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Tag No.: A0747
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Based on observation, interview, and document review, the Hospital failed to develop and implement an effective Infection Prevention and Control and Antibiotic Stewardship Program that ensured compliance with COVID-19 Healthcare Staff Vaccination mandate.
Failure to fully develop and implement an effective Infection Prevention and Control and Antibiotic Stewardship Program puts patients, staff, and visitors at risk of illness of communicable diseases.
Findings included:
1. The hospital failed to fully implement COVID-19 vaccination processes and procedures for the healthcare staff.
Cross Reference: Tag A792
Due to the scope and severity of deficiencies cited under 42 CFR 482.42, the Condition of Participation for Infection Prevention and Control and Antibiotic Stewardship Program was NOT MET.
Tag No.: A0792
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Based on interview and document review, the hospital failed to develop and implement policies and procedures to ensure that all staff are fully vaccinated for Covid-19 (Item #1), that staff vaccination status is securely tracked and documented (Item #2), and that the hospital uses a standardized method for evaluating and securely documenting requests for religious accommodation for Covid-19 vaccination exemption (Item #3).
Failure to develop and implement policies and procedures to ensure that all staff are fully vaccinated for Covid -19, for tracking mandatory Covid-19 vaccinations, and use of a standardized method for evaluating and securely documenting requests for religious accommodation for Covid-19 vaccination exemption places patients, visitors, staff, and the community at risk for illness, disability, and death.
Findings included:
Item #1 - Vaccination of Staff
1. Review of the hospital policy titled, "SRH COVID Vaccine Healthcare Worker Requirement," #159992 Revision 9, effective 01/13/22, showed that:
a. To assure the health and safety of healthcare personnel, patients, and the communities we serve, it is essential that Skagit Regional Health (SRH) supports efforts that aim for 100% COVID-19 vaccination rate.
b. Vaccination policy applies to all healthcare personnel working at any SRH facility and those
working partially or completely remote.
c. Healthcare personnel are defined as employees, affiliated licensed independent providers, medical residents, students, volunteers, and other contractors.
2. On 03/04/22 at 10:00 AM, during a meeting with the Chief Quality Officer (Staff #1) the Regional Director of Regulatory and Accreditation (Staff #2), a Data Analyst (Staff #3), the Regional Director of Performance Improvement (Staff #4), a Quality Assurance Manager (Staff #5), and the Regional Director of Clinical Operations (Staff #6), a single page from an Excel workbook was shared with the investigator. The page showed the following information about staff numbers and vaccination status:
Fully vaccinated 2885
Exemptions 253
Temporary delays 3
Total staff 3301
Total vaccination rate 95.1 %
The Excel page did not show individual names, position or role of each staff member, or the percentage of unvaccinated staff.
3.During the same meeting on 03/04/22 at 10:00 AM, an interview with Staff #1 and Staff #2 confirmed that based on the totals provided, the vaccination status of 160 staff was unknown.
Item #2 - Tracking of Vaccination Status
1. On 03/03/22 at 1:00 PM, an interview and data review with the Regional Director of Regulatory and Accreditation (Staff #2), a Data Analyst (Staff #3), the Regional Director of Performance Improvement (Staff #4), and a Quality Assurance Manager (Staff #5) showed that:
a. The facility used Smartsheet software to track the vaccination status of employees, affiliated licensed independent providers, medical residents, students, volunteers, and other contractors.
b. Staff #3 had difficulty in manipulating the Smartsheet software to provide accurate numbers of fully vaccinated staff, total staff who received religious and medical accommodations, staff for whom vaccination was temporarily delayed, unvaccinated staff, and total number of staff. Facility staff requested more time to clean up the Smartsheet and an additional meeting was set for 03/04/22 at 10:00 PM.
3. On 03/04/22 at 10:00 AM, a review of a single page from an Excel workbook shared with the investigator by the Chief Quality Officer (Staff #1) the Regional Director of Regulatory and Accreditation (Staff #2), a Data Analyst (Staff #3), the Regional Director of Performance Improvement (Staff #4), a Quality Assurance Manager (Staff #5), and the Regional Director of Clinical Operations (Staff #6), showed total numbers of staff for the categories of Fully vaccinated, Exemptions, Temporary delays, Total staff, and Vaccination rate. The Excel page did not show individual names, the position or role of each staff member, the staff member vaccination status, or the percentage of unvaccinated staff.
2. On 03/04/22 at 1:33 PM an email was sent to the Regional Director of Quality and Accreditation (Staff #2), notifying the facility that the investigator was required to view their comprehensive staff list to calculate and confirm numbers, by close of business on 03/07/22. No reply was received from the facility and the investigator was unable to determine if the facility had an accurate and retrievable process for tracking the Covid-19 vaccination status of all staff.
Item #3 - Religious Exemption Evaluation and Approval Process
1. Review of a document titled, "New Employee exemptions," no policy number, no effective date, showed the following:
a. Staff should submit a request for accommodation online through use of a Smartsheet form
b. The Smartsheet would populate the Human Resources (HR) spreadsheet to alert Human Resources that a staff member had submitted an exemption request.
c. The Smartsheet or HR forwards the exemption request to the Committee via email or HR could manually submit the exemption request to the committee.
2. On 03/03/22 at 2:00 PM an interview with the Chief Quality Officer (Staff #1) showed:
a. At first, medical and religious exemptions were granted or denied by a committee consisting of Staff #1, the Chief Medical Officer, the head of HR, and the Vice President of Clinic Operations.
b. Staff #1 stated that no schedule of committee meetings, list of attendees, or committee meeting minutes documenting the individualized consideration of religious accommodation requests existed.
c. Staff #1 stated that the committee based the evaluation of accommodation requests on advice received from facility counsel and some materials provided by the Washington State Hospital Association (WSHA), that each case was considered individually, and that the committee could request additional information, as needed.
d. Staff #1 stated that the current process was that an exemption request would automatically be emailed from a Smartsheet to two committee members or that Human Resources would forward requests by email to two committee members. If both members indicated by email that they approved, the exemption would be granted. Staff #1 was not sure of when the process changed from committee meetings of four members to an email process involving two members.
3. On 03/03/22 at 1:00 PM, a group interview with Regional Director of Regulatory and Accreditation (Staff #2), a Data Analyst (Staff #3), the Regional Director of Performance Improvement (Staff #4), and a Quality Assurance Manager (Staff #5) showed that 268 staff had applied for religious exemption from the vaccine mandate and that 265 requests for accommodation had been approved.
4. Review of a Smartsheet used to document exemptions showed the basis for the staff request and whether an exemption had been approved or denied. No documentation was found to demonstrate the individualized decision-making process.
5. Review of the hospital policy titled, "SRH COVID Vaccine Healthcare Worker Requirement," #159992 Revision 9, effective 01/13/22, showed that the policy did not contain information regarding the process for approval or denial of religious accommodations requested by staff.
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