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Patient Safety Preanalytical Phase

Patient Safety Preanalytical Phase. Vladimir Palicka Charles University Hradec Kralove, Czech Republic. International Symposium “ Patient Safety ” , Prague, April 12, 2013. Preanalytical Phase The Weakest Point in Quality Management.

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Patient Safety Preanalytical Phase

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  1. Patient SafetyPreanalytical Phase Vladimir Palicka Charles University Hradec Kralove, Czech Republic International Symposium “Patient Safety”, Prague, April 12, 2013

  2. Preanalytical PhaseThe Weakest Point in Quality Management International Symposium “Patient Safety”, Prague, April 12, 2013

  3. The value of laboratory testing for diagnostics and therapy Quantitative at minimum 80-90 % of all objective data are results of laboratory or other complementary departments Qualitative high quality information only are of value, the others are dangerous

  4. To err is human:building a safer health system Kohn LT, Corrigan JM, Donaldson MS National Academy Press, Washington, DC, 2000

  5. Errors in medicine 10-20 % of errors negatively influence health care quality > 3 % of errors are of direct influence on patient safety „the more tests, the more errors“

  6. Laboratory error A defect occurring at any part of the laboratory cycle, from ordering tests to reporting results and appropriately interpreting and reacting to these ISO/PDTS 22367

  7. negative/risky trends for quality Consolidation pre-analytical phase Decentralization (POCT) analytical quality Outsourcing pre- and post-analytical Downsizing, shortages total quality

  8. positive trends for quality Integration of automatization and informatics improved process control Standard Operation Procedures reduction of errors in all phases Improved contact with clinicians pre- and post-analytical phase

  9. Errors in laboratory medicine analytics approx 15 % (7-13%) preanalytics approx 62 % (46 – 68%) postanalytics approx 23 % (18 – 45%)

  10. Total Testing Process Improvement prevalence of errors was reduced by automation improved laboratory technology assay standardization informatics but mostly in analytical part !

  11. Most common reasons of pre-analytical errors Haemolysis Misidentification Sampling error (wrong tube, inappropriate amount of the sample) Clotting Sample and/or request missing Wrong patient preparation

  12. Preanalytical errors Retrospective analysis 2001-2005 4.715.132 samples in 105 labs The most common reason for sample rejection Missing sample(37.5%) Haemolysis (29.3%) (serum 38.6%, plasma 68.4%) Alsina J: CCLM 2008, 46: 849

  13. preanalytical errors misidentification wrong sampling pumping with fist wet skin tourniquet time sample mixing (inverting) time for transport and centrifugation

  14. Detection of inappropriateness Visual inspection of lipaemic, icteric and/or haemolysed samples is highly unreliable and should be replaced by automated systems (serum indices)

  15. Haemolysis upper „reference limit“ for free Hb plasma 20 mg/l serum 50 mg/l Visible haemolysis after centrifugation free Hb > 300 mg/l = 18.8 mmol/l (approximately 0.5% of Ery are lysed)

  16. Haemolysis - reasons in vivo – in vitro Up to 2% samples are haemolysed At minimum 50 possible reasons inherited-acquired haemolytic anaemia haemoglobinopathias HELLP syndrome drugs, infection artificial heart valves transfusion of incompatible blood

  17. Haemolysis – common reasons in vivo – in vitro Wet skin at sampling site Thin needle (usually < 21 G) Difficult venipucture Fragile veins Vacuum in tube is too high Wrong amount of blood for the amount of additive (anticoagulant)

  18. Haemolysis - reasons Inappropriate shakingthe sample Temperature discomfort High centrifugation force Long centrifugation To early centrifugation Late serum/plasma separation Wrong separation barrier Re-centrifugation of gel-tubes Pneumatic sample transporting

  19. Haemolysis The most common reasons of the wrong samples Frequency 40 – 70% of all rejected samples (5-times more than any other reason)

  20. Haemolysis according dept Lippi G, CCLM 47: 616, 2009

  21. Haemolysis increased concentration/activity: AST, ALT, CK, LDH, lipase creatinine, urea, Fe, Mg, P, K decreased concentration/activity: ALP, GGT Alb, bilirubin, Cl, G, Na Special care: newborn bilirubin !!

  22. Haemolysis Immunoassay False negative troponin T False increase of troponin I False increase of PSA Negative bias: testosterone, cortisol, FPIA Impossibility to measure: insulin, glukagon, CT, PTH, ACTH, gastrin

  23. In the case of haemolysis • Correction of result(s) • Release of results with flags and comments • Information of ward and new-sample request

  24. In the case of haemolysis Result correction Methods with known interference (nm) rejected Release „unaffected“ results, only Potassium results corrected by recalculation

  25. Should we correct the results ? Haemolysis: potassium Linear correlation Should we use the „index“ or measured concentration ? different analyzers – different indexes different calculation of corrected K = K measured – (Hb mmol/l x 5.2) K measured– (Hb mmol/l x 10) Bland-Altman: uncertainty ± 0.4 mmol/l

  26. In the case of haemolysis Result correction Methods with known interference (nm) rejected Release „unaffected“ results, only Potassium results corrected by recalculation incorrect, error is too big ! intravascular haemolysis ?

  27. In the case of haemolysis b) Release of results with flags and comments Many types of comments Wrong decision is quite common Credibility of lab decreases Extreme situations?

  28. In the case of haemolysis c) Information of ward and new-sample request Nonconformity notification Laboratory book and hospital rules Quick reaction is necessary New sample request

  29. In the case of haemolytic sample Information to ward Consultation New sample request

  30. To err is humanbuilding a safer health system Kohn LT, Corrigan JM, Donaldson MS National Academy Press, Washington, DC, 2000

  31. To err is humanto delay is deadly Consumer Reports – Health Safe Patient Project.org

  32. Patient Identification Errors

  33. EQA - PAPA Australia, New Zealand 12-year period 59 participating laboratories 3.9 million specimens PAPA incident rate: 1.22 % most significant incident Patient or Sample Identification !

  34. Quality System Requirements ISO 15189:2007 SOPs JCI: at least two patient identifiers Bracelets bar-codes RFID (radiofrequency identifier devices) automated systems

  35. The most common system Patient – Wards Wrist-bands, electronic order, bar-code sticks Laboratory Data terminal Hand-held bare code scanner Portable label printer software

  36. systems for patient identification barcodes

  37. Bar codes History: local grocery, 1948 Patent was applied for 1949 Patent issued 1952 Today: more that 2 dozen different linear bar code symbologies Most frequent used: Code 128, Code 39 Error rate expected 1:400.000 – 1.800.000

  38. Most common sources of errors Printing defect in the barcode Suboptimal barcode orientation Lack of error detection Scanner resolution Sasavage N: Clin.Lab.News, 2011, Jan

  39. Errors in bar code technology More often in POCT More often on wristband than on paper Take care about printer heads Thick black line Turn the label stock by 90o Snyder ML, Clin.Chem. 2010, 56:1554

  40. Sasavage N: Clin.Lab.News, 2011, Jan

  41. Sasavage N: Clin.Lab.News, 2011, Jan

  42. Sasavage N: Clin.Lab.News, 2011, Jan

  43. Errors in bar code technology More often in POCT More often on wristband than on paper Take care about printer heads Thick black line Turn the label stock by 90o Quality program Cleaning and bar code verifier use Snyder ML, Clin.Chem. 2010, 56:1554

  44. systems for patient identification barcodes radio frequency identification (RFID) biometrics magnetic stripes optical character recognition „smart“ cards voice recognition

  45. causes of patient misidentification identical names

  46. China example 60 in-patient sampled in 32 of them (53 percent) common full name shared with 1 – 101 other patients attending the same hospital (Hong Kong) Lee AC: Int.J.Health Care Qual.Assur.Inc.Leadersh.Health Serv., 2005:18/1:15

  47. Astion M: Clin.Lab.News 20110,Jan

  48. causes of patient misidentification identical names wristband „problems“ CAP: 2.6 % errors (missing wristband, ID, illegible, incorrect)

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