Revista
de la
Universidad
del Zulia
Fundada en 1947
por el Dr. Jesús Enrique Lossada
77
ANIVERSARIO
DEPÓSITO LEGAL ZU2020000153
ISSN 0041-8811
E-ISSN 2665-0428
Ciencias
Exactas,
Naturales
y de la Salud
Año 15 N° 43
Mayo - Agosto 2024
Tercera Época
Maracaibo-Venezuela
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Quality and Safety Standards in Health Services: Development and
Implementation
Serhii Petryk*
Valentyna Zenkina **
Viacheslav Stepanenko ***
Anatolii Shevchuk ****
Kostiantyn Yurchenko *****
ABSTRACT
Aim. This research work aims to identify the characteristic features of the development and
implementation of quality standards for patient monitoring and safety services in medical
institutions, in order to improve quality based on the developed digital model, and describe the
requirements for the implementation of quality control according to ISO 9001:2015 and ISO
15189:2022 Standards. Methods. The work uses a digital model of the Traumatology Center,
built using the AnyLogic programming environment. This model is designed to identify and
analyze effective solutions for implementation, such as patient registration processes, staffing,
scheduling of specialized departments, identification of clinical characteristics and early
symptoms of diseases to prevent complications during the incubation period. Results. It was
discovered that modern wireless technologies and data analytics can be used to develop a
remote health monitoring system, enabling early detection of chronic diseases to prevent
complications. The scientific novelty of the study consists in the development of a sequence for
the implementation of documentation on standardization and quality of service in medical
institutions to prevent harm to patients, and improve their safety with the help of a complex of
measuring devices and technologies. of the information.
KEYWORDS: Quality improvement, Information technologies, ISO 15189:2022, ISO 9001:2015,
Sensors, Administration requirements, Technical requirements.
* Doctoral Student, Department of National Security, Public Administration and Management, Faculty of Public
Administration, Law and International Relations, Zhytomyr Polytechnic State University, Zhytomyr, Ukraine.
ORCID: https://orcid.org/0009-0002-5766-5313. E-mail: kebpua_dom@ztu.edu.ua
**Associate Professor, Department of Hygiene, Occupational Safety and Health, Bogomolets National Medical
University, Kyiv, Ukraine. ORCID: https://orcid.org/0000-0001-5125-6557. E-mail: v_zenkina@ukr.net
***Associate Professor, Department of Physical Therapy and Occupational Therapy, Lesya Ukrainka Volyn
National University, Lutsk, Ukraine. ORCID: https://orcid.org/0000-0002-8361-5507. E-mail: stlsmu@gmail.com
**** Associate Professor, Department of Emergency and Military Medicine, Vinnytsya National Pirogov
Memorial Medical University, Vinnytsya, Ukraine. ORCID: https://orcid.org/0000-0001-9646-6312. E-mail:
anatoliishevchuk2020@gmail.com
*****Candidate of Technical Sciences, Associate Professor, Deputy Head of the Department of National Security,
Security Institute, Interregional Academy of Personnel Management, Kyiv, Ukraine. ORCID:
https://orcid.org/0000-0003-2054-4307. E-mail: adunkt@gmail.com
Recibido: 24/01/2024 Aceptado: 21/03/2024
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Estándares de calidad y seguridad en servicios de salud: Desarrollo e
implementación
RESUMEN
Objetivo. Este trabajo de investigación tiene como objetivo identificar los rasgos
característicos del desarrollo e implementación de estándares de calidad del servicio de
monitoreo y seguridad del paciente en instituciones médicas, con el fin de mejorar la calidad
con base en el modelo digital desarrollado, y describir los requisitos para la implementación
del control de calidad según Normas ISO 9001:2015 e ISO 15189:2022. Métodos. El trabajo
utiliza un modelo digital del Centro de Traumatología, construido utilizando el entorno de
programación AnyLogic. Este modelo está diseñado para identificar y analizar soluciones
efectivas para su implementación, como procesos de registro de pacientes, dotación de
personal, programación de departamentos especializados, identificación de características
clínicas y síntomas tempranos de enfermedades para prevenir complicaciones durante el
período de incubación. Resultados. Se descubrió que se pueden utilizar tecnologías
inalámbricas modernas y análisis de datos para desarrollar un sistema de monitoreo remoto
de la salud, que permita la detección temprana de enfermedades crónicas para prevenir
complicaciones. La novedad científica del estudio consiste en el desarrollo de una secuencia
para la implementación de documentación sobre estandarización y calidad del servicio en
las instituciones médicas para prevenir daños a los pacientes, y mejorar su seguridad con la
ayuda de un complejo de dispositivos de medición y tecnologías de la información.
PALABRAS CLAVE: Mejora de la calidad, Tecnologías de la información, ISO 15189:2022,
ISO 9001:2015, Sensores, Requisitos de la administración, Requisitos técnicos.
Introduction
Health services are an integral part of everyday life for people, as the human body tends
to lose some functional properties of organs, and prevention and rehabilitation play a vital
role in treatment and recovery. However, in providing medical services, it is essential to
consider the trends and changes that involve improving the quality of service in the
provision of medical care and free medication for the preservation of patients' lives, referred
to as medical reform (Pelzang et al., 2019). Medical reforms aimed at improving the quality
of continuous assessment and improvement of medical care for patients are being carried
out in every country worldwide (Berman et al., 2018).
Continuous improvement in the health care system is a challenge for many countries,
especially those undergoing a complex transition from a system where quality was not
considered at an adequate level and outdated service quality standards were not taken into
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account for new developments and implementation to improve quality according to EN ISO
9001 standards. Quality is an integral part of international competition worldwide. From an
economic development perspective in the EU, standardization plays a more significant role
for companies, enterprises, academic and research institutions, laboratories, as well as
certification and inspection bodies, recognizing the importance of standards based on
legislation (McGrath et al., 2021).
Legislation is an effective tool for developing and implementing standards and potential
innovations in the context of rapid scientific and technological development (Lleshi, 2020).
Therefore, ensuring quality requires involving everyone responsible for product and service
development and implementation at each stage of the realization and production process
(Nadziakiewicz et al., 2019).
Standardization activities aim at developing, approving, publishing, and applying
standards per the methodology, principles, and standardization rules. The standards are
developed and published to serve public interests, acting as powerful tools for information
exchange (Halamoda-Kenzaoui et al., 2019).
Thus, for establishing, implementing, and controlling medical service standards, the
management of any healthcare institution should continually reassess the processes for
providing medical services to offer high-quality care to more diverse patient groups.
Modern technologies allow the development and improvement of medical service quality to
prevent and reduce unforeseen events, using computer technologies and systems to enhance
measurements and provide continuous monitoring for patient observation (Giuliano, 2017).
Healthcare institutions are complex structures with a high risk of incidents while
providing medical services. In these institutions, people may become victims of preventable
harm during medical care, raising concerns about global patient safety in such
establishments. Patient safety entails reducing the risk of unnecessary injury during
medical treatment. Some events and circumstances leading to avoidable patient harm are
safety incidents. Also, in some cases, incidents resulting in harm are adverse events. Modern
technologies, along with medical reforms, enable the identification and prevention of
incident occurrences and adverse events aimed at reducing patient harm. Among these
contemporary technologies is a strategy to enhance patient safety, characterized by
information systems and monitoring incidents in the healthcare sector (Silva et al., 2021).
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Patient involvement plays a crucial role in improving service quality to regulate and
prevent harm cases, as it facilitates the identification of existing or potential medical issues,
providing valuable insights for developing medical services. This concept allows for
anticipating qualitative outcomes and service effectiveness while efficiently reducing
patient injuries and associated medical expenses, significantly improving health status
(Han et al., 2023).
Supervision and monitoring represent separate processes in patient care. Monitoring
involves the observation, measurement, and recording of physiological parameters.
Meanwhile, supervision is a systematic, purposeful process based on early detection of
signs of change, interpretation of the clinical consequences of such changes, and initiation
of prompt appropriate intervention. Monitoring relies on observation and evaluation, while
nursing supervision involves monitoring with the recognition and interpretation of the
clinical implications of changes to make decisions about further actions (Giuliano, 2017).
The development and implementation of medical information technologies (IT) within
a complex adaptive healthcare system (integrated with all aspects of medical service
delivery) possess significant potential for improving medical care. However, it may also be
accompanied by unforeseen consequences and new safety problems, necessitating a more
detailed study (Sittig et al., 2020). Therefore, a significant challenge for enhancing patient
safety in healthcare systems using IT lies in developing and implementing evidence-based
strategies for investigating safety issues in healthcare and patient safety (Singh et al., 2016).
As noted by the Institute of Medicine, "Medical information technologies, if properly
developed, implemented, and used, can be a positive factor in transforming the way
healthcare is delivered." Hence, medical IT holds significant potential for increasing service
efficiency, enhancing healthcare quality, cost-saving, and patient engagement during
medical service provision (Wienert et al., 2019).
The development and implementation of service quality, monitoring, and patient safety
standards have significantly impacted the COVID-19 pandemic. They led to increased
demands on the work of doctors and medical personnel concerning patients care. The
pandemic presented an unexpected opportunity to elevate patient safety, involving patient
monitoring for harm and various approaches to prevent injury related to the specific
location of patient treatment in the hospital (Pronovost, 2022).
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The purpose of this study is to identify and develop standards for the quality of medical
care, monitoring, and patient safety in order to improve the effectiveness of medical care
and ensure patient safety. At the same time, the main attention is paid to the improvement
of medical care processes, as well as the development and implementation of new methods
and technologies to ensure the quality of medical care. Also, the research involves the
analysis and improvement of the management processes of medical institutions, taking into
account modern digital technologies and monitoring systems.
1. Problem statement
Monitoring and patient safety during the provision of medical services demand
increasing scientific research utilizing modern technologies to develop and implement new
quality control standards aimed at delivering effective healthcare services by medical
institutions. However, it is essential to analyze the interrelation of applying international
standards to develop an efficient strategy for planning and utilizing an appropriate
methodology concerning standardization. For instance, to implement new quality systems,
it is necessary to identify critical factors and requirements through which medical staff
could enhance service quality while providing medical assistance.
It is necessary to pay attention to the current (existing) quality control standards to
study the implementation issues and realization of guidelines, instructions, and standards.
As known, the development of contemporary documentation covering all necessary
implementation conditions is outlined in the quality service standard ISO 9001:2015 -
Quality Management Systems – Requirements. This standard applies to all existing activity
domains, including enterprises, companies, and private structures on a national level. Based
on this standard, ISO 15189:2022 - Medical laboratories - Particular requirements for
quality and competence have been developed. They reflect adherence and fulfillment of
requirements by medical personnel.
Therefore, it is vital to scrutinize available sources and standards describing the
methodology of conducting various procedures and operations to analyze potential
challenges in implementing monitoring and patient safety standards.
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2. Literature review
The World Health Organization defines patient safety as the absence of harm to
patients that can be prevented and aims to prevent unnecessary harm from medical
practitioners. It is reported that unsafe medical care results in the loss of 64 million years of
life with a disability annually worldwide. Patient harm during medical care is recognized as
one of the top 10 leading causes of disability and mortality globally (Vaismoradi et al., 2020).
The dynamic development of digital technologies provides opportunities for improving
the healthcare system, particularly in ensuring patient safety. According to the World
Health Organization, electronic tools will play a crucial role in enhancing safety, especially
in areas such as:
− using electronic health records for more accurate and comprehensive patient
tracking;
− timely and reliable exchange of medical data;
− supporting diagnosis, monitoring, and treatment of illnesses and conditions;
− behavior modification and reducing health risks;
− expanding patient and family involvement in self-care;
− facilitating communication between healthcare professionals to reduce errors and
improve coordination;
− reducing unnecessary consultations and hospitalizations;
− improving access to health knowledge and management for both specialists and
patients (Dymyt, 2020).
Modern information technologies allow data collection from various sources and
locations, such as monitors and bedside devices, as well as through physically separated
computers. The volume of such data can be vast and complex to process. Accessing and
integrating the data required for decision-making can be time-consuming and complicated
due to multiple system inputs, the need to use different computers for specific tasks, and
sources being occupied or unavailable for other reasons, leading to information flow delays
(Flohr et al., 2018).
The emergence and implementation of wireless networks using body sensors enable
continuous patient health monitoring without disrupting their daily activities while
transmitting real-time health information through wireless networks (Classen et al., 2021).
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Implementing such technology can develop a framework for remote health monitoring,
intelligent accident detection, real-time notifications, rapid response alerts, and optimizing
traffic for emergency assistance.
A pre-pandemic report hypothesized that routine monitoring of hospitalized patients
using continuous pulse oximetry and heart rate measurement devices was associated with
reduced mortality (Sullivan et al., 2022). Although there is limited evidence that patient
monitoring with COVID-19 in hospital wards improves treatment outcomes, it is likely that
enhanced patient monitoring outside intensive care units may have benefits (Pronovost et
al., 2022).
Continuous remote monitoring of hospitalized patients in general medical facilities
improves treatment outcomes. Also, when integrated into electronic medical records, it
enhances accuracy and reduces the burden on overworked and resource-constrained
personnel by automating tasks that must be performed several times a day for each patient
(Burgers et al., 2020). The patient safety monitoring system has achieved a stability level,
making it useful for consistently measuring inpatient safety.
3. Aims
The study aims to identify the features of developing and implementing service quality
standards for patient monitoring and safety in medical institutions. That will help to
improve the quality based on the developed digital model and description of requirements
for quality control implementation using ISO 9001:2015 and ISO 15189:2022 standards.
The following tasks need to be addressed to achieve the set goals:
− to conduct a literature review on patient monitoring and safety in healthcare
institutions.
− to analyze the use of international standards for developing and implementing
safety enhancement and quality control guidelines.
− to identify characteristic management and technical requirements according to
existing standards.
− to analyze the use of modern information technologies with monitoring devices
and instruments for patient safety.
The scientific novelty of this research lies in developing a sequence for implementing
documentation related to standardization and service quality in healthcare institutions to
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avoid harm to patients and enhance patient safety by utilizing a complex of measuring
devices and information technologies.
4. Methods and materials
4.1. The use of monitoring and security software
The research model considers a digital model of a traumatology center, which was
constructed using the AnyLogic software environment. The built digital model reflects the
features of monitoring medical staff and patients. For instance, these include their
movements, service delivery, and procedures performed by the specialists. Theoretical and
practical materials enable the combination of production processes with the provision of
medical services in the digital model for their reproduction in the software environment
using information technologies. Sensors (e.g., pulse, temperature, etc.) and monitors with
cameras can be utilized for transformation. They allow easy tracking of patients and
medical personnel's movements within the premises.
4.2. The main standards of quality control for health services
The main standards used in the design and implementation of service quality
improvement are ISO 9001:2015 Quality management systems - Requirements (Source: ISO
9001:2015) and ISO 15189:2022 Medical laboratories - Specific requirements for quality and
competence, which is based on ISO-9001 (Source: ISO 15189:2022). The implementation of
the international standard ISO 15189:2022 (the outdated previous version of ISO 15189:2012)
is the basis for quality assurance for healthcare facilities with laboratory environments.
ISO-9001:2015 is an international standard that describes the requirements for
managing a quality control system and contains a list of recommendations for process
approaches to developing, implementing, and improving the performance of a quality
management system (QMS). The process approach is based on the "Plan - Do - Check - Act"
methodology used to improve the QMS continuously. Therefore, in designing and
implementing healthcare services, this standard plays a vital role in healthcare reforms and
quality improvement in healthcare facilities.
ISO 15189 is an international standard defining specific medical laboratory and facility
requirements. A particular difference from ISO 9001 is that, in addition to management
requirements, it also contains technical requirements. It includes requirements for
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personnel, environmental conditions, equipment and supplies, analytical and procedural
requirements, and addresses all quality aspects. The management requirements and
technical requirements are summarized in Table 1. They reflect the main characteristics to
improve the quality system of a healthcare facility.
Table 1.
Requirements for administration and technical standards according to ISO
15189:2022
A complex of general requirements according to ISO 15189:2022
1. Administration requirements
2. Technical standards
Organization and administration
Living and environmental conditions
Quality control system
Laboratory equipment
Document control
Preliminary examination procedures
Verification of contracts
Expert proceedings
Verification by reference laboratories
Ensuring the quality of expert
procedures
External services and supplies
Follow-up procedures
Advisory services
Reporting on the results
Complaint handling
Identification and control of non-conformities
Corrective actions
Preventive actions
Constant improvement
Quality improvement
Quality and technical documentation
Internal audit
Analysis by the management team
Source: (Allen, 2013, p. 1188).
The Institute for Quality Management in Healthcare (IQMH, formerly QMP-LS - the
Quality Management Program - Laboratory Services) is engaged in the accreditation and
testing of laboratories. This is a mandatory prerequisite for licensing and providing medical
laboratories with training and resource materials, as well as for developing an accreditation
program and external evaluation.
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APLAC is a regional body of the International Laboratory Accreditation Cooperation
(ILAC), which promotes the harmonization of accreditation practices with ISO standards.
The accreditations granted by respective bodies that have signed the MRA are recognized
worldwide.
Therefore, based on the developed digital monitoring model and the use of existing
standards, it is necessary to analyze the administrative and technical requirements of
medical staff more closely. It is crucial to determine the feasibility of implementing a quality
control system with patient tracking that can effectively serve to avoid unwanted harm to
both patients and medical staff. For this reason, the latest technologies and innovations in
healthcare provision include management tools, products, and processes aimed at
improving the quality and efficiency of services provided in these patient care settings
(Silva et al., 2021).
5. Results
Let us take a closer look at the requirements for medical personnel management (Table
1) and compliance with technical standards (Table 2) based on ISO 15189:2022. These
requirements contain a list of items to be fulfilled as per the standard to ensure quality
control of a medical laboratory to provide medical services to patients. Standardization, in
this case, is aimed at the elaboration and implementation of guidelines, instructions, and
improvement of existing standards for compliance with the requirements of high-quality
service by medical personnel.
Table 2.
Requirements for medical institution administration
The facility's laboratory has an organizational chart, and responsibilities
are assigned to medical staff. The laboratory has effective
communication processes.
Processes and procedures are documented, implemented, and shared
with staff, including a program for calibration and maintenance of
existing equipment, reagents, and systems.
The laboratory has an effective document control system, including a
document-control log that lists the current versions in effect and their
distribution. All documents are uniquely identified and authorized for
their release. Employees are not allowed to use outdated documents. The
staff has up-to-date, approved records available for use.
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The requirements are set out following the contracts of the laboratories
that provide referrals.
A register of all specimens sent by the sending laboratory allows for
tracking of returned results and helps in the event of sample loss. The
sending laboratory is responsible for ensuring that the results are
communicated to the person who made the request.
Procurement and inventory procedures ensure that staff handles and
stores consumables consistently. Inspection of all consumables
(calibration devices, reagents, and control devices) prior to their use
minimizes the potential for errors during usage.
Medical staff have mechanisms for making personal contributions to the
services provided by the laboratory.
The process of recording, investigating, and addressing complaints,
which are documented and analyzed for corrective action.
The process of investigating, handling, and correcting any non-
compliance with the implemented requirements. The procedures for
disclosing the results in case of non-compliance are involved.
Processes for conducting corrective investigation actions, including
action plans and root cause analysis that have been implemented.
Potential sources of non-compliance and how they can be improved
through documented research and analysis to produce a preventive
action report.
Laboratory procedures are systematically reviewed at regular intervals to
identify potential sources of non-conformance. If non-conformities are
identified, laboratory management develops, documents, implements,
and reviews improvement action plans. The quality indicators are
established and monitored, and opportunities for improvement are
considered.
Under this requirement, all records are arranged and stored securely as
per the respective conditions.
Verification of all operations (transactions and services) for compliance
with QMS requirements. The internal audits of the QMS and technical
procedures are conducted regularly to verify their compliance with the
QMS requirements.
The management assessment process ensures the ongoing suitability and
effectiveness of the QMS. The management assessment includes
evaluating the status of all the above steps.
Source: (Allen, 2013, pp. 1190-1191).
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The digital model of the traumatology center consists of several sections, namely:
− the visitors' entrance block;
− the ambulance entrance block;
− the patient care block;
− the discharge block;
− the waiting hall block,
− the express aid block;
− the emergency aid block;
− the admission block.
Such a center can serve more than 200 patients daily and approximately 40-50
thousand patients annually. The model is designed to include a regular emergency care
department and a special emergency care department operating only during increased
workload periods. The model is developed to analyze the effectiveness of various
improvements, such as patient registration processes, staff scheduling, and special
department scheduling, as well as to identify clinical characteristics and early symptoms of
illnesses to avoid complications during the disease incubation period.
Figure 1 illustrates the functioning of the traumatology center in 3D and 2D, displaying
all the aforementioned blocks. However, it is worth noting that the radiology scanning
block serves to detect joint fracture pathologies in patients. Typically, such blocks do not
have information and measuring equipment that uses information technologies.
As a result of technological advancements, modern wireless technologies, and data
analysis, information collection sensors can be used as a system that can serve for remote
health monitoring. The wireless sensor network consists of sensor nodes that collect data
on the patient's physical health, process it, and transmit it using wireless technology. It
enables early detection of chronic illnesses to prevent complications, such as asthma, heart
attacks, diabetes, gastrointestinal infections, viral diseases during the incubation period,
and more.
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Figure 1. A digital model of a traumatology center.
Figure 2 shows the application of electronic devices with the following sensors:
− the electrocardiogram (ECG) sensor;
− carbon dioxide (CO2) sensor;
− humidity sensor;
− temperature sensor;
− blood glucose sensor;
− pulse sensor;
− arterial pressure sensor;
− motion sensor, etc.
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Figure 2. Application of information technology-based electronic devices and sensors for
monitoring and security
Source: (Singh et al., 2021).
These sensors can be implemented for everyday use and are also integrated with
other electronic devices such as smartphones, fitness bracelets, and so on.
Suppose such concepts can be visualized in 3D. In that case, it is possible to see how
the use of sensors and electronic devices can avoid undesirable consequences of harm and
illness to patients with respiratory diseases, for example, in the case of the COVID-19
pandemic. Figure 3 shows how a potential patient with respiratory disease can be tracked
remotely by using information technologies.
The analysis of the digital model of the traumatology center and its management
requirements with the technical specifications suggests that each section in Figure 1 should
be implemented based on a Quality of Care Standard. For example, it should consider the
requirements for implementation with appropriate equipment, devices, and facilities for the
provision of medical care (item 3 in Table 3), with a preliminary examination procedure for
collecting laboratory samples of the patient (item 4 in Table 3). This should ensure that the
procedure is complete and performed in a standardized manner (item 5 in Table 3).
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Figure 3. An example of using motion, pressure, and temperature sensors.
Table 3. Technical requirements for medical personnel
Personnel
Implementation of recruitment, training, skills assessment, performance
evaluation, and continuous learning procedures. Job descriptions are
available for all staff jobs. Training records are maintained to ensure that
staff have received the appropriate training. Staff competency assessments
and appraisals are conducted regularly. The management assessment
process provides the ongoing suitability and effectiveness of the QMS. The
management assessment includes evaluating the status of all the above
steps.
Living
conditions
and
environment
The environmental conditions are the temperature and humidity in the
laboratory, assessed as suitable for the optimum functioning of the
equipment. The laboratory has sufficient space, lighting and is free of
hazards. The sample collection area meets the requirements of confidentiality
and accessibility for patients with disabilities.
Laboratory
equipment
The laboratory has sufficient equipment to meet service requirements. There
are procedures for the selection, installation, calibration, operation,
maintenance, service and preventive maintenance, and taking equipment out
of service. The records that include maintenance and service, preventative
maintenance, equipment and safety checks, and calibration checks for
equipment (including small laboratory equipment such as pipettes,
thermometers, timers, and clocks) are filled out. An equipment logbook is a
useful way to document equipment requirements.
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Preliminary
examination
procedures
The Laboratory Sample Collection Manual contains procedures for all
aspects of the preliminary examination process, including ordering tests,
identifying patients, collecting, transporting, accessing, and storing the
samples. The logging of all samples received in the laboratory ensures that
results are reported for all items and helps to locate lost or misplaced
samples.
Research
procedures
The lab procedures for the tests are complete, standardized, accessible to
staff, and based on the manufacturer's guidelines. All procedures have
been validated prior to use, and shortened procedures are subject to a
document control. The procedures for all aspects of laboratory work help
with training, troubleshooting, and process updates.
Ensuring the
quality of
expertise
procedures
Quality control and external quality assessment programs are in place for
all testing procedures. All issues and non-conformities are documented,
analyzed, and responded to with a corrective action. Cross-instrument
comparisons are performed across all platforms.
Follow-up
procedures
There are appropriate processes to verify and report laboratory results.
The samples are stored appropriately for retesting if necessary. All samples
are disposed of safely.
Reporting on
the results
Patient records contain all the necessary information. The reports use
standardized vocabulary and nomenclature. The results are legible, with
no transcription errors, and there is a process for reviewing transcribed
results. The deadlines for results submission are set. The critical values are
established, and there is a procedure for reporting on essential values.
Report changes are clearly defined.
Source: (Allen, 2013, pp. 1191-1192).
Following the research procedure, verifying and publishing the laboratory research
results (item 6) and ultimately providing a report to the patient (item 7) is necessary.
Monitoring plays a significant role in this model to prevent infections, as some
patients may be infected without realizing it during the incubation period. In the case of a
COVID-19 pandemic, this would help avoid mass gatherings among infected patients
seeking medical assistance, thus protecting other patients and medical staff from exposure.
Utilizing information technology with sensors through monitoring and notification
systems can prevent undesirable health consequences for people.
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6. Discussion
After analyzing ISO 15189 standards, it becomes evident that various requirements
demand precise details. For this purpose, multiple standards support a medical laboratory
while implementing a management system that complies with ISO 15189. These standards
typically provide more detailed information to demonstrate compliance of critical processes
with the standard's requirements and guide the laboratory in planning and implementing
measures to manage risks and opportunities associated with various processes. They form
the basis for enhancing the management system's effectiveness, achieving better outcomes,
and preventing adverse consequences that could harm patients, laboratory staff, and the
surrounding environment (Fedele et al., 2022).
In the research by Sittig D. F. & Singh H. (2020), the authors argue that the safety of
medical information technologies requires more significant improvement. Even though
scientific knowledge may improve over the time, much remains to be learned and
researched. This challenges the key tasks that need to be accomplished before it is possible
to count on the safe, reliable, and efficient IT-based systems that are required to deliver
patient care.
A key challenge to improving security in healthcare systems that use medical
information technologies is to develop reasonable and feasible strategies to measure
security issues at the intersection of medical IT and patient safety (Wienert, 2019).
In response to the fundamental conceptual and methodological gaps related to the
definition and measurement of patient safety connected to health IT, Singh H. & Sittig D. F.
(2016) developed the Healthcare IT Security measurement framework (HITS) to provide a
conceptual framework for measuring, monitoring, and improving patient safety related to
healthcare IT. The HITS framework is consistent with both continuous quality
improvement (CQI) and socio-technical approaches. It calls for new actions and
measurement activities to address safety concerns within three related areas:
− the issues that are unique and technology-specific (to address challenges related
to insecure health IT that arise from unavailability or defective hardware or software);
− the problems arising from improper use or misuse of a healthcare IT (reducing the
number of unpleasant notifications in the electronic medical record (EMR));
− the use of health IT to monitor risks, processes, and outcomes of healthcare
delivery and identify potential security issues before they can harm patients (the use of
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algorithms based on electronic health record data to identify patients at risk of medication
errors or delays in medical aid).
The joint development of forms for reporting, investigating, and monitoring
healthcare incidents, as well as the development of a prototype as a tool, are contributing to
the creation of an information system. It will facilitate data collection on incident reporting
and investigation and will also be able to monitor indicators through the reporting process.
The development of the information system is ongoing, and the validation process will be
carried out at each screen and stage of development, namely: user registration, notification
screens, research screens, dashboard, as well as data export and reporting functions (Silva
et al., 2021).
In the study by Nadziakiewicz M. & Mikolajczyk A. (2019), the authors present the
quality, safety, and quality assessment system as essential tools for supervising a healthcare
organization. Quality comprises a set of properties and characteristics of a product, process,
or service that meet the specified requirements. However, in the case of healthcare, it is
difficult to assess the level of quality. Therefore, common indicators become a useful tool,
and the development of such quality indicators requires both data collection and its proper
processing. The high quality of medical services requires constant improvement and
adaptation to the patient's needs.
Therefore, after analyzing this paper, it is possible to conclude that the developed
digital model and the requirements for quality control are the same set of properties and
features of services during the treatment that meet the specified requirements according to
the international standard ISO 15189 (Source: ISO 15189:2022).
Conclusion
Healthcare and rehabilitation services are undergoing significant changes due to the
improvement of the existing methods, as well as the elaboration and implementation of
new quality assessment systems, which affect the improvement of the efficiency of medical
assistance. Even though the modern world has undergone transformational changes from
the computer to information technologies, some research methods also allow combining
information technologies with modern capabilities. For example, it becomes possible by
linking electronic devices and equipment with the human body via digital technologies,
such as sensors, electronic bracelets, etc.
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This article describes the possibility of using digital technologies to ensure
monitoring and safety during medical treatment. This involves the application of
international standards ISO 9001 and ISO 15189, which are the main standards for
implementing a quality system in healthcare facilities. ISO-9001:2015 is an international
standard that describes the requirements for managing a quality management system and
contains a list of recommendations for process approaches to developing, implementing,
and improving the performance of a Quality Management System. The international
standard ISO 15189 defines specific requirements for medical laboratories and facilities. The
standard contains management and technical requirements, including requirements for
facility personnel, environmental conditions, equipment and supplies, and analytical and
procedural requirements. It also considers compliance with all quality aspects.
The digital model of the traumatology center was developed to identify and analyze
effective solutions for its implementation. For example, this model includes the process of
patients' registration, staff scheduling, and special department scheduling, as well as
identifying clinical indicators and early symptoms of the disease to avoid any complications
during the incubation stage of the disease.
Due to modern wireless technologies and data analysis, the sensors can be used as a
system that can serve for remote health monitoring. A wireless sensor network contains
sensor nodes that collect data about a patient's physical health, process it, and then send it
via wireless technology. This, in turn, allows for early detection of chronic diseases to
prevent their complications.
Monitoring plays a significant role in this model for avoiding infection, as some
patients may be infected without realizing it during the incubation period. In the case of
the COVID-19 pandemic, this would help to avoid massive crowds of infected patients
seeking medical assistance, which could endanger other people around them and the
medical staff. With the help of information technology involving sensors, monitoring, and
information systems can help to avoid undesirable consequences that are harmful to human
health. Thus, the development of a digital model with the considered requirements for its
implementation can serve as a basis for future research on safety and health issues during
the provision of medical services in the case of a pandemic.
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