Sentinel System Bridge Contract
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Food and Drug Administration (FDA) has issued a Justification for Other than Full and Open Competition (JOFOC) for a sole-source bridge contract with Harvard Pilgrim Health Care, Inc. This contract, valued at an estimated $23,569,683.00, ensures the continued operation of the Sentinel System program. The bridge contract will cover a base period from March 29, 2026, to September 28, 2026, with two six-month option periods.
Purpose & Context
The Sentinel System is a congressionally mandated program (FDAAA 2007) requiring the FDA to develop methods for accessing and analyzing disparate data sources to monitor drug safety. This JOFOC justifies awarding a bridge contract to the incumbent, Harvard Pilgrim Health Care, Inc., to maintain critical services while the competitive acquisition process for the follow-on Sentinel 3.0 contract is completed.
Scope of Work
The bridge contract will support essential activities including:
- Implementing ARIA through query design, implementation, and reporting for insurance billing claims and electronic healthcare data.
- Maintaining 16 simultaneous queries and 152 principal programming hours.
- Analytic Tool Maintenance, including Real World Evidence (RWE) capabilities.
- Program and Project Management, including Atlassian Access and FISMA Compliance.
Contract Details
- Contract Type: Firm-fixed-price bridge contract.
- Period of Performance: Base period March 29, 2026 – September 28, 2026, plus two (2) six-month option periods.
- Total Estimated Value: $23,569,683.00.
- Set-Aside: This is a sole-source justification under FAR 6.103-1, citing "Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements."
Justification
The FDA determined that a sole-source award to Harvard Pilgrim Health Care Inc. is necessary to prevent a lapse in critical services. Harvard Pilgrim Health Care Inc. has been the incumbent for approximately 15 years. Transitioning to a new contractor would involve significant learning curves, increased risk of service disruption, reduced productivity, and higher costs. An "intent to sole source" notice was posted on SAM.gov, and no contractors responded. This bridge contract is limited in duration to allow for the completion of the competitive acquisition for the Sentinel 3.0 contract.