A02-JA Final-MALDI Biotyper Final.pdf

CUI//SP-SSEL

Control Number: JA-22-08-2217

CUI//SP-SSEL

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

1 1 SEP 2021

Justification Review Document For Sole Source - FAR Part 13.501*

(*Format follows FAR 6.303-2, but modified to reflect FAR subpart 13.5 procedures)

Program/Equipment: MALDI Biotyper System Maintenance Services

Authority: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

Amount: $679,397.17

Prepared by:

Typed Name: Amy Michels DSN: 301-319-9005

Title: Management and Program Analyst Date: _18 August 2022

E-mail: amy.e.michels.civ@health.mil

Contracting Officer:

Typed Name: Sharew Hailu DSN: 301-619-9201

Date Reviewed: 17 August 2022 E-Mail: Sharew.hailu.civ@health.mil

Technical Representative:

Title: Management and Program Analyst Date Reviewed: 18 August 2022

Requirements Representative:

Title: Management and Program Analyst Date Reviewed: 18 August 2022_ mailto:amy.e.michels.civ@health.mil mailto:Sharew.hailu.civ@health.mil

CUI//SP-SSEL

2 1 SEP 2021

Sole Source Justification and Approval

Under FAR 13.501

1. Contracting Activity: The Contracting Activity is the United States Army Medical Research Acquisition Activity (USAMRAA). The Requiring Activity is the Walter Reed Army Institute of Research (WRAIR).

2. Description of Action: Approval is being requested for a new firm fixed price contract using DHP O&M funds for a sole source to award to Bruker Daltonics, Inc.

3. Description of Supplies/Services: Contractor shall provide preventive maintenance (PM) services for three instruments: one MALDI Biotyper CA System and two MALDI Biotyper smart CA Systems.

Base Period: 15 September 2022 to 14 September 2023 Value: $105,300.00 Option Period 1: 15 September 2023 to 14 September 2024 Value: $112,671.00 Option Period 2: 15 September 2024 to 14 September 2025 Value: $120,557.97 Option Period 3: 15 September 2025 to 14 September 2026 Value: $128,997.03 Option Period 4: 15 September 2026 to 14 September 2027 Value: $138,026.82 52.217-8: 6 Month Ext. 15 September 2027 to 14 March 2028 Value: $73,844.35

Total: $679,397.17

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: The Bruker MALDI Biotyper Systems are three specialized instruments used to support Multidrug-resistant organism Repository & Surveillance Network’s (MRSN) mission of conducting epidemiological surveillance of multi-drug resistant organisms (MDROs) to enhance performance improvement and infection control across the DOD. Specifically, advances in technology (i.e., with the use of the Bruker MALDI Biotyper Systems) could help adequately inform the processes of sequencing and processing isolates, which is a fundamental function of MRSN.

Additionally, periodic service and cleaning will keep the three machines fully functioning and validated.

A lack of adequate maintenance services could adversely impact the efficient function of the Bruker MALDI Biotyper Systems, and result in potential losses in production in MRSN laboratories. Equipment’s manufacturer warranty states that “attempts to clean or service the equipment without written consent of Bruker Daltonics, Inc. could be considered a breach of the service contract” under the warranty. As the Original Equipment Manufacturer (OEM) Bruker Daltonics, is the only source that can provide certified technicians on the equipment.

CUI//SP-SSEL

3 1 SEP 2021

Preventative maintenance services directly from the equipment’s manufacturer (Bruker Daltonics Inc.) will support the current lab operations and ensuring MRSN’s capabilities to respond to directives under Executive Order 13676 to expand MDRO services across Defense Health Agencies (i.e., Army, Navy, Air force).

Without the certified equipment maintenance service, MSRN’s workflow would enter a stop-work pattern that could result in potential interruption in the testing and identification processes. This request is mission critical; fully functioning equipment is essential and will enable MRSN to fulfill its expanded mission, and the mandate under EO 17636, titled Combating Antibiotic Resistant Bacteria (CARB) (MEDCOM policy 15- 042).

A lack of the high functionality of MRSN could pose a serious health threat or outbreaks at Military Treatment Facilities (MTFs) across the entire DoD system.

6. Efforts to Obtain Competition: WRAIR conducted substantive internet searches to identify companies that provide maintenance services for Bruker MALDI Biotyper Systems. Market Research identified Bruker Daltonics Inc. as the only vendor capable of providing the required maintenance services for the Bruker MALDI Biotyper Systems.

No effective competition has been found or is anticipated and obtaining services from any other company would impact the existing equipment warranty. A notice was be publicized as required by FAR Subpart 5.2 on 27 July 2022.

7. Actions to Increase Competition: WRAIR will continue to monitor market development to identify suppliers that may provide the services in the future.

8. Market Research: Market research was conducted by Contracting Officer Representative (COR) on 1 April 2022 through internet searches to identify all qualified sources. The market research concluded that Bruker Daltonics, Inc. (Manufacturer) is the only vendor that can provide the required services.

A request for information was posted to SAM.gov by the Contracting Office on 19 July 2022 for 7 days and no response was received from the industry.

Based on market research, only one source, Bruker Daltonics, Inc., is capable providing the services.

9. Interested Sources: To date, no other sources have written to express an interest.

Notices required by FAR 5.201 have been published, any bids or proposals received shall be considered.

10. Other Facts: a. Procurement history.

(1) W81XWH-17-P-0237 POP: 15 Sep 2017 to 14 Sep 2022 Total: $340,300.04

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4 1 SEP 2021

(2) Sole Source

(3) The statutory authority previously cited permitting other than full and open competition is 10 U.S.C. 2304(c) (1). The FAR citation is 6.302-1(a) (2) (iii), only one responsible source and no other supplies or services will satisfy agency requirements.

(4) MRSN has considered the benefits and risks of using technicians from other vendors that were not certified, and has determined that preventative maintenance services directly from the equipment’s manufacturer (Bruker Daltonics Inc.) would be most beneficial for supporting current lab operations and ensuring MRSN’s capabilities to respond to directives under Executive Order 13676 to expand MDRO services across Defense Health Agencies (i.e., Army, Navy, Air force). Equipment’s manufacturer warranty states that “attempts to clean or service the equipment without written consent of Bruker Daltonics, Inc. could be considered a breach of the service contract” under the warranty.

(5) No prior contract for this requirement was accomplished using full and open competition.

(6) No unusual patterns that were revealed by the history, e.g., several consecutive, urgent buys.

(7) JA17233 was approved on 28 August 2022 under award W81XWH-17-P-0237.

Bruker Daltonics Inc., as the OEM, were determined to be the only certified source capable of providing the preventative maintenance on the equipment. Market research conducted confirmed is no significant changes in the market and continuing preventative maintenance with the manufacturer would ensure no issues and continuation of the warranty and in the best interest of the Government.

b. Other facts. None

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.

MICHELS.AMY.E.12908 Digitally signed by MICHELS.AMY.E.1290871642 Signature: 71642 Date: 2022.08.18 15:08:30 -04'00' Date: _18 August 2022

Typed Name: Amy Michels Title: Management and Program Analyst

CUI//SP-SSEL

5 1 SEP 2021

HAILU.SHAREW.1410 Digitally signed by

278207 HAILU.SHAREW.1410278207

Date: 2022.08.23 15:36:11 -04'00'

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.

Signature: Date: 18 August 2022

Typed Name: Amy Michels Title: Management and Program Analyst

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.

In accordance with FAR 15.403-1(b)(3) certified cost or pricing data will not be required.

This determination will be made using the following: cost analysis X price analysis X IGE audit: N/A other: N/A

HAILU.SHAREW.1410 Digitally signed by

HAILU.SHAREW.1410278207

Signature: 278207 Date: 2022.08.23 15:35:46 -04'00' Date:

Typed Name: Sharew Hailu Title: Contracting Officer

14. Contracting Officer Certification:

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

Signature: Date:

Typed Name: Sharew Hailu Title: Contracting Officer

MICHELS.AMY.E.1290 Digitally signed by

871642 MICHELS.AMY.E.1290871642

Date: 2022.08.18 15:08:45 -04'00'