Pre-analytics in coagulation lab: why struggle for better results?

Transcription

1 Pre-analytics in coagulation lab: why struggle for better results? Valdas Banys, MD, PhD Vilnius University Faculty of Medicine Vilnius University Hospital Santariskiu Klinikos, Center of Laboratory Medicine Lithuanian Society of Laboratory Medicine , Helsinki

2 Disclosures for Valdas Banys Travel and accomodation expences covered by Labquality Part time employment in private company distributing Labquality Oy services in Lithuania and Latvia. Otherwise NO relevant conflicts of interest to declare.

3 People need to be reminded more often than they need to be instructed. (Samuel Johnson, )

4 The story of involvement... Biochemia Medica 2013;23(1)

5 Sodium citrate blood contamination by EDTA Lima-Oliveira G et al. Int J Lab Hematol 2014; 37(3) Lippi et al. Clin Chem Lab Med DOI cclm

6 Tube under-filling Coagulation Master Class 2015, Dubrovnik Adcock DM. Am J Clin Pathol 1998;109

7 Influence of under-filling of 3.2% buffered sodium citrate blood tubes Lippi G et al. Seminars in Thrombosis & Hemostasis 2012; 38(6)

8 Coagulation Master Class 2015, Dubrovnik

9 Venous stasis effect

10 Coagulation Master Class 2015, Dubrovnik

11 Favaloro EJ et al. Labmedicine 2012; 43(2)

12 Favaloro EJ et al. Labmedicine 2012; 43(2)

13 Unresolved issue: clot in the sample! Not always seen visually CLSI H21-A5 recommendations to detect clot: Gentle inversion and observation; Insertion of 2 wooden sticks

14 Unresolved issue: high hematocrit! Guder WG, Narayanan S, Wisser H, Zawta B. Diagnostic samples:... 4th edition 2009 CLSI H21-A5, Appendix A.

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17 There is a need to assess the quality of current practices, compliance to the CLSI H3-A6 guidelines and to identify some most critical steps which occur during phlebotomy, in different healthcare settings, across Europe.

18 Q3 - Did the collector check the expiry dates of devices in use? Expire stock may result in under-filled tubes or reduced potency of additives Error frequency 71.9%

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20 E15. Patient preparation instructions do not include special recommendations about coagulation tests. Frequency 30.3%

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22 Meanwhile in Lithuania... Lithuanian Society of Laboratory Medicine had established 3 working groups on pre-analytical phase in ; Draft version of recommendations related to pre-analytical phase already prepared; Pending approval in governmental level; Published afterwards.

23 Clin Lab 2012; 58(9-10): 911-7

24 Tools: Technology solutions?

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26 Tools: Quality indicators Code QI-9 QI-10 QI-11 QI-12 QI-13 QI-16 Quality indicators Number of samples collected in inappropriate container/total number of samples (percentage) Number of samples hemolyzed (haematology, chemistry)/ total number of samples (percentage) Number of samples clotted (haematology, chemistry)/total number of samples with anticoagulant (percentage) Number of samples with insufficient sample volume/total number of samples (percentage) Number of samples with inadequate sample-anticoagulant volume ratio/total number of samples with anticoagulant (percentage) Number of samples improperly stored/total number of samples (percentage)

27 Tools: monitoring and control

28 Tools: FMEA model?

29 Why struggle? Generally speaking mission of the laboratory, irrespectively of subspecialty, always remains the same! PATIENT SAFETY!

30 Why struggle? Examples A false negative apl antibody or LA result in a patient with the APS may lead to lack of appropriate treatment with anticoagulant therapy to prevent thrombosis. A false diagnosis of VWD may lead to inappropriate treatment with factor concentrates or to a lifelong label of a congenital disorder affecting quality of life. A falsely prolonged screening test might influence a clinical decision to undertake further costly and time consuming (e.g. specific diagnostic ) investigations, unnecessarily delay invasive procedures, and raise unnecessary anxiety in the patient being investigated.

31 Why struggle? Examples continued A false normal screening test result might prevent further evaluation of factor assays, thus incorrectly discounting hemophilia and possibly placing a patient at an unjustified risk of bleeding with invasive procedures (i.e. surgery, dental extraction, biopsies). A false low or high coagulation test time in a patient being monitored for anticoagulant therapy may lead to subsequent incorrect dosing of anticoagulant therapy with a risk of thrombosis or bleeding depending on the direction of the error.

32 Pre-analytical error might lead to inaccurate result and compromise patient safety!