Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 49
April - June 2024 e-ISSN 2550-6862. pp 34-49
DOI https://doi.org/10.31876/er.v8i49.863
Prevention and control of adverse events in the clinical
laboratory process: A literature review
Prevención y control de eventos adversos en el proceso de laboratorio
clínico: Una Revisión Bibliográfica
Luis Alberto León Bajaña*
Carlos Aarón Cevallos Valencia*
Roddy Wladimir Quimis Merchán*
Received: January 23, 2024
Approved: March 30, 2024
Abstract
This is the result of the research project Prevention and control of
adverse events in the clinical laboratory process at the León Becerra
Hospital in Guayaquil, corresponding to the Higher Technology
course in On-Site Clinical Laboratory of the Instituto Superior
Tecnológico Espíritu Santo. The prevention and control of adverse
events in the clinical laboratory process is essential to ensure quality
and safety in the analysis of samples and results. This process
involves a series of measures from the reception of the sample to
the issuance of the final report. Accurate patient and sample
identification, proper labeling, transport and storage are critical
steps to avoid errors. In addition, rigorous quality control protocols
must be followed at all stages, including equipment maintenance
and calibration, as well as ongoing staff training.
Keywords:
Prevention, Control, Adverse Events, Clinical Laboratory,
Quality, Safety
* Master's Degree, Instituto Superior
Tecnológico Universitario Espíritu Santos,
ealvarado2@tes.edu.ec,
https://orcid.org/0009-0005-5448-2126
* Master's Degree, Instituto Superior
Tecnológico Universitario Espíritu Santos,
cacevallos3@tes.edu.ec,
https://orcid.org/0009-0001-5918-5404
* Master's Degree, Instituto Superior
Tecnológico Universitario Espíritu Santos,
rwquimis@tes.edu.ec, https://orcid.org/0000-
0002-9809-365X
León, L., Cevallos, C., Quimis, R.
(2024) Prevención y control de
eventos adversos en el proceso de
laboratorio clínico: Una Revisión
Bibliográfica. Espirales Revista
Multidisciplinaria de investigación
científica, 8 (49), 34-49
Luis Alberto León Bajaña, Carlos Aarón Cevallos Valencia, Roddy Wladimir Quimis Merchán
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 49
April - June 2024 e-ISSN 2550-6862. pp 34-49
35
Introduction
The clinical laboratory process plays a critical role in the diagnosis, treatment and
monitoring of disease. However, as in any area of healthcare, this process is subject to
the possibility of adverse events that can compromise the accuracy of results and,
ultimately, patient safety and well-being. Therefore, the prevention and control of these
adverse events are critical aspects of ensuring the quality and reliability of clinical
laboratory services.
The interest in this topic lies in its direct impact on medical care and in the improvement
of quality standards in clinical laboratory services. Although there are numerous studies
and protocols dedicated to risk management in the healthcare setting, specific aspects
related to the prevention and control of adverse events in the clinical laboratory have
not yet been comprehensively addressed.
Although previous work has been done on the subject, many of them have failed to
clarify certain key aspects, leaving significant gaps in the understanding of how to
effectively prevent and manage these adverse events within the clinical laboratory
setting. However, the studies that have addressed the topic have looked at several
specific aspects or at particular types of adverse events, which limits their applicability
and generalizability to other contexts. Among these, only sample identification errors
are mentioned, while others have focused on problems related to the quality of reagents
or laboratory equipment. However, the complexity of the clinical laboratory process
requires a more holistic approach that addresses a wide range of contributing factors
and potential failure points.
The main objective of this study is to investigate the various factors that contribute to
the occurrence of adverse events in the clinical laboratory process, as well as to mention
Resumen
Se presenta un resultado del proyecto de investigación Prevención
y control de eventos adversos en el proceso de laboratorio clínico
en el Hospital León Becerra de Guayaquil, correspondiente a la
carrera de Tecnología Superior en Laboratorio Clínico Presencial,
del Instituto Superior Tecnológico Espíritu Santo. La prevención y
control de eventos adversos en el proceso de laboratorio clínico es
fundamental para garantizar la calidad y seguridad en el análisis de
muestras y resultados. Este proceso implica una serie de medidas
desde la recepción de la muestra hasta la emisión del informe final.
La identificación precisa del paciente y la muestra, el adecuado
etiquetado, transporte y almacenamiento son pasos críticos para
evitar errores. Además, se deben seguir protocolos rigurosos de
control de calidad en todas las etapas, incluyendo el mantenimiento
y calibración de equipos, así como la capacitación constante del
personal.
Palabras clave:
Prevención, Control, Eventos adversos, Laboratorio
Clínico, Calidad, Seguridad
Prevention and control of adverse events in the clinical laboratory process: A literature review.
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 49
April - June 2024 e-ISSN 2550-6862. pp 34-49
36
effective prevention and control strategies. By addressing these issues, we seek to
improve the safety, quality, and efficiency of clinical laboratory services, which in turn
can have a positive impact on overall medical care and public health.
Materials and methods
The research was based on a qualitative approach because it collected, analyzed and
synthesized relevant information from various literature sources. This approach was
fundamental to obtain a comprehensive understanding of the topic by critically
examining the existing literature.
The research is of the documentary type as it refers to a theoretical framework which,
according to Bernal (2010) "is a constitutive aspect of all scientific research, whose basic
function is to serve as a theoretical basis for scientific research" Page 110, in this case,
the prevention and control of adverse events in the clinical laboratory process.
Techniques such as the review of bibliographic documents and theoretical methods such
as analysis and synthesis, historical logic and induction and deduction were used.
In terms of population and sample, the population consisted of all relevant literature on
the importance of the preanalytical phase in the clinical laboratory, for which 68 articles
were considered. The sample consisted of the specific literature sources selected for
article development. This ensured that a wide range of perspectives and opinions on
the topic were considered.
Interventions in this type of research included appropriate selection of literature sources,
critical review of texts, extraction of relevant information, and synthesis of findings to
respond to the research objectives. The research instruments included systematic
literature search using academic databases and selection of relevant sources addressing
the importance of the preanalytical phase in the clinical laboratory.
Results
Sources used in the documentary research on the importance of the preanalytical phase
in the clinical laboratory included:
• Academic articles, published in Acta Médica.
• Specialized books such as "Good Laboratory Practices (GLP)" by Baggini, S. (2022).
• Master's research papers
• Technical reports
• Scientific journal articles,
• Opinion articles, published in the Journal of Clinical Pathology.
• Specialized magazines,
• Scientific papers from preclinical trials
The analysis of the sources was able to identify the theoretical background, theoretical
foundations and a legal framework, which constitute the main result of this article.
Based on the working conditions in clinical diagnostic laboratories, where it is intended
to process biological samples, different types of errors are likely to occur, which may
Luis Alberto León Bajaña, Carlos Aarón Cevallos Valencia, Roddy Wladimir Quimis Merchán
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 49
April - June 2024 e-ISSN 2550-6862. pp 34-49
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lead to adverse events; an adverse event in the clinical laboratory includes situations
that may compromise the patient's life. The authors van Moll et al., (2023)examined 327
reports allowing to analyze in which phase of the testing process the error occurred,
showing that 77.1% of the errors occurred in the pre-analytical phase, 13.5% in the
analytical phase and 8.0% in the post-analytical phase (1.5% undetermined). In another
study by Ballesteros & Trunzo, (2021) detected a total of 818 pre-analytical errors, of
which 42% corresponded to coagulated samples, 25% to hemolyzed samples, 23% to
inadequate sample volume, 4% to poorly marked samples, 3% to unmarked samples,
2% to samples in inadequate containers and 1% to other causes (such as tube breakage
in the centrifuge or failure of the sample to arrive).
According to the authors Pilco et al., (2023) an event can occur at any stage of the
laboratory process, these errors being categorized according to their cause, phase of
the process in which they occur, responsibility and impact on the patient. However, he
mentions that most accidents occur in the preanalytical and postanalytical phase due to
the lack of control that still persists in laboratories at these stages, since almost 70% of
these incidents do not directly affect the patient and the remaining ones are due to
other factors. On the other hand, Plebani et al, Plebani et al., (2021) mentions that the
results of a laboratory influence up to 75% in the medical diagnosis, therefore it is
necessary to maintain a rigorous quality control at all stages of the laboratory process to
ensure the reliability and accuracy of the results. (Jara & Batista, 2023)..
Likewise, the authors. Wang & Ho, (2018) in their study determined a total of 187
incidents in a span10 months, which is equivalent to an error detection rate of 0.26%.
The distribution of these incidents was as follows: 17% pre-analytical incidents, 25%
analytical incidents and 59% post-analytical incidents. On the other hand Vélez et al.,
(2023) argue that the incidence of errors, also influenced by data transcription, varies
between 3% and 39%, with an average of 13% in some laboratories. These errors can
be of various kinds, either due to lack of accurate or diagnostic information.
Likewise, Hidalgo et al., (2022) also consider among the factors to be considered the
frequency of incorrect identification of patients or samples, inadequate sample
collection and insufficient quantity and quality of samples. Also, the presence of
interferences in the samples should be taken into account, which significantly affect the
accuracy of the results and, therefore, their interpretation and clinical application.
In another research work carried out by Cespedes et al., (2019) In a retrospective and
longitudinal experimental study in the Clinical Laboratory of the Hospital Oncológico
Docente Provincial Conrado Benítez García in Santiago de Cuba, with the aim of
analyzing the accuracy of analytical procedures by determining the total error and the
six sigma metric. The results showed a satisfactory performance in gamma-glutamyl
transferase and alanine aminotransferase measurements, while glycemia and cholesterol
showed an inferior performance, which guarantees the reliability of the results in the
clinical laboratory and, therefore, the quality of the medical care provided to patients.
On the other hand, Lloacana et al., (2023) conducted a study with the objective of
examining how patient safety is implemented and contributed to in clinical laboratories
Prevention and control of adverse events in the clinical laboratory process: A literature review.
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 49
April - June 2024 e-ISSN 2550-6862. pp 34-49
38
in Latin America. The results of this research highlighted a notable lack of knowledge on
the part of healthcare personnel about the criteria related to patient safety. The authors
found that crucial aspects such as patient and specimen identification, as well as
specimen transport and collection, along with equipment calibrations and maintenance
during the analytical phase, and timely reporting of results in the post-analytical phase,
were critical areas.
In Ecuador there have been few studies related to patient safety in the clinical laboratory
process, the types of errors that occur in the phases of the clinical laboratory process
and the evaluation and control of these errors. The studies found during the
bibliographic review are generally developed by researchers in the administrative area
and are more oriented to the measurement of quality in the clinical laboratory process:
Ortiz, (2022) conducted an investigation in the clinical laboratory with the purpose of
reducing errors that may affect the diagnosis of patients. The analysis was carried out at
the IESS Ambato Hospital, where the current situation of the pre-analytical phase of the
laboratory process was evaluated, especially in terms of the amount of waste generated
by defects, which serves as an indicator of the quality of the service offered to the
institution's affiliates. It was identified that the critical processes were concentrated in
reception and extraction during the pre-analytical phase, with metrics of 2.91 and 4.1
sigmas, respectively. This resulted in the generation of 6583 errors per million
opportunities of biological samples analyzed, with consequent economic losses for the
hospital.
On the other hand, Matute et al., (2022) conducted a study with the aim of providing
clinical laboratory professionals with evidence on adverse events and how to prevent
them in order to improve patient safety. As a result of this research, the main risk factors
occurring in the different phases of the clinical laboratory were identified in a general
way. In addition, a culture of patient safety was promoted among clinical laboratory
professionals and a decrease in the variability in clinical practice among the different
procedures applied by these professionals in the laboratories was achieved.
Adverse event
An adverse event refers to an undesirable or harmful outcome that arises as a direct or
indirect consequence of the medical care a patient receives. These events can be caused
by a variety of factors, such as medical errors, failures in the health care system, adverse
drug reactions, nosocomial (hospital-acquired) infections, among others. The
identification, analysis and prevention of adverse events are essential to improve the
quality and safety of health care (Hernandez et al., 2019).
Health systems usually implement specific protocols and procedures to detect, report,
investigate and prevent the occurrence of these adverse events. First, screening systems
are established to identify potential adverse events by thoroughly reviewing medical
records, analyzing reported incidents and evaluating clinical outcomes. Then, a culture
of reporting is fostered among medical staff to report any adverse incidents observed
(Lima et al., 2019).
Luis Alberto León Bajaña, Carlos Aarón Cevallos Valencia, Roddy Wladimir Quimis Merchán
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Once reported, a thorough investigation is conducted to understand the underlying
causes and determine preventive actions, these measures may include changes in
treatment protocols, improvements in staff training, and modifications to data recording
systems (Mucito, 2020). Finally, ongoing monitoring is performed to evaluate the
effectiveness of the implemented preventive measures and adjust protocols as needed,
thus ensuring constant improvement in patient safety (Severinsson et al., 2019)..
Adverse events in the clinical laboratory are undesirable situations that can arise during
the processing and analysis of biological samples, compromising the quality and
accuracy of the results (San Miguel et al., 2018). These events can occur at different
stages of the process, including pre-analytical, analytical and post-analytical (Hermosa
et al., 2023)..
The pre-analytical stage in the clinical laboratory encompasses all activities that take
place before the analysis of biological samples is performed. During this crucial phase,
processes such as accurate patient identification, proper sample collection, transport
and handling, as well as correct recording of associated information are carried out.
However, this stage is also susceptible to a number of adverse events that can
compromise the integrity of the results (Briones & Cantos, 2019)
For example, errors in patient identification can result in incorrect assignment of test
results, which could lead to misdiagnosis and mistreatment. Also, improper specimen
collection, such as contamination during extraction or the use of inappropriate collection
tubes, can lead to unrepresentative or inaccurate results. In addition, incorrect or
incomplete labeling of samples can lead to confusion and difficulties in traceability,
increasing the risk of errors in the interpretation of results (Baggini, 2022).
The analytical stage in the clinical laboratory involves the processing and analysis of
biological samples collected during the pre-analytical phase. During this process, the
samples are subjected to a series of tests and analyses to detect the presence of certain
substances, cells or microorganisms, among other elements of clinical interest(Garcia,
2021). However, this stage is also subject to adverse events that can compromise the
accuracy and reliability of the results (Santiago et al., 2021).
For example, errors in the calibration or maintenance of laboratory equipment can lead
to incorrect or inaccurate measurements. Likewise, contamination of samples or
reagents used in the analysis can introduce interferences and affect the accuracy of the
results. In addition, improper handling of samples or failure to follow standardized
procedures can generate erroneous results (Gonzales, 2021).
While the post-analytical stage in the clinical laboratory comprises all activities that take
place after the analysis of biological samples has been completed. During this phase,
test results are reviewed, interpreted and communicated to the clinical staff and
ultimately to the patient. However, as with the preanalytical and analytical stages, the
postanalytical stage can also be susceptible to adverse events that can affect the
accuracy and reliability of the results (Orth et al., 2019).
Prevention and control of adverse events in the clinical laboratory process: A literature review.
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 49
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For example, errors in transcription of test results can lead to incorrect or misinterpreted
reports, which could influence clinical and therapeutic decisions. In addition, inadequate
communication of results between the laboratory and clinical staff may result in delays
in treatment or failure to adequately follow up on certain medical conditions. Likewise,
lack of follow-up or inadequate documentation of results can compromise continuity of
care and patient health monitoring (Dávila & Parrales, 2023)..
Other adverse events during the laboratory process are failures in quality control in the
clinical laboratory are situations in which the processes and procedures designed to
ensure the accuracy and reliability of the results do not meet the established standards.
(Macias, 2023). These failures can occur at various stages of the analytical process and
can have various causes. For example, they may arise due to problems with the
calibration or maintenance of laboratory equipment, errors in the preparation or storage
of reagents, failures in the execution of internal and external quality controls, or
deficiencies in the training or supervision of technical personnel (Alonso, 2021).
These failures can have significant consequences, such as the generation of inaccurate
or unreliable results, which can lead to misdiagnosis, inappropriate treatment, or delays
in appropriate medical care for patients. Therefore, it is crucial that clinical laboratories
establish and maintain robust quality control systems, including regular internal and
external monitoring, ongoing staff training, periodic review of standard operating
procedures, and taking corrective and preventive action in response to any identified
deviations or incidents.
Likewise included are problems with information systems in the clinical laboratory
represent a significant concern that can have a direct impact on the quality and safety
of medical care (Barba, 2019). Failures in data recording or storage can lead to loss of
critical information or corruption of files, compromising the integrity of records and
traceability of results. In addition, errors in electronic transmission of results can disrupt
seamless communication between the laboratory and other electronic medical record
systems, hindering coordination and continuity of patient care.
Quality of care and patient safety in the clinical laboratory process, in adverse events
in the pre-analytical phase.
In this regard, the following concepts should be taken into account
• Quality control: Refers to actions aimed at ensuring that a product or service meets
the standards necessary to satisfy the needs of users. The ultimate goal is to provide
optimal, adequate, safe and cost-effective quality. (Benozzi, 2022).
• Quality assessment: These are actions aimed at ensuring that quality control
activities are carried out effectively, which implies a constant evaluation of the
processes and the results or products obtained. (Benozzi, 2022).
• Patient safety: Defined as the absence of unnecessary harm, whether actual or
potential, related to medical care. Errors in health care delivery have consequences
Luis Alberto León Bajaña, Carlos Aarón Cevallos Valencia, Roddy Wladimir Quimis Merchán
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for patients and their families as well as for healthcare organizations and society as
a whole (Lopez et al., 2020).
For a long time, it has been thought that, in the clinical laboratory setting, quality control
and quality assessment were limited to the analysis of control samples along with patient
samples, however, over time, the broader concept of quality assurance or quality
guarantee has been developed and adopted. (Lopez et al., 2020).
In general terms, quality assurance is the set of activities designed to assure the user
that the product meets the established quality standards, this process comprises two
main activities: quality control and quality assessment. (Panunzio et al., 2022)..
Therefore, its purpose is to prevent and control errors that occur from the moment the
physician requests the test until the result is interpreted.
This includes any error that may occur from the time the physician issues the order for
analysis until the result is analyzed and interpreted, encompassing both the analytical
process and additional aspects outside this process (Ospina et al., 2023).. Quality
management refers to the coordinated activities aimed at directing and controlling an
organization with regard to quality, where analytical, extra-analytical, management and
support processes are clearly identified, as well as their responsible parties (Cazarré et
al., 2020)..
Quality presents a different conceptualization according to each type of customer, for
the external (consumer of the final product) it can be the offer of a product or service
and will be measured according to the functionality and efficiency with which it has been
delivered, while, for the internal, that is, an operator, quality will be to comply with the
activities aligned to the business objectives and, within the same line, for a production
manager, it will be to maintain and improve the business productivity through indicators
(Diaz, 2019; Osorio, 2019)..
Quality of care and patient safety in the clinical laboratory process, especially with regard
to adverse events in the preanalytical phase, are critical aspects to ensure accurate and
reliable results in diagnosis and medical treatment (Madrid & Hernández, 2022). The
preanalytical phase spans from the request for the test to the preparation of the
specimen for analysis in the laboratory. During this phase, a variety of errors can occur
that affect the quality of the samples and, therefore, the reliability of the results (Huyhua
et al., 2023)..
This includes inadequate patient identification, which is a fundamental aspect in the
clinical laboratory process, especially during the preanalytical phase, this process ranges
from the request for tests to the collection and labeling of samples. (Cedeño et al.,
2021).. Inadequate patient identification can result in a number of errors that affect the
quality of test results and, ultimately, patient safety and well-being (Lino et al., 2023)..
Errors in identification can arise due to a variety of factors, such as similarity of names,
lack of communication between clinical and laboratory staff, or the absence of robust
identification protocols. These errors can have serious consequences, such as incorrect
Prevention and control of adverse events in the clinical laboratory process: A literature review.
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 49
April - June 2024 e-ISSN 2550-6862. pp 34-49
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sampling, misassignment of test results, delays in appropriate treatment, and even loss
of patient confidence in the health care system (Miño et al., 2022)..
Likewise, the erroneous assignment of results in the clinical laboratory process, as a
consequence of inadequate patient identification, represents a significant risk to the
quality of medical care. This error occurs when test specimens are not correctly labeled
due to errors in patient identification, which can have several negative repercussions
(Dávila & Parrales, 2023)..
When test results are incorrectly attributed to a patient, there is a risk of misdiagnosis or
inappropriate treatment. This scenario can compromise the patient's health and affect
their medical prognosis. They can also cause delays in proper medical care, as additional
time will be needed to correct the error and provide the correct results to the correct
patient (Villalta et al., 2019)
Another of the errors or adverse events is the quality of the sample in the preanalytical
process of the clinical laboratory is essential to obtain accurate and reliable results in the
analysis. When a poor quality sample is submitted, i.e., a sample that does not meet the
required standards, a series of problems can arise that affect the validity of results (Soto
& Sáez, 2022)..
One of the main consequences of a poor quality sample is the possibility of errors in the
analysis. This may be due to the presence of interfering substances, such as hemolysis,
coagulation or contaminants, which alter the measured values and lead to incorrect
interpretations of the results (Brun et al., 2021). This situation can lead to misdiagnosis
by medical personnel, resulting in inappropriate treatments or lack of treatment for a
real medical condition (Acosta et al., 2023)..
In addition, the need for repeat testing due to poor quality samples can lead to delays
in proper diagnosis and treatment. This implies an additional expenditure of resources
and time for both the patient and the laboratory staff, which can negatively affect the
efficiency of the health care system and increase the economic burden for the patient or
the health care system in general (O'Hara et al., 2020)..
Incorrect sample mislabeling in the clinical laboratory process is a problem that can have
serious consequences for the quality and safety of medical care (Carral, 2021). This error
occurs when test specimens are not correctly identified with patient information, which
can result in a number of problems: First, incorrect labeling can lead to misassignment
of test results. When samples are not labeled correctly, there is a risk that results will be
incorrectly associated with the wrong patient, which can result in misdiagnosis and
inappropriate treatment (Jorna et al., 2021)..
In addition, mislabeling can cause confusion in the handling of specimens in the
laboratory. If specimens are not clearly identified, laboratory personnel may have
difficulty tracking and processing specimens properly, which can lead to delays in
obtaining results and in patient care (Trujillo et al., 2020).. Another important
consequence of mislabeling is the loss of sample traceability; without proper
identification, it may be difficult or impossible to trace the origin of a sample, making it
Luis Alberto León Bajaña, Carlos Aarón Cevallos Valencia, Roddy Wladimir Quimis Merchán
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 49
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difficult to identify potential problems or errors in the analysis process (Gomez et al.,
2020)..
Lack of staff training in the clinical laboratory process can be a significant factor
contributing to a variety of problems, including preanalytical errors and patient safety
risks. First, lack of training can result in improper sample collection techniques. For
example, untrained personnel may not follow standard procedures for venipuncture,
which can lead to bruising, hemolysis, or other complications that affect sample quality
(Suardíaz et al., 2022)..
In addition, untrained personnel may not be aware of the importance of critical factors
in the pre-analytical phase, such as proper patient identification and correct labeling of
samples. This can result in identification errors that affect the accuracy of analysis results
and jeopardize patient safety (Mera & Lino, 2022).. It can also result in a lack of
knowledge about the proper interpretation of laboratory results. Staff may not fully
understand reference ranges and the clinical implications of abnormal results, which can
lead to incorrect medical decisions or lack of proper follow-up (Baltazar, 2023).
Poor communication between clinical staff and laboratory personnel in the health care
setting can have a significant impact on the quality and safety of the clinical laboratory
process (Gondres et al., 2022).. First, poor communication can lead to
misunderstandings about test orders. If the information provided by clinical staff is not
clear or accurate, there is a risk that incorrect tests will be ordered or relevant information
will be omitted, which can affect the quality of test results (Mucito & Sanchez, 2020).
In addition, lack of communication can lead to delays in specimen processing. If clinical
staff do not provide timely information about specimens to be sent to the laboratory,
this can lead to delays in specimen collection and processing, which in turn can delay
patient diagnosis and treatment (Marrero et al., 2022).. Poor communication can also
make it difficult to resolve problems and manage emergency situations. If unexpected
problems arise during the testing process, such as unidentified samples or samples of
poor quality, effective communication between clinical and laboratory staff is critical to
quickly address the situation and take appropriate action to resolve the issue (Guevara
et al., 2022)..
Prevention and control of adverse events in the clinical laboratory process.
The prevention and control of adverse events in the clinical laboratory process is of
utmost importance to ensure patient safety and integrity of results. Some of the quality
standards in the context of a clinical laboratory:
• ISO 15189: The international standard for clinical laboratories. It defines the general
requirements for technical competence, quality management and service quality that
clinical laboratories must meet to demonstrate that they operate competently and
can generate valid and reliable results. (Alvarez, 2022).
• Laboratory accreditation: Many countries have specific accreditation systems for
clinical laboratories. These accreditation programs evaluate the technical
Prevention and control of adverse events in the clinical laboratory process: A literature review.
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competence and quality of the services offered by the laboratory, and certify
compliance with recognized standards (Carboni & Sáenz, 2019)..
• Regulatory compliance: Clinical laboratories must comply with applicable national
and international regulations and standards, which may include requirements related
to patient safety, waste management, data privacy, and other areas. (Laz & Lino,
2022)..
• Quality management: The implementation of a quality management system based
on principles such as process approach, continuous improvement and staff
involvement is essential to maintain and improve quality in all areas of the laboratory.
(Viteri et al., 2023)..
• Internal and external quality control: Internal and external quality control programs
are essential to monitor and ensure the accuracy and precision of laboratory results.
This involves the use of quality control materials, participation in proficiency testing
programs, and regular comparison of results with other laboratories (Viteri et al.,
2023)..
• Validation and verification of analytical methods: Before implementing a new
analytical method, it is crucial to validate and verify its performance to ensure its
reliability and precision under specific laboratory conditions. (Mendoza et al., 2023).
• Personnel training and competence: Ensuring that laboratory personnel are
adequately trained and competent in their functions is essential to maintain quality
at all stages of the analytical process (Mendoza et al., 2023). (Mendoza et al., 2023).
In Ecuador, clinical laboratory quality standards are regulated and supervised mainly by
the Agency for Quality Assurance of Health Services and Prepaid Medicine (ACESS),
as well as by the Ministry of Public Health (MSP). Although specific standards may
vary, here are some relevant regulations and norms in Ecuador:
• Ecuadorian Technical Regulation: This regulation establishes the general
requirements for the quality and competence of clinical laboratories, based on the
ISO 15189:2022 standard (Curillo, 2022). (Curillo, 2022).
• Laboratory accreditation: In Ecuador, there are accreditation and certification
programs for clinical laboratories, such as the Ecuadorian Accreditation System (SEA)
and the National Health Laboratory Accreditation System (SINACAL). These systems
evaluate the technical competence and quality of services offered by clinical
laboratories (Curillo, 2022). (Curillo, 2022)..
• Ministry of Public Health (MOH) Regulations: The MOH issues regulations and
guidelines related to the quality and safety of health services in general, including
clinical laboratories. These regulations may include specific requirements on quality
management, quality control, patient safety, and data privacy (Pasquel & Burgos,
2020).
• Waste management: There are specific regulations on the proper management of
waste generated in clinical laboratories, ensuring its treatment and safe disposal to
prevent negative impacts on human health and the environment (Gonzales, 2021).
(Gonzales, 2021)..
• Biosafety regulations: The MOH establishes regulations related to biosafety in clinical
laboratories to prevent exposure to pathogenic biological agents and ensure a safe
Luis Alberto León Bajaña, Carlos Aarón Cevallos Valencia, Roddy Wladimir Quimis Merchán
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45
working environment for laboratory personnel and patients (Baggini, 2022). (Baggini,
2022).
Ecuador can adopt globally recognized standards that address quality, safety and risk
management in the field of health and, therefore, in laboratory services. These
international standards can come from organizations such as the World Health
Organization (WHO) and the International Organization for Standardization (ISO),
among others. For example, ISO 15189:2022 establishes specific requirements for the
quality and technical competence of clinical laboratories, covering aspects such as
quality management, personnel competence, method validation, internal and external
quality control, as well as document and record management (Cedeño et al., 2021)..
Biosafety regulations are a fundamental part of laboratory management, as they are
designed to protect both laboratory workers and the general public from the risks
associated with the handling of hazardous biological and chemical agents (Arias et al.,
2021).. In Ecuador, these regulations are usually established by the Ministry of Public
Health or other competent authorities, and address a number of key aspects to ensure
safety and prevent exposure to risk (Cedeño et al., 2021)..
First, these regulations often include detailed requirements on laboratory infrastructure,
ensuring that facilities are designed and constructed in a manner that minimizes the
potential for environmental contamination and provides adequate containment of
hazardous agents. This can range from adequate ventilation to the provision of security
systems and access control (Valles et al., 2024)..
In addition, biosafety regulations establish specific procedures for the safe handling of
biological and chemical materials. This may include guidelines on the proper use of
personal protective equipment, decontamination of surfaces and equipment, and safe
disposal of waste, all with the goal of minimizing the risk of exposure and contamination
(Luzuriaga et al., 2020)..
Another important aspect is personnel safety protocols, which establish the
responsibilities and training necessary to ensure that those working in the laboratory are
adequately informed and prepared to handle the risks associated with their work. This
can include everything from training in biosafety practices to participation in emergency
drills (Brun et al., 2021).
Finally, biosafety regulations also typically include measures for the management of
emergency situations, such as hazardous material spills or accidental exposures. This
involves the implementation of clear response protocols, including proper notification
and timely medical care, in order to minimize potential health and environmental
impacts (Baggini, 2022).
Also included are reporting and follow-up regulations are essential to ensure
transparency, accountability and continuous improvement in the management of
adverse events in the laboratory process. These regulations establish the procedures
and responsibilities for reporting adverse events that occur during laboratory activities,
Prevention and control of adverse events in the clinical laboratory process: A literature review.
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 49
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46
as well as for adequate follow-up to prevent their recurrence in the future (Luzuriaga et
al., 2020)..
Regulations should first establish criteria for determining which events should be
reported. This may include events such as sample processing errors, incorrect or
unexpected results, contaminations, personnel safety incidents, among others. Next,
procedures and timelines for adverse event reporting are detailed. This may include the
obligation to report immediately or within a specified period of time, depending on the
severity of the event and the potential risk to public health (Carboni & Sáenz, 2019)..
In addition, the regulations establish appropriate communication channels for adverse
event reporting, ensuring that information reaches the relevant authorities in a timely
and complete manner. This may involve the creation of online reporting systems or the
designation of specific points of contact to receive and process the information. Once
reported, follow-up regulations establish the mechanisms to investigate and analyze
adverse events, with the objective of identifying the underlying causes and taking
appropriate corrective actions (Macias, 2023).
Finally, reporting and monitoring regulations may also establish requirements for the
maintenance of detailed records of reported adverse events, as well as for the disclosure
of this information in a transparent manner to relevant stakeholders (Lloacana et al.,
2023)..
Conclusions
The prevention and control of adverse events in the clinical laboratory process are
fundamental aspects to guarantee the quality and safety of analytical results, as well as
to safeguard the health of patients. First of all, it is essential to implement quality control
measures from the beginning of the process, ensuring proper calibration of equipment,
use of quality reagents and constant training of technical staff. This helps to minimize
pre-analytical errors that could compromise the accuracy of the results.
In addition, efficient management and strict compliance with biosafety regulations are
crucial to prevent adverse events related to environmental contamination and
occupational exposure to hazardous substances. The implementation of standardized
safety protocols and the constant monitoring of their compliance are key aspects to
avoid incidents that may endanger the health of laboratory personnel and the
environment.
Every clinical laboratory requires a comprehensive approach from the pre-analytical
phase to the final waste disposal, involving the application of quality control protocols,
biosafety measures and an adequate management of environmental and occupational
risks. Only through a continuous commitment to quality and safety can the reliability of
analytical results and the protection of patients, laboratory personnel and the
environment be guaranteed.
..........................................................................................................
Luis Alberto León Bajaña, Carlos Aarón Cevallos Valencia, Roddy Wladimir Quimis Merchán
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47
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