External quality assessment (EQA) and alternative assessment procedures (AAPs) in molecular diagnostics: findings of an international survey

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Deborah A. Payne ◽  
Graciela Russomando ◽  
Mark W. Linder ◽  
Katarina Baluchova ◽  
Tester Ashavaid ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Molecular Diagnostics ◽  
Alternative Assessment ◽  
External Quality Assessment ◽  
Clinical Chemistry ◽  
Molecular Diagnostic ◽  
Internal Quality ◽  
External Quality ◽  
Iso 15189 ◽  
Eqa Schemes

AbstractObjectivesQuality management for clinical laboratories requires the establishment of internal procedures including standard operating procedures (SOPs), internal quality control (QC), validation of test results and quality assessment. External quality assessment (EQA) and alternativeassessment procedures (AAPs) are part of the quality hierarchy required for diagnostic testing. The International Organization for Standardization (ISO) document with requirements for conformance ISO 15189 and the Clinical and Laboratory Standards Institute document (CLSI) QMS24 require participation in EQA schemes and AAPs where applicable. The purpose of this study was to perform a global survey of EQA and AAPs for key procedures in molecular diagnostic laboratories.MethodsThe Committee for Molecular Diagnostics of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC C-MD) conducted a survey of international molecular laboratories that covered specific topics of molecular diagnostic services as well as methods for EQA and AAPs. The survey addressed the following aspects: (1) usage of laboratory-developed test (LDT), (2) participation in EQA schemes and (3) performance of AAPs.ResultsA total of 93 responses from laboratories located in Asia, Europe, the Middle East, North America and South America were received. The majority of the participating laboratories (65.9%) use LDTs and 81.3% stated that it is mandatory for them to participate in EQA programs, while 22% of the laboratories reported not performing AAPs. Thirty-one percent of the laboratories use EQAs for fewer than 50.0% of their reported parameters/analytes.ConclusionsWhile the majority of laboratories perform EQA and AAPs to improve their quality in molecular diagnostics, the amount of AAPs as quality procedures differs within the laboratories. Further surveys are necessary to clarify the existing needs in additional EQAs and standardized AAPs. The survey will also guide future efforts of the IFCC C-MD for identifying quality practices in need to improve harmonization and standardization within molecular diagnostics.

Combi scheme: new combined internal/external quality-assessment scheme in The Netherlands

1991 ◽  
Vol 37 (7) ◽  
pp. 1196-1204 ◽  
Author(s):  
Herman Steigstra ◽  
Rob T Jansen ◽  
Henk Baadenhuijsen
Keyword(s):  
The Netherlands ◽  
Quality Assessment ◽  
Internal Control ◽  
External Quality Assessment ◽  
Clinical Chemistry ◽  
Laboratory Data ◽  
Data Communication ◽  
Professional Organization ◽  
Internal Quality ◽  
External Quality

Abstract The Dutch Foundation for Quality Assessment in Clinical Chemistry (SKZL) is the professional organization that conducts external quality-assessment schemes in The Netherlands. However, such schemes in fact assess the performance of the internal quality-control systems of the participating laboratories. In this paper we describe a new concept, relating the data for internal control materials with those for external samples and thereby leading to a combined external/internal scheme (Combi). The statistical principles underlying the Combi scheme are discussed and examples of the graphical presentation of the results are shown. Because the laboratory data are transmitted over the public telephone system to the computers of the SKZL, we also describe the principles of the data communication. At two-month intervals a statistical presentation is sent to all participants. The central database is updated daily with the received results, making possible an on-line consultation regarding the statistics of the accumulated findings of the control materials in use.

scholarly journals External quality assessment for molecular diagnostic laboratories in Belgium: Can we improve it?

2019 ◽  
Vol 25 (1) ◽  
pp. 39-49
Author(s):  
Kelly Dufraing ◽  
Els Lierman ◽  
Anne Vankeerberghen ◽  
Sabine Franke ◽  
Els Dequeker
Keyword(s):  
Quality Assessment ◽  
Performance Monitoring ◽  
External Quality Assessment ◽  
Molecular Diagnostic ◽  
Real Patient ◽  
External Quality ◽  
Molecular Tests ◽  
Clinical Biology ◽  
Eqa Schemes ◽  
Selection Of

AbstractExternal quality assessment (EQA) is an essential part of performance monitoring for molecular laboratories. At the moment, a national law regulates participation in EQA schemes for clinical biology and pathology in Belgium. This study aimed (1) to get insights on how laboratories organize their EQA participation, (2) to poll satisfaction with the current situation (selection of EQA programs in advance by a governmental body), (3) to provide guidance for choosing the most relevant EQA provider and (4) to propose a new model for national performance monitoring. A survey was sent to Belgian laboratories performing molecular tests in the field of microbiology, hematology and pathology with (1) general questions on how they select an EQA provider and (2) their satisfaction of each provider. In total, 25 molecular laboratories [microbiology (N = 13), hematology (N = 8) and pathology (N = 4)] from 14 different hospitals completed the survey regarding their EQA organization. All three laboratory groups indicated to prefer EQA schemes using real patient materials as well as those with varying targets and concentrations. For molecular microbiology and hematology, schemes with a syndromic approach are sought. Since annual participation in EQA becomes burdensome in most laboratories, this paper also offers a risk-based strategy for determining the participation frequency. Based on the needs of Belgian laboratories, three proposals were made: (1) for the proper selection of an EQA scheme, (2) for determining the minimal participation frequency and (3) for the national organization of EQA schemes.

Quality Assessment of Tumor Marker Determinations: A Proposal for a Supraregional Scheme

1994 ◽  
Vol 9 (1) ◽  
pp. 48-52
Author(s):  
A. Piffanelli ◽  
M. Giganti ◽  
P. Colamussi ◽  
C. Cittanti ◽  
D. Pelizzola ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Tumor Marker ◽  
Tumor Markers ◽  
External Quality Assessment ◽  
Clinical Chemistry ◽  
External Quality ◽  
Realistic Information ◽  
Eqa Schemes

The use of tumor marker tests has increased progressively in the last decade concomitant with the advent of new monoclonal antibodies and their growing use in clinical oncology for various follow-up programs. External quality assessment (EQA) schemes widely adopted in clinical chemistry, have been extended in the last decade to immunoassays of hormones and tumor markers. EQA results can provide realistic information on the quality of the assays, performed under routine conditions. The goal of this article is to report the main results and discrepancies encountered so far in External Quality Assessment programs on tumor markers.

Uncertainty in measurement for 43 biochemistry, immunoassay, and hemostasis routine analytes evaluated by a method using only external quality assessment data

2015 ◽  
Vol 53 (11) ◽  
Author(s):  
Gladys Matar ◽  
Bernard Poggi ◽  
Roland Meley ◽  
Chantal Bon ◽  
Laurence Chardon ◽  
...  
Keyword(s):  
Quality Assessment ◽  
External Quality Assessment ◽  
Peer Group ◽  
Estimation Methods ◽  
Internal Quality ◽  
Factor V ◽  
External Quality ◽  
Uncertainty In Measurement ◽  
Target Values ◽  
Eqa Schemes

AbstractInternational organizations require from medical laboratories a quantitative statement of the uncertainty in measurement (UM) to help interpret patient results. The French accreditation body (COFRAC) recommends an approach (SH GTA 14 IQC/EQA method) using both internal quality control (IQC) and external quality assessment (EQA) data. The aim of this work was to validate an alternative way to quantify UM using only EQA results without any need for IQC data. This simple and practical method, which has already been described as the long-term evaluation of the UM (LTUM), is based on linear regression between data obtained by participants in EQA schemes and target values. We used it for 43 routine analytes covering biochemistry, immunoassay, and hemostasis fields.Data from 50 laboratories participating in ProBioQual (PBQ) EQA schemes over 25 months were used to obtain estimates of the median and 90th percentile LTUM and to compare them to the usual analytical goals. Then, the two UM estimation methods were compared using data from 20 laboratories participating in both IQC and EQA schemes.Median LTUMs ranged from 2.9% (sodium) to 16.3% (bicarbonates) for biochemistry analytes, from 12.6% (prothrombin time) to 18.4% (factor V) for hemostasis analytes when using the mean of all participants, and were around 10% for immunoassays when using the peer-group mean. Median LTUMs were, in most cases, slightly lower than those obtained with the SH GTA 14 method, whatever the concentration level.LTUM is a simple and convenient method that gives UM estimates that are reliable and comparable to those of recommended methods. Therefore, proficiency testing (PT) organizers are allowed to provide participants with an additional UM estimate using only EQA data and which could be updated at the end of each survey.

scholarly journals An approach for estimating measurement uncertainty in medical laboratories using data from long-term quality control and external quality assessment schemes

2017 ◽  
Vol 55 (11) ◽  
Author(s):  
Andrea Padoan ◽  
Giorgia Antonelli ◽  
Ada Aita ◽  
Laura Sciacovelli ◽  
Mario Plebani
Keyword(s):  
Quality Control ◽  
Measurement Uncertainty ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
Internal Quality ◽  
Test Results ◽  
External Quality ◽  
Iso 15189 ◽  
Medical Laboratories

AbstractBackground:The present study was prompted by the ISO 15189 requirements that medical laboratories should estimate measurement uncertainty (MU).Methods:The method used to estimate MU included the: a) identification of quantitative tests, b) classification of tests in relation to their clinical purpose, and c) identification of criteria to estimate the different MU components. Imprecision was estimated using long-term internal quality control (IQC) results of the year 2016, while external quality assessment schemes (EQAs) results obtained in the period 2015–2016 were used to estimate bias and bias uncertainty.Results:A total of 263 measurement procedures (MPs) were analyzed. On the basis of test purpose, in 51 MPs imprecision only was used to estimate MU; in the remaining MPs, the bias component was not estimable for 22 MPs because EQAs results did not provide reliable statistics. For a total of 28 MPs, two or more MU values were calculated on the basis of analyte concentration levels. Overall, results showed that uncertainty of bias is a minor factor contributing to MU, the bias component being the most relevant contributor to all the studied sample matrices.Conclusions:The model chosen for MU estimation allowed us to derive a standardized approach for bias calculation, with respect to the fitness-for-purpose of test results. Measurement uncertainty estimation could readily be implemented in medical laboratories as a useful tool in monitoring the analytical quality of test results since they are calculated using a combination of both the long-term imprecision IQC results and bias, on the basis of EQAs results.

scholarly journals Most but not all laboratories can detect the recently emerged Neisseria gonorrhoeae porA mutants – results from the QCMD 2013 N. gonorrhoeae external quality assessment programme

2014 ◽  
Vol 19 (8) ◽  
Author(s):  
D Luijt ◽  
C Di Lorenzo ◽  
A M van Loon ◽  
M Unemo
Keyword(s):  
Neisseria Gonorrhoeae ◽  
Quality Assessment ◽  
External Quality Assessment ◽  
False Negative ◽  
Molecular Diagnostic ◽  
External Quality ◽  
Diagnostic Assays ◽  
Assessment Programme ◽  
Negative Results ◽  
False Negative Results

We describe the results of the Quality Control for Molecular Diagnostics 2013 Neisseria gonorrhoeae external quality assessment programme that included an N. gonorrhoeae strain harbouring an N. meningitidis porA gene which causes false-negative results in molecular diagnostic assays targeting the gonococcal porA pseudogene. Enhanced awareness of the international transmission of such gonococcal strains is needed to avoid false-negative results in both in-house and commercial molecular diagnostic assays used in laboratories worldwide, but particularly in Europe.

scholarly journals Results of the UK NEQAS for Molecular Genetics reference sample analysis

2018 ◽  
Vol 71 (11) ◽  
pp. 989-994 ◽  
Author(s):  
Susan D Richman ◽  
Jennifer Fairley ◽  
Jacqueline A Hall ◽  
Nakul Nataraj ◽  
Mrudul Bhide ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Molecular Genetics ◽  
External Quality Assessment ◽  
Single Gene ◽  
Reference Sample ◽  
Human Cell Line ◽  
External Quality ◽  
Gene Testing ◽  
Variant Frequency ◽  
Eqa Schemes

AimsIn addition to providing external quality assessment (EQA) schemes, United Kingdom National External Quality Assessment service (UK NEQAS) for Molecular Genetics also supports the education of laboratories. As an enhancement to the Molecular Pathology EQA scheme, a human cell-line reference sample, manufactured by Thermo Fisher Scientific (AcroMetrix), was provided for analysis. This contained many variants, present at frequencies between 1% and 17.9%.MethodsOne hundred and one laboratories submitted results, with a total of 2889 test results on 53 genes being reported. Known polymorphisms, 46/2889 (1.59%) results, were excluded. Variants detected in the seven most commonly reported (and clinically relevant) genes, KRAS, NRAS, BRAF, EGFR, PIK3CA, KIT and PDGFRA, are reported here, as these genes fall within the scope of UK NEQAS EQA schemes.ResultsNext generation sequencing (NGS) was the most commonly performed testing platform. There were between 5 and 27 validated variants in the seven genes reported here. Eight laboratories correctly reported all five NRAS variants, and two correctly reported all eight BRAF variants. The validated mean variant frequency was lower than that determined by participating laboratories, with single-gene testing methodologies showing less variation in estimated frequencies than NGS platforms. Laboratories were more likely to correctly identify clinically relevant variants.ConclusionsOver 100 laboratories took the opportunity to test the ‘educational reference sample’, showing a willingness to further validate their testing platforms. While it was encouraging to see that the most widely reported variants were those which should be included in routine testing panels, reporting of variants was potentially open to interpretation, thus clarity is still required on whether laboratories selectively reported variants, by either clinical relevance or variant frequency.

scholarly journals Toward harmonization of clinical molecular diagnostic reports: findings of an international survey

2018 ◽  
Vol 0 (0) ◽  
Author(s):  
Deborah A. Payne ◽  
Katarina Baluchova ◽  
Graciela Russomando ◽  
Parviz Ahmad-Nejad ◽  
Cyril Mamotte ◽  
...  
Keyword(s):  
Molecular Diagnostics ◽  
Clinical Decision Making ◽  
Clinical Chemistry ◽  
Clinical Decision ◽  
Molecular Diagnostic ◽  
Molecular Testing ◽  
End User ◽  
Iso 15189 ◽  
Reporting Practices ◽  
Reporting Phase

Abstract Background: The International Organization for Standardization (ISO) 15189 standard provides recommendations for the postexamination reporting phase to enhance quality in clinical laboratories. The purpose of this study was to encourage a broad discussion on current reporting practices for molecular diagnostic tests by conducting a global survey of such practices. Methods: The International Federation of Clinical Chemistry and Laboratory Medicine’s Committee for Molecular Diagnostics (IFCC C-MD) surveyed laboratories on selected ISO 15189 recommendations and topics. The survey addressed the following aspects: (1) laboratory demographics, (2) report format, (3) result reporting/layout, (4) comments in report and (5) interpretation and clinical decision-making information. Additionally, participants indicated categories needing standardization. Results: Sixteen responses from laboratories located in Asia, Europe, the Middle East, North America and South America were received. Several categories yielded 100% agreement between laboratories, whereas other categories had less than or equal to 50% concordance. Participants scored “nomenclature” and “description of methodologies” as the two most frequently cited aspects needing standardization. Conclusions: The postexamination phase requires extensive and consistent communication between the laboratory, the healthcare provider and the end user. Surveyed laboratories were most likely to follow explicit ISO 15189 recommendations vs. recommendations when the term(s) “where appropriate or where applicable” was used. Interpretation and reporting of critical values varied among participants. Although the outcome of this study may not fully represent the practices of all molecular testing laboratories in countries around the world, the survey identified and specified several recommendations that are requirements for harmonized reporting in molecular diagnostics.

Correlates of External Quality Assessment and Improvement Programs in Internal Auditing: A Study of 68 Countries

2016 ◽  
Vol 15 (2) ◽  
pp. 53-71 ◽  
Author(s):  
Steven M. DeSimone ◽  
Mohammad Abdolmohammadi
Keyword(s):  
Quality Assessment ◽  
Audit Committee ◽  
External Quality Assessment ◽  
Internal Audit ◽  
Data Availability ◽  
Internal Quality ◽  
External Quality ◽  
Improvement Programs ◽  
Quality Assessment And Improvement ◽  
Committee Involvement

ABSTRACT We use survey responses from 1,053 chief audit executives (CAEs) of public companies located in 68 countries to investigate the theoretical correlates of the use of external quality assessment and improvement programs (ExternalQAIP) for the Internal Audit Function (IAF). Our test variables are (1) internal quality assessment and improvement programs (InternalQAIP) and its related components and IAF performance measures, (2) chief audit executive competence, (3) audit committee involvement with the internal audit, (4) IAF age, (5) IAF outsourcing status (in-house or outsourced), and (6) the nature of the IAF's work (work performed by IAF). We find support for our hypothesized associations between various measures of InternalQAIP and ExternalQAIP. We also find significant and positive results for associations between audit committee involvement and IAF age and ExternalQAIP. However, we do not find significant results for in-house or outsourcing of internal audit activities, CAE competence, or control variables. Our results should be of interest to management, CAEs, corporate boards, regulators, and external auditors. Data Availability: Please contact The Institute of Internal Auditors Research Foundation (IIARF) that owns the CBOK (2010) database used in this study.

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