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1200 ROBERTS AVE NE

COOPERSTOWN, ND 58425

AGREEMENT FOR CRED. AND PRIV FOR TELEMEDICINE

Tag No.: C0872

Based on bylaws review, agreement review, credentialing/physician list 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 1 of 2 distant-site hospitals' (Hospital #1) 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 "BYLAWS OF THE COOPERSTOWN MEDICAL CENTER" occurred on the afternoon of 06/27/22. These bylaws, amended on 12/02/14, stated, ". . . ARTICLE VII MEDICAL STAFF . . . The Board of Directors shall, in the exercise of its overall legal responsibilities, assign to the Medical Staff reasonable authority for ensuring appropriate professional care to the Hospital's patients . . . The medical staff shall make recommendations to the Board of Directors concerning the following: a. Appointments, reappointments, and other changes in staff status. b. Granting of clinical privileges. . . ."

Review of the "COOPERSTOWN MEDICAL CENTER MEDICAL STAFF BYLAWS" occurred on the afternoon of 06/27/22. These bylaws, adopted on 06/25/20, stated, ". . . ARTICLE III. MEDICAL STAFF MEMBERSHIP . . . Section 3.03 . . . 1) Appointments and Reappointments a. Appointments and reappointments to the Medical Staff shall be authorized by the Board. The Board shall act on appointments, reappointments, or revocation of appointments at its next regular meeting after receipt of a favorable recommendation from the Medical Director and the Administrator. . . The governing body's decision is the final approval in respect to the appointments. . . . b. Appointment to the Medical Staff shall confer on the appointee only such clinical privileges as have been granted by the Board in accordance with these Bylaws. . . . ARTICLE VII. DETERMINATION OF CLINICAL PRIVILEGES . . . Section 7.07 PRIVILEGES TO PRACTICE VIA TELEMEDICINE 1) The Medical Staff shall determine which patient care services, if any, are appropriate for delivery at a distance via electronic or other technological means. . . . b. Health Care Providers providing official readings of images, tracings or specimens through a telemedicine mechanism must do so under one of the following arrangements: i. The HCP [health care provider] is granted clinical privileges at both the originating and distant sites that include these services; or ii. The hospital contracts for the provision of these services by the provider. If the hospital contracts for the provision of these services, they must be provided consistent with the procedures addressed in the service contract. . . . 4) Practitioners providing telemedicine services will be appointed/reappointed by the . . . medical staff; i.e. Health Care Providers form contracted telehealth sites, i.e., [names of telehealth sites]. Distant site will maintain credentialing and privileging criteria and quality measurement standards used for its medical staff. The distant site will provide the CMC [Cooperstown Medical Center] with information regarding the telemedicine practitioner's status upon request, via Schedule 1 documents, or in list format. . . ."

Reviewed on 06/28/22, the CAH's "Telemedicine Services" agreement with Hospital #1, dated 03/17/22, stated, ". . . DELEGATED CREDENTIALING FOR TELEMEDICINE . . . K. [Name of hospital] Responsibilities 1. Provider Credentialing and Recredentialing Program. . . . Provider shall provide to Facility a current list of Professionals' privileges at applicable Provider-affiliated hospital(s) and, upon reasonable request, make available to Facility mutually agreed upon Credentialing Documents. Provider represents that its medical staff has independently approved the clinical services to be provided under this Agreement as services that may be provided via telemedicine. . . . III. Facility/Client Responsibilities . . . 6. Scope of Credentialing. Facility will rely upon Provider's Credentialing and Recredentialing Program when making its credentialing and privileging decisions for Professionals. . . ."

- Reviewed on 06/28/22, distant-site Hospital #1's list of telemedicine providers, dated 04/30/21, included 126 physicians. Upon request on 06/29/22, 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.

During an interview on 06/29/22 at 11:25 a.m., an administrative staff member (#1) confirmed Hospital #1 provided after hours 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 radiology providers from Hospital #1.

PATIENT CARE POLICIES

Tag No.: C1016

Based on observation, policy review, review of medication outdate sheet, and staff interview, the Critical Access Hospital (CAH) failed to ensure the removal of outdated medications from 1 of 1 treatment room (located on the medical/surgical floor). Failure to remove outdated medications may result in patients receiving expired and ineffective medications.

Findings include:

Review of the policy titled "Outdated Medications Monitoring and Removal" occurred on 06/29/22. This policy, revised 06/08/16, stated, ". . . 1. Medications will be checked monthly for outdates . . . 3. A check off sheet must be completed for each area that has been checked for outdates with date and initials. . . . 4. All areas that need to be checked for medication outdates are indicated on the checklist. . . ."

Review of the Medication Outdate Check sheet for the year 2022 showed the list lacked documentation staff had checked the treatment room for outdated medication.

Observation of the treatment room occurred on 06/29/22 at 9:30 a.m. with an administrative nurse (#5). The treatment room had a locked drawer containing medications used in procedures. Review of the contents of the drawer showed four 20 ml (milliliter) vials of Lidocaine HCl 2% injectable solution (a medication used to numb the skin) and one 5 ml syringe of Lidocaine HCl 2% topical gel, with the expiration dates of March 2022.

During an interview on 06/29/22 at 9:30 a.m., the administrative nurse (#5) confirmed the vials and syringe were expired, and nursing staff failed to remove the outdated medications or document medication outdate checks of the treatment room for January through June 2022.

NURSING SERVICES

Tag No.: C1046

Based on review of personnel files, review of facility policy, and staff interview, the Critical Access Hospital (CAH) failed to ensure all nursing staff possessed the specialized qualifications and competence needed to meet patient needs for 1 of 1 registered nurse (#6) who lacked evidence of advanced cardiovascular life support (ACLS) certification. Failure to ensure all nursing staff receive the training necessary to perform their clinical duties may result in unmet patient needs.

Findings include:

Review of the policy "ACLS Course Requirements" occurred on 06/29/22. This policy, revised 03/31/21, stated, ". . . ACLS course requirements will be attained by . . . certification. . . . Recertification is required every two years. The following personnel MUST maintain ACLS certification: Hospital RN [registered nurse] personnel . . ."

Review of personnel files occurred on the morning of 06/29/22 and identified an RN (#6) lacked evidence of ACLS certification.

During an interview on 06/29/22 at 10:00 a.m., a managerial nurse (#7) confirmed the nurse (#6) is not ACLS certified at this time.

LEADERSHIP RESPONSIBILITIES

Tag No.: C1239

Based on observation, policy and procedure review, manufacturer operating/safety instructions review, instruction sheet review, and staff interview, the Critical Access Hospital (CAH) failed to follow infection control practices for disinfection of 1 of 1 whirlpool tub (located on the medical/surgical floor). Failure to follow established infection control practices may allow transmission of organisms and pathogens from patients to patients, or to staff, and from one environment to another.

Findings include:

Review of the facility policy titled "Environmental Services General Cleaning Methods - Patient Rooms" occurred on 06/29/22. This policy, revised 10/03/2016, stated, ". . . To prevent . . . microbial contaminants on environmental surfaces . . . a potential source of nosocomial infections. . . . 2. Disinfectants are used in dilution, contact time, and manner recommended by the manufacturer. . . ."

Review of the facility policy titled "Hospital Tub Operating Instructions" occurred on 06/29/22. This policy, dated 05/19/2010, stated, ". . . Follow procedures as stated in the MasterCare Entree bath [sic] Operating and Safety Instructions Manual dated 03/09/2010 (attached). . . . Cleaning Procedures: . . . d) Close the drain. Fill tub foot well with approximately 1/2 gallon of water. . . . e) Using MasterCare's specially formulated Disinfectant cleaner concentrate, dispense 1 oz into the foot well water. . . . Allow contact time as detailed on disinfectant/cleaner. . . ."

Review of the staff instruction sheet titled "Tub Cleaning" occurred 06/29/22. This undated instruction sheet stated, "15 mL [milliliters] MasterCare Disinfectant Concentrate (equivalent to 4 pumps) to 1 spray bottle full (to fill ring) of water is proper dilution for disinfectant. . . .Spray solution on interior of tub, (sides, bottom, handle) well to saturate and let sit for 10 minutes before rinsing. . . ."

Observation of the tub room on 06/27/22 at 2:55 p.m., with a staff nurse (#3) showed a whirlpool and locked cupboard. The staff nurse (#3) removed a disinfectant jug labeled Mastercare Disinfectant from the locked cabinet to show the surveyor and explain how staff disinfect the whirlpool. The jug lacked a pump to dispense the product.

During an interview on 06/27/22 at 2:55 p.m., the staff nurse (#3) stated, "We don't measure the disinfectant to be honest, if we were to measure it would probably be about five capfuls. When we did measure, we used to use the small med cups (30 ml). It was about 3 of those (90 ml). We leave it on for 5 to 10 minutes then rinse it off."

During an interview on 06/27/22 at 3:45 p.m., an administrative nurse (#5) said she expected staff to follow the manufacturer's instructions for cleaning and disinfection of the whirlpool, and agreed the staff failed to follow the correct procedure.