Healthcare security and service continuity during the pandemic is proving to be a challenge for many organizations as staff are falling victim to COVID-19 variants, burnout and the demands and needs of their families and communities. One element adding challenges to organizations is the new Centers for Medicare & Medicaid (CMS) Vaccination Mandates. Many hospitals appear to have been encouraging staff vaccination for some time now, with little resistance. So, what are the new CMS requirements and how can organizations take a fast track to compliance?
The Omnibus COVID-19 Interim Final Rule expectation was to gain 100% compliance across healthcare organizations. The Omnibus landed on an already taxed healthcare provider landscape, so there were immediate legal responses arguing the mandate for fear of greater understaffing challenges and additional stressors being added to the current workforce. On January 13, 2022 the Supreme Court lifted injunctions blocking a CMS ruling covering more than 17 million healthcare workers.
Healthcare workers will have until March 15 to be fully vaccinated in the 24 states where the requirement was reinstated. Twenty-five states and Washington, DC continue to face a February 28 deadline.
“Medicare and Medicaid-certified facilities are required to comply with all regulatory requirements, and CMS has a variety of established enforcement remedies. For nursing homes, home health agencies, and hospice (beginning in 2022), this includes civil monetary penalties, denial of payments, and—as a final measure—termination of participation from the Medicare and Medicaid programs.
The sole enforcement remedy for non-compliance for hospitals and certain other acute and continuing care providers is termination …”1
We know there is an increased risk of exposure to certain diseases in the healthcare setting, and staff who are not vaccinated from Vaccine Preventable Diseases (VPDs) both increase their own risk of contracting a disease while also acting as a potential vector of transmission of VPDs to others. Vaccines are a proven and valuable tool to help minimize the exposure of VPDs to communities.3
Benefits of Staff Vaccinations Programs
- Increase protection against Vaccine Preventable Diseases (VPDs)
- Protect vulnerable patients
- Protect your co-workers
- Protect your family and friends
- Reduce sick leave in the workplace
- Reduce Healthcare Acquired Infections (HAIs) in your care environment
The need to track the effectiveness of vaccination programs and to understand compliance challenges is of utmost importance for the health and safety of our healthcare workers and patients.
CMS released guidance2 to state survey agency directors; providing outlines for enforcement actions and their thresholds to assist surveyors in assessing organizational compliance. In essence, covered Medicare and Medicaid organizations must show policies and procedures ensuring vaccination requirements are met.
Let’s look at the Minimum Program Components that will be audited as part of this rule:
- A process for ensuring all staff specified 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. Exceptions being 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.
- A process for ensuring all staff specified 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. Exceptions being made for those outlined above.
- A process for ensuring that all staff are fully vaccinated for COVID-19. Exceptions being made for those outlined above.
- 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
- A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified.
- 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.
- A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law.
- 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.
- 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:
- 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
- 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.
- 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
- Contingency plans for staff who are not fully vaccinated for COVID-19
What is the survey process going to include?
Starting on January 22nd, federal, state, accreditation and CMS-contracted surveyors will begin monitoring for full compliance. A three-phase survey process will assess compliance through observation, staff interviews and record review. A surveyor may ask your organization to provide the following documentation for review:
- Current COVID-19 vaccination policies and procedures
- A full list of staff and their vaccination status
- A contingency plan to mitigate the spread of COVID-19
Organizations affected by the CMS ruling should look to the provider specific guidance for full details.
What is at stake for non-compliance?
As with any survey, CMS will enforce compliance based on the severity of non-compliance and facility type, however sanctions can include a plan of correction, civil monetary penalties, denial of payment and most severe – termination from the Medicare/Medicaid program.
Understanding the immune status of your workforce also means you can mitigate risks by gaining flexibility in staff scheduling and assignments. Having insight into PPE audits, Mask Fit testing records and Hand Hygiene compliance rates is critical to maintaining a healthy environment and delivering safer care. With solutions that will help prepare and support you through the compliance process of this final rule, RLDatix software is purpose built for just this type of requirement.
Ensuring your organization can evidence compliance while at the same time ensuring staff health and providing safer care to patients and clients is complicated. RLDatix’s Staff Health Surveillance offering provides users with the ability to record, track, trace and report on the essential information needed to evidence not just compliance, but the state of your health care teams’ readiness to bring safer care to your community.
Contact our experts to assess your level of compliance to help facilitate safer patients, a safer workforce and a safer organization.
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8583029/ Maltezou, H. C., Ioannidou, E., De Schrijver, K., François, G., & De Schryver, A. (2021). Influenza Vaccination Programs for Healthcare Personnel: Organizational Issues and Beyond. International journal of environmental research and public health, 18(21), 11122. https://doi.org/10.3390/ijerph182111122