Royale Home Health Care, Inc.

“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 (CoP, refers to the requirements that healthcare organizations must meet to participate in federal healthcare programs) for Comprehensive Assessment of Patients as follows: 1. The HHA failed to ensure that the OASIS (Outcome and Assessment Information Set, a standardized assessment tool required by the Centers for Medicare & Medicaid Services [CMS] that measures a patient’s functional abilities, clinical condition, and service needs) Recertification assessment (a thorough, in-depth evaluation done near the end of a certification period to show a patient still needs ongoing skilled care) for one of 7 sampled patients (Patient 5) was completed within 5 calendar days. This failure had the potential to affect continuity of care and patient safety. (Refer to G520). 2. The HHA’s nursing staff failed to conduct pain assessment in accordance with the agency’s policy and procedure, for one of 7 sampled patients (Patient 2). This failure had the potential to result in lack of detection of unrelieved pain, thereby prolonging the patient’s pain and discomfort. (Refer to G528). 3. The HHA failed to properly assess the patient’s continuing need for home care services, for two of 7 sampled patients (Patient 1 and Patient 4). This failure led to the delivery of unnecessary home health service to patients who did not require skilled nursing care. (Refer to G532). 4. The HHA failed to review all patients’ medications and update the medication profile with currently used medications for one of 7 sampled patients (Patient 5). This failure had the potential to put the patients at risk for medication errors and adverse drug reactions (a harmful, unintended reaction to 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 are 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 therapeutics service to a patient’s personal residence) failed to ensure the Condition of Participation (CoP, refers to the requirements that healthcare organizations must meet to participate in federal healthcare programs) for Care Planning, Coordination of Services, and Quality of Care was met as follows: 1. The HHA failed to ensure that two of 7 sampled patients (Patient 1 and Patient 5) received interventions to manage pain. This failure had the potential to result in functional impairment, prolonged recovery, and an increased risk for falls. (Refer to G572). 2. The HHA failed to ensure the Plan of Care (POC, a detailed, written document outlining the services and support an individual needs to meet their healthcare goals) included patient-specific interventions and education, measurable outcomes, and goals for two of 7 sampled patients (Patient 2 and Patient 5). - For Patient 2, POC did not have patient specific interventions and goals for managing his colostomy (a surgical procedure that creates an opening from the colon through the abdominal wall so that waste can leave the body). - For Patient 5, the HHA failed to include goals and correct wound treatment orders. This failure had the potential to result in patients not receiving the identified needs and services, which could lead to a decline in their health status and that could affect their quality of care and well-being. (Refer to G574). 3. The HHA failed to ensure that all physician orders were recorded in the patient’s plan of care (POC, a detailed, written document outlining the services and support an individual needs to meet their healthcare goals) for one of 7 sampled patients (Patient 5). This failure had the potential to result in compromised patient safety and disrupted continuity of care. (Refer to G576). 4. The HHA failed to ensure that wound treatment order for one of 7 sampled patients (Patient 5) was administered only as ordered by a physician or allowed practitioner. This failure had the potential to jeopardize patient safety and delay proper care. (Refer to G580). 5. The HHA failed to clarify the physician orders regarding fluid restriction (a diet that limits the total amount of liquids consumed), intake and output monitoring (tracking all the fluid that goes into a patient’s body and all the fluid that leaves it), and cardiac rhythm monitoring (the continuous or intermittent tracking of the electrical activity of your heart to detect irregular heartbeats) for one of 7 sampled patients (Patient 7). This failure had the potential to result in increased risk for hospitalization and adverse health outcomes for the patient. (Refer to G602). 6. The HHA failed to ensure a copy of the current plan of care (POC- a document that serves as a comprehensive, physician-signed plan detailing the necessary skilled home health services for patients, that includes diagnoses, orders, medications, treatments, and goals) was provided to two of 7 sampled patients (Patient 1 and Patient 2). This failure has the potential in a lack of coordination of the plan of care with the patient and other clinicians involved in the patient’s care and treatment. (Refer to G612). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily (written law) mandated compliance with the Federal regulations for Care Planning, Coordination of Services, and Quality of Care to ensure home health benefits and services were furnished in accordance with accepted standards of practice.”

“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 observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient’s personal residence) failed to ensure two of 7 sampled patients (Patient 1 and Patient 5) received interventions to manage pain. This failure had the potential to result in functional impairment, prolonged recovery, and an increased risk for falls. a. During a review of Patient 1’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 starting from 7/3/2026 to 8/31/2026, the Home Health Certification and POC indicated Patient 1’s start of care (SOC) date was 5/4/2026, with a diagnosis which included hypothyroidism (a condition where the thyroid gland does not make enough thyroid hormones to control how your body uses energy), schizophrenia (a mental illness that is characterized by disturbances in thought), and bipolar disorder (sometimes called manic-depressive disorder; mood swings that range from the lows of depression to elevated periods of emotional highs). The Home Health Certification and POC form further indicated the skilled nurse (provides advanced medical care, often requiring specialized training and certifications) frequency of visits to once a week for 9 weeks, to check 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]), to instruct and reinforce new and changed medications and medication regimen, and to assess and evaluate patient’s pain level, to instruct on medications for pain, and assess for effectiveness of pain control therapy. The goals indicated Patient 1’s increased pain or ineffective pain control measures will be identified and promptly reported to physicians, and the reduction of pain will improve functional ability during time on service. During a joint home visit at Patent 1’s residence, on 8/26/2026 at 10:30 a.m., with the licensed vocational nurse (LVN 2), Patient 1 was observed seated in a chair, awake, alert, and oriented to person, place, and time. When questioned by LVN 2, Patient 1 stated, “I have a really bad pain right now in my right hip.” LVN 2 did not respond to the patient’s concern and/or provided any interventions to address Patient 1’s right hip pain. LVN2 did not conduct pain reassessment before the conclusion of the home visit. During an interview, on 8/27/2026 at 1:20 p.m., with the Administrator/Director of Patient Care Services (ADM/DPCS), the ADM/DPCS stated that if a patient verbalizes pain during a visit, the skilled nurse should first offer pain medications and/or implement non-pharmacologic (treatments or therapies that manage health conditions and improve well-being without using medication) interventions such as repositioning, massage, or applying a cold compress. The ADM/DPCS stated untreated pain can lead to patient’s physical decline and worsening mental health status. The ADM/DPCS stated and acknowledged the findings. b. During a review of Patient 5’s Home Health Certification and POC for the certification period of 8/17/2026 to 10/15/2026, the POC indicated the HHA admitted Patient 5 on 6/18/2026 with a primary diagnosis of polyosteoarthritis (a form of degenerative joint disease that affects multiple joints at the same time). The POC for the certification period of 8/17/2026 to 10/15/2026 indicated the Skilled Nurse (SN, a licensed nurse) visit frequency was twice per week for nine weeks. The SN responsibilities included assessing/evaluating patient’s pain level and effectiveness of pain control therapy. The POC indicated that SN should report increase in pain level to physician for prompt intervention. During a review of Patient Medication Profile for Patient 5 for the certification period of 8/17/2026 to 10/15/2026, the Patient Medication Profile indicated that Patient 5 was taking Buprenorphine Hydrochloride (a prescription pain medication for moderate to severe pain) 2 Mg, 0.5 tablet, four times a day. During a joint visit to Assisted Living Facility 1 (ALF 1, where Patient 5 resides) on 8/26/2026 at 11 a.m., with Licensed Vocational Nurse 1 (LVN 1), the surveyor observed Patient 5 alert and oriented. During the joint visit, LVN 1 asked if Patient 5 was having any pain. Patient 5 stated that he was having pain in his left lower leg. LVN 1 then asked Patient 5 to rate his pain level on a scale from 0 to 10. Patient 5 stated that his pain level was 8. According to the National Institute of Health (the official medical research agency of the United States government), the 0–10 Numeric Rating Scale (NRS) for pain indicated that scores ≤ 5 correspond to mild, scores of 6–7 to moderate, and scores ≥8 to severe pain in terms of pain-related interference with functioning. During the joint visit, LVN 1 did not do any interventions after Patient 5 reported that his pain level was 8. During a phone interview with LVN 1 on 8/26/2026 at 4:19 p.m., LVN 1 stated that he did not do any interventions for Patient 5 even though the patient reported that his pain level was 8, because Patient 5 received Buprenorphine Hydrochloride at 7 a.m., and the next dose was not due. LVN 1 stated, “Buprenorphine is given every 6 hours.” LVN 1 stated that he was going to report Patient 5’s pain to the HHA, so that the HHA could contact Patient 5’s physician and get an order for pain medication. LVN 1 stated he had not contacted the HHA or Patient 5’s physician at the time of interview. LVN 1 stated, “Every time I ask him (Patient 5) about pain, he always say a high number, but it’s not that bad. It’s tolerable.” During an interview with the Administrator/Director of Patient Care Services (ADM/DPCS) on 8/27/2026 at 10:59 a.m., the ADM/DPCS stated that pain level 8 out of 10 was considered moderate to severe pain. The ADM/DPCS stated that LVN 1 should have done non-pharmacological interventions for Patient 5’s pain, such as ice compress, warm compress, elevating the legs, or repositioning. The ADM/DPCS stated that non-pharmacological interventions were important because they could help the patient feel more comfortable and lessen medication dependency. During a review of the HHA’s policy and procedure (P & P), titled “Pain Assessment,” revised April 2021, the P & P indicated that when the patient or the clinician identified pain, the following in-depth pain assessment information should be obtained whenever possible: F. Present pain management regimen and effectiveness. During a review of the HHA’s P & P, titled “Care Planning Process,” revised January 2005, the P & P indicated that services to be provided would be based on the prioritized needs of the patient. Each patient would 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.”

“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, 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 a copy of the current plan of care (POC- a document that serves as a comprehensive, physician-signed plan detailing the necessary skilled home health services for patients, that includes diagnoses, orders, medications, treatments, and goals) was provided to two of 7 sampled patients (Patient 1 and Patient 2). This failure has the potential in a lack of coordination of the plan of care with the patient and other clinicians involved in the patient’s care and treatment. a. During a review of Patient 1’s Home Health Certification and POC form (a document 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 7/3/2026 to 8/31/2026, the Home Health Certification and POC form indicated Patient 1’s start of care (SOC) date of 5/4/2026, with a diagnosis which included hypothyroidism (a condition where the thyroid gland does not make enough thyroid hormones to control how your body uses energy), schizophrenia (a mental illness that is characterized by disturbances in thought), and bipolar disorder (sometimes called manic-depressive disorder; mood swings that range from the lows of depression to elevated periods of emotional highs). 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 once a week for 9 weeks, to check 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]), assess and evaluate patient’s pain level and effectiveness of pain control therapy, and to instruct and reinforce new and changed medications and medication regimen. During a joint home visit at Patent 1’s residence, on 8/26/2026 at 10:30 a.m., with the licensed vocational nurse (LVN 2), Patient 1 was observed seated in a chair, awake, alert, and oriented to person, place, and time. A review of Patient 1’s home health agency folder located within the residence; it was noted that a copy of the current Home Health Certification and Plan of Care (POC) form was not present. In an interview, LVN 2 confirmed that Patient 1 does not have a current copy of the POC available at home. b. During a review of Patient 2’s Home Health Certification and POC form for the certification period starting from 8/1/2026 to 9/29/2026, the Home Health Certification and POC form indicated Patient 2’s SOC date of 2/2/2026, with a diagnosis which included type 2 diabetes mellitus (DM-a disorder characterized by difficulty in blood sugar control and poor wound healing) without complication, hypothyroidism, and anxiety disorder (a mental health condition defined by persistent, excessive, and uncontrollable fear, dread, or worry that interferes with daily life). The Home Health Certification and POC form further indicated the skilled nurse frequency of visits to two times a week for 9 weeks, to assess for signs and symptoms of hypoglycemia (low blood sugar), checking/monitoring of blood sugar, to assess pain by using scale 0-10 (0 = no pain, 10 = unbearable pain), and check vital signs. During a joint home visit at Patent 2’s residence, on 8/26/2026 at 11:10 a.m., with LVN 2, Patient 2 was observed lying in bed, awake, alert, and oriented to person, place, and time. Upon reviewing Patient 2’s home health agency folder located within the residence, it was noted that a copy of the current Home Health Certification and POC form was not present. In an interview, LVN 2 confirmed that Patient 2 does not have a current copy of the POC available at home. During an interview, on 8/27/2026 at 1:20 p.m. with the Administrator/Director of Patient Care Services (ADM/DPCS), the ADM/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 ADM/DPCS stated and acknowledged the findings. During a review of the HHA’s policy and procedure (P&P) titled “Care Planning Process”, revised January 2005, the P&P indicated a written plan of care will be initiated within five days of start of care and updated at least every 60 days, or as patient’s condition warrants. 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.”

“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 interview and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient’s personal residence) failed to ensure that the OASIS (Outcome and Assessment Information Set, a standardized assessment tool required by the Centers for Medicare & Medicaid Services [CMS] that measures a patient’s functional abilities, clinical condition, and service needs) Recertification assessment (a thorough, in-depth evaluation done near the end of a certification period to show a patient still needs ongoing skilled care) for one of 7 sampled patients (Patient 5) was completed within 5 calendar days. This failure had the potential to affect continuity of care and patient safety. During a review of Patient 5’s OASIS Recertification assessment, dated 8/14/2026, the OASIS Recertification assessment indicated the HHA admitted Patient 5 on 6/18/2026 with a primary diagnosis of polyosteoarthritis (a form of degenerative joint disease that affects multiple joints at the same time). The space for “Care Staff Name” who completed the OASIS Recertification assessment was blank. The OASIS Recertification was not signed and dated. During a concurrent interview and record review with the Administrator/Director of Patient Care Services (ADM/DPCS) on 8/27/2026 at 10:59 a.m., the ADM/DPCS reviewed Patient 5’s OASIS Recertification assessment, dated 8/14/2026. The ADM/DPCS stated that the OASIS Recertification assessment, dated 8/14/2026, for Patient 5 was incomplete because it did not include the name of the Registered Nurse (RN) and was not signed and dated by the RN who assessed the patient. The ADM/DPCS stated that the purpose of signing an assessment such as the OASIS Recertification assessment was to validate the assessment was accurate. According to the ADM/DPCS, the timeframe to complete a comprehensive assessment was 24 to 48 hours. During a review of the HHA’s policy and procedure (P & P), titled “Initial and Comprehensive Assessment,” revised April 2021, the P & P indicated the following: A comprehensive patient assessment will be completed within five (5) calendar days of the patient’s start of care. For recertification, the assessment was to be conducted within the last five (5) days of every 60-day episode beginning with the start of care date(recertification). The comprehensive assessment for each patient must be completed in its entirety by a single clinician.”

“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) nursing staff (licensed vocational nurse 2/LVN 2) failed to conduct pain assessment in accordance with the agency’s policy and procedure, for one of 7 sampled patients (Patient 2). This failure had the potential to result in lack of detection of unrelieved pain, prolonging the patient’s pain and discomfort. During a review of Patient 2’s Home Health Certification and Plan of Care (POC, a document 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 8/1/2026 to 9/29/2026, the Home Health Certification and POC form indicated Patient 2’s SOC date was 2/2/2026, with a diagnosis which included type 2 diabetes mellitus (DM-a disorder characterized by difficulty in blood sugar control and poor wound healing) without complication, hypothyroidism, and anxiety disorder (a mental health condition defined by persistent, excessive, and uncontrollable fear, dread, or worry that interferes with daily life). The Home Health Certification and POC form further indicated the skilled nurse frequency of visits to two times a week for 9 weeks, to assess for signs and symptoms of hypoglycemia (low blood sugar), checking/monitoring of blood sugar, checking 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 assess pain by using scale 0-10 (0 = no pain; 10 = unbearable pain). During a joint home visit at Patent 2’s residence, on 8/26/2026 at 11:10 a.m., with LVN 2, Patient 2 was observed lying in bed, awake, alert, and oriented to person, place, and time. During the visit, LVN 2 did not perform an assessment of Patient 2’s pain During an interview conducted with LVN 2 on 8/26/2026 at 11:42 a.m., LVN 2 acknowledged that she did not perform the assessment of Patient 2’s pain and what level was the pain. LVN 2 further stated that pain assessment is a procedure that should be performed during every patient visit. During an interview, on 8/27/2026 at 1:20 p.m., with the Administrator/Director of Patient Care Services (ADM/DPCS), the ADM/DPCS stated visiting nurses should always perform pain assessment every visit. The ADM/DPCS stated nurses who do not assess a patient’s pain can lead to untreated suffering and delayed treatment of patient’s medical condition. During a review of the HHA’s policy and procedure (P&P) titled “Pain Assessment” revised April 2021, the P&P indicated that each patient will receive at least an initial pain assessment. When pain is identified, a more comprehensive pain assessment will be completed when warranted by the patient’s condition. Pain assessments will be age-appropriate and will be documented to facilitate regular reassessment and follow-up by clinicians.”

“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 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 properly assess the patient’s continuing need for home care services, for two of 7 sampled patients (Patient 1 and Patient 4). This failure led to the delivery of unnecessary home health services to patients who did not require skilled nursing care. a. During a review of Patient 1’s Home Health Certification and Plan of Care (POC, a document 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 5/4/2026 to 7/2/2026, the Home Health Certification and POC form indicated Patient 1’s start of care (SOC) date of 5/4/2026, with a diagnosis which included hypothyroidism (a condition where the thyroid gland does not make enough thyroid hormones to control how your body uses energy), schizophrenia (a mental illness that is characterized by disturbances in thought), and bipolar disorder (sometimes called manic-depressive disorder; mood swings that range from the lows of depression to elevated periods of emotional highs). The Home Health Certification and POC form further indicated the skilled nurse (provides advanced medical care, often requiring specialized training and certifications) frequency of visits to once a week for 9 weeks, to check 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]), assess and evaluate patient’s pain level and effectiveness of pain control therapy, and to instruct and reinforce new and changed medications and medication regimen. The goal included patient will verbalize understanding of medication actions and side effects (unintended secondary reactions that happen in addition to a medication’s primary, desired therapeutic effect), and will have no evidence of falls, injury or skin breakdown during treatment plan. The discharge planning included for patients to be discharged when goals are met, medical condition is stable, when patient reaches maximum functional potential and is no longer in need of skilled services. During a record review of Patient 1’s clinical record titled, Skilled Nursing Progress Notes dated starting from 6/4/2026 to 6/25/2026, and OASIS (or Outcome and Assessment Information Set, a standardized evaluation tool used by Medicare-certified home health agencies to collect data on a patient’s medical, functional, and cognitive status)-E2 Recertification (a mandatory follow-up clinical assessment completed by home health clinicians to evaluates patient progress and updates care plans) dated 7/2/2026, the Skilled Nursing Progress Notes and the OASIS Recertification assessment indicated Patient 1’s vital signs were within normal range, there were no admissions to the hospital, no change of conditions (any significant shift—either a decline or an improvement—in a patient’s physical, mental, behavioral, or functional health compared to their normal baseline), no episodes of falls, no skin breakdown nor any evidence of the need for skilled nursing services to continue. However, Patient 1 was re-certified for another 60 days starting from 7/3/2026 for continuous skilled nursing services. During a joint home visit at Patent 1’s residence, on 8/26/2026 at 10:30 a.m., with the licensed vocational nurse (LVN 2), Patient 1 was observed seated in a chair, awake, alert, and oriented to person, place, and time. There were no wounds, no IV (intravenous, or into a vein) lines or catheters (a small, flexible plastic tube placed into a vein to deliver fluids, medications, blood products, or nutrition directly into the bloodstream), and Patient 1 walked independently. Patient 1 reported daily medication use, no falls or hospitalizations, not being home bound, and being visited by his physician monthly. During a concurrent interview and record review, on 8/27/2026 at 1:20 p.m. with the Administrator/Director of Patient Care Services (ADM/DPCS), the ADM/DPCS reviewed Patient 1’s Skilled Nursing Progress Notes from 6/4/2026 to 6/25/2026, and OASIS E2 Recertification assessment dated 7/2/2026. The ADM/DPCS was unable to provide documentation showing that the skilled nurse’s comprehensive assessment and visit notes demonstrated a continuing need for home health services for Patient 1. The ADM/DPCS stated that it appeared Patient 1’s home health goals had been met during the previous episode and that the patient should have been discharged. b. During a closed record review of Patient 4’s Home Health Certification and POC for the certification period starting from 6/21/2026 to 8/19/2026, the Home Health Certification and POC form indicated Patient 4’s start of care (SOC) date was 2/21/2026, with a diagnosis which included polyosteoarthritis (a degenerative joint disease that affects multiple joints at the same time), major depressive disorder (a mood disorder that causes persistent feelings of sadness, hopelessness, and a loss of interest in activities), and chronic pain. The Home Health Certification and POC form further indicated the skilled nurse frequency of visits to once a week for 9 weeks to check vital signs every visit and assess for pain, and the physical therapy to conduct an evaluation and assessment of home safety, fall/injury risk and gait training. The goal included that patient will verbalize understanding and how to manage their disease process, will verbalize understanding of their medication regimen, and will have no evidence of falls, injury or skin breakdown during the treatment plan. Discharge planning included for patients to be discharged when goals are met, medical condition is stable and is no longer in need of skilled services. During a record review of Patient 4’s clinical record titled, Skilled Nursing Progress Notes dated starting from 6/30/2026 to 7/21/2026, the Skilled Nursing Progress Notes indicated Patient 4’s vital signs were within normal range, there were no admissions to the hospital, no change of conditions, no incident of falls or skin breakdown nor any evidence of the need for skilled nursing services to continue. During a record review of Patient 4’s clinical record revealed that the Physical Therapy (PT) Discharge/Transfer Summary dated 7/22/2026 documented discharge from PT services due to completion of care and improvement and stabilization of the patient’s condition. Despite this, Patient 4 continued to receive skilled nursing services, with no documented justification for ongoing need. The patient was officially discharged on 8/18/2026. During a phone interview on 8/27/2026 at 10:22 a.m. with Licensed Vocational Nurse (LVN 1), LVN 1 stated that Patient 4 was awake, alert, and oriented to person, place, and time, ambulatory with the use of a walker, took medications regularly, had no wounds, had no recent hospitalizations, had no history of recent falls, attended medical appointments consistently, was stable and had good support at his place of residence. LVN 1 further stated that during his visits, Patient 4’s vital signs, including oxygen saturation (the amount of oxygen circulating in the blood), were always within normal limits. During a concurrent interview and record review, on 8/27/2026 at 1:20 p.m. with the ADM/DPCS, the ADM/DPCS reviewed Patient 4’s Skilled Nursing Progress Notes dated from 6/30/2026 to 7/21/2026, and the PT Discharge/Transfer Summary form dated 7/22/2026. The ADM/DPCS was unable to provide documentation showing that the skilled nurse’s assessment and visit notes demonstrated a continuing need for home health services for Patient 4, and Patient 4 should have been discharged after PT service had ended on 7/22/2026. The ADM/DPCS stated and acknowledged the findings. During a review of the HHA’s policy and procedure (P&P) titled “Discharge Criteria and Process”, revised April 2021, the P&P indicated services will be terminated when the patient meets one (1) or more of the following discharge criteria: …patient goals are met such as medical condition is stable, patient no longer in need of skilled services and reaches maximum functional potential.”

“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 and other therapeutics service to a patient’s personal residence) failed to review all patient’s medications and update the medication profile with currently used medications for one of 7 sampled patients (Patient 5). This failure had the potential to put the patients at risk for medication errors and adverse (a harmful, unintended reaction to medication) drug reactions. During a review of Patient 5’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 8/17/2026 to 10/15/2026, the POC indicated the HHA admitted Patient 5 on 6/18/2026 with a primary diagnosis of polyosteoarthritis (a form of degenerative joint disease that affects multiple joints at the same time). The POC for the certification period of 8/17/2026 to 10/15/2026 indicated the Skilled Nurse (SN, a licensed nurse) visit frequency was twice per week for nine weeks. One of the SN responsibilities was to instruct/reinforce new and changed medication and medication regimen. During a joint visit to Assisted Living Facility 1 (ALF 1, where Patient 5 resides) on 8/26/2026 at 11 a.m., a medication review (the process of reviewing current medications to ensure they are accurate, necessary, and safe) was conducted with Licensed Vocational Nurse 1 (LVN 1) and ALF 1’s Medication Technician (MT 1). MT 1 stated that she administered the medications for the residents at ALF 1, including Patient 5. During the medication review with LVN 1 and MT 1, the surveyor observed the following discrepancies: The Patient Medication Profile for Patient 5, which was provided by the HHA, listed the following medications: - Eliquis (a blood thinner to prevent and treat blood clots) 2.5 milligrams (Mg, a unit of weight) 1 tablet, three times daily, oral. - Vitamin B12 (a vitamin to support nerve cells) 500 micrograms (Mcg, a unit of weight) 2 tablets, twice daily, oral. - Buprenorphine Hydrochloride (a prescription pain medication for moderate to severe pain) 2 Mg, 0.5 tablet four times a day. Patient 5’s medications at ALF 1 were as follows: - Eliquis 2.5 Mg, 1 tablet, twice daily, oral. - Vitamin B12 1000 Mcg, 1 tablet, once daily, oral. - Buprenorphine Hydrochloride 2 Mg, take 2 tablets every 6 hours for pain management. When MT 1 was asked if there had been a frequency and dose change for Eliquis, Vitamin B12, and Buprenorphine Hydrochloride, MT 1 stated the dose and frequency for all three medications had not been changed. MT 1 stated, “Eliquis 2.5 mg has always been given twice a day, Vitamin B12 is once a day, and Buprenorphine is 2 tablets every 6 hours.” During an interview with LVN 1 on 8/26/2026 at 12 p.m., LVN 1 stated, ““I think they made a typo for the Eliquis, it’s supposed to be twice daily. It’s also a typo for the Buprenorphine, it’s 2 tablets, not half.” LVN 1 stated that he reviewed Patient 5’s medication profile every Tuesday during his visit. LVN 1 stated that Patient 5’s Patient Medication Profile needed to be updated. LVN 1 stated that it was important to update the medication because it was related to the patient’s health. During an interview with the Administrator/Director of Patient Care Services (ADM/DPCS) on 8/27/2026 at 10:59 a.m., the ADM/DPCS stated that medication reconciliation needed to be done every visit. The ADM/DPCS stated that if the patient received more than 1 visit per week, the nurse might do it weekly. The ADM/DPCS stated that it was important to have an updated medication profile to ensure patient was getting the right medication, the right dose, at the right time. The ADM/DPCS also stated that an updated, accurate medication profile would help the nurse to monitor side effects, especially if it was a new medication, and if there were contraindications of the medications. During a review of the HHA’s policy and procedure (P & P), titled “Medication Profile,” revised April 2021, the P & P indicated that patient receiving medications administered by the organization would have a current, accurate medication profile in the clinical record. The P & P indicated that medication profiles would be updated for each change to reflect current medications, new, and/or discontinued 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, an organization that delivers skilled nursing and other therapeutics service to a patient’s personal residence) failed to ensure the Plan of Care (POC, a detailed, written document outlining the services and support an individual needs to meet their healthcare goals) included patient-specific interventions and education, measurable outcomes, and goals for two of 7 sampled patients (Patient 2 and Patient 5). For Patient 2, POC did not have patient specific interventions and goals for managing his colostomy (a surgical procedure that creates an opening from the colon through the abdominal wall so that waste can leave the body). For Patient 5, the HHA failed to include goals and correct wound treatment orders. This failure had the potential to result in patients not receiving the identified needs and services, which could lead to a decline in their health status and that could affect their quality of care and well-being. Findings: a. During a review of Patient 2’s Home Health Certification and POC for the certification period starting from 8/1/2026 to 9/29/2026, the Home Health Certification and POC indicated Patient 2’s start of care date was 2/2/2026, with a diagnosis which included type 2 diabetes mellitus (DM-a disorder characterized by difficulty in blood sugar control and poor wound healing) without complication, hypothyroidism, and anxiety disorder (a mental health condition defined by persistent, excessive, and uncontrollable fear, dread, or worry that interferes with daily life). The Home Health Certification and POC form further indicated the skilled nurse frequency of visits to two times a week for 9 weeks, to assess for signs and symptoms of hypoglycemia (low blood sugar), checking/monitoring of blood sugar, to assess pain by using scale 0-10 (0 = no pain, 10 = unbearable pain), check 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 instruct the patient/caregiver on proper colostomy pouch care. The POC form lacked detailed interventions and objectives specifying the supplies and/or equipment required for colostomy pouch care. During a joint home visit at Patent 2’s residence, on 8/26/2026 at 11:10 a.m., with the licensed vocational nurse (LVN 2), Patient 2 was observed lying in bed, awake, alert, and oriented to person, place, and time. Patient 2 was observed to have a colostomy in his right lower abdomen. During an interview, LVN 2 stated she comes to visit Patient 2 at least twice a week to perform colostomy care as follows: wipe the old colostomy dressing/pouch with normal saline (or NS, a mixture of salt and water), gently remove the old colostomy pouch, cleansed the stoma (a surgically created opening on the abdomen) and surrounding skin with normal saline, pat dry, apply adapt powder around the stoma so an ostomy pouch can stick securely, and apply the new pouch. LVN 2 stated she performed colostomy care based on the plan of care. During a concurrent interview and record review, on 8/27/2026 at 1:20 p.m. with the Administrator/Director of Patient Care Services (ADM/DPCS), the ADM/DPCS reviewed Patient 2’s Home Health Certification and POC form for the certification period starting from 8/1/2026 to 9/29/2026. The ADM/DPCS stated patient’s Home Health Certification and POC form is based on the physician’s order. The ADM/DPCS stated and confirmed Patient 2’s POC did not have specific interventions, goals, specific supplies and equipment to use during colostomy care. The ADM/DPCS stated and acknowledged the findings. b. During a review of Patient 5’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 8/17/2026 to 10/15/2026, the POC indicated the HHA admitted Patient 5 on 6/18/2026 with a primary diagnosis of polyosteoarthritis (a form of degenerative joint disease that affects multiple joints at the same time). The POC for the certification period of 8/17/2026 to 10/15/2026 indicated the Skilled Nurse (SN, a licensed nurse) visit frequency was twice per week for nine weeks. The SN responsibilities included assessing wound for indications of impaired healing, including absence of a healing ridge (a normal, temporary raised firm area that forms directly under a surgical incision during the tissue repair process), presence of drainage (also called exudate, the fluid that seeps out of a cut, scrape, or surgical incision during the healing process) or purulent exudate (a thick, opaque fluid, commonly known as pus, that oozes from a wound or infected tissue as the body fights an infection), and delayed or prolonged inflammatory response (your immune system’s response to injury or infection). The POC for the certification period of 8/17/2026 to 10/15/2026 indicated the following wound treatment for Patient 5: Apply double antibiotic ointment, then cover with sterile 4x4 gauze, secure with tape for 21 days. The wound care order did not indicate the location of the wound, the frequency of the wound treatment, or the start date of the wound treatment. The Goals/Rehabilitation Potential section in Patient 5’s POC for the certification period of 8/17/2026 to 10/15/2026 did not indicate what the goals were for Patient 5. The POC only indicated the following in the Goals/Rehabilitation Potential section: Agreed their personal goals were realistic based on the patient’s health status. Agreed their personal goals needed to be modified based on the patient’s health status. Patient helped write a measurable goal, understandable to all stakeholders. During a joint visit to Assisted Living Facility 1 (ALF 1, where Patient 5 resides) on 8/26/2026 at 11 a.m. with Licensed Vocational Nurse 1 (LVN 1), the surveyor observed Patient 5 alert and oriented. During the joint visit, observed a wound on Patient 5’s right temple with maroon colored scab covering it. Observed LVN 1 perform the following wound treatment: Cleansed wound with wound cleanser (a solution used to safely wash dirt, bacteria, and dead tissue out of a cut, scrape, or surgical site), patted dry, applied 100% medical grade manuka honey, then applied silver calcium alginate dressing (used to manage moderate to heavily exuding wounds that are infected or at a high risk for infection), and covered with bordered gauze (a type of wound dressing). During a concurrent interview and record review with LVN 1 on 8/26/2026 at 12 p.m., LVN 1 reviewed Patient 5’s POC for the certification period of 8/17/2026 to 10/15/2026. LVN 1 stated that the wound order in the POC was incorrect. LVN 1 stated that Patient 5’s wound order came from the wound specialist from Wound Clinic 1 (WC 1, a specialized medical facility that treats complex wounds that do not heal through normal processes). LVN 1 stated the wound treatment needed to be done every other day done every other day or as needed if there was soiling. During a concurrent interview and record review with the ADM/DPCS on 8/27/2026 at 10:59 a.m., the ADM/DPCS stated that Patient 5 was being seen by a wound specialist once a week. The ADM/DPCS reviewed Patient 5’s POC for the certification period of 8/17/2026 to 10/15/2026, Visit Report from WC 1, dated 7/16/2026, 7/28/2026, 8/4/2026, 8/11/2026, and 8/25/2026. The ADM/DPCS stated that Patient 5’s POC for the certification period of 8/17/2026 to 10/15/2026 was missing the goals. The ADM/DPCS that goals in the patient’s POC were important because without goals it would be difficult to monitor the patient’s progress. The ADM/DPCS stated that the lack of goals would also affect the quality of care provided to the patient. Regarding the wound treatment order in the POC, the ADM/DPCS stated that per WC 1’s recommendation, the wound treatment for Patient 5’s wound on the right temple was to cleanse with wound cleanser, then apply the calcium alginate dressing first, followed by the honey gel, and then cover with bordered dressing. The ADM/DPCS stated the treatment recommendation was made on 7/28/2026 based on the Visit Report, and as of 8/25/2026, the treatment recommendation was still the same. The ADM/DPCS stated the wound treatment indicated on the POC for the certification period of 8/17/2026 to 10/15/2026 for Patient 5 was inaccurate. The ADM/DPCS stated that the treatment recommendation was made on 7/28/2026, so it should have been included in the POC for the certification period of 8/17/2026 to 10/15/2026. The Adm/DPCS stated that it was very important to integrate all orders into the plan of care so that all disciplines would be able to follow the proper treatment. The ADM/DPCS stated that not having orders included in the POC could delay treatment. During a review of the HHA’s policy and procedure (P&P) titled “Care Planning Process”, revised January 2005, the P&P indicated a written plan of care will be initiated within five days of start of care and updated at least every 60 days, or as patient’s condition warrants. The clinical plan of care includes pertinent diagnosis, mental status, types of services/equipment, frequency of visits, goals and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, treatments, safety measures, instructions, discharge plan. 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.”

“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 and other therapeutics service to a patient’s personal residence) failed to ensure that all physician orders were recorded in the patient’s plan of care (POC, a detailed, written document outlining the services and support an individual needs to meet their healthcare goals) for one of 7 sampled patients (Patient 5). This failure had the potential to result in compromised patient safety and disrupted continuity of care. During a review of Patient 5’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 8/17/2026 to 10/15/2026, the POC indicated the HHA admitted Patient 5 on 6/18/2026 with a primary diagnosis of polyosteoarthritis (a form of degenerative joint disease that affects multiple joints at the same time). The POC for the certification period of 8/17/2026 to 10/15/2026 indicated the Skilled Nurse (SN, a licensed nurse) visit frequency was twice per week for nine weeks. The SN responsibilities included assessing wound for indications of impaired healing, including absence of a healing ridge (a normal, temporary raised firm area that forms directly under a surgical incision during the tissue repair process), presence of drainage (also called exudate, the fluid that seeps out of a cut, scrape, or surgical incision during the healing process) or purulent exudate (a thick, opaque fluid, commonly known as pus, that oozes from a wound or infected tissue as the body fights an infection), and delayed or prolonged inflammatory response (your immune system’s response to injury or infection). The POC for the certification period of 8/17/2026 to 10/15/2026 indicated the following wound treatment for Patient 5: Apply double antibiotic ointment, then cover with sterile 4x4 gauze, secure with tape for 21 days. The wound care order did not indicate the location of the wound, the frequency of the wound treatment, or the start date of the wound treatment. During a joint visit to Assisted Living Facility 1 (ALF 1, where Patient 5 resides) on 8/26/2026 at 11 a.m. with Licensed Vocational Nurse 1 (LVN 1), the surveyor observed Patient 5 alert and oriented. During the joint visit, observed a wound on Patient 5’s right temple with maroon colored scab covering it. Observed LVN 1 perform the following wound treatment: Cleansed wound with wound cleanser (a solution used to safely wash dirt, bacteria, and dead tissue out of a cut, scrape, or surgical site), patted dry, applied 100% medical grade manuka honey, then applied silver calcium alginate dressing (used to manage moderate to heavily exuding wounds that are infected or at a high risk for infection), and covered with bordered gauze (a type of wound dressing). During a concurrent interview and record review with LVN 1 on 8/26/2026 at 12 p.m., LVN 1 reviewed Patient 5’s POC for the certification period of 8/17/2026 to 10/15/2026. LVN 1 stated that the wound order in the POC was incorrect. LVN 1 stated that Patient 5’s wound order came from the wound specialist from Wound Clinic 1 (WC 1, a specialized medical facility that treats complex wounds that do not heal through normal processes). LVN 1 stated the wound treatment needed to be done every other day done every other day or as needed if there was soiling. LVN 1 stated that the HHA should be able to provide me with the notes from WC 1. LVN 1 stated, “The wound care order is in the visit notes.” During a concurrent interview and record review with the ADM/DPCS on 8/27/2026 at 10:59 a.m., the ADM/DPCS stated that Patient 5 was being seen by a wound specialist once a week. The ADM/DPCS reviewed Patient 5’s POC for the certification period of 8/17/2026 to 10/15/2026, Visit Report from WC 1, dated 7/16/2026, 7/28/2026, 8/4/2026, 8/11/2026, and 8/25/2026. The ADM/DPCS stated that per WC 1’s recommendation, the wound treatment for Patient 5’s wound on the right temple was to cleanse with wound cleanser, then apply the calcium alginate dressing first, followed by the honey gel, and then cover with bordered dressing. The ADM/DPCS stated the treatment recommendation was made on 7/28/2026 based on the Visit Report, and as of 8/25/2026, the treatment recommendation was still the same. The ADM/DPCS stated that the HHA should have notified Patient 5’s physician about the treatment recommendation from WC 1. The ADM/DPCS stated that if the physician agreed with the treatment recommendation, then the HHA would create a physician order for it and incorporate the wound treatment order to Patient 5’s POC. The ADM/DPCS stated that the plan of care was a guideline for home health team responsible for the care of the patient; therefore, the plan of care needed to have the patient’s diagnosis, medications, pertinent treatment, orders for the patient, interventions, activities allowed, and goals. The ADM/DPCS stated that not having all physician orders in the patient’s POC could delay necessary treatment. During a review of the HHA’s policy and procedure (P & P), titled “Care Planning Process,” revised January 2005, the P & P indicated that 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.”

“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 observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutics service to a patient’s personal residence) failed to ensure that wound treatment order for one of 7 sampled patients (Patient 5) was administered only as ordered by a physician or allowed practitioner. This failure resulted in the patient’s wound was not provided the appropriate treatment leading to delayed wound healing and further complications. During a review of Patient 5’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 8/17/2026 to 10/15/2026, the POC indicated the HHA admitted Patient 5 on 6/18/2026 with a primary diagnosis of poly-osteoarthritis (a form of degenerative joint disease that affects multiple joints at the same time). The POC for the certification period of 8/17/2026 to 10/15/2026 indicated the Skilled Nurse (SN, a licensed nurse) visit frequency was twice per week for nine weeks. The SN was to assess the wound for indications of impaired healing, including absence of a healing ridge (a normal, temporary raised firm area that forms directly under a surgical incision during the tissue repair process), presence of drainage (also called exudate, the fluid that seeps out of a cut, scrape, or surgical incision during the healing process) or purulent exudate (a thick, opaque fluid, commonly known as pus, that oozes from a wound or infected tissue as the body fights an infection), and delayed or prolonged inflammatory response (your immune system’s response to injury or infection). The POC for the certification period of 8/17/2026 to 10/15/2026 indicated the following wound treatment for Patient 5: Apply double antibiotic ointment, then cover with sterile 4x4 gauze, secure with tape for 21 days. The wound care order did not indicate the location of the wound, the frequency of the wound treatment, or the start date of the wound treatment. On 8/26/2026 at 11 a.m., during a joint visit with Licensed Vocational Nurse 1 (LVN1) to the Assisted Living Facility 1 (ALF 1) where Patient 5 resided was conducted. During the visit it was observed Patient 5 was alert and oriented. It was observed further observed Patient 5’s wound was on the right temple with maroon colored scab covering it. LVN 1 performed the following wound treatment: Cleansed wound with wound cleanser (a solution used to safely wash dirt, bacteria, and dead tissue out of a cut, scrape, or surgical site), patted dry, applied 100% medical grade manuka honey, then applied silver calcium alginate dressing (used to manage moderate to heavily exuding wounds that are infected or at a high risk for infection), and covered with bordered gauze (a type of wound dressing). During a concurrent interview and record review with LVN 1 on 8/26/2026 at 12 p.m., LVN 1 reviewed Patient 5’s POC for the certification period of 8/17/2026 to 10/15/2026. LVN 1 stated the wound order on the POC was incorrect. LVN 1 stated Patient 5’s wound order came from the wound specialist from Wound Clinic 1 (WC 1, a specialized medical facility that treats complex wounds that do not heal through normal processes). During a concurrent interview with LVN 1 when asked if he had the physician’s order for the wound treatment he performed, LVN 1 stated, “The wound care order is in the visit notes.” During a concurrent interview and record review with the Administrator/Director of Patient Care Services (ADM/DPCS) on 8/27/2026 at 10:59 a.m., the ADM/DPCS stated that Patient 5 was being seen by a wound specialist once a week. The ADM/DPCS reviewed Patient 5’s POC for the certification period of 8/17/2026 to 10/15/2026, active physician orders, and Visit Report from WC 1, dated 7/16/2026, 7/28/2026, 8/4/2026, 8/11/2026, and 8/25/2026. The ADM/DPCS stated the correct wound treatment order was supposed to be what was recommended by WC 1 on 7/28/2026, which indicated that the wound on the right temporal head to be cleansed with wound cleanser, then the Calcium alginate dressing should be applied first, followed by the honey gel, and then covered with bordered dressing. The ADM/DPCS stated that Patient 5 current did not have a physician’s order for the wound treatment that LVN 1 did. The ADM/DPCS stated, “We need an order from the patient’s physician because the physician is the one overseeing the patient’s care.” The ADM/DPCS stated that the HHA should have notified Patient 5’s physician about the treatment recommendation from WC 1. The ADM/DPCS stated that if the physician agreed with the treatment recommendation, then the HHA would create a physician order for it and incorporate the wound treatment order to Patient 5’s POC. During a review of the HHA’s policy and procedure (P & P), titled “Verification of Physician Orders,” revised April 2021, the P & P indicated that orders would be obtained from a licensed physician (or other authorized licensed independent practitioner) for care and services to be 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, an organization that delivers skilled nursing and other therapeutics service to a patient’s personal residence) failed to clarify the physician’s orders regarding fluid restriction (a diet that limits the total amount of liquids consumed), intake and output monitoring (tracking all the fluid that goes into a patient’s body and all the fluid that leaves it), and cardiac rhythm monitoring (the continuous or intermittent tracking of the electrical activity of your heart to detect irregular heartbeats) for one of 7 sampled patients (Patient 7). This failure had the potential to result in increased risk for hospitalization and adverse health outcomes for the patient. During a review of Patient 7’s Home Health Certification and Plan of Care (POC, a detailed, written document outlining the services and support that an individual needs to meet their healthcare goals) for the certification period of 6/12/2026 to 8/10/2026 (previous period), the POC indicated the HHA admitted Patient 7 on 4/13/2026 with a primary diagnosis of polyosteoarthritis (a form of degenerative joint disease that affects multiple joints at the same time). The POC for the certification period of 6/12/2026 to 8/10/2026 indicated the Skilled Nurse (SN, a licensed nurse) visit frequency was once per week for nine weeks. During a review of Patient 7’s Physician’s Order, dated 6/9/2026, indicated the physician had recertified Patient 7 to receive home health services. The Physician’s Order indicated for the SN to educate the patient on fluid and sodium (salt) restriction, monitor urine output, and weigh the patient daily. Patient 7’s POC for the certification period of 6/12/2026 to 8/10/2026 did not specify how much fluid Patient 7 was to take within 24 hours. The POC for the certification period of 6/12/2026 to 8/10/2026 also did not specify how many grams (a unit of measurement) of sodium Patient 7 was allowed to take within 24 hours. During a review of Skilled Nursing Progress Notes, dated 6/16/2026, 6/23/2026, 6/30/2026, 7/7/2026, and 7/17/2026, there was no documented evidence Patient 7’s was adhering to the fluid and sodium restrictions or was monitored for the urine output. The Skilled Nursing Progress Notes did not indicate Patient 7’s weight was taken daily as ordered by the physician. During a review of Patient 7’s Home Health Certification and Plan of Care for the certification period of 8/11/2026 to 10/9/2026 (current period), the POC indicated the SN visit frequency was once per week for nine weeks. During a review of Patient 7’s Physician Order, dated 8/10/2026, Patient 7 was recertified to receive home health services. The Physician’s Order indicated for the SN to monitor the patient’s cardiac rhythm (the pattern and timing of how the heart beats, controlled by electrical signals that move through the heart muscles). Patient 7’s POC for the certification period of 6/12/2026 to 8/10/2026 did not include cardiac rhythm monitoring as one of the nursing interventions. During a review of Skilled Nursing Progress Notes, dated 8/14/2026, 8/21/2026, and 8/26/2026, there was no documented evidence in the Skilled Nursing Progress Notes Patient 7’s cardiac rhythm was monitored during the home visits. A phone call was placed on 8/27/2026 at 12:47 p.m., and 3:22 p.m., to interview Patient 7, but the phone calls were not answered. During a concurrent interview and record review with the Administrator/Director of Patient Care Services (ADM/DPCS) on 8/27/2026 at 1:14 p.m., the ADM/DPCS reviewed Patient 7’s Home Health Certification and Plan of Care for the certification period of 6/12/2026 to 8/10/2026, Home Health Certification and Plan of Care for the certification period of 8/11/2026 to 10/9/2026, Physician Order, dated 6/9/2026 and 8/10/2026, Skilled Nursing Progress Notes, dated 6/16/2026, 6/23/2026, 6/30/2026, 7/7/2026, 7/17/2026, 8/14/2026, 8/21/2026, and 8/26/2026. The ADM/DPCS stated that for the certification period of 6/12/2026 to 8/10/2026, he did not know how much fluid or how many grams of sodium Patient 7 was supposed to take within 24 hours. The ADM/DPCS also stated that he did not see in Patient 7’s clinical records where urine output was monitored and daily weight being taken. The ADM/DPCS stated that Patient 7 resided in an assisted living facility (ALF 1). The ADM/DPCS stated that he had spoken to Medication Technician 1 (MT 1) at ALF 1, who was responsible for administering medications to the residents. The ADM/DPCS stated that according to MT 1, ALF 1 did not put Patient 7 on fluid and sodium restriction. The ADM/DPCS stated that per MT 1, she took Patient 7’s weight weekly. The ADM/DPCS stated that assisted living facilities did not typically do clinical monitoring, such as fluid restriction and intake and output monitoring. The ADM/DPCS stated that LVN 1 had not been monitoring Patient 7’s cardiac rhythm as ordered, as LVN 1 did not have the capacity to perform cardiac rhythm monitoring. The ADM/DPCS stated that cardiac rhythm monitoring required an electrocardiogram device (a medical device that records the electrical signals moving through your heart); and the HHA staff was not equipped with one. The ADM/DPCS stated that he should have communicated with Patient 7’s physician and informed the physician that Patient 7 resided in an assisted living facility, which did not typically do clinical monitoring. The ADM/DPCS stated the physician also needed to be aware that the frequency of SN visit was once per week, so the SN could not effectively monitor fluid and sodium restriction, monitor urine output, or take daily weight. The ADM/DPCS stated that he should also have clarified the cardiac rhythm monitoring order for Patient 7 as the HHA staff did not have the capability to do it. The ADM/DPCS stated that Patient 7 could potentially have problems such as fluid overload (a medical condition where your body holds onto too much water and sodium), cardiac (related to the heart) issues, and hospitalization from the lack of monitoring. During a review of the HHA’s policy and procedure (P & P), titled “Verification of Physician Orders,” revised April 2021, the P & P indicated that a qualified individual would review each order or prescription before care was provided. The P & P also indicated that an order or prescription would be verified when there was a question or discrepancy in the order/prescription.”

“Documentation of competency evaluation CFR(s): 484.80(c)(5) The HHA must maintain documentation which demonstrates that the requirements of this standard have been met. 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’s personal residence) failed to maintain documentation to prove that a qualified evaluator validated the Certified Home Health Aide (CHHA, Certified Home Health Aide; a trained health care professional who provides personal care such as bathing, dressing, grooming, and using the bathroom, and basic medical monitoring, such as checking and recording vital signs like pulse, temperature, and blood pressure) competency to care for patients in their homes. This failure had the potential to negatively affect all certified patients’ health and safety, and provision of a substandard care and services. During a review of CHHA 1’s employee file, the employee file indicated that the HHA hired CHHA 1 on 3/25/2025. During a review of Personnel Orientation Checklist for CHHA 1, the Personnel Orientation Checklist did not indicate when the orientation was completed by CHHA 1. During a review of Initial Competency Assessment Skills Checklist for CHHA 1, the Initial Competency Assessment Skills Checklist indicated that CHHA 1 was evaluated for skills such as taking the patient’s vital signs, such as temperature, blood pressure, and respiration, giving bed bath, providing oral care, assisting with toileting, and transferring techniques. The Initial Competency Assessment Skills Checklist for CHHA 1, however, did not indicate if a qualified evaluator, such as a Registered Nurse, validated CHHA 1’s skills. The preceptor’s initial and date column in the Initial Competency Assessment Skills Checklist for CHHA 1 was blank. The Initial Competency Assessment Skills Checklist for CHHA 1 was not signed by a preceptor. During a concurrent interview and record review with the Administrator/Director of Patient Care Services (ADM/DPCS) on 8/27/2026 at 1:49 p.m., the ADM/DPCS reviewed CHHA 1’s employee file. The ADM/DPCS stated that the Personnel Orientation Checklist should have listed the date the orientation was provided to CHHA 1. The ADM/DPCS stated that the purpose of the Initial Competency Assessment Skills Checklist was to make sure the CHHA was competent to safely provide service to the patient. The ADM/DPCS stated that the CHHA’s skills needed to be validated by a qualified preceptor to make sure the CHHA “properly and correctly provide care for the patient.” The ADM/DPCS stated that if CHHA 1’s skills were not validated by a qualified preceptor, the CHHA could possibly harm a patient or hurt herself while providing care for a patient. During a review of a document provided by the HHA, titled “Job Description Summary – Certified Home Health Aide,” revised April 2021, the document indicated that the qualification for a CHHA included the following: A competency evaluation that meets the requirements of §484.80(c).”

“Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and 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 [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 one of five clinical staff (licensed vocational nurse 3 or LVN 3) maintained a valid CPR (or cardiopulmonary resuscitation - an emergency life-saving procedure performed when someone’s breathing or heartbeat has stopped) certification. This deficient practice could result in staff lacking the necessary knowledge and being unable to respond appropriately during emergency crises requiring CPR. During a review of LVN 3’s employee records, on 8/27/2026 at 11:30 a.m., indicated a hire date of 9/30/2022. LVN 3’s CPR certification indicated it had expired on 7/2026. During an interview, on 8/27/2026 at 11:50 a.m., with the Operations Manager (OM), OM stated that she was responsible for maintaining the employee files. OM stated and confirmed LVN 3’s CPR certification had expired on 7/2026. During an interview, on 8/27/2026 at 1:20 p.m., with the Administrator/Director of Patient Care Services (ADM/DPCS), the ADM/DPCS confirmed that clinical staff visiting patients must hold current CPR certification due to evolving criteria and the need for updated skills and confidence during emergencies. The ADM/DPCS acknowledged these findings. During a review of the HHA’s record titled “Job Descriptions for Job Title/Position: Licensed Practical/Vocational Nurse”, revised April 2021, it indicated the Licensed Practical/Vocational Nurse is responsible for providing direct patient care under the supervision of a registered nurse. One of the position qualifications is to possess and maintain valid CPR certification.”