LABORATORY INFORMATICS MANAGEMENT SYSTEMS (LIMS)

LABORATORY INFORMATICS MANAGEMENT SYSTEMS (LIMS)

• Product Service Code: 7D20
• NAICS Code: 541511
• Place of Performance: NIH CLINICAL CENTER - PET Department

POTS: 23-009191

Description

This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested.

The National Institutes of Health (NIH) intends to award a fixed price contract to transform its paper records related to PET drug production to a digital platform from the company MARKETING FOR TECHNOLOGY LLC, Massachusetts 02038-2341 UEI: T6Y5PP6CD9N4 on a sole source basis to provide a digital platform that provides a real-time graphical user interface- showing the PET drug production work flow process for multiple concurrent users (up to 5) for the PET Department at the NIH Clinical Center (CC).

Components of this software system should include

•           Material management, supplier management, and inventory management

•           Equipment management- digital records of installation and routine maintenance of crucial scientific equipment

•           PET drug production- production and quality control steps

•           PET drug batch reports- a digital report that contains all relevant data for a given production method.  Data integrity must be under strict control and have a corresponding audit trail (e.g. 21 CFR Part 11 compliant)

•           A real-time graphical user interface- showing the PET drug production work flow process for multiple concurrent users (up to 5)

•           Expandability- the current procurement is chiefly geared to automating CC/PET’s inventory and demonstrating the feasibility of electronic batch record formation via a representative F-18 PET drug product.  Based on results of this current procurement, CC/PET would seek additional custom software/training that allows for easy expansion to other PET drugs products that CC/PET produces (e.g. C-11 and Ga-68 labeled PET tracers).

•           Training- extensive training (up to 100 hours per half year) is required from the vendor so as to provide support after software is installed so that particular work flow processes unique to CC/PET are facilitated by the software.

This procurement is for installation, installation qualification/operational qualification (IQ/OQ) and training of an easy-to-use Laboratory Informatics Management Systems (LIMS) designed for a PET production facility.  The LIMS system will be used to manage CC/PET inventory and create an electronic batch report of a PET radiopharmaceutical.  See Part 2 above for details.

Three major components of the LIMS should include:

1. Software- Including system setup of one representative PET drug that CC/PET prepares and IQ/OQ of the installed software.
2. Equipment integration- the vendor will integrate typical report outputs from scientific instruments (e.g. HPLC and GC) into the digital batch record workflow.
3. Support service- 100 man-hour consultancy via remote means (e.g. e-mail, phone, video chat)

The Period of Performance (POP) shall consist of twelve (12) months from time of award.

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.

Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Comments to this announcement, referencing this posting number, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Gregory Noland, Contract Specialist, gregory.noland@nih.gov by the due date (09/20/2023) marked in this notice.