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An error management system in a veterinary clinical laboratory

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Journal of Veterinary Diagnostic
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An error management system in a veterinary clinical laboratory

Emma Hooijberg, Ernst Leidinger and Kathleen P. Freeman
J VET Diagn Invest 2012 24: 458
DOI: 10.1177/1040638712441782

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441782
berg et al.Error management in a veterinary laboratory
JVDXXX10.1177/1040638712441782Hooij

Special Article
Journal of Veterinary Diagnostic Investigation

An error management system in 24(3) 458­–468

© 2012 The Author(s)
Reprints and permission:
a veterinary clinical laboratory sagepub.com/journalsPermissions.nav
DOI: 10.1177/1040638712441782
http://jvdi.sagepub.com

Emma Hooijberg,1 Ernst Leidinger, Kathleen P. Freeman

Abstract. Error recording and management is an integral part of a clinical laboratory quality management system.
Analysis and review of recorded errors lead to corrective and preventive actions through modification of existing processes
and, ultimately, to quality improvement. Laboratory errors can be divided into preanalytical, analytical, and postanalytical
errors depending on where in the laboratory cycle the errors occur. The purpose of the current report is to introduce an
error management system in use in a veterinary diagnostic laboratory as well as to examine the amount and types of error
recorded during the 8-year period from 2003 to 2010. Annual error reports generated during this period by the error recording
system were reviewed, and annual error rates were calculated. In addition, errors were divided into preanalytical, analytical,
postanalytical, and “other” categories, and their frequency was examined. Data were further compared to that available from
human diagnostic laboratories. Finally, sigma metrics were calculated for the various error categories. Annual error rates per
total number of samples ranged from 1.3% in 2003 to 0.7% in 2010. Preanalytical errors ranged from 52% to 77%, analytical
from 4% to 14%, postanalytical from 9% to 21%, and other error from 6% to 19% of total errors. Sigma metrics ranged from
4.1 to 4.7. All data were comparable to that reported in human clinical laboratories. The incremental annual reduction of error
shows that use of an error management system led to quality improvement.

Key words: Error management; laboratory error; quality management; veterinary laboratory.

Introduction
Error recording and management is an important part of any
clinical laboratory quality management system (QMS), and
all QMS require the identification and monitoring of
errors.18 Veterinary laboratories participating in accredita-
tion schemes such as those from the International Organization
for Standardization (ISO) or quality improvement initiatives
may be required to have formal processes for identifying
opportunities for improvement.5,9,10 For example, although
the European College of Veterinary Clinical Pathology
(ECVCP, http://www.esvcp.com) has no specific guidelines
regarding error management, facilities applying for recogni-
tion as a training laboratory for the ECVCP residency
program are required to submit a copy of the laboratory’s
Quality Plan. The plan must include details of internal and
external quality control (QC) procedures for various depart-
ments. Likewise, the American Society of Veterinary
Clinical Pathology (ASVCP) does not discuss error manage-
ment in their QC Guidelines; however, recording of sam-
ple quality problems and client feedback is specifically
recommended (http://www.asvcp.org/pubs/pdf/ASVCP
QualityControlGuidelines.pdf ). In an article discussing the
relevance to and implementation of ISO 15189 in veterinary
laboratories, the authors state that out of 12 laboratories
undergoing review by the ECVCP Laboratory Standards
Committee, only 4 facilities had formal means for identify-
ing improvement opportunities.5 Laboratories with either
ISO 9001 or ISO 15189 accreditation must have a system for
identifying errors. The definitions for the concepts involving
laboratory error used in the ISO norms are provided in Table 1.
The ISO 9001:2008 Standard for Quality Management
Systems requires that a nonconforming product should be
identified and controlled and that records of the nonconfor-
mities as well as resulting actions should be maintained.9
The ISO 15189:2007 Standard for Medical Laboratories
requires documentation and recording of each episode of
nonconformity as well as regular review of these records.8
Identification may take the form of incident reports, improve-
ment opportunity processes, internal audits, and/or risk anal-
yses.10 Once errors have been identified, regular analysis by
management should take place in order to identify the causes
and institute corrective actions.
Although an error management system may be a compul-
sory part of a QMS, no uniform system for managing errors
exists. In addition, there is a scarcity of information regard-
ing this process in the veterinary literature. There is also no
published information regarding the numbers and types
of errors that are typically found in veterinary clinical
From Invitro Laboratory for Veterinary Diagnostics and Hygiene,
Vienna, Austria (Hooijberg, Leidinger), and IDEXX Laboratories,
Wetherby, West Yorkshire, United Kingdom (Freeman).
1
Corresponding Author: Emma Hooijberg, Rennweg 95, Vienna 1030,
Austria. emma.hooijberg@invitro.at
 Error management in a veterinary laboratory 459
Table 1. International Organization for Standardization (ISO)
definitions.*
Term Definition
Laboratory error Failure of a planned action to be completed as
intended, or use of a wrong plan to achieve
an aim, occurring at any part of the laboratory
cycle, from ordering examinations to reporting
results and appropriately interpreting and
reacting to them.
Nonconformity Nonfulfillment of a requirement.
Requirement Need or expectation that is stated, generally
implied, or obligatory.
Corrective Action to eliminate the cause of a detected
action nonconformity or other undesirable situation.
Preventive Action to eliminate the cause of a potential
action nonconformity or potential undesirable
situation.
* ISO 9001:2008. Quality management systems—requirements; ISO/
TS 22367:2008. Medical laboratories—reduction of error through risk
management and continual improvement.
laboratories. A small number of reports have been published
about error management in human laboratory medicine.
Most of the studies concerning human laboratory error
management advocate the use of an error management sys-
tem that evaluates errors within the framework of the Total
Testing Process (TTP).1,7,15,16 The TTP breaks laboratory
testing down into 11 steps, starting with a clinical question
that prompts a test selection and ending with the impact of
the test result on patient care.2 These steps are grouped into
preanalytical, analytical, and postanalytical phases, with
some authors also describing pre-preanalytical and post-
postanalytical phases.15 Alternatively, errors may also be
classified according to who bears responsibility for the
event, preventability, or the impact on patient care.10 Such
studies concerning error management in human medical
laboratories are heterogeneous, and reported error rates dif-
fer according to study design, TTP steps analyzed, and
whether results are reported per patient, per sample, or per
test result. Results vary from errors occurring in 0.05%
of patients in a clinical chemistry section to 0.61% of test
results across a whole laboratory over 3 years.3 Other stud-
ies report error frequencies as 1:1,000 (0.1%), 1 error per
33–50 events (2–3%), or 1 error per 214–8,300 (0.01–0.5%)
of laboratory results.11,15,16 In 2 studies 10 years apart report-
ing error frequencies and types in a human hospital stat lab,
total error frequency decreased significantly from 0.47% to
0.31% per result.4,16
It is therefore hypothesized that the total error rates and
error patterns in a veterinary clinical diagnostic laboratory
are similar to those reported for human clinical diagnostic
laboratories and that the use of an error management system
will lead to a reduction of errors over time. The objective of
the present study was to use data retrospectively collected
from an automated error management system in a veterinary
clinical diagnostic laboratory over an 8-year period in order
to test these hypotheses.
Materials and methods
Error recording and management system
The data that were examined in the current study originated
from a commercial veterinary clinical laboratory offering a
diagnostic service for veterinarians in practice. A wide range
of tests were performed, including hematology, clinical
chemistry, endocrinology, serology, coprology, urinalysis,
cytology, and microbiology. Hematology, clinical chemis-
try, and endocrinology testing was mostly performed on
automated analyzers. The evaluation of blood smears,
enzyme-linked immunosorbent assays (ELISAs), and immu-
nochromatography (IC) tests relevant to these fields took
place manually. Internal QC for the analyzers included the
daily use of multiple levels of control material. Results were
evaluated against various control rules and performance
goals based on total allowable errors, which had been set for
various tests. The laboratory participated in a national exter-
nal quality assurance scheme (OEQUASTA, the Austrian
Society of Quality Assurance and Standardisation) aimed
primarily at human diagnostic laboratories, which involved
hematology and clinical chemistry testing. Serological test-
ing included indirect fluorescent antibody tests, ELISAs, IC
tests, passive agglutination tests, and agar gel immunodiffu-
sion tests. Quality control for these tests depended on the
use of positive and negative controls. Quality control for
microscope-based testing such as cytology, coprology, and
urinalysis took the form of regular comparison of results
from specimens independently examined by 2 individuals.
Quality control procedures and assessment of and response
to QC results were documented in standard operating proce-
dures. Results that did not meet the set performance goals for
internal and external quality assurance were recorded in
the system as analytical errors. The laboratory has ISO 9001
accreditation and was also approved as a training laboratory
by the ECVCP Laboratory Standards Committee. ISO certi-
fication was achieved in April 2001 and required the estab-
lishment of an error identification and management system.
During the design of the QMS, error management was
assigned to the control of nonconformities process, which
falls under the Measurement, Analysis, and Improvement
Process section. This is illustrated in Figure 1, which shows
the process landscape of the QMS. Processes are described
in the QMS in the form of flow diagrams. Figure 2 shows the
control of nonconformities process flow diagram. Initially,
error recording in the laboratory took place by hand using
customized forms, but this system was discarded, as record-
ing incidents and processing of information were excessively
time-consuming and there was no standardization in the
wording used. A recording systema integrated into the
Laboratory Information System (LIS) was subsequently
460 Hooijberg, Leidinger, Freeman
Figure 1. Quality management (QM) system process landscape.
used. The module was designed to follow the control of non-
conformities process flow diagram. An earlier version of this
application has been described previously (Leidinger E:
2008, LIMS-integrated error management in an ISO
9001-certified diagnostic lab [poster]. European Society of
Veterinary Clinical Pathology 10th Annual Congress.). The
automated system was well received by ISO auditors
involved in the annual internal and external audits. Both
internal and external audits are required for ISO 9001 certi-
fication.2 During an audit, various aspects of the QMS are
examined, and the presence of an automated error manage-
ment system provides proof of ISO 9001 compliance, good
documentation, and measurement of performance. The error
recording software could be accessed directly from the LIS,
and errors were recorded by all employees after appropriate
training in the various error categories and details of data
entry. It was important that staff members understood the
different types of errors and entered errors in the correct cat-
egories, as this formed the basis for the monthly and annual
error reports. The initials of the employee submitting the
information were recorded, but there was no field for record-
ing the name of the person who may have caused the error;
this was in an effort to avoid a “blaming and shaming” envi-
ronment and personal strife and stress among employees.
Figure 3 shows the data entry screen of the error manage-
ment application. Upon first entering data, a choice was made
from a list of error categories. The categories corresponded to
steps in sample processing and also included management
functions not directly related to a processing step. Once the
appropriate category had been selected, a subcategory of that
error was chosen. The subcategories were freely defined, and,
once used, stayed in the list for future use. The subcategories
field in the database was set to “unique index,” which pre-
vented the entry of exactly the same term twice. To prevent
duplication of entries where the terms used are similar (e.g.,
“wrong veterinarian name” and “incorrect client name,”
which both refer to the same error), further maintenance of
the subcategory file was manually performed by the system
administrator, who was the only person permitted to access
the maintenance mode. Details regarding the identification of
the error, the sample number concerned, and a short descrip-
tion of the error and its cause were then included. In addition,
fields for recording the immediate and planned corrective
actions were also available. An immediate corrective action
was usually carried out prior to error recording when possible
and was recorded in the appropriate field. Finally, a checklist
defining the status of the error and whether corrective or pre-
ventive actions were carried out was completed. The check-
list options were not mutually exclusive and more than 1
option could be selected. If a sample was affected by more
than 1 error or an error fell into more than 1 category, then
multiple entries were made for that sample number categoriz-
ing the different error types. Explanations and further details
of the categories and terms used in the application are found
 Error management in a veterinary laboratory 461

Figure 2. Control of nonconformities process flow diagram. The central column indicates the steps in the process, and the left and right
columns indicate the process inputs and outputs, respectively.

in Table 2. The error categories were grouped into preanalyti-
cal, analytical, postanalytical, and other error types in order to
better compare the data to that published for human laborato-
ries. Sources of information contributing to error recording
included client complaints, staff information, nonconformi-
ties detected by internal QC and QC statistics, results of
external proficiency testing, nonconformities reported during
internal and external audits, and information from suppliers.
Documents created by the softwarea included a monthly
error report, an annual error report, and lists of corrective
and preventive actions. The monthly and annual error reports
were examined by the laboratory director. Planned correc-
tive and preventive actions were also decided on by the labo-
ratory director, usually after consultation with the quality
manager and occasionally other staff members for whom the
error may have been relevant. Immediate corrective actions
462 Hooijberg, Leidinger, Freeman
Figure 3. Error management system data entry screen.
were generally carried out by the staff member reporting the
error without prior consultation. Monitoring of the effective-
ness of corrective and preventive actions was also the
responsibility of the laboratory director, and a report was
included in the annual management review.
Data analysis
The monthly and annual error reports generated by the soft-
ware application listed the number of errors falling into each
category per month or year as well as the total number of
errors as a percentage of total sample number. The monthly
reports contained all errors recorded for that month, and the
annual error report contained all errors recorded for that
year. The data from the annual error reports from 2003 to
2010 were transcribed to a spreadsheet.b All data were
included. The absolute number of each type of error per year,
the number of corrective and preventive actions carried out
in each year, and the error rate per total number of samples
were recorded. Descriptive statistics were used to further
examine the data. The frequencies of error types were calcu-
lated as a percentage of total errors for each year from 2003
to 2010. Confidence intervals (95% CI) for total error rates
for each year were calculated. Sigma metrics were calculated
for the different error types over the period of the study. The
total number of errors was calculated for each of the 4 cate-
gories by including the annual total errors for each category
from 2003 to 2010. This number was divided by the total
number of samples processed by the laboratory over the
8-year period and converted to defects per million using an
online Six Sigma calculator (http://www.westgard.com/six-
sigma-calculators-2.htm). The defects per million result was
converted to a sigma metric by the calculator.
The described software was not used to record hemolytic
and lipemic samples. This was purposefully excluded during
the programming of this particular software application as it
was recorded elsewhere in the system. The presence of
hemolysis and/or lipemia was noted in the comments section
of the clinical chemistry report. The degree of lipemia and
hemolysis was graded from + to +++ using visual assess-
ment, as no automated indexes were available on the chem-
istry analyzer used in this particular laboratory. If samples
were considered too hemolytic to process by the technician,
the samples were rejected, and the veterinarian was informed.
Lipemic samples were ultracentrifuged to clear the lipemia
and then pipetted. Data concerning the number of hemolytic
and lipemic samples (but not the grade) appeared on the
annual statistical reports comparing process goals (e.g., turn-
around times) with yearly data and was examined separately
from other types of errors. Data were presented as the total
number of hemolytic and lipemic samples recorded per year
as well as the percentage of hemolytic and/or lipemic sam-
ples of total clinical chemistry samples. These data were
tabulated in order to compare the total number of hemolytic
and lipemic samples per year. The data were presented sepa-
rately for the following reasons: a sample may be both hemo-
lytic and lipemic, and as each incidence of hemolysis and
lipemia was recorded as a separate event, independent of
whether they occurred simultaneously, it was not possible to
present the aforementioned data in terms of “total hemolytic
 Error management in a veterinary laboratory 463

Table 2. Error types and categories used in the error management application.*
Error type Error category Explanation Example of error
Preanalytical In-house courier Couriers employed by laboratory for local sample Courier does not pick up all samples
service pickup from a client
  Third-party courier External courier service for national sample pickup Courier service not informed by lab
service to pick up sample from a particular
client
  Reception Receiving, unpacking, and numbering of samples Serology sample number not recorded
in serology day list
  Data entry Information from submission form entered into LIS Incorrect client name entered into LIS
  Client errors Client fails to fill out submission form correctly, Client forgets to request a certain
or sends incorrect material, or makes unjust test, initially believes laboratory is
complaint responsible for the oversight
Analytical Analysis Sample preparation and analysis, includes quality Sample not diluted and rerun for
control alanine aminotransferase despite
error message from analyzer
  System control Analytical equipment maintenance and function Pipette not accurate after calibration
Postanalytical Validation Results examined for plausibility Result of serological test not entered
onto report correctly
  Reporting Validated reports sent to clients Incorrect e-mail address for client
  Invoicing Invoices sent to clients Client incorrectly charged for courier
service
Other IT problems LIS and network functions Results not transmitted from analyzer
to LIS
  Documentation All documentation aspects of the QMS Test instructions for C-reactive
protein kit missing
  Supplies Adequate supplies of analytical and nonanalytical Incorrect reagent ordered
equipment
  Maintenance Proper functioning of nonanalytical laboratory Temperature in refrigerator too high
equipment, fixtures, etc.
  Miscellaneous Errors that do not fit into the aforementioned Incorrect message regarding opening
categories times on lab answering machine
Other definitions Completed Error entry closed  
  Preliminary release Preliminary report sent, final report to follow  
  Corrective action See Table 1  
  Preventive action See Table 1  
  Client complaint Source of information is the client; may be justified  
or unjustified
* LIS = laboratory information system; QMS = quality management system.

and lipemic samples per sample number.” In addition, the
sample number herein referred to the total number of clinical
chemistry samples, not total laboratory samples. Such a dis-
tinction made the data unsuitable for inclusion into the error
rate calculations, and therefore, the number of hemolytic and
lipemic samples was not included in the preanalytical error
category.
Results
The raw error data recorded in the spreadsheet taken from
the annual reports from 2003 to 2010 are shown in Table 3.
The total number of samples submitted to the laboratory
from 2003 to 2010 was 332,882. Sample reception, data
input, validation, and in-house courier errors were the most
commonly recorded errors over the 8-year period. The total
error number fluctuated while the total number of samples
processed by the laboratory increased every year from 2003
to 2010, resulting in a decrease in total error rates over the
time period examined. The error rates, based on error per
sample number, ranged from 1.3% to 0.7% over the 8 years
of data collection (Fig. 4). There was a significant decrease
in the error rate for the 8-year period between 2003 (1.3%,
95% CI: 1.19%, 1.45%) and 2010 (0.7%, 95% CI: 0.62%,
0.77%).
The frequencies of the different types of error are pre-
sented in Table 3 and Figure 5. Errors in the preanalytical
phase can occur during the blood sampling procedure, com-
pletion of the sample submission form, transport of the sample,
unpacking and labeling of the sample, entering information
464 Hooijberg, Leidinger, Freeman

Table 3. Error data for 2003–2010

Absolute number of errors per year per category

Error type/category 2003 2004 2005 2006 2007 2008 2009 2010 Total
Preanalytical
  In-house courier service 44 24 43 48 46 33 52 25 315
  Third-party courier service 53 30 20 21 29 26 20 36 235
 Reception 40 54 40 30 61 62 139 52 478
  Data entry 111 125 119 72 85 137 63 133 845
  Client errors 14 13 20 9 27 21 24 31 159
  Error as % of total errors 64 65 68 52 67 70 72 77  
Analytical
 Analysis 55 26 15 28 16 9 14 13 176
  System control 4 3 6 11 2 6 7 10 49
  Error as % of total errors 14 8 6 11 5 4 5 7  
Postanalytical
 Validation 22 46 45 52 53 52 50 36 356
 Reporting 36 30 14 14 9 12 13 7 135
 Invoicing 7 5 6 5 5 4 5 1 38
  Error as % of total errors 15 21 18 18 18 16 16 9  
Other
  IT problems 5 6 4 14 9 10 5 2 55
 Documentation 0 4 2 3 0 1 2 0 12
 Supplies 1 1 5 7 5 9 6 5 39
 Maintenance 0 0 5 2 2 0 1 0 10
 Miscellaneous 20 8 6 28 19 12 12 9 114
  Error as % of total errors 7 6 8 19 10 10 7 7  
Corrective actions 14 16 20 33 10 10 17 7 127
Preventive actions 4 6 1 5 1 0 3 1 21
Total number of errors 412 375 350 344 368 394 412 360 3,015
Total number of samples 31,179 34,636 35,965 37,968 44,301 47,180 49,910 51,743 332,882
% error of total samples 1.3 1.1 1.0 0.9 0.8 0.8 0.8 0.7 0.9

Figure 4. Frequencies of preanalytical, analytical, postanalytical,

and other error types as a percentage of total error from 2003 to 2010.
into the LIS, and preparation of the sample for analysis.
Analytical errors include QC results outside of preset limits,
pipetting errors, photometer and analyzer lamp failures, ana-
lyzer water contamination problems, air bubbles in the sam-
ple, calibration errors, and interferents. In the postanalytical
Figure 5. Percentage of total error recorded per total number of
samples per year from 2003 to 2010.
phase, errors can occur during the review of results, interpre-
tation of results, and reporting and transmitting of reports,
among others. Most errors occurred during the preanalytical
 Error management in a veterinary laboratory 465
Table 4. Sigma metrics for the various error categories from
2003 to 2010.
Total number of Sigma
Error type errors 2003–2010 metric
Preanalytical 2,032 4.1
Analytical 225 4.8
Postanalytical 495 4.5
Other 271 4.7
Table 5. Number of hemolytic and/or lipemic samples
recorded annually.
Total nymber of hemolytic and/or lipemic samples
recorded per year
  2003 2004 2005 2006 2007 2008 2009 2010
Hemolysis 2,788 2,143 1,664 2,315 2,923 3,079 2,461 1,993
Lipemia 973 849 718 993 1,229 1,996 1,734 1,712
phase, with preanalytical errors ranging from 52% to 77% of
annual errors. Postanalytical errors ranged from 9% to 21%
and were the second highest group. Analytical errors were
the lowest, ranging from 4% to 14%. The category “other
errors” showed error frequencies of 6–19% and contained
errors that potentially affected all 3 phases and were mostly
associated with aspects of the QMS. In other words, most
errors occurred at the client-laboratory (preanalytical) and
laboratory-client (postanalytical) interfaces.
The results of the sigma metric analysis are presented in
Table 4. The preanalytical error category had the lowest met-
ric of 4.1, with a total of 2,032 errors from 2003 to 2010. The
highest sigma metric (4.8) was associated with the analytical
errors (225 over the 8-year data collection period).
The total number of hemolytic and/or lipemic samples is
presented in Table 5. The number of recorded hemolytic
samples ranged from 1,664 to 3,079 over the 8-year period.
The number of lipemic samples showed an increasing trend,
with a minimum of 718 recorded in 2005 and a maximum of
1,996 recorded in 2008. The data were not further examined
due to the difficulties in calculation explained in the data
analysis section. However, it should be noted that the annual
number of hemolytic samples was approximately 5 to 8 times
higher than the total number of errors recorded per year, and
the number of lipemic samples approximately 2–5 times
higher than the total number of annual errors. Including these
data in the error rates would have led to an inflation of the
reported error frequencies (Table 3).
Discussion
Total error rates of 0.7–1.3% were reported for a veterinary
clinical diagnostic laboratory over an 8-year period. These
figures are similar to, but slightly higher than, those reported
in the human literature, although direct comparisons are not
always possible due to different study designs and reporting
techniques. Such data support the first hypothesis that error
rates in a veterinary clinical diagnostic laboratory would be
similar to those reported for human laboratories. Error rates
reported in human laboratories ranged from 0.05% per
patient to 2.3% per event (events are not defined).3,15 It must
be stressed that the figures presented herein are only of errors
that were identified and entered into the error management
system and does not include those errors that may have gone
unnoticed. In addition, many errors were likely self-cor-
rected and remained unreported. There may also have been a
bias in error reporting over the different categories depend-
ing on the diligence of staff involved in different steps of the
testing process. However, due to the variety of staff who
entered data into the system over 8 years, it is likely that the
available data were consistent and biases negligible. In the
human laboratory studies, data were collected by means of
special notebooks, audits, and questionnaires and collection
of complaints.3,4,16 Two reports describe the use of a comput-
erized database to record and manage errors.12,17 An auto-
mated reporting system like the system used in the veterinary
laboratory described offers greater ease of use and conve-
nience than a manual system and may also explain the higher
error rates reported using this system.
The slightly higher error rates reported for the veterinary
laboratory compared to some human laboratories may be
related to lack of automation in many phases of the TTP
compared to human laboratories as well as the fact that sam-
ples were processed on an outpatient basis. This is in contrast
to many human laboratories that are based in hospitals and
receive samples on site. On-site sampling has the advantage
that patient data are entered into a single computer system,
barcodes are more frequently used, sampling procedures are
uniform, and sample transport time is short. It would be
interesting to compare the results presented herein to other
veterinary laboratories in order to determine whether the
error frequencies for this laboratory are usual for veterinary
clinical laboratories and if differences exist between com-
mercial labs and those affiliated with university animal
hospitals.
Most laboratory errors occur during the preanalytical and
postanalytical phases. Preanalytical errors in a human stat
lab ranged from 68.2% to 61.9%, analytical errors from
13.3% to 15%, and postanalytical errors from 18.5% to
23.1% of total errors over 10 years.4,16 Other sources report
preanalytical errors in the range of 46–68.2%, analytical
errors from 7% to 13%, and postanalytical error rates from
18.5% to 47%.14 The breakdown of error in the current study
is similar to that reported for human laboratories. There was
a general trend toward an increase in the proportion of pre-
analytical errors, with the exception of a decrease in 2006.
This is likely a decrease relative to an increase in analytical
and other errors. A direct review of the error management
database revealed repeated reporting of pipette problems
(“system control”), refrigerator temperature control issues
466 Hooijberg, Leidinger, Freeman
(“maintenance”), and errors of communication among staff
members (“miscellaneous”), which resulted in a relative
decrease in preanalytical errors being recorded.
That the majority of reported errors occurred in the pre-
analytical and postanalytical phases is mostly due to the fact
that these are processes that are manual rather than auto-
mated and may not all be well standardized. In addition, in
the veterinary laboratory in the present study, the preanalyti-
cal phase involved a chain of staff members working
together. This is different from the analytical and postana-
lytical phases, in which only 1 or 2 people were involved in
the analysis and postanalytical processing of a sample.
Having many people involved in a single process means that
the chance of human error is higher than if a single person is
involved. In addition, standardization is more difficult. On
the other hand, more people involved in a process means
more people looking out for errors and thus a higher detec-
tion and recording rate compared to a single person who may
not detect his or her error or simply self-correct it and not
record it. Therefore, a bias may exist toward better error
detection and recording in the preanalytical phase.
Analytical error rates in human laboratories have
decreased over the past few decades; reports indicate an
improvement from 16% to 0.04% analytical error per labora-
tory test over the last 60 years.15 This has been attributed to
increased use of automation, the application of analytical
quality goals and statistical QC, external quality schemes,
improvement of testing systems, and improved training of
personnel. However, analytical errors can be less obvious
and therefore more difficult to detect than other errors. For
example, it has been observed that up to 75% of analytical
laboratory errors still produce results that fall within the ref-
erence intervals and therefore may not be identified.6 Routine
analysis of internal QC results and comparison with analyti-
cal goals, such as total allowable error, are vital in order to
detect systematic and random errors that may affect the
validity of test results.
Many processes in the postanalytical phase are now also
automated, at least in the veterinary laboratory discussed
herein. Hematology and clinical chemistry results were
transferred automatically from the analyzer to the LIS,
reducing transcription errors. Reports were sent to clients
using an automatic e-mail and fax system. Errors with tran-
scription did occur when results were entered manually, for
example with serology and occasionally hormone results.
Manual and automated plausibility checks and validation of
results were conducted. The use of automated validation sys-
tems has been shown to improve error rates in human labo-
ratories when compared with manual validation.13
Measures to improve error rates in the pre- and postana-
lytical phases of laboratory testing depend on the standard-
ization of manual processes. Vital to this is the production of
well-written, clearly understandable standard operating pro-
cedures for each process. Human errors are to be expected
in manual systems but can be reduced by ensuring a
comfortable working environment with appropriate staffing
levels and breaks.
The sigma-metric scale is a well-established benchmark
used in many industries. Further information as to how it can
be applied to laboratory medicine can be found elsewhere.19
A sigma metric ≥6 is the goal, reflecting “world class perfor-
mance,” and 3.0 sigma is considered the minimum accept-
able performance. As shown in Table 4, the different error
types in the laboratory in the current study achieved sigma
metrics of between 4.0 and 5.0, which indicate a need for
further improvement in order to achieve world class perfor-
mance. A study carried out in human laboratories looking at
error rates and sigma metrics for a range of quality indicators
found that some processes had a sigma metric as low as 2.8
(reports from referred tests that exceeded delivery time;
Westgard S: 2011, Error rates in the total testing process.
Available at: http://www.westgard.com/testing-error-rates.
htm. Accessed February 8, 2012).
The presence of hemolysis and lipemia was not recorded
in the error reporting software and not included in the error
frequency and breakdown reported, but was considered sep-
arately. Lipemia occurs postprandium or as a result of meta-
bolic or endocrine diseases and is not caused by incorrect
sample handling. It is therefore a physiological change and
was not regarded as a preanalytical error in terms of the
recording system described. Hemolysis may also occur as a
pathophysiological process, for example in conditions like
immune-mediated anemia or associated with microvascular
trauma. However, most of the hemolytic samples received
in the veterinary laboratory were not due to a pathological
hemolysis but rather due to problems with sampling and
sample storage. The presence of hemolysis in these samples
could therefore be a preanalytical error that was not recorded
in the error management system. Because of the difficulty in
separating preanalytical error from pathophysiologic hemo-
lysis associated with disease conditions by nonveterinarian
laboratory personnel, the importance of these specimen con-
ditions as potential interferents with some types of analyses,
the concurrent presence of hemolysis and lipemia in some
samples, and the relatively high numbers of hemolyzed and/
or lipemic samples received, these were considered as a
separate category. Including the high numbers of hemolytic
and/or lipemic samples would have skewed the error data
and markedly increased the frequency of preanalytical
errors. Important information concerning other types of pre-
analytical errors would have become lost in the increased
amount of data. In a previous study of preanalytical errors in
a human hospital, hemolytic samples accounted for 50% of
preanalytical errors.3 In most of the studies in human labo-
ratories, the inclusion of hemolysis and lipemia in the error
data was either not mentioned or not included at all. In the
veterinary laboratory studied herein, the presence of hemo-
lysis and/or lipemia was recorded on the laboratory report,
with a cautionary comment regarding results that may have
been affected by hemolysis and/or lipemia.
 Error management in a veterinary laboratory 467
One of the aims of using an error management system as
part of a QMS is to assist in quality improvement. There was
a trend toward a reduction in error frequency in the veteri-
nary laboratory over the years 2003–2010, as documented by
the error management system (Fig. 4). There was a signifi-
cant decrease in error rates from 2003 to 2010, which sup-
ports the hypothesis that efficient error management using a
system similar to the system illustrated in the current study
should lead to a decrease in errors and an increase in
quality.
Reports from human laboratories indicate that the risk of
patient harm, adverse events, and problems with patient care
from laboratory errors is relatively low, with figures ranging
from 2.7% to 30% reported.15 Most of these adverse events
were associated with further unnecessary examinations and
thus higher costs and discomfort for the patient, rather than
patient harm. However, although the majority of errors may
not have a direct impact on patient care, the errors indicate
possible weaknesses in the QMS, which should not go
unaddressed.
Once an error has been detected, a corrective action
should take place in order to rectify the problem. For exam-
ple, if a client reported not receiving results because the
incorrect veterinarian name was entered under the sample
number, the name was changed to the correct one, the results
re-sent to the correct veterinarian, and the veterinarian who
incorrectly received the results contacted to explain the
error. In the veterinary laboratory studied in the present
study, this was a fairly commonly recorded preanalytical
error and occurred mainly when more than 1 veterinarian
had the same or similar surnames and the incorrect one was
selected from an alphabetical drop-down list. A long-term
corrective action was therefore initiated in 2010 whereby
every veterinarian name was matched with a unique identi-
fier or key, related in most cases to the surname and first
name of the veterinarian. This resulted in a decrease in the
number of these recorded errors from 14 over a 3-month
period (January–March 2010) to only 7 over the same 3 months
1 year later (January–March 2011).
Preventive actions are put into place after a potential error
or nonconformity has been identified in order to prevent its
occurrence. Identification of potential errors should take
place using a risk management strategy and review of labo-
ratory processes. Preventive actions were entered into the
error management system in the same way a detected error
would have been recorded, except that the “preventive
action” tab was selected. An example of a preventive action
carried out in 2010 concerned the introduction by the manu-
facturer of an altered total thyroxin reagent. A method com-
parison was carried out between the old and new method to
determine whether significant differences existed before
using the new method for patient sample analysis.
An error management system is an important part of
quality management in veterinary laboratories. Recording
laboratory errors enables further classification and enumer-
ation of various types of errors and leads to the implementa-
tion of corrective actions and introduction of preventive
actions. Error rates in the commercial veterinary laboratory
described in the current study were similar but slightly
higher compared to those reported for human laboratories.
Preanalytical errors are the most common errors found in
human medicine and this was also the case in the present
study. The use of an error management system led to a sig-
nificant decrease in the number of recorded errors from
2003 to 2010. Further studies and reviews of error rates at
other veterinary clinical pathology facilities would make for
interesting comparison.
Acknowledgements
The authors would like to thank Herwig Reichl from Hämosan,
Austria, and Alexander Tichy from the Biostatistics Working
Group at the University of Veterinary Medicine in Vienna for their
advice on the manuscript.
Sources and manufacturers
a. Omnis 7.3, Raining Data, Hamburg, Germany.
b. MS Excel 2003, Microsoft Corp., Redmond, WA.
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect
to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research,
authorship, and/or publication of this article.
References
1. Astion ML, Shojania KG, Hamill TR, et al.: 2003, Classifying
laboratory incident reports to identify problems that jeopardize
patient safety. Am J Clin Pathol 120:18–26.
2. Barr JT, Silver S: 1994, The total testing process and its impli-
cations for laboratory administration and education. Clin Lab
Manage Rev 8:526–542.
3. Bonini P, Plebani M, Ceriotti F, Rubboli F: 2002, Errors in
laboratory medicine. Clin Chem 48:691–698.
4. Carraro P, Plebani M: 2007, Errors in a stat laboratory: types
and frequencies 10 years later. Clin Chem 53:1338–1342.
5. Freeman KP, Bauer N, Jensen AL, Thoresen S: 2006, Introduc-
tion to ISO 15189: a blueprint for quality systems in veterinary
laboratories. Vet Clin Pathol 35:157–171.
6. Goldschmidt HMJ, Lent RW: 1995, Gross errors and work-
flow analysis in the clinical laboratory. Klin Biochem Metab
3:131–140.
7. Howanitz PJ: 2005, Errors in laboratory medicine: practi-
cal lessons to improve patient safety. Arch Pathol Lab Med
129:1252–1261.
8. International Organization for Standardization (ISO) Techni-
cal Committee: 2007, ISO 15189:2007. Medical laboratories
468 Hooijberg, Leidinger, Freeman
—particular requirements for quality and competence. ISO,
Geneva, Switzerland.
9. International Organization for Standardization (ISO) Techni-
cal Committee: 2008, ISO 9001:2008. Quality management
systems—requirements. ISO, Geneva, Switzerland.
10. International Organization for Standardization (ISO) Technical
Committee: 2008, ISO/TS 22367:2008. Medical laboratories—
reduction of error through risk management and continual
improvement. ISO, Geneva, Switzerland.
11. Khoury M, Burnett L, Mackay MA: 1996, Error rates in Australian
chemical pathology laboratories. Med J Aust 5:128–130.
12. Lippi G, Bonelli P, Rossi R, et al.: 2010, Development of a
preanalytical errors recording software. Biochemia Medica
20:90–95.
View publication stats
13. Oosterhuis WP, Ulenkate HJ, Goldschmidt HM: 2000, Evalu-
ation of LabRespond, a new automated validation system for
clinical laboratory test results. Clin Chem 46:1811–1817.
14. Plebani M: 2006, Errors in clinical laboratories or errors in
laboratory medicine? Clin Chem Lab Med 44:750–759.
15. Plebani M: 2010, The detection and prevention of errors in
laboratory medicine. Ann Clin Biochem 47:101–110.
16. Plebani M, Carraro P: 1997, Mistakes in a stat laboratory: types
and frequency. Clin Chem 43:1348–1351.
17. Szecsi PB, Ødum L: 2009, Error tracking in a clinical biochem-
istry laboratory. Clin Chem Lab Med 47:1253–1257.
18. Westgard J: 2000, Why is Quality Planning important? In: Basic
planning for quality, pp. 13–24. Westgard QC, Madison, WI.
19. Westgard J: 2006, Process outcome data. In: Six sigma quality
design and control, 2nd ed., pp. 29–40. Westgard QC, Madison, WI.