Otwarty dostęp

Quality assurance of genetic laboratories and the EBTNA practice certification, a simple standardization assurance system for a laboratory network


Zacytuj

Kroese M, Zimmern RL, Sanderson S. Genetic tests and their evaluation: can we answer the key questions? Genet Med. 2004;6(6):475-80.10.1097/01.GIM.0000144060.84960.3615545742KroeseMZimmernRLSandersonSGenetic tests and their evaluation: can we answer the key questions?Genet Med20046647580Open DOISearch in Google Scholar

Kaul KL, Sabatini LM, Tsongalis GJ, Caliendo AM, Olsen RJ et al The Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient Care. Acad Pathol. 2017;16:4.KaulKLSabatiniLMTsongalisGJCaliendoAMOlsenRJet alThe Case for Laboratory Developed Procedures: Quality and Positive Impact on Patient CareAcad Pathol201716410.1177/2374289517708309552895028815200Search in Google Scholar

Hallworth MJ. The “70% claim”: What is the evidence base? Ann Clin Biochem 2011;48:487-8.10.1258/acb.2011.011177HallworthMJThe “70% claim”: What is the evidence base?Ann Clin Biochem201148487822045648Open DOISearch in Google Scholar

Badrick T. Evidence-based laboratory medicine.Clin Biochem Rev. 2013;34(2):43-6.24151340BadrickTEvidence-based laboratory medicineClin Biochem Rev2013342436Search in Google Scholar

Aakre KM, Langlois MR, Watine J, Barth JH, Baum H, et al Critical review of laboratory investigations in clinical practice guidelines: proposals for the description of investigation. Clin Chem Lab Med. 2013; 51(6):1217-26.23037517AakreKMLangloisMRWatineJBarthJHBaumHet alCritical review of laboratory investigations in clinical practice guidelines: proposals for the description of investigationClin Chem Lab Med201351612172610.1515/cclm-2012-057423037517Search in Google Scholar

Kirk CJ, Shult PA. Developing Laboratory Networks: A Practical Guide and Application Public Health Rep. 2010; 125(Suppl 2): 102-109.KirkCJShultPADeveloping Laboratory Networks: A Practical Guide and Application Public Health Rep2010125Suppl 210210910.1177/00333549101250S213284680920518451Search in Google Scholar

Monach PA. Repeating tests: different roles in research studies and clinical medicine. Biomark Med. 2012 ;6(5):691-703.2307524910.2217/bmm.12.57MonachPARepeating tests: different roles in research studies and clinical medicineBiomark Med201265691703365183223075249Search in Google Scholar

Hawkins R. Managing the pre- and post-analytical phases of the total testing process. Ann Lab Med. 2012;32(1):5-16.2225977310.3343/alm.2012.32.1.5HawkinsRManaging the pre- and post-analytical phases of the total testing processAnn Lab Med2012321516325548622259773Search in Google Scholar

ISO 3534-1;3.14 “Statistics - Vocabulary and symbols part1: General statistics terms and terms used in probalility”.ISO 3534-1;3.14 “Statistics - Vocabulary and symbols part1: General statistics terms and terms used in probalility”Search in Google Scholar

Karkaousos P, Evangeloupos A. In InTech, Applications and Experiences of Quality Control. Shanghai: Springer; 2011. Quality control in clinical laboratories; pp. 321-360.KarkaousosPEvangelouposAInTech, Applications and Experiences of Quality ControlShanghaiSpringer2011Quality control in clinical laboratories32136010.5772/15865Search in Google Scholar

Endrullat C, Glökler J, Franke P, Frohme M Standardization and quality management in next-generation sequencing.. Appl Transl Genom. 2016;1;10:2-9.10.1016/j.atg.2016.06.00127668169EndrullatCGlöklerJFrankePFrohmeMStandardization and quality management in next-generation sequencingAppl Transl Genom20161029502546027668169Open DOISearch in Google Scholar

Aziz N, Zhao Q, Bry L, Driscoll DK, Funke B, et alCollege of American Pathologists’ laboratory standards for next-generation sequencing clinical tests. Arch Pathol Lab Med. 2015;139(4):481-93.10.5858/arpa.2014-0250-CPAzizNZhaoQBryLDriscollDKFunkeBet alCollege of American Pathologists’ laboratory standards for next-generation sequencing clnical testsiArch Pathol Lab Med201513944819325152313Open DOISearch in Google Scholar

Badrick T. The quality control system. Clin Biochem Rev. 2008;29 Suppl 1:S67-70.BadrickTThe quality control systemClin Biochem Rev200829 Suppl1S6770Search in Google Scholar

Westgard JO. Internal quality control: planning and implementation strategies. Ann Clin Biochem 2003;40:593-611.10.1258/00045630377036719914629798WestgardJOInternal quality control: planning and implementation strategiesAnn Clin Biochem20034059361114629798Open DOISearch in Google Scholar

External quality assessment of health laboratories: Report on a WHO Working Group,1981.External quality assessment of health laboratories: Report on a WHO Working Group1981Search in Google Scholar

Cembrowski GS, Carey RN. Adding value to proficiency testing programs. Clin Chem 2000;46:7-8.10620565CembrowskiGSCareyRNAdding value to proficiency testing programsClin Chem2000467810.1093/clinchem/46.1.7Search in Google Scholar

Berwouts S, Fanning K, Morris MA, Barton DE, Dequeker E. Quality assurance practices in Europe: a survey of molecular genetic testing laboratories. Eur J Hum Genet. 2012;20(11):1118-26.10.1038/ejhg.2012.12522739339BerwoutsSFanningKMorrisMABartonDEDequekerEQuality assurance practices in Europe: a survey of molecular genetic testing laboratoriesEur J Hum Genet20122011111826347671622739339Open DOISearch in Google Scholar

Ezzelle J, Rodriguez-Chavez IR, Darden JM, Stirewalt M, Kunwar N, et al Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories. Pharm Biomed Anal. 2008;46(1):18-29.10.1016/j.jpba.2007.10.010EzzelleJRodriguez-ChavezIRDardenJMStirewaltMKunwarNet alGuidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratoriesPharm Biomed Anal20084611829221390618037599Open DOISearch in Google Scholar

De la Salle B, Meijer P, Thomas A, Simundic AM. Special issue on External Quality Assessment in Laboratory Medicine - current challenges and future trends.Biochem Med. 2017;27(1):19-22.De la SalleBMeijerPThomasASimundicAMSpecial issue on External Quality Assessment in Laboratory Medicine - current challenges and future trendsBiochem Med2017271192210.11613/BM.2017.003538284628392722Search in Google Scholar

Kristoffersson U, Schmidtke J, Cassiman JJ, Dequeker E. Quality management systems and accreditation; in Quality Issues in Clinical Genetics Services. Springer: New York, 2010.KristofferssonUSchmidtkeJCassimanJJDequekerEQuality management systems and accreditation; in Quality Issues in Clinical Genetics ServicesSpringerNew York201010.1007/978-90-481-3919-4Search in Google Scholar

International Organization for Standardization: ISO/IEC 17025 general requirements for the competence of testing and calibration laboratories, 2005.International Organization for Standardization: ISO/IEC 17025 general requirements for the competence of testing and calibration laboratories2005Search in Google Scholar

Schneider F, Maurer C, Friedberg RC. International Organization for Standardization (ISO) 15189. Ann Lab Med. 2017;37(5):365-370.2864348410.3343/alm.2017.37.5.365SchneiderFMaurerCFriedbergRCInternational Organization for Standardization (ISO) 15189Ann Lab Med2017375365370550073428643484Search in Google Scholar

Guzel O, Guner EI. ISO 15189 accreditation: Requirements for quality and competence of medical laboratories, experience of a laboratory I. Clin Biochem.2009;42(4-5):274-8.10.1016/j.clinbiochem.2008.09.01119863920GuzelOGunerEIISO 15189 accreditation: Requirements for quality and competence of medical laboratories, experience of a laboratory IClin Biochem2009424-5274819863920Open DOISearch in Google Scholar

Berwouts S, Morris MA, Dequeker E. Approaches to quality management and accreditation in a genetic testing laboratory. Eur J Hum Genet. 2010;18 Suppl 1:S1-19.BerwoutsSMorrisMADequekerEApproaches to quality management and accreditation in a genetic testing laboratoryEur J Hum Genet201018 Suppl1S11910.1038/ejhg.2010.104332751620720559Search in Google Scholar

R. Selvakumar. Good Laboratory Practices Indian J Clin Biochem. 2010; 25(3): 221-224.10.1007/s12291-010-0077-zSelvakumarR.Good Laboratory Practices Indian J Clin Biochem2010253221224Open DOISearch in Google Scholar

Mattocks CJ, Morris MA, Matthijs G, Swinnen E, Corveleyn A, et al A standardized framework for the validation and verification of clinical molecular genetic tests.; Eur J Hum Genet. 2010;18(12):1276-88.10.1038/ejhg.2010.10120664632MattocksCJMorrisMAMatthijsGSwinnenECorveleynAet alA standardized framework for the validation and verification of clinical molecular genetic testsEur J Hum Genet20101812127688300285420664632Open DOISearch in Google Scholar

Cassiman JJ. Research network: EuroGentest - a European Network of Excellence aimed at harmonizing genetic testing services. Eur J Hum Genet. 2005;13:1103-1105.10.1038/sj.ejhg.520148416094305CassimanJJResearch network: EuroGentest - a European Network of Excellence aimed at harmonizing genetic testing servicesEur J Hum Genet2005131103110516094305Open DOISearch in Google Scholar

Kalman LV, Datta V, Williams M, Zook JM, Salit ML, Han JY. Development and Characterization of Reference Materials for Genetic Testing: Focus on Public Partnerships. Ann Lab Med. 2016;36(6):513-20.10.3343/alm.2016.36.6.51327578503KalmanLVDattaVWilliamsMZookJMSalitMLHanJYDevelopment and Characterization of Reference Materials for Genetic Testing: Focus on Public PartnershipsAnn Lab Med201636651320501110327578503Open DOISearch in Google Scholar

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Official J. L 331, 1-37 (1998).Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devicesOfficial J. L3311371998Search in Google Scholar

Burnett D: A practical guide to accreditation in laboratory medicine, 2002.BurnettDA practical guide to accreditation in laboratory medicine2002Search in Google Scholar

Hwang SH, Jung SK, Kang SJ, Cha HS, Chung SH, Lee DH. Development of a document management system for the standardization of clinical laboratory documents. Ann Lab Med. 2013;33(6):441-8.2420549410.3343/alm.2013.33.6.441HwangSHJungSKKangSJChaHSChungSHLeeDHDevelopment of a document management system for the standardization of clinical laboratory documentsAnn Lab Med20133364418381944424205494Search in Google Scholar

Westgard JO. Internal quality control: planning and implementation strategies. Ann Clin Biochem 2003;40:593-611.10.1258/00045630377036719914629798WestgardJOInternal quality control: planning and implementation strategiesAnn Clin Biochem20034059361114629798Open DOISearch in Google Scholar

Deming WE: Out of the crisis, 2000.DemingWEOut of the crisis2000Search in Google Scholar

Ho B, Ho E. The most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteria. Biochem Med. 2012;22(2):247-57.HoBHoEThe most common nonconformities encountered during the assessments of medical laboratories in Hong Kong using ISO 15189 as accreditation criteriaBiochem Med20122222475710.11613/BM.2012.027Search in Google Scholar

European cooperation for Accreditation of Laboratories: EAL-G3 internal audits and management reviews for laboratories, 1996.European cooperation for Accreditation of Laboratories: EAL-G3 internal audits and management reviews for laboratories1996Search in Google Scholar

Balague N and Saarti J. Managing Your Library and Its Quality: The ISO 9001 Way. Oxford, UK: Chandos Publishing; 2011.BalagueNSaartiJManaging Your Library and Its Quality: The ISO 9001 WayOxford, UKChandos Publishing201110.1533/9781780632797Search in Google Scholar

Gardner H. Changing minds: the art and science of changing our own and other people’s minds, 2006.GardnerHChanging minds: the art and science of changing our own and other people’s minds2006Search in Google Scholar

Walz SE. Education and training in laboratory medicine in the United States. JIFCC. 2013;24(1):1-3.WalzSEEducation and training in laboratory medicine in the United StatesJIFCC201324113Search in Google Scholar

The Maputo Declaration on strengthening of laboratory systems. Brazzaville: WHO Regional Office for Africa; htp://www.who.int/diagnostics_laboratory/Maputo-Declaration_2008.pdf accessed 20 June 2015). The Maputo Declaration on strengthening of laboratory systems. Brazzaville: WHO Regional Office for Africa;2008 http://www.who.int/diagnostics_laboratory/Maputo-Declaration_2008.pdf accessed 20 June 2015).The Maputo Declaration on strengthening of laboratory systemsBrazzavilleWHO Regional Office for Africahtp://www.who.int/diagnostics_laboratory/Maputo-Declaration_2008.pdfaccessed 20 June 2015). The Maputo Declaration on strengthening of laboratory systems. Brazzaville: WHO Regional Office for Africa;2008http://www.who.int/diagnostics_laboratory/Maputo-Declaration_2008.pdfaccessed 20 June 2015Search in Google Scholar

Joint WHO-CDC conference on health laboratory quality systems. Geneva: World Health Organization; 2008 http://www.who.int/csr/ihr/lyon/report20080409.pdf?ua=1 accessed 6 August 2015).Joint WHO-CDC conference on health laboratory quality systemsGenevaWorld Health Organization2008http://www.who.int/csr/ihr/lyon/report20080409.pdf?ua=1accessed 6 August 2015Search in Google Scholar

Health 2020: the European policy for health and wellbeing [website]. Copenhagen: WHO Regional Office for Europe; htp://www.euro.who.int/en/health-topics/health-policy/health-2020-the-european-policy-forhealth-and-well-being accessed 6 August 2015).Health 2020: the European policy for health and wellbeing [website]CopenhagenWHO Regional Office for Europehtp://www.euro.who.int/en/health-topics/health-policy/health-2020-the-european-policy-forhealth-and-well-beingaccessed 6 August 2015Search in Google Scholar

Brown CS, Zwetyenga J, Berdieva M, Volkova T, Cojocaru R, et al New policy-formulation methodology paves the way for sus tainable laboratory systems in Europe. Public Health Panorama. 2015;1(1):41-47.BrownCSZwetyengaJBerdievaMVolkovaTCojocaruRet alNew policy-formulation methodology paves the way for sus tainable laboratory systems in EuropePublic Health Panorama2015114147Search in Google Scholar

Nkengasong JN, Nsubuga P, Nwanyanwu O, GershyDamet GM, RoscignoG, et al Laboratory systems and services are critical in global health: time to end the neglect? Am J Clin Pathol. 2010;134(3):368-73.2071679110.1309/AJCPMPSINQ9BRMU6NkengasongJNNsubugaPNwanyanwuOGershyDametGMRoscignoGet alLaboratory systems and services are critical in global health: time to end the neglect?Am J Clin Pathol2010134336873710980220716791Search in Google Scholar

Olmsted SS, Moore M, Meili RC, Duber HC, Wasserman J, et al Strengthening laboratory systems in resource-limited settings. Am J Clin Pathol. 2010;134(3):374-80.2071679210.1309/AJCPDQOSB7QR5GLROlmstedSSMooreMMeiliRCDuberHCWassermanJet alStrengthening laboratory systems in resource-limited settingsAm J Clin Pathol201013433748020716792Search in Google Scholar

Goodfellow I, Reusken C, Koopmans M. Laboratory support during and after the Ebola virus endgame: towards a sustained laboratory infrastructure. Euro Surveill. 2015;20(12):21074.10.2807/1560-7917.ES2015.20.12.2107425846492GoodfellowIReuskenCKoopmansMLaboratory support during and after the Ebola virus endgame: towards a sustained laboratory infrastructureEuro Surveill2015201221074Open DOISearch in Google Scholar

Katz R, Sorrell EM, Kornblet SA, Fischer JE. Global health security agenda and the international health regulations: moving forward. Biosecur Bioterror. 2014;12(5):231-8.10.1089/bsp.2014.003825254911KatzRSorrellEMKornbletSAFischerJEGlobal health security agenda and the international health regulations: moving forwardBiosecur Bioterror2014125231825254911Open DOISearch in Google Scholar

Bruschi F, Dundar M, Gahan PB, Gartland K, Szente M, et alBiotechnology worldwide and the ‘European Biotechnology Thematic Network’ Association (EBTNA).Curr Opin Biotechnol. 2011;22 Suppl 1:S7-14.BruschiFDundarMGahanPBGartlandKSzenteMet alBiotechnology worldwide and the ‘European Biotechnology Thematic Network’ Association (EBTNA)Curr Opin Biotechnol201122 Suppl1S71410.1016/j.copbio.2011.05.50621680172Search in Google Scholar

Price CP. Evidence-based laboratory medicine: supporting decision- making. Clin Chem. 2000;46:1041-50.10926881PriceCPEvidence-based laboratory medicine: supporting decision- makingClin Chem20004610415010.1093/clinchem/46.8.1041Search in Google Scholar

eISSN:
2564-615X
Język:
Angielski
Częstotliwość wydawania:
4 razy w roku
Dziedziny czasopisma:
Life Sciences, other, Medicine, Biomedical Engineering, Physics, Nanotechnology, Biophysics