NIHDA201800074-Statement_of_Work.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Structured Assessment of Youth Psychopathology using an Algorithmic Approach

Statement of Need and Purpose:

Our team, the Mood, Brain and Development Unit’s, primary goal is the elucidation of pathophysiological mechanisms underlying depression and related mood disorders. An in-depth and efficient assessment of clinical symptomatology is the key to this endeavor. We require a system that uses an online platform to collect such data as to allow for efficient data accrual. We also require a system that uses an algorithmic approach to provide automated diagnostic information to clinicians, based on results from the general population. Moreover, the system must be secure and have a track record of efficiency in such setups and security. We have successfully used such a system in the past and have found it to reduce assessment times and cost while yielding a high quality of clinical information.

Background Information and Objective:

The contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). The contractor shall provide a website with questionnaires helpful to the lab’s research, create de-identified login as well as user names and passwords for each person interviewed for secure access. The contractor shall provide all necessary maintenance, modification for this website, and all other necessary technical support according to the Unit’s needs. The contractor shall provide an online platform that allows for the collection of basic demographic information (but not patient identifying information), as well as diagnostic information from the main psychiatric disorders as listed in the Diagnostic and Statistical Manual, 5th version. These will be collected in the form of a structured interview with spaces for open-ended comments. The required work will allow continuity with an online platform that can be used to collect data and provide data organization that can be used in analysis of pathophysiological mechanisms underlying depression and related mood disorders. A secured web platform that provides a well-validated, globally-used secure platform that will allow our Unit to assess psychopathology efficiently through its data organization and allows for easy analysis.

Period of Performance:

This Contract will consist of a one year Base with two year options.

SCOPE OF WORK

General Requirements:

The Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform.

Specific Requirements:

The government shall direct subjects to the Contractor’s website so they can securely log in and complete clinical questionnaires and interviews. These shall be made available for up to 2,000 subjects. This data shall then be processed by the Contractor and the output shall be raw data on answers to questions and the results of the algorithmic processing of the raw data, a process through which probabilities of diagnosis are estimated on the basis of normative data from general population samples. The Contractor shall provide all that is necessary which is the weblink, username, and password. This will be needed for the subjects to be able to complete questionnaires online and for the Unit to receive the data as described above within minutes of completion by the subject.

Salient characteristics

The contractor shall provide the following:

1. A secured web platform for online login of each subject.

2. User name and logins as required for each subject.

3. Storage on contractor’s server for the de-identified data. The contractor shall provide the storage for the whole duration of the contract and shall also provide the opportunity for the data download by our Unit for local storage. Transfer of data shall take place in monthly intervals and be determined by our Unit’s needs. Several formats for transfer should be available, including Excel and SPPSS.

4. The algorithmic processing of the clinical data collected, with an output of the results in Excel or SPPSS.

5. An online platform that allows for the collection of basic demographic information from the main psychiatric disorders as listed in the Diagnostic and Statistical Manual, 5th version as well as any questionnaire or other material (e.g. open-ended comments) that is relevant to the work of the Unit. These will be collected in the form of a structured interview with spaces for open-ended comments.

6. The capacity for data to be collected on multiple occasions per individual, with appropriate identification of the occasion and date on which the data have been collected.

7. The capacity to add, delete, and modify any of the questionnaires provided.

8. The capacity for members of the Unit to remove data from the server.

9. The technical support required for members of the Unit to use the software platform with reasonable independence.

10. Unlimited technical support for the set-up, maintenance and troubleshooting of the web secure platform, questionnaires, and data mentioned above. This technical support should be available Monday to Friday within working hours.

GOVERNMENT RESPONSIBILITIES

The government shall provide any information needed in relation to security requirements for online data collection. The government shall direct subjects to the Contractor’s website.

DELIVERY OR DELIVERABLES

The contractor shall provide the following:

a) A secure web platform for online login of each subject.

b) Username and logins as required for each subject.

c) Online interview and any other required questionnaires.

d) Storage on the contractor’s server for the de-identified data. The contractor shall provide the storage for the whole duration of the contract (one year plus two option years) and shall also provide the opportunity for data download by our Unit for the purpose of local storage. Transfer of the data shall take place in monthly intervals and be determined by our Unit’s needs. Several formats for transfer shall be available, including Excel and

SPPSS.

e) Sharing of the capability to add items (questionnaires) and remove them from a menu in a way that is easy and efficient.

f) Help with setting up information collection using the platform at regular time intervals per subject (e.g. weekly acquisition of data per subject).

g) The algorithmic processing of the clinical data shall output the results in Excel or SPPSS format.

h) Unlimited technical support for the setup, maintenance and troubleshooting of the web secure platform, questionnaires, and data mentioned above. This technical support shall be available Monday through Friday within business hours.

REPORTING REQUIREMENTS

As we are able to monitor directly the results of the work, there is no requirement for regular reporting. However, the Contractor shall report promptly any technical or other problems that might impede the expected work. In the event of technical or other problems arising, the Contractor shall notify via email to Dr. Stringaris (Argyris.stringaris@nih.gov) within 48 hours, any recommended solutions and a timeline for the solution.

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

The following positions are considered key personnel in support of this contract initiative.

A Senior Program Developer with more than 15 years of experience creating and developing web-based diagnostic software systems and algorithms. The developer must have a minimum of 15 years of experience in developing online psychiatric screening systems.

A Senior Informatician- a computer scientist and medical informatician with special expertise in software protyping, computer security, and health informatics. This Informatician must have mailto:Argyris.stringaris@nih.gov considerable experience in the development of large-scale, web-based clinical systems and block-chain technology and more than 15 years of experience developing online psychiatric screening systems. A minimum of 15 years of experience in developing online psychiatric screening systems is mandatory.

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)

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.

Information System Security Plan:

The Contractor shall work with de-identified data from a remote location so risks are kept at a minimum. The Contractor’s website will receive a Privacy Impact Assessment by Mr. William Hermach from the Information Security Program at NIH. The Contractor is expected to comply with any training requirements stipulated by the NIMH Institutional Review Board.

Data Rights:

The Mood, Brain and Development Unit shall have unlimited rights to and ownership of all deliverables provided under the contract including reports, recommendations, briefings, workplans, and all other deliverables. This includes the deliverables provided under this contract and any optional tasks 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.

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.

Publications and Publicity:

N/A

Confidentiality of Information:

The government will not provide to the Contractor any information or data of a personal nature about individual(s) or proprietary information or data pertaining to an institution or organization which is confidential. Whenever the contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.