Pre-analytic

Bressanone 2 Febbraio 2010
Post-MI
β-blockers
Overall Health Care in U.S. (Rand)
Hospital acquired infections
1,000,000
Airline baggage handling
100,000
10,000
Defects
Defects
per
per
1,000
million
million
Detection &
Treatment of
depression
Adverse
drug
events
100
10
U.S. Industry
Best-in-Class
1
1
2
3
4
(69%)
(31%)
(7%)
(0.6%)
5
6
(0.002%) (0.00003%)
σσ Level
Level (%
(% defects)
defects)
Jennifer Rufer age: 22 years
Underwent debilitating chemotherapy and
unnecessary hysterectomy:
"I can't have kids, and I desperately
wanted to have a family."
1 errore nella trascrizione
manuale di un risultato
3 decessi in pazienti
trapiantati d
’organo
d’organo
A focus on addressing errors in
laboratory medicine is an important
element of the international agenda for
patient safety
….
safety….
Timely and accurate laboratory test
results are a cornerstone of effective
diagnosis and treatment of patients.
Sir
Sir Liam
Liam Donaldson,
Donaldson, Chair,
Chair, World
World Alliance
Alliance for
for Patient
Patient Safety
Safety
Around two
-thirds of important
two-thirds
clinical decisions about admission
and discharge of patients from
hospital
and
prescribing
of
medicines
are
based
on
laboratory test results.
Sir
Sir Liam
Liam Donaldson,
Donaldson, Chair,
Chair, World
World Alliance
Alliance for
for Patient
Patient Safety
Safety
Even a low incidence of laboratory test
errors (0.5%??) among the billions of
tests performed every day worldwide
could have important public health and
patient safety implications
implications..
The importance of quality management
and error reduction has always been
recognized in laboratory medicine, and
in many ways, the laboratory has been
ahead of other health care areas in its
efforts to improve quality and reduce
adverse patient outcomes.
Wagar
Wagar EA,
EA, Yuan
Yuan S.
S. Clin
Clin Lab
Lab Med
Med 2007
2007
1.
2.
3.
4.
5.
6.
Heterogeneous and ambiguous definition of what
a laboratory error really is;
Difficulties in discovering and identifying all types
of errors and need for well
-designed study
well-designed
protocols aiming to evaluate all steps in the total
testing process (TTP);
Complexity of TTP and need for cooperation and
integration between different health care providers;
Poor perception by physicians and other
stakeholders of the harmfulness of errors in
laboratory medicine;
Laboratory professionals reluctant to report and
disclose data on types of errors and their
frequency;
Increasing use of complementary/alternative
testing options (e.g. point
-of-care, near
-patient,
point-of-care,
near-patient,
and self
-monitoring).
self-monitoring).
Years
•1947 – ‘90s
•’90s
• 2000
Error Detection
(types)
Milestones
Analytical errors
Belk and Sunderman (1947)
Errors within clinical
laboratory walls
Ross JW, Boone DJ (1991)
Plebani M, Carraro P (1997)
Carraro P, Plebani M (2007)
Errors in laboratory medicine
Plebani M (2007) (20)
Laboratory errors in diagnostic
medicine
ACTION
Ordering
Physician’
’
Physician’
’ss
Brain
Brain
Collection
Interpretation
Reporting
Identification
Analysis
Transportation
Preparation
ppm
Belk and Sunderman (1947)
McSwiney and Woodrow (1969)
College of American Pathologists (1996)
Witte et al. (1997)
162,116
30,0
12,904
447
ACTION
Ordering
Physician’
’
Physician’
’ss
Brain
Brain
Collection
LAB
Interpretation
Reporting
Identification
Analysis
Transportation
Preparation
Total errors patients involved: 363
Pre-analytical
steps
Pre--
Analytical steps
Post-analytical steps
218
(45.5%)
35
(7.3%)
266
(47.2%)
Ross
Ross JW,
JW, Boone
Boone DJ,
DJ, 1991
1991
68 % Pre-analytical
13 % Analytical
18 % Post-analytical
Plebani & Carraro
Clin Chem 1997:43:1348-51
Defects
Defects detection
detection steps
steps
• Wrong name of patient given
• Err. specification of hospital unit
• Physician
’s order missed
Physician’s
• Order misinterpreted
• Inappropriate container used
• Specimen collection incorrect
• Spec. collected from infusion route
Subtotal
Defects
Defects found
found
N
N°°..
5
36
34
6
5
4
39
Frequency (%)
(%)
Frequency
2.6
19.0
18.1
3.2
2.6
2.1
20.6
129
68.2
Plebani
-51
Plebani M.,
M., Carraro
Carraro P.,
P., Clin
Clin Chem
Chem 1997;43,8:1348
1997;43,8:1348-51
Absolute frequency (ppm)
1996
2006
Total errors
4667
3092
Pre-analytical
3186
Analytical
Post-analytical
Relative frequency ( %)
1996
2006
1913
68.2
61.9
617
464
13.3
15.0
864
715
18.5
23.1
Defects found
Defects: detection steps
No.
Frequency, %
Pre-analytical
Specimen collected from infusion route
3
1.9
Sample contaminated
1
0.6
Tube filling error
21
13.1
Empty tube
11
6.9
Inappropriate container
13
8.1
Non-refrigerated sample
3
1.9
Missing tube
5
3.1
Digoxin test timing error
1
0.6
Patient identification error
14
8.8
Request procedure error
12
7.5
Data communication conflict
6
3.8
Physician’s request order missed
3
1.9
Order misinterpreted
2
1.3
Check-in not performed (in the LIS)
4
2.5
99
61.9
Subtotal
Number
Number
Effect
Effect on
on
Patient
Patient care
care
(%)
(%)
Risk
of
Risk of
of
of
Inappropriate
Inappropriate
care
care
(%)
(%)
J.W. Ross and
D.J.
Boone
D.J.
336
30
7
P.A.Nutting
180
27
12
Plebani ,Carraro
P.
189
26
6.4
160
24.4
2.7%
Carraro P, Plebani M
ACTION
Ordering
Physician’s
Physician’s
Brain
Brain
Collection
LAB
Interpretation
Reporting
Identification
Analysis
Transportation
Preparation
OUTCOMES
Ordering
Physician’s
Physician’s
Brain
Brain
Interpretation
Collection
LAB
LAB
Reporting
Identification
Analysis
Analysis
Transportation
Preparation
Preparatio
LABORATORY ERROR:
a defect occurring at any
part of the laboratory
cycle
cycle,, from ordering
tests to reporting results
and
appropriately
interpreting and reacting
on these.
ACTION
Ordering
Physician’s
Physician’s
Brain
Brain
Interpretation
Collection
LAB
LAB
Reporting
Identification
Analysis
Analysis
Transportation
Preparation
From
From Bonini
Bonini P,
P, Plebani
Plebani M,
M, Ceriotti
Ceriotti F,
F,
Ruboli
Ruboli F,
F, Clin
Clin Chem
Chem 2002
2002
••Taxonomy
Taxonomy
••Classification
Classification
of
laboratory
non
non-conformities, errors and incidents
••Preventive
Preventive and corrective actions
••Assessment
Assessment of risk arising from actual and
potential non
-conformities
non-conformities
(and, in part, pre-analytical errors)
(Clinical,
(Clinical, Economical)
Economical)
The total testing cycle is the unique
framework to use for identifying and
reducing errors in laboratory medicine,
and we should never forget that
laboratory professionals must be
leaders in ensuring patient safety both
inside and outside the walls of clinical
laboratories
laboratories..
Pre
-Pre-Analytical, very
Pre-Pre-Analytical,
very high
high
frequency,
frequency, high
high risk
risk
Pre
Pre-Analytical
Pre
-Analytical,
Pre-Analytical,
high
high frequency
frequency
From Stroobans AK, Goldshmidt HMJ,
Plebani M, Clin Chim Acta 2003
12%
2%
0.2%
Analytical
Post
Post-Analytical
Frequency
(Percent of
Occurrence)
Post
-Analytical,
Post-Analytical,
high
high frequency
frequency
Post
-Post-Analytical, very
Post-Post-Analytical,
very
high
high frequency,
frequency, high
high risk
risk
2.2%
5.0%
Phase of the TTP
Type of error
PrePre-prepre-analytical
Inappropriate test request
Order entry
Patient/specimen misidentification
Sample collected from infusion route
Sample collection (hemolysis, clotting
insuff. volume, etc)
Inappropriate container
Handling, storage and transportation
PrePre-analytical
Analytical
PostPost-analytical
Relative frequency (%)
Sorting and routing
PourPour-off
Aliquoting, pipetting and labelling
Centrifugation (time and/or speed)
4646-68.2%
3.03.0-5.3%
Equipment malfunction
Sample mixmix-ups
Interference (endogenous or exogenous)
Undetected failure in quality control
7.07.0-13%
Erroneous validation of analytical data
Failure in reporting/addressing the report
Excessive turnturn-aroundaround-time
Improper data entry and manual transcription error
Failure/delay in reporting critical values
12.512.5-20%
PostPost-postpost-analytical Delayed/missed reaction to laboratory reporting
Incorrect interpretation
Inappropriate/inadequate followfollow-up plan
Failure to order appropriate consultation
2525-45.5%
Phase of the TTP
Type of error
PrePre-prepre-analytical
Inappropriate test request
Order entry
Patient/specimen misidentification
Sample collected from infusion route
Sample collection (hemolysis, clotting
insuff. volume, etc)
Inappropriate container
Handling, storage and transportation
PrePre-analytical
Analytical
PostPost-analytical
Relative frequency (%)
Sorting and routing
PourPour-off
Aliquoting, pipetting and labelling
Centrifugation (time and/or speed)
4646-68.2%
3.03.0-5.3%
Equipment malfunction
Sample mixmix-ups
Interference (endogenous or exogenous)
Undetected failure in quality control
7.07.0-13%
Erroneous validation of analytical data
Failure in reporting/addressing the report
Excessive turnturn-aroundaround-time
Improper data entry and manual transcription error
Failure/delay in reporting critical values
12.512.5-20%
PostPost-postpost-analytical Delayed/missed reaction to laboratory reporting
Incorrect interpretation
Inappropriate/inadequate followfollow-up plan
Failure to order appropriate consultation
2525-45.5%
The most common types of errors:
Pre-analytic:
test ordering (12.9%)
implementing tests (17.9%)
general administrative error (17.6%)
Post-analytic: reporting results (24.6%)
Hickner
Hickner JJ et
et al.
al. Qual
Qual saf
saf Health
Health Care,
Care, 2008
2008
n
(%)
TTP
••
Failure to obtain adequate
medical history or physical
examination
76
(42) Pre
-pre-analytic
Pre-pre-analytic
••
Failure to order an appropriate 100
diagnostic test
(55) Pre
-pre-analytic
Pre-pre-analytic
••
Failure to create a proper
follow
-up plan
follow-up
81
(45) Post
-post-anal.
Post-post-anal.
••
Incorrect interpretation
of a diagnostic test
67
(37) Post
-post-anal.
Post-post-anal.
Wahls
Wahls TL,
TL, CRam
CRam PM
PM BMC
BMC Family
Family Practice
Practice 2007
2007
Wahls
Wahls TL,
TL, Cram
Cram PM,
PM, BMC
BMC Family
Family Practice
Practice 2007
2007
Wahls
Wahls TL,
TL, Cram
Cram PM,
PM, BMC
BMC Family
Family Practice
Practice 2007
2007
Fecal occult blood test (FOBT)
PSA
Glucose
=
= 51
51 %
%
of
of all
all
missed
missed
results
results
HbA1c
Lipids
Wahls
Wahls TL,
TL, Cram
Cram PM,
PM, BMC
BMC Family
Family Practice
Practice 2007
2007
1. Failure to order test (58%)
2. Inadequate medical history and
physical examination (42%)
3. Incorrect interpretation of
tests (37%)
4. Failure to request a
consultation (33%)
Kachalia A et al. Ann Emerg Med 2007
1.
2.
3.
4.
5.
Radiographs (27%)
Computed tomography (17%)
Cardiac enzymes tests (15%)
Ultrasonography (13%)
Hematologic laboratory tests (11%)
1
On
32,563 prescription, filled for 12,825
patients 1,781 (5.5%) were dispensed in
701 patients who had elevated serum
potassium levels ((>
> 5.3 mEq/L).
Schiff
Schiff GD
GD et
et al,
al, Am
Am JJ Med
Med 2000
2000
2
A total of 498 K prescriptions (1.5%) were
written and dispensed for patients who last
recorder K value was > 5.3 mEq/L.
For 424 (85%), the prescription was written
within 3 months of the date of elevated
serum potassium level.
For 276 (0.8%), serum K was > 5.3 mEq/L on
the same date of the prescription.
Schiff
Schiff GD
GD et
et al,
al, Am
Am JJ Med
Med 2000
2000
No
follow
-up for > 20 mU/mL TSH
follow-up
results in more than 2% of patients
(2.6% in 2000, 2.1% in 2007)
An additional 5% of patients lost to
follow
-up and unaware of their
follow-up
results
This is a conservative estimate
Almost
half of 1095 discharged
patients had pending laboratory
and radiologic test results
9%
of
these
results
potentially actionable
were
Roy
Roy CL,
CL, Ann
Ann Intern
Intern Med,
Med, 2005
2005
Many nonurgent actionable results were
from radiologic studies (e.g. incidental
pulmonary nodules) or serologic tests (e.g.
H. pylori titers).
Inpatients and primary care physicians
often did not know what tests had been
ordered and had results pending at
discherge, perhaps reflecting the ordering
of tests by several team members and
physicians
-in-training.
physicians-in-training.
The task of effecting meaningful
improvements to the diagnosis process
- with its numerous clinical steps,
stretched across multiple providers and
months or years, and the heavy
reliance on patient initiative - looms as
a formidable challenge.
Ghandi
Ghandi TK
TK et
et al.,
al., Ann
Ann Int
Int Med,
Med, 2006
2006
“Steps
starting,
in
chronological
order,
clinician’s
from
the
request and including
the
examination
requisition, preparation
of the patient, collection
of the primary sample,
and transportation to
and
within
the
laboratory, and ending
when
the
analytical
procedure begins”.
ISO 15189:2003
Outside
Outsidethe
thelaboratory
laboratory
Pre-analytic
Pre-analytic phase
phase
Outside
Outsidethe
thelaboratory
laboratory
••
••
••
••
Physician’s
Physician’s
Brain
Brain
Patient
Patientidentification
identification
Blood/specimens'
Blood/specimens'collection
collection
Specimens'
Specimens'identification
identification
Specimens'
Specimens'transport
transport
Within
Within the
thelaboratory
laboratory
•• Transmission
Transmissionof
ofresults
results
•• Interpretation
Interpretationcomments
comments
•• Reference
Referencerange
rangeor
or
decisional
decisionallimits
limits
•• Medical
Medicalvalidation
validation
•• Technical
Technicalvalidation
validation
Within
Within the
thelaboratory
laboratory
•• Time
Timeof
ofspecimens's
specimens'sarrival
arrival
•• Check-in
Check-in
•• Centrifugation,
Centrifugation,decapping
decapping
•• Aliquoting,
Aliquoting,and
andlabeling
labelingof
of
secondary
secondaryspecimen
specimen
Analytic
Analytic phase
phase
•• Utilization
Utilizationof
oflaboratory
laboratorydata
data
ininpatient
patientmanagement
management
•• Reaction
Reactiontotothe
theresults
results
•• Interpretation
Interpretationof
ofresults
results
•• Reception
Receptionof
ofreports
reports
•Accuracy
•Accuracy
•Reproducibility
•Reproducibility
•Turnaround
•Turnaroundtime
time
•Internal
•Internalquality
qualitycontrol
control
•External
•Externalquality
qualityassess
assess
Post-analytic
Post-analytic phase
phase
- Appropriateness
- Repetition
- Stat vs routine
- Order entry errors
- Clinical guidelines
and algorithms
- Computerized order
entry
- Wristband use
- Barcode systems
- Labelling
- Aliquoting
- Sorting
- Centrifugation
- Rejection
criteria
- Timeless
- Transportation
- Phlebotomy
- Patient preparation
- Specimen volume
- Identification
OR
?
Reason for identification error
No. of errors
Primary specimen label error
Initial registration/order entry error
Other clerical error
Other reason for error
Aliquot/block/slide label error
Result entry error
2691
1088
604
205
184
80
%
55.5
22.4
12.4
4.2
3.8
1.7
Valenstein PN et al, 2006
Type
Type of
of event
event
No.
No. of
of adverse
adverse
events
events
%
%
Significant patient inconvenience
inconvenience;;
no known change in treatment
or patient outcome
251
72.8
Patient impacted by identification
error; nature of impact unknown
78
22.6
Change in patient treatment
treatment;; no
known change in patient outcome
16
4.6
Known change in patent morbidity
or mortal change
0
0
Valenstein PN et al, 2006
Improve the accuracy of patient
identification
improve the effectiveness of
communication among caregivers
Reduce the risk of health careassociated infections
Encourage the active involvement of
patients and their families in the
patient’s care as a patient safety
strategy
Group mean
NTQ (σ)
(conventional units)
•
•
•
•
Cholesterol (TEa=10%)
Calcium (Tea=1mg/dL)
Glucose (Tea=10%)
Glycohemoglobin (Tea=10%)
210.8
10.7
120.5
9.06
2.88
2.84
2.95
1.93
NnQ (σ)
LMQ (σ)
3.02
3.00
3.34
1.93
3.67
3.86
4.00
2.57
James O. and Sten A. Westgard. Am J Clin Pathol 2006
Processes
following
the
examination
including systematic
review,
formatting
and
interpretation,
authorization
for
release,
reporting
and trasmission of
the
results,
and
storage of samples
of the examinations.
ISO 15189:2003
Outside
Outsidethe
thelaboratory
laboratory
Pre-analytic
Pre-analytic phase
phase
Outside
Outsidethe
thelaboratory
laboratory
••
••
••
••
Physician’s
Physician’s
Brain
Brain
Patient
Patientidentification
identification
Blood/specimens'
Blood/specimens'collection
collection
Specimens'
Specimens'identification
identification
Specimens'
Specimens'transport
transport
Within
Within the
thelaboratory
laboratory
•• Transmission
Transmissionof
ofresults
results
•• Interpretation
Interpretationcomments
comments
•• Reference
Referencerange
rangeor
or
decisional
decisionallimits
limits
•• Medical
Medicalvalidation
validation
•• Technical
Technicalvalidation
validation
Within
Within the
thelaboratory
laboratory
•• Time
Timeof
ofspecimens's
specimens'sarrival
arrival
•• Check-in
Check-in
•• Centrifugation,
Centrifugation,decapping
decapping
•• Aliquoting,
Aliquoting,and
andlabeling
labelingof
of
secondary
secondaryspecimen
specimen
Analytic
Analytic phase
phase
•• Utilization
Utilizationof
oflaboratory
laboratorydata
data
ininpatient
patientmanagement
management
•• Reaction
to
the
results
Reaction to the results
•• Interpretation
Interpretationof
ofresults
results
•• Reception
Receptionof
ofreports
reports
•Accuracy
•Accuracy
•Reproducibility
•Reproducibility
•Turnaround
•Turnaroundtime
time
•Internal
•Internalquality
qualitycontrol
control
•External
•Externalquality
qualityassess
assess
Post-analytic
Post-analytic phase
phase
- Interpretation
- Transcription
- Interface
- Calculations
- Reference range
- Alert limits
- Comments
- Pull vs push
- Critical values
- Significant
findings
- Verbal
- Print
- Fax
- EMR interface
- Clarity
Accuracy
Establishment and maintenance
of high reliability organisations
Proactive
Management of risk
Development of
organisational learning
Building Awareness
Well-designed
Well-designed procedures
procedures
and
and processes
processes
Simplification
Simplification &
& Automation
Automation
DEFENCES
Training
Supervision
Effective
lab/clinical
interface
Patients’
adverse events
THE GAPS
Complex
Complex TTP
TTP
Several
Several steps
steps and
and
different
different professionals
professionals
Laboratory-clinic
Laboratory-clinic interface
interface
Shortage of staff
Increasing complexity in test
ordering/result interpretation
Prevent medical errors and ensure patient
safety!
Assess needs and outcomes
Plan for quality throughout
Quality
Develop policies;
Needs &
implement procedures
outcome
s
Continually verify
effectiveness
Plan
Continuous
Quality
Assess
Improvement
make
make changes
changes ifif necessary
necessary
Re
-assess for changes and continuous
Re-assess
quality improvement
Verify
Do
Plan
Quality
Needs &
outcome
s
Laboratory
Continuous
AssesProfessionals
Quality
s
Improvement
Verify
Do
Quality Improvement
Tools
Total Quality Management
Continuous Quality
Improvement (CQI)
Toyota Production System
Six Sigma
Proactive Hazard
Analysis Tools
Failure Mode and Effect
Analysis (FMEA)
Hazard Analysis and
Critical Control Points
(HACCP)
Hazard and Operability
Studies (HAZOP)
Probabilistic Risk
Assessment (PRA)
Total
Quality
Improvement
HAZOP
Toyota
Production
System
SIX
SISMA
FMEA
HACCP
If we are truly committed to
quality
quality,, almost any mechanism will
work.
If we are not, the most elegantly
constructed of mechanisms will fail.
Avedis Donabedian
Purpose of the project:
Modeling the laboratory process
in order to identify the critical
steps leading to errors.
PROCESS ANALYSIS
- IDEFØ (Integration Definition Analysis)
RISK ANALYSIS
- CTA (Cognitive Task Analysis)
- HAZOP (HAZard and OPerability study)
- APJ (Absolute Probability Judgment)
Procedure amministrative
Frontespizio
Richiesta d’esame
Paziente
Accettare
amministrativame
nte il paziente
Provette etichettate vuote
Etichette
Fattura
A1
Risorse umane
Risorse e strumenti
Raccogliere
campioni al
paziente
Procedure amministrative
Procedure infermieristiche
Provette
etichettate
piene
Procedure amministrative
A2
Trasportare
campioni
Risorse umane
Risorse e strumenti
A3
Risorse umane
Risorse e strumenti
Provette
etichettate
piene in
laboratorio
Procedure amministrative
Procedure tecniche
Accettare
campioni in
laboratorio
Campioni da
analizzare
Procedure tecniche
A4
Eseguire analisi
di laboratorio
Risorse umane
Risorse e strumenti
Referto
Procedure amministrative
Frontespizio
A5
Risorse umane
Risorse e strumenti
Consegnare
referti
A6
Risorse umane
Risorse e strumenti
Referto al
paziente
IDEF
COGNITIVE
TASK
ANALYSIS
HUMAN
HAZOP
RISK
ANALYSIS
R= P x D
Modeling of lab process
Analysis of tasks
Identification of hazards
Evaluation of risk probability
R
isk = P
robability x D
amage
Risk
Probability
Damage
Signori C. et al., Clin Chem Lab Med 2007
Signori C. et al., Clin Chem Lab Med 2007
Il metodo Lean della “Value Stream Mapping”
ha consentito di rappresentare ed identificare i
flussi e le aree di intervento.
Indicatori:
Indicatori:
•• tempo
tempo ciclo
ciclo (C/T),
(C/T), Lead
Lead Time
Time (L/T),
(L/T), Takt-Time
Takt-Time
•• code
code (Work
(Work in
in process
process –– WIP)
WIP)
The fundamental shift is to move from error
description and a focus on saving lives solely by
avoiding error perpetuation, to a systemic approach
to
describe
and
document
all
activities,
responsibilities and related procedures involved in
delivering care processes.
In this way, it should be possible to identify the most
critical steps in which latent failures and errors may
remain and accumulate making the system more
prone to future possible errors and adverse events.
Brennan
Brennan TA
TA et
et al.
al. N
N Engl
Engl JJ Med
Med 2005;
2005; 353:
353: 1405-9
1405-9
Moving away from a focus on saving lives solely by
preventing errors and instead emphasizing the
implementation of evidence-based practices to
improve the quality of care more generally will yield
better long-term results.
Safety: freedom from accidental injury
Effectiveness: refers to the care that is based on
systematically acquired evidence to determine whether
an intervention, such as a preventive service,
diagnostic test, or therapy, produces better outcomes
than alternatives.
Brennan
Brennan TA
TA et
et al.
al. N
N Engl
Engl JJ Med
Med 2005;
2005; 353:
353: 1405-9
1405-9
The Ugly
The Good
Impressive
reduction
of analytical
errors over
time
The Bad
Currently
Pre- and
PostAnalytical
Phases
are more
vulnerable
to errors
Little
attention
has been paid
to the clinical
side of
requesting
tests and
interpreting
test results
As healthcare becomes more
patient focused in its approach, a
greater emphasis needs to be
placed on system integration and
support for approaches that bridge
interdisciplinary
communication
gaps.
Scientific Societies
Laboratory Professionals
Clinicians
Patients
Public
WORKING GROUP (WG LEPS 9.3.8) on “LABORATORY ERRORS
and PATIENT SAFETY”.
Chairman: Mario Plebani
mario.plebani@unipd.it
Identification of intra
-analytical
intra-- and extra
extra-analytical
indicators that could be measured (at least,
potentially) in all clinical laboratories
Data collection
Statistical treatment of collected data
Definition
of
provisional
quality
specifications
Monitoring of identified quality indicators and
quality specifications
IFCC - Education and Management Division
www3.centroricercabiomedica.it
Working Group: Laboratory Errors and Patient Safety
9.3.8.
9.3.8. Laboratory
Laboratory Errors
Errors and
and Patient
Patient Safety
Safety (WG-LEPS)
(WG-LEPS)
Terms
Terms of
of references
references
The
The Education
Education and
and Management
Management Division
Division (EMD)
(EMD) of
of the
the International
International Federation
Federation
of
of Clinical
Clinical Chemistry
Chemistry and
and Laboratory
Laboratory Medicine
Medicine (IFCC)
(IFCC) has
has recently
recently established
established aa
new
new Working
Working Group
Group on
on “Laboratory
“Laboratory errors
errors and
and patient
patient safety”
safety” (WG-LEPS
(WG-LEPS 9.3.8).
9.3.8).
The
The WG
WG mission
mission is
is to
to stimulate
stimulate studies
studies on
on the
the topic
topic or
or errors
errors in
in laboratory
laboratory
medicine,
medicine, to
to collect
collect available
available data
data on
on this
this topic
topic and
and to
to recommend
recommend strategies
strategies and
and
procedures
to
improve
patient
safety.
procedures
to
improve
patient
safety.
According
According to
to the
the Chair
Chair of
of the
the World
World Alliance
Alliance for
for Patient
Patient Safety,
Safety, Sir
Sir Liam
Liam
Donaldson,
Donaldson, established
established by
by the
the WHO
WHO in
in 2004,
2004, “a
“a focus
focus on
on addressing
addressing errors
errors in
in
laboratory
laboratory medicine
medicine is
is an
an important
important element
element of
of the
the international
international agenda
agenda on
on patient
patient
safety.
Timely
and
accurate
laboratory
test
results
are
a
cornerstone
of
effective
safety. Timely and accurate laboratory test results are a cornerstone of effective
diagnosis
diagnosis and
and treatment
treatment of
of patients”
patients” (Clin
(Clin Chem
Chem Lab
Lab Med
Med 2007;
2007; 45(6):
45(6): 697-9).
697-9).
TTP phase
Pre-analytic
Intra-analytic
Post-analytic
Indicators (n.)
16
4
5
Such a focus on the total testing process
requires competent, conscientious and risk
-aware
risk-aware
individuals who work effectively within teams and
across organisational boundaries.
Indeed, the
greatest reductions in laboratory errors are likely
to be achieved through better inter
-departmental
inter-departmental
cooperation to improve the quality of specimen
collection and data dissemination (6). Leadership
is also vital. Without strong and committed
leadership the patient safety movement cannot
succeed.
Sir Liam Donaldson, Chair, World Alliance for Patient Safety
“While its true that for patients to be safe,
good
training,
skilled
staff
and
conscientious care are essential, what is
also required are strong, safe processes
and systems of care that reduce the risk to
patients.
That
is
why
spreading
information and solutions can improve the
safety record of healthcare worldwide.
Knowledge is the enemy of unsafe care”
Sir
Sir Liam
Liam Donaldson,
Donaldson, 2005
2005
Most errors in laboratory medicine originate in
the pre- and post-analytic phases
The greatest opportunity for improvement in
quality exists in pre-and post-analytic
processes
Critical areas include patient identification,
specimen collection, labeling, transport data
entry and communication of results
Gains in quality can be achieved by
collaboration
between
clinicians
and
laboratory professionals.
Surveyed physicians were unaware of
almost 2/3 of these potentially actionable
results.
More than a third of these would change the
patient’s diagnostic or therapeutic plan, and
12.6% required urgent action.
The most common results requiring urgent
action were results of microbiological tests
necessitating invitation or change of
antibiotic treatment.
Roy
Roy CL,
CL, Ann
Ann Intern
Intern Med,
Med, 2005
2005
Failure to follow up on certain results
(for example, the results of blood
cultures) could have catastrophic
consequences
consequences,, but even results that
do not require urgent action (such as
iron deficiency) could have important
consequences if overlooked.
An
error rate of 0.9 per 100 patient
discharges
2 (24 missed actionable results
10--2
among 2644 patient discharges)
270 missed actionable results in a
hospital with 30 000 discharges per
year.
““These
These include inadequate operational
procedures,
fragmented
clinical
information, poor communication, poor
design of clinical records – amongst other
things,
” he says. ““Mistakes
Mistakes are being
things,”
made because systems, tasks and
processes are poorly designed
”.
designed”.
Sir
Sir Liam
Liam Donaldson,
Donaldson, 2005
2005
Clinical laboratories have a key role to play in
improving patient safety. However, the safety
of laboratory testing needs to be everyone's
business. There is strong evidence that
demonstrates that many of the errors in
laboratory medicine occur in the pre and
post analytical phase of laboratory testing,
rather than within the walls of the laboratory.
The impact of such errors can include
unneeded treatments, unnecessary follow
-up
follow-up
of tests and inaccurate diagnosis of patients