PATIENT SAFETY MONITORING IN INTERNATIONAL LABORATORIES (SMILE)

Johns Hopkins University, Baltimore MD

Investigators

Abstract

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDS has a requirement for a comprehensive and uniform approach to evaluate initial and on-going laboratory capability and readiness to carry out NIAID-funded clinical trial protocols outside the U.S. NIAID places the highest priority on ensuring the safety and optimal management of subjects who participate in its clinical trials and on obtaining reliable laboratory-based data critical for the meaningful interpretation of study findings. Equally important is the safety of those who perform the laboratory testing. Clinical laboratories in the U.S. are required to meet Clinical Laboratory Improvement Amendments (CLIA) performance standards and participate in a variety of external proficiency testing programs. Though non-U.S. accreditation organizations and providers of proficiency testing programs exist, these vary significantly in their requirements and level of oversight of clinical laboratories. The purpose of the Patient Safety Monitoring in International Laboratories (SMILE) contract is to provide a comprehensive and uniform approach to evaluate initial and on-going laboratory capability and readiness to carry out NIAID-funded clinical trial protocols by (1) monitoring laboratories compliance with Good Clinical Laboratory Practices (GCLP), (2) monitoring the ability of laboratories to reliably perform protocol-specified tests by evaluating results obtained with panels of coded samples, (3) providing Labs with various means of assistance, guidance and training to address and prevent recurrence of deficiencies in GCLP and/or proficiency testing, and (4) maintaining a computerized data management system and document library that include lab performance data and guidance documents.