Quality Control in Coagulation Testing

ABSTRACT

The term “quality control” in laboratory medicine refers to all the procedures commonly used in clinical laboratories to monitor the routine performance of testing processes, to detect possible errors, and to correct problems before test results are reported. In particular, internal quality control (IQC) and external quality assessment (EQA) programs are used to evaluate and improve quality in laboratory medicine. Laboratory testing is necessary for the diagnosis and treatment of patients with hemostatic disorders. However, whereas the benefits of quality control and quality assessment in hemostasis have been demonstrated many times and are well documented, available scientific evidence is significantly less than that in clinical chemistry and in other fields of laboratory medicine. Currently available data on analytical quality in coagulation testing not only demonstrates that quality is often unsatisfactory, but also highlights the need for more objective establishment of performances goals. This should be useful for better addressing both IQC and EQA programs. New challenges to EQA schemes for coagulation testing derive from the introduction of innovative tests, genetic analysis, and the need to assess not only analytical procedures but also all steps included in the total testing process.

KEYWORDS

Internal quality control - external quality assessment programs - bias - imprecision - biological variability

REFERENCES

• 1 Plebani M, Carraro P. Mistakes in a stat laboratory: types and frequency.  Clin Chem. 1997;  43 1348-1351
• 2 Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine.  Clin Chem. 2002;  48 691-698
• 3 Astion M L, Shojana K G, Hamil T R, Kim S, Ng V L. Classifying laboratory incidents reports to identify problems that jeopardize patient safety.  Am J Clin Pathol. 2003;  120 18-26
• 4 Howanitz P J. Errors in laboratory medicine: practical lessons to improve patient safety.  Arch Pathol Lab Med. 2005;  129 1252-1261
• 5 Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later.  Clin Chem. 2007;  53 1338-1342
• 6 Plebani M. Errors in clinical laboratories or errors in laboratory medicine?.  Clin Chem Lab Med. 2006;  44 750-759
• 7 Westgard J O. Internal quality control: planning and implementation strategies.  Ann Clin Biochem. 2003;  40 593-611
• 8 Jennings I, Kitchen D P, Woods T AL, Kitchen S, Walker I D. Emerging technologies and quality assurance: the United Kingdom National External Quality Assessment Scheme perspective.  Semin Thromb Hemost. 2007;  33 243-249
• 9 Lippi G, Franchini M, Montagnana M, Salvagno G L, Poli G, Guidi G C. Quality and reliability of routine coagulation testing: can we trust that sample?.  Blood Coagul Fibrinolysis. 2006;  17 513-519
• 10 Lippi G, Guidi G C. Effect of specimen collection on routine coagulation assays and D-dimer measurement.  Clin Chem. 2004;  50 2150-2152
• 11 Fraser C G, Kallner A, Kenny D, Petersen P H. Introduction: strategies to set global quality specifications in laboratory medicine.  Scand J Clin Lab Invest. 1999;  59 477-478
• 12 Ricós C, Alvarez V, Cava F et al.. Current databases on biological variation: pros, cons, and progress.  Scand J Clin Lab Invest. 1999;  59 491-500
• 13 Fraser C G, Hyltoft Petersen P, Libeer J C. Proposals for setting generally applicable quality goals solely based on biology.  Ann Clin Biochem. 1997;  34 8-12
• 14 Meijer P, Haverkate F, Kluft C. Performance goals for the laboratory testing of antithrombin, protein C and protein S.  Thromb Haemost. 2006;  96 584-589
• 15 Westgard J O, Westgard S A. The quality of laboratory testing today.  Am J Clin Pathol. 2006;  125 343-354
• 16 Cunningham M T, Brandt J T, Chandler W L et al.. Quality assurance in hemostasis: the perspective from the College of American Pathologists proficiency testing program.  Semin Thromb Hemost. 2007;  33 250-258
• 17 Favaloro E J. Standardization, regulation, quality assurance and emerging technologies in hemostasis: issues, controversies, benefits and limitations.  Semin Thromb Hemost. 2007;  33 290-297
• 18 Tripodi A, Chantarangkul V. Performance of quantitative D-dimer methods: results of the Italian external quality assessment scheme.  J Thromb Haemost. 2007;  5 184-185
• 19 Hertzberg M S, Mammen J, McCraw A, Nair S C, Srivastava A. Achieving and maintaining quality in the laboratory.  Haemophilia. 2006;  12 61-67
• 20 Sunderji R, Gin K, Shalansky K et al.. Clinical impact of point-of-care vs laboratory measurement of anticoagulation.  Am J Clin Pathol. 2005;  123 184-188
• 21 Hertzberg M, Neville S, Favaloro E J, MacDonald D. External quality assurance of DNA testing for thrombophilia mutations.  Am J Clin Pathol. 2005;  123 189-193
• 22 Sciacovelli L, Secchiero S, Zardo L, Plebani M. External Quality Assessment Schemes: need for recognised requirements.  Clin Chim Acta. 2001;  309 183-199
• 23 Sciacovelli L, Zardo L, Secchiero S, Plebani M. Quality specifications in EQA schemes: from theory to practice.  Clin Chim Acta. 2004;  346 87-97