SOLICITATION NOTICE
B -- A hospital-based case-control study of leukemia in Tianjin, China
- Notice Date
- 8/13/2014
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 1050, Frederick, Maryland, 21702, United States
- ZIP Code
- 21702
- Solicitation Number
- N02CP42625-62
- Point of Contact
- Tiffany D. Kittrell, Phone: 2402765434
- E-Mail Address
-
Tiffany.kittrell@nih.gov
(Tiffany.kittrell@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, Room1E144, Bethesda, MD 20892 USA Description: The National Cancer Institute (NCI), Division of cancer and Epidemiology (DCEG) plans to procure on a sole source basis to Tianjin Medical University Qixiangtai Road, Hexi District, Tanjin 300060 for the coordination of study activities related to leukemia at 5 collaborating hospitals in Tianjin, China. This acquisition will be processed in accordance with the simplified acquisition procedures as authorized by 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 541990 and the business size standard is $15 million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. Period of performance will be 12 months from award. The etiology of myeloid malignancies is poorly understood. To further National Cancer Institute’s (NCI) understanding of the etiology of these diseases, we are conducting a case-control study of these malignancies using the same infrastructure that has been developed for AsiaLymph; a study of lymphoma conducted in the same hospitals, and are also using the same controls previously enrolled for Asialymph, which is conducted by the NCI. To this end, the NCI will enroll cases with acute myeloid leukemia, chronic myeloid leukemia, and myelodysplastic syndromes and myeloproliferative neoplasms in Tianjin, China. The major postulated risk factors for evaluation in this study are chemical exposures and genetic susceptibility. Risk factors among myeloid leukemia cases will be compared to risk factors among controls previously enrolled for AsiaLymph study. The leukemia study will be able to address more extensively the occupational, environmental, and genetic causes of myeloid leukemia, focusing in particular on chemical exposures, including benzene and formaldehyde. The contractor shall coordinate the study activities listed below at 5 collaborating hospitals in Tianjin: Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University General Hospital, Tianjin First Center Hospital, Second Hospital of Tianjin Medical University, and Institute of Hematology & Blood Diseases Hospital. The contractor shall conduct the following study tasks: 1. Ensure study coordinators and interviewers are properly trained. 2. Train and work with admission staff at each hospital to identify potential cases and controls as defined in the Study Protocol. 3. Train new study coordinators, interviewers and admission staff as necessary due to staff turnover. 4. Identify and enroll in the study 520 eligible leukemia cases, by the end of the period of performance. 5. Administer interview to enrolled cases within 24 hours of enrollment. The interview will be provided in the Study Protocol 6. Collect and process blood and buccal cell specimens from each enrolled case and control within 24 hours of enrollment as specified in the Study Protocol, which will be provided by the NCI within 15 days of award. This task must be completed by the end of the period of performance. 7. Ship blood and buccal cells from enrolled cases and controls to NCI. Samples should be shipped by express mail, frozen on dry ice, using tracking. Full shipping instructions, including the address, will be contained in the Study Protocol. 8. Prepare 10 pathology slides from the bone marrow aspirate and biopsy. 9. Ship slides from enrolled cases to the Pathology Center every 3 months during the period of performance. The Pathology center is located at the Queen Elizabeth Hospital in Hong Kong. Samples should be shipped overnight, using tracking. Full shipping instructions, including the address, will be contained in the Study Protocol. 10. Track blood, buccal cell, and pathology specimens in a specimen tracking system provided by the NCI. Tracking includes recording the receipt of the samples from the enrolled cases and controls and the shipment of the samples. The online specimen tracking system will be made available within 15 days of the award. 11. Upload interview data and participant information to the Study Management System, every workday during the period of performance, for all cases and controls that were enrolled on that workday. The Study Management system is an online database. 12. Compensate subjects for their participation in the study per guidelines in the Study Protocol. 13. Conduct monthly site-visits with each hospital to monitor enrollment, interview, specimen tracking, hospital records, and adherence to the Study Protocol. 14. Meet with NCI investigators and study personnel from Hong Kong during site-visits that will be conducted every 3 months. 15. Review study progress and monitor quality controls measures from each hospital bi-weekly. This includes collecting and reviewing: · Enrollment data · Questionnaires · Biological specimen tracking · Hospital records 16. Report the following information monthly to the Coordinating Center at the University of Hong Kong and the NCI: a. Cases enrolled b. Compensation paid to subjects c. Blood and buccal cell specimens collected and shipped d. Pathology specimens collected and shipped e. Interviews conducted f. Protocol violations Government Responsibilities: NCI will provide the study protocol and training for the study management through the study coordination center, within 15 days of the award. Access to the online specimen tracking and study management systems will be provided within 15 days of the award. The five larger hospitals in Tianjin (Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University General Hospital, Tianjin First Center Hospital, Second Hospital of Tianjin Medical University, and Institute of Hematology & Blood Diseases Hospital) represent the key leukemia centers within this geographical area, with established leadership and experience of the AsiaLymph network. These hospitals have demonstrated success capturing a high percentage of lymphoma cases and controls necessary for the AsiaLymph protocol and thus could easily extend the enrollment of leukemia cases. Also, the controls they have previously enrolled for AsiaLymph are uniquely qualified to be used as controls for the myeloid leukemia cases since they come from the same geographic area, and were studied by the same instruments and in most instances by the same interviewerThe researchers at Tianjin Medical University have the necessary historical data assessing various workplace chemical exposures. To successfully manage these hospitals, the investigator in the premier hospital must have efficiently and productively worked with clinicians, pathologists, epidemiologists, and hospital administrators within these hospital systems. Due to continuity, Tianjin Medical University Cancer Institute and Hospital system is the only candidate capable of fulfilling the tasks of this procurement. This is not a solicitation for competitive quotations. However, if any interested party, especially a small business, believes they can meet the above requirement, they may submit a statement of capabilities and or quote. All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the above unique specifications described herein. A copy of the capability statement must be received in the NCI Office of Acquisitions on or before 11:00 AM EST on August 28, 2014. Electronic capability statements will be accepted (i.e. email or fax). All questions must be in writing and can be faxed to (240) -276-5401 or emailed to Tiffany Kittrell, Contract Specialist, at Tiffany.kittrell@nih.gov. A determination by the Government not to compete this proposed contract 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. In order to receive an award, contractors must have valid registration and
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