Evaluating effectiveness of a 4-Stage Experimental Training Program combined CBL with ISO 15189 technical requirements in clinical biochemistry teaching

Abstract Background: ISO 15189:2012 is widely recommended for clinical laboratories. However, it has not been paid enough attention in medical laboratory education and experiments in clinical biochemistry courses. Methods/Approach: The teaching program of clinical biochemistry aims to improve students’ awareness and ability of quality management according to ISO 15189 technical requirements. It is a 4-stage experimental training program to teaching skills: "establish an overall testing process based on the patient's clinical indicator, clarifying principles, improve operational skills, review process and continuous improvement". The program was implemented in our college during the winter semesters of 2019 and 2020. 185 students participate in the program as an experimental group, other 172 students as control group adopt the conventional method. Participants completed an online survey after each class to evaluate the class. Results/Outcomes: The test group had significantly better examination scores not only in experimental operational skills (89.27±7.16 vs. 77.51±4.72, p<0.05 in 2019 grade, 90.31±5.35 vs. 72.87±8.41 in 2020 grade) but also total examination 83.47±6.16 vs. 68.90±5.86 in 2019 grade, 82.42±5.72 vs. 69.55±7.54 in 2020 grade) than the control group. Questionnaire results survey revealed that the test group achieved the classroom goals better and had more positive impact on learning than traditional methods (all p<0.05). Conclusions: A 4-stage experimental training program based on ISO 15189 technical requirements combined with CBL in clinical biochemistry is an effective and acceptable teaching strategy for the conventional training program.