PATIENT SAFETY MONITORING IN INTERNATIONAL LABORATORIES (pSMILE)

SOL #: 75N93025R00011Solicitation

Overview

Buyer

Health And Human Services

National Institutes Of Health

NATIONAL INSTITUTES OF HEALTH NIAID

BETHESDA, MD, 20892, United States

Place of Performance

Place of performance not available

NAICS

Research and Development in the Physical (541715)

PSC

Health R&D Services; Health Care Services; Applied Research (AN12)

Set Aside

No set aside specified

Original Source

https://sam.gov/opp/0abf99e73cf24d868852909a3904a891/view

Timeline

Posted

Jan 8, 2026

Last Updated

Feb 19, 2026

Submission Deadline

Mar 12, 2026, 7:00 PM

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 Allergies and Infectious Diseases (NIAID), has issued a Solicitation (75N93025R00011) for Patient Safety Monitoring in International Laboratories (pSMILE). This opportunity seeks to support and evaluate the capability and readiness of mostly non-U.S. laboratories participating in NIAID-funded clinical trials to perform study-specified tests in accordance with Good Clinical Laboratory Practice (GCLP) standards. The goal is to ensure reliable test results, enhance laboratory operations, and support regulatory accountability. Proposals are due March 12, 2026, by 3:00 PM ET.

Scope of Work

The contractor will be responsible for:

Monitoring compliance with GCLP standards.
Monitoring the quality and reliability of Protocol-specified laboratory test results.
Providing assistance, guidance, and training to improve laboratory operations.
Hosting and maintaining the existing electronic data management system.
Preparing and submitting various reports, including Technical Progress Reports, Final Reports, and Summary of Salient Results.
Ensuring all electronic deliverables comply with Section 508 of the Rehabilitation Act of 1973.
Adhering to NIH policy on enhancing reproducibility through rigor and transparency.
Submitting all Author Accepted Manuscripts to PubMed Central (PMC) and acknowledging federal funding.

Contract Details

Contract Type: Cost-Reimbursement/Level of Effort.
Period of Performance: A base period from February 15, 2027, through February 14, 2028, with 6 one-year option periods, for a total potential performance of 7 years.
Estimated Level of Effort: 13.70 Full Time Equivalents (FTEs) per year for the base and each option period.
Options: Includes options to extend the term and for increased level of effort for additional laboratories.
Set-Aside: This requirement is NOT set-aside for small business.
NAICS Code: 541715 (Small Business Size Standard: 1,000 employees).

Submission & Evaluation

Proposal Submission Deadline: March 12, 2026, by 3:00 PM Eastern Time.
Questions Submission Deadline: February 9, 2026.
Submission Method: Electronically via the eCPS website.
Evaluation Factors: Technical Plan/Approach (45%), Scientific and Technical Personnel (25%), Project Management (20%), Facilities, Equipment and Other Resources (10%), and Evaluation of Options (10%).
Evaluation Criteria: Proposals will be evaluated for technical merit, cost realism, and past performance.

Additional Notes

Offerors must be registered in the System for Award Management (SAM). Specific instructions for proposal preparation and submission are detailed in Attachment 1 of the solicitation. Key personnel are considered essential to work performance.