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FBO DAILY - FEDBIZOPPS ISSUE OF JANUARY 28, 2015 FBO #4813
SOLICITATION NOTICE

65 -- PowerPlex Kits - SS JUSTIFICATION

Notice Date
1/26/2015
 
Notice Type
Presolicitation
 
NAICS
325413 — In-Vitro Diagnostic Substance Manufacturing
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, Clinical Center/Office of Purchasing & Contracts, 6707 Democracy Blvd, Suite 106, MSC 5480, Bethesda, Maryland, 20892-5480
 
ZIP Code
20892-5480
 
Solicitation Number
15-004213
 
Archive Date
2/19/2015
 
Point of Contact
MILTON DARTOOZOS, Phone: 3015945919
 
E-Mail Address
MILTON.DARTOOZOS@NIH.GOV
(MILTON.DARTOOZOS@NIH.GOV)
 
Small Business Set-Aside
N/A
 
Description
SOLE SOURCE JUSTIFICATION January 26, 2015 Requisition #: 15-004213 Notice of Intent to Sole Source The National Institute of Health Office of Purchasing and Contracts intends to negotiate and award a contract to Promega Corporation to provide PowerPlex 16 HS 400rxn kits for monitoring patients after allogeneic transplant which the government intends to solicit and negotiate with only one source under the authority of 13.106-1(b)(1). The North American Industry Classification System (NAICS) code for this acquisition is 325413, and the size standard is 500 Employees This notice of intent to award is not a request for competitive quotations. Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. No solicitation is available. Information received will be evaluated for the purpose of determining whether to conduct a competitive procurement. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. The following verbiage is directly from the Justification for Other Than Full and Open Competition (JOFOC). The Department of Laboratory Medicine is in need for the Powerplex 16 system offers a diverse range of loci, providing enough different loci to be statistically relevant, it was fully validated and implemented in Allogeneic Transplant Engraftment Monitoring and is integral to several ongoing protocols in NHLBI and NCI. This kit co-amplifies16 different loci to increase the chance of finding informative allelic differences between recipient and donor. The monitoring of engraftment using STR has been done in the Molecular section of the NIH, CC, DLM, Hematology Service since 2001. A change to current protocols would risk laboratory certification by causing the laboratory to be cited as failing to be compliant to laboratory guidelines established by the College of American Pathologists Accreditation Agency. STR (a) (short tandem repeat) loci consist of short, repetitive sequence elements 3 to 7 base pairs in length. These repeats are well distributed throughout the human genome and are a rich source of highly polymorphic markers, which may be detected using the polymerase chain reaction. Alleles of STR loci are differentiated by the number of copies of the repeat sequence contained within the amplified region and are distinguished from one another using radioactive, silver stain or fluorescence detection following electrophoretic separation. The PowerPlex ® 16 HS System allows the co-amplification and three-color detection of sixteen loci (fifteen STR loci and Amelogenin), including Penta E, D18S51, D21S11, TH01, D3S1358, FGA, TPOX, D8S1179, vWA, Amelogenin, Penta D, CSFIPO, D16S539, D7S820, D13S317 and D5S818. One primer for each of the Penta E, D18S51, D21S11, TH01 and D3S1358 loci is labeled with fluorescein (FL); one primer for each of the FGA, TPOX, D8s1179, vWA and Amelogenin loci is labeled with carboxy-tetramethylrhodamine (TMR); and one primer for each of the Penta D, CSF1PO, D16S539, D7S820, D13S317 and D5S818 loci is labeled with 6-carboxy-4', 5' dichloro-2', 7'-dimethoxy-fluorescein (JOE). All sixteen loci are amplified simultaneously in a single tube and analyzed in a single injection. The DLM's Hematology Service provides engraftment monitoring (Chimerism testing) in the clinical laboratory for patients who have undergone allogeneic transplant, as a service to several groups within the National Cancer Institute and the National Heart Lung and Blood Institute (NHLBI). There are other types of kits that are on the market that utilize STR amplification, however, they either don't amply enough different loci or they amplify more than needed. The PowerPlex HS system has been fully validated for use in monitoring patient engraftment. Switching to another system would entail lengthy validations and would alter current results of our protocols. All responses are due to the Contract Specialist within seven (7) calendar days from the date of this synopsis. Government Official Designated for Receipt of Information Milton Dartoozos Contract Specialist Email: MILTON.DARTOOZOS@NIH.GOV Phone: 301-594-5919
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/CCOPC/15-004213/listing.html)
 
Place of Performance
Address: 10 CENTER DRIVE, BLDG 10 / RM 2C306, BETHESDA, Maryland, 20892, United States
Zip Code: 20892
 
Record
SN03624699-W 20150128/150126234534-1a387152595875fe58f7ed3e9115dcaa (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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