Quality assurance within clinical chemistry—a brief review emphasizing ‘good laboratory practice’

References

• Uldall A. Kvalitetssikring inden for analytisk klinisk kemi. Dissertation, Private Press, Frederiksberg 1986; 1–72, Danish Pharmaceutical University, 1986
   Google Scholar
• American National Standard. ANSI/ASQC A 3. Quality systems terminology. Approved January 18, 1979. American Society for Quality Control, Wisconsin 1978; 1–7
   Google Scholar
• BenGershôm E. Ethical aspects of clinical chemistry. Proceedings of International Congress of Clinical Chemistry. Vienna, Austrìa, 30 August-5 September 1981, E Kaiser, F Gabi, M M Müller, P M Bayer. Walter de Gruyter, New York 1982; 9–29
   Google Scholar
• Gerhardt W, Keller H. Evaluation of test data from clinical studies. Scand J Clin Lab Invest 1986; 46((Suppl. 181))1–74
   PubMed Web of Science ®Google Scholar
• Harris E K, Yasaka T. On the calculation of a ‘reference change’ for comparing two consecutive measurements. Clin Chem 1983; 29: 25–30
   PubMed Web of Science ®Google Scholar
• Tonks D B. A study of the accuracy and precision of clinical chemistry determinations in 170 Canadian laboratories. Clin Chem 1963; 9: 217–33
   PubMed Web of Science ®Google Scholar
• Elevitch F R. Proceedings of the 1976 Aspen conference on analytical goals in clinical chemistry. College of American Pathologists, Chicago 1977; 1–7
   Google Scholar
• Elion-Gerritzen W E. Analytic precision in clinical chemistry and medical decisions. Am J Clin Pathol 1980; 73: 183–95
   PubMed Web of Science ®Google Scholar
• Skendzel L P, Barnett R N, Platt R. Medically useful criteria for analytic performance of laboratory tests. Am J Clin Pathol 1985; 83: 200–5
   PubMed Web of Science ®Google Scholar
• Barnett R N. Medical significance of laboratory results. Am J Clin Pathol 1968; 50: 671–6
   PubMed Web of Science ®Google Scholar
• Hørder M. Assessing quality requirements in clinical chemistry. the Nordic clinical chemistry project (NORDKEM), Helsinki 1980; 1–144
   Google Scholar
• Healy MJR, Whitehead T P. Outlying values in the national quality control scheme. Ann Clin Biochem 1980; 17: 78–81
   PubMed Web of Science ®Google Scholar
• Fraser C G. Desirable performance standards for clinical chemistry test. Adv Clin Chem 1983; 23: 299–339
   PubMed Web of Science ®Google Scholar
• Fraser C G, Skendzel L P, Barnett R N. Correspondence and corrections. Better criteria for desirable laboratory performance exist. The author's reply: basic criteria in needs of physicians. Am J Clin Pathol 1986; 85: 251–2
   PubMed Web of Science ®Google Scholar
• Faulkner W R, Meites S. Selected methods for the small clinical chemistry laboratory. Sel Meth Clin Chem 1982; 9: 1–395
   Google Scholar
• DIN-Katalog für Technische Regeln. Beuth Verlag, Berlin, Köln 1986; vols 1–2
   Google Scholar
• Hørder M, Gerhardt W, Härkönen M, et al. Experiences with the Scandinavian recommended methods for determinations of enzymes in blood. Scand J Clin Lab Invest 1981; 41: 107–16
   PubMed Web of Science ®Google Scholar
• Saris N-E. International Federation of Clinical Chemistry. Recommendations and related documents. Walter de Gruyter, Berlin 1984; vol. 1: 1–146, 1978–1983
   Google Scholar
• Dybkær R, Jørgensen K, Nyboe J. Statistical terminology in clinical chemistry reference values. Scand J Clin Lab Invest 1975; 35(Suppl. 144)45–74
   Google Scholar
• WHO. Expert committee on biological standardization. Lists of international biological standards, international biological reference preparations and international biological reference reagents. WHO, Geneva 1982; 1–87
   Google Scholar
• Hyvärinen A. A model for the statistical description of analytical errors occurring in clinical chemical laboratories with time. Scand J Clin Lab Invest 1985; 45((Suppl. 175))1–84
   PubMed Web of Science ®Google Scholar
• Stevens S S. On the theory of scales of measurement. Sci 1946; 103: 677–80
   PubMed Web of Science ®Google Scholar
• OECD. Good laboratory practice in the testing of chemicals. OECD, Paris 1982; 1–62, Final report of the group of experts on good laboratory practice
   Google Scholar
• EFTA. Basic standards of good manufacturing practice for pharmaceutical products (PH 1/72). EFTA Secretariat, Geneva 1973; 79–87
   Google Scholar
• British Standards Institution. BS 6460, part 1. British standard. Accreditation of testing laboratories. Specification of the general requirements for the technical competence of testing laboratories. British Standards Institution, London 1983; 1–4
   Google Scholar
• Danish National Testing Board. Orientering om STP's autorisationsordning. I. Register over autoriserede laboratorier 1984/1985. Information on the national testing board's accreditation scheme. The National Testing board of Denmark. Register of Accredited Laboratories. Statens Tekniske Prøvenavn, Copenhagen 1985; 4–10
   Google Scholar
• Lott J A. Laboratory personnel: the most important aspect of quality control. Med Instrum 1974; 8: 22–5
   PubMedGoogle Scholar
• Shuey H E, Cebel J. Standards of performance in clinical laboratory diagnosis. Bull US Army Med Dep 1949; 9: 799–815
   PubMedGoogle Scholar
• Arends J, Uldall A. The reliability of pregnancy tests performed by trained and untrained persons. Dan Med Bull 1977; 24: 115–6
   PubMed Web of Science ®Google Scholar
• Smith J H. Laboratory staff and nurses' performance compared when using the blood glucose Reflotest-Reflomat system. Med Lab Sci 1983; 40: 283–5
   PubMedGoogle Scholar
• Rubin M, Lous P. Education and training for clinical chemistry. IFCC, MIP Press, Lancaster 1977; 1–196
   Google Scholar
• ISO. Quality management and quality system elements—guidelines. Draft international Standard. ISO., Geneva 1985; 1–18, 9004
   Google Scholar
• Crosby P B. Quality is Free. The Art of Making Quality Certain. McGraw-Hill, New York 1979; 1–309
   Google Scholar
• Winkel P. Operational research and cost containment: a general mathematical model of a workstation. Clin Chem 1984; 30: 1758–64
   PubMed Web of Science ®Google Scholar
• Everett G D, deBlois S, Chang P-F, Holets T. Effect of cost education, cost audits and faculty chart review on the use of laboratory services. Arch Intern Med 1983; 143: 942–4
   PubMedGoogle Scholar
• Novich M, Gillis L, Tabuer A I. The laboratory test justified. An effective means to reduce routine laboratory testing. Am J Clin Pathol 1985; 84: 756–9
   PubMed Web of Science ®Google Scholar
• Winkel P, Statland B E. Assessing cost savings when unnecessary utilization of laboratory tests can be abolish. Am J Clin Pathol 1984; 82: 418–23
   PubMed Web of Science ®Google Scholar
• ISO. Standard for atomic absorption analysis. ISO., Geneva 1982; 1–12, 1983: 1–6; 1983: 1–5.78/2–4 Layouts for standards—Part 2: Standard for chemical analysis. Part 3: Standard for molecular absorption spectrometry. Part 4
   Google Scholar
• NCCLS. Approved guideline. Clinical laboratory procedure manuals. NCCLS Publ., Villanova 1984; 4: 27–53
   Google Scholar
• ISO Catalogue. ISO., Geneva 1986, 1986
   Google Scholar
• ECCLS. Standard for specimen collection. Part 1: Blood Containers. Part 2: Blood specimen by venepuncture. ECCLS, Berlin Doc, 1984; 1: 1–6, (1) 1(4): 1–14
   Google Scholar
• NCCLS. Proposed standard procedures for the handling and processing of blood specimens. NCCLS Publ., Villanova 1982; 1: 482–530, (16)
   Google Scholar
• IFCC/IUPAC, Fraser C G, de Cediel N, Porter C J, Schwartz M K, Worth H GL, Zinder Guidelines O. J Clin Chem Clin Biochem 1985; 23: 891–7, (1985) for clinical chemists for effective communication of clinical chemistry laboratory data
   PubMedGoogle Scholar
• ECCLS. Good manufactoring practice. Good clinical laboratory practice. The value of consultation between clinicians, surgeons and laboratory scientists. ECCLS. 1983, Abstracts. Fourth seminar, Dublin, 22–23 June 1983
   Google Scholar
• Brown S, Calam D H, Gloag E A. Clinical Laboratory Science in Europe. The Roles of Industry, the Professions and Health Authorities. ECCLS., Beckenham 1983; 1–242
   Google Scholar
• Anonymous Problems with reagents, quality control and calibration materials-dialogue between the customer and the supplier. News Sheet Assoc Clin Biochem 1985; 8–10, no. 271
   Google Scholar
• ISO. Sampling procedures for inspection by attributes—Part 2. Sampling plans indexed by limiting quality (LQ) for isolated lot inspection. ISO., Geneva 1985; 1–21, 2859
   Google Scholar
• Westgard J O, Groth T, de Verdier C-H. Principles for developing improved quality control procedures. Scand J Clin Lab Invest 1984; 44((Suppl. 172))19–41
   PubMed Web of Science ®Google Scholar
• Aronsson T. Development of efficient and practical systems for quality control in clinical chemistry. Acta Univ Upsal 1985; 522: 1–55
   Google Scholar
• Levy W C, Hay K L, Bull B S. Preserved blood versus patient data for quality control—Bull's algorithm revisited. Am J Clin Pathol 1986; 85: 719–21
   PubMed Web of Science ®Google Scholar
• Wheeler L A, Sheiner L B. A clinical evaluation of various delta check methods. Clin Chem 1981; 27: 5–9
   PubMed Web of Science ®Google Scholar
• Lizuka Y, Kume H, Kitamura M. Multivariate delta check method for detecting specimen mix-up. Clin Chem 1982; 28: 2244–8
   PubMed Web of Science ®Google Scholar
• Marchandise H, Colinet E. Assessment of methods of assigning certified values to reference materials. Fresenius Z Anal Chem 1983; 316: 669–72
   Google Scholar
• Fraser C G. Urine analysis: current performance and strategies for improvement. Br Med J 1985; 291: 321–3
   PubMed Web of Science ®Google Scholar
• Watkinson L R, Fraser C G. An inter-laboratory quality-assurance survey of emergency clinical biochemistry tests. Ann Clin Biochem 1984; 21: 494–7
   PubMed Web of Science ®Google Scholar
• Boone D J, Hansen H J, Hearn T L, Lewis D S, Dudley D. Laboratory evaluation and assistance efforts: Mailed, on-site and blind proficiency testings surveys conducted by the Centres for Disease control. Am J Pub Health 1982; 72: 1364–8
   PubMed Web of Science ®Google Scholar
• Anderson J R, Linsell W D, Mitchell F M. Guidelines on the performance of chemical pathology assays outside the laboratory. Br Med J 1981; 282: 743
   PubMed Web of Science ®Google Scholar
• Holm J R, Jørgensen P J, Bonnis V, Birkemose E, Grindsted P, Hørder M. Improvement and assurance of laboratory work in general practice. Scand J Clin Lab Invest 1986; 46(Suppl. 185)192
   Google Scholar
• Fraser C G, Peake M J. Problems associated with clinical chemistry quality control materials. CRC Crit Rev Clin Lab Sci 1980; 12: 59–86
   PubMed Web of Science ®Google Scholar
• Uldall A. Apparent interlaboratory variation using different types of reference sera. Scand J Clin Lab Invest 1984; 44((Suppl. 172))163–71
   PubMed Web of Science ®Google Scholar
• Winkel P, Uldall A. Components of biological and analytical variation. Laboratory quality assurance, P J Howanitz, J H Howanitz. McGraw-Hill, New York 1987; 166–84
   Google Scholar
• NCCLS. Tentative guidelines for calibration materials in clinical chemistry. Tentative guidelines for control materials in clinical chemistry. NCCLS Publ., Villanova 1982; 2: 499–554
   Google Scholar
• Burnett O, Woods T F, Jennings R D. Acceptance of values assigned to serum-based calibration materials. Ann Clin Biochem 1986; 23: 157–67
   PubMed Web of Science ®Google Scholar