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Based on observation, interview, and policy review, the facility failed to ensure controlled substances (medications that are high risk for abuse) were secured to prevent unauthorized access in two of three anesthesia carts (carts in operating rooms #3 and #18) observed in the main operating room (OR). There were a total of 28 anesthesia carts and 28 OR suites in the main OR. The main OR completes an average of 2400 surgical cases per month. The facility census was 752.

Findings included:

1. Record review of the facility's policy titled "Security of Medications in the Operating Room" revised on 12/01/10, showed direction for controlled substances to be kept under lock in all locations at all times. The sole exception is for controlled substances in the physical presence of and under the direct control of the qualified anesthesia provider.

2. Record review of the Anesthesia Narcotic (controlled substance) Log showed the following controlled substances were dispensed in the controlled substance box used by the anesthesia staff in the OR:
-One ampule (glass container) of Hydromorphone (narcotic pain medication) 2 milligrams (mgs - unit of measurement);
-One ampule of Meperidine (narcotic pain medication) 100 mgs;
-Five vials (glass container) of Midazolam (used for sedation and to create memory loss during procedures) 2 mgs;
-One vial of Ketamine (maintains anesthesia) 500 mgs;
-Five vials of Morphine (narcotic pain medication) 10 mgs;
-Five vials of Fentanyl (narcotic pain medication) 250 micrograms (mcgs - unit of measurement);
-Five vials of Fentanyl 100 mcg;
-Three ampules of Ephedrine (stimulant) 50 mgs.

3. Observation on 09/18/12 at 10:50 AM showed a controlled substance box located in the top drawer of an anesthesia cart located in OR #3. The anesthesia cart was not locked and was not attended by anesthesia staff. The controlled substance box contained all of the controlled substances listed on the Anesthesia Narcotic Log except only three of five of the Midazolam 2 mg vials, and only three of five of the Fentanyl 100 mcgs vials remained in the controlled substance box (due to use during procedures).

4. Observation on 09/18/12 at 11:00 AM showed a controlled substance box located in the third drawer of an anesthesia cart located in OR #18. The anesthesia cart was not locked and was not attended by anesthesia staff. The controlled substance box contained all of the controlled substances listed on the Anesthesia Narcotic Log.

5. During an interview on 09/18/12 at 11:10 AM, Staff R, Certified Registered Nurse Anesthetists (who was responsible for the controlled substance box found unsecured in OR #18), stated that controlled substances should be locked in the top drawer of the cart (which has a double-locking mechanism) but she hadn't taken the time to place the controlled substance in the top drawer of the anesthesia cart to secure the medications.

6. During an interview on 09/18/12 at 2:35 PM, Staff U, Director of Pharmacy, stated that controlled substances are to be locked and secure in the OR when the medications are not attended by the anesthesia staff.

7. During an interview on 09/18/12 at 3:40 PM, Staff V, OR Pharmacist, stated that he had no concerns about diversion (when a controlled substance is used for personal use) of controlled substances in the OR, but that occasionally the Anesthesia Narcotic Log is returned to pharmacy with a discrepancy (when returned medication amounts do not equal expected medication amounts). Staff V stated that when this happens, he contacts the anesthesia staff member and asks him or her to correct the Narcotic Log discrepancy. Staff V stated that the anesthesia staff member may or may not verify the remaining controlled substance amounts with the documented amounts of the controlled substance administered, but corrects the log, and the discrepancy is not further investigated.