| Approaches to quality management and accreditation in a genetic testing laboratory. | |
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MedLine Citation:
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PMID: 20720559 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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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Authors:
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Sarah Berwouts; Michael A Morris; Elisabeth Dequeker |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: European journal of human genetics : EJHG Volume: 18 Suppl 1 ISSN: 1476-5438 ISO Abbreviation: Eur. J. Hum. Genet. Publication Date: 2010 Sep |
Date Detail:
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Created Date: 2010-08-19 Completed Date: 2010-11-09 Revised Date: 2012-04-16 |
Medline Journal Info:
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Nlm Unique ID: 9302235 Medline TA: Eur J Hum Genet Country: England |
Other Details:
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Languages: eng Pagination: S1-19 Citation Subset: IM |
Affiliation:
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Biomedical Quality Assurance Research Unit, Department of Human Genetics, University of Leuven, Leuven, Belgium. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Accreditation
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organization & administration Europe Genetic Testing / standards* Humans International Cooperation Laboratories / standards* Quality Assurance, Health Care / standards* Quality Control Total Quality Management / standards |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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