LICENSED GENETIC COUNSELING SERVICES

Notice of Intent to Sole Source for  Genetic Counseling Services

Special Notice # NIHODSN053025

The National Institutes of Health (NIH) intends to award a follow-on firm-fixed-Price purchase order to DNAFEED INC for Genetic Counseling Services.

In accordance with FAR Part 6.302-1, the Contractor is the only known responsible source who can provide the specific continued Genetic Counseling Services per SOW below.

The National Eye Institute (NEI)  has an ongoing  requirement that requires Genetic Counseling Services in relation to reference laboratory testing.

This notice is not a request for competitive quotes.  However, any party that believes it can provide the services as  stated herein may submit a written capability statement that clearly supports and demonstrates their ability to satisfy the requirement. A determination by the Government to compete this proposed award based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued approximately five (5) days after the date of this notice unless the Government determines that another organization has the capability to meet this requirement.

 Please email responses  no later than 10:00 a.m.  EST on Friday July 6, 2025.

1     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:
  • Family history
  • Explanation of risks and benefits of genetic testing, including implications for family members
  • Summary letter to participant
  • Phone call/video call with participant that allows adequate time for counseling and all participant questions
  • 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
• 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.  
• 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.

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

End.