SOLICITATION NOTICE
R -- Framingham Heart Study Support Services
- Notice Date
- 12/30/2015
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- 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-CSB-HL-2016-031-JML
- Archive Date
- 1/19/2016
- Point of Contact
- Jonathan M. Lear,
- E-Mail Address
-
john.lear@nih.gov
(john.lear@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Boston University Medical Campus, 85 East Newton Street, M-921, Boston, MA 02118-2340 to provide scientific support services to the NHLBI Division of Intramural Research (DIR) in accordance with the following information: BACKGROUND Cardiovascular disease (CVD) is the leading cause of death and serious illness in the United States. In 1948, the Framingham Heart Study -- under the direction of the National Heart Institute (now known as the National Heart, Lung, and Blood Institute; NHLBI) -- embarked on an ambitious project in health research. At the time, little was known about the general causes of heart disease and stroke, but the death rates for CVD had been increasing steadily since the beginning of the century and had become an American epidemic. The objective of the Framingham Heart Study was to identify the common factors or characteristics that contribute to CVD by following its development over a long period of time in a large group of participants who had not yet developed overt symptoms of CVD or suffered a heart attack or stroke. The Framingham Heart Study continues to make important scientific contributions by enhancing its research capabilities and capitalizing on its inherent resources. While pursuing the study's established research goals, the NHLBI and the Framingham investigators are expanding their research into other areas. An exciting new area of research inquiry is eHealth - or collecting study information using electronic tools such as digital sensors. We are performing a pilot study to determine the feasibility of using the Health eHeart Study (HeH), a digital cohort with existing infrastructure to collect internet-based, self-reported data and wearable sensor data in a pilot study with Framingham Heart Study participants. PURPOSE The purpose of the Framingham Heart Study was to identify the common factors or characteristics that contribute to CVD by following its development over a long period of time in a large group of participants who had not yet developed overt symptoms of CVD or suffered a heart attack or stroke. The Framingham Heart Study continues to make important scientific contributions by enhancing its research capabilities and capitalizing on its inherent resources. While pursuing the study's established research goals, the NHLBI and the Framingham investigators are expanding their research into other areas. An exciting new area of research inquiry is eHealth - or collecting study information using electronic tools such as digital sensors. We have completed our pilot study to determine the feasibility of using the Health eHeart Study (HeH), a digital cohort with existing infrastructure to collect internet-based, self-reported data and wearable sensor data in a pilot study with Framingham Heart Study participants and are now expending this model to a Full cohort which will be referred to as eFHS (electronic Framingham Heart Study). The purpose of this project is to conduct a full cohort eHealth study coinciding with the Framingham Heart Study Gen III Exam III clinic visit to initiate in April 2016. TASKS TO BE PERFORMED The contractor shall perform the following tasks: Conduct a full cohort eHealth study coinciding with the Framingham Heart Study Gen III Exam III clinic visit to initiate in April 2016 Framingham Heart Study (FHS) participants, called eFHS. Each eVisit is tied to the upcoming clinical exam the participants will attend at part of Gen III Exam III and will add to the clinical session a eFHS session. The Boston University (BU) Staff operating the FHS clinic will initiate the study, preview the websites, and to activate and link the sensors. Participants also will be provided a suite of sensors that will include a Bluetooth BP cuff, a Bluetooth scale, an activity monitor, and an ECG smartphone case. Each device will be activated and linked to the study website by the participant. Three months after completion of eVisit 1, they will be invited to complete eVisit 2. In addition, we will perform an "exit interview" regarding the eFHS experience with a focus on burden. In order to enhance engagement and retention, participants will receive eFHS-based automated communication and reminders via email, SMS or system alerts. Automated communications and emails will be supplemented by phone calls from FHS staff only if needed. The Overarching Aims of the eFHS program are below, but this contract will primarily focus on the BU clinical support component that pertains to FHs Participant Contact-which must be conducted by BU staff. Aim 1: App development Develop a smartphone app and associated web-based platform for use within the FHS that will collect information regarding demographic, lifestyle, and CVD risk factors. Aim 2: App validation Against quantitative clinic-collected phenotypes. Implement data collection using the app and validate these components against in-person collected data in the Third Generation FHS exam. We hypothesize that in vivo assessment of lifestyle and CVD risk factors will be similar to in-person collected examination data within the FHS. Aim 3: App development to collect health care encounters. We will develop a smartphone app module to ascertain health care encounters and we will validate MI and AF against adjudicated FHS MI and AF. We hypothesize that smartphone collected MI and AF will have at least 80% sensitivity and specificity versus gold-standard adjudicated MI and AF. Aim 4: Risk prediction of endpoints. Assess CVD (clinical and subclinical) and metabolic burden using digitally collected data and examine associations with clinical and subclinical CVD. Risk characterization of MI and AF will be augmented by combining traditional clinical data with digital, longitudinal, and more frequent in vivo behavioral and health data. Further, digitally collected risk factor data will perform as well as the components of the FRS for MI and AF when collected at in-person examinations. Aim 5: Extend data collection beyond the FHS with the launch of eFHS, an electronic and digital extension of the FHS and examine the associations between CVD risk factors and CVD endpoints. CVD risk characterization in eFHS will demonstrate similar risk-factor and outcome relationships to what has been demonstrated in cohort studies, and will augment the geographic diversity of the FHS. The contractor shall also: A.Train staff on eFHS protocols consistent with FHS Clinical Exam Policy B.Recruit FHS participants into the optional eFHS component of their Clinical Exam visit C.Conduct informed consent for eFHS segment of the Clinical Exam visit D.Maintain constant compliance with all IRB and OSMB clinical patient contact requirements E.Training of participants on use of tools and smartphone app and digital equipment F.Enrollment of participants into on-line portal of data transfer and record keeping G.Troubleshoot and act as liaison to enrolled participant that may require additional hardware or assistance with repeat trainings H.Data cleaning of electronic data I.Attend/Coordinate Meetings with Team at BU/NHLBI PERIOD OF PERFORMANCE The period of performance will be January 4, 2016 through January 3, 2017. JUSTIFICATION The sole source determination is based on the fact that this work must be conducted by Boston University staff since this requires participant contact with the Framingham Heart Study participants. Their contact information is considered sensitive PII (Personally Identifiable Information) and this is exposed to a very small set of Boston University individuals for the complete protection of the participants. No other individuals or organization can complete this task. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b) Soliciting from a single source (for purchases not exceeding the simplified acquisition threshold) and only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION The North American Industry Classification System (NAICS) Code is 541690, Other Scientific and Technical Consulting Services, and the Small Business Size Standard is $15.0M. This acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable and the resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-85 (December 4, 2015). This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.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. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by January 4, 2016 at 9:00am EST and must reference synopsis number NHLBI-CSB-(HL)-2016-031-JML. Responses shall be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6151, Bethesda, MD 20892-7902, Attention: Jonathan M. Lear. Responses may be submitted electronically to john.lear@nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-HL-2016-031-JML/listing.html)
- Place of Performance
- Address: National Institutes of Health / NHLBI, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03980168-W 20160101/151230234041-05f1ee3f672cca39c145730045ff6ed1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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