS Designee, the DPCS Designee stated medication reconciliation was done by comparing the medication list received at referral with the medications the patient had on hand. During an interview on 5/13/2026 at 1:57 PM with the Agency’s DPCS Designee, the DPCS Designee stated that blood pressure and heart rate must be checked before administering carvedilol to ensure it is safe to give and to prevent adverse effects such as low blood pressure, a slow heart rate, or Patient 8 fainting. During an interview on 5/13/2026 at 3:20 PM with the Agency’s Registered Nurse Clinical Supervisor (RN Clinical Supervisor), RN Clinical Supervisor stated medication reconciliation includes a review of parameters for medication administration. During a review of HHA’s P&P, titled “Initial and Comprehensive Assessment,” revised on November 2021, the P&P indicated during the initial and comprehensive patient assessment, all baseline data to be used in measuring the patient’s progress towards goals and other relevant information will be documented in the patient’s clinical record including, review of medication history, including prescription, over-the-counter medications and herbal medications, and identifying drug interactions, duplicative drug therapy, potential adverse effects and drug reactions, ineffective drug therapy, significant side effects and noncompliance with therapy. During a review of HHA’s P&P, titled “Medication Profile,” revised on November 2023, the P&P indicated: -Upon admission, the admitting clinician will initiate a medication profile to document the current medication regimen. -A drug regimen review will be performed at the time of admission and when updates to the comprehensive assessment are performed. The review will identify drug/food interactions, potential adverse events and drug reactions, ineffective drug therapy, and noncompliance with drug therapy. -Each patient will receive appropriate written material for specific medications he/she is receiving. The material shall contain information on any special instructions when taking the specific medication. g. During a review of Patient 14’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date of 3/10/2026 with documented diagnoses including encounter for change or removal of nonsurgical wound dressing and surgical site infection following procedure. During a review of Patient 14’s clinical record titled “OASIS E1 Start of Care,” dated 4/21/2026, the clinical record indicated Patient 14 was currently taking five or more medications, including “high-risk” medication classes (medications that have a heightened risk if causing severe paint harm or death when used incorrectly) such as antibiotic (medications used to treat bacterial infections), opioid (medications used to block pain), and antiplatelet (medications used to prevent blood cells from clumping together). During an interview on 5/13/2026 at 1:11 PM with the Agency’s DPCS Designee, the DPCS Designee stated medication reconciliation was done by comparing the medication list received at referral with the medications the patient had on hand. During a concurrent interview and record review on 5/22/2026 at 12:44 PM with the Agency’s DPCS, Patient 14’s clinical record titled “Patient Medication Record,” for the certification period 3/10/2026 – 4/30/2026 and with a signature date of 3/11/2026 was reviewed. The clinical record indicated, “no medications have been added.” The DPCS stated medication orders must be input timely during the medication reconciliation at the start of care to prevent implementation of an incorrect treatment plan. Patient 14’s medication review was not accurately documented, increasing the patient’s risk of medication administration errors, drug interactions, and unmedicated symptoms. During a review of HHA’s P&P, titled “Initial and Comprehensive Assessment,” revised on November 2021, the P&P indicated during the initial and comprehensive patient assessment, all baseline data to be used in measuring the patient’s progress towards goals and other relevant information will be documented in the patient’s clinical record including, review of medication history, including prescription, over-the-counter medications and herbal medications, and identifying drug interactions, duplicative drug therapy, potential adverse effects and drug reactions, ineffective drug therapy, significant side effects and noncompliance with therapy. During a review of HHA’s P&P, titled “Medication Profile,” revised on November 2023, the P&P indicated: -Upon admission, the admitting clinician will initiate a medication profile to document the current medication regimen. -A drug regimen review will be performed at the time of admission and when updates to the comprehensive assessment are performed. The review will identify drug/food interactions, potential adverse events and drug reactions, ineffective drug therapy, and noncompliance with drug therapy. -Each patient will receive appropriate written material for specific medications he/she is receiving. The material shall contain information on any special instructions when taking the specific medication. c. During a record review of Patient 5’s medical record on 5/12/2026, indicated a start of care (SOC) date of 5/5/2026, for the certification period of 5/505256 to 7/3/2026, with diagnoses that include Alcoholic hepatitis ( An inflammatory condition of the liver resulting from heavy alcohol consumption), without Ascites ( fluid accumulation in the abdomen), and Metabolic encephalopathy( a diffuse brain dysfunction due to systemic metabolic disturbances, which may include liver or kidney failure, electrolyte imbalance, hypoxia, and organ failure). The physician ordered for Skilled Nursing visit (SN) two times a week for 2 weeks , one time a week for one week, effective 5/5/2026, for medication management. The SN was to educate patient/caregiver regarding current medications such as medication name, dose, frequency and purpose of medications. During a concurrent home visit, medication review and interview on 5/11/2024, with RN clinical supervisor at 10:30 a.m., the following medications discrepancy were identified: The medication profile was not updated to reflect a change in the physician’s order dated 5/7/2026, which increased Gabapentin dosage form one capsule three times a day to two capsules three times a day. The skilled Nurse (SN) did not identify nor address the fact the patient had run out of K-tab and there was no indication that refill was communicated or arranged. There was no documented evidence that the SN reviewed the HHA’s in-home medication profile booklet to ensure it matched current orders and medication supply. During an interview and medication review with Patient 5, at the dining table, Patient 6 stated that she ran out of K-tab and did not have any more. Review of the HHA’s in-home Medication profile booklet indicated on 5/11/2026, the Sn did not update the current order of Gabapentin and review and inform Patient 5 of need to refill K-Dur. During an interview with RN clinical Supervisor in Patient 5’s house, she stated, it is important for the SN to review the medication every visit to ensure accuracy and ensure patient has enough medication in stock. d. During a record review of Patient 6’s Medical Record (EMR) entitled “Patient Information” dated 05/11/2026 indicated admission to the HHA with a SOC date of 05/05/2026, for a certification period from 05/05/2026 to 07/03/2026. Diagnoses included acute and chronic respiratory failure with hypoxia (a severe condition in which the lungs cannot adequately oxygenate the blood, resulting in low oxygen levels), difficulty in walking ( mobility impairment that limits safe ambulation and increases fall risk), dependence on supplemental oxygen (requiring continuous therapy to maintain adequate oxygen saturation and respiratory stability), chronic systolic congestive heart failure (a chronic cardiac condition in which the left ventricle cannot pump effectively, causing fluid retention, shortness of breath, swelling, rapid weight gain, and risk for pulmonary edema), and unspecified displaced fracture of the second cervical vertebra (C2), with a cervical and fall risk. Physician orders included Skilled Nursing visits for medication management, oxygen management and safety, and PT visits for gait‑training precautions During a concurrent home visit observation on 05/11/2026 at 10:30 AM, multiple medication discrepancies were observed between the EMR medication profile and the in‑home medication profile booklet. These included: Naloxone HCL Nasal 4 mg/0.1 mL listed on the EMR but not present in the home; Acetaminophen 325 mg listed in EMR, but Tylenol Extra Strength 500 mg was found in the home without purpose or frequency; Hydrocodone‑Acetaminophen 5‑325 mg ordered but not documented in the in‑home medication booklet; and Aspirin 81 mg found in the home but missing from the EMR. During interview, the RN Supervisor on 5/11/2026, at 11:30 a.m. she stated that the SN is required to document medication name, dose, frequency, purpose, and any special instructions, such as taking before meals or holding for low blood pressure. The RN Supervisor acknowledged that Patient 6 receives 6 L/min continuous oxygen without humidification, placing the patient at risk for nasal bleeding, and stated a humidifier would be ordered. The agency failed to ensure accurate review and reconciliation of medications at each visit as required under 42 CFR §484.55(g). This failure resulted in inaccurate medication records, potential omissions, inconsistent dosing, and increased risk of adverse drug events for a medically fragile patient dependent on continuous oxygen and with multiple comorbid conditions. During a review of the HHA’s undated policy and procedures (P&P), titled “Medication Profile,” the P&P indicated the following: Patients receiving medications administered by the organization must have a current, accurate medication profile in the clinical record. In rehabilitation therapy only cases, the patient’s therapist must submit a list of patient medications to a registered nurse for review.Medication profiles must be updated for each change to reflect current medications, new, and/or discontinued medications.A drug review must be performed at the time of admission, when updates to the comprehensive assessments are performed, when care is resumed after a patient has been placed on hold, and with the changes in medication regimen at each visit. The review must identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicate drug therapy, and noncompliance with drug therapy.Each patient must receive appropriate written material for specific medications he/she is receiving. The material must contain information on actions of the medication, potential side effects, potential contraindications the patient should be aware of and special instructions when taking the specific medication, if any.Based on review of the medication profile as well as the written material, changes in the plan of care may be required.Deviations from taking medications as ordered must be documented in clinical notes, and the physician must be notified. b. During a review of Patient 3’s undated medical record, titled “Patient Information,” the “Patient Information” indicated the SOC date of 4/30/2026 with a primary diagnosis of Alzheimer’s disease (progressive brain disorder that affects memory, mental skills, and the ability to carry out simply daily tasks). During a review of Patient 3’s referral document from General Acute Care Hospital (GACH) 1, dated 4/30/2026, the referral document indicated Patient 3 required home health services with at-home Physical Therapy (PT) for evaluation and treatment and for functional mobility training (FMT, exercise approach to help a patient move safely and efficiently through everyday activities). During a review of Patient 3’s “Patient Medication Profile,” dated 4/30/2026, Physical Therapist (PT) 3 documented Patient 3’s current medications: Losartan (medication to treat high pressure of blood against the arteries) 100 milligrams (mg, unit of measurement) 1 tablet by mouth dailyAspirin (medication to prevent blood clots) 81 mg 1 tablet by mouth dailyEscitalopram (medication to treat pervasive feelings of sadness) 5 mg 1 tablet by mouth dailySimvastatin (medication to treat high cholesterol) 40 mg 1 tablet by mouth dailyCetirizine (medication to treat allergies) 10 mg 1 tablet by mouth dailyGabapentin (medication to treat nerve pain) 100 mg 2 pills by mouth at bedtime and 1 pill in the morningHumulin N (medication to treat high blood sugar) U-100 2 units via “injection” if blood sugar higher than 130 mg/deciliterPantoprazole (medication to treat excessive stomach acid) 40 mg 1 tablet by mouth twice a dayDuring a review of Patient 3’s Physician Order, dated and signed by the Director of Patient Care Services (DPCS) on 5/4/2026, the Physician Order indicated the following: New medications included:-Amoxicillin and clavulanate potassium (medication to treat bacterial infections) 500-125 mg 1 tablet by mouth twice a day for 10 days to treat cellulitis -hydrochlorothiazide (medication to treat high blood pressure [BP, pressure of blood against the arteries]) 25 mg 1 tablet by mouth daily for BP (started on 5/4/2026) Patient 3 reported not taking the following medications:-Gabapentin 100 mg gradually increase to 2 capsules by mouth at night and one capsule in the morning for nerve pain -Pantoprazole 40 mg 1 tablet by mouth twice daily for gastric irritation -Mupirocin (medication to treat skin infections) external ointment 2% apply to affected areas twice daily (patient also reported changes in the following medication) Docusate sodium (medication to treat constipation) 100 mg 1 capsule by mouth twice daily for constipation -Polyethylene Glycol powder (medication to treat constipation) 17 grams per scoop – take 17 grams by mouth daily as needed for constipation if docusate is ineffective -Vitamin B-12 (supplement) 1000 micrograms (mcg, unit of measurement of weight) 1 tablet by mouth daily for supplement -Vitamin D3 (supplement) 25 mcg 1 tablet by mouth daily for supplement 3. Patient 3 reported changes in the following medications: -Gabapentin 100 mg 1 capsule by mouth at night daily for nerve pain -Pantoprazole 40 mg 1 tablet by mouth twice daily as needed for gastric irritation During a review of Patient 3’s “Patient Communication,” dated 5/8/2026, the “Patient Communication” indicated PT 2 “requested to pass the message to the MD’s office” regarding Patient 3’s BP readings (normal BP is less than 120/80 millimeters of mercury [mmHg, unit of measurement of pressure]) of 180/90 mmHg and 200/90 mmHg during and post-therapy. During a concurrent observation and interview on 5/8/2026 at 11:58 a.m., while on a joint home visit with Physical Therapist (PT) 2 in Patient 3’s living room with RP 4, Patient 3 was alert, confused, and sitting on the couch in the living room. Patient 3 complained of 6 our of 10 pain on the left groin with occasional grimacing during exercise with PT 2. Patient 3’s blood pressure readings were 180/90 mmHg and 200/90 mmHg. Patient 3 denied any headache or chest pain. RP 4 stated Patient 3’s Primary Care Physician (PCP) was aware of Patient 3’s high BP readings and Patient 3 has an upcoming appointment with the PCP in 4 days. RP 4 stated Patient 3 refused to take her morning medications, including BP medication. PT 2 provided teaching regarding the importance of taking her BP medication. Patient 3 eventually took the morning medications, including the BP medication, after multiple attempts of PT 2 and RP 4 to convince Patient 3 to take her morning medications. Patient 3’s medication bottles and Patient 3’s Patient Medication Record were also reviewed. The following medication discrepancies were noted: Per Responsible Party (RP) 3, Patient 3 had stopped taking hydrochlorothiazide 25 mg 1 tablet by mouth daily for blood pressure about 6 months ago per physician’s advice.Per RP 3, Patient 3 was taking over-the-counter (OTC) Tylenol 500 mg or 650 mg as needed for pain (not on the medication list).During a review of Patient 3’s “Patient Communication,” dated 5/11/2026, the “Patient Communication” indicated OT 1 “requested to pass the message to the MD’s office” regarding Patient 3’s BP readings of 174/67 mmHg and 158/64 mmHg and not taking the hydrochlorothiazide. During a concurrent interview and record review on 5/14/2026 at 11:48 a.m. with the Rehabilitation Supervisor (RS) and Registered Nurse Clinical Supervisor (RNCS), Patient 3’s medical records were reviewed. The RS stated there was no documented evidence that PT 2 and OT 1 requested a skilled nurse (SN) consult to review the effectiveness of the BP medication and follow up with the physician regarding the high BP readings. The RNCS stated it was important to request an SN consult to further evaluate the causes of high BP, such diet noncompliance (high sodium intake could lead to a higher BP), medication noncompliance, uncontrolled pain or stress, or PT exercises, and obtain an order if a change in the BP medication was necessary. In addition, the RNCS stated an SN consult was necessary if a new medication is ordered to provide teachings about the medication, including the indication, side effects, and adverse effects to the patient (in general) and the caregiver/s. The RNCS stated there was no documented evidence that an RN reviewed Patient 3’s medications and addressed ineffective drug therapy and noncompliance with drug therapy. The RNCS stated there was no documented evidence that an RN followed up with the physician regarding the high BP readings to clarify the hydrochlorothiazide order and request for the pain medication order. The RNCS stated a BP uncontrolled by BP medications could lead to more heart problems, stroke, and hospitalization. During a review of the HHA’s undated policy and procedures (P&P), titled “Medication Profile,” the P&P indicated the following: Patients receiving medications administered by the organization must have a current, accurate medication profile in the clinical record. In rehabilitation therapy only cases, the patient’s therapist must submit a list of patient medications to a registered nurse for review.Medication profiles must be updated for each change to reflect current medications, new, and/or discontinued medications.A drug regimen review must be performed at the time of admission, when updates to the comprehensive assessments are performed, when care is resumed after a patient has been placed on hold, and with the changes in medication regimen at each visit. The review must identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicate drug therapy, and noncompliance with drug therapy.Each patient must receive appropriate written material for specific medications he/she is receiving. The material must contain information on actions of the medication, potential side effects, potential contraindications the patient should be aware of and special instructions when taking the specific medication, if any.Based on review of the medication profile as well as the written material, changes in the plan of care may be required.Deviations from taking medications as ordered must be documented in clinical notes, and the physician must be notified.a. During a review of Patient 2’s Patient Information sheet, the sheet indicated a Start of Care (SOC) date of 4/14/2026 with a primary diagnosis of fracture unspecified of one femur (the thigh bone), subsequent encounter for closure fracture with routine healing. During a review of Patient 2’s medication record dated 4/29/2026 for the certification period from 4/14/2026 to 6/12/2026 indicated the following medication orders; Temazepam (prescription medication used for short term treatment of insomnia [trouble falling or staying asleep]) oral 15 milligrams (mg- unit of measurement) 1 capsule taken by mouth at bedtime for sleep Tramadol (prescription opioid medication used to treat moderate to moderately severe pain) 50 mg, take 1 tablet by mouth every 6 hours as needed for severe pain (7 to 10/10), do not exceed 4 tablets In 24 hours Zinc oxide external (an ointment that acts as a physical barrier that protects, soothes, and heals the skin) 1% apply to affected area(s) two times a day for dry skin/irritation Melatonin sublingual (a supplement taken under the tongue used as a mild sleep aid to regulate the body’s sleep-wake cycle) 5mg, dissolve 10mg under the tongue at bedtime for sleep Atropine sulfate (medication used to block nerve stimulation of muscles and glands and relaxes smooth muscles, causing decrease in secretions) take 3 drops by mouth every 4 hours as needed for dry up extra saliva or mucus Furosemide (diuretic medication that tells the kidneys to remove excess salt and water from the body through urine to help reduce swelling, and lower high blood pressure) 20 mg, take 1 tablet by mouth as needed for increase in daily weight greater than 2 pounds, leg swelling, shortness of breath, or increase in supplemental oxygen. During a joint home visit on 5/11/2026 at 2 p.m. with the Director of Patient Care Services Designee (DPCSD) at Patient 2’s residence at the Assisted Living facility, Patient 2 was observed in her room number 135, sitting up on a recliner on a waffle cushion, with pillows supporting her back, in the living room area, awake, alert and oriented to self. Patient 2 was observed able to answer simple yes or no questions with a head nod. During a concurrent interview and record review on 5/11/2026 at 2:57 p.m. with the DPCSD, Patient 2’s medication bottles, medication list from the assisted living facility and the medication record from the HHA were reviewed. During a review of Patient 2’s medication bottles, the order for the medication Temazepam indicated to take as needed, the order for the medication tramadol indicated to take every 8 hours, the order for the medication melatonin indicated to take as needed, and the order for the medication furosemide indicated to take 1 tablet by mouth daily. Patient 2’s current active medication bottles also included an order for tylenol/codeine (a prescription only combination opioid medication that treats mild to moderate pain) 300-30mg, take 1 tablet by mouth every 4 hours as needed for moderate pain, take 2 tablets by mouth for severe pain. The DPCSD stated and confirmed that the medication bottle orders for Temazepam, Tramadol, melatonin and furosemide did not match with the instruction orders on the HHA medication record. The DPCSD communicated with the assisted living nurse who informed her that Patient 2 has not been on the medication Atropine since admission. The DPCSD stated that Patient 2’s HHA medication record was missing the order for Tylenol/codeine, and that the zinc oxide treatment was no longer active or being used on the patient. The DPCSD stated that she reviews the patient’s medication at every visit but only by asking the patient’s daughter or the assisted living nurse on shift, if there had been any medication changes since the last visit. The DPCSD stated she does not review the medication bottles at every visit because sometimes the medication room is closed, so she just talks to the nurse or calls the patient’s daughter for updates on the patient’s medications. During a concurrent interview and record review on 5/11/2026 at 3:20 p.m. with the DPCSD, Patient 2’s medication record and POC for the certification period from 4/14/2026 to 6/12/2026 were reviewed. The DPCSD stated and confirmed that the HHA medication record did not match the medications listed in Patient 2’s POC. The DPCSD stated that the medication record and the POC should have the same medication order. The DPCSD stated that when there are changes to the patient’s medication treatment, the changes should be reflected on the medication record, inputted as a physician order, and on the POC, inputted as an addendum to the POC. During an interview with the DPCS on 5/15/2026 at 12 p.m., the DPCS stated that medication reconciliation should be done at every home visit by the nurse. The DPCS stated it is important that the nurse reviews the medication bottles and the medication record as well to look out for any differences that need to be addressed. The DPCS stated that Patient 2’s medication record and the medications on the POC should match, and if there are any changes in the patient’s medications then the changes should be reflected in both the medication record and the POC. The DPCS stated that the importance of the medication record and the POC to have the same medication orders is to prevent the patient from taking the wrong medication dose, to not confuse them, and to make them aware of what their medication treatment is to provide the appropriate teaching needed.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on interviews and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure a detailed, individualized plan of care (POC) for one of 22 sampled patients (Patient 7) when Patient 7’s POC did not include skilled nursing interventions for bladder and bowel incontinence (involuntary and accidental leakage of urine or stool). This failure resulted in Patient 7 developing deep tissue injuries (DTI- localized damage to the skin and underlying soft tissue), pressure injuries (localized, pressure-related damage to the skin and/or underlying tissue usually over a bony prominence), and potential to result in emotional distress by not completing the POC required elements. During a review of Patient 7’s clinical record titled “Patient Profile,” (admission record, summary of patient’s basic information) undated, the clinical record indicated a start of care date of 4/21/2026 with documented diagnoses including hypothyroidism (insufficient production of thyroid hormones, resulting in a slowed metabolism) and shortness of breath (SOB- the sensation of being unable to get enough air during breathing). During a review of Patient 7’s clinical record titled “OASIS (Outcome and Assessment Information Set- a federally mandated, multi-purpose assessment instrument for home health care)-E2 Start of Care,” dated 4/21/2026, the clinical record indicated: -Patient 7 experienced bladder and bowel incontinence. -Patient 7 was bedbound (confined to bed) requiring one person maximum assistance with all activities of daily living (ADLs- routine tasks/activities such as bathing, dressing and toileting a person performs daily to care for themselves). -“Patient’s skin was examined, found intact with no open wounds, breakdown, redness, or signs of infection. Skin integrity maintained.” During a review of Patient 7’s clinical record titled “Home Health Certification and Plan of Care,” dated 4/21/2026, the clinical record did not include documented skilled nursing interventions for bladder and bowel incontinence. During a concurrent interview and record review on 5/15/2026 at 2:55 PM with the Agency’s Director of Patient Care Services (DPCS), Patient 7’s clinical record titled, “RN – Skilled Nursing Visit,” dated 5/8/2026 was reviewed. The Clinical record indicated the presence of four new wounds with an identified onset date of 5/8/2026: -Wound 1: DTI- at the right lower back (top) appearing purple in color and measuring 4 centimeters (cm- unit of measurement) in length, 3.5 cm in width, and 0 cm in depth. -Wound 2: DTI at the right lower back (middle) appearing red in color and measuring 3.5 cm in length, 2.5 cm in width, and 0 cm in depth. -Wound 3: DTI at the right lower back (bottom) appearing red in color and measuring 4 cm in length, 3.5 cm in width, and 0 cm in depth. -Wound 4: pressure injury stage 1 (intact skin with a localized area of redness and/or changes in sensation, temperature, or firmness) at the mid lower back measuring 5 cm in length, 4 cm in width, and 0 cm in depth. The DPCS stated that visiting nurses were responsible for assessing the patient and developing a POC, including interventions such as keeping the area clean and dry and educating the patient and caregiver on repositioning to offload pressure. During a concurrent interview and record review on 5/15/2026 at 3:01 PM with the Agency’s DPCS and Registered Nurse Clinical Supervisor (RN Clinical Supervisor) Patient 7’s clinical record titled, “RN – Skilled Nursing Visit,” dated 5/11/2026 was reviewed. The Clinical record indicated: -Wound 1: pressure injury stage 2 (partial-thickness loss of skin, presenting as a shallow open sore or wound) at the right lower back (top) appearing red and purple in color and measuring 5 cm in length, 3.5 cm in width, and 0 cm in depth. -Wound 2: pressure injury stage 2 at the right lower back (middle) appearing pink in color and measuring 3 cm in length, 2.5 cm in width, and 0.1 cm in depth. -Wound 3: pressure injury stage 2 at the right lower back (bottom) appearing red in color and measuring 1 cm in length, 1.5 cm in width, and 0.1 cm in depth. The RN Clinical Supervisor stated that the three wounds identified on 5/8/2026 had progressed from DTIs to pressure injuries stage 2 and had opened. The DPCS stated that Patient 7’s health status had deteriorated. During a concurrent interview and record review on 5/22/2026 at 10:31 AM with the HHA’s Director of Patient Care Services (DPCS), Patient 7’s clinical record titled, “Home Health Certification and Plan of Care (POC),” dated 4/21/2026 was reviewed. The clinical record did not include documented skilled nursing interventions for bladder and bowel incontinence. The DPCS stated that the POC must be accurate because it is the treatment plan guiding all clinicians. The POC identifies patient needs based on assessment and physician orders, ensures care is provided as ordered, and outlines patient-specific problems, goals, and interventions. An incomplete POC had the potential to cause Patient 7 harm, discomfort, and emotional distress. During a concurrent interview and record review on 5/22/2026 at 10: 59 AM with the HHA’s DPCS, Patient 7’s clinical record titled, “OASIS-E2 Start of Care,” dated 4/21/2026 was reviewed. The clinical record indicated Patient 7 experienced bladder and bowel incontinence. The DPCS stated that bladder and bowel incontinence was assessed during the initial assessment and a care plan should have been created. The DPCS stated that clinician must address all identified patient needs in the POC. The DPCS stated failure to properly develop and implement the POC placed Patient 7 at risk of developing pressure injuries, dehydration, infection, and a decline in mental status. During a review of HHA’s policy and procedure (P&P), titled “Care Planning Process,” revised on November 2021, the P&P indicated: -At the time of initial assessment, the clinician, along with other involved disciplines, will develop the patient POC based upon the patient’s identified needs and will review it with the patient and family/caregiver. -Based on assessment and conclusions, the patient-specific clinical POC will include, but will not be limited to: Patient specific interventions and education.Identified patient problems and needs, including functional limitations, activities permitted, and nutritional status.Reasonable, measurable, and individualized goals and outcomes identified by the HHA and the patient. Specific services to be provided.Actions to be taken to meet the patient’s goals.Type, frequency, and duration of above actions.Equipment and supplies.The patient’s mental, psychosocial and cognitive status.Safety measures to prevent injury.Patient and caregiver education to facilitate timely discharge.-The care planning decisions will be reflected in the specific services that will be provided and the associated actions planned and implemented to meet individualized patient problems and goals. -The POC will be based upon the physician’s orders and will encompass the equipment, supplies, and services required to meet the patient’s needs. -Problems and/or needs related to the patient’s condition, abilities, and family/caregiver support systems will be included in the POC. -The Agency shall provide the patient and caregiver with a copy of written instructions outlining any pertinent instruction related to the patient’s care and treatments that the Agency will provide, specific to the patient’s care needs. During a review of HHA’s P&P, titled “Initial and Comprehensive Assessment,” revised on November 2021, the P&P indicated a POC will be developed and authorized by the physician utilizing information gathered during the initial and comprehensive assessment.”

“All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure the plan of care for two of 22 sampled patients (Patient 2 and Patient 7) contained all patient care orders. This failure had the potential to result in delayed or missed care and placed the patients at risk for unmet care needs, avoidable hospitalizations, and emotional distress. b. During a review of Patient 7’s clinical record titled “Patient Profile,” undated, the clinical record indicated a start of care date of 4/21/2026 with documented diagnoses including hypothyroidism (insufficient production of thyroid hormones, resulting in a slowed metabolism) and shortness of breath (SOB- the sensation of being unable to get enough air during breathing). During a review of Patient 7’s physician order titled “Frequency Order,” dated 4/28/2026, the physician orders indicated the Agency’s Quality Assurance Director (QA Nurse) notified Patient 7’s physician of a missed skilled nursing visit for the week of 4/26/2026, and changed the visit frequency to once a week for three weeks effective 5/3/2026. The physician order was not labeled as an ‘addendum to the POC’. During an interview on 5/13/2026 at 3:46 PM with the Agency’s Registered Nurse Clinical Supervisor (RN Clinical Supervisor), the RN Clinical Supervisor stated that any factor that creates a barrier to patient care must be included in the POC. The POC will contain all physician orders, including new, revised, and discontinued orders. The RN Clinical Supervisor stated any updates to the POC will be labeled as an ‘addendum to the POC’ and will include the date the addendum was made. During an interview on 5/20/2026 at 1:49 PM with the Agency’s QA Nurse, the QA Nurse stated physician orders must be included in the POC on the same day the order is received. During a concurrent interview and record review on 5/22/2026 at 10:31AM with the Agency’s Director of Patient Care Services (DPCS), Patient 7’s clinical record titled, “Home Health Certification and Plan of Care (POC),” dated 4/21/2026 was reviewed. The clinical record did not contain documentation of the visit frequency change dated 4/28/2026. The DPCS stated the POC must be accurate and complete as it identifies specific patient needs according to assessment findings and physician orders. The POC ensures patients receive care as ordered by their physician. During a review of HHA’s policy and procedure (P&P), titled “Care Planning Process,” revised on November 2021, the P&P indicated: - The POC includes all patient care orders including verbal orders. - The POC will be based upon the physician’s orders and will encompass the equipment, supplies, and services required to meet the patient’s needs. - Changes in the POC will be noted with documentation of assessment, POC with clinical outcome goals, care plan with specific services/actions to be taken, clinical notes and verbal orders. -Changes must be written, dated, and signed by the professional making the changes. a. During a review of Patient 2’s Patient Information sheet, the sheet indicated a Start of Care (SOC) date of 4/14/2026 with a primary diagnosis of fracture unspecified of one femur (the thigh bone), subsequent encounter for closure fracture with routine healing. During a review of Patient 2’s clinical record titled Home Health Certification and Plan of Care (POC) for the certification period from 4/14/2026 to 6/12/2026, the POC indicated Skilled Nurse (SN) visit frequency order of three times a week for two weeks then re-evaluate, and Physical Therapy (PT) once a week for one week, two times a week for one week, and once a week for one week. During a review of Patient 2’s Electronic Medical Records (EMR), the EMR under section orders indicated an order dated 5/8/2028 by Physical Therapist 4 (PT4). Patient 2’s order dated 5/8/2026 indicated uploaded documents from Patient 2’s visit to the General Acute Care Hospital (GACH) that indicated new orders to change the wound treatment on the sacrum (buttock bone) Moisture associated skin damage (MASD, inflammation or irritation of the skin caused by prolonged exposure to various types of moisture) from cleanse with normal saline apply honey and cover with border foam dressing three times a week for 2 weeks and then re-evaluate, to apply Calmoseptine moisture barrier ointment (a multipurpose moisture barrier ointment designed to protect skin from moisture, irritants, and bacteria) 2x/day and as needed after each episode of incontinence, keep open to air, do not cover with dressing. During a concurrent interview and record review on 5/15/2026 at 12:27 p.m. with the DPCS, Patient 2’s Order dated 5/8/2026 and POC for the certification period from 4/14/2026 to 6/12/2026 were reviewed. The DPCS stated that Patient 2’s POC for the certification period from 4/14/2026 to 6/12/2026 was not updated to include the new wound treatment orders from the physician dated 5/8/2026. The DPCS stated since the PT was the one who uploaded the new orders, the PT should have done the best practice and communicated with the nurse about the new orders received for the patient. The DPCS stated that any new physician orders should be uploaded and documented on the POC within 24 hours to reflect the patients current care services. The DPCS stated it was important to update the patient’s POC when changes in condition, medication or treatment come up, so that all clinicians are aware of the patients most current services needed and that they are provided to them.”

“Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA’s internal policies. (4) When services are provided on the basis of a physician or allowed practitioner’s verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA’s policies, must document the orders in the patient’s clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA’s internal policies. This Element is not met as evidenced by: Based on observation, interviews, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to follow its policy and procedure for obtaining verbal orders for one of 22 sampled patients (Patient 3). This failure had the potential to place the patient at risk for delayed interventions for elevated blood pressure, stroke, cardiac complications, and hospitalization due to the implementing incorrect or unauthorized physician orders. Findings: During a review of Patient 3’s undated medical record, titled “Patient Information,” the “Patient Information” indicated the start of care (SOC) date of 4/30/2026 with a primary diagnosis of Alzheimer’s disease (progressive brain disorder that affects memory, mental skills, and the ability to carry out simply daily tasks). During a review of Patient 3’s Physician Order, dated and signed by the Director of Patient Care Services (DPCS) on 5/4/2026, the Physician Order indicated the new medications included: hydrochlorothiazide (medication to treat high blood pressure [BP, pressure of blood against the arteries]) 25 mg 1 tablet by mouth daily for BP (started on 5/4/2026). During a concurrent observation and interview on 5/8/2026 at 11:58 a.m., while on a joint home visit with Physical Therapist (PT) 2 in Patient 3’s living room with RP 4, Patient 3 was alert, confused, and sitting on the couch in the living room. Patient 3 complained of 6 out of 10 pain on the left groin with occasional grimacing during exercise with PT 2. Patient 3’s blood pressure readings were 180/90 mmHg and 200/90 mmHg. RP 4 stated Patient 3’s Primary Care Physician (PCP) was aware of Patient 3’s high BP readings and Patient 3 has an upcoming appointment with the PCP in four days. RP 4 stated Patient 3 refused to take her morning medications, including BP medication. PT 2 provided teaching regarding the importance of taking her BP medication. Patient 3 eventually took the morning medications, including the BP medication, after multiple attempts of PT 2 and RP 4 to convince Patient 3 to take her morning medications. Patient 3’s medication bottles and Patient 3’s Patient Medication Record were also reviewed. Per RP 3, Patient 3 had stopped taking hydrochlorothiazide 25 mg 1 tablet by mouth daily for blood pressure about 6 months ago per physician’s advice. During a review of Patient 3’s “Patient Communication,” dated 5/11/2026, the “Patient Communication” indicated Occupational Therapist (OT) 1 reported Patient 3’s elevated BP readings of 174/67 millimeters of mercury (mmHg, unit of measurement of pressure) and 158/64 mmHg and Patient 3 not taking the hydrochlorothiazide (medication to treat high BP) to the physician via the hospital’s designated hotline. During a review of Patient 3’s audit details on “Patient Communication,” dated 5/11/2026, the audit details indicated Offshore Non-Clinical Quality Assurance (ONCQA) 1 and ONCQA 3 completed the form on 5/12/2026 and OT 1 signed the form on 5/12/2026. During a review of Patient 3’s “Physician Order,” dated 5/11/2026, the “Physician Order” indicated OT 1 obtained a verbal order with the “order read back and verified with ordering provider.” The “Physician Order” indicated Patient 3 was not taking hydrochlorothiazide for BP. During a review of Patient 3’s audit details on “Physician Order,” dated 5/11/2026, the audit details indicated ONCQA 2 and ONCQA 4 created and updated the “task details” on 5/12/2026 and OT 1 signed the form on 5/12/2026. During an interview on 5/20/2026 at 12:09 p.m., OT 1 stated she did not speak with the physician and/or obtain a verbal order regarding Patient 3’s elevated BP and hydrochlorothiazide from the physician. OT 1 stated she did not document on the “Patient Communication,” dated 5/11/2026, or “Physician Order,” dated 5/11/2026 because OT 1 only documented on the Patient 3’s Visit Note. During a concurrent interview and record review on 5/14/2026 at 11:48 a.m. with the Rehabilitation Supervisor (RS) and Registered Nurse Clinical Supervisor (RNCS), Patient 3’s medical records were reviewed. The RS stated there was no documented evidence that PT 2 and/or OT 1 requested a skilled nurse (SN) consult to review the effectiveness of the BP medication and follow up with the physician regarding the high BP readings. The RNCS stated it was important to request an SN consult to further evaluate the causes of high BP, such diet noncompliance (high sodium intake could lead to a higher BP), medication noncompliance, uncontrolled pain or stress, or PT exercises, and obtain a physician order if a change in the BP medication was necessary. The RNCS stated there was no documented evidence an RN followed up with the physician regarding the high BP readings and to clarify the hydrochlorothiazide order. The RNCS stated a BP uncontrolled by BP medications could lead to more heart problems, stroke, and hospitalization. During a concurrent interview and record review on 5/21/2026 at 3:03 p.m. with the Director of Patient Care Services (DPCS), Patient 3’s physician orders were reviewed. The DPCS stated there was no documented evidence regarding the response of Patient 3’s physician and the “verbal order” provided to OT 1 regarding Patient 3’s high BP and Patient 3 not taking hydrochlorothiazide as listed on Patient 3’s medication profile. During a review of the HHA’s undated policy and procedures (P&P), titled “Verification of Physician Orders,” the P&P indicated the following: Orders must be obtained from a licensed physician for care and services to be provided to home health patients.Verbal orders must be spoken to, taken, and documented only by professional, licensed home health personnel (Registered Nurse or qualified therapist). Orders received via text message would not be accepted.A qualified individual must review each order or prescription before care is provided.An order or prescription must be verified when there is a question or discrepancy in the order/prescription and when the order is communicated by someone other than the physician or his/her agent. The order or prescription reviewed may be the original order, a facsimile copy, if permitted by law, or the direct transcription of a verbal order.All telephone orders must be received and processed in accordance with state and federal laws and regulations.Orders must be documented on a form provided by the HHA, dated and signed by the professional receiving the order.”

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on observation, interviews, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to follow up with physician regarding change of condition for two of 22 sampled patients (Patient 3 and Patient 6). This failure had the potential to result in the patients not receiving the immediate care needs and services that could result in stroke, cardiac complications, hospitalization. During a review of Patient 3’s undated medical record, titled “Patient Information,” the “Patient Information” indicated the SOC date of 4/30/2026 with a primary diagnosis of Alzheimer’s disease (progressive brain disorder that affects memory, mental skills, and the ability to carry out simply daily tasks).During a review of Patient 3’s medical record, titled “Outcome and Assessment Information Set (OASIS-E2) Start of Care Physical Therapy (PT),” dated 4/30/2026, the “OASIS-E2 Start of Care (PT)” indicated the following: -Patient 3’s blood pressure (BP, pressure of the blood against the arteries with the normal adult BP less than 120 millimeters of mercury [mmHg, unit of measurement of pressure]) was 142/68 mmHg and a regular heart rate of 65 beats per minute (bpm). -The physician must be notified for systolic BP (SBP, maximum pressure on the artery walls when the heart beats and pumps blood into the body) above 160 mmHg or less than 95 mmHg. -The physician must be notified for diastolic BP (DBP, minimum pressure on the artery walls when the heart relaxes and refills with blood in between beats) above 100 mmHg or less than 50 mmHg. During a review of Patient 3’s “Patient Medication Profile,” dated 4/30/2026, Physical Therapist (PT) 3 documented Patient 3 had physician orders for Losartan (medication to treat high BP) 100 milligrams (mg, unit of measurement) 1 tablet by mouth daily, aspirin (medication to prevent blood clots) 81 mg 1 tablet by mouth daily, and Gabapentin (medication to treat nerve pain) 100 mg 2 pills by mouth at bedtime and 1 pill in the morning. During a review of Patient 3’s “Physician Order,” dated and signed by the Director of Patient Care Services (DPCS) on 5/4/2026, the “Physician Order” indicated the following: -Hydrochlorothiazide (medication to treat high blood pressure [BP, pressure of blood against the arteries]) 25 mg 1 tablet by mouth daily for BP (started on 5/4/2026) -Gabapentin order changed to Gabapentin 100 mg 1 capsule by mouth at night daily for nerve pain During a concurrent observation and interview on 5/8/2026 at 11:58 a.m., while on a joint home visit with Physical Therapist (PT) 2 in Patient 3’s living room with Responsible Party (RP) 4, Patient 3 was alert, confused, and sitting on the couch in the living room. Patient 3 complained of 6 out of 10 pain on the left groin with occasional grimacing during exercise with PT 2. Patient 3’s blood pressure readings were 180/90 mmHg and 200/90 mmHg. Patient 3 denied any headache or chest pain. RP 4 stated Patient 3’s Primary Care Physician (PCP) was aware of Patient 3’s high BP readings and Patient 3 has an upcoming appointment with the PCP in 4 days. RP 4 stated Patient 3 refused to take her morning medications, including BP medication. PT 2 provided teaching regarding the importance of taking her BP medication. Patient 3 eventually took the morning medications, including the BP medication, after multiple attempts of PT 2 and RP 4 to convince Patient 3 to take her morning medications. Patient 3’s medication bottles and Patient 3’s Patient Medication Record were also reviewed. The following medication discrepancies were noted: -Per RP 3, Patient 3 had stopped taking hydrochlorothiazide 25 mg 1 tablet by mouth daily for BP about 6 months ago per physician’s advice. -Per RP 3, Patient 3 was taking over-the-counter (OTC) Tylenol 500 mg or 650 mg as needed for pain but this was no physician’s order and was not on the medication list). During a review of Patient 3’s “Patient Communication,” dated 5/8/2026, the “Patient Communication” indicated PT 2 “requested to pass the message to the MD’s office” regarding Patient 3’s BP readings (normal BP is less than 120/80 millimeters of mercury [mmHg, unit of measurement of pressure]) of 180/90 mmHg and 200/90 mmHg during and post-therapy. During a review of Patient 3’s “Patient Communication,” dated 5/11/2026, the “Patient Communication” indicated OT 1 “requested to pass the message to the MD’s office” regarding Patient 3’s BP readings of 174/67 mmHg and 158/64 mmHg and not taking the hydrochlorothiazide. During a concurrent interview and record review on 5/14/2026 at 11:48 a.m. with the Rehabilitation Supervisor (RS) and Registered Nurse Clinical Supervisor (RNCS), Patient 3’s medical records were reviewed. The RS stated there was no documented evidence that PT 2 and OT 1 requested a skilled nurse (SN) consult order to review the effectiveness of the BP medication and follow up with the physician regarding the high BP readings. The RNCS stated there was no documented evidence the RN followed up with the physician regarding Patient 3’s change in condition related to the high BP readings--to clarify the hydrochlorothiazide order and request for the pain medication order. The RNCS stated it was important to request an SN consult to further evaluate the causes of high BP, such diet noncompliance (high sodium intake could lead to a higher BP), medication noncompliance, uncontrolled pain or stress, or PT exercises, and obtain an order if a change in the BP medication was necessary. The RNCS stated a BP uncontrolled by BP medications could lead to more heart problems, stroke, and hospitalization. During a review of the HHA’s undated policy and procedures (P&P), titled “Ongoing Assessments,” the P&P indicated the following: 1. During each home visit, the appropriate clinician must re-evaluate the patient according to the problems identified during the initial visit and thereafter. 2. Using the standards of care identified by the HHA, the clinician must reassess the patient for: blood pressure, pulse, respirations, and temperature; pain status, when applicable; progress towards goals and patient needs and problems, and compliance to treatment and/or medications. 3. Re-assessments should focus on patient’s response to care and changes in patient condition. 4. The clinician must report changes in condition and clinical issues to the physician. Based on the findings of the reassessment, change/verbal orders must be generated and forwarded to the physician, as needed. 5. The physician must be notified to verify any changes in medications, including over-the-counter medications and treatment/interventions that require physician approval. In addition, during a review of the HHA’s undated policy and procedures (P&P), titled “Monitoring Patient’s Response/Reporting to Physician,” the P&P indicated the following: 1. Clinicians must establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient. 2. During each home visit, the clinician must monitor the patient’s response to care against the established goals, including but not limited to: care interventions and treatments, medications, and teaching. 3. The patient’s physician must be contacted when there are significant changes in the patient’s condition, changes in the patient’s expected response to treatment or medications, or when there is any problem implementing the plan of care. 4. When unable to contact the patient’s physician, the following procedures must be followed: -The nurse or therapist must immediately notify the Clinical Supervisor/Nursing Supervisor or designee regarding the need for medical consultation and problems encountered. -An attempt must be made by the Clinical Supervisor/Nursing Supervisor or designee to contact the patient’s physician. -If the Clinical Supervisor/Nursing Supervisor or designee is unable to contact the patient’s physician, the Clinical Supervisor/Nursing Supervisor or designee must notify the organization’s Medical Director of the change in patient condition and the inability to contact the patient’s physician to request a medical consultation.”

“Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient’s updated comprehensive assessment, and contain information concerning the patient’s progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This Element is not met as evidenced by: Based on observation, interviews, and record review, the Home Health Agency failed to ensure a revised and/or individualized plan of care was developed to reflect the current medical care and/or problems for two of 22 sampled patients (Patient 2 and Patient 3). This failure had the potential to result in a decline of the patients’ health status and well-being related to the inconsistent delivery of care to the patient to address the patients’ immediate care needs. b. During a review of Patient 3’s undated medical record, titled “Patient Information,” the “Patient Information” indicated the SOC date of 4/30/2026 with a primary diagnosis of Alzheimer’s disease (progressive brain disorder that affects memory, mental skills, and the ability to carry out simply daily tasks). During a review of Patient 3’s medical record, titled “Outcome and Assessment Information Set (OASIS-E2) Start of Care Physical Therapy (PT),” dated 4/30/2026, the “OASIS-E2 Start of Care (PT)” indicated the following: -Patient 3’s blood pressure (BP, pressure of the blood against the arteries with the normal adult BP less than 120/80 millimeters of mercury [mmHg, unit of measurement of pressure]) was 142/68 mmHg. -The physician must be notified for systolic BP (SBP, maximum pressure on the artery walls when the heart beats and pumps blood into the body) above 160 mmHg or less than 95 mmHg. During a review of Patient 3’s “Patient Medication Profile,” dated 4/30/2026, Physical Therapist (PT) 3 documented Patient 3 had physician orders for Losartan (medication to treat high BP) 100 milligrams (mg, unit of measurement) 1 tablet by mouth daily. During a review of Patient 3’s “Physician Order,” dated and signed by the Director of Patient Care Services (DPCS) on 5/4/2026, the “Physician Order” indicated the following: -Hydrochlorothiazide (medication to treat high blood pressure [BP, pressure of blood against the arteries]) 25 mg 1 tablet by mouth daily for BP (started on 5/4/2026) -Gabapentin order changed to Gabapentin 100 mg 1 capsule by mouth at night daily for nerve pain During a concurrent observation and interview on 5/8/2026 at 11:58 a.m., while on a joint home visit with Physical Therapist (PT) 2 in Patient 3’s living room with Responsible Party (RP) 4, Patient 3 was alert, confused, and sitting on the couch in the living room. Patient 3 complained of 6 out of 10 pain on the left groin with occasional grimacing during exercise with PT 2. Patient 3’s blood pressure readings were 180/90 mmHg and 200/90 mmHg. Patient 3 denied any headache or chest pain. RP 4 stated Patient 3’s Primary Care Physician (PCP) was aware of Patient 3’s high BP readings and Patient 3 has an upcoming appointment with the PCP in 4 days. RP 4 stated Patient 3 refused to take her morning medications, including BP medication. PT 2 provided teaching regarding the importance of taking her BP medication. Patient 3 eventually took the morning medications, including the BP medication, after multiple attempts of PT 2 and RP 4 to convince Patient 3 to take her morning medications. Patient 3’s medication bottles and Patient 3’s Patient Medication Record were also reviewed. The following medication discrepancies were noted: -Per RP 3, Patient 3 had stopped taking hydrochlorothiazide 25 mg 1 tablet by mouth daily for BP about 6 months ago per physician’s advice. -Per RP 3, Patient 3 was taking over-the-counter (OTC) Tylenol 500 mg or 650 mg as needed for pain but this was no physician’s order and was not on the medication list). During a review of Patient 3’s “Patient Communication,” dated 5/8/2026, the “Patient Communication” indicated PT 2 “requested to pass the message to the MD’s office” regarding Patient 3’s BP readings of 180/90 mmHg and 200/90 mmHg during and post-therapy. During a review of Patient 3’s “Patient Communication,” dated 5/11/2026, the “Patient Communication” indicated OT 1 “requested to pass the message to the MD’s office” regarding Patient 3’s BP readings of 174/67 mmHg and 158/64 mmHg and not taking the hydrochlorothiazide. During a concurrent interview and record review on 5/14/2026 at 11:48 a.m. with the Rehabilitation Supervisor (RS) and Registered Nurse Clinical Supervisor (RNCS), Patient 3’s medical records were reviewed. The RS stated there was no documented evidence that Patient 3’s plan of care was individualized to address Patient 3’s high BP readings, changes in medications, and noncompliance with the medication regimen. The RNCS stated not updated the plan of care could lead to the Patient 3’s decline related to the inconsistent delivery of care and interventions and possible ineffective drug therapy. The RNCS stated a BP uncontrolled by BP medications could lead to more heart problems, stroke, and hospitalization. During a review of the HHA’s undated policy and procedures (P&P), titled “Care Planning Process,” the P&P indicated the following: 1. All clinicians must consider the conclusions of initial and ongoing assessments in their care planning process, including but not limited to: -individualized patient needs and resultant problems related to care, functional status, and family/caregiver support system -changes in patient’s condition -clinical drug monitoring, as appropriate -pain and symptom management, as appropriate -patient treatment choices -patient and caregiver education and training that the organization must provide specific to the patient’s care needs 2. Based on the assessment and conclusions, the plan of care must include, but will not be limited to: -patient specific interventions and education -identified patient problems and needs -reasonable, measurable, and individualized goals and outcomes identified by the HHA and the patient -specific services to be provided -actions to be taken to meet the patient goals -type, frequency, and duration of above actions -all medications a. During a review of Patient 2’s Patient Information sheet, the sheet indicated a Start of Care (SOC) date of 4/14/2026 with a primary diagnosis of fracture unspecified of one femur (the thigh bone), subsequent encounter for closure fracture with routine healing. During a review of Patient 2’s clinical record titled Home Health Certification and Plan of Care (POC) for the certification period from 4/14/2026 to 6/12/2026, the POC indicated Skilled Nurse (SN) visit frequency order of three times a week for two weeks then re-evaluate, and Physical Therapy (PT) once a week for one week, two times a week for one week, and once a week for one week. During a review of Patient 2’s medication record dated 4/29/2026 for the certification period from 4/14/2026 to 6/12/2026 indicated the following medication orders; Temazepam (prescription medication used for short term treatment of insomnia [trouble falling or staying asleep]) oral 15 milligrams (mg- unit of measurement) 1 capsule taken by mouth at bedtime for sleep Tramadol (prescription opioid medication used to treat moderate to moderately severe pain) 50 mg, take 1 tablet by mouth every 6 hours as needed for severe pain (7 to 10/10), do not exceed 4 tablets In 24 hours Zinc oxide external (an ointment that acts as a physical barrier that protects, soothes, and heals the skin) 1% apply to affected area(s) two times a day for dry skin/irritation Melatonin sublingual (a supplement taken under the tongue used as a mild sleep aid to regulate the body’s sleep-wake cycle) 5mg, dissolve 10mg under the tongue at bedtime for sleep Atropine sulfate (medication used to block nerve stimulation of muscles and glands and relaxes smooth muscles, causing decrease in secretions) take 3 drops by mouth every 4 hours as needed for dry up extra saliva or mucus Furosemide (diuretic medication that tells the kidneys to remove excess salt and water from the body through urine to help reduce swelling, and lower high blood pressure) 20 mg, take 1 tablet by mouth as needed for increase in daily weight greater than 2 pounds, leg swelling, shortness of breath, or increase in supplemental oxygen. During a joint home visit on 5/11/2026 at 2 p.m. with the Director of Patient Care Services Designee (DPCSD) at Patient 2’s residence at the Assisted Living facility, Patient 2 was observed in her room number 135, sitting up on a recliner on a waffle cushion, with pillows supporting her back, in the living room area, awake, alert and oriented to self. Patient 2 was observed able to answer simple yes or no questions with a head nod. During a concurrent interview and record review on 5/11/2026 at 2:57 p.m. with the DPCSD, Patient 2’s medication bottles, medication list from the assisted living facility and the medication record from the HHA were reviewed. During a review of Patient 2’s medication bottles, the order for the medication Temazepam indicated to take as needed, the order for the medication tramadol indicated to take every 8 hours, the order for the medication melatonin indicated to take as needed, and the order for the medication furosemide indicated to take 1 tablet by mouth daily. Patient 2’s current active medication bottles also included an order for tylenol/codeine (a prescription only combination opioid medication that treats mild to moderate pain) 300-30mg, take 1 tablet by mouth every 4 hours as needed for moderate pain, take 2 tablets by mouth for severe pain. The DPCSD stated and confirmed that the medication bottle orders for Temazepam, Tramadol, melatonin and furosemide did not match with the instruction orders on the HHA medication record. The DPCSD communicated with the assisted living nurse who informed her that Patient 2 has not been on the medication Atropine since admission. The DPCSD stated that Patient 2’s HHA medication record was missing the order for Tylenol/codeine, and that the zinc oxide treatment was no longer active or being used on the patient. The DPCSD stated that she reviews the patient’s medication at every visit but only by asking the patient’s daughter or the assisted living nurse on shift, if there had been any medication changes since the last visit. The DPCSD stated she does not review the medication bottles at every visit because sometimes the medication room is closed, so she just talks to the nurse or calls the patient’s daughter for updates on the patient’s medications. During a concurrent interview and record review on 5/11/2026 at 3:20 p.m. with the DPCSD, Patient 2’s medication record and POC for the certification period from 4/14/2026 to 6/12/2026 were reviewed. The DPCSD stated and confirmed that the HHA medication record did not match the medications listed in Patient 2’s POC. The DPCSD stated that the medication record and the POC should have the same medication order. The DPCSD stated that when there are changes to the patient’s medication treatment, the changes should be reflected on the medication record, inputted as a physician order, and on the POC, inputted as an addendum to the POC. During an interview with the DPCS on 5/15/2026 at 12 p.m., the DPCS stated that medication reconciliation should be done at every home visit by the nurse. The DPCS stated it is important that the nurse reviews the medication bottles and the medication record as well to look out for any differences that need to be addressed. The DPCS stated that Patient 2’s medication record and the medications on the POC should match, and if there are any changes in the patient’s medications then the changes should be reflected in both the medication record and the POC. The DPCS stated that the importance of the medication record and the POC to have the same medication orders is to prevent the patient from taking the wrong medication dose, to not confuse them, and to make them aware of what their medication treatment is to provide the appropriate teaching needed. During a review of Patient 2’s EMR, the EMR under section orders indicated an order dated 5/8/2028 by Physical Therapist 4 (PT4). Patient 2’s order dated 5/8/2026 indicated uploaded documents from Patient 2’s visit to the General Acute Care Hospital (GACH) that indicated new orders to change the wound treatment. During a concurrent interview and record review on 5/15/2026 at 12:27 p.m. with the DPCS, Patient 2’s Order dated 5/8/2026 and POC for the certification period from 4/14/2026 to 6/12/2026 were reviewed. The DPCS stated and confirmed that Patient 2’s POC for the certification period from 4/14/2026 to 6/12/2026 was not updated to include the new wound treatment orders from the physician dated 5/8/2026. The DPCS stated since the PT was the one who uploaded the new orders, the PT should have done the best practice and communicated with the nurse about the new orders received for the patient. The DPCS stated that any new physician orders should be uploaded and documented on the POC within 24 hours to reflect the patients current care services. The DPCS stated it was important to update the patient’s POC when changes in condition or medication come up, so that all clinicians are aware of the patients most current services needed and that they are provided to them.”

“Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This Element is not met as evidenced by: Based on observation, interviews, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure the interdisciplinary team (a group of professionals from different fields who collaborate closely, combining their unique skills and perspectives to achieve a common goal or solve a complex problem) coordinated care for one of 20 sampled patients (Patient 3) by failing to: 1. Ensure to coordinate with the Registered Nurse Clinical Supervisor (RNCS) to initiate a skilled nursing assessment after Physical Therapist (PT) 2 and Occupational Therapist (OT) 1 identified multiple episodes of high systolic blood pressure (SBP, maximum pressure on the artery walls when the heart beats and pumps blood into the body, ) above 160 millimeters of mercury (mmHg, unit of measurement of pressure. Normal reference range for adult less than 120 mmHg). 2. Report to interdisciplinary team that Patient 3 was not taking the ordered hydrochlorothiazide (medication to treat high blood pressure) and was taking over‑the‑counter Tylenol (medication to treat pain), which was not listed on Patient 3’s medication profile (a comprehensive, up-to-date record of every medicine a person takes). These failures placed Patient 3 at increased risk for unrelieved pain, heart problems, stroke, and hospitalization. Findings: During a review of Patient 3’s undated medical record, titled “Patient Information,” the “Patient Information” indicated Patient 3 had a start of care (SOC) date of 4/30/2026 with a primary diagnosis of Alzheimer’s disease (progressive brain disorder that affects memory, mental skills, and the ability to carry out simply daily tasks). During a review of Patient 3’s referral document from General Acute Care Hospital (GACH) 1, dated 4/30/2026, the referral document indicated Patient 3 required home health services with at-home Physical Therapy (PT) for evaluation and treatment and for functional mobility training (exercise approach to help a patient move safely and efficiently through everyday activities). During a review of Patient 3’s medical record, titled “Outcome and Assessment Information Set (OASIS-E2) Start of Care Physical Therapy (PT),” dated 4/30/2026, the “OASIS-E2 Start of Care (PT)” indicated the following: -Patient 3’s BP (normal adult BP is less than 120/80 mmHg) was 142/68 mmHg. -The physician must be notified for SBP above 160 mmHg or less than 95 mmHg. -The physician must be notified for diastolic BP (DBP, minimum pressure on the artery walls when the heart relaxes and refills with blood in between beats) above 100 mmHg or less than 50 mmHg. During a review of Patient 3’s “Patient Medication Profile,” dated 4/30/2026, PT 3 documented Patient 3 had a physician order for Losartan (medication to treat high BP) 100 milligrams (mg, unit of measurement) 1 tablet by mouth daily. During a review of Patient 3’s “Physician Order,” dated and signed by the Director of Patient Care Services (DPCS) on 5/4/2026, the “Physician Order” indicated the following: -Hydrochlorothiazide (medication to treat high BP) 25 mg 1 tablet by mouth daily for BP (started on 5/4/2026). -Gabapentin (a prescription medication primarily used to prevent and control partial seizures and to relieve nerve pain) order changed to Gabapentin 100 mg 1 capsule by mouth at night daily for nerve pain. During a review of Patient 3’s “Patient Communication,” dated 5/8/2026, the “Patient Communication” indicated PT 2 “requested to pass the message to the physician’s (MD’s) office” regarding Patient 3’s BP readings of 180/90 mmHg and 200/90 mmHg during and post-therapy. During a concurrent observation, interview and record review on 5/8/2026 at 11:58 a.m., while conducting a joint home visit with PT 2 in Patient 3’s living room with Responsible Party (RP) 4 present, Patient 3 was observed to be alert but confused, and sitting on the couch in the living room. Patient 3 complained of pain level of six (6) out of 10 on a pain rating scale (where 0 is equal to no pain and 10 is equal to the worst pain possible) in the left groin and exhibited occasional grimacing during exercise performed with PT 2. Patient 3’s blood pressure readings obtained during the visit were 180/90 mmHg and 200/90 mmHg. Patient 3 denied experiencing any headache or chest pain. RP 4 stated Patient 3’s Primary Care Physician (PCP) was aware of Patient 3’s elevated BP readings and Patient 3 had an upcoming appointment with the PCP in four (4) days. RP 4 stated Patient 3 refused to take her morning medications, including the prescribed BP medication. PT 2 provided education regarding the importance of taking her BP medication. Patient 3 eventually took the morning medications, including the BP medication, after multiple attempts of PT 2 and RP 4 to convince Patient 3 to take her morning medications. Patient 3’s medication bottles and Patient 3’s Patient Medication Record were also reviewed. The following medication discrepancies were noted: Per Responsible Party (RP) 3, Patient 3 had stopped taking hydrochlorothiazide 25 mg 1 tablet by mouth daily for blood pressure about 6 months ago per physician’s advice. Per RP 3, Patient 3 was taking over-the-counter (OTC) Tylenol 500 mg or 650 mg as needed for pain (Tylenol was not ordered and was not on the medication list, but Tylenol bottles were observed during medication profile review during home visit). During a review of Patient 3’s “Patient Communication,” dated 5/11/2026, the “Patient Communication” indicated Occupational Therapist (OT) 1 “requested to pass the message to the MD’s office” regarding Patient 3’s BP readings of 174/67 mmHg and 158/64 mmHg and not taking the hydrochlorothiazide. During a concurrent interview and record review on 5/14/2026 at 11:48 a.m. with the Rehabilitation Supervisor (RS) and Registered Nurse Clinical Supervisor (RNCS), Patient 3’s medical records were reviewed. The RS stated there was no documented evidence that PT 2 and OT 1 requested a skilled nurse (SN) consult to review the effectiveness of Patient 3’s medications and follow up with the physician regarding the high BP readings. The RNCS stated it was important to request an SN consult to further evaluate the causes of high BP, such diet noncompliance (high sodium intake could lead to a higher BP), medication noncompliance, uncontrolled pain or stress, or PT exercises, and obtain an order if a change in the BP medication was necessary. In addition, the RNCS stated an SN consult was necessary if a new medication is ordered to provide teachings about the medication, including the indication, side effects, and adverse effects to the patient (in general) and the caregivers. The RNCS stated there was no documented evidence that an RN reviewed Patient 3’s medications and addressed ineffective drug therapy and noncompliance with drug therapy. The RNCS stated there was no documented evidence the RN followed up with the physician regarding the high BP readings to clarify the hydrochlorothiazide order and request for the pain medication order. The RNCS stated a BP uncontrolled by BP medications could lead to the patient’s health decline due to increased risks for heart problems, stroke, and hospitalization. During a review of the HHA’s undated policy and procedures (P&P), titled “Continuity of Care,” the P&P indicated the following: 1. Continuity of care must be ensured by periodic communication between team members concerning the patient’s progress and special needs as evidenced in case conference reports and clinical notes. 2. The clinician—Registered Nurse (RN) or Rehabilitation Therapist in cooperation with the RNCS —must be responsible for communicating changes in orders and findings to the Clinical Supervisor/Nursing Supervisor or designee, or other team members as necessary; communicating between multiple disciplines to optimize visit schedules for the benefit of the patient and the care to be provided; communicating with all personnel caring for the patient, including the physician; updating physicians’ orders; updating his/her own discipline’s plan of care; and scheduling nursing and home health aide visits. In addition, during a review of the HHA’s undated policy and procedures (P&P), titled “Medication Profile,” the P&P indicated that patients receiving medications administered by the organization must have a current, accurate medication profile in the clinical record. The P&P indicated that medication profiles must be updated for each change to reflect current medications, new, and/or discontinued medications. The P&P indicated that in rehabilitation therapy only cases, the patient’s therapist must submit a list of patient medications to a registered nurse for review.”

“Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This Element is not met as evidenced by: Based on interviews and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to follow the physician orders for two of 20 sampled patients (Patient 13 and Patient 21) by failing to: a. Ensure Patient 13 was evaluated by a Speech Therapist (ST) as ordered by the physician. b. Ensure Patient 21’s intravenous (IV, into the vein) antibiotics (medication to treat bacterial infections) was provided as ordered by the physician. These failures had the potential to result in worsening symptoms, delayed treatment, increased risk of complications, preventable deterioration of the underlying condition, and possible rehospitalization. For Patient 13, the lack of a Speech Therapist evaluation could result in unaddressed swallowing difficulties, aspiration risk, nutritional decline, or communication deficits. For Patient 21, delays in IV antibiotic administration could result in progression of infection, sepsis, extended illness, or the need for emergent medical intervention. Findings: a. During a review of Patient 13’s medical record, titled “Patient Information,” the “Patient Information” indicated the Start of Care (SOC) date of 4/21/2026 with the primary diagnosis of malignant neoplasm of the thyroid gland (thyroid cancer) and secondary diagnosis of tracheostomy status (patient has a surgically created opening in the trachea [windpipe] for breathing). During a review of Patient 13’s referral document from General Acute Care Hospital (GACH) 1, dated 4/20/2026, the referral document indicated Patient 13’s anticipated discharge date was 4/20/2026 with home health services. The referral document indicated Patient 13 required RN services to “follow up with new tracheostomy care and suctioning (sterile or clean procedure used to remove mucus and secretions from the airway when a patient cannot effectively cough them out).” The referral document indicated Patient 13 required ST services for the new tracheostomy to “follow up Passy Muir Valve (PMV, specialized one-way speaking valve attached to a tracheostomy tube) and diet.” During a review of Patient 13’s “Admission Service Agreement,” dated 4/21/2026, RN 7, the admitting clinician, documented Patient 13 consented for the Skilled Nurse (SN) visits once a week for two (2) weeks starting on 4/21/2026 and for the ST Evaluation. During a review of Patient 13’s “Home Health Certification and Plan of Care (POC)” for the certification period from 4/21/2026 to 6/19/2026, the POC indicated ST Evaluation was ordered. The POC indicated Patient 13 “communicates effectively despite difficulty speaking due to tracheostomy.” The POC indicated Patient 13 was on aspiration precautions. During a review of Patient 13’s “Delay Evaluation Order” for ST Evaluation, dated 4/24/2026, the “Delay Evaluation Order” indicated “order read back and verified with ordering provider.” The order indicated RN 7 spoke with RP 13 on 4/24/2026 with a reason for the delayed ST visit due to RP 13 requesting to “reschedule the ST eval to the week of 5/3/2026.” During an interview on 5/11/2026 at 2:08 p.m., RP 13 stated he did not request any delay in the ST Evaluation. RP 13 stated no HHA staff contacted RP 13 or Patient 13 to schedule any ST visits or inform them regarding the delay in ST Evaluation. During an interview on 5/11/2026 at 4:20 p.m., RN 7 stated she did not speak with RP 13 regarding a request to delay the ST evaluation. RN 7 stated she recalled that ST Evaluation was ordered by the physician for Patient 13, but she (RN 7) was not responsible for making the arrangements regarding the ST Evaluation. During a concurrent interview and record review on 5/14/2026 at 1:13 p.m. with the Rehabilitation Supervisor (RS), Patient 13’s electronic health records (eHRs) and Scheduling and Care Coordination Platform (SCCP) details for Patient 13 were reviewed. RS stated he would be notified of a referral of a patient (in general) with rehabilitation orders. RS stated if a patient (in general) has referral orders RN and ST visits from the physician, but the HHA has no available ST to conduct the evaluation, the referring physician must be notified immediately to reassign the patient (in general) to another HHA to provide both services timely. RS was unable to recall if he reviewed Patient 13’s referral orders. RS stated ST Evaluation was ordered for Patient 13 to evaluate the gag reflex (automatic, involuntary muscle contraction at the back of the throat), swallowing difficulties, aspiration risk (accidental inhalation of food, liquids, or saliva past the vocal cords and into the windpipe or lungs), and voice quality with the new tracheostomy tube. RS stated not providing the ST Evaluation as ordered could lead to Patient 13’s health decline due to possible aspiration, swallowing or speech difficulties. RS stated it would be difficult to determine who entered the details regarding Patient 13’s “Delay Eval Order” for ST Evaluation, dated 4/24/2026, but RS stated it was “possible that the “Delay Evaluation Order” was entered because there was no ST available to conduct the ST Evaluation as ordered.” The RS stated as of 5/14/2026, Patient 13’s physician-ordered ST Evaluation has not been completed. During a review of the HHA’s undated policy and procedures (P&P), titled “Admission Criteria and Process,” the P&P indicated the following: Consideration must be given to the adequacy and suitability of organization personnel, resources to provide the required services, and the reasonable expectation that the patient’s nursing, rehabilitative, medical, and social needs can be adequately met in the patient’s place of residence. A patient must be referred to other resources if the organization cannot meet his/her needs. If a patient cannot be cared for by the HHA, the Clinical Supervisor/Nursing Supervisor should be notified and appropriate referrals to other sources of care should be made on behalf of the patient. The patient, referring physician, and referral source, if not the physician, should be notified of HHA non-admits. Once a patient is admitted to service, the HHA is responsible for providing care and services within its financial and service capabilities, mission, and applicable law and regulations. All admissions must be coordinated by the Case Manager to the rest of the interdisciplinary discipline involved in the patient care. Coordination can be done via phone conference or through home health notify messaging. All initial evaluation should be performed no later than 5 calendar days from the SOC date or date when additional discipline was ordered, if not ordered in the home health referral. A physician must be notified if evaluation cannot be done within five days.”

“Preparing clinical notes CFR(s): 484.75(b)(6) Preparing clinical notes; This Element is not met as evidenced by: Based on interview and record review the HHA (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure that the skilled nurses submit completed skilled visit notes for one of 20 sampled patients (Patient 12). This failure placed Patient 12 at increased risk to compromised safety, deterioration in health condition, and complications related to the underlying heart condition. Findings: During a review of Patient 12’s Patient Information sheet, the sheet indicated a Start of Care (SOC) date of 4/30/2026 with a primary diagnosis of encounter for adjustment and management of Ventricular assistive device (A mechanical pump implanted in the chest to help a weakened heart pump blood throughout the body that is often used for patients waiting for a heart transplant or as a long-term treatment). During a review of Patient 12’s clinical record titled Home Health Certification and Plan of Care (POC) for the certification period from 4/30/2026 to 6/28/2026, the POC indicated a Skilled Nurse (SN) visit frequency order of two times a week for one week, and five times a week for one week effective 4/30/2026. The POC indicated there was no documentation evidence of an electronic signature from the perspective nurse who documented the POC. During a review of Patient 12’s clinical record titled RN skilled nursing visit dated 5/2/2026, the record indicated there was no documentation of the registered nurse’s electronic signature and date. During a review of Patient 12’s clinical record titled RN skilled nursing visit dated 5/8/2026, the record indicated there was no documentation of the registered nurse’s electronic signature and date. During a concurrent interview and record review on 5/15/2026 at 12:58 p.m. with the Director of Patient Care Services (DPCS), Patient 12’s RN Skilled nursing visit notes dated 5/2/2026 and 5/8/2026 were reviewed. Patient 12’s RN skilled nursing visit dated 5/2/2026 And 5/8/2026 indicated there was no documentation of the registered nurse’s electronic signature and date. The DPCS stated and confirmed that Patient 12’s RN skilled nursing visit note dated 5/2/2026 and 5/8/2026 did not have evidence of the nurse’s signature and date. The DPCS stated that the nursing visit notes were considered incomplete because a completed documented visit note includes the clinician’s signature and date. The DPCS stated that it was important to complete all documentation with the clinician’s signature and date to validate the visit, the documented assessment findings of the patient, and any teaching/counseling provided about medications or care. During a review of the HHA’s policy and procedure (P&P) Titled Job title/position Case Manager/ Registered nurse, undated, the P&P indicated that the registered nurse organizes and directs home care services. The P&P indicated that the registered nurse’s essential job responsibilities include completing an initial assessment of the patient and family to determine home care needs, regularly re-evaluating the patient nursing needs, and prepares clinical notes. During a review of the HHA’s P&P titled Ongoing assessment, undated, the P&P indicated that during each home visit the clinician will re-evaluate the patient according to problems identified and submit the notes within 72 hours of the visit.”

“Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This Element is not met as evidenced by: Based on interviews and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) Administrator failed to ensure an accurate list of active patients was maintained and updated whenever a patient was admitted or discharged to include one of 20 sampled patients (Patient 19) and ensure care was provided to all patients with physician orders to receive home health services. This failure had the potential to cause a decline in the patients’ decline in health due to a delay in the care and service delivery related to inaccurate active patient list. Findings: During a concurrent interview and record review of the HHA’s active patient list on 5/7/2026 at 12:03 p.m., Office Staff 1 (OS 1) stated the HHA has 620 active patients and 1,989 unduplicated patient admissions in a year. During a review of the updated active patient list, submitted by the Administrator on 5/8/2026 at 9:42 a.m., the HHA has 618 active patients. During a concurrent interview and record review of the updated active patient list on 5/18/2026 at 11:45 a.m., the Administrator stated the offshore team was responsible for updating the active patient list daily. The Administrator was unable to state the reason why Patient 19, whose referral date was 5/1/2026 and SOC date was 5/6/2026, was not included on the active patients lists provided on 5/7/2026 and 5/8/2026. The Administrator stated it was important to know the number of active patients to ensure adequate staffing to provide the necessary home health care and services. During a review of the HHA’s Job Description for “Executive Director/Administrator,” dated 11/2021, the Job Description indicated the Administrator was responsible for planning, coordinating, managing, and directing all activities and programs of the HHA. The Job Description indicated the essential job function of the Administrator included the following: -Planning, directing and evaluating operations to ensure the provision of adequate and appropriate care and services -Complying with applicable laws and regulations -Assures that all business conduct is above minimum standards required by law and will not condone any activities that achieve results through violation of the law, unethical business or patient care practices -Fiscal planning, budgeting, and management of operations in accordance with fiscal parameters”

“Make patient and personnel assignments, CFR(s): 484.105(c)(1) Making patient and personnel assignments, This Element is not met as evidenced by: Based on interviews and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure the Clinical Managers managed the staff assignment for two of 20 sampled patients (Patient 13 and Patient 19) to ensure the admission physician orders were completed as ordered. This failure had the potential to result in the patients’ decline in health due to not receiving the necessary care and services ordered by the physician to address the patients’ immediate needs. Findings: a. During a review of Patient 13’s medical record, titled “Patient Information,” the “Patient Information” indicated the Start of Care (SOC) date of 4/21/2026 with the primary diagnosis of malignant neoplasm of the thyroid gland (thyroid cancer) and secondary diagnosis of tracheostomy status (patient has a surgically created opening in the trachea [windpipe] for breathing). During a review of Patient 13’s referral document from General Acute Care Hospital (GACH) 1, dated 4/20/2026, the referral document indicated Patient 13’s anticipated discharge date was 4/20/2026 with home health services. The referral document indicated Patient 13 required Registered Nurse (RN) services to “follow up with new tracheostomy care and suctioning (sterile or clean procedure used to remove mucus and secretions from the airway when a patient cannot effectively cough them out).” The referral document indicated Patient 13 required Speech Therapy/Therapist (ST) services for the new tracheostomy to “follow up Passy Muir Valve (PMV, specialized one-way speaking valve attached to a tracheostomy tube) and diet.” During a review of Patient 13’s “Admission Service Agreement,” dated 4/21/2026, RN 7, the admitting clinician, documented Patient 13 consented for the Skilled Nurse (SN) visits once a week for 2 weeks starting on 4/21/2026 and for the ST Evaluation. During a review of Patient 13’s “Home Health Certification and Plan of Care (POC)” for the certification period from 4/21/2026 to 6/19/2026, the POC indicated ST Evaluation was ordered by the physician. The POC indicated Patient 13 “communicates effectively despite difficulty speaking due to tracheostomy.” The POC indicated Patient 13 was on aspiration precautions. During a review of Patient 13’s “Delay Eval Order” for ST Evaluation, dated 4/24/2026, the “Delay Eval Order” indicated “order read back and verified with ordering provider.” The “Delay Eval Order” indicated RN 7 spoke with Responsible Party (RP) 13 on 4/24/2026 with a reason for the delayed ST visit due to RP 13 requesting to “reschedule the ST eval to the week of 5/3/2026.” During an interview on 5/11/2026 at 2:08 p.m., RP 13 stated he did not request any delay in the ST Evaluation. RP 13 stated no HHA staff contacted RP 13 or Patient 13 to schedule any ST visits or inform them regarding the delay in ST Evaluation. During an interview on 5/11/2026 at 4:20 p.m., RN 7 stated she did not speak with RP 13 regarding a request to delay the ST eval. RN 7 stated she recalls that ST Evaluation was ordered by the physician for Patient 13, but RN 7 was not responsible for making the arrangements regarding the ST Evaluation. During a concurrent interview and record review on 5/14/2026 at 1:13 p.m. with the Rehabilitation Supervisor (RS), Patient 13’s electronic health records (eHRs) and Scheduling and Care Coordination Platform (SCCP) details for Patient 13 were reviewed. RS stated he would be notified of a referral of a patient (in general) with rehabilitation orders. RS stated if a patient (in general) has referral orders ST Evaluation from the physician, but the HHA has no available ST to conduct the evaluation, the referring physician must be notified immediately to reassign the patient (in general) to another HHA to provide both services timely. RS was unable to recall if he reviewed Patient 13’s referral orders. RS stated ST Evaluation was ordered for Patient 13 to evaluate the gag reflex (automatic, involuntary muscle contraction at the back of the throat), swallowing difficulties, aspiration risk (accidental inhalation of food, liquids, or saliva past the vocal cords and into the windpipe or lungs), and voice quality with the new tracheostomy tube. RS stated not providing the ST Evaluation as ordered could lead to Patient 13’s health decline due to possible aspiration, swallowing or speech difficulties. RS stated it would be difficult to determine who entered the details regarding Patient 13’s “Delay Eval Order” for ST Evaluation, dated 4/24/2026, but RS stated it was “possible that the “Delay Eval Order” was entered because there was no ST available to conduct the ST Evaluation as ordered.” The RS stated as of 5/14/2026, Patient 13’s physician-ordered ST Evaluation has not been completed. b. During a review of Patient 19’s undated medical record, titled “Patient Information,” the “Patient Information” indicated Patient 19’s SOC date of 5/6/2026 with a primary diagnosis of “Encounter for change or removal of surgical wound dressing (routine change or removal of a surgical wound dressing)” and a secondary diagnosis of “open wound of left upper arm.” The “Patient Information” indicated Patient 19’s referral date of 5/1/2026. During a review of Patient 19’s referral document from General Acute Care Hospital (GACH) 1, dated 4/30/2026, the referral document indicated Patient 19’s anticipated discharge date was 4/30/2026 with home health. The referral document indicated Patient 19 required RN services to provide wound care as Patient 19 would be discharged home with a small chest tube drain (external, portable drainage collection device attached to a chest tube [flexible, hollow plastic tube inserted through the chest wall into the space around the lungs] to safely remove trapped air, blood, or fluid to allow the lungs to fully expand). The referral indicated per thoracic surgery (team of surgeons who specialize on the operative treatment of organs inside the chest, including the lungs, esophagus [food pipe], trachea [windpipe], and chest wall), Patient 19 required dressing changes every 3 days around the chest tube and to use a 4x4 drain gauze (sterile [free of germs], highly absorbent materials that prevent wound infections by managing exudates [fluids that may seep from wounds or surgical areas]) and tape to reinforce the dressing. The referral also indicated per thoracic surgery, Patient 19’s new chest tube drain might need to be exchanged if it fills up. During a review of Patient 19’s “SOC Delay Order,” dated 5/4/2026, the “SOC Delay Order” indicated the verbal order was obtained with “order read back and verified with ordering provider.” The “SOC Delay Order” indicated the reason for a delayed visit was “tried calling the patient to schedule the SOC visit, but the call remain unanswered.” During a review of Patient 19’s “SOC Delay Order,” dated 5/5/2026, the “SOC Delay Order” indicated the verbal order was obtained with “order read back and verified with ordering provider.” The “SOC Delay Order” indicated the reason for delayed visit was “patient reported a leaking issue and was instructed to go to urgent care or the emergency room (ER) due the leaking condition as home care was not appropriate at this time.” During a review of Patient 19’s Start of Care Order, dated 5/6/2026, the “Start of Care Order” indicated the following orders: Skilled Nurse (SN) frequency of home visits to Patient 19 was twice a week for three weeks.SN to perform chest tube draining using sterile technique and infection control measures using agency policy and procedures and to teach chest tube care and management.SN to perform wound care using infection control measures and standard precautions to the left axilla (underarm): Cleanse with normal saline (NS, salt solution to clean the wound), pat dry, apply drain sponge/gauze, secure with tape dressing, and change every 3 days.SN to perform wound care the chest tube site: cleanse with NS, pat dry, apply drain sponge/gauze, secure with tape dressing, and change every 3 days.SN to provide teaching regarding monitoring for signs and symptoms of infection and to report to the physician or SN.SN to provide teaching regarding deep breathing exercises and energy conservation techniques to prevent shortness of breath (SOB) and new Atrium Express Mini 500 Mobile Dry Seal Drain that may need to be exchanged if it fills up.During an interview on 5/18/2026 at 2:02 p.m., Patient 19 stated he had been diagnosed with Stage 4 lung cancer (cancer has spread from where it started in the lung to distant parts of the body, such as the brain, bones, or liver) for which the physician placed a PleurX catheter (small, flexible, tunneled silicone tube placed in the chest or abdomen to intermittently drain recurring fluid buildup in the lungs to relieve shortness of breath [SOB]). Patient 19 stated he was hospitalized from 4/15/2026 to 4/30/2026 due to an infection of the PleurX catheter. Patient 19 stated the physician removed the PleurX catheter, made an incision, removed a part of his rib to wash out the pus or bacteria, and inserted a chest tube. Patient 19 stated he was administered intravenous (IV, into the vein) antibiotics (medication to treat bacterial infections) for 10 days. Patient 19 stated his last wound care was done on the date of his discharge from GACH 1 on 4/30/2026. Patient 19 stated GACH 1 stated the HHA would call Patient 19 within 24 hours of discharge from GACH 1 to schedule a nurse home visit to “come in and replace the bandages of the wound, make sure there is no infection, … and put in another chest tube drain, if needed.” Patient 19 stated the HHA might have called, but he was unable to answer the phone call because he “was taking a lot of medications at the time.” Patient 19 stated he might have received a nurse visit on 5/3/2026, but he was unable to recall the name of the HHA nurse. Patient 19 was unable to recall the date when he went back to GACH 1 for the exchange of chest tube drain related to the leaking chest tube. During an interview on 5/18/2026 at 3:26 p.m., RN 8 stated the HHA received Patient 19’s referral on 5/1/2026. RN 8 stated Patient 19 was originally assigned to a different nurse. RN 8 stated there was no nurse available to see Patient 19 on 5/2/2026 and 5/3/2026. RN 8 stated she was “too busy” conducting home visits for the other patients on 5/4/2026, and no nurse was able to conduct a home visit on Patient 19 on 5/4/2026. RN 8 stated Patient 19 was assigned to RN 8 on 5/5/2026, but RN 8 was unable to visit Patient 19 because the HHA staff (unable to identify) advised Patient 19 to go to the ER to address the leaking chest tube. RN 8 stated she conducted the first home visit for Patient 19 on 5/6/2026. During a concurrent interview and record review of Patient 19’s medical records on 5/21/2026 at 12:46 p.m., with the Director of Patient Care Services (DPCS), Patient 19’s electronic health records (EHRs) and Scheduling and Care Coordination Platform (SCCP) details were reviewed. The DPCS stated the following: -Patient 19’s referral date was 5/1/2026, so the expected SOC date was no later than 5/3/2026. -The RN must conduct the initial assessment within 48 hours of the referral date to assess Patient 19’s needs, including ordering of wound care supplies and evaluating the caregiver needs. -There was no documented evidence that an RN called Patient 19 to schedule the SOC visit on or before 5/3/2026. The DPCS stated there was no documented evidence that an RN conducted an SOC visit on 5/3/2026. -There was no documented evidence that an RN was assigned to visit and/or called Patient 19 to schedule a visit on 5/4/2026. -Patient 19 reported a leaking chest tube to the HHA on 5/5/2026, and the Non-Clinical Offshore Staff 1 (NCOS 1) called Patient 19 on 5/5/2026 to advise Patient 19 to go to the ER per “Supervisor’s” instructions. The DPCS was unable to provide documented evidence of the communication details with the “supervisor” who provided the instructions. -The SOC visit and initial assessment were conducted on 5/6/2026. The DPCS stated the delay of care placed Patient 19 at increased risks for delayed wound healing, development of an infection of the wound, and rehospitalization. During a review of the HHA’s undated policy and procedures (P&P), titled “Intake Process,” the P&P indicated the following: The HHA must only accept those patients whose needs can be met by the services the HHA provides.Upon acceptance of the referral, the Clinical Supervisor/Nursing Supervisor must assign personnel and schedule an initial assessment visit. The initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of a patient’s return home, or on the SOC date ordered by the physician.If the service cannot be provided, intake personnel must give the caller the names of other agencies that can provide the required services. A log must be maintained on all patients that cannot be serviced.During a review of the HHA’s undated policy and procedures (P&P), titled “Admission Criteria and Process,” the P&P indicated the following: Consideration must be given to the adequacy and suitability of organization personnel, resources to provide the required services, and the reasonable expectation that the patient’s nursing, rehabilitative, medical, and social needs can be adequately met in the patient’s place of residence.A patient must be referred to other resources if the organization cannot meet his/her needs. If a patient cannot be cared for by the HHA, the Clinical Supervisor/Nursing Supervisor should be notified and appropriate referrals to other sources of care should be made on behalf of the patient. The patient, referring physician, and referral source, if not the physician, should be notified of HHA non-admits.Once a patient is admitted to service, the HHA is responsible for providing care and services within its financial and service capabilities, mission, and applicable law and regulations.All admissions must be coordinated by the Case Manager to the rest of the interdisciplinary discipline involved in the patient care. Coordination can be done via phone conference or through home health notify messaging. All initial evaluation should be performed no later than 5 calendar days from the SOC date or date when additional discipline was ordered, if not ordered in the home health referral. A physician must be notified if evaluation cannot be done within 5 days.During a review of the HHA’s Job Description for “Director of Patient Care Services (DPCS)/Clinical Manager,” dated 11/2021, the Job Description indicated the DPCS if functioning as a Clinical Manager, must provide oversight of all patient care services and personnel including making patient and personnel assignments; coordinating patient care; coordinating referrals; assuring patient needs are continually assessed; and assuring the development, implementation, and updates of the individualized plan of care. During a review of the HHA’s Job Description for “Rehabilitation Manager (Clinical Manager,” dated 11/2021, the Job Description indicated the Rehabilitation Manager, if functioning as a Clinical Manager, must provide oversight of all patient care services and personnel including making patient and personnel assignments; coordinating patient care; coordinating referrals; assuring patient needs are continually assessed; and assuring the development, implementation, and updates of the individualized plan of care.”

“Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This Element is not met as evidenced by: Based on observation, interviews, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure the Clinical Managers coordinated care for one of 20 sampled patients (Patient 3) to schedule a Skilled Nurse (SN) evaluation and follow up with the physician to address multiple episodes of high blood pressure (BP, pressure of the blood against the arteries with the normal adult BP less than 120/80 millimeters of mercury [mmHg, unit of measurement of pressure]) and medication discrepancies regarding hydrochlorothiazide (medication to treat high BP) and Tylenol (medication to treat pain). This failure had the potential to result in Patient 3 not receiving the immediate care needs and services related to the lack of oversight and continuity of care, which could lead to a decline in the patient’s health and well-being. Findings: During a review of Patient 3’s undated medical record, titled “Patient Information,” the “Patient Information” indicated the Start of Care (SOC) date of 4/30/2026 with a primary diagnosis of Alzheimer’s disease (progressive brain disorder that affects memory, mental skills, and the ability to carry out simply daily tasks). During a review of Patient 3’s medical record, titled “Outcome and Assessment Information Set (OASIS-E2) Start of Care Physical Therapy (PT),” dated 4/30/2026, the “OASIS-E2 Start of Care (PT)” indicated the following: -Patient 3’s blood pressure was 142/68 mmHg. -The physician must be notified for systolic BP (SBP, maximum pressure on the artery walls when the heart beats and pumps blood into the body) above 160 mmHg or less than 95 mmHg. -The physician must be notified for diastolic BP (DBP, minimum pressure on the artery walls when the heart relaxes and refills with blood in between beats) above 100 mmHg or less than 50 mmHg. During a review of Patient 3’s “Patient Medication Profile,” dated 4/30/2026, Physical Therapist (PT) 3 documented Patient 3 had physician orders for Losartan (medication to treat high BP) 100 milligrams (mg, unit of measurement) 1 tablet by mouth daily. During a review of Patient 3’s “Physician Order,” dated and signed by the Director of Patient Care Services (DPCS) on 5/4/2026, the “Physician Order” indicated the following: -Hydrochlorothiazide (medication to treat high BP) 25 mg 1 tablet by mouth daily for BP (started on 5/4/2026) -Gabapentin order changed to Gabapentin 100 mg 1 capsule by mouth at night daily for nerve pain During a concurrent observation and interview on 5/8/2026 at 11:58 a.m., while on a joint home visit with Physical Therapist (PT) 2 in Patient 3’s living room with Responsible Party (RP) 4, Patient 3 was alert, confused, and sitting on the couch in the living room. Patient 3 complained of 6 out of 10 pain on the left groin with occasional grimacing during exercise with PT 2. Patient 3’s blood pressure readings were 180/90 mmHg and 200/90 mmHg. Patient 3 denied any headache or chest pain. RP 4 stated Patient 3’s Primary Care Physician (PCP) was aware of Patient 3’s high BP readings and Patient 3 has an upcoming appointment with the PCP in 4 days. RP 4 stated Patient 3 refused to take her morning medications, including BP medication. PT 2 provided teaching regarding the importance of taking her BP medication. Patient 3 eventually took the morning medications, including the BP medication, after multiple attempts of PT 2 and RP 4 to convince Patient 3 to take her morning medications. Patient 3’s medication bottles and Patient 3’s Patient Medication Record were also reviewed. The following medication discrepancies were noted: -Per RP 3, Patient 3 had stopped taking hydrochlorothiazide 25 mg 1 tablet by mouth daily for BP about 6 months ago per physician’s advice. -Per RP 3, Patient 3 was taking over-the-counter (OTC) Tylenol 500 mg or 650 mg as needed for pain but this was no physician’s order and was not on the medication list). During a review of Patient 3’s “Patient Communication,” dated 5/8/2026, the “Patient Communication” indicated PT 2 “requested to pass the message to the physician’s (MD’s) office” regarding Patient 3’s BP readings of 180/90 mmHg and 200/90 mmHg during and post-therapy. During a review of Patient 3’s “Patient Communication,” dated 5/11/2026, the “Patient Communication” indicated Occupational Therapist (OT 1) “requested to pass the message to the MD’s office” regarding Patient 3’s BP readings of 174/67 mmHg and 158/64 mmHg and not taking the hydrochlorothiazide. During a concurrent interview and record review on 5/14/2026 at 11:48 a.m. with the Rehabilitation Supervisor (RS) and Registered Nurse Clinical Supervisor (RNCS), Patient 3’s medical records were reviewed. The RS stated PT 2 and OT 1 could call the General Acute Care Hotline (GACH) 1 during Patient 3’s home visit to notify the physician of the BP above the specified parameters and medication discrepancies and obtain orders from the physician for an SN Evaluation. The RS stated there was no documented evidence that PT 2 and OT 1 requested a skilled nurse (SN) consult order to review the effectiveness of the BP medication and follow up with the physician regarding the high BP readings. The RNCS stated there was no documented evidence the RN followed up with the physician regarding the change in condition related to high BP readings to clarify the hydrochlorothiazide order and request for the pain medication order. The RNCS stated it was important to request an SN consult to further evaluate the causes of high BP, such diet noncompliance (high sodium intake could lead to a higher BP), medication noncompliance, uncontrolled pain or stress, or PT exercises, and obtain an order if a change in the BP medication was necessary. The RNCS stated a BP uncontrolled by BP medications could lead to more heart problems, stroke, and hospitalization. During a review of the HHA’s undated policy and procedures (P&P), titled “Continuity of Care,” the P&P indicated the following: Continuity of care must be ensured by periodic communication between team members concerning the patient’s progress and special needs as evidenced in case conference reports and clinical notes.The clinician—Registered Nurse (RN) or Rehabilitation Therapist in cooperation with the RNCS —must be responsible for communicating changes in orders and findings to the Clinical Supervisor/Nursing Supervisor or designee, or other team members as necessary; communicating between multiple disciplines to optimize visit schedules for the benefit of the patient and the care to be provided; communicating with all personnel caring for the patient, including the physician; updating physicians’ orders; updating his/her own discipline’s plan of care; and scheduling nursing visits.In addition, during a review of the HHA’s undated policy and procedures (P&P), titled “Medication Profile,” the P&P indicated that patients receiving medications administered by the organization must have a current, accurate medication profile in the clinical record. The P&P indicated that medication profiles must be updated for each change to reflect current medications, new, and/or discontinued medications. The P&P indicated that in rehabilitation therapy only cases, the patient’s therapist must submit a list of patient medications to a registered nurse for review. During a review of the HHA’s Job Description for “Director of Patient Care Services (DPCS)/Clinical Manager,” dated 11/2021, the Job Description indicated the DPCS if functioning as a Clinical Manager, must provide oversight of all patient care services and personnel including making patient and personnel assignments; coordinating patient care; coordinating referrals; assuring patient needs are continually assessed; and assuring the development, implementation, and updates of the individualized plan of care. During a review of the HHA’s Job Description for “Rehabilitation Manager (Clinical Manager,” dated 11/2021, the Job Description indicated the Rehabilitation Manager, if functioning as a Clinical Manager, must provide oversight of all patient care services and personnel including making patient and personnel assignments; coordinating patient care; coordinating referrals; assuring patient needs are continually assessed; and assuring the development, implementation, and updates of the individualized plan of care.”

“Coordinate referrals; CFR(s): 484.105(c)(3) Coordinating referrals, This Element is not met as evidenced by: Based on interviews and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure the Clinical Manager reviewed the referral for one of 20 sampled patients (Patient 13) to ensure that all the required home health services were ordered and/or clarified with the physician. This failure had the potential to result in Patient 13 not receiving the immediate care needs and services related to the lack of oversight and continuity of care, which could lead to a decline in the patient’s health and well-being. Findings: During a review of Patient 13’s medical record, titled “Patient Information,” the “Patient Information” indicated the Start of Care (SOC) date of 4/21/2026 with the primary diagnosis of malignant neoplasm of the thyroid gland (thyroid cancer) and secondary diagnosis of tracheostomy status (patient has a surgically created opening in the trachea [windpipe] for breathing). During a review of Patient 13’s referral document from General Acute Care Hospital (GACH) 1, dated 4/20/2026, the referral document indicated Patient 13’s anticipated discharge date was 4/20/2026 with home health services. The referral document indicated Patient 13 required Registered Nurse (RN) services to “follow up with new tracheostomy care and suctioning (sterile or clean procedure used to remove mucus and secretions from the airway when a patient cannot effectively cough them out).” The referral document indicated Patient 13 required Speech Therapy/Therapist (ST) services for the new tracheostomy to “follow up Passy Muir Valve (PMV, specialized one-way speaking valve attached to a tracheostomy tube) and diet.” During a review of Patient 13’s “Notice of Authorization of Services” letter from GACH 1, dated 4/20/2026, the “Notice of Authorization of Services” letter indicated the referring physician requested authorization of 7 home health visits for Patient 13, including 2 RN visits, one (1) ST visit, and four (4) Physical Therapy (PT) visits. During a review of Patient 13’s “Admission Service Agreement,” dated 4/21/2026, RN 7, the admitting clinician, documented Patient 13 consented for the SN visits once a week for 2 weeks starting on 4/21/2026 and for the ST Evaluation. During a review of Patient 13’s “Delay Eval Order” for ST Evaluation, dated 4/24/2026, the “Delay Eval Order” indicated “order read back and verified with ordering provider.” The “Delay Eval Order” indicated RN 7 spoke with RP 13 on 4/24/2026 with a reason for the delayed ST visit due to RP 13 requesting to “reschedule the ST eval to the week of 5/3/2026.” During an interview on 5/11/2026 at 2:08 p.m., RP 13 stated he did not request any delay in the ST Evaluation. RP 13 stated no HHA staff contacted RP 13 or Patient 13 to schedule any ST visits or inform them regarding the delay in ST Evaluation. During an interview on 5/11/2026 at 4:20 p.m., RN 7 stated she did not speak with RP 13 regarding a request to delay the ST eval. RN 7 stated she recalls that ST Evaluation was ordered by the physician for Patient 13, but RN 7 was not responsible for making the arrangements regarding the ST Evaluation. During a concurrent interview and record review on 5/14/2026 at 1:13 p.m. with the Rehabilitation Supervisor (RS), Patient 13’s electronic health records (eHRs) and Scheduling and Care Coordination Platform (SCCP) details for Patient 13 were reviewed. RS stated the following: -RS would be notified of a referral of a patient (in general) with rehabilitation orders. RS stated Patient 13 had referral orders for RN and ST visits but there was no documented evidence that PT visits ordered or clarified with the physician if necessary. RS was unable to recall if he reviewed Patient 13’s referral orders. -RS stated PT Evaluation might be necessary to determine Patient 13’s core strength and to assess mobility and fall risks due to a new diagnosis and provide therapy, if needed. RS stated ST Evaluation was ordered for Patient 13 to evaluate the gag reflex (automatic, involuntary muscle contraction at the back of the throat), swallowing difficulties, aspiration risk (accidental inhalation of food, liquids, or saliva past the vocal cords and into the windpipe or lungs), and voice quality with the new tracheostomy tube. RS stated not providing the ST Evaluation as ordered could lead to Patient 13’s health decline due to possible aspiration, swallowing or speech difficulties. -RS stated it would be difficult to determine who entered the details regarding Patient 13’s “Delay Eval Order” for ST Evaluation, dated 4/24/2026, but RS stated it was “possible that the “Delay Eval Order” was entered because there was no ST available to conduct the ST Evaluation as ordered.” The RS stated as of 5/14/2026, Patient 13’s physician-ordered ST Evaluation has not been completed. During a review of the HHA’s undated policy and procedures (P&P), titled “Admission Criteria and Process,” the P&P indicated the following: Consideration must be given to the adequacy and suitability of organization personnel, resources to provide the required services, and the reasonable expectation that the patient’s nursing, rehabilitative, medical, and social needs can be adequately met in the patient’s place of residence.A patient must be referred to other resources if the organization cannot meet his/her needs. If a patient cannot be cared for by the HHA, the Clinical Supervisor/Nursing Supervisor should be notified and appropriate referrals to other sources of care should be made on behalf of the patient. The patient, referring physician, and referral source, if not the physician, should be notified of HHA non-admits.Once a patient is admitted to service, the HHA is responsible for providing care and services within its financial and service capabilities, mission, and applicable law and regulations.All admissions must be coordinated by the Case Manager to the rest of the interdisciplinary discipline involved in the patient care. Coordination can be done via phone conference or through home health notify messaging. All initial evaluation should be performed no later than 5 calendar days from the SOC date or date when additional discipline was ordered, if not ordered in the home health referral. A physician must be notified if evaluation cannot be done within 5 days.In addition, during a review of the HHA’s undated policy and procedures (P&P), titled “Intake Process,” the P&P indicated the following: The HHA must only accept those patients whose needs can be met by the services the HHA provides.Upon acceptance of the referral, the Clinical Supervisor/Nursing Supervisor must assign personnel and schedule an initial assessment visit. The initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of a patient’s return home, or on the SOC date ordered by the physician.If the service cannot be provided, intake personnel must give the caller the names of other agencies that can provide the required services. A log must be maintained on all patients that cannot be serviced.During a review of the HHA’s Job Description for “Director of Patient Care Services (DPCS)/Clinical Manager,” dated 11/2021, the Job Description indicated the DPCS if functioning as a Clinical Manager, must provide oversight of all patient care services and personnel including making patient and personnel assignments; coordinating patient care; coordinating referrals; assuring patient needs are continually assessed; and assuring the development, implementation, and updates of the individualized plan of care. During a review of the HHA’s Job Description for “Rehabilitation Manager (Clinical Manager,” dated 11/2021, the Job Description indicated the Rehabilitation Manager, if functioning as a Clinical Manager, must provide oversight of all patient care services and personnel including making patient and personnel assignments; coordinating patient care; coordinating referrals; assuring patient needs are continually assessed; and assuring the development, implementation, and updates of the individualized plan of care.”

“Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This Element is not met as evidenced by: Based on observation, interviews, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) Clinical Manager failed to provide oversight to ensure the medication needs of one of 20 sampled patients (Patient 3) was continually assessed. Patient 3’s Communication Note, dated 5/4/20265, indicated “Supervisory Medication Reconciliation Done,” although there was no Skilled Nurse (SN) visit on 5/4/2026 to address the medication discrepancies, and the medication profile audit indicated entries created by the offshore non-clinical Quality Assurance (ONCQA, non-licensed staff based outside of the country). This failure had the potential to place Patient 3 at risk for medication errors, ineffective drug therapy, and serious adverse effects, such as heart complications, stroke (medical emergency when blood flow to the brain is interrupted or reduced) and hospitalization. Findings: During a review of Patient 3’s undated medical record, titled “Patient Information,” the “Patient Information” indicated the SOC date of 4/30/2026 with a primary diagnosis of Alzheimer’s disease (progressive brain disorder that affects memory, mental skills, and the ability to carry out simply daily tasks).During a review of Patient 3’s referral document from General Acute Care Hospital (GACH) 1, dated 4/30/2026, the referral document indicated Patient 3 required home health services with at-home Physical Therapy (PT) for evaluation and treatment and for functional mobility training (FMT, exercise approach to help a patient move safely and efficiently through everyday activities). During a review of Patient 3’s medical record, titled “Outcome and Assessment Information Set (OASIS-E2) Start of Care (PT),” dated 4/30/2026, the “OASIS-E2 Start of Care (PT)” indicated the following: -Patient 3’s blood pressure (BP, pressure of the blood against the arteries with the normal adult BP less than 120/80 millimeters of mercury [mmHg, unit of measurement of pressure]) was 142/68 mmHg. -The physician must be notified for systolic BP (SBP, top number that reflects the maximum pressure on the artery walls when the heart beats and pumps blood into the body) above 160 mmHg or less than 95 mmHg. During a review of Patient 3’s “Patient Medication Profile,” dated 4/30/2026, PT 3 documented Patient 3’s medications included losartan (medication to treat high BP) 100 milligrams (mg, unit of measurement) 1 tablet by mouth daily. During a review of Patient 3’s Physician Order, dated and signed by the Director of Patient Care Services (DPCS) on 5/4/2026, the Physician Order indicated a new medication was added: hydrochlorothiazide (medication to treat high BP) 25 mg 1 tablet by mouth daily for BP (started on 5/4/2026). During a review of Patient 3’s “Patient Communication,” dated 5/8/2026, the “Patient Communication” indicated PT 2 “requested to pass the message to the MD’s office” regarding Patient 3’s BP readings of 180/90 mmHg and 200/90 mmHg during and post-therapy. During a concurrent observation and interview on 5/8/2026 at 11:58 a.m., while on a joint home visit with PT 2 in Patient 3’s living room with Responsible Party (RP) 4, Patient 3 was alert, confused, and sitting on the couch in the living room. Patient 3 complained of 6 out of 10 pain on the left groin with occasional grimacing during exercise with PT 2. Patient 3’s blood pressure readings were 180/90 mmHg and 200/90 mmHg. Patient 3 denied any headache or chest pain. RP 4 stated Patient 3’s Primary Care Physician (PCP) was aware of Patient 3’s high BP readings and Patient 3 has an upcoming appointment with the PCP in four days. RP 4 stated Patient 3 refused to take her morning medications, including BP medication. PT 2 provided teaching regarding the importance of taking her BP medication. Patient 3 eventually took the morning medications, including the BP medication, after multiple attempts of PT 2 and RP 4 to convince Patient 3 to take her morning medications. Patient 3’s medication bottles and Patient 3’s Patient Medication Record were also reviewed. The following medication discrepancies were noted: -Per RP 3, Patient 3 had stopped taking hydrochlorothiazide 25 mg 1 tablet by mouth daily for high BP about 6 months ago per physician’s advice. -Per RP 3, Patient 3 was taking over-the-counter (OTC) Tylenol 500 mg or 650 mg as needed for pain (medication bottle was present but Tylenol was not on the medication list). During a review of Patient 3’s “Patient Communication,” dated 5/11/2026, the “Patient Communication” indicated Occupational Therapist (OT) 1 “requested to pass the message to the MD’s office” regarding Patient 3’s BP readings of 174/67 mmHg and 158/64 mmHg and Patient 3 not taking the hydrochlorothiazide. During a concurrent interview and record review on 5/14/2026 at 11:48 a.m. with the Rehabilitation Supervisor (RS) and Registered Nurse Clinical Supervisor (RNCS), Patient 3’s medical records were reviewed. The RS stated there was no documented evidence that PT 2 and OT 1 requested a Skilled Nurse (SN) consult to review the effectiveness of the BP medication and follow up with the physician regarding the high BP readings. The RNCS stated there was no documented evidence that an RN reviewed Patient 3’s medications and addressed ineffective drug therapy and noncompliance with drug therapy. The RNCS stated there was no documented evidence the RN followed up with the physician regarding the high BP readings to clarify the hydrochlorothiazide order and request for the pain medication order. The RNCS stated a BP uncontrolled by BP medications could lead to more heart problems, stroke, and hospitalization. During a concurrent review and interview on 5/21/2026 at 3:22 p.m. with the Director of Patient Care Services (DPCS), Patient 3’s electronic health records (eHRs) were reviewed. The DPCS stated the following: -The DPCS stated she was responsible for reviewing Patient 3’s medications and ensuring Patient 3’s Medication Profile was complete and updated. -The DPCS was unable to recall communicating with Patient 3 or Patient 3’s Responsible Party (RP) regarding medication needs or medication changes. -Patient 3’s “Patient Communication,” dated 5/4/2026, indicated “Supervisory Medication Reconciliation Done,” but it was not signed and dated. -The audit log for Patient 3’s “Medication Profile,” dated 5/4/2026, was created by ONCQA 1 on 5/7/2026. -The audit log for Patient 3’s “Medication Profile,” dated 5/11/2026, was created by ONCQA 2 on 5/12/2026. During a review of the HHA’s undated policy and procedures (P&P), titled “Medication Profile,” the P&P indicated patients receiving medications administered by the organization must have a current, accurate medication profile in the clinical record. In rehabilitation therapy only cases, the patient’s therapist must submit a list of patient medications to a registered nurse for review. During a review of the HHA’s Job Description for “Director of Patient Care Services (DPCS)/Clinical Manager,” dated 11/2021, the Job Description indicated the DPCS if functioning as a Clinical Manager, must provide oversight of all patient care services and personnel including making patient and personnel assignments; coordinating patient care; coordinating referrals; assuring patient needs are continually assessed; and assuring the development, implementation, and updates of the individualized plan of care. During a review of the HHA’s Job Description for “Rehabilitation Manager (Clinical Manager,” dated 11/2021, the Job Description indicated the Rehabilitation Manager, if functioning as a Clinical Manager, must provide oversight of all patient care services and personnel including making patient and personnel assignments; coordinating patient care; coordinating referrals; assuring patient needs are continually assessed; and assuring the development, implementation, and updates of the individualized plan of care.”

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based on observation, interviews, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure complete and accurate documentation on the clinical records for two of 20 sampled patients (Patient 13 and Patient 3) by failing to: Ensure complete and accurate documentation of the Registered Nurse (RN) assessment of the tracheostomy (surgically created opening in the trachea [windpipe] for breathing) after Responsible Party (RP) 13 reported redness to the tracheostomy site during the discharge home visit on 4/28/2026.Ensure documentation of a revised individualized plan of care (POC) for Patient 3.These failures had the potential to result in a decline of the patients’ health status and well-being related to the inconsistent or delayed delivery of care and services to the patient to address the patients’ immediate care needs. Findings: During a review of Patient 13’s medical record, titled “Patient Information,” the “Patient Information” indicated the Start of Care (SOC) date of 4/21/2026 with the primary diagnosis of malignant neoplasm of the thyroid gland (thyroid cancer) and secondary diagnosis of tracheostomy status.During a review of Patient 13’s “Skilled Nursing Visit (SNV) with (W/) Discharge Summary,” dated 4/28/2026, the “SNV W/ Discharge Summary” indicated Patient 13 had a tracheostomy, decreased secretions, and improving with stable respiratory status. The “SNV W/ Discharge Summary” indicated Patient 13’s skin was warm and dry, and the surgical incision was “healing well with no signs and symptoms of infection.” During an interview on 5/11/2026 at 2:08 p.m., RP 13 stated he reported to RN 7 the redness noted on Patient 13’s surgical site (tracheostomy) on the last home visit (4/28/2026). RP 13 stated RN 7 did not notify the physician about the redness, so RP 13 took Patient 13 to the physician directly to have the tracheostomy site assessed. RP 13 stated the physician confirmed the tracheostomy site was infected and prescribed three antibiotics for Patient 13. During an interview on 5/11/2026 at 4:20 p.m., RN 7 stated RP 13 reported redness to Patient 13’s tracheostomy site on the last home visit (4/28/2026). RN 7 stated Patient 13’s tracheostomy site had “slight redness” but was resolving with some scabbing (body’s natural defense for sealing a broken skin while tissue heals underneath). During a concurrent interview and record review on 5/14/2026 at 1:13 p.m. with the Rehabilitation Supervisor (RS) and Registered Nurse Clinical Supervisor (RNCS), Patient 13’s electronic health records were reviewed. RNCS stated there was no documented evidence that “slight redness” was noted. RNCS stated there were no photos taken of the tracheostomy site to support the skin assessment. RNCS stated there was no documented evidence that RN 7 notified the physician about the redness to the tracheostomy site. RNCS stated inaccurate and incomplete assessment of the tracheostomy site could lead to an infection of the tracheostomy site that could further lead to sepsis (body’s extreme, life-threatening response to an infection). RNCS stated Patient 13 had an infection because Patient 13’s “Patient Communication,” dated 5/1/2026, indicated the physician ordered three antibiotics (medication to treat bacterial infections): mupirocin external ointment 2% apply to affected areas twice a day, Ciprofloxacin 500 milligrams (mg, unit of measurement of weight) 1 tablet by mouth twice a day for 10 days, and Clindamycin 300 mg 1 capsule by mouth four times a day for 10 days. During a review of the HHA’s policy and procedures (P&P), titled “Reassessments/Recertification,” dated 11/2021, the P&P indicated the following: The update of the comprehensive assessment must, at a minimum, include documentation of changes in the patient’s assessment findings.Documentation in the clinical record should support the assessment as well as the actions taken in response. During a review of Patient 3’s undated medical record, titled “Patient Information,” the “Patient Information” indicated the SOC date of 4/30/2026 with a primary diagnosis of Alzheimer’s disease (progressive brain disorder that affects memory, mental skills, and the ability to carry out simply daily tasks).During a review of Patient 3’s medical record, titled “Outcome and Assessment Information Set (OASIS-E2) Start of Care Physical Therapy (PT),” dated 4/30/2026, the “OASIS-E2 Start of Care (PT)” indicated the following: -Patient 3’s blood pressure (BP, pressure of the blood against the arteries with the normal adult BP less than 120/80 millimeters of mercury [mmHg, unit of measurement of pressure]) was 142/68 mmHg. -The physician must be notified for systolic BP (SBP, maximum pressure on the artery walls when the heart beats and pumps blood into the body) above 160 mmHg or less than 95 mmHg. During a review of Patient 3’s “Patient Medication Profile,” dated 4/30/2026, PT 3 documented Patient 3 had physician orders for losartan (medication to treat high BP) 100 milligrams (mg, unit of measurement) 1 tablet by mouth daily. During a review of Patient 3’s “Physician Order,” dated and signed by the Director of Patient Care Services (DPCS) on 5/4/2026, the “Physician Order” indicated the following medication orders: -Hydrochlorothiazide (medication to treat high blood pressure [BP, pressure of blood against the arteries]) 25 mg 1 tablet by mouth daily for BP (started on 5/4/2026) -Gabapentin order changed to Gabapentin 100 mg 1 capsule by mouth at night daily for nerve pain During a concurrent observation and interview on 5/8/2026 at 11:58 a.m., while on a joint home visit with PT 2 in Patient 3’s living room with Responsible Party (RP) 4, Patient 3 was alert, confused, and sitting on the couch in the living room. Patient 3 complained of 6 out of 10 pain on the left groin with occasional grimacing during exercise with PT 2. Patient 3’s BP readings were 180/90 mmHg and 200/90 mmHg. Patient 3 denied any headache or chest pain. RP 4 stated Patient 3’s Primary Care Physician (PCP) was aware of Patient 3’s high BP readings and Patient 3 has an upcoming appointment with the PCP in 4 days. RP 4 stated Patient 3 refused to take her morning medications, including BP medication. PT 2 provided teaching regarding the importance of taking her BP medication. Patient 3 eventually took the morning medications, including the BP medication, after multiple attempts of PT 2 and RP 4 to convince Patient 3 to take her morning medications. Patient 3’s medication bottles and Patient 3’s Patient Medication Record were also reviewed. The following medication discrepancies were noted: -Per RP 3, Patient 3 had stopped taking hydrochlorothiazide 25 mg 1 tablet by mouth daily for BP about 6 months ago per physician’s advice. -Per RP 3, Patient 3 was taking over-the-counter (OTC) Tylenol 500 mg or 650 mg as needed for pain but this was no physician’s order and was not on the medication list). During a review of Patient 3’s “Patient Communication,” dated 5/8/2026, the “Patient Communication” indicated PT 2 “requested to pass the message to the MD’s office” regarding Patient 3’s BP readings of 180/90 mmHg and 200/90 mmHg during and post-therapy. During a review of Patient 3’s “Patient Communication,” dated 5/11/2026, the “Patient Communication” indicated OT 1 “requested to pass the message to the MD’s office” regarding Patient 3’s BP readings of 174/67 mmHg and 158/64 mmHg and not taking the hydrochlorothiazide. During a concurrent interview and record review on 5/14/2026 at 11:48 a.m. with the Rehabilitation Supervisor (RS) and Registered Nurse Clinical Supervisor (RNCS), Patient 3’s medical records were reviewed. The RS stated there was no documented evidence that Patient 3’s plan of care was individualized to address Patient 3’s high BP readings, pain level, changes in medications, and noncompliance with the medication regimen. The RNCS stated not updating the plan of care could lead to Patient 3’s decline related to the inconsistent delivery of care and interventions and possible ineffective drug therapy. The RNCS stated a BP uncontrolled by BP medications could lead to more heart problems, stroke, and hospitalization. During a review of the HHA’s undated policy and procedures (P&P), titled “Care Planning Process,” the P&P indicated the following: Changes in the plan of care must be noted with the following documentation: assessment, plan of care with clinical outcome goals, care plan with specific services/actions to be taken, clinical notes, and verbal orders.Clinicians must information the patient’s physician of any changes that suggest a need to alter the plan of care. Changes must be written, dated, and signed by the professional making the changes.”

“Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient’s condition warrants due to a major decline or improvement in the patient’s health status, but not less frequently than- This Standard is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient at home) failed to update the comprehensive assessment (in-person clinical assessment of the patient’s physical, functional, mental, psychosocial, and cognitive status to identify the needs of the patient and caregiver that will be addressed by the home health agency’s services) for one of eight sampled patients (Patient 21). Patient 21’s comprehensive assessment failed to identify the existing peripherally inserted central catheter (PICC- is a thin, flexible tube that helps you receive treatments through a vein for various medical conditions) line for intravenous (IV-refers to a way of giving a drug or other substance through a needle or tube inserted into a vein) medication infusion at right arm antecubital area. This deficient practice resulted in the failure to develop the plan of care identifying the management of the PICC line that could lead to jeopardize the patient’s health status, safety and wellbeing. Findings: During a review of Patient 21’s “Patient Profile” (undated) indicated Patient 21’s start of care was on 9/12/2025. The primary diagnosis included for the adjustment and management of Ventricular Assist Device (VAD, device that provides support for cardiac pump function, which is used either to partially or to completely replace the function of a failing heart) and a secondary diagnosis of sepsis (a life-threatening condition that arises when the body’s response to an infection injures its own tissues and organs), unspecified organism. During a review of Patient 21’’s Medication Record, the Medication Record indicated Patient 21 was taking the following medication: Meropenem (an antibiotic medication used to treat serious bacterial infections), three grams using an Elastomeric pump ( a small portable medical device that uses pressure from a stretch elastic balloon to deliver medication at continuous set rate) to infuse three grams in to the vein in 240 milliliters (ml, unit of volume) of Normal Saline for every 24 hours for chronic osteomyelitis (a serious infection that happens when a bacteria or fungi infect the bone marrow). PICC line flushing: flush each lumen with Normal Saline IV flush 10 ml before and after IV antibiotic infusion. Skilled Nurse (SN) to change PICC line dressing weekly. During a home joint home visit with Registered Nurse (RN) 1 on 9/25/2025, at 2 p.m., to 2:40 pm at Patient 21’s residence, Patient 21 was observed with a PICC line with one port at the antecubital area (anterior [front] surface of the elbow joint) of the right arm, patent, and intact. There was dressing change label dated 9/24/2025, with the initials of the visiting nurse. During an interview on 9/25/2025 at 2:50 p.m., with family member (FM) 1, FM1 stated that Patient 21 had a PICC line at his right arm prior to being admitted to home health services. During a review of Patient 21’s Initial Comprehensive Assessment (OASIS) dated 9/12/2025, the Comprehensive Assessment indicated no documented evidence that Patient 21 had an existing PICC line at right arm antecubital area. During an interview with the Director of Patient Care Services (DPCS) on 9/26/2025 at 11 a.m., the DPCS stated the visiting nurse should have assessed the patient’s PICC line and documented it the initial OASIS per policy. During a review of the agency’s policy and procedure (P&P) titled, Initial and Comprehensive Assessment, the P&P indicated a comprehensive patient assessment will be completed within five calendar days of the patient’s start of care. This assessment will measure patient outcomes from data collected at the start of care and at the following defined intervals thereafter: 1. The last five days of every 60-day episode beginning with the start of care date (recertification) 2. Upon transfer 3. Significant change in condition resulting in a new case mix 4. Within 48 hours of the patient’s return home or of this Organization’s knowledge of the patient’s return from a 24-hour hospital admission for other than diagnostic testing, or on the physician-ordered resumption date 5. At discharge”

“Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient’s eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This Condition is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence) failed to meet the Condition of Participation (the terms healthcare organizations must meet in order to participate in federally funded healthcare programs) for Comprehensive Assessment of Patients as follows: The HHA failed to ensure the comprehensive assessment of patients included documented evidence of an accurate and current medication profile (a record of all the medications that a patient is currently taking) for one of three sampled patients (Patient 7). This failure put Patient 7 at risk for medication error, adverse drug reactions (a harmful, unintended reaction to medication) and ineffective treatment. (Refer to G536) This systemic practice resulted in the failure of the Home Health Agency to deliver statutorily mandated (a legal obligation established by a statute or law) compliance with Federal regulation for Comprehensive Assessment of Patients to ensure the quality of care are provided to patients certified to receive home health benefits.”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence) failed to ensure the Condition of Participation (the terms healthcare organizations must meet in order to participate in federally funded healthcare programs) for care planning, coordination, and quality of care was met as follows: 1. The HHA failed to provide physical therapy services as indicated in the plan of care and provided documented reasons as to why patient’s physical therapy visits decreased from twice a week to once a week for one of five sampled patients (Patient 14). This failure had the potential for Patient 14’s health and physical condition, physical mobility and quality of life to worsen. (Refer to G572) 2. The HHA failed to update the plan of care for one of five sampled discharged patients (Patient 14) to reflect the change in physical therapy visit frequency. This failure had the potential to compromise Patient 14’s recovery and quality of life. (Refer to G576). 3. The HHA an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence) failed to ensure Patient 9’s physician’s verbal order for Start of Care (SOC – initial visit, clinical assessment, and frequency of skilled nursing services) dated 6/24/2025 was signed by the physician within 30 days of receiving the verbal order. This failure placed Patient 9 at increased risk from medication errors, delayed or incorrect and inappropriate care and treatment for Patient 9. (Refer to G584) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated (written law) compliance with Federal regulation for Care planning, Coordination, and Quality of Care to ensure highest quality of care are provided to patients certified to receive home health benefits.”

“Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This Condition is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence) failed to meet the Condition of Participation (the terms healthcare organizations must meet in order to participate in federally funded healthcare programs) for organization and administration of services was met as follows: The HHA failed to ensure accurate nursing assessments for two of three sampled patients (Patient 2 and Patient 7) by failing to ensure Registered Nurse (RN) 1 and RN 3 listened to Patient 2 and Patient 7 lung and bowel sounds. This failure had the potential to result with wrong assessment to Patient 2 and Patient 7 that could result to delay in addressing health concerns, worsen illness, cause injury or even death. (Refer to G984) This systemic practice resulted in the failure of the Home Health Agency to deliver statutorily mandated (a legal obligation established by a statute or law) compliance with Federal regulation for organization and administration of services.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on interview and record review, the Home health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence) failed to provide physical therapy services as indicated on the plan of care and provide documented reason as to why patient’s physical therapy visit was decreased from twice a week to once a week for one of five sampled patients (Patient 14). This failure had the potential for Patient 14’s health and physical condition, physical mobility and quality of life to worsen. Findings: During a review of Patient 14’s “Patient Profile”, dated 8/14/2025, the Patient Profile indicated the facility admitted Patient 14, on 1/14/2025 with diagnoses including but not limited to gastrostomy (a surgical opening fitted with a device to allow feedings to be administered directly to the stomach common for people with swallowing problems) and dysphagia (difficulty swallowing). During an interview on 8/12/2025 at 4:05 p.m., with Family member (FM) 1, FM 1 stated Patient 14 physical mobility and ambulation declined, and his health condition worsen due to Patient 14 did not received physical therapy services. During a review of Patient 14’s “Home Health Certification and Plan of Care”, dated 1/14/2025, the plan of care indicated physical therapy visit frequency were twice a week for two weeks effective 1/21/2025. Physical therapy intervention included gait training, fall prevention to improve safety, transfer training and positioning, bed mobility, strengthening, range of motion and balance training. During a review of Patient 14’s “Physical Therapy Evaluation”, dated 1/21/2025, the Physical Therapy Evaluation indicated physical therapy visit frequency were twice a week for two weeks effective 1/21/2025. The evaluation indicated Patient 14 were able to ambulate 25 feet with front-wheel walker. The evaluation indicated Patient 14’s goals were as follows: 1. Patient 14 will be independent with home exercise program 2. Patient 14 and caregivers will be independent with fall prevention and safety training. 3. Patient 14 will require moderate assistance with transfers to alleviate caregiver’s burden. During a review of Patient 14’s “Patient Communication”, dated 1/24/2025, the physician was notified regarding a missed visit on 1/24/2025 due to Patient’s 14’s wife’s request. During a review of Patient 14’s “Physical Therapy Visit”, dated 1/27/2025, the visit note indicated Patient 14 were resistant with the therapy interventions and required help with navigation but was able to ambulate 125 feet. The visit note indicated Patient 14 required maximum assistance with transfers. The visit note indicated the plan for next visit were to continue with plan of care. The visit note did not indicate the change in frequency of physical therapy visits. During a review of Patient 14’s “Physical Therapy Visit”, dated 2/5/2025, the visit note indicated Patient 14 ambulated 25 feet with maximum assistance (Patient 14 ambulated 125 feet on 1/27/2025 visit), and required maximum assistance with transfer. The visit note indicated the following care plan goals were unmet. · Patient 14 will be independent with home exercise program · Patient 14 and caregivers will be independent with fall prevention and safety training. · Patient 14 will require moderate assistance with transfers to alleviate caregiver’s burden. The visit note indicated the plan for next visit were to continue with plan of care. During an interview on 8/15/2025 at 11 a.m. with the Rehabilitation Director (RD), the RD stated Plan of care should dictate the physical therapy interventions including frequency visit. During an interview on 8/15/2025 at 12:10 p.m. with the Director of Patient Services (DPCS), the DPCS stated when changing the frequency of visit for services, the licensed staff should document the patient’s record the verbal order with the reason of the change of frequency. The DPCS stated the patient’ s plan of care should be updated. During a concurrent interview and record review on 8/15/2025 at 2:20 p.m. with Rehabilitation Director (RD), Patient 14’s “Frequency Order Change”, dated 1/27/2025 was reviewed. The order indicated the physical therapy visit frequency were changed from twice a week for two weeks to once a week for four weeks effective 1/21/2025. The RD stated he assumed Patient 14’s physical therapy visits were decreased due to Patient 14’s improvement. The RD stated there were no documented reasons as to why the physical therapy visit frequency was changed and decreased from twice a week to once a week. During an interview on 8/15/2025 at 3:20 p.m. with the Director of Quality Assurance (QA), the QA stated when there is a need to change the frequency of home visit to patient, the staff should notify the physician, receive an approval for change, update the plan of care and document the reason for change of frequency. The QA stated updating the plan of care was important to coordinate the care of patients to all disciplines for continuity of care. During a review of facility’s policies and procedures (P&P) titled, “Care Planning Process”, dated November 2021, the P&P indicated “the plan of care will include type, frequency and duration of services to be provided” … “Changes in the plan of care will be noted in the clinical notes, assessments and care plan with specific services/actions to be taken.” … “The frequency of the review of the plan of care will be based on changes in the patient’s health status and needs”. During a review of facility’s policies and procedures (P&P) titled, “Rehabilitation Care Planning”, dated November 2021, the P&P indicated “Rehabilitation plans and goals will guide the provision of rehabilitation services”.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, interview and record review, the HHA failed to ensure the comprehensive assessment of patients included documented evidence of an accurate and current medication profile (a record of all the medications that a patient is currently taking) for one of three sampled patients (Patient 7). This failure had the potential to put Patient 7 at risk for medication error, adverse drug reactions (a harmful, unintended reaction to medication) and ineffective treatment. Findings: During a review of Patient 7’s “Patient Profile”, (undated), the Patient Profile indicated Patient 7’s start of care was 8/7/2025 with primary diagnosis for adjustment and management of Ventricular Assist Device (VAD, device that provides support for cardiac pump function, which is used either to partially or to completely replace the function of a failing heart) and secondary diagnosis was sepsis (a life-threatening condition that arises when the body’s response to an infection injures its own tissues and organs), unspecified organism. During a review of Patient 7’s Medication record, the Medication record indicated Patient 7 was taking the following medications: Mupirocin External (medication used to treat bacterial skin infections) 2% (percent) - apply to affected area three (3) times a day for skin irritation. Lisinopril (medication to treat high blood pressure [hypertension]) 5 milligram (mg, a unit of measurement) one (1) tablet by mouth daily for blood pressure. Alendronate Sodium (also known as alendronic acid, medication used to prevent and treat certain bone diseases) 70 mg one (1) tablet by mouth every week in the morning with 8 ounces (oz, unit of measurement) of water at least 30 minutes before the first food, drink, or other medication of the day for osteoporosis (a condition that causes bones to become weak and brittle). Cyanocobalamin (a supplement used to treat vitamin deficiency) 1000 microgram (mcg, a unit of measurement) one (1) tablet by mouth daily as supplement. During a home joint home visit observation with Registered Nurse (RN) 3 on 8/14/2025 at 2:40 pm at Patient 7’s residence receiving area, the following medications were observed on a tray on top of the table. One tube of Mupirocin External 2 % (percent) One bottle of Alendronate Sodium Oral 70 mg. One bottle of Lisinopril 5 milligram (a unit of measurement) one tablet by mouth daily for blood pressure. One bottle of Cyanocobalamin oral 1000 mcg. During an interview on 8/14/2025 at 2:42 p.m., Patient 7 stated she only used Mupirocin External 2% as needed for itchiness and not taking Lisinopril for years (unable to say how long). During an interview on 8/14/2025 at 2:48 p.m., RN 3 stated correct medication list were crucial for patient safety, preventing medication errors, and ensuring effective treatment. During an interview on 8/15/2025 at 12:15 p.m. with Director of Patient Care Services (DPCS), the DPCS stated having an accurate medication profile helps health care professionals know about their current health and minimize medication errors and adverse drug interactions. During a review of facility’s policy and procedures (P&P) titled, “Medication Profile”, dated November 2021, the P&P indicated the following: Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications. Upon admission to the organization, the admitting clinician will initiate a medication profile to document the current medication regimen, including name, dose, strength, route, frequency, date and time of administration. Each patient will receive appropriate written material for specific medications he/she is receiving. The material will contain information on actions of the medication, potential side effects, contraindications the patient should be aware of, and any special instructions when taking the specific medication.”

“All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This Element is not met as evidenced by: Based on interview and record review, the home health agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence) failed to update the plan of care for one of five sampled discharged patients (Patient 14) to reflect the change in physical therapy visit frequency. This failure had the potential to compromise Patient 14’s recovery and quality of life. Findings: During an interview on 8/12/2025 at 4:05 p.m. with the Complainant, the Complainant stated Patient 14 did not receive the services the physician ordered. The Complainant stated Patient 14 physical mobility and health condition worsen due to the services that was not provided. During a review of Patient 14’s “Patient Profile”, dated 8/14/2025, the Patient Profile indicated the facility admitted Patient 14, on 1/14/2025 with diagnoses including but not limited to gastrostomy (a surgical opening fitted with a device to allow feedings to be administered directly to the stomach common for people with swallowing problems) and dysphagia (difficulty swallowing). During a review of Patient 14’s “Physical Therapy Evaluation”, dated 1/21/2025, the Physical Therapy Evaluation indicated physical therapy visit frequency were twice a week for two weeks effective 1/21/2025. During a review of Patient 14’s “Home Health Certification and Plan of Care”, dated 1/14/2025, the plan of care indicated physical therapy visit frequency were twice a week for two weeks effective 1/21/2025. During a review of Patient 14’s “Frequency Order Change”, dated 1/27/2025, the order indicated the physical therapy visit frequency were changed to once a week for two weeks effective 1/21/2025. During an interview on 8/15/2025 at 12:10 p.m. with the Director of Patient Services (DPCS), the DPCS stated when changing the frequency of visit for services, the licensed staff should document the patient’s record the verbal order with the reason of the change of frequency. The DPCS stated the patient’ s plan of care should be updated. During an interview on 8/15/2025 at 3 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated the plan of care should be updated every visit. The DPCS stated the visiting staff should be responsible in updating the plan of care. During a concurrent interview and record review on 8/15/2025 at 3:06 p.m. with Rehabilitation Director (RD), Patient 14’s “Physical Therapy Visit”, dated 1/27/2025 was reviewed. The visit note indicated the plan for next visit were to continue with plan of care. The visit note did not indicate the change in frequency of visit. The RD stated there were no documented change in frequency in the visit note. The RD stated he assumed that documentation “continue with plan of care” meant to see the patient once a week. During an interview on 8/15/2025 at 3:20 p.m. with the Director of Quality Assurance (QA), the QA stated the when the need to change the frequency to visit, staff should notify the physician, receive an approval for change, update the plan of care and document the reason for change of frequency. The QA stated updating the plan of care was important to coordinate the care of patients to all disciplines for continuity of care. During a review of facility’s policies and procedures (P&P) titled, “Care Planning Process”, dated November 2021, the P&P indicated “the plan of care will include type, frequency and duration of services to be provided” … “Changes in the plan of care will be noted in the clinical notes, assessments and care plan with specific services/actions to be taken.” … “The frequency of the review of the plan of care will be based on changes in the patient’s health status and needs”.”

“Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA’s internal policies. (4) When services are provided on the basis of a physician or allowed practitioner’s verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA’s policies, must document the orders in the patient’s clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA’s internal policies. This Element is not met as evidenced by: Based on interview and record review, the home health agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence) failed to ensure Patient 9’s physician’s verbal order for Start of Care (SOC), dated 6/24/2025 was signed by the physician within 30 days of receiving the verbal order. This failure placed Patient 9 at increased risk from medication errors, delayed or incorrect and inappropriate care and treatment for Patient 9. Findings: During a review of Patient 9’s verbal order for SOC, dated 6/24/2025, the SOC indicated Patient 9’s SOC was dated 6/24/2025 with diagnoses including traumatic subarachnoid hemorrhage (bleeding from a damaged artery at the surface of the brain), history of falling and hypertension (high blood pressure). The SOC order indicated RN 4 received the SOC order on 6/24/2025 and the physician signed the SOC order on 7/29/2025 with the following orders: Admit Patient 9 to HHA on 6/24/2025.Instruct Patient 9 and caregiver regarding admission agreements, emergency planning, grievance policy, advance directives, transfer and discharge rights, patient rights and agency contact information prior to initiation of care.Code status: Full code (indicates patient wishes to receive all possible life saving measures in the event of emergency). Regular diet (a diet that includes a variety of foods from all the food groups without any specific restrictions).Frequency of skilled nursing services two visits a week for one week then one visit a week for one week to include teaching, assessment, pain assessment and interventions, when to notify physician, vital signs, monitoring. right forearm laceration.Check oxygen saturation (measurement of how effectively the body is receiving oxygen) level using pulse oximeter (a device that measures the blood oxygen levels and pulse) during visits.During a concurrent interview and record review on 8/14/2025 at 10:40 a.m. with the Administrator (ADM), Patient 9’s verbal order for SOC, dated 6/24/2025, was reviewed. Patient 9’s SOC indicated, RN 4 received the verbal order from the physician on 6/24/2025 and the physician signed the verbal order on 7/29/2025. The ADM stated the physician should have signed the verbal order within 30 calendar days from the date the physician gave the order to RN 4. During a concurrent interview and record review on 8/14/2025 at 10:40 a.m. with the ADM, the facility’s policy and procedure (P&P) titled “Internal Control Systems/Accountabilities”, dated 11/2023, Section C., Physician’s order was reviewed. The P&P indicated that physicians must sign all orders no later than 30 calendar days from the time the registered nurse receives the order. The ADM stated the HHA did not comply with HHA Policy & Procedures (P&P) of physicians signing orders and ensure that Patient 9’s SOC order was signed within 30 calendar days. The ADM stated the Home Health Agency (HHA) was working with the physicians to sign all orders within 30 calendar days from when the registered nurse received verbal orders from physicians.”

“In accordance with current clinical practice CFR(s): 484.105(f)(2) All HHA services must be provided in accordance with current clinical practice guidelines and accepted professional standards of practice. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence) failed to ensure to perform accurate nursing assessments for two of three sampled patients (Patient 2 and Patient 7) by failing to ensure Registered Nurse (RN) 1 and RN 3 listened to Patient 2 and Patient 7 lung and bowel sounds. This failure had the potential to result with wrong assessment to Patient 2 and Patient 7 that could result to delay in addressing health concerns, worsen illness, cause injury or even death. b. During a review of Patient 2’s “Patient Profile”, dated 8/14/2025, the Patient Profile indicated the facility admitted Patient 2, a 70 year-old male, on 7/3/2025 with diagnoses including but not limited to management of Ventricular Assistive Device (VAD, a mechanical pump implanted to help the heart to circulate blood throughout the body) and attention to artificial opening of the digestive tract. During an observation on 8/13/2025 at 11:53 a.m. in Patient 2’s home, Registered Nurse (RN) 1 changed Patient 2’s cholecystostomy dressing. RN 1 took Patient 2’s vital signs using a manual blood pressure cuff and stethoscope and pulse oximeter. RN 1 asked Patient 2 for his last bowel movement, signs of shortness of breath and Patient 2’s next appointment to his physician. During a review of Patient 2’s “RN - Skilled Nursing Visit” notes, dated 8/13/2025, the note indicated “Heart sound normal” … “[Clear to Auscultate] all lobes” and “bowel sounds normal”. During a concurrent interview and record review on 8/15/2025 at 10:26 a.m. with Registered Nurse (RN) 1, Patient 2’s “RN - Skilled Nursing Visit” notes, dated 8/13/2025 was reviewed. The note indicated “Heart sound normal”, “[Clear to Auscultate] all lobes” and “bowel sounds normal”. RN 1 stated auscultating requires a stethoscope. RN stated she used the stethoscope when taking the vital signs only. RN 1 stated she knows her patients and she does not need to use a stethoscope to hear wheezing from a patient. RN 1 stated the notes she documented for Patient 2’s visit last 8/13/2025 were not accurate. RN 1 stated documenting false information could result in wrong assessment to patients not able to address concerns or worsen patient’s health condition. During a review of facility’s policy and procedures (P&P) titled, “Ongoing Assessments”, dated November 2021, the P&P indicated, “During each home visit the appropriate clinician will re-evaluate the patient” … “the clinician will re-assess the patient for breath sounds, bowel sounds etc.” a. During a review of Patient 7’s “Patient Profile”, (undated), the Patient Profile indicated start of care (SOC is 8/7/2025) with primary diagnosis (is medical professional’s determination of the underlying cause of a patient’s illness or condition) encounter for adjustment and management of Ventricular Assist Device (VAD - is a tiny mechanical helper pump implanted to assist a weakened or damaged heart in pumping blood throughout the body). Secondary diagnosis is sepsis (a life-threatening condition that arises when the body’s response to an infection injures its own tissues and organs), unspecified organism. During a concurrent observation and interview on 8/14/2025 at 2:40 pm with Patient 7, Patient 7 stated, Registered Nurse (RN – is a licensed healthcare professional who provides direct patient care, assesses patient conditions, administers medications and treatments, monitors health status, and educates patients and families about health conditions) 3 did not check his lung sounds and bowel sounds with the use of stethoscope (a Y shaped device with earpieces and a small disk on the end that helps physicians or healthcare providers primarily to listen to the sounds generated internally by the heart, lungs, intestinal tract, and also used to check blood pressure). During a concurrent observation and interview on 8/14/2025 at 2:48 pm with RN 3, RN 3 was not seen listening to bowel and lung sounds using a stethoscope. RN 3 stated, did focus assessment as only there for the IV therapy. No need to check bowel sounds as patient had a bowel movement that day and lungs not checked with the use of stethoscope as patient is not short of breath and not in respiratory distress. Accurate assessment is important to know the correct status of the patient for safety. During a review of Patient 7’s “RN – Skilled Nursing Visit”, dated 8/14/2025, the RN – Skilled Nursing Visit indicated, Respiratory: “WNL” and Lung Sound: “CTA: clear throughout’. During an interview on 8/15/2025 at 10:40 a.m. with the Director of Patient Care Services (DPCS), the DPCS stated nurses are supposed to complete a head-to-toe assessment to patients at each visit. DPCS stated nurses are supposed to use stethoscopes to auscultate and assess the patient. During an interview on 8/15/2025 at 12:10 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated having an accurate assessment to patient is important due to the patient’s fragile health condition, their diagnosis and age. The DPCS stated the assessment will help to collaborate with the physician regarding patient’s care and educate the patient regarding their medication and health. During a review of facility’s policy and procedures (P&P) titled, “Ongoing Assessments”, dated November 2021, the P&P indicated, POLICY: The scope and intensity of ongoing assessments will be determined by the patient’s diagnoses, condition, desire for care, response to previous care, and the care setting. PROCEDURE: 1. During each home visit the appropriate clinician will re-evaluate the patient according to the problems identified during the initial visit and thereafter. 2. Using standards of care identified by the organization, the clinician will reassess the patient for: D. Breath sounds F. Bowel sounds; elimination (urinary and bowel) 5. Based on each reassessment, the plan of care, including problems, needs, goals, and outcomes, will be reviewed and revised accordingly by the clinician.”

“Condition of Participation: Patient rights. CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient’s rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This Condition is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure the Condition of Participation (refer to the requirements that healthcare organizations must meet to participate in federal healthcare programs) regarding the Patient’s Rights was met as follows: 1. The Home Health Agency (HHA) failed to ensure the written notice of rights and responsibilities, home instructions and patient/patient’s caregiver teachings for one of seventeen sampled patients (Patient 2) were written, explained, and provided in a language and manner that patient/patient family member/patient caregiver could understand. This deficient practice resulted in the patient/patient family member/patient’s caregiver not understanding the pertinent information regarding patient and had a potential to affect the patient’s quality of care and services. (Refer to G412). 2. The Home Health Agency (HHA) failed to provide information regarding the care to be furnished, expected outcomes of care, including patient-identified goals, and anticipated risks, benefits and factors that could impact treatment effectiveness for seven of seventeen sampled patients (Patient 1, Patient 2, Patient 5, Patient 6, Patient 9, Patient 10 and Patient 13). This deficient practice resulted in patients do not have a written copy and information of the care and treatment furnished as identified in the plan of care (POC, structured document outlining the specific interventions, goals, and expected outcomes for a patient’s healthcare, ensuring a coordinated and effective approach to meeting their needs.). (Refer to G434). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Patient Rights to ensure highest quality health care is provided to patients assessed to receive home health services.”

“Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient’s eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This Condition is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure the Condition of Participation (refer to the requirements that healthcare organizations must meet to participate in federal healthcare programs) regarding Comprehensive Assessment of Patient was met as follows: 1. The HHA failed to review and document all the current medications/treatments to identify any potential adverse effects and drug reactions for five of seventeen sampled patients (Patient 1, Patient 2, Patient 5, Patient 10, and Patient 13). This deficient practice had the potential to place the patients at risk for medication errors and serious adverse effects. (Refer to G536). 2. The HHA failed to provide necessary nursing needs and medical supplies (blood pressure machine, a device used to measure the force of blood pushing against the walls of your arteries, typically measured as systolic (when the heart beats) and diastolic (when the heart rests) pressure and glucometer, a small, portable device used to measure the amount of glucose (sugar) in a person’s blood, typically by testing a small blood sample from a finger prick) to one of seventeen sampled patients (Patient 2). This deficient practice had the potential to result in uncontrolled symptoms, which could affect the patient’s overall health status. (Refer to G534). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Comprehensive Patient Assessment to ensure highest quality health care is provided to patients assessed to receive home health services.”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare and Medicaid programs) for Care planning, Coordination of services, and Quality of care was met as follows: 1. The HHA failed to ensure that one of seventeen sampled patients (Patient 3) received the nursing visits as written in the individualized plan of care. (Refer to G572). This failure had the potential to delay necessary interventions and expected patient outcomes. 2. The HHA failed to include frequency of visits, medications, treatment, measurable outcomes and goals, and patient-specific education for five of seventeen sampled patients (Patient 1, Patient 2, Patient 5, Patient 9, and Patient 13). (Refer to G574). This failure had the potential to affect the quality and safety of patient care provided to the patients and impair the coordination of care amongst all disciplines involved in the patient’s care. 3. The HHA failed to record all patient care orders in the plan of care for three of seventeen sampled patients (Patient 5, Patient 9, and Patient 13). (Refer to G576). This failure had the potential to result in patients not receiving the services ordered for them based on their assessed needs. 4. The HHA failed to alert the physician regarding change of condition for one of seventeen sampled patients (Patient 5). (Refer to G590). This failure had the potential to result in the patient not receiving appropriate care and/or services that would meet the patient’s needs. 5. The HHA failed to integrate orders from all physicians or allowed practitioners involved in the plan of care to assure the coordination of all services and interventions provided to two of seventeen sampled patients (Patient 2 and Patient 5). (Refer to G604). This failure had the potential to the development of an incomplete, individualized plan of care for the patients, that could affect the care and services received by the patients. 6. The HHA failed to provide a copy of medication profile that included to medication name, dosage, and frequency to two of seventeen sampled patients (Patient 1 and Patient 2). (Refer to G616). This failure had the potential to patient not aware of their medication schedule/instructions and potential drug interactions and adverse effects. The cumulative effect of this systemic practice resulted in the failure of the HHA to deliver statutorily (decided and controlled by law) mandated compliance with federal regulation for Care planning, Coordination of services, and Quality of care to ensure quality patient care was provided to the patients.”

“Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This Condition is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure the Condition of Participation (conditions that health care organizations must meet in order to begin and continue participating in the Medicare and Medicaid programs) for Clinical Records was met as follows: 1. The HHA failed to ensure the patients’ clinical records contained completed comprehensive and ongoing assessments and plan of care for five of seventeen sampled patients (Patient 1, Patient 2, Patient 5, Patient 9, and Patient 13). (Refer to G1012). This failure resulted in an incomplete clinical records leading to misinformation and non-continuity of care and services to be provided to these patients certified to receive the home health benefits. 2. The HHA failed to ensure the clinical records included emergency contact information for one of seventeen sampled patients (Patient 13). (Refer to G1018). This failure had the potential to delay the HHA in facilitating rapid response and communication in case of unforeseen medical or other emergencies, ensuring timely notification and support for the patient and their family. 3. The HHA failed to ensure that the clinical records for one of seventeen sampled patients (Patient 12) were appropriately authenticated. (Refer to G1024). This failure resulted in the lack of accountability, which may affect effective communication within the home health staff and impair continuity of care for the patient. The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily (decided and controlled by law) mandated compliance with the federal regulations for Clinical Records to ensure the clinical records contained accurate and completed clinical information to all patients certified to receive the home health benefits.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, a healthcare organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure skilled nursing visits were done as ordered by the physician and in accordance with the plan of care for one of 17 sampled patients (Patient 3). This failure had the potential to result in the patient’s physical and psychosocial decline, and well-being due to interrupted provision of nursing services related to missed home health visits. During a review of Patient 3’s medical record, titled “Patient Information,” the “Patient Information” indicated Patient 3’s Start of Care (SOC) date of 2/5/2025 with a primary diagnosis of type 2 diabetes mellitus (chronic disorder characterized by difficulty in blood sugar control and poor wound healing). During a review of Patient 3’s medical record, titled “OASIS-E1 Start of Care,” dated 2/5/2025, it indicated the following: 1. Patient 3 was alert and oriented, had no impairment in cognition (mental action or process of acquiring knowledge and understanding). 2. Patient 3 had impaired functional mobility (ability to move safely and efficiently) and was at risk for falls. 3. Patient 3 had a surgical wound and a right biliary drain (tube inserted into the bile ducts to drain bile to relieve pressure or prevent complications due to bile blockage due to obstruction caused by gallstone, tumors, or inflammation) with a physician’s order for a biliary dressing change every 3 days or as needed for soiling/dislodgement. 4. Patient 3 had an order for Skilled Nursing (SN) visits frequency of twice a week for 2 weeks and once a week for 1 week effective 2/5/2025. 5. Patient 3/caregiver participated in the care planning and agreed with the care plan, frequencies, and discharge planning on 2/5/2025. 6. Patient 3’s physician was notified regarding the SOC assessment, plan of care, and discharge plan on 2/5/2025. 7. Registered Nurse 6 (RN 6) coordinated the assessment and plan of care with the team and scheduler on 2/5/2025. During a review of Patient 3’s medical record, titled “Home Health Certification and Plan of Care,” for Certification Period 2/5/2025 – 4/5/2025, it indicated the following: 1. Skilled Nurse (SN) frequency of visits – twice a week for 2 weeks and once a week for 1 week, effective 2/5/2025. 2. SN to monitor Patient 3’s vital signs (temperature, pulse, respirations, BP, blood sugar, oxygen saturation, pain) and notify the physician of values outside of the specified parameters. 3. SN to perform skilled nursing assessment at each visit and notify the physician for any changes in condition or significant findings. 4. SN to perform teachings regarding disease management, biliary drain management, diabetic management, medication management, oxygen management, re-hospitalization prevention, and COVID-19 prevention. During a review of Patient 3’s medical record, titled “RN – Skilled Nursing Visit,” dated 2/7/2025, it indicated the following: 1. Patient 3’s physician was notified regarding “holding of visit due to waiting for insurance.” 2. The plans for next visit included “medication education, disease process education, safety, and drain management.” 3. RN 6 “informed patient that RN will resume visit once insurance approve authorization.” RN 6 “provided 911 and emergency instructions to pt [patient].” During a concurrent interview and record review of Patient 3’s medical records on 3/21/2025 at 11:35 AM, with the DPCS, Patient 3 had 2 SN visits, dated 2/5/2025 and 2/7/2025 since the SOC on 2/5/2025. The DPCS stated Patient 3 had been authorized to receive two SN visits, so the SN visits were held until another authorization for succeeding visits were obtained. The DPCS stated SN resumed visits starting 3/11/2025. The DPCS stated the interruption of SN services could lead to surgical complications and rehospitalization. During a review of HHA’s policy and procedures (P&P), titled “Ongoing Assessments,” dated 11/2021, the P&P indicated the following: 1. The scope and intensity of ongoing assessments must be determined by the patient’s diagnoses, condition, desire for care, response to previous care, and the care setting. 2. During each home visit, the appropriate clinician must re-evaluate the patient according to the problems identified during the initial visit and thereafter. 3. Reassessments must focus on 1) patient’s response to care, 2) changes in patient condition, 3) changes in patient diagnoses, and 4) changes in patient’s care environment or support systems. 4. Based on the findings of the reassessment, change/verbal orders must be generated and forwarded to the physician as needed.”

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on observation and interview, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) staff failed to follow accepted standards of practice, including the use of standard precautions related to the disposal of contaminated waste, to prevent the transmission of infections and communicable diseases for one of seventeen sampled patients (Patient 6). This failure had the potential to expose the patient and/or caregiver to infections caused by bloodborne pathogens. During a review of Patient 6’s Patient Information indicated Patient 6 was admitted to the HHA on 2/24/2025, with diagnoses that included intraspinal abscess (a collection of pus within the spinal canal [a hollow space within the vertebral column, or spine, that runs from the base of the skull to the tip of the tailbone]) and granuloma (a localized collection of inflammatory cells that can form around an infection or foreign body). During a review of Patient 6’s Patient Medication Record for the certification period of 2/24/2025 to 4/24/2025, indicated that Patient 6 was currently on the following intravenous (IV, a medical technique that administers fluids, medications and nutrients directly into a person’s vein) medications: - Ceftriaxone Sodium (a medication used to treat infections caused by bacteria) injection 2 gram (a measurement unit). Infuse 2 gram into the vein in 20 ml (a measurement unit) sterile water over 5 minutes for every 8 hours for total of 6 weeks antibiotic course for spinal epidural abscess infection (via IV push). - Normal saline (a sterile solution of sodium chloride [salt] in water that has a number of uses in medicine, pushing any residual medication or fluid through the IV line and into the vein; this keeps the patient’s IV line clean and reduces the risk of infection or occlusion) flush IV 0.9% 10 ml. Flush 10 ml before and after IV administration and blood draw. During a joint home visit with Registered Nurse 3 (RN 3) on 3/20/2025 at 9:30 a.m., observed Patient 6 awake, alert, oriented, and ambulatory (walking) without assisted device. It was observed a peripherally inserted central catheter (PICC, a long, thin, flexible tube inserted into a vein in the upper arm and threaded to a large vein near the heart, used for long-term IV access, medication administration, and blood draws) on Patient 6’s left upper arm. During the home visit, observed RN 3 performed dressing change on Patient 6’s PICC insertion site. It was observed the existing PICC dressing was dated 3/14/2025. RN 3 removed the existing dressing using aseptic/clean technique (practices to prevent contamination and maintain a clean environment). After the existing dressing was removed, RN 3 applied the new dressing using sterile technique (the use of practices that restrict microorganisms in the environment and prevent contamination of the surgical field). RN 3 flushed the PICC with 10 ml of normal saline solution in a syringe after the new dressing was applied. After flushing the PICC, RN 3 put the empty syringe together with the old PICC dressing, used gloves that RN 3 was wearing to remove the old dressing, the wrapper of the new dressing, and other used supplies such as the topical antiseptic impregnated sponge applicator used to disinfect the skin prior to applying the new dressing. RN 3 was asked how she was going to dispose the empty syringe. RN 3 stated that she was going to dispose the empty syringe with the other used supplies in the patient’s trash can. RN 3 stated she could dispose the empty syringe in the trash can since it was the patient’s own home. RN 3 was asked if the home health policy required syringes to be disposed in a sharps container. RN 3 stated that since there was no needle and she was not starting a new IV line, it could be disposed in the trash can. RN 3 wrapped the used supplies and the empty syringe with the single use wrapping material to create a sterile barrier system that was part of the PICC dressing change kit. RN 3 then asked Patient 6 if he had a plastic bag where she could place the used supplies. RN 3 placed the used supplies inside the plastic bag and had Patient 6 dispose it. RN 3 asked Patient 6 if he had sharp disposal container (container designated for safe disposal of sharps) at home. Patient 6 stated there was one but was not presented during the visit. During a telephone interview with Patient 6 on 3/20/2025 at 1:44 p.m., Patient 6 stated there was sharps container at his home, which belonged to his wife. Patient 6 stated his wife was a diabetic and needed the sharps container to safely dispose the lancets. Patient 6 stated he was not provided a sharps container by the home health agency. During an interview with the Director of Patient Care Services (DPCS) on 3/20/2025 at 2:40 p.m., the DPCS stated that syringes that were used to flush IV lines or PICC were considered sharps, even when there were no needles attached to them; hence needed to be disposed as such. The DPCS stated used syringes needed to be disposed in a thick, puncture proof container, such as the sharps container. According to the DPCS, improper disposal of contaminated waste could lead to the spread of infection. During a review of the HHA’s policy and procedure, titled “Contaminated Waste Disposal,” revised November 2021, the policy and procedure indicated that sharps should be placed in a puncture-proof container and labeled as contaminated waste when ¾ full. Puncture-proof containers should be bagged, secured, and returned to the office for disposal.”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure all entries in the clinical record must be appropriately authenticated (include signature and title) and dated for one of seventeen sampled patients (Patient 12). This failure resulted in the lack of accountability, leading to misinformation within the home health staff and non-continuity of care and services provided to the patient. A review of Patient 12’s Personal Information indicated a Start of Care (SOC) date of 1/27/2025 with a primary diagnosis of Encounter for change or removal of surgical wound dressing and a secondary diagnosis of Infection/Inflammation reaction due to internal right knee prosthesis (surgical procedure that replaces damaged surfaces of the knee joint with artificial components made of metal and plastic). A review of Patient 12’s medical record titled Home Health Certification and Plan of Care (POC) for the certification period of 1/27/2025 to 3/27/2025, indicated an order for Skilled Nurse (SN) frequency for three times a week for four weeks, effective 1/27/2025, and at every visit SN to perform teachings regarding management of wound care, diagnosis, perform skilled nursing assessment, asses pain scale, check oxygen saturation level using pulse oximeter, and perform wound care as ordered using infection control measures and standard precautions (minimum infection prevention practice that applies to all patient care, regardless of suspected or confirmed infection status). During a review of Patient 12’s Electronic Medical Record (EMR), the EMR indicated Patient 12’s Skilled Nursing Visit notes/assessment dated 2/20/2025, 2/25/2025, 2/27/2025, 3/1/2025, 3/11/2025, 3/15/2025, and 3/18/2025 had a status of “pending clinician signature”. During a concurrent interview and record review on 3/21/2025 at 1:05pm with the Director of Patient Care Services (DPCS), Patient 12’s Skilled Nursing Visit notes/assessment were reviewed. Upon review of the Skilled nursing visit note/ assessment dated 2/20/2025 the DPCS stated and confirmed the document was not signed by the skilled nurse that filled it out. Upon review of the Skilled nursing visit note/ assessment dated 2/25/2025 the DPCS stated and confirmed the document was not signed by the skilled nurse that filled it out. Upon review of the Skilled nursing visit note/ assessment dated 2/27/2025 the DPCS stated and confirmed the document was not signed by the skilled nurse that filled it out. Upon review of the Skilled nursing visit note/ assessment dated 3/1/2025 the DPCS stated and confirmed the document was not signed by the skilled nurse that filled it out. Upon review of the Skilled nursing visit note/ assessment dated 3/11/2025 the DPCS stated and confirmed the document was not signed by the skilled nurse that filled it out. Upon review of the Skilled nursing visit note/ assessment dated 3/15/2025 the DPCS stated and confirmed the document was not signed by the skilled nurse that filled it out. When reviewing the Skilled nursing visit note/ assessment dated 3/18/2025 the DPCS stated and confirmed the document was not signed by the skilled nurse that filled it out. The DPCS further stated all the skilled nursing visit notes/assessments that were not signed by the perspective nurse not complete. The DPCS stated a document is complete when it is submitted within 48 to 72 hours of the visit date, filled out and signed and dated by the nurse. The DPCS stated it is important all clinical records are signed by the perspective staff member to indicate who did the documentation, which promotes good communication about the patients care and continuity of care. During a review of the HHA’s Policy and Procedure (P&P) titled “Assembly of Clinical Record,” with a revised date of November 2021, the P&P did not indicate that clinical records must be authenticated and dated. The policy and procedure indicated that clinical records will be assembled in chronological order, most recent first and all patient care documentation will be submitted by the staff within 72 hours from the time care was provided.”

“Written notice of patient’s rights CFR(s): 484.50(a)(1)(i) (i) Written notice of the patient’s rights and responsibilities under this rule, and the HHA’s transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; This Element is not met as evidenced by: Based on observation, interview and record review, the Home Health Agency (HHA) failed to ensure a written notice of patient’s rights and responsibilities was provided in a language preferred and understood by the patient for one of 17 sampled patients (Patient 2). This failure had resulted in the Patient 2’s lack of understanding of her rights and responsibilities as a patient of the home health agency that could affect the patient’s quality of life and wellbeing. During a review of Patient 2’s “History and Physical (H&P)” from General Acute Care Hospital 1 (GACH 1), dated 2/5/2025, the “H&P” indicated the Episode Referral with the following information regarding Patient 2: 1. Preferred language – Spanish 2. Interpreter needed? Yes 3. Primary Caregiver – Caregiver name not documented 4. Language Spoken: Spanish 5. Language Written: Spanish 6. Home Binder needed: Yes, Spanish During a review of Patient 2’s Medical Record form, titled “Patient Information,” the “Personal Information” indicated Patient 2’s Start of Care (SOC) date of 2/11/2025 with a primary diagnosis of nonsurgical wound dressing change or removal and a secondary diagnosis of type 2 diabetes mellitus (DM 2, chronic disorder characterized by difficulty in blood sugar control and poor wound healing) with foot ulcer. During a review of Patient 2’s “Admission Service Agreement,” in English language, signed by Patient 2, and dated 2/11/2025, the “Admission Service Agreement” indicated verbal and written information of the patients’ rights and responsibilities were provided to Patient 2. During a review of Patient 2’s Medical Record form, titled “OASIS-E1 Start of Care (OASIS – SOC),” dated 2/11/2025, the “OASIS-SOC” indicated Patient 2’s preferred language was Spanish and would need and want an interpreter to communicate with a doctor or health care staff. The “OASIS-SOC” indicated Patient 2 did not have any impairment in cognition (mental action or process of acquiring knowledge and understanding). During a joint home visit on 3/19/2025 at 11:37 AM, with Registered Nurse 1 (RN 1) at Patient 2’s residence, Patient 2 was observed awake, alert, oriented, and Spanish-speaking with no caregiver at the bedside. Patient 2’s HHA home binder, which enumerated the patient’s rights and responsibilities and was in English language, was observed at the bedside. RN 1 stated he provided Patient 1’s HHA home binder on the SOC date of 2/11/2025. During a concurrent interview and record review on 3/21/2025 at 2:35 PM, with the Director of Patient Care Services (DCPS), Patient 2’s medical records were reviewed. The DPCS stated there was no documented evidence that written notices specifying the patient’s rights and responsibilities were provided in Spanish and that translation services were utilized. The DPCS stated it was important to provide the written notices in Patient 2’s preferred language to ensure Patient 2’s full understanding of the information presented. During a review of the HHA’s policy and procedures (P&P), titled “Bill of Rights, dated 11/2023, the P&P indicated the following: 1. The purpose of the policy was to encourage awareness of patient rights and provide guidelines to assist patients in making decisions regarding care and for active participation in care planning. 2. The patient must be informed verbally and in writing during the initial evaluation visit and in advance of furnishing care, of their rights. 3. The patient has the right to have communication needs met. 4. The HHA must provide a verbal notice of the patient’s rights and responsibilities in the patient’s primary or preferred language and in a manner the patient understands, free of charge, with the use of a competent interpreter, if necessary, no later than the completion of the second (2nd) visit from a skilled professional (RN, PT, SLP, OT). During a review of the HHA’s policy and procedures (P&P 2), titled “Facilitating Communication,” dated 11/2021, P&P 2 indicated the following: 1. The purpose of the policy was to assure that patients, visitors, and personnel who have a limited command of the English language have access to the appropriate interpretive assistance and other aids at no cost to patient(s) being served. 2. The admitting clinician must provide each patient or his/her representative with a written copy of the Patient Rights and Responsibilities on admission. 3. The Patient Rights and Responsibilities statement must be explained (verbal) and distributed to the patient prior to the initiation of HHA services. This verbal explanation must be in a conversational language and tone and/or communication method he/she can reasonably be expected to understand. 4. The HHA personnel must consistently and clearly communicate with patients in a language or form they can reasonably understand. The HHA must facilitate communication by using special devices, interpreters, or other communication aides. 5. The patient or legal representative must be requested to sign the Patient Rights and Responsibilities form with the original form kept in the patient’s clinical record and a copy maintained by the patient. 6. The admitting clinician must document that the patient has received a copy of the Patient Rights and Responsibilities. If the patient was unable to understand his/her rights and responsibilities, documentation in the clinical notes must be made. If a communication barrier exists, special devices or interpreters must be made available, if possible. Written information must be provided to patients in English and predominant non-English languages of the population served.”

“Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to provide information regarding the care to be furnished, expected outcomes of care, including patient-identified goals, and anticipated risks, benefits and factors that could impact treatment effectiveness for seven of seventeen sampled patients (Patient 1, Patient 2, Patient 5, Patient 6, Patient 9, Patient 10 and Patient 13). This deficient practice resulted in patients did not have written copies and information of their care and treatment furnished as identified in their plans of care (POC, structured document outlining the specific interventions, goals, and expected outcomes for a patient’s healthcare, ensuring a coordinated and effective approach to meeting their needs.). g. During a review of Patient 13’s “Patient Information” indicated a start of care (SOC) date of 1/25/2025, current episode of 1/25/2025-3/25/2025, with a primary diagnosis of encounter for change or removal of non-surgical wound dressing (an acute or chronic wound which is not secondary to surgical intervention and a material applied to a wound to protect it, promote healing, and prevent infection, without requiring surgery). During a concurrent observation and interview on 3/19/2025, at 10:45 a.m., with the Registered Nurse (RN4), at Patient 13’s residence for a joint home visit, Patient 13 was comfortably sitting on his chair, alert, awake and oriented to his name, time, place and events. During review of Patient 13’s home health agency’s home folder, indicated there was no copy of POC. RN4 stated that they do not usually provide a copy of patient’s POC unless It was requested. RN4 confirmed that copy of POC was not provided to Patient 13 and stated the HHA was supposed to provide a copy of the POC to its patients. RN4 stated that this was his second visit with Patient 13 and he was new to the case. RN 4 stated that it was important to provide a copy of POC to the patient and/or the patient’s caregiver for their reference and to be aware of the care the HHA was providing. Patient 13 stated he was unsure if a copy of his POC was provided to him, and it would be helpful if he had a copy to better understand the care that he was receiving and for his reference if the nurses were not available to answer some of his questions regarding the care he was receiving. During an interview on 3/20/2025, at 11:40 a.m., with the Director of Patient Care Services (DPCS), the DPCS stated that the HHA does not provide an actual POC but in the HHA folder, there was a page for general instructions regarding POC. DPCS stated that the purpose of providing patient with a copy of the POC was to ensure the patient and his or her family or caregiver could review the POC and be familiar with it. The DPCS stated if the patient and/or family understood about their plan of care, they would be able to participate more. During a review of the HHA’s policy and procedure, titled “Bill of Rights,” revised date of November 2023, the policy and procedure indicated that each patient will be an active, informed participant in his/her plan of care, 2. The Patient Bill of Rights statement defines the right of the patient to: D. Be informed in advance about care to be furnished and of any changes in the care to be furnished. e. A review of Patient 9’s Personal Information indicated a Start of Care (SOC) date of 1/20/2025 with a primary diagnosis of Encounter for change or removal of nonsurgical wound dressing and a secondary diagnosis of unspecified open wound of left great toe without damage to nail. A review of Patient 9’s medical record titled Home Health Certification and Plan of Care (POC) for the certification period of 1/20/2025 to 3/20/2025, indicated an order for Skilled Nurse (SN) frequency for three times a week for four weeks, effective 1/20/2025, and at every visit SN to perform teaching of wound management, perform skilled nursing assessment and notify medical director (MD) for any changes in condition, assess pain scale and perform medication management. The POC also indicated an order to notify the physician if the patient’s fasting blood sugar is greater than 250 or less than 70 or random blood sugar is greater than 250 or less than 70. During a review of Patient 9’s medical record titled, Oasis Resumption of Care dated 3/16/2025, the Oasis Resumption of Care indicated an order for frequency of SN visits for two times a week for six times a week for one week, then seven times a week for three weeks starting 3/17/2025 for wound care, rehospitalization prevention, pain management, medication management, and fall and safety prevention measures. During a joint home visit on 3/19/2025 at 12:11 pm., with Registered Nurse 1 (RN1) at Patient 9’s home, Patient 9 was observed awake, alert, oriented to date of birth, date and location, wearing glasses and sitting upright on a chair. During a joint home visit on 3/19/2025 at 12:30 pm., with RN1 at Patient 9’s home, Patient 9’s Home Health Agency (HHA) booklet was reviewed. Patient 9’s HHA booklet did not indicate a copy of Patient 9’s Plan of Care (POC). RN1 stated and confirmed Patient 9’s HHA booklet did not have a copy of the patient’s POC, and the booklet only had a list of Patient 9’s medication. f. A review of Patient 10’s Personal Information indicated a Start of Care (SOC) date of 2/9/2025 with a primary diagnosis of moderate persistent asthma with acute exacerbation (a worsening condition in which the airways in the lungs narrow and swell and produce extra mucus making it difficult to breathe with frequent episodes) and a secondary diagnosis of hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney, end stage renal disease (a heart disease caused by long term high blood pressure causing kidney damage that effects its ability to filter waster and maintain fluid balance). A review of Patient 10’s medical record titled Home Health Certification and Plan of Care (POC) for the certification period of 2/9/2025 to 4/9/2025, indicated an order for Skilled Nurse (SN) frequency for two times a week for two weeks effective 2/9/2025, and at every visit SN to perform teachings regarding diagnosis, perform medication management, perform skilled nursing assessment and notify the physician for changes in condition, assess pain scale and check oxygen saturation level (O2 sat- a measurement of how much oxygen the blood is carrying as a percentage) using pulse oximeter (non-invasive medical device that measures blood oxygen saturation). During a review of Patient 10’s medical record titled, OASIS Resumption of Care dated 2/25/2025, the OASIS Resumption of Care indicated an order for frequency of SN visits for two times a week for one week, then one time a week for two weeks starting 2/25/2025 for education regarding disease management, medication management and safety. During a joint home visit on 3/19/2025 at 10:37 am., with the Skilled Nurse (SN) at Patient 10’s home, Patient 10 was observed lying in a hospital bed with head of the bed elevated, awake, alert, oriented to date of birth, date and location and wearing a nasal cannula (a small plastic tube, which fits into the person’s nostrils for providing supplemental oxygen) connected to an oxygen concentrator (medical device that takes in air from surrounding environment, filters out nitrogen (odorless unreactive gas) and delivers a concentrated, purified stream of oxygen) at 2 liters (unit of measurement) per minute. During a joint home visit on 3/19/2025 at 10:55 am., with the SN at Patient 10’s home, Patient 10’s HHA booklet was reviewed. Patient 10’s HHA booklet did not indicate to include a copy of Patient 10’s Plan of Care (POC). The SN stated and confirmed Patient 10’s HHA booklet did not include a copy of the patient’s POC, and the booklet only had a list of Patient 10’s medication. Patient 10 stated she did not have a copy of her POC from the HHA and stated she only had the discharge forms form the hospital before starting with home health services. During an interview on 3/20/2025 at 12:56 pm., with the Director of Patient Care Services (DPCS), the DPCS stated the HHA does not provide a copy of the POC to the patients. The DPCS also stated when the SN admits the patient, the patient and/or family are included when formulating the POC. During a review of the Home Health Agency’s (HHA) Policy and Procedure (P&P) titled, Care Planning Process, with a revised date of November 2021, indicated, “17. The organization shall provide the patient and caregiver with a copy of written instructions outlining: A. Visit schedule, including frequency of visits by personnel and personnel acting on behalf of the organization. B. Patient medication schedule/instructions, including medication name, dosage and frequency and which medications will be administered by the organization’s personnel and personnel acting on behalf of the organization. C. Any treatments to be administered by the organization’s personnel and personnel acting on behalf of the organization, including therapy services. D. Any other pertinent instruction related to the patient’s care and treatments that the organization will provide, specific to the patient’s care needs. E. Name and contact information of the organization’s clinical manager.” c. During a review of Patient 5’s Patient Information, the Patient Information indicated that Patient 5 was admitted to the HHA on 2/25/2025, with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (a type of bandage or covering used to protect and promote healing of wounds that does not require surgery). During a review of Patient 5’s Home Health Certification and Plan of Care, for the certification period of 2/25/2025 to 4/25/2025, the Home Health Certification and Plan of Care indicated Occupational Therapy (a form of therapy for those recuperating from physical or mental illness that encourages rehabilitation through the performance of activities required in daily life) visit twice a week for one week. The Home Health Certification and Plan of Care did not indicate the frequency for Skilled Nurse (SN, licensed nurse in general). During a joint home visit with Registered Nurse 3 (RN 3) on 3/19/2025 at 11:20 a.m., Patient 5’s home folder provided HHA was reviewed with RN 3. It was noted there was no copy of the plan of care (POC; a document outlining the services needed by the patient, health care professionals who provide these services, how often the patient needed the services, the medical equipment needed by patient, and what results the doctor expected) in the home health folder. The home folder included a patient calendar that indicated Patient 5 had a once-a-week SN visit. During an interview with RN 3 on 3/19/2025 at 12:30 p.m., stated, the HHA did not provide a copy of the plan of care to the patient. RN 3 stated the visit calendar and list of medications were included in the home folder, so patient would know when to expect the nurse. RN 3 stated that patient and their family did not have access to the electronic health record, so it would be good to provide patients with a copy of their plan of care. d. During a review of Patient 6’s Patient Information, the Patient Information indicated that Patient 6 was admitted to the HHA on 2/24/2025, with diagnoses that included intraspinal abscess (a collection of pus within the spinal canal [a hollow space within the vertebral column, or spine, that runs from the base of the skull to the tip of the tailbone]) and granuloma (a localized collection of inflammatory cells that can form around an infection or foreign body). During a review of Patient 6’s Home Health Certification and Plan of Care, for the certification period of 2/24/2025 to 4/24/2025, the Home Health Certification and Plan of Care indicated SN visit once a week for six weeks, beginning on 2/24/2025. The Home Health Certification and Plan of Care listed the treatment orders, interventions, and goals/expected outcomes for Patient 6. During a joint home visit with RN 3 on 3/20/2025 at 9:30 a.m., observed Patient 6 awake, alert, oriented, and ambulatory (walking) without assisted device. During the joint home visit, Patient 6’s home folder provided HHA was reviewed together by the surveyor and RN 3. It was noted there was no copy of the POC in the home health folder. During an interview with RN 3 on 3/20/2025 at 9:45 a.m., stated the HHA did not provide a copy of the plan of care to the patient. RN 3 stated the visit calendar and list of medications were included in the home folder. RN 3 stated that she thought it was important to provide patients with a copy of their plan of care, so that the patient and/or family could review it at home and participate in the care. During a review of the HHA’s policy and procedure, titled “Care Planning Process,” revised November 2021, the policy and procedure indicated that the organization should provide the patient and caregiver with a copy of written instructions outlining: - Visit schedule - Patient medication schedule/instructions - Any treatments to be administered by the organization’s personnel and personnel acting on behalf of the organization, including therapy services - Any other pertinent instruction related to the patient’s care and treatment - Name and contact information of the organization’s clinical manager a. During a review of Patient 1’s General Acute Care Hospital 1 (GACH 1’s) physician (MD) notes, dated 2/14/2025, the GACH 1 MD notes indicated Patient 1 had the following diagnoses: 1. Diabetes Mellitus Type 2 (DM 2, chronic disorder characterized by difficulty in blood sugar control and poor wound healing) with bilateral mild non-proliferative diabetic retinopathy (moderate damage to the blood vessels in the retina of both eyes as a complication of DM 2), chronic kidney disease Stage 3, and severe malnutrition (state of severe nutrient deficiency that significantly impairs health and well-being) 2. Anemia (condition wherein body does not have enough health red blood cells to carry adequate oxygen due to several factors, including nutrient deficiencies) 3. Sacral pressure sore (damaged skin and tissue in the sacral area due to sustained pressure), unspecified stage 4. Constipation (problem with passing stool) 5. Major depressive disorder (mood disorder that causes persistent feeing of sadness and loss of interest). During a review of Patient 1’s medical record, titled “Patient Information,” the “Patient Information” indicated Patient 1’s Start of Care (SOC) date of 3/5/2025 with a primary diagnosis of non-surgical wound dressing change or removal and a secondary diagnosis of Stage 2 sacral pressure sore. During a review of Patient 1’s medical record, titled “Home Health Certification and Plan of Care,” for Certification Period 3/5/2025 – 5/3/2025, it indicated the following SN interventions: 1. SN to perform wound care as ordered using infection control measures and standard precautions to sacral wound and left buttock wounds three times a week for 2 weeks. 2. SN to notify physician of: Fasting blood sugar greater than 250 or less than 70 and random blood sugar greater than 250 or less than 70. 3. For Re-hospitalization Prevention, SN to assess patient’s knowledge, ability, resources, and adherence to disease management. 4. For Medication Management, SN to educate patient/caregiver regarding current medication such as medication name, dose, frequency, and purpose of medications. During a review of Patient 1’s medical record, titled “OASIS-E1 Start of Care (OASIS – SOC),” dated 3/5/2025, the “OASIS-SOC” indicated Patient 1 did not have any impairment in cognition. It indicated the following: 1. No need for “diabetic supplies” was identified (no check on the box). 2. Patient 1 was not “independent with glucometer use.” 3. Patient 1’s caregiver was “independent with glucometer use.” 4. “Patient 1 is not regular in checking blood sugar.” During a concurrent interview and record review of Patient 1’s home medications while on a joint visit on 3/19/2025 at 9:55 AM with the Director of Patient Care Services (DPCS) at Patient 1’s residence, in the presence of Patient 1 and Patient 1’s family member (FM 1), Patient 1 was observed lying in bed, and was alert, oriented to name, place, date, and situation. The DPCS stated Registered Nurse 2 (RN 2) performed Patient 1’s wound care on 3/18/2025, but RN 2 ran out of wound care supplies (Medihoney and Mepilex). Patient 1 was observed with a Mepilex dressing on the Stage 2 sacral pressure sore. No wound dressing supplies were observed in Patient 1’s room. The DPCS stated Patient 1 had no dressing on the left buttock Stage 2 pressure sore because it was “healed.” In addition, Patient 1 also stated she was informed “last week” that she was diabetic and that “someone” (unable to identify) would come and check her blood sugar regularly, but “no one has checked [the blood sugar] since then.” The DPCS stated the SN did not check Patient 1’s blood sugar during home visits, because there was no physician’s order to perform blood sugar checks. The DPCS stated Patient 1 was not on any antidiabetic medication. Furthermore, during concurrent interview and record review of Patient 1’s home medications, Patient 1’s active medical record, titled “Patient Medication Record” for period 3/5/2025 – 5/3/2025 was compared with the medication bottles present in Patient 1’s home. The following medications were observed missing: 1. Sertraline hydrochloride (medication to treat depression) 50 milligrams (mg, unit of measurement of mass) 0.5 tablet by mouth daily 2. Acetaminophen (medication to treat pain or fever) 500 mg 1 tablet by mouth every 6 hours as needed for pain or fever. 3. Calcium Citrate-Vitamin D (supplement) 315-200 mg-unit 2 tablets by mouth twice a day 4. Multivitamin-minerals (supplement) 1 tablet by mouth daily 5. Lactulose (medication to treat constipation) 10 Grams/15 milliliters (ml, unit of measurement of volume) 30 ml by mouth twice a day as needed for constipation 6. Sennosides (medication to treat constipation) 8.6 mg 2 tablets by mouth daily as needed for constipation. During a concurrent observation with the DPCS, Patient 1 was observed lying in bed, and was alert, oriented to name, place, date, and situation. FM 1 stated he was not aware of any missing medications, because the HHA nurse did not review with them Patient 1’s home medications at every home visit. During a concurrent observation with the DPCS, the “Medication Profile” section in Patient 1’s HHA home binder was not accurate and up-to-date with the current medications on file. During a follow-up interview on 3/19/2025 at 11:15 AM, the DPCS stated SN must order wound care supplies in advance before they run out to ensure there was no interruption of wound care due to possible delayed wound healing and wound infection. The DPCS also stated the SN could act as a patient advocate and ask with the physician if he/she has any additional orders in relation to DM 2, since Patient 1 was diabetic and uncontrolled blood glucose could delay wound healing. The DPCS stated SN must check all medication bottles and compare with the Patient Medication Record and “Medication Profile” at each home visit to ensure the patient was taking the correct medication, dosage, frequency, and was compliant with the medication regimen. The DPCS stated although the SN would not be responsible for medication delivery to the patient’s home, the SN could verify with the patient or patient’s family who could pick up the patient’s medications from the pharmacy or could call the pharmacy and report the missing medications or medications on low supply to ensure timely delivery of medications to the patient’s home. The DPCS stated it was important to ensure patients take the medications as prescribed to avoid any decline in the patient’s condition due to the non-compliance with the medication regimen related to missing medications. During a telephone interview on 3/20/2025 at 3:23 PM, RN 2 stated Patient 1 could not check her own blood glucose levels. RN 2 stated he was not aware of her baseline blood glucose levels or any interventions to address Patient 1’s DM 2. RN 2 stated he should have reinforced diabetic teachings pertaining to the importance of adhering to a diabetic diet, keeping a log of blood glucose levels, involving the family, because uncontrolled blood glucose levels could lead to slower wound healing and hospitalization/s. RN 2 stated due to the workload and time constraints, RN 2 was not able to do the DM 2 interventions. RN 2 stated at times, there was not enough time to visit all his patients assigned for the week, which required him to conduct 10-13 patient home visits a day. In addition, RN 2 stated on several occasions, wound care supplies had to be ordered multiple times before they arrived at the patient’s home. RN 2 stated missing wound care supplies could lead to delayed wound healing. Furthermore, RN 2 stated he could not perform medication reconciliation at each home visit by checking the medication bottles against the Patient Medication Record and “Medication Profile” because FM 2 would usually “step out” and due also to the workload. During a concurrent interview and record review of Patient 1’s medical records on 3/21/2025 at 11:35 AM with the DPCS, the DPCS stated there was no documented evidence of blood sugar readings, communication with the physician and/or with GACH 1 RN liaisons regarding any need for Patient 1’s blood glucose monitoring, and Patient 1’s issues with wound care supplies. The DPCS stated there was no documented evidence of communication with the physician/s to clarify the continuation or discontinuation of all the medications in Patient 1’s Patient Medication Record. The DPCS stated Patient 1’s “Patient Medication Record” was not updated and stated it was important to keep the medication list accurate and updated to ensure no medication errors or prevent adverse effects of duplicate therapy, drug interactions, or noncompliance. b. During a review of Patient 2’s General Acute Care Hospital 1 (GACH 1) physician (MD) notes, dated 1/18/2025, the GACH 1 MD notes indicated Patient 2 has the following diagnoses: 1. DM 2 with bilateral moderate non-proliferative diabetic retinopathy 2. DM 2 with microalbuminuria (presence of albumin in the urine as an early sign of kidney damage related to DM 2) 3. DM 2 with peripheral neuropathy (complication of diabetes that damages the nerves in the hands, feet, legs, and arms) 4. Diabetic foot ulcer (open wound on the foot that develops in people with diabetes) 5. Severe bilateral open-angle glaucoma (increased pressure in the eyes due to eye fluid not draining properly, causing potential optic nerve damage that can lead to vision loss or blindness) 6. Hypertension (HTN or high blood pressure (BP), a condition where the force of blood against the artery walls is consistently too high) 7. Osteoarthritis (degenerative joint disease characterized by pain, stiffness, and reduced mobility) During a review of Patient 2’s Medical Record form, titled “Patient Information,” the “Patient Information” indicated Patient 2’s Start of Care (SOC) date of 2/11/2025 with a primary diagnosis of nonsurgical wound dressing change/removal and a secondary diagnosis of DM 2 with foot ulcer. During a review of Patient 2’s Medical Record form, titled “OASIS-E1 Start of Care (OASIS – SOC),” dated 2/11/2025, the “OASIS-SOC” indicated Patient 2’s preferred language is Spanish and would need and want an interpreter to communicate with a doctor or health care staff. The “OASIS-SOC” indicated: 1. Patient 2 did not have any impairment in cognition (mental action or process of acquiring knowledge and understanding). 2. Patient 2 has an additional order for skilled nursing (SN) visits twice a week for 1 week and thrice a week for 2 weeks effective 2/11/2025. 3. Physician must be notified if systolic BP (pressure in the arteries when the heart contracts and pumps blood throughout the body with normal values less than 120 millimeters of mercury [mmHg]) is greater than 160 and/or less than 95 mmHg. 4. Physician must be notified if diastolic BP (pressure in the arteries when the heart is resting between beats with normal values less than 80 mmHg) is greater than 100 and/or less than 50. 5. Patient 2 is at risk for polypharmacy and for falls. 6. Physician must be notified if fasting blood sugar is greater than 250 milligrams per deciliter (mg/dL) and less than 70 mg/dL. 7. Physician must be notified if random blood sugar is greater than 250 mg/dL and/or less than 70 mg/dL. 8. No need for “diabetic supplies” was identified (box was not checked). 9. Patient 2 and caregiver were not “independent of glucometer use.” During a review of Patient 2’s active medical record, titled “Patient Medication Record” as of 3/18/2025, the “Patient Medication Record” indicated some of Patient 2’s medications as ordered by the physician: 1. Timolol maleate ophthalmic (eye drops to treat glaucoma) 0.5% - ml – Instill 1 drop in both eyes every morning 2. Diclofenac sodium external 1% (topical gel used to relieve arthritis pain in the joints) - Apply 4 Grams to affected area/s twice a day as needed for pain. 3. Acetaminophen (medication to treat pain or fever) 500 mg 2 tablets by mouth every 6 hours as needed for pain or fever. 4. Gabapentin (medication that can treat nerve pain) 100 mg 1 capsule by mouth daily at bedtime. 5. Tramadol hydrochloride (controlled substance to treat moderate to severe pain) 50 mg 1 tablet by mouth twice a day as needed for severe pain. 6. Lisinopril (medication to treat HTN) 40 mg 1 tablet orally daily 7. Atenolol (medication to treat HTN) 25 mg 2 tablets orally twice a day 8. Patient 2 has no medications ordered for her DM 2 on file. During a joint home visit on 3/19/2025 at 11:37 AM with Registered Nurse 1 (RN 1) at Patient 2’s residence, Patient 2 was observed awake, alert, oriented, and Spanish-speaking with no caregiver at the bedside. Patient 2’s first BP reading on the right upper arm was 166/71 and BP reading on the left upper arm was 161/78. RN 1 asked Patient 2 if she took her morning medications and Patient 2 responded, “Yes.” During a concurrent review of Patient 2’s home medications with RN 1, Patient 2’s active medical record, titled “Patient Medication Record” for period 2/11/2025 – 4/11/2025 were compared with the medication bottles present in Patient 2’s home. The observations were as follows: 1. Timolol eye drops was missing. Patient 2 was unable to provide a clear response if Patient 2 was still administering the Timolol maleate eye drops. 2. Patient 2 stated she was not using diclofenac sodium gel for pain and was taking Tylenol (brand name of acetaminophen) 650 milligrams 2 tablets for arthritis pain. 3. Patient 2 stated her physician instructed her (Patient 2 was unable to recall the date) to discontinue all of her previously prescribed medications. 4. Patient 2 took out new medication bottles from a brown paper bag on her bed. All of the following new medications had a fill date of 3/11/2025 (date the prescription medication was refilled). Patient 2 stated her physician prescribed new medications (Patient 2 was unable to recall the date), including 1) Jardiance (antidiabetic medication) 25 mg ½ tablet by mouth once daily, 2) Lisinopril 20 mg 1 tablet by mouth twice daily, 3) Amlodipine (medication to treat HTN) 10 mg by mouth once daily, 4) Metoprolol tartrate (medication to treat HTN) 100 mg 1 tablet by mouth twice a day, and 5) Pradaxa (blood thinner to treat/prevent blood clots and reduce the risk of stroke) 110 mg 1 capsule by mouth twice a day. 5. Patient 2 stated she did not know her blood sugar level and she did not have a glucometer (medical device used to measure level of sugar in a person’s blood). When asked what Jardiance was prescribed for, Patient 2 was unable to state its indications. Patient 2 also stated she did not take her BP regularly as she did not have a BP monitor (medical device used to measure BP). 6. The “Medication Profile” section in Patient 2’s HHA home binder was not updated with Patient 2’s current medications. 7. The “Patient Blood Sugar Log/Diary” and “Patient’s Vital Signs Log/Diary” sections in Patient 2’s HHA home binder were not filled out by Patient 2 and/or Patient 2’s caregivers. During a follow-up interview on 3/19/2025 at 12:30 PM, RN 1 he was aware Patient 2 was diabetic, but Patient 2 stated upon admission to the HHA that Patient 2 was “borderline” diabetic. RN 1 stated he did not check Patient 2’s blood sugar because there was no physician’s order to check Patient 2’s blood sugar level/s. RN 1 stated Patient 2’s BP was higher than usual, so RN 1 he would report it to the physician. RN 1 stated he was not aware that Patient 2 had no glucometer and BP monitor. RN 1 stated the HHA would not be able to provide these medical devices to Patient 2, but RN 1 would be able to call the physician to order these devices for Patient 2 to ensure regular BP and blood sugar monitoring were done at home. During a telephone interview on 3/20/2025 at 10:16 AM, Patient 2’s family member (FM 2), who was physically present with Patient 2 at the time, stated Patient 2 did not have a glucometer and BP monitor for a long time, and Patient 2 could not recall the last time Patient 2 took her blood sugar level. FM 2 stated per Patient 2, the HHA nurses always took Patient 2’s BP but “never said anything” about Patient 2’s BP. FM 2 stated she accompanied Patient 2 to her primary physician’s visit about 2 weeks prior to the home visit on 3/19/2025 and obtained new medications, including an antidiabetic medication. FM 2 stated she accompanied Patient 2 to her cardiologist (physician specializing in the care of heart and blood vessels) appointment about a week prior to the home visit on 3/19/2025 and obtained new BP medications. FM 2 stated per Patient 2, “nobody checks” all of her medications with her (Patient 2). During an interview on 3/20/2025 at 1:07 PM, the DPCS stated the SN (in general) must ask that patient (in general) if he/she checked her blood sugar at each home visit. The DPCS stated if instructed by the physician to check blood sugar daily and the patient is not doing it, SN must notify the patient’s physician. The DPCS stated if the patient is diabetic, but the physician has no orders for blood sugar checks or any antidiabetic medications, the SN could act as a patient advocate and call the physician to ask for an order on how to monitor the blood glucose—whether it is Hemoglobin A1c (HbAC1, blood test that measures the average blood sugar level over the past 2-3 months) every 3 months, blood sugar checks every SN visit, or patient to check own blood sugar combined with SN teachings regarding the importance of regular blood sugar monitoring. In addition, the DPCS stated the SN must also check patient’s BP at every home visit and report to the physician any abnormal values (values outside of the parameters specified on the physician’s order) and provide teachings regarding the importance of regular BP monitoring. The DPCS stated the SN could inform the physician if the patient has no glucometer or BP monitor, so the orders could be placed on behalf of the patient. During a review of the HHA’s policy and procedures (P&P 1), titled “Bill of Rights,” dated 11/2023, P&P 1 indicated the following: 1. The purpose of the policy was to encourage awareness of patient rights and provide guidelines to assist patients in making decisions regarding care and for active participation in care planning. 2. Each patient must be empowered with the right to have communication needs met to ensure that the patient would be an active, informed participant in his/her plan of care. 3. The patient has the right to be informed in advance about care to be furnished and of any changes in the care to be furnished. 4. The patient has the right to be advised in advance of any change in the plan of care before the change is made. 5. The patient has the right to participate in planning the care or treatment and in planning changes in the care and treatment. During a review of the HHA’s policy and procedures (P&P 2), titled “Facilitating Communication,” dated 11/2021, P&P 2 indicated the following: 1. The purpose of the policy was to assure that patients, visitors, and personnel who have a limited command of the English language have access to the appropriate interpretive assistance and other aids at no cost to patient(s) being served. 2. Written materials must be made available in the recognized major languages in the area and state where the organization does business. 3. The HHA personnel must consistently and clearly communicate with patients in a language or form they can reasonably understand. The HHA must facilitate communication by using special devices, interpreters, or other communication aides.”

“Patient’s needs CFR(s): 484.55(c)(4) The patient’s medical, nursing, rehabilitative, social, and discharge planning needs; This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, healthcare organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure complete and accurate assessment of the medical and nursing needs of two of 17 sampled patients (Patient 1 & 2). These failures had the potential to cause patients’ decline of their physical and psychosocial condition related to delayed wound healing, incomplete or inaccurate medication profile, and/or inadequate monitoring of abnormal blood sugar and blood pressure (force of blood against artery walls). a. During a review of Patient 1’s General Acute Care Hospital 1 (GACH 1’s) physician (MD) notes, dated 2/14/2025, the GACH 1 MD notes indicated Patient 1 had the following diagnoses: 1. Diabetes Mellitus Type 2 (DM 2, chronic disorder characterized by difficulty in blood sugar control and poor wound healing) with bilateral mild non-proliferative diabetic retinopathy (moderate damage to the blood vessels in the retina of both eyes as a complication of DM 2), 2. DM 2 with chronic kidney disease Stage 3 3. DM 2 with severe malnutrition (state of severe nutrient deficiency that significantly impairs health and well-being) 4. Anemia (condition wherein body does not have enough health red blood cells to carry adequate oxygen due to several factors, including nutrient deficiencies) 5. Sacral pressure sore (damaged skin and tissue in the sacral area due to sustained pressure), unspecified stage 6. Constipation (problem with passing stool) 7. Major depressive disorder (mood disorder that causes persistent feeing of sadness and loss of interest) During a review of Patient 1’s medical record, titled “Patient Information,” the “Patient Information” indicated Patient 1’s Start of Care (SOC) date of 3/5/2025 with a primary diagnosis of non-surgical wound dressing change or removal and a secondary diagnosis of Stage 2 sacral pressure sore. During a review of Patient 1’s medical record, titled “Home Health Certification and Plan of Care,” for Certification Period 3/5/2025 – 5/3/2025, it indicated the following: 1. Skilled Nurse (SN) to perform wound care as ordered using infection control measures and standard precautions to sacral wound and left buttock wounds three times a week for 2 weeks by cleansing with normal saline (salt solution to clean wounds), then patting dry, applying Medihoney (honey-based wound treatment), and covering with Mepilex dressing (foam dressing designed to absorb wound drainage). 2. Patient 1’s wound care required supplies that included gloves, gauze pads, dressing supplies, normal saline, Medihoney, and Mepilex. During a concurrent interview and record review of Patient 1’s home medications during a joint visit on 3/19/2025 at 9:55 AM, with the Director of Patient Care Services (DPCS) at Patient 1’s residence, in the presence of Patient 1 and Patient 1’s family member (FM 1), Patient 1 was observed lying in bed, and was alert, oriented to name, place, date, and situation. The DPCS stated Registered Nurse 2 (RN 2) performed Patient 1’s wound care on 3/18/2025, but RN 2 ran out of wound care supplies (Medihoney and Mepilex). Patient 1 was observed with a Mepilex dressing on the Stage 2 sacral pressure sore. No wound dressing supplies were observed in Patient 1’s room. The DPCS stated Patient 1 had no dressing on the left buttock Stage 2 pressure sore because it was “healed.” Patient 1 also stated she was informed “last week” that she was diabetic and that “someone” (unable to identify) would come and check her blood sugar regularly, but “no one has checked [the blood sugar] since then.” The DPCS stated the SN did not check Patient 1’s blood sugar during home visits, because there was no physician’s order to perform blood sugar checks. The DPCS stated Patient 1 was not on any antidiabetic medication. Furthermore, during concurrent interview and record review of Patient 1’s home medications, Patient 1’s active medical record, titled “Patient Medication Record” for period 3/5/2025 – 5/3/2025 was compared with the medication bottles present in Patient 1’s home. The following medications were missing: 1. Sertraline hydrochloride (medication to treat depression) 50 milligrams (mg, unit of measurement of mass) 0.5 tablet by mouth daily 2. Acetaminophen (medication to treat pain or fever) 500 mg 1 tablet by mouth every 6 hours as needed for pain or fever. 3. Calcium Citrate-Vitamin D (supplement) 315-200 mg-unit 2 tablets by mouth twice a day 4. Multivitamin-minerals (supplement) 1 tablet by mouth daily 5. Lactulose (medication to treat constipation) 10 Grams/15 milliliters (ml, unit of measurement of volume) 30 ml by mouth twice a day as needed for constipation 6. Sennosides (medication to treat constipation) 8.6 mg 2 tablets by mouth daily as needed for constipation. Patient 1 was observed lying in bed, and was alert, oriented to name, place, date, and situation. FM 1 stated he was not aware of any missing medications, because the HHA nurse did not review with them Patient 1’s home medications every home visit. During a concurrent observation with the DPCS, the “Medication Profile” section in Patient 1’s HHA home binder was not accurate and up-to-date with the current medications on file. During a follow-up interview on 3/19/2025 at 11:15 AM, the DPCS stated SN must order wound care supplies in advance before they run out to ensure there was no interruption of wound care due to possible delayed wound healing and wound infection. The DPCS also stated the SN could act as a patient advocate and ask with the physician if he/she has any additional orders in relation to DM 2, since Patient 1 was diabetic and uncontrolled blood glucose could delay wound healing. The DPCS stated SN must check all medication bottles and compare with the Patient Medication Record and “Medication Profile” at each home visit to ensure the patient was taking the correct medication, dosage, frequency, and was compliant with the medication regimen. The DPCS stated although the SN would not be responsible for medication delivery to the patient’s home, the SN could verify with the patient or patient’s family who could pick up the patient’s medications from the pharmacy or could call the pharmacy and report the missing medications or medications on low supply to ensure timely delivery of medications to the patient’s home. The DPCS stated it was important to ensure patients take the medications as prescribed to avoid any decline in the patient’s condition due to the non-compliance with the medication regimen related to missing medications. During a telephone interview on 3/20/2025 at 3:23 PM, RN 2 stated Patient 1 could not check her own blood glucose levels. RN 2 stated he was not aware of her baseline blood glucose levels or any interventions to address Patient 1’s DM 2. RN 2 stated he should have reinforced diabetic teachings pertaining to the importance of adhering to a diabetic diet, keeping a log of blood glucose levels, involving the family, because uncontrolled blood glucose levels could lead to slower wound healing and hospitalization/s. RN 2 stated due to the workload and time constraints, RN 2 was not able to do the DM 2 interventions. RN 2 stated at times, there was not enough time to visit all his patients assigned for the week, which required him to conduct 10-13 patient home visits a day. In addition, RN 2 stated on several occasions, wound care supplies had to be ordered multiple times before they arrived at the patient’s home. RN 2 stated missing wound care supplies could lead to delayed wound healing. Furthermore, RN 2 stated he could not perform medication reconciliation at each home visit by checking the medication bottles against the Patient Medication Record and “Medication Profile” because FM 2 would usually “step out” and due also to the workload. During a concurrent interview and record review of Patient 1’s medical records on 3/21/2025 at 11:35 AM with the DPCS, the DPCS stated there was no documented evidence of blood sugar readings, communication with the physician and/or with GACH 1 RN liaisons regarding any need for Patient 1’s blood glucose monitoring, and Patient 1’s issues with wound care supplies. The DPCS stated there was no documented evidence of communication with the physician/s to clarify the continuation or discontinuation of all the medications in Patient 1’s Patient Medication Record. The DPCS stated Patient 1’s “Patient Medication Record” was not updated and stated it was important to keep the medication list accurate and updated to ensure no medication errors or prevent adverse effects of duplicate therapy, drug interactions, or noncompliance. b. During a review of Patient 2’s General Acute Care Hospital 1 (GACH 1) physician (MD) notes, dated 1/18/2025, the GACH 1 MD notes indicated Patient 2 has the following diagnoses: 1. DM 2 with bilateral moderate non-proliferative diabetic retinopathy 2. DM 2 with microalbuminuria (presence of albumin in the urine as an early sign of kidney damage related to DM 2) 3. DM 2 with peripheral neuropathy (complication of diabetes that damages the nerves in the hands, feet, legs, and arms) 4. Diabetic foot ulcer (open wound on the foot that develops in people with diabetes) 5. Severe bilateral open-angle glaucoma (increased pressure in the eyes due to eye fluid not draining properly, causing potential optic nerve damage that can lead to vision loss or blindness) 6. Hypertension (HTN or high blood pressure (BP), a condition where the force of blood against the artery walls is consistently too high) 7. Osteoarthritis (degenerative joint disease characterized by pain, stiffness, and reduced mobility) During a review of Patient 2’s Medical Record form, titled “Patient Information,” the “Patient Information” indicated Patient 2’s Start of Care (SOC) date of 2/11/2025 with a primary diagnosis of nonsurgical wound dressing change/removal and a secondary diagnosis of DM 2 with foot ulcer. During a review of Patient 2’s Medical Record form, titled “OASIS-E1 Start of Care (OASIS – SOC),” dated 2/11/2025, the “OASIS-SOC” indicated Patient 2’s preferred language is Spanish and would need and want an interpreter to communicate with a doctor or health care staff. The “OASIS-SOC” indicated: 1. Patient 2 did not have any impairment in cognition (mental action or process of acquiring knowledge and understanding). 2. Patient 2 has an additional order for skilled nursing (SN) visits twice a week for 1 week and thrice a week for 2 weeks effective 2/11/2025. 3. Physician must be notified if systolic BP (pressure in the arteries when the heart contracts and pumps blood throughout the body with normal values less than 120 millimeters of mercury [mmHg]) is greater than 160 and/or less than 95 mmHg. 4. Physician must be notified if diastolic BP (pressure in the arteries when the heart is resting between beats with normal values less than 80 mmHg) is greater than 100 and/or less than 50. 5. Patient 2 is at risk for polypharmacy and for falls. 6. Physician must be notified if fasting blood sugar is greater than 250 milligrams per deciliter (mg/dL) and less than 70 mg/dL. 7. Physician must be notified if random blood sugar is greater than 250 mg/dL and/or less than 70 mg/dL. 8. No need for “diabetic supplies” was identified (Box was not checked). 9. Patient 2 and caregiver were not “independent of glucometer use.” During a review of Patient 2’s active medical record, titled “Patient Medication Record” as of 3/18/2025, the “Patient Medication Record” indicated some of Patient 2’s medications as ordered by the physician: 1. Timolol maleate ophthalmic (eye drops to treat glaucoma) 0.5% - ml – Instill 1 drop in both eyes every morning 2. Diclofenac sodium external 1% (topical gel used to relieve arthritis pain in the joints) - Apply 4 Grams to affected area/s twice a day as needed for pain. 3. Acetaminophen (medication to treat pain or fever) 500 mg 2 tablets by mouth every 6 hours as needed for pain or fever. 4. Gabapentin (medication that can treat nerve pain) 100 mg 1 capsule by mouth daily at bedtime. 5. Tramadol hydrochloride (controlled substance to treat moderate to severe pain) 50 mg 1 tablet by mouth twice a day as needed for severe pain. 6. Lisinopril (medication to treat HTN) 40 mg 1 tablet orally daily 7. Atenolol (medication to treat HTN) 25 mg 2 tablets orally twice a day 8. Patient 2 has no medications ordered for her DM 2 on file. During a joint home visit on 3/19/2025 at 11:37 AM, with Registered Nurse 1 (RN 1) at Patient 2’s residence, Patient 2 was observed awake, alert, oriented, and Spanish-speaking with no caregiver at the bedside. Patient 2’s first BP reading on the right upper arm was 166/71 and BP reading on the left upper arm was 161/78. RN 1 asked Patient 2 if she took her morning medications and Patient 2 responded, “Yes.” During a concurrent review of Patient 2’s home medications with RN 1, Patient 2’s active medical record, titled “Patient Medication Record” for period 2/11/2025 – 4/11/2025 were compared with the medication bottles present in Patient 2’s home. The observations were as follows: 1. Timolol eye drops was missing. Patient 2 was unable to provide a clear response if Patient 2 was still administering the Timolol maleate eye drops. 2. Patient 2 stated she was not using diclofenac sodium gel for pain and was taking Tylenol (brand name of acetaminophen) 650 milligrams 2 tablets for arthritis pain. 3. Patient 2 stated her physician instructed her (Patient 2 was unable to recall the date) to discontinue all of her previously prescribed medications. 4. Patient 2 took out new medication bottles from a brown paper bag on her bed. All of the following new medications had a fill date of 3/11/2025 (date the prescription medication was refilled). Patient 2 stated her physician prescribed new medications (Patient 2 was unable to recall the date), including 1) Jardiance (antidiabetic medication) 25 mg ½ tablet by mouth once daily, 2) Lisinopril 20 mg 1 tablet by mouth twice daily, 3) Amlodipine (medication to treat HTN) 10 mg by mouth once daily, 4) Metoprolol tartrate (medication to treat HTN) 100 mg 1 tablet by mouth twice a day, and 5) Pradaxa (blood thinner to treat/prevent blood clots and reduce the risk of stroke) 110 mg 1 capsule by mouth twice a day. 5. Patient 2 stated she did not know her blood sugar level and she did not have a glucometer (medical device used to measure level of sugar in a person’s blood). When asked what Jardiance was prescribed for, Patient 2 was unable to state its indications. Patient 2 also stated she did not take her BP regularly as she did not have a BP monitor (medical device used to measure BP). 6. The “Medication Profile” section in Patient 2’s HHA home binder was not updated with Patient 2’s current medications. 7. The “Patient Blood Sugar Log/Diary” and “Patient’s Vital Signs Log/Diary” sections in Patient 2’s HHA home binder were not filled out by Patient 2 and/or Patient 2’s caregivers. During a follow-up interview on 3/19/2025 at 12:30 PM, RN 1 he was aware Patient 2 was diabetic, but Patient 2 stated upon admission to the HHA that Patient 2 was “borderline” diabetic. RN 1 stated he did not check Patient 2’s blood sugar because there was no physician’s order to check Patient 2’s blood sugar level/s. RN 1 stated Patient 2’s BP was higher than usual, so RN 1 he would report it to the physician. RN 1 stated he was not aware that Patient 2 had no glucometer and BP monitor. RN 1 stated the HHA would not be able to provide these medical devices to Patient 2, but RN 1 would be able to call the physician to order these devices for Patient 2 to ensure regular BP and blood sugar monitoring were done at home. During a telephone interview on 3/20/2025 at 10:16 AM, Patient 2’s family member (FM 2), who was physically present with Patient 2 at the time, stated Patient 2 did not have a glucometer and BP monitor for a long time, and Patient 2 could not recall the last time Patient 2 took her blood sugar level. FM 2 stated per Patient 2, the HHA nurses always took Patient 2’s BP but “never said anything” about Patient 2’s BP. FM 2 stated she accompanied Patient 2 to her primary physician’s visit about 2 weeks prior to the home visit on 3/19/2025 and obtained new medications, including an antidiabetic medication. FM 2 stated she accompanied Patient 2 to her cardiologist (physician specializing in the care of heart and blood vessels) appointment about a week prior to the home visit on 3/19/2025 and obtained new BP medications. FM 2 stated per Patient 2, “nobody checks” all of her medications with her (Patient 2). During an interview on 3/20/2025 at 1:07 PM, the DPCS stated the SN (in general) must ask that patient (in general) if he/she checked her blood sugar at each home visit. The DPCS stated if instructed by the physician to check blood sugar daily and the patient is not doing it, SN must notify the patient’s physician. The DPCS stated if the patient is diabetic, but the physician has no orders for blood sugar checks or any antidiabetic medications, the SN could act as a patient advocate and call the physician to ask for an order on how to monitor the blood glucose—whether it is Hemoglobin A1c (HbAC1, blood test that measures the average blood sugar level over the past 2-3 months) every 3 months, blood sugar checks every SN visit, or patient to check own blood sugar combined with SN teachings regarding the importance of regular blood sugar monitoring. In addition, the DPCS stated the SN must also check patient’s BP at every home visit and report to the physician any abnormal values (values outside of the parameters specified on the physician’s order) and provide teachings regarding the importance of regular BP monitoring. The DPCS stated the SN could inform the physician if the patient has no glucometer or BP monitor, so the orders could be placed on behalf of the patient. During a concurrent interview and record review of Patient 2’s medical records on 3/21/2025 at 11:35 AM with the DPCS, the DPCS stated there was no documented evidence of blood sugar readings, communication with the physician and/or with GACH 1 RN liaisons regarding clarification of Patient 2’s diet, any need for Patient 2’s blood glucose monitoring, and Patient 2 not having a glucometer or blood pressure machine. The DPCS stated there was no documented evidence of communication with the physician to clarify the continuation or discontinuation of all the medications in Patient 2’s Patient Medication Record. The DPCS stated Patient 2’s “Patient Medication Record” was not updated and stated it was important to keep the medication list accurate and updated to ensure no medication errors or prevent adverse effects of duplicate therapy, drug interactions, or noncompliance. During a review of the HHA’s policy and procedures (P&P 1), titled “Initial and Comprehensive Assessment,” dated 11/2021, P&P 1 indicated the following: 1. The comprehensive assessment must be patient-specific to determine the patient problems/needs/strengths and must include the patient’s need for home care, rehabilitative care, social, and discharge planning needs. 2. All baseline data must be used in measuring the patient’s progress towards goals identified by the patient and achievement of desired measurable outcomes identified by the organization. Other relevant information must be documented in the patient’s clinical record, including the following: a. A physical assessment, including blood pressure, pulse, temperature, respirations, skin, pain status, nutritional status, and other relevant data related to pertinent physical findings. b. Patient’s functional status, including but not limited to, the degree of self-care, and the amount and level of assistance needed. c. Patient’s medical and psychosocial history, including pertinent diagnosis and prognosis d. Patient’s and family’s/caregiver’s educational needs, abilities, motivation, and readiness to learn e. Equipment presently in the home and potentially needed by the patient. f. Specific, individualized patient needs and problems pertinent to the care being provided. 3. A plan of care must be developed and authorized by the physician utilizing information gathering during the initial and comprehensive assessment. The patient’s physician is consulted for approval if additions or modifications to the plan of care are required after the assessment is completed.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to review and document all the patients’ current medications/treatments to identify any potential adverse effects and drug reactions for five of seventeen sampled patients (Patient 1, Patient 2, Patient 5, Patient 10, and Patient 13). This deficient practice had the potential to place the patients at risk for medication errors and serious adverse effects. e. During a review of Patient 13’s “Patient Information” indicated a start of care (SOC) date of 1/25/2025, current episode of 1/25/2025-3/25/2025, with a primary diagnosis of encounter for change or removal of non-surgical wound dressing (an acute or chronic wound which is not secondary to surgical intervention and a material applied to a wound to protect it, promote healing, and prevent infection, without requiring surgery). During a concurrent observation and interview on 3/19/2025, at 10:45 a.m., with the Registered Nurse (RN4), at Patient 13’s residence for a joint home visit, Patient 13 was comfortably sitting on his chair, alert, awake and oriented to his name, time, place and events. During a reconciliation review of Patient 13’s medications with RN4, the following medications were expired: -Tamsulosin Oral (by mouth) 0.4 milligrams (mg, unit of weight) capsule, take 1 (one) capsule by mouth daily 30 minutes after a meal for proper urination (the discharge of urine from the body), with expiration date of 9/18/2024. -Potassium Chloride Oral 10 meq (milliequivalent, unit of weight), take 2 tablets by mouth daily with a meal to prevent hypokalemia (low potassium level in blood), with expiration date of 10/31/2023. During interview with RN 4, RN 4 stated that he does check the medications frequently each visit. RN 4 stated that this was his second visit with Patient 13 and he does not know why the expired medications were missed. During interview with Patient 13 stated he has a good amount of supply of all his medications and are not expired including the Tamsulosin and Potassium Chloride. During further review Patient 13 had Tamsulosin and Potassium Chloride medications with unexpired dates. During an interview on 3/21/2025, at 11:34 a.m., with the Director of Patient Care Services (DPCS), the DPCS stated that nurses should conduct medication reconciliation on each visit and if patients have new medications, nurses should coordinate with the agency or with the physician so it could also be updated to the current medication list and to avoid unnecessary discontinued medications and confusion among the healthcare team and patient. c. During a review of Patient 5’s Patient Information, the Patient Information indicated that Patient 5 was admitted to the HHA on 2/25/2025, with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (a type of bandage or covering used to protect and promote healing of wounds that does not require surgery). During a review of Patient 5’s Patient Medication Record for the certification period of 2/25/2025 to 4/25/2025, the Patient Medication Record indicated that on 2/25/2025, the HHA’s physician ordered the following medications for Patient 5: - Oncovite (a multivitamin supplement) oral tablet, take one tablet daily as supplement. - Docusate Sodium (a stool softener) 100 mg (a measurement unit) capsule, take 1 capsule by mouth twice a day for constipation. - Ventolin HFA inhalation (an inhaler used to treat and prevent bronchospasm (a sudden narrowing of the airways/bronchi in the lungs, caused by the contraction of the muscles lining the airways) 108 mcg/act, inhale 2 puffs by mouth every four hours as needed for shortness of breath. - Hydrocortisone (a corticosteroid used to relieve redness, itching, swelling, and discomfort caused by various skin conditions) external 2.5%, apply to anus two times daily for hemorrhoid (swollen veins in the anus (the opening at the end of the digestive tract through which stool [feces] is expelled from the body) and lower rectum [the final section of the large intestine, a muscular tube that connects the colon to the anus, where feces are temporarily stored before being eliminated from the body] that can cause discomfort, itching, and bleeding). During a joint home visit with Registered Nurse 3 (RN 3) on 3/19/2025 at 11:20 a.m., observed Patient 5 alert and oriented. Patient 5 was able to ambulate (walk) without assistive device, even though she had a walker and a cane in her residence. During the home visit, at 12:10 p.m., a medication review was performed with RN 3. Oncovite, Docusate Sodium, Ventolin, and Hydrocortisone were not available at Patient 5’s residence. During an interview with Patient 5 on 3/19/2025, at 12:30 p.m., Patient 5 stated she did not remember the last time she took Oncovite or used Hydrocortisone. Patient 5 stated she could not remember if she used up Oncovite or Hydrocortisone. Patient 5 stated she never had Ventolin inhaler; she denied having any shortness of breath. Per Patient 5, she no longer took Docusate Sodium because she had been having daily bowel movements. During an interview with RN 3 on 3/19/2025, at 12:40 p.m., RN 3 stated that the medications listed in the Patient Medication Record came from the hospital medication list for the patient. RN 3 stated she usually asked the patient if there had been changes in the medications. RN 3 stated she should have physically compared the medication list with the actual medications at the patient’s house on each visit in order to reconcile the medication list. Per RN 3, updated medication record was important so that nurses could monitor the side effects and provide appropriate teaching. During an interview with the Director of Patient Care Services (DPCS) on 3/20/2025, the DPCS stated that upon admission, the RN was supposed to reconcile the post-discharge medication list from the hospital with the medications that the patient had at home. Per DPCS, some of the medications in the list from the hospital might have been given when patient was hospitalized only. The DPCS stated having an accurate and updated medication list was very important so the physician and/or nurse could ensure there were no drug interactions or adverse effects. During a review of the HHA’s policy and procedure, titled “Medication Profile,” revised November 2021, the policy and procedure indicated that: - Patient receiving medications administered by the organization will have a current, accurate medication profile in the clinical record. - Medication profile will be updated for each change to reflect current medications, new, and/or discontinued medications. d. A review of Patient 10’s Personal Information indicated a Start of Care (SOC) date of 2/9/2025 with a primary diagnosis of moderate persistent asthma with acute exacerbation (a worsening condition in which the airways in the lungs narrow and swell and produce extra mucus making it difficult to breathe with frequent episodes) and a secondary diagnosis of hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney, end stage renal disease (a heart disease caused by long term high blood pressure causing kidney damage that effects its ability to filter waster and maintain fluid balance). A review of Patient 10’s medical record titled Home Health Certification and Plan of Care (POC) for the certification period of 2/9/2025 to 4/9/2025, indicated an order for Skilled Nurse (SN) frequency for two times a week for two weeks effective 2/9/2025, and at every visit SN to perform teachings regarding diagnosis, perform medication management, perform skilled nursing assessment and notify the physician for changes in condition, assess pain scale and check oxygen saturation level (O2 sat- a measurement of how much oxygen the blood is carrying as a percentage) using pulse oximeter (non-invasive medical device that measures blood oxygen saturation). During a review of Patient 10’s medical record titled, OASIS Resumption of Care dated 2/25/2025, the OASIS Resumption of Care indicated an order for frequency of SN visits for two times a week for one week, then one time a week for two weeks starting 2/25/2025 for education regarding disease management, medication management and safety. During a joint home visit on 3/19/2025 at 10:37 am, with Registered Nurse 2 (RN2) at Patient 10’s home, Patient 10 was observed lying in a hospital bed with head of the bed elevated, awake, alert, oriented to date of birth, date and location and wearing a nasal cannula (a small plastic tube, which fits into the person’s nostrils for providing supplemental oxygen) connected to an oxygen concentrator (medical device that takes in air from surrounding environment, filters out nitrogen (odorless unreactive gas) and delivers a concentrated, purified stream of oxygen) at 2 liters (unit of measurement) per minute. During a review of Patient 10’s medication record for the certification period of 2/9/2025 to 4/9/2025, it indicated a medication order of Norco (narcotic pain medication) oral 5-325 milligrams (mg- unit of measurement) take 1 tablet by mouth daily as needed for severe pain. During a joint home visit on 3/19/2025 at 11 am, with RN2 at Patient 10’s home, Patient 10’s medications were reviewed. During the review of Patient 10’s medication bottles with Patient 10’s medication record with RN2, it was noted that Patient 10 did not have the medication bottle for Norco 5-325 mg. RN2 stated and confirmed Patient 10’s medication Norco 5-325 mg was not present in patient’s home. RN2 stated he is not Patient 10’s regular visiting nurse and was not aware as to why the medication Norco 5-325 mg was not present. RN2 also stated and confirmed that Patient 10’s medication record was not updated to reflect the patient’s active and current medications. Patient 10’s Family Member 4 (FM4) also stated and confirmed Patient 10 does not have the medication Norco 5-325 mg and never got it since being discharged from the hospital because the medication is too strong for the patient. Patient 10’s FM4 stated patient tolerates Tylenol better and has not needed any other medication to control her pain since coming home from the hospital on 2/24/2025. During an interview on 3/20/2025 at 12:38 pm, with the Director of Patient Care Services (DPCS), the DPCS stated at every home visit the Skilled Nurses (SN) should do a medication reconciliation (process of comparing a patient’s medication orders to all of the medications the patient is taking), that includes checking the medication bottles with the medication record, asking the patient how they are taking the medication to verify if they are following the directions, and asking the patient if they are taking any new medication to update on the medication record and verify with the physician that all of the patients medications do not counteract with each other. The DPCS stated at any time a patient has changes in medication then the SN will verify with the patient’s physician about those changes, then medication record is to be updated, and the patient is provided with a new list that reflects those changes. The DPCS further stated it is important that the SN’s do a medication reconciliation at every visit to make sure the patients are taking the medication the right route, the right dose, that the medication is not expired, to be aware of any new or stopped medications and to provide the patients with education as needed. During a review of the HHA’s Policy and Procedure (P&P) titled, Medication Profile, with a revised date of November 2021, indicated, “Patient receiving medications administered by the organization will have a current, accurate medication profile in the clinical record… 2. A drug regimen review will be performed at the time of admission, when updates to the comprehensive assessments are performed, when care is resumed after a patient has been placed on hold, and with the addition of a new medication. The review will identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicative drug therapy, and noncompliance with drug therapy.” a. During a review of Patient 1’s General Acute Care Hospital 1 (GACH 1’s) physician (MD) notes, dated 2/14/2025, the GACH 1 MD notes indicated Patient 1 had the following diagnoses: 1. Diabetes Mellitus Type 2 (DM 2, chronic disorder characterized by difficulty in blood sugar control and poor wound healing) with bilateral mild non-proliferative diabetic retinopathy (moderate damage to the blood vessels in the retina of both eyes as a complication of DM 2), chronic kidney disease Stage 3, and severe malnutrition (state of severe nutrient deficiency that significantly impairs health and well-being) 2. Anemia (condition wherein body does not have enough health red blood cells to carry adequate oxygen due to several factors, including nutrient deficiencies) 3. Sacral pressure sore (damaged skin and tissue in the sacral area due to sustained pressure), unspecified stage 4. Constipation (problem with passing stool) 5. Major depressive disorder (mood disorder that causes persistent feeing of sadness and loss of interest) During a review of Patient 1’s medical record, titled “Patient Information,” the “Patient Information” indicated Patient 1’s Start of Care (SOC) date of 3/5/2025 with a primary diagnosis of non-surgical wound dressing change or removal and a secondary diagnosis of Stage 2 sacral pressure sore. During a concurrent interview and record review of Patient 1’s home medications while on a joint visit on 3/19/2025 at 9:55 AM with the Director of Patient Care Services (DPCS) in the presence of Patient 1 and Patient 1’s family member (FM 1), Patient 1’s active medical record, titled “Patient Medication Record” for period 3/5/2025 – 5/3/2025 was compared with the medication bottles present in Patient 1’s home. The following medications were observed missing: 1. Sertraline hydrochloride (medication to treat depression) 50 milligrams (mg, unit of measurement of mass) 0.5 tablet by mouth daily 2. Acetaminophen (medication to treat pain or fever) 500 mg 1 tablet by mouth every 6 hours as needed for pain or fever. 3. Calcium Citrate-Vitamin D (supplement) 315-200 mg-unit 2 tablets by mouth twice a day 4. Multivitamin-minerals (supplement) 1 tablet by mouth daily 5. Lactulose (medication to treat constipation) 10 Grams/15 milliliters (ml, unit of measurement of volume) 30 ml by mouth twice a day as needed for constipation 6. Sennosides (medication to treat constipation) 8.6 mg 2 tablets by mouth daily as needed for constipation. During a concurrent observation, Patient 1 was observed lying in bed, and was alert, oriented to name, place, date, and situation. FM 1 stated he was not aware of any missing medications, because the HHA nurse did not review with them Patient 1’s home medications at every home visit. During a concurrent observation with the DPCS, the “Medication Profile” section in Patient 1’s HHA home binder was not accurate and up to date with the current medications on file. During a follow-up interview on 3/19/2025 at 11:15 AM, the DPCS stated SN must check all medication bottles and compare with the Patient Medication Record and “Medication Profile” at each home visit to ensure the patient was taking the correct medication, dosage, frequency, and was compliant with the medication regimen. The DPCS stated although the SN would not be responsible for medication delivery to the patient’s home, the SN could verify with the patient or patient’s family who could pick up the patient’s medications from the pharmacy or could call the pharmacy and report the missing medications or medications on low supply to ensure timely delivery of medications to the patient’s home. The DPCS stated it was important to ensure patients take the medications as prescribed to avoid any decline in the patient’s condition due to the non-compliance with the medication regimen related to missing medications. During a telephone interview on 3/20/2025 at 3:23 PM, RN 2 stated he did not perform medication reconciliation at each home visit by checking the medication bottles against the Patient Medication Record because FM 2 would usually “step out” and due to the workload. RN 2 stated at times, there was not enough time to visit all his patients assigned for the week, which required him to conduct 10-13 patient home visits in a day. b. During a review of Patient 2’s General Acute Care Hospital 1 (GACH 1) physician (MD) notes, dated 1/18/2025, the GACH 1 MD notes indicated Patient 2 has the following diagnoses: 1. DM 2 with bilateral moderate non-proliferative diabetic retinopathy 2. DM 2 with microalbuminuria (presence of albumin in the urine as an early sign of kidney damage related to DM 2) 3. DM 2 with peripheral neuropathy (complication of diabetes that damages the nerves in the hands, feet, legs, and arms) 4. Diabetic foot ulcer (open wound on the foot that develops in people with diabetes) 5. Severe bilateral open-angle glaucoma (increased pressure in the eyes due to eye fluid not draining properly, causing potential optic nerve damage that can lead to vision loss or blindness) 6. Hypertension (HTN or high blood pressure (BP), a condition where the force of blood against the artery walls is consistently too high) 7. Osteoarthritis (degenerative joint disease characterized by pain, stiffness, and reduced mobility) During a review of Patient 2’s Medical Record form, titled “Patient Information,” the “Patient Information” indicated Patient 2’s Start of Care (SOC) date of 2/11/2025 with a primary diagnosis of nonsurgical wound dressing change/removal and a secondary diagnosis of DM 2 with foot ulcer. During a review of Patient 2’s Medical Record form, titled “OASIS-E1 Start of Care (OASIS – SOC),” dated 2/11/2025, the “OASIS-SOC” indicated Patient 2’s preferred language is Spanish and would need and want an interpreter to communicate with a doctor or health care staff. The “OASIS-SOC” indicated: 1. Patient 2 did not have any impairment in cognition (mental action or process of acquiring knowledge and understanding). 2. Patient 2 has an additional order for skilled nursing (SN) visits twice a week for 1 week and thrice a week for 2 weeks effective 2/11/2025. 3. Physician must be notified if systolic BP (pressure in the arteries when the heart contracts and pumps blood throughout the body with normal values less than 120 millimeters of mercury [mmHg]) is greater than 160 and/or less than 95 mmHg. 4. Physician must be notified if diastolic BP (pressure in the arteries when the heart is resting between beats with normal values less than 80 mmHg) is greater than 100 and/or less than 50. 5. Patient 2 is at risk for polypharmacy and for falls. During a review of Patient 2’s active medical record, titled “Patient Medication Record” as of 3/18/2025, the “Patient Medication Record” indicated some of Patient 2’s medications as ordered by the physician: 1. Timolol maleate ophthalmic (eye drops to treat glaucoma) 0.5% - ml – Instill 1 drop in both eyes every morning 2. Diclofenac sodium external 1% (topical gel used to relieve arthritis pain in the joints) - Apply 4 Grams to affected area/s twice a day as needed for pain. 3. Acetaminophen (medication to treat pain or fever) 500 mg 2 tablets by mouth every 6 hours as needed for pain or fever. 4. Gabapentin (medication that can treat nerve pain) 100 mg 1 capsule by mouth daily at bedtime. 5. Tramadol hydrochloride (controlled substance to treat moderate to severe pain) 50 mg 1 tablet by mouth twice a day as needed for severe pain. 6. Lisinopril (medication to treat HTN) 40 mg 1 tablet orally daily 7. Atenolol (medication to treat HTN) 25 mg 2 tablets orally twice a day 8. Patient 2 has no medications ordered for her DM 2 on file. During a joint home visit on 3/19/2025 at 11:37 AM, with Registered Nurse 1 (RN 1) at Patient 2’s residence, Patient 2 was observed awake, alert, oriented, and Spanish-speaking with no caregiver at the bedside. Patient 2’s first BP reading on the right upper arm was 166/71 and BP reading on the left upper arm was 161/78. RN 1 asked Patient 2 if she took her morning medications and Patient 2 responded, “Yes.” During a concurrent review of Patient 2’s home medications with RN 1, Patient 2’s active medical record, titled “Patient Medication Record” for period 2/11/2025 – 4/11/2025 were compared with the medication bottles present in Patient 2’s home. The observations were as follows: 1. Timolol eye drops was missing. Patient 2 was unable to provide a clear response if Patient 2 was still administering the Timolol maleate eye drops. 2. Patient 2 stated she was not using diclofenac sodium gel for pain and was taking Tylenol (brand name of acetaminophen) 650 milligrams 2 tablets for arthritis pain. 3. Patient 2 stated her physician instructed her (Patient 2 was unable to recall the date) to discontinue all of her previously prescribed medications. 4. Patient 2 took out new medication bottles from a brown paper bag on her bed. All of the following new medications had a fill date of 3/11/2025 (date the prescription medication was refilled). Patient 2 stated her physician prescribed new medications (Patient 2 was unable to recall the date), including 1) Jardiance (antidiabetic medication) 25 mg ½ tablet by mouth once daily, 2) Lisinopril 20 mg 1 tablet by mouth twice daily, 3) Amlodipine (medication to treat HTN) 10 mg by mouth once daily, 4) Metoprolol tartrate (medication to treat HTN) 100 mg 1 tablet by mouth twice a day, and 5) Pradaxa (blood thinner to treat/prevent blood clots and reduce the risk of stroke) 110 mg 1 capsule by mouth twice a day. 5. Patient 2 stated she did not know her blood sugar level and she did not have a glucometer (medical device used to measure level of sugar in a person’s blood). When asked what Jardiance was prescribed for, Patient 2 was unable to state its indications. Patient 2 also stated she did not take her BP regularly as she did not have a BP monitor (medical device used to measure BP). 6. The “Medication Profile” section in Patient 2’s HHA home binder was not updated with Patient 2’s current medications. 7. The “Patient Blood Sugar Log/Diary” and “Patient’s Vital Signs Log/Diary” sections in Patient 2’s HHA home binder were not filled out by Patient 2 and/or Patient 2’s caregivers. During a follow-up interview on 3/19/2025 at 12:30 PM, RN 1 stated he checked only the medication bottles that were handed to him by Patient 2. RN 1 he was aware Patient 2 was diabetic, but Patient 2 stated upon admission to the HHA that Patient 2 was “borderline” diabetic. RN 1 stated he did not check Patient 2’s blood sugar because there was no physician’s order to check Patient 2’s blood sugar level/s. RN 1 stated Patient 2’s BP was higher than usual, so RN 1 he would report it to the physician. RN 1 stated he was not aware that Patient 2 had no glucometer and BP monitor. RN 1 stated the HHA would not be able to provide these medical devices to Patient 2, but RN 1 would be able to call the physician to order these devices for Patient 2 to ensure regular BP and blood sugar monitoring were done at home. During a telephone interview on 3/20/2025 at 10:16 AM, Patient 2’s family member (FM 2), who was physically present with Patient 2 at the time, stated Patient 2 did not have a glucometer and BP monitor for a long time, and Patient 2 could not recall the last time Patient 2 took her blood sugar level. FM 2 stated per Patient 2, the HHA nurses always took Patient 2’s BP but “never said anything” about Patient 2’s BP. FM 2 stated she accompanied Patient 2 to her primary physician’s visit about 2 weeks prior to the home visit on 3/19/2025 and obtained new medications, including an antidiabetic medication. FM 2 stated she accompanied Patient 2 to her cardiologist (physician specializing in the care of heart and blood vessels) appointment about a week prior to the home visit on 3/19/2025 and obtained new BP medications. FM 2 stated per Patient 2, “nobody checks” all of her medications with her (Patient 2). During a concurrent interview and record review of Patient 2’s medical records on 3/21/2025 at 11:35 AM with the DPCS, the DPCS stated the Patient Medication Record and “Medication Profile” were not updated and stated it was important to keep the medication lists accurate and updated to ensure no medication errors or prevent adverse effects of duplicate therapy, drug interactions, or noncompliance with the medication regimen. During a review of the HHA’s policy and procedures (P&P), titled “Medication Profile,” dated 11/2021, the P&P indicated the following: 1.The patient must have a current, accurate medication profile in the clinical record. 2. Medication profiles must be updated for each change to reflect current medications, new, and/or discontinued medications. 3. A drug regimen review must be performed with a the additional of a new medication to identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicate drug therapy, and noncompliance with drug therapy. 4. Each patient must receive appropriate written material for specific medications he/she is receiving. The material must contain information on actions of the medications, potential side effects, contraindications that patient should be aware of, and any special instructions when taking the specific medication. 5. Based on the review of the medication profile as well as the written material, changes in the plan of care may be required. 6. Any conclusions and findings of patient medication use or monitoring must be communicated to the pharmacist, when appropriate, and other clinicians. 7. Deviations from taking medications as ordered must be documented in clinical notes, and the physician must be notified.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure the plan of care included the frequency of visits, treatment, measurable outcomes and goals, and patient-specific education for five of seventeen sampled patients (Patient 1, Patient 2, Patient 5, Patient 9, and Patient 13). This failure had the potential to affect the quality and safety of patient care provided to the patients and impaired coordination of care among all disciplines involved in the patient’s care. e. During a review of Patient 13’s “Patient Information” indicated a start of care (SOC) date of 1/25/2025, current episode of 1/25/2025-3/25/2025, with a primary diagnosis of encounter for change or removal of non-surgical wound dressing (an acute or chronic wound which is not secondary to surgical intervention and a material applied to a wound to protect it, promote healing, and prevent infection, without requiring surgery). During a concurrent observation and interview on 3/19/2025, at 10:45 a.m., with the Registered Nurse (RN4), in Patient 13’s residence for a joint home visit, Patient 13 was comfortably sitting on his chair, alert, awake and oriented to his name, time, place and events. During a concurrent review of Patient 13’s medications with RN 4, the following medications include: -Pradaxa Oral (by mouth) 150 milligrams (mg, unit of weight) capsule by mouth two times daily to prevent clot formation, anti-coagulants (A medication that is used to prevent and treat blood clots in blood vessels and the heart). During interview at 11:10 a.m., with Patient 13 confirmed and stated he was still taking Pradaxa anticoagulant medication to prevent any incidents of strokes or blood clots. Patient 13 stated that he was unsure if the visiting nurses provided teachings to him of what to look for while on anti-coagulant medication. During a concurrent review and interview at 11:20 a.m. with RN 4, of Patient 13’s home health agency’s home folder, there was no documented evidence of any written instructions for Patient 13 related to the use of an anti-coagulant medication. RN 4 stated that the HHA should have provided written instructions to Patient 13 for his reference when he needed to review it. RN 4 stated that it was important to provide verbal teachings and written instructions to patients if they are taking some medications that could potentially have side effects, like anti-coagulants. RN 4 stated that written instructions provided to patients and their caregivers will help them to look for symptoms that needed immediate attention and care. During a concurrent interview and record review on 3/21/2025 at 12:24 p.m., with the Director of Patient Care Services (DPCS) of Patient 13’s Electronic Medical Record (EMR), titled “Patient Medication Record,” indicated a medication that include – Pradaxa Oral 150 mg, capsule by mouth two times daily to prevent clot formation, anti-coagulants. DPCS stated that the medication has risk for bleeding and teaching should be provided to patients/caregivers and/or families on what to look for while on this medication. During a concurrent interview and record review with the DPCS of Patient 13’s EMR, titled “RN (Registered Nurse) Skilled Nursing Visit Note”, dated 1/30/2025 and 2/7/2025, indicated no nursing documentations that teachings were provided regarding bleeding precautions while on anti-coagulant medication. DPCS confirmed there was no nursing documentation that teaching was provided regarding bleeding precautions. DPCS stated that the nurses should document of the provided teaching and documentation must be accurate so that there will be no miscommunication between staff and patients. DPCS stated that nurses should document if teaching was provided to patient/caregiver/facility staff regarding a particular task to validate that it was done. During a review of HHA’s policy and procedure (P&P), titled “Patient Education Process”, revise date of November 2021, the policy indicated that patients and family/caregivers will receive education in verbal, visual, and written format, as appropriate. The scope of teaching will be determined by assessing the needs, abilities, learning preferences, and readiness to learn of the patient and family/caregiver, as well as by the plan of care, the policy indicated that 7. Documentation of patient and family/caregiver education will consist of: A. Describing what was taught to the patient, B. Describing the patient’s response to the teaching, including the level of understanding and the ability to repeat or demonstrate what was taught. d. A review of Patient 9’s Personal Information indicated a Start of Care (SOC) date of 1/20/2025 with a primary diagnosis of Encounter for change or removal of nonsurgical wound dressing and secondary diagnoses included unspecified open wound of left great toe without damage to nail and Type 2 diabetes mellitus with diabetic chronic kidney disease (a disorder characterized by difficulty in blood sugar control and poor wound healing causing injury to the kidney not being able to filter waste and excess fluid from the blood). A review of Patient 9’s medical record titled Home Health Certification and Plan of Care (POC) for the certification period of 1/20/2025 to 3/20/2025, indicated an order for Skilled Nurse (SN) frequency for three times a week for four weeks, effective 1/20/2025, and at every visit SN to perform teaching of wound management, perform skilled nursing assessment and notify medical director (MD) for any changes in condition, assess pain scale and perform medication management. The POC also indicated an order to notify the physician if the patient’s fasting blood sugar is greater than 250 or less than 70 or random blood sugar is greater than 250 or less than 70. During a review of Patient 9’s medical record titled, Oasis Resumption of Care dated 3/16/2025, the OASIS Resumption of Care indicated an order for frequency of SN visits for two times a week for six times a week for one week, then seven times a week for three weeks starting 3/17/2025 for wound care, rehospitalization prevention, pain management, medication management, and fall and safety prevention measures. During an interview on 3/19/2025 at 12:25pm with Patient 9 and Family Member 4 (FM4), Patient 9 stated and confirmed she does have diabetes and is currently on Metformin (medication to treat diabetes) for it. Patient 9 stated she is able to check her own blood sugar and does have a glucometer (a small portable machine used to measure the concentration of glucose [sugar] in the blood). Patient 9 stated the last time she checked her blood sugar level was two days ago, and it was 109. Patient 9’s FM4 stated Patient 9 does not check her blood sugar regularly like she should be doing, and stated her reason is because she does not like poking her finger and sometimes cannot get enough blood out for the sample. During a joint home visit on 3/19/2025 at 12:30 pm., with Registered Nurse 1 (RN1), Patient 9’s medication record and medication bottles were reviewed. RN1 stated and confirmed Patient 9’s medication record for certification period of 1/20/2025 to 3/20/2025 included a medication order for Metformin hydrochloric acid (medication used to treat type 2 diabetes mellitus) 850 milligrams (mg- unit of measurement) take 1 tablet by mouth two times daily with meals for diabetes. RN1 stated and confirmed Patient 9 had the medication bottle and was current. During an interview on 3/19/2025 at 12:50 pm with RN1, RN1 stated Patient 9 gets home visits from the home health agency HHA skilled nurses seven days a week for wound care. RN1 stated she does home visits with Patient 9 five days out of the week and the other two days the HHA will send another SN. RN1 stated she does not check Patient 9’s blood sugar during home visits. RN1 stated during home visits with Patient 9 she will ask her what her blood sugar level is and document it in her skilled nursing visit note/assessment. RN1 further stated she was trained by the HHA not to check a patient’s blood sugar level unless there is an order and if there is no order ask the patient for the level during the home visit and document it. During a concurrent interview and record review on 3/20/2025 at 12:30 pm., with the Director of Patient Care Services (DPCS), Patient 9’s Home Health Certification and Plan of Care for the certification period of 1/20/2025 to 3/20/2025 was reviewed. The DPCS stated and confirmed Patient 9’s Home Health Certification and Plan of Care did not have a documented care plan for her diabetes management. The DPCS stated the skilled nurses who do start of care visits are the ones to formulate the care plans based on their head-to-toe assessment and the patient medical history from the History and physical (H&P). The DPCS stated Patient 9 should have had a care plan created for the management of her diabetes that included education on monitoring her blood sugar, and how to monitor for signs and symptoms of hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar). The DPCS also stated the importance of having a care plan for Patient 9’s diabetes management was to assess the patient’s health status, was the patient checking her blood sugars regularly, was the patient having any symptoms of hyperglycemia or hypoglycemia, was the patient knowledgeable on how to monitor herself of these symptoms and know what to do. The DPCS further stated having a care plan for diabetes management for Patient 9 was to guide and help all disciplines, like the nurses, therapy, social worker and the physician, working with the patient know what is going on with the patient and what needs to be done. During a concurrent interview and record review on 3/20/2025 at 1:06 pm., with the DPCS, Patient 9’s Electronic Medical Record (EMR) was reviewed. Patient 9’s EMR indicated under the section nursing, Skilled nursing visit note/assessment submission for the dates of: 1/23/2025, 1/28/2025, 1/30/2025,2/2/2025, 2/4/2025, 2/6/2025, 2/11/2025, 2/13/2025, 2/14/2025, 2/16/2025, 2/17/2025, 2/18/2025, 2/19/2025, 2/21/2025, 2/23/2025, 2/24/2025, 3/3/2025, 3/4/2025, 3/5/2025, 3/6/2025, 3/7/2025, 3/9/2025, 3/10/2025, 3/11/2025, 3/12/2025, 3/13/2025, 3/14/2025, 3/15/2025 and 3/17/2025. The DPCS stated and confirmed that the Skilled nursing notes/assessments for the dates of 1/23/2025, 1/28/2025, 1/30/2025,2/2/2025, 2/4/2025, 2/6/2025, 2/11/2025, 2/13/2025, 2/14/2025, 2/16/2025, 2/17/2025, 2/18/2025, 2/19/2025, 2/21/2025, 2/23/2025, 2/24/2025, 3/3/2025, 3/4/2025, 3/5/2025, 3/6/2025, 3/7/2025, 3/9/2025, 3/10/2025, 3/11/2025, 3/12/2025, 3/13/2025, 3/14/2025, 3/15/2025 and 3/17/2025 did not indicate the skilled nurse assessed or documented Patient 9’s blood sugar levels during those visit dates. The DPCS stated if there is nothing documented then it can be assumed the skilled nurses did not check the blood sugar. The DPCS also stated the section for blood sugar level should have some type of documentation in it whether it is a level or a comment as to why there is no level documented. The DPCS stated the skilled nurses do not check the patients blood sugar level, unless there is an order from the physician, but the SN should encourage the patients to check their blood sugar regularly and provide education on monitoring for signs and symptoms of hyperglycemia and hypoglycemia. The DPCS stated and conformed that the Skilled nursing visit notes/assessment for the same dates also did not have documented evidence that the skilled nurse provided education to the patient or family on monitoring for signs and symptoms of hyperglycemia and hypoglycemia and what to report to the agency or physician. The DPCS further stated at every home visit the skilled nurses should be assessing the patients blood sugar level by asking them what the level was and document it on the skilled nursing visit note/assessment and educate the patient on the use of the blood sugar log provided to them in the HHA booklet. The DPCS stated it is important that for patients with diabetes, monitoring and documentation of blood sugar level is done during home visits to assess if it is stable or not and if patients are complaint with the management of their diabetes and communicate that with the physician. c. During a review of Patient 5’s Patient Information, the Patient Information indicated that Patient 5 was admitted to the HHA on 2/25/2025, with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (a type of bandage or covering used to protect and promote healing of wounds that does not require surgery). During a review of Patient 5’s Home Health Certification and Plan of Care, for the certification period of 2/25/2025 to 4/25/2025, the Home Health Certification and Plan of Care indicated Occupational Therapy (a form of therapy for those recuperating from physical or mental illness that encourages rehabilitation through the performance of activities required in daily life) visit twice a week for one week. The Home Health Certification and Plan of Care did not indicate the frequency for Skilled Nurse (SN, licensed nurse in general). The mental status, psychosocial status, DME (durable medical equipment, refers to medical devices and equipment prescribed by a healthcare provider for a patient’s routine, long-term use, such as wheelchairs, walkers, and oxygen tank) and supplies, prognosis (the predicted course and outcome of a disease or medical condition), safety measures, nutritional requirements, functional limitations, and activities permitted sections in the predicted course and outcome of a disease or medical condition Home Health Certification and Plan of Care for Patient 5 were left blank. There was no wound care treatment indicated in the Home Health Certification and Plan of Care. During a review of Patient 5’s RN – Skilled Nursing Note, dated 3/1/2025, completed by Registered Nurse 3 (RN 3), the Wound Addressed on this Visit section indicated that RN 3 performed the following treatment: - On left lower leg (top): Cleanse with normal saline (a sterile solution of sodium chloride [salt] in water that has a number of uses in medicine, including cleaning wounds), pat dry, apply triple antibiotic ointment, left open to air. - On left lower leg (bottom): Cleanse with normal saline, pat dry, apply triple antibiotic ointment, left open to air. During a joint home visit with Registered Nurse 3 (RN 3) on 3/19/2025 at 11:20 a.m., observed Patient 5 alert and oriented. Patient 5 was able to ambulate (walk) without assistive device, even though she had a walker and a cane in her residence. Observed a pinkish scar on Patient 5’s left upper shin; skin appeared intact. Also observed a scab (a dry, rough protective crust that forms over a cut or wound during healing) on Patient 5’s left shin, open to air. During an interview with RN 3 on 3/19/2025 at 12 p.m., RN 3 stated she had stopped doing wound treatment on Patient 5 for a couple weeks now because both wounds had healed. When RN 3 was asked to describe the wound treatment that she provided for Patient 5 before she stopped it, RN 3 stated she would cleanse with normal saline, pat dry, apply triple antibiotic ointment, and left open to air. During a concurrent record review and interview with RN 3 on 3/19/2025 at 12:05 p.m., RN 3 reviewed the Home Health Certification and Plan of Care for Patient 5. RN 3 confirmed that the Home Health Certification and Plan of Care did not include the wound care order. RN 3 stated she would check the Home Health Connect (HHC) application on her cellular phone if she wanted to know about a patient’s orders. RN 3 stated HHC was a communication tool used by the HHA staff. Per RN 3, the communication in HHC, including the orders are to be used internally by the staff, and it was not part of the patient’s clinical record. RN 3 stated the wound care orders still needed to be recorded on Patient 5’s Home Health Certification and Plan of Care. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 3/20/2025 at 12:20 p.m., the DPCS confirmed that Patient 5’s Home Health Certification and Plan of Care, for the certification period of 2/25/2025 to 4/25/2025, were missing mental status, psychosocial status, DME and supplies, prognosis, safety measures, nutritional requirements, functional limitations, activities permitted, and wound care treatment orders. The DPCS stated the Home Health Certification and Plan of Care was supposed to have all those components included. The DPCS stated the Home Health Certification and Plan of Care served as a guideline for the HHA staff, so they could coordinate care, monitor the patient’s progress, and make sure the patient received the care based on his/her assessed needs. During a review of the HHA’s policy and procedure, titled “Care Planning Process,” revised November 2021, the policy and procedure indicated the patient-specific clinical plan of care included: D. All patient care orders including verbal orders. G. Measurable outcomes and goals. H. Patient’s mental, psychosocial, and cognitive status. I. Functional limitations. J. Activities permitted. K. Safety measures to protect against injury. L. Nutritional requirements. M. Medications and treatments. P. Supplies and equipment required. a. During a review of Patient 1’s General Acute Care Hospital 1 (GACH 1’s) physician (MD) notes, dated 2/14/2025, the GACH 1 MD notes indicated Patient 1 had the following diagnoses: 1. Diabetes Mellitus Type 2 (DM 2, chronic disorder characterized by difficulty in blood sugar control and poor wound healing) with bilateral mild non-proliferative diabetic retinopathy (moderate damage to the blood vessels in the retina of both eyes as a complication of DM 2), 2. DM 2 with chronic kidney disease Stage 3 3. DM 2 with severe malnutrition (state of severe nutrient deficiency that significantly impairs health and well-being) 4. Anemia (condition wherein body does not have enough health red blood cells to carry adequate oxygen due to several factors, including nutrient deficiencies) 5. Sacral pressure sore (damaged skin and tissue in the sacral area due to sustained pressure), unspecified stage 6. Constipation (problem with passing stool) 7. Major depressive disorder (mood disorder that causes persistent feeing of sadness and loss of interest) During a review of Patient 1’s medical record, titled “Patient Information,” the “Patient Information” indicated Patient 1’s Start of Care (SOC) date of 3/5/2025 with a primary diagnosis of non-surgical wound dressing change or removal and a secondary diagnosis of Stage 2 sacral pressure sore. During a concurrent interview and record review of Patient 1’s home medications while on a joint visit on 3/19/2025 at 9:55 AM, with the Director of Patient Care Services (DPCS) at Patient 1’s residence, in the presence of Patient 1 and family member (FM 1), Patient 1 was observed lying in bed, and was alert, oriented to name, place, date, and situation. Patient 1 stated she was informed “last week” that she was diabetic and that “someone” (unable to identify) would come and check her blood sugar regularly, but “no one has checked [the blood sugar] since then.” The DPCS stated the SN did not check Patient 1’s blood sugar during home visits, because there was no physician’s order to perform blood sugar checks. The DPCS stated Patient 1 was not on any antidiabetic medication. During a follow-up interview on 3/19/2025 at 11:15 AM, the DPCS stated the SN could act as a patient advocate and ask the physician if he/she has any additional orders in relation to DM 2, since Patient 1 was diabetic and uncontrolled blood glucose could delay wound healing. During a telephone interview on 3/20/2025 at 3:23 PM, RN 2 stated Patient 1 could not check her own blood glucose levels. RN 2 stated he was not aware of her baseline blood glucose levels or any interventions to address Patient 1’s DM 2. RN 2 stated he should have reinforced diabetic teachings pertaining to the importance of adhering to a diabetic diet, keeping a log of blood glucose levels, involving the family, because uncontrolled blood glucose levels could lead to slower wound healing and hospitalization/s. RN 2 stated due to the workload and time constraints, RN 2 was not able to do the DM 2 interventions. RN 2 stated at times, there was not enough time to visit all his patients assigned for the week, which required him to conduct 10-13 patient home visits a day. During a concurrent interview and record review of Patient 1’s medical records on 3/21/2025 at 11:35 AM with the DPCS, the DPCS stated there was no documented evidence of any individualized plan of care related to the DM 2, including diabetic diet teachings and blood sugar monitoring, and teachings regarding Patient 1’s wound care supplies. The DPCS stated Patient 1’s Skilled Nursing Visit Notes dated 3/7/2025, 3/11/2025, 3/13/2025, 3/15/2025, 3/18/2025, 3/19/202, on 3/21/2025 at 11:34 AM with the DPCS, the skilled nursing visit notes did not indicate Patient 1’s blood sugar readings and the teaching/education provided to patient 1 and regarding the importance of checking and documenting blood sugar levels. b. During a review of Patient 2’s General Acute Care Hospital 1 (GACH 1) physician (MD) notes, dated 1/18/2025, the GACH 1 MD notes indicated Patient 2 has the following diagnoses: 1. DM 2 with bilateral moderate non-proliferative diabetic retinopathy 2. DM 2 with microalbuminuria (presence of albumin in the urine as an early sign of kidney damage related to DM 2) 3. DM 2 with peripheral neuropathy (complication of diabetes that damages the nerves in the hands, feet, legs, and arms) 4. Diabetic foot ulcer (open wound on the foot that develops in people with diabetes) 5. Severe bilateral open-angle glaucoma (increased pressure in the eyes due to eye fluid not draining properly, causing potential optic nerve damage that can lead to vision loss or blindness) 6. Hypertension (HTN or high blood pressure (BP), a condition where the force of blood against the artery walls is consistently too high) 7. Osteoarthritis (degenerative joint disease characterized by pain, stiffness, and reduced mobility) During a review of Patient 2’s Medical Record form, titled “Patient Information,” the “Patient Information” indicated Patient 2’s Start of Care (SOC) date of 2/11/2025 with a primary diagnosis of nonsurgical wound dressing change/removal and a secondary diagnosis of DM 2 with foot ulcer. During a review of Patient 2’s Medical Record form, titled “OASIS-E1 Start of Care (OASIS – SOC),” dated 2/11/2025, the “OASIS-SOC” indicated Patient 2’s preferred language is Spanish and would need and want an interpreter to communicate with a doctor or health care staff. The “OASIS-SOC” indicated: 1. Patient 2 did not have any impairment in cognition (mental action or process of acquiring knowledge and understanding). 2. Patient 2 has an additional order for skilled nursing (SN) visits twice a week for 1 week and thrice a week for 2 weeks effective 2/11/2025. 3. Physician must be notified if fasting blood sugar is greater than 250 milligrams per deciliter (mg/dL) and less than 70 mg/dL. 4. Physician must be notified if random blood sugar is greater than 250 mg/dL and/or less than 70 mg/dL. 5. No need for “diabetic supplies” was identified (Box was not checked). 6. Patient 2 and caregiver were not “independent of glucometer use.” During a review of Patient 2’s active medical record, titled “Patient Medication Record” as of 3/18/2025, the “Patient Medication Record” indicated some of Patient 2’s medications as ordered by the physician: 1. Lisinopril (medication to treat HTN) 40 mg 1 tablet orally daily 2. Atenolol (medication to treat HTN) 25 mg 2 tablets orally twice a day 3. Patient 2 has no medications ordered for her DM 2 on file. During a joint home visit on 3/19/2025 at 11:37 AM, with Registered Nurse 1 (RN 1) at Patient 2’s residence, Patient 2 was observed awake, alert, oriented, and Spanish-speaking with no caregiver at the bedside. During a concurrent review of Patient 2’s home medications with RN 1, Patient 2’s active medical record, titled “Patient Medication Record” for period 2/11/2025 – 4/11/2025 were compared with the medication bottles present in Patient 2’s home. The observations were as follows: 1. Patient 2 stated her physician instructed her (Patient 2 was unable to recall the date) to discontinue all of her previously prescribed medications. 2. Patient 2 took out new medication bottles from a brown paper bag on her bed. All of the following new medications had a fill date of 3/11/2025 (date the prescription medication was refilled). Patient 2 stated her physician prescribed new medications (Patient 2 was unable to recall the date), including 1) Jardiance (antidiabetic medication) 25 mg ½ tablet by mouth once daily, 2) Lisinopril 20 mg 1 tablet by mouth twice daily, 3) Amlodipine (medication to treat HTN) 10 mg by mouth once daily, 4) Metoprolol tartrate (medication to treat HTN) 100 mg 1 tablet by mouth twice a day, and 5) Pradaxa (blood thinner to treat/prevent blood clots and reduce the risk of stroke) 110 mg 1 capsule by mouth twice a day. 3. Patient 2 stated she did not know her blood sugar level and she did not have a glucometer (medical device used to measure level of sugar in a person’s blood). When asked what Jardiance was prescribed for, Patient 2 was unable to state its indications. Patient 2 also stated she did not take her BP regularly as she did not have a BP monitor (medical device used to measure BP). 4. The “Medication Profile” section in Patient 2’s HHA home binder was not updated with Patient 2’s current medications. 5. The “Patient Blood Sugar Log/Diary” and “Patient’s Vital Signs Log/Diary” sections in Patient 2’s HHA home binder were not filled out by Patient 2 and/or Patient 2’s caregivers. During a follow-up interview on 3/19/2025 at 12:30 PM, RN 1 he was aware Patient 2 was diabetic, but Patient 2 stated upon admission to the HHA that Patient 2 was “borderline” diabetic. RN 1 stated he did not check Patient 2’s blood sugar because there was no physician’s order to check Patient 2’s blood sugar level/s. RN 1 stated Patient 2’s BP was higher than usual, so RN 1 he would report it to the physician. RN 1 stated he was not aware that Patient 2 had no glucometer and BP monitor. RN 1 stated the HHA would not be able to provide these medical devices to Patient 2, but RN 1 would be able to call the physician to order these devices for Patient 2 to ensure regular BP and blood sugar monitoring were done at home. During a telephone interview on 3/20/2025 at 10:16 AM, Patient 2’s family member (FM 2), who was physically present with Patient 2 at the time, stated Patient 2 did not have a glucometer and BP monitor for a long time, and Patient 2 could not recall the last time Patient 2 took her blood sugar level. FM 2 stated per Patient 2, the HHA nurses always took Patient 2’s BP but “never said anything” about Patient 2’s BP. FM 2 stated she accompanied Patient 2 to her primary physician’s visit about 2 weeks prior to the home visit on 3/19/2025 and obtained new medications, including an antidiabetic medication. FM 2 stated she accompanied Patient 2 to her cardiologist (physician specializing in the care of heart and blood vessels) appointment about a week prior to the home visit on 3/19/2025 and obtained new BP medications. FM 2 stated per Patient 2, “nobody checks” all of her medications with her (Patient 2). During an interview on 3/20/2025 at 1:07 PM, the DPCS stated the SN (in general) must ask that patient (in general) if he/she checked her blood sugar at each home visit. The DPCS stated if instructed by the physician to check blood sugar daily and the patient is not doing it, SN must notify the patient’s physician. The DPCS stated if the patient is diabetic, but the physician has no orders for blood sugar checks or any antidiabetic medications, the SN could act as a patient advocate and call the physician to ask for an order on how to monitor the blood glucose—whether it is Hemoglobin A1c (HbAC1, blood test that measures the average blood sugar level over the past 2-3 months) every 3 months, blood sugar checks every SN visit, or patient to check own blood sugar combined with SN teachings regarding the importance of regular blood sugar monitoring. In addition, the DPCS stated the SN must also check patient’s BP at every home visit and report to the physician any abnormal values (values outside of the parameters specified on the physician’s order) and provide teachings regarding the importance of regular BP monitoring. The DPCS stated the SN could inform the physician if the patient has no glucometer or BP monitor, so the orders could be placed on behalf of the patient. During a concurrent interview and record review of Patient 1’s medical records on 3/21/2025 at 11:35 AM with the DPCS, the DPCS stated there was no documented evidence of any individualized plan of care related to the DM 2, including diabetic diet teachings and blood sugar monitoring, and need for glucometer. The DPCS stated Patient 2’s SN Visit Notes, dated 2/15/2025, 2/17/2025, 2/19/2025, 2/21/2025, 2/24/2025, 2/26/2025, 2/28/2025, 3/3/2025, 3/5/2025, 3/7/2025, 3/10/2025, 3/12/2025, 3/14/2025 3/17/202, did not indicate Patient 2’s blood sugar readings and the teaching/education provided to patient 2 regarding the importance of checking and documenting blood sugar levels. During a review of HHA’s policy and procedures (P&P 1), titled “Blood Glucose Monitoring (undated),” P&P 1 indicated the following: 1. The P&P’s purpose was to 1) obtain glucose reading, 2) assess changes in the blood glucose level used to modify treatment, and 3) teach client/caregivers home diabetic management and how to use a glucometer. 2. Documentation on the patient’s clinical records must include: 1) calibration or testing of the glucometer, if applicable, 2) blood glucose level, 3) method used to obtain blood glucose level, 4) dose of insulin or oral hypoglycemic agent, 5) time of test, 6) dietary intake, 7) symptoms, 8) any actions taken to correct hyperglycemia or hypoglycemia reactions, 9) patient’s response to actions, and 10) any instruction given including demonstrated ability to use the machine. During a review of HHA’s policy and procedures (P&P 2), titled “Care Planning Process,” dated 11/2021, P&P 2 indicated the following: 1. A written plan of care must be initiated and developed within five days of SOC and updated at least every 60 days or as patient’s condition warrants based upon the patient’s identified needs and must review it with the patient and family/caregiver. 2. An individualized plan of care must include, but is not limited to: a. Pertinent primary and secondary diagnoses, b. Measurable outcomes and goals identified by the HHA and the patient and anticipated to occur as a result of implementing and coordinating the plan of care c. Medications and treatments d. Orders for patient-specific home health service needs identified in the comprehensive assessment and the responsible discipline(s), treatments and procedures, including amount, frequency, and duration e. Patient-specific interventions and education f. Supplies and equipment required, and g. Patient and caregiver education and training to facilitate timely discharge. 3. The SN licensed nurses must consider the conclusions of initial and ongoing assessments in their care planning process, including but is not limited to: a) individualized patient needs and resultant problems related to care, b) clinical drug monitoring, c) patient treatment choices, and d) patient and caregiver education and training that the organization must provide specific to the patient’s care needs. 4. The care planning process must be documented on the plan of care, clinical notes, medication profiles, care conference/summary forms, and discharge or clinical summaries. 5. Clinicians must inform the patient’s physician of any changes that suggest a need to alter the plan of care. Changes must be written, dated, and signed by the professional making the changes. 6. Each patient must be monitored for his/her response to care or services provided against established patient goals and patient outcomes to determine if goals have been achieved. Care decisions and services to be provided must be made as a result of the care planning process, analysis of initial and ongoing assessments, and analysis of patient response to care against goals and outcomes. During a review of the HHA’s policy and procedures (P&P 3), titled “Patient Education Process,” dated 11/2021, P&P 3 indicated the following: 1. Education must be the responsibility of each clinician and must focus on: a. Facilitating the patient’s and family/caregiver’s understanding of his/her health status, health care options, and consequences of options b. Encouraging patient participation in decision-making about health care options c. Increasing the patient’s and family/caregiver’s ability to cope with the health status, prognosis, and outcomes 2. Unless otherwise ordered by the physician, the patient and family/caregiver must receive verbal and, as appropriate, written instructions that are in plain language on, but are not limited to: a. Patient’s disease process and prognosis b. Medication management and administration c. Nutrition interventions, modified diets d. Consequences of noncompliance e. Safe, effective use of equipment and supplies 3. Documentation of patient and family/caregiver education must consist of describing, but is not limited to: a. What was taught to the patient (if using preprinted materials, document the name of the handout), b. Patient’s response to the teaching, including the level of understanding, and the ability to repeat or demonstrate what was taught, c. Any additional learning needs not currently met, and d. Teaching planned for subsequent visits.”

“All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to record all patient care orders in the plan of care for three of seventeen sampled patients (Patient 5, Patient 9, and Patient 13). This failure had the potential to result in patients not receiving the services ordered for them based on their assessed needs. a. During a review of Patient 5’s Patient Information, the Patient Information indicated that Patient 5 was admitted to the HHA on 2/25/2025, with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (a type of bandage or covering used to protect and promote healing of wounds that does not require surgery). During a review of Patient 5’s Home Health Certification and Plan of Care, for certification period of 2/25/2025 to 4/25/2025, the Home Health Certification and Plan of Care indicated Occupational Therapy (a form of therapy for those recuperating from physical or mental illness that encourages rehabilitation through the performance of activities required in daily life) visit twice a week for one week. The Home Health Certification and Plan of Care did not indicate the frequency for Skilled Nurse (SN, licensed nurse in general). The mental status, psychosocial status, DME (durable medical equipment, refers to medical devices and equipment prescribed by a healthcare provider for a patient’s routine, long-term use, such as wheelchairs, walkers, and oxygen tank) and supplies, prognosis (the predicted course and outcome of a disease or medical condition), safety measures, nutritional requirements, functional limitations, and activities permitted sections in the predicted course and outcome of a disease or medical condition Home Health Certification and Plan of Care for Patient 5 were left blank. There was no wound care treatment indicated in the Home Health Certification and Plan of Care. During a review of Patient 5’s RN – Skilled Nursing Note, dated 3/1/2025, completed by Registered Nurse 3 (RN 3), the Wound Addressed on this Visit section indicated that RN 3 performed the following treatment: - On left lower leg (top): Cleanse with normal saline (a sterile solution of sodium chloride [salt] in water that has a number of uses in medicine, including cleaning wounds), pat dry, apply triple antibiotic ointment, left open to air. - On left lower leg (bottom): Cleanse with normal saline, pat dry, apply triple antibiotic ointment, left open to air. During a joint home visit with Registered Nurse 3 (RN 3) on 3/19/2025 at 11:20 a.m., observed Patient 5 alert and oriented. Patient 5 was able to ambulate (walk) without assistive device, even though she had a walker and a cane in her residence. It was observed a pinkish scar on Patient 5’s left upper shin; skin appeared intact. Also observed a scab (a dry, rough protective crust that forms over a cut or wound during healing) on Patient 5’s left shin open to air. During an interview with RN 3 on 3/19/2025 at 12 p.m., RN 3 stated she had stopped doing wound treatment on Patient 5 for a couple weeks now because both wounds had healed. RN 3 described the wound treatment provided before the wounds were healed. RN 3 stated she cleansed the wounds with normal saline, pat dry, apply triple antibiotic ointment, and left open to air. During a concurrent record review and interview with RN 3 on 3/19/2025 at 12:05 p.m., RN 3 reviewed the Home Health Certification and Plan of Care for Patient 5. RN 3 confirmed that the Home Health Certification and Plan of Care did not include the wound care order. RN 3 stated she would check the Home Health Connect (HHC) application on her cellular phone if she wanted to know about a patient’s orders. RN 3 stated HHC was a communication tool used by the HHA staff. Per RN 3, the communication in HHC, including the orders are to be used internally by the staff, and it was not part of the patient’s chart. RN 3 stated the wound care orders still needed to be recorded on Patient 5’s Home Health Certification and Plan of Care. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 3/20/2025 at 12:20 p.m., the DPCS confirmed that Patient 5’s Home Health Certification and Plan of Care, for the certification period of 2/25/2025 to 4/25/2025, were missing assessment of patient’s mental status, psychosocial status, DME and supplies, prognosis, safety measures, nutritional requirements, functional limitations, activities permitted, and wound care treatment orders. During a review of the Start of Care order addendum, dated 2/25/2025, the Start of Care order addendum indicated the physician ordered the following wound treatment for the left lower leg bottom: Cleanse with normal saline, pat dry, apply triple antibiotic ointment, left open to air, daily. The DPCS stated the wound care order should have been included in the patient’s Home Health Certification and Plan of Care. The DPCS stated the Home Health Certification and Plan of Care served as a guideline for the HHA staff, so they could coordinate care, monitor the patient’s progress, and make sure the patient received the care based on his/her assessed needs. During a review of the HHA’s policy and procedure, titled “Monitoring Patient’s Response/Reporting to Physician,” revised November 2021, the policy and procedure indicated that all physician (or other authorized licensed independent practitioner) orders shall be integrated into the plan of care. c. During a review of Patient 13’s “Patient Information” indicated a start of care (SOC) date of 1/25/2025, current episode of 1/25/2025-3/25/2025, with a primary diagnosis of encounter for change or removal of non-surgical wound dressing (an acute or chronic wound which is not secondary to surgical intervention and a material applied to a wound to protect it, promote healing, and prevent infection, without requiring surgery). During a review of Patient 13’s Home Health Certification and Plan of Care (POC, a document that maps out needs and services supplied for a homebound patient, as well as the patient’s family/caregiver), with a certification period from 1/25/2025 to 3/25/2025, the Home Health Certification and POC indicated in the orders and treatments section which include: SN (Skilled Nurse) frequency of once a week for week one, twice a week for week two and notify physician of fasting blood sugar greater than 250 or less than 70, and random blood sugar greater than 250 or less than 70. During a concurrent observation and interview on 3/19/2025, at 10:45 a.m., with the Registered Nurse (RN4), at Patient 13’s residence for a joint home visit, Patient 13 was comfortably sitting on his chair, alert, awake and oriented to his name, time, place and events. During interview with Patient 13 stated, that he goes to the laboratory every 3 months to have his HgbA1c (a blood test that shows the average blood sugar level over the past 2-3 months, helping to diagnose and monitor diabetes) blood test done per his primary doctor’s order. Patient 13 stated he does not check his blood sugar on a daily basis, stated he has the glucometer (a small, portable device used to measure blood sugar (glucose) levels, typically by pricking a fingertip and applying a drop of blood to a test strip inserted into the meter) provided by his primary doctor but he does not know if he needs to do a blood sugar check daily, stated nobody told him to do a daily blood sugar check and to write down the blood sugar readings. During concurrent review and interview at 11:07 a.m., with RN4, he stated that nurses are not allowed to check patient’s blood sugar since it is an invasive test, unless there is an order. RN 4 stated they provided teachings and encourage patients to do a routine blood sugar check. RN 4 stated patients supposed to keep a log of their blood sugar readings to monitor effectively if the current diabetic medications are appropriate or not, and to determine if there are any patterns of low blood sugar or high blood sugar episodes. During a concurrent review of Patient 13’s “RN (Registered Nurse) Skilled Nursing Visit,” dated 1/30/2025 and 2/7/2025, the RN skilled nursing visit indicated no documentation of blood sugar readings and teachings or education provided to Patient 13 regarding importance of checking his blood sugar levels. RN 4 confirmed that the RN skilled nursing visit notes dated 1/30/2025 and 2/7/2025 had no documentations of blood sugar readings and teachings or education provided to Patient 13 regarding importance of checking his blood sugar levels. RN 4 stated that Patient 13 was newly assigned to him and stated he only saw the patient for the third time. RN 4 stated that should have documented the teachings he provided to Patient 13 regarding importance of monitoring his blood sugar routinely to validate that it was done. RN 4 stated that it is important to have a routine blood sugar monitoring, stated that with no recorded blood sugars, stated will not be able to determine if the physician needs to be notified of blood sugar less than 70 or greater than 250 as indicated in Patient 13’s POC. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 3/20/2025 at 1:38 p.m., the DPCS confirmed that Patient 13’s skilled nursing visit notes dated 1/30/2025 and 2/7/2025 had no documentations of blood sugar readings and teachings or education provided to Patient 13 regarding importance of checking his blood sugar levels. DPCS confirmed that Patient 13’s clinical records for admission titled “History and Physical,” indicated the following orders that include: -Blood-glucose meter (One Touch Verio Flex Start) Miscellaneous kit, start date of 10/6/2023 and end date of 10/5/2025, use as directed to test blood sugar -Lancets (a small, sharp, disposable needle-like device used to prick the skin, typically a fingertip, to obtain a small blood sample for testing blood sugar levels using a blood glucose meter), start date of 10/6/2023 and end date of 10/5/2025, use two times a day as directed to test blood sugar. DPCS confirmed that Patient 13’s “Patient Medication Record,” indicated that the blood glucometer and lancets and the frequency to test the blood sugar were not transcribed and included as active medications and/or treatments. DPCS stated that Patient 13’s history and physical records were the baseline of all admission orders to start, and all orders should have been transcribed including the glucometer, lancets and frequency of blood sugar checks or should have been communicated with the physician for the clarification if orders are still in need. DPCS stated that it is important for patients to have a routine blood sugar records to monitor and in relation to notify the physician if it is less than 70 or more than 250 as indicated in Patient 13’s POC. DPCS stated that visiting nurses should have documented the teachings they provided to patients regarding importance of monitoring his blood sugar routinely to validate that it was done. DPCS stated that nurses are not allowed to check patient’s blood sugar since it is an invasive test, unless there is a physician’s order. DPCS stated visiting nurses provided teachings and encourage patients to do a routine blood sugar check if needed. b. A review of Patient 9’s Personal Information indicated a Start of Care (SOC) date of 1/20/2025 with a primary diagnosis of Encounter for change or removal of nonsurgical wound dressing and a secondary diagnosis of unspecified open wound of left great toe without damage to nail. A review of Patient 9’s medical record titled Home Health Certification and Plan of Care (POC) for the certification period of 1/20/2025 to 3/20/2025, indicated an order for Skilled Nurse (SN) frequency for three times a week for four weeks, effective 1/20/2025, and every visit SN to perform teaching of wound management, perform skilled nursing assessment and notify medical director (MD) for any changes in condition, assess pain scale and perform medication management. The POC also indicated an order to notify the physician if the patient’s fasting blood sugar is greater than 250 or less than 70 or random blood sugar is greater than 250 or less than 70. During a review of Patient 9’s medical record titled, OASIS Resumption of Care dated 3/16/2025, the OASIS Resumption of Care indicated an order for frequency of SN visits for two times a week for six times a week for one week, then seven times a week for three weeks starting 3/17/2025 for wound care, re-hospitalization prevention, pain management, medication management, and fall and safety prevention measures. During a joint home visit on 3/19/2025 at 12:11 pm, with Registered Nurse 1 (RN1) at Patient 9’s home, Patient 9 was observed awake, alert, oriented to date of birth, date and location, wearing glasses and sitting upright on a chair. During a concurrent interview and record review on 3/21/2025 at 12:50 pm, with the Director of Patient Care services (DPCS), Patient 9’s medical record untitled dated 1/10/2025, from Acute Care Hospital 1 was reviewed. The DPCS stated the medical record was the History and Physical (H&P) orders from the Acute Care Hospital 1. The H&P orders indicated an order for blood sugar diagnostic (identifying), check your blood sugar two times a day (every morning before breakfast and every evening before dinner). The DPCS stated and confirmed the order should have been transcribed over to Patient 9’s Home Health Agency (HHA) Plan of care. The DPCS stated the skilled nurse that did Patient 9’s admission visit was responsible for reviewing and transcribing over the admission orders. The DPCS also stated the case manager for the patient also looks over all the orders. The DPCS stated and confirmed she is the case manager listed for Patient 9 and missed that order not being transcribed to the Plan of Care. The DPCS stated the importance of reviewing a patient’s admission orders from the physician or hospital and transferring over to the Plan of Care, is to make sure that what the patient needs in care is followed and all disciplines who work with the patient are aware of what the patient needs and how to care for the patient.”

“Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to alert the physician regarding change of condition for one of seventeen sampled patients (Patient 5). This failure had the potential to result in the patient not receiving the immediate care needs and services that could affect the patient’s health status and wellbeing. During a review of Patient 5’s Patient Information, the Patient Information indicated that Patient 5 was admitted to the HHA on 2/25/2025, with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (a type of bandage or covering used to protect and promote healing of wounds that does not require surgery). During a review of the Start of Care order addendum, dated 2/25/2025, the Start of Care order addendum indicated the physician ordered the following wound treatment for the left lower leg bottom: Cleanse with normal saline, pat dry, apply triple antibiotic ointment, left open to air, daily. During a review of Patient 5’s RN – Skilled Nursing Note, dated 3/13/2025 and 3/18/2025, the notes indicated that the wounds on Patient 5’s left lower leg (top) and left lower leg (bottom) had healed. There was no indication that wound care was done. During a joint home visit with Registered Nurse 3 (RN 3) on 3/19/2025 at 11:20 a.m., observed Patient 5 alert and oriented. Patient 5 was able to ambulate (walk) without assistive device, even though she had a walker and a cane in her residence. Observed a pinkish scar on Patient 5’s left upper shin; skin appeared intact. Also observed a scab (a dry, rough protective crust that forms over a cut or wound during healing) on Patient 5’s left shin, open to air. During an interview with RN 3 on 3/19/2025 at 12 p.m., RN 3 stated she had stopped doing wound treatment on Patient 5 for a couple weeks now because both wounds had healed. RN 3 was asked if she notified the physician regarding Patient 5’s wound progress and if there was an order from the physician to discontinue wound care. RN 3 stated, “I’m pretty sure I let the doctor know. Look, there is no more open wound, there’s only a scab, she doesn’t need the wound care anymore.” During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 3/20/2025 at 3 p.m., the DPCS reviewed the Skilled Nursing Note, dated 3/13/2025 and 3/18/2025, for Patient 5. The DPCS confirmed that based on the notes, there was no indication wound care was done. The DPCS stated if the wound got better or healed, the nurse had to notify the physician. The DPCS stated, based on the patient’s wound condition, the physician might want to order a different treatment or discontinue the treatment. After the DPCS reviewed Patient 5’s electronic health record, the DPCS confirmed there was no physician notification regarding Patient 5’s wound progress. The DPCS also confirmed there was no order to discontinue the wound care for Patient 5. Per DPCS, even though the nurse considered Patient 5’s wounds had improved or healed, she still had to notify the physician and obtain an order before stopping the wound care. During a review of the HHA’s policy and procedure, titled “Monitoring Patient’s Response/Reporting to Physician,” revised November 2021, the policy and procedure indicated that the patient’s physician will be contacted when significant changes in the patient’s condition occurred. Based on the communication with the physician, a verbal order will be obtained for any change in the plan of care and communicated to all appropriate team members to ensure that care is provided according to the revised plan of care. During a review of the HHA’s policy and procedure, titled “Ongoing Assessments,” revised November 2021, the policy and procedure indicated the clinician will report changes in condition and clinical issues to the physician. Based on the findings of the reassessment, change/verbal orders will be generated and forwarded to the physician as needed.”

“Communication with all physicians CFR(s): 484.60(d)(1) Standard: Coordination of Care. The HHA must: (1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, a healthcare organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure communication with all the physicians involved in the plan of care were documented for one of 17 sampled patients (Patient 2). This failure had the potential to negatively affect Patient 2’s physical and psychosocial well-being related to the lack of communication with the physician/s issuing orders to address Patient 2’s needs. During a review of Patient 2’s General Acute Care Hospital 1 (GACH 1) physician (MD) notes, dated 1/18/2025, the GACH 1 MD notes indicated Patient 2 has the following diagnoses: 1. Diabetes Mellitus type 2 (DM 2, chronic disorder characterized by difficulty in blood sugar control and poor wound healing) with bilateral moderate non-proliferative diabetic retinopathy (moderate damage to the blood vessels in the retina of both eyes as a complication of DM 2) 2. DM 2 with microalbuminuria (presence of albumin in the urine as an early sign of kidney damage related to DM 2) 3. DM 2 with peripheral neuropathy (complication of diabetes that damages the nerves in the hands, feet, legs, and arms) 4. Diabetic foot ulcer (open wound on the foot that develops in people with diabetes) 5. Severe bilateral open-angle glaucoma (increased pressure in the eyes due to eye fluid not draining properly, causing potential optic nerve damage that can lead to vision loss or blindness) 6. Hypertension (HTN or high blood pressure (BP), a condition where the force of blood against the artery walls is consistently too high) 7. Osteoarthritis (degenerative joint disease characterized by pain, stiffness, and reduced mobility) During a review of Patient 2’s Medical Record form, titled “Patient Information,” the “Patient Information” indicated Patient 2’s Start of Care (SOC) date of 2/11/2025 with a primary diagnosis of nonsurgical wound dressing change/removal and a secondary diagnosis of DM 2 with foot ulcer. During a review of Patient 2’s Medical Record form, titled “OASIS-E1 Start of Care (OASIS – SOC),” dated 2/11/2025, the “OASIS-SOC” indicated Patient 2’s preferred language is Spanish and would need and want an interpreter to communicate with a doctor or health care staff. The “OASIS-SOC” indicated: 1. Patient 2 did not have any impairment in cognition (mental action or process of acquiring knowledge and understanding). 2. Patient 2 has an additional order for skilled nursing (SN) visits twice a week for 1 week and thrice a week for 2 weeks effective 2/11/2025. 3. Physician must be notified if systolic BP (pressure in the arteries when the heart contracts and pumps blood throughout the body with normal values less than 120 millimeters of mercury [mmHg]) is greater than 160 and/or less than 95 mmHg. 4. Physician must be notified if diastolic BP (pressure in the arteries when the heart is resting between beats with normal values less than 80 mmHg) is greater than 100 and/or less than 50. 5. Patient 2 is at risk for polypharmacy and for falls. 6. Physician must be notified if fasting blood sugar is greater than 250 milligrams per deciliter (mg/dL) and less than 70 mg/dL. 7. Physician must be notified if random blood sugar is greater than 250 mg/dL and/or less than 70 mg/dL. 8. No need for “diabetic supplies” was identified (Box was not checked). 9. Patient 2 and caregiver were not “independent of glucometer use.” During a review of Patient 2’s active medical record, titled “Patient Medication Record” as of 3/18/2025, the “Patient Medication Record” indicated some of Patient 2’s medications as ordered by the physician: 1. Timolol maleate ophthalmic (eye drops to treat glaucoma) 0.5% - ml – Instill 1 drop in both eyes every morning 2. Diclofenac sodium external 1% (topical gel used to relieve arthritis pain in the joints) - Apply 4 Grams to affected area/s twice a day as needed for pain. 3. Acetaminophen (medication to treat pain or fever) 500 mg 2 tablets by mouth every 6 hours as needed for pain or fever. 4. Gabapentin (medication that can treat nerve pain) 100 mg 1 capsule by mouth daily at bedtime. 5. Tramadol hydrochloride (controlled substance to treat moderate to severe pain) 50 mg 1 tablet by mouth twice a day as needed for severe pain. 6. Lisinopril (medication to treat HTN) 40 mg 1 tablet orally daily 7. Atenolol (medication to treat HTN) 25 mg 2 tablets orally twice a day 8. Patient 2 has no medications ordered for her DM 2 on file. During a joint home visit on 3/19/2025 at 11:37 AM, with Registered Nurse 1 (RN 1) at Patient 2’s residence, Patient 2 was observed awake, alert, oriented, and Spanish-speaking with no caregiver at the bedside. Patient 2’s first BP reading on the right upper arm was 166/71 and BP reading on the left upper arm was 161/78. RN 1 asked Patient 2 if she took her morning medications and Patient 2 responded, “Yes.” During a concurrent review of Patient 2’s home medications with RN 1, Patient 2’s active medical record, titled “Patient Medication Record” for period 2/11/2025 – 4/11/2025 were compared with the medication bottles present in Patient 2’s home. The observations were as follows: 1. Timolol eye drops was missing. Patient 2 was unable to provide a clear response if Patient 2 was still administering the Timolol maleate eye drops. 2. Patient 2 stated she was not using diclofenac sodium gel for pain and was taking Tylenol (brand name of acetaminophen) 650 milligrams 2 tablets for arthritis pain. 3. Patient 2 stated her physician instructed her (Patient 2 was unable to recall the date) to discontinue all of her previously prescribed medications. 4. Patient 2 took out new medication bottles from a brown paper bag on her bed. All of the following new medications had a fill date of 3/11/2025 (date the prescription medication was refilled). Patient 2 stated her physician prescribed new medications (Patient 2 was unable to recall the date), including 1) Jardiance (antidiabetic medication) 25 mg ½ tablet by mouth once daily, 2) Lisinopril 20 mg 1 tablet by mouth twice daily, 3) Amlodipine (medication to treat HTN) 10 mg by mouth once daily, 4) Metoprolol tartrate (medication to treat HTN) 100 mg 1 tablet by mouth twice a day, and 5) Pradaxa (blood thinner to treat/prevent blood clots and reduce the risk of stroke) 110 mg 1 capsule by mouth twice a day. 5. Patient 2 stated she did not know her blood sugar level and she did not have a glucometer (medical device used to measure level of sugar in a person’s blood). When asked what Jardiance was prescribed for, Patient 2 was unable to state its indications. Patient 2 also stated she did not take her BP regularly as she did not have a BP monitor (medical device used to measure BP). 6. The “Medication Profile” section in Patient 2’s HHA home binder was not updated with Patient 2’s current medications. 7. The “Patient Blood Sugar Log/Diary” and “Patient’s Vital Signs Log/Diary” sections in Patient 2’s HHA home binder were not filled out by Patient 2 and/or Patient 2’s caregivers. During a follow-up interview on 3/19/2025 at 12:30 PM, RN 1 was aware Patient 2 was diabetic, but Patient 2 stated upon admission to the HHA that Patient 2 was “borderline” diabetic. RN 1 stated he did not check Patient 2’s blood sugar because there was no physician’s order to check Patient 2’s blood sugar level/s. RN 1 stated Patient 2’s BP was higher than usual, so RN 1 he would report it to the physician. RN 1 stated he was not aware that Patient 2 had no glucometer and BP monitor. RN 1 stated the HHA would not be able to provide these medical devices to Patient 2, but RN 1 would be able to call the physician to order these devices for Patient 2 to ensure regular BP and blood sugar monitoring were done at home. During a telephone interview on 3/20/2025 at 10:16 AM, Patient 2’s family member (FM 2), who was physically present with Patient 2 at the time, stated Patient 2 did not have a glucometer and BP monitor for a long time, and Patient 2 could not recall the last time Patient 2 took her blood sugar level. FM 2 stated per Patient 2, the HHA nurses always took Patient 2’s BP but “never said anything” about Patient 2’s BP. FM 2 stated she accompanied Patient 2 to her primary physician’s visit about 2 weeks prior to the home visit on 3/19/2025 and obtained new medications, including an antidiabetic medication. FM 2 stated she accompanied Patient 2 to her cardiologist (physician specializing in the care of heart and blood vessels) appointment about a week prior to the home visit on 3/19/2025 and obtained new BP medications. FM 2 stated per Patient 2, “nobody checks” all of her medications with her (Patient 2). During an interview on 3/20/2025 at 1:07 PM, the DPCS stated the SN (in general) must ask that patient (in general) if he/she checked her blood sugar at each home visit. The DPCS stated if instructed by the physician to check blood sugar daily and the patient is not doing it, SN must notify the patient’s physician. The DPCS stated if the patient is diabetic, but the physician has no orders for blood sugar checks or any antidiabetic medications, the SN could act as a patient advocate and call the physician to ask for an order on how to monitor the blood glucose—whether it is Hemoglobin A1c (HbAC1, blood test that measures the average blood sugar level over the past 2-3 months) every 3 months, blood sugar checks every SN visit, or patient to check own blood sugar combined with SN teachings regarding the importance of regular blood sugar monitoring. In addition, the DPCS stated the SN must also check patient’s BP at every home visit and report to the physician any abnormal values (values outside of the parameters specified on the physician’s order) and provide teachings regarding the importance of regular BP monitoring. The DPCS stated the SN could inform the physician if the patient has no glucometer or BP monitor, so the orders could be placed on behalf of the patient. During a concurrent interview and record review of Patient 2’s medical records on 3/21/2025 at 11:35 AM with the DPCS, the DPCS stated there was no documented evidence of communication with the physician regarding any need for Patient 2’s blood sugar monitoring and/or Patient 2 not having a glucometer or blood pressure monitor. The DPCS stated there was no documented evidence of communication with the physician to clarify the continuation or discontinuation of all the medications in Patient 2’s Patient Medication Record. The DPCS stated all patient medication bottles must be reviewed at every SN home visit. The DPCS stated it was important to keep the medication list accurate and updated to prevent medication errors or any adverse effects from duplicate therapy, drug interactions, or noncompliance.” During a review of the HHA’s policy and procedures (P&P 1), titled “Initial and Comprehensive Assessment,” dated 11/2021, P&P 1 indicated the following: 1. A plan of care must be developed and authorized by the physician utilizing information gathering during the initial and comprehensive assessment. The patient’s physician is consulted for approval if additions or modifications to the plan of care are required after the assessment is completed. 2. All baseline data must be used in measuring the patient’s progress towards goals identified by the patient and achievement of desired measurable outcomes identified by the organization. Other relevant information must be documented in the patient’s clinical record, including the following: a. A physical assessment, including blood pressure, pulse, temperature, respirations, skin, pain status, nutritional status, and other relevant data related to pertinent physical findings. b. Patient’s medical and psychosocial history, including pertinent diagnosis and prognosis c. Patient’s and family’s/caregiver’s educational needs, abilities, motivation, and readiness to learn d. Equipment presently in the home and potentially needed by the patient. e. Specific, individualized patient needs and problems pertinent to the care being provided. During a review of HHA’s policy and procedures (P&P 2), titled “Ongoing Assessments,” dated 11/2021, P&P 2 indicated the following: 1. Based on each reassessment, the plan of care, including problems, needs, goals, and outcomes must be reviewed and revised accordingly by the clinician. 2. The physician must be notified to verify any changes in medications, which might interact or be duplicative with other patient medications, and treatment/interventions that require physician approval. 3. During each home visit, the appropriate clinician must re-evaluate the patient according to the problems identified during the initial visit and thereafter. The clinician must reassess the patient for patient’s compliance to treatment and/or medications. 4. Based on the findings of the reassessment, change/verbal orders must be generated and forwarded to the physician as needed.”

“Integrate all orders CFR(s): 484.60(d)(2) Integrate orders from all physicians or allowed practitioners involved in the plan of care to assure the coordination of all services and interventions provided to the patient. This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to integrate orders from all physicians or allowed practitioners involved in the plan of care to assure coordination of all services and interventions provided to two of seventeen sampled patients (Patient 2 and Patient 5). This failure had the potential to the development of an incomplete plan of care for the patients that could affect the care and services received by the patients. b. During a review of Patient 5’s Patient Information, the Patient Information indicated Patient 5 was admitted to the HHA on 2/25/2025, with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (a type of bandage or covering used to protect and promote healing of wounds that does not require surgery). During a review of the Start of Care order addendum, dated 2/25/2025, the Start of Care order addendum indicated the physician ordered the following wound treatment for the left lower leg bottom: Cleanse with normal saline, pat dry, apply triple antibiotic ointment, left open to air, daily. During a review of Patient 5’s Home Health Certification and Plan of Care, for the certification period of 2/25/2025 to 4/25/2025, the Home Health Certification and Plan of Care indicated Occupational Therapy (a form of therapy for those recuperating from physical or mental illness that encourages rehabilitation through the performance of activities required in daily life) visit twice a week for one week. The Home Health Certification and Plan of Care did not indicate the frequency for Skilled Nurse (SN, licensed nurse in general). The mental status, psychosocial status, DME (durable medical equipment, refers to medical devices and equipment prescribed by a healthcare provider for a patient’s routine, long-term use, such as wheelchairs, walkers, and oxygen tank) and supplies, prognosis (the predicted course and outcome of a disease or medical condition), safety measures, nutritional requirements, functional limitations, and activities permitted sections in the predicted course and outcome of a disease or medical condition Home Health Certification and Plan of Care for Patient 5 were left blank. There was no wound care treatment indicated in the Home Health Certification and Plan of Care. During a concurrent record review and interview with RN 3 on 3/19/2025 at 12:05 p.m., RN 3 reviewed the Home Health Certification and Plan of Care for Patient 5. RN 3 confirmed that the Home Health Certification and Plan of Care did not include the wound care order. RN 3 stated she would check the Home Health Connect (HHC) application on her cellular phone if she wanted to know about a patient’s orders. RN 3 stated HHC was a communication tool used by the HHA staff. Per RN 3, the communication in HHC, including the orders are to be used internally by the staff, and it was not part of the patient’s chart. RN 3 stated the wound care orders still needed to be recorded on Patient 5’s Home Health Certification and Plan of Care. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 3/20/2025 at 12:20 p.m., the DPCS confirmed that Patient 5’s Home Health Certification and Plan of Care, for the certification period of 2/25/2025 to 4/25/2025, were missing mental status, psychosocial status, DME and supplies, prognosis, safety measures, nutritional requirements, functional limitations, activities permitted, and wound care treatment orders. The DPCS stated the wound care order should have been included in the patient’s Home Health Certification and Plan of Care. The DPCS stated the Home Health Certification and Plan of Care served as a guideline for the HHA staff. The DPCS stated by integrating all physician orders into the patient’s plan of care, the HHA would be able to ensure the patient received all the services or care ordered by the physician. During a review of the HHA’s policy and procedure, titled “Monitoring Patient’s Response/Reporting to Physician,” revised November 2021, the policy and procedure indicated that all physician (or other authorized licensed independent practitioner) orders shall be integrated into the plan of care.”

“Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, a healthcare organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure an accurate and up-to-date medication schedule/instructions was provided to two of 17 sampled patients (Patients 1&2). This failure had the potential to cause a decline in the patients’ physical well-being related to medication adverse effects and drug interactions from medication errors, such as duplicate therapy. A. During a review of Patient 1’s General Acute Care Hospital 1 (GACH 1’s) physician (MD) notes, dated 2/14/2025, the GACH 1 MD notes indicated Patient 1 had the following diagnoses: 1. Diabetes Mellitus Type 2 (DM 2, chronic disorder characterized by difficulty in blood sugar control and poor wound healing) with bilateral mild non-proliferative diabetic retinopathy (moderate damage to the blood vessels in the retina of both eyes as a complication of DM 2). 2. DM 2 with chronic kidney disease Stage 3. 3. DM 2 with severe malnutrition (state of severe nutrient deficiency that significantly impairs health and well-being). 4. Anemia (condition wherein body does not have enough health red blood cells to carry adequate oxygen due to several factors, including nutrient deficiencies). 5. Sacral pressure sore (damaged skin and tissue in the sacral area due to sustained pressure), unspecified stage. 6. Constipation (problem with passing stool). 7. Major depressive disorder (mood disorder that causes persistent feeing of sadness and loss of interest). During a review of Patient 1’s medical record, titled “Patient Information,” the “Patient Information” indicated Patient 1’s Start of Care (SOC) date of 3/5/2025 with a primary diagnosis of non-surgical wound dressing change or removal and a secondary diagnosis of Stage 2 sacral pressure sore. During a concurrent interview and record review of Patient 1’s home medications during a joint visit on 3/19/2025 at 9:55 AM, with the Director of Patient Care Services (DPCS) in the presence of Patient 1 and family member (FM 1), “Patient Medication Record” for period 3/5/2025 – 5/3/2025 was reviewed and compared with the medication bottles present in Patient 1’s home. The following medications were observed missing: 1. Sertraline hydrochloride (medication to treat depression) 50 milligrams (mg, unit of measurement of mass) 0.5 tablet by mouth daily 2. Acetaminophen (medication to treat pain or fever) 500 mg 1 tablet by mouth every 6 hours as needed for pain or fever. 3. Calcium Citrate-Vitamin D (supplement) 315-200 mg-unit 2 tablets by mouth twice a day 4. Multivitamin-minerals (supplement) 1 tablet by mouth daily 5. Lactulose (medication to treat constipation) 10 Grams/15 milliliters (ml, unit of measurement of volume) 30 ml by mouth twice a day as needed for constipation 6. Sennosides (medication to treat constipation) 8.6 mg 2 tablets by mouth daily as needed for constipation. Patient 1 was observed lying in bed, and was alert, oriented to name, place, date, and situation. FM 1 stated he was not aware of any missing medications, because the HHA nurse did not review with them Patient 1’s home medications at every home visit. During a concurrent observation with the DPCS, the “Medication Profile” section in Patient 1’s HHA home binder was not accurate and up to date with the current medications on file. During a follow-up interview on 3/19/2025 at 11:15 AM, the DPCS stated SN must check all medication bottles and compare with the Patient Medication Record and “Medication Profile” at each home visit to ensure the patient was taking the correct medication, dosage, frequency, and was compliant with the medication regimen. The DPCS stated although the SN would not be responsible for medication delivery to the patient’s home, the SN could verify with the patient or patient’s family who could pick up the patient’s medications from the pharmacy or could call the pharmacy and report the missing medications or medications on low supply to ensure timely delivery of medications to the patient’s home. The DPCS stated it was important to ensure patients take the medications as prescribed to avoid any decline in the patient’s condition due to the non-compliance with the medication regimen related to missing medications. During a telephone interview on 3/20/2025 at 3:23 PM, RN 2 stated he did not perform medication reconciliation at each home visit by checking the medication bottles against the Patient Medication Record because FM 2 would usually “step out” and due to the workload. RN 2 stated at times, there was not enough time to visit all his patients assigned for the week, which required him to conduct 10-13 patient home visits in a day. B. During a review of Patient 2’s General Acute Care Hospital 1 (GACH 1) physician (MD) notes, dated 1/18/2025, the GACH 1 MD notes indicated Patient 2 has the following diagnoses: 1. DM 2 with bilateral moderate non-proliferative diabetic retinopathy 2. DM 2 with microalbuminuria (presence of albumin in the urine as an early sign of kidney damage related to DM 2) 3. DM 2 with peripheral neuropathy (complication of diabetes that damages the nerves in the hands, feet, legs, and arms) 4. Diabetic foot ulcer (open wound on the foot that develops in people with diabetes) 5. Severe bilateral open-angle glaucoma (increased pressure in the eyes due to eye fluid not draining properly, causing potential optic nerve damage that can lead to vision loss or blindness) 6. Hypertension (HTN or high blood pressure (BP), a condition where the force of blood against the artery walls is consistently too high) 7. Osteoarthritis (degenerative joint disease characterized by pain, stiffness, and reduced mobility) During a review of Patient 2’s Medical Record form, titled “Patient Information,” the “Patient Information” indicated Patient 2’s Start of Care (SOC) date of 2/11/2025 with a primary diagnosis of nonsurgical wound dressing change/removal and a secondary diagnosis of DM 2 with foot ulcer. During a review of Patient 2’s Medical Record form, titled “OASIS-E1 Start of Care (OASIS – SOC),” dated 2/11/2025, the “OASIS-SOC” indicated Patient 2’s preferred language is Spanish and would need and want an interpreter to communicate with a doctor or health care staff. The “OASIS-SOC” indicated: 1. Patient 2 did not have any impairment in cognition (mental action or process of acquiring knowledge and understanding). 2. Patient 2 has an additional order for skilled nursing (SN) visits twice a week for 1 week and thrice a week for 2 weeks effective 2/11/2025. 3. Physician must be notified if systolic BP (pressure in the arteries when the heart contracts and pumps blood throughout the body with normal values less than 120 millimeters of mercury [mmHg]) is greater than 160 and/or less than 95 mmHg. 4. Physician must be notified if diastolic BP (pressure in the arteries when the heart is resting between beats with normal values less than 80 mmHg) is greater than 100 and/or less than 50. 5. Patient 2 is at risk for polypharmacy and for falls. 6. Physician must be notified if fasting blood sugar is greater than 250 milligrams per deciliter (mg/dL) and less than 70 mg/dL. 7. Physician must be notified if random blood sugar is greater than 250 mg/dL and/or less than 70 mg/dL. 8. No need for “diabetic supplies” was identified (Box was not checked). 9. Patient 2 and caregiver were not “independent of glucometer use.” During a review of Patient 2’s active medical record, titled “Patient Medication Record” as of 3/18/2025, the “Patient Medication Record” indicated some of Patient 2’s medications as ordered by the physician: 1. Timolol maleate ophthalmic (eye drops to treat glaucoma) 0.5% - ml – Instill 1 drop in both eyes every morning 2. Diclofenac sodium external 1% (topical gel used to relieve arthritis pain in the joints) - Apply 4 Grams to affected area/s twice a day as needed for pain. 3. Acetaminophen (medication to treat pain or fever) 500 mg 2 tablets by mouth every 6 hours as needed for pain or fever. 4. Gabapentin (medication that can treat nerve pain) 100 mg 1 capsule by mouth daily at bedtime. 5. Tramadol hydrochloride (controlled substance to treat moderate to severe pain) 50 mg 1 tablet by mouth twice a day as needed for severe pain. 6. Lisinopril (medication to treat HTN) 40 mg 1 tablet orally daily 7. Atenolol (medication to treat HTN) 25 mg 2 tablets orally twice a day 8. Patient 2 has no medications ordered for her DM 2 on file. During a joint home visit on 3/19/2025 at 11:37 AM with Registered Nurse 1 (RN 1) at Patient 2’s residence, Patient 2 was observed awake, alert, oriented, and Spanish-speaking with no caregiver at the bedside. Patient 2’s first BP reading on the right upper arm was 166/71 and BP reading on the left upper arm was 161/78. RN 1 asked Patient 2 if she took her morning medications and Patient 2 responded, “Yes.” During a concurrent review of Patient 2’s home medications with RN 1, Patient 2’s active medical record, titled “Patient Medication Record” for period 2/11/2025 – 4/11/2025 were compared with the medication bottles present in Patient 2’s home. The observations were as follows: 1. Timolol eye drops was missing. Patient 2 was unable to provide a clear response if Patient 2 was still administering the Timolol maleate eye drops. 2. Patient 2 stated she was not using diclofenac sodium gel for pain and was taking Tylenol (brand name of acetaminophen) 650 milligrams 2 tablets for arthritis pain. 3. Patient 2 stated her physician instructed her (Patient 2 was unable to recall the date) to discontinue all of her previously prescribed medications. 4. Patient 2 took out new medication bottles from a brown paper bag on her bed. All of the following new medications had a fill date of 3/11/2025 (date the prescription medication was refilled). Patient 2 stated her physician prescribed new medications (Patient 2 was unable to recall the date), including 1) Jardiance (antidiabetic medication) 25 mg ½ tablet by mouth once daily, 2) Lisinopril 20 mg 1 tablet by mouth twice daily, 3) Amlodipine (medication to treat HTN) 10 mg by mouth once daily, 4) Metoprolol tartrate (medication to treat HTN) 100 mg 1 tablet by mouth twice a day, and 5) Pradaxa (blood thinner to treat/prevent blood clots and reduce the risk of stroke) 110 mg 1 capsule by mouth twice a day. 5. Patient 2 stated she did not know her blood sugar level and she did not have a glucometer (medical device used to measure level of sugar in a person’s blood). When asked what Jardiance was prescribed for, Patient 2 was unable to state its indications. Patient 2 also stated she did not take her BP regularly as she did not have a BP monitor (medical device used to measure BP). 6. The “Medication Profile” section in Patient 2’s HHA home binder was not updated with Patient 2’s current medications. 7. The “Patient Blood Sugar Log/Diary” and “Patient’s Vital Signs Log/Diary” sections in Patient 2’s HHA home binder were not filled out by Patient 2 and/or Patient 2’s caregivers. During a follow-up interview on 3/19/2025 at 12:30 PM, RN 1 he was aware Patient 2 was diabetic, but Patient 2 stated upon admission to the HHA that Patient 2 was “borderline” diabetic. RN 1 stated he did not check Patient 2’s blood sugar because there was no physician’s order to check Patient 2’s blood sugar level/s. RN 1 stated Patient 2’s BP was higher than usual, so RN 1 he would report it to the physician. RN 1 stated he was not aware that Patient 2 had no glucometer and BP monitor. RN 1 stated the HHA would not be able to provide these medical devices to Patient 2, but RN 1 would be able to call the physician to order these devices for Patient 2 to ensure regular BP and blood sugar monitoring were done at home. During a telephone interview on 3/20/2025 at 10:16 AM, Patient 2’s family member (FM 2), who was physically present with Patient 2 at the time, stated Patient 2 did not have a glucometer and BP monitor for a long time, and Patient 2 could not recall the last time Patient 2 took her blood sugar level. FM 2 stated per Patient 2, the HHA nurses always took Patient 2’s BP but “never said anything” about Patient 2’s BP. FM 2 stated she accompanied Patient 2 to her primary physician’s visit about 2 weeks prior to the home visit on 3/19/2025 and obtained new medications, including an antidiabetic medication. FM 2 stated she accompanied Patient 2 to her cardiologist (physician specializing in the care of heart and blood vessels) appointment about a week prior to the home visit on 3/19/2025 and obtained new BP medications. FM 2 stated per Patient 2, “nobody checks” all of her medications with her (Patient 2). During an interview on 3/20/2025 at 1:07 PM, the DPCS stated the SN (in general) must ask that patient (in general) if he/she checked her blood sugar at each home visit. The DPCS stated if instructed by the physician to check blood sugar daily and the patient is not doing it, SN must notify the patient’s physician. The DPCS stated if the patient is diabetic, but the physician has no orders for blood sugar checks or any antidiabetic medications, the SN could act as a patient advocate and call the physician to ask for an order on how to monitor the blood glucose—whether it is Hemoglobin A1c (HbAC1, blood test that measures the average blood sugar level over the past 2-3 months) every 3 months, blood sugar checks every SN visit, or patient to check own blood sugar combined with SN teachings regarding the importance of regular blood sugar monitoring. In addition, the DPCS stated the SN must also check patient’s BP at every home visit and report to the physician any abnormal values (values outside of the parameters specified on the physician’s order) and provide teachings regarding the importance of regular BP monitoring. The DPCS stated the SN could inform the physician if the patient has no glucometer or BP monitor, so the orders could be placed on behalf of the patient. During a concurrent interview and record review of Patient 2’s medical records on 3/21/2025 at 11:35 AM with the DPCS, the DPCS stated the Patient Medication Record and “Medication Profile” were not updated and stated it was important to keep the medication lists accurate and updated to ensure no medication errors or prevent adverse effects of duplicate therapy, drug interactions, or noncompliance with the medication regimen. During a review of the HHA’s policy and procedures (P&P), titled “Medication Profile,” dated 11/2021, the P&P indicated the following: 1.The patient must have a current, accurate medication profile in the clinical record. 2. Medication profiles must be updated for each change to reflect current medications, new, and/or discontinued medications. 3. A drug regimen review must be performed with a the additional of a new medication to identify drug/food interactions, potential adverse effects and drug reactions, ineffective drug therapy, duplicate drug therapy, and noncompliance with drug therapy. 4. Each patient must receive appropriate written material for specific medications he/she is receiving. The material must contain information on actions of the medications, potential side effects, contraindications that patient should be aware of, and any special instructions when taking the specific medication.”

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that provides skilled nursing and other therapeutic services to patients in their own homes, rather than in a traditional healthcare facility setting) failed to ensure the patients’ clinical records contained completed comprehensive and ongoing assessments and plans of care for five of seventeen sampled patients (Patient 1, Patient 2, Patient 5, Patient 9, and Patient 13). This failure resulted in an incomplete clinical records leading to misinformation and non-continuity of care and services to be provided to these patients certified to receive the home health benefits. e. During a review of Patient 13’s “Patient Information” indicated a start of care (SOC) date of 1/25/2025, current episode of 1/25/2025-3/25/2025, with a primary diagnosis of encounter for change or removal of non-surgical wound dressing (an acute or chronic wound which is not secondary to surgical intervention and a material applied to a wound to protect it, promote healing, and prevent infection, without requiring surgery). During a review of Patient 13’s Home Health Certification and Plan of Care (POC, a document that maps out needs and services supplied for a homebound patient, as well as the patient’s family/caregiver), with a certification period from 1/25/2025 to 3/25/2025, the Home Health Certification and POC indicated in the orders and treatments section which include: SN (Skilled Nurse) frequency of once a week for week one, twice a week for week two and notify physician of fasting blood sugar greater than 250 or less than 70, and random blood sugar greater than 250 or less than 70. During a concurrent observation and interview on 3/19/2025, at 10:45 a.m., with the Registered Nurse (RN4), in Patient 13’s residence for a joint home visit, Patient 13 was comfortably sitting on his chair, alert, awake and oriented to his name, time, place and events. During interview with Patient 13, he stated that he goes to the laboratory every 3 months to have his hgba1c (a blood test that shows the average blood sugar level over the past 2-3 months, helping to diagnose and monitor diabetes) blood test done per his primary doctor’s order. Patient 13 stated that he does not check his blood sugar on a daily basis, stated he has the glucometer (a small, portable device used to measure blood sugar (glucose) levels, typically by pricking a fingertip and applying a drop of blood to a test strip inserted into the meter) provided by his primary doctor but he does not know if he needs to do a blood sugar check daily, stated nobody told him to do a daily blood sugar check and to write down the blood sugar readings. During concurrent review and interview at 11:07 a.m., with RN4, he stated that nurses are not allowed to check patient’s blood sugar since it is an invasive test, unless there is an order. RN 4 stated they provided teachings and encourage patients to do a routine blood sugar check. RN 4 stated patients supposed to keep a log of their blood sugar readings to monitor effectively if the current diabetic medications are appropriate or not, and to determine if there are any patterns of low blood sugar or high blood sugar episodes. During a concurrent review of Patient 13’s “RN (Registered Nurse) Skilled Nursing Visit,” dated 1/30/2025 and 2/7/2025, the RN skilled nursing visit indicated no documentation of blood sugar readings and teachings or education provided to Patient 13 regarding importance of checking his blood sugar levels. RN 4 confirmed that the RN skilled nursing visit notes dated 1/30/2025 and 2/7/2025 had no documentations of blood sugar readings and teachings or education provided to Patient 13 regarding importance of checking his blood sugar levels. RN 4 stated that Patient 13 was newly assigned to him and stated he only saw the patient for the third time. RN 4 stated that should have documented the teachings he provided to Patient 13 regarding importance of monitoring his blood sugar routinely to validate that it was done. RN 4 stated that it is important to have a routine blood sugar monitoring, stated that with no recorded blood sugars, stated will not be able to determine if the physician needs to be notified of blood sugar less than 70 or greater than 250 as indicated in Patient 13’s POC. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 3/20/2025 at 1:38 p.m., the DPCS confirmed that Patient 13’s skilled nursing visit notes dated 1/30/2025 and 2/7/2025 had no documentations of blood sugar readings and teachings or education provided to Patient 13 regarding importance of checking his blood sugar levels. DPCS confirmed that Patient 13’s clinical records for admission titled “History and Physical,” indicated the following orders that include: -Blood-glucose meter (One Touch Verio Flex Start) Miscellaneous kit, start date of 10/6/2023 and end date of 10/5/2025, use as directed to test blood sugar. -Lancets (a small, sharp, disposable needle-like device used to prick the skin, typically a fingertip, to obtain a small blood sample for testing blood sugar levels using a blood glucose meter), start date of 10/6/2023 and end date of 10/5/2025, use two times a day as directed to test blood sugar. DPCS confirmed that Patient 13’s “Patient Medication Record,” indicated that the blood glucometer and lancets and the frequency to test the blood sugar were not transcribed and included as active medications and/or treatments. DPCS stated that Patient 13’s history and physical records were the baseline of all admission orders to start, and all orders should have been transcribed including the glucometer, lancets and frequency of blood sugar checks or should have been communicated with the physician for the clarification if orders are still in need. DPCS stated that it is important for patients to have a routine blood sugar records to monitor and in relation to notify the physician if it is less than 70 or more than 250 as indicated in Patient 13’s POC. DPCS stated that visiting nurses should have documented the teachings they provided to patients regarding importance of monitoring his blood sugar routinely to validate that it was done. DPCS stated that nurses are not allowed to check patient’s blood sugar since it is an invasive test, unless there is a physician’s order. DPCS stated visiting nurses provided teachings and encourage patients to do a routine blood sugar check if needed. d. A review of Patient 9’s Personal Information indicated a Start of Care (SOC) date of 1/20/2025 with a primary diagnosis of Encounter for change or removal of nonsurgical wound dressing and a secondary diagnosis of unspecified open wound of left great toe without damage to nail. A review of Patient 9’s medical record titled Home Health Certification and Plan of Care (POC) for the certification period of 1/20/2025 to 3/20/2025, indicated an order for Skilled Nurse (SN) frequency for three times a week for four weeks, effective 1/20/2025, and at every visit SN to perform teaching of wound management, perform skilled nursing assessment and notify medical director (MD) for any changes in condition, assess pain scale and perform medication management. The POC also indicated an order to notify the physician if the patient’s fasting blood sugar is greater than 250 or less than 70 or random blood sugar is greater than 250 or less than 70. During a review of Patient 9’s medical record titled, OASIS Resumption of Care dated 3/16/2025, the OASIS Resumption of Care indicated an order for frequency of SN visits for two times a week for six times a week for one week, then seven times a week for three weeks starting 3/17/2025 for wound care, rehospitalization prevention, pain management, medication management, and fall and safety prevention measures. During a joint home visit on 3/19/2025 at 12:11 pm, with Registered Nurse 1 (RN1) at Patient 9’s home, Patient 9 was observed awake, alert, oriented to date of birth, date and location, wearing glasses and sitting upright on a chair. During a review of Patient 9’s Skilled nursing visit notes/assessments dated 2/4/2025, 2/9/2025, 2/11/2025, 2/13/2025, 2/16/2025, 2/17/2025, 2/23/2025, and 2/24/2025, they indicated that the SN signed the note/assessments, but they were left blank. During a concurrent interview and record review on 3/20/2025 at 12:20pm with the Director of Patient Care Services (DPCS), Patient 9’s skilled nursing visit notes/assessment were reviewed. The DPCS stated and confirmed that Patient 9’s Skilled nursing visit notes/assessment dated 2/4/2025, 2/9/2025, 2/11/2025, 2/13/2025, 2/16/2025, 2/17/2025, 2/23/2025, and 2/24/2025 were not filled out and left blank, being incomplete. The DPCS stated clinical records submitted by a skilled nurse is deemed complete when it is filled out, submitted within the deadline and signed and dated. The DPCS stated the HHA has different field skilled nurse teams, and each has a supervisor, who on a weekly basis, should be reviewing the skilled nurse’s documentation, pulling any incomplete documents and discussing it with the nurse who did it. c. During a review of Patient 5’s Patient Information, the Patient Information indicated that Patient 5 was admitted to the HHA on 2/25/2025, with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (a type of bandage or covering used to protect and promote healing of wounds that does not require surgery). During a review of Patient 5’s Home Health Certification and Plan of Care, for the certification period of 2/25/2025 to 4/25/2025, the Home Health Certification and Plan of Care indicated Occupational Therapy (a form of therapy for those recuperating from physical or mental illness that encourages rehabilitation through the performance of activities required in daily life) visit twice a week for one week. The Home Health Certification and Plan of Care did not indicate the frequency for Skilled Nurse (SN, licensed nurse in general). The mental status, psychosocial status, DME (durable medical equipment, refers to medical devices and equipment prescribed by a healthcare provider for a patient’s routine, long-term use, such as wheelchairs, walkers, and oxygen tank) and supplies, prognosis (the predicted course and outcome of a disease or medical condition), safety measures, nutritional requirements, functional limitations, and activities permitted sections in the predicted course and outcome of a disease or medical condition Home Health Certification and Plan of Care for Patient 5 were left blank. There was no wound care treatment indicated in the Home Health Certification and Plan of Care. During a review of Patient 5’s RN Skilled Nursing Note, dated 3/1/2025, completed by Registered Nurse 3 (RN 3), the wound addressed on this Visit section indicated RN 3 performed the following treatment: - On left lower leg (top): Cleanse with normal saline (a sterile solution of sodium chloride [salt] in water that has a number of uses in medicine, including cleaning wounds), pat dry, apply triple antibiotic ointment, left open to air. - On left lower leg (bottom): Cleanse with normal saline, pat dry, apply triple antibiotic ointment, left open to air. During a concurrent record review and interview with RN 3 on 3/19/2025 at 12:05 p.m., RN 3 reviewed the Home Health Certification and Plan of Care for Patient 5. RN 3 confirmed that the Home Health Certification and Plan of Care did not include the wound care order. RN 3 stated she would check the Home Health Connect (HHC) application on her cellular phone if she wanted to know about a patient’s orders. RN 3 stated HHC was a communication tool used by the HHA staff. Per RN 3, the communication in HHC, including the orders are to be used internally by the staff, and it was not part of the patient’s clinical record. RN 3 stated the wound care orders still needed to be recorded on Patient 5’s Home Health Certification and Plan of Care. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 3/20/2025 at 12:20 p.m., the DPCS confirmed that Patient 5’s Home Health Certification and Plan of Care, for the certification period of 2/25/2025 to 4/25/2025, were missing assessments of patient’s mental status, psychosocial status, DME and supplies, prognosis, safety measures, nutritional requirements, functional limitations, activities permitted, and wound care treatment orders. The DPCS stated having a complete, accurate, and timely submission of the clinical record was crucial to ensure quality care, patient safety, and also to comply with the regulation. During a review of the HHA’s policy and procedure, titled “Assembly of Clinical Record,” revised November 2021, the policy and procedure did not indicate that clinical records must be complete and accurate. The policy and procedure indicated that clinical records will be assembled in chronological order, most recent first. a. During a review of Patient 1’s General Acute Care Hospital 1 (GACH 1’s) physician (MD) notes, dated 2/14/2025, the GACH 1 MD notes indicated Patient 1 had the following diagnoses: 1. Diabetes Mellitus Type 2 (DM 2, chronic disorder characterized by difficulty in blood sugar control and poor wound healing) with bilateral mild non-proliferative diabetic retinopathy (moderate damage to the blood vessels in the retina of both eyes as a complication of DM 2), 2. DM 2 with chronic kidney disease Stage 3 3. DM 2 with severe malnutrition (state of severe nutrient deficiency that significantly impairs health and well-being) 4. Anemia (condition wherein body does not have enough health red blood cells to carry adequate oxygen due to several factors, including nutrient deficiencies) 5. Sacral pressure sore (damaged skin and tissue in the sacral area due to sustained pressure), unspecified stage 6. Constipation (problem with passing stool) 7. Major depressive disorder (mood disorder that causes persistent feeing of sadness and loss of interest) During a review of Patient 1’s medical record, titled “Patient Information,” the “Patient Information” indicated Patient 1’s Start of Care (SOC) date of 3/5/2025 with a primary diagnosis of non-surgical wound dressing change or removal and a secondary diagnosis of Stage 2 sacral pressure sore. During a review of Patient 1’s medical record, titled “Home Health Certification and Plan of Care,” for Certification Period 3/5/2025 – 5/3/2025, it indicated the following: 1. Skilled Nurse (SN) to perform wound care as ordered using infection control measures and standard precautions to sacral wound and left buttock wounds three times a week for 2 weeks by cleansing with normal saline (salt solution to clean wounds), then patting dry, applying Medihoney (honey-based wound treatment), and covering with Mepilex dressing (foam dressing designed to absorb wound drainage). 2. Patient 1’s wound care required supplies that included gloves, gauze pads, dressing supplies, normal saline, Medihoney, and Mepilex. During a concurrent interview and record review of Patient 1’s home medications while on a joint visit on 3/19/2025 at 9:55 AM with the Director of Patient Care Services (DPCS) at Patient 1’s residence, in the presence of Patient 1 and Patient 1’s family member (FM 1), Patient 1 was observed lying in bed, and was alert, oriented to name, place, date, and situation. The DPCS stated Registered Nurse 2 (RN 2) performed Patient 1’s wound care on 3/18/2025, but RN 2 ran out of wound care supplies (Medihoney and Mepilex). Patient 1 was observed with a Mepilex dressing on the Stage 2 sacral pressure sore. No wound dressing supplies were observed in Patient 1’s room. The DPCS stated Patient 1 had no dressing on the left buttock Stage 2 pressure sore because it was “healed.” In addition, Patient 1 also stated she was informed “last week” that she was diabetic and that “someone” (unable to identify) would come and check her blood sugar regularly, but “no one has checked [the blood sugar] since then.” The DPCS stated the SN did not check Patient 1’s blood sugar during home visits, because there was no physician’s order to perform blood sugar checks. The DPCS stated Patient 1 was not on any antidiabetic medication. Furthermore, during concurrent interview and record review of Patient 1’s home medications, Patient 1’s active medical record, titled “Patient Medication Record” for period 3/5/2025 – 5/3/2025 was compared with the medication bottles present in Patient 1’s home. The following medications were observed missing: 1. Sertraline hydrochloride (medication to treat depression) 50 milligrams (mg, unit of measurement of mass) 0.5 tablet by mouth daily 2. Acetaminophen (medication to treat pain or fever) 500 mg 1 tablet by mouth every 6 hours as needed for pain or fever. 3. Calcium Citrate-Vitamin D (supplement) 315-200 mg-unit 2 tablets by mouth twice a day 4. Multivitamin-minerals (supplement) 1 tablet by mouth daily 5. Lactulose (medication to treat constipation) 10 Grams/15 milliliters (ml, unit of measurement of volume) 30 ml by mouth twice a day as needed for constipation 6. Sennosides (medication to treat constipation) 8.6 mg 2 tablets by mouth daily as needed for constipation. Patient 1 was observed lying in bed, and was alert, oriented to name, place, date, and situation. FM 1 stated he was not aware of any missing medications, because the HHA nurse did not review with them Patient 1’s home medications at every home visit. During a concurrent observation with the DPCS, the “Medication Profile” section in Patient 1’s HHA home binder was not accurate and up-to-date with the current medications on file. During a follow-up interview on 3/19/2025 at 11:15 AM, the DPCS stated SN must order wound care supplies in advance before they run out to ensure there was no interruption of wound care due to possible delayed wound healing and wound infection. The DPCS also stated the SN could act as a patient advocate and ask with the physician if he/she has any additional orders in relation to DM 2, since Patient 1 was diabetic and uncontrolled blood glucose could delay wound healing. The DPCS stated SN must check all medication bottles and compare with the Patient Medication Record and “Medication Profile” at each home visit to ensure the patient was taking the correct medication, dosage, frequency, and was compliant with the medication regimen. The DPCS stated although the SN would not be responsible for medication delivery to the patient’s home, the SN could verify with the patient or patient’s family who could pick up the patient’s medications from the pharmacy or could call the pharmacy and report the missing medications or medications on low supply to ensure timely delivery of medications to the patient’s home. The DPCS stated it was important to ensure patients take the medications as prescribed to avoid any decline in the patient’s condition due to the non-compliance with the medication regimen related to missing medications. During a telephone interview on 3/20/2025 at 3:23 PM, RN 2 stated Patient 1 could not check her own blood glucose levels. RN 2 stated he was not aware of her baseline blood glucose levels or any interventions to address Patient 1’s DM 2. RN 2 stated he should have reinforced diabetic teachings pertaining to the importance of adhering to a diabetic diet, keeping a log of blood glucose levels, involving the family, because uncontrolled blood glucose levels could lead to slower wound healing and hospitalization/s. RN 2 stated due to the workload and time constraints, RN 2 was not able to do the DM 2 interventions. RN 2 stated at times, there was not enough time to visit all his patients assigned for the week, which required him to conduct 10-13 patient home visits a day. In addition, RN 2 stated on several occasions, wound care supplies had to be ordered multiple times before they arrived at the patient’s home. RN 2 stated missing wound care supplies could lead to delayed wound healing. Furthermore, RN 2 stated he could not perform medication reconciliation at each home visit by checking the medication bottles against the Patient Medication Record and “Medication Profile” because FM 2 would usually “step out” and due also to the workload. During a concurrent interview and record review of Patient 1’s medical records on 3/21/2025 at 11:35 AM with the DPCS, the DPCS stated there was no documented evidence of blood sugar readings, communication with the physician and/or with GACH 1 RN liaisons regarding any need for Patient 1’s blood glucose monitoring, and Patient 1’s issues with wound care supplies. The DPCS stated there was no documented evidence of communication with the physician/s to clarify the continuation or discontinuation of all the medications in Patient 1’s Patient Medication Record. The DPCS stated Patient 1’s “Patient Medication Record” was not updated and stated it was important to keep the medication list accurate and updated to ensure no medication errors or prevent adverse effects of duplicate therapy, drug interactions, or noncompliance. b. During a review of Patient 2’s General Acute Care Hospital 1 (GACH 1) physician (MD) notes, dated 1/18/2025, the GACH 1 MD notes indicated Patient 2 has the following diagnoses: 1. DM 2 with bilateral moderate non-proliferative diabetic retinopathy 2. DM 2 with microalbuminuria (presence of albumin in the urine as an early sign of kidney damage related to DM 2) 3. DM 2 with peripheral neuropathy (complication of diabetes that damages the nerves in the hands, feet, legs, and arms) 4. Diabetic foot ulcer (open wound on the foot that develops in people with diabetes) 5. Severe bilateral open-angle glaucoma (increased pressure in the eyes due to eye fluid not draining properly, causing potential optic nerve damage that can lead to vision loss or blindness) 6. Hypertension (HTN or high blood pressure (BP), a condition where the force of blood against the artery walls is consistently too high) 7. Osteoarthritis (degenerative joint disease characterized by pain, stiffness, and reduced mobility) During a review of Patient 2’s Medical Record form, titled “Patient Information,” the “Patient Information” indicated Patient 2’s Start of Care (SOC) date of 2/11/2025 with a primary diagnosis of nonsurgical wound dressing change/removal and a secondary diagnosis of DM 2 with foot ulcer. During a review of Patient 2’s Medical Record form, titled “OASIS-E1 Start of Care (OASIS – SOC),” dated 2/11/2025, the “OASIS-SOC” indicated Patient 2’s preferred language is Spanish and would need and want an interpreter to communicate with a doctor or health care staff. The “OASIS-SOC” indicated: 1. Patient 2 did not have any impairment in cognition (mental action or process of acquiring knowledge and understanding). 2. Patient 2 has an additional order for skilled nursing (SN) visits twice a week for 1 week and thrice a week for 2 weeks effective 2/11/2025. 3. Physician must be notified if systolic BP (pressure in the arteries when the heart contracts and pumps blood throughout the body with normal values less than 120 millimeters of mercury [mmHg]) is greater than 160 and/or less than 95 mmHg. 4. Physician must be notified if diastolic BP (pressure in the arteries when the heart is resting between beats with normal values less than 80 mmHg) is greater than 100 and/or less than 50. 5. Patient 2 is at risk for polypharmacy and for falls. 6. Physician must be notified if fasting blood sugar is greater than 250 milligrams per deciliter (mg/dL) and less than 70 mg/dL. 7. Physician must be notified if random blood sugar is greater than 250 mg/dL and/or less than 70 mg/dL. 8. No need for “diabetic supplies” was identified (Box was not checked). 9. Patient 2 and caregiver were not “independent of glucometer use.” During a review of Patient 2’s active medical record, titled “Patient Medication Record” as of 3/18/2025, the “Patient Medication Record” indicated some of Patient 2’s medications as ordered by the physician: 1. Timolol maleate ophthalmic (eye drops to treat glaucoma) 0.5% - ml – Instill 1 drop in both eyes every morning 2. Diclofenac sodium external 1% (topical gel used to relieve arthritis pain in the joints) - Apply 4 Grams to affected area/s twice a day as needed for pain. 3. Acetaminophen (medication to treat pain or fever) 500 mg 2 tablets by mouth every 6 hours as needed for pain or fever. 4. Gabapentin (medication that can treat nerve pain) 100 mg 1 capsule by mouth daily at bedtime. 5. Tramadol hydrochloride (controlled substance to treat moderate to severe pain) 50 mg 1 tablet by mouth twice a day as needed for severe pain. 6. Lisinopril (medication to treat HTN) 40 mg 1 tablet orally daily 7. Atenolol (medication to treat HTN) 25 mg 2 tablets orally twice a day 8. Patient 2 has no medications ordered for her DM 2 on file. During a joint home visit on 3/19/2025 at 11:37 AM with Registered Nurse 1 (RN 1) at Patient 2’s residence, Patient 2 was observed awake, alert, oriented, and Spanish-speaking with no caregiver at the bedside. Patient 2’s first BP reading on the right upper arm was 166/71 and BP reading on the left upper arm was 161/78. RN 1 asked Patient 2 if she took her morning medications and Patient 2 responded, “Yes.” During a concurrent review of Patient 2’s home medications with RN 1, Patient 2’s active medical record, titled “Patient Medication Record” for period 2/11/2025 – 4/11/2025 were compared with the medication bottles present in Patient 2’s home. The observations were as follows: 1. Timolol eye drops was missing. Patient 2 was unable to provide a clear response if Patient 2 was still administering the Timolol maleate eye drops. 2. Patient 2 stated she was not using diclofenac sodium gel for pain and was taking Tylenol (brand name of acetaminophen) 650 milligrams 2 tablets for arthritis pain. 3. Patient 2 stated her physician instructed her (Patient 2 was unable to recall the date) to discontinue all of her previously prescribed medications. 4. Patient 2 took out new medication bottles from a brown paper bag on her bed. All of the following new medications had a fill date of 3/11/2025 (date the prescription medication was refilled). Patient 2 stated her physician prescribed new medications (Patient 2 was unable to recall the date), including 1) Jardiance (antidiabetic medication) 25 mg ½ tablet by mouth once daily, 2) Lisinopril 20 mg 1 tablet by mouth twice daily, 3) Amlodipine (medication to treat HTN) 10 mg by mouth once daily, 4) Metoprolol tartrate (medication to treat HTN) 100 mg 1 tablet by mouth twice a day, and 5) Pradaxa (blood thinner to treat/prevent blood clots and reduce the risk of stroke) 110 mg 1 capsule by mouth twice a day. 5. Patient 2 stated she did not know her blood sugar level and she did not have a glucometer (medical device used to measure level of sugar in a person’s blood). When asked what Jardiance was prescribed for, Patient 2 was unable to state its indications. Patient 2 also stated she did not take her BP regularly as she did not have a BP monitor (medical device used to measure BP). 6. The “Medication Profile” section in Patient 2’s HHA home binder was not updated with Patient 2’s current medications. 7. The “Patient Blood Sugar Log/Diary” and “Patient’s Vital Signs Log/Diary” sections in Patient 2’s HHA home binder were not filled out by Patient 2 and/or Patient 2’s caregivers. During a follow-up interview on 3/19/2025 at 12:30 PM, RN 1 he was aware Patient 2 was diabetic, but Patient 2 stated upon admission to the HHA that Patient 2 was “borderline” diabetic. RN 1 stated he did not check Patient 2’s blood sugar because there was no physician’s order to check Patient 2’s blood sugar level/s. RN 1 stated Patient 2’s BP was higher than usual, so RN 1 he would report it to the physician. RN 1 stated he was not aware that Patient 2 had no glucometer and BP monitor. RN 1 stated the HHA would not be able to provide these medical devices to Patient 2, but RN 1 would be able to call the physician to order these devices for Patient 2 to ensure regular BP and blood sugar monitoring were done at home. During a telephone interview on 3/20/2025 at 10:16 AM, Patient 2’s family member (FM 2), who was physically present with Patient 2 at the time, stated Patient 2 did not have a glucometer and BP monitor for a long time, and Patient 2 could not recall the last time Patient 2 took her blood sugar level. FM 2 stated per Patient 2, the HHA nurses always took Patient 2’s BP but “never said anything” about Patient 2’s BP. FM 2 stated she accompanied Patient 2 to her primary physician’s visit about 2 weeks prior to the home visit on 3/19/2025 and obtained new medications, including an antidiabetic medication. FM 2 stated she accompanied Patient 2 to her cardiologist (physician specializing in the care of heart and blood vessels) appointment about a week prior to the home visit on 3/19/2025 and obtained new BP medications. FM 2 stated per Patient 2, “nobody checks” all of her medications with her (Patient 2). During an interview on 3/20/2025 at 1:07 PM, the DPCS stated the SN (in general) must ask that patient (in general) if he/she checked her blood sugar at each home visit. The DPCS stated if instructed by the physician to check blood sugar daily and the patient is not doing it, SN must notify the patient’s physician. The DPCS stated if the patient is diabetic, but the physician has no orders for blood sugar checks or any antidiabetic medications, the SN could act as a patient advocate and call the physician to ask for an order on how to monitor the blood glucose—whether it is Hemoglobin A1c (HbAC1, blood test that measures the average blood sugar level over the past 2-3 months) every 3 months, blood sugar checks every SN visit, or patient to check own blood sugar combined with SN teachings regarding the importance of regular blood sugar monitoring. In addition, the DPCS stated the SN must also check patient’s BP at every home visit and report to the physician any abnormal values (values outside of the parameters specified on the physician’s order) and provide teachings regarding the importance of regular BP monitoring. The DPCS stated the SN could inform the physician if the patient has no glucometer or BP monitor, so the orders could be placed on behalf of the patient. During a concurrent interview and record review of Patient 2’s medical records on 3/21/2025 at 11:35 AM with the DPCS, the DPCS stated there was no documented evidence of blood sugar readings, communication with the physician and/or with GACH 1 RN liaisons regarding clarification of Patient 2’s diet, any need for Patient 2’s blood glucose monitoring, and Patient 2 not having a glucometer or blood pressure machine. The DPCS stated there was no documented evidence of communication with the physician to clarify the continuation or discontinuation of all the medications in Patient 2’s Patient Medication Record. The DPCS stated Patient 2’s “Patient Medication Record” was not updated and stated it was important to keep the medication list accurate and updated to ensure no medication errors or prevent adverse effects of duplicate therapy, drug interactions, or noncompliance. During a review of the HHA’s policy and procedures (P&P), titled Assembly of Clinical Record,” dated 11/2021, the P&P indicated the following: 1. The purpose of the policy was to establish a consistent structure for the clinical record. 2. Documentation must be assembled in chronological order, most recent order first. 3. Documentation must include that which is provided directly by the organization and by contracted personnel. 4. All patient care documentation must be submitted by the staff within 72 hours from the time care was provided. 5. The contents of the record must be assembled as follows: a. Section II: Physician Orders -Plan of Care/Treatment -Verbal Orders -Pharmaceutical Orders b. Section III: Clinical Notes -Case Conference Forms -Communication Notes c. Section IV: Plan of Care -Nursing Care Plan -Medication Profile d. Section V: Nurses Clinical Notes -Initial Assessment, Comprehensive Assessment, and Ongoing Assessments -Clinical Notes”

“Contact information for the patient CFR(s): 484.110(a)(4) Contact information for the patient, the patient’s representative (if any), and the patient’s primary caregiver(s); This Element is not met as evidenced by: based on record review and interview the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure the clinical record included emergency contact information for one of seventeen sampled patients (Patient 13). This failure had the potential to delay in facilitating rapid response and communication in case of unforeseen medical or other emergencies, ensuring timely notification and support for the patient and their family. During a review of Patient 13’s “Patient Information” indicated a start of care (SOC) date of 1/25/2025, current episode of 1/25/2025-3/25/2025, with a primary diagnosis of encounter for change or removal of non-surgical wound dressing (an acute or chronic wound which is not secondary to surgical intervention and a material applied to a wound to protect it, promote healing, and prevent infection, without requiring surgery). During a review of Patient 13’s Home Health Certification and Plan of Care (POC, a document that maps out needs and services supplied for a homebound patient, as well as the patient’s family/caregiver), with a certification period from 1/25/2025 to 3/25/2025, the Home Health Certification and POC indicated in the orders and treatments section which include: SN (Skilled Nurse) frequency of once a week for week one, twice a week for week two. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 3/21/2025 at 2:15 p.m., the DPCS confirmed and stated that Patient 13’s Patient Information indicated no emergency contact information. DPCS stated that she was unsure why Patient 13’s emergency contact was left blank and an emergency contact information should have been included in there in case there will be circumstances that patient is unable to get hold of. The HHA was unable to provide a policy and procedure related to patient’s emergency contact information to be included during the intake process.”