scholarly journals Selecting a Risk-Based SQC Procedure for a HbA1c Total QC Plan

2017 ◽  
Vol 12 (4) ◽  
pp. 780-785 ◽  
Author(s):  
Sten A. Westgard ◽  
Hassan Bayat ◽  
James O. Westgard
Keyword(s):  
Risk Management ◽  
Practice Guidelines ◽  
Clinical Laboratory ◽  
Method Performance ◽  
Minimum Requirement ◽  
Control Rules ◽  
Graphical Tool ◽  
The Us ◽  
Practical Tool ◽  
Total Testing Process

Background: Recent US practice guidelines and laboratory regulations for quality control (QC) emphasize the development of QC plans and the application of risk management principles. The US Clinical Laboratory Improvement Amendments (CLIA) now includes an option to comply with QC regulations by developing an individualized QC plan (IQCP) based on a risk assessment of the total testing process. The Clinical and Laboratory Standards Institute (CLSI) has provided new practice guidelines for application of risk management to QC plans and statistical QC (SQC). Methods: We describe an alternative approach for developing a total QC plan (TQCP) that includes a risk-based SQC procedure. CLIA compliance is maintained by analyzing at least 2 levels of controls per day. A Sigma-Metric SQC Run Size nomogram provides a graphical tool to simplify the selection of risk-based SQC procedures. Applications: Current HbA1c method performance, as demonstrated by published method validation studies, is estimated to be 4-Sigma quality at best. Optimal SQC strategies require more QC than the CLIA minimum requirement of 2 levels per day. More complex control algorithms, more control measurements, and a bracketed mode of operation are needed to assure the intended quality of results. Conclusions: A total QC plan with a risk-based SQC procedure provides a simpler alternative to an individualized QC plan. A Sigma-Metric SQC Run Size nomogram provides a practical tool for selecting appropriate control rules, numbers of control measurements, and run size (or frequency of SQC). Applications demonstrate the need for continued improvement of analytical performance of HbA1c laboratory methods.

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

Medicina ◽  
2021 ◽  
Vol 57 (5) ◽  
pp. 477
Author(s):  
Jeonghyun Chang ◽  
Soo Jin Yoo ◽  
Sollip Kim
Keyword(s):  
Risk Management ◽  
Failure Mode ◽  
Clinical Laboratory ◽  
Flow Diagram ◽  
Management Tool ◽  
Laboratory Errors ◽  
Testing Sequence ◽  
Fmea Method ◽  
Total Testing Process ◽  
One Year

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.

scholarly journals A Qualitative Study on the US Forest Service’s Risk Management Assistance Efforts to Improve Wildfire Decision-Making

Forests ◽  
2021 ◽  
Vol 12 (3) ◽  
pp. 344
Author(s):  
Courtney A. Schultz ◽  
Lauren F. Miller ◽  
Sarah Michelle Greiner ◽  
Chad Kooistra
Keyword(s):  
Decision Making ◽  
Risk Management ◽  
Decision Support ◽  
Qualitative Study ◽  
Fire Management ◽  
Perceived Value ◽  
Forest Service ◽  
The Us ◽  
Decision Biases ◽  
Line Officers

To support improved wildfire incident decision-making, in 2017 the US Forest Service (Forest Service) implemented risk-informed tools and processes, together known as Risk Management Assistance (RMA). The Forest Service is developing tools such as RMA to improve wildfire decision-making and implements these tools in complex organizational environments. We assessed the perceived value of RMA and factors that affected its use to inform the literature on decision support for fire management. We sought to answer two questions: (1) What was the perceived value of RMA for line officers who received it?; and (2) What factors affected how RMA was received and used during wildland fire events? We conducted a qualitative study involving semi-structured interviews with decision-makers to understand the contextualized and interrelated factors that affect wildfire decision-making and the uptake of a decision-support intervention such as RMA. We used a thematic coding process to analyze our data according to our questions. RMA increased line officers’ ability to communicate the rationale underlying their decisions more clearly and transparently to their colleagues and partners. Our interviewees generally said that RMA data analytics were valuable but did not lead to changes in their decisions. Line officer personality, pre-season exposure to RMA, local political dynamics and conditions, and decision biases affected the use of RMA. Our findings reveal the complexities of embracing risk management, not only in the context of US federal fire management, but also in other similar emergency management contexts. Attention will need to be paid to existing decision biases, integration of risk management approaches in the interagency context, and the importance of knowledge brokers to connect across internal organizational groups. Our findings contribute to the literature on managing change in public organizations, specifically in emergency decision-making contexts such as fire management.

The Clinical Laboratory and the Commitment to Quality

2020 ◽  
pp. 204-239
Author(s):  
Marilena Stamouli ◽  
Antonia Mourtzikou
Keyword(s):  
Clinical Laboratory ◽  
Medical Laboratory ◽  
Main Role ◽  
Total Quality ◽  
Clinical Laboratories ◽  
Preventive Actions ◽  
Harmonization Process ◽  
Six Sigma Methodology ◽  
Total Testing Process ◽  
Definition Of

The main role that clinical laboratories play in the detection, diagnosis, and treatment of diseases is clearly evident. Clinical laboratories need to sustain a commitment to quality and demonstrate a certifiable level of compliance. Many strategies are used to reduce laboratory errors, including internal QC procedures, external quality assessment programs, implementation of QIs and six-sigma methodology. All strategies should be consistent with the requirements of the international standard for medical laboratory accreditation and suitable for promoting corrective/preventive actions. They must promote total quality and patient safety and be consistent with the definition of a laboratory error. Harmonization process is in progress; however, further efforts must be made. Total quality management must be evaluated periodically. For a patient-centered approach, there is the need to assure that each and every step of the total testing process is correctly performed, that weaknesses are recognized, and that corrective and preventive actions are designed and implemented.

ALWR PRA Standard Development

2013 ◽  
Author(s):  
James R. Chapman
Keyword(s):  
Risk Management ◽  
Low Power ◽  
Working Group ◽  
Current Generation ◽  
The Us ◽  
Level 3 ◽  
External Events ◽  
Level 2 ◽  
Standard Development

In 2012 a review and comment ballot containing requirements for use of the Standard on ALWRs was issued. The ballot is based on the ASME/ANS PRA Standard (i.e., RA-Sa-2009). The ballot was developed by the Joint Committee on Nuclear Risk Management (JCNRM) working group (WG) on ALWRs. Based on the charter of the working group and stakeholder interest, Parts 1 through 5 of the Standard have been addressed. Thus, address internal events at power, internal flooding at power, internal fires at power, and seismic at power have been addressed. Other external events started in 2012 and will be balloted in 2013. Low power and shutdown (LP/SD) modes, and Level 2 PRA and Level 3 PRA Standards (when they are available) will then be considered. A formal ballot for Parts 1 through 5 is planned for 2013. This paper provides the approach and results. The mandatory appendix is important because an ALWR plant in the preoperational cannot meet the standard as written, and the US NRC expects that the PRA will meet the Standard. Thus changes are needed to the standard to address the differences in preoperational and operational plants and the differences in current generation and ALWR plants. This will assist vendors and licensees in successfully developing PRAs to meet US NRC requirements.

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