HospitalInspections.org

Based on observations, document review and interviews, the Hospital failed to conduct the minimum training requirements for pharmacy personnel who have been designated to compound (mixing intravenous drugs) medications for human use, as outlined both in the United States Pharmacopeia (USP) 797 authoritative guideline and the Hospital's pharmacy policy.

Findings include:

The training document, dated 04/18/18, indicated that six pharmacy personnel (Pharmacist #2, #3, Technician #2, #3, #4, #5) did not complete the media fill (a practical test that validates a user's technique during drug compounding (MF)) and glove fingertip (a practical test that validates a user can put on gloves without contaminating them (GFT)) competencies prior to compounding for human use in accordance with the standards of USP 797 guidelines.

The training document, dated 04/18/18, indicated that Pharmacist #2 and Pharmacist #3 (current employees) did not complete an annual MF nor a GFT competency (MF and GFT are annual requirements for current employees per USP 797 guidelines).

The training document, dated 04/18/18, indicated that Technician #2 (new employee) completed only one of three GFT competencies (three GFT tests are required for new employees before compounding for human use per USP 797 guidelines).

The training document, dated 04/18/18, indicated that Technician #3 (new employee) completed only two of three GFT competencies and did not complete the MF testing.

The training document, dated 04/18/18, indicated that Technician #4 (new employee) completed only one of three GFT competencies.

The training document, dated 04/18/18, indicated that Technician #5 (current employee) did not complete an annual MF nor GFT competency.

The pharmacy policy titled Clean Room Aseptic Work Practices, dated 09/22/17, indicated that "All compounding personnel shall successfully complete at least three gloved fingertip/thumb sampling procedures before initially being allowed to prepare Compounded Sterile Preparations (CSPs) and quarterly thereafter."

The training document, dated 04/18/18, indicated that at least 12 pharmacy personnel did not complete a GFT in the past three months or what would otherwise indicate a quarterly basis schedule in accordance with the pharmacy policy.

The pharmacy policy titled Clean Room Aseptic Work Practices, dated 09/22/17, indicated that "Compounding personnel who prepare low and medium CSPs shall complete three media fills before initially being allowed to prepare CSPs. Following initial qualification, compounding personnel shall complete one media fill at least quarterly."

The training document, dated 04/18/18, indicated that at least ten pharmacy personnel did not complete a MF in the past three months or what would otherwise indicate a quarterly basis schedule in accordance with the pharmacy policy stated above.

The cleanroom test report, dated 04/05/18, stated a failure to maintain a differential pressure of at least 0.02 inches of water gauge (this is the measurement utilized to determine the amount of pressure exerted from one room to another room) between the cleanroom and the doorway to the pharmacy area.

The Surveyor interviewed the Pharmacy Director at 9:45 A.M. on 04/18/18. The Pharmacy Director stated there is no ongoing pressure monitoring for the pharmacy compounding room.