Laboratory research testing of Anniston, AL blood samples to measure lipids and glycemic parameters.

The Center for Disease Control and Prevention (CDC), Agency for Toxic Substances and Disease Registry (ATSDR), intends to award a sole source purchase order to Northwest Lipid Metabolism & Diabetes Research Laboratory (University of Washington), 401 Queen Anne Ave N, Seattle, WA 98109, for the purchase of laboratory research testing of Anniston, AL blood samples to measure lipids and glycemic parameters. The statutory authority for this sole source acquisition is 10 U.S.C 2304(c)(1) in accordance with FAR Part 6.302-1- only one responsible source and no other supplies or services will satisfy the agency requirement. The NAICS code for this procurement is 611310, Colleges, Universities, and Professional Schools. The purpose of this acquisition is to purchase laboratory research testing of Anniston, AL blood samples to measure lipids and glycemic parameters. The Northwest Lipid Metabolism and Diabetes Research Laboratories (NWLRL) is the only laboratory to meet all the requirements of the study. The NWLRL is a Washington state-licensed, CAP-accredited clinical laboratory. It is the only laboratory that for the last twenty years has specialized only in clinical and research testing of lipids and metabolic components of diabetes. The laboratory has achieved highest level of sensitivity and precision in measurement of these compounds. The components to be measured included following glycemic parameters:HbA1c, Glucose, Insulin, Anti-GAD, Anti-IA2; and following lipids: Total cholesterol, Triglycerides, LDL, HDL, Phospholipids, and Free Fatty acids. Both glycemic parameters and lipids were to be measure in 1 ml of sera. Glycosylated hemoglobin in 1 ml of whole blood. The NWLRL is the only laboratory to meet all the requirements of the study including the same methodology, low volume of the sera needed and high sensitivity and precision of measurements with low within run and inter run variability. The study required that coefficient of variations (CV) for the study measurements were below 5% and that is consistently achieved only by this laboratory. For example, for insulin we required detection limit of 0.5?U/mL, and within run CV<3% and between run CV<4.5% which were only met by this laboratory. For glycosylated hemoglobin the CV% were all below 1.10%. For lipids, the analytical sensitivity for cholesterol was 2 mg/dL; the precision as represented by within run CV did not exceed 1%, and were less than 2% for between run CVs. This laboratory also analyzed the specialized glycemic parameters for the Anniston study samples in 2005-07. Additional requirement of the study is that, where available, repeated measures of analytes under study are to be performed using the same laboratory to eliminate inter-laboratory differences and differences in analytical methodologies - provided other requirements are met. NWLRL is the only one fulfilling that criteria for insulin, anti-GAD and IA2. Inter-laboratory differences may introduce measurement bias in the analyses of research data that is difficult to correct for in the statistical analyses of repeated measures. NWLRL provides continuity because it eliminates the inter-laboratory differences to the testing of glycemic parameters for the Anniston cohort to compare to the 2005-07 results and thus fulfills the requirement of the study. The requirement was to perform analyses of insulin, Glucose, Insulin, Anti-GAD, Anti-IA2 in 1 ml of sera that will be available for these analyses. This is the only laboratory capable to perform all these test with this amount of sera. We also required having six lipid parameters (total cholesterol, Triglycerides, LDL, HDL, Phospholipids, and Free Fatty acids) measured in 1 ml of sera. Other laboratories contacted needed either more sera or could not perform all the required tests. NWLRL is the only organization that can provide the services to meet all of the program requirements. They are using techniques with highest sensitivity and precision for detecting lipid and glycemic analytes in samples from the general population. In addition, the laboratory has the unique capability to perform these analyses in small volumes of sera thus requiring the collection of less blood from participants and reducing the burden on participants. This is a significant concern in this study because of the high volumes of blood required for analyzing many of the environmental toxicants including PCBs, dioxins, and furans. As a result of this synopsis, no competitive solicitation will be posted on FedBizOpps. We will issue only one solicitation to Northwest Lipid Metabolism & Diabetes Research Laboratory (University of Washington). However, firms that believe they can meet these requirements are encouraged to identify themselves and give written notice by providing a capability statement to the Contracting Officer by September 20, 2012. The Contracting Officer will not respond to verbal request. All requests must be in writing. A determination by the Government not to compete this proposed action will be based on responses to this notice and are solely within the discretion of the Contracting Officer. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Inquiries shall be sent to Vallerie Redd by email at contact@example.gov and reference solicitation number 2012-Q-15198 on the subject line.