HospitalInspections.org

Based on observation, interview and record review, pharmacy services procedures for compounded sterile preparations (CSPs) were not implemented in accordance with United States Pharmacopeia (USP) 797 (the practice standard for the compounding of sterile preparations). Findings are:

-The Pharmacy service was reviewed on 5/29/2018. While touring the pharmacy department on 5/29/2018 at approximately 11:00 AM it was observed that preventive maintenance for the laminar flow hood was overdue. The maintenance sticker on the device indicated that preventive maintenance was due by April 2018. The sticker indicated the most recent inspection of the equipment occurred in October 2017.

-The Pharmacy Director verified on interview on 5/29/2018 at approximately 11:30 AM that the maintenance contractor had not yet visited the hospital to conduct the preventive maintenance.

-Review of Pharmacy Policy and Procedure entitled "Aseptic Enclosure Management, Cleaning and Testing (rev 7/17)" indicates that "semiannual testing and certification of the equipment is to be performed".

-While conducting the review of pharmacy policies and procedures, survey staff noted no written policy for training and periodic competency assessments in aseptically preparing CSPs consistent with USP 797 for staff who compound CSPs.

-Written records of training and competency assessments for pharmacists who compound sterile preparations were also requested while touring the pharmacy. The Pharmacy Director verified upon interview on 5/29/2018 that there is no written documentation of annual competencies completed by compounding personnel who prepare CSPs.