HospitalInspections.org

Based on observation and interview it was determined that the EOC had not been maintained to ensure the provision of safe and appropriate care to patients in the hospital. A nurses' station security door did not automatically latch shut.

Findings include:

1. During tour of the hospital on 05/05/2022 beginning at 1200 the following observation was made: The security door into the nurses' station from the CSU seclusion room area was observed to not close and latch shut automatically when opened. During the observation it was opened to test and although it started to close, it remained partially opened and did not latch shut. It only latched shut when it was manually closed.

This is a repeat observation from the original 04/28/2021 survey that was cited under Tag A144 and had not been corrected. Findings from that survey had additionally revealed a patient had accessed the nurses' station after a nurse had exited through the door and left it ajar.

2. During interview with the CEO, CFO and CNO at the time of the observation they explained that staff had been trained to keep hands on all doors until they were securely closed and latched. However, that mitigation does not relieve the hospital of its responsibility to ensure all security doors work properly.

Based on interview, review of CSV documentation for 2 of 16 hospital staff who were listed as vaccinated (Staff 1 and 4), review of exemption documentation for 6 of 6 hospital staff who were listed as not vaccinated (Staff 16, 17, 18, 20, 21 and 22), review of CSV documentation for 8 of 8 contracted vendors (Vendors 23 through 30), review of CSV lists and review of CSV P&Ps it was determined that the hospital failed to fully develop and implement CSV P&Ps that complied with the requirements and that ensured CSV status for all staff was clear and complete, including as follows:
* CSV P&Ps were not clear or complete.
* Vaccination documentation was not complete for all vaccinated staff.
* Exemption documentation for staff exemption requests, determinations, and mitigation requirements and contingency plans was not clear or complete.
* Mitigation and contingencies implementation for exempt staff was not evident or not complete.
* Contracted vendor staff were not identified and the hospital had not maintained documentation of vaccination or exemption for those staff.

Please note that CFR 482.42(g)(3)(ii) was not included in the template regulatory language above in this Tag. That part of the regulation requires "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."

Findings include:

1.a. The CHH P&P titled "Mandatory COVID-19 Vaccination - Behavioral Health Division" dated as "Effective ... January 2022" and the P&P titled "Medical Staff: Mandatory COVID-19 Vaccination Requirements and COVID-19 Mitigation Precautions" dated as "Effective ... January 2022" were reviewed. No other COVID-19 staff vaccination P&Ps were provided. Those P&Ps were not clear or complete as required, not customized to reflect requirements for CHH, and it was unclear why there were different P&Ps for medical staff versus all staff.

1.b. The two CHH P&Ps did not conform to the requirement specified at CFR 482.42(g)(3)(i) as they contained different and contradictory definitions or descriptions of staff who were excluded from the CSV requirements. For example:

* The "Medical Staff" P&P specified that "... individuals who ... infrequently provide ad hoc non-health services ..., infrequently enter a Facility location for specific limited purposes and for a limited amount of time ..." were excluded from the requirements. The P&P further reflected that "If an individual does not clearly meet the definition of [staff], then the Facility will consider the following three (3) elements in making a classification determination: (1) frequency of presence, (2) services provided, and (3) proximity to patients and staff. Facility will then notify the affected individual of its determination and vaccination requirements pursuant to this Policy, if any."

* However, the "Behavioral Health Division" P&P specified that the requirements DID apply to "... those individuals who provide services primarily off site (including via tele) who enter the Facility from time to time and have contact with any member of the Facility Workforce, including administrative staff at the Facility. For clarity, this includes UHS of Delaware, Inc. employees or contractors who perform site visits to the Facility or any vendor representatives who are on site at a Facility ... "

1.c. The CHH P&Ps did not conform to the requirement specified at CFR 482.42(g)(3)(ii) as they contained different, contradictory and unclear definitions or descriptions for "fully vaccinated" and the related timelines. For example:

* The "Behavioral Health Division" P&P specified that "All [staff] (including ... Contractors On Site) must have the following vaccinations to enter the Facility, unless an exemption has been granted ... On or before January 4, 2022: All [staff] must have completed the primary vaccination series and be fully vaccinated, except for those persons that have been granted exemptions, or those workers for whom COVID-19 vaccination must be temporarily delayed ... even if they have not yet completed the 14-day waiting period required for full vaccination ... After January 4, 2022: All [staff] mut (sic) have both vaccinations or an approved exemption to enter the Facility. All new hires ... must be fully vaccinated or have an approved exemption in order to begin work."

* However, the "Medical Staff" P&P specified that "'Fully Vaccinated' means an individual who is fourteen (14) days or more post completion of a primary COVID-19 vaccination series ... either a single-dose vaccine ... or all required doses of a multi-dose vaccine ... Unless exempted ... On or before January 27, 2022: All On-Site Practitioners shall complete a single-dose primary COVID-19 vaccine or receive the first dose of a multi-dose COVID-19 vaccine. On or before February 28, 2022: All On-Site Practitioners shall complete a primary COVID-19 vaccination series ... On or before March 14, 2022: All On-site Practitioners shall be Fully Vaccinated ... On or after March 15, 2022: All new On-Site Practitioners shall be Fully Vaccinated as a minimum eligibility requirement when applying for clinical privileges ..."

1.d. The CHH P&Ps did not conform to the requirement specified at CFR 482.42(g)(3)(iii) as they contained different, contradictory and unclear definitions or descriptions for implementation of additional precautions. For example:

* The "Medical Staff" P&P reflected the following:
- "'COVID-19 Mitigation Precautions' ... include, but are not limited to, masking protocols, use of personal protective equipment, social distancing measures, and removal and/or quarantining of COVID-19-positive [staff] from on-site Facility locations."
- "'COVID-19 Mitigation Precautions for Not Fully Vaccinated On-Site Practitioners' ... include, but are not limited to, enhanced masking protocols, voluntary individual testing on a weekly basis at the On-Site Practitioner's expense, workplace contact tracing, mandatory Facility-wide testing as implemented for all Not Fully Vaccinated On-Site Practitioners at the On-Site Practitioner's expense, and removal and/or quarantining of COVID-19-positive Not Fully Vaccinated On-Site Practitioners from on-site Facility locations."
- "COVID-19 Mitigation Precautions for Not Fully Vaccinated On-Site Practitioners. In addition to complying with the Facility's general COVID-19 Mitigation Precautions, On-Site Practitioners shall also comply with the following additional precautions ... for all [staff] who are Not Fully Vaccinated for COVID-19: ... must wear a surgical mask or higher-level respirator approved by the [NIOSH], such as an N95 ... at all times while in a Facility location ... Where State law requires mandatory testing of unvaccinated and/or incompletely vaccinated [staff] the Facility will comply with such mandatory testing requirements ... Not Fully Vaccinated On-Site Practitioners who have been granted an exemption may participate in voluntary weekly testing ... The Facility will track any positive test results, conduct workplace contact tracing, and report results to local public health department ... Practitioner members who test positive for COVID-19 are required to follow the removal and/or quarantine procedures set out in the current version of the UHS COVID-19 Employee Actions Decision Tree."

* The "Behavioral Health Division" P&P specified only "... for all [staff] who are not fully vaccinated for COVID-19 ... Although testing is not required under the CMS Rule, the Facility should continue to review the number of employees who have received a medical or religious exemption as well as local community transmission rate of COVID-19 to determine whether a weekly testing program should be implemented as part of its overall processes to control the spread and transmission of COVID-19 ... [staff] members who test positive for COVID-19 are required to follow the current version of the UHS Covid-19 Employee Actions Decision Tree." There were no other precautions identified for staff who were not fully vaccinated.

* The P&Ps were not clear or complete. For example: They did not clearly delineate the additional precautions required by the hospital; masking and testing requirements were unclear including references to "voluntary" testing; processes for tracking positive test results and for contact tracing and reporting were not specified; and neither P&P reflected how the requirements for additional precautions were to be conveyed to staff. Further, although there were multiple requests for all P&Ps and related documents at the survey entrance conference and during the survey, the "UHS COVID-19 Employee Actions Decision Tree" was not provided.

1.e. The CHH P&Ps did not conform to the requirement specified at CFR 482.42(g)(3)(iv) as they contained unclear and incomplete descriptions for tracking and documentation of staff vaccination status. For example:

* The "Behavioral Health Division" P&P required that "The Facility must track [staff] vaccination status ... records must include the type of vaccine administered and the dates of the dosages ... also include tracking of ... booster doses as recommended by the CDC ... Documentation will be maintained in the employee's confidential HR Medical files ... Contractors On Site ... documentation will be maintained by [HR]."

* The "Medical Staff" P&P reflected that "The Medical Staff Office will track the vaccination status for On-Site Practitioners ... records will include the type of vaccine administered and the dates of the dosages. The Medical Staff Office will also track CDC-recommended vaccine booster doses received by On-Site Practitioners."

* The P&Ps were not clear or complete. For example: They contained no information about how, where and when vaccination status was to be tracked; what elements the tracking was to include, including for exemptions; and only one of them identified who was responsible for the tracking.

1.f. The CHH P&Ps did not conform to the requirement specified at CFR 482.42(g)(3)(v) as they contained unclear and incomplete descriptions for tracking of booster doses. Refer to Finding 1.e. directly above.

1.g. The CHH P&Ps did not conform to the requirement specified at CFR 482.42(g)(3)(vi) as they contained different and unclear descriptions for staff exemption requests. For example:

* The "Behavioral Health Division" P&P specified that "... [staff] may request an exemption from the vaccination requirements by submitting a signed request for an exemption form indicating one of the following: 1) Medical Reason b) Religious Beliefs.
... To be eligible for a medical exemption, [staff] must complete the COVID-19 Exemption Request Form and include documentation confirming recognized clinical contraindications to COVID-19 vaccines, and which supports the [staff's] request. Such documentation must be 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 ... Such documentation must contain all information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the [staff] to receive, the recognized clinical reasons for the contraindications, and a statement by the authenticating Practioner recommending that the [staff] be exempted from the facility's COVID-19 vaccination requirements based on the recognized clinical contraindications.
... To be eligible for an exemption based on a sincerely held religious belief, [staff] must complete the COVID-19 Exemption Request Form and provide a written statement as to the sincerely held religious belief preventing the workers from receiving the vaccination and answering applicable questions.
... A record of signed exemption forms and, if applicable healthcare provider statement of exemption must be maintained ..."

* The P&P did not include further information about the process. For example: What were the next steps after staff submitted the request; how were requests reviewed and by whom; what steps were taken if the request was unclear or incomplete; how were request decisions (approvals and denials) documented and conveyed to staff, etc.

* The "Medical Staff" P&P contained similar language and did specify that "Exemption requests may be granted by the Medical Executive Committee or jointly by the CEO and at least one of the following Medical Staff leaders: ..." However, there were no other processing steps included.

1.h. The CHH P&Ps did not conform to the requirement specified at CFR 482.42(g)(3)(vii) as they contained no specific language related to a process for tracking staff exemption information.

1.i. The CHH P&Ps did not conform to the requirement specified at CFR 482.42(g)(3)(ix) as they contained no language related to a process for tracking temporary delays of staff vaccinations.

1.j. The CHH P&Ps did not conform to the requirement specified at CFR 482.42(g)(3)(x) as they contained unclear descriptions of contingency plans for staff that were not fully vaccinated. For example:

* The "Behavioral Health Division" P&P included a section for "Consequences of Failure to Provide Proof of Vaccinated Status." It reflected that staff "... may be placed on unpaid administrative leave until proof of vaccination or a properly completed exemption form is provided and approved. Continued non-compliance will be considered a voluntary resignation from the Facility." It was not clear what "may be placed" on leave meant and if there were then circumstances where staff would be allowed to continue working. It was not clear how determinations about "voluntary resignation" for "continued non-compliance" would be made, who would make those decisions and how that would be processed and managed.

2. For Staff 1 a CDC CVRC reflected his/her first dose was administered on 01/10/2021 and the manufacturer, lot # and the healthcare site at which the vaccination was administered were recorded. The CVRC contained a second date of 02/05/2021. However, the manufacturer, lot # and the healthcare site for the second dose of vaccination were not recorded.

3. For Staff 4 a CDC CVRC reflected the first dose was administered on 01/26/2021. However, the healthcare site at which the vaccination was administered was not recorded.

4. For Staff 16, an LIP on the hospital's medical staff with an undisclosed hire/start date, religious exemption and contingencies documentation was not clear or complete:

* A "Covid-19 Vaccine Religious Exception Request Form" was signed and dated by Staff 16 on 11/09/2021.

* There was no documentation of a review of the request, including who conducted the review and made the final determination, and when it was conducted.

* A letter on CHH letterhead to Staff 16 was dated 10/28/2021, prior to Staff 16's request. The letter included the following information:
- "[CHH] approves your COVID-19 vaccine exemption request under the current conditions ... with the following contingency: ... all healthcare workers with exemptions on file must submit evidence of a weekly negative COVID-19 test result. As a continued condition of employment, your weekly test results must be submitted by 8:00 a.m. every Monday morning from date of hire and every Monday thereafter. Testing must be done by a professional service ... Weekly testing must be submitted to HR Director ... and Infection Control/Nurse Manager ... via email every Monday by no later than 8:00 a.m. ... If your weekly test results are late, you will not be able to work ... you may be subject to corrective action up to and including termination of employment."
- The letter contained no other mitigation requirements and contingency plans.
- At the end of the letter it indicated "I understand that my exemption approval is contingent on the requirements outlined in this letter ..." It was signed with an illegible signature and dated 11/09/2021.

* An untitled spreadsheet/table of exempt staff weekly testing status and results reflected the following for Staff 16:
- Spaces for weekly testing dates 11/08/2021 through 01/02/2022 had "N/A" recorded in them. There was no documentation of explanation for those entries.
- Spaces for weekly testing dates of 01/16/2022 and 01/23/2022 had "positive" recorded in them. There was no documentation to reflect what actions were taken in response to the positive test results.
- Spaces for weekly testing dates of 01/20/2022, 02/06/2022, 02/20/2022, 02/27/2022, 03/13/2022, 03/20/2022, 03/27/2022, 04/03/2022, 04/17/2022 and 04/24/2022 were blank.

* There was no documentation of any other mitigation and contingencies implemented and monitored for Staff 16.

5. For Staff 17 with a hire/start date of 07/13/2020, religious exemption and contingencies documentation was not clear or complete:

* A "Covid-19 Vaccine Religious Exception Request Form" was signed and dated by Staff 17 on 09/18/2021. However, the reason for the request was not clear:
- Staff 17 checked the box on the form next to the following language: "Receiving the COVID-19 vaccination conflicts with my religious observances, practices or beliefs as described below. Please describe your religious belief and how it affects your ability to receive a COVID-19 vaccination."
- The only information documented by Staff 17 was " Receiving the COVID vaccine is against my religious values and beliefs." That information was already stated on the form in that space that Staff 17 had checked and there was no description of specific religious beliefs recorded as required.
- Three copies of the same form were provided and there was no other documentation by Staff 17 to "describe your religious belief and how it affects your ability to receive a COVID-19 vaccination."

* There was no documentation of a review of the request, including who conducted the review and made the final determination, and when it was conducted.

* A letter on CHH letterhead to Staff 17 was dated 10/18/2021 and included the following information:
- "[CHH] approves your COVID-19 vaccine exemption request under the current conditions ... with the following contingency: ... all healthcare workers with exemptions on file must submit evidence of a weekly negative COVID-19 test result. As a continued condition of employment, your weekly test results must be submitted by 8:00 a.m. every Monday morning beginning October 25, 2021 and every Monday thereafter. Testing must be done by a professional service ... Weekly testing must be submitted to HR Director ... and Infection Control/Nurse Manager ... via email every Monday by no later than 8:00 a.m. ... If your weekly test results are late, you will not be able to work ... you may be subject to corrective action up to and including termination of employment."
- The letter contained no other mitigation requirements and contingency plans.
- At the end of the letter it indicated "I understand that my exemption approval is contingent on the requirements outlined in this letter ..." It was signed by Staff 17 and dated 10/19/2021.

* An untitled spreadsheet/table of exempt staff weekly testing status and results reflected the following for Staff 17:
- There was no documentation for weekly testing on 10/25/2021 as required in the letter.
- The space for weekly testing date 01/16/2022 had "missing" recorded in it. There was no documentation of explanation for that entry.
- The space for weekly testing date 04/03/2022 was blank.

* There was no documentation of any other mitigation and contingencies implemented and monitored for Staff 17.

6. For Staff 18 with a hire/start date of 04/12/2021, religious exemption and contingencies documentation was not clear or complete:

* A "Covid-19 Vaccine Religious Exception Request Form" was signed and dated by Staff 18 on 01/26/2022. Staff 18 checked the box on the form next to the following language: "Receiving the COVID-19 vaccination conflicts with my religious observances, practices or beliefs as described below. Please describe your religious belief and how it affects your ability to receive a COVID-19 vaccination." However, that space was blank and there was no information recorded on the form. An email from Staff 18 to CHH staff dated 10/12/2021 contained a narrative request for exemption with a description of specific religious beliefs, however, the email had not been referenced on the "Request Form."

* There was no documentation of a review of the request, including who conducted the review and made the final determination, and when it was conducted.

* A letter on CHH letterhead to Staff 18 was dated 10/18/2021, three months prior to the exemption request form. The letter included the following information:
- "[CHH] approves your COVID-19 vaccine exemption request under the current conditions ... with the following contingency: ... all healthcare workers with exemptions on file must submit evidence of a weekly negative COVID-19 test result. As a continued condition of employment, your weekly test results must be submitted by 8:00 a.m. every Monday morning beginning October 25, 2021 and every Monday thereafter. Testing must be done by a professional service ... Weekly testing must be submitted to HR Director ... and Infection Control/Nurse Manager ... via email every Monday by no later than 8:00 a.m. ... If your weekly test results are late, you will not be able to work ... you may be subject to corrective action up to and including termination of employment."
- The letter contained no other mitigation requirements and contingency plans.
- At the end of the letter it indicated "I understand that my exemption approval is contingent on the requirements outlined in this letter ..." It was signed by Staff 18 and dated 10/20/2021.

* An untitled spreadsheet/table of exempt staff weekly testing status and results reflected the following for Staff 18:
- There was no documentation for weekly testing on 10/25/2021 as required in the letter.
- Spaces for weekly testing dates 01/23/2022, 01/30/2022, 03/06/2022 and 03/13/2022 had "positive" recorded in them. There was no documentation to reflect what actions were taken in response to the positive test results.
- Spaces for weekly testing dates of 03/27/2022 and 04/03/2022 were blank.

* There was no documentation of any other mitigation and contingencies implemented and monitored for Staff 18.

7. For Staff 20 with a hire/start date of 03/07/2022, religious exemption and contingencies documentation was not clear or complete:

* A "Religious Accommodation Request Form" for Staff 20 was dated 02/24/2022 and was unsigned. The form had an "Accommodation Decision" section, in which the box next to the language "approved but different from the original request" was checked. It was unclear what that meant. A handwritten notation on the form reflected "Approved exemption per UHS policy; Must test weekly." That author of that entry was recorded with initials only and it was not dated.

* There was no documentation of an approval letter or document provided to Staff 20 that specified mitigation requirements and contingency plans.

* An untitled spreadsheet/table of exempt staff weekly testing status and results reflected the following for Staff 20:
- The space for weekly testing date of 04/17/2022 had "Missing" recorded in it. There was no documentation of explanation for that entry.

* There was no documentation of any other mitigation and contingencies implemented and monitored for Staff 20.

8. For Staff 21 with a hire/start date of 04/08/2021, medical exemption and contingencies documentation was not clear or complete:

* A "Covid-19 Vaccine Medical Exception Request Form" for Staff 21 was reviewed. The form was not signed and dated by Staff 21 or by a medical provider and did not contain information specified by the hospital's P&P as identified under Finding 1.g. in this Tag above.

* There was no documentation of a review of the request, including who conducted the review and made the final determination, and when it was conducted.

* A letter on CHH letterhead to Staff 21 was dated 10/18/2021. The letter included the following information:
- "[CHH] approves your COVID-19 vaccine exemption request under the current conditions ... with the following contingency: ... all healthcare workers with exemptions on file must submit evidence of a weekly negative COVID-19 test result. As a continued condition of employment, your weekly test results must be submitted by 8:00 a.m. every Monday morning beginning October 25, 2021 and every Monday thereafter. Testing must be done by a professional service ... Weekly testing must be submitted to HR Director ... and Infection Control/Nurse Manager ... via email every Monday by no later than 8:00 a.m. ... If your weekly test results are late, you will not be able to work ... you may be subject to corrective action up to and including termination of employment."
- The letter contained no other mitigation requirements and contingency plans.
- At the end of the letter it indicated "I understand that my exemption approval is contingent on the requirements outlined in this letter ..." It was signed by Staff 21 and dated 10/25/2021.

* An untitled spreadsheet/table of exempt staff weekly testing status and results reflected the following for Staff 21:
- There was no documentation for weekly testing on 10/25/2021 as required in the letter.
- The space for weekly testing date 11/08/2021 had a question mark, "?", in it. There was no documentation of explanation for those entries.
- The space for weekly testing date 01/09/2022 had "missing" recorded in it. There was no documentation of explanation for that entry.
- Spaces for weekly testing dates of 03/13/2022, 03/20/2022, 03/27/2022, 04/03/2022, 04/10/2022 and 04/17/2022 were blank.

* There was no documentation of any other mitigation and contingencies implemented and monitored for Staff 21.

* In addition, several different documents were provided in relation to a request by Staff 21 to not wear an N95 respirator. That documentation was disorganized and unclear and consisted of numerous emails, forms and handwritten notes from numerous individuals that were dated with a range of dates between 12/02/2021 through 01/06/2022, more than two months after the date of the exemption approval letter. The final resolution and approval, including additional mitigations for an exempted staff to not wear the N95 were not documented.

9. For Staff 22 with a hire/start date of 03/20/2022, medical exemption and contingencies documentation was not clear or complete:

* A "Covid-19 Vaccination Exemption Request Form" was signed and dated by Staff 22 on 03/04/2022. There was no information on the form that described the reason for the request.

* A letter on a medical clinic letterhead was dated 10/06/2021 and reflected only the following: "Due to a health problem [Staff 22] should not get any of the Covid-19 vaccines currently available. Please allow [his/her] exemption from mandatory vaccination for this reason." Although the name of an MD was typed on the letter, there was no physician's signature. There was no other information and this information did not conform to the requirements specified by the hospital's P&P as identified under Finding 1.g. in this Tag above.

* There was no documentation of a review of the request, including who conducted the review and made the final determination, and when it was conducted.

* There was no documentation of an approval letter or document provided to Staff 22 that specified mitigation requirements and contingency plans.

* An untitled spreadsheet/table of exempt staff weekly testing status and results reflected the following for Staff 22:
- Spaces for weekly testing dates for 03/06/2022 through 04/17/2022 had "N/A" recorded in them. There was no documentation of explanation for those entries.
- Spaces for weekly testing dates of 04/24/2022 and 05/01/2022 had "tested onsite" recorded in them. There was no documentation of the results of those tests.

* There was no documentation of any other mitigation and contingencies implemented and monitored for Staff 22.

10. A list of eight contracted "vendors" was provided. Eight CSV "attestation" contracts between the hospital and vendors were provided. Those contracts were dated with varying dates between 10/13/2021 and 10/26/2021. Those reflected that the vendor attested that all of its staff were "either fully vaccinated ... or has an exemption on file ..." For contracted vendors 23 through 30 there were no individual contracted staff names identified on the vendor list or on each vendor's attestation. The hospital provided no evidence that it had identified all contracted staff associated with those vendors and no evidence that it had maintained documentation of CSV and exemptions for those staff as required.

11. During interview with the HRD and IP at the time of the staff vaccination record review on 05/05/2022 beginning at 1600 findings in this Tag were confirmed, including that the hospital did not maintain evidence or documentation of vaccination or exemption for individual staff providing services under those "attestation" contracts.

Additional documentation and clarification was requested at the onsite closing conference that included the CEO, CNO, HRD, IP and others and that was conducted on 05/05/2022 at 1830. In an email from UHS corporate staff received on 05/06/2022 @ 1353 additional documentation was provided for Staff 4, 17, 18, 21 and 22 that is reflected in the findings above. No additional documentation was provided for Staff 1, 16 and 20.