S26-123 LIMS Request for Proposal Matrix.pdf

P.O. Box B, Frederick, MD 21702-1201 • 301-846-1000

A subsidiary of

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

SOLICITATION/RFP NUMBER: S26-123 DATE ISSUED: 05/11/2026

NAICS NUMBER and DESCRIPTON: 541512 – Computer System Design Services (or similar) SIZE STANDARD: $34,000,000

ISSUED BY:

Leidos Biomedical Research, Inc.

Research Contracts Department P.O. Box B 1050 Boyles Street Frederick, MD 21702

ADDRESS OFFERS TO/FOR INFORMATION REGARDING THIS

SOLICITATION CONTACT:

JOSH WYNNE

JOSH.WYNNE@NIH.GOV

IMPORTANT:

To be considered for award, offers must be received at the location specified above by CLOSE OF BUSINESS (COB) ON FRIDAY, 12 JUNE 2026. Offers must be clearly identified with the Solicitation/RFP Number listed above.

The cover letter shall acknowledge that your transmission of an offer in response to this Solicitation is valid for a period of 120 days from date of submission.

A. Introduction

This Solicitation is issued by Leidos Biomedical Research, Inc. (Leidos Biomed), a wholly owned subsidiary of Leidos Corporation under its Prime Contract with the National Cancer Institute (NCI/Government) at Frederick. The provisions and clauses contained herein and attached are influenced by and reflect the relationship of the parties in said Prime Contract, which was awarded and is administered under the provision of the Federal Acquisition Regulation (FAR).

B. Anti-Kickback Act of 1986

The Anti-Kickback Act of 1986 as referenced in FAR 52.203-7 is hereby incorporated into this Solicitation and any subsequent award(s) as a condition of acceptance. If you have reasonable grounds to believe that a violation, as described in paragraph (b) of FAR 52.203-7, may have occurred, you should report this suspected violation to the Leidos Ethics Hotline at (855) 753-4367 or via the internet at www.leidos.ethicspoint.com.

C. Solicitation Package

This Solicitation Package consists of three documents: (i) this one, which is referred to as the Request for Proposal (RFP) Document; (ii) draft Subcontract Document (which will be provided at a later date); and

(iii) Subcontractor’s Representations and Certifications.

mailto:josh.wynne@nih.gov http://www.leidos.ethicspoint.com/

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

D. Contract Type

The resulting Subcontract will be a Commercial Subcontract issued under FAR Part 12. It is anticipated that the agreement will be Firm-Fixed-Price, with the possibility of Time and Materials work for implementation.

For Firm-Fixed Price Tasking:

The resulting Subcontract will be a Firm-Fixed-Price contract providing for a price that is not subject to any adjustment on the basis of contractor’s cost experience in performing the contract.

For Time and Materials Tasking:

The resulting Subcontract will be a Time and Materials contract type. A Time and Materials contract type provides for acquiring supplies or services on the basis of: (1) direct labor hours at specified fixed hourly rates that include wages, overhead, general and administrative expenses and profit; and (2) materials at cost, including, if appropriate, material handling costs as part of material costs. The Subcontractor may not exceed the established Total Ceiling Amount without the prior approval of the Leidos Biomed Subcontracts Administrator.

E. Instructions to Offerors

E.1. General Information

IMPORTANT – ELECTRONIC SUBMISSION:

OFFERS MUST BE SUBMITTED ELECTRONICALLY IN EITHER SEARCHABLE ADOBE ACROBAT, MICROSOFT WORD, OR MICROSOFT EXCEL FORMATS AS APPLICABLE. SAVED FILES MUST NOT EXCEED 15 MB IN SIZE;

THIS MAY REQUIRE THAT A DOCUMENT BE BROKEN INTO TWO OR MORE SEPARATE FILES.

ALL OFFERS MUST BE RECEIVED BY CLOSE OF BUSINESS ON FRIDAY, 12 JUNE 2026. OFFERS SHALL BE

SUBMITTED TO JOSH WYNNE AT JOSH.WYNNE@NIH.GOV.

All offer submissions must be clearly identified to include the Offeror’s name, Principal Investigator’s name (or Project Manager’s name), and Solicitation/RFP Number.

Late offers will not be considered for award.

F. Proposal Instructions to Offeror

To be considered responsive to this Solicitation, the Offeror must provide and/or complete the following requirements:

- Volume 1 – Request for Proposal Document

- Volume 2 – Technical Proposal (to include completion of the LIMS Requirements Response Matrix) mailto:josh.wynne@nih.gov

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

- Volume 3 – Price (Cost) Proposal

- Subcontractor’s Representations and Certifications (provided as a separate document with this Solicitation Package).

- An IRS Form W-9. All Offerors MUST be registered with the System for Award Management (SAM).

Offerors may register with SAM at https://www.sam.gov/SAM/. The address included on the W- 9 MUST match the address registered at SAM, and/or included with Subcontractor’s Representations and Certifications.

- A draft Subcontract will be provided at a later date, as needed, as part of this Solicitation Package to provide Offerors with an opportunity to review Leidos Biomed Terms and Conditions. It is requested that the Offeror exercises due diligence in reviewing the Terms and Conditions prior to submitting a formal offer in response to this Solicitation and in the context of the proposed Statement of Work. Any requested exceptions or risk areas identified shall be part of the proposal submission as redlined changes to include alternate language and a justification for each proposed change in the Subcontract. Negotiations in good faith are expected; however, excessive exceptions requested may result in significant delays in award.

F.1. VOLUME 1 – RFP Document

This Volume shall contain the RFP Document with all items completed as required below and submitted as prescribed in E.1. General Information above and be clearly named Volume 1 – RFP.

Requirements:

Complete Section J. Certifications

Complete Section K. Offeror Representatives

Complete Section L. Offeror Signature

F.2. VOLUME 2 – TECHNICAL PROPOSAL

This Volume shall contain the Technical Proposal Document with all items completed as required below and submitted as prescribed in E.1. General Information above and shall be clearly named Volume 2 – Technical Proposal.

IMPORTANT:

Technical Proposals shall not include cost or pricing information.

Technical Proposals must include page numbers on all pages, including all appendices and attachments.

There must also be a cover page that lists all appendices and attachments. The LIMS Requirements Response Matrix must be completed as a part of the Offeror’s Technical Proposal.

https://www.sam.gov/SAM/

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

Requirements:

The Offeror must provide Technical Proposals that clearly demonstrate the Offeror’s current capabilities to meet each of the various requirements as established in RFP Attachment 1: Statement of Work and in accordance with the guidelines set forth below. Responses shall be focused, succinct, and free of extraneous data or information responding solely to the requirements contained in the RFP Attachment 1: Statement of Work. Additionally, Technical Proposals shall be formatted in such a way to clearly cross-reference the relevant sections in the RFP Document.

Provided below is the outline of specific information to be addressed in the Technical Proposal and for maximum page limitations for each of the required sections.

F.2.a. Executive Summary (1 page limit)

The summary shall contain the most important elements from sections below but should at a minimum clearly specify the following elements:

Brief identification and qualifications for this Solicitation of your organization/team, including any lower-tier subcontractors and their roles.

The purpose and anticipated end result of this Technical Proposal.

Technical and management approach discriminators.

The summary shall be on separate pages or include a section break before the rest of the Technical Proposal.

F.2.b. Technical Approach (5 page limit)

Understanding

Provide your understanding of what needs to be done, the scope of the work, the estimated length of time for the work to be finished, the challenges, and how you are going to address those challenges.

Approach

Describe a sound technical approach to the proposed work and critical technology challenges required for accomplishing proposed tasks. Describe any unique aspects of the approach, and why you believe it will be the most efficient and effective way of achieving project objectives. Describe how this approach will meet both project and overall objectives as described in RFP Attachment 1: Statement of Work.

F.2.c. Architecture and Integration (5 page limit)

Describe how the system will integrate with our existing technological environment, support effective deployment, and scale with organizational growth and evolving needs. Address out of the box capabilities and customization options. Is the system compatible with enterprise security?

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

F.2.d. Compliance and Security (5 page limit)

Describe how the system ensures regulatory compliance, data integrity, and security of laboratory information. Describe security controls and options, and provide proof of compliance with regulatory requirements.

F.2.e. Experience and Stability (5 page limit)

Team and Company Profile

Describe the teams overall experience with development, processes, and technologies similar to those described in the RFP Attachment 1: Statement of Work. Clearly indicate which organization or personnel on your team is providing this experience. Give a brief overview of Company History, Business Size, etc.

Past Performance

Provide a description of previous projects successfully performed in the past that indicate the ability to perform on this effort. Summaries shall be given here, and more complete descriptions may be included in the Appendix.

Controls

Describe your project management approach and what control mechanism you can put in place to track progress and ensure project schedules will be met in according to agreed-upon schedules.

Risk Management

Describe your overall risk mitigation strategy.

Provide an initial risk table. This table should include a list of project risks, an estimation of the severity of the risk (H,M,L), and a risk mitigation approach for that risk.

Subcontractor Management

Describe management controls to be put in place for lower-tier subcontractor management if lower-tier subcontractors are a part of the proposed team.

F.2.f. Project Plan and Work Breakdown Structure (5 page limit)

Describe in summary form the set of tasks that will be performed in order to accomplish project objectives.

Detail the methods for producing deliverables, allocation of staff, and other resources necessary to produce deliverables, and timelines.

Provide a draft project plan in MS Excel or PDF format as a separate attachment (no page limit). This document should contain tasks that demonstrate how objectives described in the RFP Attachment 1:

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

Statement of Work will be accomplished. The draft project plan shall show tasks, dependences, and milestones, any milestone reviews as requested in RFP Attachment 1: Statement of Work, as well as any requested Offeror-supplied dates for deliverables.

F.2.g. Appendix (no page limit)

F.3. VOLUME 3 – COST (OR PRICE) PROPOSAL

This Volume shall contain the Cost (or Price) Proposal Document with all items completed as required below and submitted as prescribed in E.1. General Information above and shall be clearly named Volume 3 – Cost (or Price) Proposal.

Requirements:

Offerors shall submit Cost (or Price) Proposals that provide a budgetary estimate for the project proposed.

The Cost (or Price) Proposal shall include the information required in Sections One and Two below. Budget estimates provided in response to this Solicitation will be used for planning and evaluation purposes. Any requests from Offerors to revise the original budget estimate, as the result of changes requested to the original technical approach during Subcontract negotiations, may be considered but these requests from Offerors must be accompanied by a detailed explanation of the nature and impact of the change and the need for monetary adjustment.

F.3.a. Section One – Cost (or Price) Proposal

The Cost (or Price) Proposal shall contain sufficient information to allow Leidos Biomed to perform an analysis of the proposed cost (or price) of the work proposed. This information shall include the amounts of the basic elements of the proposed cost (or price) including, but not limited to, labor hour rates, travel, materials, and lower-tier subcontracts.

In preparing your Cost (or Price) Proposal, the following shall be considered:

FAR 52.215-17 Waiver of Facilities Capital Cost of Money is incorporated in this Solicitation;

therefore, Facilities Capital Cost of Money is an unallowable cost under any resulting Subcontract.

As prescribed in HHSAR 331.101.70 Salary rate limitation, in response to this Solicitation/Request for Proposal, the Offeror cannot use any resulting Subcontract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date the funding is obligated.

Offeror is to prepare their Cost (or Price) Proposal using RFP Attachment 2: Cost (or Price) Template and submit with Offer in Microsoft Excel format.

Costs shall be broken out by task.

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

A milestone payment schedule shall be provided, if applicable. Milestones shall be identified by number, title and description. Provide amount of milestone and if applicable, include unit of measure, quantity and unit price.

In performance of the work, Offerors are expected to attend programmatic meetings/calls as needed.

Offerors shall provide substantive detail regarding the cost (or price) proposed to enable reviewers to objectively determine the reasonableness. Failure to provide a level of detail to facilitate this determination may result in the offer being considered nonresponsive.

F.3.b. Section Two – Cost (or Price) Justification and Documentation

In this section, provide justifications and explanations of all proposed costs. This INCLUDES explanation of the processes by which extended costs were derived and a basis for why the proposed costs should be considered reasonable. The supporting information to be provided includes, but is not limited to:

Labor costs: For Time and Materials proposals, please provide labor categories and a description of the position’s planned role on the project. If the proposed positions have not been filled or are to be named or hired, provide description of anticipated position and estimated labor category and rate. For Firm-Fixed-Price proposals, price per Milestone should be provided.

Demonstration of the reasonableness of any proposed lower-tier subcontractor costs, including demonstration that the proposed rates/costs are in keeping with those normally charged for the work to be performed.

G. Proposal Evaluation Criteria

G.1. Basis for Award

Leidos Biomed intends to award a Subcontract(s) resulting from this Solicitation to the responsible organization(s) whose offer(s) conforming to this Solicitation will be of the best value to Leidos Biomed, price and other factors considered. Although technical factors are of paramount consideration in the award of a Subcontract, cost and/or price is also important to the overall award decision.

G.2. Potential Award Without Discussions

Leidos Biomed reserves the right to award a Subcontract without discussions if the Leidos Biomed Subcontracts Administrator determines that the initial offer(s) are fair and reasonable and that discussions are not necessary. Therefore, the Offeror’s initial offer should contain the Offeror’s best terms from a price and technical standpoint. However, Leidos Biomed reserves the right to conduct discussions if later determined by the Leidos Biomed Subcontracts Administrator to be necessary. Leidos Biomed may reject any or all offers; accept other than the lowest priced offer; and waive informalities and minor irregularities in offers received.

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

The assessment of the offers received in response to this Solicitation will be carefully considered against the needs of Leidos Biomed and the Government. This assessment is not intended to be a solely mechanical or mathematical analysis of an offer, but rather the product of both objective and subjective measurements and judgments of the source selection officials after consideration of the relevant information.

H. Proposal Evaluation Factors

Evaluation of the offers submitted will be considered against the following evaluation factors.

General Evaluation Criteria

H.1. Technical Approach (20%)

The Offeror demonstrates good understanding of the scope, objectives, and challenges of this project.

The proposed approach is capable of meeting project objectives as stated in the RFP Attachment 1: Statement of Work.

The proposed approach can support the requirements for the initiative.

The solution proposed is within the scope of the effort.

H.2. Architecture and Integration (30%)

The system demonstrated flexibility and scalable architecture capable of supporting growth in users, data volume, and multi-site operations

The system demonstrates ease of integrating with external systems (e.g., instruments, analytics platforms) using standard methods

The system demonstrated availability and quality of APIs and support for standard data, and high-speed data exchange formats

The system is compatible with enterprise security (e.g., SSO, OAuth2) and deployment environments (cloud, on-premise, hybrid)

The system can extend functionality and maintain integrations without significant customization or upgrade risk

H.3. Compliance and Security (10%)

The system can generate, maintain, and review secure, time-stamped audit trails and provide continuous system monitoring

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

The system can implement security controls, including SSO, role-based access control (RBAC), and data encryption

The system demonstrated compliance with relevant regulatory and security requirements (e.g., 21 CFR Part 11, GMP).

o If it is a SaaS offering, it must be FedRAMP. Please confirm if you have FedRAMP Authorization.

o If an On-Premise offering, please advise on your plan to implement (Badged staff for remote system deployment and support? Onsite support? Alternate approach?).

H.4. Experience and Stability (15%)

The vendor demonstrated experience implementing and supporting LIMS solutions in comparable environments

The vendor demonstrated organizational stability and long-term business viability

The vendor demonstrated qualifications and expertise of proposed Key Personnel. Offeror is expected to propose at least 1-2 Key Personnel

H.5. Project Plan and Work Breakdown Structure (15%)

The vendor has described in summary the set of tasks that will be performed to accomplish project objectives.

The vendor provides details of the methods for producing deliverables, allocation of staff, and other resources necessary to produce deliverables, and timelines.

The vendor provided a draft project plan outlining tasks, dependencies, milestones (including required reviews), and deliverable dates in alignment with the Statement of Objectives

H.6. Cost (or Price) Reasonableness (10%)

Costs (or prices) proposed are commensurate with the technical tasks bid.

The vendor has provided a detailed, year-over-year cost proposal for software and associated models, including justification for any price increases.

The vendor has provided a comprehensive, one-time implementation cost, with a detailed breakdown of all labor, materials, and associated services.

I. RFP Attachments

The following are considered attachments to this RFP Document:

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

Attachment No. Document Description

1 Statement of Work

2 Cost (or Price) Template

3 LIMS Requirements Response Matrix

The following is provided as a separate document in this Solicitation Package:

Subcontractor’s Representations and Certifications

J. Certifications

J.1. Organizational Conflicts of Interest (OCI)

This certification is required to ensure OCIs do not exist for the anticipated performance of the Subcontract or that any potential OCI is identified, neutralized or mitigated when:

Offeror hereby certifies that Offeror’s performance of its obligations under any Subcontract that may be issued as a result of this Solicitation will not be biased because of its financial, contractual, organizational or other interests which relate to the proposed work; Offeror will be able to render impartial, technically sound, and objective assistance or advice; and Offeror will not obtain any unfair competitive advantage over other parties by virtue of its performance of the proposed Subcontract.

Offeror hereby certifies that the circumstances as to why it cannot make the foregoing “No OCI Representation” certification are fully disclosed in the attached pages (Offeror to provide as a separate document in advance of full proposal) and reflect:

- The category of conflict (organizational, contractual and/or financial);

- The company, agency, organization in which you have a past, present, or currently planned interest or activity (financial, contractual, organizational, or otherwise);

- A brief description of the relationship, period of relationship and the extent of relationship (e.g., value of financial interest of work; percent of total holdings, total work, etc.).

Offerors who have a real or potential conflict of interest must notify Leidos Biomed in writing and provide a mitigation plan addressing the conflict prior to the submittal due date for offers.

If this direction is not followed, Offeror will be disqualified from the competition.

J.2. Place of Performance (FAR 52.215-6)

In performance of any Subcontract resulting from this Solicitation, the Offeror certifies that it:

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

Does not intend to use one or more plants or facilities located at a different location from the Offeror’s primary performance address as proposed in this RFP Document.

Intends to use one or more plants or facilities located at a different location from the Offeror’s primary performance address as proposed in this RFP Document, and provides the following information for the other plants or facilities where work will be performed below:

Place of Performance Street Address, City, State, County, Zip Code

Name and Address of Owner/Operator of Plant/Facility if Other than Offeror/Respondent

J.3. FAR 52.215-22 Limitations on Pass-Through Charges

Select one:

The proposal excludes excessive passthroughs.

The offeror/subcontractor intends to subcontract to a lower-tier subcontractor more than 70 percent of the total cost of work to be performed under its subcontract, the offeror/subcontractor has identified in their proposal, (i) The amount of the subcontractor’s indirect costs and profit/fee applicable to the work to be performed by the lower-tier subcontractor(s); and (ii) A description of the added value provided by the subcontractor as related to the work to be performed by the lower-tier subcontractor(s).

The offeror/subcontractor shall complete the following representation and certification providing the percentage of effort that would be conducted by your employee personnel during the execution of the Statement of Work as provided herein including any optional tasks/periods, if applicable.

By submission of this signed offer, Insert Organization Name hereby certifies that:

% of the effort expended in the execution of the Statement of Work as provided by Leidos Biomed in Solicitation/RFP Number will be conducted by employees of this organization.

J.4. FAR 52.215-23 Limitations on Pass-Through Charges

Select one:

The offeror/subcontractor does not certify

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

The offeror subcontractor does certify

Required reporting of performance of work by the offeror/subcontractor. The offeror/subcontractor shall notify the cognizant LBR Subcontract Administrator in writing if:

The offeror/subcontractor changes the amount of lower-tier subcontractor effort after award such that it exceeds 70 percent of the total cost of the work to be performed under its subcontract. The notification shall identify the revised cost of the subcontract effort and shall include verification that the subcontractor will provide added value as related to the work to be performed by the lower-tier subcontractor(s).

J.5. Utilization of Small Business Concerns

In accordance with the terms of its Prime Contract, under which a resulting Subcontract will be issued, Leidos Biomed is committed to maximizing small business subcontracting opportunities to the greatest extent practicable.

Any lower-tier subcontractor effort shall be detailed in the Offeror’s Technical Proposal.

Small Business Subcontracting Plan (FAR 52.219-9)

Select One:

Not applicable, the offeror/subcontractor is a small business.

Not applicable, the offeror/subcontractor is other than a small business and the award is not expected to exceed the threshold specified in FAR 19.702(a) at date of subcontract award.

Not applicable, the offeror/subcontractor is other than a small business and the award will be performed entirely outside of the United States and its outlying areas.

OR

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

If the offeror/subcontractor selects this option, both boxes must be checked:

Not applicable at time of award, the offeror/subcontractor is other than a small business and certifies that they do not anticipate any subcontracting opportunities.

Should subcontract opportunities exist in the future the offeror/subcontractor will comply with the requirements in FAR 52.219-9.

Offeror/subcontractor without subcontracting opportunities must submit a waiver letter using the template provided: https://frederick.cancer.gov/sites/default/files/2026- 03/LBR%20Subcontracting%20Opportunity%20Waiver%20Letter.docx The letter must:

• Provide a detailed explanation of why no subcontracting opportunities exist

• Acknowledge understanding of FAR 52.219-9 requirements

• Confirm commitment to submit a subcontracting plan if opportunities arise during performance

OR

Applicable, the offeror/subcontractor is other than a small business and is providing a small business subcontracting plan in accordance with FAR 52.219-9. The Leidos Biomed Subcontracting Plan template can be found at:

https://frederick.cancer.gov/media/4374/download?ext=pdf

J.6. Certificate of Minimum Labor Category Requirements

In order to be considered for a Time and Materials, Labor Hour or Level-of-Effort type subcontract, the Offeror must agree to maintain minimum labor qualification standards and requirements.

Select one:

Offeror/Subcontractor is exempt because the proposal being submitted is for other than Time and Materials, Labor Hour or Fixed Price Level-of-Effort.

The Offeror/Subcontractor certifies that it does and will conduct and maintain records of all employees’ background verifications (employment education, licensing and professional certifications) performing under the anticipated Subcontract resulting from this Solicitation and such documented verifications will be provided to Leidos Biomed immediately upon request.

The Offeror/Subcontractor certifies that it does not and will not conduct and maintain records of all employees’ background verifications (employment education, licensing and professional certifications) performing under the anticipated Subcontract resulting from this Solicitation.

https://frederick.cancer.gov/sites/default/files/2026-03/LBR%20Subcontracting%20Opportunity%20Waiver%20Letter.docx https://frederick.cancer.gov/sites/default/files/2026-03/LBR%20Subcontracting%20Opportunity%20Waiver%20Letter.docx https://frederick.cancer.gov/media/4374/download?ext=pdf

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

J.7. Health and Human Services Acquisition Regulation – 352.231-70 Salary Rate Limitation

The Offeror/Subcontractor Certifies or Does not Certify that the “direct salary” as defined in 352.231-70 and as proposed in response to this RFP/solicitation is compliant with 352.231-70.

J.8. Offeror Representatives

J.2. Offeror Authorized Representative

The following individual is the designated representative of the Offeror; this will be the Official authorized to obligate your organization and sign the resulting Subcontract:

Name

Title

Organization

Address Line 1

Address Line 2

City, State, and ZIP Code

Phone

Email

J.3. Offeror Key Personnel

The following individual(s) are considered to be essential to the work being performed hereunder, and shall not be re-assigned, removed or substituted without the concurrence of the Leidos Biomed Subcontracts Administrator:

Name Title Email Address

J.4. Offeror Invoice Representative

The following individual is the designated representative to submit invoices:

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

Name

Title

Organization

Address Line 1

Address Line 2

City, State, and ZIP Code

Phone

Email

J.4.a. Offeror Invoice Remittance Address

Organization

Address Line 1

Address Line 2

City, State, and ZIP Code

K. Offer Signature

By signing of this document, I hereby affirm that I am duly authorized on behalf of my organization to submit this offer and all information including Subcontractor’s Representations and Certifications submitted to be accurate and complete.

By:

Title:

Signature:

Date:

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

Attachment 1: Statement of Work

A. Background

A.1. General

NIH is establishing the Standardized Organoid Modeling (SOM) Initiative, a transformative national effort to address a critical gap in biomedical research: the lack of validated, scalable, and reproducible Novel Alternative Methods (NAMs). The SOM Initiative will provide advanced technical infrastructure, specialized expertise, and integrated operational capabilities to accelerate the development and deployment of standardized, human-relevant organoid systems.

These systems will serve as predictive tools for elucidating disease mechanisms, improving drug discovery pipelines, and enabling reproducible, clinically relevant translational research. Designed as a pan-NIH resource, the initiative will remain adaptable to evolving scientific priorities and emerging public health challenges.

A.2. Project Background

The purpose of this solicitation is to evaluate and select a LIMS solution that offers these comprehensive capabilities within a modern, extensible, and scalable architecture that can evolve with future scientific and operational needs.

As part of its implementation of New Approach Methodologies (NAMs), SOM seeks a LIMS platform that enables the standardization and advancement of organoid-based research. The selected platform must support five core pillars of the SOM framework: (1) development of standardized protocols; (2) an AI/ML-informed optimization engine; (3) high-throughput robotic pipelines; (4) incorporation of biological heterogeneity and sample diversity; and (5) validation of NAMs for regulatory submission.

B. Scope of Work

The scope of this effort encompasses the evaluation, selection, configuration, and initial implementation of a Laboratory Information Management System (LIMS) to support the NIH Standardized Organoid Modeling (SOM) Initiative. The selected subcontractor will deliver a scalable, extensible platform capable of supporting integrated laboratory workflows, including protocol development, assay management, automation integration, and AI/ML-enabled analytics. This includes system architecture design, configuration of core data models, integration with laboratory instrumentation, and implementation of secure, compliant data management practices aligned with federal standards.

The LIMS must support key SOM functional priorities, including standardized protocol execution, high-throughput experimental workflows, and comprehensive biological sample tracking with associated metadata. The system must also enable efficient, programmatic access to data through well-defined APIs and standardized formats, allowing seamless extraction and integration into downstream AI/ML pipelines. This capability is critical to support SOM’s AI/ML-driven optimization and decision support functions, ensuring that experimental data can be readily ingested with minimal transformation and

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026 latency. The subcontractor will collaborate with NIH stakeholders to ensure interoperability with related systems and alignment with the broader SOM framework, with initial implementation focused on core capabilities and future scalability.

C. Objectives

This section lists the areas that must be appropriately addressed by the proposed the LIMS.

• AI-Driven Analytics and Insights

• Array and Plate Management

• Electronic Lab Notebook (ELN) Functionality

• Instrument Management and Integration

• Reagent Tracking and Management

• Reporting and Data Visualization

• Sample Management

• Storage and Inventory Management

• System Configuration, Security, and Compliance

• System Integration and Interoperability

• User Experience and Usability Design

• Workflow Configuration and Management

D. Project Description and Requirements

This section expands on the objectives outlined in Section C by providing detailed, must-have requirements for each area. The Offeror shall address each requirement and describe how the proposed solution will meet these requirements. A vendor that can deploy, configure, and maintain a modern LIMS is needed. Only must-have requirements are listed below. For a complete list of requirements, please refer to the “LIMS Requirements Response Matrix” document (attachment 4 to this RFP).

AI-Driven Analytics and Insights:

• The system shall support AI-based organoid image analysis linked to source datasets.

• The system shall capture failed experiments and include them in analytics datasets with structured failure metadata.

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• The system shall support referencing and linking to large image datasets without requiring full duplication within the LIMS database.

• The system shall capture structured image metadata including acquisition parameters (instrument, magnification, exposure, timestamp, operator).

Array and Plate Management:

• The system shall support rule-based and manual cherry-picking methods with audit logging of automated selections and overrides.

• The system shall support configuration and version control of multiple instrument file formats for array/plate processing.

Electronic Lab Notebook (ELN) Functionality:

• The system shall provide an electronic lab notebook (ELN) with rich-text entry, attachments (images, raw files), tables, embedded plate/layout views, and versioned entries linked to user identity and timestamps.

• The system shall support structured form fields within ELN entries (controlled vocabularies, mandatory fields, numeric units, calculated fields) and enforce validation before saving or advancing workflows.

• The system shall link ELN entries to LIMS objects (samples, reagents, plates, instruments, runs) bidirectionally so records, genealogy, and attachments are discoverable from either system.

• The ELN shall support compliant electronic signatures, immutable audit trails for entry creation/edits, and retention policies consistent with regulated record requirements.

• The system shall expose APIs/webhooks to create, update, and export ELN entries and support event triggers (e.g., instrument run complete → create ELN log) for automation pipelines.

• The system shall support extraction of structured metadata and searchable tags from ELN attachments (images, PDFs) and expose metadata for analytics and AI workflows.

Instrument Management and Integration:

• The system shall validate, import, version, and trace instrument data from acquisition through final result.

• The system shall provide UI-based configuration of instrument interface mappings, file formats, and endpoints without requiring vendor code changes

Reagent Tracking and Management:

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

• The system shall manage reagent master data including versioning, required attributes, and suitability rules.

• The system shall support in-house reagent preparation, internal lot creation, calculations, and barcode labeling.

• The system shall maintain traceability of reagent lots to associated samples and results.

Reporting and Data Visualization:

• The system shall support audit-ready reporting, while providing dashboards and tools for analytics, capacity planning, and operational insight.

Sample Management:

• The system shall support a configurable governance framework for samples, organoids, derivatives, arrays, and batches with controlled attributes, required metadata, lifecycle states, and role-based access controls.

• The system shall encode structured metadata for attachments to support search and traceability.

• The system shall maintain full parent–child genealogy across samples, organoids, reagents, arrays, instruments, and results.

• The system shall support multi-level traceability across plates, wells, and imaging structures.

• The system shall support configurable plate or array master records with reusable templates.

• The system shall validate controlled mapping of samples to plate positions.

• The system shall support cherry-picking with full source-to-destination traceability.

• The system shall uniquely identify and track arrays and plates using barcode or RFID technologies.

• The system shall support multiple external identifiers per sample and enforce configurable uniqueness rules while including external IDs in search, labels, and reports.

Storage and Inventory Management:

• The system shall manage hierarchical storage structures with capacity and compatibility controls.

• The system shall integrate with environmental monitoring systems to capture time-stamped condition data.

• The system shall maintain immutable audit trails of storage movements and condition changes.

System Configuration, Security, and Compliance:

• The system shall enforce globally unique identifiers for all entities and prevent unauthorized modification or deletion of regulated records.

• The system shall generate secure, immutable, computer-generated audit trails for regulated records.

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

• The system shall enforce role-based access control, MFA where applicable, and privileged access auditing.

• The system shall enforce record retention policies and prevent unauthorized deletion of regulated records.

• The system shall support validation lifecycle management and controlled configuration change governance.

• The system shall ensure data protection, secure transmission, backup, and disaster recovery.

• The system shall support validated cloud, on-premise, or hybrid deployment with high availability.

• The system shall provide controlled data schemas and governed extract mechanisms for analytics.

• The system shall support hybrid storage architectures across on-premise, cloud, and HPC environments with tiered data policies.

• The system shall meet defined RTO and RPO objectives with documented and tested recovery procedures.

• The system shall enforce configurable account lockout thresholds after failed login attempts and log all authentication events.

• The system shall enforce accurate, time-synchronized timestamps across audit logs, instruments, and integrations.

• The system shall support continuous security monitoring and logging of privileged and configuration-level activities.

• The system shall support configurable governance modes (e.g., Exploratory, Developmental, Regulated) with varying enforcement strictness for workflows, approvals, audit, and data controls.

System Integration and Interoperability:

• The system shall support secure bidirectional integration with AI/ML platforms and high-performance computin environments. E.g API, standardized communication protocols, etc..

• The system shall provide documented, versioned REST and/or GraphQL APIs for core objects.

• The system shall support secure programmatic authentication including OAuth2, tokens, and SSO integration.

• The system shall log all programmatic operations in immutable audit trails.

• The system shall provide transaction traceability with correlation IDs across integrations.

• The system shall support controlled reprocessing of failed integrations with full audit logging.

• The system shall provide and maintain supported client SDKs (e.g., Python, R) with documented version compatibility and deprecation policies.

• The system shall support integration with external image repositories for retrieval, indexing, and linkage of imaging datasets.

• The system shall capture and associate real-time data streams from automated systems with relevant workflow batch, and sample records.

User Experience and Usability Design:

• The system shall support bulk actions, barcode scanning, and plate visualization tools.

• The system shall support configurable user notifications with mandatory alerts for critical events.

• The system shall support secure mobile access for role-permitted activities with MFA and session controls.

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

Workflow Configuration and Management:

• The system shall provide an end-to-end, configurable workflow management capability that supports automated execution, while enabling export of workflow data in machine-readable formats.

E. Conformance and Compliance: Program Policies and Practices

The offeror will conform to all relevant Federal, State, and Local laws and regulations. (21 CFR Part 11, FedRAMP or other Security Requirements, and Industry best practices).

F. Deliverables

Please propose in the below table table a list of deliverables with notation of due dates. All days identified are intended to be normal business days unless otherwise specified. The Offeror may propose alternative schedules if they have multiple options for implementation.

F.1. Deliverable Summary and Due Dates

Deliverable Due Date

F.2. Deliverable Descriptions and Acceptance Criteria

F.2.a. Descriptions and Specific Acceptance Criteria

The following deliverables shall be developed in this Project. Offeror’s proposed Project Management Plan (PMP) should clearly contain all tasks and milestones required to produce these deliverables.

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

All deliverables shall be developed according to constraints listed in Section E.

Conformance and Compliance: Program Policies and Practices above where applicable.

F.2.b. General Acceptance Criteria

In addition to specific acceptance criteria listed above, general quality measures, as set forth below, will be applied to each deliverable received from Subcontractor under this Statement of Work.

• Accuracy – Deliverables shall be accurate in presentation, technical content, and adherence to accepted elements of style.

• Clarity – Deliverables shall be clear and concise. Any/all diagrams shall be easy to understand and be relevant to the supporting narrative.

• Consistency to Requirements – All deliverables must satisfy the requirements of this Statement of Work.

• Timeliness – Deliverables shall be submitted on or before the due date specified in this Statement of Work or submitted in accordance with a later scheduled date determined by the Leidos Biomed TPM.

G. Reporting Requirements

G.1. Monthly Status Report

Subcontractor shall submit Monthly Status Reports documenting the efforts performed in the completion of each task. The required information must be submitted on or before time of invoice, otherwise invoice payment may be delayed.

It is expected that the Monthly Status Report will include, but not be limited to:

Subcontractor name and address

Name of person submitting the Monthly Status Report

Subcontract/Task Order number

Monthly Status Report date

Period covered by the Monthly Status Report

Program status, to include objectives met, work completed and work outstanding

Notable achievements

Issues or obstacles impeding progress and recommended solutions

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

Status of Deliverables/Milestones

Resource planning/status

Description of work completed and plans for next month (including any anticipated travel)

G.2. Final Report

Subcontractor shall submit a Final Report within 30 days of completion of work.

It is expected that the Final Report will include, but not be limited to:

Subcontractor name and address

Name of person submitting the Final Report

Subcontract/Task Order number

Final Report date

Period covered by the Final Report

A comprehensive summary of work performed during reporting period

H. Place of Performance

All work will be performed at Subcontractor’s facilities in (location TBD) or at the Leidos Biomed location in Frederick, Md.

I. Government Furnished Data, Materials, or Equipment

TBD

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

Attachment 2: Pricing Template (T&M and FFP)

Cost Estimate Worksheet - Time and Materials

Period of Performance

From:

Through:

DIRECT LABOR:

Labor Category Hourly Rate Number of Hours Total Labor

$0.00

$0.00

$0.00

$0.00

$0.00

$0.00

$0.00

$0.00

SUBTOTAL DIRECT LABOR $0.00

OTHER DIRECT COSTS:

CONSULTANT/SUBCONTRACT COSTS (List names and services to be provided – attach agreement and pricing) $0.00

EQUIPMENT (Provide description and price for each item) $0.00

SUPPLIES (Provide itemized list with prices) $0.00

OTHER DIRECT COSTS (Provide itemized list with prices) $0.00

SUBTOTAL OTHER DIRECT COSTS $0.00

TOTAL COSTS (Subtotal Direct Labor + Subtotal Other Direct Costs) $0.00

Pricing Worksheet - Fixed Price

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

Period of Performance

From:

Through:

Milestone/Item/Deliverable # Title/Description/Requirements

Unit of Measure Quantity

Unit Price

Extended Amount

$0.00 $0.00

$0.00 $0.00

$0.00 $0.00

$0.00 $0.00

$0.00 $0.00

$0.00 $0.00

$0.00 $0.00

$0.00 $0.00

TOTAL PRICE $0.00

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

Attachment 3: LIMS Requirements Response Matrix

LIMS Requirements Response Matrix – Instructions

Purpose:

This document is provided to capture the Offeror’s response to LIMS requirements and will also be used as a reference for Section D (Project Description and Requirements) in the RFP.

Response Expectations:

• Must Have Requirements:

The Offeror shall provide detailed responses describing how the proposed solution will fulfill each requirement.

• Nice to Have Requirements:

Responses are preferred. The Offeror may describe capabilities that address these requirements where applicable.

• Optional Requirements:

Responses are optional. The Offeror may provide additional information on capabilities or future roadmap alignment.

General Guidance:

• Responses should include sufficient technical and functional detail.

• Include supporting information, examples, or references where applicable.

• Please feel free to use the filters throughout the spreadsheet to help navigate and provide responses to the requirements.

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026

Category Requirement Priority Requirement Description

Vendor Response

AI-Driven Analytics and Insights Must Have The system shall support AI-based organoid image analysis linked to source datasets.

AI-Driven Analytics and Insights Must Have

The system shall capture failed experiments and include them in analytics datasets with structured failure metadata.

AI-Driven Analytics and Insights Must Have

The system shall support referencing and linking to large image datasets without requiring full duplication within the LIMS database.

AI-Driven Analytics and Insights Must Have

The system shall capture structured image metadata including acquisition parameters (instrument, magnification, exposure, timestamp, operator).

AI-Driven Analytics and Insights Nice to Have

The system shall maintain version control and audit logging of AI/ML models, inputs, and outputs.

AI-Driven Analytics and Insights Nice to Have

The system shall support model approval workflows and controlled promotion or rollback of AI/ML model versions.

AI-Driven Analytics and Insights Nice to Have

The system shall support automated workflow interruption or gating when AI, environmental, or instrument alerts exceed defined thresholds.

AI-Driven Analytics and Insights Optional

The system shall allow configurable inclusion or exclusion of experimental runs in analytics reporting.

AI-Driven Analytics and Insights Optional

The system shall support linkage and traceability between raw image files and processed image derivatives.

AI-Driven Analytics and Insights Optional

The system shall record whether AI-generated recommendations were accepted, modified, or rejected.

AI-Driven Analytics and Insights Optional The system shall support predictive analytics for organoid

RFP No. S26-123 Revision: 4, Effective Date: 17 March, 2026 growth trends and assay outcomes.

AI-Driven Analytics and Insights Optional

The system shall store model metadata and explainability attributes (model version, parameters, confidence, input dataset) for AI-generated results.

Array and Plate Management Must Have

The system shall support rule-based and manual cherry-picking methods with audit logging of automated selections and overrides.

Array and Plate Management Must Have

The system shall support configuration and version control of multiple instrument file formats for array/plate processing.

Array and Plate Management Nice to Have

The system shall validate ad hoc and template array layouts for physical and logical constraints prior to save or execution.

Array and Plate Management Nice to Have

The system shall support creation, graphical configuration, saving, and version control of ad hoc plate/array layouts.

Array and Plate Management Nice to Have

The system shall support configurable array result data formats and validation rules for import and reprocessing.

Array and Plate…