Safety Management Of Clinical Process Of Continuous Renal Replacement Therapy

Objective: Acute kidney injury(AKI)is a common complication in critically ill patients,usually associated with poor prognosis,increased mortality and medical costs.Continuous renal replacement therapy(CRRT)is recognized as the preferred treatment for AKI in critically ill patients due to its hemodynamic stability,high solute clearance and easy control of fluid balance.CRRT has been widely used all over the world,while the controversies on the indications,treatment mode,dosage,anticoagulant and so on have lasted for many years,and it has never reached an agreement on the best scheme.There are great variability in practical models among different countries and medical institutions.The difference has become a hidden danger to patient safety.At the same time,related adverse events and complications occur frequently,which poses a direct threat to the safety of patients.The application of CRRT has been increasing rapidly in recent years in China,but there are few studies on the medical safety of CRRT.Recent studies have shown that the application of CRRT is different from that of other countries,while the details of characteristic of CRRT are still inadequate.In the meanwhile,the related medical safety management research is scarce,and the incidence of adverse events of CRRT is still unclear.The purpose of this study is to explore the clinical process factors that affect the safety of CRRT by describing the characteristics of clinical application and adverse event and constructing failure mode and effect analysis(FMEA)to determine the high-risk failure modes that threatened the safety of patients and to develop improvement measures and verify the effect of intervention with the aim to provide theoretical basis and practical experience for improving quality control and patient safety of CRRT.Methods: The first stage of the study was designed as a cross-sectional investigation,Member units of the branches of nephrology and critical care medicine in the Liaoning branch of the Chinese Medical Association were included in this study,To investigate the clinical application characteristics and adverse events of patients treated with CRRT in intensive care unit(ICU)and department of renal medicine.The questionnaire is designed based on the related research abroad and modified by experts.The second stage study focuses the adverse events found in the phase I survey.Combining with the risk factors obtained from other related safety studies on CRRT safety management,the failure mode and effect analysis(FMEA)was conducted through the risk score matrix identifying and evaluating potential security vulnerabilities,with the aim of determining the high-risk failure mode and the corresponding failure reasons of the clinical process of CRRT.Through the analysis of the potential causes of failure,targeted improvement measures were developed.A control study was conducted in the third stage of the study with the implementation of a checklist developed by the FMEA analysis with the aim of verifying the effectiveness of this safety measure.Results: A total of 72 departments in 51 hospitals were included in the survey with a overall feedback rate of 92.3%.In the returned questionnaire,66(91.7%)was included in the final data analysis.A total of 3006 patients were included in the survey of adverse events of CRRT.A total of 2262 questionnaires were collected with the feedback rate of 75.2%.The most commonly used mode of CRRT is continuous venous hemofiltration(CVVH),applied in 63 departments(95.5%).Most of the departments(50,75.8 %)take l/h as the common dose mode.Regardless of CVVH or continuous venovenous hemodiafiltration,before-after combination is the most commonly used dilution mode.When CVVH is prescribed in l/h mode,dosage of ?2l/h is the most frequently uses(30,47.6%).If it is prescribed in ml/kg/h,the dosage of >25ml/kg/h is the most common(10,15.9%).Generally the duration of daily treatment of CRRT is 7-8 hours(22,33.3%)and the 24-hour treatment is common in ICU(16,24.2%),The internal jugular vein is the most commonly used site of catheter placement(45,68.2%)and heparin is the most commonly used anticoagulant(43,65.1%).A total of3006 questionnaires were distributed in the adverse events survey with 2262 copies returned.The feedback rate was 75.2%.Among them,412 questionnaires reported 430 adverse events and the incidence of adverse events was 14.3%.Of the 430 reported adverse events,more was releated to extracorporeal coagulation and decreased blood flow(89,20.7%),metabolic alkalosis(46,10.7%),metabolic acidosis(38,8.8%),hypertension(28,6.5%),hypocalcemia(26,6.0%),arrhythmia(24,5.6%),hypercalcemia(23,5.3%)and bleeding at puncture site(22,5.1%).There were 131 questionnaires(4.4%)reporting defects of medical records,involving 159 cases of missed information in the prescription and monitoring records.During the FMEA analysis,the team drew up a flow chart and listed 22 potential failure modes and 98 failure reasons.Hazard analysis was conducted then 12 potential failure modes and 25 corresponding failure causes were determined.Through root cause analysis,14 improvements and a checklist were developed.There were 96(before FMEA)and 89patients(after FMEA)involved in the control study,and no severe coagulopathy,hypothermia,lack of prescription information and renal function monitoring were reported after the intervention.Other adverse events such as filter coagulation and pipeline coagulation were also significantly reduced.Conclusions: According to our study,there are significant variations with professional service ability and practice mode on CRRT in Liaoning Province,and the incidence of adverse events of CRRT practice is high.The most frequent adverse events are extracorporeal coagulation and decreased blood flow.Through the FMEA analysis,we developed a checklist and found it could decrease the related risks and adverse events of CRRT,and improve the safety and standardization in the clinical process of CRRT treatment.