Meta-audit of laboratory ISO accreditation inspections: measuring the old emperor's clothes.
Ontology highlight
ABSTRACT:
SUBMITTER: Wilson IG
PROVIDER: S-EPMC4767433 | biostudies-other | 2016 Feb
REPOSITORIES: biostudies-other
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Project description:Medical laboratories, and specifically genetic testing laboratories, provide vital medical services to different clients: clinicians requesting a test, patients from whom the sample was collected, public health and medical-legal instances, referral laboratories and authoritative bodies. All expect results that are accurate and obtained in an efficient and effective manner, within a suitable time frame and at acceptable cost. There are different ways of achieving the end results, but compliance with International Organization for Standardization (ISO) 15189, the international standard for the accreditation of medical laboratories, is becoming progressively accepted as the optimal approach to assuring quality in medical testing. We present recommendations and strategies designed to aid genetic testing laboratories with the implementation of a quality management system, including key aspects such as document control, external quality assessment, internal quality control, internal audit, management review, validation, as well as managing the human side of change. The focus is on pragmatic approaches to attain the levels of quality management and quality assurance required for accreditation according to ISO 15189, within the context of genetic testing. Attention is also given to implementing efficient and effective quality improvement.
| S-EPMC3327516 | biostudies-other
Project description:BackgroundThere is a significant variation among individual primary care providers in prescribing of potentially problematic, low-value medicines which cause avoidable patient harm. Audit and feedback is generally effective at improving prescribing. However, progress has been hindered by research waste, leading to unanswered questions about how to include audit and feedback for specific problems and circumstances. Trials of different ways of providing audit and feedback in implementation laboratories have been proposed as a way of improving population healthcare while generating robust evidence on feedback effects. However, there is limited experience in their design and delivery.AimTo explore priorities, feasibility, and ethical challenges of establishing a primary care prescribing audit and feedback implementation laboratory.Design and settingTwo-stage Delphi consensus process involving primary care pharmacy leads, audit and feedback researchers, and patient and public.MethodParticipants initially scored statements relating to priorities, feasibility, and ethical considerations for an implementation laboratory. These covered current feedback practice, priority topics for feedback, usefulness of feedback in improving prescribing and different types of prescribing data, acceptability and desirability of different organization levels of randomization, options for trial consent, different methods of delivering feedback, and interest in finding out how effective different ways of presenting feedback would be. After receiving collated results, participants then scored the items again. The consensus was defined using the GRADE criteria. The results were analyzed by group and overall score.ResultsFourteen participants reached consensus for 38 out of 55 statements. Addressing antibiotic and opioid prescribing emerged as the highest priorities for action. The panel supported statements around addressing high-priority prescribing issues, taking an "opt-out" approach to practice consent if waiving consent was not permitted, and randomizing at lower rather than higher organizational levels. Participants supported patient-level prescribing data and further research evaluating most of the different feedback methods we presented them with.ConclusionsThere is a good level of support for evaluating a wide range of potential enhancements to improve the effects of feedback on prescribing. The successful design and delivery of a primary care audit and feedback implementation laboratory depend on identifying shared priorities and addressing practical and ethical considerations.
| S-EPMC7792204 | biostudies-literature
Project description:Animals experience complex odorant stimuli that vary widely in composition, intensity and temporal properties. However, stimuli used to study olfaction in the laboratory are much simpler. This mismatch arises from the challenges in measuring and controlling them precisely and accurately. Even simple pulses can have diverse kinetics that depend on their molecular identity. Here, we introduce a model that describes how stimulus kinetics depend on the molecular identity of the odorant and the geometry of the delivery system. We describe methods to deliver dynamic odorant stimuli of several types, including broadly distributed stimuli that reproduce some of the statistics of naturalistic plumes, in a reproducible and precise manner. Finally, we introduce a method to calibrate a photo-ionization detector to any odorant it can detect, using no additional components. Our approaches are affordable and flexible and can be used to advance our understanding of how olfactory neurons encode real-world odor signals.
| S-EPMC6918787 | biostudies-literature
Project description:BackgroundAs next-generation sequencing (NGS) oncology tests vary by platform, application, and target of genes, specific methods for external quality assessment (EQA) have not been universally applied. Hence, we have attempted to implement on-site evaluation as EQA in the accreditation program under ISO 15189 for laboratories that perform NGS oncology tests.MethodsA total of 10 laboratories that performed NGS oncology tests were enrolled. Two types of EQA samples were prepared (Acrometrix Oncology Hotspot Control DNA and OncoSpan gDNA DNA samples), and the variant allele frequency of targeted genes was assigned. The samples were subjected to NGS oncology tests in participant laboratories according to their routine protocols. Based on the result reports, auditors visited the participant laboratories to perform on-site evaluations and provided feedback regarding possible laboratory process improvement.ResultsThe participant laboratories identified the targeted variants in the Acrometrix Oncology Hotspot Control DNA and OncoSpan gDNA samples with a success rate of 31-100% and 9.5-100%, respectively, compared with reference information, depending on their sequencing systems, and reported a few lower-variant allele frequencies. Six of the eight evaluated laboratories failed to report at least three pathogenic variants due to errors in wet-lab and/or dry-lab processes. Based on the feedback reports and self-assessment, auditors and laboratory staff discussed potential improvements to processes during on-site evaluations for laboratory accreditations.ConclusionsOn-site evaluation as EQA for NGS oncology tests in the laboratory accreditation program under ISO 15189 was successfully implemented and proved applicable to a broad spectrum of NGS tests.
| S-EPMC10388225 | biostudies-literature
Project description:BackgroundDifferent laboratory methods are used to quantify ferritin concentrations as a marker of iron status. A systematic review was undertaken to assess the accuracy and comparability of the most used methods for ferritin detection.Methods and findingsNational and regional databases were searched for prospective, retrospective, sectional, longitudinal and case-control studies containing the characteristics and performance of at least one method for serum/plasma ferritin determinations in humans published to date. The analysis included the comparison between at least 2 methods detailing: sensitivity, precision, accuracy, predictive values, inter-methods adjustment, and use of international reference materials. Pooled method performance was analyzed for each method and across methods.OutcomesSearch strategy identified 11893 records. After de-duplication and screening 252 studies were assessed, including 187 studies in the qualitative analysis and 148 in the meta-analysis. The most used methods included radiometric, nonradiometric and agglutination assays. The overall within-run imprecision for the most reported ferritin methods was 6.2±3.4% (CI 5.69-6.70%; n = 171), between-run imprecision 8.9±8.7% (CI 7.44-10.35%; n = 136), and recovery rate 95.6% (CI 91.5-99.7%; n = 94). The pooled regression coefficient was 0.985 among all methods analyzed, and 0.984 when comparing nonradiometric and radiometric methods, without statistical differences in ferritin concentration ranging from 2.3 to 1454 μμg/L.ConclusionThe laboratory methods most used to determine ferritin concentrations have comparable accuracy and performance. Registered in PROSPERO CRD42016036222.
| S-EPMC5933730 | biostudies-literature
Project description:A growing body of literature suggests that higher engagement in a range of activities can be beneficial for cognitive health in old age. Such studies typically rely on self-report questionnaires to assess level of engagement. These questionnaires are highly heterogeneous across studies, limiting generalisability. In particular, the most appropriate domains of activity engagement remain unclear. The Victoria Longitudinal Study-Activity Lifestyle Questionnaire comprises one of the broadest and most diverse collections of activity items, but different studies report different domain structures. This study aimed to help establish a generalisable domain structure of the Victoria Longitudinal Study-Activity Lifestyle Questionnaire. The questionnaire was adapted for use in a sample of UK-based older adults (336 community-dwelling adults aged 65-92 with no diagnosed cognitive impairment). An exploratory factor analysis was conducted on 29 items. The final model retained 22 of these items in a six-factor structure. Activity domains were: Manual (e.g., household repairs), Intellectual (e.g., attending a public lecture), Games (e.g., card games), Religious (e.g., attending religious services), Exercise (e.g., aerobics) and Social (e.g., going out with friends). Given that beneficial activities have the potential to be adapted into interventions, it is essential that future studies consider the most appropriate measurement of activity engagement across domains. The factor structure reported here offers a parsimonious and potentially useful way for future studies to assess engagement in different kinds of activities.
| S-EPMC8648112 | biostudies-literature
Project description:Background Despite the recent trend toward developing and applying quality control measures in the forensic science disciplines, there is a heightened interest to efforts to ameliorate disparate quality among laboratories through the enforcement of standards and best practices.Objective This protocol aims to set up the Arab Forensic Laboratories Accreditation Center (AFLAC) to act as a key driving legal force for accreditation of the different forensic laboratories in the Arab region.Methods Upon its development, the Forensic Laboratory-Arabian Gate (FLAG) platform will serve as a preliminary stage for the AFLAC, and 2 preparatory steps will be achieved through the FLAG platform: the first one is a scoping study to analyze the international guidelines regarding the forensic laboratory practices in different specialties, and the second one is mapping surveys to explore how the international and national guidelines are translated into practice in Arab forensic laboratories. Development of the Arab forensic laboratories accreditation center will be initiated by building the AFLAC quality management system, which comprises formation of the forensic science committees to achieve the standards required for accreditation in each discipline. This will be followed by the attainment of regional accreditation recognition of the Arab Accreditation Cooperation (ARAC) and the International Laboratory Accreditation Cooperation. This recognition necessitates achieving International Organization for Standardization/International Electrotechnical Commission 17011 standard requirements prior to official application to the ARAC.Results The first phase of our work (the FLAG platform) began in February 2022 and is expected to end in December 2022. The FLAG platform was proposed to the Arab Society of Forensic Sciences and Forensic Medicine in March 2022, and we received approval to host this web development project. Subsequent phases are anticipated to begin in January 2023 and are expected to end in 2025.Conclusions This work describes our approach to provide a valuable tool for forensic laboratory accreditation services to promote the best practice and its consistency in the field of forensic sciences in the Arab region.International registered report identifier (irrid)PRR1-10.2196/36778.
| S-EPMC9280477 | biostudies-literature
Project description:Background: Audit data is important in creating a clear picture of clinical reality in clinical services, and evaluating treatment outcomes. This paper explored the data from an audit of a large national eating disorder (ED) service and evaluated the outcome of inpatient and day treatment programmes for patients with anorexia nervosa (AN) with and without autistic traits. Methods: Four hundred and seventy-six patients receiving treatment for AN at inpatient (IP), day-care (DC) and step-up (SU) programmes were assessed at admission and at discharge on the following measures: autistic traits, body-mass-index (BMI), ED symptoms, depression and anxiety symptoms, work and social functioning, and motivation for change. Outcomes were analyzed first at a within-group level based on change in mean scores and then at an individual level based on the clinical significance of improvement in eating disorder symptoms. Outcomes were compared between patients with high autistic traits (HAT) and low autistic traits (LAT) in each programme. Results: The findings suggest that 45.5% of DC and 35.1% of IP patients showed clinically significant changes in ED symptoms following treatment. Co-occurring high autistic traits positively predicted improvement in ED symptoms in IP setting, but was a negative predictor in DC. In IP, more HAT inpatients no longer met the BMI cut-off for AN compared to LAT peers. In terms of general psychopathology, patients with AN and HAT exhibited more severe depression symptoms, anxiety symptoms and social functioning impairment than their LAT peers, and these symptoms stayed clinically severe after treatment. Conclusions: Patients with AN and hight autistic traits are more likely than their peers with low autistic traits to show weight restoration and improvement in ED systems after inpatient treatment. This reverses in DC, with high autistic trait patients less likely to improve after treatment compared to low autistic trait patients. Our results suggest that inpatient treatment with individualized and structured routine care may be an effective model of treatment for patients with AN and high autistic traits.
| S-EPMC7736031 | biostudies-literature
Project description:BackgroundLaboratory tests and transfusions are sometimes ordered inappropriately, particularly in the critical care setting, which sees frequent use of both. Audit and Feedback (A&F) is a potentially useful intervention for modifying healthcare provider behaviors, but its application to the complex, team-based environment of critical care is not well understood. We conducted a systematic review of the literature on A&F interventions for improving test or transfusion ordering in the critical care setting.MethodsFive databases, two registries, and the bibliographies of relevant articles were searched. We included critical care studies that assessed the use of A&F targeting healthcare provider behaviors, alone or in combination with other interventions to improve test and transfusion ordering, as compared to historical practice, no intervention, or another healthcare behaviour change intervention. Studies were included only if they reported laboratory test or transfusion orders, or the appropriateness of orders, as outcomes. There were no restrictions based on study design, date of publication, or follow-up time. Intervention characteristics and absolute differences in outcomes were summarized. The quality of individual studies was assessed using a modified version of the Effective Practice and Organisation of Care Cochrane Review Group's criteria.ResultsWe identified 16 studies, including 13 uncontrolled before-after studies, one randomized controlled trial, one controlled before-after study, and one controlled clinical trial (quasi-experimental). These studies described 17 interventions, mostly (88%) multifaceted interventions with an A&F component. Feedback was most often provided in a written format only (41%), more than once (53%), and most often only provided data aggregated to the group-level (41%). Most studies saw a change in the hypothesized direction, but not all studies provided statistical analyses to formally test improvement. Overall study quality was low, with studies often lacking a concurrent control group.ConclusionsOur review summarizes characteristics of A&F interventions implemented in the critical care context, points to some mechanisms by which A&F might be made more effective in this setting, and provides an overview of how the appropriateness of orders was reported. Our findings suggest that A&F can be effective in the context of critical care; however, further research is required to characterize approaches that optimize the effectiveness in this setting alongside more rigorous evaluation methods.Trial registrationPROSPERO CRD42016051941.
| S-EPMC7303577 | biostudies-literature
Project description:This study developed a patient-level audit tool to assess the appropriateness of antibiotic prescribing in acute National Health Service (NHS) hospitals in the UK. A modified Delphi process was used to evaluate variables identified from published literature that could be used to support an assessment of appropriateness of antibiotic use. At a national workshop, 22 infection experts reached a consensus to define appropriate prescribing and agree upon an initial draft audit tool. Following this, a national multidisciplinary panel of 19 infection experts, of whom only one was part of the workshop, was convened to evaluate and validate variables using questionnaires to confirm the relevance of each variable in assessing appropriate prescribing. The initial evidence synthesis of published literature identified 25 variables that could be used to support an assessment of appropriateness of antibiotic use. All the panel members reviewed the variables for the first round of the Delphi; the panel accepted 23 out of 25 variables. Following review by the project team, one of the two rejected variables was rephrased, and the second neutral variable was re-scored. The panel accepted both these variables in round two with a 68% response rate. Accepted variables were used to develop an audit tool to determine the extent of appropriateness of antibiotic prescribing at the individual patient level in acute NHS hospitals through infection expert consensus based on the results of a Delphi process.
| S-EPMC6627925 | biostudies-literature