The Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS) Planning Branch, Division of Health and Nutrition Examination Surveys, intends to award under a sole source basis, a purchase order to the Mayo Clinic, Celiac Disease Laboratory in Rochester, MN. The purpose of this action is to secure the services of the Mayo Clinic to conduct laboratory tests. The NCHS has a new test requirement for the diagnosis of Celiac disease. The purpose of this procurement is to enlist a laboratory to perform IgA tissue transglutaminase (IgA-TTG) and IgA endomyseal antibody (EM_IgA) testing needed for the diagnosis of Celiac disease. The government utilizes various methods for conducting laboratory specimen testing for the NHANES surveys. Some are conducted in various CDC laboratories and others are contracted to various laboratories around the world depending on the specimen and the specific laboratory's expertise. Other federal agencies were consulted for possible sources of laboratories that could perform this testing. A detailed search of the Centers within the Centers for Disease Control and Prevention was performed in an effort to locate a laboratory that would perform the IgA-TTG, and EMA_IgA testing. The CDC telephone directory was browsed for any possible leads in each Center. Telephone calls were made to the Office of the Directors. Telephone calls to known laboratory contacts within NCEH and NCID who perform most of the laboratory testing within CDC were also made. It was determined that no CDC lab can be used for these celiac tests. Since the prevalence of celiac disease is close to 1% of the US population, which is relatively rare, IgA-TTG and EM_IgA testing isn't routinely performed in most laboratories; therefore, only specialty laboratories perform this testing. It is imperative that an expert laboratory with sufficient experience and capacity perform this testing for NHANES. The testing must be an integral part of the laboratory where testing occurs daily. The laboratory for testing NHANES must be performing the work on a continuing basis to assure to assure compliance for CDC results. The laboratory must have the necessary reagents and supplies on hand to meet the NHANES three week requirement for delivery of test and quality control results. Based on all the research of alternatives within CDC, contracting out is the only viable alternative. Market research determined that there is only one source with the qualifications to meet the needs of NCHS to fill this requirement. Of the few labs that could perform the testing, the Mayo Clinic is the only laboratory that can meet the requirements of NHANES laboratory testing of IgA-TTG and EMA_IgA. The period of performance shall be for a base period of 12 months, with two 12-month option periods for a total of 36 months. Award is scheduled for on or around August 16, 2010. This acquisition is being procured applying Simplified Acquisition Procedures, in accordance with Federal Acquisition Regulations (FAR) 13.106-1(b). The circumstances of the contract action deem only one source reasonably available. The Mayo Clinic is the only available source with the required expertise to provide the services. The CDC is not requesting proposals and no solicitation is available. Firms that believe they can provide the services are encouraged to identify themselves and give written notification to the Contracting Officer no later than 4:00 pm EST, on August 9, 2010 (15 days). Determination not to compete the proposed action based on responses to this notice is solely within the discretion of the Contracting Officer. Information received will be considered solely for the purpose of determining whether to conduct a future competitive procurement. Respondents will assume all financial costs for preparing a response to this notice. The U.S. Government assumes no financial obligation for the preparation and distribution of responses. Inquiries may be sent to Penny Holley by email at
[email protected].