Redacted JA_under-SAT_ FY25 BD MGIT ____Supplies_Signed (1).pdf

CUI//SP-SSEL Control Number: 24-RHCO-C-57

CUI//CP-PROCURE

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

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 Government’s requirement is to obtain a cost-per-test arrangement for equipment and reagents/consumables, plus delivery, installation, training, and repair/maintenance services, to perform incubation and recovery, of mycobacterial specimens for the Department of Pathology and Area Laboratory Services,(DPALS) Brooke Army Medical Center (BAMC). Under this cost-per-test arrangement, the end user (e.g., hospital) pays “per test” price and runs the tests in-house, and all consumables, controls, analyzers/equipment, and any service necessary to maintain that equipment are provided by the vendor, who retains ownership of the equipment. The Government projects award before 30 September 2024, with performance to start 1 October 2024; award will be subject to the availability of Defense Health Program, (DHP) FY25 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).

3. Name of Proposed Contractor(s) and Address:

Becton, Dickinson, and Company (UEI:)

Brand Name Buy: Yes

Description of Services or Supplies: This requirement is a follow-on to the current contract of W81K00-20-P-0161 with Becton, Dickinson, and Company (BD), expiring 30 September 2024. The Department of Pathology and Area Laboratory Services (DPALS) at Brooke Army Medical Center, JBSA Fort Sam Houston, Texas has a requirement for an automated mycobacterial detection system for mycobacterial liquid culture and susceptibility testing, i.e. BD BACTEC™ MGIT™ Systems The equipment must be able to connect to the MHS Genesis and must come with an un-interruptible power supply capable of providing power for at least 45 to 60 minutes. All equipment and supplies must be approved by the FDA. The system shall have FDA Approved Guided programming. The Government’s requirement is to purchase reagents and other consumables for approximately 3,000 tests per 12-month period.

Delivery Period: 1 October 2024 to 30 September 2029

Amount: $61,500.00 (Base + Four (4) Option years)

Year Delivery Period Price Escalation Total

Base Period (1 October 2024 – 30 September 2025) -

Option 1 (1 October 2025 – 30 September 2026)

Option 2 (1 October 2026 – 30 September 2027)

Option 3 (1 October 2027 – 30 September 2028)

Option 4 (1 October 2028 – 30 September 2029)

Total Amount

$64,995.87

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

Mandatory Tests/Functions and Estimated Volumes

(BASE

YEAR)

(OPTION

1)

(OPTION

2)

(OPTION

3)

(OPTION

4)

Mycobacterial culture 3,000

Mycobacterial supplement

Mycobacterial digestion/decontamination kit

4. Authority: FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

5. Reasons for Authority Cited:

a. A notice of intent to sole source to Becton, Dickinson, and Company was posted to http://sam.gov (the Government’s Point of Entry) with the http://sam.gov/

Government’s requirements (e.g., needed tests, salient characteristics for the equipment, etc.) from 11 December 2023 – 3 January 2024. Only one response was received from Becton, Dickinson and Company on 19 December 2023. This vendor provided an email on 28 December 2023 confirming that Becton Dickinson is the sole manufacturer of the BD BACTEC™ MGIT™ Systems.

b. Mycobacterial testing provides the ability to detect bacteria that cause tuberculosis and other infections caused by similar bacteria. If the BAMC Laboratory is not able to perform this testing in-house there would be a significant delay in the ability of providers to diagnose for these highly contagious infections, increasing the potential for transmission of a disease, delaying appropriate treatment, and once diagnosed would then increase the amount of time that a patient would need to stay in isolation, an additional cost to the government. Additionally, market research has determined that Becton Dickinson and Company is the only vendor offering an “open” system, BD BACTEC™ MGIT™ Systems, that provides hourly fluorescence readings for mycobacterial pathogens in non-blood culture specimens.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.201 and FAR 5.203 apply and will be followed. The Contracting Officer shall publish the notices required by FAR 5.201. A Sources Sought Notice was posted on 11 December 2023; 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 as required. Action is a brand name restriction, over $25K. It will be redacted and posted with the solicitation.

7. Market Research: A Sources Sought Notice was posted on Sam.Gov on 11 December 2023 with a response due date of 03 January 2024 in order to find companies (small and large) that could provide reagents for mycobacterial liquid culture and susceptibility testing as listed on the notice issued by the Government.

Only one response was received from Becton, Dickinson and Company on 19 December 2023. 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 as well as the General Service Administration (GSA) schedule for mycobacterial reagents. This Market Research was conducted from October to December 2023. To date, the current market search has confirmed that only 1 vendor has the FDA approved BD BACTEC™ MGIT™ System. The DPALS Technical Team has reviewed the Capability Statement submitted by Becton, Dickinson, and Company on 19 December 2023 and has confirmed on 28 December 2023 that this vendor meets the requirements for this action. Based on the previous procurement efforts, there is only one vendor, Becton, Dickinson, and Company (UEI: DP4CNEMUF5F3), that can provide the mycobacterial reagents deemed technically acceptable to detect the bacteria that cause tuberculosis and other infections caused by similar bacteria. This Mycobacterial testing provides the ability to detect bacteria that cause tuberculosis and other infections caused by similar bacteria. If the BAMC Laboratory is not able to perform this testing in-house there would be a significant delay in the ability of providers to diagnose for these highly contagious infections, increasing the potential for transmission of a disease, delaying appropriate treatment, and once diagnosed would then increase the amount of time that a patient would need to stay in isolation, an additional cost to the government. Additionally, market research has determined that Becton Dickinson and Company is the only vendor offering an “open” system, BD BACTEC™ MGIT™ Systems, that provides hourly fluorescence readings for mycobacterial pathogens in non-blood culture specimens, therefore, no further efforts will be made to obtain competition at this time.

8. Other Facts:

Procurement history:

Contract W81K00-20-P-0161 was issued with a base period 26 May 2020 – 30 September 2020, plus Four (4) twelve-month option periods through 30 September 2024. This action was solicited as a sole source acquisition to Becton, Dickinson, and Company (UEI: DP4CNEMUF5F3).

9. Technical/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.

Digitally signed by

LATIF.1108297936

Date: 2024.01.10 11:16:23 -06'00'

Date: see electronic signature OIC, Immunology and Molecular Diagnostics Department of Pathology and Area Laboratory Services Brooke Army Medical Center

10. Contracting Officer Certification/Approval:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon based on price analysis techniques. As a part of the basis, certified cost and pricing data is not required per FAR 13.106-1(b).

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government. Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Digitally signed by 035373 Date: 2024.01.10 08:28:44 -06'00'

Date: see electronic signature Contracting Officer, MRCO-W