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Based on observation, staff interview and record review, the CAH (Critical Access Hospital ) failed to assure drugs and biological utilized by Perioperative Services were appropriately stored under proper temperature conditions and managed by the Pharmacy Department in accordance with accepted professional principles. Findings include:

During a tour on 9/23/13 at 2:22 PM with the Director of Surgical Services, which includes preoperative, operating rooms and post-anesthesia recovery) the thermometer in a refrigerator where medications, irrigation solutions and orthopedic cements are stored and utilized during surgical procedures by anesthesia and surgeons was observed registering a temperature of 50 degrees Fahrenheit. (F.) Per review of the CAH's "Record of Refrigerator Temperature", the acceptable temperature range for medications was 36 - 46 F. Further review of documentation noted the refrigerator temperatures were consistently documented once every 24 hours and were within a safe range, but no monitoring was performed on weekends, the thermometer presently used by staff did not provide or record continuous monitoring nor could it be calibrated to ensure accuracy. Per interview at the time of observation, the Director for Surgical Services, confirmed the present temperature was not in acceptable range.

Per review of CAH's Pharmacy policy Monthly Unit Inspections effective date 2/28/08 stated "A pharmacist or designee will make a monthly inspection of all Pharmacy items stored on Nursing Stations, Speciality units, and other locations where drugs may be stored....". However, per interview on 9/23/13 at 2:43 PM, the Pharmacy Director stated s/he was unaware of the medications being stored by Perioperative staff, stated the refrigerator used for drug storage was overcrowded, the thermometer was inappropriate for consistent monitoring to maintain product stability and acknowledge there was a failure by the Pharmacy Department to ensure proper monitoring of all drugs and biological throughout the CAH and acknowledged a failure in communication between Periopertive Services and Pharmacy.

Per American Society of Hospital Pharmacy Technical Assistance Bulletin on Hospital Drug Distribution and Control , last reviewed/updated 2005 by the Council on Professional Affairs states: page 88, Drug Control in Operating and Recovery Rooms : " The institution's drug control system must extend to its operating room complex. The pharmacist should ensure that all drugs used within this area are properly ordered, stored, prepared, and accounted for."

Per interview on 9/24/13 at 8:30 AM, the CAH Biomed Technician confirmed the present thermometer utilized in the Periopertive services refrigerator was not appropriate, noting other CAH outpatient medical offices utilize a refrigerator thermometer which can be calibrated and records temperature ranges. In addition, the Pharmacy Director stated, in all other areas of the hospital where there is refrigerated drug storage, thermometers are wired to a master panel, and if a variation in temperature ranges did occur either the pharmacy or maintenance are paged to troubleshoot the issue.

When concerns regarding drug storage monitoring and stability of medications stored in the Periopertive refrigerator was brought to the attention of CAH Administrative staff, the Director of Pharmacy and the Director of Surgical Services a corrective action plan was developed and implemented. A medical grade refrigerator was ordered, drugs and biologicals removed from the refrigerator in Perioperative, and a review of inventory was conducted by Pharmacy with further follow up regarding stability and safety of medications that had been stored in the perioperative location.