Quality Indicators for the Total Testing Process

Quality Indicators of the Pre-Analytical PhaseQuality indicatorsare tools that allow the quantification of quality in each of the segments of health care in comparison with selected criteria. They can be defined as an objective measure used to assess the critical health care segments such as, for instance, patient safety, effectiveness, impartiality, timeliness, efficiency, etc. In laboratory medicine it is possible to develop quality indicators or the measure of feasibility for any stage of the total testing process. The total process or cycle of investigation has traditionally been separated into three phases, the pre-analytical, analytical and post-analytical phase. Some authors also include a »pre-pre« and a »post-post« analytical phase, in a manner that allows to separate them from the activities of sample collection and transportation (pre-analytical phase) and reporting (post-analytical phase). In the year 2008 the IFCC formed within its Education and Management Division (EMD) a task force calledLaboratory Errors and Patient Safety (WG-LEPS)with the aim of promoting the investigation of errors in laboratory data, collecting data and developing a strategy to improve patient safety. This task force came up with the Model of Quality Indicators (MQI) for the total testing process (TTP) including the pre-, intra- and post-analytical phases of work. The pre-analytical phase includes a set of procedures that are difficult to define because they take place at different locations and at different times. Errors that occur at this stage often become obvious later in the analytical and post-analytical phases. For these reasons the identification of quality indicators is necessary in order to avoid potential errors in all the steps of the pre-analytical phase.

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Performance criteria and quality indicators for the pre-analytical phase

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2014-1124 ◽

2015 ◽

Vol 53 (6) ◽

Cited By ~ 9

Author(s):

Mario Plebani ◽

Laura Sciacovelli ◽

Ada Aita ◽

Michela Pelloso ◽

Maria Laura Chiozza

Keyword(s):

Quality Indicators ◽

Performance Criteria ◽

Analytical Quality ◽

Performance Targets ◽

Laboratory Services ◽

Quality Specifications ◽

Analytical Phase ◽

Total Testing Process ◽

The Individual

AbstractThe definition, implementation and monitoring of valuable analytical quality specifications have played a fundamental role in improving the quality of laboratory services and reducing the rates of analytical errors. However, a body of evidence has been accumulated on the relevance of the extra-analytical phases, namely the pre-analytical steps, their vulnerability and impact on the overall quality of the laboratory information. The identification and establishment of valueable quality indicators (QIs) represents a promising strategy for collecting data on quality in the total testing process (TTP) and, particularly, for detecting any mistakes made in the individual steps of the pre-analytical phase, thus providing useful information for quality improvement projects. The consensus achieved on the developed list of harmonized QIs is a premise for the further step: the identification of achievable and realistic performance targets based on the knowledge of the state-of-the-art. Data collected by several clinical laboratories worldwide allow the classification of performances for available QIs into three levels: optimum, desirable and minimum, in agreement with the widely accepted proposal for analytical quality specifications.

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Evaluating Laboratory Performance on Quality Indicators With the Six Sigma Scale

Archives of Pathology & Laboratory Medicine ◽

10.5858/2000-124-0516-elpoqi ◽

2000 ◽

Vol 124 (4) ◽

pp. 516-519 ◽

Cited By ~ 11

Author(s):

David Nevalainen ◽

Lucia Berte ◽

Cheryl Kraft ◽

Elizabeth Leigh ◽

Lisa Picaso ◽

...

Keyword(s):

Quality Indicators ◽

Laboratory Data ◽

Current Data ◽

Service Industries ◽

National Data ◽

Laboratory Performance ◽

Process Manufacturing ◽

Indicator Data ◽

Total Testing Process ◽

Benchmarking Performance

Abstract Context.—Laboratory quality indicator data, most often presented and reported as a percentage of variance, may be misleading, inasmuch as variances, and therefore percentages, appear to be low. Method.—Current data from laboratory quality indicators and national data derived from several years of College of American Pathologists Q-Probes studies were normalized to parts-per-million defects, as commonly practiced in the manufacturing and service industries for benchmarking performance. Results.—Laboratory data in parts-per-million defects demonstrated opportunities for significant improvements in laboratory performance across the total testing process. Conclusions.—Historical quality assurance programs do not appear to be significantly improving the total testing process. Manufacturing and service industries are using quality systems strategies, such as ISO 9000 and the Baldridge Award Criteria, to effect improvements in both productivity and cost. Quality system solutions for performance improvement may provide a systematic approach to improving laboratory performance.

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National surveys on 15 quality indicators for the total testing process in clinical laboratories of China from 2015 to 2017

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2018-0416 ◽

2018 ◽

Vol 57 (2) ◽

pp. 195-203 ◽

Cited By ~ 2

Author(s):

Min Duan ◽

Xudong Ma ◽

Jing Fan ◽

Yanhong Guo ◽

Wei Wang ◽

...

Keyword(s):

Quality Indicators ◽

Clinical Chemistry ◽

Turnaround Time ◽

Laboratory Medicine ◽

General Information ◽

Critical Values ◽

Medical Quality ◽

Clinical Laboratories ◽

Analytical Phase ◽

Total Testing Process

Abstract Background As effective quality management tools, quality indicators (QIs) are widely used in laboratory medicine. This study aimed to analyze the results of QIs, identify errors and provide quality specifications (QSs) based on the state-of-the-art. Methods Clinical laboratories all over China participated in the QIs survey organized by the National Health Commission of People’ Republic of China from 2015 to 2017. Most of these QIs were selected from a common model of QIs (MQI) established by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). All participants were asked to submit general information and original QIs data through a medical quality control data collection system. The results of QIs were reported in percentages and sigma, except turnaround time (TAT) which was measured in minutes. The 25th, 50th and 75th percentiles were, respectively, calculated as three levels of QSs, which were defined starting from the model proposed during the 1st Strategic Conference of the EFLM on “Defining analytical performance 15 years after the Stockholm Conference on Quality Specification in Laboratory Medicine”. Results A total of 76 clinical laboratories from 25 provinces in China continuously participated in this survey and submitted complete data for all QIs from 2015 to 2017. In general, the performance of all reported QIs have improved or at least kept stable over time. Defect percentages of blood culture contamination were the largest in the pre-analytical phase. Intra-laboratory TAT was always larger than pre-examination TAT. Percentage of tests covered by inter-laboratory comparison was relatively low than others in the intra-analytical phase. The performances of critical values notification and timely critical values notification were the best with 6.0σ. The median sigma level of incorrect laboratory reports varied from 5.5σ to 5.7σ. Conclusions QSs of QIs provide useful guidance for laboratories to improve testing quality. Laboratories should take continuous quality improvement measures in all phases of total testing process to ensure safe and effective tests.

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The use of preanalytical quality indicators: a Turkish preliminary survey study

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2020-1426 ◽

2020 ◽

Vol 0 (0) ◽

Author(s):

Bagnu Orhan ◽

Derya Sonmez ◽

Hikmet Can Cubukcu ◽

Oguzhan Zengi ◽

Humeyra Ozturk Emre ◽

...

Keyword(s):

Quality Indicators ◽

Clinical Chemistry ◽

Quality Standards ◽

Survey Study ◽

Iso 15189 ◽

Laboratory Errors ◽

Medical Laboratories ◽

Information Management Systems ◽

Survey Results ◽

Total Testing Process

AbstractObjectivesThe utilization of reliable quality indicators (QIs) proven to be suitable for monitoring and improvement tools is one of the best choices to minimize of the risk of errors in all laboratory processes called as total testing process (TTP). In 2008, a Working Group “Laboratory Errors and Patient Safety” (WG-LEPS) established by International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) developed the Model of Quality Indicators (MQI) complying with requirements of the ISO 15189:2012 standard for laboratory accreditation. They have also been dealing with harmonizing the QIs in most laboratories worldwide since then. The present study was set out to investigate the frequency of using IFCC WG-LEPS’ pre-QIs by Turkish laboratories and to assess the conformity of them, by taking into account Turkey’s conditions.MethodsA survey consisting nine questions was applied in 81 laboratories using SurveyMonkey.ResultsAccording to the survey results, most of the laboratories reported they have used pre-QIs in the quality standards of health prepared by Turkish Ministry of Health (MOH). A part of IFCC WG-LEPS’ pre-QIs were being utilized by more than 80% of the laboratories, the rest of which only used by 10% of laboratories.ConclusionsThe majority of the medical laboratories have been using the pre-QIs included in the guidelines of Quality Standards prepared by the MOH. The pre-QIs are partially compatible with IFCC WG-LEPS’ pre-QIs. The definitions of IFCC WG-LEPS’ pre-QIs may also be revised to make them more clear and understandable by IFCC WG-LEPS. The insufficiency of Health Information Management Systems (HIMS) limits the use of pre-QIs proposed by IFCC WG-LEPS. Finally, the education of relevant personnel about the use of HIMS and pre-QIs is very crucial to harmonize and to extend the use of IFCC WG-LEPS’ pre-QIs in Turkish medical biochemistry laboratories.

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Risk assessment of the total testing process based on quality indicators with the Sigma metrics

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2019-1190 ◽

2020 ◽

Vol 58 (8) ◽

pp. 1223-1231

Author(s):

Yong Xia ◽

Xiaoxue Wang ◽

Cunliang Yan ◽

Jinbin Wu ◽

Hao Xue ◽

...

Keyword(s):

Risk Assessment ◽

High Risk ◽

Quality Indicators ◽

Objective Assessment ◽

Corrective Action ◽

Management Tools ◽

Effect Analysis ◽

Novel Strategy ◽

Total Testing Process ◽

Risk Processes

AbstractBackgroundEvidence-based evaluation of laboratory performances including pre-analytical, analytical and post-analytical stages of the total testing process (TTP) is crucial to ensure patients receiving safe, efficient and effective care. To conduct risk assessment, quality management tools such as Failure Mode and Effect Analysis (FMEA) and the Failure Reporting and Corrective Action System (FRACAS) were constantly used for proactive or reactive analysis, respectively. However, FMEA and FRACAS faced big challenges in determining the scoring scales and failure prioritization in the assessment of real-world cases. Here, we developed a novel strategy, by incorporating Sigma metrics into risk assessment based on quality indicators (QIs) data, to provide a more objective assessment of risks in TTP.MethodsQI data was collected for 1 year and FRACAS was applied to produce the risk rating based on three variables: (1) Sigma metrics for the frequency of defects; (2) possible consequence; (3) detection method. The risk priority number (RPN) of each QI was calculated by a 5-point scale score, where a value of RPN > 50 was rated as high-risk.ResultsThe RPNs of two QIs in post-analytical phase (TAT of Stat biochemistry analyte and Timely critical values notification) were above 50 which required rigorous monitoring and corrective actions to eliminate the high risks. Nine QIs (RPNs between 25 and 50) required further investigation and monitoring. After 3 months of corrective action the two identified high-risk processes were successfully reduced.ConclusionsThe strategy can be implemented to reduce identified risk and assuring patient safety.

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A pilot study for establishing quality indicators in molecular diagnostics according to the IFCC WG-LEPS initiative: preliminary findings in China

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2018-0966 ◽

2019 ◽

Vol 57 (6) ◽

pp. 822-831 ◽

Cited By ~ 1

Author(s):

Rui Zhou ◽

Yali Wei ◽

Laura Sciacovelli ◽

Mario Plebani ◽

Qingtao Wang

Keyword(s):

Patient Safety ◽

Quality Indicators ◽

Molecular Diagnostics ◽

Clinical Chemistry ◽

Priority Level ◽

Laboratory Errors ◽

Promising Tool ◽

Laboratory Services ◽

Total Testing Process

Abstract Background Quality indicators (QIs) are crucial tools in measuring the quality of laboratory services. Based on the general QIs of the Working Group “Laboratory Errors and Patient Safety (WG-LEPS)” of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), specific QIs have been established in order to monitor and improve the quality of molecular diagnostics, and to assess the detection level of associated disease. Methods A survey was conducted on 46 independent commercial laboratories in China, investigated using questionnaires and on-site inspections. Specific QIs established were mainly based on the specific laboratory work-flow for molecular diagnoses. The specific QI results from three volunteer laboratories were collected and used to validate their effectiveness. Results Of the 46 laboratories participating in the study, 44 (95.7%), conducted molecular diagnostics. Of 13 specific established QIs, six were priority level 1, and seven, priority level 3. At pre-evaluation of data from the three volunteering laboratories, it was found that the newly classified specific QIs had outstanding advantages in error identification and risk reduction. Conclusions Novel specific QIs, a promising tool for monitoring and improving upon the total testing process in molecular diagnostics, can effectively contribute to ensuring patient safety.

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Preliminary probe of quality indicators and quality specification in total testing process in 5753 laboratories in China

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2015-0958 ◽

2016 ◽

Vol 54 (8) ◽

Cited By ~ 4

Author(s):

Yang Fei ◽

Fengfeng Kang ◽

Wei Wang ◽

Haijian Zhao ◽

Falin He ◽

...

Keyword(s):

Blood Culture ◽

Quality Indicators ◽

Critical Values ◽

Sample Container ◽

Clinical Laboratories ◽

Quality Specifications ◽

Catch Up ◽

Total Testing Process ◽

State Of Art ◽

Minimum Quality

AbstractThe aim of the study was to promote the establishment and implementation of quality indicators (QIs) in clinical laboratories, catch up with the state of art, and provide preliminary quality specifications for established QIs.Clinical laboratories from different provinces in China were included in this QIs survey in 2015. All participants were asked to collect data related to QIs and complete QIs questionnaires. Defect percentages and sigma values were calculated for each QI. The 25th percentile, median, and the 75th percentile of defect percentages and TATs were calculated as optimum, desirable and minimum quality specifications. While 25th, median, and 75th of sigma values were calculated as minimum, desirable and optimum quality specifications, respectively.Five thousand seven hundred and fifty-three clinical laboratories from 28 provinces in China participated in this survey. Median defect percentages of pre-examination QIs varied largely from 0.01% (incorrect sample container) to 0.57% (blood culture contamination) with sigma values varied from 4.0σ to 5.1σ. Median defect percentages of examination phase QIs were all really high. The most common problem in examination phase was test uncovered by inter-laboratory comparison (86.67%). Defect percentages of critical values notification and timely critical values notification were all 0.00% (6.0σ). While the median of defect percentages of incorrect laboratory reports was only 0.01% (5.4σ).Improvements are needed in all phases of total testing process (TTP) in laboratories in China, especially in examination phase. More attention should be paid when microbiology specimens are collected and results are reported. Quality specifications can provide directions for laboratories to make effort for.

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