QA Investigation Results

Pennsylvania Department of Health
CARESIFY, LLC
Health Inspection Results
CARESIFY, LLC
Health Inspection Results For:


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Initial Comments:




Based on the findings of an onsite unannounced state re-licensure survey conducted on October 29, 2024, Caresify, 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 unannounced home care agency state re-licensure survey conducted on October 29, 2024, Caresify, 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:




611.56(a) LICENSURE
Health Screening

Name - Component - 00
(a) A home care agency or home care registry shall insure 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.

Observations:



Based on review of personnel files (PF) and interview with the agency administrator, it was determined the agency failed to ensure direct care workers were screened for and were free from active mycobacterium tuberculosis (TB) prior to assignment with consumers in five (5) of ten (10) files reviewed. (PFs # 3, # 6-# 7 and # 9- # 10)


Findings include:

The CDC guidelines state that all Health Care Workers (HCW) should receive baseline tuberculosis screening upon hire, using a two-step tuberculin skin test (TST) of a single blood assay for tuberculosis (TB) to test for infection with tuberculosis. After baseline testing for infection with tuberculosis, HCWs should receive TB screen annually. HCWs with a baseline positive test for tuberculosis infections should receive one chest radiograph result to exclude tuberculosis disease. CDC Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care settings, 2005. Morbidity and Mortality World Report 2005;(RR-17)
.



Reviews of personnel files conducted on 10/29/24 between 10:45 AM and 12:25 PM revealed the following:

PF# 3, date of hire (DOH): 2/24/22, contained no documentation of Two-step testing upon hire. There was a one-step test dated 7/22/21.

PF # 6, DOH: 1/24/22; contained no documentation of TB testing upon hire.

PF # 7, DOH: 12/7/21; contained no documentation of TB testing upon hire.

PF # 9, DOH:11/22/22; contained no documentation of TB testing upon hire.

PF # 10, DOH: 10/5/22; contained no documentation of TB testing upon hire.



An interview conducted with the agency administrator on 10/29/24 at approximately 1:00 pm confirmed the above findings.







Plan of Correction:

Corrective Action Plan: Compliance with 611.56(a) - Health Screening for Mycobacterium Tuberculosis
Issue:
The agency did not ensure that all direct care workers were screened for and verified free from active mycobacterium tuberculosis (TB) prior to consumer contact, as required by regulation 611.56(a). In five of the ten reviewed personnel files, documentation of the required two-step TB testing upon hire was absent.
Immediate Action Taken:
1. File Review & Audit: A full audit of all personnel files for active employees is being conducted to identify and rectify any missing or outdated TB screenings.
2. Notification to Affected Employees: Direct care workers with missing TB screening documentation were immediately informed of the requirement and scheduled for TB testing to ensure compliance.
3. Suspension of Client Contact: Any staff found non-compliant with TB screening requirements were temporarily removed from direct client contact until screening documentation was completed.
Plan of Correction:
1. TB Screening Compliance Tracking:
- Implement a dedicated tracking system to monitor TB screening for all new and current employees.
- Ensure that all new hires complete the required two-step TB test or single blood assay for tuberculosis before the start date of client contact.
2. Policy Update and Reinforcement:
- Re educate HR Supervisor on the hiring policy to emphasize the TB screening requirement as a prerequisite for employment.
- Include a checklist within onboarding materials to verify that TB screening is completed and documented before client assignment.
3. Training for HR and Administrative Staff:
- Conduct training for all HR and administrative staff on the updated CDC guidelines for TB testing and the agency's policy on health screenings.
- Reinforce the importance of obtaining and documenting TB screenings as part of the onboarding process for direct care workers.
4. Ongoing Audits and Quality Assurance:
- Conduct quarterly audits of personnel files to ensure ongoing compliance with TB screening and other health-related requirements.
- Designate a Compliance Coordinator or Health Screening Coordinator to oversee health screening compliance, maintain up-to-date records, and manage audits.
Responsible Personnel:
- Compliance Coordinator/Administrator – Oversee the implementation and monitoring of TB screening compliance.
- Human Resources Department – Ensure all new hires complete and document TB screening as required.
- Training Coordinator – Conduct regular training for HR and administrative staff on health screening policies and CDC guidelines.
Completion Timeline:
- Immediate Action Steps: Already in process and completed by 11/6/24.
- Re Education and Procedure Updates: By 11/30/24.
- Staff Training: By 12/15/24.
- Quarterly Audits: Beginning 1/30/25 and recurring quarterly.
Verification of Compliance:
- Regular quarterly audit reports will be reviewed by the agency administrator to ensure full compliance.
- A review of new hire files during monthly meetings will verify that no employee begins work with clients before completion of the TB screening requirement.



611.56(b) LICENSURE
Health Screening

Name - Component - 00
(b) A home care agency or home care registry shall require each direct care worker, and other office staff or contractors with direct consumer contact, to update the documentation required under subsection (a) at least every 12 months and provide the documentation to the agency or registry. The 12 months must run from the date of the last evaluation. The documentation required under subsection (a) shall be included in the individual's file.

Observations:



Based on review of personnel files (PF) and interview with the agency administrator, it was determined the agency failed to ensure direct care workers were screened on annual basis for active mycobacterium tuberculosis (TB) in six (6) of ten (10) files reviewed. (PFs # 2- # 3,
# 6- # 7, and # 9- # 10)



Findings include:

The CDC guidelines state that all Health Care Workers (HCW) should receive baseline tuberculosis screening upon hire, using a two-step tuberculin skin test (TST) of a single blood assay for tuberculosis (TB) to test for infection with tuberculosis. After baseline testing for infection with tuberculosis, HCWs should receive TB screen annually. HCWs with a baseline positive test for tuberculosis infections should receive one chest radiograph result to exclude tuberculosis disease. CDC Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care settings, 2005. Morbidity and Mortality World Report 2005;(RR-17)
.


471

Reviews of personnel files conducted on 10/29/24 between 10:45 AM and 12:25 PM revealed the following:


PF # 2, date of hire (DOH): 3/14/23; contained no documentation of TB risk assessment/screening for year 2024.

PF# 3, DOH: 2/24/22; contained no documentation of TB risk assessment/screening for year 2023 and year 2024.

PF # 6, DOH: 1/24/22; contained no documentation of TB risk assessment/screening for year 2023 and year 2024.

PF # 7, DOH: 12/7/21; contained no documentation of TB risk assessment/screening for year 2022, 2023 and year 2024.

PF # 9, DOH:11/22/22; contained no documentation of TB risk assessment/screening for year 2023 and year 2024.

PF # 10, DOH: 10/5/22; contained no documentation of TB TB risk assessment/screening for year 2023 and year 2024.



An interview conducted with the agency administrator on 10/29/24 at approximately 1:00 pm confirmed the above findings.






Plan of Correction:

Corrective Action Plan: Compliance with 611.56(b) - Annual Health Screening for Mycobacterium Tuberculosis
Issue:
The agency did not ensure that direct care workers received annual TB screenings or risk assessments, as required by regulation 611.56(b). In six of the ten personnel files reviewed, there was missing documentation for TB risk assessments for one or more years.
Immediate Actions Taken:
1. Personnel File Audit: An on going audit of all personnel files for active employees in being conducted to identify any missing or outdated annual CDC TB Screening Questionnaire screenings
2. Notification to Affected Employees: All employees identified as missing recent TB screening documentation were promptly notified and scheduled for CDC TB Questionnaire screenings.
3. Suspension of Client Contact: Staff missing current CDC TB Questionnaire screenings were notified to complete screening questionnaire by 11/30/2024 or will be removed from direct client contact until they completed the required screening Questionnaire.
Plan of Correction:
1. Implement a Health Screening Compliance Tracking System:
o Set up a dedicated tracking system for all employees that automatically flags when annual TB screening Questionnaire are due.
2. Policy Re Education:
o Re Educate the HR Supervisor on the agency's health screening policy to emphasize annual TB screening as a strict requirement for continued employment. Direct Care Workers missing or with outdated TB documentation will result in removal from direct client contact until compliance is restored.
3. Training for HR and Administrative Staff:
o Provide targeted training for HR staff to ensure they are aware of annual TB screening Questionnaire requirements and proficient with the tracking system.
o Emphasize the importance of timely follow-up with employees on pending TB screenings to maintain compliance.
4. Regular Compliance Audits:
o Conduct quarterly audits of personnel files to ensure ongoing compliance with annual TB screening requirements.
o Designate a Compliance Coordinator to oversee TB screening compliance, track employee status, and facilitate audits.
5. Employee Education and Reminders:
o Implement an annual reminder system that sends notifications to employees at least 30 days before their annual TB screening Questionnaire is due.
o Provide information on the importance of regular CDC screenings Questionnaire for TB prevention and agency compliance.
Responsible Personnel:
- Compliance Officer– Oversee implementation of the tracking system, compliance audits, and notifications.
- Human Resources Department – Ensure employee compliance with annual TB screenings Questionnaire, manage follow-ups, and verify documentation.
- Training Coordinator – Conduct initial and refresher training for HR staff on policy requirements and CDC guidelines.
Completion Timeline:
- Immediate Actions and Notifications: Completed by 11/06/24.
- Policy and System Updates: By 11/30/24.
- Staff Training: By 12/15/24.
- Quarterly Audits: Beginning 1/30/25 and conducted quarterly.
Verification of Compliance:
- Quarterly Compliance Reports: The Compliance Officer will prepare and review quarterly reports to monitor adherence to the annual TB screening requirement.
- Monthly Review of New Hires: Monthly reviews will ensure all staff have completed the initial and annual screenings, preventing lapses in future compliance.



Initial Comments:




Based on the findings of an onsite unannounced home care agency state re-licensure survey conducted on October 29, 2024, Caresify, Llc, was found to be in compliance with the requirements of 35 P.S. 448.809 (b).



Plan of Correction: