Investigation and analysis of internal quality control on clinical chemistry, clinical immunology and clinical hematology of mutual recognition laboratories in 142 medical institutions in Beijing

Abstract

Objective To investigate the internal quality control (IQC) on clinical chemistry, clinical immunology and clinical hematology in mutual recognition laboratories in medical institutions in Beijing. Methods By means of questionnaire survey and on-site investigation, fresh frozen serum and whole blood samples with assigned values by reference method were measured to investigate the status of IQC on clinical chemistry, clinical immunology and clinical hematology in 142 mutual recognition laboratories in medical institutions of Beijing, and results were analyzed. Results 142 copies of questionnaireson clinical chemistry, clinical immunology and clinical hematology were send out and 120, 97, and 101 laboratories returned the questionnaires respectively .The information feedback rate was 84.5%, 68.3% and 71.1% respectively.All the questionnaires were effective. Questionnaires survey results showed that more than 50% laboratories set up quality control goals and the most of the goals were probability for error detection (Ped) 95%, probability for false rejection(Pfr)5%; About 70% laboratories usecd the same quality control plan for different tests ; The most frequently used quality control rules are 12s/13s/22s. On-site investigation showed that , take the results of clinical chemistry for example, based on the desirable biological variation and WS/T 403-2012 , most of the tests can't meet the quality control goalsunder the existing quality control condition. Conclusion Clinical laboratories should consider their actual situations, assess their own quality levels that they can reach , set reasonable quality standards for themselves , and make appropriate individualized quality control plan. (Chin J Lab Med, 2016, 39: 922-929) Key words: Clinical chemistry tests; Immunologic tests; Hematologic tests; Quality control