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Achievement of USP Chapter <797> Compliance by a 35-Bed Rural Hospital: A Case Study

Author(s):  Peters Gregory F, McKeon Marghi R, Nerbun Richard G

Issue:  Nov/Dec 2007 - High-Technology Compounding
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Abstract:  To comply with pharmacy-practice and occupational safety standards and guidelines (“the standards”) for the compounding of sterile preparations, a small community hospital that had an extended care unit as part of its facility had to make improvements to its pharmacy. The typical financial, staffing, and space constraints of the smaller institution had to be accommodated in a comprehensive plan for the low-cost conceptualization, qualification, design, construction, certification, operation, and maintenance of a modern compounded sterile preparation pharmacy. Pharmacy demographic data were collected and a marketing survey completed to identify projected hospital service areas, population trends, and compounded sterile preparation needs. On the basis of this survey, a facility and process were designed to ensure uncongested operations in the short, intermediate, and long terms. As part of the master plan, facility and process design, installation, operational, and performance qualifications were developed. The facility was then built in accordance with the qualifications, and operative personnel were selected and trained and their technique verified. Complete standard operating procedures and a comprehensive information technology data-management system were installed and made operational. In August 2006, the hospital’s compounded sterile preparation pharmacy and program were inspected by the Joint Commission on Accreditation of Healthcare Organizations, with no exceptions noted. In April 2007, the State of Wisconsin Board of Pharmacy completed its final review of the complete compounded sterile preparation pharmacy design upgrade, and the hospital’s pharmacy was unconditionally approved for continued operation. Correct design and implementation of a low-cost plan to modernize the pharmacy operations of a 35-bed rural hospital resulted in a compounded sterile preparation pharmacy and process designed, built, and qualified in compliance with the standards, and the reasonable assurance of troublefree future operation consistent with the anticipated growth and diversification of its compounded sterile preparation services.

Related Keywords: Gregory F. Peters, AAS, Marghi R. McKeon, BS, Richard G. Nerbun, BSPharm, community hospital pharmacy, United States Pharmacopeia Chapter <797>, standards, quality control, glossary, design qualifications, sterile preparations, facility design, cleanroom, laminar airflow workstation, air return, ventilation, installation qualification, operational qualification, biological safety cabinet, process qualification, standard operating procedures, aseptic technique training, personnel verification, air quality monitoring, pharmacy director, particulates

Related Categories: ENVIRONMENTAL , LEGAL, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, HOSPITAL PHARMACY

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