Survey and Solutions for the Current Status of Quality Control in Small Hospital Laboratories

Jae Han Kim, Eun Jin Choi, Gyuhyeon Hwang, Jae Ho Lee, and Mi-Soon Han Department of Laboratory Medicine, U2 Clinical Laboratories, Jangwon Medical Foundation; Department of IT Research Institute, U2Bio Co. Ltd., Seoul, Korea Background: To prevent medically significant errors, hospital laboratories must perform thorough statistical quality control (QC) procedures. We surveyed the QC status of small laboratories and created new statistical QC software that they can easily use for improving QC. Methods: A questionnaire on the status of external and internal QC was created and sent to clinics and hospitals with small-scale laboratories. We then created QC software that can be downloaded and installed for free. Results: External quality assessments were performed in 32% of the clinics (22 of 66) and 52% of the hospitals (12 of 23). Seventy-three percent of all institutions (66 of 90) carried out an internal quality assessment based on their own guidelines, mostly using commercialized QC materials. However, only 52% of clinics and 23% of hospitals used their own acceptable range instead of the manufacturer’s expected range. In addition, the proportion of manual QC management reached 52% in clinics and 82% in hospitals. The QC software we designed covers all the basic functions of statistical QC and aims to improve the quality of laboratories. Conclusions: We obtained basic data on the current status of external and internal QC in small-scale laboratories using this survey. Furthermore, we suggested that new QC software may actually help to improve QC of small laboratories. (J Lab Med Qual Assur 2018;40:101-108)