Palicka simpozion management risc

Patient SafetyPreanalytical PhaseVladimir PalickaCharles University Hradec Kralove, Czech RepublicInternational Symposium Patient Safety, Prague, April 12, 2013

Preanalytical PhaseThe Weakest Point in Quality ManagementInternational Symposium Patient Safety, Prague, April 12, 2013

The value of laboratory testing for diagnostics and therapyQuantitativeat minimum 80-90 % of all objective data are results of laboratory or other complementary departmentsQualitativehigh quality information only are of value, the others are dangerous

To err is human:building a safer health systemKohn LT, Corrigan JM, Donaldson MSNational Academy Press, Washington, DC, 2000

Errors in medicine

10-20 % of errors negatively influence health care quality> 3 % of errors are of direct influence on patient safetythe more tests, the more errors

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

negative/risky trends for quality

Consolidation pre-analytical phase

Decentralization (POCT) analytical quality

Outsourcing pre- and post-analytical

Downsizing, shortages total quality

positive trends for quality Integration of automatization and informaticsimproved process control

Standard Operation Proceduresreduction of errors in all phases

Improved contact with clinicianspre- and post-analytical phase

Errors in laboratory medicineanalyticsapprox 15 % (7-13%)

preanalyticsapprox 62 % (46 68%)

postanalyticsapprox 23 % (18 45%)

Total Testing Process Improvementprevalence of errors was reduced byautomationimproved laboratory technologyassay standardizationinformaticsbut mostly in analytical part !

Most common reasons of pre-analytical errorsHaemolysisMisidentificationSampling error (wrong tube, inappropriate amount of the sample)ClottingSample and/or request missingWrong patient preparation

Preanalytical errorsRetrospective analysis2001-20054.715.132 samples in 105 labsThe most common reason for sample rejectionMissing sample (37.5%)Haemolysis (29.3%)(serum 38.6%, plasma 68.4%)Alsina J: CCLM 2008, 46: 849

preanalytical errorsmisidentificationwrong samplingpumping with fistwet skintourniquet timesample mixing (inverting)time for transport and centrifugation

Detection of inappropriatenessVisual inspection of lipaemic, icteric and/or haemolysed samples is

highly unreliable

and should be replaced by automated systems (serum indices)

Haemolysisupper reference limit for free Hbplasma 20 mg/lserum 50 mg/lVisible haemolysis after centrifugationfree Hb > 300 mg/l = 18.8 mmol/l(approximately 0.5% of Ery are lysed)

Haemolysis - reasonsin vivo in vitroUp to 2% samples are haemolysedAt minimum 50 possible reasonsinherited-acquired haemolytic anaemiahaemoglobinopathiasHELLP syndromedrugs, infectionartificial heart valvestransfusion of incompatible blood

Haemolysis common reasonsin vivo in vitroWet skin at sampling siteThin needle (usually < 21 G)Difficult venipuctureFragile veinsVacuum in tube is too highWrong amount of blood for the amount of additive (anticoagulant)

Haemolysis - reasonsInappropriate shaking the sampleTemperature discomfortHigh centrifugation forceLong centrifugationTo early centrifugationLate serum/plasma separationWrong separation barrierRe-centrifugation of gel-tubesPneumatic sample transporting

HaemolysisThe most common reasons of the wrong samples

Frequency40 70% of all rejected samples(5-times more than any other reason)

Haemolysis according deptLippi G, CCLM 47: 616, 2009

Haemolysisincreased concentration/activity:AST, ALT, CK, LDH, lipasecreatinine, urea, Fe, Mg, P, Kdecreased concentration/activity: ALP, GGTAlb, bilirubin, Cl, G, NaSpecial care: newborn bilirubin !!

HaemolysisImmunoassayFalse negative troponin TFalse increase of troponin IFalse increase of PSANegative bias: testosterone, cortisol, FPIAImpossibility to measure:insulin, glukagon, CT, PTH, ACTH, gastrin

In the case of haemolysis

Correction of result(s)Release of results with flags and commentsInformation of ward and new-sample request

In the case of haemolysis

Result correctionMethods with known interference (nm) rejectedRelease unaffected results, onlyPotassium results corrected by recalculation

Should we correct the results ?Haemolysis: potassiumLinear correlationShould we use the index or measured concentration ?different analyzers different indexesdifferent 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

In the case of haemolysisResult correctionMethods with known interference (nm) rejectedRelease unaffected results, onlyPotassium results corrected by recalculationincorrect, error is too big !intravascular haemolysis ?

In the case of haemolysis

b) Release of results with flags and commentsMany types of commentsWrong decision is quite commonCredibility of lab decreasesExtreme situations?

In the case of haemolysis

c) Information of ward and new-sample requestNonconformity notificationLaboratory book and hospital rulesQuick reaction is necessaryNew sample request

In the case of haemolytic sample

Information to wardConsultationNew sample request

To err is humanbuilding a safer health systemKohn LT, Corrigan JM, Donaldson MSNational Academy Press, Washington, DC, 2000

To err is humanto delay is deadlyConsumer Reports HealthSafe Patient Project.org

Patient Identification Errors

EQA - PAPAAustralia, New Zealand12-year period59 participating laboratories3.9 million specimensPAPA incident rate: 1.22 %most significant incidentPatient or Sample Identification !

Quality System RequirementsISO 15189:2007SOPsJCI: at least two patient identifiersBraceletsbar-codesRFID (radiofrequency identifier devices)automated systems

The most common systemPatient WardsWrist-bands, electronic order, bar-code sticksLaboratoryData terminalHand-held bare code scannerPortable label printersoftware

systems for patient identificationbarcodes

Bar codesHistory: local grocery, 1948Patent was applied for 1949Patent issued 1952Today: more that 2 dozen different linear bar code symbologiesMost frequent used: Code 128, Code 39Error rate expected 1:400.000 1.800.000

Most common sources of errors

Printing defect in the barcodeSuboptimal barcode orientationLack of error detectionScanner resolutionSasavage N: Clin.Lab.News, 2011, Jan

Errors in bar code technologyMore often in POCTMore often on wristband than on paperTake care about printer headsThick black lineTurn the label stock by 90oSnyder ML, Clin.Chem. 2010, 56:1554

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

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

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

Errors in bar code technologyMore often in POCTMore often on wristband than on paperTake care about printer headsThick black lineTurn the label stock by 90oQuality programCleaning and bar code verifier useSnyder ML, Clin.Chem. 2010, 56:1554

systems for patient identificationbarcodesradio frequency identification (RFID)biometricsmagnetic stripesoptical character recognitionsmart cardsvoice recognition

causes of patient misidentificationidentical names

China example60 in-patient sampledin 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

Astion M: Clin.Lab.News 20110,Jan

causes of patient misidentificationidentical nameswristband problemsCAP: 2.6 % errors(missing wristband, ID, illegible, incorrect)

wristband errorsJoin Commission on AccreditationCAP Q-Probesmean wristband error rates5.4 8.4 %after the introduction of QIM< 1.0 %

wristband errors4-years study464 bed public hospitalbar-coded wristbandstotal wristband error rates 10.6-16.5%training sessionstotal wristband error rates 0.4-1.5%

Dhatt GS: CCLM 2001, 49/5: ??

wristband errors2 hospitals in Sweden (230+152 beds)295 nurses/phlebotomistsquestionnaireundesirable practice9.6% not asking name and ID17% not checking identity79% not checking wristband during ID43% using health care card for IDWallin O: Scand.J.Caring Sci. 2010, 24/3: 581

Patient Identification Errorsdifferences between type of labstransfusion medicine 0.05 %clinical chemistry up to 1 %most common reasonsmalpractice (low interest), low adherence to QSRhigh workflowwrong technique

What about relabelingVery strict policyBlood and urine rarely will be candidatesSometimes indicated for irreplaceable specimens(cerebrospinal fluid, bone marrow, surgical)The risk of recollection is greater than a risk for relabelingSOPAstion M: Clin.Lab.News 20110,Jan

home mesageidentification mistakes are not easily detectableno immediate harm or signalmany steps no personal responsibilitymostly not systematicnot considered as the big problemfear of blamehuman factor involved

home mesagepatient identification is common duty of clinicians, phlebotomists and clinical chemiststechnical equipment is necessary(but must be under the control)ISO, SOP, EQA are extremely importanteducation and enthusiasm of people is the corner stone

home mesagebefore any test we should be sure whom are we testing !

Patient safetyand proper careis the target !