Every finding on record at Hand in Heart Home Health Inc

The following reflects the findings of the California Department of Public Health, Licensing and Certification, during a Centers for Medicaid and Medicare Services (CMS) authorized COMPLAINT VALIDATION SURVEY for Conditions of Participation (COP): Patient Rights; Care Planning Coordination, Quality of Care; Organization and Administration of Services; and Clinical Records, triggered by federal complaint # 106035, conducted from 5/13/24 to 5/20/24. Complaint #: 106035 – Substantiated. Representing the Department: 37886 - HFEN 39912 - HFEN 44589 – HFEN Census: 150 Sample: 9 (included 2 expanded samples) Out of the 4 COPS authorized by CMS, the home health agency (HHA) was out of compliance in 3 COPS as follows: Care Planning Coordination Quality of Care; Organization and Administration of Services; and Clinical Records.

Patient refuses services CFR(s): 484.50(d)(4) The patient refuses services, or elects to be transferred or discharged; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to ensure communication with the physician was documented in the clinical records for three of nine patients (Patients 5, 7 & 8) when: One patient (Patient 5) refused occupational therapy services (OT). Two patients (Patients 7 & 8) refused physical therapy (PT) services. These failures had the potential for the physician to be uninformed of Patient 5's refusal of OT and Patients 7 & 8's refusal of PT, resulting in the patients not meeting their maximum potential. Findings: 1. During a record review and concurrent interview on 5/16/24 at 2:26 p.m. with the Clinical Manager (CM), Patient 5’s "Order Requisition," dated 1/15/24, was reviewed. The "Order Requisition" indicated, OT was ordered. A review of the skilled visit calendar for Patient 5 revealed, no evidence that OT services were provided. Further record review revealed, no indication of the patient/family’s refusal of OT services, nor did it show that the physician was notified of patient’s refusal. CM stated, “The OT was not done because the patient and or family refused the OT services.” CM acknowledged that Patient 5’s refusal of OT was not mentioned in the clinical record and the physician was not notified. 2. During a review of Patient 7’s “Home Health Certification and Plan of Care (POC),” certification period dated, 2/29/2024 – 4/28/2024, the POC indicated, “PT evaluation refused at this time.” Review of Patient 8’s “POC,” certification period dated, 4/24/2024 – 6/22/2024, indicated, “PT services refused at this time.” During a review of Patients 7 & 8 clinical records, there was no documentation if the attending physician had been notified of Patients 7 or 8's refusal for PT services and no documentation if the services were re-offered and explained to the patients. During an interview on 5/15/24, at 2:40 p.m., with the CM, the CM verified Patient 7’s refusal for PT evaluation on the HHCPOC. CM confirmed no documentation was found regarding the refusal, including MD notification. The CM acknowledged the missing documentation of Patient 7's refusal for PT services was communicated to the office. During an interview on 5/20/24 at 11:30 a.m. with the Director of Patient Care Services (DPCS), the DPCS verified Patient 8’s refusal for a PT evaluation. The DPCS confirmed no documentation was found regarding the refusal, including MD notification and no communication notes of Patient 8's refusal for PT services. During a review of the agency's policy and procedure (P&P) titled, “Informed Consent/Refusal of Treatment,” (undated), the P&P indicated, “Upon admission and throughout the course of care/service, the patient and family/caregiver will be: … 2. Encouraged to participate in the care/service planning process, including planning for transfer, referral, and discharge. 3. Allowed to refuse all or part of his/her care/service to the extent permitted by law: … Procedure 1. During admission visit and follow-up visits, the patient and family/caregiver will be given information (verbally and/or in writing) that describes A. The services and/or disciplines anticipated to be involved in the care/service of the patient … C. The potential benefits and effects of the procedure, including who will perform the procedure … 5. The patient will be informed of the expected consequences whenever any treatment/care/services is refused. Documentation of such refusal and physician notification will be made part of the clinical record and includes: A. Date and time of visit or phone contact. B. Specific care, treatment, or service being refused. C. Description of what was explained to the patient regarding consequences of decision. D. Date and time of physician contact. E. Action to be taken per physician (or other authorized licensed independent practitioner) orders. F. Patient response after any explanations … 7. If the physician is not available or does not take action, the Program Director will notify the organization Executive Director/Administrator and/or Medical Director, as well as the Ethics Committee.

Death of patient CFR(s): 484.50(d)(6) The patient dies; or This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to ensure accurate documentation of Patient 3’s death. This failure resulted in the licensed nurse (LN) re-certifying Patient 3 for another episode of services after Patient 3’s death. Findings: During a review of Patient’s 3’s “Nursing Progress Notes (NPN),” dated 1/4/24, the "NPN" indicated, Patient 3 was alert, oriented to person, place and time, had clear lung sounds, with blood pressure of 123/75, Pulse rate 74, Respiratory rate 17 and Oxygen saturation of 96% (percent). Patient 3 had a complaint of pain to both knees with pain scale of three out of ten. During a review of Patient 3’s "Clinical Record," the "Record" indicated, there was no documentation of Patient 3's death on 1/1/24, no documentation the attending physician was notified and no documentation that it was communicated with the office staff. During a concurrent record review and interview on 5/15/24 at 2:40 p.m. with the Clinical Manager (CM), the NPN was reviewed. The CM acknowledged the inaccurate data and the missing documentation of Patient 3’s death, and no notification with the attending physician and communication with the office staff. During a review of the agency's policy and procedure (P&P) titled, “Monitoring Patient’s Response/Reporting to Physician,” (undated), the P&P indicated, “Policy: Clinicians will monitor, document, and report the patient’s response to care and treatment provided on each home visit … Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care of the patient. Procedure 1. During each home visit, the clinician will monitor the patient’s response to care against the established goals including but not limited to: A. Care interventions and treatments … 3. The patient’s physician will be contacted on the same day when any of the following occur: A. Significant changes in the patient’s condition. “ During a review of the agency's P&P titled, “Patient Notification of Changes in Care,” (undated), the P&P indicated, “… 2. Any significant changes will be called into the office … Plan of care changes … 2. Documentation of the notification will include A. Date and time of notification. B. Specific changes in the plan of care …” During a review of the agency's P&P titled, “Continuity of Care,” (undated), the P&P indicated, “Continuity of care will be ensured by: 1. Periodic communication between team members concerning the patient’s progress and special needs as evidenced in case conference reports and clinical notes … The clinician will be responsible for: A. Communicating with all personnel caring for the patient including the physician. B. Updating physician’s (or other authorized licensed independent practitioner’s) orders … C. Updating plan of care. D. Updating his/her own discipline’s plan of care. E. Communicating changes in orders and findings to the Clinical Supervisor or Designee, or other team members as necessary. F Communicating between multiple disciplines to optimize visit schedules for the benefit of the patient and the care to be provided. G. Discharge planning.”

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 CONDITION OF PARTICIPATION (COP) is not met when the Home Health Agency (HHA) failed to: G0572: Ensure the plan of care included all of the durable medical equipment (DME). G0576: Review, reconcile, and provide accurate medication list to patient at home. G0584: Ensure the physician signed the verbal orders for a patient. G0612: Provide a copy of plan of care (POC – information identified based upon the patient identified needs and development of appropriate interventions) to patients at home. G0614: Ensure the written visit schedule and frequency of visits provided to the patient were consistent with the most recent plan of care (POC). The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment.

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 record review and interview, the home health agency (HHA) failed to ensure: Missed skilled home visits were documented in the clinical records (CR) for four of nine sampled patients (Patient 1, 3, 5, and 7). These failures had the potential for Patients 1, 3, 5, and 7 to not meet their maximum functional potential. The plan of care (POC) included all of the durable medical equipment (DME) used for one of nine patients (Patient 9) observed during a home visit. This failure had a potential for Patient 9 to be unaware of how the given DME was used. Findings: 1. During a review of the facility’s policy and procedure (P&P) titled, “Missed Visits,” (undated), the “P&P” indicated, “Procedure: 1. If visit is missed for any reason, the clinician should attempt to reschedule it for the same week so that the physician ordered frequency is maintained and would not be considered a missed visit. 2. If a visit is missed and not rescheduled the clinician will: A. Notify the physician and clinical supervisor of the missed visit and reason for missed visit. B. Document in the patient’s clinical record the following information: 1. Patient name. 2. Date and type of visit that was missed. 3. Reason for the missed visit. 4. Description of any unmet needs and how the patient’s needs were met. 5. Physician notification including date, time, physician name, method of notification and the staff reporting the information. 6. Other person(s) that were notified of the missed visit. 7. Any other follow-up needed. 8 Signature of staff member reporting the information. “ During a concurrent interview and review of Patient 1’s "Plan of Care (POC)," dated 3/14/24 – 5/12/24 with the clinical manager (CM), Patient 1's "POC" was reviewed. The POC indicated, SN visits, “SN 1x/week x 9 weeks.” Review of Patient 1's "CR," the "CR" indicated, missed Skilled Nursing (SN) visits from week 8 and week 9 (4/28/24/ to 5/11/24).The CM acknowledged the missing SN visits and was unable to provide proof of documentation for the SN visits from 4/28/24 to 5/12/24. The CM further acknowledged no documentation was found related to the missed visits including physician notification. During a concurrent record review and interview on 5/20/24, at 11:45 a.m., with the Director of Patient Services (DPCS), Patient 3's "POC" dated 11/17/23 – 1/15/24 was reviewed. The POC SN order indicated, “SN 2x /week X 1 week then 1x /week x 8 weeks.” Review of Patient 3's "CR," the "CR" indicated, missed Skilled Nursing (SN) visits for week 1 and week 9. The DPCS acknowledged no additional nurse saw Patient 3 for weeks 1 and 9. The CM was unable to provide proof of nursing visit documentation or physician notification of the missed SN visits. During a concurrent interview and record review on 5/16/24 at 2:26 p.m. with the director of patient care services (DPCS), Patient 5’s plan of care (POC) for the certification period of 3/18/24- 5/16/24 was reviewed and indicated, skilled nurse (SN) would visit once a week for nine weeks. A review of Patient 5’s visit calendar indicated, no SN visit occurred during week nine and the physician had not been notified of the missed visit. The DPCS confirmed no skilled nurse visit was made during week nine of Patient 5's certification period, and the physician had not been notified. During a concurrent record review and interview on 5/15/24 at 4:45 p.m. with the CM, Patient 7's "POC" dated 2/29/24 – 4/28/24 was reviewed. Review of Patient 7's "CR," the "CR" indicated, missed Skilled Nursing (SN) visits for weeks 6 and 7. The CM was unable to provide proof of nursing visit documentation or physician notification of the missed SN visits. 2. During a concurrent home visit observation, interview, and record review on 5/15/24 at 10 a.m. with the PT, in Patient 9's home. DME observed in the home included, an incentive spirometry (measures the volume inhaled into the lungs during inspiration) and an oxygen concentrator (provides oxygen therapy). Patient 9's POC was reviewed and did not include the DME. The physical therapist (PT) confirmed the DME was not on the POC. During a review of the agency's policy and procedure (P&P) titled, “Care Planning Process,” (undated), the P&P indicated, “… The plan of care will include, but will not be limited to: G. Equipment and supplies …”

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to review, reconcile, and provide an accurate medication list for one of nine sampled patients (Patient 9). This failure had the potential for Patient 9 to have complications, such as medication errors, hospitalization, and adverse drug reactions. During a home visit and concurrent interview on 5/15/24 at 10 am with Patient 9, Patient 9's current medication list was reviewed. A medication, Atorvastatin (medication used to manage levels of cholesterol) 10 milligrams tablet by mouth daily was not documented on the home health agency’s plan of care (POC). Patient 9 indicated he has been taking this medication for a long time. During an Interview on 5/15/24 at 4:18 p.m. with the clinical manager (CM), the CM confirmed Atorvastatin was not on the POC and should have been. During a review of the agency's policy and procedure (P&P) titled, “Medication Profile,” (undated), the P&P indicated, “Upon admission to the organization, the admitting clinician will initiate a medication profile to document the current medication regimen, including name, dose, strength, route, frequency, date and time of administration.”

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 physician verbal orders were signed timely for one of the nine sampled patients (Patient 4). This failure had the potential for Patient 4 to receive care without physician approval. During a review of the agency's policy and procedure (P&P) titled, “Verification Of Physician’s Order,” (undated), the P&P indicated in part, "Orders will be documented on a form provided by Hand In Heart Health Inc, dated and signed by the professional receiving the order … Signed orders will be in the clinical record within 30 days of initiation of care or interim order, unless otherwise specified by applicable state law and regulation.” During review of Patient 4’s "Physician Orders" the "Order" indicated, the physician made a telephone order on 3/20/24. The order was an admission order for patient 4. The order was was not signed by the physician within 30 day. In addition, on 3/29/24 a telephone order for physical therapy (PT) visits for 1 visit for 1 week, 2 visits a week 4 weeks was not signed by the physician within 30 days. During an interview on 5/16/24 with the director of patient care services (DPCS), the DPCS confirmed orders must be signed by the physician within 30 days and the orders were not.

Written instructions to patient include: CFR(s): 484.60(e) Standard: Written information to the patient. The HHA must provide the patient and caregiver with a copy of written instructions outlining: This STANDARD is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) failed to provide a plan of care (POC – information identified based upon the patient identified needs and development of appropriate interventions) for three of nine sampled patients (Patients 7, 8, and 9). This failure had the potential to result in a lack of coordination among professionals providing care to the patient. During a concurrent home visit and interview on 5/14/24 at 10:15 a.m. at Patient 7's home with family member (FM), Patient 7's home folder was reviewed and indicated, a copy of the POC was not provided to the patient. Interview with Patient 7's FM, the FM indicated there had never been a copy of the POC in the home folder. During a concurrent home visit and interview on 5/14/24 at 3 p.m. at Patient 8's home with Patient 8, Patient 8's home folder was reviewed and indicated, a copy of the POC was not provided to the patient. Interview with Patient 8, the patient indicated she was unaware the POC should be in the home folder. During a concurrent home visit and interview on 5/15/24 at 10 a.m. at Patient 9's home with Patient 9, Patient 9's home folder was reviewed and indicated, a copy of the POC was not provided to the patient. Interview with Patient 9, the patient indicated he was unaware the HHA should provide him a copy of the POC. During an interview on 5/15/24 at 3:10 p.m. with the clinical manager (CM), the CM indicated they do not provide a copy of the POC to patients unless the patient requested a copy. During a review of the agency's policy and procedure (P&P) titled, "Care Planning Process," (undated), the P&P indicated, "The organization shall provide the patient and caregiver with a copy written instructions outlining: A. Visit schedule, including frequency of visit by personnel and personnel acting on behalf of the organization. B. Patient medication schedule/instructions, including medication name, dosage and frequency and which medication will be administered by the organization's personnel and personnel acting in behalf of the organization. C. Any treatments to be administered by the organization's personnel and personnel acting on behalf of the organization, including therapy services. D. Any other pertinent instruction related to the patient care and treatments that the organization will provide, specific to the patient's care needs.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to ensure the written visit schedule and frequency of visits provided to the patient were consistent with the most recent plan of care (POC) for one of nine sampled patients (Patient 3). This failure had the potential of not fulfilling patient’s needs as scheduled which may result in poor patient outcomes. Findings: During a concurrent record review and interview on 5/20/24 at 11:45 a.m., with the Director of Patient Service (DPCS), Patient 3's "Home Health Certification and Plan of Care (POC)," dated 9/18/23 – 11/16/23 was reviewed. The "POC" indicated, Patient 3 was to receive skilled nursing (SN) visits “SN 2x /week X 1 week then 1x /week x 8 weeks.” Review of Patient 3’s clinical record indicated, only one SN visit was made the week of 9/18/24 instead of the two visits ordered. There was no documentation in Patient 3's clinical record regarding the missed visit or that the physician was notified. The DPCS acknowledged Patient 3 only received one SN visit the week of 9/18/24 and not the ordered two visits and the physician was not notified. The DPCS was unable to locate documentation of the missed SN visit in Patient 3's clinical record. During a review of the agency's P&P titled, “Missed Visits,” (undated), the “P&P” indicated, “Procedure: 1. If visit is missed for any reason, the clinician should attempt to reschedule it for the same week so that the physician ordered frequency is maintained and would not be considered a missed visit. 2. If a visit is missed and not rescheduled the clinician will: A. Notify the physician and clinical supervisor of the missed visit and reason for missed visit. B. Document in the patient’s clinical record the following information: 1. Patient name. 2. Date and type of visit that was missed. 3. Reason for the missed visit. 4. Description of any unmet needs and how the patient’s needs were met. 5. Physician notification including date, time, physician name, method of notification and the staff reporting the information. 6. Other person(s) that were notified of the missed visit. 7. Any other follow-up needed. 8 Signature of staff member reporting the information. “

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 CONDITION OF PARTICIPATION (COP) is not met when the Home Health Agency (HHA) failed to: G0942: Establish a continuous quality program that specifies the detail of data collected and shows verifiable improvement. G0952: Ensure employee files contained signed job descriptions, pre-employment/annual physical exams, and yearly skill competencies. G0954: Ensure the governing board had designated an administrator designee. G0962: Ensure factual information in patient care and services were coordinated among clinicians. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment.

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 record review and interview, the home health agency’s (HHA) governing body (GB) failed to establish a continuous quality program that specified the detail of data collected and show verifiable improvement. This failure had the potential to leave unfavorable patterns in care quality unidentified and unmeasured potentially leading to inadequate quality care. During a review of the agency's policy and procedure (P&P) titled, “Quality Outcomes/Performance Improvement," the P&P indicated, “…As part of the organization-wide performance improvement process, opportunities for improvement related to patient outcomes will be identified through continuous measurement of patient satisfaction survey results, clinical record review, monitoring of incidents, complaints, grievances … Program, or process related performance improvement activities will focus on opportunities to improve overall organizational performance…” During a concurrent interview and document review on 5/20/24 with the administrator (ADM), the agency's Quality Assurance Performance Improvement (QAPI) binder was reviewed. The QAPI binder was empty; there was no QAPI for the last two quarters of 2022, no QAPI for 2023, and no QAPI for the first quarter of 2024. The QAPI binder did not show what the performance improvement plans were, how they were being monitored, the frequency of activities, data gathering techniques, acceptable reports received, or plans to re-evaluate. In addition, no proof of meeting minutes was presented. The ADM was unable to define the frequency and specifics of data collection and monitoring for service efficacy and safety. The ADM acknowledged that there had been no documented QAPI information since the last two quarters of the year 2022.

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 personnel file review and interview, the home health agency (HHA) failed to ensure: 1. Three of five employees' (Case Manager [CM], Director of Patient Care Services [DPCS] and Certified Home Health Aide [CHHA]) personnel files contained signed job descriptions. There was no clinical manager, no administrator designee, no director of patient care services and no director of patient care services designee. This failure had the potential for the employees to not perform their job duties as expected. 2. Four of five employees' files (CM, CHHA, LN, and RN) included a pre-employment physical examination. In addition, three of five employees' file (CHHA, LN and RN) included an annual physical examination This failure had the potential for the HHA hiring workers that were unable to perform the duties of the job. 3) Three of five employees' files (CM, DPCS, and CHHA) included a yearly skill competency. This failure had the potential to result in the HHA hiring unqualified staff. These failures had the potential for the HHA to hire unqualified employees that may be unable to perform their job duties as expected, which may cause patients to not receive adequate care. 1. During a concurrent record review and interview on 5/16/24 at 10:35 a.m. with the administrator (ADM), CM, DPCS, and a CHHA's personnel files were reviewed. The personnel files indicated, CM, DPCS and the CHHA did not have job descriptions in their files. The CM did not have a job description for clinical manager. The DPCS did not have a job description for director of patient care services or administrator designee. The CHHA did not have a job description for a certified home health aide. The ADM acknowledged job descriptions were not in the employee files. During a review of the agency's policy and procedure (P&P) titled, "Job Descriptions," (undated), the P&P indicated a job description will be developed for each position in the organization and will delineate the essential elements of the position." 2. During a concurrent record review and interview on 5/16/24 at 10:35 a.m., with the ADM, the personnel files for the CM, CHHA, LN and RN were reviewed. The personnel files did not have pre-employment physicals for the CM, CHHA, LN and RN. In addition, CHHA, LN and RN personnel files did not include annual physicals. The ADM indicated we don’t do pre-employment physicals, only annual physicals. The ADM acknowledged annual physicals for HHA, LN and RN were not in the employee files. The agency was unable to provide a P&P for pre-employment physicals. 3. During a concurrent record review and interview on 5/16/24 at 10:35 a.m. with the administrator (ADM), CM, DPCS, and a CHHA's personnel files were reviewed. The personnel files indicated, CM, DPCS and the CHHA did not include annual skill competencies. The ADM acknowledged annual competencies were not in the employee files. The agency was unable to provide a P&P for annual competencies.

Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to ensure the governing board (GB) designated an administrator designee. This failure had the potential to result in the HHA lacking leadership in the event the administrator was unable to carry out the stipulated duties. During a concurrent interview and document review on 5/20/24 at 2:45 p.m., with the administrator (ADM), the agency organizational chart was reviewed. The ADM confirmed there was no ADM designee named on the organizational chart. During an interview on 5/20/24 at 3 p.m. with the ADM, the ADM was unable to produce the agency GB meeting minutes for the years 2023 and 2024. The ADM verbalized the minutes could not be located. There was no documentation to support the appointment of an ADM designee by the GB.

Coordinate patient care CFR(s): 484.105(c)(2) Coordinating patient care, This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to ensure that factual information in patient care and services were coordinated among clinicians for one of nine sampled patient (patient 3). This failure may have resulted in the licensed nurse (Employee 2) re-certifying Patient 3 for another episode of services, 28 days after the patient's death, without realizing that the patient had passed away. Findings: During a review of the document titled, “Home Health Certification and Plan of Care (HHCPOC),” certification period dated, 1/16/2024 – 3/15/2024, the HHCPOC indicated, Patient 3’s recertification assessment was completed and signed by the DPCS on 1/17/24. During an interview on 5/15/24, at 10:00 a.m., with the Administrator (Admin), the Admin verified that Patient 3 died on 1/1/24. During a concurrent record review and interview on 5/20/24, at 11:00 a.m., with the Employee 2, the HHCPOC was reviewed. The Employee 2 acknowledged that the electronic signature at the bottom of the completed assessment was her name. Employee 2 verbalized, the assessment was completed by mistake and denied completing the assessment. Employee 2 unable to provide explanation for the completed assessment of the deceased patient. During a review of the facility’s policy and procedure (P&P) titled, “Reassessments/Recertification,” undated, the P&P indicated, “Purpose To outline the requirements for ongoing updates to the comprehensive assessment (reassessment) and recertification. Policy The comprehensive assessment must be updated and revised every 60 days beginning with the start of care…The total plan of care must be renewed at least every 60 days, or more as warranted by the condition of the patient. Any assessment findings that suggest a need to alter the plan of care will be reported to the patient’s physician. OASIS (Outcome and Assessment Information Set – patient specific assessment for Medicare home health care) for recertification, significant change in condition, transfer, resumption of care and discharge will be completed within the mandated time frames…Procedure…3. For each new episode of care, a comprehensive assessment will be completed no earlier that five (5) days before and no later than one (1) day before the calendar day on which the new episode of care will begin…4. Each patient will be reassessed using a comprehensive OASIS assessment tool the review and revision of the plan of acre when: A. There is significant change in patient’s condition, care environment and/or support system…D. The patient is discharged. 5. The physician will be notified of any of the above situations…10. The physician will be contacted to verify the continued need for care, his/her agreement with the continued plan of care and an estimate of how much longer the skilled services will be required.”

Clinical records CFR(s): 484.110 Condition of participation: Clinical records. The HHA must maintain a clinical record containing past and current information for every patient accepted by the HHA and receiving home health services. Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician(s) or allowed practitioner(s) issuing orders for the home health plan of care, and appropriate HHA staff. This information may be maintained electronically. This CONDITION is not met as evidenced by: The CONDITION OF PARTICIPATION (COP) is not met when the Home Health Agency (HHA) failed to: G1012: Ensure the clinical record accurately reflected the patient's medical condition. G1022: Ensure the reason for discharge for a patient was accurately documented in the clinical record. G1028: Ensure clinical records for one of nine patients (Patient 3) was retained and not erased. The cumulative effect of these systemic problems resulted in the home health agency's inability to ensure the provision of quality health care in a safe environment.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to ensure the clinical record accurately reflected one of three patient's (Patient 3) medical conditions, including vital signs (essential body functions i.e., heartbeat, temperature, blood pressure, breathing rate), cognitive (mental) status, and respiratory (lung) status. On 1/4/24, a licensed nurse documented Patient 3 as living, unaware that patient 3 had passed away on 1/1/24. This failure demonstrated that Patient 3 was not observed and cared for, resulting in inaccurate recording in Patient 3’s clinical record. Findings: During a review of Patient’s 3’s “Nursing Progress Notes (NPN),” dated 1/4/24, the "NPN" indicated, Patient 3 was alert, oriented to person, place and time, had clear lung sounds, with blood pressure of 123/75, pulse rate 74, respiratory (breathing) rate 17 and oxygen saturation of 96% (percent). Patient 3 had a complaint of pain to both knees with pain scale of three out of ten. During a review of Patient 3’s "Clinical Record (CR)," the "CR" indicated, there was no documentation regarding Patient 3's death on 1/1/24, no documentation of the notification of the attending doctor and no documentation that it was communicated with the office staff. During a concurrent record review wand interview on 5/15/24, at 2:40 p.m., with the Clinical Manager (CM), Patient 3's NPN was reviewed. The CM acknowledged the inaccurate data and the missing documentation of Patient 3’s death, and notification with the attending physician and communication with the office staff. During a review of the agency's policy and procedure (P&P) titled, “Monitoring Patient’s Response/Reporting to Physician,” (undated), the P&P indicated, “Policy: Clinicians will monitor, document, and report the patient’s response to care and treatment provided on each home visit … Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care of the patient. Procedure 1. During each home visit, the clinician will monitor the patient’s response to care against the established goals including but not limited to: A. Care interventions and treatments … 3. The patient’s physician will be contacted on the same day when any of the following occur: A. Significant changes in the patient’s condition. “ During a review of the P&P titled, “Patient Notification of Changes in Care,” (undated), the “P&P” indicated, “…2. Any significant changes will be called into the office … Plan of care changes … 2. Documentation of the notification will include A. Date and time of notification. B. Specific changes in the plan of care …” During a review of the P&P titled, “Continuity of Care,” (undated), the “P&P” indicated, “Continuity of care will be ensured by: 1. Periodic communication between team members concerning the patient’s progress and special needs as evidenced in case conference reports and clinical notes …The clinician will be responsible for: A. Communicating with all personnel caring for the patient including the physician. B. Updating physician’s (or other authorized licensed independent practitioner’s) orders … C. Updating plan of care. D. Updating his/her own discipline’s plan of care. E. Communicating changes in orders and findings to the Clinical Supervisor or Designee, or other team members as necessary. F Communicating between multiple disciplines to optimize visit schedules for the benefit of the patient and the care to be provided. G. Discharge planning.”

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 record review and interview, the home health agency (HHA) failed to ensure the reason for discharge for one of the three sampled patients (patient 3) was accurately documented in the clinical record. This failure had the potential to confuse clinicians regarding patient's status throughout the transition of care. Findings: During a review of Patient 3’s “Discharge Summary Assessment (DSA),” dated 2/1/24, the "DSA" indicated, “M0090. Date Assessment was Completed: 01/30/2024. M0100. This Assessment is Currently Being Completed for the following Reason. Enter Code: 9 (Discharge from agency). M0906. Discharge/Transfer/Death Date. Enter the date of the discharge, transfer, or death (at home) of the patient. 01/30/2024.” During a review of the document titled, “Order/Telephone Order Discharge from Agency (OTTDA),” dated 1/30/24, the "OTTDA" indicated, “Reasons: Please discharge patient from Home Health services.” Electronically signed by the Director of Nursing (DON) on 1/30/24. During an interview on 5/15/24, at 10 a.m., with the Administrator (Admin), the Admin verified that Patient 3 died on 1/1/24. During a concurrent record review and interview on 5/15/24, at 2:40 p.m., with the Clinical Manager (CM), the DSA and the OTTDA were reviewed. The CM acknowledged the incorrect information on the DSA and the OTTDA. The CM further acknowledged the date of discharge must be the last day the patient receives home health services from the agency. During a review of the agency's policy and procedure (P&P) titled, “Verification of Physician’s Orders,” (undated), the P&P indicated, “To ensure that accurate physician (or other authorized licensed independent practitioner) orders are obtained in accordance with applicable law and regulation. Policy Orders will be obtained from a physician (or other authorized licensed independent practitioner) for care and services to be provided to home health patients. Verbal orders will be spoken to, taken, and documented only by professional, licensed home health personnel … A qualified individual will review each order or prescription before care is provided … Procedure … 2. All telephone orders will be received and processed in accordance with state and federal laws and regulations. 3. Telephone orders or verbal orders will be “read back” to the physician (or other authorized licensed independent practitioner) or designee to assure accuracy. 4. Orders will be documented on a form provided by HAND IN HEART HOME HEALTH INC, dated and signed by the professional receiving the order. 5. A copy of the physician’s (or other authorized licensed independent practitioner) order will be kept in the clinical record. 6. The original of the order form will be delivered to the physician (or other authorized licensed independent practitioner) for signature. 7. When the signed order form is returned to HAND IN HEART HOME HEALTH INC, the copy will be removed from the clinical record and destroyed, and the original will be retained in the clinical record. During a review of the agency's P&P titled, “Clinical/Service Data Collection,” (undated), the “P&P” indicated, “Documentation in the clinical/service record will be timely, detailed, and accurate, and reflect the care or services provided. A clinical/service record will be initiated and maintained for each patient receiving care or services according to organization policies found in this manual and will include at a minimum: H. Reasons for interruptions in the provision of care and services … 6. Entries clinical/service record will be made on the day care/service is provided to the patient.

Protection of records CFR(s): 484.110(d) Standard: Protection of records. The clinical record, its contents, and the information contained therein must be safeguarded against loss or unauthorized use. The HHA must be in compliance with the rules regarding protected health information set out at 45 CFR parts 160 and 164. This STANDARD is not met as evidenced by: Based on record review and interview, the home health agency (HHA) failed to ensure clinical records for one of nine patients (Patient 3) was retained and not erased. This failure raised the possibility of intentional manipulation of patient records. Findings: During a review of Patient 3’s "Nursing Progress Notes (NPN)," and "Nursing Visit Calendar (NVC)," for the months of December 2023 and January 2024, the NVC indicated, a missing note pad icon for 12/28/23 and 1/4/24. However, the visiting nurse signed a completed NPN for 12/28/23 and 1/4/24. During a concurrent record review and interview on 5/20/24 at 10:33 a.m. with the Administrator (ADM) and Director of Patient Care Services (DPCS) Patient 3’s NPN and NVC records were reviewed. The ADM verbalized she scheduled a planned visit on the calendar so that nurses could see when they were supposed to visit the patient. The nurse may visit at any moment during the week of the scheduled appointment. The Director of Patient Care Services (DPCS) indicated that the note pad icon with a pen on the calendar indicated the patient was seen, and the nurse visit note was completed. The DPCS confirmed the visiting nurse signed a completed NPN for 12/28/23 and 1/4/24 but was unable to explain why the note pad icon was missing on those dates. The ADM explained that the visiting nurse informed her that the 12/28/23 and 1/4/24 documentation was incorrect, and the patient was not seen on those dates. The ADM admitted to deleting the NPN for 12/28/23 and 1/4/24, and emphasized that nurses should not open and complete an NPN if they had not visited the patient. During a review of the agency's policy and procedure (P&P) titled, “Clinical/Service Data Collection,” (undated), the P&P indicated, "Documentation in the clinical/service record will be timely, detailed, and accurate, and reflect the care or services provided. A clinical/service record will be initiated and maintained for each patient receiving care or services according to organization policies found in this manual and will include at a minimum: H. Reasons for interruptions in the provision of care and services…6. Entries clinical/service record will be made on the day care/service is provided to the patient. All documentation will be turned into the office at the end of the workday…13. Errors in documentation will be corrected as follows: A. draw a line through the entry, date and initial…”

The following reflects the findings of the California Department of Public Health - Licensing and Certification during an investigation of a complaint. Complaint: CA71941 - Substantiated Representing the Department: 37886 - HFEN The inspection was limited to the investigation of the complaint and does not reflect the findings of a full inspection of the facility.

HHA can no longer meet the patient's needs CFR(s): 484.50(d)(1) The transfer or discharge is necessary for the patient's welfare because the HHA and the physician or allowed practitioner, who is responsible for the home health plan of care agree that the HHA can no longer meet the patient's needs, based on the patient's acuity. The HHA must arrange a safe and appropriate transfer to other care entities when the needs of the patient exceed the HHA's capabilities; This ELEMENT is not met as evidenced by: Based on record review, and interview, the agency failed to ensure the patient (Patient 1) and Patient 1's family were assisted promptly in arranging a safe and appropriate transfer to another home health agency or other entities when the initial admission assessment cannot be done for Patient 1. This failure resulted in Patient 1 not being provided home health care in a timely manner. During a review of the agency's Policy and Procedure (P&P) titled, "Admission Criteria and Process" undated, the P&P indicated, "A patient will be referred to other resources if the organization cannot meet his /her needs. In the event that the time frame for assessment cannot be met, the patient’s physician, the referral source, and the patient, will be notified for the approval of the delay. Such notification and approval will be documented. If approval is not obtained for the delay, the patient will be referred to another organization for services.” During a review of the patient 1’s clinical record (CR), the CR revealed the following: >Patient 1 was discharged home from the hospital with home health (HH) referral to a HH agency (agency name) on 9/11/22. >The referral indicated the HHA is to provide skilled nursing (SN) for six weeks, a physical therapy (PT) for two months, an occupational therapy (OT) for three weeks, and pressure injuries care. >The first clinical visit was made by the HH staff (HHS1) on 9/13/22, two days after the referral. No agreement was signed. Patient 1 was not evaluated and not accepted for admission. >The second visit was made by the HH staff (HHS2) on 9/15/22. No agreement was signed. >The third visit was made by the HHS2 on 9/16/22. The service agreement or consent was signed by the patient 1’s family member (FM). >No physical therapy evaluation from HHA can be located in patient 1’s CR. >No occupational therapy evaluation from HHA can be located in patient 1’s CR. >No subsequent skilled visits were made after the signed contract was obtained by HHS2. >No physician notification nor approval for the delay in initial assessment can be found in the CR. During a review of the patient 1’s CR and concurrent interview with the Administrator (ADM) on 10/13/22 at 3:46 PM, the ADM was asked to locate in the CR if the delay of the initial assessment was communicated and approved by the physician. The ADM stated, it was not recorded in the patient’s CR, and she acknowledged the physician was not notified of the assessment not done within 48 hours of referral and should be. No further information was provided on why subsequent skilled visits were not made. During an interview with the FM on 10/13/22 at 8:59 AM, the FM stated, the case worker from the hospital is the one who assisted the FM to transfer to another HH agency.

Revisions communicated to patient and MDs CFR(s): 484.60(c)(3)(i) (i) Any revision to the plan of care due to a change in patient health status must be communicated to the patient, representative (if any), caregiver, and all physicians or allowed practitioner's issuing orders for the HHA plan of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency failed to notify the prescriber for approval of changes in the plan of care when an initial assessment for one patient (Patient 1) was not completed within 48 hours of referral. This failure resulted in patient 1 not being evaluated for admission timely and a potential delay in receiving home care services. During a review of the patient 1’s clinical record (CR), the CR included a home health (HH) services referral order on 9/11/22 timestamped 4:22 PM. Patient 1 was discharged home from the hospital on 9/11/22. The HHA is to provide skilled nursing (SN) for six weeks, a physical therapy (PT) for two months, an occupational therapy (OT) for three weeks, and pressure injuries care. The first clinical visit was made on 9/13/22, two days after the referral. No consent was signed. The initial admission assessment was not done. During an interview on 10/13/22, at 8:59 AM with the complainant, the complainant stated, "...The HH staff (HHS1) first came to patient 1’s home on 9/13/22 and patient’s family member (FM) was asked to sign documents the FM was not sure and uncomfortable signing. The HHS1 took that as refusing the service. On 9/15/22, a second visit was made by another nurse (HHS2) to drop off the documents for FM to review and sign. HHS2 came back on 9/16/22 to pick up the signed consent and to do assessment on patient 1. HHS2 indicated someone would come and see the patient next and that next visit never happened…” During a review of the patient 1’s CR and concurrent interview with the Administrator (ADM) on 10/13/22 at 3:46 PM, the ADM was asked to locate in the CR if the delay of the initial assessment was communicated and approved by the physician. The ADM stated, it was not recorded in the patient’s CR, and she acknowledged the physician was not notified of the assessment not done within 48 hours of referral and should be. During a review of the agency's Policy and Procedure (P&P) titled, "Admission Criteria and Process" undated, the P&P indicated, "In the event that the time frame for assessment cannot be met, the patient’s physician, the referral source, and the patient, will be notified for the approval of the delay. Such notification and approval will be documented.”