Justification Final REDACTED.pdf

USAMRAA J&A CONTROL NO: JA-22-08-1234

CUI

Source Selection Information (FAR 2.101 & 3.104)

JUSTIFICATION REVIEW DOCUMENT

FOR SOLE SOURCE - FAR PART 13.501

Program/Equipment: Purchase of Certified Drug Reference Standards for the Armed Forces Medical

Examiner Systems (AFMES)

Authority: FAR 13.501(a): For Purchases for the acquisition of supplies and services in amounts greater than the simplified acquisition threshold but not exceeding $7.5 million. Only one source has been deemed reasonably available and responsible, and no other supplies or services will satisfy agency requirements.

Source Selection Information (FAR 2.101 & 3.104)

SOLE SOURCE JUSTIFICATION AND APPROVAL

UNDER FAR 13.501

1. Contracting Activity: United States Army Medical Research Acquisition Activity (USAMRAA)

2. Description of Action: Approval is being requested for the purchase of Certified Drug Reference

Standards for the Armed Forces Medical Examiner Systems (AFMES). This will be a new Firm-Fixed-

Price (FFP) Blanket Purchase Agreement (BPA) in order to provide critical chemicals for the AFMES mission. Funding for this effort will utilize Research, Development, Test & Evaluation (RDT&E) FY’23

Funding.

3. Description of Supplies/Services: AFMES has a Requirement for a Contractor to provide standard products as well as customized orders upon request for current and newly identified emerging drugs.

Ampules containing neat solutions or dried materials are used in the preparation of calibrators, standards and/or control materials. These materials are used to quantitate many of the frequently analyzed prescription and illegal drugs reported by the AFMES.

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation

13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: The AFMES has been established as a subordinate command of the

Defense Health Agency (DHA) to perform forensic pathology investigations in accordance with Section

1471 of Title 10, U.S.C., and exercises DoD scientific authority for the identification of remains of DoD-

Affiliated Personnel from both past and current conflicts as provided in Section 1509 of Title 10, U.S.C.

The forensic testing procedures at AFMES require Certified Drug Reference Standards, in accordance with the Department of Defense (DoD) Instruction 5154.30, Armed Forces Institute of Pathology

Operations, from two (2) different sources for quantitative assays, and calibration stock solutions in order to meet ISO and ABFT standards.

Cerilliant Corporation has also been certified by the American National Standards Institute (ANSI)

National Accreditation Board (ANAB) with dual accreditation to ISO/IEC 17025:2017, and ISO

17034:2016, which is important for testing and laboratory accreditation within the Forensic Community.

Cerilliant Corporation is the only Contractor that can supply the required certified drug reference standards AFMES needs in order to meet these standards.

6. Efforts to Obtain Competition: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 apply and will be followed. A Request for Information (RFI) was posted on 29 June 2022 for a period of Fifteen (15) Days. No responses were received.

7. Actions to Increase Competition: A Special Notice will be posted to the website along with the

Redacted Sole Source Justification (SSJ) Document for a period of Fifteen (15) Days in order to allow interested parties to express interest in this Requirement, although none are expected.

8. Market Research: A Requests for Information (RFI) was posted on 29 June 2022 for a period of

Fifteen (15) Days. No responses were received. Therefore, a sole source contract is being sought from

Cerilliant Corporation.

9. Interested Sources: To date, no other sources have written to express an interest. In addition, the notices required by FAR 5.201 will be published, and any bids or proposals received shall be considered.

Source Selection Information (FAR 2.101 & 3.104)

10. Other Facts:

A. Procurement History:

(1) Contract numbers and dates of all awarded contracts for these same requirements.

i. Blanket Purchase Agreement (BPA) # W81WH-18-A-0004 was awarded on 23 October 2017 with a maximum value of all call orders issued of $500,000.00.

(2) The competitive status of these actions.

i. BPA # W81WH-18-A-0004 was awarded under Full and Open Competition on the

Governmentwide Point of Entry. Only Cerilliant Corporation responded under Solicitation

#W81XWH-17-T-0270. A Technical Evaluation was completed, and the BPA was subsequently awarded on 23 October 2017 for a Twelve (12) Month Base Period, and Four (4) 12-Month

Option Periods.

(3) Authority previously cited if less than full and open competition was used.

i. Not Applicable

(4) 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.

i. Not Applicable

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

i. The prior procurement was solicited under Full and Open Competition seeking a Contractor that would be able to provide AFMES with most of the Certified Drug Reference Standards needed and necessary to complete AFMES’s Mission. The Cerilliant Corporation was able to propose all of the required chemicals requested by AFMES.

ii. Additionally, over the last Five (5) Years, the Cerilliant Corporation has made custom chemicals for the AFMES Studies which have been validated through AFMES in accordance with ISO/IEC 17025:2017, and ISO 17034:2016. To discontinue using these validated chemicals now would not only severely delay the Armed Forces Medical Examiner’s mission, it would cost over $2 Million in duplicative costs not only to get a new Contractor, but to duplicate the already governmentally validated chemical formulas that Cerilliant Corporation has created.

iii. Therefore, in accordance with the Federal Acquisition Regulation (FAR)13.5001(a)(1)(ii), a

Sole Source Blanket Purchase Agreement (BPA) is being sought from Cerilliant Corporation in order to continue the AFMES mission uninterrupted at the expected price.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

Source Selection Information (FAR 2.101 & 3.104)

i. Not Applicable. No unusual patterns or urgent buys have occurred.

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

i. Not Applicable.

B. Additional Information:

(1) Not Applicable. All information has been provided above.