JA_redacted.pdf

Form 02.4G.AB 18 Apr 2016

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a

“Justification for other than full and open competition.”

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD, on behalf of the Navy, to meet the requirements of U.S. Naval Hospital Okinawa and Yokosuka, Japan; Branch Medical Clinics located in Atsugi, Iwakuni, and Sasebo, Japan; and the Health Service Department in Diego Garcia.

2. Nature and/or description of the action being approved.

This is a follow-on contract action to a firm, fixed-price supply contract N00406-16-P-0015. Request approval to solicit, negotiate, and award a contract to a medical supply company capable of providing the forty-one brand name manufacturer’s regents in Japan. The brand name manufacturers include the following: Alere, Bayer Diagnostics, Bio laboratories, American Master Tech Scientific, Beckman Coulter, Bio Test Medical, Azer Scientific, Becton

Dickinson, BioMerieux Vitek, Cancer Diagnostics, Fisher Scientific, Immucor Gamma, Lav Pulse Med/Energy

Beam Sci 2, Ortho Clinical Diagnostics, Polymed Co, Remel, Simmler, Terumo, Trinity Biotech, Whatman, Dynarex, Globe Scientific, Kimberly Clark, LifeSign, Pacific Hemostasis, Quantimetrix, Sakura Finetek, Smiths

Medical, Thermo Scientific, Wampole Lab/Inverness, Wilkens Anderson Co, EN Sciences, HemoCue, Kimble

Chase, Orasure Tech, Phlebotic, Quidel, Siemens Medical, Streck Laboratories, Triangle Biomedical, and Wescor.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

This requirement is for various types of test reagents and laboratory supplies for U.S. Naval Hospital Okinawa and

Yokosuka, Japan; Branch Medical Clinics located in Atsugi, Iwakuni, and Sasebo, Japan; and the Health Service

Department in Diego Garcia. The brand name reagents are to be drop shipped directly by the contractor to the medical facilities in Japan and Diego Garcia. Delivery will be required starting 01 October 2018 and continue until

30 September 2019, with two option years through 30 September 2021, if both options are exercised.

4. An identification of the statutory authority permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 41 U.S.C. 1901 and

FAR 6.302-1 sole source (including brand name) acquisitions OR FAR 13.501(a)(1)(ii) soliciting from a single source.

5. A Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The medical Facilities in Japan and Diego Garcia use reagents with testing equipment, machines, and other medical tools to test and diagnose patients for various medical conditions and diseases. The machines, equipment, and other medical tools have been tested, calibrated, and inspected using the College of American Pathologist (CAP) procedures for use with a specific manufacturer’s reagents.

Standard Operating Procedure (SOP) manuals have been written on the proper use of the machines, equipment, and other medical tools using these reagents. The procedures go through parallel testing to establish a baseline for the reading. For example, baseline for a normal reading of glucose in the blood may be 80 if using a specific manufacturer’s reagent and it may be 120 if using another reagent manufacturer. As a result, the different readings for “normal” could create a serious health risk. A patient may be declared diabetic when in fact the reading is normal, depending on what brand of reagent is being used for the blood sugar test. This is precisely why extensive testing is done with each reagent to develop the SOP and guidelines for use with each particular reagent.

The same reagents have been in use at the medical treatment facilities in Japan and Diego Garcia for the past twenty one years. If the medical treatment facilities were to change the brand of reagents used, the medical treatment

Form 02.4G.AB 18 Apr 2016 facilities would have to go through a costly and timely process of parallel testing, calibration, and CAP inspection.

Furthermore, new procedures would have to be adopted, new SOP manuals would need to be written, and new SOP training conducted. Additionally, there is a risk for loss of human life. Changing the brands of reagents could result in a misdiagnosis, leading to incorrect treatment and/or serious health complications. Therefore, the items required must integrate with existing equipment already installed.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

A combined synopsis/solicitation will be posted on Federal Business Opportunities as brand name only acquisition in order to solicit offers from as many sources as possible.

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. A description of the market research conducted (see Part 10) and the results, or a statement of the reason market survey was not conducted.

Market research was conducted by technical experts in April 2018. This research consisted of reviews of similar previous procurements and using search engines to review open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Bing, GSA Advantage and the ECRI sourcebook catalog. This requirement is a follow-on contract to contract 00406-16-P-0015. Solicitation N00406-15-T-0517 was posted on

Navy Electronic Business Opportunities to deliver forty-one brand name manufacturer’s regents to various naval hospitals and clinics in Japan. The government received two proposals (Henry Schein and Quotient Biodiagnostics) in response to the solicitation N00406-15-T-0517. The government evaluated the two proposals and deemed

Henry’s proposal offered the best value to the government. The government awarded contract N00406-15-T-0517 to

Henry Schein on Oct 2015. The market research indicates Henry Schein and Quotient Biodiagnostics are still able to satisfy the government requirements. Hence, it is recommended that this requirement is competed on Federal

Business Opportunities as brand name only acquisition in order to solicit offers from as many sources as possible.

9. Any other facts supporting the use of other than full and open competition.

None.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. Any sources expressing interest in response to the synopsis will receive consideration.

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203. For the reasons set forth in Paragraph 5, Naval Medical Logistics Command has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, (NMLC) will assess whether competition for future requirements is feasible.