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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 8 of 10 providers' (Providers #1, #2, #3, #4, #5, #6, #7, and #8) credentialing files reviewed. 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 Medical Staff Bylaws and Rules and Regulations" occurred on 10/11/22 at 4:30 p.m. These bylaws, dated 04/19/18, stated,
" . . . Article IV. Amended Procedure for Credentialing and Recredentialing
Section 1. Application for Appointment (Credentialing)
a. . . . Application . . . shall require detailed information . . . including the names of at least three persons . . . who can provide adequate references pertaining to the applicant's professional competence and ethical character. . . .
g. . . . Credentialing, at a minimum before granting even emergency/temporary privileges, shall include verification of the applicant's . . . reference/education check, query to the National Physician's data bank . . .
Section 2. Initial Appointment Process
a. . . . All recommendations to appoint must also specifically recommend the clinical privileges to be granted . . .
b. . . . the Medical Executive Committee . . . shall determine, through information contained in references given by the practitioner and from other sources . . . to see whether the practitioner . . . meets all of the necessary qualifications for the category of staff membership and the clinical privileges requested by the applicant. The Medical Executive Committee shall transmit to the Board of Directors the completed application . . .
n. . . . the Chief Executive Officer will query the National Practitioner Data Bank when screening applicants for Medical Staff appointment. The report shall be part of the credentials file. The query is also required every two (2) years for reappointment to the Medical Staff and prior to granting temporary privileges. . . .
Section 3. Reappointment (Recredentialing) Process
a. . . . Reappointment to the Medical Staff shall be made for a period of not more than two (2) years. . . .
Article V. Clinical Privileges
Section 1. Clinical Privileges
a. Written privileges shall be granted . . . upon appointment to the Medical Staff and approved by the Board of Directors. . . ."

Review of providers' 2019-2022 credentialing files occurred on October 12-13, 2022, and identified the following:
- Provider #1: as a member of the active medical staff, recommended approval of himself for reappointment on 02/03/21. The CAH failed to query the National Practitioners Data Bank before reappointment on 02/24/21.
- Provider #2: The CAH failed to query the National Practitioners Data Bank before reappointment on 05/26/21. Provider #2 provides surgical services for the CAH.
- Provider #3: The CAH failed to query the National Practitioners Data Bank before reappointment on 03/24/21. Provider #3 provides ophthalmological surgical services for the CAH
- Provider #4: The CAH failed to reappoint Provider #4 after previous appointment ended on 09/23/21. Provider #4 is the primary physician providing radiology interpretation for the CAH.
- Provider #5: The CAH failed to query the National Practitioners Data Bank and check references before initial appointment on 02/24/21. Provider #5 provides after hours radiology interpretation for the CAH.
- Provider #6: The CAH failed to query the National Practitioners Data Bank before reappointment on 03/23/22. Provider #6 is a member of the active medical staff and provides emergency department and inpatient treatment for the CAH.
- Provider #7: The CAH failed to check references before initial appointment on 09/10/22. Provider #7 provided emergency department and inpatient treatment for the CAH September 23-25, 2022.
- Provider #8: The CAH failed to delineate/approve privileges and query the National Practitioners Data Bank before reappointment on 05/11/22. Provider #8 provides anesthesia services for the CAH.

During interview on 10/13/22 at 10:30 a.m., a staff member (#3) responsible for credentialing confirmed the above findings for Providers #1-#8.

Based on bylaws review, policy review, record review, and staff interview, the Critical Access Hospital (CAH) failed to evaluate the quality and appropriateness of the diagnosis and treatment furnished by 4 of 6 reappointed medical staff providers' (Providers #1, #2, #3, and #6) credentialing records reviewed from 2019-2022. Failure to evaluate the quality and appropriateness of the diagnosis and treatment provided by the providers limited the CAH's ability to ensure the providers furnished quality and appropriate care to the CAH's patients.

Findings include:

Review of "The Medical Staff Bylaws and Rules and Regulations" occurred on 10/11/22 at 4:30 p.m. These bylaws, dated 04/19/18, stated,
". . . Article IV. Amended Procedure for Credentialing and Recredentialing . . .
Section 2. Initial Appointment Process . . .
k. The quality and appropriateness of patient care will be monitored, evaluated and addressed by the Chief of the Medical Staff through peer review action . . . This clinical documentation will become part of the physician's credential file to be submitted to the Medical Executive Committee and the Board of Directors. . . .
Section 3. Reappointment (Recredentialing) Process . . .
c. Each recommendation concerning the reappointment of a Medical Staff member and the clinical privileges to be granted upon reappointment shall be based upon the following: professional and clinical performance . . .
Article VIII - Divisions of the Staff . . .
Section 9. Nurse Practitioners . . .
d. Responsibility for Performance: . . . A physician member of the Medical Staff shall direct and review the work, records and practice of the nurse practitioner on a continuous basis to ensure that appropriate, safe and quality treatment is rendered. . . ."

Review of the "Policy for Peer Review for medical providers" occurred on 10/13/22. This policy, dated 03/13/17, stated,
"Purpose: To verify that quality standards are met in the delivery and documentation of care.
Policy: A peer review [an evaluation of the quality and appropriateness of the diagnosis and treatment furnished] will be conducted on an annual basis for each provider by an M.D. [medical doctor] or D.O. [doctor of osteopathy] Each peer review will require evaluation of the quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine or osteopathy at the CAH by a network hospital or QIP or equivalent for all physicians. The review will involve a random sampling of at least one case per clinician per year. . . ."

Reviewed on October 12-13, 2022, the 2019-2022 credentialing files failed to include evidence of the evaluation of the quality and appropriateness of the diagnosis and treatment furnished by practitioners at the CAH before the following reappointments:
- Provider #1: reappointed 02/24/21; last peer review on 07/26/18.
- Provider #2: reappointed 05/26/21; last peer review on 06/13/18.
- Provider #3: reappointed 03/24/21; last peer review on 06/06/18.
- Provider #6: reappointed 03/23/22; last peer review on 12/14/20.

Upon request on 10/13/22, the CAH failed to provide evidence of the evaluation of the quality and appropriateness of the diagnosis and treatment furnished by Providers #1, #2, #3, and #6 before reappointment in 2021-2022.

During interview on 10/13/22 at 10:30 a.m., a staff member (#3) responsible for credentialing confirmed the CAH had failed to complete peer review before reappointment for Providers #1, #2, #3, and #6.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the removal of outdated medications for 2 of 4 medication carts (anesthesia cart located in the Operating Room (OR) and medication cart located in the Emergency Room (ER)) observed. Failure to remove outdated medications may result in patients receiving expired and ineffective medications.

Findings include:

Review of the policy "Disposal and Dating Checks" occurred on 10/13/22. This policy, revised November 2020, stated, ". . . Purpose: Ensure that outdated, mislabeled or other unusable drugs are not available for patient use . . . Dating checks are done monthly and as needed . . . by pharmacy staff. These checks are done within the pharmacy, nursing medication room, ER, OR . . ."

Observation of the anesthesia cart located in the operating room occurred on 10/12/22 at 11:50 a.m. with a surgical nurse (#4). The cart contained medications used in surgical procedures. Review of the cart contents showed one 2 ml (milliliter) vial of Solu-Cortef 100 mg (milligram) injectable solution (a medication used in allergic reactions) with an expiration date of September 2022, and five 3 ml unit dose vials of Sodium Chloride 0.9%, with the expiration date of July 2022.

During interview on 10/12/22 at 11:50 a.m., the surgical nurse (#5) confirmed the vials were expired, and pharmacy staff failed to remove the outdated medications.

Observation of the ER medication cart occurred on 10/13/22 at 9:35 a.m. with an administrative nurse (#2). The top drawer of the locked medication cart contained medications used in the ER. Review of the contents of the cart showed five 5 ml vials of Dexamethasone Sodium Phosphate 20 mg injectable solution (a medication used to treat allergies and asthma) with expiration dates of September 2022.

During interview on 10/13/22 at 9:35 a.m., the administrative nurse (#2) confirmed the vials were expired and pharmacy staff failed to remove the outdated medications.

During interview on 10/13/22 at 10:45 a.m., a pharmacy technician (#6) agreed she failed to remove the outdated medications from the anesthesia cart and ER medication cart.

Based on policy review, document review, meeting minutes review, and staff interview, the Critical Access Hospital (CAH) failed to evaluate services furnished under contracts for 1 of 1 year (October 2021-September 2022) reviewed. Failure to evaluate services furnished by contractors limited the CAH's ability to ensure the contractors provided quality services for the CAH and its patients.

Findings include:

Review of the policy "Organizational Quality Improvement Plan" occurred at 11:15 a.m. on 10/13/22. This policy, approved 07/28/21, stated,
". . . Authority and Responsibility
Governing Body: The Board of Directors of Towner County Medical Center has the overall responsibility and accountability for the quality of care and organizational performance in all of the services provided by the organization. . . .
Departmental Responsibilities
Each person that has direct supervisory control over a specific department of the organization is responsible for directing the development of patient-oriented quality improvement activities within their department . . . The table below identifies the party responsible for each department. . . .
Contracted Services
Anesthesia
Occupational Therapy
[name of radiology service]
[name of mobile radiology service]
[name of reference laboratory]
[name of biomedical service]
Responsible Party
OR Coordinator
Contracted Service Company
Radiology Manager
Radiology Manager
Laboratory Manager
Director of Nursing."
The policy failed to include all the contractors providing direct and indirect patient care services under contract.

Review of the CAH's list of contracted services occurred on 10/13/22. This undated list showed thirty-eight contractors provided direct and indirect patient care services at the CAH.

Reviewed on 10/13/22, the quarterly quality assurance meeting minutes from October 2021 through July 2022 failed to include evidence the CAH staff had evaluated contracted services (except for radiology mobile services and blood products).

Upon request on 10/13/22, the CAH failed to provide evidence staff had evaluated thirty-six of the contracted services in the past year to ensure the contractors provided quality services for the CAH and its patients.

During interview on 10/13/22 at 11:30 a.m., an administrative staff member (#1) confirmed CAH staff had failed to evaluate all the contracted services in the past year.

Based on observation, professional literature, policy and procedure review, review of temperature/humidity records, review of manufacturer's instructions, and staff interview, the Critical Access Hospital (CAH) failed to ensure humidity levels in the Operating Room remained in acceptable parameters, failed to ensure staff followed manufacturer's instructions for the use of chemicals used for cleaning and disinfecting equipment and supplies for the endoscopy procedure area, failed to ensure staff stored endoscopes in a secure/sanitary manner, failed to ensure endoscope reprocessing staff completed competencies, and failed to ensure staff document and test the concentration levels of the sanitizing solution to disinfect food preparation surfaces. (Refer to C1206). Failure to ensure adherence to recognized infection prevention and control guidelines placed patients at risk of infection and could result in patients experiencing adverse consequences.




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OPERATING ROOM HUMIDITY LEVELS:
1. Based on review of policy, professional literature, and temperature/humidity records, observation, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff followed acceptable surgical standards of practice regarding the temperature and humidity of 1 of 1 surgical area observed (Operating Room). Failure to ensure the temperature and humidity of the Operating Room (OR) are within the recommended ranges may result in the growth of bacteria and an increase in patient infections.

Findings include:

Review of the policy titled "Policy for notifying maintenance department, of temperature or humidity which falls outside of acceptable ranges" occurred on 10/13/22. This policy, dated 05/01/13, stated, ". . . To monitor and maintain acceptable OR temperature and humidity to ensure infection prevention and the environmental safety . . . Humidity ranges must remain between 30-60% . . ."

An article from the "Association of Perioperative Registered Nurses (AORN)" found at https://doi.org/10.1002/aorn.13563, dated 11/30/21, stated, ". . . Temperature or relative humidity variations that fall outside the recommended parameters for the perioperative environment can have serious implications for patient safety . . . Some pathogenic microbes can thrive in prolonged elevated humidity. Supplies and equipment in perioperative environments exposed to variations in temperature and humidity may become sources of infection or undergo alterations in function, putting patients at increased risk of harm. . . ."

During observation of the OR on 10/12/22 at 11:29 a.m. with a surgical nurse (#4), a hygrometer (gauge used to measure the amount of humidity [moisture] in the air) located in the OR identified a humidity level of 25%.

Review of the OR humidity logs occurred on 10/13/22. The logs for the months of July-October 2022 showed humidity levels below 30% or above 60% on 22 occasions.

During interview on 10/12/22 at 11:50 a.m., a surgical nurse (#4) confirmed the humidity levels were out of acceptable parameters and stated, "We notify maintenance if the readings are off and they adjust it [the boiler]."

SCOPE REPROCESSING:
2. Based on observation, policy review, review of manufacturer's instructions, and staff interview, the Critical Access Hospital (CAH) failed to ensure staff followed manufacturer's instructions for the use of chemicals used for cleaning and disinfecting equipment and supplies, separated clean endoscopes from contaminated items, stored endoscopes in secure/sanitary manner, and performed a staff competency evaluation for 1 of 1 Endoscopy procedure area. Failure to follow appropriate infection control policies/practices and manufacturer's instructions may result in transmission of organisms and pathogens from equipment to patients.

Findings include:

Review of the policy "Reprocessing Flexible Endoscopes" occurred on 10/13/22. This policy, dated November 2020, stated, ". . . All personnel involved in the reprocessing of endoscopes receive ongoing education, training, and assessment of competency . . . After leak testing and before high-level disinfection (HLD) or sterilization, flexible endoscopes will be manually cleaned. . . . Chemicals and solutions used for cleaning and reprocessing flexible endoscopes and endoscope accessories will be handled in accordance with . . . the manufacturer's manual . . . Flexible endoscopes and accessories will be stored in a manner that minimizes contamination and protects the device or item from damage . . . . Manual Cleaning . . . Follow the cleaning solution manufacturer's manual for: . . . Concentration and dilution . . . Storing . . . Identify processed endoscopes with the facility-specific visual cue. . . ."

Review of the reprocessing instructions for the "Olympus Evis Exera II Gastrointestinal Videoscope" occurred on 10/13/22. These instructions stated, ". . . Detergent Solution . . . Use a . . . enzymatic detergent and follow the manufacturer's dilution and temperature recommendations. . . . Storage and Disposal . . . After reprocessing, keep the endoscope and accessories separate from any contaminated equipment. . . ."

Observation of the Endoscopy procedure area occurred on 10/12/22 at 2:45 p.m. with a licensed practical nurse (LPN) (#5). Observation showed endoscopes reprocessed in the soiled utility room of the medical/surgical unit. The LPN (#5) demonstrated the reprocessing procedure which included preparation of a sink of water with enzymatic detergent solution for manual cleaning prior to HLD. Upon removal of the endoscope from HLD, staff laid the clean endoscope on a counter directly to the right of a garbage can and rinse hopper utilized for the medical/surgical unit, where staff left the scope to air dry prior to storage.

Observation of the endoscope storage area showed an unlabeled, unsecured room with five endoscopes hanging on the wall. Each endoscope lacked a reprocessing date, expiration of reprocessing date, or indication of dirty or clean.

The Endozime AW Triple Plus with A.P.A. enzymatic detergent (used for manual cleaning) undated manufacturer's instructions, reviewed 10/12/22, stated, "use 1/2 ounce of solution to one gallon of water."

During interview on 10/12/22 at 3:00 p.m., the LPN (#5) who reprocessed the endoscopes stated she used "two pumps of the enzymatic detergent to approximately two-thirds full sink of water." The LPN (#5) confirmed she does not follow manufacturer's instructions for mixing the enzymatic detergent, no one has assessed her competency for scope reprocessing as "no one knows how," and there is no visual cue to indicate it has been reprocessed.

During interview on 10/13/22 at 9:30 a.m., an administrative nurse (#2) confirmed the facility failed to ensure the LPN (#5) completed a competency evaluation for endoscope reprocessing.


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TESTING SANITIZER CONCENTRATION:
3. Based on observation, review of the 2017 Food and Drug Administration (FDA) Food Code, review of hospital policy, and staff interview, the Critical Access Hospital (CAH) failed to ensure the correct concentration of chemical sanitizer for dishware and food preparation surfaces in 1 of 1 kitchen. Failure to ensure the correct concentration of the chemical sanitizer used for dishware and food preparation surfaces has the potential to result in a concentration that is too weak and not effective to sanitize or too high and may be toxic.

Findings include:

The 2017 FDA Food Code, Annex 3 - Public Health Reasons/Administrative Guidelines page 506, states, "The effectiveness of chemical sanitizers is determined primarily by the concentration . . . of the sanitizer solution. Therefore, a test kit is necessary to accurately determine the concentration of the chemical sanitizer solution."

Review of the policy "Testing Sanitizer Concentration" occurred on 10/12/22. This policy, dated, March 2016, stated, "POLICY: To ensure proper sanitizing of work surfaces . . . PROCEDURE: Testing sanitizing solution. . . 2. Staff will test sanitizer concentration. . . 4. Staff will record the concentration. . . ."

Observation of the kitchen occurred on 10/12/22 at 1:00 p.m. with the dietary manager (#7) and showed the following:
A bucket with a pink sanitizer solution, identified as quaternary ammonia.
An automated sanitizer solution dispensing system attached to the three-compartment sink which the dietary manager stated staff use to fill the sanitizer buckets.
No test strips or record/log for staff to document the concentration of the sanitizer solution from the automated dispenser.

During an interview with the dietary manager (#7) on 10/12/22, at 1:20 p.m., the dietary manager stated staff do not test the concentration, she was not aware of a log to document the concentration, or if there were test strips available.