PATIENT SAFETY MONITORING IN INTERNATIONAL LABORATORIES (pSMILE)

The National Institute of Allergy and Infectious Diseases (NIAID) under the Department of Health and Human Services is seeking a contractor to provide Patient Safety Monitoring in International Laboratories (pSMILE) services through a cost-reimbursement, level-of-effort contract. The contractor will support approximately 150 laboratories across 18 countries participating in NIAID-funded clinical trials by ensuring compliance with good clinical laboratory practice (GCLP) standards, monitoring laboratory quality and reliability, delivering training and technical assistance, and maintaining a secure web-based electronic data management system. Key responsibilities include reviewing audit reports and preparing corrective action plans within 10 business days, monitoring proficiency testing performance monthly, conducting approximately six 14-day laboratory visits annually, hosting training webinars, and submitting tri-annual progress reports. Offerors must submit separate technical (175-page maximum) and business proposals via the NIH electronic Contract Proposal Submission (eCPS) website by 3:00 p.m. Eastern Time on March 12, 2026, with the anticipated award date of February 15, 2027. All proposals must include a small business subcontracting plan if the total contract exceeds $900,000, demonstrate Section 508 accessibility compliance, and address IT security requirements per NIST SP 800-171 standards.

This solicitation does not contain a set-aside designation and is open to all qualified contractors. Johns Hopkins University is the current incumbent contractor, having held the pSMILE contract since 2004 under contract number 75N93025C00001. The contract requires 13.70 full-time equivalents (FTEs) annually during the base period (February 15, 2027 through February 14, 2028) and throughout six one-year option periods extending through February 14, 2034, with additional options (Options 7-27) available to support up to 21 additional laboratories at 1.7 FTEs per option. While the RFP does not specify exact dollar amounts, the contract structure and staffing requirements indicate a substantial multi-year commitment with potential for significant expansion through exercise of options. Performance will take place in the United States, and a transition period of approximately two months is planned between contract award and the official start date.