26-007408 - HHS-JOFOC-Genesis_2026-06-22.docx

Justification for Other than Full and Open Competition (JOFOC)

RFO - FAR 6.103-1/FAR 6.302-1

1. Acquisition Title: Purchase of IOPQ Services from Genesis.

Division: The National Institutes of Health (NIH), Clinical Center (CC).

Contracting Activity: The National Institutes of Health (NIH), Clinical Center (CC), has a need to approve a "Justification for Other Than Full and Open" requirement in accordance with FAR 6.3, Other Than Full and Open Competition.

This is a sole source request in accordance with IAW FAR 13.103-1, 6.302-1 is based on the need to contract cGMP qualification of equipment to be used in patient care testing.

Author: Chung Shin, Clinical laboratory scientist

Basis for approval under RFO - FAR 6.104(c): Individual Basis.

2. Nature and/or Description of the Action being Approved:

Approval of a purchase order for cGMP equipment qualification services from Genesis is needed for critical equipment used by the Sterility Testing Service including refrigerators, freezers, incubators, centrifuges, and biological safety cabinets. These services will demonstrate proper installation of the equipment, operation to manufacturer’s requirements, and controlled performance of the equipment based on user’s application. Thus, ensuring the highest quality of testing services in support of the NIH cGMP program and ultimately patient care.

The FDA expects cGMP product manufacturing facilities and testing laboratories to perform vendor audits and establish quality agreements with vendors providing supplies, equipment, and services which are to be used in support of cGMP product manufacturing. This requirement is established in ICH Q10, 2.7 and 2.7a, and ICH Q10, 2.7(b). It is critical that the qualification services have been purchased from a vendor that has documented products that meet the cGMP requirements and have been approved for used in cGMP facility by the Quality unit.

NIH-CC-DLM requests a firm-fixed-price new contract on Genesis, with purchase order (to be assigned) with the contractor listed in the table below. The Government projects award for (Insert Month) 2026 using fiscal year 2026. type of funding, 25723--EQUIPMENT MAINTENANCE AGREEMENT being used.

Contractor: GENESIS ENGINEERS, INC.

One Sentry Parkway, Suite 100, Blue Bell, PA 19422

Estimated Total Dollar Value:

$35,000

Original Contract Value:

N/A

New Contract Value:

$35,000

3. Description of Supplies and/or Services:

The Sterility Testing Service is seeking Installation Qualification, Operational Qualification, and Performance Qualification (IOPQ) services for validation of equipment that are to be used in cGMP Sterility Testing Laboratory.

4. Statutory Authority Cited and Rationale:

The Sterility Testing Service is seeking IOPQ services for validation of equipment that are to be used in cGMP Sterility Testing Laboratory.

a. RFO - FAR 6.103-1, Only one responsible source and no other supplies or services will satisfy agency requirements. Authority: 41 U.S.C. 3304(a)(1). Per RFO - HHSAR 306.103-1, for acquisitions covered by 42 U.S.C. 247d-6a(b)(2)(A), “available from only one responsible source” must be deemed to mean “available from only one responsible source or only from a limited number of responsible sources.”

Genesis is both ISO 9001 and ISO 17025 certified, meaning they have the necessary quality and process systems in place to perform cGMP work. The Sterility Testing Service has reviewed their credentials and technical knowledge and has qualified them to perform these types of services for the Sterility Testing Service. Other market research indicates other companies' similar products, or products lacking the specific GMP requirement, do not meet, or cannot be modified to meet Division needs in accordance with RFO - FAR part 11.

5. Special Considerations for Certain Contract Extensions or Bridge Contracts: N/A

6. Actions to Increase Competition:

a. A Notice Was / Was Not Published: Indicate whether a notice was or will be published, as required by RFO - FAR 5.201(a); or identify which exemption under RFO - FAR 5.201(b) applies.

b. Responses Were / Were Not Received: If a notice was published, discuss the number of written responses to the synopsis and the results of the assessment of the written responses.

c. Sources Expressing Interest: List sources, if any, that expressed in writing, an interest in the acquisition. Provide rationale if interested sources were rejected. If applicable, state that no other sources have expressed interest, but all offers received must be considered.

d. Actions to Foster Competition for Future, Similar Requirements: Describe what actions will be taken to increase competition before subsequent acquisition of the supplies or services is required. You may state that an action is a one-time requirement, but if a similar requirement arises, will be made to compete it to the maximum extent possible. If the action is non-competitive because of proprietary data or licensing rights and there may be a continuing need for the requirement, there must be evidence that advanced planning has been initiated to overcome the barriers to competition, or there should be documentation to support an analysis that replacement/licensing costs outweigh the benefits of competition. If the action is a contract extension or bridge, explain any planned actions to compete the follow-on. If the action is an urgent, new requirement and a competitive follow-on is anticipated, address any efforts underway to facilitate a full and open competition.

7. Market Research: Other vendors were evaluated as part of this process such as FreshLoc, Unity Lab Services, and ThermoFisher Scientific. But they did not meet all the necessary requirements. FreshLoc was not ISO 9001 accredited. Unity Lab Services, does not have ISO 17025 accreditation in the US and is also part of the ThermoFisher which presents a conflict if they are part of the equipment vendor. ThermoFisher offered the necessary services but is also the equipment vendor, which poses a conflict if the equipment vendor is also performing the full qualification on the equipment. Alcami (formerly Masy) offered the necessary services, but they are not based locally and as such have much higher prices associated with the same work and quality of work provided. Based on this assessment the Sterility Testing Service determined that Genesis was the best vendor for the required services and met all of the cGMP requirements.

8. Procurement History: various contracts have been awarded to Genesis Inc on our previous IOPQ certifications of DLM-Sterility services as listed below 22-011621/22-011704/23-011287/24-010637/24-011117/25-007943/25-008104/26-005553

Contractor:

Contract or Order Number: To be assigned Award Date and Period of Performance: 08/15/26-03/30/26 Value (including all options):$35,000 Competitive Status: non-competitive.

Authority formerly relied upon if Not Competed: (If the action was not competed, state the cited authority from any previous justification, summarize the rationale, describe the actions taken to increase competition and the results thereof.)

9. Additional Information or Other Facts: If Sterility Testing Services were procured through a competitive contracting process, it would likely result in delays that could adversely affect patient care and ongoing clinical trials. Failure to obtain these services in a timely manner would jeopardize the ability of the DLM to operate as a clinical laboratory within an acute care hospital setting

10. Technical or Requirements Program Management 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. [Always required.] (Only the Program or Project Manager or higher-level program official with specific knowledge of the individual requirement may sign the technical and requirements certifications.)

Typed Name Amanda East

11. Fair and Reasonable Price Determination: As the contracting officer, I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable.

Select the applicable squares to mark the techniques used:

This determination will be made using the following: ☐ cost analysis ☐ price analysis ☐ cost realism ☐ market pricing ☐ historical pricing ☐ other: Describe the methodology or combination of methodologies that will be used. See RFO - FAR subpart 15.2 for proposal analysis guidance.

As a part of this basis, certified cost, or pricing data (see RFO - FAR 15.403)— ☐ will be required. ☐ will not be required and the following FAR part 15 exception applies:

☐ Prices that will be agreed upon are based on adequate price competition.

☐ Prices that will be agreed upon are based on prices set by law or regulation.

☐ A commercial item is being acquired.

☐ A waiver has been granted by the HCA in accordance with RFO - FAR 15.403-2(c)(4).

☐ The contract action is a modification to a contract or subcontract for commercial item(s).

☐ The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

12. Contracting Officer (CO) Certification and Determination: I hereby certify that this justification is accurate and complete to the best of my knowledge and belief. And, based upon the foregoing, I also determine that using a sole-source contract is in the best interest of (insert Division). [Always required; CO approval authority is limited to $900 thousand.]

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(The following Reviews and Approvals will ordinarily be provided on a separate page at the end of the justification to allow for minor, administrative changes to be made during the review process; delete any individual reviews/approvals not applicable.)

ELEVATED REVIEWS & APPROVALS

13. Insert Division Division Director: I reviewed this justification find that it adequately supports other than full and open competition.

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14. NIH Head of the Contracting Activity (HCA) Review and Approval: I reviewed this justification and find that it adequately supports other than full and open competition. [Division HCA approval authority is limited to $90 million.]

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15. NIH Advocate for Competition (AfC) Review and Approval: I reviewed this justification find that it adequately supports other than full and open competition. [Division AfC approval authority is limited to $20 million.]

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16. HHS Office of General Counsel Review and Concurrence: I reviewed this justification and concur that it adequately supports other than full and open competition. [Mandatory when SPE approval is required, unless otherwise waived in writing by the SPE.]

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17. HHS Advocate for Competition (AfC) Review and Concurrence: I reviewed this justification and concur that it adequately supports other than full and open competition. [Mandatory when SPE approval is required.]

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FINAL APPROVAL

18. HHS Senior Procurement Executive: Based on the foregoing, I hereby approve this justification for other than full and open competition pursuant to the authority of 41 U.S.C. 3304(a)(1) and in accordance with RFO - FAR 6.103. [Required if the total action value, including all options and FAR 52.217-8 value, exceeds $90 million.]

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