Attachment 1_Salient Characteristics_Whole Blood Collection Bags.pdf
PDF 60 KB Posted
- Attached to
- Blood Collection Bags and Consumables
- Solicitation number
- W81K0226QA017
- Issued by
-
Department of the Army Medical Command
About this file
This document outlines the salient characteristics for whole blood collection bags and consumables to be supplied to The Armed Services Blood Bank Center-Pacific Northwest (ASBBC-PNW) at Madigan Army Medical Center, Joint Base Lewis-McChord (JBLM), Washington. The contractor must provide products and services in compliance with FDA, AABB, CLIA, DoD, Army regulations, and MTF-specific policies.
The whole blood collection bags must have a primary container volume of 500 milliliters, utilize CPDA-1 as an anticoagulant, and include an in-line leukoreduction filter meeting or exceeding AABB and FDA standards for residual white blood cell counts of less than 5.0 × 10⁶ WBCs per unit. Bags must have at least two satellite containers for sterile separation of blood components, be equipped with a sample diversion pouch for diagnostic and infectious disease testing, include adapters for specimen collection, and be FDA 510k cleared with compatibility for existing collection and manufacturing equipment including centrifuges, component mixers/scales, and leukoreduction stands. The contractor shall deliver monthly on business days between 0800-1400 hours, with adjustments for federal holidays and provisions for emergency same-day deliveries upon government request. The contractor must provide customer service via toll-free telephone Monday through Friday during business hours to facilitate emergency delivery scheduling. All deliveries shall be made to ASBBC-PNW at 9904 East Johnson Street, JBLM, Washington 98431.
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| File | Type | Posted |
|---|---|---|
| W81K0226QA017 Amendment 1.pdf | ||
| W81K0226QA017.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.
Collection bags 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, component, mixer/scales, leukoreduction stands etc.)
Bags must be equipped with a sample diversion pouch that allows for collection of diagnostic and infectious disease testing.
The contractor shall make standing deliveries every month on business days between the hours of 0800-1400. If a federal holiday occurs on a scheduled delivery day, the delivery will be made the following business day between the hours of 0800 – 1400, unless directed differently by the ASBBC-PNW personnel. Unscheduled deliveries due to anticipation of increased collections and/or emergency same day deliveries may be requested by the government if mission required.
Customer Service. The Contractor shall provide customer service which shall be accessible by toll-free telephone service during business hours M-F to assist ASBBC-PNW/MAMC staff in scheduling emergency same day deliveries if required. The Contractor shall provide toll-free number(s).
Delivery Services. The contractor shall deliver goods under this contract to ASBBC-PNW (9904 East Johnson Street, JBLM WA 98431).
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