Maryland Bids > Bid Detail

NOI: GTX and ATX Electroporation Systems Preventative Maintenance Service

Agency: HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Level of Government: Federal
Category:
  • J - Maintenance, Repair, and Rebuilding of Equipment
Opps ID: NBD00159954377139522
Posted Date: May 26, 2023
Due Date: Jun 2, 2023
Solicitation No: 23-007610
Source: https://sam.gov/opp/f460c877d5...
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NOI: GTX and ATX Electroporation Systems Preventative Maintenance Service
Active
Contract Opportunity
Notice ID
23-007610
Related Notice
Department/Ind. Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier
NATIONAL INSTITUTES OF HEALTH
Office
NATIONAL INSTITUTES OF HEALTH - CC
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General Information
  • Contract Opportunity Type: Solicitation (Original)
  • All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
  • Original Published Date: May 26, 2023 03:21 pm EDT
  • Original Date Offers Due: Jun 02, 2023 12:00 pm EDT
  • Inactive Policy: 15 days after date offers due
  • Original Inactive Date: Jun 17, 2023
  • Initiative:
    • None
Classification
  • Original Set Aside:
  • Product Service Code: J066 - MAINT/REPAIR/REBUILD OF EQUIPMENT- INSTRUMENTS AND LABORATORY EQUIPMENT
  • NAICS Code:
    • 811210 - Electronic and Precision Equipment Repair and Maintenance
  • Place of Performance:
    Bethesda , MD 20892
    USA
Description

Title: GTX and ATX Electroporation Systems Preventative Maintenance Service



Product Service Code: J066



NAICS Code: 811210-Electronic and Precision Equipment Repair and Maintenance



Place of Performance: Bethesda, MD 20892



POTS: 23-007610



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), Clinical Center, Purchasing and Contract Office on behalf of the Department of Transfusion Medicine/Center for Clinical Engineering intends to award a fixed price contract to MaxCyte located in Rockville, MD 20850 on a sole source basis to provide GTX and ATX Electroporation System Preventative Maintenance and Calibration Services (Serial Numbers 194 and 266) for a base period.



The Department of Transfusion Medicine/Center for Clinical Engineering has a requirement for annual calibration services and preventative maintenance services on government owned Electroporation Systems. The Center for Cellular Engineering manufactures cell-based therapies for patients who either have no, or have exhausted all other standard treatment options. The manufacturing operations are regulated by the Current Good Manufacturing Practices (cGMPs) as mandated by the Food and Drug Administration (FDA) in 21CFR 210, 211, 600 and 1271. The FDA mandates that critical equipment used in the manufacturing, processing and testing of drug product must be maintained in a controlled manner (21 CFR 211.63, 21 CFR 211.67). The only known sole capable of performing these services is the original equipment manufacturer, MaxCyte. MaxCyte has trained and qualified technicians to perform preventative maintenance, software upgrades, and annual calibration services. The highly specialized equipment is proprietary in nature. If an unauthorized third-party service provider performs work on the GTX and ATX Electroporation Systems, it will void the manufacturer’s warranty. Therefore, MaxCyte, the original equipment manufacturer is the known source capable of performing the required services.





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 Sheri Eiri Contract Specialist, sheri.eiri@nih.gov by the due date and time marked in this notice.




Attachments/Links
Contact Information
Contracting Office Address
  • 6707 DEMOCRACY BLVD, SUITE 106
  • BETHESDA , MD 20892
  • USA
Primary Point of Contact
Secondary Point of Contact


History
  • May 26, 2023 03:21 pm EDTSolicitation (Original)

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