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Based on review of professional literature and staff interview, the Critical Access Hospital (CAH) failed to ensure staff monitored and documented the temperature and humidity of 1 of 1 Operating Room (OR). Failure to monitor and document the temperature and humidity of the OR limited the CAH's ability to ensure the temperature and humidity was within the recommended ranges to inhibit the growth of bacteria and mold and decrease floating particulate matter and electrostatic electricity.

Findings include:

An article from the Association of Perioperative Registered Nurses (AORN), updated 06/30/09, stated, ". . . The recommended temperature range in an operating room is between 68 [degrees] F [Fahrenheit] and 73 [degrees] F . . . The recommended humidity range in an operating room is between 30% [percent] to 60%. Both the temperature and humidity should be monitored and recorded daily using a log or electronic documentation of the heating, ventilation, and air conditioning (HVAC) system.
. . ."

During interview on 11/05/14 at 2:00 p.m., an administrative nurse (#8) stated the CAH performed general, ophthalmologic, and podiatric surgery cases in the OR. The nurse (#8) stated staff checked the temperature and humidity of the OR on the days the CAH performed surgery, but failed to monitor and document the temperature and humidity daily.

Based on bylaws review, credentialing file review, agreements review, emergency department record review, operating room record review, and staff interview, the Critical Access Hospital (CAH) failed to ensure appointments and reappointments to Medical Staff followed their bylaws for 7 of 10 medical staff members' (Providers #1, #2, #3, #4, #5, #6, and #7) files reviewed and for 2 of 3 telemedicine entities (Entity #8 and #9). Failure to follow the bylaws for appointing and reappointing medical staff members limits the CAH's ability to ensure their patients receive treatment from qualified providers.

Findings include:

Review of "Unity Medical Center Bylaws of the Medical Staff" occurred on 11/03/14. These bylaws, adopted 01/24/12, stated, ". . .
Article III Medical Staff Membership . . .
Section 4. Conditions and Durations of Appointment
A. Condition for Appointment
1. . . . The Board shall act on appointments, reappointments . . . only after there has been a recommendation from the Medical Staff . . .
3. . . . b) Duration of Reappointments
Reappointments . . . shall be for a period of two years. . . .
Article IV Categories of the Medical Staff . . .
Section 7. Telemedicine Staff
A. . . . Individuals providing telemedicine services from a 'distant site' must be appointed to the Telemedicine Staff . . .
Article VII Determination of Clinical Privileges
. . .
Section 5. Temporary Privileges
A. . . . 1. . . . an appropriately licensed applicant may be granted temporary privileges for an initial period of thirty days, with subsequent renewals not to exceed the pendency of the application. . . ."

Review of the following provider credentialing files occurred on November 4-5, 2014:

- Provider #1's file showed the governing board approved reappointment to courtesy staff on 05/22/12 with an expiration date of 06/30/14. The file failed to show evidence of reappointment after 06/30/14.

- Provider #2's file showed a reappointment to active staff with an expiration date of 06/30/12 and temporary privileges granted for 30 days on 06/30/12. The governing board approved reappointment on 08/28/12 (29 days after the temporary privileges expired).

- Provider #3's file showed approval of temporary privileges for 30 days on 03/20/14. The governing board approved appointment to active staff on 06/24/14 (66 days after the temporary privileges expired).

- Provider #4's file showed approval of temporary privileges for 30 days on 06/13/14. The governing board approved appointment of this nurse practitioner to active staff on 07/29/14 (16 days after the temporary privileges expired).

- Provider #5's file showed approval of temporary privileges for 30 days on 07/11/12. The governing board approved appointment to courtesy staff on 08/28/12 (18 days after the temporary privileges expired).

- Provider #6's file showed approval of temporary privileges on 08/26/14 for 30 days. As of 11/05/14 the governing board had not approved appointment to courtesy staff (41 days after the temporary privileges expired).

- Provider #7's file showed approval of temporary privileges on 08/26/14 for 30 days. As of 11/05/14 the governing board had not approved appointment to courtesy staff (41 days after the temporary privileges expired).

Review of the following telemedicine entities' credentialing agreements occurred on November 4-5, 2014:

- Telemedicine Entity #8 had a telemedicine agreement with the CAH dated 10/11/12. The CAH failed to provide evidence the CAH's medical staff had recommended and the governing body had approved the appointment of the telemedicine entity's providers.

- Telemedicine Entity #9 had a telemedicine agreement with the CAH dated 12/08/11. The CAH failed to provide evidence the CAH's medical staff had recommended and the governing body had approved the appointment of the telemedicine entity's providers.

Reviewed on 11/05/14, the July 2014 emergency department provider schedule listed Provider #4 for July 13, 14, and 24-28. Reviewed on 11/05/14, the July 2014 emergency department patient logbook indicated Provider #4 treated CAH patients during the timeframe of July 13, 14, and 24-28.

Reviewed on 11/05/14, the 2012 operating room patient logbook indicated Provider #5 performed surgery for CAH patients on 08/14/12.

During an interview on 11/03/14 at approximately 8:15 a.m., an administrative laboratory staff member (#4) stated Provider #1 was the director of the laboratory.

During an interview the afternoon of 11/04/14, an administrative assistant staff member (#3) verified Providers #6 and #7 interpreted sleep studies for the CAH's patients. During an interview the afternoon of 11/04/14, a respiratory therapy staff member (#6) confirmed the CAH had provided services to sleep study patients in the past week.

During an interview on 11/05/14 at approximately 1:45 p.m., an administrative staff member (#1) confirmed the CAH's medical staff bylaws allowed for temporary privileges for a period of 30 days with subsequent renewals up to 90 days and confirmed the CAH had not renewed temporary privileges before appointment or reappointment for Providers #2, #3, #4, #5, #6, and #7.

During an interview on 11/05/14 at approximately 1:45 p.m., an assistant administrative staff member (#3) confirmed the CAH had not reappointed Provider #1 before the expiration of the last reappointment on 06/30/14.

During an interview on 11/05/14 at approximately 4:15 p.m., an assistant administrative staff member (#3) confirmed the CAH's medical staff had not recommended and the governing body had not approved the appointments of Telemedicine Entity #8 and #9 providers.

During an interview on 11/05/14 at approximately 5:00 p.m., an administrative staff member (#2) confirmed Provider #3 had provided treatment for the CAH's patients during the timeframe of April 19, 2014 through June 24, 2014

During an interview on 11/05/14 at approximately 5:15 p.m., an administrative staff member (#5) confirmed Provider #2 had provided treatment for the CAH's patients during the timeframe of July 31, 2012 through August 28, 2012.

Based on observation, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to store all drugs and biologicals in locked rooms, containers, and/or in a manner to prevent access by unauthorized personnel in 1 of 1 medication room and nurse station on the nursing unit, 1 of 1 emergency department (ED), and 1 of 1 surgery department. Failure of the CAH to adequately secure and restrict access of all drugs and biologicals created an opportunity for unsafe and unauthorized use of medications.

Based on review of the North Dakota Department of Health, Division of Health Facilities provider files, this facility has not sustained correction of this issue. The previous survey completed on 12/15/10 found this requirement out of compliance.

Findings include:

Review of the policy "Drug Storage" occurred on 11/05/14. This policy, dated 01/12/11, stated, ". . . A. All drugs and biologicals must be kept in a locked room or container. B. If container is mobile or readily portable, when not in use must be stored in a locked room, monitored location or secured location that will ensure the security of the drugs or biologicals. C. All drugs and biologicals must be stored in a manner to prevent access by unauthorized individuals. Persons without access to drugs or biologicals cannot have unmonitored access to drugs or biologicals. D. Persons without legal access to drugs or biologicals cannot have keys to medication storage rooms, carts, cabinets, or containers. . . ."

- Observation of the medication room on the nursing unit occurred on 11/03/14 at 5:15 p.m. with a staff nurse (#7) and showed a keypad lock secured the room. The nurse (#7) stated nursing staff and housekeeping staff accessed the room with the code to the keypad lock.

During an interview on 11/05/14 at 10:50 a.m., three unidentified housekeeping staff members confirmed they accessed the medication room with the code to perform cleaning of the room and stated they accessed and cleaned the room unsupervised.

- Observation of the nurses station occurred on all days of survey and showed a crash cart stored behind the station. Observation of the crash cart, on 11/05/14 at 10:00 a.m. with a staff nurse (#16), showed the cart contained various medications used in life-threatening situations and identified a numbered plastic break away lock secured the cart. The cart contained additional plastic locks, used as replacements, in clear plastic bags on top of the crash cart and attached to the side of the cart. Observation of the nurses station showed a lack of constant monitoring from nursing staff throughout the day and showed various staff members (nursing assistant, social worker, and housekeeping to name a few) utilized the station.

- Observation of the ED occurred on 11/05/14 at 11:20 a.m. with an administrative nurse (#8) and showed a crash cart stored in the main ED room. Observation of the crash cart showed the cart contained various medications used in life-threatening situations and identified a numbered plastic break away lock secured the cart. The cart contained additional plastic locks, used as replacements, in clear plastic bags on top of the crash cart. The administrative nurse (#8) stated the ED room remained unlocked and unmonitored when not in use for patients and stated housekeeping and maintenance staff had unmonitored access to the ED room for cleaning and maintenance.


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- Observation of the surgery department on 11/05/14 at 2:00 p.m. with an administrative nurse (#8), showed one operating room (OR) suite with an unlocked anesthesia cart containing various medications used in surgery. An unlocked cupboard in the suite contained local anesthetics including: 8 vials of Lidocaine, 4 vials of Xylocaine, 3 vials of Bupivacaine, and 2 vials of Sensorcaine. Observation of a small sterilizing room located in the surgery department showed an open box containing several vials of Tylenol. The administrative nurse (#8) indicated staff did not lock the anesthesia cart or the cupboard in the OR suite, and housekeeping staff cleaned the OR suite including the sterilization room at times without supervision.

During an interview on 11/05/14 at 10:15 a.m., an administrative nurse (#2) stated the CAH must lock or secure all medications to prevent unauthorized access. The nurse (#2) confirmed housekeeping staff should not have access to the code for the medication room and nursing staff must store the plastic locks for the crash carts in a secure place rather than on the cart.

1. Based on review of infection control reports, logs, and meeting minutes, and staff interview, the Critical Access Hospital (CAH) failed to implement a system to identify, report, investigate, and control infections and communicable diseases for 2 of 2 outpatient areas (Emergency Room (ER) and outpatient rehabilitation) of the CAH. Failure to identify and address incidents of infections among all patients has the potential for infections to go unreported, spread, or reoccur; affecting the health of all patients, personnel, and visitors of the CAH.

Findings include:

Reviewed on 11/04/14, the infection control records lacked evidence the CAH identified and recognized nosocomial and community-acquired infections of outpatients treated in the ER and those receiving outpatient rehabilitation. The current infection reports/logs/minutes failed to include information and documentation of all outpatients with known or suspected cases of infections and/or communicable diseases.

During an interview on 11/04/14 at 8:00 a.m., an administrative nurse (#6) stated the facility does not receive or request infection control information from all outpatients, including outpatient rehabilitation patients and ER patients. The nurse (#6) confirmed the CAH did not formally document and include all outpatients in infection control surveillance.

Failure to document all incidents of infection and communicable disease and perform surveillance among all outpatients of the CAH limited the staff's ability to identify, monitor, track, control, and prevent infections.


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2. Based on observation and staff interview, the Critical Access Hospital (CAH) failed to ensure staff followed professional standards of care related to infection control practices on 1 of 4 days of survey (11/05/14). Failure to follow established infection control practices may allow transmission of organisms and pathogens to patients.

Findings include:

Observation of an operating room (OR) suite (identified as the main room) on 11/05/14 at 3:00 p.m. with an administrative nurse (#8), showed an anesthesia machine set up for patient use with an attached rebreathing bag, breathing circuit, and anesthesia/face mask contained in an open package. Observation showed the anesthesia cart set up for patient use with a towel covering three laryngoscope blades attached to handles, an oral airway, and a tongue depressor. The nurse (#8) stated staff used the room for general, podiatric, and eye procedures with administration of general anesthesia. She stated staff had not used the anesthesia machine or supplies since the previous day and confirmed the CAH would not use the room until next week for surgical procedures.

Staff failed to store medical supply items in a manner to prevent contamination. Attaching, opening, and placing medical supply items prior to immediate use on a patient and not monitoring those items increased the risk for contamination.

During an interview on 11/06/14 at 7:45 a.m., an administrative nurse (#6) stated the above practice as unacceptable and stated staff should not prepare and open patient care supplies prior to immediate use on a patient.

Based on review of the North Dakota Board of Nursing practice statements, personnel files, and staff interview, the Critical Access Hospital (CAH) failed to ensure nursing staff possessed the qualifications related to each of their specific roles within the CAH for 1 of 1 registered nurse (RN) (Staff #8) personnel file reviewed required to possess current Pediatric Advanced Life Support (PALS) certification and for 2 of 2 RN (Staff #8 and #9) personnel files reviewed required to ensure competency in administering moderate sedation. Failure to ensure nursing staff possessed the certification and competency needed to perform their clinical duties has the potential to place patients at risk of adverse events.

Findings include:

Review of the North Dakota Board of Nursing Practice Statement "Role of Registered Nurse (RN) in the Management of Patients Receiving Moderate Sedation/Analgesia for Therapeutic, Diagnostic, or Surgical Procedures" occurred on 11/05/14. The practice statement, reviewed/revised October 2012, stated, ". . . B. Qualifications . . . 6. The institution or practice setting has in place an educational/competency validation mechanism that includes a process for evaluating and documenting the individuals' demonstration of the knowledge, skills, and abilities related to the management of patients receiving sedation/analgesia. Evaluation and documentation of competence occurs on a periodic basis according to institutional policy. . . ."

During an interview on 11/05/14 at 10:15 a.m., an administrative nurse (#2) stated the CAH staffed the emergency department (ED) with an RN and stated the CAH required current Advanced Cardiac Life Support (ACLS) and PALS certification for the RNs staffing the ED.

During an interview on 11/05/14 at 11:20 a.m., an administrative nurse (#8) confirmed the above interview and identified herself as one of the RNs who worked in the ED. At 2:00 p.m., the nurse (#8) stated she received training and education to administer moderate sedation to patients undergoing surgical procedures, as well as one other nurse (RN) (#9) who worked within the CAH. The nurse (#8) confirmed she and another nurse (#9) had administered moderate sedation for a number of years.

Review of personnel files occurred on the afternoon of 11/05/14. The file of an RN (#8) currently working in the ED included a PALS certification which expired in October 2012. The files of two RNs (#8 and #9) currently administering moderate sedation to patients failed to include evidence of a competency evaluation for administering moderate sedation.

During an interview on 11/06/14 at 9:10 a.m., an administrative nurse (#8) confirmed her PALS certification expired in October of 2012 and stated she has not taken the class for recertification. The nurse (#8) confirmed she and another nurse (#9) had not received competency evaluations for administering moderation sedation.