SOLICITATION NOTICE
B -- A Hospital-Based Case-Control Study of Leukemia in Chengdu, China
- Notice Date
- 8/10/2014
- 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
- N02CP42632-57
- Archive Date
- 9/9/2014
- Point of Contact
- Reyes Rodriguez, Phone: 240-276-5442, Terry L. Galloway, Phone: 240-276-5384
- E-Mail Address
-
reyes.rodriguez@nih.gov, gallowaytl@mail.nih.gov
(reyes.rodriguez@nih.gov, gallowaytl@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Cancer Institute (NCI), Division of Cancer Epidemiology & Genetics (DCEG), Occupational and Environmental Epidemiology Branch (OEEB), plans to procure on a sole source basis services to coordinate the study activities listed below at 3 collaborating hospitals in Chengdu: West China (Huaxi) Hospital of Sichuan University, Sichuan Province People's Hospital, Sichuan Tumor Hospital from West China Hospital of Sichuan University, No. 37, Guoxuexuang, Wuhou Dist., Chengdu, Sichuan, China, 610041. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1). The North American Industry Classification System code is 541990 and the business size standard is $14.0 Million. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance is twelve (12) months from date of award. It has been determined there are no opportunities to acquire green products or services for this procurement. To further NCI's understanding of the etiology of these diseases, the Division of Cancer Epidemiology & Genetics (DCEG) is 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 National Cancer Institute. To this end, the National Cancer Institute plans to enroll cases with acute myeloid leukemia, chronic myeloid leukemia, and myelodysplastic syndromes and myeloproliferative neoplasms in Chengdu, 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 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 720 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, which will be provided by the NCI within in 15 days of the award. This task must be completed by the end of the period of performance. 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, which will be provided by the NCI within 15 days of the award. This task must be completed for all enrolled cases and controls by the end of the period of performance. 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, which will be provided by the NCI within 15 days of the award. This task must be completed for all enrolled cases by the end of the period of performance. 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. This task must be completed for all enrolled cases and controls by the end of the period of performance. 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. The online Study Management system will be made available within 15 days of the award. This task must be completed for all enrolled cases by the end of the period of performance. 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: a. Enrollment data b. Questionnaires c. Biological specimen tracking d. 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. West China Hospital of Sichuan University system is the only candidate capable of fulfilling the tasks of this procurement based on the work previously conducted. No other contractor could perform the work without significant cost to the Government for retraining and for recruiting new staff. In addition, if a new PI and group of hospitals had to be brought on-board, this would require a stoppage of all study operations for at least nine months to establish new infrastructure, which would be detrimental to the validity of the study. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 11 AM EST, on August 25, 2014. All responses and questions must be in writing and faxed 240-276-5399 or emailed to Reyes Rodriguez, Contracting Specialist via electronic mail at reyes.rodriguez@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 certification in the Central Contractor Registration (CCR) and the Online Representations and Certifications Applications (ORCA) through sam.gov. Reference: N02PC42632-57 on all correspondence.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/N02CP42632-57/listing.html)
- Place of Performance
- Address: Contractor's Site, United States
- Record
- SN03459195-W 20140812/140810233323-389ee00862edc56e169c814af69d86cb (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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