Mycoplasma testing of cell therapy products for Clinical Center patients.

INTRODUCTION  

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:

BIONIQUE TESTING LABORATORIES, INC.

156 FAY BROOK DR 

SARANAC LAKE, NY, 12983-5802,  

UNITED STATES 

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541380 with a Size Standard $16.5 million.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2020-02 December 23, 2019. 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 ($250,000).

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-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

GENERAL INFORMATION

1. Title: Mycoplasma testing of cell therapy products for Clinical Center patients.

2. Background Information: The Department of Laboratory Medicine 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: Mycoplasma testing of cell therapy products for Clinical Center patients.

4. Period of Performance: One (1) year beginning on or around 2/1/2020.

CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

Independently, and not as an agent of the government, the contractor shall provide necessary personnel, supplies, and services to perform the work required below:

Real-time Direct qPCR Mycoplasma testing and USP<63> Mycoplasma culture that is compliant with the culture-based compendial method (1993 FDA Points to Consider) method for the testing of cell therapy products performed in a cGMP FDA certified laboratory. Testing should consist of the following validated platforms with supporting documentation available for FDA and end-user audit:

Real-time qPCR based on Applied Biosystems MycoSEQ Mycoplasma Detection Kit and using Applied Biosystems 7500 Real-time PCR sustems

Nucleic acid extraction using PrepSEQ

Validated testing systems using intact, viable mycoplasma and not previously purified genomic DNA

Demonstrated equivalence of real time qPCR method to culture-based compendia method (1993 FDA Points to Consider method) available upon execution of corporate non-disclosure agreement

Limit of detection of most Mycoplasma species at 10 CFU/ml

10 CFU/ml A. laidlawii in CHO

10 CFU/ml M. hyorhinis in CHO

10 CFU/ml M. orale in CHO

80 CFU/ml M. pneumoniae in CHO

Defined procedures for suitability testing of the product

Periodic performance evaluation and inter-laboratory comparison studies

Guaranteed turnaround time to final report within 5 days of sample submission for PCR

USP<63> Mycoplasma culture

Guaranteed turnaround time to final report within 40 days of sample submission for culture

Notification of positive results

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

This is a requirement for testing from a testing laboratory. Bionique Testing Laboratories, Inc. is the only known cGMP FDA certified facility that provided an identical testing platform to the one used in the NIH CC DLM Sterility Testing Service. This is critical for test method validation purposes and to ensure accuracy and comparability of results from in-house testing and vendor testing. 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 a technical proposal, a cost-price proposal, 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 29, 2020, 03:00 PM Eastern time and must reference solicitation number 20-003365. Responses may be submitted electronically to Mr. Christopher Lauver, Contracting Specialist at christopher.lauver@nih.gov. Fax responses will not be accepted.

"All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."