SOURCES SOUGHT
A -- Atherosclerosis Risk in Communities (ARIC) Study - Echocardiography Reading Center
- Notice Date
- 7/29/2009
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-HC-11-08
- Archive Date
- 8/28/2009
- Point of Contact
- Kristiane E Cooper, Phone: 301-435-0345, Elizabeth Zoller, Phone: 301-435-0374
- E-Mail Address
-
cooperke@mail.nih.gov, zollere@mail.nih.gov
(cooperke@mail.nih.gov, zollere@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute (NHLBI) is conducting a market survey to determine the availability and potential capability of small businesses as defined by NAICS Code 541711 to perform as the Echo Reading Center as part of the renewal of the Atherosclerosis Risk in Communities (ARIC) study. The ARIC renewal involves a clinical examination (Exam 5) of the cohort that includes repeat and new measures to be performed in May 2011 through April 2013; as well as continued follow-up contact and clinical events surveillance of the cohort through October 31, 2016. The Echo RC’s effort is expected to begin on November 1, 2010 and to end October 31, 2016. The ARIC Echo RC contractor shall be responsible for the various tasks related to the echocardiographic measurements to be collected and assessed in the ARIC Exam 5. The ARIC study began in 1985 and was designed to monitor the trends in incidence and mortality of coronary heart disease (CHD) in four U.S. communities (Washington County, MD; Forsyth County, NC; Jackson, MS; and Minneapolis, MN) and to investigate the etiology and natural history of subclinical and clinical cardiovascular disease. Accordingly, ARIC includes a community-wide surveillance and a prospective cohort Study. In the community surveillance component, the four communities are investigated to determine the long term trends in hospitalized myocardial infarction (MI) and CHD deaths in approximately 470,000 men and women aged 35-84 years. Events are investigated by review of hospital records and by query of physicians and family members and are given standardized diagnoses. Starting in 2006, surveillance of inpatient (ages 55 years and older) and outpatient heart failure (ages 65 years and older) is included for the events occurring in 2005 and later. In the cohort study, approximately 4,000 individuals aged 45-64 years were recruited from each of the four communities under surveillance. A total of 15,792 participants (11,478 whites, 4,266 African Americans, and 48 other) received an extensive baseline examination in 1987-1989. The examination consisted of questionnaires on sociodemographic characteristics, health behaviors, and psychological factors; anthropometry and physical examination; resting electrocardiography; B-mode carotid ultrasound; a diet history assessment; pulmonary function testing; resting blood pressure; and fasting blood measurements. Three repeat examinations were conducted in 1990-92 (Exam 2), 1993-95 (Exam 3), and 1996-98 (Exam 4), with a response rate of 93%, 86%, and 80%, respectively. Repeat measurements on several traditional risk factors have used the same methods at each examination to assess the changes over time in these factors. In Exam 3, additional measurements were made, including retinal photography (in the full cohort), echocardiography in the full cohort of the Jackson Field Center (all are African Americans), and brain MRI in the full cohorts of the Jackson and Forsyth County Field Centers. Follow-up occurs yearly by telephone to maintain contact with participants and to assess health status of the cohort. Retention rate remains high (92%). There were approximately 13,000 participants alive as of December 2008. In Exam 5 (to be conducted from May 2011 through April 2013), participants will be 67-89 years old, when heart failure and heart failure risk factors become prevalent. ARIC offers the opportunity to phenotype heart failure stages using echocardiography and novel biomarkers, and to update crucial missing information on heart failure risk factors (e.g., dyslipidemia, hypertension, diabetes, renal insufficiency, and obesity). With risk factor and biomarker data from the previous exams, ARIC has the ability to study how the entire trajectory of mid-life to old-age risk factors and their control affects development and progression of ventricular dysfunction and vascular stiffness. The renewal of the ARIC study will address five objectives: 1) re-examine the ARIC cohort to characterize heart failure stages in the community, identify genetic and environmental factors leading to ventricular dysfunction and vascular stiffness, and assess longitudinal changes in pulmonary function and identify determinants of its decline, 2) continue cohort follow-up for cardiovascular events occurring through the year 2014, including CHD, heart failure, stroke, and atrial fibrillation; and for the study of risk factors related to progression of subclinical to clinical CVD, 3) enhance the ARIC cohort study with cardiovascular outcomes research to assess quality and outcomes of medical care for heart failure and heart failure risk factors, 4) continue community surveillance to monitor long-term trends through the year 2014 in hospitalized MI, CHD deaths, and heart failure (inpatient and outpatient); and 5) provide a platform for ancillary studies, training for new investigators, and data sharing. The technical requirements associated with this acquisition for the ARIC Echo RC include the following: 1. Work collaboratively with the Field Centers and the Coordinating Center to develop the protocol for the acquisition, reading, quality control and assurance, and information abstraction of the echocardiograms to be performed as part of the ARIC Exam 5. 2. Determine comparability of the proposed echocardiographic protocol for the Exam 5 to that for the Exam 3 (at Jackson Field Center only). 3. Train and certify echocardiography technicians for each Field Center according to protocol. 4. Train and certify echocardiography readers at the Echo RC according to protocol, as well as orient professional staff from the ARIC Coordinating Center and NHLBI Project Office who have quality assurance responsibilities. 5. Conduct a pretest of the echocardiography protocol, including quality assurance activities, during the pilot testing phase of the Exam 5, in collaboration with the ARIC Coordinating and Field Centers. 6. Perform readings and information abstractions of echocardiograms in a timely manner during the pilot phase and throughout the Exam 5 period (the approximate numbers of participants anticipated to have echocardiograms measured in the pilot phase and the Exam 5 are ~ 10 and ~ 9,000, respectively). 7. Track the receipt, reading, and storage of echocardiograms. 8. Develop and implement long-term archiving of echocardiograms and timely creation of backup copies. 9. Visit ARIC field centers during the early phase of the Exam 5 and then as needed, in support of quality assurance efforts of the study. 10. Participate in the Steering Committee, Echo Committee, and Quality Control Committee, as appropriate. 11. Maintain confidentiality and security of the data files. Transmit results of the echocardiography reading, data analyses, and quality control assessments at all phases of the study to the Coordinating Center on a regular and timely basis. 12. Participate actively in data analysis, presentation, and publication using the echocardiographic data. 13. Mentoring junior investigators by providing formal and/or informal training opportunities for junior or inexperienced investigators (assistant professors, fellows, and students). This includes but is not limited to the junior investigator working on data analyses and publications and serving on study subcommittees. 14. Provide technical reports as required by the Government (up to one semiannually and a final). All responsible sources are welcome to submit a written capability statement by August 13 2009 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, operational and scientific coordination, 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 Echocardiography Reading Center, and between the Echocardiography Reading Center 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 to manage data, including tracking of all Echocardiography Reading Center activities; 7) evidence of ability to analyze data from longitudinal epidemiologic studies, and publish results in peer reviewed journals; and 8) the small business status of the firm. Evaluation of the capability statements shall be based on the first seven of the technical points (criteria) above. Each technical point (criterion) shall be weighted equally. Do not include budget information. 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 address below no later than 15 days from the publication date of this notice. Responses that do not adhere to these guidelines will not be considered. Electronic submissions are also acceptable and may be sent the following e-mail address: cooperke@mail.nih.gov. This is not a Request for Proposals (RFP) and the Government is not committed to award a contract pursuant to this annoucement. 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, Kristiane Cooper, cooperke@mail.nih.gov, 301-435-0345 or the Contract Specialist, Elizabeth Zoller, zollere@mail.nih.gov, 301-435-0374. Kristiane Cooper, 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-HC-11-08/listing.html)
- Record
- SN01892654-W 20090731/090730002435-75b17357f391be13d94bbb61e14b6feb (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |