Inactive
Notice ID:23-009948
Title Lab Vantage LIMS system package with licensing, professional services, and support/maintenance for the Department of Laboratory Medicine of the NIH Clinical Center Product Service Code: 6640 NAI...
Title Lab Vantage LIMS system package with licensing, professional services, and support/maintenance for the Department of Laboratory Medicine of the NIH Clinical Center Product Service Code: 6640 NAICS Code: 334516 Place of Performance: Bethesda, MD 20892 USA POTS: 23-009948 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 Lab Vantage Solutions Inc. of Somerset, New Jersey 08873 on a sole source basis to procure a Lab Vantage LIMS software solution package with licensing, professional services, and support/maintenance. This request is for the procurement of a CGMP compliant Commercial Off the Shelf (COTS) Laboratory Information Management System (LIMS) for capturing raw data and results associated with CGMP testing activities performed by the Sterility Testing Service (STS), in the Department of Laboratory Medicine, CC, NIH. The STS provides CGMP microbiology testing (e.g., in-process testing, product release testing, and environmental monitoring) and support to thirteen Aseptic Processing Facilities (APF) from the CC Center for Cellular Engineering, NCI Surgery Branch, NCI Vector Processing Facility, NCI Molecular Imaging Branch, CC PET Department, CC Radio pharmacy, and CC Pharmacy. The FDA expects the testing lab, whether internal or external, to operate at a level that is equivalent to or better than the manufacturing facility. This extends to data integrity, electronic systems, and documentation practices. The lack of a CGMP compliant LIMS in the STS has been cited as a critical deficiency in several internal audits managed by the CC Office of Research Support and Compliance (ORSC) since 2019. Because the STS supports the NIH GMP program our failure to comply with CGMP regulations constitutes a compliance risk to the entire NIH GMP program. Currently the STS utilizes the existing CC CRIS and SOFT LIS for test data management. These systems are specifically designed for clinical applications and do not contain all the functionalities required to meet CGMP requirements for data integrity and electronic records. In short, a LIS is designed to be patient centric; compliant with HIPPA, CAP, and CLIA; and focused on tracking samples and associated test results by patient. For CGMP workflows and compliance the STS requires a LIMS that is designed to be sample/batch centric; compliant with ISO 17025, GMP, and 21 CFR Part 11; focused on tracking individual or batches of samples throughout their lifecycle, capable of capturing critical test data (e.g., lot numbers, expiry dates, and critical processing steps), and has been fully validated to meet the strict CGMP validation and data integrity requirements. Lab Vantage has provided LIMS solutions to the life science / pharmaceutical industries for over four decades and the sole focus of the organization is to LIMS. The proposed vendor, Lab Vantage Solutions Inc., is the only source capable of supplying the items for this request. 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 Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Shasheshe Goolsby, Lead Contract Specialist, shasheshe.goolsby@nih.gov by July 13, 2023, 6:30AM EST. *** Please send your capability statements ONLY. This IS NOT a request for proposal. ***
