Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 50
July - September 2024 e-ISSN 2550-6862. pp 1-14
DOI https://doi.org/10.31876/er.v8i50.866
Quality of care and patient safety in the clinical
laboratory process
Calidad de atención y seguridad del paciente en el proceso de laboratorio
clínico
Ángel Antonio Palomino Castillo*
Gabriela Antonieta Saldaña Sánchez*
Alexandre Rodriguez Peñafiel*
Received: May 03, 2024
Approved: June 12, 2024
Abstract
This study is part of a result of the research project Prevention and
control of adverse events in the pre-analytical phase of the clinical
laboratory process at the Hospital León Becerra of Guayaquil. It is
focused on offering a theoretical, analytical and comparative
contribution of previous research carried out at the León Becerra
Hospital in Guayaquil. Principle of the form The general objective of
this work is to evaluate the quality of care in the clinical laboratory
processes of different studies and to provide feedback for the quality
of care and patient safety in the clinical laboratory process.
Keywords:
Hospital, Laboratory, Laboratory Clinical, Care
* Msc. Instituto Superior Tecnologico
Universitario Espiritu Santo,
https://orcid.org/0009-0007-1213-5518,
apalomino@tes.edu.ec
* Msc. Instituto Superior Tecnologico
Universitario Espiritu Santo,
https://orcid.org/0000-0003-0155-5238,
gasaldana@tes.edu.ec
* Msc. Instituto Superior Tecnologico
Universitario Espiritu Santo,
https://orcid.org/0009-0001-0407-9399,
jarodriguez5@tes.edu.ec
Palomino, A., Saldaña, G.,
Rodríguez, A. (2024) Calidad de
atención y seguridad del paciente
en el proceso de laboratorio clínico.
Espirales Revista Multidisciplinaria
de investigación científica, 8 (50), 1-
14
Quality of care and patient safety in the laboratory process
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 50
July - September 2024 e-ISSN 2550-6862. pp 1-14
2
Introduction
Exploring the inner workings of hospital institutions is fundamental to understanding
their essential operations and functions, including the work performed by the clinical
laboratory department. This study focuses on providing a theoretical, analytical and
comparative contribution of research conducted on patient care and safety in the clinical
laboratory process.
The purpose is to provide an assessment of satisfaction levels with respect to service in
these areas, as well as to examine the instruments used to analyze samples and
determine their reliability. In addition, it seeks to analyze the necessary infrastructure for
a hospital and each of its units, with the aim of identifying areas for improvement and
strengthening the quality of care offered to patients.
The quality of care in the clinical laboratory is crucial to ensure accurate and reliable
results, which directly influences the diagnosis and treatment of patients. Therefore, it
is essential to identify possible areas for improvement and propose recommendations
to optimize the quality of the services provided by the clinical laboratory for the León
Becerra Hospital in Guayaquil (Huamán & Guevara, 2023).
One of the problems identified was the absence of clear protocols and established
quality standards to ensure consistency and accuracy in the performance of laboratory
tests, which could lead to variations in the quality of care between different procedures
and laboratories.
The lack of clear protocols and quality standards in clinical laboratory processes has
become a significant concern in the healthcare setting. This absence of established
guidelines can lead to inconsistencies and variations in the quality of care between
different laboratories, compromising the reliability of the results obtained. The lack of
standards also makes it difficult to compare and evaluate services between institutions,
Resumen
Este estudio forma parte de un resultado del proyecto de
investigación Prevención y control de eventos adversos en la fase pre
analítica del proceso de laboratorio clínico en el Hospital León
Becerra de Guayaquil. El mismo se centra en ofrecer un aporte
teórico, analítico y comparativo de investigaciones previas realizadas
en el Hospital León Becerra de Guayaquil. Principio del formulario El
objetivo general de este trabajo es evaluar la calidad de atención en
los procesos de laboratorio clínico de distintos estudios y realizar una
retroalimentación para la calidad de la atención y la seguridad del
paciente en el proceso de laboratorio clínico.
Palabras clave:
Hospital, Laboratorio Clínico, Atención
Ángel Antonio Palomino Castillo, Gabriela Antonieta Saldaña Sánchez, Alexandre Rodriguez Peñafiel
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 51
July - September 2024 e-ISSN 2550-6862. pp 1-15
3
which can affect patient confidence in laboratory services and ultimately impact the
overall quality of care provided.
In addition, few clear protocols and quality standards can lead to confusion and
ambiguity among clinical laboratory personnel (Bazán, M., & Valencia, E. 2023). Without
defined guidance on how to perform certain procedures and maintain the quality of
results, practitioners may be less certain about the best practices to follow. This can lead
to a lack of consistency in internal laboratory processes, increasing the risk of errors and
negatively affecting the accuracy and reliability of test results. Ultimately, this lack of
clarity can undermine laboratory efficiency and its ability to provide quality patient care
and safety.
The general objective of this work is to evaluate the quality of care and patient safety in
the clinical laboratory process, based on different studies and to provide feedback for
the clinical laboratory processes of the León Becerra Hospital in Guayaquil. To achieve
this objective, an investigation will be carried out to analyze the quality of the services
provided by the clinical laboratory, identifying both strengths and areas for
improvement. In addition, the results obtained from different existing scientific
documents will be compared in order to identify possible gaps in terms of quality
standards. Based on the findings, specific recommendations will be proposed to
improve the quality of care in the clinical laboratory of the León Becerra Hospital in
Guayaquil and other clinics.
The study "Analysis of the quality of attention to clinical laboratory processes for the
León Becerra Hospital in Guayaquil. "is relevant for several fundamental reasons. First,
the overall objective of the study, which is to evaluate the quality of care in clinical
laboratory processes, is crucial to ensure the accuracy and reliability of medical test
results. This analysis will provide valuable information on the effectiveness of current
procedures and practices in the hospital's clinical laboratory, identifying areas for
improvement and opportunities to strengthen the quality of care offered to patients.
In addition, conducting this study will provide significant feedback to the clinical
laboratory processes at Hospital León Becerra de Guayaquil, by comparing the results
obtained in different studies on quality of care in clinical laboratories, best practices and
successful strategies implemented elsewhere can be identified. This feedback will help
laboratory staff to better understand areas for improvement and to implement effective
and sustainable changes to raise quality standards at Hospital León Becerra de
Guayaquil.
Ultimately, the purpose of this study is to improve the quality of care provided to
patients at the León Becerra Hospital in Guayaquil. By identifying and addressing
deficiencies in clinical laboratory processes, it ensures that patients receive accurate and
reliable results from their medical tests. This not only improves the patient experience,
but also contributes to more effective and safer medical care at the hospital, thus
promoting the health and well-being of the community it serves.
According to Panunzio, A. (2022), the vulnerability of the borderline stages of the clinical
laboratory process, i.e. the pre-analytical and post-analytical phases, is pointed out, and
Quality of care and patient safety in the laboratory process
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 50
July - September 2024 e-ISSN 2550-6862. pp 1-14
4
the importance of external quality assessment in the laboratory is highlighted. This is
based on the experiences shared by expert researchers in the field.
The text by Panunzio, A. (2022) highlights the vulnerability of the preanalytical and
postanalytical phases in the clinical laboratory process, emphasizing the importance of
external quality assessment today. This evaluation is based on the experiences shared
by researchers specialized in the field, which underlines the need to strengthen quality
controls at all stages of the laboratory process to ensure the reliability and accuracy of
analytical results.
During their operation, clinical laboratories, also known as the total examination
process, use medical devices and are therefore subject to the possibility of failures that
can lead to incidents and affect patient safety. These incidents can result in direct or
indirect harm, as errors in the laboratory can lead to medical errors (Mucito, E., 2020).
The text highlights the importance of recognizing that clinical laboratories, when using
medical devices during their operation, are exposed to the possibility of failures that
can jeopardize patient safety. This underscores the need to implement effective quality
control and risk management measures in these environments to prevent incidents that
may result in direct or indirect harm to patients. Furthermore, it emphasizes the
relevance of continuous monitoring and constant improvement of laboratory processes
to ensure the reliability and accuracy of analytical results, thus minimizing the risk of
medical errors associated with laboratory failures.
Quality in the clinical laboratory is defined as the ability of laboratory processes and
services to meet established standards and requirements, both in technical terms and
in terms of patient care. This encompasses the accuracy and reliability of the results
obtained, as well as the reliability of the equipment and reagents used. It also
encompasses patient satisfaction in aspects such as waiting time, courtesy in the
treatment received and access to relevant information. Optimal quality in the clinical
laboratory is essential to ensure adequate diagnosis and treatment for patients (Sanchez
& Juseth, 2023).
The text highlights the importance of quality and safety in the clinical laboratory,
emphasizing that this is related to the capacity of the laboratory's processes and services
to comply with technical and patient care standards. This quality encompasses the
accuracy of the results, the reliability of the equipment, and patient satisfaction in
aspects such as waiting time and treatment received. It is fundamental to ensure proper
diagnosis and treatment, highlighting its crucial role in medical care.
It is of great importance to ensure accurate and safe results, which in turn contributes
to appropriate medical decision-making. A clinical laboratory that meets high quality
standards can provide accurate and timely data for disease diagnosis, treatment
monitoring and prevention of complications. In addition, optimal quality in clinical
laboratory processes promotes patient confidence and satisfaction, which enhances the
hospital's image and reputation (Litardo, 2021).
Ángel Antonio Palomino Castillo, Gabriela Antonieta Saldaña Sánchez, Alexandre Rodriguez Peñafiel
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 51
July - September 2024 e-ISSN 2550-6862. pp 1-15
5
The text highlights the importance of maintaining high quality standards in the clinical
laboratory, as this ensures the reliability of results and facilitates appropriate medical
decision-making. A laboratory that meets these criteria can provide accurate and timely
information for diagnosis, monitoring and disease prevention, which ultimately
improves the quality of medical care. In addition, quality in clinical laboratory processes
not only benefits patients by generating confidence and satisfaction, but also
contributes to strengthening the reputation and image of the laboratory and the
hospital or clinic in general.
The analysis of patient samples in laboratories is a highly complex process in which
errors can occur at any stage. Therefore, it is essential that laboratories implement
measures to ensure the reliability and accuracy of the results obtained. It is necessary
for the laboratory to thoroughly examine its procedures for possible weaknesses or risks
that may lead to errors, and to take the corresponding measures to detect and prevent
such errors before they influence the test results (Lino, W. et al, 2021).
The text underscores the critical importance of ensuring accuracy and reliability in the
results of laboratory testing of patient samples. Given the complexity of the process and
the potential for errors at any stage, it is essential that laboratories conduct a thorough
assessment of their procedures to identify potential weaknesses or risks. Taking
proactive steps to detect and prevent errors before they impact test results is critical to
ensuring the quality and reliability of clinical laboratory services, which ultimately
contributes to optimal patient safety and care.
Materials and methods
The research process on the analysis of the quality of care of clinical laboratory
processes for the León Becerra Hospital in Guayaquil was carried out using a
documentary research approach. In this type of research, data are collected and
analyzed from various documentary sources to obtain relevant information on the topic
under study (Vargas. I, et al, 2021). In this case, documents, government reports and
previous studies related to quality of care in clinical laboratories were used.
The study sample included patients and hospital personnel from the different studies
performed at the León Becerra Hospital in Guayaquil. Patients who had used the
hospital's clinical laboratory services and medical and laboratory personnel involved in
the provision of these services were selected. This selection made it possible to obtain
an integral perspective of the quality of care in clinical laboratory processes, both from
the patients' experience and from the hospital staff's perspective.
To carry out the research, content analysis and documentary review techniques were
used (Rodríguez, A. et al, 2021). These techniques made it possible to examine in detail
the documents collected and extract relevant information related to the quality of care
in clinical laboratory processes. In addition, data collection sheets were applied to
organize and record the information obtained from documents and government
sources. These cards provided a structure for collecting specific data related to quality
Quality of care and patient safety in the laboratory process
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 50
July - September 2024 e-ISSN 2550-6862. pp 1-14
6
of care in the clinical laboratory, safety and facilitated the analysis and interpretation of
the results obtained. In summary, the research process was conducted in a systematic
and rigorous manner, using a variety of techniques and tools to obtain a complete
understanding of the quality of care in the clinical laboratory processes at the León
Becerra Hospital in Guayaquil.
Results
The studies by different authors offer a broad and varied view of the quality of care in
clinical laboratory processes, providing a solid basis for feedback at the León Becerra
Hospital in Guayaquil.
In the doctoral research by Cantero, F. (2015) on "Analysis of excellence criteria in
laboratory tests performed at the point of patient care", considerable error rates were
observed in tests performed at the point of patient care (POCT), with medians reaching
up to 25.8% for patient identification and 15.2% for aborted samples in neonatology.
However, monitoring of these indicators revealed a significant decrease thanks to the
implementation of our quality assurance program. It is important to note that POCT
stands for Point Of Care Testing.
In contrast, the criteria established in the delivery room, with medians reaching up to
11% for parity error and up to 39.2% for air detection in fetal calyx samples, did not
exhibit a notable decrease. The late inclusion of this analyzer in the POCT quality
assurance program and the challenges experienced in training personnel in this area
may account for these findings.
In the results of his research entitled "Level of satisfaction of users with requests for
urgent examination in the clinical laboratory of the Type B Health Center No. 1 in the
city of Esmeraldas", Chila, A. (2020) found that 55% of users expressed dissatisfaction.
This is attributed to the fact that laboratorians present delays in the preparation,
sampling and processing stages, which generates a negative perception. On the other
hand, it was observed that 27% of the users indicated that teamwork helps to improve
the chemical analysis process, since it coordinates activities in a
In the study entitled "Perspective of Emergency users of the National Institute of Child
Health - 2016" conducted by Mendivil, A. (2017) on the quality of care in the clinical
laboratory, it is observed that users describe confidence in the results issued by the
clinical laboratory as reliability. This aspect of care is highly valued by medical
professionals, since the results of complementary tests play a crucial role in determining
the therapeutic approach. Therefore, these professionals identify two components that
contribute to the reliability of the results: verification of results and diagnostic utility,
which provide them with the certainty that the results obtained accurately reflect the
patient's clinical condition and relate to their diagnostic impression or therapeutic
follow-up, as appropriate.
Principle of the form
Ángel Antonio Palomino Castillo, Gabriela Antonieta Saldaña Sánchez, Alexandre Rodriguez Peñafiel
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 51
July - September 2024 e-ISSN 2550-6862. pp 1-15
7
In their thesis entitled "Evaluation of the quality of health care using the Avedis
Donabedian model in the emergency area of Hospital Paravida from July to December
2014", Chávez, A., and Molina, J. (2015), point out that when evaluating the quality of
health care in the emergency area, the results related to the process reveal that of the
total number of surveyed internal users working in this sector, 48% have been employed
at the hospital for less than one year, 38% from one to four years, and 14% more than
five years. However, it is of concern that the majority of the human resources stated that
they were unaware of the processes related to user care in the emergency unit. It is
important to note that 67% of these resources state that they have received training in
customer service, while the remaining 33% have not. On the other hand, the results also
show that a large percentage of employees indicate that the institution offers annual
training, but 10% are unaware of this fact, which is worrisome, given that all institutions
are expected to have fully trained personnel.
Principle of the form
Within the findings of the study conducted by Navas, M., & Ulloa, M. (2013) on the
"Evaluation of the quality management of health services offered by the Hospital San
Sebastián de Cantón Sígsig", it is observed that users in general show a moderate level
of satisfaction. This was perceived positively by patients. However, with regard to the
laboratory equipment and material available at the hospital, the evaluation is negative
in terms of satisfaction.
In his thesis, Calderón, R. (2018) found that regarding the quality of care variable, 71.6%
of the cases were classified as "Very good", 22.7% as "Good", and 5.4% as "Fair".
These results indicate satisfactory levels of quality. These data are similar to those
obtained in Zamora's research, where 87.65% high quality was recorded, and in Jinez's
study, where 82% of the quality was reported as "Very good" and 18% as "Good". In
contrast, Tuesta reported a "fair" rating for quality in 86.2% of the cases in its evaluation.
Intriago, S. (2022) established quality criteria in two stages of sample processing for
shipment to participating laboratories. In the pre-analytical stage, SERISCANN from
QCA was used to obtain high quality samples. In the analytical stage, calibration of the
automated equipment and pipettes was performed, emphasizing the importance of
temperature control. After analyzing and distributing the samples in Eppendorf tubes,
they were kept at controlled temperature to guarantee the quality of the results, since
this depends on each phase of the analytical process.
Calderon (2018) presents a mostly positive assessment of the quality of health care, with
a high percentage of cases classified as "Very good" and "Good". This suggests that
the hospital could be obtaining satisfactory results in the provision of services. On the
other hand, Navas and Ulloa (2013) identified a discrepancy in user satisfaction in
relation to the laboratory equipment and material available in the hospital studied. This
finding indicates a specific area that may require improvement to align the quality of
laboratory services with user expectations.
Intriago (2022) highlights the importance of establishing quality parameters at the
sample processing stages to ensure accurate and reliable results. His focus on quality
Quality of care and patient safety in the laboratory process
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 50
July - September 2024 e-ISSN 2550-6862. pp 1-14
8
control in the pre-analytical and analytical phases, along with maintaining proper
sample temperature, provides valuable guidance for improving clinical laboratory
processes at Hospital Guayaquil. In addition, Chavez and Molina's (2015) research
reveals a critical need to improve staff training and internal communication in the
emergency area, which could be applied to clinical laboratory processes to strengthen
the quality of care at the hospital.Principle of the form.
The studies analyzed provide a variety of perspectives on the quality and safety of care
in clinical laboratory processes. While some aspects, such as overall user satisfaction,
appear to be in line with expectations, others, such as equipment availability and staff
training, point to specific areas that require attention. Feedback from these findings can
serve as an important starting point to identify areas for improvement and strengthen
clinical laboratory processes in the hospital, with the aim of improving the quality of
care offered to patients.
The study presented by Cantero, F. (2015) highlights the importance of examining
quality indicators in laboratory tests performed at the point of patient care (POCT). The
results reveal significant error rates, particularly in patient identification and sample
management in the context of neonatology. The analysis also highlights a positive
aspect: the implementation of a quality assurance program has led to a significant
reduction in these errors. This underscores the importance of a proactive approach to
monitoring and improving the quality of laboratory testing at the point of patient care.
The results presented by Chila, A. (2020) in his study on the level of user satisfaction
with urgent examinations in the clinical laboratory of the Type B Health Center No. 1 of
Esmeraldas offer a detailed view of the perceptions and experiences of users in relation
to the services provided. Factors such as delays at different stages of the process by
laboratorians, the importance of teamwork to improve chemical analysis, and lack of
communication leading to lack of knowledge of technical procedures were identified.
These findings highlight critical areas that require attention and improvement,
underscoring the need for greater operational efficiency, internal coordination and
effective communication to ensure satisfaction and quality in health care.
The author Mendivil, A. (2017), highlights the fundamental importance that users of
emergency services assign to the reliability of the results issued by the clinical
laboratory. These results are considered as fundamental pillars in therapeutic decision
making by medical staff. Confidence in the accuracy and relevance of these results is
closely related to the laboratory's ability to verify the results and provide effective
diagnostic assistance. This confidence is essential to ensure that the results accurately
reflect the patient's health status and can be used effectively in the diagnostic and
treatment process.
The results presented by Chávez, A., and Molina, J. (2015) point out important areas of
concern regarding the quality of health care in the emergency area of Hospital Paravida
during the period from July to December 2014. They highlight the lack of knowledge
on the part of the staff about the processes related to user care in the emergency unit,
as well as the need to improve staff training in customer service. In addition, they
Ángel Antonio Palomino Castillo, Gabriela Antonieta Saldaña Sánchez, Alexandre Rodriguez Peñafiel
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 51
July - September 2024 e-ISSN 2550-6862. pp 1-15
9
highlight the importance of ensuring that all facilities have an effective training program
and that staff are fully informed about procedures and regulations to provide quality
care. These findings underscore the importance of investing in ongoing staff training
and implementing effective knowledge management policies to improve the quality of
health care.
The results of the study conducted by Navas, M., & Ulloa, M. (2013) regarding the
evaluation of the quality management of the health services offered by the Hospital San
Sebastián de Cantón Sígsig, reflect a mixed perception on the part of the users.
Although there is a moderate degree of overall satisfaction with the services provided,
a specific concern stands out in relation to the laboratory equipment and material
available at the hospital, which is evaluated as unsatisfactory. This discrepancy suggests
that, while some aspects of the care received are perceived favorably, there are still
areas of critical improvement that require immediate attention, particularly in the
infrastructure and technical resources used in the health care process. This argument
underscores the importance of addressing as a priority the deficiencies identified in the
laboratory equipment to ensure the quality and effectiveness of the health services
offered to patients.
The results obtained by Calderón, R. (2018), and the research by Zamora, Jinez and
Tuesta provide a varied but comprehensive view on the quality of care in the context
studied. While Calderón highlights a predominance of high and good quality levels,
mainly represented by a "Very good" rating, the studies by Zamora and Jinez reinforce
this perception by recording notable percentages of high and very good quality. These
findings suggest a general trend toward satisfactory and positive quality of care in the
setting investigated. However, the Tuesta report presents a different perspective by
showing a significant percentage of "fair" quality. This discrepancy underscores the
importance of considering a variety of perspectives and methodologies when assessing
quality of care, and highlights the need to identify and address specific areas that
require improvement to ensure optimal and consistent care for all patients.
The approach established by Intriago, S. (2022) to ensure quality in the sample
processing stages of his research is crucial to obtain accurate and reliable results in the
laboratory. By establishing quality parameters at both the pre-analytical and analytical
stages, rigorous control over fundamental aspects such as sample collection and
calibration of the equipment used in their analysis is ensured. In addition, attention to
temperature and maintenance of the samples in cold chain after preparation are
essential measures to preserve the integrity of the specimens and guarantee the quality
of the final results. This comprehensive approach underscores the importance of each
step in the analytical process and highlights the need to implement rigorous quality
control practices at all stages of the study to obtain reliable and meaningful
data.Principle of the Form
Conclusions
Quality of care and patient safety in the laboratory process
Espirales. Revista multidisciplinaria de investigación científica, Vol. 8, No. 50
July - September 2024 e-ISSN 2550-6862. pp 1-14
10
After analyzing the results obtained from the different authors, it can be concluded that
the objective of the study to evaluate the quality of care in clinical laboratory processes
and provide feedback for the León Becerra Hospital in Guayaquil was met. The findings
reveal a range of perspectives on quality of care in the clinical laboratory, from positive
assessments to identified areas for improvement. The research has identified key issues,
such as the lack of clear protocols and quality standards, the need for staff training, and
the importance of quality control at all stages of the laboratory process.
Studies by authors such as Calderón (2018), Navas and Ulloa (2013), Intriago (2022), and
others provide a comprehensive view on the quality of care in clinical laboratory
processes. Through the analysis of these results, valuable feedback has been provided
to the hospital. Areas for improvement have been identified and possible strategies
have been suggested to strengthen the quality of care in the clinical laboratory, such as
implementing clear protocols, training staff, and maintaining rigorous quality standards.
In conclusion, the study has successfully met its overall objective by providing a
comprehensive assessment of the quality of care in clinical laboratory processes and by
providing meaningful feedback to the hospital. These findings can not only serve as a
guide for improving clinical laboratory services at the hospital, but can also contribute
to the continued advancement of overall health care quality.
..........................................................................................................
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