Ogada Home Health Care, Inc.

“Condition of Participation: Patient rights. CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient’s rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This Condition is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure the Condition of Participation regarding patient rights was met as follows: - The HHA failed to ensure one of seven sampled patients (Patient 7) received all care/services outlined in the plan of care. This deficient practice resulted in Patient 7’s colostomy (a surgical procedure that bypasses part of the colon and redirects the feces to come out of a new hole in the abdomen, called a stoma) site, daily intravenous (the process of administering substances like fluids, medications, or blood into a vein using a needle or tube) antibiotic (a medicine that treats or prevents bacterial infections in people and animals by killing bacteria or stopping them from reproducing) administration, and negative-pressure wound therapy or wound vacuum (a therapeutic technique using a suction pump, tubing, and a dressing to remove excess exudate and promote healing in acute or chronic wounds) was not monitored by the Registered Nurse, putting Patient 7’s colostomy at risk for infection and delay in healing process jeopardizing the patient’s health and safety. Refer to G436. - The HHA failed to ensure one of seven sampled patients (Patient 7) received proper written notice in advance of the non-covered services being furnished by the HHA that resulted to an abrupt termination of the on-going provision of the RN services including care and treatment to be furnished as indicated in the patient’s plan of care (POC). Refer to G442. The cumulative effect of this systemic practice resulted in the failure of the HHA to deliver statutorily (written law) mandated compliance with Federal regulation for Patient Rights to ensure the highest quality patient care was provided to the 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 interview and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure the Condition of Participation for Care planning, Coordination of services, and Quality of care are met as follows: 1 --The HHA failed to provide care and services in accordance with the patient’s written plan of care for one of seven sampled patients (Patient 7). This deficient practice resulted in Patient 7’s ostomy (a surgical procedure that creates an opening in the abdominal wall to allow waste to exit the body in a different way) site, daily intravenous/IV (the process of administering substances like fluids, medications, or blood into a vein using a needle or tube) antibiotic (a medicine that treats or prevents bacterial infections in people and animals by killing bacteria or stopping them from reproducing) administration, and negative-pressure wound therapy or wound vacuum (a therapeutic technique using a suction pump, tubing, and a dressing to remove excess exudate and promote healing in acute or chronic wounds) unmonitored by a qualified clinician, putting Patient 7 at risk for infection and inappropriate healing. Refer to G 572. -- The HHA failed to provide written instruction in the form of a copy of the plan of care (POC, a document that maps out needs and services supplied for a homebound patient, as well as the patient’s family/caregiver) for two of seven sampled patients (Patient 1 and Patient 4). This deficient practice had the potential to result in patient’s family member/caregiver’s inability to participate effectively in the patients identified care and needs as indicated in the POC. Refer to G 612. -- The HHA failed to provide written instructions related to care and treatments for two of seven patients receiving anticoagulant (medication to prevent and treat blood clots) and steroid (help inflammatory conditions such as asthma and eczema) therapy (Patient 1 and Patient 2). This deficient practice had the potential to result in the patients’ lack of knowledge to watch and report for any significant signs and symptoms manifested while taking these medications. Refer to G 620. 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 care, and Quality of care to ensure highest quality of patient care and services are provided to certified patients receiving the home health benefits.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to provide care and services in accordance with the patient’s written plan of care for one of seven sampled patients (Patient 7). This deficient practice resulted in Patient 7’s ostomy (a surgical procedure that creates an opening in the abdominal wall to allow waste to exit the body in a different way) site, daily intravenous/IV (the process of administering substances like fluids, medications, or blood into a vein using a needle or tube) antibiotic (a medicine that treats or prevents bacterial infections in people and animals by killing bacteria or stopping them from reproducing) administration, and negative-pressure wound therapy or wound vacuum (a therapeutic technique using a suction pump, tubing, and a dressing to remove excess exudate and promote healing in acute or chronic wounds) unmonitored by a qualified clinician, putting Patient 7 at risk for infection and inappropriate healing. During a review of Patient 7’s Patient Profile By Episode, indicated Patient 7 was admitted to the HHA on 9/12/2024 with a primary diagnosis of encounter for attention to colostomy (a surgical procedure that bypasses part of the colon and redirects the feces to come out of a new hole in the abdomen, called a stoma). The Initial Orders section in Patient 7’s Patient Profile By Episode indicated Patient 7 was referred to the HHA for skilled registered nursing services for the new ostomy (a surgical procedure that creates an opening in the abdominal wall to allow waste to leave the body) care, wound vac care (a therapeutic technique using a suction pump, tubing, and a dressing to remove excess exudate and promote healing in acute or chronic wounds), and IV antibiotics antibiotic (a medicine that treats or prevents bacterial infections in people and animals by killing bacteria or stopping them from reproducing, which is administered into a vein using a needle or tube). During a review of Patient 7’s Home Health Certification and Plan of Care (POC- a document that maps out needs and services supplied for a homebound patient, as well as the patient’s family/caregiver), for the certification period of 9/12/2024 to 11/10/2024, the POC indicated the Skilled Nursing (licensed nurse) visit frequency was daily for fifteen days, then twice a week for six weeks or until further new orders from the physician. The POC indicated that Patient 7 was on Piperacillin/Tazobactam (antibiotic) 10.125 gram (a unit measurement) 240 ml (a unit measurement) Easy Pump IV (a single-use, elastomeric balloon pump that delivers medication to a patient’s bloodstream through an IV or PICC (peripherally inserted central catheter, a long, flexible tube that is inserted into a vein in the arm and threaded into a large vein near the heart; it is used to deliver fluids, medications, blood transfusions, chemotherapy, and to draw blood samples) line over 24 hours via continuous infusion through 9/27/2024. The POC also indicated wound vac dressing change two times a week (Monday and Thursday) and ostomy bag change two times a week. During a phone interview with Patient 7 on 10/4/2024 at 9:43 a.m., Patient 7 stated he was being visited by Registered Nurse 1 (RN 1) daily from 9/12/2024 until 9/21/2024. Patient 7 stated that on 9/21/2024, RN 1 visited him and administered the IV antibiotic and changed his colostomy bag. Patient 7 stated that during his visit on 9/21/2024, RN 1 told Patient 7 that RN 1 would see him the following day. Patient 7 stated that RN 1 did not visit him on 9/22/2024. Patient 7 stated he contacted the DPCS and informed her that RN 1 did not visit him as agreed on 9/21/2024. According to Patient 7, DPCS stated that RN 1 did not visit him that day because he had exhausted all visits authorized by the insurance. During the same phone interview, when Patient 7 was asked who administered his IV antibiotic on 9/22/2024 until 9/27/2024 since he was no longer visited by an RN from the HHA, Patient 7 stated that his sister had been administering his IV antibiotic. Patient 7 stated that RN 1 had taught his sister how to disconnect the empty IV bag and administer a new IV bag. Patient 7 stated he had a PICC line for the IV antibiotic purpose. When asked if his sister was a Registered Nurse, Patient 7 stated she was not. Patient 7 stated since he was no longer visited by RN 1 after 9/21/2024, on 9/22/2024 he had to have his wound vac dressing and ostomy bag changed at the emergency room at Hospital 1. Patient 7 stated he also had to have his PICC line dressing change done at his physician’s office. During a phone interview with RN 1 on 10/4/2024 at 12:27 p.m., RN 1 stated he last visited Patient 7 on 9/21/2024. RN 1 stated he was planning to see Patient 7 again the following day for his daily visit. RN 1 stated he had been providing IV antibiotic infusion, ostomy care, and wound vac management for Patient 7 during his visits. RN 1 was asked if he visited Patient 7 as planned on 9/22/2024, RN 1 stated he did not, because in the evening of 9/21/2024, he received a text message from the HHA instructed him to hold the visit for Patient 7 due to pending authorization from the insurance. During an interview with the DPCS on 10/4/2024 at 1:25 p.m., the DPCS stated that on 9/21/2024, she instructed RN 1 to hold the visit for Patient 7 pending insurance authorization. The DPCS stated Patient 7’s sister was able to administer IV antibiotic and change the colostomy bag. When the DPCS was asked if Patient 7’s sister was a Registered Nurse who had the required knowledge and skills to monitor a PICC line, change a PICC line dressing, and change the wound vac dressing, the DPCS stated she did not know. During the same interview, the DPCS stated there could be negative outcome as a result from not having a Registered Nurse do the daily visit per Patient 7’s written plan of care, such as risk for infection and inappropriate wound healing. During a review of the HHA’s policy and procedure, titled “Plan of Care,” effective 1/3/2022, the policy and procedure indicated that care/services to be provided will be coordinated and will follow the patient’s written plan of care. During a review of the HHA’s policy and procedure, titled “PICC and Midline Care Protocol,” undated, the policy and procedure indicated that home health nurses will assess the catheter site during weekly visits, change dressings, and perform flushes using the SASH technique (a technique for flushing a catheter with saline, administering medication, and flushing again with saline and heparin).”

“Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This Standard is not met as evidenced by: Based on observation, interview, and record review the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence, rather than in a more traditional healthcare facility setting) failed to provide written instruction in the form of a copy of the plan of care (POC, a document that maps out needs and services supplied for a homebound patient, as well as the patient’s family/caregiver) for two of seven sampled patients (Patient 1 and Patient 4). This deficient practice had the potential to result in patient’s family member/caregiver’s inability to participate effectively in the patients identified care and needs as indicated in the POC. a. A review of Patient 1’s “Patient Profile” indicated a Start of Care (SOC) date of 4/19/2024 with a diagnosis which include Sepsis (a serious condition in which the body responds improperly to an infection) due to other specified staphylococcus (a group of bacteria that causes many diseases). During a concurrent observation and interview on 10/3/2024, at 10 a.m., with the Director of Patient Care Services (DPCS), in Patient 1’s residence for a joint home visit, Patient 1 was observed comfortably sitting on the chair with her walker by her side. During review of Patient 1’s home health agency’s home folder, there was no copy of POC included. DPCS stated that they don’t usually provide a copy of patient’s POC unless it was requested. DPCS confirmed that copy of POC was not provided to Patient 1 and stated the HHA was supposed to provide a copy of the POC to each patient. The DPCS stated the purpose of providing patient with a copy of the POC was to ensure the patient and his or her family or caregiver could review the POC and be familiar with it. The DPCS stated if the patient and/or family understood about their plan of care, they would be able to participate more. b. During a review of Patient 4’s Patient Profile By Episode, the Patient Profile By Episode indicated that Patient 7 was admitted to the HHA on 9/6/2024 with a primary diagnosis of acute cholecystitis (Inflammation of the gallbladder, a small, digestive organ beneath the liver). During a joint home visit with the Director of Patient Care Services (DPCS) on 10/3/2024 at 12 p.m.., Patient 4 was observed awake, alert, and oriented. Patient 4 was sitting in bed. Observed a walker (a mobility aid that helps a person maintain balance and stability while walking) in Patient 4’s bedroom. During the concurrent home visit, it observed Patient 4 had a home health folder at her residence. A review inside the folder 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 Family Member 1 (FM 1) on 10/3/2024 at 12:20 p.m., FM 1, who acted as Patient 4’s primary caregiver stated that all documents the home health agency provided were in the folder. FM 1 was not sure if the HHA provided a copy of the plan of care. During an interview with the DPCS on 10/3/2024 at 12:25 p.m., the DPCS stated the HHA should have provided all patients with the plan of care, so they would know what the plan was for them, the frequency of visit, and the set goals. 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. During a review of the HHA’s policy and procedure, titled “Ogada Home Health Agency: Contents of Home Folder Policy,” undated, the policy and procedure indicated that the required contents of the home folder included care plan: An individualized care plan outlining patient’s needs, goals, services provided, and treatment strategies.”

“Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This Standard is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence, rather than in a more traditional healthcare facility setting) failed to ensure clinical records were authenticated by the author of the note for one of seven sampled patients (Patient 1). This deficient practice resulted in an incomplete record of patient’s clinical information that could affect the patient’s quality of care and well-being. A review of Patient 1’s “Patient Profile” indicated a Start of Care (SOC) date of 4/19/2024 with a diagnosis which include Sepsis (a serious condition in which the body responds improperly to an infection) due to other specified staphylococcus (a group of bacteria that causes many diseases). During a review of Patient 1’s “Nursing Progress Note” with the following dates of 9/16/2024, 9/20/2024 and 9/23/2024, the “Nursing Progress Note” indicated no clinician’s (LVN 1) signatures and dates. During an interview on 10/3/2024, at 10 a.m., with Patient 1 at home visit stated, Licensed Vocational Nurse (LVN1) was her regular nurse that visited her and stated LVN 1 visited 9/16/2024, 9/20/2024 and 9/23/2024. Patient 1 stated that LVN1 did not miss any visits yet. During a concurrent review and interview on 10/4/24, at 1:12 p.m., with the Director of Patient Care Services (DPCS), Patient 1’s “Field Route Sheet”, the “Field Route Sheet” indicated LVN 1 visited Patient 1 on 9/16/2024, 9/20/2024 and 9/23/2024 with Patient 1 signature affixed in it. The DPCS stated that “Field Route Sheet” will provide information of the date and time the nurse visited and serviced the patient. The DPCS stated that it was important clinician signed their clinical records entries and documentation to validate the authenticity of the documents. The DPCS stated that LVN1 might have forgotten to sign her visit notes, and it was not an excuse. During a review of HHA’s policy and procedure (P&P), titled “Medical Record Entries and Authentication”, revision date of March 2018, the policy indicated that all medical record entries will be dated and authenticated. “Medical Record Entries and Authentication” procedure indicated that all entries in the medical records will be authenticated by staff’s signature and title.”

“Receive all services in plan of care CFR(s): 484.50(c)(5) Receive all services outlined in the plan of care. This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure one of seven sampled patients (Patient 7) received all care/services outlined in the plan of care. This deficient practice resulted in Patient 7’s colostomy (a surgical procedure that bypasses part of the colon and redirects the feces to come out of a new hole in the abdomen, called a stoma) site, daily intravenous (the process of administering substances like fluids, medications, or blood into a vein using a needle or tube) antibiotic (a medicine that treats or prevents bacterial infections in people and animals by killing bacteria or stopping them from reproducing) administration, and negative-pressure wound therapy or wound vacuum (a therapeutic technique using a suction pump, tubing, and a dressing to remove excess exudate and promote healing in acute or chronic wounds) was not monitored by the Registered Nurse, putting Patient 7’s colostomy at risk for infection and delay in healing process jeopardizing the patient’s health and safety. During a review of Patient 7’s “Patient Profile By Episode”, indicated Patient 7 was admitted to the HHA on 9/12/2024 with a primary diagnosis of encounter for attention to colostomy (a surgical procedure that bypasses part of the colon and redirects the feces to come out of a new hole in the abdomen called a stoma). The Initial Orders section in Patient 7’s “Patient Profile By Episode” indicated that Patient 7 was referred to the HHA for skilled nurse (registered nurse) for new ostomy (a surgical procedure that creates an opening in the abdominal wall to allow waste to leave the body) care, wound vac care (a therapeutic technique using a suction pump, tubing, and a dressing to remove excess exudate and promote healing in acute or chronic wounds), and IV antibiotics antibiotic (a medicine that treats or prevents bacterial infections in people and animals by killing bacteria or stopping them from reproducing, which is administered into a vein using a needle or tube). During a review of Patient 7’s Home Health Certification and Plan of Care (POC, a document that maps out needs and services supplied for a homebound patient, as well as the patient’s family/caregiver), for the certification period of 9/12/2024 to 11/10/2024, the POC indicated the Skilled Nursing (registered nurse) visit frequency was daily for fifteen days, then twice a week for six weeks or until further new orders from the physician. The POC indicated that Patient 7 was on Piperacillin/Tazobactam (antibiotic) 10.125 gram (a unit measurement) 240 ml (a unit measurement) Easy Pump IV (a single-use, elastomeric balloon pump that delivers medication to a patient’s bloodstream through an IV or PICC (peripherally inserted central catheter, a long, flexible tube that is inserted into a vein in the arm and threaded into a large vein near the heart; it is used to deliver fluids, medications, blood transfusions, chemotherapy, and to draw blood samples) line over 24 hours via continuous infusion through 9/27/2024. The POC also indicated wound vac dressing change two times a week (Monday and Thursday) and ostomy bag change two times a week. During a phone interview with Patient 7 on 10/4/2024 at 9:43 a.m., Patient 7 stated he was being visited by Registered Nurse 1 (RN 1) daily from 9/12/2024 until 9/21/2024. Patient 7 stated that on 9/21/2024, RN 1 visited him and administered the IV antibiotic and changed his colostomy bag. Patient 7 stated during RN 1’s visit on 9/21/2024, that RN 1 would see him the following day. Patient 7 stated that RN 1 did not visit him on 9/22/2024. Patient 7 stated he contacted the DPCS and informed her that RN 1 did not visit him as agreed on 9/21/2024. According to Patient 7, the DPCS stated that RN 1 did not visit him on 9/22/24, because Patient 7 had exhausted all visits authorized by the insurance. During the same phone interview, Patient 7 was asked who administered his IV antibiotic on 9/22/2024 until 9/27/2024 since he was no longer visited by the RN from the HHA, Patient 7 stated that his sister had been administering his IV antibiotic. Patient 7 stated that RN 1 had taught his sister how to disconnect the empty IV bag and administer a new IV bag. Patient 7 stated he had a PICC line for the IV antibiotic purpose. Patient 7 was asked if his sister was a Registered Nurse, Patient 7 stated she was not. Patient 7 stated since he was no longer visited by RN 1 after 9/21/2024, on 9/22/2024 he had to have his wound vac dressing and ostomy bag changed at the emergency room at Hospital 1. Patient 7 stated he also had to have his PICC line dressing change done at his physician’s office. During a phone interview with RN 1 on 10/4/2024 at 12:27 p.m., RN 1 stated he last visited Patient 7 on 9/21/2024. RN 1 stated he was planning to see Patient 7 again the following day for his daily visit. RN 1 stated he had been providing IV antibiotic infusion, ostomy care, and wound vac management for Patient 7 during his visits. RN 1 was asked if he visited Patient 7 as planned on 9/22/2024, RN 1 stated he did not, because in the evening of 9/21/2024, he received a text message from the HHA that instructed him to hold the visit for Patient 7 due to pending authorization from the insurance. During an interview with the DPCS on 10/4/2024 at 1:25 p.m., the DPCS stated that on 9/21/2024, she instructed RN 1 to hold the visit for Patient 7 pending insurance authorization. The DPCS stated Patient 7’s sister was able to administer IV antibiotic and change the colostomy bag. DPCS was asked if Patient 7’s sister was a Registered Nurse who had the required knowledge and skills to monitor a PICC line, change a PICC line dressing, and change the wound vac dressing, the DPCS stated she did not know. During the same interview, the DPCS stated there could be a negative outcome as result from not having a Registered Nurse do the daily visit per Patient 7’s written plan of care, such as risk for infection and inappropriate wound healing. During a review of the HHA’s policy and procedure, titled “Patient Rights and Responsibilities,” effective 1/3/2022, the policy and procedure indicated that patient rights will include but not limited to receive all care/services outlined in the plan of care.”

“Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, a public or private organization that delivers skilled nursing and other therapeutic services to a patient at home) failed to ensure one of seven sampled patients (Patient 7) received proper written notice in advance of the non-covered services being furnished by the HHA that resulted to an abrupt termination of the on-going provision of the RN services including care and treatment to be furnished as indicated in the patient’s plan of care (POC). During a review of Patient 7’s Patient Profile By Episode, the Patient Profile By Episode indicated that Patient 7 was admitted to the HHA on 9/12/2024 with a primary diagnosis of encounter for attention to colostomy (a surgical procedure that bypasses part of the colon and redirects the feces to come out of a new hole in the abdomen, called a stoma). During a review of Patient 7’s Home Health Certification and Plan of Care (POC, a document that maps out needs and services supplied for a homebound patient, as well as the patient’s family/caregiver), for the certification period of 9/12/2024 to 11/10/2024, the POC indicated the Skilled Nursing (registered nurse) visit frequency was daily for fifteen days, then twice a week for six weeks or until further new orders from the physician. The POC indicated that Patient 7 was on Piperacillin/Tazobactam (antibiotic) 10.125 gram (a unit measurement) 240 ml (a unit measurement) Easy Pump IV (a single-use, elastomeric balloon pump that delivers medication to a patient’s bloodstream through an IV or PICC (peripherally inserted central catheter, a long, flexible tube that is inserted into a vein in the arm and threaded into a large vein near the heart; it is used to deliver fluids, medications, blood transfusions, chemotherapy, and to draw blood samples) line over 24 hours via continuous infusion through 9/27/2024. The POC also indicated wound vac dressing change two times a week (Monday and Thursday) and ostomy bag change two times a week. During a phone interview with Patient 7 on 10/4/2024 at 9:43 a.m., Patient 7 stated he was being visited by Registered Nurse 1 (RN 1) daily from 9/12/2024 until 9/21/2024. Patient 7 stated that on 9/21/2024, RN 1 visited him and administered the IV antibiotic and changed his colostomy bag. Patient 7 stated that during his visit on 9/21/2024, RN 1 told Patient 7 that RN 1 would see him the following day. Patient 7 stated that RN 1 did not visit him on 9/22/2024. Patient 7 stated he contacted the DPCS and informed her that RN 1 did not visit him as agreed upon on 9/21/2024. According to Patient 7, the DPCS stated that RN 1 did not visit him that day because he had exhausted all visits authorized by the insurance. Patient 7 stated the HHA never notified him in advance that the services would be terminated after 9/21/2024. During the same phone interview, Patient 7 was asked who administered his IV antibiotic on 9/22/2024 until 9/27/2024 since he was no longer visited by an RN from the HHA, Patient 7 stated that his sister had been administering his IV antibiotic. Patient 7 stated that RN 1 had taught his sister how to disconnect the empty IV bag and administer a new IV bag. Patient 7 stated he had a PICC line for the IV antibiotic purpose. When asked if his sister was a Registered Nurse, Patient 7 stated she was not. Patient 7 stated he was no longer visited by RN 1 after 9/21/2024, on 9/22/2024 he had to have his wound vac dressing and ostomy bag changed at the emergency room at Hospital 1. Patient 7 stated he also had to have his PICC line dressing change done at his physician’s office. During an interview with the DPCS on 10/4/2024 at 1:25 p.m., the DPCS stated that on 9/21/2024, she instructed RN 1 to hold the visit for Patient 7 pending insurance authorization. The DPCS stated Patient 7’s sister was able to administer IV antibiotic and change the colostomy bag. When the DPCS was asked if Patient 7’s sister was a Registered Nurse who had the required knowledge and skills to monitor a PICC line, change a PICC line dressing, and change the wound vac dressing, the DPCS stated she did not know. The DPCS was asked if Patient 7 was notified in writing prior to the HHA terminating the services, the DPCS stated there was no written notification. The DPCS stated that she notified Patient 7 over the phone on 9/22/2024 that he would not be visited due to pending insurance authorization. During a review of Communication Note for Patient 7, dated 9/12/2024, 9/14/2024, 9/18/2024, 9/21/2024, and 9/22/2024. The Communication Note did not mention that the HHA provided Patient 7 with a written notice prior to the HHA terminating the services on 9/22/2024. During a review of the HHA’s policy and procedure, titled “Patient Rights and Responsibilities,” effective 1/3/2022, the policy and procedure indicated that patient rights will include but not limited to receive proper written notice in advance of a specific care/service being furnished, if the HHA believes that the care/service may be non-covered care, or in advance of the HHA reducing or terminating ongoing care.”

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum, the following information: (1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence, rather than in a more traditional healthcare facility setting) failed to conduct a complete initial assessment of the peripherally inserted central catheter (PICC is a thin, flexible tube that is inserted into a vein in the upper arm and guided (threaded) into a large vein above the right side of the heart called the superior vena cava) and failed to reflect in the clinical record care/assessment for one of seven sampled patients (Patient 1). This deficient practice resulted in the inability to ensure the provision of quality health and wellbeing of patient. A review of Patient 1’s “Patient Profile” indicated a Start of Care (SOC) date of 4/19/2024 with a diagnosis which include Sepsis (a serious condition in which the body responds improperly to an infection) due to other specified staphylococcus (a group of bacteria that causes many diseases). During a review of Patient 1’s Home Health Certification and Plan of Care (POC, a document that maps out needs and services supplied for a homebound patient, as well as the patient’s family/caregiver) for certification period of 8/17/2024 to 10/15/2024, the Home Health Certification and POC indicated for Patient 1 to have skilled nursing services daily for 5 days, then twice a week for 7 weeks to perform every visit which include to assess/monitor for any complications related to PICC line left upper arm care and status to check for cellulitis (common skin infection caused by bacteria), phlebitis (inflammation of a vein), infiltration (the accidental leakage of the intravenous (IV) solution into the surrounding tissue instead of flowing into the vein), extravasation (leakage of fluid in the tissues around the IV site) of IV site. During a concurrent interview and record review with the Director of Patient Care Services (DPCS) on 10/4/2024 at 11:47 a.m., of Patient 1’s clinical record titled “Recertification Assessment”, with certification period of 8/17/2024 to 10/15/2024, the “Recertification Assessment” indicated that Patient 1 has PICC line located at her left upper extremity, but no documented assessment of its characteristics, appearance, dressing or signs and symptoms to suggest cellulitis, phlebitis, infiltration and extravasation as provided in the POC. The DPCS confirmed that the documented assessment was incomplete and stated that Patient 1’s PICC line was discontinued and had no complications. DPCS stated it was important a complete description and appearance of the PICC line was assessed and documented in the initial assessment as this was the baseline to compare if any significant changes of the PICC line does occur. During a review of HHA’s policy and procedure (P&P), titled “Initial and Comprehensive Assessment”, dated 01/03/2022, the policy indicated that HHA will then provide each patient a patient-specific comprehensive assessment that accurately reflects the patient’s current health. During a review of the HHA’s policy and procedure, titled “HHA PICC and Midline Protocol”, undated, the procedure indicated that initial assessment includes: -Inspect the catheter insertion site at every visit for signs of infection (redness, swelling, warmth, or discharge), bleeding or displacement. -Evaluate the condition of the dressing to ensure it is intact, dry and secure.”

“Other pertinent instructions CFR(s): 484.60(e)(4) Any other pertinent instruction related to the patient’s care and treatments that the HHA will provide, specific to the patient’s care needs. This Element is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA, an organization that delivers skilled nursing and other therapeutic services to a patient’s personal residence, rather than in a more traditional healthcare facility setting) failed to provide written instructions related to care and treatments for two of seven patients receiving anticoagulant (medication to prevent and treat blood clots) and steroid (help inflammatory conditions such as asthma and eczema) therapy (Patient 1 and Patient 2). This deficient practice had the potential to result in the patients’ lack of knowledge to watch and report for any significant signs and symptoms manifested while taking these medications. a. A review of Patient 1’s “Patient Profile” indicated a Start of Care (SOC) date of 4/19/2024 with a diagnoses which include Sepsis (a serious condition in which the body responds improperly to an infection) due to other specified staphylococcus (a group of bacteria that causes many diseases). During a review of Patient 1’s clinical record “Patient Medication Profile (Active list of medication)” listed the following medications: -- Clopidogrel 75 milligrams (mg-unit of weight) one tablet, oral (by mouth), daily for CVA (Cerebrovascular Accidents, are caused by blood clots and broken blood vessels in the brain). During a concurrent observation and interview on 10/3/2024, at 10 a.m., with the Director of Patient Care Services (DPCS), in Patient 1’s residence for a joint home visit, Patient 1 was observed comfortably sitting on the chair with her walker by her side. Patient 1 confirmed she was still taking Clopidogrel anticoagulant medication to prevent further incidents of strokes or blood clots. Patient 1 stated that she was unsure if DPCS provided teachings to her of what to look for while on anti-coagulant medication. During review of Patient 1’s home health agency’s home folder, there was no documented evidence of any written instructions for Patient 1 related to the use of an anti-coagulant medication. DPCS stated that she should have provided written instructions to Patient 1 for her reference when she needed to review it. DPCS stated that it was important for the clinical staff to provide verbal teachings and written instructions to patients if they are taking some medications that could potentially have side effects, like anti-coagulants. DPCS stated that written instructions provided to patients and their caregivers will help them to look for symptoms that needed immediate attention and care. b. A review of Patient 2’s “Patient Profile” indicated a Start of Care (SOC) date of 4/19/2024 with a diagnoses which include type 2 diabetes mellitus (A disease in which the body does not control the amount of glucose (a type of sugar) in the blood and the kidneys make a large amount of urine) with hyperglycemia (high blood sugar). During a review of Patient 2’s clinical record “Patient Medication Profile (Active list of medication)” listed the following medication: ---- Advair (a combined medication with steroids used to control symptoms of asthma and to prevent symptoms such as wheezing) HFA (hydrofluoroalkane, a propellant) 45 microgram (mcg- unit of weight) 21 mcg/ actuation aerosol inhaler (a device that gets medicine directly into an individual’s lungs), 2 puffs orally, deep breath twice daily. Spasmolytics/Bronchodilators (A type of drug that causes small airways in the lungs to open up). During a concurrent observation and interview on 10/3/2024, at 1:30 p.m., with the Director of Patient Care Services (DPCS), in Patient 2’s residence for a joint home visit, Patient 2 was observed comfortably sitting on the reclining chair with her walker by her side. Patient 2 confirmed she was still taking Advair inhaler for her shortness of breath. Patient 2 stated that she was not aware she needed to rinse her mouth after each use of the inhaler to prevent oral thrush (fungal infection in the mouth or throat, which is also a serious side effect of a steroid inhalers), Patient 2 stated she was not aware that steroid inhalers such as Advair inhaler can cause fungal infection of the mouth. Patient 1 stated that she was unsure if DPCS provided teachings regarding proper oral care after each use of Advair inhaler. During review of Patient 2’s home health agency’s home folder indicated no documented evidence of any written instructions related to oral care while on Advair inhaler. DPCS stated that she was unsure if she provided some teachings to Patient 2 of what to look for while on steroid inhaler. DPCS stated that she should have provided written instructions to Patient 2 for her reference when she needed to review it. DPCS stated that it was important for the clinical staff to provide verbal teachings and written instructions to patients if they are taking some medications that could potentially have side effects, like steroid inhaler. DPCS stated that written instructions provided to patients and their caregivers will help them to look for symptoms that needed immediate attention and care. During a review of HHA’s policy and procedure (P&P), titled “Patient Education”, dated 01/03/2022, the policy indicated that HHA will provide patient/caregiver education that will enable the patient and caregiver (s) to better understand the pathology of the patient’s diagnosis (es), assist them in establishing realistic and measurable goals, allow them to better assist in the development and revision of their plan of care, and maintain compliance with their plan of care. It also indicated in the procedure that the provision of patient education will be provided, and further reinforced per patient response, the education provided may include but not limited to the following: -Medication Management -Plan of care education and understanding”