JA Sole Source FAR Part 13.5 (REDACTED).PDF

CUI//SP-SSEL Control Number: 25-MRCO-West-129

CUI//SP-SSEL

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

1 JUN 2023

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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: One (1) Immunochemistry and One (1) Clinical Chemistry analyzer(s) and Reagents/Consumables Cost-Per-Reportable-Result (CPRR). General Leonard Wood Army Community Hospital (GLWACH), Fort Leonard Wood, MO, Fort Leonard Wood, Missouri 65473.

Authority: 41 U.S.C. 1901(e)(2) implemented by Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii): sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

Amount: The estimated value of this effort is $ (no options)

Prepared by:

Date: 28 March 2025 Contract Specialist

Contracting Officer:

Contracting Officer

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Control Number:

Technical Representative:

Requirements Representative:

Reviews

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

Date: see digital signature Associate General Counsel Contract Law MTF Support Branch Defense Health Agency

1 JUN 2023

Sole Source Justification and Approval

Under FAR 13.501

1. Contracting Activity: Medical Readiness Contracting Office-West, Building 36038 Wratten Drive, Ft. Cavazos, Texas 76544

2. Description of Action: New Contract Action (NOT A FOLLOW-ON). Indefinite Delivery Indefinite Quantity (IDIQ) Firm Fixed Price – 5 Years, Defense Health Program funds, Army, Medical Supplies.

Name of Proposed Contractor and Address:

Ortho-Clinical Diagnostics, Inc.

1001 US Highway 202, Raritan, New Jersey 08869-1424 CAGE Number: 1C0L5 SAM UEI: Number: JG5JF2JQJ121

3. Description of Supplies/Services: The Department of Pathology, Laboratory Section at General Leonard Wood Army Community Hospital, (GLWACH), Fort Leonard Wood, Missouri 65473 has a requirement for one (1) immunochemistry and one (1) clinical chemistry analyzer(s) to include on-site training, equipment, reagents, consumables, controls, and any necessary services (e.g. maintenance of furnished equipment) for use at GLWACH. The requested analyzers (that will be leased) and reagents/consumables are for use at GLWACH. The analyzers must be able to perform the specific tests the Government requires. GLWACH Laboratory has a fluctuation of testing requirements due to its mission at Fort Leonard Wood, Missouri. The contract will also cover all maintenance of the analyzers, analyzer trouble shooting, replacement, and software support for the analyzers. An Indefinite Delivery Indefinite Quantity (IDIQ) five (5) year firm-fixed-price contract is contemplated. Fiscal year 2026 Defense Health Program funds are subject to the availability of funds.

Proposed Delivery Period:

1 October 2025 – 30 September 2026 $

1 October 2026 – 30 September 2027 $

1 October 2027 – 30 September 2028 $

1 October 2028 – 30 September 2029 $

1 October 2029 – 30 September 2030 $

Proposed Total $

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

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4. Authority Cited: The statutory authority permitting other than full and open competition is 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: Ortho-Clinical Diagnostics, Inc. is the only responsible source capable of meeting the Government’s supply needs with two (2) waterless Immunochemistry (1 each) and Clinical Chemistry (1 each) Analyzers and Reagents.

The Government has a current need in the Department of Pathology, Laboratory Services, GLWACH to provide a diverse array of reagents required to accommodate the potential variety of patients to include basic training personnel, active duty, retirees and civilians. Current market research to include a sources-sought notice, has not revealed any vendors other than Ortho-Clinical Diagnostics, Inc. who could provide the required two waterless analyzers and reagents. The cost of the waterless instruments (to include maintenance) and consumables are included in the costs of the required reagents. Failure to award a contract to a vendor other than Ortho-Clinical Diagnostics, Inc. would result in a lapse in testing, further resulting in potential mission failure in providing health care supplies to the basic training population, military treatment facility and the broad beneficiary population.

Pursuing an award for a water-based system would require additional plumbing work necessary for the installation of a water-based analyzer. This would require changes to the current laboratory footprint and possible disruption of services until the work is completed. This in turn would require additional costs for overtime work from the facilities team to perform the necessary facility changes during non-working hours of the clinical laboratory. It was confirmed additional construction costs to allow access to water would be an unnecessary burden to the taxpayer. Furthermore, per the department, DHA has stated along with the current construction contractor that changing the area will not occur.

The Analyzers and CPRR are for the new hospital to be opened sometime within FY26 at GLWACH. The Government does not retain ownership of the analyzers at the conclusion of the agreement period.

In addition to the aforementioned items the following minimum salient characteristics must be met:

1. The chemistry analyzers must have or be able to:

a. Test for measles, mumps, rubella, and varicella zoster on one reagent pack.

b. Analyzer must be fully automated and random-access Multiplexing Analyzer.

c. No batch testing required.

d. Analyzer technology must minimal hands-on processing to reduce errors.

e. Primary tube sampling.

f. Clot detection.

g. Multiplexed Quality Control and Calibration.

h. No reagent preparation.

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i. Icon driven touch screen software.

j. Consumable loading on the spot.

k. Minimal time needed to perform daily maintenance.

l. Must provide a Bidirectional Laboratory Information System interface.

n. A chemistry analyzer that does not require the water filter system, the system must be waterless based.

o. Must not require any added expense for plumbing, drainage, or water systems.

Self-contained, on-board water management eliminates special requirements for off-board plumbing.

6. Efforts to Obtain Competition: A sources sought notice for Integrated Immunochemistry and Clinical Chemistry Analyzer and Reagents (CPRR) was posted with the minimum reagent requirements to https://SAM.gov from 07 March 2025 through 10 March 2025, and re-posted again (to clarify the location of where analyzers will be located) from 12 March 2025 to 17 March 2025. There were three (3) responses to the sources sought.

a. Effective Competition. Based on market research that was conducted and the results of the Sources Sought Notice, competition is not anticipated for this requirement. The Government will continue to assess the market for new entrants. It is anticipated that only one vendor can meet this requirement for the waterless analyzers and requested reagents.

b. Subcontracting competition. As per FAR 19.705-2, if a subcontracting possibility exists, the contractor will be required to submit a subcontracting plan.

Therefore, at this time only Ortho-Clinical Diagnostics, Inc. can provide the two (2) waterless analyzers and required reagents.

7. Actions to Increase Competition: Based on market research, acquisition history, and the results of the Sources Sought Notice, competition is not anticipated for this requirement because there is currently only one vendor that can meet the requirement for waterless Immunochemistry and Immunoassay analyzers.

Previous actions were evaluated and found that one vendor is consistently capable of providing the Immunochemistry and Immunoassay Analyzer and requested comprehensive list of reagents for testing.

The Medical Readiness Contracting Office-West will continue to evaluate the capabilities of other vendor’s products and re-procure the products that provides the best value to the Government.

8. Market Research:

Market research was conducted by the Contract Specialist from January 2025 through March 2025. General Leonard Wood Army Community Hospital (GLWACH) requirements include continued efforts for conserving water and protecting the

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environment from additional waste that is returned via the wastewater. Ortho Clinical Diagnostics provides a waterless system where the reagents require no water, plumbing or drains. The VITROS® systems are currently the only systems that do not require a water system, nor the associated drains and maintenance associated with such, allowing GLWACH to continue their efforts for conserving water and protecting the environment. Secondarily the VITROS® system offers the capability of continued use in the case of a natural disaster due to no water or drainage being required. Lastly, Ortho is the Original Equipment Manufacturer (OEM) of the annotated equipment/CPRR stated in their capability statement.

An SBA Dynamic small business search and Quick Market search was conducted using key words “325413” and Immunochemistry and Immunoassay Analyzer with no small businesses that are currently listed.

Previous actions were evaluated and found that one vendor is consistently capable of providing the waterless Immunochemistry and Immunoassay Analyzers and requested comprehensive list of reagents for testing with a waterless analyzer system.

DLA ECAT and Medical Master Catalog were researched and the DLA and ECAT platforms with the requested two (2) waterless Immunochemistry (1 each) and Immunoassay (1 each) analyzer and requested comprehensive list of reagent supplies are currently not available.

Internet Research found two (2) companies, Roche Diagnostics and Siemens USA that offer Immunoassay & Immunochemistry Analyzers. However, none of the other two vendors are able to perform fully and completely on 1 October 2025. Both vendors would have to make extensive changes to the water systems in order to come up to speed.

There would be facilities building changes to be made if the other two (2) vendors would be considered for award. As stated above, it is important to note the units will sit in the middle of a very large open area, but will not have access to water, which requires the use of a dry system only. It was confirmed additional construction costs to allow access to water would be an unnecessary burden to the taxpayer. Furthermore, per the department, DHA has stated along with the current construction contractor that changing the area will not occur.

Federal Supply Schedules, Government wide acquisition contracts, multi-agency contracts, and any other procurement instruments intended for use by multiple agencies, including blanket purchase agreements (BPAs) under Federal Supply Schedule contracts (e.g., Federal Strategic Sourcing Initiative (FSSI) agreements accessible at https://www.ebuy.gsa.gov/ebuy/ were researched. Ortho Diagnostics has a current federal supply schedule however requested items appear to be unavailable. Abbott Laboratories and Roche Diagnostics also have an FSS schedule. However, they do not have the requested items, and their analyzers do not offer a waterless system.

Internet Research found two companies, Abbott Laboratories and Roche Diagnostics and that offer clinical chemistry & Immunochemistry Analyzers. However, the two vendors do not meet the requirement for a waterless analyzer system. As stated above these are

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changes that DHA has stated along with the current construction contractor that changing the area will not occur. All vendors would have to make extensive changes to the water systems to come up to speed. Wide-ranging facilities building changes would have to be made if these vendors would be considered for award, which would necessitate a break in service for the required reagents.

9. Interested Sources:

Ortho-Clinical Diagnostics, Incorporated: Ortho-Clinical Diagnostics, Inc. submitted a response to the sources sought. Ortho-Clinical Diagnostics, Inc. is capable of providing all elements of the requested requirement with a 1 October 2025 contract performance start date. The Ortho Clinical Diagnostics, Vitros XT7600 Immunochemistry and Chemistry analyzer offers the government required waterless based system and is compatible with the Department's pathology department’s interfaces which allows for the 1 October 2025 start date.

Roche Diagnostics Corporation: Roche submitted a response to the sources sought in-directly to another Contract Specialist (KS) instead of the contacts annotated on the sources sought. Roche stated that they were responding and requested multiple changes to the government requirements stated in the sources sought. The contract specialist contacted Roche via telecom on 19 Mar 25 and asked the following question: We have a question concerning ROCHE analyzers. Are the analyzers water based (Specifically Immunochemistry and Clinical Chemistry)? The Roche representative informed the specialist that their immunoassay was wet based, but the clinical chemistry analyzers were not.

Abbott Laboratories: Based on KS knowledge of this contractor and prior market research, it was discovered this contractor does not meet the requirements for waterless analyzers.

Beckman Coulter, Incorporated: Beckman did not submit a capability statement. Beckman instead submitted an email to the KS requesting the requirement be re-called and stating ORTHO Clinical would be the only vendor that can meet this requirement.

All notices required by FAR 5.201 shall be or have been published. Any proposals received shall be considered.

10. Other Facts: The following facts support the use of other than full and open competition:

a. Procurement history.

(1) Contract Numbers and dates of all awarded contracts for the same requirements:

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W81K00-24-D-0001 was awarded to Ortho-Clinical Diagnostics Inc. on 12 April 2024 with a delivery period of 1 April 2024 through 31 March 2029 (no options) at Reynolds Army Health Clinic, Fort Sill, OK.

W81K00-22-P-0266 was awarded to Ortho-Clinical Diagnostics Inc. on 20 September 2022 with a base period of 1 October 2022 through 30 September 2023 plus one (1) twelve-month option period from 1 October 2023 through 30 September 2024.

W81K00-18-D-0008 was awarded to Ortho-Clinical Diagnostics, Inc., on 31 January 2018 with a base period of 31 January 2018 – 30 September 2018 plus four (4) twelve-month option period from 1 October 2018 through 30 September 2022.

W81K00-17-P-0303 was awarded to Ortho-Clinical Diagnostics, Inc., on 30 March 2017, with a period of 1 April 2017 through 30 September 2017.

W81K00-17-P-0741 was awarded to Ortho-Clinical Diagnostics, Inc. on 27 September 2017, with a period 1 October 2017 through 31 March 2018.

(2) Competitive Status:

W81K00-24-D-0001, Sole Source acquisition W81K00-22-P-0266, Sole Source acquisition W81K00-18-D-0008, Full and Open Competition W81K00-17-P-0303, Full and Open Competition W81K00-17-P-0741, Sole Source acquisition

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

W81K00-24-D-0001 W81K00-22-P-0266 W81K00-17-P-0741

The above contract(s) all cited FAR 13.501(a)(1)(ii): sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results – N/A.

(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

W81K00-18-D-0008, Full and Open Competition Lowest Price Technically Acceptable

Basis for fair and reasonable pricing: Only One timely offer was received that complied with the terms of the solicitation.

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W81K00-17-P-0303, Full and Open Competition, Only one timely offer was received that complied with the terms of the solicitation

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

(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 – N/A.

a. Other facts. Per OEM Letter Ortho-Clinical Diagnostics Inc. is the sole source manufacturer of the VITROS ® Analyzers, including the reagents calibrators, controls & supplies.

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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.

Chief of Chemistry, Department of Pathology

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.

Chief of Chemistry, Department of Pathology

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.

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14. Contracting Officer Certification:

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

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Approval

Based on the foregoing justification, I hereby approve the procurement of One (1) Immunochemistry and One (1) Clinical Chemistry analyzer(s) and Reagents/Consumables Cost-Per-Reportable-Result (CPRR) on an other than full and open competition basis pursuant to the authority of 41 United States Code 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