SOLICITATION NOTICE
Q -- Laboratory Testing Services of Serum Enzymes for Patients at Risk of Shwachman-Diamond Syndrome
- Notice Date
- 3/2/2015
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CP52535-76
- Archive Date
- 3/18/2015
- Point of Contact
- Catherine Muir, Phone: (240) 276-5434
- E-Mail Address
-
muirca@mail.nih.gov
(muirca@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E144, Bethesda, MD 20892, UNITED STATES Description: National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Clinical Genetics Branch (CGB), plans to procure on a sole source basis the services for serum enzymes isoamylase and trypsinogen testing and measurement with the appropriate age-associated normal control data from The Hospital for Sick Children, 555 University Ave., Toronto, Ontario, CANADA M5G 1X8. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 621511 and the business size standard is $32.5M. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price, Indefinite Delivery Indefinite Quantity (IDIQ) type contract. The period of performance of the IDIQ contract is sixty (60) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. The Division of Cancer Epidemiology and Genetics (DCEG) is a research program of the National Cancer Institute (NCI), one of the National Institutes of Health (NIH). The Division is the world's most comprehensive cancer epidemiology research group. Its renowned epidemiologists, geneticists, and biostatisticians conduct population and multidisciplinary research to discover the genetic and environmental determinants of cancer and new approaches to cancer prevention. The Division's research impacts public health policy in the United States and around the world. The Clinical Genetics Branch (CGB), Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health is engaged in an ongoing clinical genetics study of inherited bone marrow failure syndromes. One of these disorders is Shwachman-Diamond Syndrome, characterized by exocrine pancreatic insufficiency and neutropenia. The most precise and least invasive test for exocrine pancreatic function is serum trypsinogen and isoamylase. The utility of this test has been published. This is an ongoing study, and this submission is a continuation of that work and not new work. This study is an integral part of the NCI protocol 02-C-0052.This particular study is part of a comprehensive, multidisciplinary, intramural research program within DCEG's Human Genetics Program which is focused upon elucidation of the entire spectrum of scientific and clinical issues related to familial and hereditary forms of cancer. CGB's study is ongoing, and the performance characteristics and quality of the needed services are required for maintaining the integrity of on-going studies. A change would be disruptive to the ability to analyze the study's cumulative results. Contractor shall perform the following tasks: • The Contractor will accurately measure serum isoamylase and trypsinogen, from fresh or frozen serum samples, and provide age-associated control data. • The Contractor will be a CLIA-certified laboratory or its equivalent. • The Contractor shall provide a written report of the results of serum trypsinogen and isoamylase, and data on the levels of these enzymes in appropriate normal control sera. • In lieu of meetings, the results shall be provided for each sample to the NCI Contracting Officer's Representative within one (1) month of submission. • A report must be provided for each individual whose serum is analyzed. The individual patient reports must include the CGB identification number, the Contractor's sample identification number, date sample obtained, date received in laboratory, sample type, and type of study. This laboratory testing service is provided by The Hospital for Sick Children. The proposed source is the only laboratory that can perform the studies required. They published their analyses in 2002. They have experience and age-appropriate control data, and have demonstrated that their assay is sensitive and specific for diagnosis or exclusion of Shwachman-Diamond syndrome, an inherited disorder of pancreatic function. CGB has relied on their test for peer-reviewed publications, and to properly classify patients and distinguish those with Shwachman-Diamond syndrome from their healthy relatives and from patients with other disorders. Use of the proposed source's assay is imperative for the integrity and continuity of CGB's on-going study. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 12:00PM EST, on March 17, 2015. All responses and questions must be in writing and faxed (240) 276-5401 or emailed to Catherine Muir, Contracting Officer via electronic mail at muirca@mail.nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: N02CP52535-76 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/RCB/N02CP52535-76/listing.html)
- Record
- SN03656320-W 20150304/150302235031-52ffef3651e1825530d610eda1d951de (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |