Every finding on record at Premier Caregivers of Northern Ohio Inc

EXTENDED SUBSTANTIAL ALLEGATION SURVEYSUBSTANTIAL ALLEGATION 61840 An entrance conference was conducted on 03/14/22 at 2:25 PM with the Administrator. An exit conference was conducted on 03/17/22 at 4:00 PM with the Administrator. The Federal Vaccine Mandate QSO 22-09- All review resulted in a determination of Immediate Jeopardy related to Infection Prevention and Control. On 03/16/22 at 3:56 PM the Administrator was informed, based on the findings, a determination of immediate jeopardy existed to the health and safety of the patients receiving care at this agency. Based on the agency's Plan of Action and the immediate steps taken, the immediate jeopardy was removed and the Administrator was informed on 03/17/22 at 4:00 PM. The following deficiencies are based on the Federal Vaccine Mandate QSO 22-09- All review, completed on 03/17/22 at Heart and Home Health Care 368463. No deficiencies were issued in regard to allegations contained in substantial allegation 61840 investigated concurrently. Heart and Home Health Care is precluded from offering its own aide training and/or competency evaluation program for a period of two years from the exit date of this survey.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: Based on review of QSO memo 22-09-ALL Attachment G, review of facility COVID-19 vaccination records, staff interview, and review of the facility policy, the facility failed to ensure 100% of the staff were vaccinated within 60 days from the effective date of the healthcare worker vaccine mandate and failed to develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. The cumulative effect of these systemic practices resulted in the agency's inability to ensure that the patients' infection control needs would be met. (G687)

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: Based on review of QSO memo 22-09-ALL Attachment G, review of facility COVID-19 vaccination records, staff interview, and review of facility policy, the facility failed to ensure 100% of the staff were vaccinated within 60 days from the effective date of the healthcare worker vaccine mandate. The agency also failed to develop a contingency plan for staff not fully vaccinated to prevent transmission of COVID-19, a process to track and document COVID vaccine doses, a process to track and document boosters, a process for staff to request exemption, a process to track who has requested exemptions and what type of exemptions and a process to ensure all medical exemption information is required. This affected three of five staff members (Staff A, C and H). The agency census was six. Findings include: Review of QSO memo 22-09-ALL Attachment G, dated 01/14/22, revealed within 60 days of issuance of this memorandum, 100% of staff will have received all doses of COVID-19 vaccine or have been granted a qualifying exemption, or are identified as having a temporary delay as recommended by the Centers for Disease Control and Prevention (CDC). Review of the agency's policy titled, "COVID-19 Vaccination," with no effective date, revealed no contingency plan for staff not fully vaccinated to prevent transmission of COVID-19, no process to track and document COVID vaccine doses, no process to track and document boosters, no process for staff to request exemption, no process to track who has requested exemptions and what type of exemptions and no process to ensure all medical exemption information is required . Further review of this policy revealed all staff will have received the second vaccine dose by 03/14/22. Per interview on 03/15/22 at 3:00 PM Staff A stated she, Staff C and Staff H were scheduled to receive the second dose later this week. Interview with Staff A on 03/15/22 at 5:00 PM confirmed the facility policy was missing the stated required components. Per review of the vaccine status report and confirmed by review of vaccine cards submitted by staff revealed as of 03/16/22 at 11:00 AM three of five staff (Staff A, C and H) had not received the second vaccine dose per policy. There were no exemptions or delays as recommended by CDC. The agency’s percentage of vaccinated staff for COVID-19 was 40%.