RFI Attachment 1 CODS Biological Safety Cabinet.pdf
PDF 125 KB Posted
- Attached to
- Bioligical Safety Cabinet
- Solicitation number
- W81K0425Q1985
- Issued by
-
Department of the Army Medical Command
About this file
This document is a Request for Information (RFI) for a Biological Safety Cabinet issued by the US Army Health Contracting Activity (USAHCA) for the Program Executive Office (PEO) Soldier, Soldier Medical Devices (SMD) located at Fort Detrick, MD. The RFI seeks market research to identify a commercial solution meeting specific Critical Operational Device Specifications (CODS), with key requirements including an FDA-cleared Class II, Type A/A2 Biological Safety Cabinet that weighs no more than 270 lbs, features a 29" high work area, supports 110-120 VAC and 220-240 VAC power ranges, and meets NSF/ANSI 49-2018 standards.
Vendors must submit electronic responses by 4:00 PM Central Time on March 21, 2025, to werner.b.martin.civ@health.mil, with the email subject "RFI response for W81K04-Q-25-1985". The solicitation is a pre-solicitation market research effort and does not guarantee a future contract. Additional requirements include providing repair parts support, user/maintenance manuals, training capabilities, and potential collaboration with DLA Troop Support for future procurement. The contract type is anticipated to be a Firm Fixed Price order, with the primary NAICS code 621511 for Medical Laboratories.
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Text version
Attachment 1
Critical Operational Device Specification (CODS)
1. Critical Specifications: The below are critical specifications and the minimum must be met for the device to be considered acceptable by the government. They are separated by “minimum” and “desired” columns.
2. Instructions: Indicate “yes” or “no” under both minimum and desired columns below. Additional comments may be added.
3. Critical Operational Device Specifications
# Operational Characteristic Minimum Required Desired Characteristics
Meets Minimum Y/N?
Meets Desired Y/N? Comments
1 Food and Drug Administration (FDA) Regulatory Oversight
The Biological Safety Cabinet shall be cleared by the FDA with a 510(k) approval if it is a Class II medical device.
If the system is a Class I medical device, it shall be registered with the FDA for human use.
Minimum Requirement
N/A
2 NSF International Standard / American National Standard Biosafety Cabinetry
(NSF/ANSI 49-2018)
The Biological Safety Cabinet shall meet the NSF/ANSI 49-2018 standard for Biosafety Cabinetry: Design, Construction, Performance, and Field Certification.
3 Biological safety Classification Level
The Biological Safety Cabinet shall have a Class II, Type A/A2 classification level.
4 Viewing Panel contain a viewing panel that hinges and is also removable.
Minimum Requirement N/A
5 Viewing Window contain a contoured front window.
6 Filter
The Biological Safety Cabinet filter must be a front-loading HEPA.
The supply and exhaust HEPA filters must be parallel to work area and prevent turbulence
7 Lights
Dual, non-glare fluorescent lights
8 Controls
Isolated switched power for blower and lighting
9 Weight
The system shall weigh no more than 270 lbs.
The system shall weigh no more than 150 lbs.
10 Work environment
The device will have a 29" high work area
The device should be a tabletop unit, with a 29" high work area
11 Power
The power supply shall provide a balanced power source for the device, supporting both 110-120 VAC, 60Hz, and 220-240 VAC, 50Hz. It must include auto-detection and simultaneous switching capability between both voltage ranges.
Additionally, if battery charging is necessary, the device must support charging for both voltage ranges.
Minimum Requirement
4. Critical Logistic Specifications
Operational Characteristic Minimum Required Desired Characteristics
Meets Minimum Y/N?
Meets Desired Y/N? Comments
1 Trade Agreements Act (TAA) Compliance
The Biological Safety Cabinet and repair parts shall be compliant with TAA regulations.
2 Repair Parts Support
The Vendor shall provide a full listing of repair parts and distinguish the items to be considered high-failure repair parts (identified by OEM and Government Subject Matter
Experts). The country of origin, availability, proprietary parts, and procurement accessibility of each item shall be provided on the list.
Minimum Requirement N/A
3 Manuals The vendor shall provide 1 physical and 1 digital User/Operator and 1 physical and 1 digital Maintenance/Service Manual with each system procured.
Training Upon request the vendor shall provide in person training and video training on the use of the Biological Safety Cabinet.
Minimum Requirement N/A
5 Risk Management Framework RMF/ Authority to Operate
(ATO)
The vendor shall provide supporting documentation as required by the client to complete Risk Management Framework procedures and Authority to Operate activities for cybersecurity protections if deemed relevant
Minimum Requirement N/A
6 Copywrite Release The vendors will provide an operational and Maintenance copyright/ distribution release for supporting Army Technical manuals to be distributed throughout the force.
5. ADDITIONAL PERFORMANCE PARAMETERS
These are desired Additional Performance Parameters (APPs) but are not essential.
# Additional Performance Parameters (APPs) Minimum Requirement
The vendor shall work with DLA troop support to their products on the ECAT contract vehicle for future procurement and make available any service
2 If requested by the client, the vendor shall work on creating maintenance kits.
The vendor will provide information on manufacturing capability to help support the client in understanding supportable order quantities and schedule
***End of CODS***
File details come from the government source that posted it. Updated .