STATEMENT-OF-WORK-GENETIC-COUNSELING (1).pdf

NIH/OD/OLAO/OA

Statement of Work (SOW) Office of Acquisitions

Statement of Work – Genetic Counseling Service

TABLE OF CONTENTS

1.0 Introduction 2

1.1 Background 2

1.2 Scope 3

1.3 Objectives 3

2.0 Requirements 3

2.1 Tasks 4

2.2 Assumptions 5

3.0 Security Requirements 6

4.0 Evaluation Criteria 6

1.0 INTRODUCTION/OVERVIEW

The National Ophthalmic Disease Genotyping and Phenotyping Network (eyeGENE®) is a research venture created by the National Eye Institute (NEI), part of the National Institutes of Health (NIH). eyeGENE® aims to advance studies of eye diseases and their genetic causes by giving researchers access to DNA samples, clinical information, and patients that may meet their criteria to participate in research studies and clinical trials.

The eyeGENE® research program will require a genetic counseling service for the newest protocol, per NIH institutional guidance. The eyeGENE® program is offering whole exome sequencing (WES) and whole genome sequencing (WGS) to participants in its recruitment protocol (NIH IRB #: 001647), National Ophthalmic Genotyping and Phenotyping Network, Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases. Genetic testing will be completed by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory and the results received by the eyeGENE® study team. This clinical testing may return primary results and/or results with secondary findings unrelated to a participant’s eye condition.

1.1 BACKGROUND

The ability to detect disease-causing variants in individuals with inherited ophthalmic diseases offers several benefits for patients and their families. When eyeGENE® began in 2007, this type of molecular testing was not widely available. The eyeGENE® program helped overcome the challenge of providing genetic information to individuals who want to know the molecular basis for their condition, the chance of recurrence, and whether they could benefit from the treatments that were being developed. Clinical genetic testing has now become more readily available, and technologies have advanced to broaden testing and decrease costs. Techniques such as whole exome sequencing (WES) or whole genome sequencing (WGS) allow researchers to look at thousands of genes.

This new way of testing increases the chances of finding the genetic cause of an individual’s eye condition; however, it may also detect genetic changes related to other medical conditions distinct from the eye condition.

Pre- and post- genetic test counseling is a part of standard healthcare. Since the eyeGENE® research program is offering clinical genetic testing, the program is obligated to provide genetic counseling per the NIH IRB Guidance for the Return of Secondary Genomic Findings.

https://ohsrp.nih.gov/confluence/display/ohsrp/Genetic+and+Genomic+Research

1.2 SCOPE

To fulfill its clinical research mission and NIH institutional requirements, eyeGENE® Stage 3 requires genetic counseling services. Since participant recruitment will be directly between eyeGENE® and participants, without a clinician intermediate, it is necessary for eyeGENE® to ensure that participants receive genetic counseling as a part of the study.

The solution requirements are listed below in Section 2.

1.3 OBJECTIVES

Through this contract, the Company shall supply the Customer a solution which includes licensed genetic counseling services, a hosted instance of a patient web portal, Coordinating Center dashboard, implementation services (one-time setup) and professional services. The Customer solution shall be configured to include the following modules, endpoints, capabilities, services, and support.

Privacy Policy & Terms of Use

Coordinating Center Dashboard

Audit Log

Participant Web Portal

2.0 REQUIREMENTS

2.1 TASKS

Task 1. Provide Licensed Genetic Counseling Services

Timely availability of licensed genetic counseling services in all 50 states, including pre-and post-test counseling. Counseling must include:

o Family history o Explanation of risks and benefits of genetic testing, including implications for family members o Summary letter to participant o Phone call/video call with participant that allows adequate time for counseling and all participant questions o Documentation of participant interaction

Task 2. Platform hosting and maintenance – The platform license is inclusive of platform hosting and maintenance as follows:

Management of the solution, to include all necessary software and hardware maintenance

Commented [NA([1]: Any considerations needed for minors?

Also, do we want to add something about the quality of customer service?

Commented [NA([2R1]: Silly question‐ is there a difference between licensed and board certified?

Commented [R[3R1]: Most counselors must be board certified to obtain a license. Some states require a license to practice.

Commented [NA([4]: I think it would be beneficial to outline what we expect to occur during pre‐ and post‐ counseling such as a review of family history, general risks/benefits, implications for self and family, etc. I think it could be easy for a company to skirt by doing the bare minimum based on the current list. I would hope a credentialed GC would perform as we expect but good to cover our bases?

Compliance with applicable standards, regulations and guidelines including those applicable to the federal government

System training and platform user guides

End user, site, and administration support

Task 3. Professional Service - Professional services in support of platform management, distribution and management, content management and reporting. Professional Service are to be billed as time and materials. Platform Support Package includes:

Copyright and Creative Support

Language translations

Managed Services

Solution Enhancements

Training

Task 4. System Requirements - The list of requirements for the application functionality are as follows:

21 CFR Part 11 compliance

WCAG 2/508 compliance

Compatible with screen reading software (i.e. JAWS, ZoomText)

On-demand access to participant status and download for Customer

Participant structured data bulk download

Long-term participant access to genetic counseling report

Customer access to Participant interface for demo use and system testing

Ensures appropriate government encryption, security, etc. for both archive and retrieval.

Participant requirements for personal details to confirm their identity.

The application will include a ‘More Information’ link which will direct users to eyegene.nih.gov in a new browser tab.

Commented [GK([5]: Is this access to the genetic testing results? In other words, are we looking for the solution to store and share the GT results for the participants?

Commented [N[6R5]: All of the companies I've talked to have a patient portal, like many other EHRs, where patients have access forever to any documents produced by genetic counseling. Would include pedigree, genetic counseling report.

The application will specify to contact program administration with any questions throughout. The application and all subsequent pages on the website will include contact info and links for the NIH Terms of Services, Privacy Policy, and Antispam Policy.

Search functionality by participant name minimally. Preferred search function to include status (complete, incomplete, not started).

Basic summary statistics available in administrative dashboard, including how many participants have had counseling.

2.2 ASSUMPTIONS

The company will not be held responsible for delays in the timetable due to unavailability of data or resources from Customer participating in the project. The target dates will be adjusted accordingly to account for those delays.

Company will have a dedicated project manager/point of contact.

Company will have reasonable and timely access to business and IT representatives from the eyeGENE® staff dedicated to the project.

Company will help identify dependencies and possible areas where slippage might occur.

Timelines will be dependent on the availability of eyeGENE® resources and outputs.

No scope of work is implied unless explicitly addressed in this document.

All dates and timelines referenced in this SOW are subject to change based upon modifications to Project scope and/or dates as approved by Customer, and mutually agreed to by both parties.

All deliverables requested by eyeGENE® are completed in accordance with this SOW.

The eyeGENE® team will assign a single point of contact to support the team with setting the direction of the project, obtaining access to eyeGENE® information, scheduling meetings/interviews with key resources, and reviewing and approving deliverables.

eyeGENE® staff will be responsible for submission of materials to the NIH Institutional Review Board.

3.0 SECURITY REQUIREMENTS

21 CFR Part 11 compliance WCAG 2/508 compliance

4.0 SELECTION EVALUATION CRITERIA

Final selection of vendor will be evaluated by the following criteria:

Ability to meet requirements as described in section 2 Past performance with government contracts Timeline of deliverables as proposed by vendor Vendor price Counselor experience in ophthalmology/rare disease counseling