HospitalInspections.org

Based on record review, interview, and observation, the hospital failed to:

I. report and correct controlled substance discrepancies in the Omnicell (automated medication dispensing machine) in a timely manner. This failed practice resulted in three observed control substance discrepancies from 05/1/18 to 05/08/18 and 160 documented discrepancies from 10/01/17 to 04/27/18, all of which had the likelihood to create circumstances conducive for controlled substance diversion.

Findings:

I. Controlled Substance Discrepancies:
A review of the Omnicell manual defined a discrepancy as the difference between the "expected amount" of a medication stocked in the machine and the "actual amount". The manual showed a discrepancy could be triggered during issue, return, restock, cycle counts or bin level changes.

A review of the "Pharmacy and Therapeutics Committee Minutes" from 10/11/17 to 04/09/18 showed the following:
* 04/09/18: 31 discrepancies with comment of "Clinical Coordinator will begin resolving all discrepancies by end of shift."
* 03/09/18: 14 discrepancies
* 02/09/18: 23 with comments 2 miss keys, 10 miscounts, 1 input errors, 1 miss pulls, 1 restock errors, 9 miscounts carrying forward
* 01/05/18: 22 with comments 10 miscounts, 3 miss pulls, 1 restock error, 3 miscounts carrying forward, 5 timing of count
* 12/07/17: 21 with comments 7 miss key, 9 miscounts, 2 input errors, 3 timing of counts
* 11/07/17: 22 with comments 4 miss key, 16 miscounts, 1input errors

A review of the document titled, "Pharmacy Discrepancy Report" from 10/01/17 to 04/30/18 showed 160 discrepancies. Some examples of discrepancies and of resolutions not being performed within the 12 shift time frame on this report were as follows:
* On 04/01/18 at 9:38 am, a discrepancy involving Marinol 2.5mg capsule was created and nine more discrepancies followed until resolved on 04/06/18 at 6:29 pm. Staff documented reasons for the discrepancies as "carry over", "miscount", "correct count 11 per count sheet", "paper count correct".
* On 03/28/18 at 4:49 pm, a discrepancy involving Morphine Sulfate injection was created and resolved 04/02/18 at 6:56 am with documented reason "error in previous countback quantity".
* On 02/15/18 at 9:34 am, a discrepancy involving Dilaudid injection was created and resolved on 02/16/18 at 10:04 am with documented reason "destocked 2 x 2mg and replaced with 4 mg".
* On 01/07/18 at 9:17 am, a discrepancy involving Lyrica 75mg was created and resolved on 01/12/18 at 8:22 am with documented reason "previous miscount".
* On 12/16/17 at 8:03 pm, a discrepancy involving Norco tablets was created and resolved on 12/18/17 at 12:07 pm with documented reason "error in count back".
* On 11/02/17 at 12:35 pm, a discrepancy involving Duragesic patch was created and resolved on 11/09/17 at 9:17 am with documented reason "Count after med removed".
* On 10/28/17 at 6:35 pm, a discrepancy involving Norco tablets was created and resolved on 11/01/17 at 4:55 pm with documented reason "error in previous count".

A review of policy titled, "Automatic Dispensing Machines- Control Substances (date 06/17)" documented:
* controlled substances inventory count should be performed once a shift.
* if a inventory count was incorrect, the user should be prompted to perform a recount. If the recount remained incorrect, a discrepancy should be created and communicated to Pharmacy Service.
* controlled substances shall be reported to the Pharmacy and Therapeutic Committee immediately.
* controlled substances discrepancies must be resolved at the time of discovery or by the end of shift.
* resolution of each discrepancy must be documented in the automatic dispensing system and witnessed by a second nurse. The policy failed to instruct how the resolution "reason" should be described in a uniform manner.

On 05/01/18 at 11:58 am, Staff TTTT, the Pharmacist stated discrepancies should be resolved at time when occurred and too many were occurring.

On 05/01/18 at 11:22 am, Staff E stated when the Omnicell detected a discrepancy, a notification message would appear in the Omnicell's screen which queued the staff to reassess the count. The Omnicell allowed staff to bypass the message and obtain the medication; an icon would appear on the screen which indicated a discrepancy existed. Staff E stated when staff created a discrepancy, they should notify the Charge Nurse as soon as possible.

On 05/01/18 at 11:22 am, Staff XX, Charge Nurse stated he/she was not notified of the 05/01/18 Ultram discrepancies. Staff XX and Staff A stated the discrepancies must be resolved by end of each shift (within 12 hours).

On 05/01/18 at 11:22 am, surveyor observed 2 discrepancies in the Omnicell involving Ultram 50 milligram tablets. The Omnicell showed discrepancies occurred at 05/01/18 at 9:34 am by Staff V and another cascading discrepancy resulted at 10:21 am when Staff Y removed an Ultram for another patient.

On 05/01/18 at 3:15 pm, Staff E and Staff Y performed an Omnicell narcotic count. The surveyor observed the bin designated for Halcion 0.125mg vial was empty and the Omnicell count was one. Staff E called the pharmacy and was told the Halcion had expired, was removed, and the technician failed to select zero as correct count.