ArticleEuropean journal of human genetics : EJHG2010
Approaches to quality management and accreditation in a genetic testing laboratory.
Article in European journal of human genetics : EJHG, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- EMQN best practice guidelines for the molecular genetic diagnosis of hereditary hemochromatosis (HH).European journal of human genetics : EJHG · 2016Guideline
- Recommendations for reporting results of diagnostic genetic testing (biochemical, cytogenetic and molecular genetic).European journal of human genetics : EJHG · 2014Guideline
- Genetic testing in pituitary adenomas: a Pituitary Society International Consensus Statement.Nature reviews. Endocrinology · 2026Review
- Development and Implementation of an Internal Quality Control and External Quality Assessment Information System for a Regional Medical Laboratory Center: Pilot Design and Implementation Study.JMIR formative research · 2025Article
- Genetic testing in inherited endocrine disorders: joint position paper of the European reference network on rare endocrine conditions (Endo-ERN).Orphanet journal of rare diseases · 2020Review
- Mutational Screening of BRCA1/2 Genes as a Predictive Factor for Therapeutic Response in Epithelial Ovarian Cancer: A Consensus Guide from the Spanish Society of Pathology (SEAP-IAP) and the Spanish Society of Human Genetics (AEGH).Virchows Archiv : an international journal of pathology · 2020Review
- Development of a real-time PCR method for the genoserotyping of Salmonella Paratyphi B variant Java.Applied microbiology and biotechnology · 2019Article
- RAS testing in metastatic colorectal cancer: advances in Europe.Virchows Archiv : an international journal of pathology · 2016Review
- Validation of Novaprep(®) HQ+ liquid-based cytology medium for high-risk human papillomavirus detection by hc2.Infectious agents and cancer · 2016Article
- EMQN Best Practice Guidelines for molecular and haematology methods for carrier identification and prenatal diagnosis of the haemoglobinopathies.European journal of human genetics : EJHG · 2015Article
- Guidance for laboratories performing molecular pathology for cancer patients.Journal of clinical pathology · 2014Review
- Cost effectiveness of adopted quality requirements in hospital laboratories.Iranian journal of public health · 2013Article
- Quality assurance practices in Europe: a survey of molecular genetic testing laboratories.European journal of human genetics : EJHG · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.