Patient safety monitoring in international laboratories (SMILE)

The National Institute of Allergy and Infectious Diseases (NIAID), a component of the Department of Health and Human Services National Institutes of Health, seeks contractor capability to perform laboratory monitoring and quality assurance services for the Patient Safety Monitoring in International Laboratories (SMILE) program. The primary objective is to provide comprehensive monitoring and quality assurance services for approximately 170 non-U.S. laboratories in 15 countries participating in NIAID-sponsored HIV/AIDS clinical trials. Key requirements include reviewing laboratory audit reports and providing corrective action guidance, monitoring laboratory accuracy across viral, fungal, bacterial, parasitic, hematology, chemistry, liver function, and drug resistance testing, providing training and assistance on laboratory quality management and Standard Operating Procedures, and maintaining and hosting the existing SMILE computerized data management system with FISMA compliance. Prospective contractors must demonstrate relevant staff expertise, past performance on similar projects of comparable size and complexity, the capability to travel internationally for training delivery, and current GSA Schedule registration. Capability statements of no more than five pages (excluding resumes) must be submitted electronically to Patrick Finn, Contracting Officer, at patrick.finn@nih.gov by 3:00 PM (local time) on March 6, 2026.

This procurement is a Research and Development Sources Sought Notice with no set-aside designation and represents a follow-on opportunity to the incumbent contractor, Johns Hopkins University, School of Medicine, which currently holds Contract 75N93020C00001 with a total value of $28,283,334. The anticipated follow-on requirement involves a term/level of effort contract for 6.85 Full Time Equivalents (FTEs) during November 15, 2026 through May 14, 2027, with an option to extend for an additional six months through November 14, 2027, which would increase the total to 13.70 FTEs for 12 months of effort. The current contract, awarded on November 15, 2019, is set to expire on November 14, 2026, making the proposed follow-on contract a direct continuation of services with a slightly modified scope and staffing model. This Sources Sought Notice is for market research purposes only and does not obligate the Government to award a contract or pay for submitted information.