Justification FAR 13 - 25-MRCO-WEST-224 _Redacted.pdf

Control Number: 25-MRCO-WEST-224

JUN 2025

JUSTIFICATION REVIEW DOCUMENT

FAR Part 13 Justification and Approval Simplified Procedures for Certain Commercial Items

Program/Equipment: Pathology testing Cost Per Reportable Results (CPRR), Cost Per Kit (CPK), and associated supplies for the Healthcare Technology Management Department (HTMD) at the Moncrief Army Health Clinic (MAHC), Fort Jackson, South Carolina.

Authority: Title 41 United States Code (U.S.C.) §1901(e)(2) as implemented in 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 total value of this effort to include all options is

Prepared by:

Contracting Officer:

Technical:

Program Manager/Program Executive Officer:

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

Program Manager/Program Executive Officer:

Legal Counsel:

FAR Part 13 Justification and Approval

Simplified Procedures for Certain Commercial Items

1. Requiring Activity: Healthcare Technology Management Department (HTMD) at the Moncrief Army Health Clinic (MAHC), Fort Jackson, South Carolina.

2. Contracting Activity: Fort Hood Health Contracting Branch, Fort Hood, Texas

3. Description of Action: Request approval to award a noncompetitive five-year (base and four one-year options to include FAR 52.217-6) Firm-Fixed-Priced (FFP) definitive contract to Bio Rad Laboratories Inc., Cage Code , 4000 Alfred Nobel Dr., Hercules, CA 94547, for Pathology Testing Support in the form of CPRR, CPK, and associated supplies for Fort Jackson Initial Entry Training (IET) Soldiers, as well as Moncrief Army Health Clinic Soldiers and beneficiaries for the following tests: ABO/Rh, MMRV, Hgb A1C, and Syphilis Total. This is an all or none requirement. This procurement will consist of using the Contractor’s analyzers along with the necessary CPRR, CPK, consumables, and equipment servicing to support the hospital’s needs. The contractor shall provide unscheduled maintenance according to the CPRR agreement to include parts and labor on the provided analyzers. The contract will include all usage of the contractor’s analyzer equipment and associated consumables. This requirement will be met with Fiscal Year (FY26) Defense Health Program funds, Army, Medical Supplies funds, subject to funds availability.

4. Description of Supplies/Services: The Government does not own Immunohematology, Microbiology, or HbA1c analyzers and has a need for the equipment, CPRR, CPK, and consumables to support the Military Treatment Facility (MTF) needs.

Period Period of Performance (POP) Base 1 OCT 2025 to 30 SEP 2026

Option 1 1 OCT 2026 to 30 SEP 2027 Option 2 1 OCT 2027 to 30 SEP 2028 Option 3 1 OCT 2028 to 30 SEP 2029 Option 4 1 OCT 2029 to 30 SEP 2030

Estimated Overall Total Price

5. Authority Cited: 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.

6. Reason for Authority Cited:

a. Background:

The Government requires Pathology Testing support in the form of CPRR, CPK, and associated supplies for Fort Jackson IET Soldiers, as well as Moncrief Army Health Clinic Soldiers and beneficiaries for these tests: ABO/Rh, MMRV, Hgb A1C, and Syphilis Total.

The explanation of the types of tests are as follows:

• ABO/Rh blood typing is a blood test that determines a person’s blood type based on the presence or absence of specific protein on their red blood cells.

It Identifies the ABO blood group (A, B, AB or O) and the Rh factor (positive or negative). This test is crucial for blood transfusions, organ transplants, and pregnancy care.

• Hemoglobin A1c (HbA1c) testing via high-performance liquid chromatography

(HPLC) is a common method for determining a person's average blood sugar level over the past few months. It's used to diagnose diabetes and prediabetes, and to monitor glycemic control in individuals with diabetes.

HPLC separates and identifies different types of hemoglobin, including HbA1c, based on their electrical charge.

• An MMRV test checks for antibodies against measles, mumps, rubella, and varicella-zoster (VZV) viruses, indicating immunity to these diseases. The test determines if an individual has been previously vaccinated or has had natural exposure to these viruses.

• A Syphilis Total test, also known as a Syphilis Total Antibody test, detects the presence of antibodies to the bacteria Treponema pallidum, which causes syphilis. This test is typically used as a screening test and can indicate past or present infection. It's often paired with other tests like the RPR (Rapid Plasma Reagin) test for confirmation and diagnosis.

b. Alternatives: Four (4) alternatives were considered in lieu of approving this justification. First, this requirement may be competitively solicited. Soliciting this requirement is anticipated to be unproductive because the previous competitive requirement accumulated four (4) responses: One vendor was Bio-Rad Laboratories (the incumbent), one (1) vendor was not capable of meeting all the Government’s requirements, and the other two (2) vendors, that were Small Businesses, were affiliated with Bio-Rad Laboratories as either a distributor or some level of partnership. Nevertheless, all three (3) of the other vendors were and remain small businesses, and the Manufacturing Rule applies since there are no waivers to the NAICS code (325413 – In-Vitro Diagnostic Substance Manufacturing) Other vendors were sought via a Sam.gov sources sought and by requesting capabilities of vendors who were awarded similar contracts; however, it was found that there were no other vendors who can support the entirety of the Government’s needs for this requirement. Therefore, it is highly anticipated that a solicitation will not result in a more competitive result. This alternative is not in the best interest of the Government and is therefore not acceptable.

Secondly, the requirement for ABO/Rh, HbA1c, MMRV and Syphilis testing may be separated into separate requirements. Currently, all of the testing is being done using three (3) models of equipment. Competitively soliciting for each test type is anticipated to be even more problematic. Providing MMRV testing is a niche field of expertise in the marketplace. Market research reflects that there are a limited number of vendors that can provide MMRV or all elements of MMRV (measles, mumps, or varicella), and vendors that provide any variation of MMRV may not be able to provide ABO/Rh. Procuring these tests under separate requirements will also likely result in multiple analyzers being used, with some analyzers being assigned to one test per the contract, but capable of accommodating more than one test. Additionally, separate contracts for each test may likely exceed the Requiring Activity’s allocable space and access to necessary water sources. The all-encompassing scenario of running multiple tests on various analyzers, coupled with coordination between multiple contractors performing tests on multiple machines, and possibly needing more samples from the patient, will be logistically time constraining. This will steer the Requiring Activity and Contracting Office away from their core responsibility of providing medical care to IET Soldiers, Moncrief Army Health Clinic Soldiers, and beneficiaries in a timely manner. Based on the Requiring Activity’s limited space and manpower necessary to manage the tests, separating this requirement would be out of sync with the Government commitment to streamline processes.

This alternative is not in the best interest of the Government and is therefore not acceptable.

Third, the Requiring Activity may be able retain this requirement in-house by purchasing outright the necessary analyzers, procuring the reagents and consumables, and entering into separate analyzer maintenance services as necessary. Though some reagents may be able to be procured via Electronic Catalogue (ECAT), any necessary ‘live’ reagents will have to be procured via open market. Providing that live reagents exceeds the Government Purchase Card (GPC) limit, additional contracts will be required, presumably placing the Government in the same Justification and Approval (J&A) circumstance currently under consideration. The cost, complexity, and attrition of procuring and maintaining these analyzers will likely result in the Government spending more money, time, and manpower resources to sustain the equipment, supplies and consumables. This alternative is not in the best interest of the Government and is therefore not acceptable.

Finally, the current and separate contract was considered as an interim solution in support of this requirement’s procurement strategy. On 13 June 2025, the Requiring Activity’s point of contact highlighted several challenges with integrating the tests such as funding limitations, approval to increase spending (competition considerations also included), and the anticipated turnaround times for ABO/Rh that may delay the mission. Also, the contract only provides for MMR tests and a separate test for Varicella Immunity. The Requiring Activity needs the MMRV tests to be processed and formulated into one result. This alternative is not in the best interest of the Government and is therefore not acceptable.

c. Impact if not approved:

Without this contract/equipment for an ABO/Rh, HbA1c, MMRV and Syphilis testing platform, Moncrief’s Clinical Laboratory will lose the capability to perform in-house blood type testing support for the new trainee population at Fort Jackson and any possible testing needs for beneficiaries to include Active-Duty, Families, and retirees. The MAHC’s laboratory would have to ship out these tests to other MTFs or commercially contracted reference laboratory which would in turn result in delay of training for the new trainees arriving at Fort Jackson, resulting in higher shipping costs, the possible risk of compromised or lost samples during transport to other facilities, longer wait times for results, and may possibly negatively impact overall Soldier readiness and patient care. In the absence of timely results, any infectious diseases are likely to spread throughout and further impact Soldier readiness.

Although there are multiple vendors on the open market that may be able to provide some variation of tests required by MAHC (Fort Jackson), there is only one supplier that can provide all the required pathology testing support for this supply requirement. Bio-Rad Laboratories Inc. (incumbent) is the only vendor that has the capability to provide all Pathology Testing support requirements in the form of CPRR, CPK, or Cost Per Test (CPT) and associated supplies.

7. Efforts to Obtain Competition: The Contracting Officer will publish the notices required by FAR 5.201 and any bids or proposals received shall be considered.

a. Effective competition:

A Sources Sought Notice was posted on Sam.gov for 14 days from 9 May 2025 to 23 May 2025 and accumulated three (3) responses from interested vendors. The vendors were evaluated by the Requiring Activity. The Contract Specialist collaborated subsequent Requests for Information (RFI) with respondents, and also sought additional vendors who historically competed for similar requirements.

b. Subcontracting competition:

Per Bio-Rad Laboratories, Inc. email response on 13 June 2025, there is no teaming agreement between Bio-Rad laboratories Inc. and any Small Businesses, and there are no current subcontracting opportunities available.

8. Actions to Increase Competition: This requirement is a follow-on to contract W91YTZ-20-C-0028 which was a competitive action. Therefore, a sole-source justification was not completed at the time of the previous procurement.

As part of the efforts to obtain competition, in accordance with FAR 5.202, a Notice of Intent to Award Sole Source (with the redacted justification document) will be posted on Sam.gov as required by FAR Subpart 5.2.

Should MAHC continue to have a need for this testing support beyond the conclusion of FY30, additional market research will be performed and a sources sought notice will be posted to the Government Point of Entry (GPE) to continue to foster competition and ensure fair and reasonable pricing for any future effort.

9. Market Research: Market research was conducted by Contract Specialist, from 19 May 2025 to 24 June 2025. ECAT does not offer retail, leasing, or provisioning of equipment. This requirement is being procured externally because the awarded contractor’s equipment will be provided as part of the contract. The ‘all or none’ supplies, analyzer, and analyzer servicing are not available from wholesale supply sources (e.g. Defense Logistics Agency (DLA), Department of Veterans Affairs, General Services Administration (GSA), and military control points.) The contract specialist reviewed the DLA and Medical Master Catalog platforms, and the supplies and leased analyzer are not available.

Per FAR 19.502-2 a review for small business socioeconomic contracting programs was conducted. A search of the Small Business Administration’s (SBA) Dynamic Small Business Search (DSBS) using North American Industry Classification System (NAICS) 325413 – In-Vitro Diagnostic Substance Manufacturing, and using keywords, ‘Analyzer’, ‘ABO-Rh Analyzer’, Syphilis Analyzer’, and ‘MMRV Analyzer’, and ‘Cost Per Reportable Result’. The search revealed there are no small businesses that can support the requirement.

There are five (5) known vendors who can provide ‘variations’ of ABO/Rh, MMRV, Hgb A1C, and Syphilis Total testing support, but only one (1) vendor – Bio-Rad Laboratories, Inc. can provide all testing altogether as requested by the Requiring Activity.

Market research reflects that Bio-Rad Laboratories, Inc. provided quote is similar to prices that are generally offered on the market. Based upon the historical and current market pricing comparisons, the anticipated cost to the Government for this contract action will be fair and reasonable.

Market research results revealed that there are not two or more ‘authorized’ Small Businesses that can fill this requirement. The manufacturer, Bio-Rad Laboratories, Inc.

is a Large Business (019S4), therefore the Nonmanufacturer rule applies. This is an all or none requirement. Bio-Rad Laboratories, Inc. is the only vendor that can provide ABO/Rh, MMRV, Hgb A1C, and Syphilis Total tests and associated equipment, and also meet the Requiring Activity’s space requirements. Due to the Requiring Activity’s need for CPRR and CPK for an all or none pathology testing with associated equipment, this requirement is Sole Source.

10. Interested Sources: A Sources Sought Notice was posted on Sam.gov for 14 days from May 9, 2025 to May 23 2025, and accumulated three (3) responses from interested vendors. The vendors were evaluated by the Requiring Activity. The Contract Specialist also collaborated subsequent Requests for Information (RFI) with respondents. In total, seven (7) vendors were assessed to identify which source was capable of meeting all of the requirement, and whether it can be competitively solicited.

Below is a synopsis from the Sources Sought (SS) and Requests for Information (RFI):

1. Bio Rad Laboratories Inc. – Fully capable of fulfilling the needs of this requirement.

2. is a Small Business and distributor of Bio-Rad Laboratories, Inc. On 16 June 2025, responded to the Contract Specialist’s (KS) request for information (RFI) and stated that the organization is not able to ascertain a quote from Bio-Rad for this procurement.

Also, the non-manufacturers rule applies, and there are no waivers.

3. was communicated with via a series of RFI correspondences from 2 June 2025 through 16 June 2025, and several confirmations as it pertains to equipment capability and size were being clarified as part of market research.

On 16 June 2025, responded to an RFI requesting confirmation of which analyzers will be used for each test. The representative stated that does not offer testing for ABO/Rh. Therefore, is not capable of meeting all the Pathology testing requirements addressed in this procurement.

4. solely offers ABO/Rh and cannot meet all the Government’s requirements.

5. Inc. does not provide measles, mumps, or varicella from

MMRV.

6. cannot meet any of the Government’s requirements.

7. was deemed not capable as a result of the Requiring Activity’s open market review, and the vendor not responding to the request for capability statement.

The Contract Specialist emailed all six (6) non-capable vendors informing their point of contacts that their capabilities were not a fit for this ‘all or none’ requirement. The results indicate that there is only one (1) vendor who can fully satisfy this requirement.

was Technically Unacceptable, and two (2) offerors were also Small Businesses that are distributors for Bio Rad. All offerors, except Bio-Rad Laboratories Inc., were Small Businesses and they are excluded from participation in this follow-on requirement because the non-manufacturers rule applies.

5) There are no unusual patterns that may be revealed by the history.

6) None of the requirements resulted in a protest as a result of the solicitation or award.

b. Other facts. Market Research results indicate that there is only one (1) vendor who can fully satisfy this requirement. Bio-Rad Laboratories, Inc. is the only vendor that can fully support ABO/Rh, MMRV, Hgb A1C, and Syphilis Total tests and associated equipment, and also meet the Requiring Activity’s space requirements.

CUI//SP-PROCURE//FEDCON

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.

Chief of Pathology

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.

Chief, Healthcare Technology Management Department

14. Fair and Reasonable Cost Determination: I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable. This determination will be made using pricing for similar CPRR on price analysis techniques and the independent Government estimate.

Contracting Officer

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

Contracting Officer

CUI//SP-PROCURE//FEDCON

Approval

Based on the foregoing justification, I hereby approve the procurement of Pathology testing CPRR, CPK, and associated supplies for the Healthcare Technology Management Department (HTMD) at the Moncrief Army Health Clinic (MAHC), Fort Jackson, South Carolina Department at the MAHC, Fort Jackson, South Carolina 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 contract is for a five-year (base and four one-year options to include FAR 52.217-6) period of performance from 1 October 2025 to 30 September 2030. 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.

Command Advocate for Competition