Study Of Key Quality Indicator For Clinical Laboratories:Appropriateness Of Laboratory Reports In China

ObjectiveTesting report is the final output of clinical laboratory. The accuracy and reliability of the report is important for prevention, diagnosis, treatment and prognosis of disease, and may even affects the life safety of patients. The appropriateness of reports, including the integrity, timeliness, and accuracy of results reporting, are important quality indicators of post-examination process. This study aims to investigate the status quo of reports appropriateness in China for clinical biochemistry, hematology, and immunology, and to identify its potential influence factors. We seek to improve and refine the laboratory reporting system for clinical laboratories and provide the baseline data for related quality specifications establishment.MethodQuality indicators on reports appropriateness suitable for China were selected through reviewing the literature. The questionnaire was prepared and the network platform was designed for data reporting and feedback. A total number of1209,1120, and991laboratories were included in the study for clinical biochemistry, hematology, and immunology, respectively. All the participants had been enrolled in National External Quality Assessment(EQA) scheme organized by National Center for Clinical Laboratories(NCCL) in2013. The questionnaires were assigned to all the participants in both electronic and print form. The survey consists of three parts:1) General survey: basic information about hospitals and laboratories, laboratory information system construction, and laboratory reporting system;2) Integrity of the report: Integrity of report template and content filling;3) Six quality indicators on reports appropriateness: reporting delays, instruments and LIS data non-conformities, report and request non-conformities, erroneous report transportation, report recall, and report modification. The integrity of the content filling survey was conducted in April2013, and other quality indicators investigation were retrospective surveys for year2012. The survey results can be reported back via network platform, E-mail or regular mail. Data reported via network platform were automatically imported into self-developed special statistical analysis software, while data of the latter two ways were manually entered. All quality indicators were evaluated in two ways: percentage and sigma (a) scale. SPSS13.0was used to perform the group comparison.ResultTotally659(54.51%),609(54.38%), and530(53.48%) laboratories submitted the survey results for clinical biochemistry, hematology, and immunology, respectively, among which60%were tertiary-A hospitals. The most common way for testing request was in electronic form. Print reports produced by LIS were the primary reports generation program. And electronic transmission was the main way for reports delivery. The percentage of laboratories with unqualified report template integrity achieved as high as69.0%, of which the laboratory address or telephone number, time of specimen collection, clinical diagnosis or symptoms, and time of specimens receiving had higher vacancies. The overall failure rate of content filling integrity was45.9%, of which clinical diagnosis or symptoms, time of specimen collection and time of specimens receiving had higher rates. Only about26%of laboratory whose content filling integrity could reach an acceptable level (3a). The overall sigma levels of six quality indicators on report appropriateness were more than4, and there was no significant difference among outpatient, inpatient and emergency department. The main reason for reports delay was equipment failure. More than90%of laboratories had a sigma level higher than3for all six quality indicators. Group comparison suggested that the reports appropriateness of laboratories in tertiary-A hospitals or accredited by ISO15189was more excellent. Reports appropriateness with electronic request, electronic form and electronic transmission were superior than that with other ways.ConclusionThe level of report appropriateness in China differs from laboratory to laboratory. Integrity of report template and content filling are unsatisfied. The standardization of report format and filling is extremely urgent now. Laboratories should develop emergency action plan to ensure the integrity, timeliness and accuracy of the report, especially when the instrument breaks down. Strengthening information technology can help improve the appropriateness of the reports. The platforms and frameworks established in the study will promote the long-term internal quality control and external quality assessment scheme. Laboratories should monitor the report appropriateness through ongoing horizontal and longitudinal comparison to identify the insufficient performance and improve laboratory quality services.