The U.S. Department of Health and Human Services, National Institute of Allergy and Infectious Diseases has a continuing requirement for a comprehensive program to ensure that clinical laboratories in developing countries around the world can reliably perform tests to monitor the safety and efficacy of preventive and therapeutic products as part of clinical HIV/AIDS trials sponsored by the NIAID.

The Division of AIDS (DAIDS) in the National Institute of Allergy and Infectious Diseases (NIAID) supports a global research portfolio to advance biological knowledge of human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), its related coinfections, and its co-morbidities. With the ultimate goal of creating an “AIDS-Free Generation,” DAIDS develops and supports the infrastructure and biomedical research needed to: 1) reduce HIV incidence through the development of an effective vaccine and biomedical prevention strategies that are safe and desirable; 2) develop novel approaches for the treatment and cure of HIV infection; 3) develop interventions to treat and/or prevent HIV co-infections and co-morbidities of greatest significance; and 4) foster partnerships with scientific and community stakeholders to develop and implement effective interventions. NIAID supports four HIV/AIDS clinical trial networks as part of its HIV clinical research enterprise. High quality test results support the safety of study participants and the reliability of study results. DAIDS employs a variety of Laboratory Quality Assurance oversight contractual resources to monitor and enhance the ability of laboratories to accurately and reliably perform trial-specified clinical laboratory testing (https://www.niaid.nih.gov/research/daids-clinical-research-policies-standard-procedures).

SMILE will continue to serve current and future NIAID-sponsored clinical trial networks and collaborating study groups (User Groups), as well as individual grantees conducting clinical research. The current contract supports approximately 150 laboratories in 18 countries. The current contract has been held by Johns Hopkins University, Baltimore, Maryland since its inception in 2004. The current contract is held under contract number 75N93020C00001. The period of performance of the current contract is November 15, 2019 through November 14, 2026.

• The objective of this acquisition is to continue to provide a comprehensive and uniform approach to evaluate initial and on-going capability and readiness to carry out NIAID-funded clinical trial protocols (Protocols) by (1) monitoring compliance with good clinical laboratory practice standards, (2) monitoring the quality and reliability of Protocol-specified laboratory test results, (3) providing Labs with various means of assistance, guidance and training to improve the quality of laboratory operations, and (4) hosting and maintaining the existing electronic data management system.
• Reviewing laboratory audit reports to identify deficiencies in good clinical laboratory practices and providing laboratories with guidance for corrective action
• Monitoring laboratories ability to accurately and reliably perform tests used to diagnose viral, fungal, bacterial and parasitic infections, hematology and blood chemistry assays, liver function tests, and drug resistance assays. The contractor must have experience in reviewing and interpreting proficiency testing reports from providers such as the College of American Pathologists
• Providing assistance, guidance and training on procedures and Standard Operating Procedures related to laboratory qualify management, instrument and test validation, specimen management, data management, equipment maintenance, personnel safety, test QA/QC. The contractor must have experience with creating and utilizing training tools and must have staff able to travel to various laboratories outside the U.S. to provide training
• Maintaining and hosting an existing SMILE computerized data management system and document library to track and make available documents in support of activities performed under the contract. Further enhancement of the system may be necessary. The contractor must have the ability to maintain the computerized system security documentation as required by OMB Circular A-130, Appendix III and the Federal Information Security Management Act (FISMA)