PATIENT SAFETY MONITORING IN INTERNATIONAL LABORATORIES (pSMILE)
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 Institute of Allergy and Infectious Diseases (NIAID), under the National Institutes of Health (NIH), has issued a Presolicitation for Patient Safety Monitoring in International Laboratories (pSMILE). This effort aims to enhance the ability of mostly non-U.S. laboratories participating in NIAID-funded and collaborative clinical trials to perform study-specified tests in accordance with Good Clinical Laboratory Practices (GCLP) and produce reliable test results. The anticipated Request for Proposal (RFP) will be available on or about January 26, 2026, with proposals due by January 23, 2026.
Scope of Work
The selected contractor will be responsible for:
- Reviewing GCLP audit reports, capturing deficiencies, providing guidance, and tracking corrective actions.
- Supporting method verification/validations for laboratories.
- Determining laboratory accuracy and reliability through Proficiency Testing (PT) panels, including purchasing, monitoring, grading results, and assisting with root cause investigations.
- Providing guidance and training to laboratories via various communication channels and site visits.
- Maintaining a 508 and FISMA-compliant web-based information repository for lab-specific documents and an open-access resource library.
- Providing overall program management for the integration and coordination of all contract activities.
Contract & Timeline
- Type: Cost-Reimbursement, Level-of-Effort (Term) Contract
- Duration: One (1) Base Year + Six (6) One-Year Options, for a total possible performance period of 7 years, beginning on or about February 15, 2027.
- Level of Effort: 13.70 Full Time Equivalents (FTEs) per year, with additional options for increased effort (1.7 FTEs per 15 additional labs).
- Set-Aside: None specified
- RFP Availability: On/about January 26, 2026
- Proposal Due: January 23, 2026, 8:00 PM EST
- Published: January 8, 2026
Additional Notes
Offerors should possess qualifications and experience in clinical laboratory testing, proficiency testing assessment, and GCLP. Advanced programmer capabilities are required for electronic systems. ISO 9001:2015 certification for contract operations is recommended. Proposals must be submitted online via the NIH’s electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov). This is a Presolicitation and does not commit the Government to award a contract.