QA Investigation Results

Pennsylvania Department of Health
CARING LIFE SERVICES, INC.
Health Inspection Results
CARING LIFE SERVICES, INC.
Health Inspection Results For:


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Initial Comments:

Based on the findings of an onsite home care agency state re-licensure survey conducted on February 26, 2024, Caring Life Services Inc., 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 home care agency state re-licensure survey conducted on February 26, 2024, Caring Life Services Inc., 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:




611.4(c) LICENSURE
Requirements for HCA and HCR

Name - Component - 00
Home care agencies and home care registries licensed under this Chapter shall comply with applicable environmental, health, sanitation and professional licensure standards which are required by Federal, State, and local authorities.

Observations:

Based on a review of personnel files (PF), an interview with the administrator, the City of Philadelphia Memorandum: Emergency Regulation Governing The Control and Prevention of COVID-19 Mandating Vaccines for Healthcare Workers and In Higher Education, Healthcare, and Related Settings ( " Vaccine Mandate Regulation " ) dated August 16, 2021; an Update to Mandatory Healthcare Vaccination from the City of Philadelphia, dated October 12, 2021; and a third update from the City of Philadelphia, Division of Disease Control dated October 5, 2022 pertaining to updates to vaccination and masking requirements for health care workers, the home care agency failed to provide evidence of direct care worker vaccination status or direct care worker exemption. The requirement was not evident in three (3) of six (6) PF's reviewed: (PF# 1, 5 and 6).

Findings include:

The City of Philadelphia Memorandum - Emergency Regulation Governing the Control and Prevention of COVID-19 Mandating Vaccines for Healthcare Workers and In Higher Education, Healthcare and Related Settings ( " Vaccine Mandate Regulation " ), dated August 16, 2021, and reviewed October 6, 2022 at approximately 1:30 PM provides the following definitions: 1. "Covered Healthcare Personnel - an individual who falls into one or more of the following categories - a) an employee, contract workers, student or volunteer affiliated with a Healthcare Institution who performs duties in a builing where patients, clients or their visitors are present; b) a Healthcare Worker;" 2. "Healthcare Institution - any person or entity that employs, coordinates, or otherwise engages the services of Covered Healthcare Personnel in the City;' 3. "Healthcare Worker - an individual who provides Healthcare Related Services in person to patients or clients.." The regulation further states, "Effective October 15, 2021, no Healthcare Worker may work at a Healthcare Institution or provide Healthcare Related Services to a patient or client in Philadelphia unless such Healthcare Worker (i) has been Fully Vaccinated; or (ii) has been granted an exemption under paragraph 3 of this Regulation from any applicable Healthcare Institution for whom such individual works and documents ongoing compliance with one or more accommodation(s) set forth in paragraph 4 of this regulation. Paragraph 3 - Exemptions: For the purposes of this Regulation only, a Healthcare Institution subject to this Regulation shall grant a Covered Individual an exemption from the vaccination requirements of this Regulation if such individual qualified for one or both of the exemptions and agrees in writing to abide by the accommodation required by the Healthcare Institution. Medical Exemption - for the purpose of this Regulation only, an exemption shall be granted if the Healthcare Institution determines that the administration of any COVID-19 vaccine is contraindicated because the administration would be detrimental to the health of the Covered Individual (CI). A CI shall request an exemption by submitting a certification from a licensed healthcare provider to the Healthcare Institution certifying that the exemption applies and stating the specific reason that the vaccine is contraindicated for the CI. Such certification must be signed by both the healthcare providers and the CI...... Religions Exemption - For the purpose of this Regulation only, an exemption shall be granted if the CI certifies in writing that such individual has a sincerely held religious belief that precludes such individual from receiving the COVID-19 vaccination. Such certification must be signed the CI. Accommodations: Routine Testing - For Healthcare Institutions and Healthcare Workers - Requiring exempt Covered Healthcare Personnel to submit to either a PCR or antigen test at least twice per week, timed appropriately under the circumstances."

The City of Philadelphia Updates to Mandatory Healthcare Vaccination, dated October 12, 2021 and reviewed October 6, 2022 at approximately 1:30 PM, provided timeline updates for three groups......"Group Two: Group Two includes those designated as healthcare worker or healthcare institution worker that are NOT working in a hospital or LTCF. Employers of workers in all 3 groups must complete a written policy detailing how the employer will verify compliance with extended deadlines." The Update also provided the following definitions: 1. "Direct Care Worker: a) the individual employed by a home care agency or referred by a home care registry to provide home care services to a consumer; or b) a person employed for compensation by a provider or participant who provides personal assistance services or respite services. 2. Healthcare Workers: any individual involved in providing any of the following healthcare regulated services in-person to patients or clients or any individual working in a Healthcare Institution....3. Personal Care, which may include services provided in a personal care home or at the home of a patient or client....." The Update further clarified the following: 1. " Who is Covered Under the Mandate: Healthcare Institution Workers.....includes Direct Care Workers; 2. Limited Vaccination Deadline Extensions..... All other Healthcare Workers and Healthcare Institution Workers are required to receive at least one dose of vaccine in a two-dose vaccination series or the single dose in a one-dose series by October 22, 2021 and comply with all Interim Precautions. The second dose of a two-dose vaccine must be received by November 22, 2021. All workers hired after the vaccination deadline must receive at least one shot in a two-dose series or a single dose in a one-dose series before beginning in-person shifts. Final doses must be received within one month of hire. 3. Limited Home-Based Services Enforcement Exception - The Department will not enforce the Healthcare Worker Vaccine Mandate against certain individuals providing care for a Relative as defined below UNTIL the end of calendar year 2021 or until federal mandates require vaccinations for these individuals, whichever occurs first. Such individuals should be treated as employee who have received a valid religious or medical exemption. 4. Full Summary: The Emergency Regulation Governing the Control and Prevention of COVID-19 Mandating Vaccines for Healthcare Workers and In Higher Education, Healthcare and Related Settings ("Vaccine Mandate Regulation"), effective August 16, 2021, will not be enforced against a Direct Care Workers employed by a Pennsylvania licensed Home Care Agency or Home Care Registry or Participant or a Direct Support/Service Professional employed by a Provider or Participant to provide Personal Assistance Services (Instrumental Activities of Daily Living or Activities of Daily Living) or Respite Services to a Relative in such Relative's home until December 31, 2021 or until such time as the Centers for Medical and Medicaid Services (CMS) issue federal directives on the application of mandatory vaccines to such individuals, whichever occurs first. The term "Direct Care Worker" may have the definition provided in 28 PA. Code 611.5 or 55 PA. Code 52.3, depending upon employing entity and services provided. 5. Exemptions - An individual may not simply opt out of vaccination. The must submit a medical or religions exemption to the Healthcare Institution where such individual works according to policies set by the Institution. Healthcare Institutions and organizations that are granting exemptions must create appropriate exemption policies to implement this regulation. Healthcare Institutions are required to keep records of vaccination status of all vaccinated individuals, exemptions requested and granted, and participation in accommodations granted."

The City of Philadelphia Updates to Vaccination and Masking Requirements for Healthcare Workers dated October 5, 2022 states that healthcare institutions are no longer required to perform asymptomatic screening testing of exempt individuals.

A review of PF's was conducted on February 26, 2024 at approximatley 11:52 am.

PF#1 Date of Hire 3/1/22 did not contain evidence that COVID-19 vaccination had been received, nor was there evidence of a religious exemption being granted by the agency, nor a medical exemption being granted by a medical provider. Direct care worker providing services in Philadelphia County.

PF#5 Date of Hire 6/16/23 did not contain evidence that COVID-19 vaccination had been received, nor was there evidence of a religious exemption being granted by the agency, nor a medical exemption being granted by a medical provider. Direct care worker providing services in Philadelphia County.

PF#6 Date of Hire 2/1/24 did not contain evidence that COVID-19 vaccination had been received, nor was there evidence of a religious exemption being granted by the agency, nor a medical exemption being granted by a medical provider. Direct care worker providing services in Philadelphia County.

An interview conducted with the administrator on February 26, 2024 at 12:54 pm confirmed the above findings.














Plan of Correction:

In order to correct and comply with POC 0120, 611.4 Licensure requirements regarding The Vaccine Mandate Regulation, CLS has created a policy in accordance with The City of Philadelphia.

CLS COVID-19 Vaccine Policy

All Caring Life Services, Inc. Personal Care workers are required to receive at least one dose of their initial COVID-19 Vaccine series prior to beginning employment.
Any employee who is symptomatic must continue to test, regardless of vaccination status.

Exemptions
CLS employees may not simply opt out of vaccination. They must submit a medical or religious exemption to the Managing Director of CLS. CLS will determine if an exemption applies..
A CLS Personal Care worker may request a medical exemption by submitting a certification from a licensed healthcare provider to CLS. Medical exemptions must include a statement signed by a licensed healthcare provider (physician, Nurse or physician's assistant) that states the exemption applies to the specific individual submitting the certification because the COVID-19 vaccine is medically contraindicated for the individual. The certification must also be signed by the Personal Care Worker.

Religious
CLS Personal Care Worker may request an exemption by submitting a signed statement in writing that the individual has a sincerely held religious belief that prevents them from receiving the COVID-19 vaccination. An institution may request the worker explain in the certification why the worker's religious belief prevents them receiving the COVID-19 vaccine.

Philosophical or moral exemptions are not permitted.

Testing
Screening testing is no longer required.
a. Any CLS employee with even mild symptoms of COVID-19, regardless of vaccination status, should receive a viral test as soon as possible.
b. Asymptomatic patients with close contact with someone with SARS-CoV-2 infection, regardless of vaccination status, should have a series of three viral tests for SARS-CoV-2 infection, each 48 hours apart.
C. CLS employees with high-risk exposures and those who have tested positive must test again if symptoms develop at any time after previous infection resolves. If unable to find a test, a symptomatic employee should assume that they are positive and isolate.
d If positive, the individual must isolate.
E. When CLS chooses to allow employees to use a rapid-antigen/at-home test, CLS requires that A CLS representative be present with employee for the test to be performed prior to a shift so that CLS can verify the employee's result. If positive, the individual must isolate.
Masking
Masking is not required for Personal Care Workers, but CLS recommends and supplies masks as apart of CLS Personal Care Workers standard uniform.

Vaccination Records
CLS will maintain all employee's vaccination records and exemption records in each employee's file. These records will not include any confidential information such as names, dates of birth, social security numbers, or employee identification numbers.

All vaccinations records will include numbers of fully, partially, unvaccinated and vaccination status unknown staff/contractors; and numbers of staff/contractors with medical or religious exemptions.
When CLS is performing rapid testing under a CLIA certificate or waiver, positive results need to be reported to PDPH within 24 hours of result. Results will be reported directly via a REDCap Database or by exporting a standardized file from an EHR or other data collection system and sending via a secure File Transfer Protocol (sFTP).

If CLS is not performing the testing, CLS does not need to report the results to PDPH. The results will be reported directly to PDPH by the lab or provider.

When an employee is performing a CLS supervised over-the-counter test, all positive and negative COVID test results will be documented and recorded into the testing logs and made available to PDPH upon request.

CLS will also have the employee application located in the Bolt electronic system updated to include a request for COVID-19 Vaccination for all CLS Personal Care Workers.

CLS will notify all employees who do not have proof of Covid-19 Vaccinations or exemptions by phone, Email and text. They will be given 30days to provide CLS proof of Covid-19 Vaccinations or exemptions.

CLS will include the title of Covid-19 Vaccine (Dates received or Exempt) to the Checklist located in the front of each employees file to assure that CLS has obtained documetation of the employees Covid-19 Vaccination or the employees exempt status.

In order to assure these corrections and policy are sustained the Human Resource coordinator will audit, date & sign all employee files for accuracy every quarter.


611.51(a) LICENSURE
Hiring or Rostering Prerequisites

Name - Component - 00
Prior to hiring or rostering a direct care worker, the home care agency or home care registry shall: (1) Conduct a face-to-face interview with the individual. (2) Obtain not less than two satisfactory references for the individual. A satisfactory reference is a positive, verifiable reference, either verbal or written, from a former employer or other person not related to the individual that affirms the ability of the individual to provide home care services. (3) Require the individual to submit a criminal history report, in accordance with the requirements of 611.52 (relating to criminal background checks), and a ChildLine verification, if applicable, in accordance with the requirements of 611.53 (relating to child abuse clearance).

Observations:

Based on a review of personnel files (PF) and an interview with the administrator, the agency failed to provide documentation of obtaining two satisfactory and verifiable references for three (3) of the six (6) PF's, (PF # 2, 5 and 6).

Findings include:

A review of PF's was conducted on February 26, 2024 at approximately 11:35 am.

PF # 2 Date of Hire 4/3/23 did not contain any documentation of two satisfactory and verifiable references.

PF #5 Date of Hire 6/16/23 did not contain any documentation of two satisfactory and verifiable references.

PF # 6 Date of Hire 2/1/24 did not contain any documentation of two satisfactory and verifiable references.

An interview with the administrator on February 26, 2024 at approximately 12:30 pm confirmed the above findings.







Plan of Correction:

To correct citation 0200 to match required policy under PA Code 611.51 (a) (1). CLS will conduct and audit all files, Human Resource will contact each employee whose files are missing the two required satisfactory and verifiable reference(s) to notify them that they must provide the required verifiable references within the next 10 days.

(1)CLS will request BOlt to update our employee electronic employee application to include the request for two appropriate verifiable references.

(2) Human resource will review the check list form in the front of each employees file to confirm all required hiring documents have been obtained. This review is to be conducted after the Application is completed & prior to employee ID pick up.


In order to assure these corrections and policy are sustained the Human Resource Coordinator will audit, date & sign all employee files for accuracy every quarter.


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 personnel files (PF), recommendations from the Centers for Disease Control (CDC), an interview with the administrator the agency did not contain documentation using a two-step tuberculin skin test (TST) of a single blood assay for tuberculosis (TB) to test for infection with tuberculosis for five (5) of six (6) PF's, (PF # 1, 3, 4, 5 and 6). Also the agency did not contain documentation that the individual had completed symptom screen questionnaire and an individual TB risk assessment for six (6) of six (6) PF's, (PF # 1, 2, 3, 4, 5 and 6). The agency did not contain documentation that the individual had completed annual TB education for three (3) of six (6) PF's, (PF # 1, 3 and 4).

Findings include:

The CDC guidelines state that all Health Care Workers (HCW) should received 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) http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf.

*Baseline (preplacement) screening and testing, in addition to the IGRA (interferon-gamma release assay) or TST, shall include a symptom screen questionnaire and an individual TB risk assessment. Serial screening and testing not routinely recommended. Annual TB education is recommended. (CDC/MMWR/May 17, 2019/Vol. 68/No. 19).

A review of PF's was conducted on February 26, 2024 at approximately 10:50 am.

PF # 1 Date of Hire 3/1/22, did not contain documentation using a two-step tuberculin skin test (TST) of a single blood assay for tuberculosis (TB) to test for infection with tuberculosis. Also did not contain documentation of completion of a tuberculosis (TB) symptom screen questionnaire nor a TB risk assessment upon hire. Did not contain any documentation of a completed annual TB education for 2023.

PF # 2 Date of Hire 4/3/23 did not contain documentation of completion of a tuberculosis (TB) symptom screen questionnaire nor a TB risk assessment upon hire.

PF # 3 Date of Hire 1/19/22, did not contain documentation using a two-step tuberculin skin test (TST) of a single blood assay for tuberculosis (TB) to test for infection with tuberculosis. Also did not contain documentation of completion of a tuberculosis (TB) symptom screen questionnaire nor a TB risk assessment upon hire. Did not contain any documentation of a completed annual TB education for 2023 and 2024.

PF # 4 Date of Hire 6/30/22, did not contain documentation using a two-step tuberculin skin test (TST) of a single blood assay for tuberculosis (TB) to test for infection with tuberculosis. Also did not contain documentation of completion of a tuberculosis (TB) symptom screen questionnaire nor a TB risk assessment upon hire. Did not contain any documentation of a completed annual TB education for 2023.

PF # 5 Date of Hire 6/16/23 did not contain documentation using a two-step tuberculin skin test (TST) of a single blood assay for tuberculosis (TB) to test for infection with tuberculosis. Also did not contain documentation of completion of a tuberculosis (TB) symptom screen questionnaire nor a TB risk assessment upon hire.

PF # 6 Date of Hire 2/1/24 did not contain documentation using a two-step tuberculin skin test (TST) of a single blood assay for tuberculosis (TB) to test for infection with tuberculosis. Also did not contain documentation of completion of a tuberculosis (TB) symptom screen questionnaire nor a TB risk assessment upon hire.

An interview conducted with the administrator on February 26, 2024 starting at 12:44 pm confirmed the above findings.















Plan of Correction:

In order to correct the POC 0701 documented deficiency regarding 611.56 (a) In order to prevent a recurrence from happening. the title Health screening signature spot will be added to CLS Bolt electronic employee application.

Human Resource Coordinator will require that all new employees complete, turn in and sign off on the health screening verifying that all employee's have received a two-step tuberculin skin test (TST) of a single blood assay for tuberculosis (TB) to test for infection with tuberculosis, a tuberculosis (TB) symptom screen questionnaire two-step Tuberculin Skin Test (TST) and a a TB risk assessment upon hire before an HHA Assignment id and CLS employee id can be assigned. Current employees will be required to answer the health screening questionnaire during their yearly evaluation before a raised can be given.


611.57(c) LICENSURE
Information to be Provided

Name - Component - 00
(c) Prior to the commencement of services, the home care agency or home care registry shall provide to the consumer, the consumer's legal representative or responsible family member an information packet containing the following information in a form that is easily read and understood: (1) A listing of the available home care services that will be provided to the consumer by the direct care worker and the identity of the direct care worker who will provide the services. (2) The hours when those services will be provided. (3) Fees and total costs for those services on an hourly or weekly basis. (4) Who to contact at the Department for information about licensure requirements for a home care agency or home care registry and for compliance information about a particular home care agency or home care registry. (5) The Department's complaint Hot Line (1-800-254-5164) and the telephone number of the Ombudsman Program located with the local Area Agency on Aging (AAA). (6) The hiring and competency requirements applicable to direct care workers employed by the home care agency or referred by the home care registry. (7) A disclosure, in a format to be published by the Department in the Pennsylvania Bulletin by February 10, 2010, addressing the employee or independent contractor status of the direct care worker providing services to the consumer, and the resultant respective tax and insurance obligations and other responsibilities of the consumer and the home care agency or home care registry.

Observations:

Based on a review of consumer files (CF) and an interview with the administrator, the agency failed to provide documentation to consumer providing: The telephone number of the Ombudsman Program located with the local Area Agency on Aging (AAA) for nine (9) of nine (9) CF's, (CF # 1, 2, 3, 4, 5, 6, 7, 8 and 9).

Findings include:

A review of CF's was conducted on February 26, 2024 at approximately 11: 04 am.

CF #1, Start of Care: 11/9/21, did not contain any documentation stating the telephone number of the Ombudsman Program located with the local Area Agency on Aging (AAA).

CF #2, Start of Care: 2/8/24, did not contain any documentation stating the telephone number of the Ombudsman Program located with the local Area Agency on Aging (AAA).

CF #3, Start of Care: 4/4/22, did not contain any documentation stating the telephone number of the Ombudsman Program located with the local Area Agency on Aging (AAA).

CF #4, Start of Care: 12/19/23, did not contain any documentation stating the telephone number of the Ombudsman Program located with the local Area Agency on Aging (AAA).

CF #5, Start of Care: 1/22/22, did not contain any documentation stating the telephone number of the Ombudsman Program located with the local Area Agency on Aging (AAA).

CF #6, Start of Care: 12/18/23, did not contain any documentation stating the telephone number of the Ombudsman Program located with the local Area Agency on Aging (AAA).

CF #7, Start of Care: 1/21/24, did not contain any documentation stating the telephone number of the Ombudsman Program located with the local Area Agency on Aging (AAA).

CF #8, Start of Care: 1/9/24, did not contain any documentation stating the telephone number of the Ombudsman Program located with the local Area Agency on Aging (AAA).

CF #9, Start of Care: 5/5/21, did not contain any documentation stating the telephone number of the Ombudsman Program located with the local Area Agency on Aging (AAA).

An interview with the administrator on February 26, 2024 at approximately 11:25 am confirmed the above findings.









Plan of Correction:

POC 0820 CLS Consumer Liason will audit each CLS's consumers file to confirm it contains a copy of the Ombudsmans contact information that each consumer received advising them that an ombudsman is a person who will be appointed to look into complaints about companies and organisation. (including CLS) and to assure consumers Ombudsmans schemes are independent, free and impartial and they don't take sides.

CLs consumer Liason will contact any consumer whose file does not include Ombudsman information to confirm that they were made aware of thier rights to an Ombudsman and to be given the Ombudsmans contact information should the consumer desire to contact an Ombudsman.

This will be completed in 30days

Office of the State Long-Term Care Ombudsman
Pennsylvania Department of Aging
555 Walnut Street, 5th floor
Harrisburg, PA 17101-1919
717-783-8975


Initial Comments:

Based on the findings of an onsite home care agency state re-licensure survey conducted on February 26, 2024, Caring Life Services Inc., was found to be in compliance with the requirements of 35 P.S. 448.809 (b).







Plan of Correction: