Attachment 1- Redacted Sole Source Justification_Sysmex America.pdf

CUI//SP-SSEL

Hematology Testing Reagents

William Beaumont Army Medical Center, El Paso, Texas

CUI//SP-SSEL

(Source Selection information - See FAR 2.101 and 3.104-4) AUG 2022

Sole Source Justification and Approval

Program/Equipment: This action is a firm fixed price contract with Sysmex America for the continuation of procuring reagents for XN10 analyzers for fully automated Hematology system on Red and White cell count testing at William Beaumont Army Medical Center (WBAMC), El Paso, Texas.

Authority: 41 U.S.C. 1901 as implemented by Federal Acquisition Regulation (FAR) Subpart 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

Prepared by:

Contracting Officer:

Technical Representative:

Requirements Representative:

William Beaumont Army Medical Center, El Paso, Texas

(Source Selection information - See FAR 2.101 and 3.104-4) AUG 2022

Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

Legal Counsel Office of General Counsel

Command Advocate for Competition

Sole Source Justification and Approval

1. Contracting Activity: Medical Readiness Contracting Office- West (MRCO-W)

2. Description of Action: The Pathology Department at William Beaumont Army Medical Center (WBAMC) requests a firm-fixed- price follow-on contract with Sysmex America.

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. Description of Supplies/Services: Procure hematology testing reagents for four (4) fully-automated Sysmex hematology analyzer systems in support of William Beaumont Army Medical Center-Main hospital, Donor Center and Hugo Mendoza Clinic

This requirement is .

4. Authority Cited: The statutory authority permitting other than full and open competition is 41 U.S.C. 1901 as implemented in FAR 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 current Defense Health Agency (DHA) Cyber-security posture, the laboratory systems require both approval for MHS Genesis and a valid RMF Authorization to Operate to connect with DHA Genesis. Sysmex America is the only vendor that provided proof of ATO/RMF certification required for this requirement, and the only one that has Food and Drug Administration blood bank approved software license for blood donor platelets aphaeresis transfusion quality assurance. Additionally, Sysmex America is the Original Equipment Manufacturer (OEM) of the government’s hematology testing equipment. The required hematology reagents are proprietary to Sysmex America; there are no other authorized providers for the service of the Sysmex analyzers, the proprietary letter is on file.

Failure to award a contract to Sysmex America to provide the required hematology testing reagents will jeopardize the Pathology Department’s mission of providing accurate and timely care to its beneficiary population.

6. Efforts to Obtain Competition: Previous acquisition competition as required by FAR 5.201. Sysmex America was the only vendor out of two that was considered technically acceptable. Additionally, based on current market research conducted in June 2024 and previous acquisition history, competition is not anticipated for this requirement, therefore, it is not practical to solicit contract and expect responses from other sources because of the proprietary nature of the reagents.

7. Actions to Increase Competition: After award, this justification will be available at the Government wide point of entry (GPE), www.sam.gov. If in the future other compatible products become available, market research will be performed to consider other sources that meet or exceed the current requirement. Additionally, an evaluation of the market will be conducted prior to any renewal related to this requirement. Pricing, availability, and any alternative solutions will be the focus of that research. The contract file will be properly documented with any findings.

8. Market Research: A recent sources sought notice was posted on SAM.gov from 12 June 2024 to 18 June 2024 as part of market research. The results yielded only two (2) responses, one from Sysmex America and Beckman Coulter.

Beckman Coulter’s response was reviewed by the government technical team and it did not meet the government’s requirement. Beckman’s response was technically unacceptable because their reagents are not compatible with the Sysmex system at the WBAMC facility. Furthermore, their technical approach did not have an FDA approved system for the Blood donor center analyzer and their system cannot connect to the WBAMC automated processor.

Research in ECAT was conducted and the reagents are not listed. Additionally, the required hematology reagents are proprietary to Sysmex America, the proprietary letter is on file.

9. Interested Sources: A Notice of Intent to Sole Source this action to Sysmex America will be posted in the GPE, www.sam.gov. Future requirements of this type will continue to be researched within the market to ascertain if additional vendors have entered the market offering the required services. To date, no other sources have written to express interest in this acquisition except Beckman Coulter which has been considered technically unacceptable.

10. Other Facts:

a. Procurement history

(1) Contract numbers and dates of the last several contracts for these same requirements.

(2) The competitive status of these actions.

(3) Authority previously cited if less than full and open competition was used.

Not applicable.

(4) No justification was prepared to support the procurement made before this one.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

Sysmex America, Inc. as a competitive acquisition. Sysmex America was the only vendor that provided proof of ATO/RMF certification. Since the current Defense Health Agency (DHA) Cyber-security posture, the laboratory systems require both approval for MHS Genesis and a valid RMF Authorization to Operate to connect with DHA Genesis, procuring the requirement through GSA is not preferred as approved devices may not be included on the GSA contracts nor continuing to procure competitively. Additionally, market research resulted in no other vendor can comply the requirements of this solicitation , thus indicates there are no small businesses that can met the requirement.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

Based on the procurement historical data, it was procured competitively via GSA eight (8) years ago and the same vendor Symex America has been the consecutive awardee since 2016.

Although the DHA Cyber-security posture has been updated and the government’s requirement of reagents workload has increased, Sysmex America continues to validate they can continue to meet the ATO/RMF certification in addition to successfully perform the contract.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

b. Other Facts-

Not applicable

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

None. Required supply of reagents is proprietary to Sysmex America and is the only reagent that can be used in the government’s equipment. ECAT/DLA, DAPA, Owen & minor, and prime vendor cannot provide these reagents.

12. 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.

13. 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.

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. This determination will be made using the IGCE. 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.

Contracting Officer

MRCO-W

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

Contracting Officer

MRCO-W

APPROVAL

Based on the foregoing justification, I hereby approve the procurement of hematology testing reagents in the amount of on an other than full and open competition basis to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Command Advocate for Competition