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Quality Assurance Procedures



Manual: Compounded Sterile Preparation - USP 797 Compliance Manual (Ver 2)
External Reference: "(TJC HR.01.06.01, HR.01.07.01, IC.01.05.01, IC.02.01.01, MM.05.01.01, MM.05.01.07, MM.05.01.09)"

As the health care industry's most comprehensive library of customizable policy and procedure templates, MCN Healthcare's Compounded Sterile Preparation - USP 797 Compliance Manual includes this customizable template, Quality Assurance Procedures. MCN's policy library helps you meet compliance with Joint Commission and federal regulations including CMS, CDC, OSHA, OIG, HIPAA and more.

Health care organizations around the world utilize MCN's compliant ready templates and workflow process tools to help them meet the latest changes in regulations and standards.

Here is some sample content from Quality Assurance Procedures:

     POLICY: Low-Risk Level CSPs: Routine cleaning and disinfection of direct compounding areas to minimize surface contamination. Air quality testing of the direct compounding environment. Air quality testing of the immediate compounding area, i.e., laminar airflow workbench to ensure maintenance of ISO Class 5 air quality. Visual validation of compounding personnel wearing the appropriate personal protective equipment, gowns, head and shoe covers, masks and goggles, as appropriate. Documented review of physicians' orders and ingredients used, including correct amounts of the ingredients. ...
Second excerpt:
     ... cloudiness, package integrity and correct and complete labeling. Media-fill tests performed and passed annually by compounding personnel. Medium-Risk Level CSPs: Quality assurance procedures for medium-risk level CSPs are the same as those performed for low-risk level CSPs. Media-fill tests may be more challenging and given annually or as needed. High-Risk Level CSPs: Quality assurance procedures for high-risk level CSPs are the same as those performed for low-risk level CSPs. ...


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