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Based on interview and review of pharmacy certification documents, the hospital pharmacy failed to certify the laminar flow hood in the pharmacy sterile IV compounding room, and perform air quality checks for the IV compounding room in accordance with accepted professional principles and established national standards.

[Reference: UNITED STATES PHARMACOPOEIA, INC. U.S. PHARMACOPOEIA 27. Chapter <797>; Pharmaceutical Compounding - Sterile Preparations. Rockville, MD, and American Society of Health-System Pharmacists. ASHP Guidelines on Quality Assurance for Pharmacy-prepared Sterile products. Am J Health-Syst Pharm. 2000; 57-1150-69.]

Failure to certify the laminar flow hood and perform air particle checks in the pharmacy sterile IV compounding room according to accepted professional principles and national standards places all patients at risk of receiving contaminated pharmacy-prepared sterile preparations.

Findings:

During an interview on 4/5/11 at 10 AM, the Pharmacy Manager (Staff Member #2) stated the hoods had not had certifications checked at 6 month intervals and no air particle counts for the IV sterile compounding room (buffer area) had been done.

Hospital pharmacy equipment records verified the laminar flow hood was on an annual certification frequency..

Based on observation and staff interview, the hospital failed to implement policies and procedures for compounded sterile preparations, and staff training, according to accepted professional principles and national standards.

[Reference: UNITED STATES PHARMACOPOEIA, INC. U.S. PHARMACOPOEIA 27. Chapter <797>; Pharmaceutical Compounding - Sterile Preparations. Rockville, MD, and American Society of Health-System Pharmacists. ASHP Guidelines on Quality Assurance for Pharmacy-prepared Sterile products. Am J Health-Syst Pharm. 2000; 57-1150-69.]

Failure to implement policies and procedures for compounded sterile preparations according to accepted professional principles and national standards places all patients at risk of receiving contaminated pharmacy-prepared sterile preparations.

Findings:

During a tour of the hospital pharmacy on 4/5/11, Staff Member #1 was observed preparing a medium risk sterile medication in the IV compounding room at 9:30 AM. The staff member did not don head covering, mask, or shoe covers for preparation of the sterile compounded IV ( " banana bag " ). S/he did wash hands and don a gown and gloves as well as sanitize the non-sterile gloves with filtered isopropyl alcohol prior to starting preparation. S/he did not wipe down/sanitize the critical area (laminar flow hood) work surface or the component vials prior to manipulation. During an interview at 9:50 AM, s/he explained s/he had been trained in 2000 and had no updates since then. S/he explained s/he did not know to wear a mask or head covering or shoe covers.

During an interview on 4/5/11 at 10 AM the Pharmacy Manager (Staff Member #2) stated that s/he expects staff to use head covers, shoe covers, and masks during IV sterile compounding. S/he also stated staff competency checks or updated training for three (3) hospital staff pharmacists responsible for preparing sterile IV medications, and four (4) pharmacy technicians responsible for preparing sterile IV medications have not been done. In addition, s/he stated policies and procedures were currently being updated for sterile IV compounding consistent with USP <797>.