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UT SOUTHWESTERN UNIVERSITY HOSPITAL 6201 HARRY HINES BLVD DALLAS, TX 75390 Jan. 4, 2019
VIOLATION: REPORTING ABUSES/LOSSES OF DRUGS Tag No: A0509
Based on record review and interview, the facility failed to report abuses and losses of controlled substances in accordance with applicable Federal and State laws, in that,

Known, unaccounted for (Pulled from Pyxis, not documented as given or wasted) controlled substances were not reported to the DEA/BOP (Drug Enforcement Administration/Board of Pharmacy) in a timely manner upon their (hospital's) discovery during:

Three (3) respective (Personnel #6, #7, and #8) investigations; and the

Most current - Diversion Investigation Report findings (September to November 2018).

Findings included

(intravenous-IV; milligrams-mg; microgram-mcg; milliliters-ml; patient controlled analgesia-PCA)

~ 2016 event report (Personnel #6) reflected...suspected theft...Medications (Controlled Substances) that were not documented as given (or wasted) in the MAR (Medication Administration Record) but withdrawn from the Pyxis (Unaccounted for) were...Dilaudid PCA 25 mg/ml syringe; Fentanyl 100 mcg; Dilaudid 1 mg; Benadryl 50 mg...Fentanyl 100 mcg, Dilaudid 1 mg; Zofran 4 mg..."

~ The September to December 2016 (Personnel #7) Unaccounted for Controlled Substance Report included: Hydrocodone liquid 20 ml; Fentanyl 75 mcg; Fentanyl 25 mcg; Fentanyl 25 mcg; Dilaudid 0.5 mg; Dilaudid 0.4 mg; Propofol 1000 mg; Versed (Midazolam) 1 mg/mil - 77 mil; Propofol 1000 mg; Dilaudid 0.5 mg."

~ The (Most current) September to November 2018 "Monthly Diversion Report Investigation" Unaccounted (Not given or wasted) for medications included: (listed in order the report reflected) 9/4/18 Fentanyl 150 mcg; 9/14/18 hydromorphone 0.5 micrograms; 9/14/18 hydromorphone 0.4 mcg; 9/20/18 Tylenol #3, 1 tablet; 9/28/18 Fentanyl 25 mcg; 9/25/18 Hydrocodone 10-325 mg, 1 tab; 10/25/18 Dronabinol 5 mg, 1 capsule; 10/18/18 Diazepam 2 mg; 10/22/18 Fentanyl 25 mcg; 10/09/18 Fentanyl 50 mcg; 10/03/18 Tramadol 25 mg; October 2018 Hydromorphone 0.25 mg; Tramadol 50 mg; Morphine 2 mg; 11/30/18 Midazolam (Versed) 5 mg; 11/21/18 Midazolam 5 mg; and 11/03/18 Midazolam 5 mg.

There were no submitted reports to Drug Enforcement Administration (DEA) or Board of Pharmacy (BOP) for the above known, unaccounted for medications.

During a telephone interview on 1/04/19 ending at 5:30 PM, Personnel #5 was asked if the DEA/BOP reporting was completed for the above findings. Personnel #5 stated, "No."

The 5/31/18 "Drug Analysis Test Report" (Personnel #8) reflected, "...one IV Bag (Fentanyl bag) containing clear liquid...No controlled substance was identified..."

During an interview on 1/04/19 from 9:15 AM to 10:48 AM, Personnel #5 showed pictures that were of the Fentanyl labeled IV bag that was tested . Personnel #5 was asked since the Fentanyl Bag did not contain Fentanyl, then there was unaccounted for medication. Personnel #5 stated, "Yes." Personnel #5 was asked if it was reported to the DEA/BOP. Personnel #5 stated, "No."

The hospital's 09/17/18 "Report of Loss-Theft, Destruction, Return to Suppliers" Procedure required, "recorded amounts are to be reconciled and documented in a timely manner...Any theft or loss of a significant amount of a controlled substance, will be reported by the Director of Pharmacy...to the Drug Enforcement Administration (DEA #106 form Electronically), The Texas State Board of Pharmacy/BOP...Forward a copy of the form to BOP..."

https://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html

(21 C.F.R. 1301.76(b)) The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft. When determining whether a loss is significant, a registrant should consider, among others, the following factors:
(1) The actual quantity of controlled substances lost in relation to the type of business;
(2) The specific controlled substances lost;
(3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
(4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,
(5) Whether the specific controlled substances are likely candidates for diversion;
(6) Local trends and other indicators of the diversion potential of the missing controlled substance.