JOFOC_Filmarray_PM_June.2016.docx

MEMORANDUM

Date: June 6, 2016

From: Anna F. Lau, Senior Staff, Microbiology Service within DLM

Subject: Justification and Approval for Other than Full and Open Competition IAW FAR 6.302-2

To: Procurement

1. AGENCY IDENTIFICATION AND CONTRACTING ACTIVITY

The National Institutes of Health (NIH), Clinical Center (CC), has a need to approve a “Justification for Other Than Full and Open” requirement in accordance with FAR 6.3, Other Than Full and Open Competition.

This is a sole source request in accordance with IAW FAR 13.103-1, 6.302-1 is based on the need to contract maintenance for equipment to be used in patient care testing.

2. NATURE AND/OR DESCRIPTION OF THE ACQUISITION BEING APPROVED

Approval of a purchase order for preventative maintenance from BioFire is needed for use on three instruments that are already on site and in use for current testing for Microbiology Service (FA1182, 2FA00546, and 2FA00386). No other manufacturer can provide this proprietary instrument care.

3. DESCRIPTION OF THE SUPPLIES AND SERVICES REQUIRED TO MEET THE AGENCY’S NEEDS

Proper maintenance of the equipment and a reliable instrument exchange program is critical to providing these important patient care results. Inability to use this instrumentation could result in unnecessary isolation of patients, or lack of isolation for infectious diseases that might be spread to hospital personnel or other patients. The availability of properly operating instruments is critical in maintaining appropriate clinical care.

4. IDENTIFICATION OF STATUTORY AUTHORITY

The requirement will be solicited under citation 10 U.S.C. 13.103-1. 6.302-1 Single/sole source

5. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED Because this is proprietary technology, no other vendor can provide the service required for these instruments.

6. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED FROM AS MANY POTENTIAL SOURCES AS PRACTIABLE This vendor has covered this equipment as long as we have owned it. Because this is proprietary technology no other vendor can provide the service required for these FDA approved instruments. No other vendor can supply parts or trained engineers to service this equipment.

7. DEMONSTRATION THAT THE ANTICIPATED COST WILL BE FAIR AND REASONABLE

The Government anticipates that the proposed cost will be fair and reasonable in accordance with FAR 15.404-1(b)(ii) and (v). As noted, no one else can provide these services.

8. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND THE RESULTS OR STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED Market research has been performed to the extent that the department's senior staff reviewed competing instrumentation in June of 2011, which resulted in the purchase of this platform. Since then additional assays have been validated and have added to the clinical utility of this identification method.

9. OTHER FACTS SUPPORTING

In accordance with FAR 6.303-2(iii), the nature of harm that would be brought to NIH CC patients may result in delayed diagnosis and treatment. Having state-of-the-art equipment available which the department has is an asset but only insofar as the adequacy of the associated supplies and the purpose they serve. Scientists and physicians alike depend on the efficiency and proficiency at which we test for the patients who come here from around the world with the trust that our NIH CC clinicians can assess and treat patients thoroughly and at the highest clinical expertise.

10. ADMINISTRATIVE OFFICER/PROGRAM OFFICIAL CERTIFICATION

“I certify that the facts and representations under my cognizance and which are included in this Justification and Approval are accurate and complete to the best of my knowledge and belief.”

Senior Staff, Microbiology Service, DLM, CC, NIH

11. CONTRACTING OFFICER’S CERTIFICATION

“I certify that the facts and representations under my cognizance and which are included in this Justification and Approval are accurate and complete to the best of my knowledge and belief.”

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