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USP Chapter <797> and Preparing for a JCAHO Survey

Author(s):  McElhiney Linda F

Issue:  Jan/Feb 2005 - Sterile Preparations
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Abstract:  The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) conducts triennial surveys of healthcare systems that wish to obtain JCAHO accreditation. Although not required, accreditation means that the facility adheres to standards that exist to ensure high-quality patient care and patient and worker safety. In April 2004, JCAHO announced that its surveys would include compliance with United States Pharmacopeia (USP) Chapter <797> standards for sterile compounding. This article is intended as a guide for hospital pharmacy administrators and compounders to prepare for the JCAHO survey. The first step is to read Chapter <797> carefully (and repeatedly, if necessary) to understand everything that needs to be done to achieve compliance. The next step is assessment of the pharmacy for compliance with those standards. A pharmacy may develop its own assessment procedure of purchase a professional prepared “gap analysis” tool to assist with the assessment. The action plan developed following this analysis should focus on implementing the following requirements as top priorities: personnel training and evaluation, beyond-use dating and labeling, verification of automated compounding devices, finished-preparation release checks and tests, and aseptic technique.

Related Keywords: Linda F. McElhiney, PharmD, RPh, United States Pharmacopeia, USP Chapter <797>, Joint Commission on Accreditation of Healthcare Organizations, gap analysis, beyond use dating, aseptic technique, training, automated compounding devices, ACDs, documentation

Related Categories: STERILE PREPARATIONS, UNITED STATES PHARMACOPEIA CONVENTIONS, FDA, HOSPITAL PHARMACY

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