A03_JA_18-83_Redacted.pdf

Control No. JA 18-83

Justification Review Document for Other Than Full and Open Competition

Program/Equipment: Consolidated Laboratory Accreditation of US Army Public Health Center’s Public Health Enterprise

Authority: FAR 6.302-1, Only One Responsible Source Amount: $312,260.00

Prepared by:

Type Name: Heidi Taylor DSN: 410-436-4336 Title: Contracting Officer Representative Date: 26 February 2018

Contracting Officer:

Type Name: Jennifer C. Jackson DSN: 301-619-2054 Title: Contracting Officer Date: 28 February 2018

Technical Representative:

Requirements Repesentative:

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition

Program Manager/Project Manager/COR

Justification and Approval For Other than Full and Open Competition

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD on behalf of the U.S. Army Public Health Center (APHC)

2. Description of Action: This approval is being requested for a new firm fixed- price service contract with the American Association for Laboratory Accreditation (A2LA) using FY 18 O&M funds.

3. Description of Supplies/Services: The purpose of this contract is to allow the United States Army Public Health Enterprise (PHE) to renew its laboratory accreditations. The contractor will be required to provide the capabilities to accredit various matrices, be internationally recognized to provide auditing of and accrediation to the appropriate standars each PHE laboratory identiifed in the Performance Work Statement (PWS).

The estimated value of this 1-year Base plus 3 (Three) Option Years period contract is

$312,260.00.

4. Authority Cited: The statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(1). The FAR citation is 6.302-1 (b)(1)(i) and the FAR citation title is only one responsible source and no other supplies or services will satisfy agency requirements. The Government has a resonable basis that the agency’s minimum needs can only be satisfied by the unqiue services available from only one source.

5. Reason for Authority Cited: The PHE Laboratories required the accreditation of each laboratory to the standards identified in the PWS. The accrediations for PHE must comply with a comprehensive list of standars and requirements that are specified under nationally and internationally accepted criteria for competence. The standards are ISO/IEC 17025:2005, AOAC International Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals (dtd April 2015), The NELAC Institute (TNI) Standards: 2009 for Chemical, Radiochemistry and Microbiology Testing, The EPA National Lead Laboratory Accreditation Program (NLLAP), Clinical Lab Improvement Amendments (CLIA), Clinical Laboratory Improvement Program (CLIP) and ISO/IEC 15189 for Medical Laboratories Based on Market Research by APHC and the RFI posted by USAMRAA, the A2LA Contractor is the only known source that can accredit to all of the required standards.

6. Efforts to Obtain Competition: A Sources Sought notices was published in the Federal Business Opportunities on 19 January 2018. Potential sources were given the opportunity to provide capability information by 26 January 2018. Two responses were received from industry. The responses received was from American Assosication for Laboraty Accrediation (A2LA) and ANSI-ASQ National Accrediation Board. The Quality Compliance Office of PHE reviewed the provided information from each company. A2LA was determined to be the only source that can provide all of the accrediation requirements of the PWS. ANSI-ASQ was found unable to meet the Governments requirements. The following capabitlies ANSI-ASQ was found not have to execute the accrediations: 1. The NELAC Institutes (TNI) Standards:2009 for Chemical, Radiochemistry, and Microbiology Testing. 2. Reciprocity agreements in place as third party accrediation bodies and 3. approved by CMS to accredit clinical labs to CLIP all of these requirements are critical in for the contractor to execute the requirement. As a result of A2LA is the only source capable of meeting the Governments requirement. Although this notice was an effort to ensure offers were solicited from as many potential sources as practicable, there was no expectation that effective competition would be the result.

a. Effective competiton. No effective competition is anticipated for this acquisition.

b. Subcontracting competition. There is no potiental for subcontractoring oportunites under this requirement.

7. Actions to Increase Competition: It is not possible to compete the current acquisition as A2LA is the unique source with the only capabilities to meet all accrediation requirements of the PHE. Therefore, no action have been taken by USAMRAA to increase competiton for the acquisition.

8. Market Research: Market research and commerciality determination was performed by the quality office at APHC. A2LA was the only identified accrediting body that meets all the requirements in the PWS. There are no other accrediting bodies identified for this purpose.

9. Interested Sources: In accordance with FAR 5.201, a notice was published in Federal Business Opportunities on announcing the Government’s intent to procure via sole source the services to Consolidated Laboratory Accreditation from A2LA. Reponses to the announcement were due on 23 February 2018. There were no responses from any companies or institutions.

10. Other facts:

a. Procurement history.

i. Contract numbers and dates of the last several awards.

• W91ZLK-16-P-0054; 31 March 2016 – 30 March 2018

ii. Competitive status of these actions. Full and Open Competition

iii. Authority previously used for less than full and open competition.

Not applicable

iv. . If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

Not Applicable

v. If any prior award was accomplished by full and open competition, a detailed explanation of the changed circumstances.

There were no other identified Accrediting bodies during the previous procurement in 2016 that could meet the requirement standards of the PWS.

Market research was performed in February 2018 and there are still no identified Accrediting Bodies that can meet the requirements of the PWS.

vi. An explanation of any unusual patterns which may be revealed by the history, e.g., several consecutive urgent buys.

vii. If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the buy and whether there have been any significant changes.

b. Acquisition data availability. A purchase description suitable for full and open competition exists for this action.

c. Unusual and compelling urgency. Not Applicable

d. Subcontracting competition. Not Applicable

22580

11. Technical Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: Heidi Taylor Date: 1 Ma_r_ch 2_0_1_8

Title: Contracting Officer Representative Signature:

12. Requirements Certification: I certify that the following data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: Heidi Taylor Date:_1 M_a_r_c_h_2_0_1_8

Title: Contracting Officer Representative Signature:

13. Fair and Reasonable Cost Determination: I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable. The price established for the required services will be determined to be fair and reasonable by using the price analysis technique of comparing the proposed prices received with published commercial rates.

Name: JENNIFER C. JACKSON Date: _ 9 Marc_h_2_0_18

Digitally signed by

JACKSON.JENNIF JACKSON.JENNIFER.C.12293225

ER.C.1229322580 Date: 2018.03.09 14:23:03

Title: Contracting Officer Signature: -0_5'00_' _

14. Contracting Officer Certification. I certify that this justification is accurate and complete to the best of my knowledge and belief.

Name: JENNIFER C. JACKSON Date:_9 M_a_rc_h 20_1_8

Title: Contracting Officer Signature:

Digitally signed by

JACKSON.JENNIF JACKSON.JENNIFER.C.12293

ER.C.1229322580 Date: 2018.03.09 14:23:18

-05_'00'