Nationwide Investigation and Analysis of Present Status of Independent Clinical Laboratories in China / 现代检验医学杂志

ABSTRACT

Objective To build a supervision mechanism for independent clinical labs (ICL),surveyed the current situation of such novel institutions in China.Methods By way of the nationwide network of clinical labs,ICL in China were surveyed by written questionnaires and spot inspection.Results In the surveyed 38 ICLs,the maximum registered capital was 44 900 thousands,the minimum was 2 000 thousands.The maximum number of employee was 1 105,the minimum was 19.6 labs passed ISO15189 ratification,4 labs passed CAP ratification.17 labs participated in local external quality control,29 labs par-ticipated in national external quality control.Conclusion Although ICL in our country have developed well in the past dec-ade,such vulnerabilities as unbalanced staff ratio,full-range quality control bugs,cutthroat competition,asymmetrical infor-mation disclosure and bio-safety have loomed in the meantime.It is time to formulate a stricter industry access system and appropriate regulatory modes.