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Chapter

Control of Clinical Laboratory

Errors by FMEA Model
Hoda Sabati, Amin Mohsenzadeh and Nooshin Khelghati

Abstract

Patient safety is an aim for clinical applications and is a fundamental principle

of healthcare and quality management. The main global health organizations have
incorporated patient safety in their review of work practices. The data provided by
the medical laboratories have a direct impact on patient safety and a fault in any
of processes such as strategic, operational and support, could affect it. To provide
appreciate and reliable data to the physicians, it is important to emphasize the need
to design risk management plan in the laboratory. Failure Mode and Effect Analysis
(FMEA) is an efficient technique for error detection and reduction. Technical
Committee of the International Organization for Standardization (ISO) licensed a
technical specification for medical laboratories suggesting FMEA as a method for
prospective risk analysis of high-risk processes. FMEA model helps to identify qual-
ity failures, their effects and risks with their reduction/elimination, which depends
on severity, probability and detection. Applying FMEA in clinical approaches can
lead to a significant reduction of the risk priority number (RPN).

Keywords: Patient Safety, Medical Laboratory, Risks, Failure Modes, Processes

1. Introduction

All medical cares, including clinical laboratories, carries an intrinsic risk of errors
that can result in harm, disability, and even death so today their activities have seen
a significant increase in monitoring [1]. In the past, laboratory processes performed
in clinical laboratories focused only on results, while today, they focus on issues
related to reliability, safety and effectiveness. It is very important in health world,
being aware of the error rate attributable to health system that has great impact on
patients [2]. Currently, some strategies are proposed to analyze and to see how you
can decline the rate of preventable errors. In order to guarantee reliable results and
improved data consistency, while operating with reduced funding, laboratories
need to acquire a new culture of management, more tools and specific training [3].
Research management founded on a quality approach is emerging as an essential tool
to ensure valuable, vigorous and dependable consequences, within a framework of
the best practice. Risk management has been disseminated in clinical laboratories
only for the last years, although it has been applied in healthcare since the 80s. That
was partly due to constant inspections during the cycle of laboratory examination,
rework, removal of any defects and adjustment after the identification of possible
causes of flaws or errors. One of the instruments used in risk management is the
analysis of failure modes and effects analysis (FMEA). The FMEA model has been
applied in various medical fields, including clinical laboratory activities to improve

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Contemporary Topics in Patient Safety - Volume 1

patient safety before serious harm to their health. By reducing/eliminating errors,

the FMEA model helps to prevent and control failures and their risks in clinical
approaches [4].

2. Failure mode and effect analysis: background and description

Failure mode and effect analysis (FMEA) which was first developed in the 1940s
is a systematic technique for identifying all possible errors in a system or process.
Adoption of this analysis by National Aeronautics and Space Administration
(NASA) in relation with aerospace missions in mid-1960s made its practical applica-
tion possible. Since then, this analysis has been widely used in diverse industries
such as oil and gas, food and automotive and electronics systems. In recent years
FMEA has been also successfully applied in the health system as an effective tool for
improving patient safety and performance in hospitals. Today, The FMEA is emerg-
ing as a tool for assessing the risk of clinical trial processes and clinical analytical
methods. However, there are still too few reports about this last use and even fewer
data are available on the application of the methodology in clinical laboratories
[5–8]. The risk assessment in this technique involves identification of potential
errors, determining the severity (S), occurrence (O) and effects of each error and
reviewing the control actions implemented to prevent or detect (D) errors [9]
(Figure 1). In the traditional FMEA, to measure these criteria, a numeric scale of 1
to 10 is used (Table 1). Thus, each failure mode is been ranked by a scale called Risk
Priority Number (RPN) characterized by multiplying the numbers of three criteria
(S, O, D) together. Therefore, the higher the RPN value, the more important the
error is and its correction has more priority. So, RPN is so beneficial to identify high
risk failures modes requiring priority functions [10, 11].
Prevention, reducing or excluding of errors and their risk is an essential
requirement in clinical analytical tests which is been established by the laboratory
according to RPN limit. The laboratory decided the assessing scale of frequency, the
severity and errors detection which is being different for each test. There are three
main categories of errors [12, 13]:

I. Critical errors – Mainly through request for analysis, if not identified and
corrected early, have serious consequences for the patient’s health

II. Major errors – resulting from the inappropriate application of the sampling
method

III. Minor errors – considered so, because of the low probability of occurrence,
the high probability of detection or low/absent severity. These errors are
taken into account only with the purpose to review the method and the
technical instruction

Classification of potential errors occurred in the clinical laboratory processes

which are subjected to the samples shown in Table 2 (The following items only
examples of errors and do and does not include all clinical laboratory failure
modes) [14, 15].
In clinical laboratories all errors should be controlled by quality indicators.
To monitor and assess periodically laboratories’ involvement in patients’ care the
implementation of quality indicators is necessary. ISO/TS 22367 supports the
non-conformities, errors and incidents identifying in the clinical laboratory, with
an emphasis on the pre-analytical and post-analytical processes. These processes are

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Control of Clinical Laboratory Errors by FMEA Model
DOI: http://dx.doi.org/10.5772/intechopen.97602

Figure 1.
FMEA elements.

Severity scale (scale 1 [least severe] to 10 [most severe] for each effect)
Minor (1) Low (2,3) Moderate (4-6) High (7,8) Very high (9,10)
The minor Because of Failure can Dissatisfaction This failure affects safety or
nature of this this failure, lead to patient with the nature increases mortality. This may
failure will the patient dissatisfaction, of the failure endanger the patient’s life
not have a experiences which may leads to serious
significant only a minor include disruption
effect on the injury or discomfort or and risk to the
patient or a minor failure patient’s health
the choice of discomfort
treatment
(I)
Probability scale (scale 1 [least frequent] to 10 [most frequent] for the occurrence)
Remote (1) Very low (2) Low (3,4,5) Moderate (6,7) High (8,9) Very high
(10)
Failure is Only a few Isolated failures Occasional minor Failure is often Failure
unlikely; separates have been failures have been encountered is almost
This failure failures have encountered encountered inevitable
was never ever been
observed observed or
reported
(II)
Detection scale for occurrence (scale 1 [always detected] to 10 [never detected] for each occurrence)
Very high High (3,4) Moderate (5,6) Low (7,8) Very low (9) No
(1,2) detection
(10)
It is almost There is a One may detect There is a poor One probably The
certain to good chance the existence of chance of will not detect existence of
detect the of detecting the failure mode detecting the the existence the failure
failure mode the failure existence of the of the failure mode will
mode failure mode mode not or
cannot be
detected
(III)

Table 1.
Failure Modes and Effects Analysis Scale for Severity, Probability, and Detection. (I): Severity score (S): 1 to
10 scales from least to most severe (II) Probability score (P): 1 to 10 scales from least to most probable
(III) Detectability score (D): 1 to 10 scales from most to least detectable.

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Contemporary Topics in Patient Safety - Volume 1

Pre-analytical Analytical Post-analytical

Incorrect identification of Procedural non-conformity Incorrect result

the patient

Mislabeling of samples Errors of equipment or Result sent to a different patient

reagents

Incorrect tube for sampling Discrepancies in the results of Introducing incorrectly the results in
or incorrect storage the internal control the system

Improper or prolonged Delay in analyzing the Lack of information about the limits
transport conditions samples concerning the results’ interpretation

Table 2.
Potential errors occurred in the clinical laboratory processes.

the most critical and the most difficult ones to control due to involving of various
specialists, sections and centers [16]. Clinical laboratory process map is shown in
Figure 2. The processes map together with the risk map can give us an overview of
the failures distribution in each of the processes [3].
Like any analytical method, FMEA should be thoroughly understood prior to
being introduced in laboratory practice. There are five stages in its implementation
which will be explained in more detail in the methodology [17–19].
FMEA assessment resulted in actions to address the root causes, determining the
following situations:

• risk reduction through the development of a preventive action plan to promote

process improvement;

• immediate removal of the risk source when the pieces of equipment were
increased;

• change in the probability of certain risks when the selection process for new
employees was initiated;

• sharing the risk with other staff members when the clinical emergency staff
was involved in the potential problem.

FMEA contributed to quality planning, allowing the evaluation of intercon-

nected activities designed to generate products and assisting in the identification of
controls.

2.1 FMEA in clinical laboratory activities and patient’ safety

Errors in the laboratory activities can lead to consequences in patients’ safety.

That’s why these errors should be identified, controlled and reduced. Effective
patient treatment can be improved by prevention and detection of the errors at the
time of occurrence which in turn ensures the patient’ safety. Currently, the tendency
to move from the traditional technical adopted like internal quality control (IQC)
and external quality assessment (EQA) to risk management is seen in all quality
systems of clinical laboratories. It is conclusive the need for risk management in
clinical laboratories and monitoring them within the quality plan, a fact that would
lead to an increase on patient safety. Studies have revealed that FMEA is useful for
detecting errors and improving patients’ safety and it can yield benefits, for failures
management and general process improvement, within a laboratory system where

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Control of Clinical Laboratory Errors by FMEA Model
DOI: http://dx.doi.org/10.5772/intechopen.97602

Figure 2.
Processes map of clinical laboratory.

time and team input is limited, and within a process that was considered to have few
obstacles [1–4]. Former study showed that FMEA can effectively reduce errors in
clinical chemistry laboratories [20].
Woodhouse et al. showed applying FMEA for identified processes in a hemo-
therapy service, can reduced the possibility of error occurrence and increased the
probability of detection [21]. Momenizadeh et al. concluded that implementing
FMEA can significantly reduce laboratory errors [22]. Molavi-Taleghani et al. argued
that FMEA method is very effective in identifying the possible failure of treatment
procedures, determining the cause of each failure mode, and proposing improve-
ment strategies [23]. Applying the FMEA risk assessment tool to laboratory processes
can increase effectiveness, efficiency and reproducibility of the results [24]. Risk
management in the clinical laboratory by FMEA can decrease the possibility of errors
occurrence and ensures the accuracy of results and patient’s safety. Risk management
guidelines recommended that the clinical laboratories must have a proactive and indi-
vidualized role in reducing the potential errors by developing an appreciate Quality

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Contemporary Topics in Patient Safety - Volume 1

Control Plan (QCP). The laboratories must create their own analytic process to
identify the weakness of each testing stage. As errors and their risks were identified,
the laboratories select the appropriate control processes to detect and to prevent the
occurrence of errors. All errors and control processes are mentioned in the QCP [25].

2.2 FMEA benefits and barriers

The Benefits of implementing FMEA approach in clinical laboratories include

enhancing patients’ safety, improving quality of tests, reducing the chances of
repeating the same failure, cost and time and encouragement for teamwork and
effective communication between functions – collaboration [26]. In comparison
with other quality improvement tools FMEA can be fairly compared, its risk can be
assessed, and a score can be assigned.
FMEA also has some barriers such as limits of human error analysis (traditional
FMEA uses potential equipment/system failures) and missing interactions between
faults and external influences. The reproducibility and generalizability of FMEA in
clinical laboratory approaches are factors of concern but since this method is based
on hypothetical possibilities uncertainty is still likely to remain [27]. Previous study
showed that using FMEA is more time-consuming than other hazard analysis that
identifies failure modes but the improvement potentially obtainable by FMEA in
a clinical laboratory is high, and this fact should suggest further experiences in
this field. Despite the barriers, FMEA represents an appreciate, comprehensive,
and organized approach to known potential patient safety failure modes in clinical
laboratory [28–30]. processes. According to the risk-based thinking introduced by
new ISO 9001:2015 standard, FMEA is an appropriate approach errors analysis of
operational processes under an ISO-certified Quality Management System [31].

3. Methodology

Analytical methodology of FMEA is very effective in maintaining patient safety.

Laboratory staffs trained in FMEA methodology can greatly reduce time require-
ments and guarantee that all activities involved are coordinated increasing the
accuracy of laboratory results [17–19].
The FMEA process including 5 steps as follow:

1. Selecting a process for study;

2. Assembling a multidisciplinary team;

3. Collecting and organizing data about the selected process;

4. Analysis of hazards;

5. Developing and implementing appropriate actions and measuring the

outcomes;

3.1 Selecting a process for study

The intricacy of laboratory processes increases the probability of undesirable

errors. The more steps in the process and the greater their dependency, the greater
the chance of error. In this step the laboratory identifies the critical processes based
on the severity of possible harmful errors and the potentially dangerous impact on
patient safety [17–19].

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Control of Clinical Laboratory Errors by FMEA Model
DOI: http://dx.doi.org/10.5772/intechopen.97602

3.2 Assembling a multidisciplinary team

Gathering specialists with different levels and types of training, with specific
knowledge and experience of the selected process. A team head can lead team
members through the process, and can help ensure that team members complete
each step and record the results of FMEA [17–19].

3.3 Collecting and organizing data about the selected process

In this step the assembled team creates an accurate diagram of potential failure
modes of each listed activity using focus laboratory staff activities and reaching a
common conclusion and recording it on FMEA form (Table 3) [17–19].

3.4 Analysis of hazards

This step including identifying failure modes in each step, determining the
potential effect of each failure mode, ranking the severity of failure mode effects,
ranking the probability and detectability of each failure mode and identifying the
critical failure modes [17–19].

3.5 Developing and implementing appropriate actions and measuring the

outcomes

Identifying the root causes of critical failures is an important step in develop-

ing an appropriate action plan. Traditional root cause analysis methods are used to

Project: Date: FMEA number:

Product: Prepared by: Reference
documents:
System:
Potential consequences/effects of failure

Responsibility And completion date

Potential causes of failure

Current design controls

Recommended actions
Potential failure mode
Component

Probability

Detection
Function

Severity

Critical
System

RPN

Table 3.
FMEA form.

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Contemporary Topics in Patient Safety - Volume 1

determine the underlying cause of each critical failure so that appropriate actions
can be taken. Once the root causes of critical failures have been identified, the team’s
aim is to eliminate the risk of failures, reduce the likelihood of failure or mitigate the
effects of failure should it affect the patient [17–19].

4. Discussion

Clinical laboratories processes tend to errors due to human interactions and

instrumental mistakes. Therefore, it is essential to design plans to make errors
preventable. In the clinical laboratory, most errors are in the pre-analytical phase.
The criteria for risk assessment designing plans for preventive errors were defined in
the laboratory. There is no standard for developing and implementing of these plans
in the laboratory, impediment the comparison between pairs and application of best
practices. Some of the staff laboratory features, namely the ability to think analyti-
cal and simultaneously to establish standard policies and strict adherence to proto-
cols, helped in the prevention of the potential errors. These plans for risk assessment
can help reduce the occurrence of adverse errors. FMEA may become the common
standard for measurement and comparison, particularly in clinical laboratories. In
fact, the total testing process is intricate, consisting of numerous steps that are not
always taken under the control of laboratory experts. Current evidence on the strati-
fication of errors in clinical laboratory strongly supports the introduction of FMEA
for further reducing error rates, particularly in the extra-analytical steps. While the
first aim of FMEA is to promote an approach to ensuring the safety of laboratory
processes, total cost reduction should be simultaneously achieved when considering
the entire process of patient safety [13–16].
Mascia et al. shows that the FMEA risk management approach as applied to
a scientific processes is in line with the current needs of management models to
raise effectiveness and efficiency, to enhance reproducibility, and to facilitate a
rapid industrialization of obtained results [24]. In order to achieve reliable results
in long run of clinical laboratory approaches Momenizadeh et al. suggested that
the managers of the laboratories of Markazi province (Iran) should focus on the
implementation of the FMEA [22]. Sudhakar et al. reported that FMEA is a ben-
eficial technique to decrease quality failures in clinical biochemistry laboratories.
As compared to other prospective risk analysis approaches, FMEA prevent and
solve high risk failure modes in clinical laboratories [32]. Previous study stated
the efficiency of FMEA risk assessment to detect and to adjust the quality control
procedures in order to improve the analytical performance of clinical chemistry
laboratories [33].
In all clinical laboratories a risk assessment approach is required according to ISO
17025:2017 standard dedicated to laboratories measurement, in order to improve
uncertainty and thus the reliability and reproducibility of results. Performing
FMEA to processes in the laboratory facilitates evaluation high-risk processes tend
to failure before an error happen. By assuming and compensating for less-than-per-
fect human performance, FMEA promotes error prevention through identification
of valuable and consensually accepted quality indicators in all steps of the testing
process [34].

5. Conclusion

Clinical laboratories are inseparable part of health care system as they help
in appropriate diagnosis of patient’s health. Their working process is a complex

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Control of Clinical Laboratory Errors by FMEA Model
DOI: http://dx.doi.org/10.5772/intechopen.97602

procedure which may associate with certain errors. Improvement of the patients’
safety by reducing the errors and their risks in clinical laboratories is a great chal-
lenge. High-quality clinical laboratories ensure that they perform standard tasks,
monitor, and improve their performance, creating a culture of transparency,
defining responsibilities, and optimizing patients’ safety. FMEA is very effective
and successful technique in preventing errors, improving quality and safety of
tests, identifying potential errors, and prioritizing clinical laboratory improvement
strategies. FMEA had a multidisciplinary approach and its complex configuration
processes involvement facilitated the management of errors. As compared to other
prospective risk analysis methods, FMEA analysis provides a good solution for
high risk failure modes in clinical laboratories. Therefore, FMEA is a suitable and
efficient tool to identify most clinical laboratory errors to improving the quality of
laboratory processes and ensuring the accuracy of obtained results and maintaining
patient health and safety. The overall purpose of this paper is to encourage clinical
laboratories to assess and monitor their own. In addition, it should be possible to
identify and monitor error rates to improve upon the process on the basis of objec-
tive and desirable quality specifications.

Conflict of interests

The authors declare that they have no conflicts of interest.

Author contributions

All authors contributed equally to this manuscript, and approved the final
version of manuscripts.

Ethical declarations

Not applicable.

Financial support

None to be declared.

9
Contemporary Topics in Patient Safety - Volume 1

Author details

Hoda Sabati1*, Amin Mohsenzadeh2 and Nooshin Khelghati3

1 Faculty of Science, Biotechnology and Biological Science Research Center, Shahid

Chamran University of Ahvaz, Ahvaz, Iran

2 Faculty of Science, Department of Microbiology, Ardabil Branch, Islamic Azad

University, Ardabil, Iran

3 Faculty of Science, Department of Chemistry, Shahid Chamran University of

Ahvaz, Ahvaz, Iran

*Address all correspondence to: h.sabati@yahoo.com

© 2021 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms
of the Creative Commons Attribution License (http://creativecommons.org/licenses/
by/3.0), which permits unrestricted use, distribution, and reproduction in any medium,
provided the original work is properly cited.

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Control of Clinical Laboratory Errors by FMEA Model
DOI: http://dx.doi.org/10.5772/intechopen.97602

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Control of Clinical Laboratory Errors by FMEA Model
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