SOLICITATION NOTICE
Q -- Laboratory Testing Services for Red Cell Adenosine Deaminase and Purine/Pyrimidine Metabolism Enzymes for Patients with Diamond- Blackfan Anemia
- 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
- N02CP52534-76
- 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 red cell adenosine (ADA) testing and profiling of red cell purine and pyrimidine metabolism enzymes from the Anatomic Pathology & Clinical Laboratories at Stanford Health Care, 300 Pasteur Drive, Stanford, CA 94305-2200. 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. Diamond-Blackfan Anemia is one of the specific diseases that this larger rubric encompasses. CGB has a need to obtain results of the red cell adenosine deaminase (ADA) test and the profile of red cell purine and pyrimidine metabolism enzymes to provide confirmatory support of the diagnosis of Diamond-Blackfan anemia. The samples will be derived from individuals who are members of families in which there is a clinical basis to suspect the diagnosis of Diamond-Blackfan anemia. 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. This study is an integral part of the NCI protocol 02-C-0052. Contractor shall perform the following tasks: • The cells derived from coded samples of peripheral blood in EDTA will be analyzed for red cell adenosine deaminase (ADA) levels and the levels of red cell purine and pyrimidine metabolism enzymes. • Red cell adenosine deaminase (ADA) test and the profile of red cell purine and pyrimidine metabolism enzymes on each sample in a CLIA-certified laboratory. • A 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. The report will include the levels of the red cell adenosine deaminase and of the other enzymes which were measured. These levels shall be reported as international units of enzyme per gram of hemoglobin. This information shall be reported for each patient specimen submitted and for the control samples that are run in the same assay concurrently. • In lieu of meetings, the contractor will provide an updated cumulative excel file at 6 month intervals, containing the data discussed above under requirements, for all samples received prior to that date. The dates will be January and July, for the preceding 6 months to be added to the file. This laboratory testing service is provided by the Anatomic Pathology & Clinical Laboratories at Stanford Health Care. The proposed source is the only laboratory that can perform the required studies. They have been analyzing red cell enzymes for more than 30 years and are the "gold standard" for CGB's own cohort study. This laboratory has extensive experience with the documentation of elevated red cell adenosine deaminase (ADA) in patients with Diamond-Blackfan anemia (DBA), and distinction of DBA from all other inherited bone marrow failure syndromes. Most laboratories that measure ADA do so in the context of decreased levels in some immune disorders, the opposite of the direction CGB find in its patients. The assay is both sensitive and specific, and is critical for proper classification of our patients, and is imperative for the integrity and continuity of the 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: N02CP52534-76 on all correspondence.
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