Every finding on record at Tender Home Health

Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the agency failed to ensure an ongoing interdisciplinary assessment or case conference participated by the registered nurse (RN), physical therapist (PT), and certified home health aide (CHHA) was conducted every 30 days according to the HHA policy and procedure for one of eight patients (Patient 9). This deficient practice had the potential to affect the continuity of coordinated care and skilled professional involvement to achieve the patient care goals identified in the plan of care (POC). A review of Patient 9's plan of care (POC) for the certification period from 4/28/2022 to 6/26/2022, indicated start of care (SOC) dated 4/27/2021, with diagnoses that included Myasthenia gravis (a rare chronic autoimmune disease marked by muscular weakness without atrophy [loss of muscle tissue], and management of ventricular assistive device (VAD - mechanical circulatory support device that helps pump blood from the lower chambers of your heart (ventricles) to the rest of your body). The POC included for the Registered Nurse (RN) to visit once a week for 8 weeks, for assessment all body system and to administer Gamunex (immune globulin intravenous - to treat primary immune deficiency) 40 grams intravenous (IV) weekly. The CHHA was to visit once or twice weekly to monitor the patient during shower and assist with some household tasks. Patient 9’s physician’s order in the POC dated 4/26/2022, indicated SN visit once a week for 9 weeks, and CHHA visit two times a week for 7 weeks. The CHHA was to check and record vital signs at every visit and assist with personal care/activities of daily living (ADLs)/Instrumental ADL (IADLs) per Aide Care plan under supervision of RN. A review of Patient 9’s Physical Therapy Evaluation and Plan of Care dated 5/24/2022, indicated physical therapy re-evaluation and treatment two times a week for 5 weeks for therapeutic exercise instruction, gait training with balance, and endurance and stair training. On 6/22/2022, at 1:10 p.m., during a home visit, Patient 9 was observed lying in her bed receiving IV therapy via IV port on the right chest. RN 3 was observed next to the patient. Patient 9 was alert and oriented and was able to communicate well. During an interview with Patient 9, stated she had been receiving services by the RN, CHHA and PT. A review of Patient 9’s record from for certification period of 5/17/2022 to 6/23/2022, indicated RN, CHHA, and PT services were provided to the patient. A review of the ongoing assessment or the interdisciplinary conference indicated no documented evidence it was held with the participation of the RN, the CHHA, and PT. On 6/23/2022, at 11:50 a.m., during an interview, the Director of Patient Care Services (DPCS) designee was unable to provide documented evidence the case conference had been held with the participation of the RN, the CHHA, and the PT. A review of the agency's undated policy titled "Case Management" indicated the case conference should be held every 30 days with all involved disciplines, including review of patient’s progress toward goals.

Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This STANDARD is not met as evidenced by: Based on observation, interview and record review, the agency failed to ensure a Registered Nurse (RN) provided written patient care instructions to the home health (HH) aide for one of 8 sampled patients provided HH aide services (Patient 9). This deficient practice has the potential for the HH aide will not be able to perform and provide quality care services without the written instructions by the RN that could affect the health status and well being of the patient. A review of Patient 9's plan of care (POC) for the certification period from 4/28/2022 to 6/26/2022, indicated start of care (SOC) dated 4/27/2021, with diagnoses that included Myasthenia gravis (a rare chronic autoimmune disease marked by muscular weakness without atrophy), and management of ventricular assist device (VAD - mechanical circulatory support device that helps pump blood from the lower chambers of your heart (ventricles) to the rest of your body). The POC included an order for the Registered Nurse (RN) visit once a week for 8 weeks, for assessment all body system and to administer Gamunex 40 gram intravenous (IV) weekly. The CHHA was to visit once or twice weekly to monitor the patient in shower and assist with some household tasks. Patient 9’s physician’s order dated 4/26/2022, indicated CHHA to visit two times a week for 7 weeks. The CHHA was to check and record vital signs every visit and assist with personal care/activities of daily living (ADLs)/Instrumental ADL (IADLs) per Aide Care plan under supervision of RN. On 6/22/2022, at 1:10 p.m., during a home visit, Patient 9 was observed lying in her bed receiving IV therapy via IV port on the right chest. RN 3 was next to the patient. Patient 9 was alert and oriented and was able to communicate well. During an interview with the patient, she stated a CHHA had been coming two times a week, helping her for shower/bathe. A review of Home Health Aide Visit Notes dated 5/23 2022 to 6/23/2022, indicated “Bath Activity” (such as tub shower bath or chair bath) and “Hygiene Grooming” (such as personal care, assist dressing, shampoo) were completed. A review of Patient 9’s record indicated there was no documented evidence of a written CHHA care instructions by the RN. On 6/23/2021, at 11:50 a.m., during an interview with the Director of Patient Care Services (DPCS) designee, DPCS designee was not able to provide the documented evidence the RN had provided CHHA the written patient care instructions. DPCS confirmed the RN should have provided CHHA the written instructions for patient care. A review of the agency's undated position policy titled "Home Health Aide Services” indicated the RN would create a home health aide plan of care according to the doctor’s order or needs of the patient.

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the Home Health Agency (HHA) failed to coordinate the oxygen therapy care and management with the durable medical equipment company (DME) for 1 of 8 sample patients receiving oxygen therapy (Patient 9). This deficient practice has the potential to result in respiratory infection that could affect the patient’s health status and wellbeing. A review of Patient 9's plan of care (POC) for the certification period from 4/28/2022 to 6/26/2022, indicated start of care (SOC) dated 4/27/2021, with diagnoses that included Myasthenia gravis (a rare chronic autoimmune disease marked by muscular weakness without atrophy, and caused by a defect in the action of acetylcholine at neuromuscular junctions) and management of ventricular assist device (VAD - mechanical circulatory support device that helps pump blood from the lower chambers of your heart (ventricles) to the rest of your body). The POC included an order for the Registered Nurse (RN) visit once a week for 8 weeks, for assessment of all body system and to administer Gamunex 40 gram intravenous (IV) weekly. The POC indicated the patient used oxygen as needed. Patient 9’s physician’s order dated 4/26/2022 indicated the patient had dyspnea (difficulty of breathing) as functional limitation and to administer oxygen at 2 liters per minute as needed for shortness of breath. On 6/22/2022, at 1:10 p.m., during a home visit, Patient 9 was observed lying in her bed receiving IV therapy via IV port on the right upper chest. RN 3 was next to the patient. Patient 9 was alert and oriented and was able to communicate well. During the home visit it was observed a yellowish discolored nasal canula (connected to the oxygen tubing) hanging on the wall, not labeled, not stored in a bag, and further observed a long oxygen tubing on the floor from the oxygen concentrator to the nasal canula. During an interview with the Patient 9, at 1:55 p.m., stated she had been using the nasal canula since approximately one month ago every night when she slept. She stated she had cleaned the outside of the nasal canula with alcohol swab. Patient 9 stated she was not instructed on how often the nasal canula was to be changed or how to clean it except wiping outside of the nasal canula with the alcohol swab. During an interview with RN 3, stated he did not know how long Patient 9 had been using the nasal canula, how to clean the nasal canula except wiping it with alcohol swab, and how often it had to be changed. RN 3 stated the oxygen tubing (connected to the oxygen concentrator to nasal canula) was changed approximately 6 months ago. A review of the agency’s undated policy titled “Oxygen Maintenance” indicated continuous flow nasal cannulas and ancillary equipment should be changed or replaced every 2 weeks. As needed oxygen equipment should be changed or replaced when visibly dirty. The policy did not indicate how long “as needed” oxygen tubing/canula was good when it was not visibly dirty. A review of the agency’s undated procedure titled “Cleaning and Disinfecting Oxygen Equipment” indicated as follows: · Rinse cannula or mask with water and dry with paper towel daily. · Soak reusable equipment in a disinfectant solution (commercial solution or 3:1 vinegar solution) for 10 minutes after rinsing. Rinse well and air dry. · Store clean, dry articles in a plastic bag. During an interview with the Director of Patient Care Service (DPCS) designee on 6/23/2022, at 10:40 a.m., he stated the agency did not have documentation when the patient had changed/cleaned the nasal canula. He stated the agency nursing staff should have labeled the nasal canula and oxygen tubing with the date they were changed. The DPCS designee stated the agency’s policy did not indicate how long the “as needed” oxygen equipment could be used without changing/replacing/cleaning. He stated the agency should have developed the policy/guideline according to the manufacturer recommendations and current reference for the use of oxygen delivery systems at home.

The following reflects the findings of the California Department of Public Health during a complaint investigation. Complaint number: 62970 and 70608 Representing the California Department of Public Health: Surveyor #19096, Health Facility Evaluator Nurse The inspection was limited to the specific complaints and facility-reported incidents investigated and does not represent the findings of a full inspection of the facility. One deficiency was issued for Complaint numbers 62970 and 70608

Contents of clinical record CFR(s): 484.110(a) Standard: Contents of clinical record. The record must include: This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to follow the plan of care (POC) for one of three sampled patients (Patient 1). The HHA failed to ensure Patient 1’s skilled nursing visit notes that Registered Nurse 1 (RN 1) had completed the home visits, were available for review of health care professional staff and during the recertification survey. This deficient practice had the potential for the patient not reaching her highest potential and needs not being communicated to all health care professional staff. On 5/16/2022 during an on-going recertification revisit survey, two complaints investigation conducted regarding allegations of un-ethical recertification survey and patient’s rights on discharge. A review of Patient 1’s electronic clinical record indicated, Patient 1 was admitted to the home health agency (HHA) with a start of care date (SOC) of 7/27/2018, for the certification period of 5/27/22 to 7/27,/22 with diagnoses including Lupus (an inflammation disease causes when the immune system attacks its own tissue), chronic left side low back pain , with left side sciatica (a nerve pain from an injury or irritation to the sciatic nerve (the longest nerve in the body, starts in the lower back and splits to run through hips, buttocks, legs, and feet), upper back pain, neck pain, and adhesive capsulitis of shoulder ( a condition characterized by stiffness and pain in your shoulder joint). A review of Patient 1’s medical record, “IV League Prescription Form” dated 5/27/21 – 5/21/22, indicated a physician’s order and instruction, for Patient 1, to receive every 14 days and for the RN to administer VYEPTi (Eptinezezumb-JJMR, a prescription medicine used for the preventive treatment of migraine in adults) 100 milligrams (mg, a unit of measurement), 1 milliliter (ml, unit of measurement) and add to normal saline 100 ml, gently mix via, port-a-cath (a surgically inserted device which allows easy access to a patient's veins connected to the port) line over 30 minutes . A review of Patient 1’s medical record, there were no skilled nurses (SN) notes for 4/27/2022 and 4/29/2022, in Patient 1’s electronic medical record. On 5/17/2022, at 2:30 pm., during an interview with the Administrator and an RN supervisor, the Administrator stated, the agency has been trying to contact RN 1, who provided a visit to the patient, was terminated due to prior counseling regarding non-submission of his skilled nursing (SN) notes and not being compliant with the HHA’s policy of notes submission, and not returning the agency calls to submit his SN notes. The Administrator stated SN notes has to be submitted weekly, by all disciplines providing service. A review of the HHA policy and procedure titled, “4.5.2 Nursing Documentation under process of description stipulates, “submit completed paperwork -After the visit, the Registered Nurse or appropriate therapist will submit appropriate paperwork within 24 hours.” .

Amended 3/15/2022 The following reflects the findings of the Department of Public Health during a Recertification Survey. Representing the Department of Public Health: 19096 43929 09697 Total Sample-17 Home Visit-8 Active Patients- 193 On 2/7/22 at 12: 50 p.m., an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) was identified in the presence of the agency’s Administrator (ADM), Registered Nurse 1 (RN 1), and Staff 3 for the agency’s failure to ensure Patient 1 received treatments on the patient’s stage 4 pressure sores as indicated in the physician’s referral and plan of care. On 2/12/22 at 10:00 a.m., the IJ was removed after the agency submitted an acceptable IJ Removal Plan in the presence of the agency office staff and the Director of Nurses (DON) was on the phone was notified. The survey team verified and confirmed on-site the implementation of the removal plan through observation, interview, and record review. The following five Conditions of Participation (COP) were not met: 484.50- Patient rights 484.55- Comprehensive Assessment of Patients 484.60-Care planning, coordination, quality of care 484.65- Quality assessment/performance improvement 484.110- Clinical Record

The following reflects the findings of the Department of Public Health during RECERTIFICATION survey. Representing the Department of Public Health: Representing the Department of Public Health: 19096 43929 09697 Total Sample-17 Home Visit-8 Active Patients- 193

Accuracy of encoded OASIS data CFR(s): 484.45(b) Standard: The encoded OASIS data must accurately reflect the patient's status at the time of assessment. This STANDARD is not met as evidenced by: Based on interview and record review, the HHA failed to ensure the OASIS data accurately reflected the patient’s condition at the time of assessment for 1 of 17 sampled patients (Patient 2). This deficient practice resulted in the patient receiving services the patient did not need. Patient 2’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 11/6/2021 to 1/5/2022, indicated Patient 2's start of care (SOC) date was 11/6/2021, with diagnosis of idiopathic aseptic necrosis of bone (bone infection). During a concurrent interview and record review on 2/14/22, at 2:52 p.m., with RN 1, of Patient 2’s medical record titled, “RN OASIS Recertification Notes”, dated 1/5/22 indicated “This assessment is currently being completed for the following reason Recertification reassessment”. RN 1 stated there was no need for nursing services. RN 1 stated Patient 2 should have been discharged from the agency on 1/5/22. RN 1 stated the documentation did not support justification for skilled nursing services, nor did it reflect the current status of the patient in the OASIS recertification assessment. A review of the HHA census provided to the survey team on 2/4/22, indicated Patient 2’s status to be “active”. A review of the facility’s undated policy and procedures titled, “Recertification and Discharge”, indicated “Tender Home Health will discharge a patient when he/she is fully capable of providing his/her own needs”.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on observation, interview, and record review the facility failed to meet the Condition of Participation for Patient rights by failing to: Provide an advance written information to the patient before initial treatments were provided for two of 17 sampled patients, Patients 1 and 3. (Refer to G-410)Provide an advance written notice of the patient's bill of rights in a language easily understood to three of 17 sampled patients, Patients 1, 3, and 8. (Refer to G-412)Provide the contact information of the home health agency (HHA) including the administrator’s name, business address, and business phone number to receive complaints for two of 17 sampled patients, Patients 1 and 3. (Refer to G-414)Obtain the signature of the patient or legal representative to confirm that they had received a copy of the notice of rights and responsibilities for two of 17 sampled patients, Patients 1 and 3. (Refer to G-418)Provide services as indicated in the plan of care for three of 17 sampled patients, Patients 1, 5 and 8. (Refer to G-436)Provide an advance written notice of transfer and discharge rights during the initial evaluation or prior to providing care for two of 17 sampled patients, Patients 1 and 3. (Refer to G-452) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal regulations for Patient Rights to ensure that HHA protect and promote the exercise of these rights.

Information to patient CFR(s): 484.50(a)(1) Provide the patient and the patient's legal representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to the patient: This ELEMENT is not met as evidenced by: Based on observation, interview and record review the HHA failed to provide an advance written information to the patient before the initial treatments were provided for two of 17 sampled patients, Patients 1 and 3. This deficient practice had the potential that patient’s needs will not be properly assessed and can potentially affect the quality of care provided to the all the patients under the agency’s care. a. A review of Patient 1’s clinical record titled, “Home Health certification and plan of care (POC) for the certification period 2/3/2022 to 4/4/2022, indicated a start of care (SOC) date of 2/3/2022, with diagnosis that included pressure ulcer, Stage IV (wounds that reach the muscle or bone) pressure ulcer, and paraplegia (inability to move legs). During an interview on 2/6/2022 at 10:22 a.m., Registered Nurse 2 (RN 2) stated that during the first visit, one of the tasks of the HHA nurse was supposed to explain the purpose of the visit and provide a folder to the patient with the written information regarding their rights. RN 2 also stated that the HHA nurse should ask the patient to sign the consent forms after it had been explained. During an interview on 2/6/2022 at 11:57 a.m., RN 3 stated she did not provide any written information or obtain Patient 1's signature on the consent for the services during the first visit on 2/3/2022 because she ran out of blank consent form and needed to stop by the office to get more and have Patient 1 sign the consents later. During a home visit and concurrent interview on 2/6/2202 at 4:05 p.m., Patient 1 stated that when the nurse visited him on 2/3/2022, the HHA nurse did not leave any information to him in writing and had not signed any paperwork. Patient 1 also stated he needed all information in Spanish, his preferred language. During a home visit observation on 2/6/2022 at 4:20 p.m., RN 2 gave Patient 1 a folder that contained information in English about consents, patient’s rights, contact information, and other documents regarding the HHA. RN 2 did not obtain the patient’s signature on the consent forms. b. A review of Patient 3’s clinical record titled, “Home Health Certification and Plan of Care (POC) for the certification period 12/18/2021 to 2/15/2022, indicated an SOC date of 10/17/2021, with diagnosis that included urinary tract infection, primary hypertension (high blood pressure), sepsis (infection in the blood), and unspecified severe protein-calorie malnutrition (deficient in protein and calorie intake). During a home visit interview on 2/5/2022 at 7 p.m., Patient Representative 1 (PR 1) stated the HHA did not give them a folder that contained information about the agency, patient rights, consents, or contact information and was 99% positive the agency did not leave any information or folder. PR 1 also stated that Patient 3 had signed for verification of nurse visits and no other forms. On 2/6/2022 at 11:56 a.m., a request was made to Staff 1 for a copy of admission consents for Patient 3, however staff was unable to provide the requested documents. On 2/7/2022 at 10:52 a.m., a request was made to Staff 1 for a copy of admission consents for Patient 3, however staff was unable to provide the requested documents. On 2/15/2022 at 9:30 a.m., a request was made to Staff 1 for a copy of admission consents for Patient 3, however staff was unable to provide the requested documents. A review of the facility’s undated policy and procedures titled, “Agency Consent”, indicated that each patient admitted is given written and verbal information regarding rights by the admitting nurse regarding any care being rendered; the admitting professional reviews the Patients’ Rights and Responsibilities with the patient; the patient or caregiver signs an acknowledgement of receipt of the information; the original signed acknowledgement is placed in the patient’s medical record in the agency and a copy placed in the patient’s home folder.

Written notice of patient's rights CFR(s): 484.50(a)(1)(i) (i) Written notice of the patient's rights and responsibilities under this rule, and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section. Written notice must be understandable to persons who have limited English proficiency and accessible to individuals with disabilities; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to provide an advance written notice of the patient's bill of rights in a language easily understood to three of 17 sampled patients, Patients 1, 3, and 8. The deficient practice can result to patients and representative not understanding their rights and responsibilities as a patient while under the HHA’s care. b. During a review of Patient 1’s clinical record, the document titled, “Home Health Certification and Plan of Care (POC)”, with the certification period from 2/3/2022 to 4/4/2022, indicated a start of care (SOC) date of 2/3/2022, with diagnosis that included pressure ulcer, stage 4 (deep wounds that reach the muscle or bone), paraplegia (inability to move legs). During an interview on 2/6/2022 at 10:22 a.m., Registered Nurse 2 (RN 2) stated that during the first visit, one of the tasks of the HHA nurse was supposed to explain the purpose of the visit and provide a folder to the patient with the written information regarding their rights. RN 2 also stated that the HHA nurse should ask the patient to sign the consent forms after it had been explained. During an interview on 2/6/2022 at 11:57 a.m., RN 3 stated she did not provide any written information or obtain Patient 1's signature on the consent for the services during the first visit on 2/3/2022 because she ran out of blank consent form and needed to stop by the office to get more and have Patient 1 sign the consents later. During a home visit and concurrent interview on 2/6/2202 at 4:05 p.m., Patient 1 stated that when the nurse visited him on 2/3/2022, the HHA nurse did not leave any information to him in writing and had not signed any paperwork. Patient 1 also stated he needed all information in Spanish, his preferred language. During a home visit observation on 2/6/2022 at 4:20 p.m., RN 2 gave Patient 1 a folder that contained information in English about consents, patient’s rights, contact information, and other documents regarding the HHA. RN 2 did not obtain the patient’s signature on the consent forms. c. A review of Patient 3’s clinical record titled, “Home Health Certification and Plan of Care (POC) for the certification period 12/18/2021 to 2/15/2022, indicated an SOC date of 10/17/2021, with diagnosis that included urinary tract infection, primary hypertension (high blood pressure), sepsis (infection in the blood), and unspecified severe protein-calorie malnutrition (deficient in protein and calorie intake). During a home visit interview on 2/5/2022 at 7 p.m., Patient Representative 1 (PR 1) stated the HHA did not give them a folder that contained information about the agency, patient rights, consents, or contact information and was 99% positive the agency did not leave any information or folder. PR 1 also stated that Patient 3 had signed for verification of nurse visits and no other forms. On 2/6/2022 at 11:56 a.m., a request was made to Staff 1 for a copy of admission consents for Patient 3, however staffs were unable to provide the requested documents. On 2/7/2022 at 10:52 a.m., a request was made to Staff 1 for a copy of admission consents for Patient 3, however staffs were unable to provide the requested documents. On 2/15/2022 at 9:30 a.m., a request was made to Staff 1 for a copy of admission consents for Patient 3, however staffs were unable to provide the requested documents. A review of the facility’s undated policy and procedures titled, “Agency Consent”, indicated that each patient admitted is given written and verbal information regarding rights by the admitting nurse regarding any care being rendered; the admitting professional reviews the Patients’ Rights and Responsibilities with the patient; the patient or caregiver signs an acknowledgement of receipt of the information; the original signed acknowledgement is placed in the patient’s medical record in the agency and a copy placed in the patient’s home folder. During a review of Patient 8's clinical record, the document titled "Patient Information", indicated Patient 8 was admitted to general acute care hospital (GACH) on 1/12/2022, with a diagnosis of gram-negative bacteremia (a bacterial infection in the blood and is resistant to antibiotic treatment. A review of the GACH’S “Patient Orders” from the primary care providers (PCP) dated 1/19/2022, indicated, “I certify based on my finding, the following services are medically necessary home health services. Start of care date will be within 48 hours unless otherwise specified.” During the review of the clinical record for Patient 8, the documentation did not indicate that the home health agency admitted Patient 8 for home health services within 48 hours as per PCP on 1/19/2022. There was no documentation that the PCP was notified or had approved the delay in start of care. The home health agency’s current census for 2/5/2022 indicated Patient 8 had a start of care date of 2/5/2022. During the interview on 2/5/2022 at 10 a.m., the office staff stated that patient was to be seen today. On 2/5/2022 at 11 a.m., a joint home visit was conducted with Registered Nurse 3 (RN 3) to perform Patient 8's start of care assessment. RN 3 reviewed and provided the consents for home health services to Patient 8 and patient caregiver (PCG) in english. However, Patient 8’s PCG was observed translating the questions asked by RN 3 from english to spanish. During a concurrent interview with PCG, PCG stated that they would like the information in spanish rather than english. Patient 8 does not read and speak English.

HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator's name, business address, and business phone number in order to receive complaints. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to provide their contact information including the administrator’s name, business address, and business phone number to receive complaints for 2 of 17 sampled patients, Patients 1 and 3. This deficient practice had the potential that patients under the home health agency’s care are not able to contact the agency for any concerns regarding the provision of their care. a. During a review of Patient 1’s clinical record, the document titled, “Home Health Certification and Plan of Care (POC)”, with the certification period from 2/3/2022 to 4/4/2022, indicated a start of care (SOC) date on 2/3/2022, with diagnosis that included pressure ulcer, stage 4 (deep wounds that reach the muscle or bone), paraplegia (inability to move legs). During an interview on 2/6/2022 at 10:22 a.m., Registered Nurse 2 (RN 2) stated that during the first visit, one of the tasks of the HHA nurse was supposed to explain the purpose of the visit and provide a folder to the patient with the written information regarding their rights. RN 2 also stated that the HHA nurse should ask the patient to sign the consent forms after it had been explained. During an interview on 2/6/2022 at 11:57 am, RN 3 stated she did not provide a written information regarding how to contact the administrator on the first visit on 2/3/2022 because she ran out of consents and needed to stop by the office to get more. RN 3 also stated she would have given the HHA information and have Patient 1 sign the consents later. During a home visit and concurrent interview on 2/6/2202 at 4:05 p.m., Patient 1 stated that when the nurse visited him on 2/3/2022, the HHA nurse did not leave any information to him in writing and had not signed any paperwork. Patient 1 also stated he needed all information in Spanish, his preferred language. b. A review of Patient 3’s clinical record titled, “Home Health Certification and Plan of Care (POC) for the certification period 12/18/2021 to 2/15/2022, indicated an SOC date of 10/17/2021, with diagnosis that included urinary tract infection, primary hypertension (high blood pressure), sepsis (infection in the blood), and unspecified severe protein-calorie malnutrition (deficient in protein and calorie intake). During a home visit interview on 2/5/2022 at 7 p.m., Patient Representative 1 (PR 1) stated the HHA did not give them a folder that contained information about the agency, patient rights, consents, or contact information and was 99% positive the agency did not leave any information or folder. PR 1 also stated that Patient 3 had signed for verification of nurse visits and no other forms. A review of the facility’s undated policy and procedures titled, “Agency Consent”, indicated that each patient admitted is given written and verbal information regarding rights by the admitting nurse regarding any care being rendered; the admitting professional reviews the Patients’ Rights and Responsibilities with the patient; the patient or caregiver signs an acknowledgement of receipt of the information; the original signed acknowledgement is placed in the patient’s medical record in the agency and a copy placed in the patient’s home folder.

Patient's or legal representative's signature CFR(s): 484.50(a)(2) Obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the HHA failed to obtain the signature of the patient or legal representative to confirm that they had received a copy of the notice of rights and responsibilities for two of 17 sampled patients, Patients 1 and 3. This failure had the potential that the affected patients and the other patients under the agency’s care did not receive a copy of the notice of their rights and responsibilities while under the agency’s care. A review of Patient 1’s clinical record titled, “Home Health certification and plan of care (POC) for the certification period 2/3/2022 to 4/4/2022, indicated a start of care (SOC) date of 2/3/2022, with diagnosis that included pressure ulcer, Stage IV (wounds that reach the muscle or bone) pressure ulcer, and paraplegia (inability to move legs). During an interview on 2/6/2022 at 10:22 a.m., Registered Nurse 2 (RN 2) stated that during the first visit, one of the tasks of the HHA nurse was supposed to explain the purpose of the visit and provide a folder to the patient with the written information regarding their rights. RN 2 also stated that the HHA nurse should ask the patient to sign the consent forms after it had been explained. During an interview on 2/6/2022 at 11:57 a.m., RN 3 stated she did not provide any written information or obtain Patient 1's signature on the consent for the services during the first visit on 2/3/2022 because she ran out of blank consent form and needed to stop by the office to get more and have Patient 1 sign the consents later. During a home visit and concurrent interview on 2/6/2202 at 4:05 p.m., Patient 1 stated that when the nurse visited him on 2/3/2022, the HHA nurse did not leave any information to him in writing and had not signed any paperwork. During a home visit observation on 2/6/2022 at 4:20 p.m., RN 2 gave Patient 1 a folder that contained information in English about consents, patient’s rights, contact information, and other documents regarding the HHA. RN 2 did not obtain the patient’s signature on the consent forms. A review of Patient 3’s clinical record titled, “Home Health Certification and Plan of Care (POC) for the certification period 12/18/2021 to 2/15/2022, indicated an SOC date of 10/17/2021, with diagnosis that included urinary tract infection, primary hypertension (high blood pressure), sepsis (infection in the blood), and unspecified severe protein-calorie malnutrition (deficient in protein and calorie intake). During a home visit interview on 2/5/2022 at 7 p.m., Patient Representative 1 (PR 1) stated the HHA did not give them a folder that contained information about the agency, patient rights, consents, or contact information and was 99% positive the agency did not leave any information or folder. PR 1 also stated that Patient 3 had signed for verification of nurse visits and no other forms. A review of the facility’s undated policy and procedures titled, “Agency Consent”, indicated that each patient admitted is given written and verbal information regarding rights by the admitting nurse regarding any care being rendered; the admitting professional reviews the Patients’ Rights and Responsibilities with the patient; the patient or caregiver signs an acknowledgement of receipt of the information; the original signed acknowledgement is placed in the patient’s medical record in the agency and a copy placed in the patient’s home folder.

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 provide services as indicated in the plan of care for three of 17 sampled patients, Patients 1, 5 and 8. This deficient practice can affect the quality of care provided to the patients and can result to a delayed healing due to missed treatments. b. During a review of Patient 1’s clinical record, the document titled, “Home Health Certification and Plan of Care (POC)”, with the certification period from 2/3/2022 to 4/4/2022, indicated a start of care (SOC) date on 2/3/2022, with diagnosis that included pressure ulcer, stage 4 (deep wounds that reach the muscle or bone), paraplegia (inability to move legs). A review of Patient 1’s clinical record titled, “Home Health Certification and Plan of Care”, for the certification period of 2/3/2022 to 4/4/2022 indicated “RN-7 time(s) a week for 8 week (s)”. During an interview on 2/5/2022 at 2:45 p.m., Patient 1 stated a nurse was supposed to visit and provide wound treatment on 2/4/2022, but the nurse did not come. Patient 1 also stated that RN 3 visited him initially on 2/3/2022 and informed Patient 1 someone will come daily to help him with his wounds. During an interview and concurrent record review with RN 1 on 2/6/2022 at 11:09 a.m., Patient 1’s untitled medical record dated 2/4/2022 at 11:59 p.m., indicated a documentation by RN 3 the reason for the missing patient visit was due to Patient 1’s refusal and was requesting for spanish speaking clinician only. RN 1 was unable to find documentations that other measures were taken to ensure visit will be made and stated that there should have been a translator provided to communicate with Patient 1 or transfer the care to a HHA that can provide the services requested. During an interview on 2/6/2022 at 11:14 a.m., Patient 1 stated he did not receive wound care on 2/5/2022 and the agency did not reschedule any visits with him on 2/6/2022. During an interview and concurrent record review on 2/6/2022 at 11:09 a.m. with RN 1, the Patient 1’s untitled medical record dated 2/5/2022 at 11:59 p.m., indicated RN 4’s documentation of the reason for Patient 1’s missing visit was because there was no spanish speaking staff. RN 1 also stated Patient 1 did not refuse care, but he was requesting for a staff who can speak his spanish language. RN 1 also stated that Patient 1 was at high risk of injury due to his medical problems and he can get very sick to the point that his life is in danger. During an interview on 2/6/2022 at 11:25 a.m., RN 4 stated Patient 1 was on her assignment to provide wound care on 2/5/2022 and 2/6/2022. RN 4 stated she spoke to Patient 1 over the phone on 2/4/2022 and informed her that he had refused services due to the language barrier. RN 4 stated Staff 1 was notified on 2/4/2202 to assign Patient 1 a different nurse. RN 4 also stated she did not feel she needed to inform RN 1, RN 2, or the Administrator of the missed treatment visits because she believed Staff 1 would send a nurse who spoke Patient 1’s language. When asked, RN 4 stated when wound care is not being provided, the wound healing will be delayed and the risk for infection is higher. During a review of Patient 1’s referral titled “Providence”, dated 1/31/2022, indicated “Wound care to right trochanter/sacrococcyx/ left ischial tuberosity dressing change frequency daily.” c. During a review of Patient 5’s clinical record, the document titled, “Home Health Certification and Plan of Care (POC), for the certification period of 12/15/2021 to 2/13/2022, indicated the start of care (SOC) date for Patient 5 was 10/17/2021, with diagnosis that included acute pancreatitis (inflammation of the pancreas), and encounter for adjustment and management of VAD (vascular access device). A review of Patient’s 5 clinical record titled, “Home Health Certification and Plan of Care (POC), for the certification period of 12/15/2021 to 2/13/2022, indicated “RN- 1 time(s) a week for 8 week(s). During an interview on 2/14/2022 at 3:35 p.m., RN 2 stated she could not find other visit notes to indicate PICC line was given weekly except on 12/15/2021 when Patient 5 received PICC line care. RN 2 also stated Patient 5 should have received the next PICC line care on 12/22/21. During a review of Patient 8's clinical record, the document titled "Patient Information", indicated Patient 8 was admitted to general acute care hospital (GACH) on 1/12/2022, with a diagnosis of gram-negative bacteremia (a bacterial infection in the blood and is resistant to antibiotic treatment. A review of the GACH’S “Patient Orders” from the primary care providers (PCP) dated 1/19/2022, indicated, “I certify based on my finding, the following services are medically necessary home health services. Start of care date will be within 48 hours unless otherwise specified.” During the review of the clinical record for Patient 8, the documentation did not indicate that the home health agency admitted Patient 8 for home health services within 48 hours as per PCP on 1/19/2022. There was no documentation that the PCP was notified or had approved the delay in start of care. The home health agency’s current census for 2/5/2022 indicated Patient 8 had a start of care date of 2/5/2022. During the interview on 2/5/2022 at 10 a.m., the office staff stated that patient was to be seen today. On 2/5/2022 at 11 a.m., a joint home visit was conducted with Registered Nurse 3 (RN 3) to perform Patient 8's start of care assessment. RN 3 reviewed and provided the consents for home health services to Patient 8 and PCG in english. However, Patient 8’s PCG was observed translating the questions asked by RN 3 and the survey team from english to spanish. During a concurrent interview with PCG, PCG stated that they would like the information in spanish rather than english. Patient 8 does not read and speak English.

Transfer and discharge CFR(s): 484.50(d) Standard: Transfer and discharge. The patient and representative (if any), have a right to be informed of the HHA's policies for transfer and discharge. The HHA may only transfer or discharge the patient from the HHA if: This STANDARD is not met as evidenced by: Based on observation, interview and record review the HHA failed to provide an advance written notice of transfer and discharge rights during the initial evaluation or prior to providing care for two of 17 sampled patients, Patients 1 and 3. This deficient practice had the potential that patient’s needs will not be properly assessed and determined by the staff and had the potential to affect the quality of care provided to the all the patients under the agency’s care. a. During a review of Patient 1’s clinical record, the document titled, “Home Health Certification and Plan of Care (POC)”, with the certification period from 2/3/2022 to 4/4/2022, indicated a start of care (SOC) date on 2/3/2022, with diagnosis that included pressure ulcer, stage 4 (deep wounds that reach the muscle or bone), paraplegia (inability to move legs). During an interview on 2/6/2022 at 10:22 a.m., Registered Nurse 2 (RN 2) stated that during the first visit, one of the tasks of the HHA nurse was supposed to was explain the purpose of the visit and provide a folder to the patient with the written information regarding their rights. RN 2 also stated that the HHA nurse should ask the patient to sign the consent forms after it had been explained. During an interview on 2/6/2022 at 11:57 a.m., RN 3 stated she did not provide any written information or obtain Patient 1's signature on the consent for the services during the first visit on 2/3/2022 because she ran out of blank consent form and needed to stop by the office to get more and have Patient 1 sign the consents later. During a home visit and concurrent interview on 2/6/2202 at 4:05 p.m., Patient 1 stated that when the nurse visited him on 2/3/2022, the HHA nurse did not leave any information to him in writing and had not signed any paperwork. Patient 1 also stated he needed all information in Spanish, his preferred language. During a home visit observation on 2/6/2022 at 4:20 p.m., RN 2 gave Patient 1 a folder that contained information in English about consents, patient’s rights, contact information, and other documents regarding the HHA. RN 2 did not obtain the patient’s signature on the consent forms. b. A review of Patient 3’s clinical record titled, “Home Health Certification and Plan of Care (POC) for the certification period 12/18/2021 to 2/15/2202, indicated an SOC date of 10/17/2021, with diagnosis that included urinary tract infection, primary hypertension (high blood pressure), sepsis (infection in the blood), and unspecified severe protein-calorie malnutrition (deficient in protein and calorie intake). During a home visit interview on 2/5/2022 at 7 p.m., Patient Representative 1 (PR 1) stated the HHA did not give them a folder that contained information about the agency, patient rights, consents, or contact information and was 99% positive the agency did not leave any information or folder. PR 1 also stated that Patient 3 had signed for verification of nurse visits and no other forms. On 2/6/2202 at 11:56 a.m., a request was made to Staff 1 for a copy of admission consents for Patient 3, however staffs were unable to provide the requested documents. On 2/7/2022 at 10:52 a.m., a request was made to Staff 1 for a copy of admission consents for Patient 3, however staffs were unable to provide the requested documents. On 2/15/2022 at 9:30 a.m., a request was made to Staff 1 for a copy of admission consents for Patient 3, however staffs were unable to provide the requested documents. A review of the facility’s undated policy and procedures titled, “Agency Consent”, indicated that each patient admitted is given written and verbal information regarding rights by the admitting nurse regarding any care being rendered; the admitting professional reviews the Patients’ Rights and Responsibilities with the patient; the patient or caregiver signs an acknowledgement of receipt of the information; the original signed acknowledgement is placed in the patient’s medical record in the agency and a copy placed in the patient’s home folder.

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Comprehensive Assessment of Patients as follows: HHA failed to conduct an initial visit within 48 hours of the patients return home for 2 of 17 (Patient 7 and 8). (G-514) HHA failed to ensure the comprehensive assessment accurately reflected the patient’s continuing need for home care for 2 of 17 sampled patients (Patient 2 & 10). (G-532) HHA failed to ensure 1 of 17 sample patients social needs were assessed and evaluated by a social worker. This deficient practice delayed in patient current living status. (G-534) HHA failed to review and document all the medications being taken by 2 of 17 sampled patients (Patient 5 and Patient 6). (G-536) HHA failed to document the information about the patient’s primary physician in the comprehensive assessment for 4 of 17 sampled patients (Patient 1, Patient 4, Patient 5, and patient 7). (G-538) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with the Federal regulations for Comprehensive Assessments of patients to ensure home health care benefits are verified for eligibility to patients provided home health services.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on interview and record review, the HHA failed to conduct an initial assessment visit within 48 hours of the patients return home for 2 of 17 (Patient 7 and 8). This deficient practice placed the patient at risk of re-hospitalization due to the delay in assessment. Patient 7’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period 12/29/2021 to 2/17/2022, indicated the star of care (SOC) date for Patient 7 was 12/29/2021, with diagnoses of chronic obstructive pulmonary disease with acute exacerbation and chronic diastolic congestive heart failure (hear unable to pump blood effectively to the body). During a concurrent interview and record review on 2/14/22, at 3:15 p.m., of Patient 7’s medical record titled, “RN OASIS SOC”, dated 12/29/21, indicated “Hospitalization assessment #1 discharge date 12/23/2021”. RN 1 stated the start of care visit was on 12/29/21 and Patient 7 should have been seen the following day following hospitalization on 12/24/21. RN 1 stated visits can be made at a later date if there is a physician’s order to indicate a different start of care date. RN 1 stated there was no order for Patient 7 to start care at a different date. RN 1 stated Patient 7 was placed at risk of re-hospitalization because nobody saw the patient for 5 days. A review of Patient 7’s referral to the HHA agency, dated 12/16/21, indicated “DC plan for tomorrow with home abx” (antibiotics). A review of the facility’s undated policy and procedures titled, “New Patients Admission”, indicated “Admit patient into agency-Once the agency determines that it can meet the needs of the patient, it will admit the patient and assess the patient within 48 hours. If the patient refused to be seen or cannot be seen within the 48 hours, the nurse will communicate with the physician to gain approval for the late start of care”. On 2/5/22, a review of the home health agency’s current census, indicated Patient 8, start of care date of 2/5/22, During an interview with office staff on 2/5/22, in the office, she stated the patient was to be seen today, however, the appointment was changed due to the daughter being unavailable and having to move their dogs. A review of patient 8, Patient Information form indicated Patient 8 was admitted to General Acute Care Hospital (GACH) on 1/12/22, with a diagnosis of Gram-Negative Bacteremia (a bacteria that can get into the blood stream and is resistant to antibiotic treatment. A review of the GACH’S “PATIENT ORDERS” from the Primary Care Providers (PCP) dated 1/19/22, stipulated, “I certify based on y finding, the following services are medically necessary home health services. Start of care date will be within 48 hours unless otherwise specified.” During a joint home visit for the start of care with patient 8, RN… , [RL1] and Patient caregiver (PCG). RN 3 reviewed and provided the consents for HH service to patient 8 and PCG in English. Patient 8’s PCG translated the questions from RN and surveyor in Spanish to Patient 8. Patient 8,s PCG stated he is a diabetic( high blood sugar) on oral medication from Mexico, patient 8 has End Stage Renal Disease ( a medical condition in which a person’s kidneys cease functioning on a permanent basis leading to the need for regular course of long-term dialysis or kidney transplant), in which he gets dialysis three times a week and was hospitalized due infection and had a right IJ tunneled placed at the GACH on 12/721, for his hemodialysis. The PCG also stated, patient 8 is blind out of left eye and only drinks 4 oz. of water a day. During the visit, patient 8 and PCG stated, they would like the information in Spanish since PCG has to work and Patient 8 does not read English. There was no documentation that the PCP was notified or approved the delay in start of care.

Continuing need for home care CFR(s): 484.55(c)(3) The patient's continuing need for home care; This ELEMENT is not met as evidenced by: Based on interview and record review, the HHA failed to ensure the comprehensive assessment accurately reflected the patient’s continuing need for home care for 2 of 17 sampled patients (Patient 2 & 10). This deficient practice has the potential for the patient receiving home health services he did not need. Patient 2’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 11/6/2021 to 1/5/2022, indicated the start of care (SOC) date for patient 2 was 11/6/2021, with diagnosis of idiopathic aseptic necrosis of bone (bone infection). During a concurrent interview and record review on 2/14/22, at 2:45 p.m., with RN 2, Patient 2’s medical record titled “Skilled Nursing Notes”, indicated: 11/12/21: “Skilled treatment provided: none at this time” 11/17/21: “Skilled treatment provided: none at this time” 11/24/21: “Skilled treatment provided: nothing for today” 12/4/21: “Skilled treatment provided: Safety evaluation” 12/9/21: “Skilled treatment provided: safety evaluation” 12/15/21: “Skilled treatment provided: none” RN 2 stated Patient 2’s wound had closed and the other wound was being cared for by his doctor. RN 2 stated there was no need for nursing services. RN 2 stated there was no documented reason or justification for the skilled nursing visits. During a concurrent interview and record review on 2/14/22, at 2:52 p.m., with RN 1, Patient 2’s medical record titled, “RN OASIS Recertification Notes”, dated 1/5/22 indicated “This assessment is currently being completed for the following reason Recertification reassessment”. RN 1 stated there was no need for nursing services. RN 1 stated Patient 2 should have been discharged from the agency on 1/5/22. RN 1 stated the documentation did not support justification for skilled nursing services, nor did it reflect the current status of the patient in the OASIS recertification assessment. A review of the HHA census provided to the survey team on 2/4/22, indicated Patient 2’s status to be “active”. A review of the facility’s undated policy and procedures titled, “Recertification and Discharge”, indicated “Tender Home Health will discharge a patient when he/she is fully capable of providing his/her own needs”. A review of patient 10’s Electronic clinical record of Patient 10 indicated a SOC of 12/20/2021, for the certification period of 12/20/21to 2/17/2021, with diagnoses of Injury of nerves at ankle and foot level, right leg and Gullain Barre’ syndrome (A condition where the Immune system attack the nerves causing weakness, tingling in feet and legs to the upper body, Paralysis’s can occur). Patient 10 was wheelchair bound and lived in an Assisted living Facility (ALF- a housing facility for adults with disabilities, adults who cannot or choose not to live independently).” Review of the Plan of care (CMS 485) included Physical Therapy (PT) to visit 2 times a week for 4 weeks to include balance training, transfer training, mobility training, therapeutic exercise program, safety training, fall prevention, and caregiver training to improve independence with functional mobility to decrease fall risk. During a joint home visit with the the RN 3, Patient 10 could not be found to conduct the scheduled home visit. RN 3 and the survey team were informed by the ALF staff, "if Patient 10 is not here he wheeled himself to the Stater Bros Market or was hanging out at the Market". Review of Patients 10’s RN Evaluation Notes dated 12/21/2021, instructed Skilled Nurse frequency 1w1, 1w8, to assess vital signs, medication management, and signs and symptoms of complications/exacerbation necessitating attention. Physical therapy to evaluate for home safety training and strengthen exercise. There were no signed physician's progress notes and assessment to clearly demonstrate the continuing need for the patient to receive HH services.

Patient's needs CFR(s): 484.55(c)(4) The patient's medical, nursing, rehabilitative, social, and discharge planning needs; This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency failed to ensure the patients social needs were assessed and evaluated by a social worker for one of 17 sample patients (Patient 9). This deficient practice has the potential in the delay of determining the social needs of the patient current living status. A review of the HHA’s current census given to the survey team on 2/5/22, indicated patient 9’s start of care date as 12/18/22, A review of Patient 9, s Plan of care indicated patient 9’s start of 4/27/21, for the certification period of 10/31/21 to 12/28/2021. Review of the Prescribed Orders for the period of services Covered from 3/3/2021 to 3/3/2022, indicated patient 9’s diagnosis of Myasthenia gravis (a weakness and rapid fatigue of muscles and under voluntary control which is caused by a breakdown in communication between nerves and muscles.) The Prescribed order instruct Skilled Nurse (SN) to administer/teach Gamunex-C 40G IV Q week Via Port A Cath and for the SN to administer care for vascular access device per agency policy and Catheter Flush per SASH( Saline-Administration-Saline Heparin- flushing steps used before and after each infusion of a catheter) protocol of Heparin 100 units/milligram) 5 ml PFS., SIG: 5 ml SASH PORT line flush and Normal Saline 10 ml PFS, SIG: 10-20 ml SASH PORT line flush. During a joint home visit with RN 3, Patient 9 stated she has been with this home health agency for 6 years and RN 3 stated he has been providing weekly IV infusions to patient 9 for 5 years. Patient 9 stated during the home visit that she was receiving physical therapy due to her need to get up/downstairs in her house and getting in her car. Patient 9 stated she needs to relocate to another residence due to the stairs and has been having a hard time trying to find one due to her income. During an interview with the RN 3 on 2/6/2022, via telephone in the HHA’s conference room, he stated he would have liked to refer Patient 9 to see a social worker but never did. A review of Patients 9’s POC, orders for PT and prescriber orders were not signed by the Primary Care Physician.

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 interview and record review, the HHA failed to review and document all the medications the patient is currently using for 2 of 17 sampled patients (Patient 5 and Patient 6). This deficient practice placed patients at risk of drug to drug interaction and harm by not knowing which medications the patients were taking. a. Patient 5’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 12/15/2021 to 2/13/2022, indicated the start of care (SOC) date for Patient 5 was 10/17/2021, with diagnoses which included acute pancreatitis (inflammation of the pancreas), and encounter for adjustment and management of VAD (vascular access device). During concurrent observation and interview during a home visit on 2/11/22, at 3:41 p.m., Patient 5 showed the surveyor the medications she was taking and stated she was taking the following medications: Creon 36,000 unit 1 capsule by mouth three times a day Metformin 500 mg by mouth twice a day Eliquis 5 mg 1 tablet by mouth twice a day. A review of Patient 5’s record titled, “RN OASIS Recertification Notes”, dated 12/15/22, indicated “mediation profile”. No medications were listed for Patient 5. b. Patient 6’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 1/13/2022 to 3/14/2022, indicated the start of care (SOC) date for Patient 6 was 1/13/2022, with a diagnosis of urinary tract infection. During a concurrent observation and interview during a home visit on 2/11/22 at 11:15 a.m., CV 4 showed the surveyor the medications she was taking and stated she was taking the following medications: Levetiracetam 500 mg 1 tablet by mouth daily. Methenamine 1 gm twice a day. Vitamin C 1000 mg every day Folic Acid 1 mg tablet every day Zinc 50 mg 1 tablet every day Cranberry pills twice daily as needed for UTI (urinary tract symptoms). Probiotics Melatonin 10 mg as needed for sleep. A review of Patient 6’s record titled, “RN OASIS SOC Notes”, dated 1/13/22, indicated “mediation profile”. No medications were listed for Patient 6. During an interview on 2/14/22, at 3:35 p.m., RN 2 stated medications needed to be reviewed and the medication profile updated every visit and re-certification period. RN 2 stated this process was important because there can be medication duplicates and contraindications which can put the patient at risk of harm. A review of the facility’s undated policy ad procedure titled, “Medication Administration”, indicated “4. During the admission process and throughout the course of care the nurse will review all current medication the patient is taking, notations will be made on the medication list of new changed and discontinued medication (all which must be verified with the physician).

Primary caregiver(s), if any CFR(s): 484.55(c)(6)(i,ii) The patient's primary caregiver(s), if any, and other available supports, including their: (i) Willingness and ability to provide care, and (ii) Availability and schedules; This ELEMENT is not met as evidenced by: Based on interview and record review, the HHA failed to document the information about the patients primary caregiver in the comprehensive assessment for 4 of 17 sampled patients (Patients 1, 4, 5, and 7). a. Patient 1’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 2/3/2022 to 4/4/2022, indicated the start of care (SOC) date for Patient 1 was 2/3/2022, with diagnoses which included pressure ulcer, stage 4 (deep wounds that reach the muscle or bone), paraplegia (inability to move legs). During an interview at a home visit on 2/6/22, at 4:05 p.m., Patient 1 stated he has had a primary doctor for 25 years. Patient 1 stated his primary doctors knows his medical conditions very well and has great trust in him. A review of Patient 1’s medical record titled, “RN OASIS SOC Notes”, dated 2/3/2022, did not indicate the patient’s primary caregiver. b. Patient 4’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 1/7/2022 to 3/7/2022, indicated the start of care (SOC) date for Patient 4 was 1/7/2022, with diagnosis of encounter for adjustment and management of VAD (vascular access device). A review of Patient 4’s medical record titled, “RN OASIS SOC Notes”, dated 1/7/22, did not indicate the patient’s primary caregiver. c. Patient 5’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 12/15/2021 to 2/13/2022, indicated the start of care (SOC) date for Patient 5 was 10/17/2021, with diagnoses which included acute pancreatitis (inflammation of the pancreas), and encounter for adjustment and management of VAD (vascular access device). During an interview on 2/11/22, at , Patient 5 indicated the name of her primary care physician. Patient 5 stated she has had this primary care physician for over 10 years. A review of Patient 5’s medical record titled, “RN OASIS SOC Notes”, dated 10/16/21, did not indicate the patient’s primary caregiver. d. Patient 7’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period 12/29/2021 to 2/17/2022, indicated the star of care (SOC) date for Patient 7 was 12/29/2021, with diagnoses of chronic obstructive pulmonary disease with acute exacerbation and chronic diastolic congestive heart failure (hear unable to pump blood effectively to the body). A review of Patient 7’s medical record titled, “RN OASIS SOC Notes”, dated 12/19/21, did not indicated the patient’s primary caregiver. A review of the facility’s undated policy and procedure titled, “Case Management”, indicated “Once the initial visit is completed, the registered nurse must contact the physician…for initial updates on the patient”.

Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This ELEMENT is not met as evidenced by: Based on interview and record review, the HHA failed to update the comprehensive assessment to when a change of condition occurred for 3 of 17 sampled patients (Patients 2, 3, and 5). This deficient practice has the potential to result result in the patients receiving services they did not need. a. A review of Patient 2’s clinical record included a form titled, “Home Health Certification and Plan of Care (POC), certification period from 11/6/2021 to 1/5/2022. Patient 2's start of care (SOC) date was 11/6/2021, with diagnosis of idiopathic aseptic necrosis of bone (bone infection). During a concurrent interview and record review on 2/14/22, at 2:45 p.m., with RN 2, of Patient 2’s medical record titled “Skilled Nursing Notes”, indicated: 11/12/21: “Skilled treatment provided: none at this time” 11/17/21: “Skilled treatment provided: none at this time” 11/24/21: “Skilled treatment provided: nothing for today” 12/4/21: “Skilled treatment provided: Safety evaluation” 12/9/21: “Skilled treatment provided: safety evaluation” 12/15/21: “Skilled treatment provided: none” RN 2 stated the skilled nursing visits should have been focused to provide wound care or check the status of the wound. RN 2 stated Patient 2’s wound had closed and the other wound was being cared for by his doctor. RN 2 stated there was no need for nursing services. RN 2 stated there was not documented reason or justification for the skilled nursing visits. During a concurrent interview and record review on 2/14/22, at 2:52 p.m., with RN 1, of Patient 2’s medical record titled, “RN OASIS Recert Notes”, dated 1/5/22 indicated “This assessment is currently being completed for the following reason Recertification reassessment”. RN 1 stated there was no need for nursing services. RN 1 stated Patient 2 should have been discharged from the agency on 1/5/22 when it was determined that the patient no longer needed HHA services. A review of the HHA census provided to the survey team on 2/4/22, indicated Patient 2’s status to be “active”. b. A review of Patient 3’s clinical record indicated the start of care (SOC) of 10/17/2021, with diagnoses which included urinary tract infection, primary hypertension (high blood pressure), sepsis (infection in the blood), and unspecified severe protein-calorie malnutrition (not enough protein and calories eaten). During an interview on 2/5/22, at 7:00 p.m., CV 3 stated Patient 3 was transferred to the hospital for treatment on 1/27/22, and then to hospice care, as recommended by his doctor on 2/6/22. During an interview on 2/14/22, at 1:23 p.m., RN 4 stated CV 3 notified her of Patient 3’s hospitalization on 1/27/22. RN 4 stated an OASIS transfer to inpatient note should have been entered once there was knowledge the patient was hospitalized on 1/27/22. During a concurrent interview and record review on 2/4/22, at 12: 13 p.m., of Patient 3’s record titled, “OASIS Transfer Notes”, dated 2/6/22, was reviewed. The record indicated “This assessment is currently being completed for the following reason: transferred to an inpatient facility not discharged from agency”. RN 2 stated the record was not correct. RN 2 stated the entry indicated he was not discharged from the agency, which is not the case; he should have been discharged from the agency when he began hospice care on 2/6/22. A review of the facility’s undated policy and procedure titled, “Transfer/Resumption of Care”, indicated “A patient admission of 24 hours or more will require a transfer OASIS to be completed”. A review of the HHA census provided to the survey team on 2/4/22, indicated Patient 3’s status to be “active”. c. A review of Patient 5’s clinical record included a form titled, “Home Health Certification and Plan of Care (POC), certification period from 12/15/2021 to 2/13/2022, indicated the start of care (SOC) date for Patient 5 was 10/17/2021, with diagnoses which included acute pancreatitis (inflammation of the pancreas), and encounter for adjustment and management of VAD (vascular access device). During an interview on 2/11/22, at 2:10 p.m., RN 2 stated the reason the patient was continued on HHA services was for PICC line care. During concurrent observation and interview during a home visit on 2/11/22, at 3:41 p.m., Patient 5 stated the PICC line was removed on 12/17/21. Patient 5 stated she continued to receive visits from the HHA. RN 2 was observed telling the patient the purpose of the visit was to discharge her from the HHA. During an interview on 2/11/22, at 4:05 p.m., RN 2 stated the patient should have been discharged from the agency when the PICC line care was no longer needed upon removal of the line on 12/17/21. RN 2 stated an OASIS discharge should have been done earlier in the care instead of 2/11/22. A review of the HHA census provided to the survey team on 2/4/22, indicated Patient 5’s status to be “active”. A review of the facility’s undated policy and procedures titled, “Recertification and Discharge”, indicated “Tender Home Health will discharge a patient when he/she is fully capable of providing his/her own needs”.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on record review and interview, the HHA failed to ensure a comprehensive assessment at discharge would include a summary of the patient's progress in meeting the care plan goals for 2 of 17 sample patients ( Patients 11 and 12). This deficient practice has the potential to result in the patients progress not being assessed. 1. A review of Patient 11’s plan of care in the agency’s electronic record indicated a start of care of 10/8/2021, for the certification period of 12/7/2021 to 2/5/2022, with diagnoses of disorder of the kidney and ureter ( diabetes mellitus without complication ( high blood sugar), Acute kidney failure ( A condition in which the kidneys suddenly can’t filter waste from the blood.)the duct by which urine passes from the kidneys to the bladder or cloaca.) and Urinary tract infection ( infection in any part of your urinary system). The physician ordered the Registered Nurse (RN) to re-admit patient to HHA and to visit patient one time a week for 8 weeks to assess vital signs, medication management, and signs and symptoms of complication/exacerbation necessitating medical attention and for Physical Therapy to re-evaluate for home safety training and strengthening exercises. During an attempt to schedule a home visit with patient 11, Staff 1 informed the surveyor she just found out patient 11 was discharged on 2/5/22. There was updated comprehensive assessment which included a summary and patients progress in meeting the care plan goals. 2. A review of Patient 12’s Plan of Care for the certification period of 12/4/2021 to 2/2/2022, indicated patient 12 was admitted to the home health on12/4/2021, with diagnoses of Urinary tract infection (UTI-) and encounter/adjustment of VAD (Vascular access Device (any device utilized for venous access regardless of location-Peripherally Inserted Central catheter (PICC line). The Physician instructed the RN to visit patient 12 one a week for 4 weeks administer ertapenem( an antibiotic that treats severe bacteria of the skin, lungs stomach ,pelvis, and urinary tract 1gm/100 ml every 24 hrs. Via PICC line, flush line using SASH protocol (Saline- Administration-Saline-Heparin), labs on Monday, PICC dressing to be changed every 7 days. Review of Patient 12's electronic clinical record indicated the patient was discharge from the home health agency on 1/5/22. There was no updated comprehensive assessment which included a summary and patients progress in meeting the care plan goals.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on interview and record review, the HHA failed to send all necessary medical information to the receiving health care practitioner of the patient's transfer to another service for 1 of 17 patients (Patient 3). This deficient practice has the potential to affect the continuity of care provided to the patient. Patient 3’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 12/18/2021 to 2/15/2022, indicated the start of care (SOC) date for Patient 3 was 10/17/2021, with diagnoses which included urinary tract infection, primary hypertension (high blood pressure), sepsis (infection in the blood), and unspecified severe protein-calorie malnutrition (not enough protein and calories eaten). During an interview on 2/5/22, at 7:00 p.m., CV 2 stated Patient 3 was transferred to the hospital for treatment on 1/27/22, and then to hospice care, as recommended by his doctor on 2/6/22. During an interview on 2/15/22, at 12:13 p.m., RN 2 stated Patient 3 was transferred to hospice care on 2/6/22. RN 2 stated she did not know the name of the hospice facility, nor did she know if the HHA had sent the medical information to the hospice facility. The HHA did not provide evidence of sending all necessary medical information to the hospice agency.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to meet the Condition of Participation for Care planning, Coordination, and Quality of care as follows: HHA failed to ensure 6 of 17 sampled patients (Patients 1, 8, 9, 10, 11 and 12), received care according to their plans of care (G572). HHA failed to include information required in the plan of care for 11 of 17 sampled patients (Patients 1, 2, 3, 4, 5, 7, 8, 9, 10, 11 and 12 ). (G574). HHA failed to administer drugs, services, and treatments as ordered by the physician for 2 of 17 sampled patients (Patients 3 and 4). (G580) HHA facility failed to ensure 5 of 17 patient's physician (Patient 1, 8, 9, 10, and 11) was notified when treatments were not provided on 2/4/22 and 2/5/22. (G602) HHA facility failed to ensure pain was being managed for 1 of 17 sampled patient (Patient 1). (G606) HHA failed to coordinate care delivery to meet the patient's needs and representative in coordination of care activities of patients for 1 of 17 patients (Patient 1). (G608) HHA failed to provide written information regarding the plans of care for 2 of 17 patients (Patients 1 and 3. (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 facility failed to ensure each patient received treatments or services in accordance with the written plan of care for 6 of 17 sampled patients (Patient 1, 8, 9, 10, 11, and 12) by failing to: Ensure Patient 1 received treatments on the patient’s stage 4 pressure sores (deep wounds that reach the muscle or bone) on the sacral (bone at the base of the spine), right trochanter (hip), and left ischial tuberosity (lower part of the pelvis) daily on 2/4/22 and 2/5/22 as indicated in the physician’s referral and plan of care.Ensure a Spanish-speaking licensed nurse or translator was provided as requested by Patient 1 for the continuity of care.Ensure Patient 1’s physician was notified when the treatments were not provided to Patient 1 on 2/4/22 and 2/5/22.Ensure assessments and visits were done per plan of care for Patient 8, 9, 10, 11 and 12. These deficient practices resulted in Patient 1 not received the treatments to his pressure sores for two days (2/4/22 and 2/5/22).” During a treatment observation on 2/6/22, the dressings covering the pressure sores were dry, the pressure sores started bleeding when the dressings were removed, and Patient 1 exhibited facial grimacing as sign of discomfort. These deficient practices also had the potential to result in delay wound healing of pressure sores, worsening of pressure sores that can result in infection that could lead to hospitalization and/or death and delay in care and services. On 2/7/22 at 12: 50 p.m., an Immediate Jeopardy (IJ, a situation in which the facility’s noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) was identified in the presence of the agency’s Administrator (ADM), Registered Nurse 1 (RN 1), and Staff 3 for the agency’s failure to ensure Patient 1 received treatments on the patient’s stage 4 pressure sores as indicated in the physician’s referral and plan of care. On 2/12/22 at 10:00 a.m., the IJ was removed after the agency submitted an acceptable IJ Removal Plan in the presence of the agency office staff and the Director of Nurses (DON) was on the phone was notified. The survey team verified and confirmed on-site the implementation of the removal plan through observation, interview, and record review. The accepted IJ Removal Plan included the following actions: Revised agency’s policy on Missed Visits.Hired several Spanish-speaking nurses as well as other languages.Daily wound care patient will be monitored.All patients with wounds will be reviewed by one of the following staff members to ensure that patients are being properly cared for.Started emergency nurse meeting/in-service. a. Patient 1’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 2/3/2022 to 4/4/2022, indicated the start of care (SOC) date for Patient 1 was 2/3/2022, with diagnoses which included pressure ulcer, stage 4 (deep wounds that reach the muscle or bone), paraplegia (inability to move legs). During an interview on 2/5/22, at 2:45 p.m., Patient 1 stated a nurse was supposed to visit and provide wound treatment on 2/4/22, but the nurse did not come. During a concurrent interview and record review on 2/6/22, at 11:09 a.m., with RN 1, of Patient 1’s untitled medical record, dated 2/4/2022 at 11:59 p.m., indicated RN 3 documented “Reason for missing visit patient refused nursing visit today. Requesting for Spanish speaking clinician only”. RN 1 stated she could not find evidence that other measures were taken to ensure the visit was made. During an interview on 2/6/22, at 11:14 a.m., Patient 1 stated he did not receive wound care on 2/5/22. Patient 1 stated the agency did not schedule any visits with him on 2/6/22. During an interview on 2/6/22, at 11:25 a.m., RN 4 stated Patient 1 was on her assignment list, to provide wound care for him on 2/5/22 and 2/6/22. RN 4 stated she spoke over the phone on 2/4/22, with Patient 1, who had refused services due to the language barrier. RN 4 stated Staff 1 was informed on 2/4/22 to assign a different nurse to Patient 1. RN 4 stated she did not feel she needed to inform RN 1, RN 2, or the ADM, of the missed treatment visits because she believed Staff 1 would send a nurse who spoke patient 1’s language. RN 4 stated by not providing wound care the healing of the wound could be delayed, and there is a greater risk of infection. A review of Patient 1’s referral titled “Providence”, dated 1/31/22, indicated “Wound care right trochanter/sacrococcyx/ left ischial tuberosity dressing change frequency daily.” A review of Patient 1’s medical record titled: “Home Health Certification and Plan of Care”, certification period 2/3/22-4/4/22 indicated, “RN-7 time(s) a week for 8 week (s)”. During an interview while on a home visit on 2/9/22, at 8:44 a.m., Patient 1 stated, he needed Physical therapy. Patient 1 stated, he was concerned about getting contractures and was wondering when his PT sessions would begin. During an interview on 2/11/22, at 12:55 p.m., Patient 1 stated he was still waiting for Physical Therapy to see him. During a concurrent interview and record review of the HHA’s emails regarding PT, on 2/14/22, at 2:10 p.m., Staff 2 stated the HHA was still waiting for a Spanish-speaking PT. The HHA’s emails indicated request for PT services for Patient 1 on “Feb 6, 2022, Feb 7, 2022, Feb 8, 2022”. Staff 2 stated the reason the contracted PT services could not send services to Patient 1 was due to not having Spanish speaking PT. Staff 2 stated she was not sure if the agency could provide interpretation services for the visits. During an interview on 2/15/22, at 1:04 p.m., Staff 1 stated the HHA was able to get a Spanish speaking PT to see Patient 1. Staff 1 stated was not sure when the visit was going to occur. A review of Patient 1’s record titled, “Providence Referral to Home Health”, dated 2/2/22, indicated “primary services needed: skilled nursing, physical therapy”. A review of Patient 1’s medical record titled: “Home Health Certification and Plan of Care”, certification period 2/3/22-4/4/22 did not indicate Physical Therapy in the orders for discipline and treatments. b. Patient 2’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 11/6/2021 to 1/5/2022, indicated the start of care (SOC) date for patient 2 was 11/6/2021, with diagnosis of idiopathic aseptic necrosis of bone (bone infection). During a concurrent interview and record review on 2/14/22, at 2:52 p.m., of Patient 2’s medical record titled, “Home Health Certification of Plan of Care”, certification period 11/6/2021 to 1/5/2022 was reviewed. The record indicated “Home health services needed for Physical Therapy and Occupational Therapy”. RN 2 stated there was no documentation or evidence Patient 2 received PT and OT services. RN 2 stated if the services were not documented, they were not rendered. c. Patient 5’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 12/15/2021 to 2/13/2022, indicated the start of care (SOC) date for Patient 5 was 10/17/2021, with diagnoses which included acute pancreatitis (inflammation of the pancreas), and encounter for adjustment and management of VAD (vascular access device). During a concurrent interview and record review on 2/14/22, at 3:35 p.m., of Patient 5’s documented visits, form titled “RN OASIS Recert Notes”, dated 12/15/2021, was reviewed. RN 2 stated patient received PICC line care on 12/15/2021. RN 2 stated she could not find other visits notes to indicate PICC line was given weekly. RN 2 stated Patient 5 should have received the next PICC line care on 12/22/21. A review of Patient’s 5 record titled “Home Health Certification and Plan of Care (POC), certification period from 12/15/2021 to 2/13/2022, indicated “RN- 1 time(s) a week for 8 week(s). Findings: A review of the agency’s census during a recertification survey on 2/4/2022 indicated the home health agency (HHA) was actively caring for 180 patients. 1. A review of Patient 1’s referral to the HHA, dated 1/31/22, indicated wound care to the right trochanter (hip bone)/sacrococcyx (tail bone)/ left ischial tuberosity (seat bones) dressing change frequency daily. Apply acquacel AG (dressing that contains silver to fight bacteria) to wound base, fill with gauze roll, cover with foam dressing foam. Left lateral and medial heel dressing change frequency every other day, cover dressing with foam. Left trochanter dressing change frequency every other day, apply duoderm (waterproof dressing). Right heel dressing change frequency twice daily, paint with betadine (topical antiseptic) leave open to air, off load heel. A review of Patient 1’s record titled, “Home Health Certification and Plan of Care (POC), with a certification period from 2/3/2022 to 4/4/22, indicated the start of care (SOC) date for Patient 1 was 2/3/22, with diagnoses which included pressure ulcer stage 4 (deep wounds that reach the muscle or bone), paraplegia (inability to move legs). A review of Patient 1’s medical record titled, “Home Health Certification and Plan of Care,” with a certification period of 2/3/22-4/4/22 indicated RN-seven time(s) a week for eight week (s). During a telephone interview, on 2/5/22 at 2:45 p.m., Patient 1 stated a nurse was supposed to visit and provide wound treatment on 2/4/22, but the nurse did not come. Patient 1 stated, RN 3 visited him initially on 2/3/22 and informed Patient 1 someone would come daily to help him with his wounds. During an interview, on 2/6/22 at 11:09 a.m., RN 1 stated she could not find evidence that other measures were taken to ensure the visits to Patient 1 was made. RN 1 stated there should have been a translator available to communicate with Patient 1 or transfer the care to a HHA that can provide the services requested. RN 1 stated Patient 1 was not refusing care, he was requesting for staff who can speak his language. RN 1 stated Patient 1 was at high risk of injury due to his medical problems, and he can get really sick to the point his life is in danger. During an interview, on 2/6/22 at 11:14 a.m., Patient 1 stated he did not receive wound care on 2/5/22. Patient 1 stated the agency did not schedule any visits with him for 2/6/22. During an interview, on 2/6/22 at 11:25 a.m., RN 4 stated Patient 1 was on her assignment list to provide wound care treatment for him on 2/5/22 and 2/6/22. RN 4 stated she spoke over the phone to Patient 1 on 2/4/22, who had refused services due to the language barrier. RN 4 stated Staff 1 was informed on 2/4/22 to assign a different nurse to Patient 1. RN 4 stated she did not feel she needed to inform RN 1, RN 2, or the ADM, of the missed treatment visits because she believed Staff 1 would send a nurse who spoke Patient 1’s language. RN 4 stated by not providing wound care the healing of the wound could be delayed, and there is a greater risk of infection. During an observation, on 2/6/22 at 4:05 p.m., a home visit was made at Patient 1’s residence to observe the care being given by RN 2. RN 2 placed Patient 1 on the right lateral (side) position at 5:05 p.m., to begin wound care of the sacral area. Caregiver 1 (CV 1) gave RN 2 a wound cleansing spray called “Skin Integrity”. CV 1 stated the spray was used specifically for the sacral wound, to soften the dressing for removal, and to lessen the pain. CV 1 stated to RN 2 how dry the dressing was. RN 2 stated the dressing was very dry. The observation of the removed dressing showed old, dry substance covering the entire area. The sacral wound began to bleed during the removal. During the wound cleansing, Patient 1 grimaced and RN 2 asked about his pain. Patient 1 stated he had pain but had to tolerate it. RN 2 applied acquacel inside the wound and covered the sacral area with foam dressing. RN 2 stated the wound measurement was 9.6 centimeters (cm) (height) x 7.5 cm (width), 0.6 cm (depth), width 1.7 cm at 2 o’clock. RN 2 stated she could not assess if the wound had worsened or improved because she did not have the previous measurements to compare to. RN 2 proceeded the wound treatment to the left ischial tuberosity. RN 2 removed the dressing. Old, dry substance was noted on the dressing. Bleeding was noted upon dressing removal. During the wound cleansing, Patient 1 grimaced and RN 2 asked about his pain. Patient 1 stated he had a little pain. RN 2 applied acquacel inside the wound and covered the sacral area with foam dressing. RN 2 stated the wound measurement was 4.7 cm (height) x 3 cm (width) x 0.9 cm (depth), 2.9 cm underlying from 11-1. RN 2 stated she could not assess if the wound had worsened or improved because she did not have the previous measurements to compare to. During an observation, on 2/6/22 at 4:20 p.m., RN 2 proceeded the wound treatment to the right trochanter. RN 2 removed the dressing. Old, dry substance was noted on the dressing. Bleeding was noted upon dressing removal. During the wound cleansing, RN 2 asked Patient 1 if he had pain. Patient 1 stated he had pain, but it was less than the previous two sites. RN 2 applied acquacel inside the wound and covered the sacral area with foam dressing. RN 2 stated the wound measurement was 7.5 cm (height) x 6.5 cm (width), 0.6 cm (depth), with 1.5 cm underlying from 9-12. RN 2 stated she could not assess if the wound had worsened or improved because she did not have the previous measurements to compare to. RN 2 proceeded the wound treatment to the right heel. RN 2 stated the skin on the heel was open. RN 2 stated this wound had worsened. RN 2 cleaned the wound and applied foam dressing. No measurements were taken for the right heel. RN 2 proceeded the wound treatment to the left heel. RN 2 stated there was a red spot that needed to be watched to make sure it did not get worse. No measurements were taken for the left heel. During a concurrent interview and record review, on 2/7/22 at 12:42 p.m., Patient 1’s record titled, “RN OASIS SOC Notes,” dated 2/3/22 was reviewed. Staff 3 stated the wound assessment was not complete because there was no unit of measurements. Staff 3 stated specific information regarding wound size could not be obtained. Staff 3 stated it doesn’t take long for a wound to get worse if no one is paying attention to it. A review of Patient 1’s medical record titled: “RN OASIS SOC Notes”, dated 2/3/22, indicated wound details: 1. Wound location right heel: status closed, type pressure ulcer, length 3, width 3, wound bed color black, drainage none, surrounding tissue intact, wound pain 0, 2. Wound location lower back: status open, type pressure ulcer, thickness full, length 15, width 10, depth 04, wound bed color red, pink/red 95%, wound edges non-attached, drainage bloody, drainage amount small, drainage odor pink, surrounding tissue fragile, wound pain 0, 3. Wound location sacral area: status open, type pressure ulcer, length 10, width 10, depth 0.4, wound bed color red, pink/red% 95, slough 5%, wound edges non-attached rolled, drainage bloody, drainage amount, small, drainage odor pink, surrounding tissue excoriated, wound pain 0, 4. Wound location right hip: status open, type pressure ulcer, thickness full, length 10, width 10, depth 05, wound bed color grey, slough 10%, necrotic% 10, wound edges non-attached rolled, drainage bloody, drainage amount small, drainage odor pink, surrounding tissue erythema, wound pain 0”. No wound staging was noted for each of the sites mentioned above. A review of Patient 1’s untitled medical record, dated 2/4/2022 at 11:59 p.m., indicated RN 3 documented reason for missing visit was patient refused nursing visit today. Requesting for Spanish speaking clinician only. A review of Patient 1’s untitled medical record, dated 2/5/22 at 11:59 p.m., indicated RN 4 documented reason for missing visit patient requested to be seen by Spanish speaking staff only. A review of Patient 1’s medical record titled, “Physician Order,” dated 2/7/22, indicated daily wound care right trochanter, let trochanter, left-ischial tuberosity, sacrococcyx: cleanse with normal saline (NS), pat dry, apply collagen powder (helps with wound healing) to wound bed, apply medihoney (helps with wound healing), apply agquacell ag to wound bed, pack wound with gauze, cover with foam dressing. Wound care right heel: paint with betadine twice daily, off load heel. Wound care left lateral and medial heel: apply foam dressing, change every other day. During an observation and interview, on 2/9/22 at 8:44 a.m., a second home visit was done. RN 2 and RN 4 visited Patient 1. During an observation of the wound care, RN 2 stated the dressings of the sacral area and left ischial tuberosity were not as soaked. RN 2 stated the wound on the right heel was “iffy”. RN 2 stated no wound measurements were taken because she had run out of measuring sticks. A review of Patient 1’s medical record titled, “Skilled Nursing Note,” dated 2/9/22, indicated wound care performed to right trochanter, left ischial tuberosity and sacrococcyx were done as follow: cleansed with NS, pat dry, apply aquacell aq to wound bed, covered with foam dressing. Right heel painted with betadine; medial heel covered with foam dressing. Wound Details: Wound location #1 RT heel: status closed, type pressure ulcer, length 3, width 3, Wound bed color red, wound edges attached, drainage none, surrounding tissue intact, wound pain 3, additional information off load heel. Wound location #2 sacrococcyx: status open, type pressure ulcer, thickness full, length 9.6, width 7.5, depth 0.6, wound bed color red, pink/red% 95, wound edges non-attached attached, drainage bloody, drainage amount small, drainage odor, none, surrounding tissue fragile intact, wound pain 3. Wound location #3 right trochanter: status open, type pressure ulcer, length 6.5, width 7.5, depth 0.6, wound bed color red, pink/red 95, slough % 5, wound edges none-attached rolled, drainage bloody, drainage amount small, drainage odor none, surrounding tissue intact fragile, wound pain 3. Wound location #4 left ischial tuberosity: status open, type pressure ulcer, thickness full, length 3, width 4.7, depth 0.9, wound bed color grey, wound edges non-attached rolled, drainage bloody, drainage amount small, drainage odor pink, surrounding tissue erythema, wound pain 0.” No wound staging documented. The record did not indicate medihoney was applied as ordered. A review of all the HHA’s policy and procedure given indicated there was no wound care or pressure sore policy. The facility did not provide a wound care or pressure sore policy upon request. 2. During an interview, on 2/5/22 at 2:45 p.m., Patient 1 stated he informed the HHA at the beginning of his care requesting a Spanish speaking nurse. Patient 1 stated the HHA told him they would provide someone who would speak Spanish. During an interview, on 2/6/22 at 11:57 a.m., RN 3 stated Patient 1 had requested a Spanish speaking nurse to see him, when she initially saw him on 2/3/22. RN 3 stated she informed Staff 1 on 2/3/22, a Spanish speaking staff needed to see him. During an interview, on 2/6/22 at 10:00 a.m., the ADM stated the agency had Spanish speaking staff. The ADM stated the HHA makes sures staff can communicate with patients. The ADM stated the HHA are not supposed to accept the patients if they are unable to communicate with them. During an interview, on 2/6/22 at 1:05 p.m., Staff 1 stated RN 3 had come to the office on 2/3/22 to report Patient 1 had requested a Spanish speaking nurse. Staff 1 stated the HHA was still looking for a Spanish speaking staff. Staff 1 did not provide an explanation of alternative interventions to be able to care for Patient 1 in his preferred language. During an observation, on 2/6/22 at 4:05 p.m., a home visit was made at Patient 1’s residence to observe the care being given by RN 2. RN 2 was observed speaking English to Patient 1. Patient 1 did not understand RN 2 and requested the Surveyor to assist with Spanish interpretation. RN 2 did not use interpretation services. During an interview, on 2/6/22 at 4:33 p.m., Patient 1 stated he did not refuse care from the agency due to staff not speaking Spanish. Patient 1 stated the HHA told him the reason they could not provide care was due to staff not speaking Spanish. Patient 1 stated the HHA did not offer him translation services. During an observation, on 2/9/22 at 8:44 a.m., a home visit was made at Patient 1’s residence to observe the care being given by RN 2. RN 2 was observed speaking English to Patient 1. Caregiver 2 was observed interpreting English to Spanish for Patient 1. A review of Patient 1’s medical record titled, Home Health Certification and Plan of Care, with a certification period of 2/3/22-4/4/22 did not indicate his language preference. A review of the facility’s undated policy and procedure titled, “Plan of Care,” indicated include patient preference- The RN should include the patient’s preferences in their care, as appropriate. A review of the facility’s undated policy and procedure titled, Appropriate Communication Facilitation,” indicated the agency will facilitate communication by using special devices, interpreters, or other organizational aides. 3.During an interview, on 2/6/22 at 11:25 a.m., RN 4 stated Patient 1 was on her assignment list, to provide wound care for him on 2/5/22. RN 4 stated she did not visit Patient 1. RN 4 stated she did not know Patient 1’s visit was missed because she thought the office would send a Spanish speaking nurse. RN 4 stated she only notified Staff 1 of Patient 1’s missed visit and did not notify anyone else. During an interview, on 2/6/22 at 10:00 a.m., the ADM stated an incident report was created for missed visits and the reasons for the missed visit are investigated. The ADM stated the family and physician would be informed of the findings of the investigation. The ADM did not provide evidence that the physician was notified of Patient 1’s missed home visits scheduled for 2/4/22 and 2/5/22. A review of the facility’s undated policy and procedure titled, “Missed Visits,” indicated if a visit is missed, the following steps will be taken physician (MD) will be informed of missed visits and plans for next visits…”. 4. On 2/5/22, a review of the home health agency’s current census, indicated Patient 8, start of care date of 2/5/22, During an interview with office staff on 2/5/22, stated the patient was to be seen today. 4a. A review of patient 8, Patient Information form indicated Patient 8 was admitted to General Acute Care Hospital (GACH) on 1/12/22, with a diagnosis of Gram-Negative Bacteremia (a bacteria that can get into the blood stream and is resistant to antibiotic treatment. A review of the GACH’S “PATIENT ORDERS” from the Primary Care Providers (PCP) dated 1/19/22, stipulated, “I certify based on y finding, the following services are medically necessary home health services. Start of care date will be within 48 hours unless otherwise specified.” During a home visit on 2/11/22, at 1:00 p.m./, Patient 8's PCG stated he was a diabetic( high blood sugar) on oral medication from Mexico, Patient 8 has End Stage Renal Disease ( a medical condition in which a person’s kidneys cease functioning on a permanent basis leading to the need for regular course of long-term dialysis or kidney transplant), in which he gets dialysis three times a week and was hospitalized due infection and had a right IJ catheter placed at the GACH on 12/721, for hemodialysis. The PCG also stated, Patient 8 was blind on the left eye and only drinks 4 oz. of water a day. There was no documentation that the PCP was notified of the staff's delay of Patient 8 start of care assessment, and there was no documented evidence the physician was consulted/approved additional or modifications to the plan of care. 4b. A review of the HHA’s current census given to the survey team on 2/5/22, indicated Patient 9’s start of care date as 12/18/22, A review of Patient 9's Plan of care indicated Patient 9’s start of care date of 4/27/21, for the certification period of 10/31/21 to 12/28/2021. Review of the Prescribed Orders for the period of services covered from 3/3/2021 to 3/3/2022, indicated Patient 9’s diagnosis of Myasthenia gravis (a weakness and rapid fatigue of muscles and under voluntary control which is caused by a breakdown in communication between nerves and muscles.) The Prescribed order instruct Skilled Nurse (SN) to administer/teach Gamunex-C 40G IV Q week Via Port A Cath and for the SN to administer care for vascular access device per agency policy and Catheter Flush per SASH( Saline-Administration-Saline Heparin- flushing steps used before and after each infusion of a catheter) protocol of Heparin 100 units/milligram) 5 ml PFS., SIG: 5 ml SASH PORT line flush and Normal Saline 10 ml PFS, SIG: 10-20 ml SASH PORT line flush. During a joint home visit with RN 3, Patient 9 stated she has been with this home health agency for 6 years and RN 3 stated he has been providing weekly IV infusions to patient 9 for 5 years. Patient 9 stated during the home visit that she was receiving physical therapy due to her need to get up/downstairs in her house and getting in her car. Patient 9 stated she needed to relocate to another residence due to the climbing the stairs was very hard and was trying to find one to fit to her income. A review of all Patients 9’s POC, orders for Physical Therapy and her Prescriber orders were not signed by her Primary Care Physician. There was no documentation that the PCP was notified of the delay of Patient 8's start of care assessment, and there was not documented evidence the physician was consulted/approved additional or modifications to the plan of care. 4c. A review of patient 10’s Electronic clinical record of Patient 10 indicated a SOC of 12/20/2021, for the certification period of 12/20/21to 2/17/2021, with diagnoses of Injury of nerves at ankle and foot level, right leg and Gillian Barre’ syndrome, (A condition where the Immune system attack the nerves causing weakness, tingling in feet and legs to the upper body, Paralysis’s can occur). Patient 10 was wheelchair bound and lived in an Assisted living Facility (ALF- a housing facility for adults with disabilities, adults who cannot or choose not to live independently).” Review of the Plan of care (CMS 485) instructed Physical Therapy to visit 2 times a week for 4 weeks to include balance training, transfer training, be mobility training, therapeutic exercise program, safety training, fall prevention, and caregiver training to improve independence with functional mobility to decrease fall risk. Review of Patients 10’s RN Evaluation Notes dated 12/21/2021, instructed Skilled Nurse frequency 1w1, 1w8, to assess vital signs, medication management, and signs and symptoms of complications/exacerbation necessitating attention. Physical Therapy to evaluate for home safety training and strengthen exercise. There were no physicians signature for the continuation of PT or the Plan of care for required services by the HHA. There was no documentation that the PCP was notified of the delay in start of care, and there was not documented evidence the physician was consulted/approved additional or modifications to the plan of care. 4d. A review of Patient 11’s plan of care in the agency’s electronic record indicated a start of care of 10/8/2021, for the certification period of 12/7/2021 to 2/5/2022, with diagnoses of disorder of the kidney and ureter ( diabetes mellitus without complication ( high blood sugar), Acute kidney failure ( A condition in which the kidneys suddenly can’t filter waste from the blood.)the duct by which urine passes from the kidneys to the bladder or cloaca.) and Urinary tract infection ( The physician ordered the Registered Nurse (RN) to re-admit patient to HHA and to visit patient one time a week for 8 weeks to assess vital signs, medication management, and signs and symptoms of complication/exacerbation necessitating medical attention and for Physical Therapy to re-evaluate for home safety training and strengthening exercises. There was no physicians signature on Patient 11’splan of care (485) or orders for frequency of physical therapy. There was no documentation that the PCP was notified of the delay in start of care, and there was not documented evidence the physician was consulted/approved additional or modifications to the plan of care. 4e. A review of Patient 12’s Plan of Care for the certification period of 12/4/2021 to 2/2/2022, indicated Patient 12 was admitted to the home health on12/4/2021, with diagnoses of Urinary tract infection (UTI-) and encounter/adjustment of VAD (Vascular access Device (any device utilized for venous access regardless of location-Peripherally Inserted Central catheter (PICC line). The Physician instructed the RN to visit Patient 12 one a week for 4 weeks administer ertapenem( an antibiotic that treats severe bacteria of the skin, lungs stomach ,pelvis, and urinary tract 1gm/100 ml every 24 hrs. Via PICC line, flush line using SASH protocol (Saline- Administration-Saline-Heparin), labs on Monday, PICC dressing to be changed every 7 days. Review Skilled Nursing Notes dated 12/5/21, 12/6/2021 & 12/7/2021, documented patient teaching and returned demonstration in giving himself the antibiotic via PICC line, however, there was no documentation the Physician had been notified that patient was administering the medication through his PICC line himself. There was no documentation that the PCP was notified of the delay in start of care assessment, and there was not documented evidence the physician was consulted/approved additional or modifications to the plan of care. During a joint interview with the Administrator in the HHA's conference room and Director of Nurses (DON), via telephone on 2/6/2022, at 2: 30 p.m., when asked the reason none of the patients Plan of Care was signed by their physician, both stated they usually get the referrals from the hospital physician and when they follow up they refuses to sign. The Administrator and DON stated they were not aware of the patients had a primary physician.

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 interview and record review, the HHA failed to include information required in the plan of care for 6 of 17 sampled patients (Patients 1, 8, 9, 10, 11, and 12). 6. Patient 1’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 2/3/22 to 4/4/22, indicated the start of care (SOC) date for Patient 1 was 2/3/2022, with diagnoses which included pressure ulcer, stage 4 (deep wounds that reach the muscle or bone), paraplegia (inability to move legs). During an interview on 2/6/22, at 11:57 a.m., RN 3 stated she visited Patient 1 for the start of care visit on 2/3/22. RN 3 stated she provided wound care treatment during the visit. A review of Patient 1’s medical record titled: “Home Health Certification and Plan of Care”, certification period 2/3/22-4/4/22 did not indicate wound care supplies, nutritional requirements, mental status, and prognosis in the plan of care. 7. Patient 2’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 11/6/21 to 1/5/22, indicated the start of care (SOC) date for patient 2 was 11/6/2021, with diagnosis of idiopathic aseptic necrosis of bone (bone infection). A review of Patient 2’s medical record titled, “Home Health Certification and Plan of Care (POC), certification period from 11/6/21 to 1/5/22, did not indicate nutritional requirements, functional limitations, mental status, and prognosis. 8. Patient 3’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 12/18/21 to 2/15/22, indicated the start of care (SOC) date for Patient 3 was 10/17/21, with diagnoses which included urinary tract infection, primary hypertension (high blood pressure), sepsis (infection in the blood), and unspecified severe protein-calorie malnutrition (not enough protein and calories eaten). During an interview on 2/5/22, at 7:00 p.m., CV 3 stated the HHA did not provide supplies for Patient 3’s nephrostomy care. CV 3 stated when the HHA did provide supplies, they were the incorrect ones. A review of Patient 3’s medical record titled: “Home Health Certification and Plan of Care”, certification period from 12/18/21 to 2/15/22, did not indicate nephrostomy care supplies, nutritional requirements, allergies, functional limitations, activities permitted, mental status, prognosis and frequency of PT services in the plan of care. 9. Patient 4’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 1/7/2022 to 3/7/2022, indicated the start of care (SOC) date for Patient 4 was 1/7/2022, with diagnosis of encounter for adjustment and management of VAD (vascular access device). A review of Patient 4’s medical record titled, “Skilled Nursing Note”, dated 2/1/22, indicated “Treatment: PICC line dressing change”. A review of Patient 4’s medical record titled, “Home Health Certification and Plan of Care (POC), certification period from 1/7/2022 to 3/7/2022, did not indicate PICC line care supplies in the plan of care. 10. Patient 5’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 12/15/2021 to 2/13/2022, indicated the start of care (SOC) date for Patient 5 was 10/17/2021, with diagnoses which included acute pancreatitis (inflammation of the pancreas), and encounter for adjustment and management of VAD (vascular access device). During an interview on 2/11/22, at 2:10 p.m., RN 2 stated Patient 5 was receiving PICC line care from the HHA. A review of Patient 5’s medical record titled “Home Health Certification and Plan of Care (POC), certification period from 12/15/2021 to 2/13/2022, did not indicate PILL line care supplies in the plan of care. 11. Patient 6’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 1/13/2022 to 3/14/2022, indicated the start of care (SOC) date for Patient 6 was 1/13/2022, with a diagnosis of urinary tract infection. A review of Patient 6’s medical record titled, “Home Health Certification and Plan of Care (POC), certification period from 1/13/2022 to 3/14/2022, did not indicate DME and supplies, allergies, nutritional requirement, mental status and prognosis. 12. Patient 7’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period 12/29/2021 to 2/17/2022, indicated the star of care (SOC) date for Patient 7 was 12/29/2021, with diagnoses of chronic obstructive pulmonary disease with acute exacerbation and chronic diastolic congestive heart failure (hear unable to pump blood effectively to the body). A review of Patient 7’s medical record titled, “Home Health Certification and Plan of Care (POC), certification period from 12/29/2021 to 2/17/2022 did not indicate DME and supplies, allergies, nutritional requirement, mental status and prognosis. During an interview on 2/6/22, at 10:23 a.m., the ADM stated all sections of the Home Health Certification and Plan of Care needed to be completed. The ADM stated all services ordered should have a frequency indicated in the plan of care. A review of the facility’s undated policy and procedure titled, “Plan of Care”, indicated “7. Fill out 485 worksheet-After analyzing the patient’s needs, the RN will complete the 485 worksheets to assist in the completion of the plan of care”. 1. On 2/5/22, a review of the home health agency’s current census indicated Patient 8's start of care date of 2/5/22. During an interview with office staff on 2/5/22, in the office, she stated the patient was to be seen today. A review of Patient 8's "Patient Information" form indicated Patient 8 was admitted to General Acute Care Hospital (GACH) on 1/12/22, with a diagnosis of Gram-Negative Bacteremia (a bacteria that can get into the blood stream and is resistant to antibiotic treatment. A review of the GACH’S “PATIENT ORDERS” from the Primary Care Providers (PCP) dated 1/19/22, stipulated, “I certify based on y finding, the following services are medically necessary home health services. Start of care date will be within 48 hours unless otherwise specified.” . Patient 8's PCG stated the patient was diabetic( high blood sugar) on oral medication from Mexico, patient 8 has End Stage Renal Disease ( a medical condition in which a person’s kidneys cease functioning on a permanent basis leading to the need for regular course of long-term dialysis or kidney transplant), in which he gets dialysis three times a week and was hospitalized due infection and had a right IJ catheter placed at the GACH on 12/721, for hemodialysis. The PCG also stated, Patient 8 was blind on the left eye and only drinks 4 oz. of water a day. There was no documentation that the PCP was notified or approved the delay in start of care and the patients need for diabetic supplies. 2. A review of the HHA’s current census given to the survey team on 2/5/22, indicated Patient 9’s start of care date was on 12/18/22. A review of Patient 9's Plan of care indicated Patient 9’s start of 4/27/21, for the certification period of 10/31/21 to 12/28/2021. Review of the Prescribed Orders for the period of services Covered from 3/3/2021 to 3/3/2022, indicated Patient 9’s diagnosis of Myasthenia gravis (a weakness and rapid fatigue of muscles and under voluntary control which is caused by a breakdown in communication between nerves and muscles.) The Prescribed order instruct Skilled Nurse (SN) to administer/teach Gamunex-C 40G IV Q week Via Port A Cath and for the SN to administer care for vascular access device per agency policy and Catheter Flush per SASH( Saline-Administration-Saline Heparin- flushing steps used before and after each infusion of a catheter) protocol of Heparin 100 units/milligram) 5 ml PFS., SIG: 5 ml SASH PORT line flush and Normal Saline 10 ml PFS, SIG: 10-20 ml SASH PORT line flush. A review of all patients 9’s POC, indicated there was no documentation of Patient 9's PICC line supplies, nutritional status, mental/social status and prognosis and the orders for Physical Therapy and her Prescriber orders were not signed by her Primary Care Physician. 3. A review of Patient 10’s Electronic clinical record indicated a SOC of 12/20/2021, for the certification period of 12/20/21to 2/17/2021, with diagnoses of Injury of nerves at ankle and foot level, right leg and Gillian Barre’ syndrome, (A condition where the Immune system attack the nerves causing weakness, tingling in feet and legs to the upper body, Paralysis’s can occur). Patient 10 was wheelchair bound and lived in an Assisted living Facility (ALF- a housing facility for adults with disabilities, adults who cannot or choose not to live independently).” Review of the Plan of care (CMS 485) instructed Physical Therapy to visit 2 times a week for 4 weeks to include balance training, transfer training, be mobility training, therapeutic exercise program, safety training, fall prevention, and caregiver training to improve independence with functional mobility to decrease fall risk. Review of Patients 10’s RN Evaluation Notes dated 12/21/2021, instructed Skilled Nurse frequency 1w1, 1w8, to assess vital signs, medication management, and signs and symptoms of complications/exacerbation necessitating attention. Physical Therapy to evaluate for home safety training and strengthen exercise. There were no physicians signature for the continuation of PT or the Plan of care for required services by the HHA and there was no documentation of patient 10's nutritional /mental status or prognosis. 4. A review of Patient 11’s plan of care in the agency’s electronic record indicated a start of care of 10/8/2021, for the certification period of 12/7/2021 to 2/5/2022, with diagnoses of disorder of the kidney and ureter ( diabetes mellitus without complication ( high blood sugar), Acute kidney failure ( A condition in which the kidneys suddenly can’t filter waste from the blood.)the duct by which urine passes from the kidneys to the bladder or cloaca.) and Urinary tract infection). The physician ordered for the the Registered Nurse (RN) to re-admit patient to HHA and to visit patient one time a week for 8 weeks to assess vital signs, medication management, and signs and symptoms of complication/exacerbation necessitating medical attention and for Physical Therapy to re-evaluate for home safety training and strengthening exercises. There was no physicians signature on Patient 11’s plan of care (CMS 485) or orders for frequency of physical therapy and no documentation on the POC of Patient 11's nutritional/mental status. 5. A review of Patient 12’s Plan of Care for the certification period of 12/4/2021 to 2/2/2022, indicated Patient 12 was admitted to the home health on12/4/2021, with diagnoses of urinary tract infection (UTI-) and encounter/adjustment of VAD (Vascular access Device (any device utilized for venous access regardless of location-Peripherally Inserted Central catheter (PICC line). The Physician instructed the RN to visit Patient 12 once a week for 4 weeks administer ertapenem( an antibiotic that treats severe bacteria of the skin, lungs stomach ,pelvis, and urinary tract 1gm/100 ml every 24 hrs. Via PICC line, flush line using SASH protocol (Saline- Administration-Saline-Heparin), labs on Monday, PICC dressing to be changed every 7 days. Review of Patient 12’s RN OASIS SOC notes, page 16 dated 12/4/2021 under current medication and route taken documents ertapenem 1gm/100ml to be given by injection. there was no documentation the Physician had been notified that patient was administering the medication through his PICC line himself. During an interview with RN 2 on 2/15/2022, at 1:30pm, she stated the physician should have been informed regarding the patient self-administering his medication via his PICC line. There was no PICC line supplies, mental/nutritional status or prognosis and the need for continuation of care on Patient 12's POC.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on interview and record review, the HHA failed to administer drugs, services, and treatments as ordered by the physician for 2 of 17 sampled patients (Patients 3 and 4). a. Patient 3’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 12/18/2021 to 2/15/2022, indicated the start of care (SOC) of 10/17/2021, with diagnoses which included urinary tract infection, primary hypertension (high blood pressure), sepsis (infection in the blood), and unspecified severe protein-calorie malnutrition (not enough protein and calories eaten). During a record review of Patient 3's record titled, “Home Health Aide Visit Notes" dated: 1/6/22 1/12/22 1/14/22 1/17/22 1/20/22 1/23/22 indicated the home health aide (HHA) visits were made. During a record review of Patient 2's record titled, “Home Health Certification and Plan of Care (POC), certification period from 12/18/2021 to 2/15/2022", did not indicate an order for HHA services. During an interview on 2/6/22, at 10:40 a.m., RN 2 stated she did not find an order for HHA services and did not know who had made the decision to provide HHA services to the patient. b. Patient 4’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 1/7/2022 to 3/7/2022”, indicated the start of care (SOC) date for Patient 4 was 1/7/2022, with diagnosis of encounter for adjustment and management of VAD (vascular access device). During a concurrent interview and record review on 2/15/22, at 11:50 a.m., of Patient 4’s , “Home Health Certification and Plan of Care (POC), certification period from 1/7/2022 to 3/7/2022 was reviewed. The record indicated “Registered Nurse to evaluate and infuse daptomycin 600 mg IV 1 gm”. RN 2 stated the order directed the RN to infuse the antibiotic. Further review of Patient 4’s record titled, “RN OASIS SOC noted”, dated 1/7/22, indicated “Educated pt who is a former RN, niece and caregiver on how to infuse daptomycin…”. RN 2 stated there was no documentation that the patient was requesting to infuse the medication nor evidence of notification to the physician. RN 2 stated the care plan should accurately reflect the care being given. A review of the HHA’s undated policy and procedure titled, “Intravenous Therapy”, indicated “The patient and caregiver shall be assessed for the ability to safety administer the prescribed IV therapy per agency requirements upon physician’s orders.”

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the facility failed to ensure the physician was notified of treatments not provided to 6 of 17 patients (Patients 1, 8, 9, 10, 11, and 12). This deficient practice resulted in the physician not being aware of the missed treatment visits. 6. Patient 1’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 2/3/2022 to 4/4/2022, indicated the start of care (SOC) date for Patient 1 was 2/3/2022, with diagnoses which included pressure ulcer, stage 4 (deep wounds that reach the muscle or bone), paraplegia (inability to move legs). During an interview on 2/6/22, at 11:25 a.m., RN 4 stated Patient 1 was on her assignment list, to provide wound care for him on 2/5/22. RN 4 stated she did not visit Patient 1. RN 4 stated she did not know Patient 1’s visit was missed because she thought the office would send a Spanish speaking nurse. RN 4 stated she only notified Staff 1 of Patient 1’s missed visit and did not notify anyone else. During an interview on 2/6/22, at 10:00 a.m., the ADM stated an incident report is created for missed visits and the reasons for the missed visit are investigated. The ADM stated the family and physician would be informed of the findings of the investigation. The ADM did not provide evidence that the physician was notified of Patient 1’s missed home visits scheduled for 2/4/22 and 2/5/22. A review of the facility’s undated policy and procedure titled: “Missed Visits”, indicated “If a visit is missed, the following steps will be taken: MD will be informed of missed visits and plans for next visits…”. 1. On 2/5/22, a review of the home health agency’s current census, indicated Patient 8, start of care date of 2/5/22, During an interview with office staff on 2/5/22, in the office, she stated the patient was to be seen today. A review of Patient 8's "Patient Information", form indicated Patient 8 was admitted to General Acute Care Hospital (GACH) on 1/12/22, with a diagnosis of Gram-Negative Bacteremia (a bacteria that can get into the blood stream and is resistant to antibiotic treatment. A review of the GACH’S “PATIENT ORDERS” from the Primary Care Providers (PCP) dated 1/19/22, stipulated, “I certify based on y finding, the following services are medically necessary home health services. Start of care date will be within 48 hours unless otherwise specified.” During a home visit on 2/11/22, at 1:00 p.m., Patient 8's PCG stated the patient was diabetic( high blood sugar) on oral medication from Mexico, Patient 8 has End Stage Renal Disease ( a medical condition in which a person’s kidneys cease functioning on a permanent basis leading to the need for regular course of long-term dialysis or kidney transplant), in which he gets dialysis three times a week and was hospitalized due infection and had a right IJ catheter placed at the GACH on 12/721, for hemodialysis. The PCG also stated, Patient 8 was blind on the left eye and only drinks 4 oz. of water a day. There was no documentation that the PCP was notified of the delay of the start of care, and there was not documented evidence the physician was consulted/approved additional or modifications to the plan of care. 2. A review of the HHA’s current census given to the survey team on 2/5/22, indicated patient 9’s start of care date as 12/18/22, A review of Patient 9, s Plan of care indicated patient 9’s start of 4/27/21, for the certification period of 10/31/21 to 12/28/2021. Review of the Prescribed Orders for the period of services Covered from 3/3/2021 to 3/3/2022, indicated patient 9’s diagnosis of Myasthenia gravis (a weakness and rapid fatigue of muscles and under voluntary control which is caused by a breakdown in communication between nerves and muscles.) The Prescribed order instruct Skilled Nurse (SN) to administer/teach Gamunex-C 40G IV Q week Via Port A Cath and for the SN to administer care for vascular access device per agency policy and Catheter Flush per SASH( Saline-Administration-Saline Heparin- flushing steps used before and after each infusion of a catheter) protocol of Heparin 100 units/milligram) 5 ml PFS., SIG: 5 ml SASH PORT line flush and Normal Saline 10 ml PFS, SIG: 10-20 ml SASH PORT line flush. During a joint home visit with patient 9 and RN 3, patient 9 stated she has been with this home health agency for 6 years and RN 3 stated he has been providing weekly IV infusions to patient 9 for 5 years. Patient 9 stated during the home visit that she is receiving physical therapy due to her need to get up/downstairs in her house and getting in her car. Patient 9 stated she needs to relocate to another residence due to the stairs and has been having a hard time trying to find one due to her income. A review of all patients 9’s POC, orders for Physical Therapy and her Prescriber orders were not signed by her Primary Care Physician. There was no documentation that the PCP was notified of the delay in start of care, and there was not documented evidence the physician was consulted/approved additional or modifications to the plan of care. 3. A review of patient 10’s Electronic clinical record of patient 10 indicated a SOC of 12/20/2021, for the certification period of 12/20/21to 2/17/2021, with diagnoses of Injury of nerves at ankle and foot level, right leg and Gullian Barre’ syndrome, (A condition where the Immune system attack the nerves causing weakness, tingling in feet and legs to the upper body, Paralysis’s can occur). Patient 10 was wheelchair bound and lived in an Assisted living Facility (ALF- a housing facility for adults with disabilities, adults who cannot or choose not to live independently).” Review of the Plan of care (485) instructed Physical Therapy to visit 2 times a week for 4 weeks to include balance training, transfer training, be mobility training, therapeutic exercise program, safety training, fall prevention, and caregiver training to improve independence with functional mobility to decrease fall risk. Review of Patients 10’s RN Evaluation Notes dated 12/21/2021, instructed Skilled Nurse frequency 1w1, 1w8, to assess vital signs, medication management, and signs and symptoms of complications/exacerbation necessitating attention. Physical Therapy to evaluate for home safety training and strengthen exercise. There were no physicians signature for the continuation of PT or the Plan of care for required services by the HHA. There was no documentation that the PCP was notified of the delay in start of care, and there was not documented evidence the physician was consulted/approved additional or modifications to the plan of care. 4. A review of Patient 11’s plan of care in the agency’s electronic record indicated a start of care of 10/8/2021, for the certification period of 12/7/2021 to 2/5/2022, with diagnoses of disorder of the kidney and ureter ( diabetes mellitus without complication ( high blood sugar), Acute kidney failure ( A condition in which the kidneys suddenly can’t filter waste from the blood.)the duct by which urine passes from the kidneys to the bladder or cloaca.) and Urinary tract infection ( The physician ordered the Registered Nurse (RN) to re-admit patient to HHA and to visit patient one time a week for 8 weeks to assess vital signs, medication management, and signs and symptoms of complication/exacerbation necessitating medical attention and for Physical Therapy to re-evaluate for home safety training and strengthening exercises. There was no physicians signature on Patient 11’splan of care (485) or orders for frequency of physical therapy. There was no documentation that the PCP was notified of the delay in start of care, and there was not documented evidence the physician was consulted/approved additional or modifications to the plan of care. 5. A review of Patient 12’s Plan of Care for the certification period of 12/4/2021 to 2/2/2022, indicated patient 12 was admitted to the home health on12/4/2021, with diagnoses of Urinary tract infection (UTI-) and encounter/adjustment of VAD (Vascular access Device (any device utilized for venous access regardless of location-Peripherally Inserted Central catheter (PICC line). The Physician instructed the RN to visit patient 12 one a week for 4 weeks administer ertapenem( an antibiotic that treats severe bacteria of the skin, lungs stomach ,pelvis, and urinary tract 1gm/100 ml every 24 hrs. Via PICC line, flush line using SASH protocol (Saline- Administration-Saline-Heparin), labs on Monday, PICC dressing to be changed every 7 days. Review Skilled Nursing Notes dated 12/5/21, 12/6/2021 & 12/7/2021, documented patient teaching and returned demonstration in giving himself the antibiotic via PICC line, however, there was no documentation the Physician had been notified that patient was administering the medication through his PICC line himself. There was no documentation that the PCP was notified of the delay in start of care, and there was not documented evidence the physician was consulted/approved additional or modifications to the plan of care. During a joint interview with the Administrator in the HHA's conference room and RN 1, Via telephone on 2/6/2022, at 2: 30 p.m., when asked the reason the none of the patients Plan of Care not signed by their physician, they stated the usually get the referral from the hospital physician and when they follow up they refuses to sign. The Administrator and RN 1 stated they were not aware of the patients had a primary physician.

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 observation and record review, the HHA failed to manage the pain during wound treatment for 1 of 17 (Patient 1) patients. Patient 1’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 2/3/2022 to 4/4/2022, indicated the start of care (SOC) date for Patient 1 was 2/3/22, with diagnoses which included pressure ulcer, Stage IV (deep wounds that reach the muscle or bone), paraplegia (inability to move legs). On 2/6/22, at 4:05 p.m., a home visit was made at Patient 1’s residence to observe the care being given by RN 2. RN 2 placed the patient on the right lateral (side) position at 5:05 p.m., to begin wound care of the sacral area. During the wound cleansing, Patient 1 grimaced (facial expression of disgust or pain) and RN 2asked if he had pain. Patient 1 stated he had pain but had to tolerate it. RN 2 did not ask Patient 1 any more questions to get a better understanding of his pain being experienced nor did she offer any pain management interventions. A review of Patient 1's medical record titled, "Skilled Nursing Note", dated 2/6/22, indicated, "Pain 3". The facility did not provide any policy and procedure for pain assessment or pain management upon request.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the HHA failed to coordinate care delivery to meet the patient's needs and representative in coordination of care activities of patients for one of 17 patients (Patient 1). Patient 1’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 2/3/22 to 4/4/22, indicated the start of care (SOC) date for Patient 1 was 2/3/22, with diagnoses which included pressure ulcer, stage 4 (deep wounds that reach the muscle or bone), paraplegia (inability to move legs). During an interview on 2/6/22, at 11:25 a.m., RN 4 stated Patient 1 was on her assignment list, to provide wound care for him on 2/5/22. RN 4 stated she did not visit Patient 1. RN 4 stated she did not know Patient 1’s visit was missed because she thought the office would send a Spanish speaking nurse. RN 4 stated she only notified Staff 1 of Patient 1’s missed visit and did not notify anyone else. During an interview on 2/6/22, at 10:00 a.m., the ADM stated an incident report is created for missed visits and the reasons for the missed visit are investigated. The ADM stated the family and physician would be informed of the findings of the investigation. The ADM did not provide evidence that the physician was notified of Patient 1’s missed home visits scheduled for 2/4/22 and 2/5/22. A review of the facility’s undated policy and procedure titled: “Missed Visits”, indicated “If a visit is missed, the following steps will be taken: MD will be informed of missed visits and plans for next visits…”.

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 HHA failed to provide written information regarding the plans of care for 2 of 17 patients (Patient 1 and Patient 3). a. Patient 1’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 2/3/22 to 4/4/22, indicated the start of care (SOC) date of 2/3/22, with diagnoses which included pressure ulcer, stage 4 (deep wounds that reach the muscle or bone), paraplegia (inability to move legs). During an interview on 2/6/22, at 10:22 a.m., RN 2 stated during the first visit, one the tasks the HHA nurse was supposed to do was to explain the purpose of the visit and provide a folder to the patient with written information regarding the care being provided by the HHA. During an interview on 2/6/22, at 11:57 a.m., RN 3 stated she had not provide Patient 1 with written information on the first visit on 2/3/22. RN 3 stated she would give HHA information and and forms later. During a home visit interview on 2/6/22, at 4:05 p.m., Patient 1 stated he had not received any information in writing from the HHA. Patient 1 stated a nurse had visited him on 2/3/22 and did not leave any information about the HHA nor had he signed any forms. Patient 1 stated he needed all information and communication to be in his preferred language (Spanish). During a home visit observation on 2/6/22, at 4:20 p.m., RN 2 was observed giving Patient 1 a folder containing information about consents, patient rights, contact information, and other documents regarding the HHA. All documents provided were in English. b. Patient 3’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 12/18/2021 to 2/15/2022, indicated the start of care (SOC) date of 10/17/2021, with diagnoses which included urinary tract infection, primary hypertension (high blood pressure), sepsis (infection in the blood), and unspecified severe protein-calorie malnutrition (not enough protein and calories eaten). During a home visit interview on 2/5/22, at 7:00 p.m., Patient Representative 1 (PR 1) stated the HHA did not give them written information about the HHA services. PR 1 stated she was 99% positive the agency did not leave any information or folder. A review of the facility’s undated policies and procedures titled: “Agency Consent”, indicated “1. Each patient admitted is given written and verbal information regarding rights by the admitting nurse regarding any care being rendered. 2. The admitting professional reviews the Patients’ Rights and Responsibilities with the patient. 3. The patient or caregiver signs an acknowledgement of receipt of the information. 4. The original signed acknowledgement is placed in the patient’s medical record in the agency and a copy placed in the patient’s home folder”.

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: This CONDITION was not met: Based on interview and record review, the agency failed to develop, implement, evaluate and maintain an effective and ongoing QAPI (Quality assessment and performance improvement) program to ensure 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 agency's performance across the spectrum of care. The agency failed to maintain a documented evidence of its QAPI program and and be able to demonstrate its operation upon request. The cumulative effect of these systemic problems resulted in the HHA's inability to ensure the provision of quality health care in a safe environment. Findings: 1.The HHA failed to have its QAPI program that include procedure for measurement and analysis of indicators and address the frequency which measurement and analysis. (Refer to G642) 2.The HHA's QAPI program failed to provide to the survey team with evidence that the agency had QAPI program that focus on high risk, high volume, or problem-prone areas. (Refer to G644) 3.The HHA's QAPI program failed to have evidence that the agency considered incidence, prevalence and severity of problem areas. (Refer to G650) 4.The HHA's QAPI failed to measure success and track performance to ensure that improvements were sustained. (Refer to G656) 5.The HHA's governing body failed to be responsible for ensuring the following: (1) an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) clear expectations for patient safety are established, implemented, and maintained; and (4) any findings of fraud or waste are appropriately addressed. (Refer to G660)

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 HHA failed to have the QAPI program that include procedure for measurement and analysis of indicators and address the frequency which measurement and analysis. This deficiency practice resulted in the inability of the agency to identify issue, improve health outcomes, patient safety, and quality of care. Findings: On 2/9/22, at 11 a.m., the 6th day of recertification survey, the survey team requested the agency for its QAPI program. Staff 1 indicated the QAPI program was in their computer. The survey team asked if there was a hard copy of the meetings and the program. Staff 1 indicated it was all in the computer. The survey team requested to print out the result/report of the program that the agency conducted. On 2/15/22 at 3:30 p.m., the survey team conducted exit conference with the Administrator and the agency's QAPI program report was not provided. However, the "Qapi.netha icgoensure" was presented during the exit conference.

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 HHA failed have the evidence to show that the HHA's governing body approved the frequency and detail of the data collection done by the HHA's QAPI program. This deficiency practice resulted in the inability of the agency to monitor the effectiveness and safety services and quality of care, and identify opportunities of improvements. Findings: On 2/9/22, at 11 a.m., the 6th day of recertification survey, the survey team requested the agency's QAPI program regarding the HHA's governing body approved the frequency and detail of the data collection done by the HHA's QAPI program. Staff 1 indicated the QAPI program was in their computer. The survey team asked if there was a hard copy of the meetings and program. Staff 1 indicated it was all in the computer. The survey team requested to print out the result of the program conducted. However, until the survey team exited with the Administrator on 2/15/22, at 3:30 p.m. the QAPI program record was not provided.

High risk, high volume, or problem-prone area CFR(s): 484.65(c)(1)(i) (i) Focus on high risk, high volume, or problem-prone areas; This ELEMENT is not met as evidenced by: Based on interview and record review, the HHA's QAPI program failed to provide to the survey team with evidence that the agency had QAPI program that focus on high risk, high volume, or problem-prone areas. This deficient practice resulted in the inability of the agency to identify the problems, prevent the re-occurring, and make improvement Findings: On 2/9/22, at 11 a.m., the 6th day of recertification survey, the survey team requested the agency's QAPI program that focus on high risk, high volume, or problem-prone areas. Staff 1 indicated the QAPI program was in their computer. The survey team asked if there was a hard copy of the meetings and program. Staff 1 indicated it was all in the computer. The survey team requested to print out the result of the program conducted. However, until the survey team exited with the Administrator on 2/15/22, at 3:30 p.m., the QAPI program was not provided. This was presented during the exit conference.

Incidence, prevalence, severity of problems CFR(s): 484.65(c)(1)(ii) (ii) Consider incidence, prevalence, and severity of problems in those areas; and This ELEMENT is not met as evidenced by: Based on interview and record review, the HHA's QAPI program failed to have evidence that the agency considered incidence, prevalence and severity of problem areas. This deficient practice had the potential to cause negative events which may result in the decline in patient's conditions. Findings: On 2/9/22, at 11 a.m., the 6th day of recertification survey, the survey team requested the agency's QAPI program that indicated the agency considered incidence, prevalence and severity of problem areas. Staff 1 indicated the QAPI program was in their computer. The survey team asked if there was a hard copy of the meetings and program. Staff 1 indicated it was all in the computer. The survey team requested to print out the result of the program conducted. However, until the survey team exited with the Administrator on 2/15/22, at 3:30 p.m. the QAPI program record was not provided.

Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This ELEMENT is not met as evidenced by: Based on interview and record review, the HHA's QAPI failed to measure success and track performance to ensure that improvements were sustained. This deficient practice had the the potential to cause negative and unexpected events that impact a patient's plan of care which may cause a decline in a patient's condition. Findings: On 2/9/22, at 11 a.m., the 6th day of recertification survey, the survey team requested the agency's QAPI program to show that the agency measured success and tracked performance to ensure that improvements were sustained. . Staff 1 indicated the QAPI program was in their computer. The survey team asked if there was a hard copy of the meetings and program. Staff 1 indicated it was all in the computer. The survey team requested to print out the result of the program conducted. However, until the survey team exited with the Administrator on 2/15/22, at 3:30 p.m. the QAPI program record was not provided.

Executive responsibilities for QAPI CFR(s): 484.65(e)(1)(2)(3)(4) Standard: Executive responsibilities. The HHA's governing body is responsible for ensuring the following: (1) That an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) That the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) That clear expectations for patient safety are established, implemented, and maintained; and (4) That any findings of fraud or waste are appropriately addressed. This STANDARD is not met as evidenced by: Based on interview and record review, the HHA's governing body failed to be responsible for ensuring the following: (1) an ongoing program for quality improvement and patient safety is defined, implemented, and maintained; (2) the HHA-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety, and that all improvement actions are evaluated for effectiveness; (3) clear expectations for patient safety are established, implemented, and maintained; and (4) any findings of fraud or waste are appropriately addressed. These failures had the potential for the HHA's inability to provide safety and quality of patient care and services. Findings: On 2/9/22, at 11 a.m., the 6th day of recertification survey, the survey team requested the agency's QAPI program. Staff 1 indicated the QAPI program was in their computer. The survey team asked if there was a hard copy of the meetings and program. Staff 1 indicated it was all in the computer. The survey team requested to print out the result of the program conducted. However, until the survey team exited with the Administrator on 2/15/22, at 3:30 p.m., the QAPI program record was not provided.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech-language pathology services, a registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in §484.80(g), must make an onsite visit to the patient's home no less frequently than every 14 days. The home health aide does not have to be present during this visit. This ELEMENT is not met as evidenced by: Based on interview and record review, the HHA failed to perform supervisory visits for Home Health Aide (HHA) services for 1 of 17 patients (Patient 3). This deficient practice resulted in the home health aide not be evaluated for patient care and services. Patient 3’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 12/18/2021 to 2/15/2022, indicated the start of care (SOC) date for Patient 3 was 10/17/2021, with diagnoses which included urinary tract infection, primary hypertension (high blood pressure), sepsis (infection in the blood), and unspecified severe protein-calorie malnutrition (not enough protein and calories eaten). During a record review of Patient 3's record titled, “Home Health Aide Visit Notes", dated: 1/6/22 1/12/22 1/14/22 1/17/22 1/20/22 1/23/22 indicated a home health aide visit was made. During an interview on 2/6/22, at 10:22 a.m., RN 2 stated she was responsible for providing CHHA supervisory visits. RN 2 stated visits were made when needed. RN 2 did not provide information regarding frequency of visits. A review of Patient 3's medical record did not indicate documentation of supervisory visits.

Compliance with Federal, State, Local Law CFR(s): 484.100 Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients. The HHA and its staff must operate and furnish services in compliance with all applicable federal, state, and local laws and regulations related to the health and safety of patients. If state or local law provides licensing of HHAs, the HHA must be licensed. This CONDITION is not met as evidenced by: Based on observation, record review, and interview, the HHA and its staff failed to disclose and inform the Department of Public Health or the survey team of their on-line staffing business which is located at same place as the home health agency. This deficient practice resulted in the HHA not in compliance with state and federal laws. Findings: On 2/4/22, at 4:00 p.m., upon entrance to HHA, the survey team was taken a book room which had a large conference table with chairs, a projector, and a white board with "GENTO" and the password written on it. During the entrance conference with Staff 3 on 2/4/22, he stated "GENTO" is the electronic clinical record software the HHA uses. On 2/6/22, at 10:30 a.m., during an interview with the Administrator in the HHA conference room and RN 1 via telephone, they both stated "GENTO" is the electronic clinical record for the HHA and based on the RN's OASIS (Outcome and Assessment Information), "GENTO" creates all the plan of cares (485). On 2/14.22, at around 10:00 a.m., it was revealed that the HHA also had another business listed with the same address as the HHA. A call was placed to the number listed under the business in which a male person answered the call indicating this was GENTO. When asked for the address to the location, the unknown male was heard fumbling the telephone and after a few minutes of fumbling, the phone was hung up. On 2/14/22, at 1:00 p.m., during an observation in the HHA, there was a letter from another HHA addressed to "Nurses Without Walls" with the same address as this HHA. On 2/15/22, at 2:00 p.m., an interview with the property management company's owner in the building downstairs, he stated that the HHA has two suites upstairs. One is suite 201 and the other (the conference room) is suite 202. The owner of the property management company stated that "Nurses without walls and GENTO is the HHA's business and has one of the suites. The owner also stated, the HHA/GENTO staff uses his conference room downstairs to hold meetings as well. On 2/15/22, at 3:15 pm. during an interview with the Administrator(ADM) in the conference room regarding GENTO, the ADM stated," GENTO is a software and GENTO does staffing: All kinds of staffing for clinicians. We work with them to make sure the software was capable for the HHA. They are using our office for their address. We would get a discount for using our address, because they closed down their office during COVID." During a telephone interview with RN 1 on 2/14/22, at 3:21pm., regarding "GENTO" she stated it was an electronic medical record and that Nurses without walls is GENTO, and she thinks they are located in California and I'm not sure sure about their business aspect." The ADM was asked to review the contract with GENTO. Observed on the bottom of each page of the contract documented " Nurses without walls dba as GENTO". A copy of the contract was made for the survey TEAM.

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 HHA failed to ensure information contained in the clinical records were accurate, adhered to current clinical record documentation standards of practice (refer to G1020, 1022, and 1024). The cumulative effect of these systemic problems resulted in the HHA's inability to ensure the provision of quality health care in a safe environment. Findings: 1. The HHA failed to document the contact information of the patients' primary physicians in the comprehensive assessment for 4 of 17 sampled patients (Patient 1, Patient 4, Patient 5, and patient 7). Refer to G1020. 2. The HHA failed to send all necessary medical information to the receiving health care practitioner when transitioning to another service for 1 of 17 sampled patients (Patient 3). Refer to G1022. 3. The Home Health Agency (HHA) failed to ensure the Plan of Care was signed by the Physician for 7 of 17 sampled patients (Patients 1, 2, 3, 4, 5, 6, and 7). Refer to G1024.

Contact info for primary care practitioner CFR(s): 484.110(a)(5) Contact information for 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; and This ELEMENT is not met as evidenced by: Based on interview and record review, the HHA failed to document the contact information of the patients' primary physicians in the comprehensive assessment for 4 of 17 sampled patients (Patient 1, Patient 4, Patient 5, and patient 7). This deficient practice resulted in the HHA staff inability to contact the patients' physicians when need orders for care and services. Findings: a. Patient 1’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 2/3/2022 to 4/4/2022, indicated the start of care (SOC) date for Patient 1 was 2/3/2022, with diagnoses which included pressure ulcer stage 4 (deep wounds that reach the muscle or bone) and paraplegia (inability to move legs). During an interview at a home visit on 2/6/22, at 4:05 p.m., Patient 1 stated he has had a primary doctor for 25 years. Patient 1 stated his primary doctor knows his medical conditions very well and has great trust in him. A review of Patient 1’s medical record titled, “RN OASIS SOC Notes”, dated 2/3/2022, did not indicate the contact information for patient’s primary caregiver. b. Patient 4’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 1/7/2022 to 3/7/2022, indicated the start of care (SOC) date for Patient 4 was 1/7/2022, with diagnosis of encounter for adjustment and management of VAD (vascular access device). A review of Patient 4’s medical record titled, “RN OASIS SOC Notes”, dated 1/7/22, did not indicate the contact information for the patient’s primary caregiver. c. Patient 5’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 12/15/2021 to 2/13/2022, indicated the start of care (SOC) date for Patient 5 was 10/17/2021, with diagnoses which included acute pancreatitis (inflammation of the pancreas), and encounter for adjustment and management of VAD (vascular access device). During an interview on 2/11/22, at , Patient 5 indicated the name of her primary care physician. Patient 5 stated she has had this primary care physician for over 10 years. A review of Patient 5’s medical record titled, “RN OASIS SOC Notes”, dated 10/16/21, did not indicate the contact information for the patient’s primary caregiver. d. Patient 7’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period 12/29/2021 to 2/17/2022, indicated the star of care (SOC) date for Patient 7 was 12/29/2021, with diagnoses of chronic obstructive pulmonary disease with acute exacerbation and chronic diastolic congestive heart failure (hear unable to pump blood effectively to the body). A review of Patient 7’s medical record titled, “RN OASIS SOC Notes”, dated 12/19/21, did not indicate the contact information for the patient’s primary caregiver. A review of the facility’s undated policy and procedure titled, “Case Management”, indicated “Once the initial visit is completed, the registered nurse must contact the physician…for initial updates on the patient”.

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 HHA failed to send all necessary medical information to the receiving health care practitioner when transitioning to another service for 1 of 17 sampled patients (Patient 3). Patient 3 was transferred to the acute care hospital then to the hospice care, the HHA did not send a completed transfer summary to the hospice agency. This deficient practice resulted in the hospice agency not getting the information regarding Patient 3's condition. Findings: Patient 3’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 12/18/2021 to 2/15/2022, indicated the start of care (SOC) date for Patient 3 was 10/17/2021, with diagnoses which included urinary tract infection, primary hypertension (high blood pressure), sepsis (infection in the blood), and unspecified severe protein-calorie malnutrition (not enough protein and calories eaten). During an interview on 2/5/22, at 7:00 p.m., CV 2 stated Patient 3 was transferred to the hospital for treatment on 1/27/22, and then to hospice care, as recommended by his doctor on 2/6/22. During an interview on 2/15/22, at 12:13 p.m., RN 2 stated Patient 3 was transferred to hospice care on 2/6/22. RN 2 stated she did not know the name of the hospice agency, nor did she know if the HHA had sent the medical information to the hospice agency. The HHA did not provide evidence of sending all necessary medical information to the hospice agency.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the Plan of Care was signed by the Physician for 7 of 17 sampled patients (Patients 1, 2, 3, 4, 5, 6, and 7). This deficient practice resulted in the incompletion of patients' medical records. Findings: a. Patient 1’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 2/3/2022 to 4/4/2022, indicated the start of care (SOC) date for Patient 1 was 2/3/2022, with diagnoses which included pressure ulcer stage 4 (deep wounds that reach the muscle or bone) and paraplegia (inability to move legs). The form did not indicate the physician's signature. b. Patient 2’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 11/6/2021 to 1/5/2022, indicated the start of care (SOC) date for patient 2 was 11/6/2021, with diagnosis of idiopathic aseptic necrosis of bone (bone infection). The form did not indicate the physician's signature. c. Patient 3’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 12/18/2021 to 2/15/2022, indicated the start of care (SOC) date for Patient 3 was 10/17/2021, with diagnoses which included urinary tract infection, primary hypertension (high blood pressure), sepsis (infection in the blood), and unspecified severe protein-calorie malnutrition (not enough protein and calories eaten). The form did not indicate the physician's signature. d. Patient 4’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 1/7/2022 to 3/7/2022, indicated the start of care (SOC) date for Patient 4 was 1/7/2022, with diagnosis of encounter for adjustment and management of VAD (vascular access device). The form did not indicate the physician's signature. e. Patient 5’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 12/15/2021 to 2/13/2022, indicated the start of care (SOC) date for Patient 5 was 10/17/2021, with diagnoses which included acute pancreatitis (inflammation of the pancreas), and encounter for adjustment and management of VAD (vascular access device). The form did not indicate the physician's signature. f. Patient 6’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period from 1/13/2022 to 3/14/2022, indicated the start of care (SOC) date for Patient 6 was 1/13/2022, with a diagnosis of urinary tract infection. The form did not indicate the physician's signature. f. Patient 7’s record was reviewed. The forms titled, “Home Health Certification and Plan of Care (POC), certification period 12/29/2021 to 2/17/2022, indicated the star of care (SOC) date for Patient 7 was 12/29/2021, with diagnoses of chronic obstructive pulmonary disease with acute exacerbation and chronic diastolic congestive heart failure (hear unable to pump blood effectively to the body). The form did not indicate the physician's signature. During an interview on 2/7/22, at 10:52 a.m., Staff 1 stated the POC is sent to the doctor who ordered the HHA service. Staff 1 did not indicate the timeframe for having the POC signed. A review of the HHA's undated policy and procedure titled, "Physician's Orders", indicated “All verbal orders are to be signed by the physician within 30 days after the receipt of the order and filed in the clinical record within 14 working days after receipt of the order”.