Redacted JA Sole Source_PAN 0315_Hologic_25 Nov 2024_all signed.pdf

CUI//SP-SSEL

(Source Selection information - See FAR 2.101 and 3.104-4)

CUI//SP-SSEL

Control Number: 25-MRCO-WEST-13

Memorandum for Record – Limiting Competition at or below the Simplified

Acquisition Threshold

1. Contracting Activity: Joint Base San Antonio Health Contracting Branch (JBSA HCB), Medical Readiness Contracting Office – West (MRCO-W), US Army Health Contracting Activity, 3551 Roger Brooke Drive, JBSA Fort Sam Houston, Texas.

2. Description of Action: The purpose of this action is to establish a cost-per-test agreement for instrumentation, reagents, controls, calibrators, and associated consumables in support of the Nucleic Acid Amplification Testing (NAAT) mission for the Department of Laboratory and Pathology Services (DPALS) Molecular (Microbiology) Laboratory at the Brooke Army Medical Center (BAMC), Fort Sam Houston, TX 78234.

The current purchase order, W81K00-23-P-0139, has a period of performance of 01 October 2023 to 30 September 2024 with 1 option period from 01 October 2024 to 31 May 2025. There is a need for a sole source follow-on contract for the period of performance of four (4) months, i.e.1 June 2025 through 30 September 2025.

The Contractor shall perform to the standards of the Statement of Objectives (SOO) supplies and services for four months to ensure continuity of sexually transmitted illness/disease molecular testing for the BAMC beneficiaries. The Government projects award before 15 December 2024, with performance to start 1 June 2025; award will be subject to the availability of Defense Health Program (DHP) FY25 Funds in the amount of $249,425.00. 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, Inc. (UEI: WHWJBKU5SX73) 250 Campus Dr.

Marlborough, MA 01752-3020

Items (Assay) Quantity (Kits) W81K00-23-P-0139

Hologic, Inc.

Cost per KIT

TOTAL

CT/GC APTIMA COMBO 2 26 $2,062.50 $53,625.00

Trich APTIMA 12 $650.00 $7,800.00

M GEN APTIMA 10 $2,000 $20,000.00

BV ASSAY 35 $2,200 $77,000.00

CV/TV ASSAY 35 $2,600 $91,000.00

TOTAL $249,425.00

CUI

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

3. Delivery Period: The base for the 4-month sole source follow-on contract starts 01 June 2025 to 30 September 2025. The total estimated amount of this requirement for the base period is $249,425.00.

4. Authority Cited: FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available. Hologic, Inc is the only contractor who meets the Government needs at this time due to specification constraints.

5. Reason for Authority Cited:

a. Hologic, Inc. is the only vendor that has proprietary ownership for the Hologic Panther Instrument. Hologic provided a sole source letter to the Government confirming the proprietary ownership of the Hologic Panther Instrument on 7 November 2024. If Hologic Panther is replaced with the instruments from other vendors, the supplies of the task order will fail to be compatible with the new instruments, which disrupts the continuity of testing and carries a negative consequence on the patient safety. The contemplated contract must be considered on a sole source basis.

b. During the ongoing global pandemic of Covid-19, BAMC has been utilizing a task order W81K00-24-F-0167 from the centralized contract W81K04-24-D-0010 to purchase reagents and consumables for SARS-CoV-2 and Flu A/B test. Contract W81K04-24-D-0010 only provides supplies compatible with Hologic Panther instrument. Therefore, the Hologic Panther has been used as the primary high through-put instruments to perform daily SARS-CoV-2 and Flu A/B Testing. BAMC will keep utilizing the task order W81K00-24-F-0167 until 30 September 2025. In order to maintain the existing SARS-COV-2 and Flu A/B Testing, BAMC must hold Hologic Panther Instrument in the DPALS Molecular Laboratory. Currently, DPALS hold two Panther Instruments provided by Hologic, Inc. through the CPT Purchase Order W81K00-23-P-0139, which will expire on 31 May 2025.

c. The sole source follow-on contract will allow time and resource conditions to ensure sufficient time is available to avoid any lapse in the laboratories capability while aligning with the current contract W81K04-24-D-0010 Task Order W81K00-24-F- 0167 with Hologic, Inc which will provide the SARS-CoV-2 and Flu A/B testing until 30 September 2025. Additionally, the unique requirements of establishing a completely new instrument platform that is capable of accurately reporting patient testing into MHS-GENESIS will take approximately six (6) months, creating a significant cost burden to the hospital, and a failure of the patient care mission from testing delays.

6. Efforts to Obtain Competition: This sole source contract is anticipated to be awarded with four (4) months of performance from 01 June 2025 to 30 September 2025 in order to align with the existing Hologic task order W81K00-24-F-0167, which ends on 30 September 2025. At such time the two contracts expire, the government will consolidate them and open the requirement for competition. The Contracting Officer shall publish the notices required by FAR 5.201. A Sources Sought Notice was posted for 14 days (11 October - 24 October 2024) and resulted in responses from two (2) vendors:

Becton, Dickinson, and Company (BD (a large business, CAGE 22790), and Hologic Inc ( a large business, CAGE 0UJ21). Upon finalization of this Justification and Approval document, a notice of intent to sole source will be posted to the GPE, with the final J&A to be published within 14 days of contract award.

There are no alternatives to the re-awarding a short-term contract to the incumbent that would not result in mission failure. BAMC 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 that allow physicians to make a diagnosis and develop a treatment plan. This contract will serve to ensure no lapse in testing services critical for the hospital’s patient care objectives. The next procurement for the period of performance starting on 1 October 2025 will be available for competition.

7. Actions to Increase Competition: The short-term sole source follow-on contract will not be available for competition. The follow-on procurement for the period of performance starting on 1 October 2025 will be available as a full and open competition and history shows there will be adequate competition.

8. Market Research: 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 August to October 2024.This market research is being used for the sole source follow-on contract.

A Sources Sought Notice was posted to https://sam.gov, the official Government Point of Entry, on 11 October 2024 with a response due date of 24 October 2024 to find interested sources (small and other-than-small) that could provide equipment/instruments and reagents to conduct the COVID-19, Flu A/B, Trichomonas vaginalis testing, Chlamydia trachomatis and Neisseria gonorrhoeae (CT/GC) testing.

Responses were received from two (2) companies: Hologic’s, Inc (other-than-small business), and Becton, Dickinson, and Company (other-than-small business).

1) Hologic, Inc. - The capability statement received from Hologic Inc., meets all the requirements of the Sources Sought Notice issued on 11 October 2024.

Hologic’s system is FDA approved and compatible to run the Hologic Aptima SARS-CoV-2 and Flu A/B Assays which DPALS is mandated to purchase through 30 September 2025. These two test can only be run utilizing the Hologic Panther or Hologic Panther Fusion systems and the laboratory is in urgent need of an FDA approved system to run these to tests. In conclusion, Hologic meets all requirements for this FY25 action.

2) Becton, Dickinson, and Company (BD) - The technical team reviewed the capability statement received from BD on 28 October 2024 and has determined that BD does not meet the requirements necessary for this action for two reasons:

a. BD does not offer any assay/test for M. genitalium as outlined in the

SOO. BAMC currently runs this test, and therefore would lose the testing capability for this reagent.

b. BD does not allow for testing using the following: rectal swabs and throat swabs. BAMC currently tests these specimens and would lose this testing capability as well.

9. Interested Sources: To date there are no other interested sources that have written to express interest in the acquisition.

10. Other Facts:

Procurement history:

The current Purchase Order W81K00-23-P-0139 was issued with a base period from 01 October 2023 to 30 September 2024 and Option Year 1 from 01 October 2024 to 31 May 2025. W81K00-23-P-0139 was solicited as a sole source acquisition to Hologic, Inc. in the amount of $737,475.00. (UEI: WHWJBKU5SX73).

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.

ZEIDAN.AMINA.

Digitally signed by

ZEIDAN.AMINA.RAL.1108297936

RAL.1108297936 Date: 2024.11.25 15:14:33 -06'00'

CPT Amina Zeidan

Date: see electronic signature

OIC, Immunology and Molecular Diagnostics

DPALS, BAMC

12. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification is accurate and complete to the best of my knowledge and belief.

Digitally signed by

JONES.ANTHONY.R.106017661 Y.R.1060176619 9

Date: 2024.11.2_6 07:39:10 -06'00'

LTC Anthony R. Jones Microbiology Chief

Date: see electronic signature

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. It is anticipated that pricing for the sole source effort will remain the same as the final option year of the awarded contract, which was deemed fair and reasonable at contract award. Certified cost or pricing data is not required per FAR 15.403-1(b)(3).

PAULOUSKAYA.SA Digitally signed by

LAMEYA.12460353 PAULOUSKAYA.SALAMEYA.124

73 Date: 2024.11.26 14:05:12 -06'00' _ Date: see electronic signature Salameya Paulouskaya Contracting Officer

14. Contracting Officer Certification:

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

PAULOUSKAYA.SA Digitally signed by

LAMEYA.12460353 PAULOUSKAYA.SALAMEYA.124

73 Date: 2024.11.26 14:05:40 -06'00' _ Date: see electronic signature Salameya Paulouskaya Contracting Officer

JONES.ANTHON

6035373

6035373