Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process

Abstract

Background and Objectives: Risk management is considered an integral part of laboratory medicine to assure laboratory quality and patient safety. However, the concept of risk management is philosophical, so actually performing risk management in a clinical laboratory can be challenging. Therefore, we would like to develop a sustainable, practical system for continuous total laboratory risk management. Materials and Methods: This study was composed of two phases: the development phase in 2019 and the application phase in 2020. A concept flow diagram for the computerized risk registry and management tool (RRMT) was designed using the failure mode and effects analysis (FMEA) and the failure reporting, analysis, and corrective action system (FRACAS) methods. The failure stage was divided into six according to the testing sequence. We applied laboratory errors to this system over one year in 2020. The risk priority number (RPN) score was calculated by multiplying the severity of the failure mode, frequency (or probability) of occurrence, and detection difficulty. Results: 103 cases were reported to RRMT during one year. Among them, 32 cases (31.1%) were summarized using the FMEA method, and the remaining 71 cases (68.9%) were evaluated using the FRACAS method. There was no failure in the patient registration phase. Chemistry units accounted for the highest proportion of failure with 18 cases (17.5%), while urine test units accounted for the lowest portion of failure with two cases (1.9%). Conclusion: We developed and applied a practical computerized risk-management tool based on FMEA and FRACAS methods for the entire testing process. RRMT was useful to detect, evaluate, and report failures. This system might be a great example of a risk management system optimized for clinical laboratories.

Identifying risk management challenges in laboratories

“…Another technique which is commonly used in organizations is failure reporting, analysis and corrective action system (FRACAS). It is a technique for identifying and correcting the deficiencies in a system or a product and, thus, prevent further occurrence of them [29]. It is based upon the systematic reporting and analysis of failures, making, thus, maintenance of historical data a crucial issue.…”

Reliability Modeling and Analysis of a Diesel Engine Design Phase Based on 4F Integration Technology

“…Tool System [12] FMECA Diesel engine [13] FMECA Vehicle [14] FMECA Vehicle turbocharging [15] FMECA Fighter engine [16] FMECA and FTA Power plant [20] FHA Aircraft resistance runway [21] FHA Aircraft control system [22] FHA Aircraft flight system [23] FHA Aircraft landing gear [24] FHA New electric vertical lift vehicles [25] FTA Automatic driving vehicle control [26] FTA Diesel engine turbocharging [27] FTA Diesel fuel system [28] FTA Gantry crane [32] FRACAS Ship weapon system [33] FRACA and FMECA Shipborne combat system [34] FRACA and FMECA Aviation industry management system [35] FRACAS UAV [36] FRACA and FMECA Rail vehicle [37] FRACA, FMECA, and FTA Vehicle power system…”

“…In the existing studies, a FRACAS has often been used in the development and design of new complex systems [32] to facilitate fault management during system operation or maintenance. The FRACAS has often been used in combination with other reliability assessment methods in many of the existing studies and its compatibility has been documented in many references [33,34]. In the aerospace industry, a FRACAS was used to control the reliability of unmanned aerial vehicles [35] throughout their life cycle.…”

Quality Status of the Preanalytical Phase of Clinical Laboratories in Korea

“…미국 College of American Pathologist (CAP)에서도 Q-probe라는 이름으로 검사전단계를 포함한 검사 전반에 걸친 품질지표를 관리하고 있다 [7]. 반면, 국내에서는 검사 전단계와 관련한 연구들이 매우 부족한 상황이다 [8,9] 병상 이상, 300-499병상, 300병상 미만이 각각 13.6%, 19.8%, 19.8% 였다. 연간 검사 건수, 연간 검체 수, 연간 채혈환자 수, 임상병리사 수, 진단검사의학 전문의 수는 모두 병상 규모가 커질수록 증가하 는 경향을 보였다(Table 1).…”