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Contaminated IV Solution Points to Need for USP 797 Implementation and Compliance
Recent IV TPN solution contamination illnesses in Alabama demonstrate need for USP 797 implementation. The IV infection outbreak is being investigated to determine if bacterial contamination is the cause of nine patient deaths.
The United States Pharmacopoeia National Formulary chapter 797 (USP 797) was written in order to prevent contamination incidents such as this from occurring. The standards in USP 797 apply to all people and facilities that prepare compounded sterile preparations including pharmacies, health care clinics and hospitals. These requirements include routine biological monitoring of the compounding area, including identification by an appropriately credentialed laboratory of any microorganisms recovered. If fully implemented, the measures described by chapter 797 are designed to greatly reduce the chances of compounded sterile preparations from becoming contaminated and causing illness. EMLab P&K helps organizations with USP 797 compliance and provides analytical services, customer support, and the BioCassette, a sampler with design features advantageous for USP 797 compliance.
EMLab P&K carries AIHA EMLAP accreditation for fungal as well as bacterial analysis in multiple facilities across the United States. Further, it developed the BioCassette – a patented sampling device that by design avoids high capital expense and importantly, in the case of USP 797, is less prone to contamination issues during the sampling process. The BioCassette is available through EMLab P&K’s Products Division.
Belinda Vega, EMLab P&K’s President said, “EMLab P&K is not a newcomer to USP 797. We have been providing USP 797 testing services for many years, and we stay up-to-date on changes in the USP 797 specifications. Our patented BioCassette with its intrinsic sampling advantages demonstrates EMLab P&K’s commitment to the highest quality in the industry. With our highly qualified analysts and experience imamn in providing analysis and support for USP 797, we are able to provide support for CSP personnel and facilities who are trying to comply with USP 797 requirements. We are here to help.”
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EMLab P&K, a TestAmerica company, is one of the leading commercial indoor air quality laboratories in North America with over 60 service and drop-off locations throughout the United States. EMLab P&K specializes in analyzing air and surface samples to identify mold, bacteria, fungi, asbestos, and allergens. EMLab P&K also offers USP 797 testing, PCR testing, radon analysis, and materials testing. EMLab P&K has an extensive list of accreditations from leading organizations and government agencies including: AIHA, NVLAP, CA-ELAP, NY-ELAP, Texas DSHS, and other accrediting programs.