Specialized Blood Testing for Neurological, Endocrine, and Nephrology disorders

JUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN COMPETITION 1. Requiring Activity: Naval Medical Center San Diego (NMCSD) Contracting Activity: Naval Medical Logistics Command (NMLC) 2. Description of the Action Being Approved. The purpose of this contract is to provide accurate, timely neurological laboratory testing services (attachment #1) for Naval Medical Center San Diego. Eighty percent of the tests required confirm if a patient has a genetic disease. The remaining twenty percent of tests are diagnosis for DNA markers that are needed to determine if a patient is prone to a disease. Services will include all necessary qualified personnel, transportation, materials, equipment, and supplies to perform and report accurate and timely laboratory testing. The following is required: a. NMCSD will ship samples to vendor using a rapid delivery service. b. Shipping kits will be provided by vendor. c. All reports must conform to College of American Pathologists (CAP) standards (e.g. a report must contain the patient's full name, patient number, requesting physician, data and time of collection, date and time of receipt by requesting lab, date and time reported, test results with appropriate test range, initials or number of laboratory technician performing the test and the name of the laboratory performing the test). d. All laboratory test results will either be mailed, faxed or delivered to Naval Medical Center San Diego when results are completed A firm, fixed-price, Indefinite delivery - Indefinite quantity contract is anticipated. 3. Description of Supplies/Services. Laboratory specimens from patients at NMCSD are to be sent to Athena for testing and processing. Athena is a laboratory dedicated to the development and commercialization of diagnostic testing for neurological disorders. The dates of service will run from 01 January 2009 until 30 December 201. The testing will cost an estimated $120,000 in FY 09 and increase each year an estimated $20,000, for a total of approximately $800,000.00 The contractor's laboratory will meet the following requirements: a. Supplier to provide a copy of their College of American Pathologists Certification as required by CAP Accreditation and their Clinical Laboratory Improvement Act (CLIA) accreditation. b. Reference lab must act in accordance with commercial practices. c. All subcontracted referral facilities used by the contractor shall also meet the above requirements. Estimated Dollar Value FY 09 FY 10 FY 11 FY 12 FY 13 Total Total $120,000 $140,000 $160,000 $180,000 $200,000 $800,000 This requirement will be funded using Defense Health Program funding. 4. Statutory Authority Permitting Other Than Full and Open Competition. The statutory authority permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(1), Only One Responsible Source as implemented by paragraph 6.302-1( c) of the Federal Acquisition Regulation. 5. Rationale Justifying Use of Cited Statutory Authority. Athena Diagnostics provides extensive and comprehensive diagnostic testing for neurological, endocrine, and nephrology disorders. Ninety-eight percent of all tests performed by Athena are patented and therefore will not be available from any other reference laboratory (Attachement #1). This is listed on the company website at www.athenadiagnostics.com webpage, which lists every test that Athena offers. This has also been confirmed by contacting the company directly. In addition, Athena is the only lab that offers all of the required tests at one facility using the same methodology. It is critical for evaluation of results that the same methodology is used to test the specimens. According to the medical experts at NMCSD, accurate interpretation of the complete panel set of diagnostic test results on a patient can be achieved only if all tests have been performed by the same laboratory using the same method. NMCSD conducted extensive research. The research identified that no other labs perform all of the test indicated above. It is critical that the vendor is able to provide all of the tests as a complete and accurate diagnosis cannot be made without all of the critical elements. 6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable. NMCSD has performed market research by contacting other large labs and is currently working with Quest Diagnostic laboratories to evaluate test menu availability and methodology sensitivity and specificity. This evaluation project will require some time and effort to complete but will be conducted as a work-in-progress task. Quest does not offer all of the required test at the current time. In addition, a notice will be posted to www.fbo.gov . Proposals from all interested vendors will be reviewed. 7.Determination of Fair and Reasonable Cost. The contracting officer has determined the anticipated cost to the Government of the supplies/services covered by this J&A will be fair and reasonable. 8.Actions to Remove Barriers to Future Competition. Future actions will be procured in accordance with FAR regulations.