Sources Sought PCA-NCI-04352.docx

Reagents and consumables for Roche immunostainers Sources Sought Notice Solicitation Notice Number: PCA-NCI-04352

Contracting Office Address Department of Health and Human Services, National Institutes of Health, Office of Acquisitions, OA Office of the Director, OD, 6701 Rockledge Drive, Bethesda, MD, 20892.

Introduction This is a notice issued on behalf of the National Institutes of Health (NIH), Office of Acquisitions, OA Office of the Director, OD, DHHS, UNITED STATES. This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this Sources Sought is to seek the availability and capability of small business concerns, including 8(a) small business and/or small qualified small business concerns [including Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, Veteran-Owned Small Businesses (VOSB) and Service-Disabled Veteran-owned Small Businesses (SDVOSB] that are interested in and capable of performing the work described in the statement of work. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

Background The National Institutes of Health, National Cancer Institute (NCI), Laboratory of Pathology at the Cancer Center Research (CCR) is seeking small businesses with the ability to provide stains/reagents and consumables and software upgrades needed to conduct immunohistochemical and in situ hybridization testing for cancer diagnostics and research. The reagents and consumables must be compatible with Roche Ultra Plus immunostainers.

STATEMENT OF NEED:

The purpose of the proposed acquisition is to issue a new Indefinite Delivery Indefinite Quantity (IDIQ) contract to ensure that the Laboratory of Pathology at the Cancer Center Research (CCR) can continue to purchase stains/reagents and consumables and software upgrades needed to conduct immunohistochemical and in situ hybridization testing for cancer diagnostics and research. These stains/reagents have become an essential part of cancer diagnosis and have an equally important role in the diagnosis of many infectious diseases. The period of performance for this requirement shall be a base period plus four option periods.

The reagents and consumables must be compatible with Roche Ultra Plus immunostainers. The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW).

SPECIAL ORDER REQUIREMENTS

The reagents and consumables must be compatible with Roche Ultra Plus immunostainers. The reagents and consumables must be compatible with current government owned equipment and systems. The Laboratory of Pathology currently has 4 Ventana Medical Systems (VMS) Benchmark ULTRA immunostainers that requires the procurement of proprietary reagents from Roche Diagnostics, the parent company of VMS. No generic reagents can be used on these instruments, so Roche is the only source that can provide these reagents.

CONTRACT REQUIREMENTS

Independently, and not as an agent of the Government, Contractor shall furnish all necessary labor, materials, supplies, equipment, and services not otherwise provided by the Government to perform the following tasks:

Task 1. Reagents and Consumables Contractor shall provide the latest reagents, kits and supplies that are compatible with NCI’s Roche immunostainers. Contractor shall ship all requested reagents, kits and supplies with expiration dates greater than 12 months beyond each shipping date. All reagents shall be shipped overnight on dry ice, wet ice or other conditions according to industry best practices. All shipments shall be delivered at no cost to Government for the duration of the contract with the exception of expedited shipments. Contractor warrants that all reagents delivered shall perform to industry specifications and any defective reagents shall be replaced at no cost to Government.

The laboratory currently has four (4) Ventana Medical Systems (VMS) Benchmark Ultra immunostainers that require proprietary reagents from Roche Diagnostics, the parent company of VMS. The use of the Ventana automated immunostainers has allowed the laboratory to provide high volume clinical service and offer a full menu of specialized tests. Approximately 80% of the laboratory’s slide volume is run on these systems, and over 300 different antibodies have been validated and optimized on these systems at considerable expense. The validation of these stains has been in accordance with regulatory requirements established by the College of American Pathologists (CAP). The LP’s accreditation that is issued by CAP allows the Immunohistochemistry Section to perform patient testing in accordance with Federal statutes cited in the Clinical Laboratory Improvement Amendments (CLIA-88). Revalidation of any third-party reagents is not possible, and would nullify LP’s compliance with the CAP.

Task 2. Equipment

NA

Task 3. Software Contractor shall upgrade equipment software at no cost to Government within one month of software release. Government reserves the right to defer and/or postpone software upgrades at any time. The current VConnect software shall be covered for the term of extension of this contract. NCI technologists will be trained in new software applications by qualified Roche IT Specialists.

Task 4. Consultation Contractor shall provide access to its scientists and engineers for consultation on procedures and instrumentation at no cost to Government.

PERIOD OF PERFORMANCE: This is a Firm-Fixed-Price IDIQ contract on the basis of best value tradeoff for Offerors who meet minimum requirements. The base year period of performance is expected to begin on 12/01/2026 and end on 11/30/2027.

The period of performance for the option years are listed below:

Option Number Option Period

1) 12/01/2027 – 11/30/2028

2) 12/01/2028 – 11/30/2029

3) 12/01/2029 – 11/30/2030

4) 12/01/2030 – 11/30/2031

PLACE OF PERFORMANCE

Immunohistochemistry Section Laboratory of Pathology, CCR, NCI 10 Center Drive, Room 2S253 Bethesda, Maryland 20892-1500

DELIVERABLES AND DELIVERY SCHEDULE

Time of Delivery: Unless a delivery/task order specifies a different delivery time, the Contractor shall deliver reagents within five (5) days or after receipt of each delivery/task order.

Deliveries and Acceptance

1. Satisfactory performance of this contract shall be deemed to occur upon the Contractor’s delivery and acceptance by the Contracting Officer’s Representative (COR) or the duly authorized representative. The Contracting Officer’s Representative (COR) or the duly authorized representative will perform an inspection and acceptance of materials and services provided. Inspection and acceptance shall be performed at the address of the duly authorized representative. Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer’s Representative (COR) or the duly authorized representative within 30 days of delivery.

2. The Contractor shall make required deliveries f.o.b. destination with the consignee’s premised address as it is provided by the NCI Purchasing Agent.

3. Unless otherwise specified, deliveries shall be made to the delivery point provided by the Purchasing Agent, Mondays through Fridays (excluding Federal holidays) between the hours of 8:30 a.m. EST and 3:30 p.m. EST only. The product(s) shall be delivered to the address stated on the delivery/task order: Complete building and room details shall be provided on the delivery/task orders when placed against the contract.

The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). Subject to prior approval of the Contracting Officer (CO), the Contractor may acquire the services of a subcontractor and/or consultants to provide specialized services if deemed appropriate and within scope by the COR.

The Contractor shall employ a technical approach, utilize organizational resources, and implement management controls to achieve the cost, schedule, and performance requirements throughout the execution of the Contract Requirements. The Contractor shall be responsible for providing, managing, and overseeing its personnel, as well as any subcontractor/consultant efforts used in the performance of the Contract Requirements.

This is intended to be a firm-fixed price contract.

Capability Statement Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capability statement should include:

1)Name and address of the vendor,

2) Size and type of business,

3) Point of contact with the name, title, phone, fax, and email,

4) UEI number.

5) the professional qualifications of experts, and technical personnel as it relates to the above outlined requirements, any other information considered relevant to this service.

The capability statement must not exceed 7 pages. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number.

Responses to this requirement must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria.

Point of Contact:

Luz Casey, Contract Specialist, Office of the Director, OD, Luz.Casey@nih.gov.

Department of Health and Human Services, National Institutes of Health, Office of Acquisition, Office of the Director, 6701 Rockledge Dr., Bethesda, MD 20892, USA Submission Instructions:

Interested parties shall submit capability statements via email to Luz Casey at Luz.Casey@nih.gov. Due Wednesday, October 28, 2026 @ 09:00 am EST.

All responses must be received by the specified due date and time in order to be considered. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to provide the item. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, pre-solicitation and solicitation notices will be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation. When submitting this information, please reference the solicitation notice number.