SOURCES SOUGHT
A -- Coronary Artery Risk Development in Young Adults (CARDIA) Echocardiography Reading Center – Market Research
- Notice Date
- 4/8/2008
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- SSA-NHLBI-HC-09-08
- Point of Contact
- CherylJennings,, Phone: (301) 435-0347, Jeffrey A Williams,, Phone: (301) 435-0338
- E-Mail Address
-
cj19f@nih.gov, williamsja2@nhlbi.nih.gov
- Description
- The National Heart, Lung, and Blood Institute (NHLBI) plans to negotiate on a competitive basis to award an Echocardiography Reading Center (Echo RC) contract as part of the renewal of the Coronary Artery Risk Development in Young Adults (CARDIA) study. The CARDIA renewal involves a Year 25 clinical examination (Year 25 Exam) of the cohort that includes repeat and new measures to be performed June 2010 through May 2011; and continued follow-up contact and clinical events surveillance of the cohort through September 30, 2013. The Echo RC’s effort is expected to begin on March 1, 2009 and to end September 30, 2013. The CARDIA Echo RC contractor will be responsible for the various aspects related to the echocardiographic measurements to be collected and assessed in the Year 25 Exam. The CARDIA Study started as a study of the distribution and evolution of risk factors for cardiovascular disease during young adulthood in black and white men and women. The Study began recruitment in 1985 and has completed 7 examinations over 20 years in a cohort of 5,115 men and women aged 18-30 years in four communities. The original cohort had approximately equal representation by blacks and whites, men and women, those aged 18-24 and 25-30 years, and those with no more than and more than a high school education. The baseline examination (Year 0) was conducted over a 14-month period during 1985-86. The examination consisted of questionnaires on sociodemographic characteristics, health behaviors, and psychological factors; an exercise treadmill test; resting electrocardiography; a diet history assessment; anthropometry; pulmonary function testing; resting blood pressure; and fasting blood measurements. Six additional examinations have been completed every 2-5 years, including most recently a Year 20 examination completed in 2006. Retention of the surviving cohort was 90, 86, 81, 79, 74, and 72 percent at each of the respective follow-up examinations. Repeat measurements on several traditional risk factors have used the same methods at each examination to assess age and secular trends in these factors during young adulthood. In selected years, additional measurements have been made, including echocardiography at Year 5 (in nearly the full cohort) and Year 10 (in a subset of the cohort). At the Year 25 Exam (to be conducted from June 2010 through May 2011), participants will be 43-55 years old, when risk factors and subclinical abnormalities become more prevalent and clinical events begin to emerge. CARDIA offers the opportunity to address aspects of the development and progression of subclinical vascular, ventricular, and pulmonary function abnormalities that cannot be addressed in older cohorts. The renewal of the CARDIA study will address five objectives: 1) Assess the impact of timing and varying levels of risk factors throughout young adulthood on the development of subclinical ventricular, vascular, and pulmonary function abnormalities in mid-life; 2) Examine young adult antecedents and consequences of obesity and the longitudinal relationships and interactions among adiposity, insulin resistance, and inflammation; 3) Identify determinants and trajectories of subclinical disease development in women during menopause transition compared to men of similar age; 4)Further assess the basis for racial differences in subclinical disease development; 5) Provide a platform for in-depth ancillary studies in cardiovascular and other areas. The technical requirements associated with this acquisition for the CARDIA Echo RC include the following: 1.Develop the protocol for the acquisition, reading, and information abstraction of the echocardiograms to be performed as part of the CARDIA Year 25 Exam. As much as feasible, the protocol shall aim to be comparable to the echocardiographic examination performed during the Year 5 Exam. 2.Determine comparability of the proposed echocardiographic protocol for the Year 25 Exam to that for the Year 5 Exam by performing repeat measures of a subset of videotaped echocardiograms and 10% blind duplicated measures of studies from the Year 5 Exam. 3.Convert the videotaped echocardiograms from the CARDIA Year 5 and Year 10 Exams into digital electronic files and copied onto disks for secure archival storage. 4.Train and certify technicians for each Field Center according to protocol. 5.Train and certify echocardiography readers at the Echo RC according to protocol, as well as orient professional staff from the CARDIA Coordinating Center and NHLBI Project Office who have quality assurance responsibilities. 6.Conduct a pretest of the Year 25 echocardiography protocol, including quality assurance activities, during the pilot testing phase of the Year 25 Exam, in collaboration with the CARDIA Coordinating and Field Centers. 7.Perform readings and information abstractions of echocardiograms in a timely manner during the pilot phase and throughout the Year 25 Exam period (the approximate numbers of participants anticipated to have echocardiograms measured in the pilot phase and the Year 25 Exam are ~ 9 and ~ 3,500, respectively). 8.Track the receipt, reading, and storage of echocardiograms. 9.Develop and implement long-term archiving and storage of echocardiograms and timely creation of backup copies. 10.Visit CARDIA Field Centers during the early phase of the Year 25 Exam and as needed, in support of quality assurance efforts of the study. 11.Participate in the Steering Committee, as well as the Imaging Committee and Quality Control Committee, as appropriate. 12.Participate actively in data analysis, presentation, and publication using the echocardiographic data. All responsible sources are welcome to submit a written capability statement by April 22, 2008, as revised from the original date of February 29, 2008, demonstrating their ability to perform the aforementioned technical requirements. This notice will close fifteen calendar days after posting. The capability statement shall include 1) the professional qualifications of scientific and technical personnel in accordance with the above requirements; 2) demonstrated capacity of individuals and the institutional support to perform the functions of an echocardiography reading center for a multi-center collaborative epidemiology study, including protocol development, information processing, and coding; 3) facilities and equipment available, including computer equipment and software to read echocardiograms and capability of transferring data between Field Centers and the Echo RC, and between the Echo RC and the Coordinating Center ; 4) evidence of ability to integrate potential advances in echocardiographic imaging technology into study protocol; 5) evidence of the ability to assess and monitor quality control for obtaining and reading echocardiograms; 6) evidence of ability for data management, including tracking of all Echo RC activities; and 7) the small business status of the firm. Evaluation of the capability statements shall be based on the first six of the technical points (criteria) above. Each technical point (criteria) shall be weighted equally. Do not include budget information. All responsible Small Businesses to include Small Disadvantaged, Women-Owned, Veteran-Owned, Service-Disabled Veteran-Owned, and HUBZone businesses, and Historically Black College, University, and Minority Institutions are encouraged to submit capability statements. We ask that the capability statement not exceed 20 single sided or 10 double sided pages in length. Three (3) copies of the capability statement must be received at the following address no later than 10 working days from the publication date of this notice. Responses that do not adhere to these guidelines will not be considered. This is not a Request for Proposals (RFP). No RFP is available. If the program is approved for implementation and it is determined to be a small business set aside, then a competitive RFP will be set aside for small business concerns. When released, the RFP will be available on the Federal Business Opportunities website. Questions may be directed to the Contracting Officer, Cheryl Jennings, jenningsca@nhlbi.nih.gov, 301-435-0347 or the Contract Specialist, Jeffrey Williams, williamsja2@nhlbi.nih.gov, 301-435-0338. Cheryl A. Jennings, Contracting Officer, Office of Acquisitions, DERA National Heart, Lung, and Blood Institute, NIH, DHHS 6701 Rockledge Drive, Rockledge II, Room 6120, MSC 7902 Bethesda, MD 20892-7902 For overnight deliveries use zip code 20817; no MSC is required.
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