Como citar APA:

Palomino, A., Rodríguez, J. (2024) Control and prevention of adverse

events in the clinical laboratory process . Repique, 6(2), 21-40

Vol. 6 Núm. 2

Julio - Diciembre 2024

e-ISSN: 2550-6676

pp 21-41

Control and prevention of adverse events in the clinical

laboratory process

Ángel Antonio Palomino Castillo

Jaime Alexandre Rodríguez Peñafiel

Abstract

The article responds to the research project: Prevention and control

of adverse events in the pre-analytical phase of the clinical laboratory

process in the Veris Medical Centers of the city of Guayaquil, carried

out by the Clinical Laboratory career of the Instituto Superior

Tecnológico Universitario Espíritu Santo. The essential core to ensure

the quality of health services and the main axis of patient care is

patient safety. The purpose of the article is to provide a theoretical

framework related to quality management of health services, patient

care and safety in the clinical laboratory setting. This study was

carried out at the León Becerra Hospital in Guayaquil, where the

effectiveness of control and prevention measures for adverse events

in the clinical laboratory process was evaluated. A mixed

methodology was adopted, combining field and descriptive

research, which allowed the active participation of the community in

all stages of the research. Several methods were used, including

analysis-synthesis, inductive-deductive and structural systemic

methods at the theoretical level, while observation, interviews,

surveys and document review were used at the empirical level. The

* Lic. Instituto Superior Tecnológico Universitario Espíritu Santo, appalomino@tes.edu.ec

https://orcid.org/0009-0007-1213-5518

* Lic. Instituto Superior Tecnológico Universitario Espíritu Santo, jarodriguez5@tes.edu.ec

https://orcid.org/0009-0001-0407-9399

Ángel Antonio Palomino Castillo, Jaime Alexandre Rodríguez Peñafiel

main result obtained focused on improving the quality of care and

patient safety through the implementation of preventive and

corrective measures during the pre-analytical phase of the clinical

laboratory process.

Key words:

Laboratory, Clinical, Hospital, Safety, Health

Control y prevención de acontecimientos adversos en el

proceso del laboratorio clínico

Resumen

El artículo responde al proyecto de investigación: Prevención y

control de eventos adversos en la fase preanalítica del proceso de

laboratorio clínico en los Centros Médicos Veris de la ciudad de

Guayaquil, realizado por la carrera de Laboratorio Clínico del

Instituto Superior Tecnológico Universitario Espíritu Santo. El núcleo

esencial para garantizar la calidad de los servicios de salud y eje

principal de la atención al paciente es la seguridad del mismo. El

propósito del artículo es proporcionar un marco teórico relacionado

con la gestión de la calidad de los servicios de salud, la atención al

paciente y la seguridad en el ámbito del laboratorio clínico. Este

estudio se realizó en el Hospital León Becerra de Guayaquil, donde

se evaluó la efectividad de las medidas de control y prevención de

eventos adversos en el proceso de laboratorio clínico. Se adoptó

una metodología mixta, combinando investigación de campo e

investigación descriptiva, que permitió la participación activa de la

comunidad en todas las etapas de la investigación. Se utilizaron

varios métodos, entre ellos el análisis-síntesis, el inductivo-deductivo

y el sistémico estructural en el plano teórico, mientras que en el

plano empírico se recurrió a la observación, las entrevistas, las

Repique. Revista de Ciencias Sociales.

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encuestas y la revisión de documentos. El principal resultado

obtenido se centró en la mejora de la calidad asistencial y la

seguridad del paciente mediante la implantación de medidas

preventivas y correctoras durante la fase preanalítica del proceso del

laboratorio clínico.

Palabras clave:

Laboratorio, Clínico, Hospital, Seguridad, Salud.

Received : 19-02-2024

Approved: 08-04-2024

INTRODUCTION

Monitoring the functions within the entities that care for health

within a population is of vital importance in the health care setting.

In particular, the clinical laboratory plays a critical role in the

diagnosis and treatment of disease, underscoring the need to

maintain rigorous control and an effective prevention system to

avoid adverse events. The accuracy and reliability of clinical test

results are crucial for making sound medical decisions, so any error

in this process can have serious consequences for patients' health.

In this context, establishing solid control and prevention

mechanisms in the clinical laboratory becomes a crucial barrier to

mitigate the risk of adverse events. The implementation of

standardized protocols and procedures, as well as the continuous

monitoring of activities within the laboratory, are fundamental

strategies to ensure the safety and quality of the medical services

provided. Therefore, it is essential to understand the importance of

this function within healthcare institutions and to work on its

constant improvement in order to protect the health and well-being

of patients.

The problem is that, in healthcare practice, the fundamental

principle of patient care is not always complied with, because a

series of errors are made, particularly in the pre-analytical phase of

Ángel Antonio Palomino Castillo, Jaime Alexandre Rodríguez Peñafiel

the clinical laboratory process, which affect clinical results and,

therefore, patient safety. Adverse events that occur in the clinical

laboratory process affect the diagnosis, prognosis and follow-up of

the evolution of the disease. When a disease is incorrectly

diagnosed, patients suffer damage, and sometimes this damage is

irreversible and can lead to death.

Inadequate training could result in improper execution of

laboratory procedures, misinterpretation of results, and unsafe

handling of samples, increasing the risk of errors and adverse

events in the process. In addition, lack of training could affect the

understanding of safety protocols and the importance of following

standard operating procedures, which could jeopardize both the

health of staff and the quality of services provided to patients.

The objective is to provide a theoretical reference related to quality

management of health services, patient care and safety in the

clinical laboratory process, particularly in the pre-analytical phase;

carried out at the León Becerra Hospital in Guayaquil, which

evaluated the effectiveness of the control and prevention of events

in the clinical laboratory process.

The inclusion of a theoretical reference related to quality

management of health services, patient care and safety in the

clinical laboratory process, specifically in the pre-analytical phase,

is an indispensable element to support and contextualize the

importance of this process in the hospital setting. In the case of the

León Becerra Hospital in Guayaquil, this theoretical approach

acquires even greater relevance when applied to the evaluation of

the effectiveness of the control and prevention of events in the

clinical laboratory process.

The relevance of providing a theoretical reference is justified in the

first place by the need to establish a solid conceptual framework to

understand the fundamentals and principles that govern quality

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management in health services. In a context where accuracy,

reliability and safety of results are vital for patient welfare, a solid

theoretical basis is essential to guide practices and decisions in the

clinical laboratory process.

In addition, the integration of a theoretical reference provides an

academic underpinning that supports the actions and strategies

implemented to ensure quality and safety in the pre-analytical

phase of the clinical laboratory. This theoretical basis not only

provides intellectual support, but also facilitates the identification

of best practices, risk assessment and the implementation of

preventive and corrective measures.

In the specific context of the León Becerra Hospital in Guayaquil,

where the evaluation of the effectiveness of the control and

prevention of events in the clinical laboratory process is carried out,

the theoretical reference acquires additional relevance by providing

a frame of reference for interpreting the findings, analyzing the

underlying causes and proposing recommendations for

improvement. It also allows comparisons to be made with

internationally recognized standards and allows practices and

protocols to be adapted according to the best available evidence

in the field of quality management in health.

The inclusion of a theoretical reference related to quality

management of health services, patient care and safety in the

clinical laboratory process, particularly in the pre-analytical phase,

is not only relevant but essential to ensure excellence in the

provision of health services and promote the welfare of patients. In

the case of León Becerra Hospital in Guayaquil, this theoretical

approach becomes an essential pillar for the evaluation and

continuous improvement of clinical laboratory processes, thus

contributing to excellence in health care and patient safety.

Ángel Antonio Palomino Castillo, Jaime Alexandre Rodríguez Peñafiel

A study conducted in 2021 in some recognized Hospitals in the city

of Guayaquil addressed the fall prevention protocol with the

objective of improving the safety of hospitalized pediatric patients.

This study points out the importance of nursing professionals

receiving periodic training on the proper management of patients,

as well as the need for them to remain focused on meeting and

maintaining standards of care and safety. This ensures the

protection and well-being of patients, preserving their integrity

during their stay in the hospital (Mendoza, D. 2022).

The aforementioned study highlights the need for continuous

training for nursing professionals, among others; especially in topics

related to patient management, suggesting a proactive approach

towards improving healthcare. In addition, it underscores the

importance of nursing staff strictly adhering to established

standards of care and safety, which reinforces confidence in the

integrity and well-being of patients. These measures not only

directly benefit pediatric patients admitted to the León Becerra

Hospital in Guayaquil, but also contribute to the overall quality of

medical care provided at the hospital.

According to Cañarte, G. (2018), Hospitals should consider all

regulations, manuals and procedures established in the biosafety

guidelines issued by the Ministry of Health. These regulations are

fundamental to prevent occupational hazards. It is essential to apply

the biosafety manual in all processes carried out within clinical

laboratories.

Hospital compliance with the regulations and procedures set forth

in the biosafety manual is crucial to ensure a safe working

environment and protect the health of both staff and patients.

These guidelines provided by the Ministry of Health are specifically

designed to prevent occupational hazards and ensure the integrity

of all those involved in hospital operations. By implementing the

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biosafety manual in the processes performed in clinical laboratories,

a culture of safety is promoted and the chances of occupational

health-related incidents are reduced, resulting in safer and higher

quality medical care.

Considering the lack of adequate research on the current state of

patient safety in clinical laboratories in Jipijapa Canton, province of

Manabi, it is necessary to conduct a systematic review. The

objective of this review is to analyze and improve this area within

the health services, thus seeking to obtain a more complete

understanding of the situation and promote the implementation of

measures that guarantee the safety and well-being of patients in

these medical environments (Yambay, C. et al. 2023).

The absence of sufficient studies on patient safety in clinical

laboratories in this case indicates a gap in the understanding and

management of the risks associated with health services in this

specific area. A systematic review presents itself as a vital tool to

address this dearth of information, as it will allow for a

comprehensive identification and analysis of the challenges and

areas for improvement in terms of patient safety in clinical

laboratories. This, in turn, will facilitate the implementation of

measures and policies aimed at improving the quality and safety of

medical care in these settings, thus contributing to the protection

and well-being of patients.

Standard Precautions comprise a set of actions aimed at reducing

the likelihood of transmission of infections between medical

personnel and patients, as well as among patients themselves.

These precautions are designed to prevent the spread of

pathogens that are transmitted through contact with high-risk

blood and body fluids (Calahorrano, L. 2020).

It is essential in clinical practice, as they are specifically designed to

minimize the risk of transmission of infections both from patients to

Ángel Antonio Palomino Castillo, Jaime Alexandre Rodríguez Peñafiel

healthcare personnel and between patients themselves. These

measures are essential to protect the health and safety of everyone

involved in healthcare by reducing the possibility of transmission of

pathogens transmitted by blood and other high-risk body fluids.

According to Hernandez, A. et al (2018) ordering laboratory tests

that are not necessary can cause a variety of problems, such as

technical errors, misinterpretations, patient harm due to procedures

based on incorrect interpretations, or information overload that

influences medical decision making.

The importance of requesting laboratory tests in a selective and

informed manner lies in the need to avoid potential technical and

patient harm. Requiring unnecessary tests increases the risk of

errors in the interpretation of results, which can lead to erroneous

medical decisions and unnecessary procedures that could harm the

patient. In addition, information overload from superfluous tests

can make it difficult to make appropriate clinical decisions,

underscoring the importance of careful and accurate assessment

before ordering any laboratory tests.

In the laboratory, the priority in terms of safety lies in preventing,

detecting and minimizing adverse events at all times, in addition to

thoroughly examining the underlying causes of these incidents

(Evia, J. 2014).

According to the author, focusing on the prevention, detection and

reduction of adverse events is essential to ensure process integrity

and patient protection. Proactively addressing these events not

only promotes a safer work environment, but also strengthens

confidence in outcomes and reduces the risk of harmful errors.

Previously, according to Cenzual, M. (2015), the clinical laboratory

was not considered as an environment prone to cause adverse

events. This new perspective underscores the importance of

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assessing and addressing the risks inherent in laboratory

operations, which can lead to greater error prevention, earlier

detection of problems, and a significant reduction in adverse events

affecting patients. This shift in focus reflects a commitment to

continuous improvement and prioritization of patient welfare in

healthcare.

METHODOLOGY

The research project of which this analysis is being made, worked

with a polymodal or mixed methodology; with a field and

descriptive research development; which made possible the

involvement of the community during the whole research process;

a variety of methods were used, among the theoretical ones, the

analysis, synthesis, inductive, deductive and structural systemic;

among the empirical ones, observation, interview, survey and

documentary review were used. To collect qualitative data, the

documentary review technique was used, which involved analyzing

and synthesizing relevant information from written sources, such as

reports, previous studies and institutional documents related to the

control and prevention of adverse events in the clinical laboratory.

This provided a solid base of prior and contextual knowledge on

the subject.

In addition, a documentary data collection form was used to record

and organize the information obtained through the documentary

review and the analysis of survey results. This facilitated the

systematization of the data and its subsequent comparative analysis

(Bastar, S. 2019).

The use of the Likert scale in the study is of vital importance due to

its ability to provide a quantitative measurement of the perceptions

and attitudes of respondents regarding the control and prevention

of adverse events in the clinical laboratory of the León Becerra

Ángel Antonio Palomino Castillo, Jaime Alexandre Rodríguez Peñafiel

Hospital in Guayaquil. This scale allows participants to express their

degree of agreement or disagreement with specific statements,

which facilitates obtaining structured and comparable data

(Morales, N., et al., 2016).

RESULTS

The main result obtained from the study conducted at the León

Becerra Hospital in Guayaquil is a significant milestone in the

constant search for excellence in the provision of health services.

The orientation towards improving the quality of care and patient

safety reflects an institutional commitment rooted in medical ethics

and responsibility towards those who rely on the institution for their

care. Focusing on the pre-analytical phase of the clinical laboratory

process recognizes the critical importance of this initial stage in

obtaining accurate and reliable results, which are fundamental to

guiding sound medical decisions and ensuring the effectiveness of

treatments.

The adverse event prevention and control actions deployed as a

result of this study not only represent a timely response to identified

challenges, but also establish a paradigm of continuous

improvement in health quality management.

Implementing preventive measures, such as reviewing and

optimizing protocols, training staff and adopting innovative

technologies, demonstrates a commitment to innovation and

excellence in healthcare. This proactive approach not only

addresses existing problems, but also paves the way for an

organizational culture focused on patient safety and continuous

improvement.

Ultimately, the results obtained at León Becerra Hospital in

Guayaquil transcend the boundaries of the institution by providing

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an exemplary model that can inspire and guide other healthcare

institutions in their quest for excellence. By sharing the lessons

learned and best practices developed during this study, we

contribute to the global advancement of quality management in

healthcare, thus promoting safer, more effective and patient-

centered healthcare worldwide.

The doctoral research entitled "Clinical safety and occurrence of

adverse events in the clinical experiences of nursing students at the

University of Malaga" conducted by Garcia, M. (2020), help us to

identify four main areas of study in the literature reviewed on

adverse events in nursing students: adverse events themselves,

clinical safety competencies, student experiences in clinical safety

and pedagogical approaches, such as methods and content for

teaching clinical safety. It has been observed that nursing students

face adverse events during their clinical practice, with the incidence

of sharps accidents ranging from 17% to 18%.

According to Dionisio, D. (2017) in his research entitled "Adverse

events arising from care in a public hospital in Córdoba", five

adverse events were identified. Upon evaluation, it was determined

that 75% of the adverse events appeared to occur during the

provision of floor care, while 25% occurred during procedures,

including one during a surgical intervention and another during the

insertion of an intravenous line. However, statistical analysis

revealed no significant associations between the occurrence of

these events and specific periods (P-value: 0.2689). Furthermore,

no clear association could be established between the occurrence

of adverse events and a specific service within the hospital.

In her research on adverse event management in the context of the

patient-centered care model, Peña, L. (2018) found a total of eight

relevant articles. Of these, one study links the Patient-Centered

Model of Care (PCMC) with healthcare-associated infections (HAIs),

Ángel Antonio Palomino Castillo, Jaime Alexandre Rodríguez Peñafiel

while seven studies establish a relationship between PCMC and

medication errors. The results reveal various interventions carried

out by different healthcare professionals, such as nurses, physicians

and pharmacists, who implement various elements of the MACP in

order to contribute to the control of adverse events.

In research on the detection of adverse events in adult patients

discharged from a Critical Patient Unit using a specific search tool,

Astargo (2016) found that 93% of adverse events (AEs) occurred

during hospitalization, being more common (61%) in patients with

hospital stays of at least 15 days. It was observed that 57% of

triggers led to the identification of an adverse event, with 64%

being of moderate severity. Adverse events related to care and care

accounted for 29%, healthcare-associated infections (HAIs) for 20%,

medication use for 18%, and those related to surgical procedures

for 17%. Surprisingly, 92% of the adverse events detected had not

been previously reported at the institution.

In the thesis entitled "Biosafety measures applied by the nursing

staff during the patient's hospital stay at the Dr. José Garcés

Rodríguez Hospital", Panimboza, C., and Pardo, L. (2013), revealed

that knowledge about the principles of biosafety measures reached

71%, while knowledge about the adequate use of personal

protection barriers was 75%. Regarding the application of physical

protection barriers, it was observed that these were always

implemented in 19%, while chemical barriers were always applied

in 41%. As for the proper management of hospital waste, this was

always carried out in 55% of the cases. In general terms, with regard

to the application of biosecurity measures, 36% of the respondents

indicated that they always applied them, 31% sometimes, and 33%

never. These results underscore the urgent need to implement an

education and awareness project through lectures to improve the

application of biosafety measures by nursing staff.

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Peñaloza, A. et al. (2016) examined in their research the

identification of failures that lead to more common adverse events

during the administration of medications by nursing staff in hospital

institutions in Latin America. They focused on the importance of

analyzing the classification of errors committed by nurses when

administering medications, since according to the guidelines of the

patient safety policy established by the Colombian Ministry of

Social Protection, these errors are defined as "a deficiency in the

performance of a planned action as planned or the use of an

incorrect plan, which may manifest itself through the execution of

incorrect processes (failure of action) or through the non-execution

of correct processes (failure of omission), in the planning or

execution phases, where the failures are, by definition,

unintentional".

Comparison of these results with previous research, such as that

conducted by Astargo (2016) on adverse event detection,

highlights the importance of addressing identified gaps in training,

safety in adverse event identification and reporting, and availability

of resources in the clinical laboratory to ensure safe and quality care

for patients. These findings underscore the need for a

multidisciplinary approach and close collaboration between care

teams to address identified challenges and continuously improve

patient safety in the hospital setting.

Garcia's doctoral study (2020) provides a comprehensive overview

of clinical safety and the occurrence of adverse events in nursing

students, focusing on the University of Malaga. Through a

comprehensive literature review, he identifies four crucial areas of

research: adverse events, clinical safety competencies, student

experiences, and pedagogical approaches.

This multidimensional approach provides a better understanding of

the challenges and needs in the training of future professionals at

Ángel Antonio Palomino Castillo, Jaime Alexandre Rodríguez Peñafiel

the León Becerra Hospital in Guayaquil. In addition, the revelation

of a significant incidence of sharps accidents during clinical

internships highlights the importance of improving safety measures

and practical training of students in clinical settings. This analysis

underscores the importance of addressing not only the adverse

events themselves, but also the pedagogical aspects and lived

experiences of students to promote more effective and safer

nursing education.

The study conducted by Dionisio, D. (2017) on adverse events in a

public hospital in Cordoba provides an important perspective on

the safety and quality of medical care in hospital settings. The

identification of five adverse events and their distribution between

floor care and during surgical procedures underscores the need for

a comprehensive approach to address patient safety in all areas of

care. However, the lack of significant association between the

occurrence of adverse events and specific periods, as well as the

inability to determine a clear association with particular hospital

services, highlights the underlying complexity in understanding and

preventing these events. This analysis suggests the importance of

ongoing surveillance, as well as the implementation of preventive

measures and standardized safety protocols at all levels of hospital

care to mitigate the risks of adverse events and improve the quality

of patient care.

The research work conducted by Peña (2018) provides an

enlightening view on adverse event management within the

framework of the patient-centered care model. The collection and

selection of eight relevant articles provides a detailed overview of

how the Patient-Centered Model of Care (PCMC) relates to various

aspects of health care, including healthcare-associated infections

(HAIs) and medication errors. The findings highlight the variety of

interventions implemented by different healthcare professionals,

such as nurses, physicians, and pharmacists, who, through the

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integration of MACP elements, contribute significantly to the

control of adverse events. This analysis underscores the importance

of adopting a holistic and collaborative approach to healthcare,

where the priority is patient well-being and safety, and where the

Patient-Centered Model of Care plays a fundamental role in the

continuous improvement of the quality of care.

The study conducted by Astargo (2016) provides revealing insight

into the detection of adverse events in adult patients who have

been discharged from a Critical Patient Unit. The findings highlight

the high incidence of adverse events during hospitalization,

particularly in patients with prolonged stays. In addition, different

triggers were identified, with care-related triggers being the most

frequent. The surprising revelation that the vast majority of these

adverse events had not been previously reported at the institution

underscores the importance of improving reporting and

surveillance systems to ensure safer and higher quality medical

care.

The study conducted by Panimboza and Pardo (2013) on the

biosafety measures applied by the nursing staff at the Dr. José

Garcés Rodríguez Hospital reveals a mixed picture in terms of

compliance and knowledge of these measures. Although an

acceptable level of knowledge about the principles and use of

personal protective barriers is observed, the results indicate a

significant gap between knowledge and practical application of

biosafety measures. There is a clear need to implement educational

and awareness strategies to improve nursing staff adherence to

these measures and ensure a safer hospital environment for both

patients and healthcare personnel.

The research work led by Peñaloza et al. (2016) highlights the

importance of analyzing the errors made by nursing staff during

medication administration in Latin American hospitals. By

Ángel Antonio Palomino Castillo, Jaime Alexandre Rodríguez Peñafiel

examining the classification of these errors according to patient

safety guidelines, it underscores the need to understand both

failures of action and failures of omission in the planning and

execution of medication administration processes. This approach

not only highlights the importance of attention to detail in clinical

practice, but also highlights the need to implement preventive

measures to minimize the incidence of adverse events related to

medication administration.

In order to advance in the understanding and improvement of the

control and prevention of events in the clinical laboratory process

of the León Becerra Hospital of Guayaquil, it is recommended to

carry out new studies that explore specific aspects of this problem.

Among the possible lines of research, it would be possible to

investigate the effectiveness of training programs aimed at clinical

laboratory personnel, evaluating their impact on the reduction of

adverse events. In addition, it would be relevant to investigate the

underlying causes of the insufficiency of resources and tools for the

prevention of adverse events, as well as to identify effective

strategies to improve their availability and use in the hospital

context. Another aspect to consider would be to investigate the

role of technology and the implementation of quality management

systems in the clinical laboratory to improve early detection and

response to adverse events.

CONCLUSIONES

In conclusion, the results obtained at Hospital León Becerra

transcend the boundaries of the institution, offering an exemplary

model that can inspire and guide other institutions in their quest for

quality and patient safety. By sharing the knowledge gained and

successful strategies developed during this study, a positive change

in the healthcare landscape is promoted, driving towards safer,

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more effective and patient-centered care throughout the healthcare

setting.

Contrasting these findings with previous research, such as the

identification of adverse events, highlights the importance of

addressing identified gaps in training, safety in the identification

and reporting of adverse events, and availability of resources in the

clinical laboratory, all with the purpose of ensuring safe and high

quality care for patients. These findings highlight the need to adopt

a multidisciplinary approach and foster close collaboration between

care teams to address the challenges identified and continuously

improve patient safety in the hospital environment.

The objective of this research study was to provide a theoretical

reference related to quality management of health services, patient

care and safety in the clinical laboratory process, particularly in the

pre-analytical phase; conducted at the León Becerra Hospital in

Guayaquil, which evaluated the effectiveness of control and

prevention of events in the clinical laboratory process. It highlights

the importance of improving safety measures and practical training

of students in clinical settings to ensure safe and high quality care.

In this regard, the study provides valuable information to improve

training programs and ensure that personnel are adequately

prepared to provide safe and effective care in the clinical laboratory

and other health care settings.

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