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Based on bylaws review, agreement review, credentialing document review, and staff interview, the Critical Access Hospital's (CAH's) medical staff failed to recommend and the governing body failed to approve the appointment/reappointment and privileges for 2 of 3 distant-site hospitals' (Hospital #1 and #2) physicians reviewed who provided services to the CAH through telemedicine. Failure of the medical staff to recommend and the governing body to approve appointments/reappointments and privileges of telemedicine medical staff members placed the CAH's patients at risk of receiving services from unqualified practitioners.

Findings include:

Review of the governing board's "BY-LAWS OF ST. LUKE'S HOSPITAL (A NON-PROFIT CORPORATION)" occurred on the afternoon of 06/13/22. These bylaws, approved on 03/27/08, stated, ". . . ARTICLE VI MEDICAL STAFF SECTION 1 - APPOINTMENT: The Board of Directors shall appoint for the hospital a medical staff which may be composed of the following: (a) Physicians licensed in North Dakota to practice medicine. Privileges may be granted each physician by the Board of Directors after consultation with the medical staff. . . . SECTION 4 - BY-LAWS, RULES AND REGULATIONS: By-laws, rules and regulations for the medical staff setting forth its organization, government and responsibilities, shall be recommend (sic) by the medical staff, and the officers elected thereunder shall be subject to the approval of the Board of Directors in accordance with the regulation requirements of the Hospital Licensing Act, and become effective only if and when approved by the Board of Directors. As approved by the Board of Directors, such by-laws, rules and regulations shall be a basis for the medical staffs accountability to the Board of Directors for medical care rendered to the Hospital's patients. . . ."

Review of the "BYLAWS, RULES AND REGULATIONS MEDICAL AND DENTAL STAFF ST. LUKE'S HOSPITAL" occurred on the afternoon of 06/13/22. These bylaws, adopted on 11/29/11, stated, ". . . ARTICLE III . . . Section 3. Terms of Appointment. Subsection 1. Appointment to the medical and dental staff shall be made by the governing body after recommendations by the medical staff for a provisional seven-month period. After a six-month review is completed, the appointee will then be reappointed by the governing body until the next scheduled credentialing cycle. The governing body of St. Luke's Hospital may reappoint members of the staff for a further period of two years unless not recommended by the staff. . . . Subsection 4. Appointment to the medical and dental staff shall confer on an appointee only such privileges as are listed in the form 'Medical Staff Privileges' herein after provided. . . . Section 4. Procedures for Appointment . . . Subsection 4. After consideration of the report, the staff shall recommend to the governing body that the application be accepted, deferred, or rejected. . . ."
The bylaws failed to include a provision allowing the CAH to rely on the distant site hospital's credentialing and privileging through a written agreement.

Reviewed on 06/15/22, the CAH'S "PHYSICIAN CREDENTIALING AND PRIVILEGING AGREEMENT" with Hospital #1, effective 04/17/17, stated, ". . . WHEREAS, in order for the Physicians to provide the Contracted Services to patients of Hospital, such Physicians must be appropriately privileged and credentialed by Hospital; and WHEREAS, to the extent permitted by law Hospital would like to rely on the credentialing and privileging decisions of Telemedicine Entity in making credentialing and privileging decisions for the Physicians. NOW THEREFORE, in consideration of the mutual promises herein, the parties hereto hereby agree as follows: . . . 4. Decision of Governing Body. Hospital's governing body and medical staff may rely on Telemedicine Entity's credentialing and privileging decisions for purposes of Hospital's governing body and medical staff recommending and determining whether or not to issue privileges to each Physician. Hospital's governing body shall have access to all information of Telemedicine Entity reasonable required to allow it to confirm that credentialing services provided to Hospital by Telemedicine Entity comply with all laws, regulations and standards applicable to Hospital as they apply to credentialing and privileging of physicians . . ."

Reviewed on 06/15/22, the CAH'S "Radiology Interpretation Services Agreement" with Hospital #2, dated December 2011, stated, ". . . Credentialing and Privileging: [name of hospital] governing body shall be responsible for the following with regard to the . . . Physician's providing the Services:
(i) Determining, in accordance with applicable state law, which physicians are eligible candidates for appointment to the [name of hospital] medical staff . . .
(ii) Appointing members to the medical staff after considering the recommendations of the existing members of the medical staff:(iii) Assuring the medical staff has bylaws:(iv) Approving medical staff bylaws and other medical staff rules and regulations;
(v) Ensuring the medical staff is accountable to the governing body for quality of care provided to patients; . . . [name of hospital] further represents and agrees that each . . . Physician providing interpretative services under this Agreement (i) holds a license to practice medicine in the State of North Dakota;
(ii) is credentialed and privileged according to [name of hospital] credentialing and privileging processes . . . The parties agree and acknowledge that Referring Facility has chosen to rely on Trinity Health's credentialing and privileging decisions for purposes of Referring Facility's medical staff determining whether or not to issue privileges to . . . Physician. [Name of hospital] will provide Referring Facility with a list identifying each . . . Physician who will provide interpretative services, and will update that list as needed. . . ."

- Review of the list of telemedicine providers for electrocardiogram interpretation from distant-site Hospital #1 occurred on 06/14/22. Upon request on 06/14/22 and 06/15/22, the CAH failed to provide evidence the medical staff recommended and the governing board approved telemedicine appointment/reappointment and privileges for the providers on the list from Hospital #1.
- Review of the list of telemedicine providers for radiology imaging interpretation from distant-site Hospital #2 occurred on 06/14/22. Upon request on 06/14/22 and 06/15/22, the CAH failed to provide evidence the medical staff recommended and the governing board approved telemedicine appointment/reappointment and privileges for the providers on the list from Hospital #2.

During an interview on 06/14/22 at 3:30 p.m., an administrative staff member (#3) confirmed Hospital #1 provided electrocardiogram interpretation telemedicine services for the CAH and Hospital #2 provided radiology imaging interpretation services for the CAH. The administrative staff member confirmed the CAH did not have evidence the medical staff had recommended, and the governing body approved the telemedicine appointments/reappointments and granting of privileges for the providers from Hospital #1 and Hospital #2.

THIS IS A REPEAT DEFICIENCY FROM THE SURVEY COMPLETED ON 03/29/17.

Based on observation, policy review, Safety Data Sheets (SDSs) review, and staff interview, the Critical Access Hospital (CAH) failed to safely store hazardous chemicals for 2 of 3 days of survey (June 13-14, 2022). Failure to safely store hazardous chemicals may result in cognitively impaired patients sustaining an injury.

Findings include:

Review of the policy titled "Cleaning Supplies and Chemicals" occurred on 06/15/22. This undated policy stated, ". . . St. Luke's Hospital shall ensure that all cleaning supplies and chemicals used for cleaning are properly selected, used, stored, and maintained. . . . All chemical [sic] will be stored per manufacturer instruction . . ."

Observations showed the following:
* On 06/13/22 at 3:45 p.m., a spray bottle labeled "HDQL 10 [a disinfectant]" hung on the handrail in the shower in the whirlpool room. A staff nurse (#1) reported environmental services used it to clean the shower between residents and stated, "This should not be in here."
* On 06/14/22 at 8:45 a.m., a spray bottle labeled "1 Step Disinfectant Cleaner" sat on top of a table (wheelchair height) in the rehabilitation therapy gym. The label read, ". . . causes irreversible eye damage and skin burns." A managerial therapist (#10) revealed there was a second bottle of the disinfectant in the treatment room and reported the therapists use the disinfectant to sanitize equipment between residents. The managerial therapist (#10) confirmed staff lock the doors to the pool area but leave the doors to the gym unlocked.

Per request, a managerial maintenance staff member (#15) provided the SDSs for the disinfectants observed during the observations. Review of the SDSs occurred on 06/15/22 and identified the following:
* Clean on The Go Super HDQL 10: ". . . Harmful if swallowed. . . . Harmful if inhaled. . . . Causes severe skin burns and serious eye damage. . . . Store locked up. . . . Corrosive . . ."
* BNC-15 (1 Step Disinfectant Cleaner): ". . . Harmful if swallowed. Causes severe skin burns and serious eye damage. . . . Corrosive . . . Inhalation of vapors or mist may cause respiratory irritation . . . Probable mucosal damage . . . Keep out of reach of children . . ."

During interview on 06/15/22 at 9:30 a.m., an administrative staff member (#2) confirmed staff should lock the HDQL 10 in an environmental services cart or closet.





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Based on observation, review of the kitchen cleaning checklist, and staff interview, the Critical Access Hospital (CAH) failed to ensure a clean environment on 3 of 3 days of survey (June 13-15, 2022). Failure to ensure a clean kitchen environment may result in unsanitary dietary conditions and contribute to foodborne illness outbreaks.

Findings include:

The CAH failed to provide a copy of their policy regarding cleaning per request.

Observation on June 13-15, 2022, showed build-up (approximately one half inch) and/or strings of dust/lint on the boiler pipes and vents located directly above the dry food stock/supplies in the kitchen storage room.

During an interview on 06/13/22 at 2:00 p.m. in the kitchen, a managerial dietary staff member (#14) acknowledged the build-up and/or strings of dust/lint on the boiler pipes and vents located directly above the dry food stock/supplies in the kitchen storage room.

The dietary staff member (#14) provided a copy of the "Daily/Weekly [Cleaning] Checklist," which did not include the storeroom boiler pipes and vents. The dietary staff member (#14) reported maintenance staff clean the boiler pipes and vents on a quarterly basis.

During an interview on 06/15/22 at 8:00 a.m. in the kitchen, a managerial maintenance staff member (#15) acknowledged the build-up and/or strings of dust/lint on the boiler pipes and vents located directly above the dry food stock/supplies in the kitchen storage room. The maintenance staff member (#15) reported maintenance staff do not clean the boiler pipes or vent grates.

Based on bylaws review, record review, and staff interview, the Critical Access Hospital's (CAH's) governing board failed to ensure appointment/reappointment to medical staff and granting of privileges followed the bylaws for 6 of 6 providers' files reviewed (Physicians #1, #2, #3, #4, #5 and #6). Failure to follow the bylaws when appointing/reappointing providers to the medical staff and granting privileges placed the CAH's patients at risk of receiving services from unqualified providers.

Findings include:

Review of the governing board's "BY-LAWS OF ST. LUKE'S HOSPITAL (A NON-PROFIT CORPORATION)" occurred on the afternoon of 06/13/22. These bylaws, approved on 03/27/08, stated, ". . . ARTICLE VI MEDICAL STAFF SECTION 1 - APPOINTMENT: The Board of Directors shall appoint for the hospital a medical staff which may be composed of the following: (a) Physicians licensed in North Dakota to practice medicine. Privileges may be granted each physician by the Board of Directors after consultation with the medical staff. . . . SECTION 4 - BY-LAWS, RULES AND REGULATIONS: By-laws, rules and regulations for the medical staff setting forth its organization, government and responsibilities, shall be recommend [sic] by the medical staff, and the officers elected thereunder shall be subject to the approval of the Board of Directors in accordance with the regulations requirements of the Hospital Licensing Act, and become effective only if and when approved by the Board of Directors. As approved by the Board of Directors, such by-laws, rules and regulations shall be a basis for the medical staffs [sic] accountability to the Board of Directors for medical care rendered to the Hospital's patients. . . ."

Review of the "BYLAWS, RULES AND REGULATIONS MEDICAL AND DENTAL STAFF ST. LUKE'S HOSPITAL" occurred on the afternoon of 06/13/22. These bylaws, adopted on 11/29/11, stated, ". . . ARTICLE III . . . Section 3. Terms of Appointment. Subsection 1. Appointment to the medical and dental staff shall be made by the governing body after recommendations by the medical staff for a provisional seven-month period. After a six-month review is completed, the appointee will then be reappointed by the governing body until the next scheduled credentialing cycle. The governing body of St. Luke's Hospital may reappoint members of the staff for a further period of two years unless not recommended by the staff. . . . Subsection 4. Appointment to the medical and dental staff shall confer on an appointee only such privileges as are listed in the form 'Medical Staff Privileges' herein after provided. . . . Section 4. Procedures for Appointment . . . Subsection 4. After consideration of the report, the staff shall recommend to the governing body that the application be accepted, deferred, or rejected. . . ."

Review of the providers' credentialing files occurred on June 14-15, 2022, and identified the following:
- Provider #1: no evidence of St Luke's medical staff's recommendation and governing board's approval of reappointment and privileges in 2021 (previous recommendation and approval of reappointment/privileges on 11/01/19).
- Provider #2: no evidence of St Luke's medical staff's recommendation and governing board's approval of reappointment and privileges in 2021 (previous recommendation and approval of reappointment/privileges on 11/01/19).
- Provider #3: no evidence of St Luke's medical staff's 6 month review and medical staff's recommendation and governing board's approval of reappointment after initial appointment/privileges on 08/26/19. No evidence of St Luke's medical staff's recommendation and governing board's approval of reappointment and privileges in 2021.
- Provider #4: no evidence of St Luke's medical staff's recommendation and governing board's approval of reappointment and privileges in 2021 (previous recommendation and approval of reappointment/privileges on 11/01/19).
- Provider #5: no evidence of St Luke's medical staff's recommendation and governing board's approval for initial appointment/privileges.
- Provider #6: no evidence of St Luke's medical staff's recommendation and governing board's approval of reappointment/privileges.

Upon request on 06/14/22, the CAH failed to provide evidence St Luke's Medical Center medical staff recommended and the governing board approved reappointment/privileges for Provider #1, #2, #4, and #6; completed a six month review and recommended/approved reappointment/privileges for Provider #3; and recommended and approved initial appointment/privileges for Provider #5.

During interview on 06/14/22 at 3:30 p.m., an administrative staff member (#3) confirmed the following: Providers #1 and #2 provided medical services to the CAH's patients, and the CAH did not have evidence the medical staff recommended and the governing board approved reappointment/privileges; Provider #3 provided medical services for the CAH's patients and the CAH did not have evidence the medical staff completed a six month review and recommended and the governing board approved reappointment/privileges; Provider #4 provided surgical services to the CAH's patients and the CAH did not have evidence the medical staff recommended and the governing board approved reappointment/privileges; Provider #5 provided pathology services and the CAH did not have evidence the medical staff recommended and the governing board approved initial appointment/privileges; Provider #6 provided anesthesia services to the CAH's patients and the CAH did not have evidence the medical staff recommended and the governing board approved appointment/privileges.

Based on record review, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure 2 of 2 staff members unvaccinated for COVID-19 (#11 and #12) met all the requirements for a medical exemption. Failure to ensure medical exemptions contained the required information allows staff to remain unvaccinated, placing residents, staff, and visitors at risk for infection with COVID-19.

Findings include:

Review of the policy titled "COVID-19 Pandemic Personnel Mandatory Vaccination Policy" occurred on 06/15/22. This undated policy stated, ". . . Staff who have previously had COVID-19 are not exempt from these vaccination requirements. Available evidence indicated that COVID-19 vaccines offer better protection than natural immunity alone and that vaccines, even after prior infection, help prevent reinfections. . . . Facilities must ensure that all documentation confirming recognized clinical contraindications to COVID-19 vaccinations for staff seeking a medical exemption are signed and dated by a licensed practitioner . . . This documentation must contain 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. Additionally, a statement by the authenticating practitioner recommending that the staff member be exempted from the facility's COVID-19 vaccination requirements is also expected. . . ."

Review of unvaccinated staff members (#11 and #12) "Request for a Medical Exemption to the COVID-19 Vaccination Requirement" forms occurred on 06/15/22. The forms identified the following:
* The physician marked "Immediate allergic reaction of any severity to a previous dose of known (diagnosed) allergy to a component of the vaccine" on staff member #11's form but failed to specify which vaccine was clinically contraindicated.
* The physician marked "Other" and "Permanent," and wrote "Had COVID-19 Has natural immunity" on staff member #12's form.

During interview on 06/15/22 at 11:45 a.m., an administrative nurse (#13) confirmed staff member #11 and #12's COVID-19 medical exemptions did not meet the criteria laid out in the facilities policies.