B01-Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

Date: 12 April 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 –

Bioprocess Systems “Fermenters” Maintenance, Walter Reed Army Institute of Research (WRAIR)

Solicitation Number: W81XWH22R0043

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

The Medical Maintenance Department within the Logistics Division (LOG) at WRAIR 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.

The purpose of this requirement is to conduct full maintenance services for a Bioprocess Systems. The work required under this contract shall include: (1) Planned Maintenance Service; (2) Repair Service; and (3) Technical Support Service

Objectives:

1.1. Objectives

The objective of this requirement is to acquire a non-personal services contract for preventive maintenance (PM) services on three Government owned Bioprocess Systems. The systems are:

1. Model: BioFlo Pro 75 Serial# 901044178

2. Model: BioFlo Pro 500 Serial# BPR0HJ302695

3. Model: BioFlo 320 Serial# B320IQ302132

1.2. Specific Tasks / Requirements

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

• Performance assurance checks

• Functionality and safety checks

• Safety inspections in accordance with all applicable regulations

• Components check

• Device Software update

• Routine inspections and replacement of parts

Following each scheduled preventative maintenance, the contractor shall provide a service report to include calibration certificate and performance measurements (Deliverable 1).

1.2.2. 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 (Deliverable 2).

1.2.3. 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 (Deliverable 3).

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. 25 April 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