Salient Characteristics_Whole Blood Collection Bags.pdf
PDF 105 KB Posted
- Attached to
- Whole Blood Collection Bags
- Solicitation number
- W81K0225Q9999
- Issued by
-
Department of the Army Medical Command
About this file
This is a Salient Characteristics document specifying requirements for whole blood collection bags and consumables for the Armed Services Blood Bank Center-Pacific Northwest (ASBBC-PNW) at Madigan Army Medical Center, JBLM, WA.
The document outlines specific technical requirements for the blood collection bags, including: a primary container volume of 500mL with CPDA-1 anticoagulant, an in-line leukoreduction filter meeting AABB and FDA standards (<5.0x106 WBCs per unit), at least two satellite containers for sterile separation of blood components, adapters for test specimen collection from sample diversion pouch, and FDA 510k clearance. The equipment must be compatible with existing collection and manufacturing equipment at ASBBC-PNW, including centrifuges, compomat, mixer/scales, and leukoreduction stands. All products must comply with FDA, AABB, CLIA, DoD, and Army regulations and policies.
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| File | Type | Posted |
|---|---|---|
| SOW_Whole Blood Collection Bags.pdf |
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Text version
SALIENT CHARACTERISTICS
WHOLE BLOOD COLLECTION BAGS
The Contractor shall provide whole blood collection bags and consumables at The Armed Services Blood Bank Center-Pacific Northwest (ASBBC-PNW), Madigan Army Medical Center, JBLM, WA. The Contractor shall provide whole blood collection bags and consumables in accordance with established standards, principles and ethics of the profession and applicable professional specialty organizations, The Food and Drug Administration (FDA), the Association for the Advancement of Blood and Biotherapies (AABB), The Clinical Laboratory Improvement Act (CLIA), applicable Department of Defense (DoD) and Army specific regulations, directives, and policies, and military treatment facility (MTF) specific policies, and procedures.
Must have a primary container volume of 500mL, utilize CPDA-1 as an anticoagulant and have an in-line leukoreduction filter that meets or exceeds the AABB and FDA required residual WBC counts of <5.0x106 WBCs per unit.
Must have at least two satellite containers that allow for the sterile separation of whole blood components (plasma and packed red blood cells).
Must provide adapters for the collection of test specimens from sample diversion pouch.
Must be FDA 510k cleared and be able to interface with existing collection and manufacturing equipment at the ASBBC-PNW (i.e. centrifuges, compomat, mixer/scales, leukoreduction stands etc.)
File details come from the government source that posted it. Updated .