Endorsed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) with an aggressive compliance schedule, USP 797 has received great attention from hospital administrative, clinical and pharmacy staff.
However, its requirements also extend to architectural and environmental areas. Consequently, hospital design, construction and operations professionals should also become familiar with it.
Far-reaching regulation
USP 797 is a far-reaching regulation that governs a wide range of pharmacy policies and procedures. It is designed both to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals.
Issued by U.S. Pharmacopeia (USP), the regulation governs any pharmacy that prepares "compounded sterile preparations" (CSPs). Many pharmacies fit this description. Moreover, many large hospitals have several pharmacies--a main one and several satellite pharmacies--that will be affected.
The schedule for compliance with USP 797 per JCAHO is as follows:
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JCAHO began surveying for compliance with USP 797 on July 1, 2004; |
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JCAHO's deadline for an "Approved Facility Renovation Plan" (AFRP) is July 31, 2005; and |
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JCAHO's deadline for completion of construction called for in the AFRP is July 31, 2008. First step in complianceThe first step in the process of compliance is to categorize a pharmacy into one of the following classifications: "Low-Risk Level CSP," "Medium-Risk Level CSP" or "High-Risk Level CSP." A complete description of each level is outside the scope of this article. However, a general idea can be derived from examples excerpted from the USP 797 document, which can be purchased directly from USP through their Web site at www.usp.org... |
