Roche cobas® z 480 Analyzer Maintenance Service

The National Institute of Health, Clinical Center (CC) intends to award a a Firm-Fixed price purchase order to Roche Diagnostics, Indianapolis, IN 46250, for maintenance service agreement for the Roche cobas® z 480 analyzer. This instrument is currently in use in the Department of Laboratory Medicine (DLM), Hematology Services for the detection and genotyping of human Factor II (Prothrombin) and human Factor V in patients with suspected thrombophilia. Approval of a maintenance agreement is required by regulatory agencies to ensure the equipment is operating optimally and export support is readily available when needed for safe and quality patient care.

Roche Diagnostics is the sole manufacturer and authorized service provider for this instrument. Due to proprietary nature of technology, no other vendor is authorized or capable of providing the required services. Establishment of this preventative maintenance agreement would allow for uninterrupted provision of critical patient test results. The systems are not sold in the United States by any distributors or other third parties. Because of the proprietary technology and supplies used with the instruments, no other vendor can provide the service required for them. Establishing an agreement with this vendor is therefore critical to ensure the proper maintenance and functionality of the equipment. Period of Performance shall be for a base year of twelve (12) months and four (4) 12-month option years.

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. The total dollar value of this requirement shall not exceed the Simplified Acquisition Threshold (SAT) $250,000.00.

The North American Industry Classification System (NAICS) code for this acquisition is 811210 with a large business standard size of $34.0 million.

Each response should include the following Business Information:

a. SAM UEI

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.