JA IDIQ Redacted version.pdf

CUI

Control Number: FY26-0683

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2024

chemistry analysis program. Navy personnel rotating into the Naples hospital have already received training while at other Navy hospital commands on the Vitros systems and use of a different system will risk impact to the quality and timeliness of patient care. Thus, investing in a different line of equipment would result in substantial duplication of cost to the Government that is not expected to be recovered through competition. Therefore, only one responsible source exists and no other competitive sources can fulfill the requirement.

Award of a sole-source contract to CIDICHEM is mission-critical to prevent a disruption in essential medical services at USNH Naples.

CIDICHEM SRL is the only authorized seller and lessor of the Ortho Clinical Diagnostics instruments. CIDICHEM reagents and supplies are used to perform dry-slide technology diagnosis testing via the Vitros 5600 testing equipment. The CIDICHEM supplied reagents are the only authorized products to be utilized by the Vitros 5600. The tests and instruments are used to provide critical care immunochemistry on patients, as requested by health care providers. This critical care testing includes cardiac markers, liver enzymes, kidney function and other testing needed for emergent patient care, which is essential to successful hospital operations

United States Naval Hospital (USNH) Naples operates two Ortho Vitros 5600 chemistry analyzers, which are critical to our clinical laboratory and patient care mission. These analyzers were installed in 2023 and remain well within their operational life expectancy. Continued operation of this equipment is essential for providing in-house chemistry testing capabilities. The current support contract is projected to exhaust all funding within the next three months, necessitating the immediate award of a new contract to ensure seamless continuation of services.

Upon contract approval and execution, the Contractor (CIDICHEM) shall conduct a comprehensive validation study of green top tubes to verify their clinical suitability for all designated laboratory assays on the Ortho Clinical Diagnostics VITROS 5600 analyzers. This rigorous assessment must evaluate sample integrity, compatibility with existing laboratory instrumentation, and overall analytical performance across all relevant assays. To ensure strict adherence to patient safety protocols, no green top tubes shall be utilized for live patient testing until U.S. Naval Hospital Naples has successfully reviewed and formally accepted the validation results. Furthermore, the Contractor is required to submit a finalized, written technical report detailing these validation outcomes to the hospital within thirty (30) days of contract execution.

CIDICHEM is uniquely qualified to perform this critical service, as Ortho Clinical Diagnostics has officially designated them as the exclusive authorized distributor and service provider for this region. This exclusive designation makes CIDICHEM the sole source capable of guaranteeing the technical accuracy and operational readiness of this highly specialized diagnostic equipment. Utilizing an unauthorized or non-specialized vendor to conduct this validation study introduces severe operational and clinical risks. Specifically, it could lead to improper system calibration and delayed implementation, ultimately creating an unacceptable risk of generating inaccurate patient laboratory results that would directly compromise clinical decision-making and patient care.

Failure to secure this contract will result in a complete and immediate loss of chemistry analysis capabilities at USNH Naples. This degradation of service would have severe consequences, including:

Diversion of Care: Patients requiring chemistry testing would need to be diverted to other medical facilities, causing significant delays in diagnosis and treatment.

Compromised Mission Capability: The loss of essential diagnostic services would critically impact our inpatient and Emergency Department capabilities, potentially leading to a reduction in services and compromising the hospital's mission to provide care to our service members and their families.

Given the market research documented in section 6, the award of a sole-source contract to CIDICHEM is a mission-critical to prevent a disruption in essential medical services at USNH, Naples.

6. Efforts to Obtain Competition

A pre-solicitation notice (also known as Notice of Intent to Sole Source) required by RFO 5.101 will be posted to SAM.gov, and the Government will consider any bids or proposals received.

Additionally, a separate Sources Sought Notice (SSN) was posted to SAM.gov on 11 June 2026 with a response due date of 30 June 2026. Respondents were instructed to respond with a capabilities document to document their ability (or inability) to meet the requirements as indicated in the sample performance work statement provided. The only response received was from BHPE LLC indicating their �interest in participating as an interested vendor�. Their response stated, �Please bear with us as we coordinate with all departments; we will address your needs as soon as possible. In the meantime, you can request a capabilities statement directly from our website.�. A capability statement was not provided by this entity. Given that the SSN explicitly instructed the respondent to respond with a capabilities document, the failure of the entity to submit a capabilities document in response to this SSN results in them not being considered as a viable source for this contract requirement.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition:

For the reasons set forth in this justification document, DHACA has no plans at this time to compete future contracts for the types of products covered by this document. The USNH�s requirement for this type of product will continue in the near future and CIDICHEM SRL is currently the only company capable of providing such products. If additional potential sources able to provide these products emerge, the contracting activity will assess whether competition for future requirements is feasible.

8. Market Research:

Pursuant to our market research conducted in January through February 2026, it has been determined that only one vendor, CIDICHEM, possesses the unique qualifications and authorizations to provide the required proprietary supplies and maintenance for the Ortho Vitros 5600 analyzers in Italy. No other contractor can meet the government's needs. The manufacturer, Ortho Clinical Diagnostics, has confirmed CIDICHEM as their exclusive authorized distributor and service provider in this region, making them the only source capable of guaranteeing the operational readiness of this specialized equipment.

Members of the technical and contracting teams conducted market research to determine the availability of clinical chemistry testing systems throughout the European region. Based on information gathered, the Vitros 5600 systems from Ortho Clinical Diagnostic are the only chemistry analyzers that offer dry slide technology which can test clinical chemistry assays without a water source, and this model is the standard for Navy hospitals.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement?

No

(2) If 9.a.(1) is No, was the action just prior to this one competed?

No

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? N/A

b. Additional Information: N/A

10. Interested Sources:

As stated in section 6, a Sources Sought Notice (SSN) was posted to SAM.gov on 11 June 2026 with a response due date of 30 June 2026. Respondents were instructed to respond with a capabilities document to document their ability to meet the requirements as indicated in the sample performance work statement provided. The only response received was from BHPE LLC indicating their interest in participating as a vendor. Their response stated, �Please bear with us as we coordinate with all departments; we will address your needs as soon as possible. In the meantime, you can request a capabilities statement directly from our website.�. A capability statement was not provided. Given that the SSN explicitly instructed the respondent to respond with a capabilities document, the failure of the vendor to submit a capabilities document in

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2024

response to this SSN results in them not being considered a viable source for this contract requirement.

11. Technical Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

12. Requirements Certification:

I certify 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. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

14. Contracting Officer Determination of Fair and Reasonable Pricing and Certification of Accuracy and Completion.

Fair and Reasonable Cost Determination: This determination shall be made by the Contracting Officer who will sign the contract resulting from this justification and approval.

I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis for Determination: Prior to award of the resultant contract award, a fair and reasonableness determination will be made using techniques identified in the FAR (including but not limited to price analysis using Independent Government Cost Estimate).

Contracting Officer Certification:

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