Centers for Disease Control and Prevention (CDC), Procurement and Grants Office, 2920 Brandywine Road, Colgate Building, Atlanta, Georgia 30341-4146

R -- PROFESSIONAL, GLYCOHEMOGLOBIN STANDARDIZATION PROGRAM SOL 1999N00230 POC Phillip Green, Contract Specialist, (770) 488-2638 The Centers for Disease Control and Prevention intends to enter into negotiation for a sole source contract (base with four options) with the University of Missouri to acquire a National Glycohemoglobin Standardization Program (NGSP) as currently operated as the NGSP, established in 1996, and perform the following tasks: 1. MAINTAIN central reference laboratory for primary reference method for GHB testing (High Performance Liquid Chromatography system/Bio-Rex 70 ion exchange resin) and set initial calibration based on the "set-point" used in the DCCT, 2. DEVELOP and support a network of reference laboratories to provide backup for and traceability to primary reference method. 3. CERTIFY new network laboratories with 100 whole blood specimen samples (residual clinical specimen material) analyzed in duplicate. 4. MONITOR certified network laboratories monthly using analysis of 10 whole blood specimen samples (must meet criteria of precision less than or equal to 3% and bias less than or equal to 3%). 5. WORK with manufacturers to improve and standardize their methods through analysis of fresh blood specimen samples, calibrator evaluation and value assignment, and development of conversion equation. 6. ASSESS the effectiveness of the program, in part by examination of College of American Pathologist (CAP) Survey data from participating clinical laboratories (using three-fresh-specimen panels). 7. COORDINATE target value assignment for the CAP. 8. COORDINATE certification process for network laboratories and manufacturers: analyze certification data; issue certificates. 9. PROVIDE information about GHB and GHB testing through forums, workshops, seminars, and electronically (website). 10. CONTINUE work with International Federation of Clinical Chemistry on analyte definitions, primary reference materials, and definitive reference methods. No solicitation document currently exists. The anticipated date of award of the sole source procurement is September 15, 1999 The standard industrial classification code(SIC) is 8099. Small business size standard: Average annual receipts for each of the three preceding fiscal years do not exceed $5M. See Numbered Note 22. Posted 07/20/99 (I-SN356405). (0201)

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