Combined_syn_sol PCA-NCI-04352.docx

Hospital and Laboratory Support Division Office of Logistics and Operations (OLAO) Office of Acquisition and Logistics Management (OALM)

Title: Reagents and consumables for Roche immunostainers

Combined Synopsis Solicitation

Synopsis No. 75N98027Q00026 Synopsis No. 75N98027Q00026

COMBINED SYNOPSIS / SOLICITATION WORKFORM

Action Code: Combined Synopsis/Solicitation Date: October 30, 2026 Classification Code: 6640

NAICS: 325413

Contracting Office Address: 6701 Rockledge Drive, Bethesda, MD 20817 Subject/Title: Reagents and consumables for Roche immunostainers Solicitation Number: 75N98027Q00026 Closing Response Date: November 16, 2026 at 8:00 A.M. Eastern Daylight Time (EDT) Questions Due Date: November 04, 2026 at 8:00 A.M Eastern Daylight Time (EDT) Contact Point(s): Luz Casey, Contract Specialist Contract Award Type: Firm Fixed Price Brand Name or Equal Acquisition (FAR 52.211-6): Yes Place of Contract Performance: Bethesda, MD Set-aside Status: N/A

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This is intended to be a firm-fixed price contract.

The solicitation number is 75N98027Q00026 and the solicitation is issued as a request for quote (RFQ) for reagents and consumables for Roche immunostainers. The solicitation document, the incorporated provisions, and clauses are those in effect through Federal Acquisition Circular 2024-07, effective August 29, 2024. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at www.acquisition.gov. This solicitation is being released unrestricted. The NAICS code is 325413 and the business size standard is 1,250 employees. This requirement is not set aside for small business. This acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13.

OBJECTIVE

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.

BACKGROUND

The Laboratory of Pathology of the Center for Cancer Research (CCR) provides immunohistochemical and in–situ hybridization assays on formalin-fixed, paraffin embedded sections from patients enrolled in clinical trials at the National Cancer Institute as well as other institutes throughout the National Institutes of Health. Immunohistochemistry and in-situ hybridization are widely accepted techniques used in nearly every clinical and research pathology laboratory in the world. These assays have become an essential part of cancer diagnosis and treatment and have an equally important role in the diagnosis of many infectious diseases.

Over 200 tests and approximately 35,000 slides/year are performed on the Benchmark Ultra stainers that are currently used in the laboratory. These instruments were installed 2014 and need replacement based on system depreciation and new upgraded technologies in hardware. The addition of the new Benchmark Ultra Plus stainers will provide this upgrade as well as facilitate ease in incorporating assays that are validated on the Benchmark Ultra stainers, since reagents, consumables and software will remain the same. There will be no change in reagent pricing in extending this contract for an additional 5 years, which will result in significant savings for the federal government.

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.

NCI uses the Roche Ventana Benchmark Plus equipment in the Laboratory of Pathology at the CCR for patient diagnostics and treatment. The Laboratory of Pathology has developed and optimized standard operating procedures (SOPs) for over 200 antibodies on these systems over many years and the high quality of its clinical immunostains is a result of constant refinements of the SOPs on these systems. It is critical for the Laboratory of Pathology to continue using the same immunostainers, and the reagents and consumables needed to operate these immunostainers can only be purchased from Roche Diagnostics.

The reagents and materials listed in the current Roche reagent contract, 75N91019D00038 which was awarded on 9/22/2019, are primarily used to support the clinical mission of the Laboratory of Pathology, NCI, as well as to support its research mission.

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.

TYPE OF ORDER

This is a Firm Fixed-Price IDIQ contract with a minimum amount of $20,000 and maximum amount (ceiling) of $1,500,000. The Government may place firm fixed price delivery/task orders against this IDIQ contract in an amount not less than the minimum and not more than the maximum for the five (5) year period as follows:

For the 5 year Contract: Minimum = $20,000.00 and Maximum = $1,500,000.00

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.

The Statement of Work and any terms and conditions relevant to the requirement are included as attachments. The provisions at FAR Clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition. The following addendum related to the Instructions to Offerors is included: Addendum to FAR Clause 52.212-1, Instructions to Offerors – Commercial Items. Please refer to this addendum for additional attachments, including the Statement of Work and other relevant information.

Evaluations will be conducted in accordance with the provision at FAR Clause 52.212-2. Offerors will be evaluated as follows: EVALUATION-COMMERCIAL ITEMS (OCT 2014) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Technical Proposal/Equipment Capability, Delivery, and Price.

The Government will make award to the responsible vendor whose quote represents best value tradeoff for Offerors who meet minimum requirements. The Government may select a higher-priced quote if it is determined that the additional technical merit or lower performance risk warrants the price premium.

Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. Please refer to the addendum for additional evaluation information. Each Offeror must include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, with its offer. Please note, each Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal.

· FAR Clause 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition. The terms and conditions outlined in the following addendum also apply:

· Addendum to FAR Clause 52.212-4, Contract Terms and Conditions – Commercial Items. Please refer to this addendum for additional terms and conditions related to the requirement.

· FAR Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition. The full text version of FAR 52.212-5 included in the addenda as Attachment 5 indicate which FAR clauses and provisions are applicable to this acquisition.

The following Terms and Conditions apply:

· 52.203-17 - Contractor Employee Whistleblower Rights

· 52.204-9 - Personal Identity Verification of Contractor Personnel

· 52.204-13 - Personal Identity Verification of Contractor Personnel

· 52.209-6 - Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment

· 52.209-10 - Prohibition on Contracting with Inverted Domestic Corporations

· 52.212-4 - Terms and Conditions-Commercial Products and Commercial Services

· 52.222-3 - Convict Labor

· 52.222-19 - Child Labor-Cooperation with Authorities and Remedies

· 52.222-36 - Equal Opportunity for Workers with Disabilities

· 52.222-50 - Combating Trafficking in Persons

· 52.222-90 - Addressing DEI Discrimination by Federal Contractors

· 52.223-23 - Sustainable Products and Services

· 52.226-8 - Encouraging Contractor Policies to Ban Text Messaging While Driving

· 52.232-33 - Payment by Electronic Funds Transfer-System for Award Management

· 52.232-40 - Providing Accelerated Payments to Small Business Subcontractors

· 52.233-3 - Protest After Award

· 52.233-4 - Applicable Law for Breach of Contract Claim

· 52.240-91 - Security Prohibitions and Exclusions

· 52.244-6 - Subcontracts for Commercial Products and Commercial Services

· 52.246-16 - Responsibility for Supplies

· 52.216-18 - Ordering

· 52.216-19 - Order Limitations

· 52.216-22 - Indefinite Quantity Evaluation of Options Provision, The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic award. This solicitation notified offerors that the award will include the Government's unilateral option to extend performance for an additional period up to six months under FAR 52.217-8, during which the pricing and terms of the period in which the option was exercised would apply. The Government cannot predict if or when the option may be exercised. Because any exercise of the Government's option extends the pricing and terms of the period in which the option was exercised, the Government expressly and affirmatively evaluates pricing for the option to extend under 52.217-8 co-extensive with the Government's price evaluation for each of the base and option periods of this award. Because pricing for each period subject to possible extension under the 52.217-8 has been evaluated, pricing for any possible future use of that option to extend has, likewise, been evaluated and would apply in strict accordance with this evaluation in the event of the Government’s exercise of the option to extend services. (End of Provision)

Submission Requirements: Responses must include sufficient information to demonstrate the respondent’s capability to provide the required product or service. Price quotations shall include, at a minimum: unit price, list price, shipping and handling costs, delivery timeframe after award, delivery terms, prompt payment discount terms, F.O.B. point (destination or origin), product or catalog numbers, product descriptions, and any other relevant information.

Evaluation factors may include, but are not limited to: equipment capability, equipment warranty and maintenance coverage, delivery, past performance, technical capability, special features, trade-in considerations, expected lifecycle, warranty, maintenance availability, and environmental or energy efficiency considerations.

Respondents claiming to be manufacturers or authorized resellers of a specified brand-name product must provide: (a) Product, catalog, model, and/or part number(s); (b) Product description; (c) Documentation demonstrating that the offered item meets all required salient characteristics; (d) Quantity; (e) Estimated price or cost; (f) Shipping, handling, and/or installation charges; and (g) Delivery timeframe after receipt of order.

Responses must also include the Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification. All offerors must be actively registered in the System for Award Management (SAM) at www.sam.gov.

All responses must be received by November 16, 2026 and must reference solicitation number 75N98027Q00026. Responses may be submitted electronically to Luz.Casey@nih.gov. All responses must be received by the specified due date and time in order to be considered. Fax responses will not be accepted.

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