SOLICITATION NOTICE
Q -- Laboratory Testing Services of Telomere Length Assays for the Inherited Bone Marrow Failure Study
- Notice Date
- 8/24/2015
- 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
- N02CP52664-76
- Archive Date
- 9/8/2015
- 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 telomere length Assay testing from the Repeat Diagnostics, Suite 309-267 West Esplanade, North Vancouver, BC V7M 1A5 CANADA. 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 (DCEG), National Cancer (NCI), National Institutes of Health (NIH) is engaged in an ongoing clinical genetics study of inherited bone marrow failure syndromes. A major component of this study is dyskeratosis congenita (DC), a disorder in which we have literally defined the critical laboratory test for this diagnosis, using the flow-FISH assay, the CGB has a need to obtain the results of the blood leucocyte telomere length test in order to appropriately classify family members as affected or unaffected by this disease. The samples will be derived from individuals who are members of families in which there is a clinical basis to suspect the diagnosis of DC. There will also be samples from individuals with other types of inherited bone marrow failure syndromes, in order to document that DC has been ruled out. This particular study is part of a comprehensive, multidisciplinary, intramural research program within the 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. This is an ongoing study, and this submission is a continuation of that work and not new work. The CGB has used this laboratory with their specific methods for many years. Contractor shall perform the following tasks: • The Contractor will receive samples of peripheral telomere length assay, or with identifiers from some patients. If the Contractor is blinded to identifying information pertaining to the individuals from whom these specimens were derived, the Contractor will be prohibited from seeking such information. Therefore, from the Contractor's perspective, those samples shall be anonymous. • The Contractor must be a CLIA-certified laboratory, so that the results can be conveyed to the patient for use in clinical management. • The specimens will consist of peripheral blood. • The cells derived from these samples will be analyzed for telomere length in the laboratory, using standard testing protocols. • The Contractor shall provide a written report for each patient, recording the telomere length for granulocytes, lymphocytes, naïve and memory T cells, B cells, and NK cells, and other cell types if requested. The report will include the age of the patient, and age-matched mean and standard deviation for normal controls. The report will indicate whether a specific cell type has telomeres that are "VL", ie. Very low compared with the normal. • CGB will not require an official interpretation as to whether the individual sample is diagnostic of DC or not. • Include a milestone or performance schedule. The written report for blood samples shall be returned to the CGB Investigator within twenty-one (21) working days from specimen receipt, except in the case of unusual problems requiring additional investigation. These exceptions must be negotiated directly via telephone discussion with the CGB Investigator. • Progress Meetings. In lieu of meetings, the CGB will discuss any unusual results on a case-by-case basis. Reporting and/or Deliverables • Reports. The individual patient reports must include the CGB identification number and/or patient name, the Contractor's sample identification number, date sample obtained, date received in laboratory, and presumed diagnosis • The individual written reports including graphs are to be sent by email to the Project Officer at CGB and to the Research Nurse identified by CGB. Government Responsibilities • The Government will notify the Contractor prior to shipment of specimens so that the recipient will be available to receive the shipment. Samples will usually be sent individually, but for family studies several samples may be sent at the same time, and the Contractor will be so-informed. Inspection and Acceptance. • The reports defined in section E will be scrutinized and subsequently accepted within 30 days of receipt. This laboratory testing service is provided by Repeat Diagnostics. Repeat Diagnostics is the only laboratory that can perform the studies required in the SOW. They have US CLIA-certification, and were the originators of the leukeocyte subset telomere length assay by flow-FISH. There have been no errors in the CGB's prior studies over ten (10) years. They are experienced in this assay, which is both sensitive and specific to this requirement. The CGB has used their data for peer-reviewed publications, and to properly classify patients and distinguish those with dyskeratosis congenita from their healthy relatives and from patients with other disorders. The 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 their cumulative results. This study is an integral part of the NCI protocol 02-C-0052. 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 2:00PM EDT, on Sept. 7, 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: N02CP52664-76 on all correspondence.
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