The CRSS contract has a team of laboratory professionals, which includes members of the American Society of Clinical Pathology (ASCP) and the Health Professions Council of South Africa (HPCSA). These staff members have laboratory management experience in Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) and South African National Accreditation System (SANAS) accredited laboratories. In addition, our laboratory team members have College of American Pathologists (CAP) and HPCSA inspection experience, and are especially familiar with the various inspection checklists and auditing processes utilized by these organizations.
Currently the CRSS Laboratory Services Team, upon approved request, audits laboratory capabilities in continents such as Africa, Asia, and South America, and the Caribbean Islands. The Laboratory Services Team currently conducts initiation, interim, and follow-up visits to facilities ranging from small satellite laboratories to 5000-specimen throughput contract facilities.
In addition to auditing services, the CRSS Laboratory Services Team also offers Good Clinical Laboratory Practices (GCLP) training. This is delivered in an interactive workshop environment, together with didactic presentations and group activities. A typical content course includes the following:
- GCLP Introduction
- Organization and Personnel
- Laboratory Equipment/Instrumentation
- Testing Facility Operations
- Laboratory Information Systems
- Laboratory Safety
- Quality Management Systems
- Records and Reports
- Specimen Management and Tracking
- Verification of Performance Specifications
- Laboratory Audits
General questions regarding the CRSS contract can be directed to NIAIDCRSS@mail.nih.gov.