evaluation of errors in clinical hematology practice
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How to cite this article: Pavani B, Sri Manvitha V. Evaluation of errors in clinical hematology practice. MedPulse International Journal
of Pathology. October 2017; 4(1): 07-12. https://www.medpulse.in/Pathology/
Original Research Article
Evaluation of errors in clinical hematology practice
Pavani B1, Sri Manvitha V
2*
1Associate Professor, Department of Pathology, Kamineni Academy of Medical Sciences (KAMSRC), L.B. Nagar, Hyderabad, Telangalna
2MBBS 3
rd year, Department of Pathology, Mediciti Institute of Medical sciences (MIMS), Medchal, Telangana.
Email: [email protected]
Abstract Background: Medical laboratory errors are one of the major factors that affect the diagnosis and future clinical course of
management. These errors have a tremendous impact on patient safety and can translate into the risk of adverse events for
patients. Errors still prevail despite automated innovations in the field of laboratory science. Aim: We conducted this
study to evaluate and identify pre-analytical, analytical, and post-analytical laboratory errors with regard to our practice
in clinical hematology and their effect on patient health care. Materials and Methods: A total of 47, 800 samples were
received in to the laboratory from both in patients and out patients between January 2015 to December 2017. Out of
which 22,800 were received from In patients while 25,000 were received from out patients. Results: A total of 1200
errors were detected from the total of 47,800 samples with the error rate of 2.5%.Of all the total errors, pre-analytical
errors were most common, with a frequency of 82%, followed by post-analytical at9.1% and analytical at16.6%.The total
number of errors recorded on inpatient sampleswere1081 out of the 22,800 tests, with an error rate of 4.7%, while the
total number of errors on outpatient samples were 119 out of the 25,000 tests (an error rate of 0.4%). Conclusions: There
is every need for the lab to establish a reliable policy on error recording, possibly through informatics aids and settle
universally agreed “laboratory sentinel events” throughout the total testing process, which would allow gaining important
information about serious incidents and thereby holding both providers and stakeholders accountable for patient safety.
Key Words: Laboratory Errors, Quality control, Quality management system.
*Address for Correspondence:
Dr. Sri ManvithaVallam, H/no 16-11-310/6/2, Saleemnagar colony, Malakpet Extension, Hyderabad, Andhra Pradesh, INDIA.
Email: [email protected]
Received Date: 22/07/2017 Revised Date: 18/08/2017 Accepted Date: 10/09/2017
DOI: https://doi.org/10.26611/105412
INTRODUCTION Medical laboratories play a significant role in the
healthcare system and clinical decision-making.
According to official data, 60–70% of clinical decisions
about hospitalization, discharge, and prescription are
based on laboratory results. According to the
International Organization for Standardization (ISO),
laboratory error sac knowledge as “any defect from
ordering test store porting result switch appropriate
interpretation. A detailed understanding of the steps involved in the total testing process is required to identify
the hierarchy of risks and challenges to be addressed.
Various studies have reported the frequency of errors
ranging from 46% to 68.2% during there-analytical phase.
Complexity of lab testing and increasing automation,
frequently poses problems for clinical laboratories,
clinicians and patients due to lack of constant monitoring
on the overall system non conformities. Despite the low
incidence of errors, among the large number of total
laboratory tests performed all over the labs, there are
important implications for patient safety8,9.Quantification
of adverse events related to laboratory errors is a
challenging and still-little known subject, due to: (i) study
design heterogeneity; (ii) under-reporting in incident
notification systems (many times out of fear); (iii)
difficulty in associating diagnostic errors with adverse
events. According to the requirements of standard
15189:2012 of the International Organization for
Standardization (ISO) - Medical laboratories - particular
requirements for quality and competence -, laboratories
must adopt investigation processes to identify
nonconformities with the procedures or requirements of
their quality system. Such processes must be related to
corrective and preventive actions.7 Last few decades
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MedPulse International Journal of Pathology, Print ISSN: 2550-7605, Volume 4, Issue 1, October 2017 pp 07-12
MedPulse International Journal of Pathology, Print ISSN: 2550-7605, Volume 4, Issue 1, October 2017 Page 8
shows a significant decrease in the rates of analytical
errors in clinical laboratories. Improvements and
advancement sin automation, internal and external quality
control programs, accreditations and laboratory
standardization have greatly reduced the number of
overall analytical errors. The available evidence
demonstrates that the pre- and post-analytical steps of the
to attesting process are more error- prone than the
analytical phase.
MATERIALS AND METHODS An observational cum prospective study was designed to
evaluate laboratory errors during the period between Jan
2013 to Jan 2017. A total of 47, 800 samples were
received to the laboratory from both in patients and out
patients. Out of which 22,800 were received from In
patients while 25,000 were received from out patients.
Though the laboratory comprises of all the main six
disciplines, Clinical Chemistry, Hematology, Blood
Banking, Histopathology, Immunology, Microbiology
and molecular genetics. Data was collected exclusively
from the hematology test samples received from both in-
patient and outpatients. As per the hospital policy,
samples from inpatients were to be collected from
different wards by the phlebotomy technicians and
nursing staff throughout 24 hrs, as per the clinician’s
requirement. Test samples from the out patients were
usually registered between 08:00 am to 10:00 pm only.
Documentation of pre-analytical and analytical errors
during sample processing and post analytical errors
during the report dispatch were meticulously documented
and analyzed by the quality manager and lab director, as
per the ISO 15189: 2012 standard guide lines, with
appropriate root cause analysis. A proforma was designed
to document the non conformities, based on the number
of lab errors encountered.
RESULTS Table 1: Frequency of error variables on in-patient and outpatient samples
Type of Errors In-patient
(%)
Out-patient
(%)
Total number of
individual
variables(IP+OP)
Pre-analytical
Haemolysis Labeling errors / incomplete test request forms from consultants.
Inadequate sample/anticoagulant volume ratio
239 (19%)
71(5%)
10(0.8%)
13(1%)
249
84
Quantity Not Sufficient (QNS)/overfilling. 56(04%) 5(0.4%) 61
In appropriate container 80(06%) 33(7%) 83
Incorrect labeling 200(16%) 2(0.16%) 202
Physician Test request missed 44(3.6%) 6(0.5%) 50
Request slip without sample 40(3.3%) 0 34
Illegible handwriting 96(08%) 2(0.16%) 98
Sample not on ice 28(2.2%) 3(0.25%) 31
Incorrect request voucher
Defective screening MP cards without validation and usage of wrong cards by the
undertrained staff.
Equipment break down
20(1.6%)
7(0.5%)
6(0.5%)
4(0.3%) 33
Total 881 84 965
Analytical Errors
Undetected failure in quality control
Erroneous validation of analytical data
Non-conformity with QC
26(02%) 10(0.8%) 36
Calibration drift 31(2.5%) 5(0.4%) 36
Random error 20(1.6%) 0 20
Probe error
Undetected failure in quality control
Erroneous validation of analytical data
8(0.6%) 10(0.8%) 18
Total 85 25 110
Post-analytical
System input error of the requested test. 20(1.6%) 03(0.25%) 23
Delayed reporting 80(6.6%) 07(0.5%) 87
Wrong delivery of reports to patients.
Lack of patient andtreating physician contact details.
Lack of awareness to retrieve reports from the LIS.Critical result reporting errors.
15(1.25%) 00 15
Total 115 10 125
Copyright © 2017, Medpulse Publishing Corporation,
Phases (Types)
Preanalytical
Phase
Analytical Phase
Post Analytical Phase
A total of 47, 800 samples were received in to the
laboratory from both in patients and out patients between
January 2015 to December 2017. Out of which 22,800
were received from in patients while 25,000 were
received from out patients. A total of 1200 err
detected from the total of 47,800 samples with the error
rate of 2.5%.Of all the total errors, pre-analytical errors
were most common, with a frequency of
by post-analytical at 9% and analytical at
2).The total number of errors recorded on inpatient
Figure 1
Legend
Figure 1: Frequency of Preanalytical errors in laboratory
Postanalytical errors in laboratory
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
In Patients Error
Rate (%)
Out Patients
Error Rate (%)
Total Error Rate
73%
7%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
In Patients Error Rate
Pavani B, Sri Manvitha V
Copyright © 2017, Medpulse Publishing Corporation, MedPulse International Journal of Pathology, Volume 4, Issue 1 October 201
Table 2: Total errors in the laboratory
In Patient Error
Rate (%) Out Patient Error Rate (%)
Total Error Rate
(%)
881 {73%} 84 {7%} 965 {80%}
85 {7%} 25 {2%} 110 {9%}
115 {9.5%} 10 {0.83%} 125 {10.3%}
A total of 47, 800 samples were received in to the
laboratory from both in patients and out patients between
2017. Out of which 22,800
were received from in patients while 25,000 were
received from out patients. A total of 1200 errors were
detected from the total of 47,800 samples with the error
analytical errors
were most common, with a frequency of 80%, followed
% and analytical at 10.3% (Table-
errors recorded on inpatient
samples were 1081 out of the 22,800 tests, with an error
rate of 4.7%, while the total number of errors on
outpatient sampleswere119outofthe 25,000tests (an error
rate of 0.4%). Pre analytical phase errors were mainly
pertaining to sample in adequacy, errors during analytical
phase of sample processing were mainly due to IQC
outliers and calibration drift. Post
due to transcription errors and variation sin turnaround
time (Table 2).
Figure 2
Figure 3
Frequency of Preanalytical errors in laboratory; Figure 2: Frequency of Analytical errors in laboratory; Figure 3:
Total Error Rate
(%)
80%
0%
1%
2%
3%
4%
5%
6%
7%
8%
9%
10%
In Patients Error
Rate (%)
Out Patients Error
Rate (%)
7%
2%
In Patients Error Rate
(%)
Out Patients Error
Rate (%)
Total Error Rate (%)
10%
1%
11%
, Volume 4, Issue 1 October 2017
Total Error Rate
965 {80%}
110 {9%}
125 {10.3%}
samples were 1081 out of the 22,800 tests, with an error
rate of 4.7%, while the total number of errors on
outpatient sampleswere119outofthe 25,000tests (an error
rate of 0.4%). Pre analytical phase errors were mainly
ng to sample in adequacy, errors during analytical
phase of sample processing were mainly due to IQC
outliers and calibration drift. Post-analytical errors were
due to transcription errors and variation sin turnaround
Figure 3: Frequency of
Out Patients Error Total Error Rate
(%)
9%
MedPulse International Journal of Pathology, Print ISSN: 2550-7605, Volume 4, Issue 1, October 2017 pp 07-12
MedPulse International Journal of Pathology, Print ISSN: 2550-7605, Volume 4, Issue 1, October 2017 Page 10
DISCUSSION A laboratory error is defined as “a defect occurring during
any part of the laboratory cycle, commencing from
accession of lab tests to the reporting of final results with
appropriate interpretation. This broad definition has
several advantages and, in particular, it encourages a
patient-centered evaluation of errors within laboratory
medicine. The quality of patient care depends up on
accurate and precise lab test reporting. The negative
feedback information provided by the users on the overall
lab performance must be evaluated and resolved
promptly. Our study revealed total error rate of 2.5%,
which appears to be within acceptable statistical limits
and also highlights the competency of our hospital
laboratory. The major number of errors in this study were
noted within pre-analytic phase and is in accordance with
other previousstudies2,6,7
.The study by Lippiet al.
highlights the frequency of pre-analytic errors up to 70%
which is higher than analytical and post-analytic errors 3.
The pre-analytical errors constituted the highest number
for inpatients than the outpatient category, despite the
total number of outpatient samples constituting the
greatest number. The variable receiving the highest rating
among in patients was specimen hemolysis, constituting
up to 19%. For both inpatients andoutpatients, a total pre
analytical error rate of 80% is reported from our lab.
These errors for inpatient samples were more during the
night shift, an observation similar to that of Akanetal2006
5. There as on attributed for the increased frequency of
haemolysis during night shift, is lack of awareness and
training among the nursing staff and phlebotomists about
sample collection and transportation which itself high
lights the need for training andperiodic competency
assessments. For the outpatients category, pre analytical
error variable associated with highest frequency rating
was that of loading of sample in an inappropriate
container constituting up to 7%,followed by other
miscellaneous group of errors such as sample container
labeling errors and incomplete test request forms from
consultants etc. The consultants were therefore informed
about the need for avoiding incomplete filling up of the
request slip. For both inpatients and outpatients, a total analytical error rate of 9.1% was reported. The variable
receiving the highest frequency rating among in patients
was calibration drift, constituting up to 2.5%. For the
outpatients, the analytical error variable with the highest
frequency rating was QC failure (0.8%). The error
variable associated with sample without request slip was
found to be nil for outpatients. The advancements in
automation, implementation of internal quality control
program and participation in proficiency testing are the
factors which cause reduction of errors during analytical
phase. Our study highlights that most analytic errors were
instrument related, including the malfunctioning of
instruments and calibration drift that resulted in
unacceptable quality control. The laboratories should
ideally draft an SOP on equipment care, operation,
calibration, daily maintenance and corrective action
procedure for managing the QC outliers. Most of the IP
and OP errors (10.3%) within the post-analytic category
were mainly associated with delayed reporting accounting
to 6.6% for IP casesand0.5% for OP cases, which again
led to the increased turnaround time. This particular
aspect was due to unpredictable increases within the
workload and non–availability of adequate staff. The
other related errors were linked to the LIS, e.g. patient
input errors, unrecognized barcodes and lack of
implementation of LIS inallsections, due to which the
results were not transferred via direct interfacing from the
instruments. Root cause analysis of the latter revealed that
periodic function checks and validation of LIS were not
conducted as per the scheduled guidelines. Departmental
sections without interface facility had higher error rate as
compared to the departments with interface facility, since
the review criteria before report release was well placed
in the latter. The second most common error was the
discrepancy between tests marked on the request form
and system entry data of the same. This is important
because missing tests could cause increased TAT and
delay with the patient management. Most of the
discrepancies between the requisition and LIS entry
originated from input error of the requested test,
accounting up to 1.6% for IP samplesand0.25% for OP
samples. Few things such as inappropriate use of
laboratory test results, critical result reporting, and
transmission of correct results are areas of potential error
in the post-analytical phase of the total laboratory testing
process. The other potential reason for post analytical
errors were due to invalid data entry, missing computer
entry of one or more of the tests marked on the request
form and lack of review by the concerned authorities.
Few miscellaneous errors on in patient samples were due
to lack of communication to the treating physicians either
due to non availability of the contact details or
information lapse regarding the exact patient location,
which also led to wrong delivery of the test reports. Lack
of awareness to retrieve reports through hospital
information system also formed an important quality
indicator and in appropriate use of the LIS when the
results were transferred from the instruments to the LIS,
which led to delayedturnaroundtime11. All the above
mentioned miscellaneous post analytical errors
accounting to 15 cases (1.25%) exclusively on IP
samples. For OP reports, the recorded errors were nil
(0%).Therefore an efficient software was strongly
recommended by the lab management to handle the IP
Pavani B, Sri Manvitha V
Copyright © 2017, Medpulse Publishing Corporation, MedPulse International Journal of Pathology, Volume 4, Issue 1 October 2017
post analytical errors thereby including a provision for
better retrieval and display of interfaced test reports and
transmission of critical alerts within the wards. In an article by Plebani
7, the authors give a comprehensive
overview on the ongoing efforts for improving actual
consensus on the definition and notification of laboratory
critical values, and for evaluating their contribution to
improve clinical outcomes and patient safety. The article
also provides some highlights on a valuable experience of
automated notification, which is a reliable tool for
improving the timeliness of communication results are
released to and avoiding potential errors for which
accreditation programs require read-back of the results. Incident Reporting in Laboratory Diagnostics: While
major efforts have been made to monitor the pre-
analytical phase and provide reliable solutions, it is
surprising that concrete formal programs of incident
reporting have not been so pervasive in laboratory
diagnostics. The major focus in health care is placed on
incident reporting for several medical conditions with
lesser effort devoted to translating this noteworthy
practice into laboratory diagnostics. If, in fact, laboratory
errors are being underreported, then current statistics
reveal only a small portion of the medical errors actually
taking place. Some of these sentinel events have already
been identified, including inappropriate test requests and
patient misidentification (pre-analytical phase), use of
wrong assays, severe analytical errors, tests performed on
unsuitable samples, release of lab results in spite of poor
quality controls (analytical phase), and failure to alert
critical values and wrong report destination (post-
analytical phase). The Drafting Group of WHO’s
International Classification for Patient Safety (ICPS) has
also developed a conceptual framework that might also be
suitable for diagnostics errors. Development and
widespread implementation of a Total Quality
Management (TQM) system is the most. Effective
strategy to minimize uncertainty in laboratory
diagnostics. Pragmatically, this can be achieved. Using 3
complementary actions: preventing adverse events (error
prevention), making them visible (error Detection), and
mitigating their adverse consequences when they occur
(error management). A laboratory information
management system (LIMS), sometimes referred to as a
laboratory. Information system (LIS) or laboratory
management system (LMS), is a software-based
laboratory and laboratory system with features that
support a modern laboratory's operations. The features
and uses of a LIMS have evolved over the years from
simple sample tracking to an enterprise resource planning
tool that manages multiple aspects of laboratory
informatics. The definition of a LIMS is somewhat
controversial: LIMSs are dynamic because the
laboratory's. Requirements are rapidly evolving and
different labs often have different needs. Therefore, a
working. Definition of a LIMS ultimately depends on the
interpretation by the individuals or groups involved12
Other methodologies can also be used to prevent errors.
Failure Mode and Effect Analysis (FMEA) has been
broadly cited as reliable approach to risk management. It
is a systematic process for identifying potential process
failures before they occur, with the aim to eliminate them
or minimize the relative risk. Root Cause Analysis (RCA)
is an additional most commonly adopted valuable aid,
since it is based on a retrospective analytical approach.
An RCA focuses on identifying the latent conditions
underlying variation in medical performance and, if
applicable, developing recommendations for
improvements to decrease the likelihood of a similar
incident in future. Risk management is a planned process
that is part of both corrective and preventive actions, and
is related to stability and predictability of results. It is
worth noting that both kinds of action need reports or
notifications that depend on the existence and
implementation of a culture directed to quality care and
patient safety. In a hospital lab with large work load,
negligent attitude of the persons involved in whole
process can cause problems, and therefore, manual entry
of patient data with lab numbers, must be replaced by
electronic entries. Electronic data should be made secure
via password protection. Documentation of the strategies
for evaluation of error detection and risk evaluation must
be adopted to document the errors occurring all the three
phases of sample processing in order to improve the
efficiency of lab. Laboratory errors, besides carrying
deleterious effect on patient overall health, they also
translate into huge amount of financial losses for the
hospital management.
CONCLUSION It is possible to reduce the errors in laboratory medicine
during whole testing process but impossible to completely
eradicate errors. Significant progress has been made since
the release of “To Err is Human.” Basically what has
changed is the willingness to recognize the challenge and
not argue about the numbers, but appreciate care must be
safe always and everywhere for each patient. This has led
to remarkable changes in the culture of health care
organizations, so medical errors can no longer be seen as
inevitable, but as something that can be actively
streamlined and prevented. Sample collection errors may
be prevented via continuous training programs and
competency assessments of the staff The laboratory
professionals must be leaders in ensuring patient safety
both inside and outside the walls of clinical laboratories.
MedPulse International Journal of Pathology, Print ISSN: 2550-7605, Volume 4, Issue 1, October 2017 pp 07-12
MedPulse International Journal of Pathology, Print ISSN: 2550-7605, Volume 4, Issue 1, October 2017 Page 12
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Source of Support: None Declared
Conflict of Interest: None Declared