HospitalInspections.org

29354

Based on observation, record review, interview, policy review, and Centers for Medicare and Medicaid (CMS) Service guidance review, the provider failed to ensure:
*They had followed their Severe Acute Respiratory Syndrome (SARS) and Coronavirus Disease 2019 (COVID-19) Plan policy and procedure for staff vaccinations.
*Policies and procedures developed and implemented ensured all required staff were fully vaccinated for COVID-19.
*A process for tracking and documenting required staff had received, at a minimum, the first dose of a multi-dose COVID-19 vaccine, or a one-dose COVID-19 vaccine.
*A process was implemented for tracking and documenting the COVID-19 vaccination status for all staff.
*A process was implemented for tracking and documentation of the vaccination status of staff for whom COVID-19 vaccination must be delayed.
*A process was implemented for ensuring staff had obtained any recommended booster doses.
*A contingency plan was implemented for staff who were not fully vaccinated for COVID-19.
*A plan to achieve a 100% staff vaccination rate was implemented.
*Weekly testing for exempted staff and staff who had not completed their primary vaccination series.
*Staff who had not completed their primary vaccination series had worn the appropriate personal protective equipment (PPE) (NIOSH-approved N95 or equivalent or higher-level respirator for source control).
*A list was provided on all required staff that had verified their COVID-19 vaccination status.
Findings include:

1. Interview on 3/29/22 at 5:25 p.m. with administrator A regarding COVID-19 vaccinations for all staff revealed:
*South Dakota Bureau of Human Resources (SD BHR) kept track of the COVID-19 vaccinations.
*They did not have to "say who was vaccinated" according to the governor's declaration.
*They were following the directions of their governing board.
-The governing board was the SD Department of Social Services (DSS).

Interview on 3/30/22 at 10:35 a.m. with human resource (HR) manager B and HR generalist C regarding COVID-19 vaccination status for all employees revealed:
*They did not keep vaccination cards by direction from the governing body.
*There were sixteen staff who chose to be exempted from receiving the vaccine.
*They had exemption forms for the staff who chose to be exempted from receiving the vaccine.
-They tracked the staff who had exemptions.
-They presumed the rest of the staff have been vaccinated.
*The other staff who had not provided exemption forms fell into the "presumed category and they did not track presumed vaccinated staff."
*They were not able to share any level of detail for staff who had exemptions unless pre-authorized.
*They were following the guidance of the governing body and the executive order from the governor.
*They did not have a separate HR policy for COVID-19.
-They had followed the provider's policies for COVID-19.
*During a recertification survey health information was shared with surveyors.
-HR manager B would have to contact her supervisor regarding the possibility for the surveyors to review the staff records with exemptions.

Interview and document review on 3/30/22 at 10:51 a.m. with HR manager B regarding the sixteen staff with exemptions for religious matters revealed:
*The surveyors could view the documents but were not allowed to write down staff names or make copies of the documents.
*There were sixteen staff who had signed and dated the exemption forms.
*None of the exemptions had been for medical reasons.

Interview on 3/30/22 at 11:50 a.m. with administrator A regarding COVID-19 staff vaccinations revealed:
*They received Medicare and Medicaid reimbursement for their patients.
*The hospital was following the governing body directions for all required staff COVID-19 vaccinations.
*PPE was kept at a higher level and used the strongest version and testing when needed.
*They were not tracking and securing COVID-19 vaccination documentation for all required staff.
*They had no plan to ensure 100% of the staff vaccination rate had been completed.
-There was no documentation of the percent of staff who had been vaccinated.
*Exempted staff not vaccinated were not tested for COVID-19.
*Staff wore surgical masks at all times.
-An N95 mask was worn when caring for COVID-19 positive patients.
*He was aware of the CMS Memo for staff vaccinations.
*As an administrator he felt his role was to follow the governing body philosophy and mission.
*Every entry into the building had a screening point set-up for COVID-19 self-screening.

Review of the COVID-19 Staff Vaccination Status for Providers letter received on 3/29/22 from administrator A revealed:
*"In accordance with Governor [name of governor] Executive Orders 2021-08 and 2021-14 and the guidance from the SD Bureau of Human Resources regarding South Dakota State Employee COVID-19 vaccinations, all state employees working in a CMS-certified facility who are required to be vaccinated pursuant to this federal requirement are presumed to be vaccinated.
*CMS was notified of this position on February 28, 2022.
*Employees who have a medical or religious exemption submit the appropriate documentation to the Bureau of Human Resources for retention and privacy."
*"Below is a list containing the information requested as of March 29, 2022:
-Total # [number] of staff: 219
-# of staff granted exemption: 16
-# of presumed vaccinated staff: 203."
*Signed by [administrator's name].
*[Name of facility].

Review of the SD Bureau of Human Resources memorandum received on 3/29/22 during the survey regarding the COVID-19 Vaccination Status policy revealed:
*"South Dakota state facilities are complying with the CMS IFC requiring COVID-19 vaccination and with Governor [name] executive orders.
*All state employees working in a CMS-certified facility who are required to be vaccinated pursuant to this federal requirement are presumed to be vaccinated.
*Employees who have a medical or religious exemption submit the appropriate documentation to the Bureau of Human Resources for retention and privacy.
*Each week, the Bureau of Human Resources reports the aggregate number of active employees who have provided either medical or religious exemption documentation for employee reporting purposes to the employing facility, but no individual or personal information shall be reported.
*Under no circumstance will an individual's vaccination status be shared by the Bureau of Human Resources to an agency or a state-operated facility, and no vaccination cards may be requested or collected.
*No state employee may be tested more or less frequently based on vaccination status."

Review of the "Executive Order Follow-up" email from the Commissioner (name of individual) of the SD BHR provided to the facility dated 10/27/21 at 2:10 p.m. revealed:
*"As follow-up to the recent announcement of Governor [name] executive order, I wanted to highlight the process that we will follow.
-Employees in positions impacted by this federal mandate will be presumed to have met the requirement to receive a COVID vaccine.
-Only those providing accommodation notification for a religious exemption or a doctor note that indicates a medical reason for not having the vaccine will need to provide documentation.
-We will not request or retain copies of a COVID vaccination card.
-When collected to support an exemption, the documentation should be sent to your BHR Human Resources Specialist for retention. As confidential documents, these should not be retained at the local, supervisory level.
-The notification document will be available on the BHR website under Policies and Forms later this afternoon.
*Please let me know if you have any questions."
*Signed by Commissioner [name of individual].

Review of the State of South Dakota Office of the Governor Executive Order 2021-08 revealed:
*"1. No state agency, department, board, commission, or other executive branch entity or official under the direct control of the Governor shall require an individual to present a COVID-19 vaccine passport as described above, or any similar proof-of COVID-19-vaccination, in order to enter government premises, receive a government benefit, license, or do business with the government."
*"5. All state agencies, departments, boards, commissions, or other executive branch entities or officials under the direct control of the Governor are directed to immediately take steps to rescind, alter, or suspend any order, policy, administrative rule, or guidance that is in conflict with this Executive order."
*Signed by [Governor's name] on 4/20/21.

Review of the State of South Dakota Office of the Governor Executive Order 2021-14 revealed:
*"1. This Executive Order applies to any person who:
-(a) works for any state agency, department, bureau, division, board, commission, or other executive branch entity or official of the executive branch under the direct control of the Governor;
-(b) works for any authority authorized by state law pursuant to chapters 11-11, 5-12, 1-16A, 1-16H, and 1-16J; or
-(c ) works for the board of Regents and Board of Technical Education."
*"2. No person to whom this Executive Order applies may be required to receive a COVID-19 vaccination if the person submits an accommodation notification to the state Bureau of Human Resources or the person's respective human resources department providing either:
-a) a written statement from a physician stating that the COVID-19 vaccination is contraindicated for medical reasons, or
-b) a signed statement from the person on a form prescribed by the commissioner of the Bureau of Human Resources that shall read in full,
--"I, [insert person's full name], dissent and object to receiving a COVID-19 vaccine on religious grounds, which includes moral, ethical, and philosophical beliefs or principles."
*Signed by [Governor's name] on 10/27/21.

Review of the provider's last reviewed and revised 3/1/22 5.3.39 Severe Acute Respiratory Syndrome (SARS) and Coronavirus disease 2019 (COVID-19) plan policy and procedure revealed:
*"COVID-19 Vaccination:
-Staff:
--Record of COVID-19 vaccinations will be maintained in the staff member's Employee Health file.
--Unvaccinated staff will be provided with education regarding the benefits and potential risks and side effects associated with the COVID-19 vaccine.
--Unvaccinated staff will sign and date the COVID-19 Vaccine Declination form upon receiving education and decision to decline vaccination."

Review of CMS Quality Safety and Oversite (QSO)-22-09-ALL memorandum dated 1/14/22 and Hospital Attachment QSO-22-11-ALL revealed:
*"The guidance in this memorandum specifically applies to the following states: ...South Dakota..."
*The provider was not in compliance with the Federal vaccine mandate for staff vaccination.