Justification and Approval___Reagents for BCR-ABL TEST ((KO Signed 30 June 2022) (6) Signed by __Redacted.pdf

CUI//CP-PROCURE Control No: 23-RHCO-C-000032

Controlled by: USAHCA Controlled by: RHCO-C CUI Category: PROCURE

LDC: FED ONLY

CUI//CP-PROCURE

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: The Brooke Army Medical Center Department of Pathology and Area Laboratory Services requirement is to obtain BCR-ABL1, Major (p210), Quantitative and BCR-ABL1, Minor (p190), Quantitative reagents for BCR- ABL testing.

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5.

Amount: $1,037,640.00 (Base + Four (4) Options) Base Period (1 October 2022 – 30 September 2023):

Option 1 (1 October 2023 – 30 September 2024):

Option 2 (1 October 2024 – 30 September 2025):

Option 3 (1 October 2025 – 30 September 2026):

Option 4 (1 October 2026 – 30 September 2027):

Prepared by: DSN:

Contract Specialist Date:

Contracting Officer:

Contracting Officer Date: 20 June 2022

Technical: DSN: 429-3168

Brooke Army Medical Center

Requirements:

Date: 20 June 2022

Controlled by: RHCO-C

04'00'

Reviews: I have reviewed this justification and find it adequate to support a sole source contract action.

Program Manager:

Typed Name:

Signature:

Legal Counsel:

DSN: 471-5804

signed by

P.1054172059 Date: 2022.07.25 11:37:48

Command Advocate for Competition:

US Army Health Contracting Activity

185865882

Digitally signed by

1185865882 Date: 2022.07.25 12:30:33 -05'00'

Controlled by: RHCO-C

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval

1. Contracting Activity: Joint Base San Antonio Health Contracting Branch (JBSA HCB), Regional Health Contracting Office – Central (RHCO-C), US Army Health Contracting Activity, 3551 Roger Brooke Drive, JBSA Fort Sam Houston, Texas.

2. Description of Action: Purchase of reagents and consumables via firm-fixed-price contract for the Department of Pathology and Area Laboratory Services, Brooke Army Medical Center, JBSA Fort Sam Houston, Texas that are compatible with Government-owned equipment. The Government projects award before 30 September 2022, with performance to start 1 October 2022; award will be subject to the availability of Defense Health Program, (DHP) FY23 funds. An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

Name of Proposed Contractor(s) and Address:

Asuragen, Inc.

3. Description of Supplies/Services: This requirement is a follow-on to the current contract W81K00-18-P-0123 with Asuragen, Inc. (Asuragen) expiring 30 September 2022. This contract is currently in place to provide testing reagents compatible with the Government owned Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument. BCR-ABL reagents is used for diagnosis and therapeutic monitoring for Chronic Myeloid Leukemia and Acute Lymphocytic Leukemia.

The BCR-ABL1, Major (p210), Quantitative is an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9;22) positive Chronic Myeloid Leukemia (CML) patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The BCR-ABL1, Minor (p190), Quantitative reagent Kit is a clinical research tool enabling ultra-sensitive and precise detection of BCR-ABL1 minor fusion transcripts (e1a2) from whole blood specimens. These real-time Polymerase Chain Reaction (PCR) assays are designed to run on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instruments.

Hematology oncology physicians use the BCR-ABL data to assess the patient’s response to therapy, patient compliance, and whether a change in therapy is indicated. In the BAMC molecular diagnostics lab, this test is done in support of clinical care and is not used for research purposes. The test results are used in support of patient treatment plans primarily by Hem/Onc physicians. It is imperative that the laboratory has the ability to perform this diagnostic function for the identification of the above items for patient treatment. If this contract is not awarded, the Molecular Laboratory will be unable to offer the BCR-ABL tests for the treatment regimens required by health care providers within BAMC and from outlying facilities.

NOTE: As a supply contract, FAR 52.217-8 is not available for use.

Controlled

Total for the Base Period and each Option Year

Amount: $1,037,640.00 Base Period (1 October 2022 – 30 September 2023):

Option 1 (1 October 2023 – 30 September 2024):

Option 2 (1 October 2024 – 30 September 2025):

Option 3 (1 October 2025 – 30 September 2026):

Option 4 (1 October 2026 – 30 September 2027):

4. Authority Cited: The statutory authority permitting other than full and open competition is 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority exceeding the simplified acquisition threshold for simplified procedures for certain commercial items.

5. Reason for Authority Cited: Asuragen is the only reagent company in the United States that has a proprietary assay for both BCR-ABL Major and Minor that’s compatible with the ABI 7500 Fast DX Real Time Instrument. In order to purchase the proprietary QuantideX BCR ABL Major/Minor assays in the United States, the individual would have to directly contact Asuragen, Inc. Asuragen does not partner with any outside distributors in the United States. Asuragen is the sole manufacturer and distributor of the reagents and supplies that are compatible with the existing Government-owned Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument; this system is manufactured by Thermo Fisher. The BCR-ABL reagent kits offered by Asuragen are compatible with the laboratory instrument; no other cartridges are compatible with the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument; alternative reagents are different in shape and provided different results. Biosystem 7500 Fast DX Real Time PCR Instrument is still in use as a testing phase by the laboratory; another manufacturer’s reagents would alter the results received by testing and would not be usable for the end product decision-making phase.

Controlled by: RHCO-C

The Government-owned Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument was purchased in Mar 2020 and the life expectancy for this equipment is ten (10) years. Alternative reagents are not compatible with current instrumentation and would void warranties.

6. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C.

1901 as implemented by FAR Subpart 13.5: Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

7. Reason for Authority Cited:

a. A Sources Sought Notice was initially posted to https://beta.sam.gov, the official

Government Point of Entry, on 19 May 2022 with a response due date of 26 May 2022 in order to find companies (small and other-than-small) that could provide reagents to conduct BCR-ABL Testing. The Government did not receive a response from any interested offeror. The Government extended the sources sought notice from 27 May 2022 to 01 June 2022. No responses from the industry were received on 01 June 2022. The notice of intent to sole source will be posted to the https://beta.sam.gov for 15 days.

b. Alternatives. There are not any alternatives to Asuragen that would not result in mission failure; other reagents that are not compatible to the Government-own equipment cannot be used, but would cause a significant delay in obtaining test results. Brooke Army Medical Center provides healthcare services to Active Duty and Retired military members as well as their dependents, as mandated by statute. Part of those healthcare services involves performing laboratory tests in order for physicians to make a diagnosis and develop a treatment plan.

8. Efforts to Obtain Competition: No further efforts will be made to obtain competition. The Contracting Officer shall publish the notices required by FAR 5.201. A Sources Sought Notice was already posted twice; upon finalization of this Justification and Approval document, a notice of intent to sole source will be posted to the GPE -https://beta.sam.gov for 15 days with the final J&A to be published within 14 days of contract award.

9. Actions to Increase Competition: Should BAMC continue to have a need for these BCR-ABL reagents at the conclusion of the last option period, a sources sought notice will be posted to the GPE to determine if there are any new entrants to the marketplace.

10. Market Research: Prior to the posting of the sources sought notices, market research was conducted by DPALS personnel in conjunction with contracting personnel to determine the likelihood of other laboratory testing companies being able to provide for the complete requirement. The methods used included internet searches, to include a review of the College of American Pathologists’ website. This Market Research was conducted from March to June 2022.

Controlled by: RHCO-C

Thermo Fisher Scientific offers both the BCR-ABL1, Major (p210), Quantitative and the BCR-ABL1, Minor (p190), Quantitative Reagent Kits that are compatible with the Government-owned equipment. The reagent kits sold by this vendor is not FDA Approved and is not made for clinical use and therefore, Thermo Fisher Scientific does not meet the requirements for this effort.

ARUP Laboratories only provides BCR-ABL testing service. No reagents for supply are provided by ARUP Laboratories.

Asuragen, Inc. provides the Quantidex BCR-ABL1, Major (p210), Quantitative and the

Quantidex BCR-ABL1, Minor (p190), Quantitative Reagent Kits that are compatible with the Government-owned equipment. Asuragen’s reagent kits are FDA Approved and is made for clinic use therefore, this vendor meets the requirement for this effort.

As discussed above, Asuragen, Inc. is the only vendor that can provide the PCR reagents that are FDA approved; developed for clinical use and is compatible with the Government-owned equipment.

11. Interested Sources: Other than Asuragen, Inc., no other sources that can provide all BCR-ABL reagents have written to express interest in the acquisition.

12. Other Facts:

a. Procurement History:

i. Contract W81K00-18-P-0123 was issued with a base period of 01 February 2018 – 30 September 2018 plus Four (4) twelve-month option periods through 30 September 2022.

ii. This action was solicited on a full and open basis

iii. Authority previously cited if less than full and open competition: N/A

iv. Summary of previous justification: N/A

v. The solicitation for the current contract solicited on a full and open basis yielded only one offeror, Asuragen, Inc.

vi. Unusual patterns: N/A

vii. Significant changes: N/A

b. Asuragen does not have any known distributors or other authorized vendors that could provide the required testing reagents.

(End of page)

Controlled by: RHCO-C

13. 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.

14. Requirements 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: Date:

Title:

Laboratory Services, Controlled by: RHCO-C CUI Category: PROCURE

POC:

15. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based on the independent Government estimate and previous prices paid. As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Typed Name: Date: 8

Title: Contracting Officer Signature:

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

Typed Name: Date:

Title: Contracting Officer Signature:

Digitally signed by 1072303

Date: 2022.06.30 10:53:19 05'00'

Controlled by: RHCO-C

Approval

Based on the foregoing justification, I hereby approve the procurement of Asuragen, Inc. BCR-ABL reagents under a cost-per-test arrangement for Brooke Army Medical Center on a sole source basis, in the amount of $1,037,640.00 pursuant to the authority of the Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5, subject to availability of funds, and provided that the services or supplies herein described have otherwise been authorized for acquisition.