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Quality assurance practices in Europe: a survey of molecular genetic testing laboratories.

ABSTRACT: In the 2000s, a number of initiatives were taken internationally to improve quality in genetic testing services. To contribute to and update the limited literature available related to this topic, we surveyed 910 human molecular genetic testing laboratories, of which 291 (32%) from 29 European countries responded. The majority of laboratories were in the public sector (81%), affiliated with a university hospital (60%). Only a minority of laboratories was accredited (23%), and 26% was certified. A total of 22% of laboratories did not participate in external quality assessment (EQA) and 28% did not use reference materials (RMs). The main motivations given for accreditation were to improve laboratory profile (85%) and national recognition (84%). Nearly all respondents (95%) would prefer working in an accredited laboratory. In accredited laboratories, participation in EQA (P<0.0001), use of RMs (P=0.0014) and availability of continuous education (CE) on medical/scientific subjects (P=0.023), specific tasks (P=0.0018), and quality assurance (P<0.0001) were significantly higher than in non-accredited laboratories. Non-accredited laboratories expect higher restriction of development of new techniques (P=0.023) and improvement of work satisfaction (P=0.0002) than accredited laboratories. By using a quality implementation score (QIS), we showed that accredited laboratories (average score 92) comply better than certified laboratories (average score 69, P<0.001), and certified laboratories better than other laboratories (average score 44, P<0.001), with regard to the implementation of quality indicators. We conclude that quality practices vary widely in European genetic testing laboratories. This leads to a potentially dangerous situation in which the quality of genetic testing is not consistently assured.

SUBMITTER: Berwouts S

PROVIDER: S-EPMC3476716 | biostudies-literature | 2012 Nov

REPOSITORIES: biostudies-literature

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Quality assurance practices in Europe: a survey of molecular genetic testing laboratories.

Berwouts Sarah S Fanning Katrina K Morris Michael A MA Barton David E DE Dequeker Elisabeth E

European journal of human genetics : EJHG 20120627 11

In the 2000s, a number of initiatives were taken internationally to improve quality in genetic testing services. To contribute to and update the limited literature available related to this topic, we surveyed 910 human molecular genetic testing laboratories, of which 291 (32%) from 29 European countries responded. The majority of laboratories were in the public sector (81%), affiliated with a university hospital (60%). Only a minority of laboratories was accredited (23%), and 26% was certified. ...[more]

PMID: 22739339

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Project description:BackgroundMolecular oncology testing (MOT) to detect genomic alterations underlying cancer holds promise for improved cancer care. Yet knowledge limitations regarding the delivery of testing services may constrain the translation of scientific advancements into effective health care.MethodsWe conducted a cross-sectional, self-administered, postal survey of active cancer physicians in Ontario, Canada (N = 611) likely to order MOT, and cancer laboratories (N = 99) likely to refer (i.e., referring laboratories) or conduct (i.e., testing laboratories) MOT in 2006, to assess respondents' perceptions of the importance and accessibility of MOT and their preparedness to provide it.Results54% of physicians, 63% of testing laboratories and 60% of referring laboratories responded. Most perceived MOT to be important for treatment, diagnosis or prognosis now, and in 5 years (61% - 100%). Yet only 45% of physicians, 59% of testing labs and 53% of referring labs agreed that patients in their region were receiving MOT that is indicated as a standard of care. Physicians and laboratories perceived various barriers to providing MOT, including, among 70% of physicians, a lack of clear guidelines regarding clinical indications, and among laboratories, a lack of funding (73% - 100%). Testing laboratories were confident of their ability to determine whether and which MOT was indicated (77% and 82% respectively), and perceived that key elements of formal and continuing education were helpful (75% - 100%). By contrast, minorities of physicians were confident of their ability to assess whether and which MOT was indicated (46% and 34% respectively), and while majorities considered various continuing educational resources helpful (68% - 75%), only minorities considered key elements of formal education helpful in preparing for MOT (17% - 43%).ConclusionPhysicians and laboratory professionals were enthusiastic about the value of MOT for cancer care but most did not believe patients were gaining adequate access to clinically necessary testing. Further, our results suggest that many were ill equipped as individual stakeholders, or as a coordinated system of referral and interpretation, to provide MOT. These challenges should inspire educational, training and other interventions to ensure that developments in molecular oncology can result in optimal cancer care.

Project description:OBJECTIVE:To assess hospital practices in obstetric quality management activities and identify institutional characteristics associated with utilization of evidence-supported practices. METHODS:Data for this study came from a statewide survey of obstetric hospitals in California regarding their organization and delivery of perinatal care. We analyzed responses from 185 hospitals that completed quality assurance sections of the survey to assess their practices in a broad spectrum of quality enhancement activities. The association between institutional characteristics and adoption of evidence-supported practices (ie, those supported by prior literature or recommended by professional organizations as beneficial for improving birth outcome or patient safety) was examined using bivariate analysis and appropriate statistical tests. RESULTS:Most hospitals regularly audited adherence to written protocols regarding critical areas of care; however, 77.7% and 16.8% reported not having written guidelines on diagnosis of labor arrest and management of abnormal fetal heart rate, respectively. Private nonprofit hospitals were more likely to have a written protocol for management of abnormal fetal heart rate (P=.002). One in 10 hospitals (9.7%) did not regularly review cases with significant morbidity or mortality, and only 69.0% regularly tracked indications for cesarean delivery. Moreover, 26.3%, 14.3%, and 8.7% of the hospitals reported never performing interprofessional simulations for eclampsia, shoulder dystocia, or postpartum hemorrhage, respectively. Teaching status was associated with more frequent simulations in these three areas (P?.04 for all), while larger volume was associated with more frequent simulations for eclampsia (P=.04). CONCLUSION:Hospitals in California engage in a wide range of practices to assure or improve quality of obstetric care, but substantial variation in practice exists among hospitals. There is opportunity for improvement in adoption of evidence-supported practices.

Project description:BackgroundTesting for epidermal growth factor receptor (EGFR) mutations is an essential recommendation in guidelines for metastatic non-squamous non-small-cell lung cancer, and is considered mandatory in European countries. However, in practice, challenges are often faced when carrying out routine biomarker testing, including access to testing, inadequate tissue samples and long turnaround times (TATs).Materials and methodsTo evaluate the real-world EGFR testing practices of European pathology laboratories, an online survey was set up and validated by the Pulmonary Pathology Working Group of the European Society of Pathology and distributed to 64 expert testing laboratories. The retrospective survey focussed on laboratory organisation and daily EGFR testing practice of pathologists and molecular biologists between 2018 and 2021.ResultsTATs varied greatly both between and within countries. These discrepancies may be partly due to reflex testing practices, as 20.8% of laboratories carried out EGFR testing only at the request of the clinician. Many laboratories across Europe still favour single-test sequencing as a primary method of EGFR mutation identification; 32.7% indicated that they only used targeted techniques and 45.1% used single-gene testing followed by next-generation sequencing (NGS), depending on the case. Reported testing rates were consistent over time with no significant decrease in the number of EGFR tests carried out in 2020, despite the increased pressure faced by testing facilities during the COVID-19 pandemic. ISO 15189 accreditation was reported by 42.0% of molecular biology laboratories for single-test sequencing, and by 42.3% for NGS. 92.5% of laboratories indicated they regularly participate in an external quality assessment scheme.ConclusionsThese results highlight the strong heterogeneity of EGFR testing that still occurs within thoracic pathology and molecular biology laboratories across Europe. Even among expert testing facilities there is variability in testing capabilities, TAT, reflex testing practice and laboratory accreditation, stressing the need to harmonise reimbursement technologies and decision-making algorithms in Europe.

Project description:Till date, with over 137,000 certified members, the most successful rancher educational program has been the Beef Quality Assurance (BQA) program. The BQA program was established in the mid-1990's to improve animal health and welfare with a primary objective to reduce the incidence of injection site lesions by instructing producers to administer injections in the neck only. The present study investigated the drivers of this success to inform future rancher education programs around agricultural sustainability. An online multistate survey was administered to cattle ranchers in collaboration with state cattlemen's associations to better understand rancher motivations for adopting new practices and to gain insight on current involvement in BQA. In total, the survey consisted of 45 questions and was divided into 3 sections: (1) rancher demographics, (2) BQA participation and current best management practice (BMP) application, and (3) willingness to join new rancher educational programs. Data from 842 respondents are including in this study. Of the survey participants, 70% were currently BQA certified or had been BQA certified at one time, and 30% had never been certified. Ranchers who were BQA certified at any time were less likely to administer injections in areas other than the neck compared to ranchers who were not certified (P < 0.05), demonstrating the effectiveness of the BQA program. More than 80% of survey respondents who joined the BQA program stated they believed the BQA program improved animal health and welfare on their operation (n = 617). Among those who had not joined the BQA program, 40% believed BQA practices did not align with their ranching operation, while 38% had not heard of the BQA program (n = 256). The survey indicated that male ranchers, those with more years ranching, those with a larger percent of income coming from ranching, and ranches with larger total acres grazed were more likely to be BQA certified at any time (P < 0.05). Finally, ranchers who were BQA certified at any time were more likely to state that joining a rancher sustainability program would be beneficial to their operation. In conclusion, not only did the survey provide valuable insight into BQA program adoption but highlighted how BQA pedagogy and program structure may be a suitable framework for creating future rancher sustainability programs.

Project description:IntroductionThe quality of tuberculosis laboratory services in health facilities is a mandatory component of detecting active pulmonary TB cases and treatment follow-up. However, ensuring the quality of laboratory test results is a concern. This study aimed to assess the quality assurance practices in the tuberculosis diagnostic health facilities of Ethiopia.Materials and methodsA cross-sectional study was conducted from October 2018 to March 2019 at nine governmental TB-culture laboratories and 34 randomly selected GeneXpert® MTB/RIF (Xpert® MTB/RIF) testing health facilities in Ethiopia. Participating health facilities were interviewed and laboratory documents and records present since 2017 were observed. Prior to the data collection, training was given to the data collectors. Descriptive statistics were used to produce results and were presented with tables and graphs.ResultsFrom a total of 34 Xpert® MTB/RIF testing laboratories, 50% run Internal Quality Control (IQC) for Acid-Fast Bacillus (AFB) Microscopy and 67.6% had lot-to-lot verification of staining reagents. For the Xpert® MTB/RIF assay, a lot-to-lot verification of cartridge and method validation was performed only in 8.8%and 20.6% of Xpert® MTB/RIF testing laboratories respectively. All TB-culture laboratories included in the study ran negative control (start and end IQC) during TB-culture sample processing and performed lot-to-lot verification for Mycobacteria Growth Indicator Tube (MGIT) in 88.9% of TB-culture laboratories. External Quality Assessment (EQA) Proficiency Testing (PT) for AFB microscopy is practiced in 79.4% Xpert® MTB/RIF testing laboratories and 100.0% for the Xpert® MTB/RIF assay. TB-Culture PT participation practice among TB-culture laboratories was 88.9%. A major challenge for health facilities during PT participation was the AFB PT-sample transportation delay (40.7%) and the Xpert® MTB/RIF assay EQA-PT feedback missing (38.2%).ConclusionThis assessment reveals that IQC for AFB microscopy, lot-to-lot verification, method validation, and equipment calibration were not well-practiced. The majority of TB diagnostic health facility laboratories had EQA-PT participation practice, but a significant gap in PT-sample transportation and missing feedback was identified.

Project description:IntroductionBlood culture (BC) testing before initiation of antimicrobial therapy is recommended as a standard of care in international sepsis guidelines and has been shown to reduce intensive care unit (ICU) stay, antibiotic use, and costs in hospitalized patients. Whereas microbiological laboratory practice has been highly standardized, shortfalls in the preanalytic procedures in the ICU (that is indication, time-to-incubation, blood volume and numbers of BC sets) have a significant effect on the diagnostic yield. The objective of this study was to gain insights into current practices regarding BC testing in intensive care units.MethodsQualitative survey, data collection by 138 semi-structured telephone interviews in four European countries (Italy, UK, France and Germany) between September and November 2009 in 79 clinical microbiology laboratories (LABs) and 59 ICUs.ResultsWhereas BC testing is expected to remain the gold standard for sepsis diagnostics in all countries, there are substantial differences regarding preanalytic procedures. The decision to launch BC testing is carried out by physicians vs. ICU nurses in the UK in 92 vs. 8%, in France in 75 vs. 25%, in Italy in 88 vs. 12% and in Germany in 92 vs. 8%. Physicians vs. nurses collect BCs in the UK in 77 vs. 23%, in France in 0 vs. 100%, in Italy in 6 vs. 94% and in Germany in 54 vs. 46%. The mean time from blood collection to incubation in the UK is 2 h, in France 3 h, in Italy 4 h, but 20 h in German remote LABs (2 h in in-house LABs), due to the large number of remote nonresident microbiological laboratories in Germany. There were major differences between the perception of the quality of BC testing between ICUs and LABs. Among German ICU respondents, 62% reported that they have no problems with BC testing, 15% reported time constraints, 15% cost pressure, and only 8% too long time to incubation. However, the corresponding LABs of these German ICUs reported too many false positive results due to preanalytical contaminations (49%), insufficient numbers of incoming BC sets (47%), long transportation time (41%) or cost pressure (18%).ConclusionsThere are considerable differences in the quality of BC testing across European countries. In Germany, time to incubation is a considerable problem due to the increasing number of remote LABs. This is a major issue of concern to physicians aiming to implement sepsis guidelines in the ICUs.

Dataset Information

Quality assurance practices in Europe: a survey of molecular genetic testing laboratories.

Publications

Quality assurance practices in Europe: a survey of molecular genetic testing laboratories.

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