Center for Improvement in Healthcare Quality Newsletter
July 2022

News You Can Use

July’s Compliance Tip of the Month

July’s compliance tip of the month is focused on the COVID-19 Mandatory Vaccination regulations for healthcare workers along with attendant documentation requirements. The CMS Regulation is provided below for your reference.
Overall organizations are doing an excellent job in complying to these requirements. Citations given by surveyors has been minimal and most often the citation includes the lack of documentation of all the required items.
Organizations are required to ensure that there is a mechanism to track and secure documentation regarding the vaccination status of their staff as defined in Requirement A. While no specific tool is mandated, records shall contain the following information – as applicable – for each individual:
  • Start of Employment Date
  • End of Employment Date
  • Last Name, First Name, Date of Birth
  • Medical or Religious Exemption Granted / Date
  • Declined COVID Vaccine / Date
  • Vaccinated with Dose 1
    • Date Administered
    • Vaccine Manufacturer Name
  • Vaccinated with Dose 2
    • Date Administered
    • Vaccine Manufacturer Name
  • Is Vaccination Series Complete? Yes / No
  • Eligible for Additional/Booster Dose? Yes / No, if Yes
    • Additional/Booster Dose Vaccination Date?
    • Additional/Booster Dose Manufacturer
  • Employee or Non-Employee
Documentation shall be kept confidential and stored separately from the individual’s personnel file.
CIHQ encourages organization to evaluate their policies and documentation mechanisms to assure that they comply to the regulations in order to avoid a deficiency during survey.

CMS

A-0792
§ 482.42 Condition of participation: Infection prevention and control and antibiotic stewardship programs.
  • (g) Standard: COVID-19 Vaccination of hospital staff. The hospital 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 hospital staff, who provide any care, treatment, or other services for the hospital and/or its patients:
      • (i) Hospital employees;
      • (ii) Licensed practitioners;
      • (iii) Students, trainees, and volunteers; and
      • (iv) Individuals who provide care, treatment, or other services for the hospital and/or its patients, under contract or by other arrangement.
    • (2) The policies and procedures of this section do not apply to the following hospital staff:
      • (i) Staff who exclusively provide telehealth or telemedicine services outside of the hospital setting and who do not have any direct contact with patients and other staff specified in paragraph (g)(1) of this section; and
      • (ii) Staff who provide support services for the hospital that are performed exclusively outside of the hospital setting and who do not have any direct contact with patients and other staff specified in paragraph (g)(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 (g)(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 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 hospital and/or its patients;
      • (ii) A process for ensuring that all staff specified in paragraph (g)(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 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 (g)(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 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 hospital 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 hospital’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.
The following tools available to ARS members:
Resource Library:
#3213 – Policy – Mandatory COVID-19 Vaccination
#3214 – Form – Template COVID-19 Vaccination Exemption Form Due to Medical Condition
#3215 – Form – Template COVID-19 Vaccination exemption Form Due to Religious Belief
#3220 – Tool – COVID-19 Mandatory Vaccine Dates
#3216 – Tool – Healthcare Worker COVID-19 Vaccination Log

CIHQ to Expand its Accreditation Programs

CIHQ became an accreditor the first time in July of 2013. We were given a four year designation and reapplied to CMS in 2017. We were awarded the maximum term of 6 years and that means that the reapplication process begins in 2022 prior to the expiration in July 2023.
Our reapplication was submitted to CMS early and has been accepted as complete. This will be published in the Federal Register by July 28, 2022 with the final designation being published no later than December 22, 2022.
Through strategic planning and at the request of some facilities CIHQ will be applying to CMS not only for hospitals as a redesignation but also for Critical Access hospitals as well as All Psychiatric Hospitals. These application and publication will happen later this year and the designation should be published around the first quarter of 2023. We are excited to expand to include these organizations and provide them with all the partnership and resources that we provide to hospitals that are accredited by us in the hospital program.