Initial Comments:
Based on the findings of an onsite unannounced state license survey completed April 9, 2025, Companion Care, Llc was found to be in compliance with the requirements of PA Code, Title 28, Health and Safety, Part IV, Health Facilities, Subpart A, Chapter 51.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced state license survey completed April 9, 2025, Companion Care, Llc was found not to be in compliance with the requirements of PA Code, Title 28, Health and Safety, Part IV, Health Facilities, Subpart H, Chapter 611, Home Care Agencies and Home Care Registries.
Plan of Correction:
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 a review of CDC (Center for Disease Control and Prevention) guidelines, direct care worker personnel files (PF), and staff (EMP) interview, the agency failed to ensure each direct care worker was screened for mycobacterium tuberculosis (TB) in accordance with CDC (Center for Disease and Control) guidelines prior to consumer contact for six (6) of six (6) personnel files (PF1-PF6).
Findings included:
According to the "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005," "Baseline testing for M. Tuberculosis infection is recommended for all newly hired HCWs [health care workers] ... If TST [tuberculin skin testing] is used for baseline testing, two-step testing is recommended for HCWs whose initial TST results are negative ... A second TST is not needed if the HCW has a documented TST result from any time during the previous 12 months. If a newly employed HCW has had a documented negative TST result within the previous 12 months, a single TST can be administered in the new setting ... This additional TST represents the second stage of the two-step testing." Retrieved from http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf
According to "Tuberculosis Screening, Testing, and Treatment of U.S. Health Care
Personnel: Recommendations from the National Tuberculosis Controllers
Association and CDC, 2019," "Baseline (preplacement) screening and testing, in addition to the IGRA (interferon-gamma release assay) or TST [tuberculin skin testing], shall include a symptom screen questionnaire and an individual TB risk assessment." Retrieved from https://www.cdc.gov/mmwr/volumes/68/wr/pdfs/mm6819-H.pdf
Review of personnel files was conducted on April 9, 2025, at 10 a.m.
PF1 was hired on 3/5/2024 and in contact with consumers beginning 3/6/2024. PF1 contained two negative TSTs from 5/19/2024 and 5/20/2024 (both late and after consumer contact). PF1 had no risk assessment completed.
PF2 was was hired on 6/12/2022 and in contact with consumers beginning 6/19/2022. PF2 contained two negative TSTs from 6/10/2022 and 6/24/2022 (incomplete test -- 2nd TST completed after consumer contact). PF2 had no risk assessment completed.
PF3 was hired on 2/28/2024 and in contact with consumers beginning 3/8/2024. PF3 contained two negative TSTs from 4/11/2024 and 4/18/2024 (both late). PF3 had no risk assessment completed.
PF4 was also hired 3/21/2024 and in contact with consumers beginning 3/28/2024. PF4 contained two negative TSTs from 3/22/2024 and 4/28/2024 (2nd TST late). PF4 had no risk assessment completed.
PF5 was hired on 7/17/2024 and in contact with consumers beginning 7/18/2024. PF5 contained two negative TSTs from 7/14/2024 and 7/29/2024 (2nd TST late). PF5 had no risk assessment completed.
PF6 was hired on 9/9/2024 and in contact with consumers beginning 9/11/2024. PF6 contained two negative TSTs from 9/12/2024 and 10/3/2024 (both TSTs late). PF6 had no risk assessment completed.
Interview with EMP1 (manager) on April 9, 2025, at 11:30 a.m. confirmed above findings.
Plan of Correction:Plan of Correction: Tuberculosis (TB) Screening – Home Health
Agency Name: Companion Care
Date of Plan: 4/14/2025
Date of Completion/Correction: 5/14/2025
Deficiency Identified: Noncompliance with TB screening protocols for healthcare personnel, as required by the Pennsylvania Department of Health and CDC guidelines.
Citation Reference: 2567
1. Immediate Corrective Actions: TB Screening Protocol
In compliance with Pennsylvania Department of Health, CDC guidelines, and findings under Citation 2567, Companion Care is implementing the following:
a. Baseline Testing for New Hires
All newly hired direct care staff will receive baseline TB screening, Symptom Screen, and Risk Assessment prior to any patient contact.
Acceptable screening methods include:
A two-step Tuberculin Skin Test (TST), or
A single Interferon-Gamma Release Assay (IGRA).
For employees with prior BCG vaccination or a known positive TB history, a chest x-ray and symptom screening will be completed in lieu of TST/IGRA.
b. Documentation and Recordkeeping
Employee health records, including TB screenings and risk assessments, will be:
Updated regularly monthly audits for each employee
Maintained securely in compliance with HIPAA and state regulations.
2. Staff Training and Education
All employees will complete mandatory TB education and individual TB risk assessments:
Upon hire and annually thereafter.
Education will include:
TB transmission, symptoms, and risk factors
CDC TB precautions specific to home health care
Companion Care's TB screening and exposure response policies
Completion of training and risk assessments will be documented in individual personnel files.
3. Monitoring and Quality Assurance
Monthly Internal Audits
Companion Care will conduct monthly audits of employee health records to verify:
Timely completion of baseline TB screenings
Completion and documentation of annual TB risk assessments
Audit results will be reviewed by management, and any noncompliance will prompt immediate corrective action.
4. Responsible Party
Director of Care Coordination, will be responsible for overseeing the full implementation and ongoing compliance with this Plan of Correction. Responsibilities include:
Ensuring completion of staff training
Maintaining documentation and record integrity
Conducting and reviewing audits for each employee for office compliance
Coordinating annual risk assessments
Initial Comments:
Based on the findings of an onsite unannounced state license survey completed April 9, 2025, Companion Care, Llc was found to be in compliance with the requirement of 35 P.S. 448.809 (b).
Plan of Correction:
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