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Justification and Approval for Other Than Full and Open Competition Diagnostic Genetic Testing Services

1. Contracting Activity: Contracting activity is Western Regional Contracting Office (WRCO), 9902 Lincoln St., Fort Lewis, WA 98433.

2. Description of Action: This acquisition is for Madigan Army Medical Center, (MAMC) Fort Lewis, WA, 98433. MAMCis requesting approval of a Sole Source Contract to Esoterix Genetic Laboratories, LLC for diagnostic genetic testing and consultation service. FY12 OMA funds are anticipated to be committed for this requirement.

3. Description of Supplies/Services: Diagnostic Genetic Testing and consultation services at the Department of Pathology located in MAMC. The estimated value of this acquisition for a base and two option years is $1,143,000.

4. Authority Cited: IAW FAR 13.500 Test Program for Certain Commercial items, and 13.501(a), Sole Source (including Brand name) acquisitions. PL 104-106 Section 4202 (Clinger-Cohen Act).

5. Reason for Authority Cited: Although there are other vendors that can provide Diagnostic Genetic Testing, to encompass a wide variety of tests. Esoterix is the only vendor that can supply the 97 mutation (gene) cystic fibrosis screen. A lack of the 97 gene cystic fibrosis screen is unacceptable to MAMC Clinicians. MAMC’s extreme diversity of population at MAMC does not fit the usual obstetric practice profile. Demographics collected in 2005 demonstrated a 22% black and 11% Hispanic population in our army; therefore, for MAMC to offer cystic fibrosis screening in an equitable manner, MAMC needs a screening test that is appropriate for a pan-ethnic population. A 97 mutation panel provides higher detection rates among Hispanic and Black individuals.

6. Efforts to Obtain Competition: This requirement will be posted on FedBizOpps as required by FAR 5.101(a)(2).

7. Actions to Increase Competition: No action on the part of this office will decrease this type barrier to competition. Esoterix is the only vendor that can supply the appropriate cystic fibrosis screening for the MAMC population.

8. Market Research: Market research indicates that there are several other contractors that offer similar diagnostic genetic testing. However, Esoterix is the only vendor that can supply the 97 mutation (gene) cystic fibrosis screen. The use of the 97 mutation cystic fibrosis screen meets important clinical requirements. The diversity of cultures in the MAMC military and family population requires a more stringent examination of genes in order to diagnosis any possible illnesses.

Additionally, the contract specialist did a dynamic small business search to determine the number of vendors that are found under NAICS 621511, eight hundred and fifty sources were identified. Market Research documentation is attached.

9. Interested Sources: To date, no other sources have written to express an interest. The notices required by FAR 5.201 shall be published, and that any bids or proposals received shall be considered.

10. Other Facts: Discuss any other facts supporting the use of other than full and open competition, such as the following:

a. Procurement history. Reasonable efforts to retrieve the following items from computer records, contract files, competition advocate office files or other sources are expected:

(1) W91YU0-07-D-0008, 1 March 07 through 30 September 11.

(2) Contract was completed as full and open competition.

(3) Although the previous contract was accomplished by full and open competition it was discovered that Esoterix is the only vendor capable of supplying the 97 mutation cystic fibrosis screening test to cover the diverse cultures within MAMC military and family patient population. Market research determined that this vendor is currently the only supplier of this particular screening test. Other vendors have determined to adhere to the findings of the American College of Medical Genetics (ACMG) testing guidelines with a mutation of 31 instead of 97. It is the organizations belief that there is only 31 truly certifiable mutations. A lack of the 97 gene cystic fibrosis screen is unacceptable to MAMC Clinicians. They have determined that it is more accurate when taking into account the multi-cultures that are within the Army population.

(4) Effective 1 December 2010, Esoterix Genetic Laboratories, LLC, a wholly-owned subsidiary of Laboratory Corporation of America Holdings (LabCorp) acquired the Genetics business unit of Genzyme Corporation. A modification to implement the Novation Agreement was completed on 11 May 2011.

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