The healthcare context is characterized by a high degree of
complexity, involving a kaleidoscope of medical disciplines networked in
prevention, diagnosis, therapy and follow-up of diseases. Traditionally,
medical errors are identified with incorrect diagnoses, mishandled
clinical procedures or, globally, as results of inappropriate clinical
decision making. As other medical areas, laboratory diagnostics is often
delivered in a pressurized and fast-moving environment, involving a vast
array of innovative and complex technologies, so that it is no safer than
other areas of healthcare. Under some circumstances things might and do go
wrong, and can produce unintentional harm to the patients. Although most
healthcare professionals would agree that the relative frequency of
laboratory errors is only modest, being comprised between 0.25 and 0.75%,
even such a small rate might reflect meaningful numbers due to the vast
amount of tests performed in the modern era of managed care.1-3
Remarkably, although most laboratory errors would not affect patients’
care, they can be associated with further inappropriate investigations in
nearly 20% of the cases, resulting in an unjustifiable increase in costs
as well as in patient inconvenience. More importantly, inappropriate care
or unjustified changes in therapy might also be a result of laboratory
errors.1-3 Missed, wrong or delayed diagnosis, in particular, can result
from failure to order an appropriate diagnostic test, identification
errors, tests performed on unsuitable specimens for quantity or quality,
release of results despite a poor performance of quality controls, delayed
notification of critical values, incorrect interpretation of test
results.1,4
In a recent issue of this journal, Ian Scott emphasized that first step to
optimal care is making the correct diagnosis, which might be missed or
delayed in between 5% and 14% of acute hospital admissions. Autopsy
studies also confirm a diagnostic error rates of 10-20%, with autopsy
disclosing previously undiagnosed problems in up to 25% of cases.5 The
importance of quality management and reduction of uncertainty throughout
the total testing process has been for long recognized in laboratory
diagnostics, and the laboratory has even anticipated other healthcare
areas in the effort to improve quality and reduce adverse patient
outcomes.1,4,6,7 Since its inception in 1946 the College of American
Pathologists (CAP) has contributed resources to organized approaches for
reducing or eliminating laboratory errors, providing the most extensive
databases describing error rates in pathology. These databases, started in
1989, include the CAP's Q-Probes and Q-Tracks programs, which provide
information on error rates from more than 130 interlaboratory studies.8
Process and risk analysis, as well as implementation of evidence-based
practices, have also been largely promoted and widely implemented in
several clinical laboratories over the past decade.9 Recent data on
diagnostic errors in primary care and in the emergency department setting
demonstrate that inappropriate test requesting and incorrect
interpretation account for a large percentage of total errors whatever the
discipline involved, be it radiology, pathology or laboratory
medicine.10,11
Error reporting is sorrowful and frustrating, because disclosure typically
exposes clinical labs and individual practitioners to financial penalties,
punitive actions concerning professional and organizational licenses, and
legal and public scrutiny. However, identification of patient
misidentification and problems in communicating results, which affect the
delivery of all diagnostic services, are widely recognized as the main
goals for quality improvement and are currently being proposed as
“sentinel events” in laboratory diagnostics.12 However, specific faults
characterising errors in laboratory medicine might lead to preventive and
corrective actions only when evidence-based quality indicators are
developed, implemented and continuously monitored. Most recently, with the
institution of a Working group devoted to Laboratory Errors and Patient
Safety (WG-LEPS), the International Federation of Clinical Chemistry and
Laboratory Medicine (IFCC) has acknowledged the global relevance of this
problem.13 The main scope of this working group is to increase awareness
on laboratory errors, develop an international process to identify quality
specifications throughout the total testing process and reliable outcome
measures to help identify, monitor and ultimately reduce the burden of
diagnostic errors in the field of laboratory medicine. In this ongoing
effort, the six steps proposed by Roger Chafe to follow when addressing
adverse events involving large numbers of patients5 are fulfilled.
References.
1. Plebani M. Errors in clinical laboratories or errors in laboratory
medicine? Clin Chem Lab Med 2006;44:750-9.
2. Plebani M, Carraro P. Mistakes in a stat laboratory: types and
frequency. Clin Chem 1997;43:1348-51.
3. Carraro P, Plebani M. Errors in a stat laboratory: types and
frequencies 10 years later. Clin Chem 2007;53:1338-42.
4. Lippi G, Fostini R, Guidi GC. Quality improvement in laboratory
medicine: extra-analytical issues. Clin Lab Med 2008;28:285-94.
5. Scott IA. Errors in clinical reasoning: causes and remedial
strategies. BMJ. 2009 Jun 8;338:b1860. doi: 10.1136/bmj.b1860.
6. Lippi G, Guidi GC, Plebani M. One hundred years of laboratory
testing and patient safety. Clin Chem Lab Med 2007;45:797-8.
7. Plebani M. Errors in laboratory medicine and patient safety: the
road ahead. Clin Chem Lab Med 2007;45:700-7.
8. Howanitz PJ. Errors in laboratory medicine: practical lessons to
improve patient safety. Arch Pathol Lab Med 2005;129:1252-61.
9. Signori C, Ceriotti F, Sanna A, Plebani M, Messeri G, Ottomano C,
Di Serio F, Lippi G, Guidi GC. Risk management in the preanalytical phase
of laboratory testing. Clin Chem Lab Med 2007;45:720-7.
10. Gandhi TK, Kachalia A, Thomas EJ, Puopolo AL, Yoon C, Brennan TA,
Studdert DM. Missed and delayed diagnoses in the ambulatory setting: a
study of closed malpractice claims. Ann Intern med 2006; 145: 488-96.
11. Kachalia A, Gandhi TK, Pupolo AL, Yoon C, Thomas EJ, Griffey R,
Brennan TA, Studdert DM. Missed and delayed diagnoses in the Emergency
department: a study of closed malpractice claims from 4 liability
insurers. Ann Emerg Med 2007;49:196-205.
12. Lippi G, Mattiuzzi C, Plebani M. Event reporting in laboratory
medicine. Is there something we are missing? MLO Med Lab Obs 2009;41:23.
13. Sciacovelli L, Plebani M. The IFCC Working Group on laboratory
errors and patient safety. Clin Chim Acta 2009;404:79-85.
Competing interests:
None declared
Competing interests:
No competing interests
24 June 2009
Giuseppe Lippi
Associate Professor of Clinical Biochemistry
Mario Plebani
Sez. Chimica Clinica, Dip. Scienze Morfologico-Biomediche, Università di Verona, Italy
Rapid Response:
Diagnostic errors and patient safety.
The healthcare context is characterized by a high degree of
complexity, involving a kaleidoscope of medical disciplines networked in
prevention, diagnosis, therapy and follow-up of diseases. Traditionally,
medical errors are identified with incorrect diagnoses, mishandled
clinical procedures or, globally, as results of inappropriate clinical
decision making. As other medical areas, laboratory diagnostics is often
delivered in a pressurized and fast-moving environment, involving a vast
array of innovative and complex technologies, so that it is no safer than
other areas of healthcare. Under some circumstances things might and do go
wrong, and can produce unintentional harm to the patients. Although most
healthcare professionals would agree that the relative frequency of
laboratory errors is only modest, being comprised between 0.25 and 0.75%,
even such a small rate might reflect meaningful numbers due to the vast
amount of tests performed in the modern era of managed care.1-3
Remarkably, although most laboratory errors would not affect patients’
care, they can be associated with further inappropriate investigations in
nearly 20% of the cases, resulting in an unjustifiable increase in costs
as well as in patient inconvenience. More importantly, inappropriate care
or unjustified changes in therapy might also be a result of laboratory
errors.1-3 Missed, wrong or delayed diagnosis, in particular, can result
from failure to order an appropriate diagnostic test, identification
errors, tests performed on unsuitable specimens for quantity or quality,
release of results despite a poor performance of quality controls, delayed
notification of critical values, incorrect interpretation of test
results.1,4
In a recent issue of this journal, Ian Scott emphasized that first step to
optimal care is making the correct diagnosis, which might be missed or
delayed in between 5% and 14% of acute hospital admissions. Autopsy
studies also confirm a diagnostic error rates of 10-20%, with autopsy
disclosing previously undiagnosed problems in up to 25% of cases.5 The
importance of quality management and reduction of uncertainty throughout
the total testing process has been for long recognized in laboratory
diagnostics, and the laboratory has even anticipated other healthcare
areas in the effort to improve quality and reduce adverse patient
outcomes.1,4,6,7 Since its inception in 1946 the College of American
Pathologists (CAP) has contributed resources to organized approaches for
reducing or eliminating laboratory errors, providing the most extensive
databases describing error rates in pathology. These databases, started in
1989, include the CAP's Q-Probes and Q-Tracks programs, which provide
information on error rates from more than 130 interlaboratory studies.8
Process and risk analysis, as well as implementation of evidence-based
practices, have also been largely promoted and widely implemented in
several clinical laboratories over the past decade.9 Recent data on
diagnostic errors in primary care and in the emergency department setting
demonstrate that inappropriate test requesting and incorrect
interpretation account for a large percentage of total errors whatever the
discipline involved, be it radiology, pathology or laboratory
medicine.10,11
Error reporting is sorrowful and frustrating, because disclosure typically
exposes clinical labs and individual practitioners to financial penalties,
punitive actions concerning professional and organizational licenses, and
legal and public scrutiny. However, identification of patient
misidentification and problems in communicating results, which affect the
delivery of all diagnostic services, are widely recognized as the main
goals for quality improvement and are currently being proposed as
“sentinel events” in laboratory diagnostics.12 However, specific faults
characterising errors in laboratory medicine might lead to preventive and
corrective actions only when evidence-based quality indicators are
developed, implemented and continuously monitored. Most recently, with the
institution of a Working group devoted to Laboratory Errors and Patient
Safety (WG-LEPS), the International Federation of Clinical Chemistry and
Laboratory Medicine (IFCC) has acknowledged the global relevance of this
problem.13 The main scope of this working group is to increase awareness
on laboratory errors, develop an international process to identify quality
specifications throughout the total testing process and reliable outcome
measures to help identify, monitor and ultimately reduce the burden of
diagnostic errors in the field of laboratory medicine. In this ongoing
effort, the six steps proposed by Roger Chafe to follow when addressing
adverse events involving large numbers of patients5 are fulfilled.
References.
1. Plebani M. Errors in clinical laboratories or errors in laboratory
medicine? Clin Chem Lab Med 2006;44:750-9.
2. Plebani M, Carraro P. Mistakes in a stat laboratory: types and
frequency. Clin Chem 1997;43:1348-51.
3. Carraro P, Plebani M. Errors in a stat laboratory: types and
frequencies 10 years later. Clin Chem 2007;53:1338-42.
4. Lippi G, Fostini R, Guidi GC. Quality improvement in laboratory
medicine: extra-analytical issues. Clin Lab Med 2008;28:285-94.
5. Scott IA. Errors in clinical reasoning: causes and remedial
strategies. BMJ. 2009 Jun 8;338:b1860. doi: 10.1136/bmj.b1860.
6. Lippi G, Guidi GC, Plebani M. One hundred years of laboratory
testing and patient safety. Clin Chem Lab Med 2007;45:797-8.
7. Plebani M. Errors in laboratory medicine and patient safety: the
road ahead. Clin Chem Lab Med 2007;45:700-7.
8. Howanitz PJ. Errors in laboratory medicine: practical lessons to
improve patient safety. Arch Pathol Lab Med 2005;129:1252-61.
9. Signori C, Ceriotti F, Sanna A, Plebani M, Messeri G, Ottomano C,
Di Serio F, Lippi G, Guidi GC. Risk management in the preanalytical phase
of laboratory testing. Clin Chem Lab Med 2007;45:720-7.
10. Gandhi TK, Kachalia A, Thomas EJ, Puopolo AL, Yoon C, Brennan TA,
Studdert DM. Missed and delayed diagnoses in the ambulatory setting: a
study of closed malpractice claims. Ann Intern med 2006; 145: 488-96.
11. Kachalia A, Gandhi TK, Pupolo AL, Yoon C, Thomas EJ, Griffey R,
Brennan TA, Studdert DM. Missed and delayed diagnoses in the Emergency
department: a study of closed malpractice claims from 4 liability
insurers. Ann Emerg Med 2007;49:196-205.
12. Lippi G, Mattiuzzi C, Plebani M. Event reporting in laboratory
medicine. Is there something we are missing? MLO Med Lab Obs 2009;41:23.
13. Sciacovelli L, Plebani M. The IFCC Working Group on laboratory
errors and patient safety. Clin Chim Acta 2009;404:79-85.
Competing interests:
None declared
Competing interests: No competing interests