JA_Redacted.pdf

CUI//SP-PROCURE//FEDCON

Control Number:

25-MRCO-WEST-201

CUI//SP-PROCURE//FEDCON

JUNE 2025

Requirements:

Typed Name:

Title: Health System Specialist

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

Legal Counsel:

Legal Counsel E-mail:

25-MRCO-WEST-201

CUI//SP-PROCURE//FEDCON

JUNE 2025

It is a huge undertaking to transition to a new vendor, and the transition will affect every section in the lab. An Automated Core Lab is not a plug and play system. This is a fully Automated Core Lab, which includes multiple analyzers with a fully automated track that can run multiple tests. The installation of this system will be extensive and requires months of coordination between multiple stakeholders i.e., Facilities, Lab and IT.

During installation a portion of the track will need removed, and then that portion will be correlated/validated. Once that is complete, the rest of the track will be removed and then again correlated/validated. This process all needs to be coordinated through both Facilities and IT. It could possibly mean reconfiguration of the laboratory, including movement of electrical outlets, waterlines, adding electrical panel and moving countertops.

This system performs all the testing for MACH, which includes over 36,000 tests per month or over one million tests a year. MACH supports more than 42,000 active-duty personnel and more than 145,000 family members and retirees. A break in testing services would result in completely shutting down the Core Laboratory, effective 01 October 2025; conducting no tests mission failure will occur. Without a Core Laboratory there would be a negative impact on the Military Treatment Facility (MTF); because all testing would need to be sent out on the network, which would also shut down the emergency room and Operating Rooms.

a. Background: Cost-per-reportable results automated core laboratory is inclusive of instruments, ancillary equipment, maintenance, services, repairs, support, parts as required to maintain the systems in optimal operating condition, and any installation.

Additionally, the contractor provides immunoassay and chemistry testing reagents, supplies, and materials used in triage of medical emergencies. MACH currently has an active emergency room (ER), operating room (OR), intensive care unit (ICU) and labor & delivery. The clinical tests provided by this instrument will help provide appropriate patient care and avoid unnecessary costs and delays in diagnosis. The instrument provides patients the results needed for diagnosis and treatment.

The automated core lab is vital in support of the ER, OR, ICU, and Labor & Delivery.

This requirement is an automation line with a track and analyzers attached to MACH core laboratory including the chemistry, hematology, urinalysis, and coagulation sections.

It is a huge undertaking to transition to a new vendor, and the transition will affect every section in the lab. The follow-on contract is estimated to be awarded in November 2025;

however, it is not a plug and play system. This is a fully Automated Core lab, which includes multiple analyzers with a fully automated track that can run multiple tests.

Each vendor�s automated track is different. The coordination between Facilities, IT, Lab and the vendor cannot take place until the competitive requirement is executed. Once the award is made the vendor must submit the layout of their automated track to the

25-MRCO-WEST-201

CUI//SP-PROCURE//FEDCON

JUNE 2025

Lab. Their design plan may require extensive construction/reconfiguration of the Lab (i.e. moving water lines, adding water lines, electrical outlets, removing counter tops, adding another Uninterrupted Power Supply (UPS) or adding an electrical panel).

After approval of the layout the vendor must submit their phase in plan, construction plan, and installation plan to Facilities, which are very extensive plans. The design and construction plans are used to develop the Government�s Risk Assessment which occurs prior to construction/reconfiguration. The plans are as-build drawings reflecting what change will occur to the Government�s infrastructure.

The vendor does not have the required plans readily available because the design and construction plans are based on the individual Military Treatment Facility�s (MTF) Lab.

Therefore, the plans are created after contract award. This process could take approximately 5-6 months to complete. During this process multiple meetings and site visits are taking place between Facilities and the vendor�s engineers.

Once the Risk Assessment is approved by the MTF Commander the vendor can start the construction/reconfiguration of the Lab. This process could take up to 5-6 months depending on how much construction/reconfiguration is required.

After the construction/reconfiguration is complete the installation process is done in multiple phases. A portion of the track would be removed, and then that portion will be correlated/validated. Once that is complete, the rest of the track will be removed and then again correlated/validated. Validation and correlation could take 3-4 months due to the number of analyzers on the automated track.

Reprocuring an Automated Core Lab requires a lot of coordination between multiple stakeholders within the MTF. Historically, it could take up to 18 months from the time the contract is awarded to when the Automated Core Lab is ready to go live. The estimated timeline does not account for any obstacles that may occur during the process.

7. Efforts to Obtain Competition: This bridge contract will serve to ensure no lapse in testing services critical for the hospital's patient care objectives. There are not any alternatives to the re-awarding a short-term contract to the incumbent that would not result in mission failure. Martin Army Community Hospital 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 for physicians to make a diagnosis and develop a treatment plan. The contracting officer will publish the notices required by FAR 5.201 and any bids or proposals received shall be considered.

a. Effective competition: Describe the extent of effective competition anticipated for this acquisition. N/A

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b. Subcontracting competition: In single source situations, address efforts by the Government to assure that the prime contractor obtains as much competition as possible in its subcontracting. N/A

8. Actions to Increase Competition: A competitive acquisition is currently in progress and is anticipated to be awarded early in FY26. This bridge contract will allow services to continue while the competitive re-procurement is completed. For the bridge contract, market research was conducted by Department of Pathology personnel in conjunction with contracting personnel to determine the likelihood of other laboratory testing companies being able to provide for the complete requirement in a short amount of time without degradation to patient care.

9. Market Research: Market Research was conducted by the contract specialist from 30 May � 10 June 2025. Reviewed results of recent market research of similar or identical requirements. Queried the Small Business Administration website and General Services Administration contracts. Source Sought notice was posted from 30 May 2025 to 10 June 2025 on SAM.gov with a response from six (6) interested vendors. Siemens Health (Large Business), BHPE LLC (Small Business), Roche (Large Business), Beckman Coulter (Large Business), Abbott (Large Business) and Ortho (Large Business). These vendors are available and capable of providing the type of cost-per-reportable results with automated core laboratory.

No vendor, other than the current incumbent contractor, would be able to be fully operational on 01 October 2025, due to the length of set-up time after the award of a new contract which includes: designing and installing the automated core laboratory, facilities department to prepare the laboratory with properly place electrical outlets, source of water, a water drains, and other modifications, calibrate and validate the equipment, and the time required for Information Technology IT setup. The unique requirements of establishing a completely new instrument platform that is capable of accurately reporting patient testing into MHS-GENESIS (a brand-new Hospital Information System/Electronic Health Record) will take approximately six (6) to 24 months. A break in testing services will have a negative impact on the Military Treatment Facility (MTF) and patient care.

10. Interested Sources: The only acceptable vendor is the current vendor Beckman Coulter Inc. Beckman Coulter currently successfully provides cost-per-reportable results with automated core laboratory at MACH, and use of any other vendor would incur an unacceptable lengthy break in service.

Interested Sources that were identified during market research, Abbott, Beckman Coulter, BHPE LLC, Ortho Clinical Diagnostics, Roche, and Siemens.

11. Other Facts: N/A

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JUNE 2025

Approval

Based on the foregoing justification, I hereby approve the procurement of Cost-Per- Reportable Result (CPRR) with Automated Core Laboratory System on an other than full and open competition basis pursuant to the authority of Title 41 U.S.C. §1901(e)(2) 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. The estimated value of the Bridge contract is $2,133,804.00 for one year delivery window and two six-month delivery window options, delivery period from 01 Oct 2025 to 30 Sep 2027. The approval is subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for this acquisition.

Signature: Date: ________________________

Typed Name:

Title: Command Advocate for Competition