Amax Care Services, Inc.

“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 observation, interview and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing [a specialized level of medical care provided to patients who require assistance with daily activities and medical treatments] and other therapeutic service to a patient at home) failed to record all patient care orders in the plan of care (POC, a detailed, written document outlining the patient’s specific needs, including skilled nursing care, rehabilitative, and supportive care provided to a patient at home) and to revise (update) the plan of care for two of four sampled patients (Patient 8 and Patient 10). This failure could lead to patients not receiving the necessary services, causing a decline in health status and impacting their quality of care and well-being. b. During a review of Patient 10’s Face Sheet (front page of the chart that contains a summary of basic information about the patient), the face sheet indicated a start of care date (SOC) of 6/25/2024, with a diagnosis which included encounter for change or removal of nonsurgical wound dressing, stage 2 pressure ulcer (partial-thickness loss of skin, presenting as a shallow open sore or wound) of the right and left buttocks, and pleural effusion (a condition where excess fluid accumulates in the pleural space, the thin area between the lungs and the chest wall). During a review of Patient 10’s Home Health Certification and POC (a form that a physician signs to attest to a patient’s need for home health care and to outline the services to be provided) for the certification period starting from 8/19/2025 to 10/17/2025, the Home Health Certification and POC form indicated the skilled nurse (provides advanced medical care, often requiring specialized training and certifications) frequency of visits to two visits for 1 week and three visits for 8 weeks plus 3 visits as needed for any disease process complications that may arise affecting care plan. During a review of Patient 10’s medical record form titled “Order/Telephone Orders” dated 9/3/2025, the Order/Telephone Orders indicated that Patient 11 had a new skin tear (wound that occurs when the skin is stretched or pulled apart, causing a separation of the skin layers) to right lower leg with the instructions to cleanse the wound with wound cleanser, dress with xeroform (a moist yellow dressing that covers the wound), cover with bordered gauze dressing and secure with tape. During a joint home visit at Patent 10’s residence, on 10/7/2025 at 11:15 a.m., with the licensed vocational nurse (LVN 4), Patient 10 was seen in a wheelchair, awake and alert but hard-of-hearing. A skin tear on the patient’s right lower leg was treated by LVN 4. During a concurrent interview and record review, on 10/8/2025 at 12:25 p.m. with the Director of Patient Care Services (DPCS 2), the DPCS 2 reviewed Patient 10’s most current Home Health Certification and POC form dated 8/19/2025 to 10/17/2025, and the Order/Telephone Orders form dated 9/3/2025. The DPCS 2 stated Patient 11 had a new treatment order for right lower leg skin tear on 9/3/2025, but the POC was not updated with the new order. The DPCS 2 stated POC should have been updated to reflect the current wound care treatment for the patient. During a review of the HHA’s policy and procedure (P&P) titled “Care Plan Process”, dated 1/5/2018, the P&P indicated a written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days or as patient’s condition warrants. The plan of care will be revised as frequently as deemed necessary by the clinician, based on the ongoing assessments of the patient. Revision dates will be noted in the plan of care. a. During a review of Patient 8’s Home Health Certification and Plan of Care – (also known as Plan of Care or POC), effective from 8/23/2025 to 10/21/2025, the Home Health Certification and Plan of Care indicated that Patient 2 was admitted to the HHA on 6/25/2025 with a primary diagnosis of laceration without foreign body (a cut or tear in the skin or soft tissues that does not contain any foreign objects, such as glass, metal, or dirt) of right forearm, subsequent encounter. Patient 8’s Home Health Certification and Plan of Care, effective from 8/23/2025 to 10/21/2025, indicated the following integumentary interventions under Orders for Discipline and Treatments: Skilled nurse (a licensed nurse in general) to assess abdominal peritoneal dialysis (PD – a treatment for kidney failure that uses the lining of the abdomen/peritoneum as a filter to remove waste products and excess fluid from the blood) catheter (a thin, hollow, flexible tube used in medicine to transfer liquids into or out of the body) site every visit and instruct patient/caregiver on signs/symptoms of PD catheter site complications reportable to physician. The Home Health Certification and Plan of Care did not identify any lacerations or wounds and there were no orders related to lacerations or skin tears, which was indicated as the patient’s primary diagnosis. During a review of Skilled Nursing Visit Note for Patient 8, dated 9/19/2025, the Skilled Nursing Visit Note indicated left elbow skin tear, left shin skin tear, and left leg skin tear. The Skilled Nursing Visit Note indicated that wound care performed as follows for the left shin skin tear and left leg skin tear: Removed soiled dressing gently, cleansed with normal saline solution (a mixture of sodium chloride [salt] and water that has several uses in medicine, including cleaning wounds), patted dry, applied Xeroform gauze (a sterile, non-adherent gauze dressing impregnated with petrolatum and 3% bismuth tribromophenate [an antimicrobial component] used to maintain a moist wound environment, protect the tissue, and promote healing), covered and secured with island dressing (a type of wound dressing). During a review of Skilled Nursing Visit Note for Patient 8, dated 9/24/2025, the Skilled Nursing Visit Note indicated right arm skin tear, left upper arm/elbow skin tear, right lateral upper leg skin tear, and left anterior shin skin tear. The Skilled Nursing Visit Note indicated that wound care performed as follows for the left upper arm/elbow skin tear, right lateral upper leg skin tear, and left anterior shin skin tear: Removed soiled dressing gently, cleansed with normal saline solution, patted dry, applied Xeroform gauze, covered and secured with island dressing. During a joint home visit with the Director of Patient Care Services Designee (DPCSD) on 10/7/2025 at 10:25 a.m., Patient 8 was observed alert and oriented to person, place, and time (aware of own identity, location, and the current date and time). Observed Patient 8 ambulating (walking) independently. Observed multiple bruises and wound dressings on Patient 8’s limbs. After taking Patient 8’s vital signs (physiological measurements that indicate a person’s basic health status), the DPCSD was observed performing wound care for multiple wounds: skin tear on right lateral leg, left anterior leg (shin), left inner thigh, and left arm. The DPCSD first cleansed the wounds with a wound cleanser, patted dry, applied Xeroform gauze only on the right lateral leg wound, and then applied silicon gel bordered foam dressing on the right lateral leg, left anterior leg (shin), left inner thigh wounds. The wound on the left arm was left open to air. During a concurrent interview and record review with the DPCSD on 10/7/2025 at 11:45 p.m., the DPCSD reviewed he Home Health Certification and Plan of Care, effective from 8/23/2025 to 10/21/2025, for Patient 8. The DPCSD stated there were wound care orders for Patient 8 even though they were not written in the plan of care. The DPCSD stated the wound care orders for Patient 8 should be available in the electronic health records. During a review of a form called “Order/Telephone Orders,” dated 9/6/2025, in the electronic health records, the form indicated that the physician ordered the following wound care interventions for Patient 8: SN (skilled nurse) to assess and perform aseptic wound care to left elbow and right elbow skin tears once a week for one week, then twice a week for two weeks, then reassess: Cleanse with normal saline, pat dry, apply Xeroform to wound bed, covered with bordered foam dressing. During a concurrent interview and record review with the Director of Patient Care Services (DPCS) on 10/8/2025 at 11:30 a.m., the DPCS reviewed Patient 8’s Home Health Certification and Plan of Care/POC, effective from 8/23/2025 to 10/21/2025, Skilled Nursing Visit Note, dated 9/19/2025 and 9/24/2025, and Order/Telephone Orders,” dated 9/6/2025. The DPCS stated that all patient care orders, including telephone orders, needed to be recorded in the patient’s plan of care. The DPCS stated the plan of care was what guided staff in providing care for the patient. During a review of the HHA’s policy and procedure (P & P), titled “Care Plan Process,” addendum 1/5/2018, the P & P indicated that all orders, including verbal orders, must be recorded in the plan of care.”

“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 therapeutics service to a patient at home) failed to meet the Condition of Participation (conditions that healthcare organizations must meet in order to begin and continue participating in Medicare [is federal health insurance for people 65 or older, and some people under 65 with certain disabilities or conditions] and Medicaid [a joint federal and state program that helps cover medical costs for some people with limited income and resources] programs) for Comprehensive Assessment of Patients as follows: 1. The HHA failed to conduct an initial assessment within 48 hours of the referral, for one of 7 sampled patients (Patient 7). This failure could delay Patient 7’s identified needs for treatment and intervention that could directly affect the patient’s quality of care and well-being. (Refer to G514). 2. The HHA nursing staff failed to perform skin assessment of the patient’s wound for two of 7 sampled patients (Patient 2 and Patient 4). This failure could result in undetected changes in wound condition, leading to delayed healing and an increased risk of infection, thereby prolonging the patient’s pain and discomfort. (Refer to G528). 3. The HHA failed to properly assess the patients’ continuing need for home care services for one of 7 sampled patients (Patient 5). This failure led to the delivery of unnecessary home health service to Patient 5 who did not require skilled nursing care. (Refer to G532). 4. The HHA staff failed to review all the medications and update the medication profile with currently used medications for two of 7 sampled patients (Patient 2 and Patient4). This deficient practice had the potential to put Patient 2 and Patient 4 at risk for medication errors and adverse drug reactions (a harmful, unintended reaction to a medication). (Refer to G536). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily (written law) mandated compliance with Federal regulation for Comprehensive Assessment of patients to ensure the highest quality of care were being provided to patients certified to receive home health care and 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 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 Care Planning, Coordination of Services, and Quality of Care as follows: 1 The HHA failed to ensure interventions and reassessment of pain were implemented in accordance with the plan of care (POC, a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) to one of 7 sampled patients (Patient 4). This failure has the potential to result in ineffective pain management to Patient 4. (Refer to G572). The HHA failed to ensure that the plan of care included all medications, treatments, equipment, patient-specific intervention and education for one of seven sampled patients (Patient 2). This failure had the potential to affect the quality of care and the safety of Patient 2. (Refer to G574). The HHA failed to notify the physician regarding the pain during wound care for one of seven sampled patients (Patient 2). This failure resulted in Patient 2 not having adequate pain management. (Refer to G590). HHA failed to integrate orders from all physicians involved in patient care for two of seven sampled patients (Patient 1 and Patient 2). This failure had the potential to result in a lack of coordination of services and interventions provided to Patient 1 and Patient 2. (Refer to G604). The HHA failed to provide a copy of the plan of care for two of seven sampled patients (Patient 2 and Patient 4). This failure had the potential to result in patients and families not understanding what services to expect from the HHA, the purpose of each service, and when to expect the services. (Refer to G612). The cumulative effect of these systemic practices 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 Care Planning, Coordination of Services, and Quality of Care to ensure the quality of care is provided to patients certified to receive 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, an organization that delivers skilled nursing [a specialized level of medical care provided to patients who require assistance with daily activities and medical treatments] and other therapeutic service to a patient at home) failed to ensure interventions and reassessment of pain were implemented in accordance with the plan of care (POC) to one of 7 sampled patients (Patient 4). This deficient practice has the potential to result in ineffective pain management to Patient 4. Findings: During a review of Patient 4’s Face Sheet (front page of the chart that contains a summary of basic information about the patient), the face sheet indicated a start of care date (SOC) of 10/31/2024, with a diagnoses which included infection and inflammatory reaction due to indwelling urethral catheter (a flexible tube inserted into the urethra to drain urine from the bladder into a collection bag), benign prostatic hyperplasia (a common condition in older men where the prostate gland gets larger, potentially causing urinary problems), and retention of urine (the inability to completely empty your bladder). During a review of Patient 4’s Home Health Certification and POC (a form that a physician signs to attest to a patient’s need for home health care and to outline the services to be provided) for the certification period from 6/28/2025 to 8/26/2025, the Home Health Certification and POC form indicated the skilled nurse (provides advanced medical care, often requiring specialized training and certifications) frequency of visits of two visits a week for 8 weeks plus 2 visits as needed to complete a comprehensive assessment (a thorough health evaluation that includes a patient’s complete health history and physical examination) of all body systems, checked vital signs (essential measurements that indicate a person’s basic physiological status, which includes body temperature, pulse rate [the number of times the heart beats per minute], respiratory rate [the number of breaths taken per minute], and blood pressure [the force of blood against the artery walls]), and pain management interventions, assessment of pain, effectiveness of pain management regimen and skilled teaching related to pain management. During a review of Patient 4’s Skilled Nursing Visit Note, dated 7/15/2025 and 7/21/2025, the notes indicated Patient 4 was experiencing aching pain rated 5/10 (on a pain scale of 0 – 10: 0=no pain; 10=unbearable pain), to his lower back. There was no documented evidence of any interventions or reassessment conducted for the pain. During a concurrent interview and record review, on 8/8/2025 at 12:15 p.m., with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 4’s Skilled Nursing Visit Note dated 7/15/2025 and 7/21/2025. The DPCS stated comprehensive pain management should include pain intervention that was implemented and the effectiveness of the intervention. The DPCS acknowledged that in the case for Patient 4, it was not done. During a review of the agency’s policy and procedure (P&P) titled, “Pain Assessment Scale”, dated 8/29/2011, the P&P indicated the purpose of the policy is to assess level of pain or discomfort and seek intervention that provides relief and a sense of well­being. Pain will be evaluated using a 1 - 10 scale. Pain control will be assessed at each visit. The physician will be notified, if medical or analgesic interventions are needed. During a review of the agency’s P&P titled “Plan of Care”, dated 8/29/2011, the P&P indicated a plan of care shall be established for every patient accepted for care and incorporated in the patient’s medical record. The plan of care will 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.”

“Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This Standard is not met as evidenced by: Based on observation, 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 provide a copy of the current plan of care (POC, a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) for two of seven sampled patients (Patient 2 and Patient 4). This failure had the potential to result in patients and families not understanding what services to expect from the HHA, the purpose of each service, and when to expect provision of the services. Findings: b. During a review of Patient 4’s Face Sheet (front page of the chart that contains a summary of basic information about the patient), the face sheet indicated a start of care date (SOC) of 10/31/2024, with a diagnosis which included infection and inflammatory reaction due to indwelling urethral catheter (a flexible tube inserted into the urethra to drain urine from the bladder into a collection bag), benign prostatic hyperplasia (a common condition in older men where the prostate gland gets larger, potentially causing urinary problems), and retention of urine (the inability to completely empty your bladder). During a review of Patient 4’s Home Health Certification and POC (a form that a physician signs to attest to a patient’s need for home health care and to outline the services to be provided) for the certification period from 6/28/2025 to 8/26/2025, the Home Health Certification and POC form indicated the skilled nurse (provides advanced medical care, often requiring specialized training and certifications) frequency of visits of two visits a week for 8 weeks plus 2 visits as needed to complete a comprehensive assessment (a thorough health evaluation that includes a patient’s complete health history and physical examination) of all body systems, checked vital signs (essential measurements that indicate a person’s basic physiological status, which includes body temperature, pulse rate [the number of times the heart beats per minute], respiratory rate [the number of breaths taken per minute], and blood pressure [the force of blood against the artery walls]), and perform wound care interventions to patient’s stage 3 sacrum pressure injury ((Full-thickness loss of skin. Dead and black tissue may be visible). During a joint home visit at Patent 4’s residence, on 8/7/2025 at 10:00 a.m., with the registered nurse (RN 2), Patient 4 was observed laying in a hospital bed, awake, alert, and oriented x 3 (to person, place and time), accompanied by his caregiver (PCG 1). A review of Patient 4’s home health agency folder located inside the patient’s home indicated there was no copy of his Home Health Certification and Plan of Care. During an interview, RN 2 stated the agency does not provide a current copy of the POC at patient’s home. During an interview, on 8/8/2025 at 12:15 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated the HHA should provide patients a copy of their current POC at home to ensure all healthcare providers have a shared understanding of the patient’s needs and treatment and facilitates communication among the care team. The DPCS stated and acknowledged the findings. During a review of the HHA’s policy and procedure (P&P) titled “Plan of Care”, dated 8/29/2011, the P&P indicated a plan of care shall be established for every patient accepted for care and incorporated in the patient’s medical record. All clinicians involved in the patient’s care, either directly or indirectly, will contribute to the plan of care. The patient and family/caregiver will participate in decisions regarding the plan of care whenever possible. a. During a review of Patient 2’s Home Health Certification and Plan of Care (also known as POC), effective from 8/2/2025 to 9/30/2025, the Home Health Certification and Plan of Care indicated that Patient 2 was admitted to the HHA on 6/14/2023 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (a visit done by a healthcare provider to examine and to manage a wound that was not created or treated by surgery). The Home Health Certification and Plan of Care, effective from 8/2/2025 to 9/30/2025, indicated the Skilled Nurse (licensed nurse in general) visit frequency was twice a week for eight weeks and two as needed visits for any wound care/disease related complications that may arise. The SN would be responsible for performing wound care on left lateral (outer part) lower leg and right anterior (front part) lower leg and medication management. During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 8/7/2025 at 11:30 a.m., Patient 2 was observed alert and oriented to person, place, and time (aware of own identity, location, and the current date and time). Observed Patient 2 ambulating (walking) independently. During the joint home visit, Patient 2’s home folder was reviewed with LVN 1. There was no copy of the Home Health Certification and Plan of Care observed inside the home folder. Patient 2 stated that all the home health paperwork was inside the home folder. During an interview with LVN 1 on 8/7/2025 at 12:04 p.m., LVN 1 stated that the HHA provided the POC for some patients. LVN 1 stated she had never seen a copy of the POC at Patient 2’s residence. LVN 1 stated she was not sure why only certain patients were provided with the copy of the POC.”

“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 interview and record review, the home health agency (HHA, an organization that delivers skilled nursing [a specialized level of medical care provided to patients who require assistance with daily activities and medical treatments] and other therapeutic service to a patient at home) failed to conduct an initial assessment within 48 hours of the referral, for one of 7 sampled patients (Patient 7). This failure could delay Patient 7’s identified needs for treatment and intervention that could directly affect the patient’s quality of care and well-being. Findings: During a review of Patient 7’s Face Sheet (front page of the chart that contains a summary of basic information about the patient), the face sheet indicated a start of care date (SOC) of 5/31/2025, with a diagnoses which included essential hypertension (high blood pressure), diabetes mellitus (DM-a disorder characterized by difficulty in blood sugar control and poor wound healing), and end-stage renal disease (ESRD-irreversible kidney failure). During a review of Patient 7’s referral order from GACH 1 (General Acue Care Hospital, a licensed hospital that offers 24-hour inpatient care), the referral order indicated Patient 7 was confined to her home and needs intermittent skilled nursing care, physical therapy (is treatment provided by a physical therapist or physical therapist assistant that helps people improve their movement and physical function) and/or speech therapy (a type of treatment that helps people improve their communication skills and address swallowing difficulties), or continues to need 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). The referral order was dated 5/26/2025. During a concurrent interview and record review, on 8/8/2025 at 12:15 p.m. with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 7’s clinical records and GACH 1 referral order dated 5/26/2025. The DPCS stated the HHA received the referral on 5/26/2025 and Patient 7 was discharged to home from GACH on 5/28/2025. The DPCS stated the initial assessment visit must be conducted within 48 hours of referral, or within 48 hours of the patient’s return home to determine the care needed by the patient. The DPCS stated and confirmed there was one day delay in performing the initial SOC assessment for Patient 7 and a physician order to delay the SOC had not been obtained prior to SOC. During a review of the HHA’s policy and procedure (P&P) titled “Initial Assessment”, dated 9/1/2011, the P&P indicated each patient admitted to the Home Health Agency program shall have a complete Initial Assessment performed and documented at the time of admission visit by a registered nurse, physical therapist or speech pathologist. The initial assessment visit must be performed either within 48 hours of the referral, within 48 hours of the patient’s return home, on the start of care date ordered by the physician (or other authorized licensed independent practitioner), or at the patient/family request with the approval of the physician (or another authorized licensed independent practitioner).”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum, the following information: (1) The patient’s current health, psychosocial, functional, and cognitive status; 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 therapeutics service to a patient at home) staff failed to perform skin assessment of the patient’s wound for two of 7 sampled patients (Patient 2 and Patient 4). This failure could result in undetected significant changes in wound condition, leading to delayed healing and an increased risk of infection, prolonging the patient’s pain and discomfort. Findings: b. During a review of Patient 4’s Face Sheet (front page of the chart that contains a summary of basic information about the patient), the face sheet indicated a start of care date (SOC) of 10/31/2024, with a diagnosis which included infection and inflammatory reaction due to indwelling urethral catheter (a flexible tube inserted into the urethra to drain urine from the bladder into a collection bag), benign prostatic hyperplasia (a common condition in older men where the prostate gland gets larger, potentially causing urinary problems), and retention of urine (the inability to completely empty your bladder). During a review of Patient 4’s Wound Note, dated 7/18/2025, the Wound Note indicated Patient 4 has a sacrum (triangular-shaped bone in the lower back, at the base of the spine) stage 3 pressure injury (full-thickness loss of skin, dead and black tissue may be visible) measuring 3 cm (centimeter, a unit of measurement) in length, and 4 cm in width. During a review of Patient 4’s Home Health Certification and Plan of Care (a form that a physician signs to attest to a patient’s need for home health care and to outline the services to be provided) for the certification period from 6/28/2025 to 8/26/2025, the Home Health Certification and Plan of Care form indicated the skilled nurse (SN- provides advanced medical care, often requiring specialized training and certifications) frequency of visits of two visits a week for 8 weeks plus 2 visits as needed to complete a comprehensive assessment (a thorough health evaluation that includes a patient’s complete health history and physical examination) of all body systems, checked vital signs (essential measurements that indicate a person’s basic physiological status, which includes body temperature, pulse rate [the number of times the heart beats per minute], respiratory rate [the number of breaths taken per minute], and blood pressure [the force of blood against the artery walls]), and to perform and instruct patient/caregiver to perform wound care to sacrum pressure injury stage 3 (full-thickness loss of skin, dead and black tissue may be visible), then re-assess. During a joint home visit at Patent 4’s residence, on 8/7/2025 at 10:00 a.m., with the registered nurse (RN 2), Patient 4 was observed laying in a hospital bed, awake, alert, and oriented x 3 (to person, place and time), accompanied by his caregiver (PCG 1). During the visit, RN 2 performed wound care treatment of the patient’s wound but did not properly assessed Patient 4’s Stage 3 sacral pressure injury, that includes examining the wound bed (the underlying tissue surface of a wound), wound edge, and peri-wound skin (the skin surrounding a wound), and evaluating size, depth, exudate (drainage that seeps out of wounds), odor and signs of infection. During an interview, RN 2 stated a wound care company comes once a week and does the skin assessment of the wound that includes wound measurement. During an interview, on 8/8/2025 at 12:15 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated field nurses should assessed patients’ wounds on every visit that includes current wound condition, the peri-wound skin, presence of drainage and signs of infection in order to monitor the progress of healing, identify and manage complications like infection, and ensure the effectiveness of the current treatment plan. During a review of the HHA’s undated policy and procedure (P&P) titled “Ongoing Assessments”, the P&P indicated 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. During each home visit, the clinician or other discipline will re-evaluate the patient according to the problems identified during the initial visit and subsequent visits. Using the standards of care identified by the organization, the clinician will reassess the patient (as appropriate) for: …skin integrity. a. During a review of Patient 2’s Home Health Certification and Plan of Care (POC, a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved), effective from 8/2/2025 to 9/30/2025, the Home Health Certification and Plan of Care indicated that Patient 2 was admitted to the HHA on 6/14/2023 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (a visit done by a healthcare provider to examine and to manage a wound that was not created or treated by surgery). The Home Health Certification and Plan of Care, effective from 8/2/2025 to 9/30/2025, indicated the Skilled Nurse (licensed nurse in general) visit frequency was twice a week for eight weeks and two as needed visits for any wound care/disease related complications that may arise. The SN would be responsible for completing a comprehensive assessment of all body systems with focus on integumentary system (the organ system that includes the skin and its accessory structures like hair, nails, and glands) related to left lateral (outer part) lower leg wound and right anterior (front part) lower leg wound. During a review of Patient 2’s Skilled Nursing Visit Note, dated 7/21/2025, the Skilled Nursing Visit Note, under Integumentary section, indicated there were no negative findings, color was within normal limits, and the skin was warm and dry. The box indicating “Wound – refer to diagram and wound assessment,” was not checked. The Skilled Interventions/Teachings section indicated the nurse performed wound care on left lower leg and right lower leg. There was no documentation on wound assessment, such as the characteristics of the wound bed (the base of a wound) and exudate/drainage (a fluid that leaks from blood vessels into surrounding tissues, often due to inflammation or injury), status of surrounding tissue, and if there was any indication of infection. During a review of Patient 2’s Skilled Nursing Visit Note, dated 7/25/2025, the Skilled Nursing Visit Note, under Integumentary section, indicated there were no negative findings, color was within normal limits, and the skin was warm and dry. The box indicating “Wound – refer to diagram and wound assessment,” was not checked. The Skilled Interventions/Teachings section indicated the nurse performed wound care on left lower leg and right lower leg. There was no documentation on wound assessment, such as the characteristics of the wound bed and exudate/drainage, status of surrounding tissue, and if there was any indication of infection. During a review of Patient 2’s Skilled Nursing Visit Note, dated 7/28/2025, the Skilled Nursing Visit Note, under Integumentary section, indicated there were no negative findings, color was within normal limits, and the skin was warm and dry. The box indicating “Wound – refer to diagram and wound assessment,” was checked The Skilled Interventions/Teachings section indicated the nurse performed wound care on left lower leg and right lower leg. There was no documentation on wound assessment, such as the characteristics of the wound bed and exudate/drainage, status of surrounding tissue, and if there was any indication of infection. During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 8/7/2025 at 11:30 a.m., Patient 2 was observed alert and oriented to person, place, and time (aware of own identity, location, and the current date and time). Observed Patient 2 ambulating (walking) independently. During the joint home visit, observed LVN 1 perform wound care on Patient 2’s venous stasis ulcer (a type of skin ulcer that occurs on the lower leg due to poor blood flow in the veins) on the left lateral lower leg. Observed LVN 1 cleaned the wound with wound cleanser and patted the wound bed dry. Observed LVN 1 cut the Ioplex dressing (a type of dressing that contains controlled release iodine [an antiseptic to prevent and treat infection]) to fit Patient 2’s wound. LVN 1 then applied Tetracyte topical spray (a topical [applied directly to body surfaces such as the skin] antibiotic used to prevent skin infections in minor cuts, scrapes, and burns) to the Ioplex dressing, followed by spreading Therahoney (a sterile, medical-grade Manuka honey used to treat a variety of wounds, including burns, cuts, and chronic wounds) on the Ioplex dressing. LVN 1 subsequently applied the Tetracyte and Therahoney-saturated Ioplex to Patient 2’s venous stasis ulcer on the left lateral lower leg and then covered it with a 6 x 6 Silicate silicone foam dressing (a type of dry dressing). LVN 1 applied a cut-off sock to keep the dressing in place. Did not observe LVN 1 measure the wound. During an interview with LVN 1 on 8/7/2025 at 12:29 p.m., when LVN 1 was asked the last time she took measurement of Patient 2’s wounds, LVN 1 stated, “I only measure the wound if there’s a change, whether it gets worse or it gets better. I will also take a picture if there’re any changes.” LVN 1 was asked what she used as a basis for determining change if she did not take measurements and/or pictures regularly. LVN 1 stated, “I’ve been seeing this patient for a long time, so I know what the wounds look like. I’ll know when it doesn’t look the same.” LVN 1 stated that since Patient 2 was also seen by a wound specialist weekly, assessing, including measuring the wounds, was the responsibility of the wound specialist. During an interview with the Director of Patient Care Services (DPCS) on 8/8/2025 at 10:33 a.m., the DPCS stated the visiting nurse was to measure and take picture of wounds weekly, per policy. The DPCS stated the staff should determine if a wound improved or worsened based on measurement, pictures, and other assessments such as the drainage or wound bed appearance. The DPCS stated that even though a wound specialist was seeing Patient 2 once a week, the HHA’s nurse still needed to assess the wound. During a review of the HHA’s policy and procedure (P & P), titled “Wound Assessment Procedure,” effective 8/29/11, the P & P indicated that wound assessments would be performed using Agency for Health Care Policy and Research (AHCPR) guidelines. The P & P indicated the following to be included in wound documentation: dimension and depth, status of wound base, presence/absence of undermining (a type of wound where the tissue under the edges of the wound erodes, creating a space or pocket beneath the surface, while the visible wound opening is smaller than the actual damaged area) and tunneling (a type of wound where channels or tracts extend into the surrounding tissue, creating tunnels beneath the skin’s surface), exudate/drainage, indication of infection, and status of surrounding tissue.”

“Continuing need for home care CFR(s): 484.55(c)(3) The patient’s continuing need for home 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 therapeutics service to a patient at home) failed to accurately assess the patient’s continuing need for home care services for one of 7 sampled patients (Patient 5). This failure led to the delivery of unnecessary home health services to the patient who did not require skilled nursing care. Findings: During a review of Patient 5’s Face Sheet (front page of the chart that contains a summary of basic information about the patient), the face sheet indicated a start of care date (SOC) of 3/17/2025, with a diagnosis which included sepsis (a life-threatening blood infection), gross hematuria (refers to the presence of blood in the urine), and end-stage renal disease (ESRD-irreversible kidney failure) . During a review of Patient 5’s Home Health Certification and Plan of Care (a form that a physician signs to attest to a patient’s need for home health care and to outline the services to be provided) for the certification period from 5/16/2025 to 7/14/2025, the Home Health Certification and Plan of Care form indicated the frequency of visits by the skilled nurse (SN- provides advanced medical care, often requiring specialized training and certifications) to once a week for 8 weeks plus 2 visits as needed to complete a comprehensive assessment (a thorough health evaluation that includes a patient’s complete health history and physical examination) of all body systems, assessed vital signs (essential measurements that indicate a person’s basic physiological status, which includes body temperature, pulse rate [the number of times the heart beats per minute], respiratory rate [the number of breaths taken per minute], and blood pressure [the force of blood against the artery walls]), and medication regimen including dosage/side effect/name/route/frequency/desired action/adverse reactions and compliance, and by the physical therapist (PT- a healthcare professional who helps people with injuries, disabilities, or health conditions improve their movement and function) to evaluate and treat. The goal included patient will remain free from signs and symptoms of sepsis and gross hematuria, patient/caregiver will verbalize understanding of the disease process and its associated care and treatment, and medication regimen, and will remain home safe with no complications. Discharge planning indicated for patient to be discharged to care of caregiver with physician follow-up when goals are met, or skilled care is no longer needed. During a phone interview, on 8/7/2025 at 12:04 p.m., with the licensed vocational nurse (LVN 2), LVN 2 stated Patient 5 was awake, alert, oriented x 3 (to person, place, and time), ambulatory using a walker, takes his medications as ordered, independent of his ADLs (activities of daily living- routine tasks/activities such as bathing, dressing, and toileting a person performs daily to care for themselves), had no wounds, no current hospitalization, no falls, goes to his doctor’s appointment regularly, and had good family support at home. During review of Patient 5’s SN Visit notes for the period starting from 5/16/2025 to 7/14/2025, the Visit notes indicated Patient 5’s vital signs were within normal range, there were no admissions to the hospital, no episodes of falls, no wound care performed, nor any evidence of the need for skilled nursing services to continue. However, Patient 5 was re-certified for another 60 days for continuous skilled nursing services. During a phone interview, on 8/7/2025 at 4:42 p.m. with the physical therapist (PT 1), PT 1 stated he visits Patient 5 at least once a week since the SOC in March 2025, as instructed by the HHA. PT 1 stated Patient 5 mostly required supervised level with his functional status (an individual’s ability to perform daily activities and tasks necessary for self-care, work, and social participation) and could not justify continued physical therapy service for 4-5 months. During a concurrent interview and record review, on 8/8/2025 at 12:15 p.m. with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 5 assessments and SN visit notes from 5/16/2025 to 7/14/2025. The DPCS stated Patient 5 had no recent hospitalization, no falls, no wound care, home health goals have been met, and should have been discharged. During a review of the HHA’s policy and procedure (P&P) titled “Discharge Criteria and Process”, dated 1/5/20218, the P&P indicated services will be terminated when the patient meets one (1) or more of the following discharge criteria: …the goals of home health have been attained or are no longer attainable.”

“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 delivers skilled nursing [a specialized level of medical care provided to patients who require assistance with daily activities and medical treatments] and other therapeutic service to a patient at home) ) staff failed to review all the medications and update the medication profiles with currently used medications for two of 7 sampled patients (Patient 2 and Patient 4). This deficient practice had the potential to put Patient 2 and Patient 4 at risk for medication errors and adverse drug reactions (a harmful, unintended reaction to a medication). Findings: b. During a review of Patient 4’s Face Sheet (front page of the chart that contains a summary of basic information about the patient), the face sheet indicated a start of care date (SOC) of 10/31/2024, with a diagnosis which included infection and inflammatory reaction due to indwelling urethral catheter (a flexible tube inserted into the urethra to drain urine from the bladder into a collection bag), benign prostatic hyperplasia (a common condition in older men where the prostate gland gets larger, potentially causing urinary problems), and retention of urine (the inability to completely empty your bladder). During a review of Patient 4’s Home Health Certification and Plan of Care (a form that a physician signs to attest to a patient’s need for home health care and to outline the services to be provided) for the certification period from 6/28/2025 to 8/26/2025, the Home Health Certification and Plan of Care form indicated the skilled nurse (SN- provides advanced medical care, often requiring specialized training and certifications) frequency of visits of two visits a week for 8 weeks plus 2 visits as needed to complete a comprehensive assessment (a thorough health evaluation that includes a patient’s complete health history and physical examination) of all body systems, checked vital signs (essential measurements that indicate a person’s basic physiological status, which includes body temperature, pulse rate [the number of times the heart beats per minute], respiratory rate [the number of breaths taken per minute], and blood pressure [the force of blood against the artery walls]), perform wound care interventions to patient’s stage 3 sacrum pressure injury ((Full-thickness loss of skin. Dead and black tissue may be visible), and to assess medication compliance during every SN visit and instruct patient/caregiver regarding medication name, actions, frequency, and side effects of any new/changed medications. During a joint home visit at Patent 4’s residence, on 8/7/2025 at 10:00 a.m., with the registered nurse (RN 2), Patient 4 was observed laying in a hospital bed, awake, alert, and oriented x 3 (to person, place and time), accompanied by his caregiver (PCG 1).During a review of Patient 4’s current medications with RN 2, a bottle of Melatonin (it helps individuals who have trouble sleeping) 1 mg (milligram, a unit of measurement) 1 tablet by mouth daily, and Guaifenesin (used to relieve chest congestion and coughs) 100 mg/5 ml (milliliter, a unit of volume) oral liquid 10 ml by mouth every 4-6 hours as needed for cough could not be found. However, the medication profile provided by the HHA indicated Patient 4 was still taking Melatonin 1 mg and Guaifenesin. During an interview with PCG 1, PCG 1 stated Patient 4 was not taking Melatonin 1 mg and Guaifenesin oral liquid for a couple of months. During an interview, on 8/8/2025 at 12:15 p.m. with the Director of Patient Care Services (DPCS), the DPCS stated patient’s medication profile should have been reconciled and updated on every SN visit to prevent inaccurate patient medication list and preventing medication errors. During a review of the HHA’s undated policy and procedure (P&P) titled “Medication Profile”, the P&P indicated the registered nurse or therapist will complete a medication profile for each client at the time of admission. The medication profile shall include all prescription and nonprescription drugs, including regularly scheduled medications and those taken intermittently or as needed. The profile will be reviewed and updated as needed to reflect current medications the client is taking. a. During a review of Patient 2’s Home Health Certification and Plan of Care (POC, a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved), effective from 8/2/2025 to 9/30/2025, the Home Health Certification and Plan of Care indicated that Patient 2 was admitted to the HHA on 6/14/2023 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (a visit done by a healthcare provider to examine and to manage a wound that was not created or treated by surgery). The Home Health Certification and Plan of Care, effective from 8/2/2025 to 9/30/2025, indicated the Skilled Nurse (licensed nurse in general) visit frequency was twice a week for eight weeks and two as needed visits for any wound care/disease related complications that may arise. The SN would be responsible for performing wound care on left lateral (outer part) lower leg and right anterior (front part) lower leg and medication management. During a review of Patient Medication Profile for Patient 2, the Patient Medication Profile listed the following: - Vitamin D3 25 mcg (microgram, a measurement unit) (1000 units), one soft gel by mouth once daily. - Preservision 2 (a brand of eye supplement), one capsule by mouth once daily. - Losartan-Hydrochlorothiazide (a medication to treat high blood pressure) 100-25 mg (milligram, a measurement unit), one tablet by mouth once daily. During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 8/7/2025 at 11:30 a.m., Patient 2 was observed alert and oriented to person, place, and time (aware of own identity, location, and the current date and time). Observed Patient 2 ambulating (walking) independently. During the joint home visit, a review of Patient 2’s available medications at home and Patient Medication Profile was conducted with LVN 1. The following medications and/or treatments were observed at Patient 2’s residence but not listed in the Patient Medication Profile: - Tetracyte topical spray (a topical [applied directly to body surfaces such as the skin] antibiotic used to prevent skin infections in minor cuts, scrapes, and burns). - Dakin’s solution 0.25% ( a solution commonly used to prevent or treat infections in cuts, abrasions, lacerations, and various types of ulcers and burns). - Therahoney (a sterile, medical-grade Manuka honey used to treat a variety of wounds, including burns, cuts, and chronic wounds). - Wound cleanser (a solution used to cleanse wounds by removing debris, foreign materials, and microorganisms, promoting optimal healing conditions). During an interview with LVN 1 on 8/7/2025 at 12:18 p.m., LVN 1 stated that medication reconciliation (the process of comparing a patient’s medication orders to all of the medications that the patient has been taking) was supposed to be done by the Registered Nurse during the recertification (the process where a physician confirms a patient’s continued need for home health services after an initial 60-day episode of care; it ensures the patient still meets the eligibility criteria, including being homebound and requiring skilled care) assessment. LVN 1 stated that Tetracyte, Dakin’s solution, Therahoney, and wound cleanser were ordered by the physician or wound specialist, so they need to be part of Patient Medication Profile. During an interview with the Director of Patient Care Services (DPCS) on 8/8/2025 at 10:12 a.m., the DPCS stated that medication reconciliation should be done with each visit. The DPCS stated that during every visit the nurse needed to ask the patient if there was a new medication, if there were any changes, or if any medication was discontinued. The DPCS stated that keeping an accurate and updated medication profile was important so that the nurse would be able to monitor side effects, provide appropriate teaching, and monitor effectiveness of the medications.”

“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, agency providing skilled nursing and other therapeutic services to a patient’s personal residence) failed to ensure the plan of care (POC, a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) included all medications, treatments, equipment, patient-specific intervention and education for one of seven sampled patients (Patient 2). This failure had the potential to affect the quality of care and the safety of Patient 2. During a review of Patient 2’s Home Health Certification and Plan of Care – (also known as Plan of Care or POC), effective from 8/2/2025 to 9/30/2025, the Home Health Certification and Plan of Care indicated that Patient 2 was admitted to the HHA on 6/14/2023 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (a visit done by a healthcare provider to examine and to manage a wound that was not created or treated by surgery). Patient 2’s Home Health Certification and Plan of Care, effective from 8/2/2025 to 9/30/2025, indicated the Skilled Nurse (licensed nurse in general) visit frequency was twice a week for eight weeks and two as needed visits for any wound care/disease related complications that may arise. The SN would be responsible for performing wound care on left lateral (outer part) lower leg and right anterior (front part) lower leg and medication management. There was no pain management or pain intervention included in the Home Health Certification and Plan of Care. During a review of Patient 2’s Skilled Nursing Visit Note, dated 7/21/2025, the Skilled Nursing Visit Note indicated that Patient 2 had pain 3/10 during right anterior lower leg wound care. The narrative section indicated that instructions were given to take medication half an hour before scheduled wound care to minimize pain during wound care. There was no pain reassessment documented post wound care. During a review of Patient 2’s Skilled Nursing Visit Note, dated 7/25/2025, the Skilled Nursing Visit Note indicated that Patient 2 had pain 5/10 during right anterior lower leg wound care. The narrative section indicated that instructions were given to take medication half an hour before scheduled wound care to minimize pain during wound care. There was no pain reassessment documented post wound care. During a review of Patient 2’s Skilled Nursing Visit Note, dated 7/28/2025, the Skilled Nursing Visit Note indicated that Patient 2 had pain 3/10 during right anterior lower leg wound care. There was no pain reassessment documented post wound care. According to the National Institute on Aging (a U.S. federal agency, part of the National Institutes of Health [NIH], dedicated to research on aging and the health and well-being of older adults), most pain scales use numbers from 0 to 10. A score of 0 means no pain, and 10 means the worst pain possible. During a review of Patient Medication Profile for Patient 2, the Patient Medication Profile listed the following: - Vitamin D3 25 mcg (microgram, a measurement unit) (1000 units), one soft gel by mouth once daily. - Preservision 2 (a brand of eye supplement), one capsule by mouth once daily. - Losartan-Hydrochlorothiazide (a medication to treat high blood pressure) 100-25 mg (milligram, a measurement unit), one tablet by mouth once daily. During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 8/7/2025 at 11:30 a.m., Patient 2 was observed alert and oriented to person, place, and time (aware of own identity, location, and the current date and time). Patient 2 was ambulating (walking) independently. During the joint home visit, Patient 2 stated she had wound care done on her left lateral lower leg and right anterior lower leg the day before by a wound nurse from Wound Clinic 1 (WC 1). Patient 2 stated that she always had more pain during wound care on her right anterior lower leg. During the joint home visit, observed LVN 1 perform wound care on Patient 2’s venous stasis ulcer (a type of skin ulcer that occurs on the lower leg due to poor blood flow in the veins) on the left lateral lower leg. LVN 1 cleansed the wound with wound cleanser and patted the wound bed dry. LVN 1 cut the Ioplex dressing (a type of dressing that contains controlled release iodine [an antiseptic to prevent and treat infection]) to fit Patient 2’s wound. LVN 1 then applied Tetracyte topical spray (a topical [applied directly to body surfaces such as the skin] antibiotic used to prevent skin infections in minor cuts, scrapes, and burns) to the Ioplex dressing, followed by spreading Therahoney (a sterile, medical-grade Manuka honey used to treat a variety of wounds, including burns, cuts, and chronic wounds) on the Ioplex dressing. LVN 1 subsequently applied the Tetracyte and Therahoney-saturated Ioplex to Patient 2’s venous stasis ulcer on the left lateral lower leg and then covered it with a 6 x 6 Silicate silicone foam dressing (a type of dry dressing). LVN 1 applied a cut-off sock to keep the dressing in place. No pain assessment was observed during the wound care or the home visit. During an interview with LVN 1 on 8/7/2025 at 12:20 p.m., when LVN 1 was asked about the lack of pain assessment during the wound care and/or home visit, LVN 1 stated that she was familiar with Patient 2. LVN 1 stated that she knew what Patient 2’s level of pain. LVN 1 did not specify what Patient 2’s level of pain was during the interview. When LVN 1 was asked what pain medication she instructed Patient 2 to take half an hour before the scheduled wound care, LVN 1 stated, “Tylenol.” Tylenol was not observed at the patient’s home during medication review with LVN 1. During a concurrent interview and record review with the Director of Patient Care Services (DPCS) on 8/8/2025 at 10:12 a.m., the DPCS reviewed Patient 2’s Home Health Certification and Plan of Care, effective from 8/2/2025 to 9/30/2025, Patient Medication Profile, and Skilled Nursing Visit Note, dated 7/21/2025, 7/25/2025, and 7/28/2025.The DPCS stated, “The plan of care is the doctor’s order for the patient.” The DPCS stated the plan of care had to have the patient’s diagnosis, all physician orders, including medications, supplies, and durable medical equipment (DME, medical equipment that is used repeatedly and is primarily used for medical purposes). The DPCS stated that the plan of care needed to list the patient’s problems, goals, and interventions. The DPCS stated that there was no pain management in Patient 2’s current plan of care. The DPCS stated the lack of pain management in the plan of care resulted in poor pain management, as the staff was unable to address it. The DPCS stated that the plan of care was supposed to provide guidance to the staff, so that they know the services to provide, what to follow, and what to teach the patient and family/caregiver. During a review of the HHA’s policy and procedure (P & P), titled “Care Plan Process,” addendum 1/5/2018, the P & P indicated the following: Based on the assessment and conclusions, the plan of care will include, but not be limited to: Identified patient problems and needs. Reasonable, measurable, and individualized goals. Specific services to be provided. Actions to be taken to meet the patient goals. During a review of the HHA’s P & P, titled “Plan of Care,” effective 8/29/11, the P & P indicated the following: 4.1. The Plan of Care is developed within seven working days in consultation with the agency staff shall cover pertinent information, including: Types of services and equipment required. 4.1.3. Statement of treatment goals. 4.1.4. Medications and treatments. 4.1.5. Functional limitations. 4.1.2. Any other appropriate items. 4.1.5. Instructions to patients and family.”

“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, agency providing skilled nursing and other therapeutic services to a patient’s personal residence) failed to notify the physician regarding the patient’s complaint of pain during wound care treatment for one of seven sampled patients (Patient 2). This failure resulted in not notifying the physician promptly for further treatment and intervention to mitigate the patient’s pain. During a review of Patient 2’s Home Health Certification and Plan of Care (also known as Plan of Care or POC, a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved), effective from 8/2/2025 to 9/30/2025, the Home Health Certification and Plan of Care indicated that Patient 2 was admitted to the HHA on 6/14/2023 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (a visit done by a healthcare provider to examine and to manage a wound that was not created or treated by surgery). Patient 2’s Home Health Certification and Plan of Care, effective from 8/2/2025 to 9/30/2025, indicated the Skilled Nurse (licensed nurse in general) visit frequency was twice a week for eight weeks and two as needed visits for any wound care/disease related complications that may arise. The SN would be responsible for performing wound care on left lateral (outer part) lower leg and right anterior (front part) lower leg and medication management. There was no pain management or pain intervention included in the Home Health Certification and Plan of Care. During a review of Patient 2’s Skilled Nursing Visit Note, dated 7/21/2025, the Skilled Nursing Visit Note indicated Patient 2 had pain 3/10 during right anterior lower leg wound care. The narrative section indicated that instructions were given to take medication half an hour before scheduled wound care to minimize pain during wound care. There was no pain reassessment documented post wound care. During a review of Patient 2’s Skilled Nursing Visit Note, dated 7/25/2025, the Skilled Nursing Visit Note indicated Patient 2 had pain 5/10 during right anterior lower leg wound care. The narrative section indicated that instructions were given to take medication half an hour before scheduled wound care to minimize pain during wound care. There was no pain reassessment documented post wound care. During a review of Patient 2’s Skilled Nursing Visit Note, dated 7/28/2025, the Skilled Nursing Visit Note indicated Patient 2 had pain 3/10 during right anterior lower leg wound care. There was no pain reassessment documented post wound care. According to the National Institute on Aging (a U.S. federal agency, part of the National Institutes of Health [NIH], dedicated to research on aging and the health and well-being of older adults), most pain scales use numbers from 0 to 10. A score of 0 means no pain, and 10 means the worst pain possible. During a review of Patient Medication Profile for Patient 2, the Patient Medication Profile listed the following: - Vitamin D3 25 mcg (microgram, a measurement unit) (1000 units), one soft gel by mouth once daily. - Preservision 2 (a brand of eye supplement), one capsule by mouth once daily. - Losartan-Hydrochlorothiazide (a medication to treat high blood pressure) 100-25 mg (milligram, a measurement unit), one tablet by mouth once daily. During a concurrent interview and record review with the Director of Patient Care Services (DPCS) on 8/8/2025 at 10:12 a.m., the DPCS reviewed the Home Health Certification and Plan of Care, effective from 8/2/2025 to 9/30/2025, Patient Medication Profile, and Skilled Nursing Visit Note, dated 7/21/2025, 7/25/2025, and 7/28/2025 for Patient 2. The DPCS confirmed there was no pain medication ordered for Patient 2. The DPCS stated that if the patient experienced pain but there was no pain medication ordered, the physician should have been notified. When the DPCS was asked if the physician was made aware regarding Patient 2’s pain, the DPCS stated, “I’m sure the physician was notified.” However, the DPCS was not able to provide documentation when the physician was notified and if an order to manage Patient 2’s pain was received. During a review of the HHA’s policy and procedure (P & P), titled “Pain Assessment Scale,” effective 8/29/11, the P & P indicated that, “Pain will be evaluated using a 1-10 scale. Pain control will be assessed at each visit. The physician will be notified, if medical or analgesic interventions are 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, agency providing skilled nursing and other therapeutic services to a patient’s personal residence) failed to integrate orders from all physicians involved into the plan of care (POC, a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved) for two of seven sampled patients (Patient 1 and Patient 2). This failure had the potential to result in a lack of coordination of services and interventions provided to Patient 1 and Patient 2. a. During a review of Patient 1’s Home Health Certification and Plan of Care – (also known as Plan of Care or POC), effective from 6/8/2025 to 8/6/2025, the Home Health Certification and Plan of Care indicated that Patient 1 was admitted to the HHA on 6/8/2025 with a primary diagnosis of infection following a procedure, deep incisional surgical site, initial encounter (a deep wound infection that developed after a surgical procedure; the “initial encounter” part means this is the first time the patient is being treated for this infection). Patient 1’s Home Health Certification and Plan of Care, effective from 6/8/2025 to 8/6/2025, indicated the Skilled Nurse (licensed nurse in general) visit frequency was daily for eleven days, then effective 6/19/2025 one visit per week for one week, then three visits per week for three weeks, then one visit per week for four weeks, plus three as needed visits for any disease process complications that may arise. Patient 1’s Home Health Certification and Plan of Care, effective from 6/8/2025 to 8/6/2025, included ileostomy (a surgical operation in which a piece of the ileum [the last part of the small intestine that helps to further digest food coming from the stomach and other parts of the small intestine] is diverted to an artificial opening in the abdominal wall) interventions. The durable medical equipment (DME, medical equipment that is used repeatedly and is primarily used for medical purposes) and supplies section indicated ostomy pouches as one of the supplies needed for Patient 1. The type of ostomy pouches was not specified. During a telephone interview with Patient 1 on 8/6/2025 at 8:34 a.m., Patient 1 stated he had been receiving daily nursing visits from the HHA for wound care and ileostomy care. Patient 1 stated he was having leaking issues with his ostomy pouch, so he decided to inform his primary physician about it. Patient 1 stated his primary physician then ordered him the Hollister 8614 premier 1-piece drainable ostomy pouch, 1 ¼ inch (32 mm). Patient 1 stated he informed his nurse, Registered Nurse 1 (RN 1), about the order. Patient 1 stated RN 1 took a picture of the physician order. Patient 1 stated when RN 1 used the Hollister 8614 pouch he did not experience leaking. Patient 1 stated the HHA has been inconsistent with providing him with the correct ostomy pouch as ordered by his physician, and as a result he had the leaking issues again. During a telephone interview with RN 1 on 8/7/2025 at 2:22 p.m., RN 1 stated Patient 1 was experiencing leaking issues with his ostomy pouch. RN 1 stated he tried different types of ostomy pouch that the HHA had, since there was no order for a specific type of ostomy pouch when Patient 1 was admitted to the HHA. RN 1 stated that Patient 1 liked the Hollister 8614 because it did not leak. RN 1 stated that Patient 1 decided to get an order from his primary physician for Hollister 8614 so that the HHA would only supply him with that particular ostomy pouch. RN 1 stated he took a picture of the physician order, dated 7/28/2025, and sent it to the HHA’s administrator. RN 1 stated after the order, the HHA did not always have the Hollister 8614 ostomy pouch in stock, so he would use a different type of ostomy pouch. RN 1 stated he noticed a significant difference in leaking when Patient 1 used the Hollister 8614 and other type of ostomy pouch. RN 1 stated, “When I use the Hollister 8614, it doesn’t leak.” During a review of Patient 1’s primary physician order, dated 7/28/2025, the physician order indicated the following: “8614 (Hollister) Premier Colostomy Pouch 1 ¼ inch (32 mm). 1-piece drainable ostomy pouch, transparent, convex, tape, plus 1 clamp. 18 boxes for 90-day supply.” During an interview with the Director of Patient Care Services (DPCS) on 8/8/2025 at 11:18 a.m., the DPCS stated she was unaware that Patient 1 had a physician order for a specific ostomy pouch. The DPCS stated if she had received the physician order, she would have integrated it into the plan of care. The DPCS stated the HHA had been supplying Patient 1 with Hollister 8614 ostomy pouch, but they did not have a large quantity on hand, therefore sometimes they had to provide him with a different ostomy pouch. The DPCS stated it was important to make sure that all physician orders were incorporated into the patient’s plan of care to ensure the patient receive appropriate services and interventions. During an interview with the administrator on 8/8/2025 at 1:50 p.m., the administrator confirmed she received the physician order dated 7/28/2025 from RN 1. b. During a review of Patient 2’s Home Health Certification and Plan of Care ), effective from 8/2/2025 to 9/30/2025, the Home Health Certification and Plan of Care indicated that Patient 2 was admitted to the HHA on 6/14/2023 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (a visit done by a healthcare provider to examine and to manage a wound that was not created or treated by surgery). Patient 2’s Home Health Certification and Plan of Care, effective from 8/2/2025 to 9/30/2025, indicated the Skilled Nurse (licensed nurse in general) visit frequency was twice a week for eight weeks and two as needed visits for any wound care/disease related complications that may arise. The SN would be responsible for performing wound care on left lateral (outer part) lower leg and right anterior (front part) lower leg and medication management. During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 8/7/2025 at 11:30 a.m., Patient 2 was observed alert and oriented to person, place, and time (aware of own identity, location, and the current date and time). Patient 2 was ambulating (walking) independently. During the joint home visit, Patient 2 stated that she had wound care done on her left lateral lower leg and right anterior lower leg the day before by a wound nurse from Wound Clinic 1 (WC 1). Patient 2 stated that she always had more pain during wound care on her right anterior lower leg. During the joint home visit, observed LVN 1 perform wound care on Patient 2’s venous stasis ulcer (a type of skin ulcer that occurs on the lower leg due to poor blood flow in the veins) on the left lateral lower leg. LVN 1 cleaned the wound with wound cleanser and patted the wound bed dry. LVN 1 cut the Ioplex dressing (a type of dressing that contains controlled release iodine [an antiseptic to prevent and treat infection]) to fit Patient 2’s wound. LVN 1 then applied Tetracyte topical spray (a topical [applied directly to body surfaces such as the skin] antibiotic used to prevent skin infections in minor cuts, scrapes, and burns) to the Ioplex dressing, followed by spreading Therahoney (a sterile, medical-grade Manuka honey used to treat a variety of wounds, including burns, cuts, and chronic wounds) on the Ioplex dressing. LVN 1 subsequently applied the Tetracyte and Therahoney-saturated Ioplex to Patient 2’s venous stasis ulcer on the left lateral lower leg and then covered it with a 6 x 6 Silicate silicone foam dressing (a type of dry dressing). LVN 1 applied a cut-off sock to keep the dressing in place. During a concurrent interview and record review with LVN 1 on 8/7/2025 at 12:10 p.m., LVN 1 reviewed the wound care order for the left lateral lower leg in Patient 2’s plan of care. The order was as follows: SN cleanse the wound, pat dry, apply Tetracyte to the wound bed, followed by med honey hydrofera. Cover with foam with silicone bordered dressing 3x weekly and PRN for soiled or loose dressing and wrap with rolled gauze. LVN 1 stated that Patient 2 had a new order for Ioplex dressing. LVN 1 was not able to show the order for Ioplex. During a review of Orders/Telephone Orders for Patient 2, dated 7/28/2025 and 7/29/2025, there was no order for Ioplex dressing. During a concurrent interview and record review with the Director of Patient Care Services (DPCS) on 8/8/2025 at 10:12 a.m., the DPCS reviewed Patient 2’s Home Health Certification and Plan of Care, effective from 8/2/2025 to 9/30/2025, and Orders/Telephone Orders for Patient 2, dated 7/28/2025 and 7/29/2025. The DPCS confirmed there was no physician’s order for Ioplex dressing. The DPCS stated Patient 2 had a wound specialist from Wound Clinic 1 (WC 1) that visited her once a week. The DPCS stated, “Probably the order for Ioplex was from the wound specialist.” During a review of Patient 2’s Progress Report, dated 7/30/2025, generated by WC 1, the Progress Report indicated that Ioplex dressing was to be applied on the left lateral lower leg wound. During an interview with the DPCS on 8/8/2025 at 10: 47 a.m., the DPCS stated the HHA should have obtained a treatment order that included the Ioplex dressing from Patient 2’s primary physician so that it could be integrated into the plan of care. The DPCS stated it was very important that all orders were transcribed into the plan of care, so all staff involved in the patient’s care would know what services to provide, what to follow, and what to teach the patient and family/caregiver. During a review of the HHA’s policy and procedure (P & P), titled “Supplementary Physician’s Order – HHA Patients,” effective 1/22/2001, the P & P indicated that a signed supplementary physician’s order must be obtained anytime an order is taken, which modifies or adds to existing orders on a Plan of Treatment. Supplementary physician’s orders may only be documented in this format when there is a current Plan of Treatment in place.”

“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, agency providing skilled nursing and other therapeutic services to a patient’s personal residence) failed to ensure the clinical records for two of seven sampled patients (Patient 1 and Patient 2) included all physicians orders and completed clinical notes that reflected the patients’ current health status. This failure resulted in Patient 1 and Patient 2 not having complete and accurate clinical records, placing patient safety at risk by increasing the chance of errors in medication, treatment, diagnoses, related to lack in continuity of care, and coordination between agency’s staff and clinicians providing care. a. During a review of Patient 1’s Home Health Certification and Plan of Care – (POC, a document detailing a patient’s health needs, created by a healthcare team based on a comprehensive assessment of the patient’s condition and goals, outlining interventions and expected outcomes to be achieved), effective from 6/8/2025 to 8/6/2025, the Home Health Certification and Plan of Care indicated Patient 1 was admitted to the HHA on 6/8/2025 with a primary diagnosis of infection following a procedure, deep incisional surgical site, initial encounter (a deep wound infection that developed after a surgical procedure; the “initial encounter” part means this is the first time the patient is being treated for this infection). Patient 1’s Home Health Certification and Plan of Care, effective from 6/8/2025 to 8/6/2025, included ileostomy (a surgical operation in which a piece of the ileum [the last part of the small intestine that helps to further digest food coming from the stomach and other parts of the small intestine] is diverted to an artificial opening in the abdominal wall) interventions. The durable medical equipment (DME, medical equipment that is used repeatedly and is primarily used for medical purposes) and supplies section indicated ostomy pouches as one of the supplies needed for Patient 1. The type of ostomy pouches was not specified. During a telephone interview with Patient 1 on 8/6/2025 at 8:34 a.m., Patient 1 stated he had been receiving daily nursing visits from the HHA for wound care and ileostomy care. Patient 1 stated that he was having leaking issues with his ostomy pouch, so he decided to inform his primary physician about it. Patient 1 stated that his primary physician then ordered him the Hollister 8614 premier 1-piece drainable ostomy pouch, 1 ¼ inch (32 mm). Patient 1 stated he informed his nurse, Registered Nurse 1 (RN 1), about the order. Patient 1 stated that RN 1 took a picture of the physician order. Patient 1 stated when RN 1 used the Hollister 8614 pouch he did not experience leaking. Patient 1 stated the HHA has been inconsistent with providing him with the correct ostomy pouch as ordered by his physician, and as a result he had the leaking issues again. During a telephone interview with RN 1 on 8/7/2025 at 2:22 p.m., RN 1 stated Patient 1 was experiencing leaking issues with his ostomy pouch. RN 1 stated he tried different types of ostomy pouch that the HHA had, since there was no order for a specific type of ostomy pouch when Patient 1 was admitted to the HHA. RN 1 stated that Patient 1 liked the Hollister 8614 because it did not leak. RN 1 stated that Patient 1 decided to get an order from his primary physician for Hollister 8614 so that the HHA would only supply him with that particular ostomy pouch. RN 1 stated he took a picture of the physician order, dated 7/28/2025, and sent it to the HHA’s administrator. RN 1 stated after the order, the HHA did not always have the Hollister 8614 ostomy pouch in stock, so he would use a different type of ostomy pouch. RN 1 stated he noticed a significant difference in leaking when Patient 1 used the Hollister 8614 and other type of ostomy pouch. RN 1 stated, “When I use the Hollister 8614, it doesn’t leak.” During a review of Patient 1’s primary physician order, dated 7/28/2025, the physician order indicated the following: “8614 (Hollister) Premier Colostomy Pouch 1 ¼ inch (32 mm). 1-piece drainable ostomy pouch, transparent, convex, tape, plus 1 clamp. 18 boxes for 90 day supply.” During an interview with the Director of Patient Care Services (DPCS) on 8/8/2025 at 11:18 a.m., the DPCS stated she was unaware that Patient 1 had a physician’s order for a specific ostomy pouch. The DPCS stated the physician’s order for the ostomy pouch was not transcribed into the home health orders for Patient 1, resulting an incomplete clinical record for Patient 1. b. During a review of Patient 2’s Home Health Certification and Plan of Care, effective from 8/2/2025 to 9/30/2025, the Home Health Certification and Plan of Care indicated that Patient 2 was admitted to the HHA on 6/14/2023 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (a visit done by a healthcare provider to examine and to manage a wound that was not created or treated by surgery). The Home Health Certification and Plan of Care, effective from 8/2/2025 to 9/30/2025, indicated the Skilled Nurse (licensed nurse in general) visit frequency was twice a week for eight weeks and two as needed visits for any wound care/disease related complications that may arise. The SN would be responsible for completing a comprehensive assessment of all body systems with focus on integumentary system (the organ system that includes the skin and its accessory structures like hair, nails, and glands) related to left lateral (outer part) lower leg wound and right anterior (front part) lower leg wound. During a review of Patient 2’s Skilled Nursing Visit Note, dated 7/21/2025, the Skilled Nursing Visit Note, under Integumentary section, indicated there were no negative findings, color was within normal limits, and the skin was warm and dry. The box indicating “Wound – refer to diagram and wound assessment,” was not checked. The Skilled Interventions/Teachings section indicated the nurse performed wound care on left lower leg and right lower leg. There was no documentation on wound assessment, such as the characteristics of the wound bed (the base of a wound) and exudate/drainage (a fluid that leaks from blood vessels into surrounding tissues, often due to inflammation or injury), status of surrounding tissue, and if there was any indication of infection. During a review of Patient 2’s Skilled Nursing Visit Note, dated 7/25/2025, the Skilled Nursing Visit Note, under Integumentary section, indicated there were no negative findings, color was within normal limits, and the skin was warm and dry. The box indicating “Wound – refer to diagram and wound assessment,” was not checked. The Skilled Interventions/Teachings section indicated the nurse performed wound care on left lower leg and right lower leg. There was no documentation on wound assessment, such as the characteristics of the wound bed and exudate/drainage, status of surrounding tissue, and if there was any indication of infection. During a review of Patient 2’s Skilled Nursing Visit Note, dated 7/28/2025, the Skilled Nursing Visit Note, under Integumentary section, indicated there were no negative findings, color was within normal limits, and the skin was warm and dry. The box indicating “Wound – refer to diagram and wound assessment,” was checked The Skilled Interventions/Teachings section indicated the nurse performed wound care on left lower leg and right lower leg. There was no documentation on wound assessment, such as the characteristics of the wound bed and exudate/drainage, status of surrounding tissue, and if there was any indication of infection. During a concurrent interview and record review with the Director of Patient Care Services (DPCS) on 8/8/2025 at 12:55 p.m., the DPCS reviewed the Skilled Nursing Visit Note for Patient 2, dated 7/21/2025, 7/25/2025, and 7/28/2025. The DPCS stated the nurse should not have indicated that there were no negative findings if the patient had wounds. The DPCS stated that the box indicating “Wound – refer to diagram and wound assessment,” should have been checked. The DPCS also stated that the Skilled Interventions/Teachings section should have indicated the assessment done on the wounds. The DPCS stated the documentation for the Skilled Nursing Visit Note dated 7/21/2025, 7/25/2025, and 7/28/2025 was incomplete and inaccurate. During a review of the HHA’s policy and procedure (P & P), titled “Clinical Patient Care Records,” effective 8/15/11, the P & P indicated that the patient’s medical records should be current and kept in detail, consistent with good medical and professional practice based on the services provided to each patient. During a review of the HHA’s P & P, titled “Clinical Progress/Visit Notes,” effective 8/15/11, the P & P indicated that one visit note will be completed for each home visit by the person providing care and will document all pertinent information, and be signed and dated. The P & P indicated that visit note documentation shall include: - Pertinent observations. - Direct care provided. - Instructions given. - Patient response.”