SOLICITATION NOTICE
R -- Study to determine the feasibility of collecting biospecimens & additional data and to assess recruitment within the existing infrastructure of a HMO
- Notice Date
- 9/6/2013
- 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, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- NCI-130125-HN
- Archive Date
- 10/5/2013
- Point of Contact
- Huy Nguyen, Phone: 2402765570, Seena Ninan, Phone: 240-276-5419
- E-Mail Address
-
anh-huy.nguyen@nih.gov, ninans@mail.nih.gov
(anh-huy.nguyen@nih.gov, ninans@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 1E154 Bethesda, MD 20892 Description: The National Cancer Institute (NCI), Division of Cancer Epidemiology & Genetics (DCEG), Epidemiology and Biostatistics Program (EBP) plans to procure on a sole source basis with Kaiser Permanente Colorado (KPCO) to conduct a study to determine the feasibility of collecting biospecimens & additional data and to assess recruitment within the existing infrastructure of a HMO. The products herein are being procured in accordance with the simplified acquisition procedures as authorized by FAR Part 13.106-1(b)(1). The North American Industry Classification System code is 541990 and the small business standard is $14 million. Only one (1) award will be made as a result of this solicitation. This will be awarded as a Firm Fixed Price (FFP) contract. 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) has a long history of developing and running major cohort studies, and many of these form the backbone of the research portfolio in the division. Existing cohorts, including but not limited to American Association of Retired Persons (AARP), Prostate, Lung, Cancer, and Ovarian (PLCO) and United States Radiologic Technologist (USRT) have been extremely productive and have generated a wealth of information about potential cancer risk factors and biological markers. In the next decade, these cohorts will reach the end of their natural lifetime due to the length of time since the baseline questionnaire, the average age of the participants, and the depletion of biological samples. There is the need, therefore, to start planning now for the next generation of cohorts that will be able to continue to address current and future hypotheses about the etiology of cancer. DCEG defined a prerequisite set of essential and desirable criteria for a new cohort biobank. Health Maintenance Organizations (HMOs) were identified by DCEG as a potential setting for a successful new cohort. The overarching objective of this requirement is to build a new prospective multi-center adult cohort study set with rich exposure information and accurate outcome information that will be used as a division-wide resource to investigate novel hypotheses about the etiology of cancer by combining questionnaire data, medical records, tumor tissue and serial biospecimens. However, the participation rates and feasibility of collecting information and biospecimens from members of a HMO is unknown. Therefore, a small study is required to assess recruitment and determine the feasibility of collecting biospecimens and additional data within the existing infrastructure of a HMO. The specific aims of the feasibility study are to: 1.Estimate the percent participation of eligible HMO members a.Compare participation rates from mailed vs. email invitation letters. b.Compare demographic and other available characteristics of HMO members who participate vs. do not agree to participate 2.Estimate the percent of blood draws completed among enrolled subjects 3.Estimate the time between enrollment and blood draw among enrolled subjects The contractor shall: 1.Assist in the development of the study protocol, recruitment materials, and data forms that may be required for various approvals and clearances, such as the DCEG's Senior Advisory Group (SAG), the DCEG's Technical Evaluation of Protocol Committee (TEP), the DCEG's Technical Evaluation of Questionnaires Committee (TEQ), Institutional Review Boards, and Office of Management and Budget (OMB). 2.Obtain IRB approval from their organization. 3.Create and run a program to identify eligible members and randomly select 1000 individuals in strata determined by NCI. 4.Create unique study IDs for each eligible participant. Mail packet containing the Invitation/Cover Letter, Information and Consent Form (2 copies), questionnaire and self-addressed return envelope to 500 individuals 5.Send invitation letters via email to 500 individuals. Send one reminder email to those who did not respond to the invitation email. 6.Mail questionnaire and consent form to email individuals who agree to participate 7.Receipt the returned consent forms and completed questionnaires within 1 week of return. De-identify the questionnaires, add the unique ID and send to NCI for manual review. 8.Flag individuals who agree to participate in the electronic record system as active participants and create an order for a research blood draw in preparation for when they present at the lab. 9.Set up and use the IVR (Interactive Voice Recognition) call system to contact those who did not respond to the invitation to participate. The first reminder should be made no earlier than three weeks from the initial mailing date. Up to three IVR reminders should be made. 10. Set up and use the IVR to remind individuals who decided to participate about blood draw every 30 days for 3 months. 11.Oversee the collection, processing, shipping and storage of blood collected from study participants and link with study IDs. 12.Determine response rates and report on differences between participants and non-participants (e.g. age, sex etc.). 13.Arrange for communications and meetings as needed between the NCI research investigators, other NCI contractors, collaborating institutions, and/or agents for those whose cooperation or approval is necessary 14.Provide additional data from medical records of participants for research purposes Kaiser Permanente Colorado (KPCO) possess the ability to complete the requirement because of their unique comprehensive nature of data collection and data maintenance systems including the long-term electronic medical records, availability of tumor tissue, high-quality internal cancer registries, geographic and racial/ethnic diversity of potential study sites and existing clinical infrastructure for biospecimen collection. Using KPCO's real-time, electronic medical records system, KPCO can routinely identify and use both traditional mail methods and electronic mailing to recruit participants. KPCO can also provide important information on differences between who decides to participate and those who decline to enroll in the study. KPCO is the only known center with the capability and expertise to implement electronic recruitment. KPCO is uniquely situated to allow participants to present for a blood draw solely for research purposes at a time convenient to the individual, which is a key requirement to evaluate the blood collection protocol designed for this study. Period of Performance: •12 months from the date of award. This is not a solicitation for competitive quotations. However, if any interested party believes they can meet the above requirement, especially small businesses, they may submit a tailored statement of capabilities via fax or email. In addition, all responsible sources may submit a bid, proposal, or quotation which shall be considered by the NCI. 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. All information must be received in the NCI contracting office on or before 4:00 PM EST on September 20, 2013. All questions must be in writing and can be faxed (240) 276-5401 or emailed to Anh-Huy Nguyen, Contract Specialist at anh-huy.nguyen@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 certification in the System for Award Management (SAM) www.sam.gov. No collect calls will be accepted. Please reference solicitation number NCI-130123-HN on all correspondences.
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- Record
- SN03178154-W 20130908/130907000155-8e0a9bbd0dae651ef7eed7c30cfc8804 (fbodaily.com)
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