PATIENT SAFETY MONITORING IN INTERNATIONAL LABORATORIES (SMILE)
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 National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), is issuing a Sources Sought Notice for Patient Safety Monitoring in International Laboratories (SMILE). This R&D market research aims to identify qualified sources, including small and small disadvantaged businesses, capable of supporting international clinical trials related to HIV/AIDS. Responses are due by March 6, 2026, at 3:00 PM Local Time.
Purpose & Background
This notice is for information and planning purposes only, not a solicitation. It supports the Division of AIDS (DAIDS) within NIAID, which seeks to advance biological knowledge of HIV/AIDS and related conditions. The SMILE project enhances the ability of international laboratories participating in NIAID-supported clinical trials to perform tests according to good clinical laboratory practices and produce reliable results, ensuring patient safety and data integrity.
Current & Anticipated Requirements
The current contract (No. 75N93020C00001) is held by Johns Hopkins University, supporting approximately 170 non-U.S. laboratories in 15 countries, valued at $28,283,334, and ends November 14, 2026. The anticipated future requirement is a term/level of effort contract from November 15, 2026, through May 14, 2027, with a potential 6-month option, requiring approximately 6.85 FTEs, potentially increasing to 13.70 FTEs over 12 months.
Project Requirements
Respondents should demonstrate capabilities in:
- Reviewing laboratory audit reports and providing corrective action guidance.
- Monitoring laboratory performance for various diagnostic tests (e.g., viral, fungal, bacterial, hematology, blood chemistry).
- Providing training and guidance on laboratory quality management, instrument validation, specimen management, data management, and safety.
- Maintaining and hosting the existing SMILE computerized data management system and document library.
- Ensuring computerized system security compliance with OMB Circular A-130 and FISMA.
Submission Requirements
Interested parties must submit a capability statement (five-page limit, excluding resumes) detailing staff expertise, in-house capability, prior similar projects, corporate experience, prior Government contracts, references, professional qualifications, and facilities. Resumes for proposed key personnel, including the Principal Investigator, are required. Business information such as Unique Entity ID, company name, address, points of contact, GSA Schedule, accounting system, and company type must also be included.
Submission Details
Capability statements are due by 3:00 PM Local Time on March 6, 2026. Submissions must be electronic (PDF or Microsoft Word) via email to Patrick Finn at patrick.finn@nih.gov. The email subject line must be HHS–NIH–NIAID–RDSS–26-75N93026R00010.
Important Notes
This is for informational and planning purposes only and does not obligate the Government to award a contract. Responses will not be considered adequate for a solicitation, and no proprietary or sensitive information should be included.