Every finding on record at Triune Home Health Provider, Inc

The following reflects the findings of the California Department of Public Health during a recertification survey conducted August 19, 2024, through August 23, 2024. Census: 18 Unduplicated Admissions: 26 Home Visits with record reviews: 3 Record Reviews without home visits: 4 Sample Size: 7 Emergency Preparedness and Plan for Triune Home Health Provider Agency. All Conditions of Participations were met.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to implement an alternate office or command post site to ensure business operations will continue during an actual emergency, which was necessary for supporting the care continuation, in a universe of 18 patients, when staff members were unable to provide information regarding the agency's Emergency Preparedness Plan for the designated alternate office site during emergency event. This failure had the potential to disrupt the agency’s ability to maintain continuous care, placing the agency's patients at risk, and compromising their safety and quality of care during an emergency event. Findings: During an interview with a License Vocational Nurse 1 (LVN 1), on August 20, 2024, at 10:45 AM, LVN 1 stated she had started working with the agency less than a month ago. She remembered getting information about the Emergency Preparedness Plan but did not remember being told where the alternate office site will be during an emergency. LVN 1 further stated she does not know where the alternative office site was. During an interview with a Home Health Aide 1 (HHA 1), on August 21, 2024, at 10:10 AM, HHA 1 stated she was not sure when the agency’s Emergency Preparedness Plan in-services was given, it might have been last year, around November 2023. The HHA 1 further stated she was not sure where the alternate office site was to get more instruction during an emergency event. During an interview with the Registered Nurse/Director of Patient Care Services (RN/DPCS) on August 21, 2024, at 1:10 PM, the DPCS stated that he had started working with the agency less than a month ago. Furthermore, the DPCS stated that while he was certain he received materials related to the Emergency Preparedness Plan, he does not remember the location of the alternate office site during an emergency. During a concurrent interview and record review, on August 23, 2024, at 2:10 PM, with the Administrator (Admin), the Admin reviewed the agency’s policy and procedure (P&P) titled, “Emergency Management Plan,” revised 2020, which indicated, “PURPOSE To establish guidelines for client care during periods of emergency or disaster. To provide direction and instruction for staff to follow in the event of a life threatening or potentially life-threatening situation that disrupts delivery of home care services. To identify the process for disaster readiness and emergency management. To establish a structure that identifies the agency's relationship to a community wide emergency management program. POLICY Agency will have an identified plan in place to ensure the safety and well-being of patients and employees during periods of an emergency or disaster that disrupts agency services. SPECIAL INSTRUCTIONS: … 14. In the event of damage to the office, the Director/Administrator will make arrangements for an alternate location to conduct business activities. Operations would continue from the alternate site. A defined plan will be established to allow for safe, confidential transfer of client and personnel records…. Emergency Supply Storage Area An emergency supplies storage area will be maintained at the Agency office and at the alternate site for employees during the time period that they are working in the event of an emergency and will be updated and maintained by the Administrator…. SITES FOR MANAGEMENT AND COORDINATION OF EMERGENCY MANAGEMENT PLAN A. Primary Site: Company Office Triune Home Health Provider, Inc. 4959 Palo Verde Street Suite 206C-6, Montclair, CA 91763 Phone: (909) 447-1988 Fax: (909) 447-1989 B. Secondary Site Identified: Administrator's Residence Name [Administrator name] Home Address 19153 TURRELL WAY RIVERSIDE, CA 92508 Phone: 909.703.9750 C. Third Site Identified by Administrator if secondary site is not functional: DPCS Designee Residence Name [DPCS Designee name] Home Address 1308 OLD RANCH RD. CORONA, CA 92882 Phone: 951.520.3482…” The Admin stated he was responsible for the agency’s Emergency Management Plan. He further stated the agency did not follow the policy.

Policies/Procedures for Medical Documentation CFR(s): 484.102(b)(4) §403.748(b)(5), §416.54(b)(4), §418.113(b)(3), §441.184(b)(5), §460.84(b)(6), §482.15(b)(5), §483.73(b)(5), §483.475(b)(5), §484.102(b)(4), §485.68(b)(3), §485.542(b)(5), §485.625(b)(5), §485.727(b)(3), §485.920(b)(4), §486.360(b)(2), §491.12(b)(3), §494.62(b)(4). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(5) or (3),(4),(6)] A system of medical documentation that preserves patient information, protects confidentiality of patient information, and secures and maintains availability of records. *[For RNHCIs at §403.748(b) and REHs at §485.542(b):] Policies and procedures. (5) A system of care documentation that does the following: (i) Preserves patient information. (ii) Protects confidentiality of patient information. (iii) Secures and maintains the availability of records. *[For OPOs at §486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure an updated patient records were readily available to support continuity of care during an emergency, when the agency’s emergency preparedness policy and procedure did not contain the most current patient roster. This failure had the potential for the agency to not be able to adequately assess and address the needs of patient to implement immediate intervention during emergencies, putting 18 patients’ safety and well-being at risk. Findings: A review of the agency's "Emergency Management Program Binder" was conducted for the period from August 1, 2023, to August 23, 2024. The binder indicated that the last patient roster was from the last quarter of 2023. This roster included patients who had been discharged from the agency and did not account for active patients currently receiving care. During an interview with the Administrator (Admin) on August 23, 2024, at 2:00 PM, the Admin stated he was the person responsible for the agency’s emergency preparedness plan, including updating patient roster. The Admin was not able to provide an explanation as to why the patient roster had not been updated since last quarter of 2023. A concurrent interview and record review on August 23, 2024, at 2:30 PM, was conducted with the Admin. The Admin reviewed of the agency's policy and procedure (P&P) titled, "Emergency Management. Patient Acuity Level Classification System”, revised 2020, which indicated “PURPOSE To provide a mechanism to classify patients in 3 acuity level for the purposes of disaster planning. To develop Individual plans for each as part of the comprehensive patient assessment. This includes patient classification. To provide essential care while maximizing resources and staff during emergency. To maintain a list of patients that may be, or are, in need of evacuation…. POLICY Agency will establish guidelines for Acuity Level at Start of Care for the purposes of disaster planning. The agency will have a tracking and communication system in place for staffs during the emergency. SPECIAL INSTRUCTIONS 1. A three-level patient acuity and prioritization classification system is utilized and is defined in writing. 2. Each patient's acuity and classification level will be determined upon admission by the RN Case Manager and/or Supervisor. 3. Acuity and Classification level is assessed on an ongoing basis, designated by diagnosis, care and/or treatment plan, support systems in place, special equipment needs and safety needs. PROCEDURES 1. At ALL times the agency maintains a current, complete roster which includes: name, address, telephone number, patient classification and at one emergency notification number. The patient roster should be readily accessible (within 15 minutes of request) to administrative/supervisory staff. 2. In the event of an emergency, staffing will be reprioritized and scheduling done by the agency designee utilizing the Patient Classifying System, …”. The Admin stated he was aware the patient roster needed to be updated weekly as per the agency’s P&P. The Admin further stated the agency did not follow the policy.

The following reflects the findings of the California Department of Public Health during a recertification survey conducted August 19, 2024, through August 23, 2024. Census: 18 Unduplicated Admissions: 26 Home Visits with record reviews: 3 Record Reviews without home visits: 4 Sample Size: 7 All Conditions of Participations were met.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the facility failed to ensure a review of all patients’ current medications was being conducted for three of seven sampled patients (Patients 1, 2, and 3). These failures have the potential to result in the facility and patients to not have an updated “Plan of Care” (patient treatment plan), or “Medication Profile” (a comprehensive summary of all medications taken by the patient), when compared to the actual medications the patient was taking in the home which may contribute to medication administration errors, discrepancies, or non-compliance with physician’s orders. Findings: 1. A review of Patient 1’s Home Health Certification (a document that gives a summary of patient information), and Plan of Care (a document that provides direction of type of nursing care a patient needs), indicated a start of care date of August 4, 2024, with a certification period of August 4, 2024, to October 2, 2024. Further review indicated Patient 1 had a primary diagnosis of open wound to the left elbow (an injury to elbow). During a home visit on August 20, 2024, at 11:00 AM, with a Licensed Vocational Nurse 1 (LVN 1), Patient 1’s medication bottles were compared with Patient 1’s “Medication Profile” dated, August 4, 2024, and “Plan of Care”, with a certification period of August 4, 2024, through October 2, 2024. The following were on Patient 1’s medication profile and plan of care, but was not in his home: 1a. Buspirone HCL (used to treat anxiety) 15 milligrams (mg – unit of measurement) tablet, 1 tab 2 times daily. 1b. Sevelamer HCL (used to treat high levels of phosphorus in the blood) 800 mg tablet, 3 tabs 3 times a day. 1c. Isosorbide Mononitrate ER (used to prevent chest pain) 12.5 mg tablet, 1 tab one time a day. 1d. Amlodipine Besylate (relaxes blood vessels so blood can flow through) 12.5 mg, 1 tab 2 times a day. 1e. Labetalol HCL (used to slow heart rate) 200 mg, 1 tab every 8 hours as needed. 1f. Baclofen oral packet (used to relax muscles) 10 mg, 1 packet every 8 hours as needed. 1g. Lorazepam (used to treat anxiety) 1 mg, 1 tab every 4 hours as needed. 1h. Melatonin (used to treat insomnia) 10 mg tab, 1 tab every 24 hours at bedtime as needed. 1i. Vitamin C (supplement) 500 mg, 1 tab, 1 time a day. 1j. Nephro-Vite (vitamin for end stage renal failure) 1 mg, 1 tab 1 time a day. 1k. Omega 3 (supplement) 1000 mg capsule, 1 cap 1 time a day. 2. A review of Patient 2’s Home Health Certification, and Plan of Care, indicated a start of care date of May 9, 2024, with a certification period of July 8, 2024, to September 5, 2024. Further review indicated Patient 2 had a primary diagnosis of type 2 diabetes mellitus (high blood sugar). During a home visit on August 21, 2024, at 10:20 AM, with a Certified Home Health Aide 1 (CHHA 1), Patient 2’s medications bottles were compared with Patient 2’s “Medication Profile” dated, May 9, 2024, and “Plan of Care”, with a certification period of July 8, 2024, through September 5, 2024. The following medications were on Patient 2’s medication profile but was not in the home: 2a. Robitussin (used to suppress coughs) 5 ml (ml – milliliters – unit of measurement), 5ml as needed. 2b. Fluocinolone Acetonide Body External (used to treat itching) 0.01%, use every 12 hours as needed for itching. 2c. Hydromorphone HCL (used to treat pain) 2 mg, 1 tab every 8 hours as needed for severe pain. 2d. Lanthanum Carbonate (medication used to reduce phosphorous levels in patients with esrd) 1000 mg, 1 tab 3 times a day. 2e. Lidocaine-Prilocaine external cream (used to numb areas to be accessed by a needle) 2.5-2.5%, 1 time per day for pain management. 2f. Clonidine HCL (medication used to treat high blood pressure) 0.1 mg, 1 tab every 8 hours as needed. 2g. Cefadroxil tab (medication used to treat infection) 500 mg 2 times a day, for 5 days for left toe infection. Start 6/6/2024. 2h. Naloxone spray (used to reverse an overdose) 4mg as needed. 2i. Tylenol with Motrin (used for pain relief) 250 mg with 125 mg as needed. 3. A review of Patient 3’s Home Health Certification and Plan of Care indicated a start of care date of May 31, 2024, with a certification period of July 30, 2024, to September 27, 2024. Further review indicated Patient 3 had a primary diagnosis of type 2 diabetes mellitus. During a home visit on August 21, 2024, at 1:20 PM, with a Registered Nurse/Director of Patient Care Services (RN/DPCS), Patient 3’s medications bottles were compared with Patient 3’s “Medication Profile” dated, May 31, 2024, and “Plan of Care”, with a certification period of July 30, 2024, through September 27, 2024. The following medications were on Patient 3’s medication profile and plan of care but not in the home: 3a. Zinc Sulfate (an electrolyte supplement) 50 mg, 1 tab every day. 3b. A medication bottle, unlabeled and with unknown tablets inside, was found in with the patient’s medications. During a concurrent interview and record review, on August 22, 2024, at 2:30 PM, with the RN/DPCS, the RN/DPCS acknowledged there were multiple discrepancies when comparing the actual medications of Patients 1, 2, and 3 were taking, their medication profile, and their plan of care. The RN/DPCS stated the Registered Nurse was responsible for reconciling medications. The RN/DPCS further stated the medication profile, and plan of care should match the medications patients were taking. During a record review of the facility’s policy and procedure, titled, “Medication Profile”, revised April 2019, “POLICY: …Medication profiles will be updated for each change to reflect current medications, new, and/or discontinued medications. PROCEDURE: … 2. A drug regimen review will be performed at the time of admission, when updates to the comprehensive assessments are performed, when care is resumed after a patient has been placed on hold, and with the addition of a new medication….7. Deviations from taking medications as ordered will be documented in clinical notes and the physician (or other authorized licensed independent practitioner) will be notified”. The RN/DPCS stated the policy was not followed.

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 facility failed to ensure that the physicians orders were followed for one of seven sampled patients (Patients 5) when Patient 5's physical therapy evaluation was not performed timely, as ordered by the physician. This failure had the potential to delay healing and recovery placing Patient 5’s health at risk. FINDINGS: A review of Patient 5’s Home Health Certification, and Plan of Care, indicated a start of care date of July 14, 2024, with a certification period of July 14, 2024, to September 11, 2024. Further review indicated Patient 5 had a primary diagnosis of Alzheimer’s (type of dementia that affects memory, thinking, and behavior). During a record review on August 22, 2024, at 2: 50 PM of Patient 5’s plan of care and physician’s orders, dated July 14, 2024, indicated “… Physician order… PT [Physical Therapy] evaluation…” During a review of patient 5’s schedule of visits and progress notes, on August 22, 2024, at 2:57 PM, indicated “… PT Evaluation… Visit Date: 08/20/2024 FROM: 1600 TO: 1645…”. This was a delay of one month and six days services. During a concurrent interview and record review with the Registered Nurse/Director of Patient Care Services (RN/DPCS), on August 22, 2024, at 3:57 PM, that there was a delay in physical therapy services. The RN/DPCS acknowledged there was a delay in services. A review of the facility’s policy and procedure (P&P), titled, “Physician Participation in Plan of Care”, dated April 2019, indicated, POLICY: “A physician will direct the care of every home health care patient admitted for service…The care will be provided in compliance with the therapeutic and diagnostic orders and accepted standards and practice”. PROCEDURE:… 2. When services are provided on the basis of a physician’s verbal orders, a registered nurse, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law shall document the orders in the patient’s clinical record, and sign, date, and time the orders”. RN/DPCS acknowledged the policy was not followed.

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the agency failed to ensure that the office was open and available to provide care to patients during operational hours, when the agency office was found to be closed during operational hours on Monday, August 19, 2024, from 9:00 AM to 2:00 PM. This failure had the potential to disrupt the agency’s ability to maintain continuous care, placing the agency at risk and affecting the quality of care in universe of 18 patients. Findings: During an observation of the agency’s office, on August 19, 2024, at 9:00 AM, the office door was locked, and no staff were available. During a phone interview with the Administrator (Admin), on August 19, 2024, at 9:33 AM, the Admin stated that he was three hours away from the office and the Registered Nurse/Director of Patient Care Services (RN/DPCS) was also about three hours away. Furthermore, the Admin stated he and RN/DPCS will be available at the office around 2:00 PM. During a follow up interview with the Admin, on August 19, 2024, at 2:10 PM, the Admin stated that he knew he will be late today and did not realize that the California Department of Public Health (CDPH) would be coming for a recertification survey [an inspection to ensure everything is being done correctly and safely]. He further stated that he was aware the agency’s policy requires the office to remain open during operational hours, regardless of whether the CDPH visits, to ensure availability for patients. During further interview with the Admin on August 19, 2024, at 2:35 PM, the Admin stated that it was his responsibility to have arranged for someone to be in the office during operational hours if either he or the RN/DPCS was going to be late or unavailable. During a concurrent interview and record review, on August 23, 2024, at 3:10 PM, with the Admin, the Admin reviewed the agency’s policy and procedure (P&P) titled, “Scope of Service,” revised April 2019, which indicated,” POLICY. Triune Home Health Provider, Inc. will operate an office that will provide a safe and adequate location related to space, facilities, and administrative services. Triune Home Health Provider, Inc. will be open from 9:00 a.m. to 5:00 p.m., Monday through Friday, except designated holidays or other days decided by the Executive Director/Administrator.…” and furthermore, the Admin reviewed the agency’s P&P titled, “Home Health Administrator,” revised April 2019, indicated, “… PURPOSE To define the overall responsibilities of the home health administrator position. POLICY The Executive Director/Administrator position will be responsible for the direction, coordination, and general supervision of all home health services. PROCEDURE… 3. Responsibilities of the position will include but not be limited to: A. Planning, organizing, directing and evaluating operations to ensure the provision of adequate and appropriate care and services B. Ensuring organizational compliance with legal, regulatory, and accreditation requirements…N. Appointing a similarly qualified alternate to be available at all times during operating hours in the absence of the Executive Director/Administrator… R. Ensuring standards of ethical business and clinical practice are maintained…” The Admin stated the agency did not follow the policy.

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 agency failed to follow their policy and procedure to ensure a discharge summary was completed within two calendar days for one of seven sampled patients (Patients 7), when Patient 7’s discharge summary was not completed 51 days after it was ordered. This failure had the potential to cause ineffective transition to provide continuous and effective care for the Patient 7. Findings: A review of Patient 7’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of May 5, 2024, with a certification period of May 5, 2024, to July 3, 2024. Patient 7 had diagnoses that included pressure ulcer of sacral region, stage 4 (a severe sore on the lower back area caused by staying in one position too long, and it needs careful medical attention to heal properly) and aftercare following surgery for neoplasm (after care surgery to remove an abnormal growth, like a tumor) A review of Patient 7’s clinical record titled “Physician order “dated July 2, 2024, indicated “… Discharge while inpatient… May discharge patient from [name of home health agency]…”. During an interview with the Registered Nurse/Director of Patient Care Services (RN/DPCS) on August 22, 2024, at 4:15 PM, the RN/DPCS stated a complete discharge must be completed within 3 days of the discharge date. The RN/DPCS further stated that the discharge summary for Patient 7 has not been completed. (Patient 7’s discharge summary was not completed 51 days after it was ordered.) During a concurrent interview and record review with the RN/DPCS, on August 22, 2024, at 4:20 PM, the DPCS reviewed the agency’s policy and procedures titled "Discharge Summary" revised April 2019, indicated, " PURPOSE To define the requirements for documentation of discontinuation of a service and when patients are discharged from the organization. POLICY Each patient discharged from a service and/or from the organization will have a written discharge summary completed and filed in the clinical record. PROCEDURE 1. Each clinician who provides care will complete a discharge summary at the time his/her discipline is discharged, which may include as appropriate: … 2. The discharge summary and other relevant clinical record documents will be completed and submitted within 72 hours of discharge from service. 3. A copy of the discharge summary will be provided to the patient's primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the organization within five (5) business days of the patient's discharge.” The DPCS stated that the agency did not follow the policy.

The following reflects the findings of the California Department of Public Health during the investigation of a complaint. Complaint Number: 61588 Representing the California Department of Public Health: Surveyor: 35183 The inspection was limited to the specific complaint investigated and does not represent the findings of a full inspection of the facility. One deficiency was issued as a result of the investigation for complaint number 61588

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the comprehensive assessment was updated by a discharge assessment and summary for one of three sampled patients (Patient 2). This failure had the potential to cause Patient 2 to lose services before a resolution of major depressive episodes. A review of Patient 2’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of February 6, 2021, with a recertification period of December 3, 2021 to January 31, 2022. Patient 2 had diagnoses that included major depressive disorder (a mental health disorder characterized by persistently depressed mood or loss of interest in activities, causing significant impairment in daily life). A review of Patient 2’s verbal order dated December 7, 2021 indicated “Please discharge patient from home health services.” A review of Patient 2’s clinical record from December 7, 2021 to January 11, 2022 was conducted. There was no documented evidence to show an OASIS (Outcome and Assessment Information Set-a patient-specific, standardized assessment used in Medicare home health care to plan care, determine reimbursement, and measure quality) discharge assessment had been conducted. There was no documented evidence to show a discharge summary had been completed. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) on January 11, 2022 at 3:34 PM, the AD/DPCS stated she was aware of the physician’s order to discharge Patient 2. The AD/DPCS stated she was behind on her work and had not conducted Patient 2’s OASIS discharge assessment or completed the discharge summary. The AD/DPCS stated she had not followed the agency’s policy titled, “Discharge Criteria and Process,” dated April 2019. A review of the agency’s policy and procedure titled, “Discharge Criteria and Process,” dated April 2019, indicated the following: “Procedure: … 3. An update to the comprehensive assessment, including required OASIS data elements, will be completed, as required by regulation. … 8. Organization Discharge: A discharge summary will be completed for all discharged patients. A copy may be mailed to the primary physician. … 11. All discharge paperwork will be due in the office within 72 hours of the discharge date. This will include the discharge order, discharge summary, plan of care, medication profile, and OASIS.”

Verbal orders CFR(s): 484.60(b)(3)(4) (3) Verbal orders must be accepted only by personnel authorized to do so by applicable state laws and regulations and by the HHA's internal policies. (4) When services are provided on the basis of a physician or allowed practitioner's verbal orders, a nurse acting in accordance with state licensure requirements, or other qualified practitioner responsible for furnishing or supervising the ordered services, in accordance with state law and the HHA's policies, must document the orders in the patient's clinical record, and sign, date, and time the orders. Verbal orders must be authenticated and dated by the physician or allowed pracitioner in accordance with applicable state laws and regulations, as well as the HHA's internal policies. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure verbal orders were signed, within 30 days of the interim order, for one of three sampled patients (Patient 2). This failure resulted in Patient 2 not being properly discharged from the agency. A review of Patient 2’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of February 6, 2021, with a recertification period of December 3, 2021 to January 31, 2022. Patient 2 had diagnoses that included major depressive disorder (a mental health disorder characterized by persistently depressed mood or loss of interest in activities, causing significant impairment in daily life). A review of Patient 2’s verbal order dated December 7, 2021 indicated “Please discharge patient from home health services.” There was no documented evidence to show the physician had signed the order. Thirty-five days had passed without a physician’s signature. During an interview with the Administrator/Director of Patient Care Services (AD/DPCS) on January 11, 2022 at 3:34 PM, the AD/DPCS stated she was aware of the doctor’s order to discharge Patient 2. The AD/DPCS stated the doctor’s order should have been signed within 30 days and it was not. The AD/DPCS stated the agency’s policy and procedure titled, “Verification of Physician Orders,” dated April 2019 had not been followed. A review of the agency’s policy and procedure titled, “Verification of Physician Orders,” dated April 2019, indicated, “Signed orders will be in the clinical record within 30 days of initiation of care or interim order …”

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to follow physician’s orders documented on the CMS 485 (a form provided by the Centers for Medicare and Medicaid Services-CMS-which documents a patient’s plan of care and physician’s orders) for one of three sampled patients (Patient 3) when three Skilled Nursing (SN) visits were not made as ordered. This failure had the potential to cause Patient 3 not to receive skilled nursing services. A review of Patient 3’s face sheet (a document that gives a summary of patient’s information), undated, indicated a start of care date of December 2, 2020, with a recertification period of November 27, 2021 to January 25, 2022. Patient 3 had diagnoses that included opened wound of right ear. A review of Patient 3’s CMS 485 dated November 27, 2021 to January 25, 2022, indicated the skilled nurse (SN- a Registered Nurse-RN or a Licensed Vocational Nurse-LVN) was to make visits to Patient 3, two times a week for four weeks and one time a week for five weeks. A review of Patient 3’s SN visit notes for recertification period November 27, 2021 to January 25, 2022, was conducted. The SN visit notes indicated the following visits were made: a. December 12, 2021 to December 18, 2021, two SN visit were ordered, one SN visit was made. b. December 19, 2021 to December 25, 2021, two SN visits were ordered, no SN visits were made. The Licensed Vocational Nurse (LVN 1) who had been scheduled to make the visits was unavailable for interview. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) on January 11, 2022 at 3:40 PM, The AD/DPCS verified that the three visits had been missed and there was no documentation as to why. The AD/DPCS stated the agency's policy and procedure titled, "Missed Visits," dated 2019 had not been followed. A review of the agency’s policy and procedure titled, “Missed Visits,” dated April 2019, indicated, “Policy: Missed visits will be communicated to the clinical supervisor and the patient’s physician. A missed visit will be rescheduled the same week if possible. Missed visits will be documented in the clinical record.”

The following reflects the findings of the California Department of Public Health during a full validation survey conducted March 8, 2021 through March 16, 2021. Representing the Department: Surveyors: 35183 42764 Census: 33 Unduplicated Admissions: 48 Home Visits with record reviews: 3 Record Reviews without home visits: 4 Sample Size: 7 The following Condition of Participation was not met: E 001 484.22 Establishment of the Emergency Program (EP)

Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms "facility" or "facilities" in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This CONDITION is not met as evidenced by: The agency failed to ensure that the Condition of Participation: E 001 484.22 Establishment of the Emergency Program (EP) was in compliance as follows: 1. Based on interview and record review, the agency failed to review and update its Emergency Plan annually, for 15 of 15 months reviewed, in a universe of 33 patients. (Refer to E 004) 2. Based on interview and record review, the agency failed to develop individual patient emergency preparedness plans, based on, and included in, the patients' comprehensive assessments, for 15 of 15 months reviewed, in a universe of 33 patients. (Refer to E 017) 3. Based on interview and record review, the agency failed to provide training to all staff, as well as contracted staff, on the agency's Emergency Preparedness Program, for 15 of 15 months reviewed, in a universe of 33 patients. (Refer to E 037) 4. Based on interview and record review, the agency failed to conduct full-scale emergency preparedness exercises that were community based (a full-scale exercise is a multi-agency, multi-jurisdictional, multi-discipline exercise involving functional [for example, joint field office, emergency operation centers, etc.] and "boots on the ground" response [for example, firefighters decontaminating mock victims]) or tabletop emergency preparedness exercises (an exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and set a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan), for 15 of 15 months reviewed, in a universe of 33 patients. (Refer to E 039) The cumulative effect of these systemic practices resulted in the potential to place the agency's patients at risk when the agency was not prepared to respond in an emergency or disaster.

Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to review and update its Emergency Plan annually, for 15 of 15 months reviewed, in a universe of 33 patients. This failure had the potential to place the agency's patients at risk when the agency was not prepared to respond in an emergency or disaster. Findings: A review of the Governing Body (GB) meeting minutes from January 1, 2020 to March 16, 2021, was conducted. There was no documented evidence to show the Emergency Plan had been reviewed and updated. During an interview with the Administrator (Admin 4) in the presence of the Administrator Designee/Director of Patient Care Services (AD/DPCS) on March 16, 2021 at 11 AM, Admin 4 stated he was a member of the GB. Admin 4 stated the Emergency Plan had not been reviewed and updated by the GB for the year 2020. In a continued interview with Admin 4, Admin 4 stated the agency did not have a policy and procedure that indicated the GB would review and update its Emergency Plan annually.

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to develop individual patient emergency preparedness plans, based on, and included in, the patients' comprehensive assessments, for 15 of 15 months reviewed, in a universe of 33 patients. This failure had the potential to place the agency's patients at risk when the agency was not prepared to respond in an emergency or disaster. Findings: During an interview with the Administrator Designee/Director of Patient Care Services AD/DPCS, in the presence of the Administrator (Admin 4), on March 16, 2021 at 11:20 AM, the AD/DPCS stated she was responsible for the agency's Emergency Preparedness Program. The AD/DPCS stated the patients' individual emergency preparedness plans were based on a triage system: Category I - most at risk, Category II - moderately at risk and Category III - least at risk. The AD/DPCS stated the triage codes were determined at the time of the start of care and recertification assessments. The AD/DPCS stated the triage codes were indicated on the patients' comprehensive assessments under "Acuity Level." The AD/DPCS stated this was how the agency prioritized the patients during an emergency situation. A review of the initial and recertification assessments for seven of seven sampled patients (Patients 1, 2, 3, 4, 5, 6, and 7) was conducted. The assessments indicated acuity levels as follows: 1. Patient 1's initial assessment dated January 29, 2021, indicated, "Acuity Level: [blank]." 2. Patient 2's recertification assessment dated February 17, 2021, indicated, "Acuity Level: [blank]." 3. Patient 3's recertification assessment dated February 1, 2021, indicated, "Acuity Level: 2 - Medium." 4. Patient 4's recertification assessment dated February 26, 2021, indicated, "Acuity Level: [blank]." 5. Patient 5's initial assessment dated January 20, 2021, indicated, "Acuity Level: [blank]." 6. Patient 6's initial assessment dated February 3, 2021, indicated, "Acuity Level: [blank]." 7. Patient 7's initial assessment dated February 3, 2021, indicated, "Acuity Level: [blank]." During an interview with the Administrator Designee/Director of Patient Care Services AD/DPCS, in the presence of the Administrator (Admin 4), on March 16, 2021 at 11:30 AM, the AD/DPCS stated six of the seven patient assessments reviewed, did not indicate an acuity level. The AD/DPCS stated, "I guess the nurses aren't really doing them." A review of the agency's policy and procedure titled "Emergency Management Plan," dated March 2007, indicated the following: "Policy: The Program Supervisors or designee(s) will assign category classifications for all current patients. The Program Supervisors or designee(s) will assign all available, qualified personnel to care for Category I patients first and Category II patients second. Category III patients and any Category II patients who do not receive scheduled care will be notified by phone as soon as possible."

EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, "Organizations" under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF's emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to provide training to all staff, as well as contracted staff, on the agency's Emergency Preparedness Program, for 15 of 15 months reviewed, in a universe of 33 patients. This failure had the potential to place the agency's patients at risk when the agency was not prepared to respond in an emergency or disaster. Findings: During an interview with a Certified Home Health Aide (CHHA 1) on March 10, 2021 at 3:17 PM, CHHA 1 stated she had not received an in service on the agency's Emergency Preparedness Plan. During an interview with a Registered Nurse (RN 1) on March 11, 2021 at 11:04 AM, RN 1 stated, "I don't remember receiving a formal training on the emergency plan but I know how to keep the patients safe." During an interview with a Physical Therapist (PT 1) on March 11, 2021 at 12:38 PM, PT 1 stated he had not received an in service on the agency's Emergency Preparedness Plan. A review of the agency's in-service binder from January 1, 2020 to March 16, 2021 was conducted. There was no documented evidence to show a training on the agency's Emergency Preparedness Program had been offered or attended. During an interview with the Administrator Designee/Director of Patient Care Services AD/DPCS, in the presence of the Administrator (Admin 4), on March 16, 2021 at 12:10 PM, the AD/DPCS stated she was responsible for the agency's Emergency Preparedness Program. The AD/DPCS stated she had not provided an in service to the agency's staff for the Emergency Preparedness Program. The AD/DPCS stated she had not provided training on the agency's Emergency Preparedness Program to new hires. In a continued interview with the Administrator (Admin 4), Admin 4 stated the agency did not have a policy and procedure indicating training requirements for staff on the agency's Emergency Preparedness Program.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to conduct full-scale emergency preparedness exercises that were community based (a full-scale exercise is a multi-agency, multi-jurisdictional, multi-discipline exercise involving functional [for example, joint field office, emergency operation centers, etc.] and "boots on the ground" response [for example, firefighters decontaminating mock victims]) or tabletop emergency preparedness exercises (an exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and set a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan), for 15 of 15 months reviewed, in a universe of 33 patients. This failure had the potential to place the agency's patients at risk when the agency was not prepared to respond in an emergency or disaster. Findings: A review of the agency's Emergency Preparedness Program binder from January 1, 2020 to March 16, 2021 was conducted. There was no documented evidence to show a full-scale emergency preparedness exercises that was community based or a tabletop emergency preparedness exercise was conducted. During an interview with the Administrator Designee/Director of Patient Care Services AD/DPCS, in the presence of the Administrator (Admin 4), on March 16, 2021 at 12:20 PM, the AD/DPCS stated she was responsible for the agency's Emergency Preparedness Program. The AD/DPCS stated a full-scale emergency preparedness exercises that was community based or a tabletop emergency preparedness exercise had not been conducted for 2020. In a continued interview with the Administrator (Admin 4), Admin 4 stated the agency did not have a policy and procedure indicating testing requirements for the agency's Emergency Preparedness Program.

The following reflects the findings of the California Department of Public Health during a full validation survey conducted March 8, 2021 through March 16, 2021. Representing the Department: Surveyors: 35183 42764 Census: 33 Unduplicated Admissions: 48 Home Visits with record reviews: 3 Record Reviews without home visits: 4 Sample Size: 7 One complaint was investigated during the full validation survey: CA00728083: 2 deficiencies were issued (Refer to G 942 and G 958) The following Conditions of Participation were not met: G 510 484.55 Comprehensive Assessments of Patients G 570 484.60 Care planning, coordination, quality of care G 640 484.65 Quality assessment/performance improvement G 680 484.70 Infection prevention and control G 940 484.105 Organization and administration of services An Immediate Jeopardy (IJ-a situation with the potential to harm the health and safety of the patients) was called under 42 CFR 484.105(a) G 942 Governing body, on March 8, 2021 at 5:00 PM, in the presence of the Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS). The Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS) were verbally notified of the IJ situation identified based on the agency's Governing Body's failure to manage and operate the agency to ensure safe and effective care to patients. The agency submitted a corrective action plan which was reviewed and accepted on March 15, 2021 at 4:06 PM, in the presence of the Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS). After interviews with Admin 4, AD/DPCS, the New Administrator Designee/Director of Patient Care Services Designee (New AD/DPCSD), and a review of the March 10, 2021 special Governing Body Meeting minutes, the IJ was lifted on March 15, 2021 at 4:06 PM, in the presence of the Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS). An Immediate Jeopardy (IJ-a situation with the potential to harm the health and safety of the patients) was called under 42 CFR 484.105(c) G 958 Clinical manager, on March 8, 2021 at 5:00 PM, in the presence of the Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS). The Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS) were verbally notified of the IJ situation identified based on the agency's failure to ensure clinical oversight of all patient care services and personnel 24 hours a day, seven days a week. The agency submitted a corrective action plan which was reviewed and accepted on March 15, 2021 at 4:06 PM, in the presence of the Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS). After an interview with the New Administrator Designee/Director of Patient Care Services Designee (New AD/DPCSD) and a review of the New AD/DPCSD's qualifications and agency's orientation checklist, the IJ was lifted on March 15, 2021 at 4:06 PM, in the presence of the Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS).

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: The agency failed to ensure the Condition of Participation: G 510 484.55 Comprehensive Assessment of Patients was in compliance when: 1. Based on interview and record review, the agency failed to ensure the comprehensive assessment, which included the patients' care plan, was completed in its entirety by one clinician for seven out of seven sampled patients (Patients 1, 2, 3, 4, 5, 6, and 7). (Refer G 518) 2. Based on interview and record review, the agency failed to ensure the comprehensive assessment, which included the patient's care plan, was completed no later than five days after the start of care for two of seven sampled patients (Patients 1 and 6). (Refer to G 520) 3. Based on interview and record review, the agency failed to ensure a review of all medications the patients were taking was conducted for three of seven sampled patients (Patients 1, 2, and 3) when: a. For Patient 1, one medication on the medication profile (MP-a current list of all medications prescribed for a specific patient), indicated a wrong dosage and four medications the patient was taking were not indicated on the MP. (Refer G 536) b. For Patient 2, eight medications the patient was taking, were not indicated on the MP. (Refer G 536) c. For Patient 3, four medications on the MP, indicated a wrong dosage and one medication the patient was taking was not indicated on the MP. (Refer G 536) 4. Based on interview and record review, the agency failed to ensure the care plan was developed within five working days of the recertification assessment for two of seven sampled patients (Patients 2 and 3). (Refer to G 546) The cumulative effect of these systemic practices resulted in the potential to cause: a. Patient care needs to be missed and patients to suffer insufficient care and services. b. Unmet nursing, therapy and psychosocial care needs. c. Patients to suffer ineffective drug therapy, significant side effects and unaddressed noncompliance with drug therapy.

Completion of the comprehensive assessment CFR(s): 484.55(b) Standard: Completion of the comprehensive assessment. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure the comprehensive assessment, which included the patients' care plan, was completed in its entirety by one clinician for seven out of seven sampled patients (Patients 1, 2, 3, 4, 5, 6, and 7). This failure had the potential to cause patient care needs to be missed and patients to suffer insufficient care and services. Findings: 1. A review of Patient 1's face sheet (a document that gives a summary of patient's information), undated, indicated a start of care date of January 29, 2021, with a certification period of January 29, 2021 to March 29, 2021. Patient 1 had diagnoses that included polyosteoarthritis (pain and inflammation in multiple joints). Prior to a home visit with Patient 1 on March 9, 2021, a review of Patient 1's Plan of Care dated January 29, 2021 to March 29, 2021 was conducted. There was no documented evidence to show interventions indicating the care Patient 1 required. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) on March 9, 2021 at 4 PM, the AD/DPCS stated Patient 1's care plan had not been completed yet. The AD/DPCS stated the agency was behind in getting the patients' care plans completed. The AD/DPCS stated the clinicians were providing patient care without a care plan to follow. The AD/DPCS stated Patient 1's care plan should have been completed by February 3, 2021 and it was not. During a home visit on March 11, 2021 at 11:39 AM with a Physical Therapist (PT 1) and in the presence of Patient 1 and Patient 1's daughter, PT 1 stated he followed the care plan he had developed for Patient 1's physical therapy. During an interview with Patient 1's daughter on March 11, 2021 at 12:14 PM, Patient 1's daughter stated Patient 1 had suffered an infection in his left hip and the bone had to be removed. Patient 1's daughter stated her father had extreme pain in his left hip and had been taking a combination of morphine (a pain medication) and NORCO (a pain medication) to control it, while he waited for replacement hip surgery. Patient 1's daughter stated they had run out of the morphine and NORCO on Monday March 2, 2021 and the home health agency had supplied tramadol (a pain medication) but it did not work. Patient 1's daughter stated she spoke with the AD/DPCS and told her the tramadol did not work. Patient 1's daughter stated the AD/DPCS stated the physician would not prescribe anymore narcotics and gave her the physician's phone number for her to call directly. Patient 1's daughter stated she had called the doctor and was waiting for a call back. During an interview with Patient 1 on March 11, 2021 at 12:27 PM, after PT 1 had finished Patient 1's physical therapy, Patient 1 stated his pain was 10 out of 10 (a pain scale were 0 equals no pain and 10 equals the worst possible pain). Patient 1 stated since he ran out of the morphine and NORCO he could not sleep. Patient 1 stated he could not move in bed and had to lay very still on his back. Patient 1 stated with the morphine and NORCO he could make short walks around the back yard and move around the house. Patient 1 stated since taking the tramadol he no longer took walks because it hurt too much. Patient 1 stated, "If I sit still and do not move the pain will come down somewhat. But I don't want to sit still and do nothing and move nowhere. That's no way to live!" During an interview and concurrent record review with the AD/DPCS on March 15, 2021 at 12:23 PM, the AD/DPCS provided a completed care plan for Patient 1. The AD/DPCS stated the Registered Nurses (RNs) who completed the patients' assessments did not complete the care plans. The AD/DPCS stated the agency sent the patients' assessments to a Registered Nurse OASIS (Outcome and Assessment Information Set) Coder (RN/Coder) to apply billing codes for the patients' diagnoses and complete the care plans. The AD/DPCS stated she had called the RN/Coder on March 8, 2021 when the surveyors had arrived and begged her to get the care plans finished as fast as possible. The AD/DPCS stated the RN/Coder had created Patient 1's care plan. The AD/DPCS stated Patient 1's care plan had been completed 45 days after Patient 1's start of care date (January 29, 2021). A review of Patient 1's initial assessment dated January 29, 2021 indicated a Registered Nurse (RN 3) had conducted the assessment. A request was made to interview RN 3 on March 15, 2021 at 12:14 PM. RN 3 did not respond to the request. During an interview with the Administrator (Admin 4) on March 15, 2021 at 12:58 PM, Admin 4 stated he paid the RN/Coder 60.00 dollars per patient to apply the billing codes and complete the care plans. 2. A review of Patient 2's face sheet (a document that gives a summary of patient's information), undated, indicated a start of care date of July 8, 2018, with a recertification period of February 22, 2021 to April 22, 2021. Patient 2 had diagnoses that included complications of colostomy (a surgical operation in which a piece of the colon is diverted to an artificial opening in the abdominal wall). Prior to a home visit with Patient 2 on March 9, 2021, a review of Patient 2's Plan of Care dated February 22, 2021 to April 22, 2021 was conducted. There was no documented evidence to show interventions indicating the care Patient 2 required. The AD/DPCS stated Patient 2's care plan should have been completed by February 22, 2021 and it was not. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) on March 9, 2021 at 4 PM, the AD/DPCS stated Patient 2's care plan had not been completed yet. The AD/DPCS stated the agency was behind in getting the patients' care plans completed. The AD/DPCS stated the clinicians were providing patient care without a care plan to follow. The AD/DPCS stated Patient 2's care plan should have been completed by February 22, 2021 and it was not. During a home visit on March 10, 2021 at 3 PM with a Certified Home Health Aide (CHHA 1) and in the presence of Patient 2 and Patient 2's wife, CHHA 1 stated she followed the home health aide care plan provided to her by the agency. CHHA 1 stated she did not have the care plan with her because she was not providing care at this visit. CHHA 1 stated she had made the visit only because the surveyors were at the agency. During an interview with Patient 2's wife on March 10, 2021 at 3:17 PM, Patient 2's wife stated Patient 2 had a rash around the opening of his colostomy and it was extending out towards his belly. Patient 2's wife stated it was very painful and they just couldn't get it to go away. Patient 2's wife reached forward and pulled up Patient 2's shirt revealing the colostomy bag and a red rash extending out from under the bag. Patient 2's wife stated, "See?" Patient 2 grabbed his shirt from his wife's hand and pulled it down over his belly. Patient 2 stated, "Don't do that!" During an interview with a Registered Nurse (RN 1) on March 11, 2021 at 9 AM, RN 1 stated she had conducted the recertification assessment for Patient 2 on February 17, 2021. RN 1 stated she had not created or updated Patient 2's care plan. RN 1 stated, "The agency does that." During an interview and concurrent record review with the AD/DPCS on March 15, 2021 at 12:32 PM, the AD/DPCS provided a completed care plan for Patient 2. The AD/DPCS stated the Registered Nurses (RNs) who completed the patients' assessments did not complete the care plans. The AD/DPCS stated the agency sent the patients' assessments to a Registered Nurse OASIS (Outcome and Assessment Information Set) Coder (RN/Coder) to apply billing codes for the patients' diagnoses and complete the care plans. The AD/DPCS stated she had called the RN/Coder on March 8, 2021 when the surveyors had arrived and begged her to get the care plans finished as fast as possible. The AD/DPCS stated the RN/Coder had created Patient 2's care plan. The AD/DPCS stated Patient 2's care plan had been completed 26 days after Patient 2's recertification assessment date (February 17, 2021). During an interview with the Administrator (Admin 4) on March 15, 2021 at 12:58 PM, Admin 4 stated he paid the RN/Coder 60.00 dollars per patient to apply the billing codes and complete the care plans. 3. A review of Patient 3's face sheet (a document that gives a summary of patient's information), undated, indicated a start of care date of August 6, 2020, with a recertification period of February 2, 2021 to April 2, 2021. Patient 3 had diagnoses that included diabetes mellitus (high blood sugar). Prior to a home visit with Patient 3 on March 9, 2021, a review of Patient 3's Plan of Care dated February 2, 2021 to April 2, 2021 was conducted. There was no documented evidence to show interventions indicating the care Patient 3 required. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) on March 9, 2021 at 4 PM, the AD/DPCS stated Patient 3's care plan had not been completed yet. The AD/DPCS stated the agency was behind in getting the patients' care plans completed. The AD/DPCS stated the clinicians were providing patient care without a care plan to follow. The AD/DPCS stated Patient 3's care plan should have been completed by February 6, 2021 and it was not. During a home visit on March 11, 2021 at 9 AM with a Registered Nurse (RN 1) and in the presence of Patient 3 and Patient 3's daughter, RN 1 stated Patient 3 was a new patient to her and she had not provided care for Patient 3 before. RN 1 stated she had not reviewed Patient 3's care plan prior to the visit because the care plan had not been completed. During an interview with Patient 3's daughter on March 11, 2021 at 9:42 AM, Patient 3's daughter stated Patient 3 had renal failure and received dialysis (the process of removing excess water, solutes, and toxins from the blood, when the kidneys had failed) every Monday, Tuesday, Wednesday and Friday. Patient 3's daughter stated Patient 3 had an AV fistula (arteriovenous fistula-a surgically created connection between an artery and vein, in an arm, for dialysis treatments) in her left arm. Patient 3's daughter stated Patient 3 was on a fluid restriction of one liter (a unit of measure) per day. Patient 3's daughter stated Patient 3 had wounds on three fingers of her left hand (middle finger, ring finger and pinky). Patient 3's daughter stated Patient 3's wounds had been there for 3 months. During an interview with a Registered Nurse (RN 2) on March 15, 2021 at 12:07 PM, RN 2 stated he had conducted Patient 3's recertification assessment on February 1, 2021. RN 2 stated he was supposed to complete Patient 3's care plan too. RN 2 stated if his signature was not on the care plan, then he had not done it. RN 2 stated, "I must have missed it." During an interview and concurrent record review with the AD/DPCS on March 15, 2021 at 12:35 PM, the AD/DPCS provided a completed care plan for Patient 3. The AD/DPCS stated the Registered Nurses (RNs) who completed the patients' assessments did not complete the care plans. The AD/DPCS stated the agency sent the patients' assessments to a Registered Nurse OASIS (Outcome and Assessment Information Set) Coder (RN/Coder) to apply billing codes for the patients' diagnoses and complete the care plans. The AD/DPCS stated she had called the RN/Coder on March 8, 2021 when the surveyors had arrived and begged her to get the care plans finished as fast as possible. The AD/DPCS stated the RN/Coder had created Patient 3's care plan. The AD/DPCS stated Patient 3's care plan had been completed 42 days after Patient 3's recertification assessment date (February 1, 2021). During a continued interview and record review with the AD/DPCS on March 15, 2021 at 12:35 PM, a review of Patient 3's completed care plan dated February 2, 2021 to April 2, 2021 was conducted. There was no documented evidence to show: Patient 3's kidney failure diagnosis, dialysis treatments, AV fistula, or fluid restriction. The AD/DPCS stated, "I guess the coder [RN/Coder] missed it." During an interview with the Administrator (Admin 4) on March 15, 2021 at 12:58 PM, Admin 4 stated he paid the RN/Coder 60.00 dollars per patient to apply the billing codes and complete the care plans. 4. A review of Patient 4's Home Health Certification and Plan of Care (a document that gives a summary of patient's diagnoses with care plan interventions and patient goals for discharge), dated February 26, 2021, indicated a start of care date of November 3, 2020, with a recertification period of March 3, 2021 to May 1, 2021. Patient 4 had diagnoses that included chronic atrial fibrillation (a type of heart arrhythmia that causes the heart to quiver and beat irregularly). During an interview and record review on March 12, 2021, at 11:23 AM, with a Registered Nurse 4, (RN 4), a review of Patient 4's completed recertification assessment dated February 26, 2021 with a recertification period of March 3, 2021 to May 1, 2021 was conducted. RN 4 stated, she had completed the recertification assessment on February 26, 2021. RN 4 stated, Administrator Designee/Director of Patient Care Services (AD/DPCS), had completed the nursing interventions for the plan of care for Patient 4. During a concurrent interview and record review on March 12, 2021, at 12:40 PM, with AD/DPCS, the Home health Certification and Plan of Care for Patient 4, dated February 26, 2021, was reviewed. The Home Health Certification and Plan of Care for Patient 4 indicated that nursing interventions, the AD/DPCS's signature, and the physician's signature were documented. The AD/DPCS stated, RN 4 did the comprehensive assessment on Patient 4. The AD/DPCS stated, RN 4 reported the findings of the comprehensive assessment, and the AD/DPCS put in the nursing interventions with the help of the RN/Coder. The Plan of Care was not completed by a single clinician. 5. During a review of Patient 5's Home Health Certification and Plan of Care (a document that gives a summary of patient's diagnoses with care plan interventions and patient goals for discharge), dated January 20, 2021, indicated a start of care date of January 20, 2021, with a certification period of January 20, 2021 to March 20, 2021. Patient 5 had diagnoses that included chronic ulcer (a spontaneous or traumatic lesion on the skin loss leaving a raw wound that does not heal) of right ankle. During an interview and record review on March 12, 2021, at 11:14 AM, with a Registered Nurse (RN 2), a review of Patient 5's completed Home Health Certification and Plan of Care comprehensive assessment was reviewed. RN 2 stated, he had completed the comprehensive assessment dated, January 20, 2021, for Patient 5 on January 20, 2021. RN 2 stated, he did not recall completing the nursing interventions for the plan of care for Patient 5. During a concurrent interview and record review on March 12, 2021, at 12:45 PM, with the Administrator Designee/Director of Patient Care Services (AD/DPCS), the Home Health Certification and Plan of Care for Patient 5, dated January 20, 2021 was reviewed. The Home Health Certification and Plan of Care for Patient 5 indicated that nursing interventions, the Admin/DPCS 3's signature, and the physician's signature were documented. The AD/DPCS stated, RN 2 did the comprehensive assessment on Patient 5. The AD/DPCS stated, RN 2 reported the findings of the comprehensive assessment, and the AD/DPCS put in the nursing interventions with the help of the RN/Coder. The AD/DPCS stated, Admin 4 told me it was ok to sign the Home health Certification and Plan of Care. The Plan of Care was not completed by a single clinician. 6. During a review of Patient 6's Home Health Certification and Plan of Care (a document that gives a summary of patient's diagnoses, with care plan interventions and patient goals for discharge), dated February 3, 2021, indicated a start of care date of February 3, 2021, with a certification period from February 3, 2021 to April 3, 2021. Patient 6 had diagnoses that included an open wound of the right forearm. . During an interview and record review on March 12, 2021, at 12:07 PM, with Registered Nurse (RN 1), the Home Health Certification and Plan of Care for Patient 6, was reviewed. RN 1 stated, she completed the comprehensive assessment on Patient 6. There was no documented evidence to show care plan interventions for the wound on Patient 6's forearm. RN 1 stated, she reported her findings from the comprehensive assessment to the Administrator/ Designee/Director of Patient Care Services (AD/DPCS). RN 1 stated, she did not complete the plan of care nursing interventions for Patient 6. During a concurrent interview and record review on March 12, 2021, at 12:35 PM, with AD/DPCS, the Home Health Certification and Plan of Care for Patient 6, dated February 3, 2021, was reviewed. The Home Health Certification and Plan of Care for Patient 6 indicated that the comprehensive assessment was not completed, lacked nursing interventions, nurse's signature, and physician signature. AD/DPCS agreed that the Home health Certification and Plan of Care was not completed within 5 days of start of care, and the RN had no nursing interventions to implement care for Patient 6. 7. During a review of Patient 7's Home Health certification and Plan of Care (a document that gives a summary of patient's diagnoses, with care plan interventions and patient goals for discharge), dated February 3, 2021, indicated a start of care date of February 3, 2021, with a certification period from February 3, 2021 to April 3, 2021. Patient 7 had diagnoses that included diabetes mellitus (high blood sugar). During an interview and record review on March 12, 2021, at 12:07 PM, with Registered Nurse (RN 1), the Home Health Certification and Plan of Care dated February 3, 2021, for Patient 7 was reviewed. RN 1 stated, she completed the comprehensive assessment on Patient 7. RN 1 stated, she reported her findings from the comprehensive assessment to the Administrator Designee/Director of Patient Care Services (AD/DPCS). RN 1 stated, she did not complete the plan of care nursing interventions for Patient 7. During a concurrent interview and record review on March 12, 2021, at 12:45 PM, with the Administrator Designee/Director of Patient Care Services (AD/DPCS), the Home Health Certification and Plan of Care for Patient 7, dated February 3, 2021, was reviewed. The Home Health Certification and Plan of Care for Patient 7 indicated, nursing interventions and AD/DPCS signature. The Home Health certification and Plan of Care was not signed by the physician. AD/DPCS stated, RN 1 did the comprehensive assessment on Patient 7. AD/DPCS stated, RN 1 reported the findings of the comprehensive assessment, and AD/DPCS put in the nursing interventions with the help of the RN/Coder. The Plan of Care was not completed by a single clinician. A review of the agency's policy and procedure titled "Initial and Comprehensive Assessment," dated April 2019, indicated the following: "Purpose: To provide guidelines for the initial assessment of patients admitted to service and for completing the plan of care. Procedure: The initial assessment and comprehensive assessment must be conducted by a registered nurse ... The comprehensive assessment for each patient must be completed in its entirety by a single clinician. The comprehensive assessment shall reflect and determine: ...Plan of Care A plan of care will be developed from the information gathered during the initial and comprehensive assessment." A review of the policy and procedure titled "Care Planning Process," dated April 2019, indicated, "Policy: A written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days or as patient's condition warrants. The patient plan of care will be developed or revised within five (5) working days of initiation of each service or of the reassessment of the patient."

5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient's immediate needs, but no later than 5 calendar days after the start of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to ensure the comprehensive assessment, which included the patient's care plan, was completed no later than five days after the start of care for two of seven sampled patients (Patients 1 and 6). This failure had the potential to cause the patients' nursing, therapy and psychosocial needs to go unmet. Findings: 1. A review of Patient 1's face sheet (a document that gives a summary of patient's information), undated, indicated a start of care date of January 29, 2021, with a certification period of January 29, 2021 to March 29, 2021. Patient 1 had diagnoses that included polyosteoarthritis (pain and inflammation in multiple joints). On March 9, 2021, a review of Patient 1's Plan of Care dated January 29, 2021 to March 29, 2021 was conducted. There was no documented evidence to show interventions indicating the care Patient 1 required. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) on March 9, 2021 at 4 PM, the AD/DPCS stated Patient 1's care plan had not been completed yet. The AD/DPCS stated the agency was behind in getting the patients' care plans completed. The AD/DPCS stated the clinicians were providing patient care without a care plan to follow. The AD/DPCS stated Patient 1's care plan should have been completed by February 3, 2021 and it was not. During an interview and concurrent record review with the AD/DPCS on March 15, 2021 at 12:23 PM, the AD/DPCS provided a completed care plan for Patient 1. The AD/DPCS stated the Registered Nurses (RNs) who completed the patients' assessments did not complete the care plans. The AD/DPCS stated the agency sent the patients' assessments to a Registered Nurse OASIS (Outcome and Assessment Information Set) Coder (RN/Coder) to apply billing codes for the patients' diagnoses and complete the care plans. The AD/DPCS stated she had called the RN/Coder on March 8, 2021 when the surveyors had arrived and begged her to get the care plans finished as fast as possible. The AD/DPCS stated the RN/Coder had created Patient 1's care plan. The AD/DPCS stated Patient 1's care plan had been completed 45 days after Patient 1's start of care date (January 29, 2021). A review of Patient 1's initial assessment dated January 29, 2021 indicated a Registered Nurse (RN 3) had conducted the assessment. A request was made to interview RN 3 on March 15, 2021 at 12:14 PM. RN 3 did not respond to the request. 2. During a review of Patient 6's Home Health Certification and Plan of Care (a document that gives a summary of patient's diagnoses, with care plan interventions and patient goals for discharge), dated February 3, 2021, indicated a start of care date of February 3, 2021, with a certification period from February 3, 2021 to April 3, 2021. Patient 6 had diagnoses that included an open wound of the right forearm. . During an interview and record review on March 12, 2021, at 12:07 PM, with Registered Nurse (RN 1), the Home Health Certification and Plan of Care for Patient 6, was reviewed. RN 1 stated, she completed the comprehensive assessment on Patient 6. There was no documented evidence to show care plan interventions for the wound on Patient 6's forearm. RN 1 stated, she reported her findings from the comprehensive assessment to the Administrator/ Designee/Director of Patient Care Services (AD/DPCS). RN 1 stated, she did not complete the plan of care nursing interventions for Patient 6. During a concurrent interview and record review on March 12, 2021, at 12:35 PM, with AD/DPCS, the Home Health Certification and Plan of Care for Patient 6, dated February 3, 2021, was reviewed. The Home Health Certification and Plan of Care for Patient 6 indicated that the comprehensive assessment was not completed, lacked nursing interventions, nurse's signature, and physician signature. AD/DPCS agreed that the Home health Certification and Plan of Care was not completed within five days of start of care, and the RN had no nursing interventions to implement care for Patient 6. A review of the policy and procedure titled "Care Planning Process," dated April 2019, indicated, "Policy: A written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days or as patient's condition warrants. The patient plan of care will be developed or revised within five (5) working days of initiation of each service or of the reassessment of the patient."

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 agency failed to ensure a review of all medications the patients were taking was conducted for three of seven sampled patients (Patients 1, 2, and 3) when: 1. For Patient 1, one medication on the medication profile (MP-a current list of all medications prescribed for a specific patient), indicated a wrong dosage and four medications the patient was taking were not indicated on the MP. 2. For Patient 2, eight medications the patient was taking, were not indicated on the MP. 3. For Patient 3, four medications on the MP, indicated a wrong dosage and one medication the patient was taking was not indicated on the MP. This failure had the potential to cause ineffective drug therapy, significant side effects and noncompliance with drug therapy. Findings: 1. A review of Patient 1's face sheet (a document that gives a summary of patient's information), undated, indicated a start of care date of January 29, 2021, with a certification period of January 29, 2021 to March 29, 2021. Patient 1 had diagnoses that included polyosteoarthritis (pain and inflammation in multiple joints). During a home visit on March 11, 2021 with a Physical Therapist (PT 1) and in the presence of Patient 1 and Patient 1's daughter, an observation of Patient 1's actual medication bottles available in the home were compared with Patient 1's Medication Profile (MP - a current list of all medications prescribed for a specific patient). During an observation and interview with Patient 1's daughter on March 11, 2021 at 12 PM, Patient 1's daughter stated she administered medications to her father. A review of Patient 1's MP indicated, "gabapentin [a nerve pain medication], by mouth, 100 mg [milligrams-a unit of measure], 2 [two] tablets, two times a day." The medication bottle available in the home indicated, "gabapentin, by mouth, 100 mg, 2 tablets, three times a day." Patient 1's daughter stated she had been giving gabapentin, 100 mg tablets, by mouth, three times a day since January 28, 2020. During a continued observation and interview with Patient 1's daughter, Patient 1's daughter provided the following medication bottles: a. Docusate (a stool softening medication), 100 mg (milligrams - a unit of measure) tablets, OTC (over-the-counter). Patient 1's daughter stated she had been giving Patient 1 two tablets every morning since admission to the home health agency. b. Tramadol (a pain medication), 50 mg tablets, take one tablet by mouth every four hours as needed. Patient 1's daughter stated she had been giving the tramadol since March 3, 2021, but it was ineffective. c. Iron (a nutritional supplement), 325 mg tablets, OTC. Patient 1's daughter stated she had been giving Patient 1, one tablet, every morning since January 28, 2021. d. Lactulose solution (a medication to treat constipation), 10 g (grams - a unit of measure) in 15 ml (milliliters - a unit of measure), take 20 gm (grams - a unit of measure), (30 ml), by mouth, every six hours, as needed. Patient 1's daughter stated she had been giving Patient 1 the lactulose when he needed it, since January 28, 2021. Patient 1's MP did not indicate the docusate, tramadol, iron or lactulose. 2. A review of Patient 2's face sheet (a document that gives a summary of patient's information), undated, indicated a start of care date of July 8, 2018, with a recertification period of February 22, 2021 to April 22, 2021. Patient 2 had diagnoses that included complications of colostomy (a surgical operation in which a piece of the colon is diverted to an artificial opening in the abdominal wall). During a home visit on March 10, 2021 with a Certified Home Health Aide (CHHA 1) and in the presence of Patient 2 and Patient 2's wife, an observation of Patient 2's actual medication bottles available in the home were compared with Patient 2's Medication Profile (MP - a current list of all medications prescribed for a specific patient). During an observation and interview with Patient 2's wife on March 10, 2021 at 3:41 PM, Patient 2's wife stated she administered medications to her husband. Patient 2's wife provided the following medication bottles: a. Atorvastatin (a medication to lower cholesterol), 40 mg (milligrams - a unit of measure), take one tablet, by mouth, daily. Patient 2's wife stated Patient 2 had been taking atorvastatin for six to seven years. b. Cimetidine (a medication to treat heartburn), 300 mg tablet, take one tablet, by mouth, two times a day. Patient 2's wife stated she gave Patient 2 one tablet, once per day, for the past two months. Patient 2's wife stated she was concerned about the medication because she heard it could hurt the kidneys. Patient 2's wife stated Patient 2 had problems with his kidneys so she had decided to cut the dose in half. c. Famotidine (a medication to treat heartburn), 20 mg tablet, take one tablet, by mouth, two times a day. Patient 2's wife stated she gave Patient 2 one tablet, once per day, for years. Patient 2's wife stated she was concerned about the medication because she heard it could hurt the kidneys. Patient 2's wife stated Patient 2 had problems with his kidneys so she had decided to cut the dose in half. d. Lisinopril (a medication to treat high blood pressure), 5 mg tablet, take one tablet, by mouth, daily. Patient 2's wife stated Patient 2 had been taking Lisinopril for 45 years. e. Ondansetron (a medication to prevent nausea and vomiting), 4 mg tablet, take one tablet, by mouth, every 8 hours, as needed. Patient 2's wife stated she had been giving Patient 2 the ondansetron, when he needed it, for two months. f. Potassium chloride (a nutritional supplement), ER (extended release), 10 mEq (milliequivalents - a unit of measure), take one tablet, by mouth, daily. Patient 2's wife stated she had been giving Patient 2 the Potassium chloride for two months. Patient 2's wife stated she did not know why Patient 2 needed to take potassium chloride. g. Vitamin D 3 (a nutritional supplement), 2000 IU (international units - a unit of measure), OTC (over-the-counter). Patient 2's wife stated she gave Patient 2, 4 tablets of the vitamin D 3, once per day. Patient 2's wife stated Patient 2 had been taking the vitamin D 3 for two months. h. Immune Formula (a nutritional supplement), OTC. Patient 2's wife stated she gave Patient 2, 2 tablets of the immune formula, once per day. Patient 2's wife stated Patient 2 had been taking the immune formula for one month. Patient 2's MP did not indicate the atorvastatin, cimetidine, famotidine, Lisinopril, ondansetron, potassium chloride, vitamin D 3, or Immune Formula. 3. A review of Patient 3's face sheet (a document that gives a summary of patient's information), undated, indicated a start of care date of August 6, 2020, with a recertification period of February 2, 2021 to April 2, 2021. Patient 3 had diagnoses that included diabetes mellitus (high blood sugar). During a home visit on March 11, 2021 with a Registered Nurse (RN 1) and in the presence of Patient 3 and Patient 3's daughter, an observation of Patient 3's actual medication bottles available in the home were compared with Patient 3's Medication Profile (MP - a current list of all medications prescribed for a specific patient). During an observation and interview with Patient 3's daughter on March 11, 2021 at 10:38 AM, Patient 3's daughter stated she administered medications to her mother. Patient 3's MP indicated the following: a. Vitamin D 2 (a nutritional supplement), 1.25 mg (milligrams - a unit of measure), take one tablet, by mouth, once daily. Patient 3's medication bottle indicated, vitamin D 2, 1.25 mg, take one tablet, by mouth, once per week. Patient 3's daughter stated Patient 3 had been taking the vitamin D 2, one tablet, once per week, for a year. b. Aspirin (a medication to reduce blood clots), 81 mg, take one tablet, by mouth, once daily. Patient 3's OTC (over-the-counter) medication bottle indicated, aspirin, 81 mg. Patient 3's daughter stated Patient 3 had been taking aspirin, 81 mg, two tablets, once per day, for one month. c. Amlodipine (a medication to lower blood pressure), 5 mg, take one tablet, by mouth, once daily. Patient 3's medication bottle indicated, amlodipine, 10 mg, take one tablet, by mouth, once daily. Patient 3's daughter stated Patient 3 had been taking 10 mg of amlodipine once per day for a year. d. Loperamide hydrochloride (a medication to treat diarrhea), 2 mg, take one tablet, by mouth, three times a day, as needed. Patient 3's daughter stated she only gave one tablet, once a day, because Patient 3 would go from diarrhea to constipation. Patient 3's daughter stated she had been giving just one tablet daily for a year. e. Patient 3's daughter provided a bottle of "Allergy Eye Relief," OTC. Patient 3's daughter stated she administrated two drops in each eye, four times a day. Patient 3's daughter stated she had been administering the eyes drops to Patient 3 for a year, "She [Patient 3] has very dry eyes." During an interview with RN 1 on March 11, 2021 at 11:04 AM, RN 1 stated she did not know why Patient 3's MP was not accurate. RN 1 stated she had not made a nursing visit to Patient 3 before. RN 1 stated she conducted admission assessments and recertification assessments for the agency. RN 1 stated a medication review should be conducted during the admission assessments, recertification assessments and during home visits. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) on March 15, 2021 at 12:41 PM, the AD/DPCS reviewed the medication inaccuracies identified during the home visits for Patients 1, 2, and 3. The AD/DPCS stated a medication review was supposed to be conducted during admission assessments, recertification assessments and at each home visit. The AD/DPCS stated the Medication Profiles (MPs) for Patients 1, 2, and 3 should have accurately reflected the medications the patients were taking and the MPs did not. A review of the agency's policy and procedure titled, "Medication Profile," dated April 2019, indicated the following: "Purpose: To define the use of the medication profile in evaluation a patient's medication regimen. Procedure: A drug regimen review will be performed at the time of admission, when updates to the comprehensive assessments are performed, and when care is resumed after a patient has been placed on hold. The review will identify drug/food interactions, potential adverse effects and drug interactions, ineffective drug therapy, duplicative drug therapy, and noncompliance with drug therapy, omissions and unclear information. During subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver, as well as other clinicians, understand the medication regimen. This includes, but will not be limited to: Using the medication profile, in conjunction with other pertinent data, to evaluate the use of drugs in the home setting. Using the medication profile to teach the purpose of medication, dosages, routes, administration times, side effects, and contraindications. Deviations in taking medications as ordered will be documented in clinical notes, and the physician...will be notified."

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 agency failed to ensure the care plan was developed within five working days of the recertification assessment for two of seven sampled patients (Patients 2 and 3). This failure had the potential to cause the patients' nursing, therapy and psychosocial needs to go unmet. Findings: 1. A review of Patient 2's face sheet (a document that gives a summary of patient's information), undated, indicated a start of care date of July 8, 2018, with a recertification period of February 22, 2021 to April 22, 2021. Patient 2 had diagnoses that included complications of colostomy (a surgical operation in which a piece of the colon is diverted to an artificial opening in the abdominal wall). On March 9, 2021, a review of Patient 2's Plan of Care dated February 22, 2021 to April 22, 2021 was conducted. There was no documented evidence to show interventions indicating the care Patient 2 required. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) on March 9, 2021 at 4 PM, the AD/DPCS stated Patient 2's care plan had not been completed yet. The AD/DPCS stated the agency was behind in getting the patients' care plans completed. The AD/DPCS stated the clinicians were providing patient care without a care plan to follow. The AD/DPCS stated Patient 2's care plan should have been completed by February 22, 2021 and it was not. During an interview with a Registered Nurse (RN 1) on March 11, 2021 at 9 AM, RN 1 stated she had conducted the recertification assessment for Patient 2 on February 17, 2021. RN 1 stated she had not created or updated Patient 2's care plan. RN 1 stated, "The agency does that." During an interview and concurrent record review with the AD/DPCS on March 15, 2021 at 12:32 PM, the AD/DPCS provided a completed care plan for Patient 2. The AD/DPCS stated the Registered Nurses (RNs) who completed the patients' assessments did not complete the care plans. The AD/DPCS stated the agency sent the patients' assessments to a Registered Nurse OASIS (Outcome and Assessment Information Set) Coder (RN/Coder) to apply billing codes for the patients' diagnoses and complete the care plans. The AD/DPCS stated she had called the RN/Coder on March 8, 2021 when the surveyors had arrived and begged her to get the care plans finished as fast as possible. The AD/DPCS stated the RN/Coder had created Patient 2's care plan. The AD/DPCS stated Patient 2's care plan had been completed 26 days after Patient 2's recertification assessment date (February 17, 2021). 2. A review of Patient 3's face sheet (a document that gives a summary of patient's information), undated, indicated a start of care date of August 6, 2020, with a recertification period of February 2, 2021 to April 2, 2021. Patient 3 had diagnoses that included diabetes mellitus (high blood sugar). On March 9, 2021, a review of Patient 3's Plan of Care dated February 2, 2021 to April 2, 2021 was conducted. There was no documented evidence to show interventions indicating the care Patient 3 required. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) on March 9, 2021 at 4 PM, the AD/DPCS stated Patient 3's care plan had not been completed yet. The AD/DPCS stated the agency was behind in getting the patients' care plans completed. The AD/DPCS stated the clinicians were providing patient care without a care plan to follow. The AD/DPCS stated Patient 3's care plan should have been completed by February 6, 2021 and it was not. During an interview with a Registered Nurse (RN 2) on March 15, 2021 at 12:07 PM, RN 2 stated he had conducted Patient 3's recertification assessment on February 1, 2021. RN 2 stated he was supposed to complete Patient 3's care plan too. RN 2 stated if his signature was not on the care plan, then he had not done it. RN 2 stated, "I must have missed it." During an interview and concurrent record review with the AD/DPCS on March 15, 2021 at 12:35 PM, the AD/DPCS provided a completed care plan for Patient 3. The AD/DPCS stated the Registered Nurses (RNs) who completed the patients' assessments did not complete the care plans. The AD/DPCS stated the agency sent the patients' assessments to a Registered Nurse OASIS (Outcome and Assessment Information Set) Coder (RN/Coder) to apply billing codes for the patients' diagnoses and complete the care plans. The AD/DPCS stated she had called the RN/Coder on March 8, 2021 when the surveyors had arrived and begged her to get the care plans finished as fast as possible. The AD/DPCS stated the RN/Coder had created Patient 3's care plan. The AD/DPCS stated Patient 3's care plan had been completed 42 days after Patient 3's recertification assessment date (February 1, 2021). A review of the policy and procedure titled "Care Planning Process," dated April 2019, indicated, "Policy: A written plan of care will be initiated within five (5) days of start of care and updated at least every 60 days or as patient's condition warrants. The patient plan of care will be developed or revised within five (5) working days of initiation of each service or of the reassessment of the patient."

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: The agency failed to ensure that the Condition of Participation: G 570 484.60: Care planning, coordination, quality of care was in compliance as follows: Based on interview and record review, the agency failed to individualize, follow, or provide physician oversight of the plan of care for five of seven sampled patients (Patients 1, 3, 5, 6 and 7) when: 1. Patient 1's plan of care was not signed or reviewed by a physician. (Refer to G 572) 2. Patient 3's plan of care did not indicate interventions for: dialysis (the process of removing excess water, solutes, and toxins from the blood, when the kidneys had failed), AV fistula (arteriovenous fistula-a surgically created connection between an artery and vein, in an arm, for dialysis treatments) assessment and monitoring, fluid restriction, or a warning for no blood pressure readings to the left arm. Patient 3's plan of care was not signed or reviewed by a physician. (Refer to G 572) 3. Patient 5, one Skilled Nurse (SN) visit was not made as ordered in the plan of care. (Refer to G 572) 4. Patient 6, four Skilled Nurse (SN) visits and two Certified Home Health Aide (CHHA) visits were not made as ordered in the plan of care. Patient 6's plan of care did not indicate any interventions for the SN to follow when providing care. (Refer to G 572) 5. Patient 7, three Certified Home Health Aide (CHHA) visits were not made as ordered in the plan of care. (Refer to G 572) The cumulative effect of these systemic practices resulted in Patients 1, 3, 5, 6, and 7 to receive clinical services not reviewed, approved or ordered by a physician. And this failure had the potential for Patient 3 to suffer dialysis treatment complications.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to individualize, follow, or provide physician oversight of the plan of care for five of seven sampled patients (Patients 1, 3, 5, 6 and 7) when: 1. Patient 1's plan of care was not signed or reviewed by a physician. 2. Patient 3's plan of care did not indicate interventions for: dialysis (the process of removing excess water, solutes, and toxins from the blood, when the kidneys had failed), AV fistula (arteriovenous fistula-a surgically created connection between an artery and vein, in an arm, for dialysis treatments) assessment and monitoring, fluid restriction, or a warning for no blood pressure readings to the left arm. Patient 3's plan of care was not signed or reviewed by a physician. 3. Patient 5, one Skilled Nurse (SN) visit was not made as ordered in the plan of care 4. Patient 6, four Skilled Nurse (SN) visits and two Certified Home Health Aide (CHHA) visits were not made as ordered in the plan of care. Patient 6's plan of care did not indicate any interventions for the SN to follow when providing care. 5. Patient 7, three Certified Home Health Aide (CHHA) visits were not made as ordered in the plan of care. This failure caused Patients 1, 3, 5, 6, and 7 to receive clinical services that were not reviewed, approved or ordered by a physician. In addition, this failure had the potential for Patient 3 to suffer dialysis treatment complications. Findings: 1. A review of Patient 1's face sheet (a document that gives a summary of patient's information), undated, indicated a start of care date of January 29, 2021, with a certification period of January 29, 2021 to March 29, 2021. Patient 1 had diagnoses that included polyosteoarthritis (pain and inflammation in multiple joints). On March 9, 2021, a review of Patient 1's Plan of Care dated January 29, 2021 to March 29, 2021 was conducted. There was no documented evidence to show interventions indicating the care Patient 1 required. There was no physician's signature. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) on March 9, 2021 at 4 PM, the AD/DPCS stated Patient 1's care plan had not been completed yet. The AD/DPCS stated the agency was behind in getting the patients' care plans completed. The AD/DPCS stated the clinicians were providing patient care without a care plan to follow. The AD/DPCS stated Patient 1's care plan was not signed by the physician. During an interview with a Receptionist (Recep 2) on March 15, 2021 at 12 PM, Recep 2 stated it was her responsibility to send the patients' care plans to the respective physicians for signature. Recep 2 stated Patient 1's care plan had not been sent to the physician and was not signed by the physician. During an interview and concurrent record review with the AD/DPCS on March 15, 2021 at 12:23 PM, the AD/DPCS provided a completed care plan for Patient 1. The AD/DPCS stated Patient 1's care plan had been completed 45 days after Patient 1's start of care date (January 29, 2021). The AD/DPCS stated Patient 1's care plan had not been signed by the physician within 30 days of the start of care. 2. A review of Patient 3's face sheet (a document that gives a summary of patient's information), undated, indicated a start of care date of August 6, 2020, with a recertification period of February 2, 2021 to April 2, 2021. Patient 3 had diagnoses that included diabetes mellitus (high blood sugar). On March 9, 2021, a review of Patient 3's Plan of Care dated February 2, 2021 to April 2, 2021 was conducted. There was no documented evidence to show interventions indicating the care Patient 3 required. There was no physician's signature. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) on March 9, 2021 at 4 PM, the AD/DPCS stated Patient 3's care plan had not been completed yet. The AD/DPCS stated the agency was behind in getting the patients' care plans completed. The AD/DPCS stated the clinicians were providing patient care without a care plan to follow. The AD/DPCS stated Patient 3's care plan was not signed by the physician. During a home visit on March 11, 2021 at 9 AM with a Registered Nurse (RN 1) and in the presence of Patient 3 and Patient 3's daughter, RN 1 stated Patient 3 was a new patient to her and she had not provided care for Patient 3 before. RN 1 stated she had not reviewed Patient 3's care plan prior to the visit because the care plan had not been completed. During an interview with Patient 3's daughter on March 11, 2021 at 9:42 AM, Patient 3's daughter stated Patient 3 had renal failure and received dialysis (the process of removing excess water, solutes, and toxins from the blood, when the kidneys had failed) every Monday, Tuesday, Wednesday and Friday. Patient 3's daughter stated Patient 3 had an AV fistula (arteriovenous fistula-a surgically created connection between an artery and vein, in an arm, for dialysis treatments) in her left arm. Patient 3's daughter stated Patient 3 was on a fluid restriction of one liter (a unit of measure) per day. Patient 3's daughter stated Patient 3 had wounds on three fingers of her left hand (middle finger, ring finger and pinky). Patient 3's daughter stated Patient 3's wounds had been there for 3 months. During an interview with a Registered Nurse (RN 2) on March 15, 2021 at 12:07 PM, RN 2 stated he had conducted Patient 3's recertification assessment on February 1, 2021. RN 2 stated he was supposed to complete Patient 3's care plan too. RN 2 stated if his signature was not on the care plan, then he had not done it. RN 2 stated, "I must have missed it." During an interview with a Receptionist (Recep 2) on March 15, 2021 at 12 PM, Recep 2 stated it was her responsibility to send the patients' care plans to the respective physicians for signature. Recep 2 stated Patient 3's care plan had not been sent to the physician and was not signed by the physician. During an interview and concurrent record review with the AD/DPCS on March 15, 2021 at 12:35 PM, the AD/DPCS provided a completed care plan for Patient 3. The AD/DPCS stated the Registered Nurses (RNs) who completed the patients' assessments did not complete the care plans. The AD/DPCS stated the agency sent the patients' assessments to a Registered Nurse OASIS (Outcome and Assessment Information Set) Coder (RN/Coder) to apply billing codes for the patients' diagnoses and complete the care plans. The AD/DPCS stated she had called the RN/Coder on March 8, 2021 when the surveyors had arrived and begged her to get the care plans finished as fast as possible. The AD/DPCS stated the RN/Coder had created Patient 3's care plan. The AD/DPCS stated Patient 3's care plan had been completed 42 days after Patient 3's recertification assessment date (February 1, 2021). The AD/DPCS stated Patient 3's care plan had not been signed by the physician within 30 days of the recertification's start of care. During a continued interview and record review with the AD/DPCS on March 15, 2021 at 12:35 PM, a review of Patient 3's completed care plan dated February 2, 2021 to April 2, 2021 was conducted. There was no documented evidence to show: Patient 3's kidney failure diagnosis, dialysis treatments, AV fistula, or fluid restriction. The AD/DPCS stated, "I guess the coder [RN/Coder] missed it." 3. During a review of Patient 5's Home Health Certification and Plan of Care (a document that gives a summary of patient's diagnoses with care plan interventions and patient goals for discharge), dated January 20, 2021, indicated a start of care date of January 20, 2021, with a certification period from January 20,2021 to March 20, 2021. Patient 5 had diagnoses that included chronic ulcer (a spontaneous or traumatic lesion on the skin loss leaving a raw wound that does not heal) of right ankle. During a concurrent interview and record review, on March 12, 2021, at 11:10 AM, with AD/DPCS, Patient 5's Electronic Medical Record and Paper Medical Record was reviewed. Patient 5's Medical Record indicated, Patient 5 missed one SN visit the week of January 31, 2021. Patient 5's Medical Record did not indicate if the physician was notified of the missed visit. AD/DPCS agreed Patient 5 had one missed visit by the SN during the week of January 31, 2021. AD/DPCS confirmed there was no documentation of the missed visits. 4. During a review of Patient 6's Home Health Certification and Plan of Care (a document that gives a summary of patient's diagnoses, with care plan interventions and patient goals for discharge), dated February 3,2021, indicated a start of care date of February 3, 2021, with a certification period from February 3, 2021 to April 3, 2021. Patient 6 had diagnoses that included an open wound of the right forearm. During a concurrent interview and record review, on March 12, 2021, at 10:59 AM, with AD/DPCS, Patient 6's Electronic Medical Record and Paper Medical Record was reviewed. Patient 6's Medical Record indicated, Patient 6 missed two Skilled Nursing (SN) visits, and two CHHA visits the week of February 10, 2021. Patient 6 missed two SN visits the week of February 17, 2021. Patient 6's Medical Record did not indicate if the physician was notified of the missed visits. AD/DPCS agreed Patient 6 had two missed visits by the SN, and two missed visits by the CHHA during the week of February 10, 2021. AD/DPCS agreed Patient 6 had two missed visits by the SN the week of February 17, 2021. AD/DPCS confirmed there was no documentation that the physician was notified of the missed visits. 5. During a review of Patient 7's Home Health certification and Plan of Care (a document that gives a summary of patient's diagnoses, with care plan interventions and patient goals for discharge), dated February 3, 2021, indicated a start of care date of February 3, 2021, with a certification period from February 3, 2021 to April 3, 2021. Patient 7 had diagnoses that included diabetes mellitus (high blood sugar). During a concurrent interview and record review, on March 12, 2021, at 10:50 AM, with AD/DPCS, Patient 7's Electronic Medical Record and Paper Medical Record was reviewed. Patient 7's Medical Record indicated, Patient 7 missed one Certified Home Health Aide (CHHA) visit during the week of February 22, 2021, and two CHHA visits the week of March 1, 2021. Patient 7's Medical Record did not indicate if the physician was notified of the missed visits. AD/DPCS agreed that Patient 7 had three missed visits by the CHHA during the weeks of February 22, 2021, and March 1, 2021. AD/DPCS confirmed there was no documentation that the physician was notified of the missed visits. A review of the agency's policy and procedure titled, "Missed Visits", dated revised April 2019, indicated, "Missed visits will be communicated to the clinical supervisor and the patient's physician. Missed visits will be documented in the clinical record." A review of the agency's policy and procedure titled "Physician Participation in Plan of Care," dated April 2019, indicated the following: "Policy: ...The attending physician will participate in the care planning process by initiating, reviewing and revising therapeutic and diagnostic orders. The care will be provided in compliance with the therapeutic and diagnostic orders and accepted standards of practice. Procedure: ...The attending physician will sign the plan of care/treatment within 30 days of the start of care. The attending physician's recertification will be obtained in intervals of at least every 60 days when the patient's plan of care is reviewed, the patient is recertified, and more often, if warranted." A review of the agency's policy and procedure titled "Care Planning Process," dated April 2019, indicated the following: "Purpose: To provide clinical direction to the clinicians providing direct patient care. Policy: ...The care planning process will be documented on the plan of care ... Individualized Plan of Care: The patient-specific plan of care includes: All pertinent primary and secondary diagnoses All patient care orders including verbal orders Measurable outcomes and goals identified by the organization and the patient anticipated to occur as a result of implementing and coordinating the plan of care Functional limitations Activities permitted Safety measures to protect against injury Nutritional requirements Patient-specific interventions and education A description of the patient's risk for emergency department visits and hospital readmissions and all necessary interventions to address the underlying risk factors. Other appropriate items such as precautions and contraindications ..."

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: The agency failed to ensure that the Condition of Participation: G 640 484.65 Quality assessment and performance improvement (QAPI) was in compliance as follows: 1. Based on interview and record review, the agency failed to track, measure and analyze quality indicators (a measurable element of the agency's practice that can be used to assess the quality of care provided) in order to assess the agency's processes of care, services, and operations, for 15 of 15 months reviewed, in a universe of 33 patients. (Refer to G 642) 2. Based on interview and record review, the agency failed to use quality indicator (a measurable element of the agency's practice that can be used to assess the quality of care provided) data to improve the quality of the agency's services. And the agency's Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program's data collection, for 15 of 15 months reviewed, in a universe of 33 patients. (Refer to G 644) 3. Based on interview and record review, the agency failed to conduct and document performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the agency had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved, for 15 of 15 months reviewed, in a universe of 33 patients. (Refer to G 658) 4. Based on interview and record review, the agency's Governing Body (GB) failed to ensure a Quality Assessment and Performance Improvement (QAPI) Program was implemented, maintained and evaluated for effectiveness, for 15 of 15 months reviewed, in a universe of 33 patients. (Refer to G 660) The cumulative effect of these systemic practices resulted in the potential to cause problems in health outcomes, patient safety and quality of care, to go unrecognized and unresolved.

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 agency failed to track, measure and analyze quality indicators (a measurable element of the agency's practice that can be used to assess the quality of care provided) in order to assess the agency's processes of care, services, and operations, for 15 of 15 months reviewed, in a universe of 33 patients. This failure had the potential to cause problems in health outcomes, patient safety and quality of care, to go unrecognized and unaddressed. Findings: A review of the agency's Quality Assessment and Performance Improvement (QAPI) binder from January 1, 2020 to March 16, 2021 was conducted. Contained within the QAPI binder was the agency's QAPI Plan, dated April 2019. The agency's QAPI Plan indicated the following quality indicators would be tracked, measured and analyzed: a. Patient/Family/Caregiver Satisfaction Surveys: The agency's QAPI binder did not contain data on Patient/Family/Caregiver Satisfaction Surveys. The agency's QAPI binder did not contain QAPI Committee meeting minutes, indicating the QAPI Committee had met to measure and analyze the Patient/Family/Caregiver Satisfaction Surveys. b. Patient Falls: The agency's QAPI binder did not contain data on Patient Falls. The agency's QAPI binder did not contain QAPI Committee meeting minutes, indicating the QAPI Committee had met to measure and analyze Patient Falls. c. Infection Reports: The agency's QAPI binder did not contain data on Infection Reports from April 2020 to March 2021. The agency's QAPI binder did not contain QAPI Committee meeting minutes, indicating the QAPI Committee had met to measure and analyze Infection Reports. d. Patient Complaints and Grievances: The agency's QAPI binder did not contain data on Patient Complaints and Grievances. The agency's QAPI binder did not contain QAPI Committee meeting minutes, indicating the QAPI Committee had met to measure and analyze Patient Complaints and Grievances. e. Pain Management Documentation: The agency's QAPI binder did not contain data on Pain Management Documentation. The agency's QAPI binder did not contain QAPI Committee meeting minutes, indicating the QAPI Committee had met to measure and analyze Pain Management Documentation. f. Medication Management: The agency's QAPI binder did not contain data on Medication Management. The agency's QAPI binder did not contain QAPI Committee meeting minutes, indicating the QAPI Committee had met to measure and analyze Medication Management. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) and Administrator (Admin 4) on March 16, 2021 at 10 AM, the AD/DPCS stated she was responsible for the QAPI Program and was the Performance Improvement Coordinator. The AD/DPCS stated the agency had not tracked, measured and analyzed the quality indicators since January 1, 2020. The AD/DPCS stated the QAPI Committee had not held a meeting since January 1, 2020. Admin 4 stated he did not know the QAPI program had not been maintained. During a continued interview with Admin 4, Admin 4 stated he was a member of the agency's Governing Body (GB). Admin 4 stated the GB had not reviewed the QAPI Program from January 1, 2020 to March 15, 2021. Admin 4 stated the GB had been unaware the QAPI program had not been maintained. A review of the agency's policy and procedure titled "Quality Assessment and Performance Improvement (QAPI) Plan," dated April 2019, indicated the following: "Purpose: ...Through QAPI activities, the organization provides a mechanism for identification and prioritization of opportunities for problem identification and improvement in care and operations. Objectives: To show measurable improvement in indicators that demonstrate an improvement in patient outcomes. To measure, analyze and track quality indicators, including adverse events, to enable the assessment of processes of care, home health services and operations. To collect data to monitor the effectiveness and safety of services and quality of care as well as to identify opportunities for improvement. To keep current with monitoring of required quality measures; submit reports in mandated format within required timeframes. Methodology: The QAPI Plan is operated through a committee structure that ensures that the QAPI program follows regulatory requirements. The QAPI Coordinator ensures that leadership priorities for improvement are evaluated. In addition, the QAPI Coordinator examines results from ongoing quality control activities to identify trends that will need follow-up action by the QAPI Committee. Responsibilities of QAPI Coordinator: The QAPI Coordinator chairs the QAPI Committee and is responsible for coordinating and facilitating all quality improvement activities. This includes, but is not limited to: Ensuring the collection of accurate and reliable data. Aggregating, trending and analyzing data using appropriate statistical techniques. Ensuring timely data submission of required quality measures. Responsibilities of QAPI Committee: The QAPI Committee is responsible for evaluating and prioritizing QAPI activities based on the aggregation of analysis of data collected."

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 agency failed to use quality indicator (a measurable element of the agency's practice that can be used to assess the quality of care provided) data to improve the quality of the agency's services. And the agency's Governing Body (GB) failed to approve the frequency and detail of the Quality Assessment Performance Improvement (QAPI) program's data collection, for 15 of 15 months reviewed, in a universe of 33 patients. This failure had the potential to cause problems in health outcomes, patient safety and quality of care, to go unrecognized and unaddressed. Findings: A review of the agency's Quality Assessment and Performance Improvement (QAPI) binder from January 1, 2020 to March 16, 2021 was conducted. Contained within the QAPI binder was the agency's QAPI Plan, dated April 2019. The agency's QAPI Plan indicated the following quality indicators would be tracked, measured and analyzed: a. Patient/Family/Caregiver Satisfaction Surveys: The agency's QAPI binder did not contain data on Patient/Family/Caregiver Satisfaction Surveys. The agency's QAPI binder did not contain QAPI Committee meeting minutes, indicating the QAPI Committee had met to measure, analyze and act upon the Patient/Family/Caregiver Satisfaction Surveys. b. Patient Falls: The agency's QAPI binder did not contain data on Patient Falls. The agency's QAPI binder did not contain QAPI Committee meeting minutes, indicating the QAPI Committee had met to measure, analyze and act upon Patient Falls. c. Infection Reports: The agency's QAPI binder did not contain data on Infection Reports from April 2020 to March 2021. The agency's QAPI binder did not contain QAPI Committee meeting minutes, indicating the QAPI Committee had met to measure, analyze and act upon Infection Reports. d. Patient Complaints and Grievances: The agency's QAPI binder did not contain data on Patient Complaints and Grievances. The agency's QAPI binder did not contain QAPI Committee meeting minutes, indicating the QAPI Committee had met to measure, analyze and act upon Patient Complaints and Grievances. e. Pain Management Documentation: The agency's QAPI binder did not contain data on Pain Management Documentation. The agency's QAPI binder did not contain QAPI Committee meeting minutes, indicating the QAPI Committee had met to measure, analyze and act upon Pain Management Documentation. f. Medication Management: The agency's QAPI binder did not contain data on Medication Management. The agency's QAPI binder did not contain QAPI Committee meeting minutes, indicating the QAPI Committee had met to measure, analyze and act upon Medication Management. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) and Administrator (Admin 4) on March 16, 2021 at 10:15 AM, the AD/DPCS stated she was responsible for the QAPI Program and was the Performance Improvement Coordinator. The AD/DPCS stated the agency had not tracked, measured, analyzed or acted upon the quality indicators since January 1, 2020. The AD/DPCS stated the QAPI Committee had not held a meeting since January 1, 2020. Admin 4 stated he did not know the QAPI program had not been maintained. During a continued interview with Admin 4, Admin 4 stated he was a member of the agency's Governing Body (GB). Admin 4 stated the GB had not reviewed the QAPI Program from January 1, 2020 to March 15, 2021. Admin 4 stated the GB had not met to approve the frequency and detail of the data collection, by the QAPI Program, in 2020. A review of the Governing Body (GB) meeting minutes from January 1, 2020 to March 16, 2021 was conducted. There was no documented evidence to show the GB had met to discuss and approve the frequency and detail of the data collection, by the QAPI Program for 2020. A review of the agency's policy and procedure titled "Quality Assessment and Performance Improvement (QAPI) Plan," dated April 2019, indicated the following: "Purpose: ...Through QAPI activities, the organization provides a mechanism for identification and prioritization of opportunities for problem identification and improvement in care and operations. Objectives: To show measurable improvement in indicators that demonstrate an improvement in patient outcomes. To measure, analyze and track quality indicators, including adverse events, to enable the assessment of processes of care, home health services and operations. To collect data to monitor the effectiveness and safety of services and quality of care as well as to identify opportunities for improvement. Methodology: The QAPI Plan is operated through a committee structure that ensures that the QAPI program follows regulatory requirements. The QAPI Coordinator ensures that leadership priorities for improvement are evaluated. In addition, the QAPI Coordinator examines results from ongoing quality control activities to identify trends that will need follow-up action by the QAPI Committee. Responsibilities of QAPI Committee: The QAPI Committee is responsible for evaluating and prioritizing QAPI activities based on the aggregation of analysis of data collected. The QAPI Committee has the authority to issue recommendations for action or further study. Under the direction of the QAPI Coordinator, the committee issues a quarterly report summarizing QAPI activities and results of actions taken." A review of the agency's policy and procedure titled "Improving Organizational Performance," dated April 2019, indicated the following: "Procedure: Senior management with Governing Body oversight will: Set expectations for performance improvement and manage processes to improve organization performance. Adopt a structured framework for performance improvement. The problem solving approach will stress the interrelationship of quality services provided, management activities, and sound business practices as applicable to the organization's: Quality indicators, data collection and analysis, and frequency of activities."

Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA's services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to conduct and document performance improvement projects (PIP - a concentrated effort on a particular problem in one area of the agency or agency wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements) the agency had undertaken, the reasons for conducting the PIP and measurable goals to show progress achieved, for 15 of 15 months reviewed, in a universe of 33 patients. This failure had the potential to cause problems in health outcomes, patient safety and quality of care to go unaddressed and continue. Findings: A review of the agency's Quality Assessment and Performance Improvement (QAPI) binder from January 1, 2020 to March 16, 2021 was conducted. There was no documented evidence to show a Performance Improvement Project (PIP) had been identified, developed or conducted. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) and Administrator (Admin 4) on March 16, 2021 at 10:45 AM, the AD/DPCS stated she was responsible for the QAPI Program and was the Performance Improvement Coordinator. The AD/DPCS stated the agency had not identified, developed or conducted a PIP since January 1, 2020. The AD/DPCS stated the QAPI Committee had not held a meeting since January 1, 2020, to identify a problem and initiate a PIP. Admin 4 stated he did not know the QAPI program had not been maintained. During a continued interview with Admin 4, Admin 4 stated he was a member of the agency's Governing Body (GB). Admin 4 stated the GB had not reviewed the QAPI Program from January 1, 2020 to March 15, 2021. A review of the agency's policy and procedure titled "Improving Organizational Performance," dated April 2019, indicated the following: "Purpose: ...To improve organizational performance by focusing on high risk, high volume, and problem-prone areas. Procedure: Senior management with Governing Body oversight will: Set expectations for performance improvement and manage processes to improve organization performance. Ensure that performance improvement projects are conducted that reflect the following standards: The number and scope of distinct improvement projects are conducted annually must reflect the scope, complexity, and past performance of the organization's services and operations. The organization must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects."

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 agency's Governing Body (GB) failed to ensure a Quality Assessment and Performance Improvement (QAPI) Program was implemented, maintained and evaluated for effectiveness, for 15 of 15 months reviewed, in a universe of 33 patients. This failure had the potential to cause problems in health outcomes, patient safety and quality of care, to go unrecognized and unresolved. Findings: A review of the agency's Quality Assessment and Performance Improvement (QAPI) binder from January 1, 2020 to March 16, 2021 was conducted. There was no documented evidence to show the QAPI Committee held and attended meetings for the year 2020. There was no documented evidence to show the QAPI Committee developed and submitted a quarterly report, to the Governing Body (GB), summarizing QAPI activities and results of actions taken. A review of the agency's GB meeting minutes from January 1, 2020 to March 16, 2021 was conducted. There was no documented evidence the GB evaluated and maintained the QAPI Program. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) and Administrator (Admin 4) on March 16, 2021 at 10:45 AM, the AD/DPCS stated she was responsible for the QAPI Program and was the Performance Improvement Coordinator. The AD/DPCS stated the QAPI Committee had not held a meeting since January 1, 2020. And had not developed and submitted a quarterly report, to the Governing Body (GB), summarizing QAPI activities and results of actions taken. During a continued interview with Admin 4, Admin 4 stated he was a member of the agency's Governing Body (GB). Admin 4 stated the GB had not received a quarterly report, from the QAPI Committee, summarizing QAPI activities and results of actions taken. Admin 4 stated the GB had not defined, implemented, maintained or evaluated the QAPI Program. A review of the agency's policy and procedure titled "Quality Assessment and Performance Improvement (QAPI) Plan," dated April 2019, indicated the following: "Responsibilities of QAPI Committee: ...Under the direction of the QAPI Coordinator, the committee issues a quarterly report summarizing QAPI activities and results of action taken. The report is submitted to the Governing Body and appropriate managers and staff." A review of the agency's policy and procedure titled "Improving Organizational Performance," dated April 2019, indicated the following: "The Governing Body is responsible for ensuring that the performance improvement program is defined, implemented and maintained, and is evaluated annually."

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: The agency failed to ensure that the Condition of Participation: G 680 484.70: Infection prevention and control was in compliance when: Based on interview and record review, the agency failed to maintain an infection control program that was integrated into the agency's Quality Assessment Performance Improvement (QAPI) program in order to: identify infection trends (analysis of a pattern), develop action plans and improve disease prevention, for 15 of 15 months reviewed, in a universe of 33 patients. (Refer to G 684) The cumulative effect of these systemic practices had the potential to result in infections to go unrecognized and unaddressed.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to maintain an infection control program that was integrated into the agency's Quality Assessment Performance Improvement (QAPI) program in order to: identify infection trends (analysis of a pattern), develop action plans and improve disease prevention, for 15 of 15 months reviewed, in a universe of 33 patients. This failure had the potential to cause trends in infections to go unrecognized and unaddressed. Findings: A review of the initial and recertification assessments for seven of seven sampled patients (Patients 1, 2, 3, 4, 5, 6, and 7) was conducted. The assessments indicated a COVID 19 (Coronavirus disease) screening as follows: 1. Patient 1's initial assessment dated January 29, 2021, indicated a completed "COVID 19 Active Screening Questionnaire." 2. Patient 2's recertification assessment dated February 17, 2021, indicated a completed "COVID 19 Active Screening Questionnaire." 3. Patient 3's recertification assessment dated February 1, 2021, indicated a completed "COVID 19 Active Screening Questionnaire." 4. Patient 4's recertification assessment dated February 26, 2021, indicated a completed "COVID 19 Active Screening Questionnaire." 5. Patient 5's initial assessment dated January 20, 2021, indicated a completed "COVID 19 Active Screening Questionnaire." 6. Patient 6's initial assessment dated February 3, 2021, indicated a completed "COVID 19 Active Screening Questionnaire." 7. Patient 7's initial assessment dated February 3, 2021, indicated a completed "COVID 19 Active Screening Questionnaire." A review of the agency's infection control log from January 1, 2020 to March 15, 2021 was conducted. There was no documented evidence to show the agency had gathered data on the patients' COVID 19 Active Screening Questionnaires. There was no documented evidence show the agency had gathered data on staff COVID 19 infections. In a continued review of the agency's infection control log, there was no documented evidence to show the agency had gathered data on (non-COVID related) patient infections from April 2020 to March 2021. A review of the agency's Quality Assessment and Performance Improvement (QAPI) binder from January 2020 to March 2021 was conducted. There was no documented evidence to show data on patients' COVID 19 Active Screening Questionnaires, staff COVID 19 infections, or (non-COVID related) patient infections from April 2020 to March 2021 had been received. There were no QAPI Committee meeting minutes do show the committee had discussed, analyzed or acted upon patient or staff infections. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) and Administrator (Admin 4) on March 15, 2021 at 3:25 PM, the AD/DPCS stated she was responsible for the agency's infection control program and was the Performance Improvement Coordinator. The AD/DPCS stated she had not gathered infection rate data from the patients' COVID 19 Active Screening Questionnaires, or COVID 19 positive staff. The AD/DPCS stated patient infection (non-COVID related) data had not been collected from April 2020 to March 2021. Admin 4 stated he did not know the infection control program had not been maintained. During a continued interview with Admin 4, Admin 4 stated he was a member of the agency's Governing Body (GB). Admin 4 stated the GB had not reviewed the QAPI Program from January 1, 2020 to March 15, 2021. Admin 4 stated the GB had been unaware the infection control program had not been maintained. A review of the agency's policy and procedure titled "Infection Control Plan," dated April 2019, indicated the following: "Purpose: To delineate an infection control plan to meet the following goals: ... Establish the mechanism by which the organization will address surveillance, prevention, identification, control and reporting of infections, utilizing current scientific methods and epidemiologic principles. Provide for surveillance systems to track the occurrence and transmission of infections. Policy: [Name of agency] is committed to reducing the risk of acquisition and transmission of health care associated infections (HAIs). Recognized prevention and control mechanisms will be implemented for planning, surveillance, identification, prevention/controls, and reporting procedures. To determine the effectiveness of the infection control plan, [name of agency] will measure, assess, improve, and redesign (as appropriate) the surveillance, identification, prevention, and control function annually through its performance improvement program. Procedure: The organization will utilize its safety and performance improvement process to identify risks for the acquisition and transmission of infectious agents on an ongoing basis. The Performance Improvement Coordinator will be responsible for managing and coordinating infection control activities and reporting of infection control activities to the Performance Improvement Committee and other appropriate authorities. Infection control activities and outcomes will be part of the organization's QAPI program. The Performance Improvement Coordinator will maintain qualifications for infection control responsibility through ongoing education and training."

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: The agency failed to ensure that the Condition of Participation: G 940 484.105 Organization and administration of services was in compliance as follows: 1. Based on interview and record review the Governing Body (GB) failed to operate and manage the agency from November 25, 2019 to March 8, 2021, in a universe of 33 patients when: a. A current California State License was not maintained. (Refer to G 942) b. A current California Department of Public Health (CDPH) Laboratory Registration was not maintained. (Refer to G 942) c. An Administrator/Director of Patient Care Services (Admin/DPCS 2) was not appointed and approved by the Governing Body (GB). (Refer to G 942) d. An Administrator/Director of Patient Care Services (Admin/DPCS 3) was not appointed and approved by the Governing Body (GB). (Refer to G 942) e. An Administrator (Admin 4) was not appointed and approved by the Governing Body (GB). (Refer to G 942) f. The California Department of Public Health (CDPH) was not notified in changes of Administrator and Director of Patient Care Services (Admin/DPCS 1, Admin/DPCS 2, Admin/DPCS 3 and Admin 4). (Refer to G 942) g. A patient complaint system was not managed or maintained. (Refer to G 942) h. A qualified Administrator Designee was not available to assume administrative responsibilities in the absence of the Administrator. (Refer to G 942) i. A Director of Patient Care Services (DPCS) or a qualified Director of Patient Care Services Designee (DPCSD) was not available to provide clinical oversight on Tuesdays and Thursdays from 9 AM to 2 PM. (Refer to G 942) 2. Based on interview, and record review, the Home Health Agency (HHA) failed to ensure the hiring of qualified employees as evidenced by incomplete employment files. This had the potential to place the patients at risk for substandard quality of care, and infectious disease, in a universe of seven Patients (Patient 1, 2, 3, 4, 5, 6, and 7). (Refer to G 952) 3. Based on interview and record review, the agency failed to ensure a Director of Patient Care Services (DPCS) or Director of Patient Care Services Designee (DPCSD) was available to provide clinical oversight of clinical care and services, 24 hours a day, seven days a week, in a universe of 33 patients. (Refer to G 958) The cumulative effect of these systemic practices resulted in: a. Conducting business without a State License for 16 months b. Performing waived laboratory testing without CDPH oversight for five months. c. Running of the agency by unqualified Administrators and Directors of Patient Care Services. d. The absence of an Administrator and/or Director of Patient Care Services to direct the agency's services and patient care. e. Patient complaints to go unheard and unaddressed for 21 months. And these failures had the potential to cause patient harm when a Director of Patient Care Services (DPCS) was unavailable to: a. Ensure patients received all essential care services. b. Coordinate all care services across all disciplines. c. Provide guidance and expertise to all clinical personnel.

Governing body CFR(s): 484.105(a) Standard: Governing body. A governing body (or designated persons so functioning) must assume full legal authority and responsibility for the agency's overall management and operation, the provision of all home health services, fiscal operations, review of the agency's budget and its operational plans, and its quality assessment and performance improvement program. This STANDARD is not met as evidenced by: Based on interview and record review, the Governing Body (GB) failed to operate and manage the agency from November 25, 2019 to March 8, 2021, in a universe of 33 patients when: 1. A current California State License was not maintained. 2. A current California Department of Public Health (CDPH) Laboratory Registration was not maintained. 3. An Administrator/Director of Patient Care Services (Admin/DPCS 2) was not appointed and approved by the Governing Body (GB). 4. An Administrator/Director of Patient Care Services (Admin/DPCS 3) was not appointed and approved by the Governing Body (GB). 5. An Administrator (Admin 4) was not appointed and approved by the Governing Body (GB). 6. The California Department of Public Health (CDPH) was not notified in changes of Administrator and Director of Patient Care Services (Admin/DPCS 1, Admin/DPCS 2, Admin/DPCS 3 and Admin 4). 7. A patient complaint system was not managed or maintained. 8. A qualified Administrator Designee was not available to assume administrative responsibilities in the absence of the Administrator. 9. A Director of Patient Care Services (DPCS) or a qualified Director of Patient Care Services Designee (DPCSD) was not available to provide clinical oversight on Tuesdays and Thursdays from 9 AM to 2 PM. These failures caused the agency to: conduct business without a State License for 16 months and perform waived laboratory testing without CDPH oversight for five months. And these failures had the potential to cause: a. The agency to be run by unqualified Administrators and Directors of Patient Care Services. b. The absence of an Administrator and/or Director of Patient Care Services to direct the agency's services and patient care. c. And, for patient complaints to go unheard and unaddressed for 21 months. Findings: 1. During an agency tour on March 8, 2021 at 10:15 AM, a California State License for the agency was posted on the front office wall. The California State License indicated an expiration date of November 25, 2019. During an interview with the Administrator (Admin 4) on March 8, 2021 at 10:40 AM, Admin 4 stated it was his responsibility to ensure the agency's license was kept current and active. Admin 4 stated he became aware that the license had expired when he received a notice last year (2020) that the license had expired. Admin 4 stated he sent a cashier check January 5, 2021 to pay for the 2020 and 2021 State License. Admin 4 stated the agency had been conducting business without a current State License for 16 months. 2. During an agency tour on March 8, 2021 at 10:15 AM, a California Department of Public Health (CDPH) Laboratory Registration, for the agency, was posted on the front office wall. The CDPH Laboratory Registration indicated an expiration date of October 28, 2020. During an interview with the Administrator (Admin 4) on March 8, 2021 at 11:11 AM, Admin 4 stated it was his responsibility to ensure the agency's CDPH Laboratory Registration was kept current and active. Admin 4 stated he became aware that the CDPH Laboratory Registration had expired on March 5, 2021. Admin 4 stated he would send a cashier's check to CDPH today (March 8, 2021) to renew the CDPH Laboratory Registration. Admin 4 stated the agency had been conducting waived laboratory testing without a current CDPH Laboratory Registration for five months. 3. During an interview with the Administrator (Admin 4) on March 8, 2021 at 12:11 PM, Admin 4 stated the agency had hired an Administrator/Director of Patient Care Services (Admin/DPCS 2) on June 15, 2020. Admin 4 stated Admin/DPCS 2 had left the agency's employ on February 5, 2021. A review of Admin/DPCS 2's personnel file indicated a hire date of June 15, 2020. There was no documented evidence to show a separation date for Admin/DPCS 2. A review of the agency's Governing Body (GB) meeting minutes from January 1, 2020 to March 8, 2021 was conducted. There was no documented evidence to show the GB had appointed and approved Admin/DPCS 2. During a continued interview with Admin 4 on March 8, 2021 at 12:11 PM, Admin 4 stated there was no documented evidence to show Admin/DPCS 2's separation from the agency. Admin 4 stated the GB had not met to appoint and approve Admin/DPCS 2. Admin 4 stated the agency's GB consisted of himself (Admin 4), the Owner (100% shareholder) and the Chief Financial Officer (CFO). Admin 4 stated that according to the agency's bylaws the Owner, who was a 100% shareholder, must be present to conduct business at a GB meeting. Admin 4 stated he did not have documentation to show the Owner of the agency had approved and appointed Admin/DPCS 2. A review of the agency's bylaws dated August 24, 2004, indicated, "Section 10. Quorum [the minimum number of members of an assembly that must be present at any of its meetings to make the proceedings of that meeting valid]; Vote; Written Consent. The holders of a majority of the voting shares shall constitute a quorum at a meeting of shareholders for the transaction of any business." 4. During an interview with the Administrator (Admin 4) on March 8, 2021 at 12:11 PM, Admin 4 stated an Administrator/Director of Patient Care Services (Admin/DPCS 3) had worked for the agency before as an Administrator/Director of Patient Care Services but had left the agency's employ around May of 2019. Admin 4 stated Admin/DPCS 3 returned to the agency October 21, 2020 as a Registered Nurse Case Manager. Admin 4 stated Admin/DPCS 3 accepted the position of Administrator/Director of Patient Care Services, for the agency, on February 6, 2021, upon the departure of Admin/DPCS 2. A review of Admin/DPCS 3's personnel file indicated paperwork from 2019. There was no documented evidence to show the Admin/DPCS 3 had separated from the agency. There was no documented evidence to show the Admin/DPCS 3 had returned to the agency or job descriptions for positions held. There was no documented evidence to show the Admin/DPCS 3 had been qualified for any position at the agency. A review of the agency's Governing Body (GB) meeting minutes from January 1, 2020 to March 8, 2021 was conducted. There was no documented evidence to show the GB had appointed and approved Admin/DPCS 3. During a continued interview with Admin 4 on March 8, 2021 at 12:11 PM, Admin 4 stated there was no documented evidence to show Admin/DPCS 3's separation from the agency or rehire. Admin 4 stated a new personnel file should have been created for Admin/DPCS 3 and it was not. Admin 4 stated the GB had not met to appoint and approve Admin/DPCS 3. Admin 4 stated the agency's GB consisted of himself (Admin 4), the Owner (100% shareholder) and the Chief Financial Officer (CFO). Admin 4 stated that according to the agency's bylaws the Owner, who was a 100% shareholder, must be present to conduct business at a GB meeting. Admin 4 stated he did not have documentation to show the Owner of the agency had approved and appointed Admin/DPCS 3. A review of the agency's bylaws dated August 24, 2004, indicated, "Section 10. Quorum [the minimum number of members of an assembly that must be present at any of its meetings to make the proceedings of that meeting valid]; Vote; Written Consent. The holders of a majority of the voting shares shall constitute a quorum at a meeting of shareholders for the transaction of any business." 5. During an interview with the Administrator (Admin 4) on March 8, 2021 at 10:15 AM, Admin 4 stated he had decided that morning (March 8, 2021 at 9 AM) to appoint himself as the Administrator and appoint the Administrator/Director of Patient Care Services (Admin/DPCS 3) as the Administrator Designee/Director of Patient Care Services (AD/DPCS). Admin 4 stated he had not brought this recommendation before Governing Body (GB) or consulted with the GB on his decision. A review of the agency's Governing Body (GB) meeting minutes from January 1, 2020 to March 8, 2021 was conducted. There was no documented evidence to show the GB had appointed and approved Admin 4 as Administrator and Administrator/Director of Patient Care Services (Admin/DPCS 3) as Administrator Designee/Director of Patient Care Services (AD/DPCS). During a continued interview with Admin 4 on March 8, 2021 at 10:15 AM, Admin 4 stated the agency's GB consisted of himself (Admin 4), the Owner (100% shareholder) and the Chief Financial Officer (CFO). Admin 4 stated that according to the agency's bylaws the Owner, who was a 100% shareholder, must be present to conduct business at a GB meeting. Admin 4 stated he did not have documentation to show the Owner of the agency had approved and appointed himself (Admin 4) as the Administrator or the Administrator/Director of Patient Care Services (Admin/DPCS 3) as Administrator Designee/Director of Patient Care Services (AD/DPCS). 6. During an interview with the Administrator (Admin 4) on March 8, 2021 at 1 PM, Admin 4 stated the agency had hired an Administrator/Director of Patient Care Services (Admin/DPCS 1) on December 16, 2019. Admin 4 stated the Governing Body (GB) held a meeting on December 16, 2019 and appointed and approved Admin/DPCS 1. Admin 4 stated at some point in September 2020 Admin/DPCS 1 decided not to continue with the Administrator/Director of Patient Care Services position and that was when Admin/DPCS 2 had taken the position. In a continued interview with Admin 4 on March 8, 2021 at 1 PM, Admin 4 stated he was aware of the following State regulation: "Title 22, section 74667(b)(6,7), Report of Changes: Changes Requiring Written Notice. The licensee shall, within 10 days, notify the Department [California Department of Public Health] in writing of the following: (6) Change of the administrator including the name and mailing address of the administrator, the date the administrator assumed office and a brief description of qualifications and background of the administrator. (7) Change of Director of Patient Care Services including the name and mailing address of the Director of Patient Care Services, the date the Director of Patient Care Services assumed office and a brief description of qualifications and background of the director of Patient Care Services." Admin 4 stated the agency had not notified the department, in writing or otherwise, of the following Administrators and Directors of Patient Care Services: a. Admin/DPCS 1 b. Admin/DPCS 2 c. Admin/DPCS 3 d. Admin 4. 7. During an agency tour on March 8, 2021, the agency's complaint log, tracking system and complaint reports were reviewed. Entries into the complaint tracking log ended on June 30, 2019. During an interview with the Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS) on March 8, 2021 at 10:15 AM, Admin 4 stated the patient complaint tracking system was managed and maintained by the AD/DPCS. Admin 4 stated he did not know the AD/DPCS had not been managing patient complaints. The AD/DPCS stated "I don't have anything to do with the complaint log." During a home visit with Patient 3 on March 11, 2021 at 9 AM, in the presence of Patient 3's daughter and a Registered Nurse (RN 1), Patient 3 described a complaint reported to the agency as follows: During a home visit with Patient 3, on March 11, 2021, at 9:13 AM, Patient 3 stated, she complained to a Licensed Vocational Nurse (LVN 1) that a previous LVN (name unknown), was rough with her, did not explain medications, and did not give Patient 3 any instructions about her care. Patient 3 further stated, the LVN (name unknown) did not come back on follow up visits, and that LVN 1 told Patient 3 the LVN (name unknown) was no longer with the Home Health Agency (HHA). Patient 3 stated, she had not received a response from the HHA on her complaint. During an interview on March 15, 2021, at 9:35 AM, with LVN 1, LVN 1 stated, she recalled receiving Patient 3's complaint in December 2020 and had reported it to the Administrator/Director of Patient Care Services (Admin/DPCS 2). LVN 1 stated she called the office when there was a complaint. LVN 1 stated, she did not recall documenting the complaint or filling out a complaint form. LVN 1 stated she had never been trained or oriented on the HHA complaint process. Admin/DPCS 2 left the agency's employ on February 5, 2021 and was unavailable for interview. A review of the agency's complaint log from June 30, 2019 to March 8, 2021 was conducted. There was no documented evidence to show a "Patient Grievance Form" had been filled out and logged into the Complaint/Grievance log. During an interview on March 12, 2021, at 2:41 PM, with the Administrator Designee/Director of Patient Care Services (AD/DPCS), AD/DPCS stated, the process for complaints was to call the patient, get the complaint, talk to the staff, and report to Admin 4. The AD/DPCS stated that Admin/DPCS 2 did not document Patient 3's complaint in the Complaint/Grievance log. During an interview on March 12, 2021, at 3:18 PM, with Admin 4, Admin 4 stated, the process for complaints was to call the patient, investigate the complaint, and find a resolution. Admin 4 stated, the AD/DPCS was responsible for complaints/grievances related to clinical issues. Admin 4 stated that Admin/DPCS 2 did not document Patient 3's complaint in the Complaint/Grievance log. A review of the agency's policy and procedure titled "Complaint/Grievance Process," dated, revised, April 2019, indicated, "The organization staff member receiving the complaint will discuss, verbally and in writing, the grievance with a supervisor ... complaints and any action taken will be documented on a complaint form ... complaints will be logged, tracked, trended, and filed in the performance improvement office." 8. During an interview with the Administrator (Admin 4) on March 8, 2021 at 10:15 AM, Admin 4 stated he had decided that morning (March 8, 2021 at 9 AM) to appoint himself as the Administrator and appoint the Administrator/Director of Patient Care Services (Admin/DPCS 3) as the Administrator Designee/Director of Patient Care Services (AD/DPCS). During an interview with the AD/DPCS on March 8, 2021 at 11:27 AM, the AD/DPCS stated she had agreed on March 8, 2021 at 9 AM to move from Administrator to Administrator Designee. The AD/DPCS stated she did not know how she would cover for Admin 4 on Tuesdays and Thursdays from 9 AM to 2 PM because she was working at another home health agency. AD/DPCS stated she had not discussed this difficulty with Admin 4. During an interview with Admin 4 on March 8, 2021 at 1 PM, Admin 4 stated he did not know the AD/DPCS was unavailable to cover as Administrator Designee on Tuesdays and Thursdays from 9 AM to 2 PM, should it be necessary. 9. During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) on March 8, 2021 at 11:27 AM, the AD/DPCS stated she had worked for the agency before, in the position of Administrator/Director of Patient Care Services. The AD/DPCS stated she had left the agency in May 2019 to work for another Home Health Agency (HHA 1), full time. The AD/DPCS stated the agency called her and asked if she would come back to work at the agency. The AD/DPCS stated she returned to the agency on October 21, 2020 as a part time Registered Nurse Case Manager (RNCM). The AD/DPCS stated she continued to work for HHA 1 on a part time basis, every Tuesday and Thursday from 9 AM to 2 PM, as a field nurse. During a continued interview with the AD/DPCS, the AD/DPCS stated in January 2021 she had become very ill and did not work for the agency or HHA 1 for the entire month of January 2021. The AD/DPCS stated the agency asked her to take over the position of Administrator/Director of Patient Care Services on February 6, 2021 and she agreed. The AD/DPCS stated she continued to work for HHA 1 every Tuesday and Thursday from 9 AM to 2 PM as a field nurse. During a continued interview with the AD/DPCS, the AD/DPCS stated she asked the agency's office staff, Receptionist 1 (Recep 1) and Receptionist 2 (Recep 2), not to call her on Tuesdays and Thursdays from 9 AM to 2 PM. The AD/DPCS stated she did not know who the Director of Patient Care Services Designee was, but there were a couple of field RNs who could cover for her on Tuesdays and Thursdays from 9 AM to 2 PM. During a continued interview with AD/DPCS, the AD/DPCS stated the Administrator (Admin 4) asked her to accept the position of Administrator Designee/Director of Patient Care Services on March 8, 2021, and she agreed. The AD/DPCS stated she had not discussed her position at HHA 1 with Admin 4 and had no intention of quitting her job at HHA 1. During an interview with Recep 1 on March 8, 2021 at 3:26 PM, Recep 1 stated she received phone calls from clinical staff with patient issues, questions and concerns. Recep 1 stated she would try to email or call the AD/DPCS and let her know the staffs' question or concern. Recep 1 stated the AD/DPCS told her not to call her on Tuesdays and Thursdays, but to email or text. Recep 1 stated the AD/DPCS would get back to her when she could. Recep 1 stated she would call a Registered Nurse (RN 4) if she did not get a timely response from the AD/DPCS. During an interview with Recep 2 on March 8, 2021 at 3:15 PM, Recep 2 stated she received phone calls from clinical staff with patient issues, questions and concerns. Recep 2 stated she had received calls from patients with medication questions or needed refills, as well as, questions about wound care. Recep 2 stated she would call the AD/DPCS and give her the information. Recep 2 stated the AD/DPCS told her not to call her on Tuesdays and Thursdays, but to email her. Recep 2 stated the AD/DPCS would usually get back to her the same day. Recep 2 stated she would call a Registered Nurse (RN 4) or a Registered Nurse OASIS (Outcome and Assessment Information Set) Coder (RN/Coder) if it was an emergency situation and she could not wait for the AD/DPCS to email her back. During an interview with the RN/Coder on March 8, 2021 at 12:26 PM, the RN/Coder stated she started working for the agency on February 16, 2021. The RN/Coder stated her primary function was to review the agency's patients' OASIS Assessments and apply billing codes for the patient's diagnoses. The RN/Coder stated she had agreed to cover for the AD/DPCS on an "as needed basis." The RN/Coder stated she worked for the agency on a per diem [by the day] basis only. The RN/Coder stated the agency had not indicated any specific days or hours to cover. The RN/Coder stated she had agreed to provide her services for about four hours per week. The RN/Coder stated there was no understanding that she would provide Director of Patient Care Services on Tuesdays and Thursdays from 9 AM to 2 PM. During an interview with RN 4 on March 8, 2021 at 12:51 PM, RN 4 stated she worked for the agency on a per diem [by the day] basis only. RN 4 stated she worked for two other agencies, in addition to this agency, on a per diem basis. RN 4 stated she agreed to cover for the AD/DPCS on an "as needed" basis. RN 4 stated she worked one to two hours per week for whoever called her. RN 4 stated she did not have an understanding to cover for the AD/DPCS on Tuesdays and Thursdays from 9 AM to 2 PM. A review of RN 4's personnel file was conducted. There was no documented evidence to show a job description for Director of Patient Care Services Designee (DPCSD). There was no documented evidence to show RN 4 had been qualified to provide services as a DPCSD. During an interview with a Registered Nurse (RN 1) on March 8, 2021 at 2:54 PM, RN 1 stated she was hired as a per diem field nurse on October 6, 2020. RN 1 stated when she needed assistance with a patient or had a question she would call the AD/DPCS. RN 1 stated if she could not get a hold of the AD/DPCS she would call the RN/Coder. During an interview with a Certified Home Health Aide (CHHA 1) on March 8, 2021 at 3:06 PM, CHHA 1 stated she started working for the agency on April 1, 2020. CHHA 1 stated when she needed help with a patient, she would call the office and speak with Receptionist 1 (Recep 1) or Receptionist 2 (Recep 2). CHHA 1 stated Recep 1 or Recep 2 would call the AD/DPCS with her question or concern and then call her back to tell her what was going to be done. CHHA 1 stated she thought RN 4 was the AD/DPCS's back up. During an interview with the Administrator (Admin 4) on March 8, 2021 at 4 PM, Admin 4 stated he was unaware the AD/DPCS was not going to fulfill the DPCS role for the agency on Tuesdays and Thursdays from 9 AM to 2 PM. A review of the agency's policy and procedure titled "Responsibilities/Supervision of Clinical Services," dated April 2019, indicated, "Purpose: To define the process for supervision of clinical services provided by [name of agency]. Policy: Supervision of clinical care and services will be available 24 hours a day, seven (7) days a week." A review of the agency's policy and procedure titled "Job Description: Clinical Director/Director of Patient Care Services," dated April 2019, indicated the following: "Job Description Summary: The Clinical Director/Director of Patient Care Services is responsible for the overall direction of home health clinical services ... Essential Job Functions/Responsibilities: Coordinates and oversees all direct and indirect patient services provided by clinical organization personnel. Provides guidance and counseling to coordinators and Clinical Supervisors to assist them in continually improving all aspects of home health care services, provided through organization personnel. Assists Clinical Supervisors in managing clinical teams and planning. Provides help in assessment, planning, implementation and evaluation of patient and family/caregiver care to all clinical personnel as indicated. If functioning as Clinical Manager: Will be available at all times during operating hours and will provide oversight of all patient care services and personnel including making patient and personnel assignments; coordinating patient care; coordinating referrals; assuring patient needs are continually assessed: and assuring the development, implementation, and updates of the individualized plan of care." A review of the agency's policy and procedure titled "Regulatory Compliance," dated April 2019, indicated the following: "Purpose: To ensure compliance with local, state, federal, and other regulatory bodies. Policy: The organization will maintain evidence of regulatory compliance, including but not limited to: Current state license ... Other state of California requirements." A review of the agency's policy and procedure titled "Designation of Individual in Absence of Executive Director/Administrator," dated April 2019, indicated, "Policy: [name of agency] will have an Executive Director/Administrator or designee available at all times." A review of the agency's policy and procedure titled "Governing Body," dated April 2019, indicated the following: "Purpose: To outline the roles and responsibilities of the Governing Body. Policy: The Governing Body will assume full legal authority, responsibility, decision-making and accountability for the overall management and operations, the provision of services ... human resource management ... The Governing Body of [name of agency] will serve as the governing authority for the home care program, which will function according to [name of agency] bylaws. Procedure: The Governing Body will appoint a qualified Executive Director/Administrator and establish procedures of systematic communication between the two. The Governing Body will comply with the organization's bylaws in relation to: Appointment of officers Attendance requirements at meetings and quorum determination Overall responsibilities. All actions taken by the Governing Body will be documented in meeting minutes, which will be retained by the organization for a minimum of five (5) years. Minutes will minimally include attendance records, summaries of agenda items and action taken, and motions documented as stated and acted upon." An Immediate Jeopardy (IJ-a situation with the potential to harm the health and safety of the patients) was called under 42 CFR 484.105(a) G 942 Governing body, on March 8, 2021 at 5:00 PM, in the presence of the Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS). The Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS) were verbally notified of the IJ situation identified based on the agency's Governing Body's failure to manage and operate the agency to ensure safe and effective care to patients. The agency submitted a corrective action plan which was reviewed and accepted on March 15, 2021 at 4:06 PM, in the presence of the Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS). The agency's corrective action plan indicated the following: "1. On 03/10/2021, a special meeting of the Governing Body was conducted to discuss the preliminary findings from the State Survey held on 03/10/2021. During the meeting, plan of corrections and corrective actions were discussed and approved, and immediate implementations of the corrective actions were initiated. Discussion includes strict compliance with the Governing Body's responsibility to ensure that the following will be kept in compliance moving forward: a. California State License is kept current b. [error] CDPH Laboratory Registration is kept current c. Any new Administrator is appointed and approved by the governing body d. Any new Director of Patient Care Services (DPCS) is appointed and approved by the Governing Body. e. A patient Complaint System is managed and maintained (Refer to Grievance and Complaint Program Binder). f. A qualified Administrator Designee is available to assume administrative responsibility in the absence of the administrator. g. A DPCS or DPCS Designee is always available to provide clinical oversight. h. The California Department of Public Health (CDPH) is notified of any changes in Administrator or DPCS. 2. On 03/10/2021, one-on-one instruction and counseling was given by the Chairman of the Governing Body to the Agency's Administrator regarding strict compliance in ensuring that the required Licenses and Certifications were kept current. Any incident of insufficient compliance will be reported to the Governing Body immediately for immediate corrective action. The Administrator verbalized understanding and compliance with the deficiencies and the corrective actions. 3. On 03/10/2021, the Governing Body approved to schedule a quarterly meeting that includes the topic of checking and verification of the expiration dates of the agency's required licenses and certifications, to ensure that all those required licenses and certifications will be kept current. The Governing Body also appointed the Administrator as the responsible personnel in monitoring and ensuring that the agency's required licenses and certifications were kept current. 4. On 03/10/2021, the agency utilizes the EMR [electronic medical record] software tracking features to track and remind the administration regarding expiration dates of the agencies required licenses and certifications. A window prompt will always appear once any of the agency's administration logged into the software. The prompt will appear once any of the required licenses and certifications are about to expire within 30 calendar days. Agency had the option of increasing the number of tracking days from 30 to 90 days, as deemed necessary. Administration includes the Governing Body, the Administrator, the DPCS, Human Resources Supervisor and Quality Assurance Supervisor. 5. On 03/10/2021, a Grievance and Complaint Program Binder is established to ensure strict compliance with the proper management, maintenance and compliance with the procedures and guidelines of the program. The program binder includes policies and procedures related to the program, forms and monthly and quarterly tracking of compliance which includes corrective actions, stated goals and evaluations of the program and effectiveness of corrective actions as applicable. It also includes [name of Administrator Designee/Director of Patient Care Services] DPCS the overall responsible personnel for the strict implementation and compliance with the program. (Refer to Grievance and Complaint Program binder). 1. Quarterly meeting topics of the Governing Body meeting include checking and verification of the expiration dates of the agency's required licenses and certifications. These licenses and certifications include but not limited to the following: a. State License b. Local Business License c. Federal CLIA [Clinical Laboratory Improvement Amendments] d. CDPH Laboratory Registration e. Professional and General Liability Insurance 2. A special meeting of the Governing body will be held to appoint and approve any new Administrator and DPCS. 3. Administrations which include the Governing Body, the Administrator, the DPCS, Human Resources Supervisor and Quality Assurance Supervisor will utilize the agency's EMR software feature in tracking the expiration dates of the required licenses and certifications to ensure strict compliance in keeping them current. 4. The DPCS will be responsible in the maintenance and implementation of the agency's Grievance and Complaint Program. Results of the reviews and audits will be trended, and appropriate corrective actions will be formulated, initiated and immediately implemented as applicable and as necessary. Agency compliance goal is 96% [percent], which will be directly monitored by the Administrator. Quarterly summary reports will be submitted to the Governing Body for review, discussion, and approval. 5. Governing Body will ensure that a qualified Administrator Designee is available to assume administrative responsibility in the absence of the administrator. The Governing Body hired a qualified Administrator designee. 6. Governing Body will ensure that a DPCS or DPCS Designee is always available to provide clinical oversight. The Governing Body hired a qualified DPCS Designee. 7. Governing Body will ensure that the California Department of Public Health (CDPH) is notified of any change in Administrator or DPCS thru [through] fax [facsimile] and letter. 1. The Governing Body is ultimately responsible for the corrective actions and overall and ongoing compliance with the following: a. Tracking, monitoring, and renewal of the following required licenses and certifications: State License Local Business License Federal CLIA [Clinical Laboratory Improvement Amendments] CDPH Laboratory Registration Professional and General Liability Insurance b. Appointment and approval of any new Administrator, DPCS and their qualified designees. c. Prompt notification of the California Department of Public Health for any change in Administrator and DPCS. Required forms will be sent to the California Department of Public Health in a timely manner as required by Federal and State regulations and guidelines (i.e., forms HS200, HS215, etc.). 2. The Administrator is ultimately responsible for the corrective actions and overall and ongoing compliance in the maintenance and implementation of the agency's Grievance and Complaint Program. After interviews with Admin 4, AD/DPCS, the New Administrator Designee/Director of Patient Care Services Designee (New AD/DPCSD), and a review of the March 10, 2021 special Governing Body Meeting minutes, the IJ was lifted on March 15, 2021 at 4:06 PM, in the presence of the Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS).

Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This ELEMENT is not met as evidenced by: Based on interview, and record review, the Home Health Agency (HHA) failed to ensure the hiring of qualified employees as evidenced by incomplete employment files. This had the potential to place the patients at risk for substandard quality of care, and infectious disease, in a universe of seven Patients (Patient 1, 2, 3, 4, 5, 6, and 7). Findings: During an interview and record review of the HHA personnel files on March 8, 2021 through March 16, 2021, at 10:28 AM, with the Administrator Designee/Director of patient Care Services (AD/DPCS), the personnel files revealed the HHA did not update the current "New-Hire" documents for the AD/DPCS at the time of re-hire date, October 21, 2020. There was no evidence of a current Job Description at the time of re-hire date, October 21, 2020. The Cardiopulmonary Resuscitation (CPR) certification for the AD/DPCS had expired on January 6, 2020. The AD/DPCS agreed that her file was not updated, and that Receptionist (Recep 2) was responsible for maintaining the personnel files. During an interview and record review of the HHA personnel files on March 8, 2021 through March 16, 2021, at 10:31 AM, with the Administrator Designee/Director of patient Care Services (AD/DPCS), the personnel files revealed the HHA did not conduct a new hire orientation for three, of eight sampled employees, Registered Nurse OASIS Coder (RN/Coder), Registered Nurse (RN 1), and Certified Home Health Aide, (CHHA 1) There was no evidence of an "Orientation Checklist" found in the personnel files. The AD/DPCS agreed that there was no "Orientation Checklist" for RN/Coder, RN 1, and CHHA 1, and that Receptionist (Recep 2) was responsible for maintaining the personnel files. During an interview and record review of the HHA personnel files conducted on March 8, 2021 through March 16, 2021, at 10:35 AM, with the Administrator Designee/Director of patient Care Services (AD/DPCS), the personnel files revealed the HHA did not conduct reference checks for five, of eight sampled employees, Administrator/Director of Patient Care Services (Admin/DPCS 2), Registered Nurse Coder (RN/Coder), (Admin/DPCS 1), Registered Nurse (RN 1), and Certified Home Health Aide (CHHA 1), prior to hire. There was no evidence that the HHA called the references listed in the personnel files to verify previous job performance prior to hire. The AD/DPCS agreed that there were no reference checks for Admin/DPCS 2, RN/Coder, Admin/DPCS 1, RN 1, and CHHA 1. During an interview and record review of the personnel files conducted on March 8, 2021 through March 16, 2021, at 10:38 AM, with the Administrator Designee/Director of Patient Care Services (AD/DPCS), the personnel files revealed the HHA did not obtain proof of a current (within a year) tuberculosis (a contagious respiratory disease) screening result for two of eight sampled employees, Physical Therapist (PT 1), and Certified Home Health Aide (CHHA 1). There was no evidence of a current tuberculosis screening result found in the personnel files. The AD/DPCS agreed there was no tuberculosis screening result found in the personnel files for PT 1, and CHHA 1. During an interview and record review of the personnel files conducted on March 8, 2021 through March 16, 2021, at 10:41 AM, with Administrator Designee/Director of Patient Care Services (AD/DPCS), the personnel files revealed the HHA did not verify In-service training hours were completed by Certified Home Health Aide (CHHA 1), for two of the past 12 months. There was no evidence of In-service training hours documented for June 2020, and November 2020. The AD/DPCS agreed that CHHA 1 had not completed In-service training hours in June 2020, and November 2020. During an interview on March 16, 2021, at 11:00 AM, with the Receptionist (Recep 2), Recep 2 stated, it was news to her that she was responsible for maintaining the personnel files. Recep 2 stated, this is a surprise to me. Recep 2 further stated that the former Office Manager maintained the personnel files at the time of Recep 2's hire. I was asked to organize the different sections of the personnel files, and put a date received for each item in the personnel files when someone was hired. If an item was missing, I would email the discipline (new hire), and ask for the missing item. If I still didn't get the missing items, I would report it to the Administrator Designee/Director of Patient Care Services (AD/DPCS) or the Owner (Member of the governing Body). I sent new hires a packet with an employment application and medical forms to complete, but I did not maintain them after the person was hired. If there is stuff missing from the personnel files it may be that the employees sent stuff to the Owner (Member of Governing Body) but he never gave it to me. I did not have access to personnel files in the old computer system, so I could not put expiration dates or notifications in the computer. Nobody told me how to maintain the personnel files, or how frequently the personnel files needed to be checked. When shown a copy of the HHA policy titled, "Personnel Record Contents", Recep 2 stated she had never read the policy and she was never told that she was responsible for maintaining the personnel files. During a review of the HHA's policy and procedure titled, Personnel Record Contents, dated revised April 2019, indicated, the HHA will maintain current personnel files on all employees and independent contractors. The content of the personnel files for regular full or part-time personnel will include ...Signed Job Description, CPR Certification, Orientation Checklist, References, TB Mantoux test Documentation (Tuberculosis Screening).

Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to ensure a Director of Patient Care Services (DPCS) or Director of Patient Care Services Designee (DPCSD) was available to provide clinical oversight of clinical care and services, 24 hours a day, seven days a week, in a universe of 33 patients. This failure had the potential to cause patient harm when a Director of Patient Care Services (DPCS) was unavailable to: a. Ensure patients received all essential care services. b. Coordinate all care services across all disciplines. c. Provide guidance and expertise to all clinical personnel. Findings: During an interview with the Administrator Designee/Director of Patient Care Services (AD/DPCS) on March 8, 2021 at 11:27 AM, the AD/DPCS stated she had worked for the agency before, in the position of Administrator/Director of Patient Care Services. The AD/DPCS stated she had left the agency in May 2019 to work for another Home Health Agency (HHA 1), full time. The AD/DPCS stated the agency called her and asked if she would come back to work at the agency. The AD/DPCS stated she returned to the agency on October 21, 2020 as a part time Registered Nurse Case Manager (RNCM). The AD/DPCS stated she continued to work for HHA 1 on a part time basis, every Tuesday and Thursday from 9 AM to 2 PM, as a field nurse. During a continued interview with the AD/DPCS, the AD/DPCS stated in January 2021 she had become very ill and did not work for the agency or HHA 1 for the entire month of January 2021. The AD/DPCS stated the agency asked her to take over the position of Administrator/Director of Patient Care Services on February 6, 2021 and she agreed. The AD/DPCS stated she continued to work for HHA 1 every Tuesday and Thursday from 9 AM to 2 PM as a field nurse. During a continued interview with the AD/DPCS, the AD/DPCS stated she asked the agency's office staff, Receptionist 1 (Recep 1) and Receptionist 2 (Recep 2), not to call her on Tuesdays and Thursdays from 9 AM to 2 PM. The AD/DPCS stated she did not know who the Director of Patient Care Services Designee was, but there were a couple of field RNs who could cover for her on Tuesdays and Thursdays from 9 AM to 2 PM. During a continued interview with AD/DPCS, the AD/DPCS stated the Administrator (Admin 4) asked her to accept the position of Administrator Designee/Director of Patient Care Services on March 8, 2021, and she agreed. The AD/DPCS stated she had not discussed her position at HHA 1 with Admin 4 and had no intention of quitting her job at HHA 1. During an interview with Recep 1 on March 8, 2021 at 3:26 PM, Recep 1 stated she received phone calls from clinical staff with patient issues, questions and concerns. Recep 1 stated she would try to email or call the AD/DPCS and let her know the staffs' question or concern. Recep 1 stated the AD/DPCS told her not to call her on Tuesdays and Thursdays, but to email or text. Recep 1 stated the AD/DPCS would get back to her when she could. Recep 1 stated she would call a Registered Nurse (RN 4) if she did not get a timely response from the AD/DPCS. During an interview with Recep 2 on March 8, 2021 at 3:15 PM, Recep 2 stated she received phone calls from clinical staff with patient issues, questions and concerns. Recep 2 stated she had received calls from patients with medication questions or needed refills, as well as, questions about wound care. Recep 2 stated she would call the AD/DPCS and give her the information. Recep 2 stated the AD/DPCS told her not to call her on Tuesdays and Thursdays, but to email her. Recep 2 stated the AD/DPCS would usually get back to her the same day. Recep 2 stated she would call a Registered Nurse (RN 4) or a Registered Nurse OASIS (Outcome and Assessment Information Set) Coder (RN/Coder) if it was an emergency situation and she could not wait for the AD/DPCS to email her back. During an interview with the RN/Coder on March 8, 2021 at 12:26 PM, the RN/Coder stated she started working for the agency on February 16, 2021. The RN/Coder stated her primary function was to review the agency's patients' OASIS Assessments and apply billing codes for the patient's diagnoses. The RN/Coder stated she had agreed to cover for the AD/DPCS on an "as needed basis." The RN/Coder stated she worked for the agency on a per diem [by the day] basis only. The RN/Coder stated the agency had not indicated any specific days or hours to cover. The RN/Coder stated she had agreed to provide her services for about four hours per week. The RN/Coder stated there was no understanding that she would provide Director of Patient Care Services on Tuesdays and Thursdays from 9 AM to 2 PM. During an interview with RN 4 on March 8, 2021 at 12:51 PM, RN 4 stated she worked for the agency on a per diem [by the day] basis only. RN 4 stated she worked for two other agencies, in addition to this agency, on a per diem basis. RN 4 stated she agreed to cover for the AD/DPCS on an "as needed" basis. RN 4 stated she worked one to two hours per week for whoever called her. RN 4 stated she did not have an understanding to cover for the AD/DPCS on Tuesdays and Thursdays from 9 AM to 2 PM. A review of RN 4's personnel file was conducted. There was no documented evidence to show a job description for Director of Patient Care Services Designee (DPCSD). There was no documented evidence to show RN 4 had been qualified to provide services as a DPCSD. During an interview with a Registered Nurse (RN 1) on March 8, 2021 at 2:54 PM, RN 1 stated she was hired as a per diem field nurse on October 6, 2020. RN 1 stated when she needed assistance with a patient or had a question she would call the AD/DPCS. RN 1 stated if she could not get a hold of the AD/DPCS she would call the RN/Coder. During an interview with a Certified Home Health Aide (CHHA 1) on March 8, 2021 at 3:06 PM, CHHA 1 stated she started working for the agency on April 1, 2020. CHHA 1 stated when she needed help with a patient, she would call the office and speak with Receptionist 1 (Recep 1) or Receptionist 2 (Recep 2). CHHA 1 stated Recep 1 or Recep 2 would call the AD/DPCS with her question or concern and then call her back to tell her what was going to be done. CHHA 1 stated she thought RN 4 was the AD/DPCS's back up. During an interview with the Administrator (Admin 4) on March 8, 2021 at 4 PM, Admin 4 stated he was unaware the AD/DPCS was not going to fulfill the DPCS role for the agency on Tuesdays and Thursdays from 9 AM to 2 PM. A review of the agency's policy and procedure titled "Responsibilities/Supervision of Clinical Services," dated April 2019, indicated, "Purpose: To define the process for supervision of clinical services provided by [name of agency]. Policy: Supervision of clinical care and services will be available 24 hours a day, seven (7) days a week." A review of the agency's policy and procedure titled "Job Description: Clinical Director/Director of Patient Care Services," dated April 2019, indicated the following: "Job Description Summary: The Clinical Director/Director of Patient Care Services is responsible for the overall direction of home health clinical services ... Essential Job Functions/Responsibilities: Coordinates and oversees all direct and indirect patient services provided by clinical organization personnel. Provides guidance and counseling to coordinators and Clinical Supervisors to assist them in continually improving all aspects of home health care services, provided through organization personnel. Assists Clinical Supervisors in managing clinical teams and planning. Provides help in assessment, planning, implementation and evaluation of patient and family/caregiver care to all clinical personnel as indicated. If functioning as Clinical Manager: Will be available at all times during operating hours and will provide oversight of all patient care services and personnel including making patient and personnel assignments; coordinating patient care; coordinating referrals; assuring patient needs are continually assessed: and assuring the development, implementation, and updates of the individualized plan of care." An Immediate Jeopardy (IJ-a situation with the potential to harm the health and safety of the patients) was called under 42 CFR 484.105(c) G 958 Clinical manager, on March 8, 2021 at 5:00 PM, in the presence of the Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS). The Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS) were verbally notified of the IJ situation identified based on the agency's failure to ensure clinical oversight of all patient care services and personnel 24 hours a day, seven days a week. The agency submitted a corrective action plan which was reviewed and accepted on March 15, 2021 at 4:06 PM, in the presence of the Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS). The agency's corrective action plan indicated the following: "We hired [name of New Administrator Designee/Director of Patient Care Services Designee] RN effective 3/11/2021 from field nurse to office staff as a backup DPCS and Administrator which she agreed to cover the DPCS and Administrator position. Her work will be a minimum of eight hours every Tuesday and Thursday and anytime the company may need her in the office. We will schedule her formal orientation on 3/11/2021. Upon reviewing her credentials [name of New Administrator Designee/Director of Patient Care Services Designee] RN BSN [bachelor degree in nursing] has been a nurse for 29 years and has at least 20 years in supervisory capacity. This meets the standard qualifications required by the state and the federal regulations. Please see attached resume. [Name of New Administrator Designee/Director of Patient Care Services Designee] RN BSN will attend orientation as back up DPCS. Orientation will be given by [name of AD/DPCS] RN, BSN, DPCS and as back up administrator orientation given by [name of Admin 4] as guided by our policy and completion of orientation checklist. Please see attached policy and orientation checklist for employee. [Name of AD/DPCS] RN will oversee implementation. The governing body, Administrator and DPCS will monitor and reinforce to Human resource that whoever is doing the orientation with new hires, should go by the checklist one by one to ensure compliance. Please see attached orientation checklist. The orientation for [name of New Administrator Designee/Director of Patient Care Services Designee] the backup DPCS and Administrator was completed 3/15/2021." After an interview with the New Administrator Designee/Director of Patient Care Services Designee (New AD/DPCSD) and a review of the New AD/DPCSD's qualifications and agency's orientation checklist, the IJ was lifted on March 15, 2021 at 4:06 PM, in the presence of the Administrator (Admin 4) and Administrator Designee/Director of Patient Care Services (AD/DPCS).