Redacted -- Justification and Approval_21-RHCO-C-700 ----- Hologic MA LLC - KO Signed - 10 Sep 2021.pdf

Control No: 21-RHCO-C-700 Contractor: Hologic, (MA), LLC.

Program/Equipment: Lab Reagents

Controlled Unclassified Information

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS –

SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: Purchase of Hologic Fetal Fibronectin (fFN) Cassettes and Control Kits compatible with the Government-owned Adeza TLiIQ System for the Department of Pathology and Area Laboratory Services, Brooke Army Medical Center, JBSA Fort Sam Houston, Texas.

Authority: Simplified Procedures for Certain Commercial Items, as implemented by FAR Subpart 13.5.

Amount: $415,990.00 (Base + Four (4) Options)

Prepared by:

Contract Specialist

JBSA HCB, RHCO-C

Date: 7 September 2021

Contracting Officer:

Contracting Officer Fort Carson, RHCO- C

Date: 7 September 2021

Technical:

OIC, Core Lab Date: 7 September 2021

Department of Pathology and Area Laboratory Services Brooke Army Medical Center

Requirements:

OIC, Core Lab Date: 7 September 2021

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

Program Manager:

Typed Name: LTC.

Chief, Core Laboratory

Army Medical Center

DSN: 429-7793

Signature:

VERSION – March 20

FOR OFFICIAL USE ONLY

Program/Equipment: Lab Reagents

VERSION – March 2017 Controlled Unclassified Information

Date: 2021.09.10 12:59:26 ‐05'00'

Program/Equipment: Lab Reagents

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

1. Contracting Activity: US Army Health Contracting Activity, Regional Health Contracting Office – Central, 3551 Roger Brooke Drive, JBSA Fort Sam Houston, Texas78234.

2. Description of Action: Purchase of fFN Cassettes and Control Kits that are compatible with Government-owned equipment via firm-fixed-price contract for the Department of Pathology and Area Laboratory Services, Brooke Army Medical Center, JBSA Fort Sam Houston, Texas The Government projects award for September 2021, with performance to start 1 October 2021; award will be subject to the availability of Defense Health Program, Army FY22 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:

Hologic (MA), LLC.

Description of Supplies/Services: This requirement is a follow-on to the current contract W81K00- 18-P-0300 with Hologic (MA), LLC. expiring on 30 September 2021. This contract is currently in place to provide fFN Cassettes and Control Kits compatible with the Government-owned Adeza TLiIQ System. The reagents will be used to test for the presence of fFN in cervicovaginal secretions of women with suspected preterm labor and women undergoing routine prenatal care.

The reagents will aid in assessing the risk of preterm delivery in less than or equal to seven days or less than or equal to 14 days from the cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes, and minimal cervical dilatation (< 3 cm), sampled between 24 weeks, 34 weeks, and six days gestation. Hologic fFN Enzyme Immunoassay, Rapid fFN, is the only FDA approved system for fFN testing in the United States. It is imperative that the laboratory has the ability to perform the testing in-house for the identification of the above items for patient treatment. If this contract is not awarded, the Core Lab Section will be unable to offer these diagnostic tests for the treatment regimens required by health care providers within BAMC and from outlying facilities.

Base Period: 01 October 2021 to 30September 2022 Option Period 1: 1 October 2022 to 30September 2023 Option Period 1: 1 October 2023 to 30September 2024 Option Period 1: 1 October 2024 to 30September 2025 Option Period 1: 1 October 2025 to 30September 2026

Total: $415,990.00

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

3. 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.

Program/Equipment: Lab Reagents

4. Reason for Authority Cited:

a. Hologic, Inc., is the sole proprietary manufacture of the Rapid fFN® test for the TLiIQ® System. In addition, Hologic, Inc., as the ultimate parent company, has authorizedHologic (MA), LLC to be the sole domestic distributor for the Rapid fFN test for the TLiIQ System.

The Rapid fFN test is performed using immunodiagnostic products that are solely manufactured by Hologic. Hologic does not sell through dealers or distributors in the U.S.;

sales are made directly to the end user only.

b. The diagnostic cassettes offered by Hologic are compatible with the Government-owned

Adeza TLiIQ System in the laboratory; no other cassettes are compatible with the Adeza TLiIQ System; alternative cassettes are different in shape and provided different results.

The Hologic system is still in use for Fetal Fibronectin testing by the laboratory; another manufacturer’s cassettes would alter the results received by testing and would not be usable for the end product decision-making phase. The Government-owned Adeza TLiIQ System was purchased in June 2016 and the life expectancy for this equipment iseight

(8) years. Alternative reagents are not compatible with current instrumentation and would void warranties.

c. Alternatives. The only known vendor that carries the compatible cassettes for the Adeza

TLiIQ System is the manufacturer, Hologic, Inc. As stated above the manufacturer prefers to satisfy this requirement by utilizing their only distributor, Hologic (MA), LLC. to be the sole domestic distributor for the Rapid fFN tests for the TLiIQ System

5. Efforts to Obtain Competition: The Contracting Officer shall publish the notices requiredby FAR 5.201 on https://beta.sam.gov (the Government’s Point of Entry) within 14 days after contract award.

6. Actions to Increase Competition: A Sources Sought Notice was posted to http://beta.sam.gov with the Government’s requirements from 24 – 27 August 2021 in order to find companies (small and large) that could provide reagents that test for the presence of fFN in cervicovaginal secretions and is compatible with the Government-owned Adeza TLiIQ System. Only (1) once response was received from Hologic (MA), LLC.

7. Market Research: Market research was conducted via the internet, brochures, literature review, and a Dynamic Small Business Search from the Small Business Administration’s website. However, this research did not reveal any other sources. The BAMC Laboratory is similarly unaware of any other commercial sources that can provide reagents that are compatible with the existing Government-owned equipment.

8. Interested Sources: A Sources Sought Notice was posted to http://beta.sam.gov (the Government’s Point of Entry) with the Government’s requirements from 24 – 27 August 2021.

Again, only (1) once response was received from Hologic (MA), LLC. To date, no other sources have written to express an interest in this acquisition.

9. Other Facts:

a. Procurement History.

Current contract: W81K00-18-P-0300 (1 October 2018 – 30 September 2021)

Program/Equipment: Lab Reagents

(1) This action was solicited on a sole source basis.

(2) Authority previously cited if less than full and open competition: FAR13.106-1(b)(1)(i)

(3) Summary of previous justification: Market research revealed that Hologic, Inc. is the Original Equipment Manufacturer (OEM) of the Hologic TLiIQ System. Hologic is the sole source provider of the consumables which include Rapid fFN Cassettes, control and collections kits, required to perform the Fetal Fibronectin (fFN) testing assessment which is used to determine high risk preterm delivery.

(4) The solicitation for the current contract yielded one (1) offer.

(5) Unusual patterns: N/A

(6) Significant changes: N/A

b. Hologic (MA), LLC. does not have any known distributors or other authorized vendors that could provide the required testing reagents.

10. 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 andbelief.

Typed Name: Date: 10 SEP 2021 Title: Deputy Chief of Core Laboratory Signature:

Department of Pathology and Area Laboratory Services,

11. 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: CPT John E. Brogie

Title: Deputy Chief of Core Lab Department of Pathology and Area Laboratory Services, Brooke Army Medical Center

Date: 10 SEP 2021 Signature:

.15552 01008

55201008 Date: 2021.09.10 11:41:43 ‐05'00'

EDWIN

BROGIE.JOHN.

55201008

WIN.1555201008

Date: 2021.09.10 11:42:07 ‐05'00'

Program/Equipment: Lab Reagents

12. 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. This determination will be made using price analysis techniques. The pricing received will be determined fair and reasonable by comparing the offer to the current and previous contracts, market research and the Independent Government Estimate (IGE). As a part of this basis, certified cost or pricing data is not required because the item and/or supplies being acquired are considered commercial.

Typed Name: Randall P. Cummins Date: 10 September 2021 Title: Contracting Officer Signature:

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

Typed Name: Randall P. Cummins Date: 10 September 2021 Title: Contracting Officer Signature:

‐06'00'

Digitally signed by

72303853

Date: 2021.09.10 13:22:15 ‐06'00'

DALL.P.107230