ABSTRACT
Diagnostic Devices 235 8.2.3 Regulation Issued by Substance Abuse and Mental Health
Administration 238 8.2.3.1 Specimen Kind and Collection 239 8.2.3.2 Analytical Aspects of WDT 240 8.2.3.3 Quality Assurance Aspects of WDT 241
8.2.4 Guidelines on Good Clinical Laboratory Practice Issued by National Institutes of Health 243 8.2.4.1 Standards for Organization and Personnel 244 8.2.4.2 Standards for Laboratory Equipment 245 8.2.4.3 Standards for Test Facility Operation 245 8.2.4.4 Quality Control Program 246 8.2.4.5 Standards for Verication of Performance
Specication 246
8.2.4.6 Standards for Records and Reports 247 8.2.4.7 Standards for Physical Facilities 249 8.2.4.8 Standards for Specimen Transport and
Management 249 8.2.4.9 Standards for Personnel Safety 250 8.2.4.10 Standards for Laboratory Information System 250 8.2.4.11 Standards for Quality Management 251
8.2.5 Recommendations of the National Research Council Concerning U.S. Forensic Sciences Community: Creation of the National Institute of Forensic Science 252
8.3 European Union Regulations and Recommendations 257 8.3.1 Quality Assurance of Human Resources Coordinated
on European Level: e Activity of the European Communities Confederation of Clinical Chemistry and Laboratory Medicine 257 8.3.1.1 Professional Competence Issues 258 8.3.1.2 Ethical Issues 260 8.3.1.3 European Coordination Issues 261
8.3.2 European Community Activity Concerning Performance of Analytical Methods and Interpretation of Results 262
8.3.3 European Committee for External Quality Assurance Programmes in Laboratory Medicine 263
8.4 Professional International and National Organizations 264 8.4.1 International Conference on Harmonisation 264 8.4.2 Joint Committee on Traceability in Laboratory Medicine 266 8.4.3 International Federation of Societies of Toxicologist
Pathologists 267 8.4.4 Recommendations of Organizations of Forensic
Toxicologists 269 8.4.4.1 Forensic Toxicology Laboratory Guidelines Issued
by SOFT/AAFS 269 8.4.4.2 Activity of the College of American Pathologists
for Forensic Sciences 276 8.4.4.3 e International Association of Forensic
Toxicologists Guidelines 276 8.4.4.4 Guidelines of the Society of Hair Testing 278 8.4.4.5 Guidelines of the German Society of Toxicological
and Forensic Chemistry 281 References 284
AAFS American Academy of Forensic Sciences BARQA British Association of Research Quality Assurance BIPM Bureau Internationale des Poids et Mesures CAP College of American Pathologists CLIA Clinical Laboratory Improvement Amendments CLSI Clinical and Laboratory Standard Institute CMS Centers for Medicare and Medical Services DAD Diode Array Detector EC4 e European Communities Confederation of Clinical
Chemistry and Laboratory Medicine EFCC European Federation of Clinical Chemistry and Laboratory
Medicine EQA External quality assurance EQALM European Committee for External Quality Assurance
Programmes in Laboratory Medicine FDA Food and Drug Administration GCLP Good Clinical Laboratory Practice GC-MS Gas chromatography-mass spectrometry GCP Good Clinical Practice GLP Good Laboratory Practice GTFCh German Society of Toxicological and Forensic Chemistry HHS U.S. Department of Health and Human Services ICH International Conference on Harmonisation IFCC International Federation of Clinical Chemistry and Laboratory
Medicine IFSTP International Federation of Societies of Toxicologist
Pathologists ILAC International Laboratory Accreditation Cooperation ISO International Organization for Standardization JCTLM Joint Committee on Traceability in Laboratory Medicine LC-MS Liquid chromatography-mass spectrometry LIS Laboratory Information System LLOQ Lower limit of quantication LOD Limit of detection MRO Medical review o²cer NIFS National Institute of Forensic Science NIH National Institutes of Health NIST National Institute of Standards and Technology PT Prociency testing QM Quality management
SAMHSA Substance Abuse and Mental Health Administration SOFT Society of Forensic Toxicologists SoHT Society of Hair Testing SOP Standard operation procedure TIAFT e International Association of Forensic Toxicologists TLC in layer chromatography ULOQ Upper limit of quantication WDT Workplace drug testing
Examinations, performed in hospital, pathological, or forensic laboratories, are applied in very sensitive areas, like, e.g., preventive cancer screening, workplace drug testing, or in emergency situations. e results of such examinations may have direct impact on the health and well-being of the society, or on the individual fate or professional career of an individual person.
