HospitalInspections.org

Based on staff interview, clinical record and administrative document review, the hospital failed to ensure the accountability for disposition of controlled drugs when 2 of 3 patients reviewed had missing documentations which were not investigated and resolved in a timely manner. There were no documented records for disposition of the remaining fentanyl drip (a powerful opiate used to treat pain that is infused into patient through the vein) that had not been administered to Patient 14 and Patient 15.
These failures had the potential to result in diversion of controlled drugs.

Findings:
Review of the hospital's Policy and Procedure (P&P) titled, "Controlled Medications" dated 5/14, read in part, "...Disposition and documentation of controlled medications must be accounted for by the pharmacy and patient care areas ...The nurse will document drug administration and wastage on the controlled substance administration record and return completed document to pharmacy. The pharmacist will reconcile all documented controlled substance administration records ..."

On 4/4/16 at 1:15 p.m., during an observation in the pharmacy department, several controlled substance administration records (CSAR) for fentanyl drip were identified. Three patients' CSARs review were initiated in the presence of the Pharmacy Supervisor, Pharmacy Manager 1, RN 14 and RN 15 on 4/4/16 at 1:50 p.m. The initial review of the CSARs showed fentanyl drip bags sent to the patients were not fully accounted for in 2 of the 3 patients.

On 4/6/16 at 1:35 p.m., Patient 14 and Patient 15's fentanyl drip CSARs and related medical record were reviewed in the presence of the Clinical Nurse Specialist, the Pharmacy Supervisor, Pharmacy Manager 1, and the Director Pharmacy/Lab services.

Patient 14's fentanyl drip 10 mcg/ml (micrograms per milliliter) 100 ml was initiated on 4/2/16 at 4:50 p.m. and the second fentanyl drip bag was started on 4/3/16 at 3:42 a.m. The electronic medication administration record (eMAR) showed 77.5 ml was administered from bag #1, however there was no documentation of disposition of the remaining solution not administered as required by the hospital's P&P. The hospital was unable to account for remaining fentanyl solution.

Patient 15's fentanyl/ropivacaine drip (2 mcg/ml/1%) 250 ml (for the production of local or regional anesthesia for surgery and for acute pain management) was initiated on 3/31/16 at 2:15 p.m. Fentanyl/ropivacaine drip bag #2 was started on 4/1/16 at 9:21 a.m. and bag #3 was started on 4/2/16 at 2:35 a.m. The eMAR showed 205.5 ml was administered from bag #2; however there was no documentation of disposition for the remaining solution not administered. The hospital was also unable to account for this contrary to their P&P.

During the concurrent staff interview, the Clinical Nurse Specialist, the Pharmacy Supervisor, Pharmacy Manager 1, and the Director Pharmacy/Lab services acknowledged the missing documentations. The Director Pharmacy/Lab services stated she had been aware of the missing documentations and had been working with the nursing services and information technology department to make it possible to document controlled drug drips wastage on the electronic medication administration record.

Based on observation, staff interview, and document review, the hospital failed to ensure the pharmacy staff implemented safe medication use. The pharmacy staff failed to properly label compounded sterile products with a beyond use date in accordance with accepted professional standards.

A beyond use date (BUD) as defined by the USP <797> as the date or time after which a compounded sterile product shall not be administered, stored or transported.

This failure had the potential to expose patients to compounded sterile products which may no longer provide the intended benefit.

Findings:

Review of the hospital's policy and procedure titled, "Sterile Product Preparation" dated 12/15, read in part, "Each compounded sterile drug product must bear an appropriate expiration date. The date assigned must be based on currently available drug stability information and the risk level of contamination based on complexity of manufacture ...Low risk compounding, (adding no more than 3 items to a bag) may carry at a maximum an expiration of 48 hours at room temperature, 14 days refrigerated or 45 days in a frozen state ...Sterile products must be labeled with ...date prepared and expiration dating ..."

On 4/6/16 at 9:05 a.m., during an observation on the pediatric intensive care unit, one liter of dextrose 5 % normal saline with 20 mEq potassium acetate (hydration, for potassium replacement) and two syringes of levetiracetam 300 mg/60 ml (for seizure control) were observed in Patient 10's cassette without any expiration date or beyond use date noted on the containers.

During the concurrent staff interview, the Pharmacy Supervisor, Pharmacy Manager 1, and the Director of Pharmacy/Lab services acknowledged the above compounded sterile products (CSP) were not labeled with the BUDs. When asked about the hospital's policy and procedure (P&P) regarding above, the Pharmacy Supervisor checked the P&P and stated the above CSPs involved low risk compounding, and should be used within 48 hours of compounding when stored at room temperature.