Every finding on record at Peace in the Valley Health Care Agency, LLC

Based on the findings of an onsite complaint investigation conducted on 7/11/2024, and off-site on 7/22/2024, Peace In The Valley Health Care Agency, LLC, was found not to be in compliance with the requirements of 42 CFR, Part 484, Subparts B and C, Conditions of Participation: Home Health Agencies.

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 review of clinical records (CR), visit schedules, and interview with the administrator, it was determined that the agency failed to provide skilled nursing (SN) and personal assistance services (PAS) according to plan of care, for two (2) of two (2) clinical records (CR) reviewed. (CR1 and CR2) Findings Include: Reviewed agency policy titled “Patient/Client Notification of Changes” on 7/22/2024 at approximately 1:12PM. Policy states, “…6. When a visit cannot be made because of an unforeseen situation, the agency staff will immediately notify the office. A. The Clinical Manager, or designee, will contact the patient and notify them that an alternate direct care staff member will be conducting their visit, in accordance with the plan of care, or give the patient the option to reschedule the visit. B. If the patient refuses the alternate direct care staff, and the visit cannot be rescheduled, the agency staff will complete a Missed Visit Report. The Physician, PA, or ARNP, CNS (as state allows), will be notified that the plan of care frequency was not followed and the reason why. An order will be obtained to accommodate scheduled frequency, as appropriate. C. All documentation, regarding the missed visit, will be placed in the patient record”. Review of clinical records (CR), was conducted on 7/11/2024 at approximately 10:28AM revealed: CR1 - (Start of Care): 3/13/2024 – The patient is a quadriplegic secondary to a gunshot wound of the neck, requiring tracheostomy care and on a ventilator. The patient receives skilled nursing (SN) services for twenty-four (24) hours per day (Monday through Saturday); and sixteen (16) hours per day (Sunday). Reviewed SN visit schedule on 7/11/2024 from approximately 11:20AM until approximately 12:00PM, for the timeframe of 6/1/2024 through 7/10/2024. The visit schedule revealed SN services were not provided for the full shift of 24 hours per day (Monday through Saturday) on the following dates: 6/15/2024: SN services provided for sixteen (16) hours (7:00AM – 3:00PM and 11:00PM – 7:00AM). Agency did not provide SN services for the remaining eight (8) hours (3:00AM – 11:00PM). 6/25/2024: SN services provided for seventeen and one-half (17.5) hours (7:00AM – 12:30AM). Agency did not provide SN services for the remaining six and one-half (6.5) hours (12:30AM – 7:00AM). 6/26/2024: SN services provided for sixteen (16) hours (7:00AM – 11:00PM). Agency did not provide SN services for the remaining eight (8) hours (11:00PM – 7:00AM). Clinical record contained missed visit notes for 6/25/2024 and 6/26/2024. Clinical record did not contain a missed visit note for 6/15/2024 per agency policy. CR2 - (Start of Care): 9/22/2022 – The patient’s primary diagnosis is Amyotrophic Lateral Sclerosis (ALS), requiring tracheostomy care and on a ventilator. The patient receives skilled nursing (SN) services for twenty-four (24) hours per day (Monday through Sunday); and Personal Assistance Services (PAS) for twenty-four (24) hours per day (Monday through Sunday). Reviewed SN visit schedule for the timeframe of 6/1/2024 through 7/10/2024. The visit scheduled revealed SN services and PAS were not provided for the full shift of 24 hours per day (Monday through Sunday) on the following dates: 6/17/2024: Agency did not provide PAS for the entire shift of twenty-four (24) hours. 6/18/2024: PAS provided for sixteen (16) hours (7:00AM – 3:00PM and 11:00PM – 7:00AM). Agency did not provide PAS for the remaining eight (8) hours (3:00PM – 11:00PM). 6/20/2024: SN services provided for sixteen (16) hours (7:00AM – 3:00PM and 11:00PM – 7:00AM). Agency did not provide SN for the remaining eight (8) hours (3:00PM – 11:00PM). 6/21/2024: SN services provided for sixteen (16) hours (7:00AM – 11:00PM). Agency did not provide SN for the remaining eight (8) hours (11:00PM – 7:00AM). 6/22/2024: SN services provided for twelve (12) hours (7:00PM – 7:00AM). Agency did not provide SN for the remaining twelve (12) hours (7:00AM – 7:00PM). 6/23/2024: Agency did not provide SN services for the entire shift of twenty-four (24) hours. 7/1/2024: SN services provided for twenty-three (23) hours. Agency did not provide SN for the remaining one (1) hour. 7/7/2024: PAS provided for twelve (12) hours (7:00AM – 7:00PM). Agency did not provide PAS for the remaining twelve (12) hours (7:00PM – 7:00AM). 7/9/2024: PAS provided for sixteen (16) hours (7:00AM – 3:00PM and 3:00PM – 11:00PM). Agency did not provide PAS for the remaining eight (8) hours (11:00PM – 7:00AM). Clinical record did not contain missed visit notes for any of the above dates per agency policy. Interview with the administrator via email on 7/24/2024 at 8:30AM confirmed the above findings.

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 review of clinical records (CR), visit schedules, and interview with the administrator, it was determined that the agency failed to provide skilled nursing (SN) and personal assistance services (PAS) per physician’s orders and visit schedule for two (2) of two (2) clinical records (CR) reviewed. (CR1 and CR2) Findings Include: Reviewed agency policy titled “Patient/Client Notification of Changes” on 7/22/2024 at approximately 1:12PM. Policy states, “…6. When a visit cannot be made because of an unforeseen situation, the agency staff will immediately notify the office. A. The Clinical Manager, or designee, will contact the patient and notify them that an alternate direct care staff member will be conducting their visit, in accordance with the plan of care, or give the patient the option to reschedule the visit. B. If the patient refuses the alternate direct care staff, and the visit cannot be rescheduled, the agency staff will complete a Missed Visit Report. The Physician, PA, or ARNP, CNS (as state allows), will be notified that the plan of care frequency was not followed and the reason why. An order will be obtained to accommodate scheduled frequency, as appropriate. C. All documentation, regarding the missed visit, will be placed in the patient record”. Review of clinical records (CR), was conducted on 7/11/2024 at approximately 10:28AM revealed: CR1 - (Start of Care): 3/13/2024 – The patient is a quadriplegic secondary to a gunshot wound of the neck, requiring tracheostomy care and on a ventilator. The patient receives skilled nursing (SN) services for twenty-four (24) hours per day (Monday through Saturday); and sixteen (16) hours per day (Sunday). Reviewed SN visit schedule on 7/11/2024 from approximately 11:20AM until approximately 12:00PM, for the timeframe of 6/1/2024 through 7/10/2024. The visit schedule revealed SN services were not provided for the full shift of 24 hours per day (Monday through Saturday) on the following dates: 6/15/2024: SN services provided for sixteen (16) hours (7:00AM – 3:00PM and 11:00PM – 7:00AM). Agency did not provide SN services for the remaining eight (8) hours (3:00AM – 11:00PM). 6/25/2024: SN services provided for seventeen and one-half (17.5) hours (7:00AM – 12:30AM). Agency did not provide SN services for the remaining six and one-half (6.5) hours (12:30AM – 7:00AM). 6/26/2024: SN services provided for sixteen (16) hours (7:00AM – 11:00PM). Agency did not provide SN services for the remaining eight (8) hours (11:00PM – 7:00AM). Clinical record contained missed visit notes for 6/25/2024 and 6/26/2024. Clinical record did not contain a missed visit note for 6/15/2024 per agency policy. CR2 - (Start of Care): 9/22/2022 – The patient’s primary diagnosis is Amyotrophic Lateral Sclerosis (ALS), requiring tracheostomy care and on a ventilator. The patient receives skilled nursing (SN) services for twenty-four (24) hours per day (Monday through Sunday); and Personal Assistance Services (PAS) for twenty-four (24) hours per day (Monday through Sunday). Reviewed SN visit schedule for the timeframe of 6/1/2024 through 7/10/2024. The visit scheduled revealed SN services and PAS were not provided for the full shift of 24 hours per day (Monday through Sunday) on the following dates: 6/17/2024: Agency did not provide PAS for the entire shift of twenty-four (24) hours. 6/18/2024: PAS provided for sixteen (16) hours (7:00AM – 3:00PM and 11:00PM – 7:00AM). Agency did not provide PAS for the remaining eight (8) hours (3:00PM – 11:00PM). 6/20/2024: SN services provided for sixteen (16) hours (7:00AM – 3:00PM and 11:00PM – 7:00AM). Agency did not provide SN for the remaining eight (8) hours (3:00PM – 11:00PM). 6/21/2024: SN services provided for sixteen (16) hours (7:00AM – 11:00PM). Agency did not provide SN for the remaining eight (8) hours (11:00PM – 7:00AM). 6/22/2024: SN services provided for twelve (12) hours (7:00PM – 7:00AM). Agency did not provide SN for the remaining twelve (12) hours (7:00AM – 7:00PM). 6/23/2024: Agency did not provide SN services for the entire shift of twenty-four (24) hours. 7/1/2024: SN services provided for twenty-three (23) hours. Agency did not provide SN for the remaining one (1) hour. 7/7/2024: PAS provided for twelve (12) hours (7:00AM – 7:00PM). Agency did not provide PAS for the remaining twelve (12) hours (7:00PM – 7:00AM). 7/9/2024: PAS provided for sixteen (16) hours (7:00AM – 3:00PM and 3:00PM – 11:00PM). Agency did not provide PAS for the remaining eight (8) hours (11:00PM – 7:00AM). Clinical record did not contain missed visit notes for any of the above dates per agency policy. Interview with the administrator via email on 7/24/2024 at 8:30AM confirmed the above findings.

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 review of personnel files (PF), Centers for Disease Control (CDC) Guidelines, and interview with the administrator, it was determined that the agency failed to document that Home Health Aides were free from mycobacterium tuberculosis (TB) by conducting TB testing for two (2) of five (5) personnel files (PF) reviewed. (PF4 and PF5) Findings Include: "Tuberculosis Screening, Testing, and Treatment of U.S. Health Care Personnel: Recommendations from the National Tuberculosis Controllers Association and CDC, 2019 - Historically, U.S. health care personnel were at increased risk for latent TB infection (LTBI) and TB disease from occupational exposures, but recent data suggest that this is no longer the case. CDC and the National Tuberculosis Controllers Association have updated the 2005 CDC recommendations for testing health care personnel. The update includes 1) TB risk assessment, symptom screening, and TB testing upon hire with a TB blood test (e.g., interferon-gamma release assay) or tuberculin skin test for those without documented prior TB or LTBI; 2) no annual TB testing for most health care personnel without a known exposure or ongoing transmission; 3) for health care personnel with LTBI treatment is strongly encouraged; 4) annual symptom screening for health care personnel with untreated LTBI; and 5) annual TB education for all health care personnel. These recommendations apply to health care personnel and volunteers in all health care settings. However, state and local TB screening and testing regulations may have different requirements." Review of personnel files (PF), was conducted on 7/11/2024 from approximately 12:47PM until approximately 1:45PM revealed: PF4 - (Date of Hire): 3/25/2024 – File contained a TB risk assessment and symptom screen dated 3/25/2024. File did not contain documentation that TB testing was conducted on hire or thereafter. PF5 - (Date of Hire): 9/22/2023 – File contained a TB risk assessment and symptom screen dated 9/22/2023. File did not contain documentation that TB testing was conducted on hire or thereafter. Interview with the administrator via email on 7/24/2024 at 8:30AM confirmed the above findings.

A qualified HH aide successfully completed: CFR(s): 484.80(a)(1)(i-iv) A qualified home health aide is a person who has successfully completed: (i) A training and competency evaluation program as specified in paragraphs (b) and (c) respectively of this section; or (ii) A competency evaluation program that meets the requirements of paragraph (c) of this section; or (iii) A nurse aide training and competency evaluation program approved by the state as meeting the requirements of §483.151 through §483.154 of this chapter, and is currently listed in good standing on the state nurse aide registry; or (iv) The requirements of a state licensure program that meets the provisions of paragraphs (b) and (c) of this section. This ELEMENT is not met as evidenced by: Based on review of personnel files (PF), Pennsylvania regulations for Chapter 601 Home Health Care Agencies, and Chapter 611 Home Care Agencies and Home Care Registries, and interview with the administrator, it was determined that the agency failed to ensure Home Health Aides who were providing personal assistance services (PAS) for patients receiving skilled care, had met all qualification standards required under State licensure regulations under 28 Pa. Code, Part IV, Health Facilities, Subpart G. Chapter 601, prior to providing personal care services, for two (2) of two (2) HHA personnel files (PF) reviewed. (PF4 and PF5) Findings Include: Chapter 601. Home Health Care Agencies - 601.6. Definitions. “…Home Health Aide—A nonprofessional person who has completed a minimum of 60 hours of classroom instruction prior to or during the first 3 months of employment. The term includes aides who are carefully trained in methods of assisting patients to achieve maximum self-reliance, principles of nutrition and meal preparation, the aging process and emotional problems of illness, changes in patient’s condition that should be reported, work of the agency and the health team, ethics, confidentiality and record keeping…” Review of personnel files (PF), was conducted on 7/11/2024 from approximately 12:47PM until approximately 1:45PM, revealed: PF4: HHA - (Date of Hire): 3/25/2024 – File contained documentation related to regulations under 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries (611.55(b)(c)). File did not contain documentation or evidence to confirm all qualification standards required under State licensure regulations under Chapter 601 were met. Chapter 601 regulations are for Home Health agencies and Chapter 611 regulations are for Home Care agencies whose training requirements of a Direct Care Worker are not equivalent to a Home Health Aide by definition and by job description. PF5: HHA - (Date of Hire): 9/22/2023 – File contained documentation related to regulations under 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries (611.55(b)(c)). File did not contain documentation or evidence to confirm all qualification standards required under State licensure regulations under Chapter 601 were met. Chapter 601 regulations are for Home Health agencies and Chapter 611 regulations are for Home Care agencies whose training requirements of a Direct Care Worker are not equivalent to a Home Health Aide by definition and by job description. Interview with the administrator via email on 7/24/2024 at 8:30AM confirmed the above findings.

HHA maintains documentation of training CFR(s): 484.80(b)(4) The HHA must maintain documentation that demonstrates that the requirements of this standard have been met. This ELEMENT is not met as evidenced by: Based on review of personnel files (PF) and interview with the administrator, it was determined that the agency failed to document completion of tracheostomy and ventilator care training for three (3) of three (3) skilled nursing (SN) personnel files (PF) reviewed. (PF1, PF2, and PF3) Findings Include: Review of personnel files (PF), was conducted on 7/11/2024 from approximately 12:47PM until approximately 1:45PM, revealed: PF1: SN - (Date of Hire): 1/17/2024 – File did not contain competency/skills evaluation for tracheostomy and ventilator care. File contained a skills core competency checklist dated 1/17/2024, that included skilled nursing tasks to be evaluated through observation by the registered nurse. The tasks were divided into categories (system assessments, teaching, wound care, patient care, use of assistive devices, medication administration, infection control, documentation, and other tasks). File did not contain documentation of competency for tracheostomy and ventilator care. PF2: SN - (Date of Hire): 4/29/2024 – File did not contain competency/skills evaluation for tracheostomy and ventilator care. File contained a skills core competency checklist dated 4/24/2024, that included skilled nursing tasks to be evaluated through observation by the registered nurse. The tasks were divided into categories (system assessments, teaching, wound care, patient care, use of assistive devices, medication administration, infection control, documentation, and other tasks). File did not contain documentation of competency for tracheostomy and ventilator caret. PF3: SN - (Date of Hire): 5/25/2022 – File did not contain competency/skills evaluation for tracheostomy and ventilator care. File contained a skills core competency checklist dated 6/1/2023, that included skilled nursing tasks to be evaluated through observation by the registered nurse. The tasks were divided into categories (system assessments, teaching, wound care, patient care, use of assistive devices, medication administration, infection control, documentation, and other tasks). File did not contain documentation of competency for tracheostomy and ventilator care. Interview with the administrator via email on 7/24/2024 at 8:30AM confirmed the above findings.

Medicaid personal care aide-only services CFR(s): 484.80(i) Standard: Individuals furnishing Medicaid personal care aide-only services under a Medicaid personal care benefit. An individual may furnish personal care services, as defined in §440.167 of this chapter, on behalf of an HHA. Before the individual may furnish personal care services, the individual must meet all qualification standards established by the state. The individual only needs to demonstrate competency in the services the individual is required to furnish. This STANDARD is not met as evidenced by: Based on review of personnel files (PF), Pennsylvania regulations for Chapter 601 Home Health Care Agencies, and Chapter 611 Home Care Agencies and Home Care Registries, and interview with the administrator, it was determined that the agency failed to ensure Home Health Aides who were providing personal assistance services (PAS) for patients receiving skilled care, had met all qualification standards required under State licensure regulations under 28 Pa. Code, Part IV, Health Facilities, Subpart G. Chapter 601, prior to providing personal care services, for two (2) of two (2) HHA personnel files (PF) reviewed. (PF4 and PF5) Findings Include: Chapter 601. Home Health Care Agencies - 601.6. Definitions. “…Home Health Aide—A nonprofessional person who has completed a minimum of 60 hours of classroom instruction prior to or during the first 3 months of employment. The term includes aides who are carefully trained in methods of assisting patients to achieve maximum self-reliance, principles of nutrition and meal preparation, the aging process and emotional problems of illness, changes in patient’s condition that should be reported, work of the agency and the health team, ethics, confidentiality and record keeping…” Review of personnel files (PF), was conducted on 7/11/2024 from approximately 12:47PM until approximately 1:45PM, revealed: PF4: HHA - (Date of Hire): 3/25/2024 – File contained documentation related to regulations under 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries (611.55(b)(c)). File did not contain documentation or evidence to confirm all qualification standards required under State licensure regulations under Chapter 601 were met. Chapter 601 regulations are for Home Health agencies and Chapter 611 regulations are for Home Care agencies whose training requirements of a Direct Care Worker are not equivalent to a Home Health Aide by definition and by job description. PF5: HHA - (Date of Hire): 9/22/2023 – File contained documentation related to regulations under 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries (611.55(b)(c)). File did not contain documentation or evidence to confirm all qualification standards required under State licensure regulations under Chapter 601 were met. Chapter 601 regulations are for Home Health agencies and Chapter 611 regulations are for Home Care agencies whose training requirements of a Direct Care Worker are not equivalent to a Home Health Aide by definition and by job description. Interview with the administrator via email on 7/24/2024 at 8:30AM confirmed the above findings