SOLICITATION NOTICE
66 -- Acquisition of a PerkinElmer Genetic Screening Processor (GSP) for newborn tests
- Notice Date
- 8/9/2011
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 01335
- Archive Date
- 9/8/2011
- Point of Contact
- Vallerie M Redd, Phone: 770-488-2845
- E-Mail Address
-
gfj3@cdc.gov
(gfj3@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention (CDC), National Center for Environmental Health (NCEH), intends to award a sole source contract to PerkinElmer Health Sciences, Inc., 710 Bridgeport Ave., Shelton, CT 06484 for the acquisition of a PerkinElmer Genetic Screening Processor (GSP) for newborn Screening tests. The statutory authority for this sole source acquisition is 10 U.S.C 2304(c)(1) in accordance with FAR Part 6.302-1- only one responsible source and no other supplies or services will satisfy the agency requirement. The NAICS code for this procurement is 334516, Analytical Laboratory Instrument Manufacturing. The period of performance for this procurement is 4 months. This project entails the purchase of equipment for the testing of dried-blood spot quality assurance materials for five biochemical markers for disorders that manifest during the newborn period (congenital hypothyroidism, congenital adrenal hyperplasia, galactose-1-phosphate uridyltransferase deficiency, and cystic fibrosis). National Screening Quality Assurance Program (NSQAP) is a unique program that provides quality assurance materials for newborn screening tests to screening laboratories worldwide. Each year the program manufactures more than one million dried blood spots that must be tested to assure the correct enrichments were achieved for biochemical markers of disease. Testing includes certifying the materials. Data is produced from laboratory multiple tests and the data are checked to assure the test runs were in control and that the variability between measurements was low. The certification process requires the use of state-of-the-art technologies that are also used by newborn screening laboratories. The Perkin Elmer GSP represents a significant advancement for newborn screening tests and is critical for NSQAP to continue its mission to provide quality control and proficiency testing materials to State Public Health Laboratories and international partners. The data NSQAP produces must be of the highest quality to assure that screening laboratories have confidence in their method performance with the CDC materials. The acquisition of the GSP will allow NSQAP to provide data that newborn screening laboratories can trust when they use the CDC materials as part of their routine quality assurance system. The Perkin Elmer GSP instrument, software and screening assays provide the following: • Continuous loading of sample allowing more flexible workflows • Barcoding of all materials to minimize risk of error and hands-on time • Multi-technology solution to support high sensitivity DELFIA as well as prompt fluorescence measurements • Extreme ease of use enabling quick user adoption and also rotation of staff duties • Newborn screening specific informatics bringing the maximum operational efficiency • Integrated screening operation supporting further growth and program changing needs Only the GSP instrument can provide time-resolved fluorescence (Delfia) and regular fluorescence technologies in one unit. The GSP reagent kits offer the most comprehensive list of newborn screening biochemical markers. All of these assays can now be performed within one instrument unit instead of multiple instruments across the laboratory. Additional biochemical markers can be added to the system as they become available. The GSP enhancements will allow NSQAP to provide high quality data on the dried-blood spots material produced for newborn screening laboratories; the instrument will reduce the variability of repeated measurements; and it uses prompt fluorescence so that these assay can be automated, reducing the hands-on time of analysts in the laboratory. The GSP versions of Delfia assays utilize a new chelate chemistry with better tolerance towards interfering substances such as EDTA. In addition, for the assay's enhancement stage, the Delfia inducer assures a superior signal over other immunochemical and enzymatic methods. A thorough internet and literature search was undertaken to identify sources providing automated newborn screening assay systems with data acquisition for the five biochemical markers needed for newborn diseases: congenital hypothyroidism (thyroid stimulating hormone and thyroxine), congenital adrenal hyperplasia (17-hydroxyprogesterone), galactose-1-phosphate uridyltransferase deficiency (galactose-1-phosphate uridyltransferase), and cystic fibrosis (immunoreactive trypsinogen). After the search was completed, only the GSP by Perkin Elmer met the criteria for automation, maximum number of biomarker reagents available, and data acquisition. As a result of this synopsis, no competitive solicitation will be posted on FedBizOpps. We will issue only one solicitation to PerkinElmer Health Sciences, Inc.. However, all responsible sources that believe they can meet these requirements may submit their capabilities/qualifications statement to provide the services to Vallerie Redd VIA E-MAIL ONLY at gfj3@cdc.gov with the solicitation number 01335 referenced in the subject line NO LATER THAN August 24, 2011. A determination by the Government not to compete this proposed action will be based on responses to this notice and are solely within the discretion of the Contracting Officer. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/01335/listing.html)
- Record
- SN02527963-W 20110811/110810000400-be30b61c46ccc442645529ecc6aef65d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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