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Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) staff failed to store cidex test strips appropriately in 1 of 1 radiology department (ultrasound room) in accordance with manufacturer's recommendations. The CAH staff identified the ultrasound staff cleaned vaginal probes 58 times from 8/2/2020 to 12/18/2020. Failure to store cidex test strips properly could result in false readings of the effectiveness of the disinfectant.

Findings included:

1. Observation on 12/28/2020 at approximately 2:00 PM, of the Ultrasound Room revealed 9 unlabeled test strips loose in a drawer.

2. Review of CAH policy "Alternative Methods of High-Level Disinfection," dated 12/19, revealed in part, "...Prior to using CIDEX OPA...the solution should be tested with CIDEX OPA SOLUTION TEST STRIPS to ensure that the Minimum Effective Concentration (MEC) of ortho-phthalaldehyde is present. Follow directions on test strip container for use of test strip...."

Review of manufacturer's directions for storage of CIDEX OPA Solution Test Strips revealed, in part, "...Store CIDEX OPA Solution Test Strips in the original bottle with the cap tightly closed...Precautions: Do not use any remaining strips 90 days after opening the bottle. Do not leave the test strip bottle open for more than 30 minutes. Improper storage or use of test strips may result in false readings...Tightly re-cap test strip bottle after each use to minimize exposure to humidity...."

3. During an interview on 12/28/2020 at approximately 2:00 PM at the time of the observation, Ultrasonographer D stated the test strips in the drawer were used to test the Cidex OPA to test the effectiveness of the disinfectant prior to disinfecting the vaginal probes. Ultrasonographer acknowledged the test strips were not in their original container and did not know the expiration date of the test strips.

I. Based on observation, document review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure all drugs are appropriately stored (properly secured) when it maintained drugs, including controlled medications (medications that can cause physical and mental dependence) in 1 of 1 mobile carts containing medications (anesthesia medication cart) in an unsecured surgery department near unlocked access doors. Failure to appropriately secure drugs, including controlled medication, could result in unauthorized access to the medication and drug diversion for personal use. The surgery staff identified it performed 222 endoscopy and 60 surgical procedures from 1/1/2020 - 12/30/2020.

Findings include:

1. Review of Surgery Department policy "Fentanyl Diversion", dated effective on 4/18, revealed in part, "To monitor and verify Fentanyl usage in the surgery department...is a powerful synthetic opioid analgesic ...similar to morphine..50 to 100 times more potent.. can be highly addictive... readily available in surgery departments.. stringent monitoring of Fentanyl use in the surgery department is necessary..."

2. Review of facility "Evacuation Route" floor plan map, revealed 8 doors led into/out of the unsecured surgery department. An east surgery department door, near the operating room where the mobile anesthesia cart was stored, led into a hallway near Materials Management and out the east side of the building by the Northeast Parking Lot.

2. Observations during a tour of the Surgery Department on 12/29/2020 at approximately 11:15 AM, revealed 1 of 1 mobile, wheeled anesthesia medication cart in an unlocked, unsecured operating room. The wheeled, mobile anesthesia cart, contained approximately 231 medications, and 64 controlled drugs (including 8 vials of Fentanyl), in a locked "Narcotic Box". Narcotic medications may be administered to a patient during a surgical procedure for sedation and pain control.


3. During an interview on 12/29/2020, at the time of the tour, Director of Surgical Services acknowledged the anesthesia cart, which contained drugs, including controlled substances, were not secured. The surgery department had at least 8 entry doors and the surgery department was not locked when the department is not staffed. The Director of Surgical Services acknowledged it would be possible for an individual person(s) to roll the cart through any of the 8 unlocked access doors, into a hallway and out of the building without detection. The Director of Surgical Services was not aware of a hospital or surgical policy related to the security of medications.

4. During an interview on 12/30/2020 at 3:36 PM, Pharmacy Manager acknowledged the pharmacy is responsible for all medications in the hospital . The Pharmacy Manager revealed he did not know the surgery department was not locked when the department was not staffed. The Pharmacy Manager reported was aware the cart was on wheels and the location of the cart, but had thought the area was secured. The Pharmacy manager acknowledged the medication cart, included controlled medications, and despite being locked, failed to be secured because the cart could be rolled out of the department and the hospital.



II. Based on observation, document review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure all drugs are appropriately stored when the surgery department maintained drugs in a surgery department refrigerator that was not monitored when the surgery was not staffed after hours on weekdays, nor on weekends or holidays. Failure to monitor the refrigerator temperature at all times may result in unrecognized failure of the refrigerator to maintain the appropriate temperature to maintain drug viability. Medications that require refrigeration can expire quickly if improperly stored becoming toxic or less effective. The surgery staff identified it performed 22 endoscopy procedures and 60 surgical procedures from 1/1/2020 - 12/30/2020.


Findings include:

1. Review of hospital policy "Temperature Checks on Medication Refrigerators", dated last revised 4/20, revealed in part, " all refrigerators that contain medication will have temperature monitored...if reading is not the acceptable range...maintenance department will be notified immediately...nurse ...responsible for moving the medication...Surgery staff will check Monday-Friday."

2. Observation during a tour of the Surgery Department on 12/29/20 at approximately 11:00 AM, revealed a locked refrigerator in a small medication room containing 39 vials of various medications, including Rocuronium and Succinylcholine, medications used for anesthesia that have a shortened expiration date when not stored in appropriate refrigerated temperature. The refrigerator temperature log revealed the temperature was checked 5 days a week, Monday through Friday, except for 12/25 holiday.

3. During an interview on 12/29/20, at the time of the tour, Director of Surgical Services reported the medication refrigerator temp was checked and recorded Monday through Friday when the department was open. The refrigerator was plugged into an electrical outlet run by the generator in times of power outage. The Director of Surgery revealed the refrigerator would alarm if it went out of range but it could only be heard if the department was staffed. The alarm was not connected to any other hospital staff alerting system. The Director of Surgical Services acknowledged that the hospital staff had no way of knowing if the temperature of the refrigerator maintained the appropriate temperature range during the time the surgery department was not staffed, which could be up to 4 days.

4. During an interview on 12/30/20 at approximately 3:45 PM, the Pharmacy Manager and the CNO acknowledged the Surgery Department Medication refrigerator was not monitored for days at a time and could go out of range without hospital staff knowledge and appropriate management of the refrigerated medications.

Based on document review and staff interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure 1 of 1 Advanced Registered Nurse Practitioners (ARNP B), selected for review, held delineated privileges for providing care to CAH inpatients, approved by the CAH Medical Staff and Board of Trustees. Failure to ensure all providers hold approved delineated privileges could potentially result in a practitioner providing care beyond their capabilities and compromise safety of CAH patients. ARNP B provided care for 29 inpatients from 1/1/2020 to 12/30/2020.

Findings include:

1. Review of the medical staff bylaws, revised 7/2020, revealed in part "... Privileges to practice at the Hospital are granted by the Board following recommendation of the Medical Staff ... A practitioner may exercise only those clinical privileges specifically granted in accordance with these Bylaws ...".

2. Review of the CAH policy "Credentialing of Medical Staff," approved 2/19/2019, revealed in part " ... According to Medical Staff Bylaws, privileges to practice at [CAH] are granted by the Board of Trustees following recommendations of the Medical Staff ... New Appointment Procedure ... Applicants for appointment to [CAH] must complete ... the universal application ... The application must contain ... Delineation of Privileges ... every two years each practitioner with privileges at the [CAH] will submit to the medical staff a signed, completed application for reappointment and renewal of privileges ... Completed packet along with reappointment form will be presented to medical staff for recommendation. Medical staff recommendation taken to Hospital Board of Trustees. Final decision made by the Hospital Board of Trustees ... ".

3. Review of ARNP B's credential file revealed a packet for an initial appointment to the CAH medical staff. A document titled "Delineation of Privileges", signed by ARNP B on 6/19/18, indicated she desired medical privileges but the document failed to identify the specific medical priceless requested. A document titled "Appointment Recommendation Flow Sheet" identified the CAH medical staff approved ARNP's appointment on 9/11/18 and the Board of Trustees approved the appointment on 9/27/18, without any delineated privileges.

ARNP B's credential file contained a document titled "Additional Privileges Requested", which identified a request for delineated privileges for wound care, signed by ARNP B on 9/16/19. The document showed wound care privileges approved and granted by the CAH medical staff on 9/17/19 and the Board of Trustees approved the appointment on 9/25/19.

ARNP B's credential file contained a packet for re-appointment to the medical staff and included a document titled "Privilege Delineation Acknowledgement", signed by ARNP B on 8/27/20. The privilege document revealed in part " ... Please review your current privileges and identify below any changes which you are requesting and the basis for these changes ... ". The document showed ARNP B selected "No Change", with an attached copy of the privileges requested on 9/16/19, which identified only delineated privileges for wound care. A document titled "Appointment Recommendation Flow Sheet" identified the CAH medical staff approved ARNP B's appointment on 9/15/20 and the Board of Trustees approved the appointment on 9/23/20.

During an interview on 12/30/20, at 11:00 AM, the Director of Inpatient Services, acknowledged ARNP B's delineation of privileges identified wound care procedures and failed to include any privileges for the medical care of CAH inpatients. She confirmed ARNP B routinely admits and follows CAH inpatients.

During and interview on 12/30/20, at 12:00 PM, Staff C, Credentialing/Health Information Management, acknowledged ARNP B's delineation of privileges identified only wound care procedures. Staff C acknowledged the oversight and confirmed she should have noticed it and the document should have been corrected by ARNP B to include all of the desired specific medical privileges for inpatient care.

Based on observation, document review, and interviews, the Critical Access Hospital's (CAH) administrative staff failed to ensure the surgery staff changed the sterile water flush bottle after endoscopy procedures for each patient, in accordance with the manufacturer's directions. Failure to change the flush bottle of sterile water after each patient could potentially result in cross contamination of the sterile water with bacteria or other microorganisms, potentially causing an infection in the next patient. The CAH Administrative staff identified the surgery staff performed approximately 222 endoscopy procedures from 01/01/2020 to 12/30/2020.

Findings include:

1. Observations during a tour of the surgery department on 12/29/2020 at approximately 11:04 AM, in the Endoscopy Room (used to perform endoscopy procedures), revealed 1 of 1 B Braun 1000 ml bottles of sterile water for irrigation, opened and sitting adjacent to the endoscopy equipment (a nonsurgical procedure where a physician inserts a flexible camera into a patient's body to examine the digestive tract). The label on the 1000 ml bottle of sterile water for irrigation read in part " Single unit container. Discard unused portion."

2. Review of manufacturer B. Braun Medical Inc. package insert instructions, dated "Revised 1/2019", revealed in part..."..Sterile, nonpyrogenic. Single unit container. Discard unused portion...since it contains no preservative. After opening the container, its contents should be used promptly... minimize the possibility of bacterial growth or pyrogen formation".

3. During an interview on at the time of the tour, 12/29/20, the Director of Surgical Services reported the surgery staff opened the bottles of sterile water for irrigation each day endoscopy procedures are scheduled and connected it to the equipment. The equipment contained a one-way valve to prevent backflow between patients to prevent contamination of the source bottle. The surgery staff changed the flush tubing between the patient and the one-way valve after each endoscopy procedure, but did not change the tubing between the one-way valve and the bottle of sterile water for irrigation or replace the bottle of sterile water for irrigation between endoscopy procedures. The surgery staff would only discard the bottles of sterile water for irrigation once they completed all of the endoscopy procedures for the day or if the bottle ran empty.

4. During an interview on 12/29/2020 at approximately 2:40 PM, the Director of Surgical Services reported she reviewed and confirmed the manufacturer's directions for B. Braun's 1000 ml of sterile water for irrigation. The Director of Surgical Services acknowledged the manufacturer's product information and product label did not support using the bottles of sterile water for irrigation for more than one patient.

Based on observation, document review and staff interview the Critical Access Hospital (CAH) Dietary Department failed to ensure the removal of outdated sanitizing solution test strips from use and ensure the sanitizing solution, used to sanitize food contact surfaces, reached the manufacturer's required concentration. The CAH administrative staff identified a census of 6 patients at the time of the survey and the Director of Dietary reported the department served approximately 12 patient meals daily. Failure to properly sanitize food contact surfaces, prior to food preparation, could potentially result in inadequate removal of microorganisms leading to foodborne illness.

Finding include:

During an observation on 12/28/20, at 11:30 AM, Staff A, cook, obtained a quaternary sanitizing solution test strip to measure the concentration of the Oasis 146 Multi-Quat solution. She held the strip in the solution and compared the strip to the color coded key on the container. Staff A showed it matched the color identified as 100 PPM and reported the minimum concentration should be 100 ppm.

Review of a document titled "Sanitizing Solution PPM (parts per million)", revealed the following "... Quaternary sanitizing solutions should be maintained at or above 200 PPM ...". The document showed columns to record the sanitizer test results three times daily, for the month of December 2020. The document showed 100 recorded for all results in each of the PPM columns, through the AM column of 12/28/20.

Observation of the sanitizer test strips container identified an expiration date of 12/2019. The Director of Dietary confirmed the test strips had expired and reported she believed she had another bottle, however when she retrieved a second container, it also identified an expiration date of 12/2019.

Review of the manufacturer directions for use of Oasis 146, a quaternary sanitizing solution, currently in use in the CAH kitchen, identified an effective concentration of 200-400 ppm.

During an interview on 12/20/2020, at 4:10 PM, the Director of Dietary reported the dietary staff have received training on the requirements of the sanitizing solution concentration but confirmed the need for additional education to ensure outdated test strips are removed from use and the solution meets the required manufacturer requirements.