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.

Improving diagnostic capability for HPV disease internationally within the NIH-NIAID Division of AIDS Clinical Trial Networks.

OBJECTIVES: To evaluate an external quality assurance (EQA) program for the laboratory diagnosis of human papillomavirus (HPV) disease that was established to improve international research capability within the Division of AIDS at the National Institute of Allergy and Infectious Disease-supported Adult AIDS Clinical Trials Group network. METHODS: A three-component EQA scheme was devised comprising assessments of diagnostic accuracy of cytotechnologists and pathologists using available EQA panels, review of quality and accuracy of clinical slides from local sites by an outside expert, and HPV DNA detection using a commercially available HPV test kit. RESULTS: Seven laboratories and 17 pathologists in Africa, India, and South America participated. EQA scores were suboptimal for EQA proficiency testing panels in three of seven laboratories. There was good agreement between the local laboratory and the central reader 70% of the time (90% confidence interval, 42%-98%). Performance on the College of American Pathologists' HPV DNA testing panel was successful in all laboratories tested. CONCLUSIONS: The prequalifying EQA round identified correctable issues that will improve the laboratory diagnosis of HPV-related cervical disease at the participating international study sites and will provide a mechanism for ongoing education and continuous quality improvement.