36C24918Q9687-001.pdf

OFOC SOP Revision 08 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2:

Request for Sole Source Justification >SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: VA249-18-AP-6131_

1. Contracting Activity: Department of Veterans Affairs, VISN 09, TVHS (603), Robley Rex Medical Center, Louisville KY 40206

2. Nature and/or Description of the Action Being Processed: This is a Justification and Approval for a Sole Source contract to Cepheid IAW all applicable FAR and VAAR regulations. The contract will be a firm fixed price commodities type contract for commercial items to supply GeneXpert Analyzer reagents to the requisite Veterans Affairs Medical Center (VAMC). This order is to supply for the Fiscal Year (FY) 2019 proprietary chemicals and agents to test for various diseases (Chlamydia, MRSA, HIV, etc.).

FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for Cepheid GeneXpert Reagents IAW FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures (SAP) are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Cepheid is the original equipment manufacturer (OEM) of the GeneXpert Chemical Analyzer. This action will supply chemical reagents from the OEM to the Louisville VA for patient testing of Chylamydia, Gonorrhea PCR, MRSA PCR, Mycobacteria Tuberculosis PCR, C.Difficile PCR, Influenza A & B PCR, and Carba R PCR as the chemical analyzer equipment (GeneXpert) is already procured and in use by the Louisville VA. Soliciting for competition would not further the interest of the American taxpayers by realizing any significant costs saving or improved efficiencies. Re-competing this requirement would require the repurchase of the chemical analyzer equipment at an exorbitant cost and produce delays diminishing standards of care for veteran patients. Estimated cost for reagents is

4. Statutory Authority Permitting Other than Full and Open Competition:

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Louisville VA requires the requested reagents as they are specific for the equipment already in utilization at this VAMC. The

OFOC SOP Revision 08 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2:

Request for Sole Source Justification >SAT instrument only runs these specifically designed, FDA approved reagents for patient testing. No other company produces or manufactures a chemical reagent that can be utilized by the proprietary equipment. Use of other reagents would potentially cause damage to the equipment and void any warranties Cepheid provides for said equipment. Furthermore, the company has confirmed they do not use authorized distributors or resellers and are the sole source for their reagents.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market Research was conducted and best efforts were maintained to find adequate sources to suffice the Government’s need. All viable information will be stored and assessed on future acquisitions.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The CO has determined that the anticipated cost is fair and reasonable based on the ICGE and CO’s own knowledge of the price of medical equipment and supplies, as well as prices found to be fair and reasonable on previous purchases from Cepheid. Various departments of the US Government have purchased similar supplies from Cepheid in the past. The following table outlines a sample of previous VA/Government contracts with Cepheid for like or similar items found via FPDS.gov.

TABLE 7.1

CONTRACT NO.

AGENCY

VENDOR POP

ACTION

OBLIGATION

TOTAL

VALUE DESCRIPTION

W81K0216T0157 Dept. of the Army

Cepheid

MO

FY18 Funds -Reagents for GeneXpert System…analyzer

VA69D13J0201

Veterans Affairs, Dept.of

Cepheid

MO

(same) Reagents… to support testing for… (MRSA) infection

The prices found on these contracts are comparable to the price proposed for the requirement under consideration by this J&A. Though exact quantities are not known, it is assumable that the amounts would be approximate to the subject requirement in order to supply each respective medical center with necessary chemicals for testing throughout a 12-month period. Neither of the above contracts were competed, bolstering the claim from the OEM that no other entity has the capability to provide necessary reagents to use in their equipment.

. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market Research was conducted IAW FAR Part 10.

Databases were queried to include VIP, GSA, FPDS, as well as NCO 9's local procurement writing system. The VA’s Rule of Two in association with Veteran’s First Contracting initiative could not be satisfied in conjunction with this requirement. Cepheid has a GSA/FSS scheduled contract already in place; however, the reagents are not available via scheduled contract as verified by a representative of Cepheid. Therefore, an open market procurement utilizing the authority of FAR 13.5 is being utilized. Full analysis of Market Research is available in the Market Research Report located in the eCMS Briefcase and is a part of the contract file.