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CLINICAL DIAGNOSIS THE NEGATIVE CONSEQUENCES OF
DIAGNOSTIC ERRORS IN LABORATORY PRACTICE AND
THE RELEVANCE OF THEIR ELIMINATION
Zamira Madaminova Qodirbergan qizi
Medical laboratory assistant of Cardo star plus
https://doi.org/10.5281/zenodo.16416930
ARTICLE INFO
ABSTRACT
Received: 19
th
July 2025
Accepted: 24
th
July 2025
Online: 25
th
July 2025
One prominent form of medical error and avoidable iatrogenic
injury is diagnostic error, which includes missed, delayed, or
incorrect diagnosis. Diagnostic errors may result from mistakes
made during the laboratory testing procedure. The purpose of
this retrospective study of voluntary event reports was to look
into the types, reasons, and clinical effects of errors—including
diagnostic errors—that occur during clinical laboratory
testing. A number of papers published in the past 20 years have
brought laboratory professionals' attention to the pre- and
post-analytical phases, which currently seem to be more
susceptible to errors than the analytical phase. This is true even
though the frequency of laboratory errors varies greatly,
depending on the study design and steps of the entire testing
process investigated. Specifically, the pre-pre- and post-
analytical phases of the cycle, which are typically outside the
laboratory's control, have been found to have a high incidence
of errors and a risk of errors that could endanger patients. The
International Organization for Standardization's 2008
publication of a Technical Specification was crucial in
gathering data and shifting public perceptions about
laboratory errors by highlighting the necessity of a patient-
centered approach to testing errors. Laboratory testing process
problems frequently result in potential diagnostic errors.
Voluntary incident reports are a useful source for research on
diagnostic error linked to clinical laboratory testing process
errors, despite their tendency to provide insufficient
information on causes and clinical consequences.
KEYWORDS
Laboratory
medicine
iatrogenic
injury,
incorrect
diagnosis,
potential
diagnostic
errors,
diagnostic
process,
diagnostic
testing phase.
Introduction.
Diagnostic errors, which are defined as a diagnosis that was incorrect,
missed, or communicated to the patient with a significant delay, are a frequent source of
iatrogenic injury to patients. According to recent data from the Netherlands, diagnostic errors
were responsible for 40% of serious incidents in hospitals reported to the Dutch Healthcare
Inspectorate and 11% of adverse events that happened in patients who died in the hospital.
Internationally, diagnostic errors are likewise seen as a serious patient safety issue. For
instance, the National Academy of Medicine in the United States came to the conclusion that
most people will encounter a diagnostic error at least once in their lives in their seminal
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report on enhancing diagnosis in healthcare [1,2,3]. In a survey of physicians, Schiff et al.
found that errors occurred most frequently (44%) in the diagnostic testing phase (failure to
order, report, and follow-up laboratory results). Clinical laboratory testing is a major
component of the diagnostic process; up to 80% of medical decisions are influenced by
laboratory data. Diagnostic errors can result from errors in the laboratory testing process. For
instance, Gandhi et al. found that incorrect interpretation of the laboratory test result caused
37% of diagnostic errors in the ambulatory setting that resulted in malpractice claims. There
are no research that have examined diagnostic error as a result of a laboratory testing
procedure error, despite the fact that the effects of errors on patients are widely recognized
from these studies. The development of focused risk management techniques to successfully
raise the safety of diagnostic testing may benefit from this information [4,5,6]. It's critical to
look at potential solutions to help reduce the likelihood of diagnostic errors in order to
protect patients from harm. Priority should be given to identifying the primary failure areas in
the diagnostic process as well as in creating, putting into practice, and testing certain
interventions, as recently indicated in their paper on the present status of research on
diagnostic errors. Numerous data sources, including claims data, obduction data reports on
significant incidents, and voluntary incident reports, can be used for this kind of research.
Compared to other sources, these reports are intriguing because they offer a comprehensive
perspective on the therapeutic process and a glimpse into the aspects of occurrences that
healthcare professionals deem pertinent and that represent circumstances that could escalate
into significant incidents [7,8,9]. Whether the incidences resulted in (possible) diagnostic
mistakes was not particularly examined in those investigations. The results of the first study
were validated by the third study conducted by the same group using data from the British
Columbia Patient Safety and Learning System. We performed a retrospective analysis of
voluntary incident reports in our hospital, a large academic teaching hospital with high
diagnostic testing volume (e.g., approximately 500,000 orders for clinical chemistry testing
annually), in order to better understand diagnostic errors related to errors in the clinical
laboratory testing process. We examined the phases of the testing process, the types of errors,
the causes, the clinical impact, including potential diagnostic errors, and the relationship
between these [10,11,12]..
The main purpose
of this review is to conduct a brief analysis of clinical and diagnostic
laboratory practice for the negative consequences of diagnostic errors and the relevance of
their elimination.
The new finding that laboratory medicine errors
are a subset of a broader problem
known as "diagnostic error" is another step in the direction of a better understanding of the
problem. This finding establishes a clear connection between laboratory-associated errors
and patient safety issues. The old paradigm, which only focused on errors found within
laboratory walls, should change as a result of the current understanding of the nature of
errors associated with laboratory testing, particularly the relationship between appropriate
test ordering and result interpretation/utilization, and their potential to reduce diagnostic
errors. A powerful technique for enhancing quality and lowering the possibility of errors in
the entire testing process is evidence-based quality indicators [1,7,8,11].
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A synopsis of laboratory medicine mistakes throughout history.
Early research only
examined the analytical phase and showed significant frequencies and seriousness of
analytical errors, beginning with the groundbreaking 1947 publication by Belk and
Sunderman and continuing through numerous works before the 1990s. Nevertheless, in spite
of the restricted research design, they offered numerous chances to enhance analytical
performance, such as the creation of external quality assurance programs (EQA) and
enhanced internal quality control (IQC) regulations [1-4]. A substantial amount of evidence
was gathered in the late 1990s that showed: a) a sharp decline in analytical error rates from
162,116 errors per million laboratory tests (parts per million, ppm) to 447 ppm; b) high rates
of errors in the pre- and post-analytical steps; and c) the risk of adverse events and
inappropriate care as a result of laboratory errors, particularly those in the pre-pre-analytical
steps [7,8]. This kind of inaccuracy occurs occasionally and is most likely underreported.
Although not strictly speaking a "analytical error," the inability of various methodologies and
clinical laboratories to be interchanged can potentially confuse clinical reasoning and patient
treatment. This, in turn, is the primary cause of the growing consciousness and worry about
the necessity of laboratory medicine standardization and harmonization initiatives [2,3,6].
Phases before and after analysis.
A series of papers published between 1989 and
2007 brought laboratory professionals' attention to the pre- and post-analytical phases, which
currently seem to be more susceptible to errors than the analytical phase, even though the
frequency of laboratory errors varies greatly depending on the study design and the specific
steps of the total testing process (TTP) investigated. Specifically, two 1997 and 2007 articles
employed a study design that enabled us to examine the majority of TTP stages in the same
clinical setting (stat laboratory) [12,13,14]. The pre-analytic phase in both experiments had
the highest error rate, with the most common issues stemming from incorrect tube filling,
improper specimen containers, and improper requesting processes. Although the study
design did not take into account the appropriateness of the test request, identification errors
were also found. These findings were supported by additional research, and it is currently
estimated that pre-analytical errors—or more precisely, pre-pre-analytical errors—account
for as much as 70% of all errors in laboratory diagnostics. These errors are primarily caused
by issues with patient preparation, sample collection, transportation, analysis preparation,
and storage [7,11,12].
Errors in laboratories and risk control.
The vast majority of laboratory errors offer
significant learning opportunities but have minimal direct effects on patient care from the
perspective of risk management. In actuality, any mistake, no matter how minor it may seem,
could point to flaws in rules and processes that, while they might not result in negative
outcomes in their specific setting, could endanger the patient in somewhat different
situations. Our takeaway is that the system as a whole should be built to account for both the
actual patient harm that was caused and the worst possible clinical consequence in the event
that such a mistake were to occur again [14,15,16]. In order to take remedial and preventative
steps before any adverse event or patient harm may occur, this prompted a patient-centered
examination of laboratory testing errors as well as a greater concern to uncover procedures
and systems' flaws and vulnerabilities. Recent evidence that laboratory medicine errors are a
component of a broader problem known as "diagnostic error" is another step in the direction
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of a better understanding of the problem. This conclusively connects laboratory-associated
errors to patient safety issues [11,14].
Moving toward a patient-centered strategy for errors related to laboratories.
The
old paradigm, which only focused on errors found within the laboratory walls, should change
as a result of the increased awareness of the current nature of errors associated with
laboratory testing, particularly the relationship between appropriateness in test ordering and
result interpretation/utilization, as well as their potential to address diagnostic errors.
Investigating and improving not only the processes and procedures carried out directly under
the clinical laboratory's control, but also the first and last steps of the testing cycle that are
typically overseen by other healthcare professionals, is crucial to putting the idea of "patient-
centered care" from theory to practice. Therefore, projects that seek to enhance both quality
and patient safety must be founded on a comprehensive quality perspective, specifically the
search for valuable quality indicators (Qls) for every stage of the testing process and the
accreditation of clinical laboratory services in accordance with the International Standard.
According to the International Standard, clinical laboratory accreditation specifically requires
the discovery and application of important Qls. According to this paper, quality indicators
"can measure how well an organization meets the needs and requirements of users and the
quality of all operational processes" and "are a measure of the degree to which a set of
inherent characteristics fulfill requirements." [1-9].
Directions for the future.
Although the majority of errors still happen in the
preanalytical stage, we discovered that their influence on the patient outcome was minimal
when compared to earlier estimations. The most detrimental incidents happened during the
analytical and postanalytical stages and were brought on by human factors. We believe that in
order to improve patient safety, these areas of clinical laboratory diagnostics currently
require the greatest focus. In addition to the new classification of laboratory testing process
fault types introduced in this study, hospital volunteer incident report systems can
incorporate classification for cause and clinical impact [13,17,21]. Widespread use would
yield useful information to direct efforts to further improve care quality. In conclusion, this
review demonstrates how AI may help pathologists with several facets of BC diagnosis and
evaluation. Even though AI has shown increased precision, effectiveness, and uniformity in
the field of breast cancer, issues with preanalytical factors, the need for manual annotation,
and the inability to distinguish between certain types of breast lesions still exist. To overcome
these obstacles and fully utilize AI's promise in BC pathology, more study and advancement
are required [19,21,22].
Discussion.
The nature, causes, and clinical implications of errors in clinical laboratory
testing are all clarified by this study. To the best of our knowledge, this is the first study
involving voluntary incident reports on laboratory testing errors that looked at the clinical
ramifications of the error and how it related to the type of error. We discovered that whereas
analytical and postanalytical errors are less common but cause more harm to patients,
preanalytical errors, which are the most common, have comparatively minor effects on
patients. This is hardly a surprising discovery. The test procedure is frequently stopped or
delayed as a result of preanalytical mistakes. Analytical and postanalytical errors are more
difficult to identify and can lead to incorrect diagnostic follow-up and therapy, which can
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seriously injure the patient [4,5,6]. Our research's overarching goal is to reduce patient harm
from diagnostic errors. The current study's findings can help us determine which steps in the
diagnostic process we should concentrate on in order to have the biggest impact. The causes
and effects of errors in laboratory testing are as varied as the errors themselves. One strategy
for preventing these kinds of errors with a systemic approach is to concentrate on the errors
that have the greatest therapeutic impact, namely analytical and postanalytical errors. We
believe that while laboratory tests are highly developed, controlled, and automated, it is
impossible to prevent analytical errors, which are primarily caused by technological faults.
Analytical errors are mainly causes by technical errors. Compared to preanalytical and
analytical errors, postanalytical errors have a greater impact despite having a relatively small
quantity. Postanalytical procedures, particularly test result follow-up, heavily rely on human
behavior at crucial stages [17,18,19]. The danger of failing to follow up on test results has
been recognized as a significant patient safety concern in recent decades. A minimum
requirement is a closed-loop system where test findings are sent to the ordering physician via
the electronic health record. These technologies must, however, assist the doctor in a way that
makes it unlikely that they will overlook a test result or neglect to follow up on it. According to
recent research, patients' health is still seriously threatened by test result follow-up. One of
the causes is the improper application of policies and solutions. This made it difficult to
categorize some of the reports; for instance, most of the reports concentrated on the primary
cause, making it impossible to examine several causes for a given incidence. Additionally, it's
possible that not all laboratory incidents were recorded because incident reporting are
optional. Nonetheless, there is little evidence to suggest that diagnostic errors are
significantly underreported in comparison to other kinds of errors. However, we are unable to
determine the frequency of laboratory errors based on our data [20,21,22].
Conclusion.
Recent data from malpractice claims suggests that, among medical errors
that occur in both inpatients and outpatients, diagnostic errors seem to be the most frequent,
expensive, and harmful. Diagnostic errors and lingering issues with test performance are
largely caused by improper ordering of laboratory tests and improper application of test data.
Thus, based on the groundbreaking idea of the brain-to-brain loop, the primary takeaway is
the necessity of enhancing the quality of laboratory services, preventing mistakes, and
enhancing patient safety while using a global strategy across the TTP. An efficient method for
raising patient safety, lowering mistake risk, and enhancing quality is the application of a
consensus-defined set of evidence-based Qls in clinical laboratory accrediting procedures in
accordance with the current International Standard.
The nature, consequences, and clinical significance of errors in laboratory testing were
better understood thanks to this study. Errors in the analytical and postanalytical phases have
a greater clinical impact, however the majority of errors happen in the preanalytical steps.
Laboratory testing mistakes frequently result in possible diagnostic errors, namely a delay in
the diagnosis procedure. Voluntary event reports must include more thorough and consistent
information, particularly regarding the cause and clinical impact, in order to be an even more
valuable source for investing in the safety of diagnostic tests.
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