Human Touch Home Health Care Agency

“Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency’s overall management and operation, the provision of all home health services, fiscal operations, review of the agency’s budget and its operational plans, and its quality assessment and performance improvement program. This Standard is not met as evidenced by: Based on interviews and administrative record review the agency failed to provide evidence of the governing body authority and responsibility for the agency’s overall management and operation, the provision of all home health services, fiscal operations, review of the agency’s budget and its operational plans, and its quality assessment and performance improvement program for 2022, 2023 and 2024. Findings include: According to an agency document, “untitled”, dated 12/14/23 (in part): “The Agency will review policies and procedures annually and the policies and procedures are utilized to direct all operational activities of the agency.” 1. On 9/23/24 a review of the agency policy and procedure manual revealed an unsigned document of a policy and procedure review for the governing body representative. The governing body failed to approve the agency policy and procedure manual for 2023. On 9/24/24 at 1:00p.m., the alternate administrator stated the corporate office oversaw the agency policy and procedures manual. She was not certain why the policy approval document was not signed by the governing body representative. She was asked to provide evidence of the governing body responsibility for the agency’s overall management and operation, the provision of all home health services, fiscal operations, review of the agency’s budget and its operational plans and its quality assessment and performance improvement program (QAPI). She said she would look for evidence of governing body meeting minutes and agendas for 2022, 2023 and 2024. On 9/25/24 at 9:30 a.m., an interview with the regional operations manager revealed the agency could not provide evidence of the governing body responsibility for the agency’s overall management and operation, the provision of all home health services, fiscal operations, review of the agency’s budget and its operational plans, and its’ QAPI program for 2022 and 2023. He stated the governing body had recognized this oversight and held an emergency governing body meeting on 9/24/24 and produced the meeting agenda, and minutes as evidence. 2. A review of the 9/24/24 governing body meeting minutes and agenda failed to reveal documented evidence the governing body had reviewed the agency’s QAPI program, the provision of all home health services or completed an annual agency evaluation. On 9/25/24 at 10:45 a.m., an interview with the agency’s corporate director of clinical compliance and assurance stated they were recently hired to assist agencies in maintenance of the QAPI program. The director of clinical compliance and assurance had requested the agency’s previous and current QAPI; however, had not received information from this agency. Therefore, the director was not aware of the information collected, data analyzed, performance improvement projects (PIPs), meetings conducted, QAPI committee members or completed agency evaluations incorporating information reviewed within the QAPI for 2024 or years prior. The corporate director of clinical compliance and assurance stated the agency governing body members were within the particular agency and not at the corporate level and were expected to include at minimum the agency administrator, alternate administrator and regional management team; however, the current alternate administrator and regional team were not aware of who the members of the governing body were who were to ensure a QAPI had not only been established but maintained for the agency. On 9/25/24 at 10:57 a.m., in an interview with the agency governing body representatives, which included the alternate administrator, acknowledged the governing body did not have documented evidence they had authority and responsibility for the agency’s overall management and operation, the provision of all home health services, fiscal operations, review of the agency’s budget and its operational plans, and its QAPI program for 2022, 2023 and 2024. The governing body representatives stated they would meet weekly and then monthly to collect and review agency compliance data until they have established an effective QAPI program and stated they would complete all outstanding governing body responsibilities in the immediate future to ensure agency compliance.”

“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, interviews and record review the agency failed to ensure an individualized plan of care included all medications and treatments for 2 of 7 active patients reviewed (Patients #2 and #3). 2. The clinical record for Patient #3 was reviewed 9/23/24. The plan of care (POC) for the certification period dated 8/10/24 to 10/8/24, signed by Patient #3’s primary care physician on 9/11/24, revealed a start of care date of 8/10/24; diagnoses included venous insufficiency, left lower limb localized swelling, lumbago (lower back pain) with sciatica, spinal stenosis, hypertension, cardiac murmur, type 2 diabetes mellitus, sleep apnea, osteoarthritis, hypothyroidism, and adjustment disorder with anxiety. POC orders included skilled nurse (SN) visits one time a week for nine weeks and three as needed (PRN) visits for medication set up, monitoring medication compliance, monitoring blood sugars and diabetic teaching including dietary teaching as needed; and physical therapy (PT) visits one time a week for one week and two times a week for seven weeks for general conditioning, transfer training, assistive device training, gait training, energy conservation strategies, effusion reduction/mitigation strategies, safety/fall prevention education and a comprehensive home exercise program. Further review of Patient #3’s POC and medication profile showed Patient #3 was taking the following medications: -81 milligrams (mg) of aspirin orally daily; -17 grams (Gm) of Miralax orally at night as needed; -20 mg Omeprazole orally daily; -500 mg acetaminophen two tablets orally every eight hours as needed; -10 mg Rosuvastatin Calcium orally once a day at night; -40 mg Lisinopril orally daily; -1.5 mg/0.5 milliliter (ml) injection Trulicity subcutaneously injected once a week on Tuesdays; -small amount of Diclofenac Sodium gel topically as needed; -one to two patches of Lidocaine applied topically daily; -600 mg cranberry concentrate orally one to two tablets daily; -1000 mg Metformin orally two times daily; and -20 mg Hydroxyzine orally daily. a. The agency failed to ensure documentation that a complete and accurate medication list was maintained within Patient #3’s POC throughout the care episode. Review of a 8/14/24 SN note showed registered nurse (RN) #9 documented in the medication section of the note that RN #9 had completed medication reconciliation and set-up. RN #9 also documented Patient #3’s medications had changed since her last SN visit (the start of care visit of 8/10/24) to include Nifedipine and Carvedilol and RN #9 had updated Patient #3’s medication profile. Review of Patient #3’s medication profile failed to show RN #9 had updated Patient #3’s medication profile to include the addition of Nifedipine and Carvedilol and failed to show the dosage and route of administration for each of these medications. Review of a 9/18/24 SN note showed RN #9 documented in the medication section of the note that RN #9 had completed medication reconciliation and set-up. RN #9 also documented Patient #3’s medication had changed since her last SN visit (completed on 9/11/24) to include Nitrofurantoin for seven days for a urinary tract infection (UTI) and RN #9 had updated Patient #3’s medication profile. Review of Patient #3’s medication profile failed to show RN #9 had updated Patient #3’s medication profile to include the addition of Nitrofurantoin, failed to show the dosage and route of administration for this medication, and failed to show what day Patient #3 started the medication and what day she would discontinue the medication. On 9/23/24, review of communication notes, from 8/10/24 to 9/23/24, showed on 9/18/24 RN #9 documented a case conference note which stated Patient #3 had a new UTI and had been placed on Nitrofurantoin for seven days. This note failed to state the dosage of Nitrofuantoin Patient #3 was prescribed, what day she started the medication and what day she was to stop taking the medication. Review of communication notes failed to show RN #9 had communicated to the agency or Patient #3’s primary care physician the addition of Nifedipine and Carvedilol to Consumer #3’s medication list. Crosswalk G718. Review of supplemental orders failed to show RN #9 had received orders for the addition of Nifedipine, Carvedilol or Nitrofurantoin to Patient #3’s medication regime. During an interview on 9/23/24 at 1:58 p.m., RN #9 confirmed she was Patient #3’s primary SN and agency case manager. RN #9 stated she filled Patient #3’s weekly medication planner at each of her visits. RN #9 stated Patient #3 was prescribed 60 mg Nifedipine extended release (ER) one time a day and 12.5 mg Carvedilol two times a day by her cardiologist shortly after RN #9’s start of care visit with Patient #3 on 8/10/24. RN #9 stated she documented the addition of these medications to the medication list kept in Patient #3’s home, but acknowledged she had not added these medications, nor the Nitrofurantoin, to Patient #3’s medication profile as she was taught to only add medications to the medication profile when she completed a recertification or change of condition comprehensive assessment with a consumer. RN #9 stated she ensured the medication list in Patient #3’s home was updated as her medications changed and RN #9 used this medication list to know which medication to place in Consumer #3’s weekly medication planner. RN #9 also stated she instructed Patient #3 to bring this medication list with her to all of her doctor’s appointments. RN #9 stated she was not sure if Patient #3’s primary care physician was aware of the addition of any medications prescribed after the POC was created and acknowledged she had not directly communicated these changes to Patient #3’s primary care physician. During an interview on 9/23/24 at 2:35 p.m., the clinical manager (CM) stated the agency expectation for a patient receiving medication set-up was for the SN to review medication changes with a patient at each visit. If a SN discovered a patient had been prescribed a new medication, the agency expected the SN to document the new medication in the SN note and update the patient’s medication profile at the time the medication was changed. The CM reviewed Patient #3’s record and acknowledged RN #9 had failed to update the medication profile to include the medication name, dosage and route of administration when additional medications were prescribed. Findings include: AGENCY POLICY According to the agency policy titled, “Physician Participation in Plan of Care”, dated 2009, (in pertinent parts): “Orders will be reviewed and revised by the patient’s physician (or other authorized licensed independent practitioner) based on: -Changes in diagnosis or treatment, including procedures, medications and equipment.” 1. On 9/23/23 a record review revealed a homebound patient with a start of care on 8/23/24 with a primary diagnosis of Multiple Myeloma and a secondary diagnosis of neoplasm related pain. Patient received skilled nursing care 5 days a week for wound and catheter care. (Patient #2) a. The agency failed to ensure the patient’s individualized plan of care included all medications and treatments. On 9/23/24 a review of the plan of care revealed Patient #2’s medication list that contained Tramadol 50mg tablet, twice daily and Tylenol 325mg tablet as needed for pain. On 9/24/24 at 8:50 a.m., an interview with the Patient #2’s wife revealed Patient #2 was taking a new medication, the label stated Hydrocodone Bitartrate- Acetaminophen oral tablet, dosage 5-325 mg on 9/4/2024 for pain. On 9/24/24 at 9:00a.m., an observation during a home visit revealed License Practical Nurse (LPN) #11 failed to ask about current medications and treatments. During an interview with LPN #11 on 9/24/24 at 9:40 a.m., she stated she was unaware of the new pain medication given to the patient on 9/4/2024. The nurse acknowledged she forgot to ask the patient or wife about medication and treatment changes during the home visit. The nurse then reviewed Patient #2’s medication list and plan of care and confirmed the medication was not listed. She then said that the medication only gets updated at the start of care or recertification since she does not administer any medication for the patient. During an interview with the clinical manager (CM) on 9/25/25 at 12:40 p.m., the CM acknowledged the plan of care had not reflected the patients’ current medications and treatment. The CM updated the plan of care for Patient #2 to include Hydrocodone Bitartrate- Acetaminophen oral tablet, dosage 5-325 mg after the interview.”

“Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This Element is not met as evidenced by: Based on interview and record review the agency failed to ensure nursing professional services communicated with the physician regarding changes in condition and to obtain orders for changes to the plan of care for 1 of 7 active patients reviewed (Patient #3). Findings include: AGENCY POLICY According to the agency policy titled, “Physician Participation in Plan of Care”, dated 2009, (in pertinent parts): “Orders will be reviewed and revised by the patient’s physician (or other authorized licensed independent practitioner) based on: -Changes in diagnosis or treatment, including procedures, medications and equipment.” “If a patient is under the care of more than one (1) physician the nurse will be responsible to the designated primary physician. All other physicians should be made aware of the services being provided to the patient. The referring physician will be informed of the involvement of additional consulting physicians, when applicable.” According to the agency policy titled, “Monitoring Patient’s Response/Reporting to Physician,” dated 2009, (in pertinent parts): “Clinicians will monitor, document, and report the patient’s response to care and treatment provided on each home visit. Progress of goals will be measured at regular intervals. Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient.” “The patient’s physician will be contacted on the same day when any of the occur: -Significant changes in the patient’s condition -Changes in the patient’s expected response to treatment or medications.” According to an agency policy tilted, “Medication Profile”, dated 2009, (in pertinent parts): “Patient receiving medications administered by the organization will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications.” “Deviations from taking medications as ordered will be documented in clinical notes, and the physician (or other authorized licensed independent practitioner) will be notified.” 1. The clinical record for Patient #3 was reviewed on 9/23/24. The plan of care (POC) for the certification period dated 8/10/24 to 10/8/24, signed by Patient #3’s primary care physician on 9/11/24, revealed a start of care date of 8/10/24; diagnoses included venous insufficiency, left lower limb localized swelling, lumbago (lower back pain) with sciatica, spinal stenosis, hypertension, cardiac murmur, type 2 diabetes mellitus, sleep apnea, osteoarthritis, hypothyroidism, and adjustment disorder with anxiety. POC orders included skilled nurse (SN) visits one time a week for nine weeks and three as needed (PRN) visits for medication set up, monitoring medication compliance, monitoring blood sugars and diabetic teaching including dietary teaching as needed; and physical therapy (PT) visits one time a week for one week and two times a week for seven weeks for general conditioning, transfer training, assistive device training, gait training, energy conservation strategies, effusion reduction/mitigation strategies, safety/fall prevention education and a comprehensive home exercise program. Further review of Patient #3’s POC and medication profile showed Patient #3 was taking the following medications: -81 milligrams (mg) of aspirin orally daily; -17 grams (Gm) of Miralax orally at night as needed; -20 mg Omeprazole orally daily; -500 mg acetaminophen two tablets orally every eight hours as needed; -10 mg Rosuvastatin Calcium orally once a day at night; -40 mg Lisinopril orally daily; -1.5 mg/0.5 milliliter (ml) injection Trulicity subcutaneously injected once a week on Tuesdays; -small amount of Diclofenac Sodium gel topically as needed; -one to two patches of Lidocaine applied topically daily; -600 mg cranberry concentrate orally one to two tablets daily; -1000 mg Metformin orally two times daily; and -20 mg Hydroxyzine orally daily. Further review of Patient #3’s POC showed the following SN goal: “Blood Pressure will be within acceptable range of no more than 140/90.” a. The agency failed to ensure the SN communicated with the physician changes in the patient’s condition. Specifically, the SN failed to communicate with Patient #3’s physician when she experienced elevated blood pressure. Review of SN notes from 8/14/24 to 9/18/24 showed registered nurse (RN) #9 documented she assessed Patient #3’s blood pressure (BP) to be to the following: -on 8/14/24 Patient #3’s BP taken in her right arm was 173/144; -on 8/21/24 Patient #3’s BP taken in her right arm was 141/100; -on 8/28/24 Patient #3’s BP taken in her left arm was 174/127; -on 9/4/24 Patient #3’s BP taken in her left arm was 170/107; -on 9/11/24 Patient #3’s BP taken in her left arm was 158/116; and -on 9/18/24 Patient #3’s BP taken in her left arm was 146/100. Further review of these SN notes failed to show RN #9 documented she communicated with Patient #3’s physician regarding Patient #3’s elevated BPs. On 9/23/24, review of communication notes between 8/14/24 to 9/23/24 for Patient #3 failed to show RN #9 had communicated to agency management or Patient #3’s physician regarding Patient #3’s elevated BP. On 9/24/24, review of communication notes for Patient #3 showed on 9/24/24 at 3:29 p.m., RN #9 had created and modified an interdisciplinary communication note for 8/28/24 which stated: Patient [#3] with elevated blood pressure [of] 178/124. Patient crying and upset over pain and family issues and states that this is why BP elevated. She feels that it is normal for her to have elevated BP after doing household tasks, even walking in the home as well as when she is having pain. Family is having financial issues and she is not sure if they will be evicted, so she is having an emotional day today. Doctors office called and message left for MD. Patient states that when she is upset, walking around the home or having pain, her BP is always elevated. She has an appointment with mD to discuss this issue and will let SN know if there are news med ordered. Waiting for MD to return call (sic). During an interview on 9/24/24 at 1:58 p.m., RN #9 confirmed she was Patient #3’s primary SN and agency case manager. RN #9 stated she took Patient #3’s BP every visit. RN #9 stated she had spoken to Patient #3’s physician several times, but not specifically about Patient #3’s elevated BP. RN #9 stated due to Patient #3’s hypertension issues, Patient #3 was taking three BP medications to try to control her BP which included Lisinopril, Nifedipine and Carvedilol. RN #9 had instructed Patient #3 to track and document her BP on a log in her home. (RN #9 acknowledged two of the three medications were not on Patient #3’s active medication list - Crosswalk to G574) RN #9 stated she instructed Patient #3 to bring this log to each doctor’s visit, particularly to her primary care physician and cardiac appointments. RN #9 stated she used her years of experience as a intensive care nurse to determine the goal she set for Patient #3’s BP to be no more than 140/90. RN #9 then stated she thought she had called Patient #3’s primary care physician one time (what specifying what day or why she chose to call the doctor that particular time) to inform him of Patient #3’s elevated BP and she thought she had written a communication note regarding this telephone call. RN #9 again acknowledged she did not call Patient #3’s physician each time her BP was elevated. RN #9 stated she was often not able to speak with patient physician(s) and typically had to leave a voicemail or speak with a medical assistant who was not able to assist her in directing patient’s care; therefore, RN #9 directed Patient #3 to maintain a BP log individually and discuss with her physician at appointments rather than notify Patient #3’s office each time BP was elevated. During an interview on 9/23/24 at 2:35 p.m., the clinical manager (CM) reviewed Patient #3’s SN notes and acknowledged Patient #3 had an elevated BP at each visit and acknowledged RN #9 failed to document she communicated with Patient #3’s physician regarding Patient #3’s elevated BP. The CM also reviewed Patient #3’s communication notes and acknowledged Patient #3 failed to have any communication notes documented regarding elevated BP. The CM stated she expected agency SNs to communicate with the ordering physician any time a patient had a change in condition, and specifically if a patient’s blood pressure was elevated, which she defined as systolic BP greater than 160 and diastolic blood pressure greater than 100; and to document this care coordination within the patient’s record. The CM stated she would review these expectations immediately to correct this deficient practice. b. The agency failed to ensure the SN communicated with the primary care physician regarding a change to Patient #3’s medication. Review of a 8/14/24 SN note showed RN #9 documented in the medication section of the note that RN #9 had completed medication reconciliation and set-up. RN #9 also documented Patient #3’s medications had changed since her last SN visit to include cardiologist-prescribed Nifedipine and Carvedilol and RN #9 had updated Patient #3’s medication profile. Review of Patient #3’s medication profile failed to show RN #9 had updated Patient #3’s medication profile to include the addition of Nifedipine and Carvedilol and the dosage and route of administration for each of these medications. On 9/23/24, review of Patient #3’s communication notes failed to show RN #9 had communicated to Patient #3’s primary care physician that her cardiologist had prescribed Nifedipine and Carvedilol to Patient #3’s after the visit on 8/14/24. During an interview on 9/23/24 at 1:58 p.m., RN #9 stated she filled Patient #3’s weekly medication planner at each of her visits. RN #9 stated Patient #3 was prescribed 60 mg Nifedipine extended release (ER) one time a day and 12.5 mg Carvedilol two times a day by her cardiologist shortly after RN #9’s start of care visit with Patient #3 on 8/10/24. RN #9 stated she documented these new medications on the medication list kept in Patient #3’s home, but acknowledged she had not added these medications to Patient #3’s medication profile as she was taught to only add medications to the medication profile when she completed a recertification or change of condition comprehensive assessment with a patient. RN #9 stated she ensured the medication list in Patient #3’s home was updated as her medications changed and she instructed Patient #3 to bring this medication list with her to all of her doctor’s appointments. RN #9 stated she was not sure if Patient #3’s primary care physician was aware of the addition of any medications added after the POC was created and acknowledged she had not directly communicated these changes to Patient #3’s primary care physician. During an interview on 9/24/24 at 9:40 a.m. the CM and the alternate administrator stated when a SN was made aware a patient had a new medication prescribed, the agency expected the SN to update the medication profile at the time of the change and to obtain an order for the new medication, particularly if the medication was prescribed by a physician other then the primary care physician signing the POC for the patient. The CM and alternate administrator stated RN #9 should have communicated with Patient #3’s primary care physician that her cardiologist prescribed Nifedipine and Carvedilol and the CM acknowledged she failed to find this communication in her review of Patient #3’s record. The CM and alternate administrator stated they would review agency expectations with the SNs to correct this deficient practice.”