11/25/2011

To Err is Human

Error in Latin means to Wander or Stray An error is deviation from accuracy and correctness

Laboratory Errors
Dr. Elizabeth A Frank

Error are a reality

Why do errors occur?

Some causes include:

No written procedures Written procedures not followed Training is not done or not completed Checks not done for transcription errors Individual responsibilities unclear

Errors can occur throughout the testing process

Errors
Pre-analytical Analytical Post-analytical may lead to the patient being harmed

Pre-analytical errors
Examples: wrong patient wrong patient preparation wrong specimen wrong specimen preparation inadequate identification data

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Pre-analytic errors examples include:

Analytic errors examples include:

Patient misidentification Specimen mislabeled or unlabeled Incorrect or compromised specimen Inappropriate specimen transport conditions Specimen processed incorrectly Specimen stored inappropriately before testing Wrong test(s) ordered

Test system not calibrated Results reported when control results out of range Improper measurements of specimen and/or reagents Reagents prepared incorrectly Reagents stored inappropriately or used after expiration date Instrument maintenance not done Dilution and pipetting errors

Analytical errors
Examples: Inaccuracy (bias) Imprecision issues Insensitivity Linearity issues

Analytical errors
Inaccuracy (bias) - invalidates reference ranges and cutoff points - may lead to inappropriate therapy or failure to treat - may lead to misdiagnosis - may lead to failure to diagnose

Analytical errors
Imprecision issues - poor reproducibility invalidates patient monitoring using laboratory results - results in non-optimal maintenance regimes - includes the monitoring of therapeutic drugs

Analytical errors
Insensitivity - a change in assay sensitivity leads to issues of detection - affects robustness of results near the detection limit

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Analytical errors
Linearity issues A clear understanding of the linearity of a method is essential to ensure that grossly inaccurate results are not reported where there are high concentrations or activities of analytes

Post-analytic errors examples include:

Transcription error in reporting Report sent to the wrong location Report illegible Information system not maintained

Errors - Review

Pre-analytical 46%-68,2% Insufficient sample Sample condition Sample handling, transport Incorrect identification Incorrect sample

J. Kalra ; Clinical Biochemistry 37 (2004) 1052 1062

Analytical 7% - 13.3% Equipment malfunction Sample mix up Interference Post-analytical: 18,5%-47% Reporting or analysis Improper data entry High turn around times

Compounding of Errors

An error will often affect more than one patient Mismatching Pre-analytical Analytical Post-analytical - will affect at least two patients

Compounding of Errors
Investigation of major incidents often reveals more than one error contributing to the serious outcome

Compounding of Errors -an example

Patient: Male, 65years, inpatient, COPD and GI malignancy Clinical incident: Day 1: 15.00 serum K reported: 3.8mM 19.25 serum K reported: 6.6mM 20.30 Rx dextrose/insulin/ Ca gluconate Day 2: 01.00 patient deceased

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Compounding of Errors -an example

15.00h Na 132mM K 3.8mM Urea 2.0mM Creat 38uM CRP 97mg/L Amylase 10U/L 19.25h Na 144mM K 6.6mM Urea 5.3mM Creat 81uM CRP <3mg/L Amylase 142U/L

Compounding of Errors -an example

Error 1: Incompatibility of results should have been detected in the laboratory and they should not have been released Error 2: Incompatibility of results should have been realised on the ward Error 3: Repeat K should have been performed before intervention

Compounding of Errors -an example

Further investigation: Error 4: PID had been entered against the SID of a different patient (highlighting a problem in handling request forms of multiple shapes and sizes)

Effects of errors

Error 5: LIS set-up allowed SID to be assigned to two different patients. (highlighting a communication problem between different databases in LIS) This ultimately led to the results from the second patient being incorporated into the electronic record of the first

Impact of Errors
Spectrum of consequences: None: reported results similar to true results Inconvenience to patient Delay in diagnosis or treatment Misdiagnosis Harm to patient (mild, moderate or severe) Death Lack of trust in laboratory services

Impact of Errors

Many incidences of error leading to incorrect results being reported go undetected The detection of laboratory errors which affect patient results is dependent on the clinical interpretative skills of both laboratory staff and staff caring for the patient

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Impact of Errors
It is an inherent part of a healthcare system that errors identified should be reported and investigated so that steps can be introduced to prevent or minimise the chance of the same error recurring.

Errors - What can we do ?

Develop a Multifaceted strategy to enhance quality through total testing process Systematic analysis workflow and bottle necks Identify critical process Continuous monitoring Mechanism for error tracking Continuous education Improved communication Definition and implementation and monitoring of QI Redesign flawed procedures

This forms the basis of Clinical

Incident Reporting

Errors -What can we do ?

Errors -What can we do ?

Predict accidental events Process analysis Disseminate operative guidelines and best practices recommended Introduce error tracking system Continuous monitoring of performances

Strengthen defenses Multiple systems to identity non conformances Diversify defenses Heterogeneous system to identify non conformances Decrease Vulnerability Reliable less vulnerable detection system Education and training

Illuminated Palace, Mysore, India