Details of HIL test system specification [9].
\r\n\t
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Venkateswarlu",coverURL:"https://cdn.intechopen.com/books/images_new/371.jpg",editedByType:"Edited by",editors:[{id:"58592",title:"Dr.",name:"Arun",surname:"Shanker",slug:"arun-shanker",fullName:"Arun Shanker"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"878",title:"Phytochemicals",subtitle:"A Global Perspective of Their Role in Nutrition and Health",isOpenForSubmission:!1,hash:"ec77671f63975ef2d16192897deb6835",slug:"phytochemicals-a-global-perspective-of-their-role-in-nutrition-and-health",bookSignature:"Venketeshwer Rao",coverURL:"https://cdn.intechopen.com/books/images_new/878.jpg",editedByType:"Edited by",editors:[{id:"82663",title:"Dr.",name:"Venketeshwer",surname:"Rao",slug:"venketeshwer-rao",fullName:"Venketeshwer Rao"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}},{type:"book",id:"4816",title:"Face Recognition",subtitle:null,isOpenForSubmission:!1,hash:"146063b5359146b7718ea86bad47c8eb",slug:"face_recognition",bookSignature:"Kresimir Delac and Mislav Grgic",coverURL:"https://cdn.intechopen.com/books/images_new/4816.jpg",editedByType:"Edited by",editors:[{id:"528",title:"Dr.",name:"Kresimir",surname:"Delac",slug:"kresimir-delac",fullName:"Kresimir Delac"}],productType:{id:"1",chapterContentType:"chapter",authoredCaption:"Edited by"}}]},chapter:{item:{type:"chapter",id:"61412",title:"Model Based System Design for Electric Vehicle Conversion",doi:"10.5772/intechopen.77265",slug:"model-based-system-design-for-electric-vehicle-conversion",body:'Development in EV conversion has been vastly improved in the recent year. However, different vehicle models have different technical specifications, so conversion kits for each one of them have to be customized in order to meet the specific requirement such as range per charge and acceleration performance. Engineers, therefore, have to make the decision on the capacity of batteries and also how many of them are required to meet the driving demand. Moreover, selection of different types of motor is also presented as the main requirement [1]. Normal design process would require high-end expensive software to model the EV system. Furthermore, building the EV without the knowledge of the parameters within the system could costly lead to the failure of the design.
In addition, poor vehicle performance safety and reliability might occur when new electric propulsion characteristics do not match with the characteristics of replaced engine sharing the same chassis.
Therefore, a sub-ECU must be developed to harmonize EV propulsion dynamics and existing vehicle chassis characteristics called drive-by-wire (DBW) [2]. DBW functionality can then improve EV drivability by providing power demand to the electric motor drive according to the driver preference. However, installation of the DBW ECU without appropriate functional safety design and evaluation could induce such system failures or component malfunctions due to unpredicted behaviors during actual driving situations. Therefore, during the initial development process, ECU functions are needed to be established and evaluated against design and functional safety aspects beforehand [3, 4].
To improve EV conversion development process, model-based design process is shown in Figure 1. The method would benefit the design engineer in making better decision for the conversion and also saving time and cost by reducing error during the design process [5, 6, 7]. The process can be employed to perform system simulation based on different scenarios and technical specification. Embedded system and DBW ECU can be realized by software rapid auto coding to shorten error correction and debugging time. Virtual prototyping test can be employed to validate design requirement and EV conversion specification. The in-the-loop tests can ensure accurate implementation of both software and hardware ECU for the conversion using real-time verification methodology.
Model-based design process for EV conversion.
In this literature, the first model-based design for EV conversion prototyping development, which describes electric vehicle modeling including EV traction, EV components, and power flow models, is defined. Then, drive-by-wire ECU design and in-the-loop testing for EV conversion process are described in details. The last section illustrates versatility of model-based design in EV conversion tuning and diagnostic application.
In order to set up the simulation of EV, mathematical models have to be generated first from the engineering principles and theories. The four core models are traction model, motor model, battery model, and power flow model as follows.
Forces acting on the vehicle govern the equation for vehicle traction as seen in Figure 2. Those forces comprised of tractive forces
The force components involved in the vehicle traction.
The governing relation can be found in Eq. (1) where traction needs to overcome the load that is equal to five other forces:
where equation for each force components can be employed from many sources such as reference [2, 4] and other automotive textbooks.
In the EV conversion system, the motor replaces the internal combustion engine (ICE) in providing the torque to drive the wheel as shown in Figure 3, which also affects the traction of the vehicle. The motor torque, speed, and efficiency equation are presented in Eqs. (2), (3), and (4), respectively.
The EV motor provides the traction to the vehicle through transmission.
- Motor torque
- Motor angular speed
- Motor efficiency
where
Battery’s dynamic behavior does have a great effect on EV performance and range. Three common types of batteries, which are lead acid, nickel cadmium, and lithium ion batteries, are governed by Eqs. (5), (6), and (7) here, respectively. As seen in [4, 6], open-circuit voltage
- Lead acid:
- Nickel cadmium:
- Li-ion:
(nominal cell voltage = 3.3 V up to 80% DoD)
where
The open-circuit voltage also affects the battery current
- Battery current discharge operating at power
- Battery current charge during regenerative braking
where
- Total charge removed from battery by the nth step of the simulation
- The depth of discharged
- Charge removed for regenerative braking
To complete the simulation, the integrated power flow model is necessary to compute and update the rate of energy going in and out of battery cells, accessories, the motor, gearing components, and wheel to the road and back. Therefore, the model needs to be capable of mathematically simulating the power flow in both driving and braking as shown in Figure 4.
Diagram show power flow in/out components within the EV system for both normal forward driving and regenerative braking operations [6].
Traction model provides the power flow between the vehicle and the road
- Energy required per second:
- Motor power in driving mode:
- Motor power in braking mode:
- Battery power:
Models described in the previous section, especially traction model, are employed to simulate the electric vehicle conversion (EVC) performance by obtaining the velocity plot. The vehicle model specifications are approximately used as the input for the simulation. Other inputs are motor specification and road condition where Refs. [2, 4, 8] explained this specification in details.
The traction model is reduced to nonlinear first-order differential forms in [6, 8] when all inputs are substituted. Then, differential equation of velocity is numerically solved using the MATLAB script (.m) file for each time step and updates the values in the program arrays. The out velocity can be plotted against time. The EVC performance here is specified as the time for vehicle to accelerate from 0 to 100 km/h.
The other important piece of information for the EV design is range per charge, which tells us how far the vehicle can travel before it needs to be recharged again. In order to obtain such information, the motor model, battery model, and power flow model introduced in the previous section are applied here along with additional inputs. Driving cycle needs to be reasonably selected to simulate the driving dynamics. For present simulation, simplified federal urban driving cycle (SFUD) in [6] is chosen since the vehicle is expected to be driven in the urban area most of the time. The main program [6, 8] is employed to call inputs, including vehicle specification and driving cycle, and then execute the power flow model and battery model for each driving cycle and update parameters, such as range and DoD simultaneously. The range per charge then can be plotted when the program is done executing the program. Scenarios for EV range design can be explored using this simulation procedure [6, 8].
EV design parameters shown in the list below can be easily obtained using the simulation done earlier. To obtain such information, we need to simply write the MATLAB commands in EV main program to update our interested parameters and then write the plot command.
An example of such torque speed map plots is shown in Figure 5, and the vehicle is still operated within the motor power range and maximum torque of 250 Nm. The constant torque region is quite small compared to the field weakening region. The plot also reveals that low motor speed is mostly required when driving in the urban area.
Torque speed map of EVC with SFUD driving cycle and no regenerative braking mode.
In current EV conversion development as shown in Figure 6, drive-by-wire (DBW) functions were developed by means of model-based design approach to synchronize the EV driving characteristics and to improve its drivability. The process starts by setting up parameters and variables for conceptual ECU system requirements. Then, the ECU I/O and signals for communications are formulated. Here, both software functions and embedded hardware design for DBW ECU should be completely determined. The next process is to virtually test DBW ECU against requirements’ virtually simulated environment. In this process, the main functionalities along with faulty software or malfunction situation for the ECU can be tested. Bug in the software or communication can be tested and tuned safely with this in-the-loop testing methodology throughout the development process.
Novel methodology for rapid and safe EV software and hardware development [9].
The main function of conceptual drive-by-wire ECU developed by [2] is to determine power demand from the driver, through vehicle supervisory control ECU, based on the pedal ratio in percentage as shown in Figure 7 and software algorithm. Next, percent pedal kickdown signal is sent to DWW ECU for torque command and regenerative percentage setting based on power to torque calculation and motor speed signals [9] in rule-based control algorithm. The input and output (I/O) parameters employed for DBW software and ECU are presented in Figure 8.
Drive-by-wire ECU functions and signal connection to the supervisory ECU and the motor drive unit [2].
Input and output signal flow of the drive-by-wire ECU with CAN bus interface [2].
Since new characteristics from EV propulsion are applied to the old chassis. New torque map shall be calculated to compensate EV conversion performance. The design process can be reviewed in Ref. [2]. The basic principle is to determine torque setting for various EV driving situations in four quadrants of torque speed map. This methodology can enable the design of more advanced features, such as driving modes, and other advanced driver assistance system (ADAS).
Initial concept of EV software functions can be tested by simulating EV system components and virtual environment of model-based software function test as seen in Figure 9 [4, 10, 11]. Model-based system design of EV component and drive-by-wire algorithm development can be consulted in details in Ref. [2]. In-the-loop models of driving test profile, supervisory control, DBW function, and motor are developed by using simulation software such as MATLAB/Simulink or others to emulate EV parameters and communication between the ECU and the driving load from vehicle dynamic model. System design requirement can be verified in this MBSF testing stage, such as toque map, and driving mode tests, which can be done by setting up driving test profile and run the simulation for analysis. However, its capability is not as effective as real-time simulation, which is presented in Section 3.4.
Model-based software function test setup where drive-by-wire function model is connected within the loop with other joint models [9].
Simulation results from model-in-the-loop test can be analyzed to verify whether system requirements are met. Driving profile in Figure 14 can be set in several driving schedules as seen in Figure 10. After simulation is performed for DBW function, the parameters such as torque speed curve can be analyzed to check EV output such as performance in driving quadrants in Figure 10.
EV torque speed in four-quadrant driving results for analysis by means of model-in-the-loop simulation [8].
Without actual driving, DBW parameters resulted from simulation can be analyzed in different scenarios such as forward driving and reverse driving. Major error can be corrected at this stage along with fault-tolerant function test such as limp home mode in case the DBW is disconnected or malfunctioned.
When ECU hardware is ready for testing, software can embed into the ECU to operate in real-time environment. The process is called hardware-in-the-loop (HIL) test when the drive-by-wire software algorithm is replaced by a physical ECU hardware while still connected to virtual environment as seen in Figure 11. Thus, HIL components consisted of an actual hardware, real-time interface, and virtual environments (models). It requires a capable communication protocol to handle real-time signal process where CAN protocol is chosen for this HIL System [12, 13, 14, 15, 16, 17]. The overall specification of HIL system can be found in Table 1.
Hardware-in-the-loop (HIL) test configuration for drive-by-wire (DBW) ECU [9].
Components | Specification |
---|---|
Drive-by-wire ECU | Real-time rapid prototyping board |
CPU: ARM Cortex-M4 32bits 168 MHz | |
RAM: 8 Mb | |
Vehicle dynamic and driving profile real-time applications | Real-time processor board |
CPU: ARM Cortex-M4 32bits 168 MHz | |
RAM: 8 Mb | |
Real-time platform | MathWork Simulink real-time workshop |
Interface | CAN bus 2.0 (high speed) |
Baud rate: 500 kBaud | |
Physical connection | CAN: DB9 connector |
Power supply | 12 V terminal |
Protocol sampling time | 10 ms |
Details of HIL test system specification [9].
Arrangement of HIL configuration allows the engineers to conduct test for DBW ECU where it is difficult to perform with the actual vehicle. EV fault and malfunction scenarios can be simulated within the system to check ECU resiliency and fault-tolerant setting. Test repetition and automation can simply be done by scheduling HIL system. Therefore, it helps to reduce testing time and test cases required for real driving. ECU performance testing can be conducted for EV high speed where it is difficult for real driving test. All model and ECU parameters can be adjusted simultaneously during the test, in real time, enabling more accurate parameter tuning. Therefore, system requirements can be verified in real time in this process.
To perform DBW ECU HIL test for this work, Simulink real-time workshop toolbox is chosen along with real-time application module for driving profile and vehicle dynamics, and CAN protocol is set for PC and ECU real-time interface as seen in Figure 12. Simple driving profile for this specific DBW test consists of different driving patterns to represent accelerator pressing by the driver in Figure 13. More complicated driving profile can be designated based on test scenarios and particular interest.
Hardware component integration setup for ECU function tests [9].
Driving profile test profile based on accelerator pedal position [9].
Based on the driving profile, the test results can be analyzed. In-depth test analysis can be consulted in Ref. [9]. In this case, performance parameters such as vehicle speed and acceleration are monitored for ECU validation.
Model-based design can be employed to simulate scenarios where problem might occur during EV conversion process or to figure out the root cause of the problem [18]. The problem can then be realized beforehand by scenario test run to prevent the damage of the EV components and saving time to reinstall new part. The examples of model-based design for tuning and diagnostics can be demonstrated below.
This problem can occur during test run of EV conversion prototype where the motor drive converter becomes too hot during initial run of the EV. This problem forces the drive component to shut down to prevent circuit overheat. Therefore, the EV has to stop early to be checked. The torque map simulation can be executed to check whether there is mismatch between driving load and motor sizing as seen in Figure 14 or there is some serge in current during EV driving simulation due to poor EV conversion system design as seen Figure 15.
EV torque map results show mismatch in driving load vs. motor power.
EV simulation show excess current drawn from batteries during some period of EV driving.
For the simplicity of modeling, PEM fuel cell with the lower heating value (LHV) plant will be reasonably modeled as a system with approximated value of efficiency [6]. Mass of liquid hydrogen supplied from cryogenic tank is calibrated to provide the same amount of energy supplied when compared to battery source. Because the fuel cell system was employed to entirely replace the batteries, regenerative braking option was not available. Comprehensive review for other types of fuel cell system and hydrogen storage for electric vehicle can be found in Larminie and Lowry’s literature [4, 6]. To model the power flow model for fuel cell electric pickup truck, the battery unit is simply replaced by fuel cell system for one way flow of power since there is no regenerative braking option available. The analysis can be seen in Ref. [8].
Another important aspect for EV reliability is the fault-tolerant function. This is the safety feature when the main components of the EV, such as ECU or sensors, are malfunctioned. It ensures that EV can still provide safe operation, although in an inefficient manner. One scenario is limp home mode where EV can still be driven under limited speed and performance. By employing model-based design, limp home mode scenarios can be simulated and analyzed. As a result, accelerator redundant system can be designed and tested to compensate when fault is detected within the EV system.
Improper installation or configuration of EV components could seriously induce noise and vibration, resulting in damage or shorter lifespan of EV components or undesirable noise level. EV mechanical system model can be simulated at early stage to validate the level of noise, and vibration is acceptable before the actual bench testing. Vibration characteristics such as resonance and force inducted due to rotating unbalance of the motor can be investigated and analyzed by means of model-based system design approach as well. Thus, proper noise and vibration handling method for EV system can be applied to protect and maintain EV components.
Model-based system analysis can be helpful to improve EV conversion system design, software and ECU development, testing, tuning, and diagnostic processes along with the actual EV prototype fabrication. It can also be used as a decision-making tool for future EV customization process. This methodology would benefit for EV conversion not only in terms of saving cost but also to shorten development period. As a result, reliable and low-cost EV conversion can be established.
This work cannot be accomplished without the support from several organizations. I would like to thank my engineering faculty at Naresuan University for establishing DRIVE center and providing budgets for equipment. Furthermore, I am grateful and appreciative for continuously supporting this R&D program from the corporations of EGAT (Electricity Generating Authority of Thailand) and NSTDA (National Science and Technology Development Agency).
Health care over time has become a complex and very careful act, which, in addition to providing users with adequate treatment for their health problems, represents a latent risk since it can cause involuntary damage. This, for obvious reasons, since 2002 the World Health Organization (WHO), requested in Resolution WHA55.18 the member states to pay as much attention as possible to the problem of patient safety [1]. This difficulty being an attenuator over time has become a public health problem that directly impacts the quality of care of users of health services and the fall in their indicators.
This World Alliance, which aims to coordinate, disseminate, and accelerate the improvement of patient safety worldwide, is a means that fosters international collaboration and the adoption of measures among member states, the WHO secretariat, the technical experts and consumers, professionals, and industrial groups [2]. Different studies conducted in our country at different levels of care, such as the ENEAS study, the National Study on Adverse Effects linked to Hospitalization [3], and the Study on Patient Safety in Primary Health Care (APEAS) [4], have quantified the importance of these effects.
Different investigations have been found in relation to patient safety, where the one carried out by Villareal [5] is found, in Third World countries and in those with transition economy; there is evidence that the probability in the occurrence of adverse events is caused due to the poor state of the infrastructure and the equipment, the quality of the medicines, the irregularity in the supply, the deficiency in waste disposal and infection control, and the poor performance of the staff due to lack of motivation or knowledge is insufficient and due to the serious lack of resources to cover essential operating costs.
Also in 2011, Blandón, Gómez, Muñoz, and Zafra [6] carried out a patient safety audit process from the analysis of the adverse event report at the Francisco Luís Jiménez Martínez de Carepa hospital (Antioquia), where flaws were evident in the fulfillment of the processes related to the prevention of events and where improvement activities were proposed in order to minimize and prevent the recurrence of events highlighting the awareness of all personnel prioritizing those who work in the emergency department on adverse events, in addition to developing improvement plans regarding the control of dangerous conditions in the physical environment.
In 2013, an investigation was conducted on safety culture and adverse events in a first-level clinic [7]; this shows the prevalence of adverse events in nursing staff, where the main errors were the lack of communication and techniques of poor application of medications in nursing staff which affects patients in 29.9% producing an adverse event. In 2014 Meléndez Concepción, Garza, González, Castillo, González, and Hernández [8] conducted an investigation on the perception of nurses towards the culture of safety in a pediatric hospital in Mexico, where the average age of the respondents was 49 years old for men, 91% were women, and 70% were general nurses. Nurses believe that the strengths that are available in the hospital are few and that many things are missing to ensure patient safety.
Poma Vanessa [9] developed an investigation with the purpose of contributing to the improvement of quality and safety in the care of patients of the internal medicine service of the Eugenio mirror hospital in the city of Quito, in 2015, for which it was carried out a parallel between the reality evidenced in the service and the national and international quality standards of process and results structure where it could be established that the institution did not meet the specific criteria in terms of structure and results compared to international standards, so which emphasized the safety culture of internal users as well as of patients as a fundamental axis for continuous improvement, revealing not only the failures of the institution but also the responsibility of the collaborators of the institution.
In the IBEAS study, Colombia specifically showed a prevalence of adverse events of 13.1%, 27.3% of the events occurred in children under 15 years, and 27.7% occurred during the performance of a procedure [10] and where it has been estimated by WHO under its studies that one in 10 hospitalized patients suffers an incident that will cause damage during their stay. Studied in countries with medium and high economies, is not yet known in countries with emerging economies, but it is thought that in these, the magnitude of the problem may be even greater [11], which allows to demonstrate that in general terms, health in Colombia is going through a difficult stage in terms of quality.
For its part, the state social enterprise Norte 2 located in the municipality of Caloto, department of Cauca, is a social enterprise of the state that provides health care of low complexity for around 7000 people living in the municipality. This institution as a company that currently provides health services has found that the patient safety protocol established by the Ministry of Health and Social Protection is not being applied under the guidelines of the patient safety policy in Resolution 0112 of 2012. In addition to this, health professionals for unknown reasons do not apply the London protocol and generally do not exercise the functions of inspection, surveillance, and control in order to provide reports in a timely manner, to take corrective actions and relevant improvement to mitigate adverse events that are becoming increasingly evident.
The objective of the present investigation is to identify the adherence of the health personnel of the state social enterprise Norte 2 health institution, Caloto, Cauca, during the first quarter of 2019, in the application of the London protocol, referring to the security policy of the patient, to propose an improvement plan according to the results obtained. In this sense, the application of the London protocol in patient safety policy in the state social enterprise Norte 2 health institution is of vital importance, in order to impact on the improvement of the quality of health care as a systematic tool for a continuous improvement defined in the mandatory quality assurance system, increasing its quality of service making it a competitive entity.
In Colombia, the Ministry of Health and Social Protection [12] defines patient safety as the set of structural elements, processes, instruments, and methodologies based on scientifically proven evidence that tend to minimize the risk of suffering, an adverse event in the process of health care or mitigate its consequences. Under the obligatory system of quality assurance of health care, the country, through its components, seeks and promotes a patient safety policy whose objective is to prevent the occurrence of situations that affect patient safety and reduce and if possible eliminate the occurrence of adverse events to have safe and competitive institutions internationally [13].
In addition to this, Resolution 2003 of 2014 [14] dictates the design of processes and procedures focused on the promotion of safe health care, the identification of the risks in health care provided to patients in different services and its prioritization and intervention, the definition of safe care processes, the education of patients and their families in the knowledge and approach of the factors that can influence in improving the safety of the care processes of which they are subjected, and the application of mandatory safe practices, reporting, measurement, analysis, and management of adverse events.
More than a concept, it is a movement that emerges worldwide as a rethinking of the effectiveness of health systems in different countries. Health systems and especially the professionals that integrate it, without a doubt, aim at the well-being of patients; however, despite their good intentions, they can also cause harm [15]. The effectiveness of health systems then depends not only on the impact caused by the improvement of the health of the users but also on the safety conditions in which care is given, which is the raison d’être of the patient’s safety policy: provide safe and effective care.
According to the Ministry of Social Action [16], the guidelines of the London protocol are taken under the guiding principles of the policy in order to achieve the purpose of establishing safe attention; it goes beyond the establishment of standards; these are only the frame of reference. The commitment and cooperation of the different actors is necessary to raise awareness and promote, arrange, and coordinate actions that really achieve effective achievements. Patient safety problems are inherent in health care. For this purpose it is relevant to establish transversal principles that guide all the actions to be implemented.
Patient safety is presented as a fundamental pillar within the patient safety protocol, which is defined as the set of organizational structures or processes that reduce the probability of adverse events resulting from exposure to the care system. Have medical attention throughout the procedures or diseases [17]. In this way, patient safety is part of a whole set of legal requirements, which must be fully complied with by health professionals, which guarantee that the patient is prevented from any risk present in medical services.
In this regard and under the London protocol in patient safety policy, according to the Ministry of Social Action [18], the guidelines of the London protocol are taken. The guiding principles of the policy are that achieving the purpose of establishing safe attention goes beyond the establishment of standards; these are only the frame of reference. The commitment and cooperation of the different actors is necessary to raise awareness and promote, arrange, and coordinate actions that really achieve effective achievements. Patient safety problems are inherent in health care. For this purpose, it is relevant to establish transversal principles that guide all the actions to be implemented [19]. These principles are as follows:
User-centered focus of attention. It means that the important thing is the results obtained in it and its safety, which is the axis around which all the patient’s safety actions revolve.
Security culture. The environment for the deployment of patient safety actions must take place in an environment of confidentiality and trust between patients, professionals, insurers, and the community. It is the duty of the different actors of the system to facilitate the conditions that allow the said environment.
Integration with the mandatory quality assurance system of health care. The patient safety policy is an integral part of the mandatory quality assurance system of health care and is transversal to all its components.
Multicausality. The problem of patient safety is a systemic and multicausal problem in which different organizational areas and different actors must be involved [20].
Under the conceptual model and basic definitions of patient safety policy, the following figure shows in a pictorial way the conceptual model on which the terminology used in this document is based, and then the definitions related to the different items raised and used are included in the patient safety policy of the compulsory quality assurance system of health care. It is necessary to integrate international terminology with specificities of the terminology requirements identified in the country [21].
The methods used were designed with the aim of promoting an open environment that contrasts with the traditional ones based on personal accusations and fault allocation. This protocol covers the process of research, analysis, and recommendations. There is no need to insist that the proposed methodology has to be separated, as far as possible, from disciplinary procedures and those designed to address permanent individual poor performance. In health, very often when something goes wrong, bosses tend to overestimate the contribution of one or two individuals and assign them to blame for what happened [22].
This does not mean that the indictment cannot exist, what it means is that this should not be the starting point, among other things, because the immediate allocation of guilt distorts and hinders subsequent serious and thoughtful investigation. Effectively reducing the risks implies taking into account all the factors, changing the environment and dealing with the failures by action or omission of the people. This is never possible in an organization whose culture puts disciplinary considerations first. In order for incident investigation to be fruitful, it must be carried out in an open and fair environment [22].
For its part, the organizational model of causality of clinical incidents is supported under the theory of the protocol, and its applications are based on research conducted outside the field of health. In aviation and in the oil and nuclear industries, accident investigation is an established routine. Safety specialists have developed a wide variety of methods of analysis, some of which have been adapted for use in clinical care contexts [23].
In this way, they raise the need to conduct the investigation and analysis of incidents (errors or adverse events), which refer to the basic process of investigation and analysis is quite standardized. It was designed with the idea that it is useful and can be used both in minor incidents and in serious adverse events. It does not change if it is executed by a person or a large team of experts. In the same way, the investigator (person or team) can decide how fast he goes through it, from a short session to a full investigation that can take several weeks, including a thorough examination of the chronology of the facts, of the unsafe actions, and of the contributory factors. The decision about the length and depth of the investigation depends on the severity of the incident, the resources available, and the potential institutional learning [24].
And where under the Reason model of causality (Swiss cheese model), belonging to the problem solving and identification models, it works to identify what aspects or decisions of the organization may have been a conditioning factor in an accident and how the organization can learn from an accident, perfecting the defenses in a cycle of continuous improvement [25, 26]. Also called Swiss cheese model, which was raised in order to analyze the possible causes that develop potential risks, the model compares the causes of risk with layers of Swiss cheese, where for an action to be generated, several failures are required to reach this, since, if there is a barrier, that potential cause will undoubtedly not allow it to become damage. It speaks of four factors that contribute to the extent of the damage: insufficient training, poor communication, lack of supervision, and inadequate apparatus [27].
On the issue of safety, the causes identified have been grouped in different ways (organizational causes, equipment, supplies, people, etc.) and specifically on the issue of patient safety. In the United Kingdom, an organizational model for the causality of errors and adverse events (organizational accident causation model) was developed in the context of the so-called London protocol or “systems analysis of clinical incidents—the London protocol” [28, 29]. Among the possible solutions is the fishbone formulated by Ishikawa who was an industrial chemist and a business administrator, in response to the need to implement quality in business processes and services. Through its proposal it is easy to observe the relationship between cause and effect. Mention six components that lead to the problem which are labor, material, method, machine, measuring, and environment [30].
This research is quantitative, observational, and descriptive, and a census was carried out on the 92 officials of the state social enterprise Norte 2, Caloto, Cauca (Colombia, Sur America) institution, under the inclusion criteria: be a worker linked to the institution by employment contract, have the institutional consent of the company, and have informed and understood consent with each of the units of analysis and where exclusion criteria are not contemplated. Study variables such as sociodemographic characteristics, knowledge variables, and improvement variables were taken into account.
The analysis plan of the present investigation had the collection of information through a survey created by the researchers and reviewed by four experts in the field; for the tabulation of the data, the researchers created an instrument to obtain a database in the Epiinfo 7.2 program; this program is a free epidemiological analysis software supplied by the World Health Organization and in which the analysis of results with descriptive statistics was performed. The bioethical component was aligned in accordance with Resolution 008430 of 1993 and Resolution 0314 of 2018 which regulates ethical responsibilities in research in humans and health institutions, taking into account that the research has a lower risk than the minimum. Complying with Colombian regulations, institutional consent and informed consent were obtained by each participant. The credits of the institution in which the research is carried out are included, according to copyright.
For research the guidelines of the London protocol are taken. The guiding principles of the policy with which, to achieve the purpose of establishing safe attention, goes beyond setting standards; these are only the frame of reference. The commitment and cooperation of the different actors is necessary to raise awareness, promote, arrange, and coordinate actions that really achieve effective achievements. Patient safety problems are inherent in health care. The transversal principles that guide the actions to be implemented are:
User-centered focus of attention. It means that the important thing is the results obtained in it and its safety, which is the axis around which all the patient’s safety actions revolve.
Security culture. The environment for the deployment of patient safety actions must take place in an environment of confidentiality and trust between patients, professionals, insurers, and the community. It is the duty of the different actors of the system to facilitate the conditions that allow the said environment.
Integration with the mandatory quality assurance system of health care. The patient safety policy is an integral part of the mandatory quality assurance system of health care and is transversal to all its components.
Multicausality. The problem of patient safety is a systemic and multicausal problem in which different organizational areas and different actors must be involved.
An instrument with 12 specific questions about patient safety and questions about demographic aspects was implemented. The specific questions, with multiple answer options, and yes or no, were:
What is the definition of adverse event?
Do you know the protocol model for the report of adverse events?
Have you received trainings from the institution in protocols that guarantee patient safety?
Does the institution have the patient safety program to obtain safer care processes? Do you know?
In case of an adverse event, would you ask for support for report?
Who is the official in charge of performing the report of the adverse event?
What is the main cause why you do not report the adverse events?
Do you notify all reports of adverse events, clinical incidents, and complications related to health care?
What do you consider is the main cause for not reporting adverse events related to health care?
What is the definition of clinical incident?
What is the definition of clinical complication?
Does the institution perform the feedback of adverse events?
It was found that demographically the female gender represents more than half of the population, being mostly people with a technical academic level, who have been in ESE for more than a year, and of which three out of four are auxiliary of nursing, which represents a population trained in technical tasks linked to day-to-day work in the ESE, with an experience of more than 1 year within the said institution in three out of four officials; on the other hand, it is observed that only 1 of every 11 people in the population are nurses, who are in charge of coordinating these assistants and are the guarantors of the proper performance of all protocols within the institution (Table 1).
Variable | Answer | Frequency | Percentage |
---|---|---|---|
Sex | Female | 61 | 66 |
Male | 31 | 34 | |
Education level | Technical | 67 | 73 |
Professional | 14 | 15 | |
Support | 6 | 7 | |
Others | 5 | 5 | |
Antiquity | Under one year | 29 | 32 |
Older than one year | 63 | 68 | |
Job that performs | Doctor | 4 | 4 |
Nurse | 6 | 7 | |
Dentist | 3 | 3 | |
Nursing assistant | 64 | 70 | |
Other | 15 | 16 |
Frequency of demographic variables of health personnel of state social enterprise Norte 2, Caloto, Cauca, Colombia, in the first half of 2019.
Main cause for not reporting adverse events related to health care.
For the frequency of response according to the definition of adverse events according to the London protocol, it is possible to justify that the entire population surveyed is clear about the concept of the definition of adverse events under current regulations, which demonstrates that the ESE performs an adequate accompaniment regarding the acquisition of knowledge regarding the definitions of the terminology used within its facilities, which allows all its collaborators to be in the same tuning, avoiding communication problems in terms of technical terminology and knowledge of the laws and resolutions of the ministry of health that define under presidential ruling the conception of these.
For the knowledge of the London protocol model for the reporting of adverse events, officials have one out of five present ignorance of the protocol, which can lead to failures in the practice of this, either due to lack of training and induction or recognition and omission which generates a latent risk both in terms of the quality of the service provided and in the care provided to the patient, putting his integrity at risk. In addition to the frequency in terms of training carried out by staff in the institution in protocols that guarantee patient safety, there is a group of people who have not received training in the patient safety protocol, which is presented as an administrative failure on the part of the institution, and the area in charge of carrying out the training of the collaborators, 1 of every remaining 11 has omitted the training provided by the ESE, generating problems that directly compromise patients and their safety.
The institution has the patient safety program to obtain safer care processes. Less than half of the respondents acknowledge that the institution has the patient safety program in terms of obtaining safer care processes, this amount being less than half of the officials surveyed, which describes a total lack of awareness for more than half of these, which generates a critical picture given that ignorance is counterproductive, given the nature of the ESE, demonstrating that more socialization of the documentation that the institution possesses, as well as training and documentation, is needed of the programs.
When an adverse event occurs, who is the person in charge of supporting the report of an adverse event? According to the established protocol, it was found that the person in charge of supporting the report of an adverse event is intended to guarantee quality of health care and serve as a bridge to generate a solution to the event presented; in this sense there is no consensus, given the ignorance of the protocol and the poor socialization of this both by the administrative area and by the same care staff, where more than half of the officials have full knowledge of who is the person in charge of carrying out the accompaniment and providing support if necessary when an adverse event occurs.
Likewise, within the knowledge of the official responsible for making the report of the adverse event according to the established protocol, it is described that within the report of the adverse event, the immediacy in the realization of this has its incidence within the quality system and of the patient safety protocol; for this reason the person who detects the adverse event must perform it in a short period of time when it is detected; in this sense more than half of the respondents know who should do it, with which you can affirm that some of these seek to separate themselves from their functions or they are not aware of the protocol and the step by step to follow when an event of these occurs, looking for a way to lighten your workload, Figure 1.
The frequency of response regarding the most frequent cause of not reporting adverse events, it was found that the main causes of failure to report adverse events are divided perceptions, since on average 3 of every 11 believe that the mistakes made within their daily work will be a cause for dismissal, which shows the lack of knowledge of the internal regulations of the institution regarding the grounds for withdrawal, and a similar average thinks that the they have used it during their rest or active breaks, which is linked to another portion, which states that the workload does not allow their report, which must be reported immediately after its occurrence, as evidenced by the ignorance of both its functions and the patient safety protocol.
Within the culture of patient safety, the reporting of adverse events, clinical incidents, and related complications in health care allows the generation of corrective and improvement actions within the health system, which by not reporting or reporting spontaneously, like 4 out of 11 of the officials surveyed, it does not allow for the maturation or improvement of this, since the causes for which adverse events are being generated are unknown and opportunities for the quality team to solve underlying problems are lost. In this sense, a percentage close to half of the respondents duly report the adverse events and other incidents and complications, this being a lack of empowerment by the collaborator who does not have a safety culture present in their work.
The most frequent cause of not reporting adverse events related to health care, evidence within the different research questions, that the workload prevails, in this sense in more than half being the main cause for not reporting an adverse event, this situation being an attenuating one, since it is possible to relate directly to the lack of human resources within the institution, or the charges within it are not level with the staff, which is supported by two out of ten who affirm that the overload of patients also does not allow an adverse event to be reported, missing opportunities for improvement within the institution that manage to generate a positive effect within the care of patients.
For the frequency of response for the definition of clinical incident according to the London protocol, it can be affirmed that within the theoretical knowledge of ESE officials, it is found that more than half of the respondents know the definition of clinical incident, and a small part present difficulties in answering correctly, this being a serious failure, when making the report of an adverse event, since the misrepresentation of the terms can cause misunderstandings and that at the time of generating a report, the indicators are erroneous regarding the nature of adverse events. However, for the definition of clinical complication, approximately four out of every five officials know its concept, which shows that only a considerable minority represents confusion, which, in a real plane, can generate confusion and ignorance of the steps to follow or perform incorrect procedures, since the nature of each event is different and must be known from the theoretical basis in order to be clear about the concepts.
Within the administrative failures found, the socialization of adverse events in the institution, only half of these are carried out, which demonstrates that the commitment that exists within the protocol is not adequate within the nature of this; there is also one in five people who do not know if they do it or not, which allows us to affirm that there is a problem of latent communication within the ESE and the collaborators; they do not know everything, given the different shifts they have and the changes in the staff schedules, as well as their lack of commitment to the quality system of the institution, being a very marked problem within the institution, seeking to improve this perception within the collaborators.
After the analysis of the results, investigations found that, under the same study theme, they manage to show similar results regarding the patient’s safety policy and what was found in state social enterprise Norte 2 of Caloto, Cauca. It was found in the study carried out by Villareal [15] that the results obtained show that the institutions of Third World countries such as Colombia do not fully meet certain requirements for the reduction of adverse events, taking into account variables such as infrastructure, the state of the equipment, the quality and adequate supply of medicines, and the motivation of the staff, which confirms what was found in state social enterprise Norte 2, where professional and care personnel do not have full knowledge of the policies, in addition there was little motivation given the high workload they maintain and the low culture of patient safety that exists.
In 2014, Meléndez, Concepción, Garza, González, Castillo, González, and Hernández [19] found that within the demographic variables, the care staff has an age greater than 6 months, and where the average age of the respondents was 49 years, 91% were women and 70% are general nurses, who presented adherence to the patient safety protocol, which differs from what was found in the state social enterprise in Caloto, Cauca, since although the majority of the population were 69% women and nurses, older than 1 year, they did not show adherence to the humanization protocol of the patient due to different causes such as ignorance of the general concepts and the low report of adverse events.
Blandón, Gómez, Muñoz, and Zafra [16] carried out a security audit process that showed flaws in the fulfillment of the processes related to the prevention of events, where improvement activities were proposed in order to minimize and prevent the recurrence of events highlighting the awareness of all personnel, which corroborates what was found in the present investigation, since the staff does not comply with the safety culture regarding the reporting of adverse events, being necessary to propose actions which improves proposals, a plan prepared for them in order to reduce this problem.
In general, the research presented a difficulty which was access to primary information, and some of the professionals were reluctant to conduct the survey, as well as access to these for their work shifts was complicated, but nevertheless within the achievements, the latent problem was found in terms of both administrative and assistance failures of professionals, which do not present a culture of patient safety, and therefore, opportunities for improvement were found by creating a plan for improvement.
Converting the organizational culture for the improvement of the processes is one of the main objectives since adopting it as a culture will be immersed in the daily life of the institution, thus leading to continuous improvement reaching the expected quality. The contribution of reading about this program executed in the aforementioned institution serves as a guide and guidance that contributes to the enrichment of knowledge that allows the implementation of the audit plan to improve the quality of health care in the institution providing health services.
With the completion of the previous investigation, it is concluded that state social enterprise Norte 2, CALOTO CAUCA does not comply with the adherence to the London protocol in patient safety policy, taking into account that only 70% of officials It has adherence to this protocol, in addition, only 52% of adverse events are reported, the main cause of not being carried out, the workload and the little time they have for administrative work.
The investigators do not declare conflicts of interest.
We thank the institution state social enterprise Norte 2 Caloto, Cauca, manager, officials, quality team, and coordinating chiefs, who allowed our research team to be part of their institution to carry out our purpose and successfully complete the planned, and the University Foundation of the Andean area that were present to give us their support through their work team offering an education with excellence.
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