THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Laboratory Medicine (DLM), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to:

UNIVERSITY OF WASHINGTON
4311 11TH AVE NE 100
SEATTLE, WA, 98105-6367
UNITED STATES

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541380 with a Size Standard of $15.0
Million.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-95, January 13, 2017. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($150,000).

STATUTORY AUTHORITY
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplifeid Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

GENERAL INFORMATION

1. Title: Microbiology Testing Contract for the Direct Molecular Detection of Bacteria and Fungi from Patient Samples.

2. Background Information: The CC is a clinical research hospital providing medical services for patients participating in human research protocols at the NIH. The CC provides patient facilities, services for clinical investigations, research in related areas, and training programs for residents.

The Department of Laboratory Medicine (DLM) serves as the clinical laboratory of the NIH Clinical Center. It provides laboratory support for patient care and research protocols and performs research and training in disciplines of Clinical Pathology. In doing so it provides state-of-the-art laboratory testing in support of Clinical Center patient care and serves as a center of excellence in research and training in laboratory medicine, particularly in areas which utilize the unique strengths of the National Institutes of Health.

3. Purpose or Objective: The purpose of this procurement is to support pan-bacterial, pan-mycobacterial, and pan-fungal testing directly from clinical specimens for routine patient care testing of Clinical Center patients. This testing is not currently offered in house by the DLM Microbiology Service due to the complexity of testing, thus these test requests are outsourced to a CLIA certified vendor.

4. Period of Performance: 1 year with an anticipated award date on or around 2/1/2017.

CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

The DLM is in need of is direct bacterial, mycobacterial, and fungal molecular testing performed in a CLIA certified laboratory as a clinical diagnostic service, not as a research test.

The laboratory must provide test results via fax within 10-14 days of specimen receipt.
• NTMPCR (Atypical Mycobacterial DNA detection amplification)
• TBCPCR (MTC Complex PCR)
• FUNPCR (Direct Fungal DNA detection amplification)
• BCTPCR (Bacterial detection by PCR)
• NGS16S (Bacterial Detection by Next Generation Sequencing)

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION

The intended sole source is the only known source that offers pan-bacterial, pan-Mycobacterial, and pan-fungal molecular detection assays directly from clinical specimens. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include the period of performance, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.
A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.
All responses must be received by January 30, 2017, 9:00 AM Eastern time and must reference pre-solicitation number 17-002983. Responses may be submitted electronically to Mr. Christopher Lauver, Contracting Specialist at [email protected]. Fax responses will not be accepted.