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

Yang, Fei; Wei, Wang; Zhao, Haijian; He, Falin; Zhong, Kangping; Wang, Zhiguo; Chen, Wenxiang

doi:10.1515/cclm-2015-0958

Cited by 9 publications

(11 citation statements)

References 7 publications

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“…Those that did not have LIS or HIS collected related data by accessing to related records manually. Laboratory leaders or quality managers were asked to upload related data via online EQA platform for critical value reporting investigation developed by the NCCL within 2 month after receiving it voluntarily ( 6 , 8 , 9 ).…”

Section: Methodsmentioning

confidence: 99%

“…It is obviously inappropriate to use recommendation of one hour without verification. Besides, quality specifications can be set based on the “state-of-the-art” ( 6 ). Based on a College of American Pathologists (CAP) Q-Probes study, a laboratory goal of reporting critical results within 15 to 30 minutes after testing is complete were proposed for inpatient settings ( 7 ).…”

Section: Introductionmentioning

confidence: 99%

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National survey on current situation of critical value reporting in 973 laboratories in China

et al. 2017

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IntroductionThe aim of the study was to investigate the state-of-the-art of the performance of critical value reporting and provide recommendations for laboratories setting critical value reporting time frames.Materials and methodsThe National Centre for Clinical Laboratories in China initiated a critical value reporting investigation in 2015. A questionnaire related to critical value reporting policy was sent to 1589 clinical laboratories in China online. The questionnaire consisted of a set of questions related to critical value reporting policy and a set of questions related to timeliness of critical value reporting. The survey data were collected between March and April 2015.ResultsA total survey response rate was 61.2%. The critical value unreported rate, unreported timely rate, and clinical unacknowledged rate of more than half of participants were all 0.0%. More than 75.0% of participants could report half of critical values to clinicians within 20 minutes and could report 90.0% of critical values to clinicians within 25 minutes (from result validation to result communication to the clinician). The median of target critical value reporting time was 15 minutes. “Reporting omission caused by laboratory staff”, “communications equipment failure to connect”, and “uncompleted application form without contact information of clinician” were the three major reasons for unreported critical value.ConclusionsThe majority of laboratories can report critical values to responsible clinical staff within 25 minutes. Thus, this value could be recommended as suitable critical value reporting time frame for biochemistry laboratories in China. However, careful monitoring of the complete reporting process and improvement of information systems should ensure further improvement of critical value reporting timeliness.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

National survey on current situation of critical value reporting in 973 laboratories in China

et al. 2017

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“…7 Other programs on QIs have been organized and implemented in several countries. [8][9][10][11] Currently, the usual external quality assessment (EQA) scheme focuses mainly on the analytical phase of laboratory work. In this study, we designed a pre-analytical EQA scheme to evaluate pre-analytical errors on specimen collection, which included in six QIs:…”

Section: Introductionmentioning

confidence: 99%

Three years’ experience of quality monitoring program on pre‐analytical errors in china

Xia

Shan

2021

Clinical Laboratory Analysis

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“…Fei et al [2] reported on a major study of quality indicators covering all phases of laboratory work. The study assessed performance for over 5000 laboratories in China against 15 quality indicators, broken down by laboratory discipline where appropriate.…”

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confidence: 99%

“…It is also important to place these activities in the spectrum of basic research and original concepts, translational research and clinical application. The papers on current laboratory performance [2,3] reflect practical applications, the opinion papers on approaches to error and uncertainty [4,5] reflect background developments and discussion and the last of these papers introduces a new concept, which will need further analysis and discussion before being considered for use in setting performance specifications in the routine laboratory.…”

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confidence: 99%

Laboratory analytical quality – the process continues

Jones

2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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Our goal in laboratory medicine is to produce information which can be used for clinical decisions that improve patient health. The basis for this is test results which are sufficiently accurate. This apparently obvious and simple statement covers a range of complex issues with which our profession is continuing to grapple. An accurate measurement result is one with low bias, low imprecision and a high level of freedom from interferences. The accuracy of the result on a patient sample can also be affected by variation which may occur during the pre-or the postanalytical phases. In addition to errors which affect the numerical value of a result, in all phases "blunders", such as mislabelling of a specimen or a short sample on an analyser, can occur making all the results potentially incorrect and dangerous. Finally the statement requires consideration of what constitutes "sufficient" accuracy. These issues remain under active research and debate as can be seen by a number of articles in the current edition of this journal, covering quality indicators and analytical quality in two major studies from China, and opinion pieces on quality concepts in the analytical phase. The papers also follow on from issues raised at the Milan conference on performance specifications [1] with decisions made about the model selected for assessment of quality.Fei et al.[2] reported on a major study of quality indicators covering all phases of laboratory work. The study assessed performance for over 5000 laboratories in China against 15 quality indicators, broken down by laboratory discipline where appropriate. This major study has considered the issue of performance specifications and selected "state of the art" as the most appropriate model, with optimal performance defined by that achieved by the best 25% of laboratories, desirable achieved by 50% and minimal as achieved by 75%. This baseline provides a basis for both individual laboratories and the combined group to assess progress over time. Comparison of data from different studies of this type however is inherently difficult, requiring the use of exact and uniform definitions of errors and thorough processes to identify failures. Such comparison could be facilitated by providing the exact definitions used in the analysis, for example the EQA performance specifications and the definition of an incorrect tube fill level.The analytical phase in China is addressed by Ge et al. [3] where the analytical performance of four electrolytes was assessed in 187 routine laboratories. The study used fresh frozen plasma, which is likely to be commutable, with reference method value assignment. This study used biological variation to set performance specifications although different approaches were taken depending on the magnitude of the relationship between the state of the art and biological variation. A specific finding of this study was the demonstrated superiority of methods where the calibrator and reagents were purchased from the same manufacturer (described as homogenous systems) compa...

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

Cited by 9 publications

References 7 publications

National survey on current situation of critical value reporting in 973 laboratories in China

National survey on current situation of critical value reporting in 973 laboratories in China

Three years’ experience of quality monitoring program on pre‐analytical errors in china

Laboratory analytical quality – the process continues

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