Justification and Approval.pdf
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- Attached to
- Quo Data - ProLab Plus Licenses
- Solicitation number
- 75F40126Q00273
About this file
This is a Justification and Approval (J&A) for Other Than Full and Open Competition document for a federal contract acquisition. The acquisition is for ProLab Plus Software Licenses to support the FDA Proficiency Testing (PT) Program, valued at $105,302.99 as a follow-on requirement in fiscal year 2026. The proposed contractor is QuoData GmbH, headquartered at Prellerstraße 14, 01309 Dresden, Germany (Tax ID: C-0000130; DUNS: 314687955-01), and the acquisition uses a Firm-Fixed Price pricing model.
The justification cites FAR 13.501 (Simplified Acquisition Procedures) as the authority for other than full and open competition, specifically noting that ProLab Plus is proprietary software developed and exclusively licensed by QuoData GmbH with no other authorized vendors capable of providing equivalent licenses. The requirement supports laboratory proficiency testing and chemical/microbiological hazard detection in food through statistical analysis compliant with ISO 13528 and ISO 17043 standards. Market research identified no commercially available alternatives capable of providing the comprehensive integrated functionality required for PT program management and ISO-compliant statistical evaluation. The previous contract (75F4021P00471) was uncompeted and awarded as a commercial item acquisition. The contracting officer (Jada Scott) determined the anticipated price as fair and reasonable through price analysis comparing reseller quotations and historical pricing under the NASA SEWP Government-Wide contract vehicle. Program Manager Kristen McLaughlin and supervisor Sylvia Smith certified the supporting data as accurate and complete on April 2, 2026, with contracting officer approval dated July 21, 2026.
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| File | Type | Posted |
|---|---|---|
| RFQ no. 75F40126Q00273 - ProLab Plus Licenses.pdf |
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JUSTIFICATION AND APPROVAL
FOR OTHER THAN FULL AND OPEN COMPETITION
Completion Instructions: The Department of Health and Human Services (HHS) has established a standard template for the preparation of a J&A for Other Than Full and Open Competition. If this is an 8(a) set-aside, please note this form is not required unless the acquisition is valued (including all options) at greater than $22 million. This template is NOT applicable for actions using simplified acquisition procedures (FAR Part 13), Federal Supply Schedule orders (FAR 8.4) or task or delivery orders subject to fair opportunity (FAR 16.505).
Tailor all aspects of this template to the individual acquisition. Consult FAR Subpart 6.3 for guidance. An addendum may be added in case additional space is needed.
When this document is printed, the blue italic instructions are automatically deleted on the printed version.
Acquisition Title:
Agency:
Acquisition Year (FY):
Author and Title:
2. Description of Action:
Nature: New Requirement Follow-on Requirement
Modification to Existing Purchase Order/Contract Number:
Pricing: Firm-Fixed Price Time & Materials Cost
Other:
Funds: OMA Other Funds:
Name of Proposed Contractor(s):
Street Address:
City, State, Zip:
3. Description of Services or Supplies:
Basis for Approval (FAR 13.501) Individual Basis Class Basis
The total estimated value of the proposed action, including all options is $
As applicable, briefly describe the services or supplies required to meet the agency's needs, including make & model number where appropriate. Include quantities of supplies or period of performance for services. Provide information for any options included. If the action is a modification to an existing contract, distinguish clearly between the work covered by the original contract and the work to be obtained by the proposed modification.
https://www.acquisition.gov/far/part-8#FAR_Subpart_8_4 https://www.acquisition.gov/far/part-13 https://www.acquisition.gov/far/part-16#FAR_16_505 https://www.acquisition.gov/far/part-6#FAR_Subpart_6_3 https://www.acquisition.gov/far/part-6#FAR_6_303_1
4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.
Actions other than simplified acquisition procedures (select only one and provide an explanation):
FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.
3304(a)(1)
Explain why the intended contractor is the only responsible source who can provide the required supplies or s ervices.
Discuss the unique capabilities, expertise, etc. that support the lack of competition/why no other type of supplies or servic es will satisfy agency requirements. Explain factors/unique qualifications such as proprietary data or exclusive licensing rights, if applicable. When competition is limited to items particular to one manufacturer, this justification must explain why the particular brand name, product, or feature is essential to the Government's requirements, and that market research indicates other companies' similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the agency's needs in accordance with FAR 11.105. If in connection with a follow-on contract for continued development or production of highly specialized equipment, detail the substantial duplication of cost or unacceptable delays.
FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2)
If unusual and compelling urgency is the basis for the justification, explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved. Describe impact of required delivery/performance date. Describe the detrimental effects/ serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. Failure to plan for expiring funds is not a valid reason for citing this exception. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.
FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5)
Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other agency.
Other (See FAR 13.501 for additional authority)
Provide the authority and citation to the applicable section of FAR 13.501.
Provide a full explanation to justify use of the exception.
5. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable):
Describe the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.
https://www.acquisition.gov/far/part-6#FAR_6_302_1 https://www.acquisition.gov/far/part-6#FAR_Subpart_6_3 https://www.acquisition.gov/far/part-11#FAR_11_105 https://www.acquisition.gov/far/part-6#FAR_6_302_2 https://www.acquisition.gov/far/part-6#FAR_6_302_5
6. Bridge Contracts:
For contract extensions or bridge contracts when a competitive follow-on is in the process of being developed, summarize history of current contract and explain the reasons for any delays in the acquisition. Include discussion of the milestones f or the follow-on action; the milestones should be as efficient as possible. Discuss why it would be neither cost effective nor realistic to expect another contractor to perform during the brief interim period; include issues such as start -up costs, phase-in, transfer of GFP, recruitment and staffing, etc. If the action is because of a protest, provide a brief discussion of the protest including the date the protest was filed and the basis of the protest. Explain that the action will provide the minimum quant ity or performance period.
7. Actions to Increase Competition:
Describe efforts made to compete the action, including whether a notice was or will be publicized as required by FAR Subpart
5.2 or which exception under FAR 5.202 applies. If a notice was publicized, discuss the number of written responses to the synopsis and the results of the assessment of the written responses. 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 shall be considered. 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, every effort will be made to compete it to the maximum extent possible. If action is sole source because of proprietary data or licensing rights and there will 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 costs/licensing purchase costs outweigh the benefits of competition. If the action is a contract extension or bridge, explain actions to compete the follow-on. If action is an urgent new requirement and a competitive follow-on is anticipated, explain that efforts are underway to facilitate a full and open competition.
8. Market Research:
Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If ac tion is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-on. See FAR 10.002(b)(2).
9. Procurement History:
Purchase order or contract number:
Was action competed? Yes No
If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:
https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_5_202 https://www.acquisition.gov/far/part-10#FAR_10_002
10.Additional Information to support the justification:
If applicable, explain why technical packages or specifications to facilitate competition were not developed or available;
describe actions taken to remedy the situation.
11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this
J&A is accurate and complete.
Program Manager
Name:
Position Title:
Email address:
Phone:
Program Manager Supervisor (or one level above Program Manager)
Name:
Position Title:
Email address:
Signature:
Date:
12. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.
Provide the basis for this determination, e.g., describe techniques to be used to determine fair and reasonable price (FAR Subpart 15.402), such as price analysis, cost analysis, cost realism. Per FAR Subpart 15.403-4(a)(1), the threshold for obtaining cost or pricing data is $750,000.
Name: Phone:
Signature: Date:
13. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.
Name: Phone:
Signature: Date:
https://www.acquisition.gov/far/part-15#FAR_15_402 https://www.acquisition.gov/far/part-15#FAR_15_402 https://www.acquisition.gov/far/part-15#FAR_15_403_4
14. Legal Review:
All J&As greater than $68 million must have a legal review from the General Law Division of the Office of the General Counsel prior to sending it to the Department.
15. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million (value calculated including all options)):
I have reviewed this justification and find that it adequately supports other than full and open competition.
Name:
Phone:
Signature:
Date:
All J&As greater than $68 million must have a review from the Office of Small & Disadvantaged Business Utilization (OSDBU) prior to sending it to the Department. The OSDBU at their discretion may review any J&A.
16. Office of Small and Disadvantaged Business Utilization Review: (Required for contracts exceeding $68 million (value calculated including all options)):
Concur:
Non-Concur:
17. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million (value calculated including all options)):
18. Department Competition Advocate (Required for contracts exceeding $68 million (value calculated including all options)):
Concur:
Non-Concur:
(The below approval paragraph is required if the cumulative contract value, including all options, exceeds $68 million.)
19. HHS Senior Procurement Executive (SPE) Approval:
Based on the foregoing justification, I hereby approve other than full and open competition for the above stated procurement, subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.
State supplies/services being procured:
State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304:
| Modificationto Existing Purchase OrderContract Number: | |
| Other: | |
| Other Funds: | |
| Name: Kristen McLaughlin | |
| Position Title: Management & Program Analyst | |
| Email address: kristen.mclaughlin@fda.hhs.gov | |
| Phone: 202-617-6920 | |
| Name_2: Sylvia Smith | |
| Position Title_2: Supervisory Management & Program Analyst | |
| Email address_2: sylvia.smith@fda.hhs.gov | |
| Date: 4/2/2026 | |
| Phone_2: | |
| Date_2: 07/21/2026 | |
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| Date_3: 07/21/2026 | |
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| Phone_4: | |
| Date_4: | |
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| Phone_5: | |
| Date_5: | |
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| Date_8: | |
| Text51: ProLab Plus Software Licenses to support the FDA Proficiency Testing (PT) Program | |
| Text52: Kristen McLaughlin, Management & Program Analyst, COR | |
| Text53: 2026 | |
| Dropdown54: [AGENCY] | |
| Check Box55: Off | |
| Check Box56: Yes | |
| Check Box57: Off | |
| Check Box58: Yes | |
| Check Box59: Off | |
| Check Box60: Off | |
| Check Box61: Off | |
| Check Box62: Off | |
| Text63: QuoData GmbH; Tax ID Number: C0-0000130; DUNS Number: 314687955-01 | |
| Text64: Prellerstraße 14 | |
| Text65: 01309 Dresden, Germany | |
| Check Box66: Yes | |
| Check Box67: Off | |
| Text68: $105,302.99 | |
| Text69: The requirement is for the renewal of ProLab Plus software licenses to support the Proficiency Testing (PT) program within FDA. ProLab Plus is a specialized statistical software platform used to plan, manage, and analyze inter-laboratory studies data to evaluate laboratory performance in detecting chemical and microbiological hazards in food. The software supports statistical evaluation of PT data in accordance with internationally recognized standards, including ISO 13528 and ISO 17043. It enables calculation of consensus values, z-scores, HORRAT analysis, kernel density estimation, and other inter-laboratory statistical methods required to ensure scientifically valid and standardized evaluations. The proposed action is a follow-on requirement to an existing contract expiring on September 1, 2026. The new contract will consist of a one-year base period with four (4) one-year option periods to ensure continuity of services and support ongoing PT program operations. | |
| Text70: | |
| Text71: | |
| Check Box72: Off | |
| Check Box73: Off | |
| Check Box74: Off | |
| Check Box75: Yes | |
| Text76: | |
| Text77: This acquisition will be conducted under FAR 13.501(a)(1)(ii), Sole source (including brand name) under simplified acquisition procedures for certain commercial items. | |
| Text78: This acquisition will be conducted under FAR 13.501(a)(1)(ii), Sole source (including brand name) under simplified acquisition procedures for certain commercial items. ProLab Plus is proprietary software developed and licensed exclusively by QuoData GmbH. No other vendors are authorized to distribute or license this software. As such, QuoData GmbH is the only source capable of providing the required licenses. In addition, ProLab Plus provides specialized statistical capabilities required for proficiency testing programs, including compliance with ISO 13528 and ISO 17043 standards. These capabilities include robust statistical methods such as z-score calculations, HORRAT analysis, kernel density estimation, and inter-laboratory data evaluation functions that are not available in general-purpose statistical software without significant customization and validation. The ProLab Plus system is currently integrated into the PT program’s workflows and has been successfully used to support analysis of inter-laboratory studies involving approximately 35–80 participating laboratories. The software has demonstrated the ability to meet program requirements and support ongoing efforts toward ISO accreditation. Transitioning to an alternative solution would require substantial duplication of cost and unacceptable delays, including redevelopment of statistical methodologies, revalidation of analytical processes, and retraining of personnel. These efforts would significantly delay PT data analysis and reporting, which are critical to ensuring laboratory readiness for detecting food safety hazards. Failure to approve this acquisition would result in disruption of PT program operations, increased reliance on manual or less robust analytical methods, and delays in reporting timelines. These impacts would negatively affect the program’s ability to provide timely, accurate, and standardized performance evaluations. | |
| Text79: The primary barrier to competition is the proprietary nature of the ProLab Plus software and its specialized functionality tailored to proficiency testing programs. The software integrates PT data management, statistical analysis, and reporting in a single validated platform aligned with ISO standards.Alternative approaches would require combining multiple tools or developing custom solutions, resulting in increased complexity, additional validation requirements, and higher risk to program timelines. The program will continue to monitor the marketplace for potential alternative solutions; however, no equivalent solutions have been identified to date. | |
| Text80: N/A | |
| Text81: Efforts to compete this requirement have been considered. However, this acquisition is for proprietary software (ProLab Plus) that is developed and exclusively licensed by QuoData GmbH. As such, no other vendors are capable of providing the required licenses.In accordance with FAR Subpart 5.2, the Government intends to publicize the proposed contract action to increase transparency and provide any potential sources the opportunity to express interest. If any responsible sources submit capability statements in response to the notice, those responses will be evaluated. To date, no other sources have been identified that can meet the Government’s requirements.Market research was conducted to identify potential alternative solutions, including commercially available statistical software and data analysis platforms. While some tools provide partial functionality, none were found to meet the Government’s requirement for an integrated, ISO-compliant proficiency testing solution within a single validated system.No other sources have expressed interest in providing the required software. Should any responsible sources express interest, all responses will be considered.To increase competition for future acquisitions, the Government will continue to conduct market research to identify emerging solutions capable of meeting the requirement. The program will also ensure, to the extent practicable, that data generated within the current system remains accessible and transferable to support potential transition to alternative platforms if viable options become available.At this time, due to the proprietary nature of the software and the lack of equivalent alternatives, competition is not feasible. However, the Government will continue to evaluate the marketplace and will compete future requirements to the maximum extent practicable if suitable alternatives are identified. | |
| Check Box82: Off | |
| Check Box83: Yes | |
| Text84: Market research was conducted to identify commercially available alternatives capable of supporting proficiency testing program requirements. This included review of statistical software tools and data analysis platforms. While alternative tools exist that provide partial functionality, such as general-purpose statistical software or Excel-based add-ins, none were found to provide the comprehensive, integrated capabilities required for PT program management and ISO-compliant statistical evaluation within a single validated system. Alternative approaches would require significant customization, validation, and integration efforts, introducing additional cost, risk, and delays. Based on this research, ProLab Plus remains the only solution that fully meets the Government’s requirements. | |
| Text85: 75F40121P00471 | |
| Text86: The previous contract for ProLab Plus licenses was not competed. The requirement was awarded as a commercial item acquisition to QuoData GmbH due to the proprietary nature of the ProLab Plus software, which is developed and exclusively licensed by QuoData GmbH. At the time of the previous acquisition, no other sources were identified that could provide equivalent software capable of meeting the Proficiency Testing (PT) program’s requirements, including ISO-compliant statistical analysis and inter-laboratory study evaluation. Actions to increase competition included consideration of alternative statistical software tools and commercially available data analysis platforms. However, these alternatives did not provide the full range of required functionality, including integrated PT program management and compliance with ISO 13528 and ISO 17043 standards. As a result, no additional qualified sources were identified, and the requirement was awarded to QuoData GmbH. Since that time, the Government has continued to monitor the marketplace, and no new sources have been identified that can meet the requirement without significant additional cost, time, and risk. | |
| Text87: The Proficiency Testing (PT) program supports the evaluation of laboratories responsible for detecting chemical and microbiological hazards in food. Timely and accurate statistical analysis of inter-laboratory data is essential to ensure laboratory capability and readiness. The current system has been successfully implemented and supports standardized, reproducible analyses necessary for program operations and ISO accreditation efforts. Continued use of ProLab Plus ensures continuity, reliability, and compliance while avoiding disruption to ongoing program activities. | |
| 2026-04-02T12:21:45-0400 | |
| Sylvia M. Smith -S |
| Text89: Jada Scott | |
| Text90: Jada Scott | |
| 2026-07-21T12:17:07-0400 | |
| JADA T. SCOTT -S |
| 2026-07-21T12:18:52-0400 | |
| JADA T. SCOTT -S |
| Text93: |
| Check Box96: Off |
| Check Box97: Off |
| Check Box98: Off |
| Check Box99: Off |
| Text102: |
| Text103: |
| Text105: The anticipated price is determined to be fair and reasonable based on adequate price analysis. This is a follow-on acquisition for existing Prolab software licenses procured through NASA SEWP authorized resellers. Pricing will be evaluated and determined fair and reasonable through comparison of reseller quotations, historical prices paid for the same or similar licenses, and verification that the proposed pricing is consistent with current market rates and applicable contract pricing under the NASA SEWP Government-Wide Acquisition Contract. |
| Text1: $105,302.99 |
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