PATIENT SAFETY MONITORING IN INTERNATIONAL LABORATORIES (SMILE)

The National Institutes of Health (NIH) is seeking information from qualified sources to perform a potential Research and Development (R&D) requirement for Patient Safety Monitoring in International Laboratories (SMILE). The purpose of this contract is to enhance the ability of non-U.S. laboratories participating in NIH-supported clinical trials to perform tests in accordance with good clinical laboratory practices and produce reliable test results. The contractor will be expected to monitor compliance with good clinical laboratory practice standards, monitor the quality and reliability of laboratory test results, provide assistance and training to laboratories, and host and maintain an existing electronic data management system. Key aspects of the job include: • Monitoring laboratory compliance with good clinical laboratory practice standards • Monitoring the quality and reliability of laboratory test results • Providing assistance, guidance, and training to laboratories • Hosting and maintaining an existing electronic data management system • Enhancing the system as necessary • Maintaining system security documentation as required by OMB Circular A-130, Appendix III and the Federal Information Security Management Act (FISMA)