Elite Home Care, Inc.

“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 observation, interview, and record review the Home Health Agency (HHA) failed to conduct and complete the comprehensive pain assessment and reassessment for one of six sample patients (Patient 13) in accordance with their policy and procedure. This failure had the potential to result in a delay in informing the physician of the patients’ decline or progress in health status, and identify significant changes, needs, and interventions in the patients’ plan of care (POC – individualize care planned for the patient). During a record review of Patient 13’s medical record forms titled “Home Health Certification and Plan of Care” dated 7/13/2024 to 9/10/2024 and 9/11/2024 to 11/9/2024, the forms indicated a start of care date of 5/14/2024, with a primary diagnosis of varicose veins of bilateral… The forms also indicated “Other Pertinent Diagnosis – chronic pain syndrome. During a joint home visit on 9/11/2024 at 9 a.m. with License Vocational Nurse 1 (LVN1) at Patient 13’s home, Patient 13 greeted the Surveyor and LVN 1 at the door. Patient 13 was observed ambulating, hunched forward with a slow steady gait and was smoking a cigarette. Patient 13 stated she does not have varicose veins and has had several back and bilateral knee surgeries that cause her to have chronic pain, which is managed by taking Percocet (narcotic pain medication). LVN1 stated Patient 13 is receiving home health services for medication management. However, LVN1 did not assess Patient 13 for pain during the home visit. LVN stated she should have assessed Patient 13’s pain to evaluate if the pain medication was effective. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with the Administrator (ADM), Patient 13’s medical record form titled “Reason for Assessment: Recertification (follow-up) assessment” for certification period 7/13/2024 to 9/10/2024 was reviewed. The ADM stated Patient 13 was receiving home health services for pain management but Patient 13 did not have a complete pain assessment documented on the form. The ADM stated it was important to assess Patient 13’s pain “Because we are treating her pain.” The ADM stated the nursing recertification was not signed by the author. The ADM stated the author’s signature indicates it was complete and done by the author. The form also indicated section “Fall Risk Assessment Tool – Required core elements - Assess on point for each core element “yes” – pain affecting level of functioning” and section “pain frequency” were left blank. The form also indicated Patient 13’s primary diagnosis was varicose veins of bilateral lower extremities with pain and other diagnoses included chronic pain syndrome. The ADM stated there was no physician recertification order in Patient 13’s medical record. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with the ADM, Patient 13’s medical record form titled “Reason for Assessment: Recertification (follow-up) assessment” certification period 9/11/2024 to 11/9/2024, was reviewed. The ADM stated Patient 13’s recertification nursing assessment was plotted into their Electronic Medical Record (EMR) system the morning of 9/11/2024.The ADM stated the information on the form was auto-populated (automatically inserted from the last documented recertification assessment). The form also indicated in the section for “Fall Risk Assessment Tool – Required core elements - Assess on point for each core element “Yes” – pain affecting level of functioning, Pain, and Pain Frequency” were left blank. The ADM stated there was no physician recertification order in Patient 13’s medical record for episode beginning 9/11/2024. The ADM stated she will work on the recertification order because she has not put in the order yet. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with the ADM of Patient 13’s EMR medical record forms titled “Skilled Nursing Clinical Note” dated 6/19/2024, 7/26/2024, 8/2/2024, 8/16/2024, 8/24/2024, 8/31/2024, and 9/7/2024, the ADM stated Patient 13 did not have a complete pain assessment documented on all skilled nursing visit notes. The ADM stated pain assessments included asking the patient what and how often she takes medication for pain, what the level of pain was, and what makes the pain better or worst. During an interview on 9/13/2024 at 11:37 a.m. with the ADM, the ADM stated the patient pain assessment should be complete at every skilled nursing visit to make ensure the patient’s pain is controlled. The ADM stated the pain assessment should be documented in the patients’ medical record the day of the visit. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with License Vocational Nurse 1 (LVN1) of Patient 13’s EMR, LVN1 stated Patient 13 was receiving home health services for “Home safety and medication management.” During an interview on 9/11/2024 at 2:56 p.m. with the Medical Director 1 (MD1), MD1 stated he does not have access to the HHA’s EMR. MD1 stated he has his own EMR2. MD1 stated the HHA emails and/or fax the patient’s orders for him to sign and he currently has a stack of documents he needs to review, sign, and send back. During a concurrent interview and record review on 9/11/2024 at 3 p.m. with MD1 of Patient 13’s medical record, MD1 stated Patient 13’s start of care was 5/14/2024 and is receiving HHA services for physical therapy and Percocet (narcotic pain medication). MD1 stated as far as he knew Patient 13 did not have a primary physician and is homebound. MD1 stated the last time he conducted a video call with Patient 13 was in May 2024 when he certified her for HHA services. MD1 stated he certified Patient 13 in May and believes her recertification was coming up soon. MD1 was informed that Patient 13 was recertified for HHA services on 7/13/2024 and 9/10/2024. MD1 stated there were a lot of orders he received form the HHA that he has not signed, and maybe Patient 13’s recertification orders were in those documents. MD 1 stated it was important to assess patients to see if they still qualify for HHA services. MD1 stated he was not aware Patient 13’s primary diagnosis for HHA services was varicose veins for the last two recertification periods. MD1 stated Patient 13’s main issues were joint and prior surgery pain. MD1 was asked if he took part in Patient 13’s plan of care. MD1 stated, “Yes, I get the order, review it and sign them.” During a record review of Patient 13’s medical record form titled “Home Health Note” dated 5/14/2024, indicated “Chief Complaint: Chronic Pain.” The form also indicated “Assessment/Plan: Chronic pain… We will start home health and physical therapy.” Lastly, the form indicated it was signed by Medical Director 1 (MD1). During a record review on 9/10/2024 at 12:13 p.m., of Patient 13’s EMR, medical record form titled “Parameter Graph,” the graph indicated the section “Pain Scale” had a value of 0 on 7/19/2024, 7/26/2024, 8/2/2024, 8/16/2024, 8/24/2024, 8/31/2024, and 9/7/2024. During a record review of the HHA’s form titled “Admission Criteria and Process” revised October 2019, indicated “Once a patient is admitted to service, the organization will be responsible for providing care and services within its financial and service capabilities, mission, and applicable law and regulations… The patient’s physician must order and approve the provision of any service. During a record review of the HHAs undated form titled “Wound Assessment” indicated “Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided. Entries into the clinical record will be made on the day care is provided to the patient.” During a record review of the HHA’s form titled “Rights/responsibilities” revised April 2013, indicated “The patient will be informed verbally and in writing during the initial evaluation visit, in advance furnishing care to the patient, of the following: L. The right to pain assessment and management.” During a record review of the HHA’s form titled “Pain Management” revised April 2014, indicated “Pain will be assessed as a part of every patient contact if the patient reports pain or is at risk for pain.” During a record review of the HHA’s form titled “Ongoing Assessment” revised October 2019, indicated “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: C. Pain status, when applicable, including: 1. Responses to pain intervention(s) 2. Progress toward pain management goals, including functional ability 3. Side effects of treatment 4. Risk factors for adverse events caused by the treatment.” During a record review of the HHA’s form titled “Care Coordination” revised April 2014, indicated “All personnel will be knowledgeable regarding patient needs, goals, of care and services.” During a record review of the HHA’s form titled “Care Planning Process” revised April 2014, indicated “Individualized Plan of Care: The patient-specific clinical plan of care includes all pertinent diagnoses... 2. All clinicians will consider the conclusions of initial and ongoing assessments in their care planning process, including, but not limited to: D. Pain and symptom management, as appropriate. 5. The plan of care will be based upon the physicians’ orders…””

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to conduct a comprehensive assessment that accurately reflected the patients’ health status for two of six sample Patients (Patient 10, and Patient 13). This failure resulted in the HHAs failure to identify Patient 13’s need for pain management and physical therapy services and recent seizure activity. This failure also had the potential to result in the delay in identifying the patient’s significant needs and provisions of services that could affect their quality of care and well-being. During a record review of Patient 10’s medical record forms titled “Home Health Certification and Plan of Care” dated 8/13/2024 to 10/11/2024, indicated a start of care date (SOC) of 4/15/2024 with a primary diagnosis of unspecified chronic bronchitis (long term inflammation of the lungs making it hard to breath). During a record review of Patient 10’s undated medical record form titled “Patient Medication Profile” listed Patient 10’s prescribed medications. Patient 10’s medications were: Doxycycline (medication to treat infection), Norco (narcotic pain medication), Coreg (high blood pressure medication), Nifedipine (high blood pressure medication), albuterol inhaler (medication to treat shortness of breath), and Colace (stool softener medication). During a record review on 9/10/2024 at 12:40 p.m. of Patient 10’s Electronic Medical Record (EMR) the section titled “Parameter Graph” dated 8/15/2024, 8/22/2024, 8/31/2024, and 9/7/2024, indicated section “02 Sat (oxygen saturation in the blood)” was given the value of zero (0). During a record review of Patient 10’s medical record forms titled “Skilled Nursing Clinical Note” dated 8/15/2024, 8/22/2024, 8/31/2024, and 9/7/2024, indicated that the documentation was the same, word for word, under section “Skilled Interventions/Instructions Procedures”, which indicated Patient 10 was educated on the use of diuretics (medication to remove water from body). The forms also indicated under section “Respiratory” LVN1 documented “02 Sat 98%” on all forms. The form also indicated License Vocational Nurse 1 (LVN1) completed all the forms. During a concurrent interview and record review on 9/12/2024 at 1:07 p.m. with LVN1 of Patient 10’s EMR, LVN1 stated she visits Patient 10 once a week. LVN1 stated that during her visits she takes Patient 10’s vital signs (temperature, blood pressure, heart rate, respiratory rate, and pain level), and provides teachings on his diet, how to use his cane, scheduling of his medications, and the dangers of smoking. LVN1 stated she documents her teachings in the visit note under section “Skilled Interventions/Instructions Procedures.LVN1 was asked to review her nursing notes dated 8/15/2024, 8/22/2024, 8/31/2024, and 9/7/2024. LVN1 stated, “They are all the same documentation; I have no idea what the heck happened. He is not taking diuretics. I’m not even sure, I am trying to think. I don’t know how all my notes are the same.” During a concurrent interview and record review on 9/12/2024 at 1:38 p.m. with the Administrator (ADM) of Patient 10’s EMR, the ADM stated that she was the nurse who completed Patient 10’s nursing reassessment for his third episode on 8/8/2024 with the primary diagnosis of chronic bronchitis. The ADM stated there was no physician recertification order for Patient 10 because she has not generated one yet. The ADM stated that Patient 10’s respiratory system was not assessed because the recertification assessment documentation is short. The ADM stated she did not recall why she indicated Patient 10 had chronic bronchitis. After looking in Patient 10’s EMR further, the ADM stated that she got confused about Patient 10’s diagnosis of chronic bronchitis because he was taking antibiotics at the time of reassessment. The ADM stated Patient 10 was taking antibiotics for a skin rash. The ADM stated she will change Patient 10’s primary diagnosis “after checking what Medicare gives me.” During a concurrent interview and record review on 9/11/2024 at 2:56 p.m. with MD1 of Patient 10’s medical record, MD1 stated he conducted a video visit with Patient 10 five times. The first time in September 2022, and four times in 2023, the last time was on 9/15/2023. MD1 stated he was looking at his notes for Patient 10 dated 9/15/2023 to be able to provide information. MD1 stated he was treating Patient 10 for osteoarthritis and foot pain. MD1 stated he was not treating Patient 10 for chronic bronchitis. MD1 stated he relies on the HHA nurses to be his eyes and ears and believes the chronic bronchitis diagnosis “trickled from where he came from.” During an interview on 9/13/2024 at 11:37 a.m. with the ADM, the ADM stated it was important to complete a comprehensive assessment of patients health conditions to create a proper individualized plan of care while receiving their HHA services. During an interview on 9/13/2024 at 11:43 a.m. with the ADM, the ADM stated a patients update assessment is done every 60 days. The ADM stated the reassessment is conducted to identify if the patient continues to need home health services. The ADM stated if a reassessment is conducted late, there would be a delay in patient care. 2. During a record review of Patient 13’s medical record forms titled “Home Health Certification and Plan of Care” dated from 7/13/2024 to 9/10/2024 and 9/11/2024 to 11/9/2024, indicated a start of care date of 5/14/2024, with a primary diagnosis of varicose veins of bilateral lower extremities. The forms also indicated “Other Pertinent Diagnosis – chronic pain syndrome and epilepsy (seizure disorder). Lastly, the forms also indicated Patient 13’s was assigned a SNV (skilled nurse) 2wk2 (twice a week for two weeks), 1wk7 (once a week for seven weeks). The forms did not indicate other disciplines assigned. 2a. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with the Administrator (ADM) of Patient 13’s medical record form titled “Reason for Assessment: Recertification (follow-up) assessment” certification period 7/13/2024 to 9/10/2024, ADM stated Patient 13 was receiving home health services for pain management. The ADM stated Patient 13 did not have a complete pain assessment. The ADM stated it was important to assess Patient 13’s pain “because we are treating her pain.” The ADM stated the nursing recertification was not signed by the author. The ADM stated the author’s signature indicates it was complete and done by the author. The form also indicated the section “Fall Risk Assessment Tool – Required core elements - Assess one point for each core element “Yes” – pain affecting level of functioning” and section “pain frequency” were left blank. The form also indicated Patient 13’s primary diagnosis was varicose veins of bilateral lower extremities with pain and other diagnoses include chronic pain syndrome. The ADM stated there was no physician recertification order in Patient 13’s medical record. ADM stated the plan of care has the physician recertification orders, which she sends to the doctor. ADM stated they do not have Patient 13’s signed plan of care. During a record review on 9/10/2024 at 12:13 p.m., of Patient 13’s EMR, section titled “Parameter Graph”, indicated section “Pain Scale” had a value of zero (0) on 7/19/2024, 7/26/2024, 8/2/2024, 8/16/2024, 8/24/2024, 8/31/2024, and 9/7/2024. During a record review of Patient 13’s medical record form titled “Home Health Note” dated 5/14/2024, indicated “Chief Complaint: Chronic Pain”. The form also indicated “Assessment/Plan: Chronic pain… We will start home health and physical therapy”. Lastly, the form indicated it was signed by the Medical Director 1 (MD1). During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with the ADM of Patient 13’s medical record form titled “Reason for Assessment: Recertification (follow-up) assessment” certification period 9/11/2024 to 11/9/2024, ADM stated Patient 13’s recertification nursing assessment was plotted into their EMR system in the morning, 9/11/2024. The ADM stated the information on the form was auto-populated (automatically inserted from last recertification assessment). The form also indicated section “Fall Risk Assessment Tool – Required core elements - Assess on point for each core element “Yes” – pain affecting level of functioning, Pain, and Pain Frequency” were left blank. The ADM stated there was no physician recertification order in Patient 13’s medical record for the episode. The ADM stated she will work on the recertification order because she has not put in the order yet. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with the ADM of Patient 13’s Electronic Medical Record (EMR) medical record forms titled “Skilled Nursing Clinical Note” dated 6/19/2024, 7/26/2024, 8/2/2024, 8/16/2024, 8/24/2024, 8/31/2024, and 9/7/2024, ADM stated Patient 13’s did not have a complete pain assessment documented on the forms. ADM stated pain assessment included asking the patient what and how often she takes for pain, what the level of pain was, and what makes the pain better or worst. During a joint home visit on 9/11/2024 at 9 a.m. with License Vocational Nurse 1 (LVN1) to Patient 13’s home, the Surveyor and VN 1 wee greeted at the door by Patient 13 who was ambulating, hunched forward with a slow steady gait and was smoking a cigarette. Patient 13 stated she does not have varicose veins. Patient 13 stated she has had several back and bilateral knee surgery that cause her to have chronic pain. LVN1 stated Patient 13 is receiving home health services for medication management. LVN1 did not assess Patient 13 for pain during the home visit. LVN stated she should have assessed Patient 13’s pain to evaluate if pain medication was effective. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with License Vocational Nurse 1 (LVN1) of Patient 13’s EMR, LVN1 stated Patient 13 was receiving home health services for “Home safety and medication management.” During a concurrent interview and record review on 9/11/2024 at 3 p.m. with MD1 of Patient 13’s medical record, MD1 stated he does not have access to the HHA’s EMR. MD1 stated he has his own EMR2. MD1 stated Patient 13’s start of care was 5/14/2024 and is receiving HHA services for physical therapy and Percocet (narcotic pain medication). MD1 stated the last time he conducted a video call with Patient 13 was in May 2024 when he certified her for HHA services. MD1 stated he certified Patient 13 in May and believes her recertification was coming up soon. MD1 was informed that Patient 13 was recertified for HHA services on 7/13/2024 and 9/10/2024. MD1 stated there were a lot of orders he received form the HHA that he has not signed, and maybe Patient 13’s recertification orders were in those documents. MD 1 stated it was important to assess patients to see if they still qualify for HHA services. MD1 stated he was not aware Patient 13’s primary diagnosis for HHA services was varicose veins for the last two recertification periods. MD1 stated Patient 13’s main issues were joint and prior surgery pain. MD1 was asked if he took part in Patient 13’s plan of care. MD1 stated, “yes, I get the order, review it and sign them.” During an interview on 9/13/2024 at 11:37 a.m. with the ADM, ADM stated patient pain assessment should be complete at every skilled nursing visit to make ensure their pain is controlled. ADM stated the pain assessment should be documented in the patients’ medical record the day of the visit. 2b. During a record review of Patient 13’s medical record form titled “Home Health Note” dated 5/14/2024, indicated “Chief Complaint: Chronic Pain”. The form also indicated “Assessment/Plan: Chronic pain… We will start home health and physical therapy”. Lastly, the form indicated it was signed by MD1. During a joint home visit on 9/11/2024 at 9 a.m. with LVN1 to Patient 13’s home, greeted at door by Patient 13 who was ambulating hunch forward with a slow steady gait. Patient 13 stated she has had several back and bilateral knee surgery that cause her to have pain. Patient 13 stated she does not receive physical therapy. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with the ADM of Patient 13’s medical record form titled “Reason for Assessment: Recertification (follow-up) assessment” certification period 7/13/2024 to 9/10/2024, ADM stated Patient 13 was receiving home health services for pain management. The form also indicated “activities permitted” included “exercises as prescribed” was selected. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with the ADM of Patient 13’s medical record form titled “Reason for Assessment: Recertification (follow-up) assessment” certification period 9/11/2024 to 11/9/2024, ADM stated Patient 13’s recertification nursing assessment was plotted into their EMR system the morning of 9/11/2024. ADM stated the information on the form was auto-populated (automatically inserted from last recertification assessment). During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with LVN1 of Patient 13’s EMR, LVN1 stated Patient 13 was receiving home health services for “home safety and medication management.” During a concurrent interview and record review on 9/11/2024 at 3 p.m. with the MD1 of Patient 13’s medical record, MD1 stated Patient 13’s start of care was 5/14/2024 and is receiving HHA services for physical therapy and Percocet (narcotic pain medication). MD1 stated the last time he conducted a video call with Patient 13 was in May 2024 when he certified her for HHA services. MD1 stated Patient 13’s main issues were joint and prior surgery pain. MD1 stated part of his recommendations in May 2024, were physical therapy for Patient 13. MD1 stated Patient 13 should have been receiving physical therapy. During a concurrent interview and record review on 9/12/2024 at 2:14 p.m. with the ADM of Patient 13’s EMR, ADM stated Patient 13 has not received physical therapy services since her start of care, 5/14/2024. On 9/12/2024 at 11:52 a.m. Office Staff (OS1) was requested to provide Patient 13’s physical therapy’s notes. OS1 stated Patient 13 did not have any physical therapy notes. 2c. During a concurrent interview and record review on 9/11/2024 at 12 p.m. with the ADM of Patient 13’s EMR, ADM stated she was not aware Patient 13 had a seizure on 9/7/2024. ADM stated there was a skilled nurse visit note on 9/7/2024 but that it did not mention the seizure episode. The ADM stated a thorough assessment is needed to prevent reoccurrence, fall, and injury. During a concurrent interview and record review on 9/11/2024 at 3 p.m. with the MD1 of Patient 13’s medical record, MD1 stated Patient 13’s start of care was 5/14/2024 and is receiving HHA services for physical therapy and Percocet (narcotic pain medication). MD1 stated she also had a seizure disorder and was on multiple seizure medications. MD1 stated, “I don’t know when her last seizure was.” MD1 stated was not aware Patient 13 had a seizure on 9/7/2024. MD1 stated Patient 13’s complaint of right arm pain and right toe numbness after her seizure would merit an emergency room visit. MD1 stated, “there is something wrong there.” During an interview on 9/11/2024 at 6:01 p.m. with MD1, MD1 stated he spoke with a nurse at the HHA after our last conversation on 9/11/2024 at 3 p.m. and was told Patient 13’s seizure episode was communicated to a different doctor. MD1 stated Patient 13 was asked if she wanted to go to the emergency room but refused. MD1 stated, “they are fixing the issues now.” During a record review of Patient 13’s medical record form titled “Communication Note” dated 9/7/2024, indicated “SN (skilled nurse) reported patient had seizures. Patient stable and not currently in need of anything further. MD (MD1) was notified and requested x-rays if needed. Patient was advised and refused the x-ray. SN will continue to monitor.” The form did not indicate who the author of the note was. During a record review of the HHA’s form titled “Face-To-Face Encounter Procedure” revised April 2014, indicated “In turn, an Agency must be able to provide, upon request, the supporting documentation that substantiates the eligibility for the Medicate home health benefit to review entities and/or CMS”. During a record review of the HHA’s form titled “Verification of Physician Orders” revised April 2014, indicated “A copy of the order will be kept in the patients clinical record.” During a record review of the HHA’s form titled “Admission Criteria and Process” revised October 2019, indicated “Once a patient is admitted to service, the organization will be responsible for providing care and services within its financial and service capabilities, mission, and applicable law and regulations… The patient’s physician must order and approve the provision of any service. During a record review of the HHA’s undated form titled “Wound Assessment” indicated “Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided. Entries into the clinical record will be made on the day care is provided to the patient.” During a record review of the HHA’s form titled “Rights/responsibilities” revised April 2013, indicated “The patient will be informed verbally and in writing during the initial evaluation visit, in advance furnishing care to the patient, of the following: I. The completion of all assessments and care to be furnished, based on the comprehensive assessment. The organization shall ensure that the patient receives all services outlined in the plan of care. L. The right to pain assessment and management.” During a record review of the HHA’s form titled “Pain Management” revised April 2014, indicated “Pain will be assessed as a part of every patient contact if the patient reports pain or is at risk for pain.” During a record review of the HHA’s form titled “Reassessment/Recertification” revised April 2019, indicated “The total plan of care must be renewed at least every 60 days, or more often as warranted by the condition of the patient. For each new episode of care, a comprehensive assessment will be completed no earlier than five (5) days before and no later than one (1) day before the calendar day on which the new episode of care began. The physician will be contacted to verify the continued need for care and his/her agreement with the continued plan of care. During a record review of the HHA’s form titled “Ongoing Assessment” revised October 2019, indicated “During each home visit, the clinician or other discipline will re-evaluation 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: C. Pain status, when applicable, including: 1. Responses to pain intervention(s) 2. Progress toward pain management goals, including functional ability 3. Side effects of treatment 4. Risk factors for adverse events caused by the treatment.” During a record review of the HHA’s form titled “Care Coordination” revised April 2014, indicated “Written evidence of care coordination will be recorded during the case conference and repeated in skilled nursing visit reports in the patients’ clinical records. All personnel will be knowledgeable regarding patient needs, goals, of care and services.” During a record review of the HHA’s form titled “Care Planning Process” revised April 2014, indicated “Individualized Plan of Care: The patient-specific clinical plan of care includes all pertinent diagnoses, 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. 2. All clinicians will consider the conclusions of initial and ongoing assessments in their care planning process, including, but not limited to: B. Changes in patients’ condition. D. Pain and symptom management, as appropriate. 3. Based on the assessment and conclusions, the plan of care will include, but not be limited to: B. All patient care orders from all physicians involved in the plan of care, including verbal orders. C. Identified patient problems and needs… 5. The plan of care will be based upon the physicians’ orders… 7. The plan of care will be revised as frequently as deemed necessary by the clinician, based on the ongoing assessments of the patient.””

“Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This Element is not met as evidenced by: Based on observation, interview, and record review the Home Health Agency (HHA) failed to ensure a Registered Nurse (RN) updated the comprehensive assessment for the recertification period for four sampled patients (Patient 2, Patient 10, Patient 11, and Patient 13). This failure had the potential to result in a delay in identifying the patient’s significant needs and provisions of services that could affect tier quality of care and well-being. 1. A record review of Patient 2’s “Home Health Certification and Plan of Care” (plan of care-POC), for the certification period 9/1/2024 to 10/30/2024, indicated a start of care (SOC) date of 1/5/2024, with a primary diagnosis of encounter of change or removal of non-surgical dressing. During a review of Patient 2’s nursing visits notes dated 8/2/2024, 8/6/2024, 8/9/2024, 8/13/2024, 8/16/2024, 8/20/2024, 8/23/2024, and 8/26/2024, the nursing visits notes indicated wound treatments were done to Patient 2’s stage 2 right buttock pressure ulcer. During a review of Patient 2’s progress report from the wound experts, dated 9/5/2024, the progress report from the wound experts indicated the stage 2 pressure ulcer on the patient’s right buttocks was healed. During an interview on 9/10/2024, at 11:55 a.m., with the ADM, the ADM stated a Registered Nurse (RN, in general) was supposed to complete an assessment within five days of the recertification date. The ADM stated the purpose of an assessment was to continue home health care and assess the needs of the patient to develop the plan of care. .... During a concurrent interview and record review on 9/12/2024, at approximately 1:17 p.m., the ADM reviewed Patient 2’s recertification assessment, dated 9/1/2024. The ADM stated the record did not indicate the skin and wound was assessed. The record did indicate the primary diagnosis was for encounter for change or removal of nonsurgical wound dressing. The ADM stated the document was not signed by a nurse. The ADM stated the nurse took a picture of the wound, but it was not in the medical record. 2. During a record review of Patient 10’s medical record forms titled “Home Health Certification and Plan of Care” dated from 8/13/2024 to 10/11/2024, indicated a start of care date (SOC) of 4/15/2024 with a primary diagnosis of unspecified chronic bronchitis (long term inflammation of the lungs making it hard to breath). During a record review of Patient 10’s medical record form titled “Reason for Assessment: Recertification (follow-up) assessment” dated 8/8/2024, indicated it was not signed by the author. During a concurrent interview and record review on 9/12/2024 at 1:38 p.m. with the Administrator (ADM) of Patient 10’s EMR, the ADM stated that she was the nurse who completed Patient 10’s nursing reassessment for his third episode on 8/8/2024 with the primary diagnosis of chronic bronchitis. ADM stated there was no physician recertification order for Patient 10 because she has not generated one yet. ADM stated that Patient 10’s respiratory system was not assessed because the recertification assessment documentation is short. ADM stated she did not recall why she indicated Patient 10 had chronic bronchitis. After looking in Patient 10’s EMR further, ADM stated that she got confused about Patient 10’s diagnosis of chronic bronchitis because he was taking antibiotics at the time of reassessment. ADM stated Patient 10 was taking antibiotics for a skin rash. ADM stated she will change Patient 10’s primary diagnosis “after checking what Medicare gives me.” Lastly, the ADM stated the nursing recertification dated 8/8/2024 was not signed by her, the author. ADM stated the author signature indicates it was complete and done by the author. During a concurrent interview and record review on 9/11/2024 at 2:56 p.m. with MD1 of Patient 10’s medical record, MD1 stated he conducted a video visit with Patient 10 five times. The first time in September 2022, and four times in 2023, the last time was on 9/15/2023. MD1 stated he was looking at his notes for Patient 10 dated 9/15/2023 to be able to provide information. MD1 stated he was treating Patient 10 for osteoarthritis and foot pain. MD1 stated he was not treating Patient 10 for chronic bronchitis. MD1 stated he relies on the HHA nurses to be his eyes and ears and believes the chronic bronchitis diagnosis “trickled from where he came from.” 3. A record review of Patient 11’s Home Health Certification and Plan of Care (POC), for certification period 9/6/2024 to 11/4/2024, the Home Health Certification and Plan of Care indicated a SOC date of 1/10/2024, with a primary diagnosis of encounter of change or removal of non-surgical dressing. A record review of Patient 11’s progress report from the wound care experts, dated 7/6/24, indicated the following wounds: - Stage 3 chronic non-healing pressure ulceration of the right midline buttock. - Unstageable chronic non-healing pressure ulceration of the right lateral right. - Stage 3 non-healing pressure ulceration of the right inferior buttocks. - A new, no stage, chronic non-healing traumatic ulceration of the center midline coccyx. During a concurrent interview and record review on 9/10/2024, at 11:55 a.m., the ADM reviewed Patient 11’s recertification assessment, for certification period 9/6/2024 to 11/4/2024. The ADM stated the recertification assessment record indicated the assessment was done on 9/5/2024. The ADM stated the assessment was not fully complete. The ADM stated the assessment was supposed to be completed within five days of the recertification date, by a Registered Nurse. The ADM stated Patient 11’s assessment needed to be completed by 9/11/2024, for the purpose of continuing home health services. The ADM stated Patient 11 continued care with the agency on 9/6/2024. The ADM stated the assessment was used to assess the needs of the patient and update the POC. During a concurrent observation and interview of the home visit on 9/11/2024, at 10:45 a.m., Registered Nurse 1 (RN 1), provided wound care to Patient 11. RN 1 stated Patient 11 had two pressure ulcers wounds in the tailbone area. RN 1 stated one of the Patient 11’s pressure ulcer was a circular and the second one was located at the base of the tailbone, in the middle, extending into the right buttocks. RN 1 stated the coccyx (the tailbone) wound was unstageable (obscured full-thickness skin and tissue loss) and the midline wound to the right buttocks was a Stage 3 (skin loss extending into the tissue). During a concurrent interview and record review on 9/11/2024, at 11:15 a.m., RN 1 reviewed Patient 11’s POC for certification period 9/6/2024 to 11/4/2024. RN 1 stated she performed wound care to three areas: the tailbone, right buttocks, and right inner thigh. RN 1 stated there was no wound on the right lateral thigh as indicated in the POC. During a concurrent interview and record review on 9/11/2024, at 1:08 p.m., the ADM provided Patient 11’s document titled, “Recert Report,” dated 9/6/2024. The ADM stated the Recert Report was a document created by the agency, used to document the wound assessment because the electronic medical record version was not a good document to use. The ADM stated the Recert Report was completed by an RN, but the document was not signed to indicate so. The ADM stated the purpose of the Recert Report was to have a better assessment of the patient. The ADM stated the Recert Report document was considered a medical record, but it had not been uploaded into Patient 11’s record. The ADM continued to review the record and stated the document was missing the whole wound assessment. During a concurrent interview and record review on 9/11/2024, at 1:30 p.m., the ADM provided Patient 11’s Home Care Weekly Wound Assessment, dated 9/6/2024. The ADM stated the Home Care Weekly Wound Assessment did not reflect a complete wound assessment. The ADM stated the components missing were the color, drainage, wound margin, surrounding tissue, and staging. 4. During a record review of Patient 13’s medical record forms titled “Home Health Certification and Plan of Care” dated from 7/13/2024 to 9/10/2024 and 9/11/2024 to 11/9/2024, indicated a start of care date of 5/14/2024, with a primary diagnosis of varicose veins of bilateral… The forms also indicated “Other Pertinent Diagnosis – Chronic Pain Syndrome. During a joint home visit on 9/11/2024 at 9 a.m. with License Vocational Nurse 1 (LVN1) to Patient 13’s home, greeted at door by Patient 13 who was ambulating hunch forward with a slow steady gait. Patient 13 was currently smoking a cigarette. Patient 13 stated she does not have and has never had varicose veins. Patient 13 stated she has had several back and bilateral knee surgery that cause her to have chronic pain. LVN1 stated Patient 13 is receiving home health services for medication management. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with the ADM of Patient 13’s medical record form titled “Reason for Assessment: Recertification (follow-up) assessment” certification period 7/13/2024 to 9/10/2024, ADM stated Patient 13 was receiving home health services for pain management. ADM stated Patient 13 did not have a complete pain assessment. ADM stated it was important to assess Patient 13’s pain “because we are treating her pain.” ADM stated the nursing recertification was not signed by the author. ADM stated the author signature indicates it was complete and done by the author. The form also indicated Patient 13’s primary diagnosis was varicose veins of bilateral lower extremities with pain and other diagnoses include chronic pain syndrome. ADM stated the plan of care has the physician recertification orders, which she sends to the doctor. ADM stated they do not have Patient 13’s signed plan of care. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with the ADM of Patient 13’s medical record form titled “Reason for Assessment: Recertification (follow-up) assessment” certification period 9/11/2024 to 11/9/2024, ADM stated Patient 13’s recertification nursing assessment was plotted into their EMR system the morning of 9/11/2024. ADM stated the information on the form was auto-populated (automatically inserted from last recertification assessment). ADM stated there was no physician recertification order in Patient 13’s medical record for episode. ADM stated she will work on the recertification order because she has not put in the order yet. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with License Vocational Nurse 1 (LVN1) of Patient 13’s EMR, LVN1 stated Patient 13 was receiving home health services for “home safety and medication management.” During a concurrent interview and record review on 9/11/2024 at 3 p.m. with the Medical Director 1 (MD1), MD1 stated he does not have access to the HHA’s EMR. MD1 stated he has his own EMR2. MD1 of Patient 13’s medical record, MD1 stated Patient 13’s start of care was 5/14/2024 and is receiving HHA services for physical therapy and Percocet (narcotic pain medication). MD1 stated the last time he conducted a video call with Patient 13 was in May 2024 when he certified her for HHA services. MD1 stated he certified Patient 13 in May and believes her recertification was coming up soon. MD1 was informed that Patient 13 was recertified for HHA services on 7/13/2024 and 9/10/2024. MD1 stated there were a lot of orders he received form the HHA that he has not signed, and maybe Patient 13’s recertification orders were in those documents. MD 1 stated it was important to assess patients to see if they still qualify for HHA services. MD1 stated he was not aware Patient 13’s primary diagnosis for HHA services was varicose veins for the last two recertification periods. MD1 stated Patient 13’s main issues were joint and prior surgery pain. MD1 was asked if he took part in Patient 13’s plan of care. MD1 stated, “yes, I get the order, review it and sign them.” During a record review of Patient 13’s medical record form titled “Home Health Note” dated 5/14/2024, indicated “Chief Complaint: Chronic Pain”. The form also indicated “Assessment/Plan: Chronic pain… We will start home health and physical therapy”. Lastly, the form indicated it was signed by Medical Director 1 (MD1). During an interview on 9/13/2024 at 11:37 a.m. with the ADM, ADM stated it was important to complete a comprehensive assessment of patients’ health conditions to create a proper individualized plan of care while receiving their HHA services. During an interview on 9/13/2024 at 11:43 a.m. with the ADM, ADM stated a patients update assessment is done every 60 days. ADM stated the reassessment is conducted to identify if the patient continues to need home health services. ADM stated if a reassessment is conducted late, there would be a delay in patient care. During a record review of the HHA’s form titled “Verification of Physician Orders” revised April 2014, indicated “A copy of the order will be kept in the patients clinical record.” During a record review of the HHA’s form titled “Admission Criteria and Process” revised October 2019, indicated “Once a patient is admitted to service, the organization will be responsible for providing care and services within its financial and service capabilities, mission, and applicable law and regulations… The patient’s physician must order and approve the provision of any service. During a record review of the HHA’s form titled “Wound Assessment” undated, indicated “Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided. Entries into the clinical record will be made on the day care is provided to the patient.” During a record review of the HHA’s form titled “Rights/responsibilities” revised April 2013, indicated “The patient will be informed verbally and in writing during the initial evaluation visit, in advance furnishing care to the patient, of the following: I. The completion of all assessments and care to be furnished, based on the comprehensive assessment.” During a record review of the HHA’s form titled “Reassessment/Recertification” revised April 2019, indicated “The total plan of care must be renewed at least every 60 days, or more often as warranted by the condition of the patient. For each new episode of care, a comprehensive assessment will be completed no earlier than five (5) days before and no later than one (1) day before the calendar day on which the new episode of care began. The physician will be contacted to verify the continued need for care and his/her agreement with the continued plan of care. During a record review of the HHA’s form titled “Ongoing Assessment” revised October 2019, indicated “During each home visit, the clinician or other discipline will re-evaluation 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) ...” During a record review of the HHA’s form titled “Care Coordination” revised April 2014, indicated “Written evidence of care coordination will be recorded during the case conference and repeated in skilled nursing visit reports in the patients’ clinical records. All personnel will be knowledgeable regarding patient needs, goals, of care and services.” During a record review of the HHA’s form titled “Care Planning Process” revised April 2014, indicated “Individualized Plan of Care: The patient-specific clinical plan of care includes all pertinent diagnoses, 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. 2. All clinicians will consider the conclusions of initial and ongoing assessments in their care planning process, including, but not limited to: B. Changes in patients’ condition. D. Pain and symptom management, as appropriate. 3. Based on the assessment and conclusions, the plan of care will include, but not be limited to: B. All patient care orders from all physicians involved in the plan of care, including verbal orders. C. Identified patient problems and needs… 5. The plan of care will be based upon the physicians’ orders… 7. The plan of care will be revised as frequently as deemed necessary by the clinician, based on the ongoing assessments of the patient.””

“Within 48 hours of the patient’s return CFR(s): 484.55(d)(2) Within 48 hours of the patient’s return to the home from a hospital admission of 24 hours or more for any reason other than diagnostic tests, or on physician or allowed practitioner - ordered resumption date; This Element is not met as evidenced by: Based on interview and record review, the HHA failed to ensure two of six sampled patients (Patient 2 and Patient 12) comprehensive assessment was updated within 48 hours of returning home from the hospital. This failure resulted in a delay of assessment and update of the plan of care to reflect the needs of the patients. 1. A record review of Patient 2’s “Home Health Certification and Plan of Care” (plan of care-POC), for certification period 9/1/2024 to 10/30/2024, indicated a start of care (SOC) date of 1/5/2024, with a primary diagnosis of encounter of change or removal of non-surgical dressing. During an interview on 9/12/2024, at 12:37 p.m., Patient 2’s caregiver (CG 1) stated Patient 2 was hospitalized for heat exhaustion on 9/5/2024. CG 1 stated Patient 2 was discharged from the hospital and arrived home on Monday, 9/9/2024. During a concurrent interview and record review on 9/12/2024, at 1:21 p.m., the Administrator (ADM) reviewed Patient 2’s record titled Transfer OASIS, dated 9/5/2024. The ADM stated Patient 2 went to the hospital on 9/5/2024 for the reason of shortness of breath and weakness. The ADM stated Patient 2’s status right now was that she was in the hospital, but did not know which hospital the patient was in. During an interview on 9/12/2024, at 1:27 p.m., the ADM the plan for Patient 2 was to do a resumption of care visit when she returned from the hospital. The ADM stated the HHA would follow up with the patient to see what the plan for discharge was. When discharged, the plan was to see her within 24 hours or within the same day, depending on the time she is discharged. The importance of the resumption of care visit is to assess what their new needs are. To see what medications she is on and to see if her wounds re-opened at the hospital. 2. A record review of Patient 12’s Home Health Certification and Plan of Care, for certification period 7/27/2024 to 9/24/2024, indicated a start of care on 5/28/2024, with a primary diagnosis of type 2 diabetes (too much sugar in the blood). During an interview on 9/13/2024, at 10:35 a.m., Patient 12’s caregiver (CG 2) stated Patient 12 was hospitalized on 8/26/2024 because he was having some abdominal distress. CG 2 stated he was released from the hospital on 8/29/2024. During a concurrent interview and record review on 9/13/2024, at 11:07 a.m., the ADM reviewed Patient 12’s record titled, Resumption of Care Assessment, for certification period 7/27/2024 to 9/24/2024. The record indicated the patient was visited on 9/7/2024. The ADM stated the assessment was incomplete because it was missing the head to toe physical assessment, vital signs (measurement of blood pressure, heart rate, respirations, body temperature), assessment of his AV fistula (a connection that is made between an artery and a vein, for dialysis (a treatment to remove extra fluid and waste products from the blood) access), and blood sugar reading. When asked about the importance of documenting an assessment, the ADM stated, “Because if we don’t’ document the assessment we kill the patient.” The ADM further stated the purpose of the assessment was for resumption of care after hospitalization, is to make sure the patient is stable. If there are changes, the plan of care needed to be revised. When asked if the plan of care had been revised, the ADM stated she had not had time to revise the POC due to the survey. During an interview on 9/13/2024, at 11:25 a.m., the ADM stated the HHA was aware of Patient 12’s discharge on 9/5/2024 from Patient 12’s doctor. Patient 12 saw the doctor and the doctor sent the order for HHA services. During an interview on 9/13/2024, at 11:35 a.m., the ADM was asked if the HHA had called the patient or CG 2 to find out about the discharge plans. The ADM stated she was sure the HHA called. The ADM stated sometimes patients don’t answer their phone. The ADM stated there was no documentation or communication note to indicate calls were made to inquire about the discharge plans from the hospitalization. During a record review of the HHA’s form titled “Reassessment/Recertification” revised April 2019, indicated “The total plan of care must be renewed at least every 60 days, or more often as warranted by the condition of the patient. For each new episode of care, a comprehensive assessment will be completed no earlier than five (5) days before and no later than one (1) day before the calendar day on which the new episode of care began. The physician will be contacted to verify the continued need for care and his/her agreement with the continued plan of care. Each patient will be reassessed during a comprehensive OASIS assessment tool for the review and revision of the plan of care when: B. The patient condition improves or deteriorates E. The patient returns home after an inpatient admission lasting 24 hours or longer for any purpose other than diagnostic testing.”

“Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician who is responsible for the home health plan of care and the HHA as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This Element is not met as evidenced by: Based on observation, interview, and record review, the HHA failed to ensure a plan of care was reviewed and revised by the doctor, for the recertification period of three of six sampled (Patient 2, Patient 11, and Patient 13) patients. This failure resulted in patients receiving services without a doctor’s order. 1. A record review of Patient 2’s “Home Health Certification and Plan of Care” (plan of care-POC), for certification period 9/1/2024 to 10/30/2024, indicated a start of care (SOC) date of 1/5/2024, with a primary diagnosis of encounter of change or removal of non-surgical dressing. During a concurrent interview and record review on 9/12/2024, at approximately 1:13 p.m., the ADM reviewed Patient 2’s POC for certification period 9/1/2024 to 10/30/2024. The ADM stated the wound treatment instructions came from the previous POC (certification period 7/3/2024 to 8/31/2024), because the patient was responding to wound treatment. The ADM stated the instructions on the POC were from the doctor, but these were not generated into a doctor’s order. Further review of the record did not indicate a doctor had signed the document to approve the POC. During a concurrent interview and record review on 9/12/2024, at approximately 1:15 p.m., the ADM reviewed Patient 2’s record tiled, Order/Telephone Orders dated 8/27/2024, at 2:36 p.m. The record did not indicate wound treatment orders and orders to recertify the patient for another episode of care. The ADM stated the orders were in Patient 2’s POC, but they had not been generated into a doctor’s order. The ADM stated a doctor’s order was required from the doctor to revise the POC. A record review of Patient 2’s nursing visits dated 8/2/24, 8/6/24, 8/9/24, 8/13/24, 8/16/24, 8/20/24, 8/23/24, and 8/26/24, indicated wound treatment had been done to Patient 2’s stage 2 right buttock pressure ulcer. A record review of Patient 2’s progress report from the wound experts, dated 9/5/2024, indicated the stage 2 pressure ulcer on the right buttocks had completely healed. 2. A record review of Patient 11’s “Home Health Certification and Plan of Care (POC)” for certification period 9/6/2024 to 11/4/2024, indicated a SOC date of 1/10/2024, with a primary diagnosis of encounter of change or removal of non-surgical dressing. The POC indicated the skilled nurse was to provide wound care, three times weekly to the following: Right midline (middle) buttock), Right inferior (lower) buttocks, right lateral (side) thigh, and center midline coccyx (tailbone area). However, the nursing visit frequency was documented as twice a week for eight weeks, followed by once a week for one week. During a concurrent interview and record review on 9/10/2024, at approximately 11:58 a.m., the ADM reviewed Patient 11’s POC for certification period 9/6/2024 to 11/4/2024. The ADM stated all the doctor’s orders for the staff and treatments came from the verbal report received from the nurse. The ADM stated she developed the POC based on the verbal report and partial assessment from the nurse. The ADM stated she had not signed the POC because she was still working on it. During an interview on 9/10/2024, at approximately 12:40 p.m., the ADM reviewed Patient 11’s recertification order. The ADM stated the doctor’s order was incomplete because it was missing the reason for recertification. During a concurrent observation and interview of the home visit on 9/11/2024, at approximately 10:45 a.m., Registered Nurse 1 (RN 1), provided wound care to Patient 11. RN 1 stated Patient 11 had 2 wounds in the tailbone area. The first one was a circular wound and the second one was located at the base of the tailbone, in the middle, extending into the right buttocks. RN 1 stated the coccyx wound was unstageable and the midline wound to the right buttocks was a stage 3 (skin loss extending into the tissue). RN 1 stated she did the following to both wounds: cleansed with wound cleanser, pat dried, applied an adhesive to surrounding wounds, applied Plurogel (a special wound dressing that is water soluble), applied Opticell (a specialized wound dressing), and covered with a silicon adhesive dressing. RN 1 continued to provide wound care to the right thigh. During the wound treatments, there was no observation of wound measurements taken by RN 1. During a concurrent interview and record review on 9/112024, at 11:15 a.m., RN 1 reviewed Patient 11’s POC for certification period 9/6/2024 to 11/4/2024. RN 1 stated she had performed wound care to three areas: the tailbone, right buttocks, and right inner thigh. RN 1 stated there was no wound on the right lateral thigh as indicated in the POC. During an interview on 9/11/2024, at approximately 12:59 p.m., the ADM stated she had just entered the order for recertification on 9/11/2024 but had not entered the orders for wound care because she did not have time. The ADM stated the recertification assessment was completed on 9/10/24 and the POC was going to be adjusted. The ADM stated she had a 5-day limit to complete the POC. The ADM stated the care provided to Patient 11 on 9/10/2024, was based on the POC for the previous certification period, dated 7/8/2024 to 9/5/2024. The ADM stated it was standard of care practice for the agency to provide the same care as the previous POC for the first 5 days of the recertification period, because they had a 5-day window to adjust the care, unless the doctor called with new orders. The ADM stated the doctor had not called the agency with new orders. During an interview a concurrent interview on 9/12/2024, at approximately 10:11 a.m., the ADM reviewed Patient 11’s POC for certification period 9/6/2024 to 11/4/2024. The ADM stated the wound treatment should have been done 3 times a week and she would change the frequency of nursing visits to 3 times a week. The ADM stated she was still working on the POC, and it still was not revised. 3. During a record review of Patient 13’s medical record forms titled “Home Health Certification and Plan of Care” dated from 7/13/2024 to 9/10/2024 and 9/11/2024 to 11/9/2024, indicated a start of care date of 5/14/2024, with a primary diagnosis of varicose veins of bilateral lower extremities. The forms also indicated “Other Pertinent Diagnosis – Chronic Pain Syndrome. Lastly, the forms also indicated Patient 13’s assigned discipline was SNV (skilled nurse) to take place 2wk2 (twice a week for two weeks) and 1wk7 (One week for seven weeks). The forms did not indicate other disciplines were assigned. During a record review of Patient 13’s medical record form titled “Home Health Note” dated 5/14/2024, indicated “Chief Complaint: Chronic Pain.” The form also indicated “Assessment/Plan: Chronic pain… We will start home health and physical therapy.” Lastly, the form indicated it was signed by the Medical Director 1 (MD1). During a joint home visit on 9/11/2024 at 9 a.m. with License Vocational Nurse 1 (LVN1) to Patient 13’s home, Patient 13 greeted the surveyor and LVN 1 at the door. Patient 13 was ambulating, hunched forward with a slow steady gait. Patient 13 was smoking a cigarette. Patient 13 stated she does not have varicose veins. Patient 13 stated she does not receive physical therapy services. Patient 13 stated she has had several back and bilateral knee surgeries that cause her to have chronic pain. LVN1 stated Patient 13 is receiving home health services for medication management. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with the Administrator (ADM) of Patient 13’s medical record form titled “Reason for Assessment: Recertification (follow-up) assessment” certification period 7/13/2024 to 9/10/2024, the ADM stated Patient 13 was receiving home health services for pain management. The ADM stated Patient 13 did not have a complete pain assessment. The ADM stated it was important to assess Patient 13’s pain “because we are treating her pain.” The ADM stated the nursing recertification was not signed by the author. The ADM stated the author’s signature indicates it was complete and done by the author. The form also indicated Patient 13’s primary diagnosis was varicose veins of bilateral lower extremities with pain and other diagnoses include chronic pain syndrome. The ADM stated there was no physician recertification order in Patient 13’s medical record. The ADM stated the plan of care has the physician recertification orders, which she sends to the doctor. The ADM stated they do not have Patient 13’s signed plan of care. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with the Administrator (ADM) of Patient 13’s medical record form titled “Reason for Assessment: Recertification (follow-up) assessment” certification period 9/11/2024 to 11/9/2024, the ADM stated Patient 13’s recertification nursing assessment was plotted into their EMR system the morning of 9/11/2024. The ADM stated the information on the form was auto-populated (automatically inserted from last recertification assessment). The form also indicated section “Fall Risk Assessment Tool – Required core elements - Assess on point for each core element “Yes” – pain affecting level of functioning, Pain, and Pain Frequency” were left blank. The ADM stated there was no physician recertification order in Patient 13’s medical record for this episode. The ADM stated she will work on the recertification order because she has not put in the order yet. Lastly, the form also indicated “activities permitted” included “exercises as prescribed” was selected. During a concurrent interview and record review on 9/11/2024 at 12 p.m. with the ADM of Patient 13’s EMR, the ADM stated she was not aware Patient 13 had a seizure on 9/7/2024. The ADM stated there was a skilled nurse visit note on 9/7/2024 but it did not mention the seizure episode. The ADM stated a thorough assessment is needed to prevent reoccurrence, fall, and injury. During a concurrent interview and record review on 9/11/2024 at 3 p.m. with the Medical Director 1 (MD1), MD1 stated he does not have access to the HHA’s EMR. MD1 stated he has his own EMR2. MD1 stated Patient 13’s start of care was 5/14/2024 and is receiving HHA services for physical therapy and Percocet (narcotic pain medication). MD1 stated the last time he conducted a video call with Patient 13 was in May 2024 when he certified her for HHA services. MD1 stated he certified Patient 13 in May and believes her recertification was coming up soon. MD1 was informed that Patient 13 was recertified for HHA services on 7/13/2024 and 9/10/2024. MD1 stated there were a lot of orders he received from the HHA that he has not signed, and maybe Patient 13’s recertification orders were in those documents. MD 1 stated it was important to assess patients to see if they still qualify for HHA services. MD1 stated he was not aware Patient 13’s primary diagnosis for HHA services was varicose veins for the last two recertification periods. MD1 stated Patient 13’s main issues were joint and prior surgery pain. MD1 stated part of his recommendations in May 2024, were physical therapy for Patient 13. MD1 stated Patient 13 should have been receiving physical therapy. MD1 was asked if he took part in Patient 13’s plan of care. MD1 stated, “Yes, I get the order, review it and sign them.” MD1 stated he was not aware Patient 13 had a seizure on 9/7/2024. During a concurrent interview and record review on 9/12/2024 at 2:14 p.m. with the ADM of Patient 13’s EMR, ADM stated Patient 13 has not received physical therapy (PT) services since her start of care, 5/14/2024. On 9/12/2024 at 11:52 a.m. Office Staff (OS1) was requested to provide Patient 13’s physical therapy’s notes. OS1 stated Patient 13 did not have any physical therapy notes. During a record review of the HHA’s form titled “Reassessment/Recertification” revised April 2019, indicated “The total plan of care must be renewed at least every 60 days, or more often as warranted by the condition of the patient. For each new episode of care, a comprehensive assessment will be completed no earlier than five (5) days before and no later than one (1) day before the calendar day on which the new episode of care began. The physician will be contacted to verify the continued need for care and his/her agreement with the continued plan of care. Each patient will be reassessed during a comprehensive OASIS assessment tool for the review and revision of the plan of care when: B. The patient condition improves or deteriorates E. The patient returns home after an inpatient admission lasting 24 hours or longer for any purpose other than diagnostic testing.”

“Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient’s updated comprehensive assessment, and contain information concerning the patient’s progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This Element is not met as evidenced by: Based on observation, 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 revise the plan of care that reflected the patient’s current health status during the recertification period to continue care for three of six sampled patients (Patient 2, Patient 11, and Patient 13) by failing to: 1. Ensure Patient 2’s plan of care was revised to reflect the patient’s healed Stage 2 pressure ulcer wound (a break in the top two layers of skin) on the right buttocks. 2. Ensure Patient 11’s plan of care was revised to reflect the patient’s three pressure ulcer wounds and refusal of care from the wound specialist. The POC indicated Patient 11 had four pressure ulcer wounds. 3. Ensure Patient 13’s plan of care was revised to reflect the patient’s back and knee pain and the physician ordered physical therapy. These failures placed Patient 2, Patient 11, Patient 13 at risk for infection, delayed wound healing, uncontrolled pain, hospitalization, or death. On 9/12/2024 at 3:30 p.m., the Department called an Immediate Jeopardy (IJ, a situation in which the provider’s non-compliance with one or more requirements of participation has caused, or likely to cause, serious injury, harm impairment, or death to a patient), in the presence of the agency’s Administrator (ADM) and the Director of Nursing Designee in training (DOND), related to the failure to revise the plan of care that reflected Patient 2’s, Patient 11’s and Patient 13’s current health status during the recertification period to continue care, which placed the patients (Patient 2, Patient 11, and Patient 13) at risk for infection, delayed wound healing, uncontrolled pain, hospitalization, or death. Findings: 1. During a review of Patient 2’s nursing visits notes dated 8/2/2024, 8/6/2024, 8/9/2024, 8/13/2024, 8/16/2024, 8/20/2024, 8/23/2024, and 8/26/2024, the nursing visits notes indicated wound treatments were done to Patient 2’s stage 2 right buttock pressure ulcer. During a review of Patient 2’s Home Health Certification and Plan of Care (POC) for certification period 9/1/2024 to 10/30/2024, the Home Health Certification and Plan of Care indicated a start of care (SOC) date of 1/5/2024, with a primary diagnosis of encounter of change or removal of non-surgical dressing. During a review of Patient 2’s progress report from the wound experts, dated 9/5/2024, the progress report from the wound experts indicated the stage 2 pressure ulcer on the patient’s right buttocks was healed. During an interview on 9/10/2024, at 11:55 a.m., with the ADM, the ADM stated a Registered Nurse (RN, in general) was supposed to complete an assessment within five days of the recertification date. The ADM stated the purpose of an assessment was to continue home health care and assess the needs of the patient to develop the plan of care. During an interview on 9/11/2024, at 1:08 p.m., with the ADM, the ADM stated a wound assessment included measurement of the wound; checking for symptoms of infection such as drainage, redness, pain, smell; assessing the wound bed to see if there was tunneling, slough (yellow-white material in a wound), bleeding, and staging (assign a classification, to know the extent of damage) the wound were important to monitor the progress of healing. During a concurrent interview and record review on 9/12/2024, at 1:04 p.m., the ADM reviewed Patient 2’s clinical records (in general). The ADM stated from 8/1/2024 to 8/31/2024 there was no documented wound assessments for Patient 2. During a concurrent interview and record review on 9/12/2024, at 1:04 p.m., the ADM reviewed Patient 2’s POC for certification period 9/1/2024 to 10/30/2024. The ADM stated Patient 2’s POC indicated Patient 2 required weekly wound treatment for her stage 2 pressure ulcer (a break in the top two layers of skin) of the right buttocks. The ADM stated the skilled nurse (in general) was to assess the wound weekly. The ADM reviewed Patient 2’s clinical records (in general) and stated there was no documented evidence Patient 2’s wounds were assessed weekly. The ADM stated she had pictures of Patient 2’s wounds on her personal cell phone, and were not uploaded into Patient 2’s clinical records. The ADM stated a nurse saw Patient 2 on 9/3/2024 and sent her a picture of the wound on 9/4/2024. The ADM stated there was no nursing documentation for the nurse visit on 9/3/2024. The ADM stated it was possible do to an entire wound assessment based on the picture only. During a concurrent interview and record review on 9/12/2024, at 1:13 p.m., the ADM reviewed Patient 2’s POC for certification period 9/1/2024 to 10/30/2024. The ADM stated the wound treatment instructions (on the POC for the certification period 9/1/2024 to 10/30/2024) came from the previous POC (certification period 7/3/2024 to 8/31/2024), because the patient was responding to wound treatment. The ADM stated the instructions on the POC (for the certification period 9/1/2024 to 10/30/2024) were from the doctor and were not generated into a doctor’s order. The ADM stated the POC did not indicate a doctor signed the document to approve the POC. During a concurrent interview and record review on 9/12/2024, at 1:15 p.m., the ADM reviewed Patient 2’s record tiled, Order/Telephone Orders dated 8/27/2024, timed at 2:36 p.m. The ADM stated the record did not indicate wound treatment orders to recertify the patient for another episode of care. The ADM stated the orders were in Patient 2’s POC, and were not generated into a doctor’s order. The ADM stated a doctor’s order was required from the doctor to update the POC. During a concurrent interview and record review on 9/12/2024, at 1:17 p.m., the ADM reviewed Patient 2’s recertification assessment, dated 9/1/2024. The ADM stated the patient’s recertification assessment did not indicate the skin and the wound were assessed (in order to revise the care plan to reflect the Patient 2’s current skin condition). The ADM stated the record indicated the primary diagnosis was for encounter for change or removal of nonsurgical wound dressing. The ADM stated the document was not signed by a nurse. The ADM stated the nurse took a picture of the wound, but it was not in the medical record. 2. A record review of Patient 11’s progress report from the wound care experts, dated 7/6/24, indicated the following wounds: - Stage 3 chronic non-healing pressure ulceration of the right midline buttock. - Unstageable chronic non-healing pressure ulceration of the right lateral right. - Stage 3 non-healing pressure ulceration of the right inferior buttocks. - A new, no stage, chronic non-healing traumatic ulceration of the center midline coccyx. During a review of Patient 11’s Home Health Certification and Plan of Care (POC), for certification period 9/6/2024 to 11/4/2024, the Home Health Certification and Plan of Care indicated a SOC date of 1/10/2024, with a primary diagnosis of encounter of change or removal of non-surgical dressing. The Home Health Certification and Plan of Care indicated the skilled nurse was to provide wound care, three times weekly to the following: Right midline (middle) buttock, right inferior (lower) buttocks, right lateral (side) thigh, center midline coccyx (tailbone area). The Home Health Certification and Plan of Care indicated he nursing visit frequency was documented as twice a week for eight weeks, followed by once a week for one week. During a concurrent interview and record review on 9/10/2024, at 11:55 a.m., the ADM reviewed Patient 11’s recertification assessment, for certification period 9/6/2024 to 11/4/2024. The ADM stated the recertification assessment record indicated the assessment was done on 9/5/2024. The ADM stated the assessment was not fully complete. The ADM stated the assessment was supposed to be completed within five days of the recertification date, by a Registered Nurse. The ADM stated Patient 11’s assessment needed to be completed by 9/11/2024, for the purpose of continuing home health services. The ADM stated Patient 11 continued care with the agency on 9/6/2024. The ADM stated the assessment was used to assess the needs of the patient and update the POC. During a concurrent interview and record review on 9/10/2024, at 11:58 a.m., the ADM reviewed Patient 11’s POC for certification period 9/6/2024 to 11/4/2024. The ADM stated all the orders for the staff and treatments came from the verbal report received from the nurse. The ADM stated she developed the POC based on the verbal report and partial assessment from the nurse. The ADM stated she did not sign the POC. During a concurrent observation and interview of the home visit on 9/11/2024, at 10:45 a.m., Registered Nurse 1 (RN 1), provided wound care to Patient 11. RN 1 stated Patient 11 had two pressure ulcers wounds in the tailbone area. RN 1 stated one of the Patient 11’s pressure ulcer was a circular and the second one was located at the base of the tailbone, in the middle, extending into the right buttocks. RN 1 stated the coccyx (the tailbone) wound was unstageable (obscured full-thickness skin and tissue loss) and the midline wound to the right buttocks was a Stage 3 (skin loss extending into the tissue). RN 1 stated she did the following to both wounds: cleansed with wound cleanser, pat dried, applied an adhesive to surrounding wounds, applied plurogel (a special wound dressing that is water soluble), applied opticell (a specialized wound dressing), and covered with a silicon adhesive dressing. RN 1 continued to provide wound care to the right thigh. During the wound treatments, there was no observation of wound measurements taken by RN 1. During a concurrent interview and record review on 9/11/2024, at 11:15 a.m., RN 1 reviewed Patient 11’s POC for certification period 9/6/2024 to 11/4/2024. RN 1 stated she performed wound care to three areas: the tailbone, right buttocks, and right inner thigh. RN 1 stated there was no wound on the right lateral thigh as indicated in the POC. During an interview on 9/11/2024, at 12:59 p.m., the ADM stated she had just entered the order for recertification on 9/11/2024 but had not entered the orders for wound care because she did not have time. The ADM stated the recertification assessment was completed on 9/10/24 and the POC was going to be adjusted. The ADM stated she had a five-day limit to complete the POC. The ADM stated the care provided to Patient 11 on 9/10/2024, was based on the POC for the previous certification period, dated 7/8/2024 to 9/5/2024. The ADM stated it was standard of care practice for the agency to provide the same care as the previous POC for the first five days of the recertification period, because they had a five-day window to adjust the care, unless the doctor called with new orders. The ADM stated the doctor had not called the agency with new orders. During an interview on 9/11/2024, at 1:08 p.m., the ADM stated a wound assessment included measuring the wound; checking for symptoms of infection such as drainage, redness, pain, smell; assessing the wound bed to see if there was tunneling, slough (yellow-white material in a wound), bleeding, and staging (assign a classification, to know the extent of damage) the wound. These components of the wound assessment were important to monitor the progress of healing. During a concurrent interview and record review on 9/11/2024, at 1:08 p.m., the ADM provided Patient 11’s document titled, “Recert Report,” dated 9/6/2024. The ADM stated the Recert Report was a document created by the agency, used to document the wound assessment because the electronic medical record version was not a good document to use. The ADM stated the Recert Report was completed by an RN, but the document was not signed to indicate so. The ADM stated the purpose of the Recert Report was to have a better assessment of the patient. The ADM stated the Recert Report document was considered a medical record, but it had not been uploaded into Patient 11’s record. The ADM continued to review the record and stated the document was missing the whole wound assessment. During a concurrent interview and record review on 9/11/2024, at 1:30 p.m., the ADM provided Patient 11’s Home Care Weekly Wound Assessment, dated 9/6/2024. The ADM stated the Home Care Weekly Wound Assessment did not reflect a complete wound assessment. The ADM stated the components missing were the color, drainage, wound margin, surrounding tissue, and staging. During a review of Patient 11’s POC for certification period 7/8/2024 to 9/6/2024, indicated wound care as follows: a. Right midline buttock: Cleanse the wound with cleanser and pat dry with gauze (a type of dressing), skin prep (preparation) to peri (around) wound and let it dry. Apply plurogel followed by opticell fiber dressing to the wound bed and cover with foam with silicone bordered dressing. b. Right inferior buttock: cleanse the wound with cleanser and pat dry with gauze. Skin prep to peri wound and let it dry. Apply plurogel followed by opticell fiber dressing to the wound bed and cover with foam with silicone bordered dressing. c. Right lateral thigh: cleanse the wound with cleanser and pat dry with gauze. Skin prep to periwound and let it dry. Apply plurogel followed by opticell fiber dressing to the wound bed and cover with foam with silicone bordered dressing. d. Center midline coccyx: cleanse the wound with cleanser and pat dry with gauze. Skin prep to peri wound and let it dry. Apply plurogel followed by oil-based dressing to the wound bed and cover with foam with silicone bordered dressing. During a concurrent interview and record review on 9/11/2024, at 1:40 p.m., the ADM reviewed Patient 11’s skilled nursing clinical note, dated 9/2/2024. The ADM stated the nursing narrative had a discrepancy and was considered wrong due to the reference to the wound locations. The ADM stated the nursing narrative was most likely copied and pasted from the POC. The ADM stated the correct document to reference to be the wound care worksheet. During a concurrent interview and record review on 9/11/2024, at 1:41p.m., the ADM reviewed Patient 11’s wound care worksheet, dated 9/2/2024. The record indicated there were three wounds and three treatments: Wound number one was a skin fungus (type of infection) on the right posterior (back) femur (thigh). The wound treatment order documented was cleanse with wound cleanser and pat dry. Apply clotrimazole (a lotion to treat skin infections) as needed and leave uncovered. Wound number two was a Stage 1 (redness of the skin, no opening) pressure ulcer in the right posterior lateral femur. The wound treatment order documented was cleanse with wound cleanser and pat dry. Apply triple antibiotic as needed and leave uncovered. Wound number three was a Stage 1 pressure ulcer in the coccyx (tailbone). The wound treatment order documented was cleanse with wound cleanser and pat dry. Apply triple antibiotic as needed and leave uncovered. During a concurrent interview and record review on 9/11/2024, at 1:40 p.m., the ADM stated the following wounds were not documented in the record: right midline buttock and right inferior buttock. The ADM stated there was a discrepancy in the wound care documented. The ADM stated the nurse (unidentified) documented the treatments wrong. The ADM stated according to the documentation the nurse did not follow the POC. The ADM stated it was important to follow Patient 11’s POC to promote proper wound healing. During a concurrent interview and record review on 9/11/2024, at 1:53 p.m., the ADM reviewed Patient 11’s nursing visit notes and wound worksheets dated 8/26/24, 8/29/24, 8/22/24, 8/19/24, 8/12/24, and 8/5/24. The ADM stated the documents did not indicate all the wounds were addressed and assessed completely. The ADM stated the wounds were not assessed according to the expectation. The ADM stated the nurses (in general) should have named the location of the wounds according to the POC, in order to monitor the status of the wound and to see if it was improving or worsening. The ADM stated based on the documentation, she did not know if the nurses were following the plan of care because there were discrepancies documented. During an interview a concurrent interview on 9/12/2024, at 10:11 a.m., the ADM reviewed Patient 11’s POC for certification period 9/6/2024 to 11/4/2024. The ADM stated the wound treatment should have been done three times a week and she would change the frequency of nursing visits to three times a week. The ADM stated she was still working on the POC, and it still was not updated. During an interview on 9/12/2024 at 10:36 a.m., the ADM stated the last time Patient 11 received a wound specialist visit was on 7/6/2024 because the patient refused further visits. The ADM stated she was pretty sure Patient 11’s doctor (MD 2) had been notified. The ADM there was no documented evidence of the notification. The ADM stated it was important for MD 2 to be aware of the refusal to be cared by the wound specialist because her refusal required a change in the plan of care. MD 2 could have ordered a different treatment or have changed the plan of care. During an interview on 9/12/2024, at approximately 12:03 p.m., Patient 11’s Nurse Practitioner (NP) stated she cared for the patient under the supervision of MD 2. The NP stated MD 2 had never examined Patient 11. The NP stated she was not aware Patient 11 was refusing care from the wound specialist and that the last visit was on 7/6/2024. The NP stated it was important for the wound care specialist to see her because the wound itself was not easy to be treated and the care team had to make sure the patient and the wound are being closely monitored. The NP stated the wound specialist had more knowledge experience and expertise. 3. During a review of Patient 13’s form titled “Home Health Note” dated 5/14/2024, the “Home Health Note” indicated “Chief Complaint: Chronic Pain”. “Assessment/Plan: Chronic pain… We will start home health and physical therapy” signed by Medical Director 1 (MD 1). During a review of Patient 13’s “Home Health Certification and Plan of Care” dated from 7/13/2024 to 9/10/2024 and 9/11/2024 to 11/9/2024, the “Home Health Certification and Plan of Care” indicated Patient 13’s start of care date was 5/14/2024, with a primary diagnosis of varicose veins (swollen veins just under the skin in your legs, feet or ankles) of bilateral… chronic pain syndrome. Patient 13’s Home Health Certification and Plan of Care assigned discipline was skilled nurse (SN) twice a week for two weeks, once a week for seven weeks. During a review on 9/10/2024 at 12:13 p.m., of Patient 13’s Electronic Medical Record (EMR), the section titled, “Parameter Graph”, the “Parameter Graph” indicated section “Pain Scale” had a value of zero (0) on 7/19/2024, 7/26/2024, 8/2/2024, 8/16/2024, 8/24/2024, 8/31/2024, and 9/7/2024. During a joint home visit on 9/11/2024 at 9 a.m. with License Vocational Nurse 1 (LVN 1) to Patient 13’s home, Patient 13 was observed ambulating with a slow steady gait, while hunched forward. Patient 13 was currently smoking a cigarette. During an interview on 9/11/2024 at 9 a.m., with Patient 13, Patient 13 stated she did not have varicose veins. Patient 13 stated she has had several back and bilateral knee surgery that caused her to have chronic pain. During an interview on 9/11/2023 at 9:05 a.m . with LVN 1, LVN 1 stated Patient 13 was receiving home health services for medication management. During the home visit observation, LVN 1 did not assess Patient 13 for pain. LVN 1stated she should have assessed Patient 13’s pain to evaluate if pain medication was effective. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with the Administrator (ADM) of Patient 13’s form titled “Reason for Assessment: Recertification (follow-up) assessment” certification period 7/13/2024 to 9/10/2024, ADM stated Patient 13 was receiving home health services for pain management. ADM stated Patient 13 did not have a complete pain assessment. ADM stated it was important to assess Patient 13’s pain “because we are treating her pain.” ADM stated the nursing recertification was not signed by the author. ADM stated the author signature indicates it was complete and done by the author. The form “Reason for Assessment: Recertification (follow-up) assessment” section “pain frequency” were left blank. ADM stated Patient 13 has no physician recertification order and. ADM stated Patient 13 did not have signed plan of care. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with the Administrator (ADM) of Patient 13’s medical record form titled “Reason for Assessment: Recertification (follow-up) assessment” certification period 9/11/2024 to 11/9/2024, ADM stated Patient 13’s recertification nursing assessment was plotted into their EMR system in the morning, 9/11/2024. ADM stated the information on the form was auto-populated (automatically inserted from last recertification assessment). The form also indicated section “Fall Risk Assessment Tool – Required core elements - Assess on point for each core element “yes” – pain affecting level of functioning, Pain, and Pain Frequency” were left blank. ADM stated there was no physician recertification order in Patient 13’s medical record for certification period 9/11/2024 to 11/9/2024, ADM stated she will work on the recertification order because she has not put in the order yet. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with the ADM of Patient 13’s Electronic Medical Record (EMR) medical record forms titled “Skilled Nursing Clinical Note” dated 6/19/2024, 7/26/2024, 8/2/2024, 8/16/2024, 8/24/2024, 8/31/2024, and 9/7/2024, ADM stated Patient 13’s pain did not have a complete pain assessment. ADM stated Patient 13 did not have pain assessment that included asking the Patient 13 what and how often she experienced pain, what the level of pain was, and what makes the pain better or worst. During a concurrent interview and record review on 9/11/2024 at 11:20 a.m. with License Vocational Nurse 1 (LVN 1) of Patient 13’s EMR, LVN 1 stated Patient 13 was receiving home health services for “home safety and medication management.” During a concurrent interview and record review on 9/11/2024 at 3 p.m. with the MD 1 of Patient 13’s medical record, MD 1 stated Patient 13’s start of care was 5/14/2024 and the patient was receiving HHA services for physical therapy and Percocet (narcotic pain medication). MD 1 stated Patient 13 did not have a primary physician and is homebound. MD 1 stated the last time he conducted a video call with Patient 13 was in May 2024 when he certified her for HHA services. MD 1 stated he certified Patient 13 in May and believes her recertification was coming up soon. MD 1 was informed that Patient 13 was recertified for HHA services on 7/13/2024 and 9/10/2024. MD 1 stated he has not signed the recertification orders he received form the HHA for Patient 13. During a concurrent interview and record review on 9/11/2024 at 3 p.m. with the MD 1, MD 1 stated it was important to assess patients to see if they still qualify for HHA services. MD 1 stated Patient 13’s main issues were joint and prior surgery pain. MD 1 was asked if he took part in Patient 13’s plan of care. MD 1 stated, “Yes, I get the order, review it and sign them.” MD 1 stated Patient 13’s main issues were joint and prior surgery pain. MD 1 stated on May 2024, he recommended for Patient 13 for physical therapy. MD 1 stated Patient 13 should have been receiving physical therapy. During an interview on 9/13/2024 at 11:37 a.m. with the ADM, ADM stated patient pain assessment should be complete at every skilled nursing visit to make ensure their pain was controlled. ADM stated the pain assessment should be documented in for Patient 13 on the day of the visit. During a record review of the HHA’s form titled “Wound Assessment” undated, indicated “Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided. Entries into the clinical record will be made on the day care is provided to the patient. It will be the policy of this agency to provide a comprehensive wound management program to promote the highest level of functioning and well-being and to minimize the development of acquired pressure ulcers, unless the individuals clinical condition demonstrates they are unavoidable. During a record review of the HHA’s medical titled, “Verification of Physician Orders” revised April 2014, indicated “A copy of the order will be kept in the patients clinical record.” During a record review of the HHA’s form titled “Rights/responsibilities” revised April 2013, indicated “The patient will be informed verbally and in writing during the initial evaluation visit, in advance furnishing care to the patient, of the following: I. The completion of all assessments and care to be furnished, based on the comprehensive assessment. The organization shall ensure that the patient receives all services outlined in the plan of care. L. The right to pain assessment and management.” During a review of the HHA’s form titled “Pain Management” revised April 2014, indicated “Pain will be assessed as a part of every patient contact if the patient reports pain or is at risk for pain.” During a review of the HHA’s form titled “Reassessment/Recertification” revised April 2019, indicated “The total plan of care must be renewed at least every 60 days, or more often as warranted by the condition of the patient. For each new episode of care, a comprehensive assessment will be completed no earlier than five (5) days before and no later than one (1) day before the calendar day on which the new episode of care began. The physician will be contacted to verify the continued need for care and his/her agreement with the continued plan of care. During a review of the HHA’s form titled “Ongoing Assessment” revised October 2019, indicated “During each home visit, the clinician or other discipline will re-evaluation 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: C. Pain status, when applicable, including: 1. Responses to pain intervention(s) 2. Progress toward pain management goals, including functional ability 3. Side effects of treatment 4. Risk factors for adverse events caused by the treatment. E. Skin integrity.” During a review of the HHA’s form titled “Care Coordination” revised April 2014, indicated “Written evidence of care coordination will be recorded during the case conference and repeated in skilled nursing visit reports in the patients’ clinical records. Coordination communication with all physicians involved in the plan of care. Integrate orders from all physicians involved in the plan of care so that all services and interventions are coordinated. 5… All personnel will be knowledgeable regarding patient needs, goals, of care and services.” During a review of the HHA’s form titled “Care Planning Process” revised April 2014, indicated “Individualized Plan of Care: The patient-specific clinical plan of care includes all pertinent diagnoses, 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. 2. All clinicians will consider the conclusions of initial and ongoing assessments in their care planning process, including, but not limited to: B. Changes in patients’ condition. D. Pain and symptom management, as appropriate. 3. Based on the assessment and conclusions, the plan of care will include, but not be limited to: B. All patient care orders from all physicians involved in the plan of care, including verbal orders. C. Identified patient problems and needs… 5. The plan of care will be based upon the physicians’ orders… 7. The plan of care will be revised as frequently as deemed necessary by the clinician, based on the ongoing assessments of the patient.””

“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) failed to meet the Condition of Participation for Comprehensive Assessment of Patients as follows: =Failed to conduct and complete the comprehensive pain assessment/reassessment for two of ten sampled patients, (Patient 9 and Patient 10) in accordance with their policy and procedure. This deficient practice has the potential to result in the delay to inform the physician of the patients’ decline or progress in health status, and identify these significant changes, needs, and interventions in the patients’ plans of care. Refer to G518. =Failed to conduct a comprehensive assessment that accurately reflect the patient’s health status for four of 10 sampled patients (Patient 2, Patient 6, Patient 7, and Patient 8). This failure has the potential to result in the delay to identify the patient’s significant needs and provision of services that could affect their quality of care and well-being. Refer to G526. =Failed to review all the medications and update the medication profile with currently used medications for one of 10 sampled patients (Patient 2). This deficient practice had the potential to put the patient at risk for medication errors and adverse drug reactions. Refer to G536. The cumulative effect of these systemic practices resulted in the home health agency’s inability to provide the highest quality health care services to patients certified to receive the home health benefits.”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on observation, interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation regarding Care planning, Coordination of services, and Quality of Care was met as follows: =Failed to develop and implement an individualized plan of care (POC) for five of 10 sampled patients (Patient 2, Patient 5, Patient 6, Patient 7 and Patient 8). This failure has the potential in the delay of the provision of care and services identified in the comprehensive assessment that could cause serious complications affecting the patients’ health status and well-being. Refer to G574. Failed to provide the current and updated plans of care for three of 10 sampled patients (Patient 1, Patient 7, and Patient 8). This deficient practice had the potential to cause the patient and/or the family/caregiver not knowing their treatment plan, services provided by the HHA, and not being an active participant in their care planning process. Refer to G612. =Failed to provide the written information regarding the patient’s medication regimen to one of 10 sampled patients (Patient 1). This deficient practice had the potential to put the patient at risk for medication errors and adverse drug reactions. Refer to G616. The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with the Federal regulations for Care planning, Coordination of services, and Quality of Care to ensure the highest quality of care are being provided to the patients certified to receive the home health benefits.”

“Completion of the comprehensive assessment CFR(s): 484.55(b) Standard: Completion of the comprehensive assessment. This Standard is not met as evidenced by: Based on interview and record review, the home health agency failed to conduct and complete the comprehensive pain assessment/reassessment for two of ten sampled patients, (Patient 9 and Patient 10) in accordance with their policy and procedure. This deficient practice has the potential to result in the delay to inform the physician of the patients’ decline or progress in health status, and identify these significant changes, needs, and interventions in the patients’ plans of care. a. A review of Patient 9’s clinical record indicated a Start of Care Date (SOC) of 11/22/2023, with diagnosis which included open wound to the left lower leg. A review of Patient 9’s Home Health Certification and Plan of Care (POC) for the certification period from 11/22/2023 to 01/20/2024, included an order for the skilled nurse (SN) to visit the patient twice a week for three weeks, then once a week for six weeks. The SN was to notify the physician of pain level greater than seven (7) out of ten (10) (a pain scale that measures pain level from zero (0) to ten (10), score of zero indicates no pain, score of ten indicates unbearable/sever pain), implement pain relief measures and evaluate effectiveness of interventions. The SN was to perform comprehensive skilled assessment, observation and evaluation of all body systems, assessment of vital signs (measure the basic functions of the body that includes body temperature, blood pressure, pulse and respiration), and pain control and management. On 12/29/2023, a review of the “Neuro/Social/Emotional/Cognitive” included the section “Pain Assessment”, which indicated the space for Pain Scale 1-10. The SN documented a pain scale of 7 (severe) out of 10 pain scale. There was no documented evidence of the intervention to mitigate the pain level of 7. The SN also documented a pain scale of 5 (moderate) out of 10 after management. On 1/5/2024, indicated in section “Neuro/Social/Emotional/Cognitive” included in this section “Pain Assessment” indicated the space for Pain Scale 1-10. The SN documented a pain scale of 7 out of 10 pain. There was no documented evidence of the intervention to mitigate the pain level of 7. The SN also documented pain scale of 5 out of 10 after management. There was no documentation of skilled nurse’s pain management interventions were done. On 1/12/2024, indicated in section “Neuro/Social/Emotional/Cognitive” indicated under the section “Pain Assessment”, indicated in the space for Pain Scale 1-10, SN documented as pain scale of 10 (worst pain) out of 10 pain scale and also indicated a pain scale of 5 (moderate) out of 10 after management. There was no documented evidence the intervention to mitigate the pain level of 10 (worst pain). There was no documented evidence the SN informed the physician of the Patient 9’s worst pain level of 10. b. A review of Patient 10’s clinical record indicated a Start of Care Date (SOC) of 9/15/2023, with diagnosis which included osteoarthritis (a joint disease in which the tissues in the joint break down over time, symptoms usually is joint pain and, after rest or inactivity, stiffness for a short period of time). A review of Patient 10’s Home Health Certification and Plan of Care (POC) for the certification period from 1/13/2024 to 3/12/2024, included an order for the skilled nurse (SN) to visit the patient once a week for eight weeks. The POC indicated the Skilled Nurse (SN) was to notify the physician of pain level greater than seven out of ten (a pain scale that measures pain level from zero (0) to ten (10), score of zero indicates no pain, score of ten indicates unbearable/sever pain), implement pain relief measures and evaluate effectiveness of interventions, pain control and management. On 2/8/2024, indicated in section “Neuro/Social/Emotional/Cognitive” under this section included “Pain Assessment”. This section indicated in the space for Pain Scale 1-10, the SN documented a pain level of 5 (moderate) out of 10 pain scale. There was no documented evidence the SN performed pain management to the patient’s pain. The pain scale after management was left blank, there was no other documentation indicating patient’s pain level of 5 was mitigated or re-assessed. On 2/18/2024, indicated in section “Neuro/Social/Emotional/Cognitive” included “Pain Assessment”. Under this section indicated in the space for Pain Scale 1-10, the SN documented a pain scale of 5 out of 10 pain scale. The pain scale after management was left blank, there was no other documentation indicating Patient 10’s pain level of 5 was treated or mitigated. On 3/2/2024, the SN documented Patient 10’s pain level of 5 out of 10 pain scale and the pain scale after management was left blank, there was no other documentation indicating patient’s pain level of 5 was mitigated or re-assessed and there was no documentation of SN pain management interventions were done. During an interview with Director of Patient Care Services (DPCS) on 5/3/2024 at 10 a.m., the DPCS stated that a pain assessment should include the intensity (level) of the pain. The DPCS stated that Patient 9’s clinical notes dated 12/29/2023, 1/5/2024 and 1/12/2024 should have skilled nurse’s documentations of what pain management interventions were done to determine if it is effective and beneficial to patient and Patient 10’s clinical notes dated 2/8/2024, 2/18/2024 and 3/2/2024 had no pain intensity after management and interventions documented and that the SN should have been documented in the patient’s clinical records to ensure pain management and interventions were effective or not to the patient. A review of the agency’s policy and procedure titled, “Pain Assessment and Reassessment”, undated, indicated appropriate agency staff will assess and reassess patient’s pain and agency staff will reassess and respond to patient’s pain, including evaluating and documenting patient’s response to pain interventions, side effects of therapy, progress toward pain management goals (including functional ability) and risk factors for adverse events as a result of therapy.”

“Content of the comprehensive assessment CFR(s): 484.55(c) 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: This Standard is not met as evidenced by: Based on observation, interview, and record review the Home Health Agency (HHA) failed to conduct a comprehensive assessment that accurately reflect the patient’s health status for four of 10 sampled patients (Patient 2, Patient 6, Patient 7, and Patient 8). This failure has the potential to result in the delay to identify the patient’s significant needs and provision of services that could affect their quality of care and well-being. b. A review of Patient 6’s clinical record indicated a Start of Care Date (SOC) of 3/24/2024, with diagnoses which included End Stage Renal Disease (is the final, permanent stage of chronic kidney disease, where kidney function has declined to the point that the kidneys can no longer function on their own). A review of Patient 6’s clinical records titled “Start of Care Assessment”, dated 3/24/2024, indicated that Patient 6 was dependent on hemodialysis (a procedure during which a machine filters wastes, salts, and fluid from the blood when the kidneys are no longer healthy enough to do this work adequately). The assessment did not identify the type of vascular (relating to blood vessels) access used for the hemodialysis. A review of Patient 6’s clinical records titled “Home Health Certification and Plan of Care (POC)”, with certification period of 3/24/24 to 5/22/2024, indicated that Patient 6 was renal (kidney) dialysis dependent. There was no POC developed to indicate care and management of the patient’s renal dialysis dependence with a Perma catheter (A tunneled hemodialysis catheter which is a soft plastic tube and is inserted into one of the large veins, it gives access to the bloodstream to filter through the hemodialysis machine) located on his left upper chest area. During a joint home visit with Licensed Vocational Nurse 3 (LVN 3) on 5/1/2024 at 11 a.m., Patient 6 was observed alert, oriented, and ambulatory. At 11:38 a.m., during an interview with Patient 6, with Spanish/English interpretation assistance of LVN 3, Patient 6 stated he had dialysis three times a week. During visit observation, Patient 6 had a Perma catheter (A tunneled hemodialysis catheter which is a soft plastic tube and is inserted into one of the large veins, it gives access to the bloodstream to filter through the hemodialysis machine) located on his left upper chest area. A review of Patient 6’s clinical records titled “Skilled Nursing Clinical Note”, dated 4/17/2024, 4/19/2024, 4/22/2024, 4/24/2024 and 4/26/2024 indicated the nursing staff did not assess the Perma catheter site, or provided the patient with education related to it. During an interview with LVN 3 on 5/1/24 at 11:45 a.m., LVN 3 stated that she assessed Patient 6’s Perma catheter site and dressing every visit, even though there was no order for her to do so. LVN 3 stated that she did not document her assessment, stated the Perma catheter needed to be checked to make sure there were no changes or signs/symptoms of infection. LVN 3 stated whenever she came after Patient 6 had dialysis, she would check it to make sure there was no bleeding on the site and the dressing is clean not saturated. LVN 3 confirmed there was no documentation regarding her assessment of Patient 6’s Perma catheter located on left upper chest area. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 5/3/24 at 1:21 p.m., the DPCS reviewed Patient 6’s start of care assessment, POC, and “Skilled Nursing Clinical Note” for the dates previously mentioned. The DPCS stated that Patient 6’s start of care assessment mentioned that patient was on dialysis, but the Perma catheter was not mentioned. The DPCS stated the Perma catheter presence should have been documented in the assessment, so it would be included in the care plan. The DPCS stated, “It’s not in the care plan because it was not in the comprehensive assessment.” c. A review of Patient 7’s clinical record indicated a Start of Care Date (SOC) of 11/25/2023, with diagnoses which included end stage renal disease (permanent stage of chronic kidney disease, where kidney function has declined to the point that the kidneys can no longer function on their own). A review of Patient 7’s clinical records titled “Start of Care Assessment”, dated 11/25/2024, indicated that Patient 7 was dependent on hemodialysis (a procedure during which a machine filters wastes, salts, and fluid from the blood when the kidneys are no longer healthy enough to do this work adequately). The assessment did not specify the type of vascular (relating to blood vessels) access Patient 7 had for the hemodialysis. A review of Patient 7’s clinical records titled Recertification Assessment”, dated 3/22/2024, also indicated that Patient 7 was renal (kidney) dialysis dependent. The recertification assessment did not specify the type of vascular access Patient 2 had for the hemodialysis. A review of Patient 7’s clinical records titled “Home Health Certification and Plan of Care (POC)”, with certification period of 3/24/24 to 5/22/2024, indicated that Patient 7 was renal (kidney) dialysis dependent. The POC did not specify the type of dialysis access, the appropriate care/management for the dialysis access, and the education to provide to patient and/or caregiver, such as signs and symptoms to monitor. During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 5/1/2024 at 12:10 p.m., Patient 7 was observed alert, oriented, and ambulatory. At 12:32 p.m., during an interview with Patient 7, with Spanish/English interpretation assistance of LVN 1, Patient 7 stated she had dialysis three times a week. During visit observation, Patient 7 had a Perma catheter (A tunneled hemodialysis catheter which is a soft plastic tube and is inserted into one of the large veins, it gives access to the bloodstream to filter through the hemodialysis machine) located on her left upper chest area. A review of Patient 7’s clinical records titled “Skilled Nursing Clinical Note”, dated 3/21/2024, 3/28/2024, 4/2/2024, 4/9/2024 and 4/16/2024 indicated the nursing staff did not assess the Perma catheter site, or provided the patient with education related to it. During an interview with LVN 1 on 5/1/24 at 1:15 p.m., LVN 1 stated that he assessed Patient 7’s Perma catheter site and dressing every visit, even though there was no order for him to do so. LVN 1 stated that he did not document his assessment, stated the Perma catheter needed to be checked to make sure there were no changes or signs/symptoms of infection. LVN 1 stated whenever he came after Patient 7 had dialysis, he would check it to make sure there was no bleeding on the site and the dressing is clean not saturated. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 5/3/24 at 1:25 p.m., the DPCS reviewed Patient 6’s start of care assessment, POC, and “Skilled Nursing Clinical Note” for the dates previously mentioned. The DPCS stated that Patient 7’s start of care assessment mentioned that patient was on dialysis, but the Perma catheter was not mentioned. The DPCS stated the Perma catheter presence should have been documented in the assessment, so it would be included in the care plan. The DPCS stated, “It’s not in the care plan because it was not in the comprehensive assessment.” DPCS confirmed there was no SN documentation regarding assessment of Patient 7’s Perma catheter located on left upper chest area. d. A review of Patient 8’s clinical record indicated a Start of Care Date (SOC) of 1/25/2024, with diagnoses which included colostomy status (a surgery to create an opening for the colon (large intestine) through the belly (abdomen), it may be a short term (temporary) or long term (permanent), and it is often done after bowel surgery or injury). A review of Patient 8’s clinical records titled “Start of Care Assessment”, dated 1/25/2024, indicated that Patient 8 was on colostomy status, there was no assessment done particular to Patient 8’s colostomy. A review of Patient 8’s clincal records titled Recertification Assessment”, dated 3/22/2024, also indicated that Patient 8 was on colostomy status, there was no assessment done particular to Patient 8’s colostomy. A review of Patient 8’s clinical records titled “Home Health Certification and Plan of Care (POC)”, with certification period of 3/25/24 to 5/23/2024, indicated that Patient 8 was on colostomy status. The POC did not specify the appropriate care/management while Patient 8 on colostomy status, and the education to provide to patient and/or caregiver, such as signs and symptoms to monitor. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 5/3/24 at 2:25 p.m., the DPCS reviewed Patient 8’s start of care assessment, reassessment and POC for the dates previously mentioned. The DPCS stated that Patient 8’s start of care assessment and reassessment mentioned that patient was on colostomy status. The DPCS stated the assessment for colostomy should have been documented, so it would be included in the care plan. The DPCS stated, “It’s not in the care plan because it was not in the comprehensive assessment.” a. A review of Patient 2’s “Patient Profile” indicated Patient 2 was admitted on 1/5/24 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (may include but is not limited to dry gauze dressings, dressings moistened with saline or other solutions, or transparent dressings). Other diagnoses included pressure ulcer of right buttock (injury to skin and underlying tissue resulting from prolonged pressure on the skin), stage 2 (indicating open wounds), and end stage renal disease (a medical condition in which a person’s kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life). A review of Patient 2’s start of care assessment, dated 1/5/24, indicated that Patient 2 was dependent on hemodialysis (a procedure during which a machine filters wastes, salts, and fluid from the blood when the kidneys are no longer healthy enough to do this work adequately). The assessment did not identify the type of vascular (relating to blood vessels) access used for the hemodialysis. A review of Patient 2’s recertification assessment, dated 3/4/24, also indicated Patient 2 was a renal (kidney) dialysis dependent. The recertification assessment did not identify the type of vascular access used for the hemodialysis. During a joint home visit with Licensed Vocational Nurse 2 (LVN 2) on 5/1/24 at 11:35 a.m., Patient 2 was observed alert, oriented, and ambulatory. During an interview with Patient 2 on 5/1/24 at 11:45 a.m., Patient 2 stated she had dialysis three times a week. It was observed that Patient 2 had an arteriovenous fistula/AV fistula (an access point for dialysis surgically created by connecting an artery [a type of blood vessel] and a vein [a type of blood vessel]) on her right upper arm. A review of Patient 2’s “Home Health Certification and Plan of Care (POC),” dated 3/4/24, identified that Patient 2 was on dialysis. There was no POC developed for Patient 2 being a renal dialysis dependent. There was no POC developed to indicate care and management of the patient’s renal dialysis dependence with an arteriovenous fistula/AV fistula access for hemodialysis. A review of “Skilled Nursing Clinical Note” for Patient 2, dated 4/5/24, 4/9/24, 4/13/24, 4/16/24, and 4/19/24, indicated the nursing staff did not assess the AV fistula, or provided the patient with education related to the AV fistula. During an interview with LVN 2 on 5/1/24 at 12:55 p.m., LVN 2 stated that she assessed Patient 2’s fistula every visit, even though there was no order for her to do so. Per LVN 2, she did not document her assessment. LVN 2 stated the fistula needed to be checked to make sure it was working. LVN 2 stated whenever she came after Patient 2 had dialysis, she would check it to make sure there was no bleeding. LVN 2 confirmed there was no documentation regarding her assessment of the fistula. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 5/3/24 at 1 p.m., the DPCS reviewed Patient 2’s start of care assessment, recertification assessment, POC, and “Skilled Nursing Clinical Note” for the dates previously mentioned. The DPCS stated that Patient 2’s start of care assessment and recertification assessment mentioned that patient was on dialysis, but the fistula was not mentioned. The DPCS stated the fistula presence should have been documented in the assessment, so it would be included in the care plan. The DPCS stated, “It’s not in the care plan because it was not in the comprehensive assessment.” A review of the HHA’s undated policy, titled “Initial Assessments/Comprehensive Assessments,” indicated that each patient admitted will receive a comprehensive assessment. The assessment will reflect the patient’s current health status and include information to demonstrate the patient’s progress toward achievement of desired outcomes.”

“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) failed to provide the current and updated plan of care for three of 10 sampled patients (Patient 1, Patient 7, and Patient 8). This deficient practice had the potential to cause the patient and/or the family/caregiver not knowing their treatment plan, services provided by the HHA, and not being an active participant in their care planning process. a. A review of Patient 1’s “Patient Profile” indicated Patient 1 was admitted on 1/31/24 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (may include but is not limited to dry gauze dressings, dressings moistened with saline or other solutions, or transparent dressings). Other diagnosis included cellulitis (a common, potentially serious bacterial skin infection) on right and left lower limb, and long-term use of anticoagulants (medicines that help prevent blood clots). During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 5/1/24 at 10 a.m., Patient 1 was observed alert and oriented. Patient 1 was ambulatory with a walker. It was observed that Patient 1 had a home health folder at his residence. It was noted there was no copy of the plan of care (POC; a document outlining the services needed by the patient, health care professionals who provide these services, how often the patient needed the services, the medical equipment needed by patient, and what results the doctor expected) in the home health folder. During an interview with Patient 1 on 5/1/24 at 10:10 a.m., Patient 1 stated he had not been given the plan of care. Patient 1 stated, “Whatever the agency gave me, it’s in the folder. I didn’t remove anything.” During an interview with LVN 1 at 5/1/24 at 10:50 a.m., LVN 1 stated the HHA should have provided Patient 1 with the plan of care, so he knew what the plan was for him, and what the agency was doing for him. During an interview with the Director of Patient Care Services (DPCS) on 5/3/24 at 11:40 a.m., the DPCS stated the HHA provided all patients with a copy of the most recent POC. The DPCS stated the POC would have the visit frequency, services ordered, interventions, and goals for the patient. The DPCS stated if the patient was not provided with the copy of POC, they may not know what the plan for them is or what to expect. A review of the HHA’s undated policy, titled “Plan of Care – CMS 485 and Physician/Practitioners Orders,” indicated the agency will provide the patient and caregiver with written instructions related to the plan of care. b. A review of Patient 6’s clinical record indicated a Start of Care Date (SOC) of 3/24/2024, with diagnoses which included End Stage Renal Disease (is the final, permanent stage of chronic kidney disease, where kidney function has declined to the point that the kidneys can no longer function on their own). During a home visit with the Licensed Vocational Nurse (LVN 3) on 5/1/2024 at 11:00 a.m., Patient 6 is comfortably sitting on his couch with his spouse (Family Member/FM 3). Patient 6 is Spanish speaking only, LVN 3 speaks Spanish to communicate with Patient 6 and his spouse (FM3). At 11:10 a.m., during interview with Patient 6 and FM3, with Spanish/English interpretation assistance of LVN 3, Patient 6 was asked about his Home health’s folder, Patient 6 stated “I am not sure where I kept it should be somewhere around my room, I am not sure what were inside the folder.” Patient 6 and FM3 were unable to find the home health folder. Patient 6 stated “the written instruction in my folder is written in English language only, I would prefer that it is written in Spanish so we can better understand the instructions to care for my surgical wound,”. FM3 stated “The written instructions in the home health folder were written in Spanish, we prefer that it is written in Spanish Language so we can clearly understand on how to care for his (Patient 6) wound when the nurse is not available”. Patient 6 and FM3 both confirmed that there was no copy of the plan of care (POC; a document outlining the services needed by the patient, health care professionals who provide these services, how often the patient needed the services, the medical equipment needed by patient, and what results the doctor expected) in the home health folder. At 11:35 a.m., during an interview with LVN 3, stated that she confirmed that she saw the home health folder multiple times, home written instructions were written in English text only and she discussed and explained it with Patient 6 and FM3 in Spanish language. LVN 3 stated that she is unsure if there is a copy of the POC in the patient’s home health folder as they only provide it when patient requested and stated the HHA should have provided Patient 6 with the plan of care, so she knew what the plan was for him, and what the agency was doing for him. c. A review of Patient 7’s clinical record indicated a Start of Care Date (SOC) of 11/25/2023, with diagnoses which included End Stage Renal Disease (is the final, permanent stage of chronic kidney disease, where kidney function has declined to the point that the kidneys can no longer function on their own). During a home visit with the Licensed Vocational Nurse (LVN 1) on 5/1/2024 at 12:10 p.m., Patient 7 was comfortably sitting on her couch with her spouse (Family Member/FM 4). Patient 7 was Spanish speaking only, LVN 1 spoke Spanish to communicate with Patient 7 and her spouse (FM4). At 12:20 p.m., during interview with Patient 7 and FM4, with Spanish/English interpretation assistance of LVN 1, Patient 7 was asked about her home health’s folder, Patient 7 stated “It is in my room but my daughter is sleeping and I don’t want to wake her up.” Patient 7 and FM4 were unable to provide the home health folder. Patient 7 stated “the written instruction in my folder is written in English language only, I would prefer that it is written in Spanish so we can understand clearly the instructions to care for myself”. FM4 stated “The written instructions in the home health folder were written in Spanish, we prefer that it is written in Spanish Language so we can clearly understand on how to care for her general health when the nurse is not available.” Patient 7 and FM4 both confirmed that there was no copy of the plan of care (POC; a document outlining the services needed by the patient, health care professionals who provide these services, how often the patient needed the services, the medical equipment needed by patient, and what results the doctor expected) in the home health folder. At 12:40 p.m., during an interview with LVN 1, stated that he confirmed that he saw the home health folder multiple times, home written instructions were written in English text only and he provide teachings and explained it with Patient 7 and FM4 in Spanish language. LVN 1 stated that home written instructions should have been written in a language and manner that patients would understand well to avoid confusion and delay of care, he further stated that interpretations and teachings were supposed to be documented on each visit to validate that it was done and understood by patients/caregivers/family members. LVN 1 stated that he is unsure if there is a copy of the POC in the patient’s home health folder as they only provide it when patient requested and stated the HHA should have provided Patient 7 with the plan of care, so he knew what the plan was for the patient. During an interview with the Director of Patient Care Services (DPCS) on 5/3/24 at 11:40 a.m., the DPCS stated the HHA provided all patients with a copy of the most recent POC. The DPCS stated the POC would have the visit frequency, services ordered, interventions, and goals for the patient. The DPCS stated if the patient was not provided with the copy of POC, they may not know what the plan for them is or what to expect.”

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to provide biohazard (puncture resistant container used to collect sharp biological or biohazardous materials including needles) sharps receptacle for two of 10 sampled patients (Patient 2 and Patient 7). This failure had the potential to expose patient and/or caregiver to skin puncture and infection caused by blood-borne pathogens. a. A review of Patient 2’s “Patient Profile” indicated Patient 2 was admitted on 1/5/24 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (may include but is not limited to dry gauze dressings, dressings moistened with saline or other solutions, or transparent dressings). Other diagnoses included pressure ulcer of right buttock (injury to skin and underlying tissue resulting from prolonged pressure on the skin) , stage 2 (indicating open wounds), and end stage renal disease (a medical condition in which a person’s kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life). During a joint home visit with Licensed Vocational Nurse 2 (LVN 2) on 5/1/24 at 11:35 a.m., Patient 2 was observed alert, oriented, and ambulatory. Patient 2 was observed ambulating without any assistive device. During the home visit, at 1 p.m., Patient 2 asked LVN 2 to help her checking her blood sugar. Observed Patient 2 preparing the glucometer (a device to check blood sugar level), lancet (a device used to obtain blood for testing blood sugar), and glucose test strips (test paper used to measure glucose levels). LVN 2 was not able to turn the glucometer on and informed Patient 2 the glucometer was not working. Did not observe a sharps container in the shelving where Patient 2 kept her blood sugar checking supplies. A review of Patient 2’s “Home Health Certification and Plan of Care,” dated 3/4/24, indicated that Patient 2 did not have a diagnosis of Diabetes Mellitus (a disease of inadequate control of blood levels of glucose). The “Home Health Certification and Plan of Care” did not list blood sugar checking supplies as part of the supplies provided. During an interview with Patient 2 on 5/1/24 at 1 p.m., Patient 2 stated that she checked her blood sugar once a week but did not write it down. During an interview with LVN 2 on 5/1/24 at 1:05 p.m., LVN 2 stated there was no order in Patient 2’s care plan to check the blood sugar. During an interview with Patient 2 on 5/2/24 at 9:44 a.m., Patient 2 stated she did not have a sharps container (a specially designed container into which used needles and other medical-waste sharps are discarded). Patient 2 stated that she discarded her used lancets in her regular trash can. During an interview with LVN 2 on 5/2/24 at 9:48 a.m., LVN 2 stated that Patient 2 had informed her that she checked her blood sugar once a week. LVN 2 stated she did not know if Patient 2 had a sharps container or not. Per LVN 2, she had never provided a sharps container for Patient 2. When asked about the negative outcome that could result of Patient 2 disposing the used lancets in the regular trash can, LVN 2 stated that Patient 2 could injure herself. LVN 2 also stated it was also a risk for infection as the trash might have bacteria that contaminated the lancet. During an interview with the Director of Patient Care Services (DPCS) on 5/3/24 at 11 a.m., the DPCS said even though blood sugar check was not ordered, if the patient checked her blood sugar at home, then a sharps container should have been used to prevent injury and infection. A review of the HHA’s policy, titled “Hazardous Materials/Waste,” revised February 2024, indicated the following: 1 The agency will assess each site and the activities supported and/or provided by each site for the need to safely handle/dispose of sharps, cytotoxic waste, and infectious waste. The agency will provide the necessary supplies, environment, or services to meet any needs identified. b. A review of Patient 7’s clinical record indicated a Start of Care Date (SOC) of 11/25/2023, with diagnoses which included End Stage Renal Disease (is the final, permanent stage of chronic kidney disease, where kidney function has declined to the point that the kidneys can no longer function on their own). During a home visit with the Licensed Vocational Nurse (LVN 1) on 5/1/2024 at 12:10 p.m., Patient 7 is comfortably sitting on her couch with her spouse (Family Member/FM 4). Patient 7 is Spanish speaking only, LVN 1 speaks Spanish to communicate with Patient 7 and her spouse (FM4). At 12:20 p.m., during interview with Patient 7 and FM4, with Spanish/English interpretation assistance of LVN 1, Patient 7 stated that she has a glucometer (a device to check blood sugar level), lancet (a device used to obtain blood for testing blood sugar), and glucose test strips (test paper used to measure glucose levels) to check her blood sugar in the morning and at night before meals. At 12:30 p.m. during an observation, no sharp container in Patient 7’s shelf where she keeps her supplies. At 12:47 p.m., during an interview with Patient 7, she stated that she checked her blood sugar twice a day daily before meals but did not write it down and it is always high, she stated she did not have a sharps container (a specially designed container into which used needles and other medical-waste sharps are discarded) and stated she discarded her used lancets in her regular trash can. A review of Patient 7’s “Home Health Certification and Plan of Care,” dated 3/24/24, indicated that Patient 7 did not list blood sugar checking supplies as part of the supplies provided. During an interview with LVN 1 on 5/1/24 at 1:10 p.m., LVN 1 stated there was no order in Patient 7’s care plan to check the blood sugar and that Patient 7 had informed him that she checked her blood sugar twice daily before meals. LVN 1 stated he did not know if Patient 7 had a sharps container or not and he had never provided a sharps container for Patient 7, LVN 1 stated that Patient 7 could injure herself and it was also a risk for infection as the trash might have bacteria that contaminated the lancet. During an interview with the Director of Patient Care Services (DPCS) on 5/3/24 at 11 a.m., the DPCS said even though blood sugar check was not ordered, if the patient checked her blood sugar at home, then a sharps container should have been used to prevent injury and infection.”

“Written notice of patient’s rights CFR(s): 484.50(a)(1)(i) (i) Written notice of the patient’s rights and responsibilities under this rule, and the HHA’s transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; This Element is not met as evidenced by: Based on interview and record review, the home health agency (HHA) staff failed to ensure a written notice to the patient or their representative of their rights and responsibilities must be provided in a language or format familiar to the patient or his/her representative for two of ten sampled patients (Patient 6 and Patient 7). This deficient practice has the potential to result in the patient/patient family member and or caregiver not fully understand the pertinent information regarding patient care and services that could affect the patient’s quality of care and well-being. a. A review of Patient 6’s clinical record indicated a Start of Care Date (SOC) of 3/24/2024, with diagnosis of End Stage Renal Disease (ESRD- permanent stage of chronic kidney disease, where kidney function has declined to the point that the kidneys can no longer function on their own). A review of Patient 6’s Home Health Certification and Plan of Care (POC) for the certification period from 3/24/2024 to 5/22/2024, included an order for the skilled nurse (SN) to visit the patient three times a week for eight weeks, then twice a week for one week. The SN was to change or remove the non-surgical wound dressing every visit and provide instructions to caregiver on days with no SN visit and as needed, if the dressing is grossly soiled or removed. The SN was to conduct skilled assessment, observation and evaluation of all body systems, assessment of vital signs (temperature, blood pressure, pulse and respiration), pain control and management. During a home visit with the Licensed Vocational Nurse (LVN 3) on 5/1/2024 at 11 a.m., Patient 6 was comfortably sitting on his couch with his spouse (Family Member/FM 3). Patient 6 is Spanish speaking only, LVN 3 spoke Spanish to communicate with Patient 6 and his spouse (FM3). At 11:10 a.m., during interview with Patient 6 and FM3, with Spanish/English interpretation assistance of LVN 3, Patient 6 was asked about his home health’s folder, Patient 6 stated “I am not sure where I kept it. It should be somewhere around my room.” Patient 6 and FM3 were unable to find the home health folder. Patient 6 stated “the written instruction in my folder was written in English language only, I would prefer it in Spanish so we can better understand the instructions to care for my surgical wound”. FM3 stated “The written instructions in the home health folder were written in English, we prefer it written in Spanish language so we can clearly understand on how to care for Patient 6’s wound when the nurse is not available.” At 11:35 a.m., during an interview with LVN 3, confirmed the written instructions inside the folder were written in English and would translate it to Patient 6 and FM3 in Spanish. LVN 3 stated that home written instructions should have been written in a language and manner that patients would understand well to avoid confusion and delay of care. A review of Patient 6’s clinical records titled “Skilled Nursing clinical note”, dated 4/17/2024, 4/19/2024, 4/22/2024, 4/24/2024 and 4/26/2024, indicated no documentations that patient teachings and instructions provided in a language and manner that patient 6 and FM3 understand. b. A review of Patient 7’s clinical record indicated a Start of Care Date (SOC) of 11/25/2023, with diagnoses which included End Stage Renal Disease (ESRD- permanent stage of chronic kidney disease, where kidney function has declined to the point that the kidneys can no longer function on their own). A review of Patient 7’s Home Health Certification and Plan of Care (POC) for the certification period from 3/24/2024 to 5/22/2024, included an order for the skilled nurse (SN) to visit the patient once a week for nine weeks,. The SN was to conduct a comprehensive skilled assessment, observation and evaluation of all body systems, assessment of vital signs (body temperature, blood pressure, pulse and respiration), pain control and management). During a home visit with the Licensed Vocational Nurse (LVN 1) on 5/1/2024 at 12:10 p.m., Patient 7 was comfortably sitting on her couch with her spouse (Family Member/FM 4). Patient 7 was Spanish speaking only, LVN 1 spoke Spanish to communicate with Patient 7 and FM4. At 12:20 p.m., during interview with Patient 7 and FM4, with Spanish/English interpretation assistance of LVN 1, Patient 7 was asked about her home health’s folder, Patient 7 stated “It is in my room but my daughter is sleeping and I don’t want to wake her up.” Patient 7 and FM4 were unable to provide the home health folder. Patient 7 stated “the written instruction in my folder is written in English language only, I would prefer that it is written in Spanish so we can understand clearly the instructions to care for myself”. FM4 stated “The written instructions in the home health folder were written in Spanish, we prefer that it is written in Spanish Language so we can clearly understand on how to care for her general health when the nurse is not available.” At 12:40 p.m., during an interview with LVN 1, he confirmed that the home health folder instructions were written in English and he would translate the teachings and explained them in Spanish to Patient 7 and FM4. LVN 1 stated that home written instructions should have been written in a language and manner that patients would understand well to avoid confusion and delay of care, he further stated that interpretations and teachings were supposed to be documented on each visit to validate that it was done and understood by patients/caregivers/family members. A review of Patient 7’s clinical records titled “Skilled Nursing clinical note”, dated 3/21/2024, 3/28/2024, 4/2/2024, 4/9/2024 and 4/16/2024, indicated no documentations that patient teachings and instructions were provided in a language and manner that Patient 6 and FM3 would understand. During an interview with the Director of Patient Care Services (DPCS) on 5/3/2024 at 11 a.m., she stated that they should provide home health documents that were written in patients’ preferred languages so they can better understand the process. The DPCS stated that visiting nurses should have been documented that translation was offered and provided to patients to validate that teachings or pertinent information related to patient care has been understood by patient/family members or caregivers. A review of the home health agency’s policy and procedure titled “Patient Education”, undated, indicated that agency staff will provide initial and ongoing education to meet each individual patient’s needs, patient/family assessment of learning needs includes communication barriers and the patient education provided will be presented in a manner that the patient understands. A review of the home health agency’s policy and procedure titled “Patient Bill of Rights and Responsibilities”, revised February 2024”, indicated that patient have the right to be informed of the patient’s rights in a language and manner the individual understands.”

“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) staff failed to review all the medications and update the medication profile with currently used medications for one of 10 sampled patients (Patient 2). This deficient practice had the potential to put the patient at risk for medication errors and adverse drug reactions. A review of Patient 2’s “Patient Profile” indicated Patient 2 was admitted on 1/5/24 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (may include but is not limited to dry gauze dressings, dressings moistened with saline or other solutions, or transparent dressings). Other diagnoses included pressure ulcer of right buttock (injury to skin and underlying tissue resulting from prolonged pressure on the skin), stage 2 (indicating open wounds), and end stage renal disease (a medical condition in which a person’s kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life). A review of Patient 2’s “Home Health Certification and Plan of Care (POC),” dated 3/4/24, indicated orders for the nursing services to assess patient’s medications. During a joint home visit with Licensed Vocational Nurse 2 (LVN 2) on 5/1/24 at 11:35 a.m., Patient 2 was observed alert and oriented. A medication review was performed with LVN 2 during the home visit. During the medication review, the following medications were listed in Patient 5’s “Patient Medication Profile” but were not available during the home visit. - Dorzolamide-Timolol (eye drops to treat glaucoma) 10 ml drops; 1 drop in left eye twice daily. - Lotemax (eye drops to treat redness, itching, and watering of the eyes caused by allergies and/or infection) 0.5% eye drop suspension; 1 drop in each eye daily. - Diamox 250 mg (medication to treat glaucoma) tablet; 2 tablets by mouth daily after dialysis. - Albuterol 90 mcg-budesonide 80 mcg/actuation HFA aerosol inhaler; 2 puffs orally twice as needed for asthma. - Zolpidem (medication for sleeping difficulties) 5 mg tablet; 1 tablet by mouth at bedtime. Mexiletine (medication used to correct irregular heartbeats to a normal rhythm) 150 mg capsule; 1 capsule by mouth every 8 hours. Famotidine (medication to treat indigestion) 20 mg tablet: 1 tablet by mouth twice daily. The following medications were found at Patient 5’s home but were not listed in the “Patient Medication Profile”: Montelukast (medication to treat allergies and prevent asthma attacks) 10 mg tablet: 1 tablet a day in the evening. Date filled: 4/16/24. - Nephrovite (supplement to treat or prevent vitamin deficiency) tablet; 1 tablet by mouth daily. Date filled: 1/19/24. - Propranolol (medication to treat high blood pressure) 40 mg tablet; 1 tablet by mouth three times daily. Date filled: 2/23/24. During an interview with LVN 2 on 5/1/24 at 12:25 p.m., LVN 2 stated that Dorzolamide-Timolol 10 ml drops, Lotemax 0.5% eye drop suspension, Diamox 250 mg tablet, Albuterol 90 mcg-budesonide 80 mcg/actuation HFA aerosol inhaler, Zolpidem 5 mg tablet, Mexiletine 150 mg capsule, and Famotidine 20 mg tablet had been discontinued by the physician. Patient 2 confirmed LVN 2’s statement. On 5/1/24, at 12:50 p.m., LVN 2 stated that medication reconciliation was supposed to be done every recertification (every 60 days) by a Registered Nurse (RN). LVN 2 stated that she checked Patient 2’s medications weekly and reported any changes to the HHA’s office. LVN 2 stated that if the medication profile was not updated, patient might continue to take old medications, and nursing staff would not be able to monitor side effects for current medications if they were not in the medication profile. During an interview with the Director of Patient Care Services (DPCS) on 5/3/24 at 11:50 a.m., the DPCS stated that visiting nurse should check if there were any changes in patient’s medications with each visit. If there were changes, the nurse should report it to the office, and the office would verify it with the prescribing physician and obtain an order. Per DPCS, the medication profile would then be reconciled, which usually would take 1-2 days to complete. The DPCS stated that medication reconciliation should be completed with any change and not only upon recertification. A review of the HHA’s policy, titled “Medication Reconciliation,” revised February 2024, indicated the medication list will be updated with each recertification and with any change in medication that is communicated by the patient, family, PCP, or clinicians during the course of their home visits.”

“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) failed to develop and implement an individualized plan of care (POC) for five of 10 sampled patients (Patient 2, Patient 5, Patient 6, Patient 7 and Patient 8). This failure has the potential in the delay of the provision of care and services identified in the comprehensive assessment that could cause serious complications affecting the patients’ health status and well-being. d. A review of Patient 6’s clinical record indicated a Start of Care Date (SOC) of 3/24/2024, with diagnoses which included End Stage Renal Disease (is the final, permanent stage of chronic kidney disease, where kidney function has declined to the point that the kidneys can no longer function on their own). A review of Patient 6’s clinical records titled “Start of Care Assessment”, dated 3/24/2024, indicated that Patient 6 was dependent on hemodialysis (a procedure during which a machine filters wastes, salts, and fluid from the blood when the kidneys are no longer healthy enough to do this work adequately). The assessment did not specify the type of vascular (relating to blood vessels) access Patient 6 had for the hemodialysis. A review of Patient 6’s clinical records titled “Home Health Certification and Plan of Care (POC)”, with certification period of 3/24/24 to 5/22/2024, indicated that Patient 6 was renal (kidney) dialysis dependent. The POC did not specify the type of dialysis access, the appropriate care/management for the dialysis access, and the education to provide to patient and/or caregiver, such as signs and symptoms to monitor. During a joint home visit with Licensed Vocational Nurse 3 (LVN 3) on 5/1/2024 at 11:00 a.m., Patient 6 was observed alert, oriented, and ambulatory. At 11:38 a.m., during an interview with Patient 6 , with Spanish/English interpretation assistance of LVN 3, Patient 6 stated he had dialysis three times a week. During visit observation, Patient 6 had a Perma catheter (A tunneled hemodialysis catheter which is a soft plastic tube and is inserted into one of the large veins, it gives access to the bloodstream to filter through the hemodialysis machine) located on his left upper chest area. A review of Patient 6’s clinical records titled “Skilled Nursing Clinical Note”, dated 4/17/2024, 4/19/2024, 4/22/2024, 4/24/2024 and 4/26/2024 indicated the nursing staff did not assess the perma catheter site, or provided the patient with education related to it. During an interview with LVN 3 on 5/1/24 at 11:45 a.m., LVN 3 stated that she assessed Patient 6’s perma catheter site and dressing every visit, even though there was no order for her to do so. LVN 3 stated that she did not document her assessment, stated the perma catheter needed to be checked to make sure there were no changes or signs/symptoms of infection. LVN 3 stated whenever she came after Patient 6 had dialysis, she would check it to make sure there was no bleeding on the site and the dressing is clean not saturated. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 5/3/24 at 1:10 p.m., the DPCS reviewed Patient 6’s start of care assessment, POC, and “Skilled Nursing Clinical Note” for the dates previously mentioned. The DPCS stated the plan of care should have included the presence of perma catheter since Patient 6 was on hemodialysis. The DPCS stated that not including the perma catheter in plan of care had resulted in field nurses not assessing and/or not documenting their assessment, and patient education not given. e. A review of Patient 7’s clinical record indicated a Start of Care Date (SOC) of 11/25/2023, with diagnoses which included End Stage Renal Disease (is the final, permanent stage of chronic kidney disease, where kidney function has declined to the point that the kidneys can no longer function on their own). A review of Patient 7’s clinical records titled “Start of Care Assessment”, dated 11/25/2024, indicated that Patient 7 was dependent on hemodialysis (a procedure during which a machine filters wastes, salts, and fluid from the blood when the kidneys are no longer healthy enough to do this work adequately). The assessment did not specify the type of vascular (relating to blood vessels) access Patient 7 had for the hemodialysis. A review of Patient 7’s clinical records titled Recertification Assessment”, dated 3/22/2024, also indicated that Patient 7 was renal (kidney) dialysis dependent. The recertification assessment did not specify the type of vascular access Patient 2 had for the hemodialysis. A review of Patient 7’s clinical records titled “Home Health Certification and Plan of Care (POC)”, with certification period of 3/24/24 to 5/22/2024, indicated that Patient 7 was renal (kidney) dialysis dependent. The POC did not specify the type of dialysis access, the appropriate care/management for the dialysis access, and the education to provide to patient and/or caregiver, such as signs and symptoms to monitor. During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 5/1/2024 at 12:10 p.m., Patient 7 was observed alert, oriented, and ambulatory. At 12:32 p.m., during an interview with Patient 7 , with Spanish/English interpretation assistance of LVN 1, Patient 7 stated she had dialysis three times a week. During visit observation, Patient 7 had a Perma catheter (A tunneled hemodialysis catheter which is a soft plastic tube and is inserted into one of the large veins, it gives access to the bloodstream to filter through the hemodialysis machine) located on her left upper chest area. A review of Patient 7’s clinical records titled “Skilled Nursing Clinical Note”, dated 3/21/2024, 3/28/2024, 4/2/2024, 4/9/2024 and 4/16/2024 indicated the nursing staff did not assess the perma catheter site, or provided the patient with education related to it. During an interview with LVN 1 on 5/1/24 at 1:15 p.m., LVN 1 stated that he assessed Patient 7’s perma catheter site and dressing every visit, even though there was no order for him to do so. LVN 1 stated that he did not document his assessment, stated the perma catheter needed to be checked to make sure there were no changes or signs/symptoms of infection. LVN 1 stated whenever he came after Patient 7 had dialysis, he would check it to make sure there was no bleeding on the site and the dressing is clean not saturated. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 5/3/24 at 1:10 p.m., the DPCS reviewed Patient 7’s start of care assessment, reassessment, POC, and “Skilled Nursing Clinical Note” for the dates previously mentioned. The DPCS stated the plan of care should have included the presence of perma catheter since Patient 7 was on hemodialysis. The DPCS stated that not including the perma catheter in plan of care had resulted in field nurses not assessing and/or not documenting their assessment, and patient education not given. f. A review of Patient 8’s clinical record indicated a Start of Care Date (SOC) of 1/25/2024, with diagnoses which included Colostomy status (a surgery to create an opening for the colon (large intestine) through the belly (abdomen), it may be a short term (temporary) or long term (permanent), and it is often done after bowel surgery or injury). A review of Patient 8’s clinical records titled “Start of Care Assessment”, dated 1/25/2024, indicated that Patient 8 was on colostomy status, there was no assessment done particular to Patient 8’s colostomy. A review of Patient 8’s clincal records titled Recertification Assessment”, dated 3/22/2024, also indicated that Patient 8 was on colostomy status, there was no assessment done particular to Patient 8’s colostomy. A review of Patient 8’s clinical records titled “Home Health Certification and Plan of Care (POC)”, with certification period of 3/25/24 to 5/23/2024, indicated that Patient 8 was on colostomy status. The POC did not specify the appropriate care/management while Patient 8 on colostomy status, and the education to provide to patient and/or caregiver, such as signs and symptoms to monitor. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 5/3/24 at 2:25 p.m., the DPCS reviewed Patient 8’s start of care assessment, reassessment and POC for the dates previously mentioned. The DPCS stated that Patient 8’s start of care assessment and reassessment mentioned that patient was on colostomy status. The DPCS stated the assessment for colostomy should have been documented, so it would be included in the care plan. The DPCS stated, “It’s not in the care plan because it was not in the comprehensive assessment.” a. A review of Patient 2’s “Patient Profile” indicated Patient 2 was admitted on 1/5/24 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (may include but is not limited to dry gauze dressings, dressings moistened with saline or other solutions, or transparent dressings). Other diagnoses included pressure ulcer of right buttock (injury to skin and underlying tissue resulting from prolonged pressure on the skin), stage 2 (indicating open wounds), and end stage renal disease (a medical condition in which a person’s kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life). A review of Patient 2’s start of care assessment, dated 1/5/24, indicated that Patient 2 was dependent on hemodialysis (a procedure during which a machine filters wastes, salts, and fluid from the blood when the kidneys are no longer healthy enough to do this work adequately). The assessment did not specify the type of vascular (relating to blood vessels) access Patient 2 had for the hemodialysis. A review of Patient 2’s recertification assessment, dated 3/4/24, also indicated that Patient 2 was renal (kidney) dialysis dependent. The recertification assessment did not specify the type of vascular access Patient 2 had for the hemodialysis. During a joint home visit with Licensed Vocational Nurse 2 (LVN 2) on 5/1/24 at 11:35 a.m., Patient 2 was observed alert, oriented, and ambulatory. During an interview with Patient 2 on 5/1/24 at 11:45 a.m., Patient 2 stated she had dialysis three times a week. It was observed that Patient 2 had an arteriovenous fistula/AV fistula (an access point for dialysis surgically created by connecting an artery [a type of blood vessel] and a vein [a type of blood vessel]) on her right upper arm. A review of Patient 2’s “Home Health Certification and Plan of Care (POC),” dated 3/4/24, indicated that Patient 2 was on dialysis. The POC did not specify the type of dialysis access, the appropriate care/management for the dialysis access, and the education to provide to patient and/or caregiver, such as signs and symptoms to monitor. A review of “Skilled Nursing Clinical Note” for Patient 2, dated 4/5/24, 4/9/24, 4/13/24, 4/16/24, and 4/19/24, indicated the nursing staff did not assess the AV fistula, or provided the patient with education related to the AV fistula. During an interview with LVN 2 on 5/1/24 at 12:55 p.m., LVN 2 stated that she assessed Patient 2’s fistula every visit, even though there was no order for her to do so. Per LVN 2, she did not document her assessment. LVN 2 stated the fistula needed to be checked to make sure it was working. LVN 2 stated whenever she came after Patient 2 had dialysis, she would check it to make sure there was no bleeding. During a concurrent record review and interview with the Director of Patient Care Services (DPCS) on 5/3/24 at 1 p.m., the DPCS reviewed Patient 2’s start of care assessment, recertification assessment, POC, and “Skilled Nursing Clinical Note” for the dates previously mentioned. The DPCS stated the plan of care should have included the presence of AV fistula since Patient 2 was on hemodialysis. The DPCS stated that not including the AV fistula in plan of care had resulted in field nurses not assessing and/or not documenting their assessment, and patient education not given. A review of the HHA’s undated policy, titled “Plan of Care – CMS 485 and Physician/Practitioners Orders,” indicated 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. b. A review of Patient 2’s “Patient Profile” indicated Patient 2 was admitted on 1/5/24 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. Other diagnoses included pressure ulcer of right buttock, stage 2, and end stage renal disease. A review of “Patient Medication Profile” for Patient 2 indicated the following blood pressure medications ordered for Patient 2: - Propranolol 40 mg tablet; 1 tablet by mouth daily. - Amlodipine 10 mg tablet; 1 tablet by mouth daily. - Hydralazine 25 mg tablet; 1 tablet by mouth twice daily. There were no hold parameters (limit) listed for those blood pressure medications. A review of Patient 2’s “Home Health Certification and Plan of Care (POC),” dated 3/4/24, indicated that Patient 2 was taking Amlodipine 10 mg tablet; 1 tablet by mouth daily, Hydralazine 25 mg tablet; 1 tablet by mouth twice daily, and Propranolol 40 mg tablet; 1 tablet by mouth daily. There were no hold parameters for all three medications. During a joint home visit with Licensed Vocational Nurse 2 (LVN 2) on 5/1/24 at 11:35 a.m., Patient 2 was observed alert, oriented, and ambulatory. At 11:55 a.m., LVN 2 took Patient 2’s blood pressure, which was 100/58 mm Hg. According to American Heart Association: https://www.heart.org: a blood pressure reading which is less than 90/60 mm Hg is considered low blood pressure. During an interview with Patient 2 on 5/1/24 at 11:55 a.m., Patient 2 stated that she had not taken her blood pressure medications. According to Patient 2, her dialysis nurse told her not to take blood pressure medications on the days she was supposed to have dialysis. On 5/2/24 at 9:44 a.m., during a telephone interview, Patient 2 stated, “For the days I don’t have dialysis, if I feel dizzy, I don’t take the blood pressure medications. When my blood pressure is low, I’m usually dizzy. That’s when I hold them.” During a concurrent record review and interview with the DPCS on 5/3/24 at 1:15 p.m., the DPCS reviewed Patient 2’s medication profile and POC. The DPCS confirmed there were no hold parameters for the blood pressure medications. The DPCS stated it was important to have hold parameters for blood pressure medications, especially since Patient 2’s blood pressure could be on the lower side due to dialysis. The DPCS stated she would ensure that hold parameters be added to Patient 2’s orders. A review of the HHA’s undated policy, titled “Plan of Care – CMS 485 and Physician/Practitioners Orders,” indicated the plan of care must include patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient. c. A review of Patient 5’s “Patient Profile” indicated Patient 5 was admitted on 1/4/23 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. A review of Patient 5’s “Home Health Certification and Plan of Care (POC),” dated 2/28/24, indicated the physician ordered daily wound care as follows: - Right buttock stage 4 pressure ulcer and sacral stage 3 pressure ulcer: Cleanse with Dakin’s Solution (a dilute solution of sodium hypochlorite and other stabilizing ingredients, traditionally used as an antiseptic), pat dry, loosely pack with Dakin’s moistened gauze, cover with border dressing. - Right heel and left heel diabetic ulcer: Cleanse with normal saline (a mixture of sodium chloride and water that has a number of uses in medicine including cleaning wounds), pat dry, apply Santyl (a topical medication used for removing damaged or burned skin to allow for wound healing and growth of healthy skin), cover with gauze, secure with Kerlix roll (a type of dressing) and tape. The frequency of nurse visit was once a week for 9 weeks. The POC indicated that Patient 5 was non-compliant with wound care and was refusing the HHA’s nurse to do treatment and assessment. The POC indicated that visiting nurse would continue education on wound care to patient’s family member, and patient and/or caregiver would have adequate knowledge about the purpose of treatment and the consequences of ineffective treatment. The POC did not include the intervention for continuous refusal for wound care and assessment. A review of Patient 5’s “Skilled Nursing Clinical Note,” dated 4/14/24, 4/15/24, 4/16/24, 4/17/24, and 4/20/24 indicated Patient 5 was alert and oriented. The notes indicated Patient 5 refused to have wound care done by nursing staff, despite education of risks and benefits of having staff provide wound care and risks of further infection related to refusal. A review of Patient 5’s “Transferred to an Inpatient Facility Assessment,” dated 4/6/24, indicated that Patient 5 was transferred to the hospital on 4/6/24 due to lethargy (a symptom that involves an unusual decrease in consciousness) and weakness. A review of Patient 5’s “Transferred to an Inpatient Facility Assessment,” dated 4/22/24, indicated that Patient 5 was transferred to the hospital on 4/22/24 due to increased fatigue and weakness. During an interview with the Director of Patient Care Services (DPCS) on 5/3/24 at 1:35 p.m., the DPCS stated that Patient 5 had been refusing wound care since January 2023. The DPCS stated that Patient 5 needed higher level of care, such as staying at a skilled nursing facility (SNF – an inpatient facility that provides 24-hour skilled nursing care, as well as rehabilitative services). According to the DPCS, she had communicated about transferring Patient 5 to a SNF with the physician, family members, and hospital case manager, but Patient 5 always refused. However, Patient 5’s need for higher level of care was not addressed in the plan of care, which might have contributed to Patient 5’s recurring hospital readmissions. The plan of care did not describe Patient 5’s risk for emergency department visits and hospital readmission, and all necessary interventions to address the underlying factors. A review of the HHA’s undated policy, titled “Plan of Care – CMS 485 and Physician/Practitioners Orders,” indicated the plan of care must include a description of the patient’s risk for emergency department visits and hospital readmission, and all necessary interventions to address the underlying factors. A review of the HHA’s policy, titled “Patient’s Bill of Rights and Responsibilities,” revised February 2024, indicated that patients will be transferred from agency based on agency transfer criteria policy: - Transfer is necessary for the patient’s welfare because the agency and the physician/practitioner who is responsible for the home health plan of care agree the agency can no longer meet the patient’s needs, based on the patient’s acuity. The agency will arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the agency’s capabilities. The HHA did not provide a policy and procedure related to patient’s noncompliance as requested by the survey team.”

“Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to provide the written information regarding the patient’s medication regimen to one of 10 sampled patients (Patient 1). This deficient practice had the potential to put the patient at risk for medication errors and adverse drug reactions. A review of Patient 1’s “Patient Profile” indicated Patient 1 was admitted on 1/31/24 with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing (may include but is not limited to dry gauze dressings, dressings moistened with saline or other solutions, or transparent dressings). Other diagnosis included cellulitis (a common, potentially serious bacterial skin infection) on right and left lower limb, and long-term use of anticoagulants (medicines that help prevent blood clots). A review of Patient 1’s “Home Health Certification and Plan of Care,” dated 3/27/24, indicated that orders for discipline included “medications.” During a joint home visit with Licensed Vocational Nurse 1 (LVN 1) on 5/1/24 at 10 a.m., Patient 1 was observed alert and oriented. Patient 1 was ambulatory with a walker. It was observed that Patient 1 had a home health folder at his residence. There was an illegible carbon copy of medication profile inside the folder. The handwriting on the carbon copy of the medication profile was barely visible. When asked to read the writing on the medication profile, Patient 1 stated that he could not read the writing, and instead he asked the surveyor to read it for him. During an interview with LVN 1 on 5/1/24 at 10:50 a.m., LVN 1 stated that patients should be provided with a medication profile that is readable, so they could use it as a reference. LVN 1 stated, “The medication profile has instruction such as when to take it, how many times a day, and for example if it needs to be taken with food or on an empty stomach.” During an interview with the Director of Patient Care Services (DPCS) on 5/3/24 at 11:30 a.m., the DPCS stated all patients were provided with a copy of medication profile. The DPCS stated she was not aware Patient 1 had an illegible copy. The DPCS stated she would instruct LVN 1 to provide Patient 1 with a legible, printed copy of his medication profile. A review of the HHA’s policy, titled “Medication Reconciliation,” revised February 2024, indicated the agency provides the patient and/or caregiver with written patient medication schedule/instruction, including medication name, dose, strength, route and frequency, as well as which medications will be administered by agency staff.”