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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 10, 2015 FBO #4977
SOLICITATION NOTICE

65 -- Notice of Intent to Sole Source Blood Bank Reagents

Notice Date

7/8/2015
 

Notice Type

Presolicitation
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

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

W81K02-15-T-0144
 

Response Due

7/15/2015
 

Archive Date

9/6/2015
 

Point of Contact

Riley Yogi, 808-433-4486
 

E-Mail Address

Pacific Regional Contr Ofc TAMC
(riley.r.yogi.civ@mail.mil)
 

Small Business Set-Aside

N/A
 

Description

This notice announces the intent by the Regional Health Contracting Office - Pacific in support of Tripler Army Medical Center to procure Blood Bank reagents Item# 71952 - Resolve Panel B; Item# 721380 - Anti-JKA BioClone; Item# 721480 - Anti-JKB BioClone; Item# 715280 - Anti-Lea; Item# 715380 - Anti-Leb for the Blood Bank at Tripler Army Medical Center, Hawaii. Specifically the government intends to procure blood bank reagents manufactured by Ortho Clinical Diagnostics, 1001 US HWY Route 202, Raritan NJ, 08869-1424. Ortho Clinical Diagnostics is the only company to provide reagents that have already been validated by Tripler Army Blood Bank and the Department of Pathology. These reagents are traditional antisera and reagent red blood cells. 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 license 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, reagent 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 tests performed using these reagents have to be correlated between 40 and 120 times between the old test methodology and the new test methodology. Additionally, reference ranges have to be established and/or validated using another 40-120 samples for each reagent. Due to manpower and other Government resource limitations, reagent validation cannot be conducted for these reagents. The NAICS code is 325413. This announcement fulfills the synopsis requirements under FAR 5.201 and 5.203. This Notice of Intent is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by 15 July 2015, the solicitation will be issued as only one source. All questions and responses concerning this notice shall be emailed to Mr. Riley Yogi, riley.r.yogi.civ@mail.mil. Interested parties shall reply to Regional Health Contracting Office - Pacific VIA EMAIL to riley.r.yogi.civ@mail.mil. TELEPHONE REQUESTS WILL NOT BE HONORED. Please indicate your interest and/or ability to provide all the items and also provide a current copy of your price list for all the items and your capabilities statement NO LATER THAN 15 JULY 2015, 8:00 AM Hawaii Standard Time or 2:00 PM Eastern Time. VENDOR MUST BE ABLE TO PROVIDE 100% OF THE SUPPLIES BEING REQUESTED. Forward any questions via email to Mr. Riley Yogi atriley.r.yogi.civ@mail.mil, Regional Health Contracting Office - Pacific, Fort Shafter, Hawaii.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/USA/MEDCOM/DADA16/W81K02-15-T-0144/listing.html)
 

Place of Performance

Address: Regional Health Contracting Office - Pacific ATTN: MCAA PC BLDG 339 Fort Shafter HI

Zip Code: 96858
 

Record

SN03789036-W 20150710/150708234921-5dde794255e0b01a1bb39df78b4d896b (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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