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Based on bylaws review, staff interview, and record review, the Critical Access Hospital's (CAH) governing body failed to grant clinical privileges for 8 of 10 physicians (Physicians #4 - #11) providing echocardiogram interpretation and 1 of 1 physician (Physician #12) providing electroencephalogram (EEG) interpretation for the CAH's patients through electronic communication (telemedicine). Failure to grant clinical privileges to physicians providing services to the CAH's patients limits the governing body's ability to ensure their patients receive services from qualified providers.

Findings include:

Review of the governing board's bylaws titled "Bylaws of St. Joseph's Hospital and Health Center" occurred on 04/20/15. These bylaws, effective 12/03/09, stated,
". . . Article IX Medical Staff
Section 9.1 Organization. The Board of Directors shall appoint a Medical Staff . . . who are privileged to attend patients in the hospital . . . Only a licensed practitioner with clinical privileges in the Hospital may be directly responsible for a patient's admission, diagnosis and treatment. Such practitioners may practice only within the scope of the privileges granted by the Board of Directors. . . ."

Review of the "St. Joseph's Hospital and Health Center Medical Staff Bylaws" occurred on 04/20/15. These bylaws, approved 06/12/14, stated,
". . . 6. Clinical Privileges
6.14 Remote Providers and Telemedicine Privileges
6.14.1. In order to meet patient care needs, the Hospital may enter into agreements with Practitioners, hospitals, or other health care entities to provide clinical services (including but not limited to interpretive and, diagnostic, or consultant services) through remote providers using telemedicine technology. In such instances, the individual Practitioners must be granted appropriate Clinical Privileges . . .
6.14.7. In all cases the MEC [Medical Executive Committee] and the Board must approve the Practitioner's Clinical Privileges. . . ."

During an interview on 04/21/15 at approximately 10:00 a.m., an administrative radiology staff member (#6) stated [name of remote entity] provided interpretation of echocardiograms through electronic communication.

On 04/21/15, an administrative staff member (#1) provided a list of the physicians from [name of remote entity] who interpret echocardiograms for the CAH. The list included Physicians #4-#11.

During an interview on 04/21/15 at approximately 1:00 p.m., an administrative respiratory therapy staff member (#7) stated Physician #12 interpreted EEGs for the CAH's patients through electronic communication.

Reviewed on 04/22/15 the CAH's 2015 Medical Staff Roster did not include Physicians #4-#12.

During an interview on 04/22/15 at approximately 9:30 a.m., an assistant administrative staff member (#3) responsible for credentialing activities confirmed the medical staff had not recommended and the governing body had not granted clinical privileges to Physicians #4-#12.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the removal of outdated medications from 3 of 14 emergency crash carts (neonatal cart and "adult" cart on the obstetric nursing unit, and a pediatric cart on the medical/surgical nursing unit). Failure to remove outdated medications may result in patients receiving expired and ineffective medications.

Findings include:

Review of the facility policy "Emergency Crash Cart" occurred on 04/22/15. This policy, reviewed August 2014, stated, ". . . Policy: 1. The Department of Medicine determines what emergency medications and/or supplies will be stocked in the Emergency Crash Cart. There are adult crash carts and pediatric crash carts. The medications are in unit-dose, age-specific and ready to administer forms whenever possible . . ."

- On 04/21/15 at 8:00 a.m., observation of the obstetrics/labor and delivery nursing unit occurred with an administrative nurse (#5). Observation identified a 250 milliliter (ml) intravenous (IV) bag of 5% dextrose, expired April 1, 2015 in the "adult" crash cart stored in the supply room on the unit.

- On 04/21/15 at 8:10 a.m., observation of the nursery occurred with an administrative nurse (#5). Observation identified a 250 ml IV bag of 5% dextrose, expired February 1, 2015; a 10 ml vial of calcium gluconate, expired February 2015; and a vial of vitamin K, expired March 1, 2015 in the neonatal crash cart.


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- Observation of the Pediatric Crash Cart located on the Medical/Surgical nursing unit, on 04/21/15 at 10:15 a.m., showed a 2 milligram/milliliter injectable Ativan with an expiration date of 04/04/15.

During an interview on 04/22/15 at 9:15 a.m., an administrative pharmacy staff member (#5) stated the pharmacy department's policy is to check the crash carts quarterly, however, pharmacy staff have been checking them monthly. Review of the crash cart checklist showed pharmacy staff last checked all of the crash carts in February 2015. The administrative pharmacy staff member confirmed staff should have removed the expired medications.

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 during observation in 3 of 3 unattended operating rooms (ORs) (outpatient surgical department #1, inpatient surgical department #3, and gastrointestinal (GI) lab). Failure to follow established infection control practices may allow transmission of organisms and pathogens to patients.

Findings include:

Observation of the surgical department (inpatient and outpatient) occurred on 04/20/15 at 1:00 p.m. with an administrative surgical nurse (#3). An unattended OR suite (#1) in the outpatient surgical department 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. The machine also included items set up for patient use such as oxygen tubing with nasal cannula and suction tubing with a yankauer contained in open packages. Observation of two other unattended OR suites (#3 and GI Lab) in the inpatient surgical department identified anesthesia machines set up as described above.

During an interview at this time, the nurse (#3) stated the CAH utilized the above OR suites for general, obstetric, GI, and orthopedic surgeries/procedures and confirmed completion of all surgical cases for the day in the above suites. She identified anesthesia as the staff members responsible for maintaining the anesthesia machines.

The above findings suggest staff prepared the anesthesia machine with patient care items for use during a future date. 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 04/22/15 at 9:40 a.m., an administrative nurse (#1) assisting with infection prevention activities, stated the above practice as unacceptable and stated staff should not prepare and open patient care supplies prior to immediate use.

Based on observation, policy review, review of professional food safety standards, and staff interview, the Critical Access Hospital (CAH) failed to ensure the provision of dietary services in accordance with recognized food safety practices in 1 of 1 kitchen. Failure to follow food safety practices regarding cooling of foods which require time and temperature control, placed patients, staff, and visitors consuming food prepared in the kitchen at risk of food borne illness.

Findings include:

Review of the CAH policy, "HACCP [Hazard Analysis Critical Control Point]/Food Safety" occurred on 04/22/15. This policy, dated July 2014, stated, "POLICY: The Nutrition Services Department monitors the effectiveness of the food safety program . . . PURPOSE: To ensure that the system prevents the transmission of food borne illness. . . . Guidelines: . . . 7. Nutrition Services use the HACCP/ServSafe Program as the guidelines for prevention of food borne illness. . . ."

ServSafe, Fifth Edition, 2008, Chapter 7, states, "Cooling Food . . . pathogens grow well in the temperature danger zone. . . . Cool TCS [time/temperature control for safety] food from 135 degrees Fahrenheit (F) to 41 degrees F or lower within 6 hours. First, cool food from 135 degrees F to 70 degrees F within two hours. Then cool it to 41 degrees F or lower in the next four hours. . . ."

The 2013 United States Public Health Service - FDA Food Code, Annex 3, Public Health Reasons, (3-501.14 Cooling and 3-501.15 Cooling Methods), states, "Safe cooling requires removing heat from food quickly enough to prevent microbial growth. . . . If the food is not cooled in accordance with this Code requirement, pathogens may grow to sufficient numbers to cause foodborne illness. . . . Large food items, such as roasts, turkeys . . . take longer to cool because of the mass and volume from which heat must be removed. By reducing the volume of the food in an individual container, the rate of cooling dramatically increased and opportunity for pathogen growth is minimized. . . ."

Observation of the kitchen's walk-in cooler on 04/22/15 at 7:00 a.m. showed three large cooked turkey roasts in a metal container. Each of the three whole roasts were in their original plastic packaging, with one corner of the packaging cut off and facing upward in the pan. Observation showed cooled drippings in the bottom of the pan.

During interview the morning of 04/22/15, an administrative dietary staff member (#4) stated the CAH purchased raw turkey roasts and staff cooked the roasts in the original packaging. Staff cooked the roasts yesterday and placed them in the walk-in cooler for use at a later time.

The CAH failed to provide documentation staff cooled the turkey roasts according to food safety guidelines.

Based on policy review, record review, and staff interview, the Critical Access Hospital (CAH) failed to have a network hospital or a quality improvement organization (QIO) or equivalent evaluate the quality and appropriateness of the treatment furnished for 3 of 3 reappointed physicians' (Physicians #1, #2, and #3) credentialing records reviewed from 2013-2015. Failure to have a network hospital or a QIO or equivalent evaluate the quality and appropriateness of the treatment furnished by physicians limits the CAH's ability to ensure physicians furnished quality and appropriate care to the CAH's patients.

Findings include:

Review of the policy titled "Medical Staff Policy: MS [Medical Staff]-8" occurred on 04/22/15. This policy, revised December 2014, stated, "Purpose: To define the . . . circumstances under which external peer review is required . . . Circumstances Under Which External Peer Review Is Required: The Medical Staff Review Committee may request the matter be reviewed by a peer who is not a member of the active medical staff at St. Joseph's Hospital and Health Center. . . ." The policy failed to require a network hospital or a QIO or equivalent evaluate the quality and appropriateness of the treatment furnished by physicians.

Reviewed on 04/21/15 the following physicians' credentialing records from 2013-2015 failed to include evidence a network hospital or a QIO or equivalent evaluated the quality and appropriateness of the treatment furnished by physicians before reappointment:
- Physician #1 approved for reappointment on 12/15/13
- Physician #2 approved for reappointment on 01/29/15
- Physician #3 approved for reappointment on 01/29/15

Upon request on 04/22/15, the CAH failed to provide evidence a network hospital or a QIO or equivalent evaluated the quality and appropriateness of the treatment furnished by physicians.

During interview at approximately 8:30 a.m. on 04/22/15, an administrative staff member (#1) confirmed the CAH did not have a network hospital or QIO or equivalent evaluate the quality and appropriateness of the diagnosis and treatment furnished by physicians.