B01-Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

Date: 15 February 2022

Contracting Office Address – US Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014

Subject: Notice of Intent to Sole Source –

Growth Direct Maintenance Support Services, Walter Reed Army Institute of Research (WRAIR)

Solicitation Number: W81XWH22Q0023

The United States Army Medical Research Acquisition Activity (USAMRAA) intends to negotiate on a sole source basis IAW FAR 6.302-1 with Rapid Micro Biosystems

The Medical Maintenance Department within the Logistics Division (LOG) provides maintenance support on several medical devices (MD), medical device systems (MDS), and medical/laboratory/scientific equipment (MLSE) provided by Waters Corporation. Other WRAIR divisions have these systems for which LOG currently does not have the proper medical maintenance certifications nor key personnel needed in order to service these systems.

MD/MDS consist of devices used in medical diagnosis, therapy, research and treatment of injury or disease (includes dental, aeromedical evacuation, home station medical response, veterinary items and medical scientific research). MD/MDS also consist of commercial off-the-shelf (COTS) equipment and device systems approved by the Food and Drug Administration (FDA) and used primarily to provide patient care. In addition, these devices are also used in medical research and scientific laboratories. Lastly, MD/MDS also refers to any maintenance significant instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory.

This Growth Direct System Service Agreement (this “Agreement”) between Rapid Micro Biosystems, Inc. (“RMB”) and the customer (“Customer”) named on the attached Service Agreement Order Sheet (“Order Sheet”) shall govern all orders for, and purchases of, services under an RMB Service Plan (“Services”) and shall prevail over any pre-printed, standard or other terms set forth in Customer’s purchase order or any other document not signed by an authorized representative of RMB. (1) Planned Maintenance Service; (2) Repair Service; and (3) Technical Support Service, (4) Application support, Objectives:

The objective of this requirement is to acquire a non-personal services contract for preventive maintenance (PM) services on the Government owned Rapidmicro Biosystems, Growth Direct. The systems are:

Model: E700-GD2 Serial# E27019519

SCOPE OF OBJECTIVE

o Specific Tasks / Requirements

Planned Preventative Maintenance: The contractor shall provide one scheduled maintenance visit per year that includes:

Basic system and refresher training for operators On-site Preventive Maintenance Service visits per year:

- inspect/align mechanical parts

- inspect pneumatic lines and cabling

- check all belts and sensors

- CRU temperature testing

- CRU (condensation removal unit) within the PM requirements

- Incubator temperature calibration

- Replace all system air filters

- address any wear points

- provide mandatory software/hardware updates

Following each scheduled preventative maintenance, the contractor shall provide a service report to include calibration certificate and performance measurements

Emergency Repair Service: The contractor shall provide repair services that apply to instrument defects and arrangement of the parts and labor for all necessary repairs. Emergency repair service calls are to be responded to within 48 hours. The response will establish an appointment to repair the bioprocess. The contractor shall provide a written report that details the nature of the repair, parts supplied, and labor hours required. The contractor shall also provide a field service report once per event basis

Technical Support Services: The contractor shall maintain a high level of availability, with low wait time, to provide customer technical support that includes interactive telephone support for the purpose of resolving technical support incidents between the hours of 0700-1900 EST from Monday to Friday, excluding Federal holidays and a detailed service documentation. The contractor shall maintain a service log that details the technical support provided, how the requirement was resolved, and recommended actions if the requirement was not resolved

THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS. Responsible, interested parties may identify their interest by submitting capability information, in writing, by 2:00 p.m. est. 1 March 2022 to Mr. Nathaniel Reus at Nathaniel.a.reus.civ@mail.mil. Supporting evidence must be furnished in sufficient detail to demonstrate the firm’s ability to provide the stated capability.

Responses will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. If no responses are received, USAMRAA will proceed with the sole source contract.

mailto:Nathaniel.a.reus.civ@mail.mil