Initial Comments:
Based on the findings of an onsite state re-licensure survey conducted on May 1, 2025, Affectionate Home Health Care Services, LLC, was found to be in compliance with the requirements of 28 Pa. Code, Health Facilities, Part IV, Chapter 51, Subpart A.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite state re-licensure survey conducted on May 1, 2025, Affectionate Home Health Care Services, LLC, was found not to be in compliance with the requirements of 28 Pa. Code, Health Facilities, Part IV, Chapter 611, Subpart H. Home Care Agencies and Home Care Registries.
Plan of Correction:
611.52(a) LICENSURE
Criminal Background Checks
Name - Component - 00
The home care agency or home care registry shall require each applicant for employment or referral as a direct care worker to submit a criminal history report obtained at the time of application or within 1 year immediately preceding the date of application.
Observations:
Based on review of personnel files (PF), and interview with the administrator, it was determined that personnel files did not include documentation of a State Police Criminal History (PATCH) report on hire for four (4) of nine (9) personnel files reviewed. (PF3, PF5, PF6, and PF8)
Findings Include:
Review of personnel files (PF) on 5/1/2025 from approximately 10:56AM until approximately 12:10PM revealed:
PF3 - (Date of Hire): 3/25/2024 - File contained a Pennsylvania Access To Criminal History report (PATCH) dated 9/17/2024, which was six (6) months after hire.
PF5 - (Date of Hire): 11/6/2024 - File contained a Pennsylvania Access To Criminal History report (PATCH) dated 2/5/2025, which was three (3) months after hire.
PF6 - (Date of Hire): 10/1/2024 - File contained a Pennsylvania Access To Criminal History report (PATCH) dated 1/17/2025, which was three (3) months after hire.
PF8 - (Date of Hire): 11/8/2024 - File contained a Pennsylvania Access To Criminal History report (PATCH) dated 2/5/2025, which was three (3) months after hire.
An interview with the administrator on 5/1/2025 at approximately 1:00PM confirmed the above findings.
Plan of Correction:1. Corrective Action:
For PF# 3, 5, 6, and 8, Pennsylvania State Police Criminal Background Checks (PATCH reports) were obtained but not completed within the required timeframe. A compliance memo was added to each personnel file documenting the delay and reaffirming the regulation.
The Administrator will educate all HR staff on 611.52(a), which states:
"The home care agency or home care registry shall require each applicant for employment or referral as a direct care worker to submit a criminal history report obtained at the time of application or within 1 year immediately preceding the date of application."
All training will be documented, and relevant guidance materials will be added to the onboarding reference binder for HR and compliance use.
2. Action for Active Files Not Audited:
The Administrator reviewed all current personnel files to verify compliance with PATCH timing requirements. Any instances of delayed background checks were identified, documented, and corrected with a memo and staff re-education. No staff were found to have active disqualifying offenses.
3. Future Prevention Measures:
Effective immediately, all job offers for direct care workers are conditional upon submission of a valid PATCH report obtained at the time of application. HR may not schedule an orientation or assign any shifts until the PATCH is received and reviewed. A new "Background Check Submission Checklist" was added to the hiring packet and must be signed by HR prior to hire.
4. Monitoring Plan:
The Administrator will audit 100% of new hire files monthly to verify PATCH reports are obtained at the time of application or are within one year immediately preceding the date of application. The compliance threshold is 100%. Monthly audits will continue for one quarter. If the threshold is met, audits may be reduced to annual. If the threshold is not met, quarterly audits will resume until compliance is achieved for two consecutive quarters. Audit results will be documented in the HR compliance log.
5. Date Fully Completed:
05/30/2025
611.56(a) LICENSURE
Health Screening
Name - Component - 00
The screening shall be conducted in accordance with CDC guidelines for preventing the transmission of mycobacterium tuberculosis in health care settings. The documentation must indicate the date of the screening which may not be more than 1 year prior to the individual's start date.
Observations:
Based on review of personnel files (PF), and interview with the administrator, it was determined that personnel files did not include documentation of TB testing on hire and annual TB education, for one (1) of nine (9) personnel files reviewed. (PF1)
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) on 5/1/2025 from approximately 10:56AM until approximately 12:10PM revealed:
PF1 - (Date of Hire): 12/7/2023 - File contained a QuantiFERON Gold blood test dated 3/14/2024, which was three (3) months after hire.
An interview with the administrator on 5/1/2025 at approximately 1:00PM confirmed the above finding.
Plan of Correction:1. Corrective Action:
For PF# 1, a TB screening (QuantiFERON Gold test) was obtained and added to the employee file, but the screening occurred three months after the date of hire. A compliance memo has been placed in the file explaining the delay.
The Administrator educated all HR staff and direct care workers on 611.56(a), which states:
"A home care agency or home care registry shall ensure that each direct care worker and other office staff or contractors with direct consumer contact, prior to consumer contact, provide documentation that the individual has been screened for and is free from active mycobacterium tuberculosis. The screening shall be conducted in accordance with CDC guidelines for preventing the transmission of mycobacterium tuberculosis in health care settings. The documentation must indicate the date of the screening which may not be more than 1 year prior to the individual's start date. The results of this screening shall be documented and retained in the employee's personnel file."
The Administrator will also provide HR staff and direct care workers education on the CDC guidelines referenced in the regulation, specifically:
- TB risk assessment, symptom screening, and testing at the time of hire
- No annual testing unless there is known exposure or ongoing transmission
- Annual TB education for all healthcare personnel
- Use of either tuberculin skin test (TST) or interferon-gamma release assay (IGRA), such as QuantiFERON Gold
- Alignment with state-specific requirements (such as Pennsylvania's rule requiring screening to be dated within one year of hire)
All training will be documented, and relevant guidance materials will be added to the onboarding reference binder for HR and compliance use.
2. Action for Active Files Not Audited:
The Administrator reviewed all active personnel files to verify that TB screening was completed prior to the start of service. Any missing or late documentation was corrected by obtaining appropriate testing and issuing compliance memos for files with delayed submission. All direct care staff have documented TB screening results on file.
3. Future Prevention Measures:
A CDC-compliant TB screening form is now required at the time of hire. HR staff must confirm the screening is dated no more than one year prior to the employee's start date. Orientation and field assignment may not proceed without this documentation. A "Medical Screening Checklist" has been added to the onboarding packet to confirm timely TB clearance before patient contact.
Additionally, all direct care workers and applicable office staff will receive annual TB education, as required by CDC guidelines and § 611.56. A centralized TB Education Tracker has been implemented to log the date of each employee's most recent training. Staff will receive automated or manual reminders 30 days before their annual due date, and education must be completed no later than the anniversary of the previous year's training. Completion will be documented and filed in each employee's personnel record.
4. Monitoring Plan:
The Administrator will audit all personnel (new and current) files monthly to ensure TB testing is obtained either upon hire or dated within one year of hire and that TB education is provided annually. The compliance threshold is 100%. Audits will continue monthly for one quarter. If the threshold is met, monitoring may be reduced to annual review. If the threshold is not met, audits will continue quarterly until compliance is maintained for two consecutive quarters. Results will be retained in the HR audit logs.
5. Date Fully Completed:
05/30/2025
Initial Comments:
Based on the findings of an onsite state re-licensure survey conducted on May 1, 2025, Affectionate Home Health Care Services, LLC, was found to be in compliance with the requirements of 35 P.S. 448.809(b).
Plan of Correction:
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