Justification and Approval- Reagents _ Beadchips Warranty Service- (COR- Supervisor- KO Signed) (5)_Redacted.pdf

CUI//CP-PROCURE Control No: 23-RHCO-C-000077

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

LDC: FED ONLY

POC:

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 Reagents Kits that are compatible to the Government-owned.

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

Amount: $213,322.50 (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): 0 Option 4 (1 October 2026 – 30 September 2027):

Prepared by: DSN:

Date: 11 August 2022

Contracting Officer: Telephone:

Date: 11 August 2022

Contract Specialist Email:

Contracting Officer

Technical: DSN:

OIC, Molecular/Immunology Date: 11 August 2022 Department of Pathology and Area Laboratory Brooke Army Medical Center Email:

Requirements: DSN:

Medical Director, Molecular Department of Pathology and Area Laboratory

Date: 11 August 2022 Department of Pathology and Area Laboratory Services Brooke Army Medical Center

CUI//CP-PROCURE Control No: 23-RHCO-C-000077

Controlled by: RHCO-C CUI Category: PROCURE

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

Program Manager:

Typed Name: , Laboratory Manager Department of Pathology and Area Laboratory Services Brooke Army Medical Center

DSN:

Signature:

114910

Digitally signed by

017114910 Date: 2022.08.29 09:38:23 -05'00'

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

Controlled by: RHCO-C CUI Category: PROCURE

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, consumables, controls, and warranty service compatible to the Government-owned BioArray Solutions Array Imaging System 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 the 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:

Immucor, Inc.

3. Description of Supplies/Services: This requirement is a follow-on to the current contract W81K00-18-P-0044 with Immucor, Inc. (Immucor) expiring 30 September 2022. This contract is currently in place to provide the human erythrocyte antigen phenotypes testing Kit and Warranty Service compatible with the Government-owned BioArray Solutions Array Imaging System. This Precise Type of Human Erythrocyte Antigen (HEA) Molecular BeadChip Kit is an in vitro diagnostic test for HEA phenotypes. The Precise Type HEA Molecular BeadChip Test provides twenty-four polymorphisms associated with thirty-five Human Erythrocyte Antigens. With the identification of the presence of blood group antigens by analysis of DNA, the clinician can order tests, make referrals, and treat as appropriate, thus saving time, eliminating unnecessary costs, and providing best patient care to soldiers and their beneficiaries to maintain a state of physical and mental health readiness.

The HEA BeadChip Kit is used to assist in the clinical care of patients. This test is not used for research purposes in DPALS. See below intended use from package insert “The HEA BeadChip Kit is an in vitro diagnostic test intended for the molecular determination of allelic variants that predict erythrocyte antigen phenotypes in the Rh (C [RH2], c [RH4], E [RH3], e [RH5], V [RH10], VS [RH20]), Kell (K [KEL1], k [KEL2], Kpa [KEL3], Kpb [KEL4], Jsa [KEL6], Jsb [KEL7]), Duffy (Fya [FY1], Fyb [FY2], GATA [FY-2], Fyx [FY2W]), Kidd (Jka [JK1], Jkb [JK2]), MNS (M [MNS1], N [MNS2], S [MNS3], s [MNS4], Uvar [MNS-3,5W], Uneg [MNS-

Controlled by: RHCO-C CUI Category: PROCURE

3,-4,-5]), Lutheran (Lua [LU1], Lub [LU2]), Dombrock (Doa [DO1], Dob [DO2], Hy [DO4], Joa [DO5]), Landsteiner-Wiener (LWa [LW5], LWb [LW7]), Diego (Dia [DI1], Dib [DI2]), Colton (Coa [CO1],Cob [CO2]), and Scianna (Sc1[SC1], Sc2 [SC2]) blood group systems in human genomic DNA. The test also detects the HgbS mutation in the Beta Globin gene.”

Overall, the above test is used primarily as an ancillary test in support of Blood Bank operations at BAMC to aid in the clinical care of patients. Mainly, the information provided by the test helps to manage the appropriate use of blood products.

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

Reagents

QTY

Kit

Unit Price

Test Unit Price

HEA 1.2 BeadChip Kit, Slide CT 5

Reagent Box, PreType BeadCheck Kit 5

AIS Service & Support 1

Total for the Base Period and each Option Year

Amount: $213,322.50 (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):

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: Immucor, Inc. is the only reagent company in the United States that has a proprietary assay for both the HEA 1.2 BeadChip Kit, Slide CT and the Reagent Box, PreType BeadCheck Kit. In order to purchase the proprietary

Controlled by: RHCO-C CUI Category: PROCURE

HEA 1.2 BeadChip Kit, Slide CT, Reagent Box, PreType BeadCheck Kit in the United States, the individual would have to directly contact Immucor, Inc. Immucor does not partner with any outside distributors in the United States. Immucor is the sole manufacturer and distributor of the reagents and supplies that are compatible with the existing Government-owned Applied BioArray Solutions Array Imaging System; this system is manufactured by Nikon (microscope) and Prior Scientific (scan system). The BeadChip reagent kits offered by Immucor are compatible with the laboratory instrument; no other cartridges are compatible with the Applied BioArray Solutions Array Imaging System; alternative reagents are different in shape and provided different results. Applied BioArray Solutions Array Imaging System 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.

The Government-owned the Applied BioArray Solutions Array Imaging System Instrument was purchased in January 2016 and the life expectancy for this equipment is ten (10) years. Alternative reagents are not compatible with current instrumentation and would void warranties.

a. A Sources Sought Notice was initially posted to https://beta.sam.gov, the official Government Point of Entry, on 14 July 2022 with a response due date of 21 July 2022 in order to find companies (small and other-than-small) that could provide reagents to conduct human erythrocyte antigen phenotypes testing.

The Government did not receive a response from any interested offeror on 21 July 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 Immucor, Inc. 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.

6. 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 posted on 14 July 2022; 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.

7. Actions to Increase Competition: Should BAMC continue to have a need for these Molecular BeadChip 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

Controlled by: RHCO-C CUI Category: PROCURE marketplace.

8. 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 August 2022.

Immucor, Inc. provides HEA 1.2 BeadChip Kits that are compatible with the Government-owned equipment. Immucor’s kits are FDA Approved and is made for clinic use therefore, this vendor meets the requirement for this effort.

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

9. Interested Sources: Other than Immucor, Inc., no other sources that can provide all Molecular BeadChip Reagents have written to express interest in the acquisition.

10. Other Facts:

a. Procurement History:

i. Contract W81K00-18-P-0044 was issued with a base period of 21 November 2017 – 30 September 2018 plus Four (4) twelve-month option periods through 30 September 2022.

ii. Competitive status of this action: small business set-aside for businesses that can meet the salient characteristics in the solicitation. Only one offer received by Immucor, Inc.

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 was solicited as a small business set-aside for all small businesses that can meet the salient characteristics in the solicitation. Only one offer from Immucor, Inc. was received by the Government for this action.

vi. Unusual patterns: N/A

vii. Justification with significant changes: N/A

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

Controlled by: RHCO-C CUI Category: PROCURE

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: Date:

Title: OIC, Molecular/Immunology Signature:

Department of Pathology and Area Laboratory Services, Brooke Army Medical Center

12. 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.

Title: Medical Director Clinical Pathology/Molecular Diagnostics Signature:

Department of Pathology and Area Laboratory Services, Brooke Army Medical Center

I.1513565301

Digitally signed by 1513565

Date: 2022.08.29 09:28:32 -05'00'

023633

Digitally signed by

124023633 Date: 2022.08.29 09:50:29 -05'00'

Controlled by: RHCO-C CUI Category: PROCURE

13. 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.

Title: Contracting Officer Signature:

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

Title: Contracting Officer Signature:

1096950213

Digitally signed by

.1096950213 Date: 2022.08.30 11:53:08 -05'00'

Digitally signed by

ODD.1096950213

Date: 2022.08.30 11:53:58 -05'00'