Statement_of_Work_Final.docx

Statement of Work A. General Information

1. Title of Project: Evaluation of Intimal medial thickness measurement in the Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS) Study.

2. Background: The National Institute on Aging (NIA) Intramural Research Program is embarking on a longitudinal study of the effects of race and socioeconomic status on healthy aging in a representative sample of community dwelling residents from the Baltimore metropolitan region. The study is called Healthy Aging in Neighborhoods of Diversity across the Life Span (HANDLS). The HANDLS study requires a detailed knowledge of the public health characteristics of this region and the ways in which racial and socioeconomic data must be collected to assess their influence on a variety of health outcomes such as cardiovascular and cerebrovascular functioning, psychophysiological and cognitive performance, and muscular strength and conditioning.

Carotid Doppler ultrasonography is the method of choice for noninvasive, in vivo examination of the structure and function of the carotid arteries. In this study, a high resolution B-mode ultrasonography on the left carotid artery for evaluating systolic and diastolic common carotid arterial diameters, carotid arterial flow, intimal-medial thickness, and plaques is performed. This test is done to demonstrate blocked or reduced blood flow in the arteries of the neck, which could predispose to cerebrovascular events.

3. Purpose and Objectives: The purpose of this requirement is to procure the services of a vascular surgeon who has the expertise to read, analyze and interpret carotid Doppler studies collected as part of the HANDLS wave 4 examinations to evaluate the quality and accuracy of Intimal Medial Thickness (IMT) measurement in the HANDLS study and perform clinical evaluation for the presence of atherosclerosis and risk for stenosis.

4. Type of Contract Contemplated: Firm Fixed Price

5. Period of Performance:

Base Year: 04/01/2016 - 03/31/2017 Optional Renewal Years:

Option Year #1: 04/01/2017 - 03/31/2018

6. Place of Performance: Place of Performance is at the Contractor’s site

B. Contractor Requirements (Scope of Work)

1. Project Description and Requirements: The contractor shall provide a Cardiologist or Vascular Surgeon who will provide the following services:

1. Review and advise sonographer's acquisition of images including feedback on the quality of the tests and quality control of the images obtained as part of the HANDLS study;

2. Evaluate the quality and accuracy of intimal-medial thickness (IMT) measurements and perform clinical evaluation for the presence of atherosclerosis and risk for stenosis;

3. Provide technical supervision for the sonographer when required, including feedback on the quality of the tests, and quality control of the images;

4. Review, on a yearly basis, the measurements that are acquired to determine whether any modifications or changes to the protocol are needed.

5. Provide on-call services as needed to review clinical status of participants presenting with plaques, stenosis, or any other relevant vascular condition conferring urgent health risk

Although the government will own the data, the Contractor will be encouraged to participate and collaborate in analyses that involve the carotid Doppler studies.

Other Important Considerations and Requirements:

Deliverables include the following:

1. No more than 30 evaluated Carotid Doppler studies per week with minimal errors in data processing

2. Participation in manuscript development and reports on quality control of data collected and coded, data and manuscript proposals

3. Written reports on quality control of data collected and coded data as well as manuscript proposals shall be delivered to the Contracting Officer’s Representative electronically on these respective dates, subject to change: July 30th, November 30th and March 31st of each year.

Key Personnel: The proposed key personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.242-70 KEY PERSONNEL, HHSAR 352.242-70 (January 2006).

a. The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

b. The cardiologist or vascular surgeon is considered key personnel and will provide the services and will be responsible for the deliverables. The education requirements include a Doctorate of Medicine and Board Certified & Licensed in the State of Maryland. Finally, experience requirements include five years of experience evaluating the quality and accuracy of intimal-medial thickness (IMT) measurements and performing clinical evaluation for the presence of atherosclerosis and risk for stenosis and collaborating on IMT data resulting in published manuscripts

C. Government Responsibilities: The Government will perform monitoring activities of the data received, for completeness, accuracy, consistency and minimal errors of the data. Government monitoring will be performed at random intervals no less than three times per year.

The Government will provide the website upon award, where the data shall be uploaded and analyzed.

D. Security Requirements: Contractor personnel performing work under this contract shall satisfy all requirements for appropriate security eligibility as specified in the solicitation, in dealing with access to sensitive information and information systems belonging to or being used on behalf of the NIA. To satisfy those requirements, a level 5 Risk Background Investigation shall be conducted prior to performing work under this contract. Appropriate background investigation forms will be provided upon contract award and are to be completed and returned to NIA within 30 days for processing. Contractors will be notified when the investigation has been completed and adjudicated.

All costs associated with obtaining clearances for contractor-provided personnel will be the responsibility of the contractor. Further, the contractor will be responsible for the actions of all individuals provided to work under this contract. If damages arise from work performed by contractor-provided personnel under the auspices of this contract, the contractor will be responsible for all resources necessary to remedy the incident.

E. Data Rights: The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided under this contract, including collected data, reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of "unlimited rights" is contained in Federal Acquisition Regulation (FAR) 27.401, "Definitions." FAR clause 52.227-14, "Rights in Data-General," is hereby incorporated by reference and made a part of this contract/order.

F. Section 508-Electronic and Information Technology Standards: The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.