Relevant quality indicators from pre-analytical phase to continuously improve the accredited medical laboratory performance in an emergency clinical hospital

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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Combined international external quality assessment results of medical laboratory performance and reporting of samples with known antimicrobial resistance

Diagnosis ◽

10.1515/dx-2018-0020 ◽

2018 ◽

Vol 5 (3) ◽

pp. 161-166

Author(s):

Michael A. Noble ◽

Robert Rennie

Keyword(s):

Antimicrobial Resistance ◽

Quality Assessment ◽

Clinical Laboratory ◽

External Quality Assessment ◽

Medical Laboratory ◽

External Quality ◽

Laboratory Performance ◽

Reporting Practices ◽

Medical Laboratories ◽

Poor Treatment

Abstract Background Reporting on the presence of antimicrobial resistance is of considerable concern both for individual patient care and for understanding the underlying health status within the community at large. Antimicrobial resistance is solely dependent upon clinical laboratory detection and thus can be impacted upon by the quality and competence of medical laboratories. Proficiency testing or external quality assessment (PT/EQA) is the international standard for the direct measurement of medical laboratory performance on critical testing. Methods An international, intercontinental collaborative retrospective study of medical laboratory performance in antibiotic resistance was performed by the Microbiology Working Group (MWG) of the European Organisation for External Quality Assurance for Laboratory Medicine (EQALM) with particular examination of laboratory performance on the testing and reporting of methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE) and carbapenem-resistant Enterobacteriaceae (CRE). Results The results of 1880 medical laboratories were compiled. Strictly accurate reporting of isolates as resistant occurred with MRSA 96.9%, with VRE 91.3% and with CRE 93.1% of the time. On the other hand, very major errors (reporting of false susceptibility) were observed with 2.2% of MRSA and 2.4% of VRE and 0.8% of CRE. Major errors (false resistance) were reported for vancomycin susceptibility testing for MRSA at a rate of 0.6%. Conclusions Depending on how clinical physicians read and understand microbiology susceptibility reports, proficient acceptable results were reported either between 91% and 94% of the time, or between 97% and 100%. While very major errors are infrequently reported, they were found in all regions and could potentially cause poor treatment decisions by clinicians. A collective analysis of multi-program PT/EQA information can provide valuable insights into the testing and reporting practices of medical laboratories.

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The pathway for introducing novel examination procedures in routine practice in accordance with ISO 15189:2012: 17-Hydroxy progesterone, dehydroepiandrosterone sulphate and vitamin D as examples

Annals of Clinical Biochemistry International Journal of Laboratory Medicine ◽

10.1177/0004563219835582 ◽

2019 ◽

Vol 56 (5) ◽

pp. 548-555 ◽

Cited By ~ 1

Author(s):

Giorgia Antonelli ◽

Laura Sciacovelli ◽

Ada Aita ◽

Dania Bozzato ◽

Mario Plebani

Keyword(s):

Vitamin D ◽

Diagnostic Testing ◽

Metrological Traceability ◽

Diagnostic System ◽

Medical Laboratory ◽

Routine Practice ◽

Dehydroepiandrosterone Sulphate ◽

Iso 15189 ◽

Hydroxy Progesterone ◽

Analytical Phase

Background In a medical laboratory, changes may be made to the analytical phase of diagnostic testing whenever a new test or the issue of a ‘new generation’ kit or new diagnostic system is required. In such cases, ISO 15189:2012 accreditation can assist laboratory professionals. The aim of the present study was to propose a working pathway for introducing new examination procedures into clinical practice in accordance with the ISO 15189:2012 standard, through the exemplars of 17-hydroxy progesterone, dehydroepiandrosterone sulphate and vitamin D. Methods The working pathway includes the following steps: (i) analysing examination procedures under evaluation, (ii) analysing examination procedures currently in use, (iii) verifying metrological traceability, (iv) verifying examination procedures and (v) evaluating comparability of results. Results The analysis of instructions for use issued by manufacturers revealed that metrological traceability was reported only for vitamin D. The imprecision verification was satisfactory, the imprecision obtained by the laboratory in terms of total imprecision always being less than the specified total imprecision. In only one case (IQC level 1, 17-hydroxy progesterone), the total upper verification limit was calculated. The trueness verification was satisfactory for all examination procedures, except for 17-hydroxy progesterone (second material). Passing–Bablok regression analyses in the comparability study demonstrated significant differences for all the examination procedures. Conclusions The working pathway described for examination procedures in routine practice is in accordance with the requirements of ISO 15189:2012 accreditation and takes feasibility into account (as its main goal), based on the cost/patient benefit ratio.

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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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Congruity in Quality Indicators and Laboratory Performance

Indian Journal of Clinical Biochemistry ◽

10.1007/s12291-017-0687-9 ◽

2017 ◽

Vol 33 (3) ◽

pp. 341-347 ◽

Cited By ~ 2

Author(s):

Suprava Patel ◽

Rachita Nanda ◽

Sibasish Sahoo ◽

Eli Mohapatra

Keyword(s):

Quality Indicators ◽

Laboratory Performance

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Role of Intervention on Laboratory Performance: Evaluation of Quality Indicators in a Tertiary Care Hospital

Indian Journal of Clinical Biochemistry ◽

10.1007/s12291-011-0182-7 ◽

2012 ◽

Vol 27 (1) ◽

pp. 61-68 ◽

Cited By ~ 7

Author(s):

Rachna Agarwal ◽

Sujata Chaturvedi ◽

Neelam Chhillar ◽

Renu Goyal ◽

Ishita Pant ◽

...

Keyword(s):

Performance Evaluation ◽

Quality Indicators ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Care Hospital ◽

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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