§483.80(i) COVID-19 Vaccination of facility staff. The facility 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.
§483.80(i)(1) Regardless of clinical responsibility or resident contact, the policies and procedures must apply to the following facility staff, who provide any care, treatment, or other services for the facility and/or its residents: (i) Facility employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the facility and/or its residents, under contract or by other arrangement.
§483.80(i)(2) The policies and procedures of this section do not apply to the following facility staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the facility setting and who do not have any direct contact with residents and other staff specified in paragraph (i)(1) of this section; and (ii) Staff who provide support services for the facility that are performed exclusively outside of the facility setting and who do not have any direct contact with residents and other staff specified in paragraph (i)(1) of this section.
§483.80(i)(3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (i)(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 facility and/or its residents; (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 (i)(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 facility 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 facility'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.
Effective 60 Days After Publication: §483.80(i)(3)(ii) A process for ensuring that all staff specified in paragraph (i)(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;
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Observations:
Based on a review of the DEPARTMENT OF HEALTH & HUMAN SERVICES QSO 22-07-ALL memo dated December 28, 2021, and select facility policy, observations and staff interviews, it was determined that the facility failed to fully develop and or follow the policy for COVID-19 vaccination for staff.
Findings include:
A review of a DEPARTMENT OF HEALTH & HUMAN SERVICES, Center for Clinical Standards and Quality/Quality, Safety & Oversight Group dated December 28, 2021, QSO 22-07-ALL memo stated that:
Within 60 days after the issuance of this memorandum 4, if the facility demonstrates that:
Policies and procedures are developed and implemented for ensuring all facility staff, regardless of clinical responsibility or patient or resident contact are vaccinated for COVID-19; and 100% of staff have received the necessary doses to complete the vaccine series (i.e., one dose of a single-dose vaccine or all doses of a multiple-dose vaccine series), or have been granted a qualifying exemption, or identified as having a temporary delay as recommended by the CDC, the facility is compliant under the rule; or Less than 100% of all staff have received at least one dose of a single-dose vaccine, or all doses of a multiple-dose vaccine series, or have been granted a qualifying exemption, or identified as having a temporary delay as recommended by the CDC, the facility is noncompliant.
A review of the facility's "COVID-19 Vaccine Immunization Requirements for Residents and Staff Protocol", dated May 11, 2021, and "COVID - 19 Vaccine Protocol Employees", last revised by the facility on February 15, 2022, revealed the following:
Procedure:
4. The infection Preventionist or designee, will educate all employees who are not fully vaccinated (i.e.., employee received one dose of a two-dose series or less than 2 weeks since the last dose of a primary COVID 19 vaccine and employees with a valid exemption) of additional precautions and measures to mitigate the transmission and spread of COVID 19 for all staff that are not fully vaccinated:
A.Personal Protective Equipment B.Transmission-Based Precautions C.Hand Hygiene D.Physical Distancing E.Screening G.Testing per facility COVID 19 testing policy and procedure H.Use of a NIOSH -approved N95 or equivalent or higher - level respirator for source control, regardless of whether they are providing direct care to or otherwise interacting with patients.
There was no documented evidence, at the time of the review during the survey of May 24, 2022, that the policy indicated above (COVID - 19 Vaccine Protocol Employees) included specific procedures or protocol to define the specific Personal Protective Equipment that is to be worn, when it is required and/or where within the facility it is required.
In addition, there was no documented evidence, at the time of the review, on May 24, 2022, that the policies above included procedures for defining the necessary dates for the required COVID vaccination.
Interview on May 24, 2022, at approximately 12:49 PM, with Employee 2, Licensed Practical Nurse (LPN), on the First Floor, revealed that she was returning from lunch. She stated that she was unvaccinated and granted a non-medical exemption. She was observed during this interview to be wearing only surgical mask, which was confirmed by Employee 2. Interview on May 24, 2022, at approximately 12:45 PM, with Employee 3, LPN, on the First Floor, indicated he was returning from lunch. He stated that he was unvaccinated and was granted a non-medical exemption. He was observed during this interview to be wearing a surgical mask, which was confirmed by Employee 3. An additional observation on May 24, 2022, at approximately 2:30 PM, of Employee 3, LPN, on the First Floor, were observed conversing with another staff member. Employee 3 was wearing a surgical mask during his conversation with the other staff member.
Interview on May 24, 2022, at approximately 1:46 PM, with Employee 4, Registered Nurse (RN), Infection Preventionist (IP), revealed that all employees who are not fully vaccinated are required to wear an N95 mask in the entire facility (all floors), for source control at all times, regardless of whether they are providing direct care to, or interacting with patients, as stated in the facility policy.
At the time of the survey ending May 24, 2022, the facility did not have a positive outbreak over the previous four weeks of COVID-19 among residents.
Review of National Healthcare Safety Network (NHSN) date for week ending May 8, 2022, revealed that the facility had 91.5% of staff fully vaccinated.
Review of the facility provided, employee vaccination status - matrix, at the time survey ending May 24, 2022, revealed that 159 staff were fully vaccinated, with 0 partially vaccinated, 17 religious exemptions, 2 medical exemption, and 1 temporary delay/medical, totaling 100% staff vaccination rate.
Interview with the NHA on May 24, 2022, at approximately 2:07 PM, confirmed that the facility's policy regarding COVID-19 vaccinations lacked specific mitigation procedures and deadlines for vaccination. In addition, she confirmed that all staff are expected to follow all mitigation procedures set forth by the facility, and that the facility failed to follow the mitigation efforts to wear an N95 mask as unvaccinated staff were observed wearing only surgical masks.
28 Pa. Code 211.10(a)(d) Resident care policies
28 Pa. Code 201.14 (a) Responsibility of Licensee
28 Pa. Code 201.18(b)(1)(d)(e)(1) Management
| | Plan of Correction - To be completed: 07/12/2022
1. Facility COVID-19 Vaccine Protocol has been revised to include specific Personal Protective Equipment that is required for employees who are unvaccinated when within the facility and the necessary dates for the required vaccinations.
2. Employees who are not fully vaccinated or have an exemption are wearing the proper PPE (Personal Protective Equipment) which includes a N95 mask for source control, regardless of whether or not they are providing direct care to or otherwise interacting with a resident.
3. HCP who are not fully vaccinated or who have an exemption on file have been re-educated on the mitigation procedures to prevent the spread of the virus.
4. IDT Team/ Designee will monitor staff compliance for appropriate wearing of N95 mask while in facility.
5. Results of audit will be discussed at QA for comment and review
6. Corrective Action Date July 12, 2022
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