Every finding on record at California Care Home Health Agency, Inc

The following reflects the findings of the California Department of Public Health during a Recertification Survey. Representing the Department of Public Health: Surveyor ID #43929, Health Facilities Evaluator Nurse Surveyor ID # 43979, Health Facilities Evaluator Nurse Census: 3 Sample Size: 9 Home Visits: 3 Closed Records: 6 The following Conditions of Participation (COP) not met: 484.60 Condition of Participation: Care Planning, Coordination of Services, and Quality of Care 484.110 Condition of Participation Clinical Records 484.65 Condition of Participation for Quality Assessment and Performance Improvement (QAPI).

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 observation, interview, and record review, the Home Health Agency (HHA) failed to ensure three of nine sampled patients (Patient 1, Patient 2, and Patient 6) received all services indicated in the Plan of Care (POC - an individualized written program for a patient that is developed by health care professionals). This failure had a potential to result in clinical staff not knowing what services the patient needs, which can cause a delay in care and possible harm to the patient. a). A review of Patient 1’s Patient Information sheet, indicated a start of care (SOC) to the HHA on 12/18/22, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe) and lung transplant status. During a concurrent interview and record review on 2/14/23, at 11:35 a.m., with the administrator (ADM), Patient 1’s records titled, “Skilled Nursing Visit Notes”, for dates 12/28/22, 1/4/23, 1/11/23, 1/18/23, 1/29/23, 2/5/23, were reviewed. The ADM stated the notes did not indicate a full body assessment was done. During an observation during the home visit, on 2/14/23, at 2:00 p.m., with Licensed Vocational Nurse 1 (LVN 1), Patient 1’s care was observed. LVN 1 listened to P1’s lung sounds. LVN 1 did not complete a full body assessment. During an interview on 2/14/23, at 2:35 p.m., LVN 1 stated he did not do a full body assessment because he does a focused assessment based on the problem. LVN 1 stated Patient 1’s focused assessment was his respiratory status. A review of Patient 1’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/28/22 to 2/15/23, indicated, “Physician-Ordered Services…skilled nurse visit schedule: 1week8 (1 visit a week for 8 weeks)…certify for skilled nursing assessment, observation and evaluation of all body systems and vital signs…” b). A review of Patient 2’s Patient Information sheet, indicated a SOC to the HHA on 12/17/22, with diagnoses including quadriplegia (paralysis of all four limbs). During an observation during the home visit, on 2/14/23, at 2:45 p.m., with Licensed Vocational Nurse 1 (LVN 1), Patient 2’s care was observed. LVN 1 did not do a full body assessment during the visit. A review of Patient 2’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/17/22 to 2/14/23, indicated, “Orders and Treatments SN (skilled nurse) 1w8 (1 visit a week for 8 weeks)…observation and evaluation of all body systems…” c). A review of Patient 6's face sheet indicated Patient 6 was admitted to the HHA on 9/25/2022 with a diagnosis of Diabetes Type II (late onset of high blood sugar). During a record review of Patient 6’s POC, dated 1/23/2023 to 3/22/2023, indicated “Recertify patient … for skilled nursing assessment, observation and evaluation of all body systems… focus on: endocrine…genitourinary…cardiopulmonary… mental/emotional… nutritional status, hydration, effectiveness of medications, activities permitted and functional status. Skilled nurse to perform per visit: 3. Perform and validate knowledge and skills of patient/caregiver on proper blood sugar checking via finger stick method/recording, daily calibration/quality control of glucometer… Skilled nurse to notify physician for… pain greater that 6/10 unrelieved with pain medication, fasting BS (Blood Sugar) ….” During an observation on 2/14/2023, at 3p.m., Patient 6’s home, Patient 6 was noted sitting on edge of bed. A dressing was noted on Patient 6’s top right chest wall. Patient 6 stated that, that it is used for her dialysis treatments, since March of last year. License Vocational Nurse 2 (LVN2) set up field for wound care at bedside. Patient 6 was assisted to bed, left foot sock removed and propped on pillow. Left heel dressing was removed, treatment performed as ordered, and new dressing applied. LVN2 took Patient 6’s vital signs (clinical measurements, specifically pulse rate, temperature, respiration rate, and blood pressure). LVN2 auscultated (a method used to listen to the sounds of the body during a physical examination by using a stethoscope), by placing the stethoscope on the right and left upper chest wall on top of Patient 6’s shirt. LVN2 asked Patient 6: 1. When was your last BM (bowel movement)? 2. Have you had any urinary discomfort? Do you have any complaints? LVN2, cleaned work field and proceeded to leave. During an interview on 2/14/2023, at 3:45 p.m., with LVN2, LVN2 was asked if she had Patient 6’s POC. LVN2 asked what a POC was. LVN2 stated that she had never seen that form before and that she knew what the wound treatment was, because the Administrator (ADM) told her what to do verbally. LVN2 stated that she asked the patient about her BM and urinary status but did not complete a head-to-toe assessment. LVN2 stated that she just looks at Patient 6’s Permcath (a special IV line into the blood vessel in your neck or upper chest just under the collarbone). LVN2 stated she does not ask about Patient 6’s blood sugar test results and she does not calibrate or check Patient 6’s glucometer (a device used to measure the sugar concentration in the blood), “They do it here, I don’t ask.” LVN2 stated that she reconciles Patient 6’s mediation once a week and that the ADM is responsible for updating the medications. LVN2 stated she did not ask Patient 6 if there were any changes in her medication routine. LVN2 stated she completes and submits her nursing visit notes every Friday and her wound assessment notes weekly. LVN2 stated that sometimes she is late in submitting and signing her nursing visit notes. During an interview on 2/16/2023 at 10:50 a.m. with the Administrator (ADM), the ADM stated that field nursing personnel have to do a head-to-toe assessment. ADM stated, “Auscultate lungs anterior and posterior upper and lower lobes with stethoscope under the clothes. So, we know that we are doing the right thing, we cannot listen to lungs. Abdominal assessment, auscultate bowel sound on all four quadrants, ask the patient or care giver about the bowel movement. Skin assessment…wound assessment should be done every week. Measure length, width, and depth, color of draining, odor.” During a review of facility’s “Job Description – Licensed Practical/Vocational Nurse” dated 5/3/20, indicated “Essential Job Function/Responsibilities – 2. Implements plan of care initiated by the registered nurse. 3. Provides accurate and timely documentation consistent with the plan of care. 4. Assesses and provides patient… pertinent to diagnosis and plan of care.” During a review of facility’s policy and procedure titled, “Neuro Assessment” undated, indicated “Neurological assessment supplements that routine measurement of temperature pulse and respiration by assessing level of consciousness, pupillary response and orientation to time, place, and person. These findings provide a tool for quickly assessing the neurological status. Changes in vital signs alone rarely indicate neurological compromise, so changes are evaluated in light of a complete neurological assessment.” During a review of facility’s policy and procedure titled, “Plan of Care” dated 11/30/10, indicated “A. A written plan of care shall be established for each patient whose care requires medical orders. The plan of care shall be: 4. Reviewed and updated by the attending physician… in consultation with the agency health professional personnel as frequently as the patient’s condition warrants… 3. The professional person responsible for any specific treatment shall notify the attending physician… and responsible agency staff of significant changes in the patient’s condition. 4. All plans of care and notifications to the attending physician… are made part of the patient’s health record.” a). A review of Patient 1's Information sheet, indicated a start of care (SOC) to the HHA on 12/18/22, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe) and lung transplant status. During a concurrent interview and record review on 2/14/23, at 11:35 a.m., with the administrator (ADM), Patient 1’s records titled, “Skilled Nursing Visit Notes”, for dates 12/28/22, 1/4/23, 1/11/23, 1/18/23, 1/29/23, 2/5/23, were reviewed. The ADM stated the notes did not indicate the full body assessment s were done. During an observation during the home visit, on 2/14/23, at 2:00 p.m., with Licensed Vocational Nurse 1 (LVN 1), Patient 1’s care was observed. LVN 1 listened to Patient 1’s lung sounds. LVN 1 did not complete a full body assessment. During an interview on 2/14/23, at 2:35 p.m., LVN 1 stated he did not do a full body assessment because he did a focused assessment based on the problem. LVN 1 stated Patient 1’s focused assessment was his respiratory status. A review of Patient 1’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/28/22 to 2/15/23, indicated, “Physician-Ordered Services…skilled nurse visit schedule: 1week8 (1 visit a week for 8 weeks) …certify for skilled nursing assessment, observation and evaluation of all body systems and vital signs…” b). A review of Patient 2's Patient Information sheet, indicated a SOC to the HHA on 12/17/22, with diagnoses including quadriplegia (paralysis of all four limbs). During an observation during the home visit, on 2/14/23, at 2:45 p.m., with Licensed Vocational Nurse 1 (LVN 1), Patient 2’s care was observed. LVN 1 did not do a full body assessment during the visit. A review of Patient 2’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/17/22 to 2/14/23, indicated, “Orders and Treatments SN (skilled nurse) 1w8 (1 visit a week for 8 weeks) …observation and evaluation of all body systems…” c). A review of Patient 6’s face sheet indicated Patient 6 was admitted to the HHA on 9/25/2022 with a diagnosis of Diabetes Type II (late onset of high blood sugar). During a record review of Patient 6’s POC, dated 1/23/2023 to 3/22/2023, indicated “Recertify patient … for skilled nursing assessment, observation and evaluation of all body systems… focus on: endocrine…genitourinary…cardiopulmonary… mental/emotional… nutritional status, hydration, effectiveness of medications, activities permitted and functional status, Skilled nurse to perform per visit: 3. Perform and validate knowledge and skills of patient/caregiver on proper blood sugar checking via finger stick method/recording, daily calibration/quality control of glucometer. Skilled nurse to notify physician for… pain greater that 6/10 unrelieved with pain medication, fasting BS (Blood Sugar)." During an observation on 2/14/2023, at 3 p.m., Patient 6 was noted sitting on edge of bed. A dressing was noted on Patient 6’s top right chest wall. Patient 6 stated it is used for her dialysis treatments, since March of last year. License Vocational Nurse 2 (LVN2) set up field for wound care at bedside. Patient 6 was assisted to bed, left foot sock removed and propped on pillow. Patient 6's left heel dressing was removed, treatment performed as ordered, and new dressing applied. LVN2 took Patient 6’s vital signs (clinical measurements, specifically pulse rate, temperature, respiration rate, and blood pressure). LVN2 auscultated (a method used to listen to the sounds of the body during a physical examination by using a stethoscope), by placing the stethoscope on the right and left upper chest wall on top of Patient 6’s shirt. LVN2 asked Patient 6: 1. When was your last BM (bowel movement)? 2. Have you had any urinary discomfort? Do you have any complaints? LVN2, cleansed work field and proceeded to leave. During an interview on 2/14/2023, at 3:45 p.m., with LVN2, LVN2 was asked if she had Patient 6’s POC. LVN2 asked what a POC was. LVN2 stated she had never seen that form before and that she knew what the wound treatment was, because the Administrator (ADM) told her what to do verbally. LVN2 stated she asked the patient about her BM and urinary status but did not complete a head-to-toe assessment. LVN2 stated she just looks at Patient 6’s Permcath (a special IV line into the blood vessel in your neck or upper chest just under the collarbone). LVN2 stated she does not ask about Patient 6’s blood sugar test results and she does not calibrate or check Patient 6’s glucometer (a device used to measure the sugar concentration in the blood), “They do it here, I don’t ask.” LVN2 stated she reconciled Patient 6’s mediation once a week and that the ADM was responsible for updating the medications. LVN2 stated she did not ask Patient 6 if there were any changes in her medication routine. LVN2 stated she completed and submitted the her nursing visit notes every Friday and patient's wound assessment notes weekly. LVN2 stated that sometimes she was late in submitting and signing her nursing visit notes. During an interview on 2/16/2023, at 10:50 a.m. with the Administrator (ADM), the ADM stated that field nursing personnel have to do a head-to-toe assessment. ADM stated, “Auscultate lungs anterior and posterior upper and lower lobes with stethoscope under the clothes. So, we know that we are doing the right thing, we cannot listen to lungs. Abdominal assessment, auscultate bowel sound on all four quadrants, ask the patient or care giver about the bowel movement. Skin assessment…wound assessment should be done every week. Measure length, width, and depth, color of draining, odor.” During a review of facility’s “Job Description – Licensed Practical/Vocational Nurse” dated 5/3/20, indicated “Essential Job Function/Responsibilities – 2. Implements plan of care initiated by the registered nurse. 3. Provides accurate and timely documentation consistent with the plan of care. 4. Assesses and provides patient… pertinent to diagnosis and plan of care.” During a review of facility’s policy and procedure titled, “Neuro Assessment” undated, indicated “Neurological assessment supplements that routine measurement of temperature pulse and respiration by assessing level of consciousness, pupillary response and orientation to time, place, and person. These findings provide a tool for quickly assessing the neurological status. Changes in vital signs alone rarely indicate neurological compromise, so changes are evaluated in light of a complete neurological assessment.” During a review of facility’s policy and procedure titled, “Plan of Care” dated 11/30/10, indicated “A. A written plan of care shall be established for each patient whose care requires medical orders. The plan of care shall be: 4. Reviewed and updated by the attending physician… in consultation with the agency health professional personnel as frequently as the patient’s condition warrants… 3. The professional person responsible for any specific treatment shall notify the attending physician… and responsible agency staff of significant changes in the patient’s condition. 4. All plans of care and notifications to the attending physician… are made part of the patient’s health record.”

Contact info Federal/State-funded entities CFR(s): 484.50(c)(10)(i,ii,iii,iv,v) Be advised of the names, addresses, and telephone numbers of the following Federally-funded and state-funded entities that serve the area where the patient resides: (i) Agency on Aging (ii) Center for Independent Living (iii) Protection and Advocacy Agency, (iv) Aging and Disability Resource Center; and (v) Quality Improvement Organization. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to provide and ensure three of nine sampled patients (Patient 1, Patient 2, and Patient 6) had Federal and State funded entity information. This failure had the potential for the patients to lack knowledge of the services that are available to them. a). A review of Patient 1’s Patient Information sheet, indicated a start of care (SOC) to the HHA on 12/18/22, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe) and lung transplant status. During an observation during the home visit, on 2/14/23, at 2:00 p.m., P1’s HHA home binder was reviewed. The HHA home binder, indicated there was no State/Federal resource numbers listed. b). A review of Patient 2’s Patient Information sheet, indicated a SOC to the HHA on 12/17/22, with diagnoses including quadriplegia (paralysis of all four limbs). During an observation during the home visit, on 2/14/23, at 2:45 p.m., Patient 2’s HHA home binder was reviewed. The HHA home binder, indicated there was no State/Federal resource numbers listed. c). A review of Patient 6’s face sheet indicated Patient 6 was admitted to the HHA on 9/25/2022 with a diagnosis of Diabetes Type II (late onset of high blood sugar). During a concurrent interview and record review on 2/14/2023 at 3:30 p.m. with License Vocational Nurse 2 (LVN2) of Patient 6’s HHA home binder, indicated there was no State/Federal resource numbers list. LVN2 stated that the binder was brought by the Administrator (ADM), she did not know that she needed those documents. During a concurrent interview and record review on 2/15/2023 at 3 p.m. with the ADM of a HHA Admission binder, the ADM stated that there was no Federal or State funded program information in the binder. ADM stated, “I don’t have it in there, there should be one so that the family can and will communicate with whatever resources if they need support.” During a review of facility’s policy and procedure titled, “Admission Criteria and Process” revised October 2011, indicated “7. If eligibility criteria is met, the patient and family/caregiver will be provided with an organization brochure and various educational materials providing sufficient information on: I. available community resources.” A review of the HHA’s policy and procedure titled, “Rights/Responsibilities”, dated 10/2011, indicated, “Procedure: Q…The availability of the applicable toll-free home health agency hotline and other resources to receive questions or complaints and assist in resolution.” a). A review of Patient 1's Patient Information sheet, indicated a start of care (SOC) to the HHA on 12/18/22, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe) and lung transplant status. During an observation during the home visit, on 2/14/23, at 2:00 p.m., Patient 1’s HHA home binder was reviewed. The HHA home binder, indicated there was no State/Federal resource numbers listed. b). A review of Patient 2’s Patient Information sheet, indicated a SOC to the HHA on 12/17/22, with diagnoses including quadriplegia (paralysis of all four limbs). During an observation during the home visit, on 2/14/23, at 2:45 p.m., Patient 2’s HHA home binder was reviewed. The HHA home binder, indicated there was no State/Federal resource numbers listed. c). A review of Patient’s Face sheet indicated Patient was admitted to the HHA on 9/25/2022 with a diagnosis of Diabetes Type II (late onset of high blood sugar). During a concurrent interview and record review on 2/14/2023, at 3:30 p.m., with License Vocational Nurse 2 (LVN2) of Patient 6’s HHA home binder, indicated there was no State/Federal resource numbers list. LVN2 stated that the binder was brought by the Administrator (ADM), she did not know she needed those documents. During a concurrent interview and record review on 2/15/2023, at 3 p.m., with the ADM of a HHA Admission binder, the ADM stated and acknowledged there was no Federal or State funded program information in the binder. ADM stated, “I don’t have it in there, there should be one so that the family can and will communicate with whatever resources if they need support.” During a review of facility’s policy and procedure titled, “Admission Criteria and Process” revised October 2011, indicated “7. If eligibility criteria is met, the patient and family/caregiver will be provided with an organization brochure and various educational materials providing sufficient information on: I. available community resources.” A review of the HHA’s policy and procedure titled, “Rights/Responsibilities”, dated 10/2011, indicated, “Procedure: Q…The availability of the applicable toll-free home health agency hotline and other resources to receive questions or complaints and assist in resolution.”

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the comprehensive assessment was completed no later than 5 calendar days from the start of care for three of nine sampled patients (Patient 4, Patient 8, and Patient 9). This deficient practice has the potential to result in the decline of the patients health status by not assessing the patient’s needs, which will cause a delay in care. a). A review of Patient 4’s record titled, “Home Health Certification and Plan of Care”, for certification period 2/12/22 to 4/12/22, indicated a start of care date of 2/12/22, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe). During an interview on 2/14/23, at 9:45 a.m., the ADM stated there was no initial comprehensive assessment done for Patient 4. The ADM stated it was important to do a comprehensive assessment so the agency can plan the care and identify the needs of the patient. b). A review of Patient’s “Home Health Certification and Plan of Care” dated from 4/6/2022 to 6/6/2022, indicated Patient 8 was admitted to the HHA on 4/6/2022 with a diagnosis of non-ST elevation myocardial Infarct (heart attack). During a concurrent interview and record review on 2/14/2023 at 2 p.m. with the Administrator (ADM) of Patient 8’s medical record, the ADM stated, “There is no initial assessment documented, I visited him, but I didn’t document.” d). During a concurrent interview and record review on 2/15/2023 at 2:40 p.m. with ADM of Patient 9’s medical record, the medical record did not have a face sheet, plan of care, medication orders, medication profile, nursing visit notes, or initial comprehensive assessment. The ADM stated that she was visiting the patient every week for six weeks changing Patient 9’s port-a-Cath (A vascular access, placing a thin hollow plastic tube into a vein to permit drawing blood tests, and giving medications, fluids and nutrition, or transfusions directly into the bloodstream), but that she did not document the initial comprehensive assessment or visit notes. During a review of facility’s “Job Description – Registered Nurse (RN)” revised December 2008, indicated “The registered nurse plans, organizes and directs home care services… Patient Care – 1. Completes an initial assessment of patient and family to determine home care needs.…” During a review of facility’s policy and procedure titled, “Admission Criteria and Process” revised October 2011, indicated “16. The initial written assessment will be completed within 24 hours of the original assessment/admission visit. All documentation needed to develop the plan of care will be completed and turned into the office no later than the next business day. 17. A comprehensive assessment must be completed within five (5) calendar days of the patient’s start of care. 19. A clinical record will be initiated for each patient admitted for home health services.” a). A review of Patient 4’s record titled, “Home Health Certification and Plan of Care”, for certification period 2/12/22 to 4/12/22, indicated a start of care date of 2/12/22, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe). During an interview on 2/14/23, at 9:45 a.m., the ADM stated there was no initial comprehensive assessment done for Patient 4. The ADM stated it was important to do a comprehensive assessment so the agency can plan the care and identify the needs of the patient. b). A review of Patient 8’s “Home Health Certification and Plan of Care” dated from 4/6/2022 to 6/6/2022, indicated Patient 8 was admitted to the HHA on 4/6/2022 with a diagnosis of non-ST elevation myocardial Infarct (heart attack). During a concurrent interview and record review on 2/14/2023 at 2 p.m. with the Administrator (ADM) of Patient 8’s medical record, the ADM stated, “There is no initial assessment documented, I visited him, but I didn’t document.” c). During a concurrent interview and record review on 2/15/2023 at 2:40 p.m. with ADM of Patient 9’s medical record, the medical record did not have a face sheet, plan of care, medication orders, medication profile, nursing visit notes, or initial comprehensive assessment. The ADM stated that she was visiting the patient every week for six weeks changing Patient 9’s port-a-Cath (A vascular access, placing a thin hollow plastic tube into a vein to permit drawing blood tests, and giving medications, fluids and nutrition, or transfusions directly into the bloodstream), but that she did not document the initial comprehensive assessment or visit notes. During a review of facility’s “Job Description – Registered Nurse (RN)” revised December 2008, indicated “The registered nurse plans, organizes and directs home care services… Patient Care – 1. Completes an initial assessment of patient and family to determine home care needs.…” During a review of facility’s policy and procedure titled, “Admission Criteria and Process” revised October 2011, indicated “16. The initial written assessment will be completed within 24 hours of the original assessment/admission visit. All documentation needed to develop the plan of care will be completed and turned into the office no later than the next business day. 17. A comprehensive assessment must be completed within five (5) calendar days of the patient’s start of care. 19. A clinical record will be initiated for each patient admitted for home health services.”

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) failed to review and document all the medications the patient was currently using for five of nine sampled patients (Patient 1, Patient 2, Patient 6, Patient 7, and Patient 9). This deficient practice placed the patients at risk of drug-to-drug interaction and harm by not knowing which medications the patients were taking. a). A review of Patient 1 (P1)’s Patient Information sheet, indicated a start of care (SOC) to the HHA on 12/18/22, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe) and lung transplant status. During an observation during the home visit, on 2/14/23, at 2:15 p.m., Licensed Vocational Nurse 1 (LVN 1), asked if P1 was taking any new medications. LVN 1 did not have a medication profile during the visit and did not ask for the medication bottles from P1 to review manually. During an interview on 2/14/23, at 2:15 p.m., P1 stated he was on 28-something medications and new medications were prescribed. P1 provided a copy of the medication list provided by the hospital. P1 stated this was the only medication list he had at home. P1 stated Pt stated he was hospitalized on 1/14/23, because he was experiencing shortness of breath. P1 stated “they de-watered me, the problem was I had too much fluid (in body and lungs). I was on Lasix (a pill that gets rid of excess water) 20 mg (unit of measurement) every day. They changed the Lasix to 40 mg once a day when I got out of the hospital on 1/17/23. Now, its 40 mg plus 20 mg a day. A review of P1’s record titled, “Medication Profile”, indicated the medications were reviewed on 12/18/22. b). A review of Patient 2 (P2)’s Patient Information sheet, indicated a SOC to the HHA on 12/17/22, with diagnoses including quadriplegia (paralysis of all four limbs). During an observation during the home visit, on 2/14/23, at 2:45 p.m., LVN 1 was observed providing care to P2. During the visit, LVN 1 did not review the medications P2 was taking. During an interview on 2/14/23, at 3:10 p.m., LVN 1 stated he asked P2 if he was taking new medication. LVN 1 stated he did not have a medication profile during the visit. During an interview on 2/14/23, at 2:35 p.m., LVN 1 stated he asks for medication updates every visit. LVN 1 stated, “you have to because meds change all the time.” A review of P2’s record titled, “Medication Profile”, indicated the medications were reviewed on 12/17/22. c). A review of Patient’s (P6) face sheet indicated P6 was admitted to the HHA on 9/25/2022 with a diagnosis of Diabetes Type II (late onset of high blood sugar). During a record review of P6’s “Physician Order” dated 1/10/2023, indicated P6 was ordered: Lasix (water pill) 40 mg (milligrams), take one tablet daily. During a record review of P6’s “Medication Profile” dated 9/25/22 and reviewed on 11/24/22, indicated Lasix 10 mg was not documented on the log. During a record review of P6’s HHA home binder, indicated there was no mentioned of Lasix on P6’s medication list. During a concurrent interview and record review on 2/13/2023 at 5 p.m. with Administrator (ADM) of P6’s Medication Profile, the profile indicated the medication Lasix was not listed. ADM stated that there is a doctor’s order for Lasix 40 mg and that she does not see Lasix listed on P6’s medication profile. ADM stated, “No, I don’t see. It is important so we can do our teaching and observe if medication is effective.” d. A review of Patient 7’s (P7) “Home Health Certification and Plan of Care” dated from 8/9/2022 to 10/9/2022, indicated P7 was admitted to the HHA on 8/9/2022 with a diagnosis of bilateral osteoarthritis knee (right and left knee pain). During a concurrent interview and record review on 2/14/2023 at 10:47 a.m. with the Administrator (ADM) of P7’s medical record, the medical record indicated there was no medication list. ADM stated, “There is none. It is important to have one so we can plan our care and teach the patient on his medications.” e). During a concurrent interview and record review on 2/15/2023 at 2:40 p.m. with ADM of P9’s medical record, the medical record indicated P9’s medication profile log was empty. ADM stated, “It’s not filled out. It is supposed to be filled out for reconciliation medication and for teaching.” During a review of facility’s policy and procedure titled, “Medication Reconciliation” undated, indicated “The medication list/medication profile will be accurately and completely reconciled across the continuum of care. 1. All medications shall be listed in a medication profile including new, changed, and discontinued medications… 3. A medication profile that was completed on the evaluation shall be reviewed every visit.” During a review of facility’s policy and procedure titled, “Medication Profile” revised October 2011, indicated “Patients receiving medications will have a current, accurate mediation profile in the clinical record. 2. The admitting nurse will initiate a medication profile… 4. During subsequent home visits, the medication profile will be uses as a care planning …guide… C. Using the medication profile as a communication tool for other clinicians involved in care. 5. Each patient… will receive appropriate written material for specific medication he/she is receiving. 7. The medication profile and other relevant data will be available to all clinicians providing care.” During a review of facility’s policy and procedure titled, “Administration and Documentation of Medications” dated 11/30/2010, indicated “Procedure – 1. As part of the assessment process, a drug history will be taken, and a comparison made between the physician’s orders and the current medication the patient is taking… 2. The nurse will document diagnosis, condition, or indication for use for each medication ordered. 8. Medications refused, removed, and/or omitted will be indicated on the medication profile… The Clinical Supervisor and attending physician will be notified. “ a). A review of Patient 1’s Patient Information sheet, indicated a start of care (SOC) to the HHA on 12/18/22, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe) and lung transplant status. During an observation during the home visit, on 2/14/23, at 2:15 p.m., Licensed Vocational Nurse 1 (LVN 1), asked if Patient 1 was taking any new medications. LVN 1 did not have a medication profile during the visit and did not ask for the medication bottles from Patient 1 to review manually. During an interview on 2/14/23, at 2:15 p.m., Patient 1 stated he was on 28-something medications and new medications were prescribed. Patient 1 provided a copy of the medication list provided by the hospital. Patient 1 stated this was the only medication list he had at home. Patient 1 stated he was hospitalized on 1/14/23, because he was experiencing shortness of breath. Patient 1 stated “they de-watered me, the problem was I had too much fluid (in body and lungs). I was on Lasix (a pill that gets rid of excess water) 20 mg (unit of measurement) every day. They changed the Lasix to 40 mg once a day when I got out of the hospital on 1/17/23. Now, its 40 mg plus 20 mg a day. A review of Patient 1’s record titled, “Medication Profile”, indicated the medications were reviewed on 12/18/22. b). A review of Patient 2’s Patient Information sheet, indicated a SOC to the HHA on 12/17/22, with diagnoses including quadriplegia (paralysis of all four limbs). During an observation during the home visit, on 2/14/23, at 2:45 p.m., LVN 1 was observed providing care to Patient 2. During the visit, LVN 1 did not review the medications Patient 2 was taking. During an interview on 2/14/23, at 3:10 p.m., LVN 1 stated he asked Patient 2 if he was taking new medication. LVN 1 stated he did not have a medication profile during the visit. During an interview on 2/14/23, at 2:35 p.m., LVN 1 stated he asks for medication updates every visit. LVN 1 stated, “you have to because meds change all the time.” A review of Patient 2’s record titled, “Medication Profile”, indicated the medications were reviewed on 12/17/22. c). A review of Patient’s (P6) face sheet indicated atient 6 was admitted to the HHA on 9/25/2022 with a diagnosis of Diabetes Type II (late onset of high blood sugar). During a record review of Patient 6’s “Physician Order” dated 1/10/2023, indicated Patient 6 was ordered: Lasix (water pill) 40 mg (milligrams), take one tablet daily. During a record review of Patient 6’s “Medication Profile” dated 9/25/22 and reviewed on 11/24/22, indicated Lasix 10 mg was not documented on the log. During a record review of Patient 6’s HHA home binder, indicated there was no mentioned of Lasix on Patient 6’s medication list. During a concurrent interview and record review on 2/13/2023 at 5 p.m. with Administrator (ADM) of Patient 6’s Medication Profile, the profile indicated the medication Lasix was not listed. ADM stated that there is a doctor’s order for Lasix 40 mg and that she does not see Lasix listed on P6’s medication profile. ADM stated, “No, I don’t see. It is important so we can do our teaching and observe if medication is effective.” d. A review of Patient 7’s (P7) “Home Health Certification and Plan of Care” dated from 8/9/2022 to 10/9/2022, indicated P7 was admitted to the HHA on 8/9/2022 with a diagnosis of bilateral osteoarthritis knee (right and left knee pain). During a concurrent interview and record review on 2/14/2023 at 10:47 a.m. with the Administrator (ADM) of P7’s medical record, the medical record indicated there was no medication list. ADM stated, “There is none. It is important to have one so we can plan our care and teach the patient on his medications.” e). During a concurrent interview and record review on 2/15/2023 at 2:40 p.m. with ADM of P9’s medical record, the medical record indicated P9’s medication profile log was empty. ADM stated, “It’s not filled out. It is supposed to be filled out for reconciliation medication and for teaching.” During a review of facility’s policy and procedure titled, “Medication Reconciliation” undated, indicated “The medication list/medication profile will be accurately and completely reconciled across the continuum of care. 1. All medications shall be listed in a medication profile including new, changed, and discontinued medications… 3. A medication profile that was completed on the evaluation shall be reviewed every visit.” During a review of facility’s policy and procedure titled, “Medication Profile” revised October 2011, indicated “Patients receiving medications will have a current, accurate mediation profile in the clinical record. 2. The admitting nurse will initiate a medication profile… 4. During subsequent home visits, the medication profile will be uses as a care planning …guide… C. Using the medication profile as a communication tool for other clinicians involved in care. 5. Each patient… will receive appropriate written material for specific medication he/she is receiving. 7. The medication profile and other relevant data will be available to all clinicians providing care.” During a review of facility’s policy and procedure titled, “Administration and Documentation of Medications” dated 11/30/2010, indicated “Procedure – 1. As part of the assessment process, a drug history will be taken, and a comparison made between the physician’s orders and the current medication the patient is taking… 2. The nurse will document diagnosis, condition, or indication for use for each medication ordered. 8. Medications refused, removed, and/or omitted will be indicated on the medication profile… The Clinical Supervisor and attending physician will be notified. “

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: This CONDITION is NOT MET as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation regarding Care Planning, Coordination, Quality of Care was met as follows: 1. The HHA failed to ensure patients receive the services as specified in the Plan of Care (POC - an individualized written program for a patient that is developed by health care professionals) for six of nine sampled patients (Patients 1, Patient 2, Patient 6, Patient 7, Patient 8, and Patient 9). This failure resulted in Patient 1 having two hospitalizations while under the care of the HHA. Patient 2 was placed at risk of health status decline due to missed assessments, and Patient 6, Patient 7, Patient 8, and Patient 9 had the potential to result in health status decline due to clinical staff, the patient, and patient’s family/caregiver not providing services according to the plan of care. (Refer to G572). 2. The HHA failed to include information required in the Plan of Care (POC - an individualized written program for a patient that is developed by health care professionals) for one of nine sampled patients (Patient 6). The HHA failed to document Patient 6’s Permcath (a special IV line placed into the blood vessel in your neck or upper chest just under the collarbone) and failed to indicate Patient 6 was receiving dialysis (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly). This failure had the potential to result in the patient not receiving the identified needs and services, and have a decline in health status, that could affect their quality of care and well-being. (Refer to G574). 3. The HHA failed to ensure physicians' orders were written for four of nine sampled patients (Patient 5, Patient 7, Patient 8, and Patient 9). This failure resulted in HHA staff not knowing what the physicians’ orders were, thereby not knowing the patients treatment plan. (Refer to G584). 4. The HHA failed to ensure the Plan of Care (POC - an individualized written program for a patient that is developed by health care professionals) was revised for one of nine sampled patients (Patient 1). This failure resulted in health status decline due to staff not being aware of the treatments and interventions needed to meet the patient needs. (Refer to 592). 5. The HHA failed to ensure a contracted agency who provided patient care communicated concerns and a change of condition for one of nine sampled patients (Patient 1). This failure resulted in the patient being hospitalized two days after the voiced concern. (Refer to G606). 6. The HHA failed to provide written information regarding the Plan of Care (POC - an individualized written program for a patient that is developed by health care professionals) and Medication Profiles for three of nine patients (Patient 1, Patient 2, and Patient 6). This deficient practice resulted in patients and their representatives not knowing their care team, treatment course or what medications were ordered. (Refer to G612). The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure highest quality health care is provided to patients assessed to receive home health services.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on observation, interview, and record review the Home Health Agency (HHA) failed to ensure patients receive the services as specified in the Plan of Care (POC - an individualized written program for a patient that is developed by health care professionals) for seven of nine sampled patients (Patients 1, Patient 2, Patient 6, Patient 7, Patient 8, and Patient 9). This failure resulted in Patient 1 having two hospitalizations while under the care of the HHA. Patient 2 was placed at risk of health status decline due to missed assessments, and Patient 6, Patient 7, Patient 8, and Patient 9 had the potential to result in health status decline due to clinical staff, patient, and patient’s family/caregiver were not providing services according to the plan of care. a). A review of Patient 1’s Patient Information sheet, indicated a start of care (SOC) to the HHA on 12/18/22, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe) and lung transplant status. During a concurrent interview and record review on 2/14/23, at 11:35 a.m., with the administrator (ADM), Patient1’s records titled, “Skilled Nursing Visit Notes”, for dates 12/28/22, 1/4/23, 1/11/23, 1/18/23, 1/29/23, 2/5/23, were reviewed. The ADM stated the notes did not indicate a full body assessment was done. The ADM stated the nurse took Patient 1’s respiratory rate and vital signs (blood pressure, respiratory rate, and temperature), and there was no indication an oxygen saturation reading (to assess how well the blood is oxygenated). The ADM stated nursing staff were expected to take an oxygen saturation reading as part of the vital sign assessment. The ADM stated taking a respiratory rate was not enough to determine if patient was okay. The ADM stated all body systems needed to be checked, including lung auscultation (listening to the lungs using a medical device) because breathing sounds that are not normal can mean there is a problem. The ADM stated it was specifically important for Patient 1 to have his oxygen saturation readings, lungs auscultated, and respiratory status (checking for shortness of breath, oxygen saturation, lung sounds) checked because he was at high risk of respiratory failure (lungs not working properly resulting in inability to breathe). The ADM stated Patient 1 was hospitalized on 1/14/23, for the reason of shortness of breath. The ADM stated a nurse visited Patient 1 on 1/11/23, and there was no indication Patient 1’s respiratory status was checked. The ADM stated Patient 1 had a second hospitalization on 1/23/23 or 1/24/23, for the reason of pneumonia (infection in the lungs). The ADM stated the nurse visited Patient 1 on 1/18/23, and there was no indication Patient 1’s respiratory status was checked. During an interview on 2/14/23, at 11:57 a.m., the ADM stated the nursing notes did not contain evidence the Home Health Agency (HHA) was monitoring the patient. The ADM stated, “I am assuming we are doing it” (monitoring the patient). During an observation during the home visit, on 2/14/23, at 2:00 p.m., with Licensed Vocational Nurse 1 (LVN 1), Patient 1’s care was observed. LVN 1 listened to Patient 1’s posterior (back) lung sounds (auscultation) over his clothes. LVN 1 did not listen to the anterior (front) chest. During an interview on 2/14/23, at 2:25 p.m., Patient 1 stated he was hospitalized on 1/14/23 because he was feeling short of breath. Patient 1 stated the reason he was feeling this way was because he had too much fluid in the body and lungs. Patient 1 stated he was hospitalized on 1/23/23 for pneumonia. Patient 1 stated he started to feel “rattling” in his lungs on 1/20/23. During an interview on 2/14/23, at 2:35 p.m., LVN 1 stated he did not do a full body assessment because he does a focused assessment based on the problem. LVN 1 stated Patient 1’s focused assessment was his respiratory status. During an interview on 2/16/23, at 10:45 a.m., the ADM stated auscultating the lungs meant to listen to the anterior upper and lower chest and the posterior upper and lower back. The ADM stated the stethoscope (medical tool used to listen to the body) should be under the clothes, not over. The ADM stated it was important for the stethoscope to touch the skin because clothes can interfere with the lung sounds. The ADM stated it was expected for nursing staff to do a full body assessment, including listening to the lungs, every visit. The ADM stated Patient 1 should have been checked for edema (puffiness caused by excess fluid trapped in the body’s tissues) because it can be an indicator of fluid buildup. A review of Patient 1’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/28/22 to 2/15/23, indicated, “Physician-Ordered Services…skilled nurse visit schedule: 1week8 (1 visit a week for 8 weeks)…certify for skilled nursing assessment, observation and evaluation of all body systems and vital signs with focus on cardiopulmonary (heart and lungs) status…SOB (shortness of breath) or dyspnea (feeling short of breath when doing activities)…respiratory status for breathing pattern, abnormal breath sounds…oxygen saturation…goals and outcomes…5.Patient’s pulmonary (lung) condition will be stabilized with absence of respiratory problems…throughout the certification period.” b). A review of Patient 2’s Patient Information sheet, indicated a SOC to the HHA on 12/17/22, with diagnoses including quadriplegia (paralysis of all four limbs). During an observation during the home visit, on 2/14/23, at 2:45 p.m., with Licensed Vocational Nurse 1 (LVN 1), Patient 2’s care was observed. A urinary catheter bag (a urine collection device coming from a tube inserted into the urethra) was observed at the side of the bed. During the visit LVN 1 did not do a full body assessment. During an interview on 2/14/23, at 2:48 p.m., Patient 2’s wife stated she changed the urinary catheter bag herself as needed, whenever she noticed the bag getting cloudy or dirty. Patient 2’s wife stated the nurse changed the catheter (tube) and she changed the bag. During an interview on 2/14/23, at 3:10 p.m., LVN 1 stated he did not listen to Patient 2’s lungs because Patient 2 did not have any respiratory issues and his oxygen saturation levels were fine. LVN 1 stated he checked for bowel sounds randomly, and he did not do it on today’s visit. LVN 1 stated he did not check the g-tube (gastrostomy tube, a tube inserted through the belly that brings nutrition directly to the stomach) because of privacy concerns and did not want to expose him. LVN 1 stated he did not check the skin because he had done it on 2/4/23. During an interview on 2/16/23, at 10:45 a.m., the ADM stated the urinary bag was supposed to be changed by the nurse and should not be delegated to the family because “we are trying to prevent infection”. A review of Patient 2’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/17/22 to 2/14/23, indicated, “Orders and Treatments SN (skilled nurse) 1w8 (1 visit a week for 8 weeks)…observation and evaluation of all body systems…genitourinary statues for care and maintenance of Foley catheter; gastrointestinal status for gastrostomy site, stoma (opening of the gastrostomy site) site for any signs/symptoms of infection…change Foley catheter bag every 2 weeks…” A review of Patient 2’s medical record titled, “Skilled Nursing Visit Notes”, for 12/21/22, 12/28/22, 1/6/23, 1/13/23, 1/20/23, 1/27/23, did not indicate observation and evaluation of all body systems. c). A review of Patient 5's record titled, “Medical History/Nursing Assessment”, dated 1/10/22, indicated a start of care date of 1/10/22, with diagnoses including spinal surgery. During an interview on 2/15/23, at 1:15 p.m., the ADM stated there was no plan of care in Patient 5’s record. The ADM stated there was no plan of care because the patient was seen only one time. d). A review of Patient 6's face sheet indicated Patient 6 was admitted to the HHA on 9/25/2022 with a diagnosis of Diabetes Type II (late onset of high blood sugar). During a record review of Patient 6's “Home Health Certificate and Plan of Care” dated from 1/23/2023 to 3/22/2023, indicated Patient 6's was ordered “Skilled Nurse Visit Schedule: Daily for 60 days.” During a concurrent interview and record review on 2/13/2023 at 5 p.m. with the Administrator (ADM) of Patient 6’s EMR, the EMR indicated the last Skilled Nurse (SN) Visit Note was documented on 1/11/2023 and the last Weekly Wound Assessment note was documented on 12/20/2022. The ADM stated, “The SN visit note should be filed weekly. The nurses are to submit their notes every week. It is important to submit so that we will know the progress of the patient.” The ADM stated, “The nurses are to submit on a weekly basis, sometimes they are so busy they cannot submit their notes. It is important so that we know the progress of the wound.” ADM stated that the Medical Doctor (MD) was not made aware. e). A review of Patient 7’s “Home Health Certification and Plan of Care” dated from 8/9/2022 to 10/9/2022, indicated Patient 7 was admitted to the HHA on 8/9/2022 with a diagnosis of bilateral osteoarthritis knee (right and left knee pain). It also indicated Patient 7 was ordered “Skilled Nurse Visit Schedule: 1w2 (once a week for two weeks). During a concurrent interview and record review on 2/14/2023 at 10:47 a.m. with the Administrator (ADM) of Patient 7’s medical record, the medical record indicated there was no nursing notes for the week of 8/9/2022. ADM stated, “The initial visit was mine; I don’t have it here.” f.) A review of Patient 8’s “Home Health Certification and Plan of Care” dated from 4/6/2022 to 6/6/2022, indicated P8 was admitted to the HHA on 4/6/2022 with a diagnosis of non-ST elevation myocardial Infarct (heart attack). It also indicated that Patient 8 was ordered “Skilled Nurse Visit Schedule: 1w2 (once a week for two weeks).” During a concurrent interview and record review on 2/14/2023 at 2 p.m. with ADM of Patient 8's medical record, the medical record indicated there were no SN visit notes. ADM stated, “It’s not documented, but I know he was visited.” g). During a concurrent interview and record review on 2/15/2023 at 2:40 p.m. with the Administrator (ADM) of Patient 9’s medical record, the medical record did not have a face sheet, plan of care, medication orders, medication profile, nursing visit notes, or initial comprehensive assessment. The ADM stated that she was visiting the patient every week for six weeks changing Patient 9’s port-a-Cath (A vascular access, placing a thin hollow plastic tube into a vein to permit drawing blood tests, and giving medications, fluids and nutrition, or transfusions directly into the bloodstream), but that she did not document the initial comprehensive assessment or visit notes. A review of the HHA’s undated policy and procedure titled, “Care Planning Process”, indicated “Procedure…4. The care planning decision will be reflected in the specific services that will be provided and the associated actions planned and implemented to meet individualized patient problems and goals. 5. The plan of care will be based upon the physician’s orders and will encompass the equipment, supplies, and services required to mee the patient’s needs.” During a review of facility’s policy and procedure titled, “Missed Visits” revised April 2017, indicated “Missed visits will be documented in the clinical record.”

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 include information required in the Plan of Care (POC - an individualized written program for a patient that is developed by health care professionals) for one of nine sampled patients (Patient 6). The HHA failed to document Patient 6’s Permcath (a special IV line into the blood vessel in the neck or upper chest just under the collarbone) and failed to indicate Patient 6 was receiving dialysis (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly). This failure had the potential to result in patients not receiving the identified needs and services, and have a decline in health status, that could affect their quality of care and well-being. During a record review of Patient 6’s Face sheet indicated Patient 6 was admitted to the HHA on 9/25/2022 with a diagnosis of Diabetes Type II (late onset of high blood sugar). During an electronic record review of Patient 6’s “OASIS (Outcome and Assessment Information Set - a standardized data set that measures quality and outcomes) E-Recertification” dated 1/22/2023, indicated there was no mentioned of Patient 6's Permcath or that she was receiving dialysis. During a record review of Patient 6’s POC, dated 1/23/2023 to 3/22/2023, indicated there was no indication of Patient 6’s Permcath or that she was receiving dialysis. During an observation on 2/14/2023, at 3p.m., Patient 6’s home, the patient was sitting on the edge of bed. A dressing was noted on Patient 6’s top right chest wall. Patient 6 stated that was used for her dialysis treatments, since starting in March of last year. During an interview on 2/14/2023, at 3:45 p.m., with LVN2, LVN2 was asked if she assessed Patient 6’s Permcath. LVN2 stated that she just looks at Patient 6’s Permcath. During a concurrent interview and record review on 2/14/2023, at 12 p.m., with the Administrator (ADM) of Patient 6’s medical record, the medical record indicated Permcath and dialysis treatments were not documented. ADM stated, “It was not mentioned, it’s my mistake. So, we can monitor patient better, usually patient that have dialysis has low blood pressure. She has a Permcath, it’s not mentioned. She was already on dialysis before we admitted her.” During a review of facility’s “Job Description – Registered Nurse (RN)” revised December 2008, indicated “The registered nurse plans, organizes and directs home care services… Patient Care – 1. Completes an initial assessment of patient and family to determine home care needs. Provides a complete physical assessment an history and previous illness. 3. Initiates the plan of care and makes necessary revisions… 5. Develops a care plan… Communication – 1. Prepares clinical notes and updates the primary physician when necessary… 2. Communicates with the physician… reports any changes in the patient’s condition…” During a review of facility’s policy and procedure titled, “Plan of Care” dated 11/30/10, indicated “A. A written plan of care shall be established for each patient whose care requires medical orders. The plan of care shall be: 3. The professional person responsible for any specific treatment shall notify the attending physician… and responsible agency staff of significant changes in the patient’s condition. 4. All plans of care and notifications to the attending physician… are made part of the patient’s health record.” During a review of facility’s policy and procedure titled, “Admission Criteria and Process” revised October 2011, indicated “16. The initial written assessment will be completed within 24 hours of the original assessment/admission visit. All documentation needed to develop the plan of care will be completed and turned into the office no later than the next business day. 17. A comprehensive assessment must be completed within five (5) calendar days of the patient’s start of care. 19. A clinical record will be initiated for each patient admitted for home health services.” During a review of facility’s policy and procedure titled, “Entries into the Medical Record” revised October 2011, indicated “Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided.” During a review of facility’s policy and procedure titled, “Coordination of Service” dated 11/30/10, indicated “Procedure – 1. A registered nurse or therapist is assigned to each patient to function as the care manager/coordinator for the patient’s care delivery. 4. The essential components of services coordination include the following task: D. Maintain efficient communications with all care providers to ensure prompt transmission of significant information, which may require action or decision making. 8. Changes in the patient’s condition during the course of care are brought to the attentions of the physician and other disciplines providing care to the patient.” During a review of facility’s policy and procedure titled, “General Guidelines for Reporting to the Physician” dated 11/30/10, indicated “3. Agency personnel shall follow the guidelines established by the agency as follows: “General Guidelines for Reporting to the Physician” C. Respirations 2. Any deviation from normal.”

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Facility (HHA) failed to ensure physicians' orders were written for four of nine sampled patients (Patient 5, Patient 7, Patient 8, and Patient 9). This failure resulted in HHA staff not knowing what the physicians’ ordered and not knowing the patient’s treatment plan. a). A review of Patient 5 record titled, “Medical History/Nursing Assessment”, dated 1/10/22, indicated a start of care date of 1/10/22, with diagnoses including spinal surgery. During an interview on 2/15/23, at 1:15 p.m., the ADM stated there was no physician’s orders for home health and no discharge order in Patient 5's record. The ADM stated the reason the physician’s orders were not in Patient 5's record was because the patient was seen only one time. A review of Patient 5 record titled, “Medical History/Nursing Assessment”, dated 1/10/22, indicated, “Primary reason for home care: evaluation, treat and f/u (follow-up) PRN (as needed). Further review of the record did not indicate physician’s orders were indicated for the type of care and services to be provided to Patient 5. b). A review of Patient 7’s Face sheet indicated the patient was admitted to the HHA on 8/9/2022 with a diagnosis of bilateral osteoarthritis knee (right and left knee pain). During a concurrent interview and record review on 2/14/2023 at 10:47 a.m. with the Administrator (ADM) of Patient 7’s medical record, the medical record indicated there were no physician orders. ADM stated, “Its empty, there none. We have a referral form. I use the orders that are on the plan of care… The Plan of Care (POC - an individualized written program for a patient that is developed by health care professionals) is updated when we get physician orders.” c). A review of Patient 8’s “Home Health Certification and Plan of Care” dated from 4/6/2022 to 6/6/2022, indicated patient was admitted to the HHA on 4/6/2022 with a diagnosis of non-ST elevation myocardial Infarct (heart attack). During a concurrent interview and record review on 2/14/2023, at 2 p.m., with the Administrator (ADM) of Patient 8’s medical record, the ADM stated, “Usually, we base our orders on the referral. I did not create an order. There is no discharge order.” d). During a concurrent interview and record review on 2/15/2023 at 2:40 p.m. with ADM of Patient 9’s medical record, the medical record did not have a medication orders. The ADM stated that she was visiting the patient every week for six weeks changing Patient 9’s port-a-Cath (A vascular access, placing a thin hollow plastic tube into a vein to permit drawing blood tests, and giving medications, fluids and nutrition, or transfusions directly into the bloodstream), but that she did not document the initial comprehensive assessment or visit notes. ADM stated that she did not write down physician orders, “No, I did not write them down. I’m basing it on the referral form.” During a review of facility’s “Job Description – Registered Nurse (RN)” revised December 2008, indicated “The registered nurse plans, organizes and directs home care services… Patient Care – 1. Completes an initial assessment of patient and family to determine home care needs. Provides a complete physical assessment an history and previous illness. 3. Initiates the plan of care and makes necessary revisions… 5. Develops a care plan… Communication – 1. Prepares clinical notes and updates the primary physician when necessary… 2. Communicates with the physician… reports any changes in the patient’s condition…” During a review of facility’s policy and procedure titled, “General Guidelines for Reporting to the Physician” dated 11/30/10, indicated “1. All communications with the physician must be documented… 2. Orders obtained from the physician must be documented…”

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) failed to ensure the Plan of Care (POC - an individualized written program for a patient that is developed by health care professionals) was revised for one of nine sampled patients (Patient 1). This failure resulted in patient's health status decline due to staff not being aware of the treatments and interventions needed to meet the patient needs. A review of Patient 1's Patient Information sheet, indicated a start of care (SOC) to the HHA on 12/18/22, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe) and lung transplant status. During an observation during the home visit, on 2/14/23, at 2:00 p.m., with Licensed Vocational Nurse 1 (LVN 1), Patient 1's care was observed. LVN 1 did not have a plan of care during the visit. During an interview on 2/14/23, at 2:25 p.m., Patient 1 stated he was hospitalized on 1/14/23 because he was feeling short of breath. P1 stated the reason he was feeling this way was because he had too much fluid in the body and lungs. Patient 1 stated he was hospitalized on 1/23/23 for pneumonia. Patient 1 stated he started to feel “rattling” in his lungs on 1/20/23. During an interview on 2/16/23, at 12:15 p.m., the Physical Therapist (PT) stated he visited Patient 1 on 1/20/23 and noticed the patient was complaining of shortness of breath for the previous two days. The PT stated he did not take an oxygen saturation reading because he was told by his supervisor not to take oxygen saturation readings unless the home health agency specified it. The PT stated he did not feel it was necessary to call the home health nurse because the shortness of breath would resolve quickly at rest, and he did not appear to be in that much distress. The PT stated he did not know Patient 1 was hospitalized again on 1/23/23. The PT stated he did not remember having a plan of care for Patient 1. During an interview on 2/16/23, at 12:40 pm., the administrator (ADM) stated she expected the PT to call the agency or the doctor if the patient complained of shortness of breath. The ADM stated the PT had an oxygen saturation machine to check and validate if the shortness of breath was a concern. The ADM stated the PT should have called the agency on 1/20/23 when he saw the patient because the findings were significant and required further evaluation. The ADM stated Patient 1was hospitalized on 1/23/23 with pneumonia. The ADM stated she did not know the PT was not allowed to take oxygen saturation readings and stated it was not a safe practice not to take oxygen saturation readings. The ADM stated the agency did not provide a plan of care to the PT and instructions should be included in the plan of care. The ADM stated the plan of care was not updated and should have been updated because there were medication changes, need for more nursing visits, and need for physical therapy services. The ADM stated more nursing visits were required because Patient 1 needed to have his lung sounds monitored more, Patient 1 required more frequent assessments. When asked by the nursing visit frequency was not changed, the ADM replied, “My mistake sorry.” The ADM stated the plan of care needed to be updated upon re-admission of care and as the condition of the patient changes because it is important to prevent re-hospitalization. A review of Patient 1’s medical record titled, “Physical Therapy Re-evaluation s/p (status post) Hospitalization Form”, dated 1/20/23, indicated, “…12.Subjective: Pt (patient) states he was very SOB (short of breath) the last two days…22. Pt is very SOB with strong wheezing, needed multiple rest breaks with tx (treatment), gait is very unsteady, has increased lateral sway.” A review of Patient 1's medical record, titled, “Skilled Nursing Visit Notes”, dated 1/18/23, indicated a skilled nursing visit was made. The record did not indicate a respiratory assessment was made. The record did not indicate an oxygen saturation reading was taken. A review of Patient 1’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/28/22 to 2/15/23, indicated, “Physician-Ordered Services…skilled nurse visit schedule: 1week8 (1 visit a week for 8 weeks): physical therapy 2week2 (2 visits a week for two weeks)…Skilled nurse to perform per visit: 4. SN to perform pulse ox (oxygen saturation readings) as needed and notify MD if result is below 90%...” Further review of the record did not indicate interventions for the PT.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure services under arrangement communicated with other staffs providing care services, the identified concerns and change of patient's condition for one of nine sampled Patients (Patient 1). This failure resulted in the patient being hospitalized two days after the voiced concern. A review of Patient 1’s Patient Information sheet, indicated a start of care (SOC) to the HHA on 12/18/22, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe) and lung transplant status. During an interview on 2/14/23, at 2:25 p.m., Patient 1 stated he was hospitalized on 1/23/23 for pneumonia. Patient 1 stated he started to feel “rattling” in his lungs on 1/20/23. During an interview on 2/16/23, at 12:15 p.m., the Physical Therapist (PT) stated he visited Patient 1 on 1/20/23 and noticed the patient was complaining of shortness of breath for the previous two days. The PT stated he did not feel it was necessary to call the home health nurse because the shortness of breath would resolve quickly at rest, and he did not appear to be in that much distress. The PT stated it was not customary to call the agency’s nurse unless there was something abnormal The PT states some reasons to call the nurse was respiratory rate over 20 breaths per minute, or if patient was having a sustained problem. During an interview on 2/16/23, at 12:40 pm., the administrator (ADM) stated she expected the PT to call the agency or the doctor if the patient is complaining of shortness of breath. The ADM stated the PT should have called the agency on 1/20/23 when he saw the patient because the findings the PT noticed were significant and needed further evaluation. A review of Patient 1’s medical record titled, “Home Health Certification and Plan of Care”, for certification period 12/28/22 to 2/15/23, indicated, “Goals and Outcomes…5. Patient’s pulmonary condition will be stabilized with absence of respiratory problems, no increasing SOB/dyspnea on exertion/rest…throughout the certification period.”

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 written information regarding the Plan of Care (POC - an individualized written program for a patient that is developed by health care professionals) and Medication Profiles for three of nine patients (Patient 1, Patient 2, and Patient 6). This deficient practice resulted in patients and their representatives not knowing their care team, treatment course or what medications were ordered. a). A review of Patient 1’s Patient Information sheet, indicated a start of care (SOC) to the home health agency (HHA) on 12/18/22, with diagnoses that included Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe) and lung transplant status. During a home visit observation on 2/14/2023, at 2:00 p.m., with Licensed Vocational Nurse 1 (LVN), Patient 1’s care was observed. LVN 1 did not have a plan of care or medication list during the visit. During an interview on 2/14/2023, at 2:15 p.m., Patient 1 stated he was on 28-something medications and new medications were prescribed. Patient 1 provided a copy of the medication list provided by the hospital. Patient 1 stated this was the only medication list he had at home. b). A review of Patient 2’s Patient Information sheet, indicated a SOC to the HHA on 12/17/22, with diagnoses including quadriplegia (paralysis of all four limbs). During a home visit observation on 2/14/23, at 2:45 p.m., with LVN 1, Patient 2’s care was observed. LVN 1 did not have a plan of care or medication list during the visit. During an interview on 2/16/23, at 11:35 p.m., the administrator (ADM) stated patients should have a copy of their plan of care at home. The ADM stated this was important so the staff taking care of the patient really knows what to do and to make sure staff are following the order of the doctor. c). A review of Patient 6’s face sheet indicated Patient 6 was admitted to the HHA on 9/25/2022 with a diagnosis of Diabetes Type II (late onset of high blood sugar). During a record review of Patient 6’s “Physician Order” dated 1/10/2023, indicated Patient 6 was ordered: Lasix (water pill) 40 milligrams, take one tablet daily. During a record review of Patient 6’s HHA home binder, indicated there was no POC, no drug classification list, no State/Federal resource numbers list, and no mentioned of Lasix (water pill) on P6’s medication list. During an interview on 2/14/2023 at 3:45 p.m. with LVN2, LVN2 was asked if she had Patient 6’s POC. LVN2 asked what a POC was. Patient 6’s POC was demonstrated to LVN2. LVN2 stated that she had never seen that form before and that she knew what the wound treatment was, because the Administrator (ADM) told her what to do verbally. LVN2 stated that she reconciles Patient 6’s mediation once a week and that the ADM is responsible for updating the medications. LVN2 stated she did not ask Patient 6’s if there were any changes in her medication routine. During a review of facility’s “Job Description – Licensed Practical/Vocational Nurse” dated 5/3/20, indicated “Essential Job Function/Responsibilities, to implement plan of care initiated by the registered nurse, provides accurate and timely documentation consistent with the plan of care, assesses and provides patient… pertinent to diagnosis and plan of care.” During a review of facility’s policy and procedure titled, “Plan of Care” dated 11/30/10, indicated “a written plan of care shall be established for each patient whose care requires medical orders.” During a review of facility’s policy and procedure titled, “Safeguarding/Retrieval of Clinical Records” revised October 2011, indicated “all patient clinical records will be maintained in locked, waterproof file cabinets in a designated clinical records room, selected documents may be kept in the patient’s home in a home clinical record while the case is active, element of the clinical record necessary to provide continuity of care included the plan of care… medication profile…” During a review of facility’s policy and procedure titled, “Medication Profile” revised October 2011, indicated “Patients receiving medications will have a current, accurate mediation profile in the clinical record. During subsequent home visits, the Each patient will receive appropriate written material from specific medication he/she is receiving. The medication profile and other relevant data will be available to all clinicians providing care.” During a review of facility’s policy and procedure titled, “Administration and Documentation of Medications” dated 11/30/2010, indicated “As part of the assessment process, a drug history will be taken, and a comparison made between the physician’s orders and the current medication the patient is taking, the nurse will document diagnosis, condition, or indication for use for each medication ordered. Medications refused, removed, and/or omitted will be indicated on the medication profile… The Clinical Supervisor and attending physician will be notified. “

Quality assessment/performance improvement CFR(s): 484.65 Condition of participation: Quality assessment and performance improvement (QAPI). The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven QAPI program. The HHA's governing body must ensure that the program reflects the complexity of its organization and services; involves all HHA services (including those services provided under contract or arrangement); focuses on indicators related to improved outcomes, including the use of emergent care services, hospital admissions and re-admissions; and takes actions that address the HHA's performance across the spectrum of care, including the prevention and reduction of medical errors. The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS. This CONDITION is not met as evidenced by: Based on interview, and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation for Quality Assessment and Performance Improvement (QAPI), the coordinated application of two mutually reinforcing aspects of a quality management system, Quality Assurance (QA), and Performance Improvement (PI) were met as follows: 1.The Home Health Agency (HHA) failed to include indicators based upon identified adverse patient outcomes for their 2022 and 2023 Quality Assessment and Performance Improvement (QAPI, the coordinated application of two mutually-reinforcing aspects of a quality management system: Quality Assurance (QA) and Performance Improvement (PI). This deficiency practice resulted in the inability of the agency to identify patient care issues, improve health outcomes, patient safety, and quality of care (Refer to G642) 2. The Home Health Agency (HHA) 2022 Quality Assessment and Performance Improvement (QAPI, the coordinated application of two mutually-reinforcing aspects of a quality management system: Quality Assurance (QA) and Performance Improvement (PI) program failed to ensure quality indicators data were derived from Outcome and Assessment Information Set [OASIS, a group of standard data elements designed to enable systematic comparative measurement of home health care patient outcomes at two points in time in adult skilled Medicare and Medicaid, non-maternity home health care patients] and other relevant data in the design of the QAPI program. This deficient practice resulted in the inability of the agency to monitor the effectiveness of services and quality of care. (Refer to G644) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with the Federal regulation for Quality Assessment and Performance Improvement (QAPI) program to ensure the provision of the highest quality of care to patients in a safe environment.

Program scope CFR(s): 484.65(a)(1),(2) Standard: Program scope. (1) The program must at least be capable of showing measurable improvement in indicators for which there is evidence that improvement in those indicators will improve health outcomes, patient safety, and quality of care. (2) The HHA must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that enable the HHA to assess processes of care, HHA services, and operations. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to include indicators based upon identified adverse patient outcomes for their 2022 and 2023 Quality Assessment and Performance Improvement (QAPI, the coordinated application of two mutually-reinforcing aspects of a quality management system: Quality Assurance (QA) and Performance Improvement (PI). This deficiency practice resulted in the inability of the agency to identify patient care issues, improve health outcomes, patient safety, and quality of care. A review of Patient 1's Patient Information sheet, indicated a start of care (SOC) to the HHA on 12/18/22, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe) and lung transplant status. During an interview on 2/13/23, at 2:10 p.m., Patient 1 stated he frequently fell at home. Patient 1 stated he tripped on his own feet and fell. Patient 1 stated his most frequent fall was 3-4 days prior in his garage. During an interview on 2/14/23, at 2:25 p.m., Patient 1 stated he was hospitalized on 1/14/23 because he was feeling short of breath. Patient 1 stated the reason he was feeling this way was because he had too much fluid in the body and lungs. Patient 1 stated he was hospitalized on 1/23/23 for pneumonia (lung infection). Patient 1 stated he started to feel “rattling” in his lungs on 1/20/23. During an interview on 2/16/23, at 9:25 a.m., the (Administrator ADM) stated she did not know Patient 1 had a history of falling. The ADM stated staff do not routinely ask patients about falls, which is the probable reason the agency did not know Patient 1 had a history of fall. The ADM stated she did not know if the physical therapist knew Patient 1 had a history of falls. The ADM further stated falls were a high-risk indicator of quality of care and should be incorporated into the QAPI program and stated, the QAPI program should also be focusing on preventing re-hospitalizations. During an interview on 2/16/2023, at 9:25 p.m., the ADM stated the QAPI program was focusing on how to improve storing the medical records and how many patients acquired infection under the agency’s care and she did not have evidence how the agency was tracking infections and stated the agency was tracking if the patient had an actual or potential infection. The ADM also stated the infection log documented the reason the patient was admitted, if the patient had an actual infection, or are at risk of getting an infection. The ADM further stated she did not have any documentation such as an agenda and meeting minutes as evidence of QAPI program for 2022 and 2023. A review of the HHA’s policy and procedure titled, “Improving Organizational Performance”, dated 10/2011, indicated, “Senior management will adopt a scientific, problem-solving approach to performance improvement. The scientific, problem-solving approach will include, minimally patient safety program, setting priorities for improvement and adjusting priorities in response to unusual or urgent events, implementing improvement on the basis of assessment and comparison date, identifying and establishing activities to measure patient outcomes.”

Program data CFR(s): 484.65(b)(1),(2),(3) Standard: Program data. (1) The program must utilize quality indicator data, including measures derived from OASIS, where applicable, and other relevant data, in the design of its program. (2) The HHA must use the data collected to- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement. (3) The frequency and detail of the data collection must be approved by the HHA's governing body. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) 2022 Quality Assessment and Performance Improvement (QAPI, the coordinated application of two mutually-reinforcing aspects of a quality management system: Quality Assurance (QA) and Performance Improvement (PI) program failed to ensure quality indicators data were derived from Outcome and Assessment Information Set [OASIS, a group of standard data elements designed to enable systematic comparative measurement of home health care patient outcomes at two points in time in adult skilled Medicare and Medicaid, non-maternity home health care patients] and other relevant data in the design of the QAPI program. This deficient practice resulted in the inability of the agency to monitor the effectiveness of services and quality of care. A review of Patient 5’s clinical record titled, “Medical History/Nursing Assessment”, dated 1/10/22, indicated a start of care date of 1/10/22, with diagnoses including spinal surgery. During an interview on 2/15/2023, at 1:15 p.m., the Administrator (ADM) stated there was no discharge order, discharge summary, consents, medication profile, plan of care, physician’s orders in Patient 5’s record. The ADM stated the reason the physician’s orders were not in Patient 5’s record was because the patient was seen only one time. During an interview on 2/16/2023, at 9:25 a.m., the ADM stated Registered Nurse 1 (RN) was involved in the QAPI program by auditing charts. The ADM stated the agency audited charts for completion of medical records at discharge and not while the patient was actively being cared for. When asked why the QAPI program was not including active patients in the QAPI program, the ADM stated, “sorry, I didn’t think about that.” The ADM also stated she did not have evidence the QAPI program had met to discuss the findings of the chart audits. During an interview and concurrent record review on 2/16/2023, at 9:55 a.m., of Patient 5’s chart audit with the ADM, titled, the record indicated, “Admission process: 1. Referral intake complete with written orders and signed by MD or RN yes…B. Admission Assessment…2.OASIS assessment form is completely filled out, signed and dated by RN yes… D. Plan of treatment 2. All sections completed yes…M. Discharge..3.Discharge summary copy sent to MD”. The ADM stated the chart audit was wrong because there was no plan of care, there was no OASIS, there was no DC summary. The ADM stated, “I am sorry, I am learning”. A review of the HHA’s form titled, “Clinical Record Review”, dated “4th quarter 2022”, indicated, “findings: admission process, admission assessment, MD orders, Plan of Care, medication profiles, skilled nurses notes, discharge. Further review of the record did not indicate OASIS data was used. A review of the HHA’s policy and procedure titled, “Improving Organizational Performance”, dated 10/2011, indicated, “Senior management will participate in educational activities to increase their level of understanding and ability to implement performance improvement activities set expectations for performance improvement and manage processes to improve organization performance.”

Nursing services supervised by RN CFR(s): 484.75(c)(1) Nursing services are provided under the supervision of a registered nurse that meets the requirements of §484.115(k). This ELEMENT is not met as evidenced by: Based on interview and record review the Home Health Agency failed to perform supervisory visits for License Vocational Nurse (LVN) services for two of nine sampled patients (Patient 1 and Patient 6). This deficient practice resulted in the LVN not be evaluated for patient care and services. a). A review of Patient 1’s Patient Information sheet, indicated a start of care (SOC) to the HHA on 12/18/22, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe) and lung transplant status. During a concurrent interview and record review on 2/14/23, at 11:35 a.m., with the administrator (ADM), Patient 1’s records titled, “Skilled Nursing Visit Notes”, for dates 12/28/22, 1/4/23, 1/11/23, 1/18/23, 1/29/23, 2/5/23, were reviewed. The ADM stated the notes did not indicate a full body assessment was done. During an interview on 2/14/23, at 11:57 a.m., the Administrator (ADM) stated she should be supervising the care provide by LVN 1 at least every 30 days. The ADM stated she had not supervised LVN 1. When the ADM was asked, “If you would have supervised the LVN and reviewed the notes, would you have identified a gap in care?”, the ADM stated, “Yes, I would’ve told him it is was important to assess the patient.” b). A review of Patient 6’s face sheet indicated patient was admitted to the HHA on 9/25/2022 with a diagnosis of Diabetes Type II (late onset of high blood sugar). During a record review of Patient 6’s Plan of Care (POC - an individualized written program for a patient that is developed by health care professionals), dated 1/23/2023 to 3/22/2023, indicated “Recertify patient … for skilled nursing assessment, observation and evaluation of all body systems…” During a concurrent interview and record review on 2/14/2023 at 12 p.m. with the Administrator (ADM) of P6’s electronic medical record (EMR), the medical record indicated there were two LVN supervisory notes documented on 10/24/2022 and 12/22/2022. The ADM stated that she is the one that overseen the LVN’s care. ADM stated that an LVN’s supervisory visit should be done every 30 or 60 days, “I do it every 30 days.” ADM was unable to locate any supervisory visits after the 12/22/2022. ADM stated, “I was to supervise every 30 days.” During a review of facility’s policy and procedure titled, “Supervisory Visit” dated 11/30/10, indicated “I. Skilled Nurse 1. License Vocational Nurse are to be supervised at the patient’s place of residence by a registered nurse or Nursing Supervisor at least once every thirty (30) calendar days.”

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on interview and record review the facility failed to ensure six of 13 staff members had updated History and Physical (Administrator (ADM), License Vocational Nurse 1 (LVN1), LVN3, Medical Social Worker (MSW), Certified Home Health Assistant (CHHA), and Office Assistant 1 (OA1), The facility failed to ensure seven of 13 staff members had an updated PPD (ADM, LVN1, LVN2, LVN3, MSW, OA1, and CHHA), The facility failed to ensure four of 13 staff members had a facility orientation (ADM, MSW, OA1, and CHHA), The facility failed to ensure one of 13 staff members had a competency review (MSW), The facility failed to ensure four of 13 staff members had a criminal background check (ADM, MSW, OA1, CHHA). This failure had the potential to result in patients being taken care of an unexperienced and untrained staff. During a concurrent interview and record review on 2/15/2023, at 2:04 p.m., with the ADM of employee records, ADM stated, “Background checks, it’s important because to protect our patients against violence maybe or negligence. History and Physicals and PPD (tuberculosis skin test) sometimes they don’t provide to me. It is important to make sure we have a healthy person taking care of our patients, for safety also. (License Vocational Nurse 2 - LVN2), she does not want to provide me her health records. We are looking for her background check. Facility orientation - It is important, so that they will be familiar with the facility and where things are about medical records and medical supplies about how we put our data.” During a review of the employee’s file on 2/15/23, the following was indicated: -Six of 13 staff members had updated History and Physical (Administrator (ADM), License Vocational Nurse 1 (LVN1), LVN3, Medical Social Worker (MSW), Certified Home Health Assistant (CHHA), and Office Assistant 1 (OA1), -Seven of 13 staff members had an updated PPD (ADM, LVN1, LVN2, LVN3, MSW, OA1, and CHHA), -Four of 13 staff members had a facility orientation (ADM, MSW, OA1, and CHHA), -One of 13 staff members had a competency review (MSW), -Four of 13 staff members had a criminal background check (ADM, MSW, OA1, CHHA). During a review of facility’s policy and procedure titled, “Competency Assessment” revised December 2008, indicated “The competence of all organization staff…will be assessed during orientation, during probation period, periodically throughout the course of the year… and during the annual performance evaluation.” During a review of facility’s policy and procedure titled, “Orientation” revised December 2008, indicated “All staff will be required to attend an initial orientation upon employment… The goal of orientation will be to address and instruct new staff regarding… mission goals, organization wide... policies and procedures…” During a review of facility’s policy and procedure titled, “Personnel Record Contents” revised December 2008, indicated “(HHA) will maintain accurate and complete personnel files on all staff. 1. The content of the personnel files for regular full or part time personnel will include: Clinical Documents - A. Skills and Experience Inventory. New Hire Documents – C. References E. Orientation check list J. Criminal background check. Performance Evaluation/Counseling Documents – A. Performance evaluations. 2. The content of a separate file, which includes health information will contain: C. TB Mantoux test documentation D. Physician’s statement of health E. HBV vaccination/HBV refusal documentation.”

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation for Clinical Records was met as follows: 1.The Home Health Agency (HHA) failed to ensure pertinent clinical records were included to accurately reflect the care for seven of nine sampled patients (Patient 1, Patient 2, Patient 4, Patient 6, Patient 7, Patient 8, and Patient 9). This failure resulted in patients' incomplete clinical records. (Refer to G1012). 2. The HHA failed to include information required in the medical record to reflect the care for one of nine sampled patients (Patient 6). The HHA failed to document Patient 6’s Permcath (a special intravenous line into the blood vessel in the neck or upper chest just under the collarbone) and that she was receiving dialysis (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly). This failure had the potential to result in patient not receiving the identified needs and services, and have a decline in health status, that could affect patient's quality of care and well-being. (Refer to G1014). 3. The HHA failed to send all necessary medical information to the primary care practitioner within five days of discharge for six of nine sampled patients (Patient 3, Patient 4, Patient 5, Patient 7, Patient 8, and Patient 9). This deficient practice resulted in the primary care practitioner not receiving information regarding the services and care provided by the HHA. (Refer to G1022). 4. The HHA failed to ensure Skilled Nursing Visit Notes clearly identified the author of each record for three of nine sampled patients (Patient 1, Patient 2, Patient 6). This failure has the potential to result in an unauthorized and inaccurate patient information or assessment will be entered in the patients’ clinical record that could affect the patient’s quality of care and well-being. (Refer to G1024). 5. The HHA failed to ensure clinical records were created for two of nine sampled discharged patients (Patient 5 and Patient 9). This failure resulted in the HHA not having any record of the services the patients received while under their care. (Refer to G1026). 6. The HHA failed to ensure patient care records were safeguarded for two of nine sampled patients (Patient 5 and Patient 9). This failure has the potential risk for these records not being protected and putting the patient's confidential information at risk for unauthorized use by unauthorized personnel. (Refer to G1028). The cumulative effect of these systemic practices resulted in the failure of the HHA to ensure the provision of a quality health care in a safe environment.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on interview, observation, and record review, the Home Health Agency (HHA) failed to ensure pertinent clinical records were included to accurately reflect the care for seven of nine sampled patients (Patient 1, Patient 2, Patient 4, Patient 6, Patient 7, Patient 8, and Patient 9). This failure resulted in patients' incomplete clinical records. a). A review of Patient 1’s Patient Information sheet, indicated a start of care (SOC) to the HHA on 12/18/2022, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe) and lung transplant status. During a home visit observation on 2/14/2023, at 2:00 p.m., with Licensed Vocational Nurse 1 (LVN), Patient 1’s care was observed. During the visit, LVN 1 was observed writing clinical notes. During an interview on 2/14/2023, at 2:35 p.m., LVN 1 stated he turned in clinical care notes on the first and fifth of the month. LVN 1 was shown nursing notes dated 2/5/2023, 1/29/2023, 1/18/2023, 1/11/2023, 1/4/2023, 12/28/2022. LVN 1 stated those were not the notes written by him. LVN 1 stated he turned in written notes, not typed notes, and did not know who had typed the notes. During an interview on 2/16/2023, at 11:15 a.m., the Administrator (ADM) stated nursing care notes are expected to be turned in every week. The ADM stated she had never seen the written notes turned in by LVN 1. A review of Patient 1’s record titled, “Skilled Nursing Visit Notes”, dated 12/28/2022, 1/4/2023, 1/11/2023, 1/18/2023, 1/29/2023, and 2/5/2023, indicated the notes were typed and the author of the notes was not indicated. b). A review of Patient 2’s Patient Information sheet, indicated a SOC to the HHA on 12/17/2022, with diagnoses including quadriplegia (paralysis of all four limbs). During a home visit observation on 2/14/2023, at 2:45 p.m., with LVN 1, Patient 2’s care was observed. During the visit, LVN 1 was observed writing clinical notes. LVN 1 did not do a full body assessment during the visit. During a concurrent interview and record review on 2/14/2023, at 3:10 p.m., Patient 2's record titled, “Skilled Nursing Visit Notes”, dated 2/14/2023, was reviewed with LVN 1. The record indicated, “Cardiovascular Heart Rhythm regular”. LVN 1 stated he determined the heart rate was normal from the reading of the blood pressure machine. When asked, “Does the machine tell you the heart rhythm is normal?”, LVN 1 stated, “no”. When asked, “How did you assess the heart rhythm?”, LVN 1 stated, “big mistake”. c). A review of Patient 4’s record titled, “Home Health Certification and Plan of Care” (POC - an individualized written program for a patient that is developed by health care professionals), for certification period 2/12/2022 to 4/12/2022, indicated a start of care date of 2/12/2022, with diagnoses including Chronic Obstructive Pulmonary Disease. During an interview on 2/14/2023, at 9:45 a.m., the ADM stated there was no initial comprehensive assessment done for Patient 4. The ADM stated it was important to do a comprehensive assessment so the agency can plan the care and identify the needs of the patient. d). A review of Patient 6's face sheet (a document that gives a patient's information at a quick glance) indicated patient was admitted to the HHA on 9/25/2022 and current episode dated from 1/23/2023 to 3/22/2023, with a diagnosis of Diabetes Type II (late onset of high blood sugar). It also stated Patient 6 had a Skilled Nurse visit frequency of daily for 60 days. During an interview and concurrent record review on 2/13/2023, at 5 p.m., of Patient 6’s medical record with the ADM, the medical record indicated there were missing skilled nursing visit notes and weekly wound notes. ADM stated, “The nurses are to submit their notes every week. It is important to submit so that we will know the progress of the patient.” e). A review of Patient 7’s “Home Health Certification and Plan of Care” dated from 8/9/2022 to 10/9/2022, indicated patient was admitted to the HHA on 8/9/2022 with a diagnosis of bilateral osteoarthritis knee (right and left knee pain). It also stated Patient 7 had a Skilled Nurse visit frequency of once a week for two weeks. During an interview and concurrent record review on 2/14/2023 at 10:47 a.m. of Patient 7’s medical record with the ADM, the medical record indicated there were no physician orders, skilled nurse visit note for the first week, and a discharge summary. ADM stated that there were no physician orders, “Its empty, there none. We have a referral form. I use the orders that are on the plan of care… The Plan of Care is updated when we get physician orders.” ADM also stated that she did not have the skilled nurse visit note and that there was no discharge summary. ADM stated, “it is important to have one so we can let the doctor know. So, the doctor is aware that the treatment is over.” f). A review of Patient 8’s “Home Health Certification and Plan of Care” dated from 4/6/2022 to 6/6/2022, indicated patient was admitted to the HHA on 4/6/2022 with a diagnosis of non-ST (stroke) elevation myocardial Infarct (heart attack). It also indicated Patient 8 had a skilled nursing visit of once a week for two weeks. During an interview and concurrent record review on 2/14/2023 at 2 p.m. of Patient 8’s medical record with the ADM, the medical record indicated there were no initial comprehensive nursing assessment, skilled nursing visit notes, physician orders, discharge summary, or end of care date documented. The ADM stated, “I visited him, but I didn’t document.” g). During an interview and concurrent record review on 2/15/2023 at 2:40 p.m. of Patient 9’s medical record with ADM, the medical record contained five documents: A weekly route sheet, Proposed services, Consent - Notice of conditions for homebound Medicare recipient, Consent - Arbitration agreement, and Consent - Statement of Patient Privacy Rights. Patient 9’s medical record was missing the following: Face sheet, POC, physician orders, medication profile, skilled nursing visit notes, initial comprehensive nursing assessment, and discharge summary. ADM stated, “I saw her every week for six weeks, I was changing the port-a-Cath (a vascular access, placing a thin hollow plastic tube into a vein to permit drawing blood tests, and giving medications, fluids and nutrition, or transfusions directly into the bloodstream) needle every week for six weeks.” ADM stated that she did not document the initial comprehensive nursing assessment, skilled nurse visit notes, physician’s orders, or medication profile. During a review of facility’s document titled, “Job Description – Registered Nurse (RN)” revised December 2008, indicated “The registered nurse plans, organizes and directs home care services, patient care, completes an initial assessment of patient and family to determine home care needs, provides a complete physical assessment, history and previous illness, initiates the plan of care and makes necessary revisions, develops a care plan, prepares clinical notes and updates the primary physician when necessary, and communicates with the physician… reports any changes in the patient’s condition…” During a review of facility’s policy and procedure titled, “General Guidelines for Reporting to the Physician” dated 11/30/2010, indicated “all communications with the physician must be documented… Orders obtained from the physician must be documented…” During a review of undated facility’s policy and procedure titled, “Care Planning Process”, indicated “A written plan of care will be initiated within five (5) days of start of care…” During a review of facility’s policy and procedure titled, “Plan of Care” dated 11/30/2010, indicated “a written plan of care shall be established for each patient whose care requires medical orders. All plans of care and notifications to the attending physician… are made part of the patient’s health record.” During a review of facility’s policy and procedure titled, “Admission Criteria and Process” revised October 2011, indicated “If the patient is accepted for home health, an initial plan of care will be developed… The initial written assessment will be completed within 24 hours of the original assessment/admission visit. All documentation needed to develop the plan of care will be completed and turned into the office no later than the next business day. A comprehensive assessment must be completed within five (5) calendar days of the patient’s start of care. 19. A clinical record will be initiated for each patient admitted for home health services.” During a review of facility’s policy and procedure titled, “Entries into the Medical Record” revised October 2011, indicated “Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided. Procedure –A clinical record will be initiated and maintained for each patient receiving care or services…” During a review of facility’s policy and procedure titled, “Medication Profile” revised October 2011, indicated “Patients receiving medications will have a current, accurate mediation profile in the clinical record.”

Interventions and patient response CFR(s): 484.110(a)(2) All interventions, including medication administration, treatments, and services, and responses to those interventions; This ELEMENT is not met as evidenced by: Based on interview, observation, and record review, the Home Health Agency (HHA) failed to include information required in the medical record to reflect the care for one of nine sampled patients (Patient 6). The HHA failed to document Patient 6’s Permcath (a special intravenous line into the blood vessel in the neck or upper chest just under the collarbone) and that she was receiving dialysis (a procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly). This failure had the potential to result in patients not receiving the identified needs and services, and have a decline in health status, that could affect their quality of care and well-being. A review of Patient 6’s face sheet (a document that gives a patient's information at a quick glance) indicated Patient 6 was admitted to the HHA on 9/25/2022 with a diagnosis of Diabetes Type II (late onset of high blood sugar). During an electronic record review of Patient 6’s “OASIS (Outcome and Assessment Information Set - a standardized data set that measures quality and outcomes) E-Recertification” dated 1/22/2023, indicated there was no mentioned of Patient 6’s Permcath or that she was receiving dialysis. During a record review of Patient 6’s POC, dated 1/23/2023 to 3/22/2023, indicated there was no documentation about Patient 6’s Permcath and that she was receiving dialysis. During a concurrent interview and record review on 2/14/2023 at 12 p.m. with the Administrator (ADM) of Patient 6’s medical record, the medical record indicated that Patient 6’s Permcath and dialysis treatments were not documented. ADM stated, “It was not mentioned, it’s my mistake. So, we can monitor patient better, usually patient that have dialysis has low blood pressure. She has a Permcath, it’s not mentioned. She was already on dialysis before we admitted her.” During an observation on 2/14/2023, at 3 p.m., in Patient 6’s home, patient was observed sitting on the edge of bed. A dressing was noted on Patient 6’s top right chest wall. Patient 6 stated that it was used for her dialysis treatments that were started since March of the last year. During an interview on 2/14/2023 at 3:45 p.m. with LVN2, LVN2 was asked if she assessed Patient 6’s Permcath. LVN2 stated that she just looks at Patient 6’s Permcath. During a review of facility’s “Job Description – Registered Nurse (RN)” revised December 2008, indicated “The registered nurse plans, organizes and directs home care services… Completes an initial assessment of patient and family to determine home care needs. provides a complete physical assessment, history, and previous illness, initiates the plan of care and makes necessary revisions, develops a care plan, prepares clinical notes and updates the primary physician when necessary, and communicates with the physician… reports any changes in the patient’s condition…” During a review of facility’s policy and procedure titled, “Plan of Care” dated 11/30/2010, indicated “A written plan of care shall be established for each patient whose care requires medical orders. The plan of care shall be: 3. The professional person responsible for any specific treatment shall notify the attending physician… and responsible agency staff of significant changes in the patient’s condition. 4. All plans of care and notifications to the attending physician… are made part of the patient’s health record.” During a review of facility’s policy and procedure titled, “Admission Criteria and Process” revised October 2011, indicated “16. The initial written assessment will be completed within 24 hours of the original assessment/admission visit. All documentation needed to develop the plan of care will be completed and turned into the office no later than the next business day. 17. A comprehensive assessment must be completed within five (5) calendar days of the patient’s start of care. 19. A clinical record will be initiated for each patient admitted for home health services.” During a review of facility’s policy and procedure titled, “Entries into the Medical Record” revised October 2011, indicated “Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided.” During a review of facility’s policy and procedure titled, “Coordination of Service” dated 11/30/2010, indicated “Procedure – 1. A registered nurse or therapist is assigned to each patient to function as the care manager/coordinator for the patient’s care delivery. 4. The essential components of services coordination include the following task: D. Maintain efficient communications with all care providers to ensure prompt transmission of significant information, which may require action or decision making. 8. Changes in the patient’s condition during the course of care are brought to the attentions of the physician and other disciplines providing care to the patient.” During a review of facility’s policy and procedure titled, “General Guidelines for Reporting to the Physician” dated 11/30/2010, indicated “3. Agency personnel shall follow the guidelines established by the agency as follows: “General Guidelines for Reporting to the Physician” C. Respirations 2. Any deviation from normal.”

Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient's discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient's care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to send all necessary medical information to the primary care practitioner within five days of discharge for six of nine sampled patients (Patient 3, Patient 4, Patient 5, Patient 7, Patient 8, and Patient 9). This deficient practice resulted in the primary care practitioner not receiving information regarding the services and care provided by the HHA. a). A review of Patient 3’s record titled, “Home Health Certification and Plan of Care”, for certification period 9/30/2022 to 11/28/2022, indicated a start of care date of 9/30/2022, with diagnoses including fracture of the right foot. During an interview on 2/14/2023 at 9:35 a.m. with the Administrator (ADM), the ADM stated, “We sent doctors order, discharge summary. discharge summary is sent a week after the patient, or less, after the patient has been discharge.” A review of Patient 3’s medical record titled, “Discharge Summary”, dated 11/28/2022, did not indicate the summary was sent to the doctor. b). A review of Patient 4’s record titled, “Home Health Certification and Plan of Care”, for certification period 2/12/2022 to 4/12/2022, indicated a start of care date of 2/12/2022, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe). During an interview on 2/14/2023, at 9:35 a.m., the ADM stated it was important to have a discharge order in the record, so the visit would be valid, and the doctor was aware the goals of care have been met. During an interview on 2/14/2023, at 9:45 a.m., the ADM stated there was no discharge order and discharge summary present in Patient 4’s medical record and did not know the reason why it was missing. c). A review of Patient 5's record titled, “Medical History/Nursing Assessment”, dated 1/10/2022, indicated a start of care date of 1/10/2022, with diagnoses including spinal surgery. During an interview on 2/15/2023, at 1:15 p.m., the ADM stated there was no discharge order and discharge summary in Patient 5 ’s record. The ADM stated the reason the physician’s orders were not in Patient 5's record was because the patient was seen only one time. A review of Patient 5 ’s medical record on 2/15/2023, at 1:15 p.m., did not indicate a discharge order and discharge summary was present. d). A review of Patient 7’s “Home Health Certification and Plan of Care” dated from 8/9/2022 to 10/9/2022, indicated Patient 7 was admitted to the HHA on 8/9/2022 with a diagnosis of bilateral osteoarthritis knee (right and left knee pain). During a concurrent interview and record review on 2/14/2023 at 10:47 a.m. with the ADM of Patient 7’s medical record, the medical record indicated there was no discharge summary or an end of care date. ADM stated, “None, it is important to have one so we can let the doctor know. So, the doctor is aware that the treatment is over.” The ADM was asked if the physician was made aware the Patient 7 was discharged. ADM stated, “No, it is important to make the doctor aware so that he knows that the treatment is over and the next time the patient has an appointment to see the doctor, the doctor can evaluate if the treatment is effective.” During an interview on 2/15/2023 at 1 p.m. with the ADM, the ADM stated, “I’m sorry I was unable to do all these discharges.” e). A review of Patient 8’s “Home Health Certification and Plan of Care” dated from 4/6/2022 to 6/6/2022, indicated Patient 8 was admitted to the HHA on 4/6/2022 with a diagnosis of non-ST elevation myocardial infarct (heart attack). During a concurrent interview and record review on 2/14/2023 at 2 p.m. with the Administrator (ADM) of Patient 8’s medical record, the ADM was unable to state what the end of care (EOC) date was for Patient 8. ADM stated, “There is no EOC date documented, the last visit was on 4/20/2022.” ADM stated that there was no discharge summary and that there is no documentation that the physician was made aware of Patient 8’s discharge. f). During a concurrent interview and record review on 2/15/2023 at 2:40 p.m. with ADM of Patient 9’s medical record, the medical record indicated there was no EOC date documented for Patient 9. ADM stated, “I don’t know, I did not write it down.” During a review of facility’s policy and procedure titled, “Documentation and Submission of Records” dated 3/10/11, indicated “E. All discharge summaries must be completed and submitted to the agency within one week after discharge.” During a review of facility’s policy and procedure titled, “Discharge Criteria and Process” revised October 2011, indicated “When the patient’s plan of care changes and this change result in discharge… the patient or his/her representative, as well as his/her primary physician will be notified… A discharge summary will be completed and filed in the clinical record. 10. The discharge record will be… completed within 30 days of the discharge…” During a review of facility’s policy and procedure titled, “Discharge Summary” revised October 2011, indicated “Each patient discharged form a service and from the organization will have a written discharge summary filed in the clinical record. 2. The discharge summary... will be completed and submitted within 72 hours of discharged from service. 4. The organization will complete all necessary audits to determine completeness of the patient’s clinical record within 30 days of the last home visit and discharge date.”

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, observation, and record review, the Home Health Agency (HHA) failed to ensure Skilled Nursing Visit Notes clearly identified the author of each record for three of nine sampled patients (Patient 1, Patient 2, Patient 6). This failure has the potential to result in an unauthorized and inaccurate patient information or assessment will be entered in the patients’ clinical record that could affect the patient’s quality of care and well-being. a). A review of Patient 1's Patient Information sheet, indicated a start of care (SOC) to the HHA on 12/18/2022, with diagnoses including Chronic Obstructive Pulmonary Disease (a group of lung diseases that block airflow and make it difficult to breathe) and lung transplant status. During an observation during the home visit, on 2/14/2023, at 2:00 p.m., with Licensed Vocational Nurse 1 (LVN 1), Patient 1's care was observed. During the visit, LVN 1 was observed writing clinical notes. During an interview on 2/14/2023, at 2:35 p.m., LVN 1 stated he turned in clinical care notes on the first and fifth of the month. LVN 1 showed the nursing notes of 2/5/2023, 1/29/2023, 1/18/2023, 1/11/2023, 1/4/2023, 12/28/2022. LVN 1 stated those were not the notes written by him. LVN 1 stated he turned in written notes, not typed notes, and did not know who had typed the notes. During an interview on 2/14/2023, at 11:30 a.m., the Administrator (ADM) stated clinical care notes were supposed to be signed by the author, to validate the care being provided. A review of Patient 1's record titled, “Skilled Nursing Visit Notes”, dated 12/28/2022, 1/4/2023, 1/11/2023, 1/18/2023, 1/29/2023, and 2/5/2023, indicated the notes were typed and the author of the notes was not indicated. Further review of the records did not indicate a full body assessment was done to document the health status of the patient. b). A review of Patient 2’s Patient Information sheet, indicated a SOC to the HHA on 12/17/2022, with diagnoses including quadriplegia (paralysis of all four limbs). A review of Patient 2's record titled, “Skilled Nursing Visit Notes”, dated 1/27/2023, 1/20/2023, 1/13/2023, 1/6/2023, indicated the notes were typed and the author of the notes was not indicated. Further review of the records did not indicate a full body assessment was done to document the health status of the patient. c). A review of Patient’s face sheet indicated Patient 6 was admitted to the HHA on 9/25/2022 and current episode dated from 1/23/2023 to 3/22/2023, with a diagnosis of Diabetes Type II (late onset of high blood sugar). The record indicated Patient 6 had a Skilled Nurse visit frequency of daily for 60 days. During a concurrent interview and record review on 2/13/2023 at 5 p.m. with the Administrator (ADM) of Patient 6’s medical record, the medical record indicated the last Skilled Nurse (SN) Visit Note was documented on 1/11/2023 and the last Weekly Wound Assessment note was documented on 12/20/2022. The ADM stated that both notes were not signed by the License Vocational Nurse 2 (LVN2). ADM stated, “It is important for the nurse to sign so that it is a valid assessment.” A review of the HHA’s undated policy and procedure titled, “Clinical Record Review”, indicated, “Policy clinical records will be reviewed at frequent intervals by the Clinical Director or designee to ensure that documentation is entered and is reliable, timely, valid and accurate.”

Retention of records CFR(s): 484.110(c)(1)(2) Standard: Retention of records. (1) Clinical records must be retained for 5 years after the discharge of the patient, unless state law stipulates a longer period of time. (2) The HHA's policies must provide for retention of clinical records even if it discontinues operation. When an HHA discontinues operation, it must inform the state agency where clinical records will be maintained. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure clinical records were created for two of nine sampled discharged patients (Patient 5 and Patient 9). This failure resulted in the HHA not having any record of the services the patients received while under their care. a). A review of Patient 5's record titled, “Medical History/Nursing Assessment”, dated 1/10/2022, indicated a start of care date of 1/10/2022, with diagnoses including spinal surgery. During an interview on 2/15/2023, at 1:15 p.m., the Administrator (ADM) stated there was no discharge order, discharge summary, consents, medication profile, plan of care, physician’s orders in Patient 5’s record. The ADM stated the reason the physician’s orders were not in Patient 5’s record was because the patient was seen only one time. b). During a concurrent interview and record review on 2/15/2023 at 2:40 p.m. with ADM of Patient 9’s medical record, the medical record contained five documents: A weekly route sheet, Proposed services, Consent - Notice of conditions for homebound Medicare recipient, Consent - Arbitration agreement, and Consent - Statement of Patient Privacy Rights. Patient 9’s medical record was missing the following: Face sheet, POC, physician orders, medication profile, skilled nursing visit notes, initial comprehensive nursing assessment, and discharge summary. ADM stated, “I saw her every week for six weeks, I was changing the port-a-Cath (a vascular access, placing a thin hollow plastic tube into a vein to permit drawing blood tests, and giving medications, fluids and nutrition, or transfusions directly into the bloodstream) needle every week for six weeks.” ADM stated that she did not document the initial comprehensive nursing assessment, skilled nurse visit notes, physician’s orders, or medication profile. During a review of facility’s “Job Description – Registered Nurse (RN)” revised December 2008, indicated “The registered nurse plans, organizes and directs home care services, completes an initial assessment of patient and family to determine home care needs, provides a complete physical assessment, history, and previous illness, initiates the plan of care and makes necessary revisions, develops a care plan, prepares clinical notes and updates the primary physician when necessary, and communicates with the physician… reports any changes in the patient’s condition…” During a review of facility’s policy and procedure titled, “Admission Criteria and Process” revised October 2011, indicated “19. A clinical record will be initiated for each patient admitted for home health services.” During a review of facility’s policy and procedure titled, “Entries into the Medical Record” revised October 2011, indicated “Documentation in the clinical record will be timely, detailed, accurate, and reflect the care or services provided. Procedure – 1. A clinical record will be initiated and maintained for each patient receiving care or services…”

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on interview and record review the Home Health Agency (HHA) failed to ensure patient care records were safeguarded for two of nine sampled patients (Patient 5 and Patient 9). This failure has the potential risk for these records not being protected and putting the patient's confidential information at risk for unauthorized use by unauthorized personnel. (Refer to G1028). potential risk for these records not protected causing the patient's confidential information at risk for unauthorized use by unauthorized personnel. On 2/15/2023, at 9 a.m., Patient 5 and Patient 9’s medical records were requested. During an interview on 2/15/2023, at 10 a.m., with the Administrator (ADM), the ADM stated she was unable to locate Patient 5’s medical record. The ADM stated she and Office Assistant 1 (OA1) were actively looking for Patient 5’s medical record. On 2/15/2023 at 12:40 p.m., Patient 9’s medical record was provided in a beige file folder. Beige file folder contained: Weekly Route Sheet, Proposed Services: Frequency and Duration, Consent - Notice of conditions for homebound Medicare recipient, Consent - Arbitration agreement, and Consent - Statement of Patient Privacy Rights. During an interview on 2/15/2023, at 1 p.m., with the ADM, the ADM stated she was unable to locate Patient 5’s medical record. ADM stated, “I don’t have it right now; I cannot find it. I need more organization.” The ADM stated, “We make the chart and then we have a bin in the file cabinet. All discharge charts I put in a crate, and I keep the crate in the supply/medical record room…For our HMO, usually they have one visit or two visits, usually I use this one.” ADM demonstrated a beige file folder. During an interview on 2/15/2023, at 1:15 p.m., the ADM stated she had found the email containing Patient 5’s medical records. The ADM stated the email came from “Gmail” and it was considered a secure method of storing medical records. The ADM stated the email contained protected health information such as the patients name and medical information. A review of the HHA’s document titled, “Gmail”, dated 1/9/2022, indicated Patient 5’s name on the subject line. The form indicated four attachments titled, “Medical History/Nursing Assessment.” During a review of facility’s policy and procedure titled, “Safeguarding/Retrieval of Clinical Records” revised October 2011, indicated “The organization will safeguard the clinical record against loss, destruction, tampering, or unauthorize use through the development of processes, policies, and procedures. Procedure – 1. All patient clinical records will be maintained in locked, waterproof file cabinets in a designated clinical records room… 7. Selected documents may be kept in the patient’s home in a home clinical record while the case is active. A. Element of the clinical record necessary to provide continuity of care included the plan of care… medication profile…”