QA Investigation Results

Pennsylvania Department of Health
CAREGIVERS AMERICA SE
Health Inspection Results
CAREGIVERS AMERICA SE
Health Inspection Results For:


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Initial Comments:

Based on the findings of an unannounced onsite Medicare recertification survey conducted April 27, 2021 through April 29, 2021, and offsite on May 3, 2021, Caregivers America SE, 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 Correction:




484.105(b)(1)(ii)  ELEMENT
Responsible for all day-to-day operations

Name - Component - 00
(ii) Be responsible for all day-to-day operations of the HHA;

Observations:


Based on review of agency policy, agency job descriptions, personnel files (PF), the Centers for Disease Control Guidelines, and an interview with the director of nursing , the agency failed to adhere to agency policy by not ensuring that the appropriate job description was contained within the PF for four (4) of ten (10) PF reviewed (PF #1, 7, 9, and 10); failed to ensure job description qualifications for CPR certification were followed for three (3) of ten (10) PF reviewed (PF #8, 9, and 10); failed to ensure personnel policies pertaining to orientation were followed for two (2) of ten (10) PF reviewed (PF # 8 and 9); failed to ensure personnel policies pertaining to background checks were followed for six (6) of ten (10) PF reviewed (PF #5, 6, 7, 8, 9, and 10); failed to ensure personnel policies pertaining to annual performance evaluations were followed for ten (10) of ten (10) (PF #1, 2, 3, 4, 5, 6, 7, 8, 9, and 10); failed to ensure personnel policies pertaining to competency evaluations were followed for three (3) of ten (10) PF reviewed. (PF #3, 6, and 10); and failed to ensure personnel policies pertaining to health screening for employment were followed for eight (8) of ten (10) PF reviewed, (PF #3, 4, 5, 6, 7, 8, 9, and 10).

Findings Included:

A review of agency policy "Employee Orientation" was conducted on May 3, 2021 at approximately 10:50 am. Policy states, "Each employee of CareGivers America who provides direct care, supervision of direct care, or management of services, will participate in an orientation program specific to his/her educational background and experience, type of care provided, physical and mental conditions of patients, and the roles and responsibilities as an employee of CareGivers America. Orientation will be provided by an Administrator-appointed qualified employee or staff member...Special Instructions:...17. Reviewof individuals job description, duties to be performed and their role in CareGivers America..."

A review of Licensed Practical Nurse (LPN) job description was completed on April 28, 2021 at approximately 12:00 pm. Job description states, "Position Qualifications:...4. CPR certified..."

A review of agency policy "Employment Policy" was conducted on May 3, 2021 at approximately 11:00 am. Policy states, "Policy: The agency seeks to hire individuals who meet the highest standards of character and subscribe to the purpose and goals of the agency. All employment practices are to be consistent with applicable laws and other such acts and regulations that control the employment relationship...The following requirments must be met after the candidate has accepted a job offer: 1. Criminal Background Check 2. Child Abuse Clearance 3 FBI Fingerprint Check..."

A review of agency policy "Child Abuse Clearance" was conducted on May 3, 2021 at approximately 11:05 am. Policy states, "All Home Health employees that will be working with or involved with a pediatric client must satisfactorily clear a Child Abuse Clearance check prior to starting work with pediatric patients..."

A review of agency policy "FBI Fingerprint Check" was conducted on May 3, 2021 at approximately 11:10 am. Policy states, "All Home Health employees must satisfactorily clear an FBI Fingerprint Based Background check during the orientation process..."

A review of agency policy "Competency Assessment B-115" was conducted on May 3, 2021 at approximately 11:15 am. Policy states, "Competency of all staff will be assessed during the interview process, orientation program and ongoing throughout employment. (Direct Care Staff will be assessed for competencies annually). Assessments of competency will be a component of the annual performance review..."

A review of agency policy "Performance Appraisal" was conducted on May 3, 2021 at approximately 11:20 am. Policy states, "All agency employees are required to have an annual performance appraisal. These performance appraisals will vary according to the status in which the person has been employed by the agency, and will be scheduled within a time frame related to the employee's date of hire..."

A review of agency policy "Health Screening" was conducted on April 30, 2021 at approximately 2:30 pm. Policy states, "Procedure: 1. Upon hire, the agency requires evidence that the individual is free of TB (tuberculosis). 2. The agency can accept evidence of previous TB screenings This protocol will be considered met if the following evidence can be provided: a. Evidence of a negative two-step PPD screening, both steps having been performed within one year of the date of hire....b. Evidence of a negative TB blood test performed within one year of the date of hire...c. Evidence of previous chest x-ray may be accepted by the agency...d. Evidence of a negative one-step PPD test performed within one year of hire may be accepted by the agency...3. If an applicant or employee does not have evidence of previous screenings within one year, the agency may accept the following to have met this protocol: a. A negative two-step PPD test....b. A negative TB blood test performed at hire...c. If the employee or applicant has tested positive for TB in blood or skin tests in the past, but does not have evidence of a chest x-ray or other approved test, the employee should be sent for a chest x-ray at a company approved screening location. Additionally, the applicant or employee must complete a screening Questionnaire to confirm that they are free of signs and symptoms of TB...4. Annually, the agency Quality Manager or other appropriate staff, must conduct a risk assessment review for all counties serviced by the agency...If the agency is found to be low risk in a county, all employees in that county will be required to complete a screening questionnaire confirming they are free from signs and symptoms of TB upon their annual evaluation...C. Hepatitis B Vaccine: The Hepatitis B vaccine and vaccination series shall be made available to all employees who are at risk for exposure to blood and body fluids/substance. This vaccine must be provided at no cost to the employee and acceptance or refusal of the vaccine must be documented..."

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) or 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.

A review of PF's conducted on April 28, 2021 from approximately 10:00 am to 11:30 am revealed the following:

PF #1, Date of Hire: 10/20/08, did not contain any documentation of a job description; and did not contain any documentation of an annual performance evaluation for 2018, 2019, or 2020.

PF#2, Date of Hire: 10/26/09, did not contain documentation of an annual performance evaluation for 2018, 2019, or 2020.

PF#3, Date of Hire: 9/11/17, did not contain documentation of an annual competency evaluation for 2019 or 2020; did not contain any documentation of an annual performance evaluation for 2019 or 2020; contained documentation of only a one-step tuberculin skin test at hire; and did not contain any documentation of annual tuberculosis symptom screening for 2019 or 2020.

PF#4, Date of Hire: 6/29/17, did not contain any documentation of an annual performance evaluation for 2018, 2019, or 2020; did not contain any documentation of annual tuberculosis symptom screening for 2018, 2019, or 2020.

PF #5, Date of Hire: 3/27/18, did not contain any documentation of a FBI Fingerprint Check; did not contain any documentation of an annual performance evaluation for 2019, 2020, or 2021; did not contain any documentation of a two-step tuberculin skin test at hire; and did not contain any documentation of having received or declined Hepatitis B vaccination.

PF #6, Date of Hire: 10/18/18, did not contain any documentation of a FBI Fingerprint Check; did not contain any documentation of annual competency evaluations for 2019 or 2020; annual performance evaluations for 2019 or 2020, and did not contain any documentation of an annual tuberculosis symptom screening for 2020.

PF #7, Date of Hire: 12/11/19, did not contain any documentation of a FBI Fingerprint Check; did not contain a job description for home health aide; did not contain any documentation of a Child Abuse Clearance; did not contain any documentation of an annual performance evaluation for 2020; did not contain any documentation of having received or declined Hepatitis B vaccination; did not contain any documentation of a two-step tuberculin skin test at hire and did not contain any documentation of an annual tuberculosis symptom screening for 2020.

PF #8, Date of Hire: 4/16/19, did not contain any documentation of a FBI Fingerprint Check; did not contain any documentation of a current CPR certification; did not contain any documentation of agency orientation; did not contain any documentation of an annual performance evaluation for 2020; did not contain any documentation of of having received or declined Hepatitis B vaccination; and did not contain any documentation of a two-step tuberculin skin test at hire.

PF #9, Date of Hire: 11/17/2020, did not contain any documentation of a FBI Fingerprint Check; did not contain any documentation of a job description; did not contain any documentation of current CPR certification; did not contain any documentation of agency orientation; did not contain any documentation of of having received or declined Hepatitis B vaccination; and did not contain any documentation of an annual tuberculosis symptom screening for 2021.

PF #10, Date of Hire: 9/22/15, did not contain any documentation of a FBI Fingerprint Check; did not contain any documentation of a job description; did not contain any documentation of a Child Abuse Clearance; did not contain any documentation of current Licensed Practical Nursing licensure for the state of Pennsylvania; did not contain any documentation of current CPR certification; did not contain any documentation of annual performance evaluations for 2018, 2019, or 2020; and did not contain any documentation of annual tuberculosis symptom screening for 2018 or 2019.

An interview with the director of nursing on April 29, 2021, at approximately 12:00 pm confirmed the above findings.






Plan of Correction:

In-service completed on 5/7/2021 at Orthodox St location reviewed hiring policy including job description, orientation checklist, CPR certification, background checks, HHA training and health screenings (including PPD), with Care Coordinator S.C.

In-service completed on 5/7/2021 at Orthodox St location with RN Case Managers P.R. H.G and E.H. to re-educate staff on performance evaluation policy, initial competency and annual competency policies.

All employee files to be reviewed for compliance with Agency policies, DOH and CMS regulations by 6/30/2021. Once compliance is achieved, 10% of employee files will be reviewed quarterly for continued compliance with a goal of 90% compliance.

All employees to be entered into Netsmart by 6/30/2021. Expired credentials report to be pulled the first week of every month. Care Coordinator to be notified of expired credentials and complete follow-up. RN Case Managers to be notified of competency and performance evaluations due.

Administrator will ensure compliance going forward.



Initial Comments:

Based on the findings of an onsite unannounced Medicare recertification survey conducted April 27, 2021 through April 29, 2021, and offsite on May 3, 2021, Caregivers America SE, was found not to be in compliance with the requirements of 42 CFR, Part 484.22, Subpart B, Conditions of Participation: Home Health Agencies - Emergency Preparedness.







Plan of Correction:




484.102(a)(1)-(2) STANDARD
Plan Based on All Hazards Risk Assessment

Name - Component - 00
403.748(a)(1)-(2), 416.54(a)(1)-(2), 418.113(a)(1)-(2), 441.184(a)(1)-(2), 460.84(a)(1)-(2), 482.15(a)(1)-(2), 483.73(a)(1)-(2), 483.475(a)(1)-(2), 484.102(a)(1)-(2), 485.68(a)(1)-(2), 485.625(a)(1)-(2), 485.727(a)(1)-(2), 485.920(a)(1)-(2), 486.360(a)(1)-(2), 491.12(a)(1)-(2), 494.62(a)(1)-(2)

[(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:]

(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.*

(2) Include strategies for addressing emergency events identified by the risk assessment.

* [For Hospices at 418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
(2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care.

*[For LTC facilities at 483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following:
(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents.
(2) Include strategies for addressing emergency events identified by the risk assessment.

*[For ICF/IIDs at 483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:

(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients.
(2) Include strategies for addressing emergency events identified by the risk assessment.

Observations:



Based on an interview with the director of nursing, review of agency policy, and the agency's emergency preparedness plan, the agency failed to base the emergency preparedness plan on and to include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.

Findings:

A review of agency policy "Emergency Management Policy and Disaster Plan" was conducted on April 28, 2021 at approximately 12:30 pm. Policy states, "Instructions:...2. Agency will complete a Hazard Vulnerability Assessment (HVA) annually..."

A review of the agency emergency preparedness plan was conducted on at approximately April 28, 2021 at approximately 12:30 pm revealed no documentation that the emergency preparedness plan was based on and included a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.

Interview with the director of nursing on April 29, 2021 at approximately 12:00 pm confirmed the above findings.


















Plan of Correction:

A Hazard Vulnerability Assessment is reviewed annually by the Emergency Preparedness Committee. It is updated upon review and as needed. The Agency has records of the annual reviews in the EP Committee meeting minutes (typically held each November). The last committee meeting, with HVA review, was held on 11/17/2020. The record of the meetings was inadvertently not presented during the survey. The Agency will continue to have annual review of the HVA at EP Committee meetings.
Administrator will ensure compliance going forward.



484.102(c)(2) STANDARD
Emergency Officials Contact Information

Name - Component - 00
403.748(c)(2), 416.54(c)(2), 418.113(c)(2), 441.184(c)(2), 460.84(c)(2), 482.15(c)(2), 483.73(c)(2), 483.475(c)(2), 484.102(c)(2), 485.68(c)(2), 485.625(c)(2), 485.727(c)(2), 485.920(c)(2), 486.360(c)(2), 491.12(c)(2), 494.62(c)(2).

[(c) The [facility] must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:

(2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.

*[For LTC Facilities at 483.73(c):] (2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) The State Licensing and Certification Agency.
(iii) The Office of the State Long-Term Care Ombudsman.
(iv) Other sources of assistance.

*[For ICF/IIDs at 483.475(c):] (2) Contact information for the following:
(i) Federal, State, tribal, regional, and local emergency preparedness staff.
(ii) Other sources of assistance.
(iii) The State Licensing and Certification Agency.
(iv) The State Protection and Advocacy Agency.

Observations:



Based on a review of agency policy, agency's emergency preparedness plan, and an interview with the director of nursing, it was determined the agency failed to establish and maintain an emergency preparedness communication plan that included contact information for local/regional/state/federal emergency preparedness staff.

Findings included:

Review of the agency policy "Emergency Management Policy and Disaster Plan" was conducted on April 28, 2021 at approximately 12:30 pm. Policy states, "Instructions:...14. In the event of an emergency, every effort will be made by the agency to provide vehicles or transportation of employees to patient homes. State and local officials (local 911, police, sheriff, and/or emergency management offices) will be notified of patients with specific and imminent needs requiring services from agency staff..."

Review of agency's emergency preparedness plan on April 28, 2021 at approximately 12:30 pm, revealed no documentation of a communication plan that included contact information for local/regional/state/federal emergency preparedness staff.

An interview with the director of nursing on April 29, 2021 at approximately 12:00 pm confirmed the above findings.












Plan of Correction:

We have a Company wide Home Health Emergency Preparedness Committee, with representation from the Orthodox St office. The committee has a shared folder that contains the aforementioned HVA and meeting minutes. In addition, the folder contains a list of the PA Emergency Management Coordinators. The list was missing some county contacts, the list was updated on 5/12/2021 and contains contacts for every county in PA. The list is accessible to print and view electronically. The Agency will ensure that the list is updated annually at the Committee meeting.
Administrator will ensure compliance going forward.



484.102(d) STANDARD
EP Training and Testing

Name - Component - 00
403.748(d), 416.54(d), 418.113(d), 441.184(d), 460.84(d), 482.15(d), 483.73(d), 483.475(d), 484.102(d), 485.68(d), 485.625(d), 485.727(d), 485.920(d), 486.360(d), 491.12(d), 494.62(d).

*[For RNCHIs at 403.748, ASCs at 416.54, Hospice at 418.113, PRTFs at 441.184, PACE at 460.84, Hospitals at 482.15, HHAs at 484.102, CORFs at 485.68, CAHs at 486.625, "Organizations" under 485.727, CMHCs at 485.920, OPOs at 486.360, and RHC/FHQs at 491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years.

*[For LTC facilities at 483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually.

*[For ICF/IIDs at 483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at 483.470(i).

*[For ESRD Facilities at 494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years.

Observations:


Based on a review of agency policy, emergency preparedness documentation, and an interview with the director of nursing, the agency failed to develop and maintain an emergency preparedness plan training and testing program that was reviewed and updated at least every two (2) years, which includes the time period prior to the Covid-19 pandemic.

Findings Included:

Review of agency policy "Emergency Management Policy and Disaster Plan" on April 28, 2021, at approximately 12:30 pm states, "Instructions: 4. All staff members will be oriented to the emergency preparedness plan/risk assessment and their associated responsibilities consistent with their roles in an emergency. Reviews will be held annually, through ongoing education programs, in order to demonstrate staff knowledge. Documentation of all emergency preparedness training will be maintained..."

Review of agency emergency preparedness documentation on April 28, 2021, at approximately 12:30 pm revealed no documentation of an emergency preparedness plan training or testing program completed annually in accordance with agency policy.

Interview with the director of nursing on April 29, 2021, at approximately 12:00 pm confirmed the above findings.



















Plan of Correction:

CareGivers America SE location including field staff will complete the annual inservice: Emergency Preparedness/Disaster Education by June 1, 2021. This education will be completed annually and verified as complete by the Care Coordinator.
Administrator will ensure compliance going forward.




484.102(d)(2) STANDARD
EP Testing Requirements

Name - Component - 00
416.54(d)(2), 418.113(d)(2), 441.184(d)(2), 460.84(d)(2), 482.15(d)(2), 483.73(d)(2), 483.475(d)(2), 484.102(d)(2), 485.68(d)(2), 485.625(d)(2), 485.727(d)(2), 485.920(d)(2), 491.12(d)(2), 494.62(d)(2).

*[For ASCs at 416.54, CORFs at 485.68, OPO, "Organizations" under 485.727, CMHCs at 485.920, RHCs/FQHCs at 491.12, and ESRD Facilities at 494.62]:

(2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following:

(i) Participate in a full-scale exercise that is community-based every 2 years; or
(A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or
(B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed.

*[For Hospices at 418.113(d):]
(2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following:
(i) Participate in a full-scale exercise that is community based every 2 years; or
(A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or
(B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.

(3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or
(B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed.


*[For PRFTs at 441.184(d), Hospitals at 482.15(d), CAHs at 485.625(d):]
(2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or
(B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed.

*[For PACE at 460.84(d):]
(2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or
(B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed.

*[For LTC Facilities at 483.73(d):]
(2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise.
(B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed.

*[For ICF/IIDs at 483.475(d)]:
(2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following:
(i) Participate in an annual full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or.
(B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event.
(ii) Conduct an additional annual exercise that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed.

*[For HHAs at 484.102]
(d)(2) Testing. The HHA must conduct exercises to test the emergency plan at
least annually. The HHA must do the following:
(i) Participate in a full-scale exercise that is community-based; or
(A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or.
(B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event.
(ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed.

*[For OPOs at 486.360]
(d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following:
(i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event.
(ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed.

*[ RNCHIs at 403.748]:
(d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following:
(i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed.

Observations:



Based on review of agency policy, emergency preparedness documentation, and interview with the director of nursing, the agency failed to conduct exercises to test the emergency plan at least annually and failed to conduct a full-scale community-based or facility-based functional exercise annually.

Findings include:

Review of agency policy "Emergency Management Policy and Disaster Plan" on April 28, 2021 at approximately 12:30 pm states,"Instructions:...3. Agency will conduct 2 drills each year. Agency employees will actively participate in EDP practice drills, both internal and community-wide drills. EDP drills are carried out to evaluate staff knowledge of role(s) in plan implementation and to assess plan effectiveness. a. Full-scale exercise that is community-based or when a community based exercise is not accessible, an individual, facility-based. If the facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the facility is exempt from engaging in a community-based or individual, facility-based full-scale exercise for 1 year following the onset of the actual event. b. Additional exercise that may include, but is not limited to the following: i. A second full-scale exercise that is community-based or individual, facility-based. ii. A tabletop exercise that includes a group discussion led by a facilitator, using narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. c. Agency will maintain documentation of the drills and/or emergency events. Agency will complete an after action review to analyze agency response and revise the emergency plan as needed. Documentation of after action reviews will also be maintained. Reviews can address, but are not limited to, the following: what was supposed to happen, what occurred, what went well, opportunities for improvement, and plan for incorporating improvements..."

Review of the emergency preparedness documentation on April 28, 2021 at approximately 12:30 pm revealed no evidence of exercises conducted to test the emergency plan annually and there was no documentation of a full-scale, community-based exercise or a facility-based functional exercise conducted annually.

Interview with the director of nursing on April 29, 2021, at 12:00 pm confirmed the above findings.











Plan of Correction:

The incorrect Emergency Preparedness file was presented at time of survey. The correct file includes a full scale exercise on 6/17/2019, an actual emergency of a ransomware attack on 11/29/2019 and an actual emergency of Covid-19 emergency in 2020. CGA is scheduled for a table-top exercise on May 25, 2021.
Administrator will ensure compliance going forward.



Initial Comments:

Based on the findings of an unannounced onsite state re-licensure survey conducted April 27, 2021 through April 29, 2021, and offsite on May 3, 2021, Caregivers America SE, was found not to be in compliance with the requirements of 28 Pa. Code, Part IV, Health facilities, Subpart G. Chapter 601.








Plan of Correction:




601.21(f) REQUIREMENT
PERSONNEL POLICIES

Name - Component - 00
601.21(f) Personnel Policies.
Personnel practices and patient care
are supported by appropriate, written
personnel policies. Personnel records
include qualifications, licensure,
performance evaluations, health
examinations, documentation of
orientation provided, and job
descriptions, and are kept current.

Observations:



Based on review of agency policy, agency job descriptions, personnel files (PF), the Centers for Disease Control Guidelines, and an interview with the director of nursing , the agency failed to adhere to agency policy by not ensuring that the appropriate job description was contained within the PF for four (4) of ten (10) PF reviewed (PF #1, 7, 9, and 10); failed to ensure job description qualifications for CPR certification were followed for three (3) of ten (10) PF reviewed (PF #8, 9, and 10); failed to ensure personnel policies pertaining to orientation were followed for two (2) of ten (10) PF reviewed (PF # 8 and 9); failed to ensure personnel policies pertaining to background checks were followed for six (6) of ten (10) PF reviewed (PF #5, 6, 7, 8, 9, and 10); failed to ensure personnel policies pertaining to annual performance evaluations were followed for ten (10) of ten (10) (PF #1, 2, 3, 4, 5, 6, 7, 8, 9, and 10); failed to ensure personnel policies pertaining to competency evaluations were followed for three (3) of ten (10) PF reviewed. (PF #3, 6, and 10); and failed to ensure personnel policies pertaining to health screening for employment were followed for eight (8) of ten (10) PF reviewed, (PF #3, 4, 5, 6, 7, 8, 9, and 10).

Findings Included:

A review of agency policy "Employee Orientation" was conducted on May 3, 2021 at approximately 10:50 am. Policy states, "Each employee of CareGivers America who provides direct care, supervision of direct care, or management of services, will participate in an orientation program specific to his/her educational background and experience, type of care provided, physical and mental conditions of patients, and the roles and responsibilities as an employee of CareGivers America. Orientation will be provided by an Administrator-appointed qualified employee or staff member...Special Instructions:...17. Reviewof individuals job description, duties to be performed and their role in CareGivers America..."

A review of Licensed Practical Nurse (LPN) job description was completed on April 28, 2021 at approximately 12:00 pm. Job description states, "Position Qualifications:...4. CPR certified..."

A review of agency policy "Employment Policy" was conducted on May 3, 2021 at approximately 11:00 am. Policy states, "Policy: The agency seeks to hire individuals who meet the highest standards of character and subscribe to the purpose and goals of the agency. All employment practices are to be consistent with applicable laws and other such acts and regulations that control the employment relationship...The following requirments must be met after the candidate has accepted a job offer: 1. Criminal Background Check 2. Child Abuse Clearance 3 FBI Fingerprint Check..."

A review of agency policy "Child Abuse Clearance" was conducted on May 3, 2021 at approximately 11:05 am. Policy states, "All Home Health employees that will be working with or involved with a pediatric client must satisfactorily clear a Child Abuse Clearance check prior to starting work with pediatric patients..."

A review of agency policy "FBI Fingerprint Check" was conducted on May 3, 2021 at approximately 11:10 am. Policy states, "All Home Health employees must satisfactorily clear an FBI Fingerprint Based Background check during the orientation process..."

A review of agency policy "Competency Assessment B-115" was conducted on May 3, 2021 at approximately 11:15 am. Policy states, "Competency of all staff will be assessed during the interview process, orientation program and ongoing throughout employment. (Direct Care Staff will be assessed for competencies annually). Assessments of competency will be a component of the annual performance review..."

A review of agency policy "Performance Appraisal" was conducted on May 3, 2021 at approximately 11:20 am. Policy states, "All agency employees are required to have an annual performance appraisal. These performance appraisals will vary according to the status in which the person has been employed by the agency, and will be scheduled within a time frame related to the employee's date of hire..."

A review of agency policy "Health Screening" was conducted on April 30, 2021 at approximately 2:30 pm. Policy states, "Procedure: 1. Upon hire, the agency requires evidence that the individual is free of TB (tuberculosis). 2. The agency can accept evidence of previous TB screenings This protocol will be considered met if the following evidence can be provided: a. Evidence of a negative two-step PPD screening, both steps having been performed within one year of the date of hire....b. Evidence of a negative TB blood test performed within one year of the date of hire...c. Evidence of previous chest x-ray may be accepted by the agency...d. Evidence of a negative one-step PPD test performed within one year of hire may be accepted by the agency...3. If an applicant or employee does not have evidence of previous screenings within one year, the agency may accept the following to have met this protocol: a. A negative two-step PPD test....b. A negative TB blood test performed at hire...c. If the employee or applicant has tested positive for TB in blood or skin tests in the past, but does not have evidence of a chest x-ray or other approved test, the employee should be sent for a chest x-ray at a company approved screening location. Additionally, the applicant or employee must complete a screening Questionnaire to confirm that they are free of signs and symptoms of TB...4. Annually, the agency Quality Manager or other appropriate staff, must conduct a risk assessment review for all counties serviced by the agency...If the agency is found to be low risk in a county, all employees in that county will be required to complete a screening questionnaire confirming they are free from signs and symptoms of TB upon their annual evaluation...C. Hepatitis B Vaccine: The Hepatitis B vaccine and vaccination series shall be made available to all employees who are at risk for exposure to blood and body fluids/substance. This vaccine must be provided at no cost to the employee and acceptance or refusal of the vaccine must be documented..."

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) or 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.

A review of PF's conducted on April 28, 2021 from approximately 10:00 am to 11:30 am revealed the following:

PF #1, Date of Hire: 10/20/08, did not contain any documentation of a job description; and did not contain any documentation of an annual performance evaluation for 2018, 2019, or 2020.

PF#2, Date of Hire: 10/26/09, did not contain documentation of an annual performance evaluation for 2018, 2019, or 2020.

PF#3, Date of Hire: 9/11/17, did not contain documentation of an annual competency evaluation for 2019 or 2020; did not contain any documentation of an annual performance evaluation for 2019 or 2020; contained documentation of only a one-step tuberculin skin test at hire; and did not contain any documentation of annual tuberculosis symptom screening for 2019 or 2020.

PF#4, Date of Hire: 6/29/17, did not contain any documentation of an annual performance evaluation for 2018, 2019, or 2020; did not contain any documentation of annual tuberculosis symptom screening for 2018, 2019, or 2020.

PF #5, Date of Hire: 3/27/18, did not contain any documentation of a FBI Fingerprint Check; did not contain any documentation of an annual performance evaluation for 2019, 2020, or 2021; did not contain any documentation of a two-step tuberculin skin test at hire; and did not contain any documentation of having received or declined Hepatitis B vaccination.

PF #6, Date of Hire: 10/18/18, did not contain any documentation of a FBI Fingerprint Check; did not contain any documentation of annual competency evaluations for 2019 or 2020; annual performance evaluations for 2019 or 2020, and did not contain any documentation of an annual tuberculosis symptom screening for 2020.

PF #7, Date of Hire: 12/11/19, did not contain any documentation of a FBI Fingerprint Check; did not contain a job description for home health aide; did not contain any documentation of a Child Abuse Clearance; did not contain any documentation of an annual performance evaluation for 2020; did not contain any documentation of having received or declined Hepatitis B vaccination; did not contain any documentation of a two-step tuberculin skin test at hire and did not contain any documentation of an annual tuberculosis symptom screening for 2020.

PF #8, Date of Hire: 4/16/19, did not contain any documentation of a FBI Fingerprint Check; did not contain any documentation of a current CPR certification; did not contain any documentation of agency orientation; did not contain any documentation of an annual performance evaluation for 2020; did not contain any documentation of of having received or declined Hepatitis B vaccination; and did not contain any documentation of a two-step tuberculin skin test at hire.

PF #9, Date of Hire: 11/17/2020, did not contain any documentation of a FBI Fingerprint Check; did not contain any documentation of a job description; did not contain any documentation of current CPR certification; did not contain any documentation of agency orientation; did not contain any documentation of of having received or declined Hepatitis B vaccination; and did not contain any documentation of an annual tuberculosis symptom screening for 2021.

PF #10, Date of Hire: 9/22/15, did not contain any documentation of a FBI Fingerprint Check; did not contain any documentation of a job description; did not contain any documentation of a Child Abuse Clearance; did not contain any documentation of current Licensed Practical Nursing licensure for the state of Pennsylvania; did not contain any documentation of current CPR certification; did not contain any documentation of annual performance evaluations for 2018, 2019, or 2020; and did not contain any documentation of annual tuberculosis symptom screening for 2018 or 2019.

An interview with the director of nursing on April 29, 2021, at approximately 12:00 pm confirmed the above findings.








Plan of Correction:

In-service completed on 5/7/2021 at Orthodox St location reviewed hiring policy including job description, orientation checklist, CPR certification, background checks, HHA training and health screenings including PPD regulation, with Care Coordinator S.C.

In-service completed on 5/7/2021 at Orthodox St location with RN Case Managers P.R. H.G and E.H. to re-educate staff on performance evaluation policy, initial competency and annual competency policies.

All employee files to be reviewed for compliance and brought up to CGA standards and DOH and CMS compliance by 6/30/2021. Once compliance is achieved, 10% of employee files will be reviewed quarterly for continued compliance with a goal of 90% compliance.

All employees to be entered into Netsmart by 6/30/2021. Expired credentials report to be pulled the first week of every month. Care Coordinator to be notified of expired credentials and complete follow-up. RN Case Managers to be notified of competency and performance evaluations due.

Administrator will ensure compliance going forward.




Initial Comments:

Based on the findings of an onsite unannounced state re-licensure survey conducted April 27, 2021 through April 29, 2021, Caregivers America SE, 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 state re-licensure survey conducted on April 27, 2021 through April 29, 2021, Caregivers America SE, was found to be in compliance with the requirements of 35 P.S. 448.809 (b).




Plan of Correction: