DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1. Contracting Activity: Department of Veterans Affairs, VISN 08, West Palm Beach Medical Center 2. Nature and/or Description of the Action Being Processed: This is a request for other than full and open competition for the performance of genetic testing on veteran patients including but not limited to BRACAnalysis® and BART genetic testing by Myriad Genetics Laboratories (MGL). The BRACAnalysis® is a panel of two tests: BRCA1 and BRCA2 breast cancer genes. Requests for genetic testing are submitted by patients' physicians and Pathology & Laboratory Medicine Service will send the specimens to the reference laboratory for testing. 3. Description of Supplies/Services Required to Meet the Agency's Needs: BRACAnalysis® and BART genetic testing is used to identify genetic mutations and variants in the BRCA1 and BRCA2 human tumor suppressor genes which is implicated in certain cancers. MGL is the only laboratory where these tests can be performed as MGL holds the patents for the procedure to identify the genetic variants (see attached listing of patent numbers). 4. Statutory Authority Permitting Other than Full and Open Competition: ( x ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3; ( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5; ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; 5. Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): There are no other laboratories legally permitted to perform this testing as MGL holds the patents for BRCA1, BRCA2 and BART genetic analysis testing as well as single site, multiple site and reflex testing. 6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research for other sources for this testing do not exist. There are multiple vendors that accomplish genetic testing, however none that were contacted as noted in the market survey perform tests that pinpoint the predisposition for breast cancer at this time. 7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: This current buy is deemed fair and reasonable based on FAR FAR 13.106-(a)(2)(i) comparable purchase history is sufficient to support this determination. Previous purchase history includes Purchase Order VA248-12-P-2-2366 which procured the same testing on a smaller basis and numerous buys by other VA facilities and civilian hospitals. Also, by contracting theses tests rather than procuring on an as needed basis a five percent discount is provided. The estimated amount of $106,110 for the base year and $424,440 for base and all optioned years is fair and reasonable. 8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted as noted in 6. above and found two particular companies that specialized in genetic testing, however neither provided breast cancer genetic testing. 9. Any Other Facts Supporting the Use of Other than Full and Open Competition: There were no FSS or NAC contracts found during the market research or in conversations with clinicians that provided a vendor other than Myriad that provides genetic testing for breast cancer. When the patents expire in 2017, however the opportunity for increased competition should be relevant and is the reason this contract will only be for a base with three one year options. 10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Only one, Myriad. 11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: With the large influx of our female veterans, the research and development community of the Veteran Affairs needs to focus or provide monetary resources to vendors to carry out such research for this type testing. Although not only a disease of women it is a focused concern of which all veterans may benefit. In addition, the NAC community could provide for all encompassing contracts to overcome barriers. 12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ Name Linda L Birmingham Date Title Health Science Specialist Facility West Palm Beach VA Medical Center 13. Approvals in accordance with FAR 6.304 This part if filled out by Contracting Staff as part of the Justification a. Contracting Officer's Certification: (required) I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____18 Jun 12____________ Terry Emory Date Contract Specialist West Palm Beach b. Product Line Supervisor (PLS): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ Eric Sullivan Date Contracting Supervisor West Palm Beach c. DNCM/NCM: (SAT to $500,000) I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ Mitchell Thomas Date Network Contract Manager VISN 8 d. SAO: I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ Jeff Ryan Date Director Service Area Office, East e. VHA HCA Review and Approval: (over $500,000) I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (over $50 million), approve (up to $ 50 million) for other than full and open competition. _____________________________ ________________________ HCA Date Chief Procurement and Logistics Officer VHA Head of Contracting Activity (HCA) f. VA Deputy Senior Procurement Executive Approval (over $10 not exceeding $50 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition. _____________________________ ________________________ Iris B. Cooper Date Deputy Senior Procurement Executive (DSPE) Office of Acquisition and Logistics Department of Veterans Affairs g. VHA Senior Procurement Executive Approval (over $50 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition. _____________________________ ________________________ Jan R. Frye Date Deputy Assistant Secretary for Acquisition and Logistics Senior Procurement Executive (SPE) Department of Veterans Affairs

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