Novel analysis of clinically relevant diagnostic errors in point-of-care devices

Journal of Thrombosis and Haemostasis

Volumn 9, Issue 9, 2011, Pages 1769-1775

  Shermock, K M ^a   Streiff, M B ^b   Pinto, B L ^a   Kraus, P ^a   Pronovost, P J ^a  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Anticoagulation monitoring; Diagnostic error; Healthcare quality assurance; International Normalized Ratio; Point of care testing; Prothrombin time; Warfarin

Indexed keywords

ANTICOAGULANT AGENT; VITAMIN K GROUP; WARFARIN;

ADVERSE DRUG REACTION; ANTICOAGULATION; ARTICLE; CORRELATION ANALYSIS; DEVICE; DIAGNOSTIC ERROR; HUMAN; INDUSTRY; INTERNATIONAL NORMALIZED RATIO; LABORATORY TEST; MEDICAL DECISION MAKING; MEDICAL INSTRUMENTATION; POINT OF CARE TESTING; PRIORITY JOURNAL; PROTHROMBIN TIME; QUALITY CONTROL; RISK ASSESSMENT;

ANTICOAGULANTS; DECISION MAKING; DIAGNOSTIC ERRORS; HUMANS; INTERNATIONAL NORMALIZED RATIO; LINEAR MODELS; POINT-OF-CARE SYSTEMS; QUALITY CONTROL; REFERENCE STANDARDS; WARFARIN;

EID: 80052396796     PISSN: 15387933     EISSN: 15387836     Source Type: Journal    
DOI: 10.1111/j.1538-7836.2011.04439.x     Document Type: Article

References (37)

1. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986; 1: 307-10.
2. Fraser CG. General strategies to set quality specifications for reliability performance characteristics. Scand J Clin Lab Invest 1999; 59: 487-90.
3. Klee GG. Establishment of outcome-related analytic performance goals. Clin Chem 2010; 56: 714-22.
4. National Committee for Clinical Laboratory Standards. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS document EP9-A2. Wayne, PA: NCCLS, 2003.
5. National Committee for Clinical Laboratory Standards. Estimation of Total Analytic Error for Clinical Laboratory Methods; Approved Guideline. NCCLS document EP21-A. Wayne, PA: NCCLS, 2003.
6. National Committee for Clinical Laboratory Standards. Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline. NCCLS document H49-A. Wayne, PA: NCCLS, 2003.
7. International Standards Organization. ISO 17593;2007(E): Clinical Laboratory Testing and In Vitro Medical Devices - Requirements for In Vitro Monitoring Systems for Self-testing of Oral Anticoagulation Therapy. London: British Standards Institute, 2007.
8. Baglin TP, Keeling DM, Watson HG. Guidelines on oral anticoagulation (warfarin): third edition - 2005 update. Br J Haematol 2006; 132: 277-85.
9. Fitzmaurice DA, Gardiner C, Kitchen S, Mackie I, Murray ET, Machin SJ. An evidence-based review and guidelines for patient self-testing and management of oral anticoagulation. Br J Haematol 2005; 131: 156-65.
10. Dhatt GS, Agarwal MM, Bishawi B, Gill J. Implementing the Stockholm Conference hierarchy of objective quality criteria in a routine laboratory. Clin Chem Lab Med 2007; 45: 549-52.
11. Fraser CG, Petersen PH. Analytical performance characteristics should be judged against objective quality specifications. Clin Chem 1999; 45: 321-3.
12. Poller L, Keown M, Chauhan N, van den Besselaar AMHP, Tripodi A, Shiach CR. Normalisation and Standardisation of Home PT Monitors (SMT4-CT98-2269). Technology Implementation Plan 2002. Brussels, Belgium: European Commission, 2002.
13. Christensen TD, Larsen TB, Jensen C, Maegaard M, Sorensen B. International normalised ratio (INR) measured on the CoaguChek S and XS compared with the laboratory for determination of precision and accuracy. Thromb Haemost 2009; 101: 563-9.
14. Meijer P, Kluft C, Poller L, van der Meer FJ, Keown M, Ibrahim S, van den Besselaar AM, Tripodi A, Jespersen J. A national field study of quality assessment of CoaguChek point-of-care testing prothrombin time monitors. Am J Clin Pathol 2006; 126: 756-61.
15. Poller L, Keown M, Ibrahim SA, van der Meer FJ, van den Besselaar AM, Tripodi A, Jespersen J, Meijer P, Kluft C. Quality assessment of CoaguChek point-of-care prothrombin time monitors: comparison of the European community-approved procedure and conventional external quality assessment. Clin Chem 2006; 52: 1843-7.
16. Shermock KM, Clarke W, Streiff MB. A superior method to report clinically relevant quality information about the point-of-care INR device performance compared with the International Organization for Standardization guidelines. Clin Chim Acta 2010; 411: 1756-60.
17. Shermock KM, Bragg LJ, Connor JT, Fink J, Mazzoli G, Kottke-Marchant K. Differences in warfarin dosing decisions based on International Normalized Ratio measurement with two point-of-care testing devices and a reference laboratory measurement. Pharmacotherapy 2002; 22: 1397-404.
18. Shermock KM, Connor JT, Lavallee DC, Streiff MB. Clinical decision-making as the basis for assessing agreement between measures of the International Normalized Ratio. J Thromb Haemost 2009; 7: 87-93.
19. Petersen PH, Sandberg S, Fraser CG. Do new concepts for deriving permissible limits for analytical imprecision and bias have any advantages over existing consensus? Clin Chem Lab Med 2011; 49: 637-40.
20. Sonu S, Harpreet S, Kost GJ. New directions for evaluating point-of-care PT-INR performance: a visual logistics approach. Clin Chim Acta 2010; 411: 127-30.
21. van den Besselaar AM, Barrowcliffe TW, Houbouyan-Reveillard LL, Jespersen J, Johnston M, Poller L, Tripodi A. Guidelines on preparation, certification, and use of certified plasmas for ISI calibration and INR determination. J Thromb Haemost 2004; 2: 1946-53.
22. Center for Medicare and Medicaid Services. Proposed decision memo for prothrombin time (INR) monitor for home anticoagulation management (CAG-00087R), 2008. Accessed 26 February 2008.
23. Cleveland WS. The Elements of Graphing Data, rev. edn. Murray Hill, NJ: AT&T Bell Laboratories, 1994.
24. Tufte ER. The Visual Display of Quantitative Information, 2nd edn. Cheshire, CT: Graphics Press, 2001.
25. Altman DG, Bland JM. Measurement in medicine: the analysis of method comparison studies. The Statistician 1983; 32: 307-17.
26. Hollis S. Analysis of method comparison studies. Ann Clin Biochem 1996; 33: 1-4.
27. Hobbs FD, Fitzmaurice DA, Murray ET, Holder R, Rose PE, Roper JL. Is the international normalised ratio (INR) reliable? A trial of comparative measurements in hospital laboratory and primary care settings. J Clin Pathol 1999; 52: 494-7.
28. Poller L. International Normalized Ratios (INR): the first 20 years. J Thromb Haemost 2004; 2: 849-60.
29. Poller L, Keown M, Chauhan N, van den Besselaar AMHP, Tripodi A, Shiach CR. European concerted action on anticoagulation. Quality assessment of the CoaguChek Mini and TAS PT-NC point-of-care whole-blood prothrombin time monitors. Clin Chem 2004; 50: 537-44.
30. Tripodi A, Arbini AA, Chantarangkul V, Bettega D, Maannucci PM. Are capillary whole blood coagulation monitors suitable for the control of oral anticoagulant treatment by the international normalized ratio? Thromb Haemost 1993; 70: 921-4.
31. Tripodi A, Bressi C, Carpenedo M, Chantarangkul V, Clerici M, Mannucci PM. Quality assurance program for whole blood prothrombin time-international normalized ratio point-of-care monitors used for patient self-testing to control oral anticoagulation. Thromb Res 2004; 113: 35-40.
32. Tripodi A, Chantarangkul V, Mannucci P. Near-patient testing devices to monitor oral anticoagulant therapy. Br J Haematol 2001; 113: 847-52.
33. van den Besselar AM. A comparison of INRs determined with a whole blood prothrombin time device and two international reference preparations for thromboplastin. Thromb Haemost 2000; 84: 410-12.
34. Shermock KM, Connor JT, Smith NT, Fink JM, Bragg L. Validity of criteria used to evaluate fingerstick devices that assess international normalized ratio. Med Decis Making 2006; 26: 239-46.
35. Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133 (Suppl. 6): 381S-453S.
36. Hylek EM, Go AS, Chang Y, Jensvold NG, Henault LE, Selby JV, Singer DE. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med 2003; 349: 1019-26.
37. Kaatz SS, White RH, Hill J, Mascha E, Humphries JE, Becker DM. Accuracy of laboratory and portable monitor International Normalized Ratio determinations. Arch Intern Med 1995; 155: 1861-7.