Center for Improvement in Healthcare Quality Newsletter
December 2021

ARS Regulatory Alerts

CIHQ-ARS notifies member organizations of any new or modified accreditation standard, or CMS COP for acute care hospitals. Each alert summarizes the standard / regulation, likely impact to members, and recommends compliance strategies. Whenever possible, alerts are limited to one-page in length so that they can be quickly read and disseminated.

New Regulatory Alert

Alert Date
November 5, 2021
Alert Subject
CMS Mandates COVID-19 Vaccination for Healthcare Workers
Source
CIHQ TJC OSHA NFPA
CMS CDC NIOSH Other:
Alert Background
Today, CMS published an Interim Final Rule creating a new standard under the Condition of Participation for Infection Control, requiring COVID-19 vaccination of healthcare workers in Medicare / Medicaid participating entities (hospitals, critical access hospitals, skilled nursing facilities, ambulatory centers, etc.). For the purpose of this alert, these providers shall collectively be referred to as “healthcare entities”. The new standard (hospital is used as the example) is noted below:
§82.42 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:
    1. Hospital employees;
    2. Licensed practitioners;
    3. Students, trainees, and volunteers; and
    4. Individuals who provide care, treatment, or other services for the hospital and/or its patients, under contract or by other arrangement.
  1. The policies and procedures of this section do not apply to the following hospital staff:
    1. 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
    2. 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.
  1. The policies and procedures must include, at a minimum, the following components:
    1. 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 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 hospital and/or its patients;
    2. 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 the CDC, due to clinical precautions and considerations;
    3. 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;
    4. A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (g)(1) of this section;
    5. 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;
    6. 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;
    7. 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:
      1. 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
      2. 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;
    8. 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
    9. Contingency plans for staff who are not fully vaccinated for COVID-19.
Discussion & Recommendations
To view the discussion & recommendations CIHQ Accredited Hospitals can download this alert in its entirety when logged-in/connected to your facility's CIHQ intranet site. All alerts are archived in the CIHQ intranet site for future access and reference.
Not a CIHQ Accredited Facility?
» CIHQ accredits a variety of healthcare organizations throughout the United States and abroad. Visit CIHQ.org to learn more, and to apply.

New Regulatory Alert

Alert Date
November 15, 2021
Alert Subject
CMS Issues Revised Interpretive Guidance on Co-Located Hospitals
Source
CIHQ TJC OSHA NFPA
CMS CDC NIOSH Other:
Alert Background
In a letter to State Enforcement Agencies (SA) issued on 11/12/21, CMS revised its interpretive guidance on co-located hospitals and compliance to the Medicare Conditions of Participation (COP). The revised guidance takes effect immediately.
Hospitals can be co-located with other hospitals or other healthcare providers. These hospitals may be located on the same campus or in the same building used by another hospital or healthcare facility. The hospital may be co-located in its entirety or only certain parts of the hospital may be co-located with other healthcare facilities.
The guidance is specific to the requirements under the hospital CoP’ at 42 CFR Part 482 and does not address specific location and separateness requirements of any other Medicare-participating entity, such as psychiatric hospitals, ambulatory surgical centers (ASCs), rural health clinics, Independent Diagnostic Testing Facilities (IDTFs), etc.
Additionally, for the purpose of this guidance, reference to “healthcare providers” does not include critical access hospitals (CAHs) due to specific distance and location requirements or private physician offices, including those that may be participating in a timesharing or leasing agreement.
Discussion & Recommendations
To view the discussion & recommendations CIHQ Accredited Hospitals can download this alert in its entirety when logged-in/connected to your facility's CIHQ intranet site. All alerts are archived in the CIHQ intranet site for future access and reference.
Not a CIHQ Accredited Facility?
» CIHQ accredits a variety of healthcare organizations throughout the United States and abroad. Visit CIHQ.org to learn more, and to apply.