SOLICITATION NOTICE
65 -- Hemocue Reagents compatible with existing Government Hb 301 analyzers under the current Correlation Study.
- Notice Date
- 5/20/2014
- Notice Type
- Presolicitation
- NAICS
- 423450
— Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
- Contracting Office
- Pacific Regional Contr Ofc TAMC, ATTN: MCAA PC BLDG 160, 160 Krukowski Road, Honolulu, HI 96859-5000
- ZIP Code
- 96859-5000
- Solicitation Number
- W81K0214T0060
- Response Due
- 5/27/2014
- Archive Date
- 7/19/2014
- Point of Contact
- Riley Yogi, 808-433-4486
- E-Mail Address
-
Pacific Regional Contr Ofc TAMC
(riley.yogi@tamc.amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- In accordance with FAR 6.302-1, the Government intends to make a sole source award to Hemocue for Reagents. The reagents requested are proprietary to Hemocue, and are the only reagents compatible with existing Government Hb 301 analyzers, which can meet the Government Requirement. Items used for blood manufacturing and distribution must gain approval from the FDA (CFRs 200-299 and parts 600-799), AABB, and MEDCOM DoD Army Blood program prior to usage. Any deviation from these reagents/supplies once validation has occurred may prohibit Tripler Army Medical Center from operating under the licensure that is shared with two other Army Testing sites for collection, manufacturing, and releasing of a biological/pharmaceutical product. In order to maintain compliance with the FDA (CFRs 200-299 and parts 600-799), AABB, and MEDCOM DoD Army Blood program, instrumentation validation including studies in precision, linearity, sensitivity, carry-over, correlation, and reference ranges must be completed before a reagent is put into use. The most cumbersome components of the validation process are the correlation and reference range studies. Each of the 100+ tests performed on some analyzers will have to be correlated between 40 and 120 times between the old and the new platform. Additionally, reference ranges have to be established and/or validated using another 40-120 samples for each of the 100+ tests. Additionally, these tests must be evaluated on-site at each individual lab, and the sizes of analytical platforms can be quite large (e.g. approximately 36 feet by 15 feet). Due to space, manpower, and other Government resource limitations, instrumentation validation cannot be conducted for this reagent. Instrumentation validation to establish a baseline for the reading must be completed for the machines, equipment and other medical tools using the reagents. For example, a baseline for a normal reading of glucose in the blood may be 80 if using one reagent, and may be 120 if using another reagent manufacturer. As a result, the different readings for quote mark normal quote mark could create a serious health risk. A patient may be declared diabetic when in fact the reading is normal, depending on what brand of reagent is being used for the blood sugar test. This type of variation in readings is the purpose of extensive testing of each reagent to develop guidelines for use with the particular reagent. The NAICS Code for this requirement is 423450. The Point of Contact for this requirement is Riley Yogi at riley.yogi@us.army.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/MEDCOM/DADA16/W81K0214T0060/listing.html)
- Place of Performance
- Address: Pacific Regional Contr Ofc TAMC ATTN: MCAA PC BLDG 160, 160 Krukowski Road Honolulu HI
- Zip Code: 96859-5000
- Zip Code: 96859-5000
- Record
- SN03371346-W 20140522/140520235033-33f630b381e64c0b493d359843bc73b6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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