SOLE SOURCE COVID PCR TEST Redacted.pdf

Justification and Approval for Other than Full and Open Competition

1. Identification of the agency and contracting activity: This justification for an exception to fair opportunity is executed by the Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division, San Diego, CA, on behalf of the Air Force to meet the requirements of the 374th Medical Group (MDG) at Yokota Air Base, Japan.

2. Nature and/or Description of Action being approved: The proposed action is conducted as a follow-on to firm-fixed-priced contract FA5209-21-D-0002 (T/O #FA5209-22-F-0230). In order to maintain a continuity of service, the 374th Medical Group (MDG), the customer, requests procurement of non-personal services to provide and maintain “SARS-CoV2 related tests (COVID PCR) Services”. The sample will be picked up from 374 MDG/Laboratory by Contractor and will perform the requested test as soon as they received. The requirement will be procured through full and open competition after the exclusion of sources.

3. Description of Supplies/Services:

Period of Performance: One base year and two option years (26 Jul 2023 – 25 Jul 2026)

Estimated Value: 3,780,000 yen ($29,584.94 – Conversion rate Y127.7677 = $1.00)

Type of Funding: Operation and Maintenance (O & M)

Type of Contract: Fixed Price

Requirement: Upon request from 374 MDG, the samples will be picked up by a currier and transported to a location where the test will be conducted. The samples will be handled by Contractor courier or by a contract logistics who are authorized to handle infectious items. The test requestor will be responsible to properly label each sample with Label Number and DODID and package the samples in triple container (clear plastic zip-lock bag as secondary container inside a carboard box as tertiary container) for shipping as specified in the guideline, “Sample Collection and Transportation of Suspected 2019-nCoV Infected Patient Samples” by the National Institute of Infectious Disease. A container with a virus transportation medium is used as the primary container to store the test sample.

The contractor shall be available from 0900 to 1630, Monday through Sunday and coordinated pickup on Sunday or on Japanese Holidays. If Sunday and Holiday pickup is desired, the designated contact person must be notified in advance to arrange the pickup.

4. Statutory and Regulatory Authority Permitting Other Than Full and Open Competition: Per FAR 11.105(a)(1), the brand name, product, or feature is essential to the Government’s requirements, and market research indicates other companies’ similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the agency’s

DHA PGI 206.3, Attachment 1 (06-21-2018) needs. The statutory exception permitting other than full and open competition for this acquisition is 41 U.S.C. 1901 Simplified Acquisition Procedures, as prescribed in FAR 13.501(a)(l)(ii) soliciting from a single source.

5. Rationale Justifying Use of the Statutory Authority Cited: There are no military, U.S or Japanese civilian reference labs other than BML that can offer that service for us, due to the 24 hours or less turnaround time for our COVID samples. We utilize BML for COVID testing when we are unable to test mass numbers of people or if we are having issues with our analyzer.

Without a sole source contract with BML for our COVID testing is has to potential of affecting ready, reliable, and safe health care.

6. Efforts to Obtain Competition: FAR 6.302-1. Two quotes were received from potential vendors for the requested service. As stated in paragraph 5 only one company can meet the government needs. This requirement will be posted to SAM as a sole source to BML, Inc. If for any reason the sole source is challenge, the acquisition strategy will be change.

7. Determination that Anticipated Cost to the Government will be Fair and Reasonable: In accordance with the proposal analysis techniques at 15.404-1(b), The Contracting Officer will conduct price analysis by utilizing a comparison of the proposed price found reasonable on similar laboratory test services and comparison to the Independent Government Estimate (IGCE) provided the requiring activity to determine the vendor's quote price fair and reasonable.

8. Market Research: Market research was conducted to determine if mandatory Government sources are available. Two sources were identified BLM, Inc and SRL, Inc. BML, Inc is the only source that can fulfill the government service needs for Yokota AB. They can come to laboratory every day to pick up samples and provide results within 24 hours. Service can be provided on the weekend. (Exclude Japanese holidays). SRL, Inc is unable to fulfil the government service needs for the following reasons: PCR tests can be done however, they cannot provide results within 24 hours, have no capability to provide the results in English.

Current IDIQ FA520921D0002 issued by the Air Force was awarded to BML, Inc which has expired, FA520922F0202 task order set to expire on 6/30/2023.

9. Other Facts: Test results need within 24 hours of sample pickup and results must be transcribe in English.

10. Interested Sources: None

11. Actions to overcome barriers: For the reason in Paragraph 5, DHA has no plans at this time to make any changes regarding covid testing.

COORDINATION:

12. Technical/Functional Representative:

I certify that the information provided in this justification, is accurate and complete to the best of my knowledge and belief.

Sumiyo Kawakami Purchasing & Contract Assistant/SCM/COR

14. Fair and Reasonable Cost Determination:

9 Jun 2023

Date

I have determined that the anticipated cost to the Government for this contract action is fair and reasonable.

MONSALVE.MARIANGELA.J.138

4866677

Mariangela Monsalve Contracting Officer

Digitally signed by

MONSALVE.MARIANGELA.J.1384866677

06/09/2023

Digitally signed by

KAWAKAMI.SUMI KAWAKAMI.SUMIYO.126770051 2

YO.1267700512 Date: 2023.06.09 15:12:20

+09'00'