Abstract:

Objective To analyze the current situation of laboratory quality management according to the on-site supervision of laboratories in different types of medical institutions in Shanghai in 2019. Methods According to the quality management standard of clinical laboratory in Shanghai medical institutions,the quality management of laboratory was evaluated by on-site inspection in 289 laboratories and the results were summarized. Results The median score was 89 in the 289 laboratories,and 98 in 37 laboratories approved by ISO 15189. The excellent rate of the laboratory of the third level hospital,second level hospital,first level hospital,medical laboratory and nongovernmental hospital were 70.0%（35/50）,23.4%（18/77）,0%（0/80）,47.8%（22/46） and 16.7%（6/36）;the unqualified rate was 0%（0/50）,7.8%（6/77）,17.5%（14/80）,2.2%（1/46） and 19.4%（7/36）,respectively. “5.6 ensuring quality of examination results” was listed in the top three terms of the frequency of non-conformity in different types of medical institutions. The other non-conformity terms are not identical,including “4.2 quality management system”“4.5 examination by referral laboratories”“4.14 evaluation and audits”“5.1 personnel”“5.3 laboratory equipments,reagents and consumables”. Conclusions The quality management of laboratories approved by ISO 15189 is better than that of non-accredited laboratories. The overall quality management of laboratories in the third level hospitals is better than that in other medical institutions. There is different frequency of noncompliance in varied medical institutions.

Key words: Quality management system, On-site inspection, Total quality management, Quality assurance