Strengthening the Application of the DAIDS GCLP Guidelines: The Implementation of an Integrated Laboratory Oversight Framework.

The Division of AIDS (DAIDS) Good Clinical Laboratory Practice (GCLP) Guidelines establish a framework to guide the oversight of laboratories supporting DAIDS-sponsored clinical research or trials. Compliance with these guidelines promotes data reliability, validity, and safety of the clinical research or trial participants and laboratory staff and ensures adherence to regulatory requirements. Acknowledgment and adoption of the DAIDS GCLP Guidelines are critical in building laboratory capacity and preparedness for conducting clinical trials. In collaboration with DAIDS, laboratory experts support the implementation of the DAIDS Integrated Laboratory Oversight Framework (Framework) activities. This article describes the implementation of the GCLP Guidelines, the Framework activities, and the coordinated efforts to strengthen laboratory performance. The Framework activities include four components: Quality Assurance Oversight, GCLP Audits, GCLP Training, and Laboratory Quality Improvement. Comparison of GCLP Guidelines with other regulations or standards, including U.S. Clinical Laboratory Improvement Amendments regulation 42 CFR 493, College of American Pathologists, World Health Organization GCLP, and International Organization for Standardization, ISO 15189:2012 standards, highlighted the differences and similarities to guide integration and harmonization efforts. Processes related to the Framework activities are outlined in detail, including key data derived from the managed activities of over 175 laboratories worldwide. Via the evolution of the DAIDS GCLP Guidelines and laboratory oversight workflows, the laboratories participating in DAIDS-sponsored clinical research and trials have successfully participated in internal and external regulatory audits. The collaborative and integrated oversight approach promotes knowledge-sharing and accountability to support the implementation of the DAIDS GCLP Guidelines and compliance monitoring. Lessons learned have helped with the implementation of the DAIDS integrated laboratory oversight approach and quality oversight programs at multiple laboratories worldwide.

A novel internal training program using Kern's 6-step approach to curriculum development for medical laboratory scientists training to be international quality assurance/quality control coordinators.

OBJECTIVE: Patient Safety Monitoring in International Laboratories (pSMILE) is a resource ensuring quality testing in clinical laboratories performing National Institutes of Health-funded HIV research requiring specific staff training. We demonstrate the development of an online asynchronous training model using Kern's 6-step approach to support pSMILE functions. METHODS: An existing curriculum was revamped to incorporate Kern's approach. Metrics for success were described in rubrics with feedback guiding improvements and updates. RESULTS: Curriculum updates took more than a year. Direct observations of skills informed curriculum changes. Module self-evaluations were reviewed to assess performance and the overall curriculum. The content, curriculum, and training documentation were deemed compliant with International Organization for Standardization (ISO) 9001:2015. CONCLUSION: Asynchronous training for highly skilled and self-directed staff is a novel way to deploy training while maintaining productivity of existing staff. Feedback and evaluation allowed for curriculum updates including previously underdeveloped topics. Kern's approach ensured that the needs of the sponsor, management, laboratories, and learners were met.