HospitalInspections.org

Based on observation, record review, and interview the facility failed to properly monitor the storage of blood products and other laboratory required monitoring.

Findings include:

On the morning of 8/31/21 during a laboratory tour the following logs were observed:
Blood Bank Refrigerator-No temperatures were recorded on 8/28/21, 8/29/21, 8/30/21, or 8/31/21.
Blood Unit Condition Check Hemolytic-Bacteria-Leaking-No checks were recorded on 8/28/21, 8/29/21, 8/30/21, or 8/31/21.
Lab office Area Humidity/Room Temp No checks were recorded on 8/28/21, 8/29/21, 8/30/21, or 8/31/21.
Lab office Fridge-No temperatures were recorded on 8/28/21, 8/29/21, 8/30/21, or 8/31/21.
Lab office Freezer-No temperatures were recorded on 8/28/21, 8/29/21, 8/30/21, or 8/31/21.

During an interview with Staff #4, lab manager, the findings were confirmed. She stated "logs are an ongoing problem. It should have been done daily".

Based on a review of facility documentation, tour observation and staff interviews, the facility failed to implement and/or enforce its own pharmacy policies related to safe dispensation of controlled pharmaceuticals and safe storage of refrigerated medications as:

a) all nurses had access to the pharmacy after hours, and counts on controlled substances were not performed according to facility policy or acceptable standards of professional practice; and

b) the facility failed to monitor the medication refrigerator temperatures on weekends.

These failed practices placed all patients at risk for receiving medications which were stored at unsafe temperatures. In addition, the facility had no real way to prevent/track possible diversion of controlled substances in a timely fashion.

Findings were:

Facility policy #15-10 for the pharmacy entitled "Control substance removal after hours," last revised/reviewed 3/21/16, included the following:
"Controlled Substance Policy
Storage ...
2. The charge nurse will have the keys on person at all times
3. Every shift change the charge nurse leaving will sign keys over to charge nurse coming on.

Removal from stock for pt use after hours
1. All controlled medications must have TWO signatures before being pulled from inventory.
2. Counts verified by both nurses at the time of removal ..."

In an interview with Staff #6, Pharmacy Manager, during a tour of the pharmacy on the morning of 8/31/21 with Staff #6 and #2, the Director of Nursing, Staff #6 indicated a locked metal cabinet at the end of a narrow alcove in the pharmacy which she identified as the place where controlled pharmaceuticals were kept. When asked how often counts were performed on the controlled medications, she stated, "We count once a month ... All nurses have access to the pharmacy. They'd have to be able to get controls out when we're not here ... They have to sign out for what they take." Surveyors, noting a camera on the wall opposite the cabinet, asked if the facility had a video view of who took medications from the cabinet. Staff #6 answered that they did. When it was pointed out by surveyors that the camera would provide only a view of the back of the individual taking controlled substances, Staff #6 and Staff #2 agreed this was the case. When surveyors pointed out that an individual could take out six vials rather than one, or a different medication entirely, and the video would look no different still showing only the staff member's back, the two staff members agreed. When asked if it was possible that a discrepancy in the narcotic counts might not be noticed for a full month, Staff #6 said, "Yes." Staff #6 was also asked how often expired narcotics were counted. She answered, "They're picked up every 3 months." When asked again several minutes later how often expired narcotics were counted, she again stated, "They're picked up every 3 months."


Facility policy #09-04 for the pharmacy entitled "Temperatures: Storage," last reviewed 10/18/19, included the following:
" ...All drugs shall be stored at appropriate temperatures that do not exceed manufacturer's recommendations or warnings ..."

Facility policy #09-05 for the pharmacy entitled "Refrigeration and Freezing," last reviewed 10/18/19, included the following:
"POLICY
Biologicals and thermolabile drugs that require refrigeration or freezing shall be stored in a refrigerator or freezer that is capable of maintaining the necessary temperature ...

THERMOMETERS
A thermometer that will indicate the normal range shall be kept in each drug refrigerator and freezer (unless built into the refrigerator or freezer).

REFRIGERATOR AND FREEZER TEMPERATURE MONITORING
Refrigerator and freezer temperatures in patient care areas shall be monitored and recorded daily. The Director of Pharmacy may require a more frequent monitoring.

If temperatures deviate from the acceptable range, an adjustment shall be made. Refrigerators and freezers that will not maintain the acceptable temperature range shall be repaired or replaced ..."

In an interview with Staff #6, Pharmacy Manager, during a tour of the pharmacy on the morning of 8/31/21 with Staff #6 and #2, the Director of Nursing, Staff #6 said the temperatures for the pharmacy refrigerator were not checked on the weekends. Review of the refrigerator temperature log revealed temperature values were left blank each weekend. Stored in the refrigerator were numerous medications available for patient use.


These above findings were confirmed a final time in an exit interview with the hospital administrator and director of nursing on the morning of 9/1/21. No additional evidence of compliance was provided to surveyors at that time.