Reagents and consumables for Roche immunostainers

Posted Date: 08/02/2019
Response Date: 08/16/2019
Contracting Office Address

Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions, 9609 Medical Center Drive, Room 1E156, Bethesda, MD 20892, UNITED STATES

Description

The National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Pathology (LP) plans to procure on a sole source basis, stains/reagents, consumables and equipment upgrades needed to conduct immunohistochemical and in situ hybridization testing for cancer diagnostics and research from Roche Diagnostics Corp, 9115 Hauge Road, PO Box 50457, Indianapolis, IN 46250-0457

This acquisition will be processed in accordance with the simplified acquisition procedures as authorized by FAR Part 13.106-1 (b) (1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System Code is 325413 and the business size standard is 1,250 employees.

Only one award will be made as a result of this solicitation.

It has been determined there are no opportunities to acquire green products or services for this procurement.

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.

The laboratory currently has one Ventana Medical Systems (VMS) Benchmark Ultra System, one Ventana Medical Systems (VMS) Discovery Ultra system and two Ventana DP 200 ID/2D Slide Scanners. Reagents are required to operate these instruments. 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 90% of the laboratory's slide volume is run on these systems.

Objective

The purpose of this Indefinite Delivery Indefinite Quantity (IDIQ) contract is to acquire the stains/reagents and consumables needed to operate immunostainers, as well as the equipment upgrades needed to conduct immunohistochemical and in situ hybridization testing for cancer diagnostics and research in the Laboratory of Pathology located in the Cancer Center for Research (CCR).

As reagents are purchased, the contractor will upgrade the lab's Benchmark XT, currently used for in-situ hybridization assays, to a Benchmark Ultra as part of a "Lease to purchase" service agreement. Benchmark Ultras currently in place for immunohistochemistry testing will remain in place until new generation Ultra Plus stainers are commercially available.

Special Order Requirements

The reagents and consumables must be compatible with VMS immunostainers.

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 VMS/Roche immunostainers including the upgraded equipment listed in Task 2 at discounted prices. 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 the Government.
Task 2. Equipment

The Government shall receive a VMS Benchmark Ultra System, a VMS Discovery Ultra system and two Ventana DP 200 ID/2D Slide Scanners as part of the "lease to purchase" agreement. The lease is financed by the procurement of reagents and consumables.

The Contractor shall deliver and install the following equipment at NCI's facilities by the deadlines listed below:

Equipment Quantity Installation Deadline

Scanner 2 Install within 6 weeks after contract award
Benchmark Ultra 1 Install within 6 weeks after contract award
Discovery Ultra 1 NCI controls shipment and installation

Contractor shall repair or replace free of charge any non-consumable part which fails during the term of this contract with the exception of equipment damaged by accident, abuse, misuse or misapplication. In the event any new technology is released within the timeframe of this contract with the Benchmark Ultra, the government reserves the right to negotiate in good faith with Roche to upgrade to the new technology at mutually agreeable terms at the time.

Task 3. Software

Contractor shall update equipment software as part of routine maintenance at no cost to Government within one month of software release. Government reserves the right to defer and/or postpone software updates at any time.

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 contract

This is a Firm Fixed-Price IDIQ with a not exceed amount of $2,030,670.

Period of performance

The period of performance shall be from 9/22/2019 thru 9/21/2024

Place of performance

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

Ordering and order limitations

FAR Clause 52.216-18 Ordering (Oct 1995)
A Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from 9/22/19 thru 9/21/24.
B All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.
C If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.
As noted in FAR 52.216-18 Ordering (a), delivery orders or task orders will be processed by procurement officials of both the NCI Office of Acquisition and Center for Cancer Research (CCR), no other individuals are authorized.

FAR Clause 52.216-19 Order Limitations (Oct 1995)
a Minimum order: When the Government requires supplies or services covered by this contract in an amount of less than $500, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.
b Maximum order: The Contractor is not obligated to honor:
(1) Any order for a single item $40,000;
(2) Any order for a combination of items $80,000; or
(3) A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

c If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)); the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.
d Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 30 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

Deliverables and delivery schedules

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.
FAR Clause 52.246-16 Responsibility for Supplies (Apr 1984)
(a) Title to supplies furnished under this contract shall pass to the Government upon formal acceptance, regardless of when or where the Government takes physical possession, unless the contract specifically provides for earlier passage of title.

(b) Unless the contract specifically provides otherwise, risk of loss of or damage to supplies shall remain with the Contractor until, and shall pass to the Government upon;

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Acceptance by the Government or delivery of the supplies to the Government at the destination specified in the contract, whichever is later, if transportation is f.o.b. destination.

(c) Paragraph (b) of this section shall not apply to supplies that so fail to conform to contract requirements as to give a right of rejection. The risk of loss of or damage to such nonconforming supplies remains with the Contractor until cure or acceptance. After cure or acceptance, paragraph (b) of this section shall apply.

(d) Under paragraph (b) of this section, the Contractor shall not be liable for loss of or damage to supplies caused by the negligence of officers, agents, or employees of the Government acting within the scope of their employment.

This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 4:00 PM EST, on August 16, 2019. All responses and questions can be emailed to Kimesha Leake, Contracting Officer via electronic mail at jolomi.omatete@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM) through sam.gov. Reference: 75N91019Q00050 on all correspondence.

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