Abstract:

Objective To investigate the status and analyze the problems of clinical test quality in non-government medical institutions in Shanghai. Methods Statistical analysis was performed on the non-conformities of on-site clinical test quality inspection of 40 medical laboratories and 36 socially run hospitals with 100 or more approved beds in Shanghai in 2019. Results A total of 654 non-conformities were found,which mainly focused on equipments,reagents and consumables（16.21%）,ensuring quality of examination results（14.98%）,evaluation and audits（7.49%）,quality management system（7.03%）,personnel（6.57%）,examination by referral laboratories（6.57%）,management review（5.50%） and organization and management responsibility（5.20%）. The corresponding sub-clauses more prevalent or severe were equipment calibration（54.72%）,inter-laboratory comparison（43.88%）,internal quality control（40.82%）,internal auditing（42.86%）,procedures and documents（82.61%）,personnel qualifications（37.21%）,training（34.88%）,capability assessment（18.60%）,selection and assessment on referral laboratories（72.09%）,management review report（58.33%）,management review procedures（38.89%）,laboratory director（47.06%）and organization（14.71%）. Conclusions There are many deficiencies and weaknesses that could affect the clinical test quality in non-government medical institutions in Shanghai,so it is imperative to strengthen the training and comprehensive supervision to promote the continued healthy and standardized development of non-government medical institutions' medical laboratories.

Key words: Non-government medical institution, Medical laboratory, Quality inspection