Roche reagents, consumables, and service maintenance

The National Institute of Health, Clinical Center (CC) intends to award a Requirements type contract to Roche Diagnostics, Indianapolis, IN 46250, to procure maintenance service, reagents, and consumables. Roche Diagnostics is the only vendor/manufacturer that can provide the maintenance and full test menu required for clinical patient care testing in the NIH CC Department of Laboratory Medicine.

The reagents and testing supplies requested from Roche Diagnostics are specific for the already existing family of three (3) VENTANA BenchMark ULTRA System, and one (1) VENTANA DISCOVERY ULTRA System currently owned in the Department of Laboratory Medicine. They cannot be interchanged with another vendor.

Since the service, reagents, and supplies are proprietary, there is only one supplier whose products can fit into the instrumentation; any other supply or service could cause the cancellation of the protocol or delays in the completion of the protocol. There is no substitution allowed nor deviation since this is specific to the Roche Diagnostics Corporation instrumentation in place in the Hematology section of Department of Laboratory Medicine.

The Department of Laboratory Medicine (DLM) will telephone or e-mail requests for required services and items on a needed basis. Period of Performance shall be for a base year of twelve (12) months and two (2) twelve-month option years. The total estimated value of the contract inclusive of the two option periods shall not exceed $750K. The contractor will supply the following IHC Detection Slides and ISH Slides products as required for three BenchMark ULTRA Systems.

PRODUCTS: EBER (Tissue Diagnostics ISH) Kappa mRNA (Tissue Diagnostics IHC) Lambda mRNA (Tissue Diagnostics IHC) OptiView (Tissue Diagnostics IHC) U6 snRNA (Tissue Diagnostics ISH) The contractor will supply the following SERVICE COVERAGE – STANDARD - for (3) VENTANA BenchMark ULTRA System, and one (1) VENTANA DISCOVERY ULTRA System: Costs for all repair and preventative maintenance parts are included.

All no charge parts shipments are made at Roche’s discretion and may be shipped from Roche’s factory or a forward stocking location. Customer will not be charged shipping costs for repair/PM parts. Unlimited on-site service support by a Roche FES is available Monday through Friday 8 a.m. to 5 p.m. local time (excluding Roche recognized holidays). Customer must contact Roche’s Customer Support Center phone at 1-800-227-2155 (available 24 hours, seven days a week) to report service issues.

All requests for repair service will be dispatched with a 48-hour priority response (for customers located within 100 miles of FES). One annual Preventative Maintenance service will be performed by and FES. All PM service is dispatched as a non-priority for completion within thirty (30) days of request. Unlimited on-site applications troubleshooting by a Roche Field Applications Specialist (FAS) is available Monday through Friday 8 a.m. to 5 p.m. local time.

Five (5) days of applications support (i.e. protocol assistance, on-site operator training) by an FAS is available Monday through Friday 8 a.m. to 5 p.m. local time. Service coverage includes the installation of all operation modifications and hardware and platform operating software enhancements by an FES during the next schedules service visit.

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation 13.501 Special documentation requirements for sole source acquisitions exceeding the Simplified Acquisition Threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities.

Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Each response should include the following Business Information:

a. DUNS.

b. Company Name, address, POC, Phone and Email address c. Current GSA Schedules or NAICS codes appropriate to this Award. d. Type of Company (i.e., small business, 8(a), woman owned, hubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1 e. Capability Statement Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Kimala Winfield, kimala.winfield@nih.gov or Malinda Dehner, dehnerm@cc.nih.gov by the due date and time marked in this notice.