Loren Data's SAM Daily™

FBO DAILY ISSUE OF FEBRUARY 04, 2012 FBO #3724
DOCUMENT

Q -- SOURCES SOUGHT-CENTRAL LABORATORY FOR BLOOD SERUM CREATININE - Attachment

Notice Date

2/2/2012
 

Notice Type

Attachment
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

US Department of Veterans Affairs;Veterans Health Administration;Service Area Organization (SAO) East;323 North Shore Drive, Suite 500;Pittsburgh PA 15212-5319
 

ZIP Code

15212-5319
 

Solicitation Number

VA24012I0067
 

Response Due

2/8/2012
 

Archive Date

3/9/2012
 

Point of Contact

Lynn Portman
 

E-Mail Address

lynn.portman@va.gov
(lynn.portman@va.gov)
 

Small Business Set-Aside

N/A
 

Description

This is a Sources Sought notice only. The NAICS code associated with this requirement is 621511with a size standard of $13.5 million. This Sources Sought Notice is not a request for proposals or quotations. However, any company that feels they can meet the requirements may give written notification to the contract speicialist. Interested persons should provide a capabilities statement and their socioeconomic category. Questions and Information may be sent to lynn.portman@va.gov. Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement is solely within the discretion of the Government. Background The Massachusetts Veterans Epidemiology Research and Information Center, Cooperative Studies Program Coordinating Center (MAVERIC CSPCC) is a national program under the Department of Veterans Affairs, Cooperative Studies Program (CSP), that performs administrative, statistical and data management for national and international, multi-center clinical trials. The MAVERIC CSPCC is conducting a randomized, double-blind, multi-center clinical trial, CSP#578, "Prevention of Serious Adverse Events Following Angiography" at 33 Department of Veterans Affairs Medical Centers nationally. The study will assess the comparative effectiveness of IV bicarbonate vs. saline and the benefit of N-acetylcysteine (NAC) vs. placebo in preventing clinically important, adverse outcomes in high-risk Veterans undergoing cardiac and non-cardiac angiography. Synopsis of Requirement The MAVERIC CSPCC is seeking a central laboratory to perform serum creatinine assays for the US sites participating. The laboratory will need to use a standardized, isotope dilution mass spectrometry (IDMS)-traceable method of measuring SCr. The MAVERIC CSPCC will therefore utilize a central laboratory to measure the pre-procedure study SCr and follow-up SCr values for endpoint ascertainment. The central laboratory will be testing the baseline blood sample of each randomized, de-identified subjects to determine the baseline serum creatinine level. Blood samples will also be taken on all subjects at 96 hours and 90 days following angiography and submitted to the central laboratory. A repeat (within 30 days) central laboratory blood specimen will be taken on the subset of subjects who show a 50% increase between their baseline and 90 day Scr measurements. The central laboratory will be required to work with the participating VA medical centers to ensure proper specimen processing, packaging and shipping of specimens. Results of the creatinine assays will be reported to the appropriate VA site and the MAVERIC CSPCC. The central laboratory will be required to provide the MAVERIC CSPCC with regular progress reports of specimens received and test results. To avoid errors related to calibration drift, a subject's three Scr measurements (baseline, 96 hours, 90 days) will be run at the same time; therefore the first two specimens will need to be stored for approximately 90 days. Following this, the samples do not require further storage unless required for laboratory quality control purposes. The central laboratory will be responsible for receiving blood specimens from participating VA study sites, performing Scr testing, and providing reports detailing the number of specimens received and tested along with results in an electronic format to be determined, back to the participating VA Medical Center and MAVERIC CSPCC. It is anticipated that samples will be shipped weekly. An estimated schedule of the volume of specimens is provided in the Table 1. Table 1. Total Number of Central Laboratory Samples per Year* Year One (N=3,072)Year Two (N=3072)Year Three (N=1536)Total 9,3399,3394,66923,347 * assumes 40% of the total sample size will be recruited in Years 1 and 2 and 20% in Year 3. Also assume that 4% of subjects each year will require a repeat Scr measurement at 90 days. The MAVERIC CSPCC will pay for shipments to the central laboratory by UPS shipping methods. The central laboratory will be responsible for purchasing return boxes and shipping used boxes they receive from participating sites back to the MAVERIC CSPCC.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/350e2547986dfdb59978c60d63254a78)
 

Document(s)

Attachment
 

File Name: VA240-12-I-0067 VA240-12-I-0067_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=293178&FileName=VA240-12-I-0067-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=293178&FileName=VA240-12-I-0067-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN02666818-W 20120204/120202235406-350e2547986dfdb59978c60d63254a78 (fbodaily.com)
 

Source

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

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