Root Cause Analysis, Failures and Effects in pediatric total quality management: a scoping review

Objectives: to analyze the applicability of Root Cause Analysis and Failure Mode and Effect Analysis tools, aiming to improve care in pediatric units. Methods: this is a scoping review carried out according to the Joanna Briggs Institute guidelines, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyzes extension for Scoping Reviews. Search took place in May 2018 on 15 data sources. Results: search totaled 8,254 studies. After using the relevant inclusion and exclusion criteria, 15 articles were included in the review. Of these, nine were published between 2013 and 2018, 12 used Failure Mode and Effect Analysis and 11 carried out interventions to improve the quality of the processes addressed, showing good post-intervention results. Final Considerations : the application of the tools indicated significant changes and improvements in the services that implemented them, proving to be satisfactory for detecting opportunities for improvement, employing specific methodologies for harm reduction in pediatrics.


INTRODUCTION
The macro-complexity of health services and the hospital environment has increasingly inserted technological innovations developed to provide assistance to customers, however these innovations can offer numerous risks to patient safety.Patients' right to quality health care is unquestionable, and it is necessary that, for this, be offered, throughout the care process.a reasoned, competent, safe and adequate health service (1) .
Errors are, by definition, unintentional.These are defined as the incorrect performance of an action that was planned, which may contribute to the development of risk to patients' health, defined as the probability of an incident occurring during care provision.Thus, errors can favor the development of incidents, which are events or circumstances that could result, or have resulted, in unnecessary harm to patients (2) .
Adverse events are when an incident results in damage to patients.Thus, risk management is important in the search for errors during care, allowing health services to guarantee quality in patient safety through improvement actions (2) .
In the context of children's hospitalization, specificities regarding weight, age, stage of development and clinical conditions are involved in the influencing factors in patient safety, with the pediatric public having damage three times greater than adults in a similar situation.Records show that, in a pediatric intensive care unit for cancer care, of 110 medication errors, 71 notifications were recorded, demonstrating the occurrence of 227 errors per 1,000 patients/day (3)(4) .
Studies on pediatric patient safety indicate the use of tools that improve the safety culture in these institutions, as there are still weaknesses in safe care in pediatric units.For the development of quality management in care, there were increases in quality tools, programs and methods to reduce errors related to health care (5) .Among the tools used, we highlight the Root Cause Analysis (RCA) and the Failure Mode and Effect Analysis (FMEA) (6) .
RCA is used by many organizations to understand their problems, thus making their recurrences difficult (6)(7) .Its use in healthcare started in the mid-1990s, being considered mandatory for sentinel hospital events, since 2007, by The Joint Commission (JC) (8) .
Therefore, RCA is a systematic and retrospective process, used by a multidisciplinary team that seeks to identify the main causal factors of the failure.This is done through the following methodological path: 1. Identify sentinel events or important events that require an RCA; 2. Assemble a tea; 3. Make a diagram of the process: what happened?; 4. Why did the event happen?Moving from proximity to root causes; 5. Develop and implement an action plan (9) .This tool analyzes the events in a reactive way, looking for the factors that contributed to the occurrence of a certain error, in order to reduce the risks of happening again through the elucidation of the causes and the elaboration of an action plan (8) .
FMEA emerged in 1949 in the USA.In 2007, JC considered this tool to be essential for the identification of security risks, being characterized as a tool that makes use of the question "what could go wrong during assistance?" and its consequences before it occurs, that is, it analyzes a high risk process to prevent the occurrence of possible errors in care (8) .FMEA, known in the healthcare sphere as Healthcare Failure Modes and Effects Analysis (HFMEA), is a proactive, systematic, multidisciplinary and preventive risk analysis tool, capable of recognizing problems in the infrastructure before the error occurs.For this, the following methodological path is used: 1. Choose a high-risk process and assemble a team; 2. Diagram the process; 3. Brainstorming of potential failure modes and ending effects; 4. Prioritize failure modes; 5. Identify causes of failure modes; 6. Redesign the process; 7. Analyze and test the new process; 8. Implement and monitor the redesigned process (10) .
Adverse events in the pediatric population are capable of causing irreparable sequelae or even death.Thus, it is necessary to be zealous in the care of pediatric patients through professionals with knowledge about the appropriate techniques in providing care to this population (4,11) .Studies state that unsafe processes are due to failures in the planning, collaboration, execution, assessment and monitoring of health care.Therefore, the use of quality management programs, especially in pediatrics, becomes significant (5,12) .
Thus, the use of tools, such as FMEA and/or RCA, in the pediatric area, can contribute to the identification of errors related to care, providing information that can assist in the development of measures that ensure the improvement of quality in health services (5,12) .

OBJECTIVES
To analyze the applicability of Root Cause Analysis and Failure Mode and Effect Analysis tools, aiming to improve care in pediatric units.

Type of study
This is a scoping review.This type of study aims to identify the main scientific evidence on a given topic, highlight existing knowledge gaps, in addition to proposing to clarify the main concepts present in literature (13) .The Joanna Briggs Institute Review Manual was used as a theoretical framework for the preparation of the study (13) .

Methodological procedures
This study was registered on the Open Science Framework platform (14) , adopting the Preferred Reporting Items for Systematic Reviews and Meta-Analyzes extension for Scoping Reviews (PRISMA-ScR) checklist (15) , in order to analyze studies that used RCA and FMEA in pediatric care.
In order to verify scoping reviews or protocols similar to the objective of this study, in May 2018, a search was made on the following platforms: Open Science Framework; JBI Clinical Online Network of Evidence for Care and Therapeutics (COn-NECT+); Database of Abstracts of Reviews of Effects (DARE); The Cochrane Library; International Prospective Register of Ongoing Systematic Reviews (PROSPERO).The search and the results found showed the need to develop studies with the scope of analyzing the applicability of RCA and FMEA, aiming to improve care in pediatric units.
For the construction of the research's guiding question, PCC strategy was used, which represents the acronym: Population (Population), Concept (Concept) and Context (Context).In order to construct the research question, the strategy was developed as follows: Population: pediatric patients; Concept: use of RCA and FMEA and the improvement of qualified assistance; Context: pediatric units.
With that, it was questioned: do the applications of RCA and FMEA collaborate for the improvement of qualified care in pediatric units?

Data source
After the identification and feasibility of the review through a pilot research, as well as the verification of the relevance of the study, we proceeded to choose the databases for the research, which were: 1. Scopus; 2. Ebsco; 3. SciELO; 4. LILACS; 5. Web of Science; 6. Medical Literature Analysis and Retrieval System Online (MEDLINE); 7. Cumulative Index to Nursing and Allied Health Literature (CINAHL); 8. Cochrane Library; 9. Science Direct; 10.National Library of Medicine and National Institutes of Health (PubMed); 11.Índice Bibliográfico Español em Ciencias de La Salud (IBECS); 12. Base de Dados de Enfermagem (BDENF); 13.Pan American Health Organization (PAHO); 14.Medical Literature Analysis and Retrieval System Online (WHOLIS); 15.Wiley Online Library.For this, the following search equation was applied: "Pediatrics" AND "Patient safety" AND "Root Cause Analysis" OR "Healthcare Failure Mode and Effect Analysis" OR "Failure Mode and Effect Analysis".
In order to guarantee a high methodological quality, the following inclusion criteria were chosen: scientific articles indexed in the databases mentioned above, that addressed the application of RCA and FMEA in pediatrics and that met 60% of the criteria established from an adaptation of Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0) (4) .Documents written in English, Brazilian Portuguese, Spanish, Italian or French were also selected, with no year restrictions during the search for articles.
To complement the electronic search, the bibliographic references of the included articles were checked and, when pertinent, selected for the present study.Exclusion criteria were review articles, editorials, letters to the editor, abstracts and expert opinion, who did not work RCA and FMEA in the field of pediatrics or who did not meet the established percentage of SQUIRE 2.0.
The bibliographic search was carried out by two researchers.Any questions or discrepancies were agreed upon during the research team meetings.Each researcher conducted a search using the same data sources and the same descriptors in the month of May/2018, however, in separate locations, in order to avoid bias during the research.All researchers were previously trained on the inclusion/exclusion and handling criteria in the data sources, to ensure standardization and adequate selection of articles.

Data analysis
In the first stage, article refinement, titles and abstracts of all articles found during the searches were read, remaining only those pertinent to the researched topic.Subsequently, in the second stage, the duplicate titles were removed and the full reading of the articles was performed, together with the extraction of significant data, such as place of study, target audience and the type of tool used (RCA or FMEA).After full reading, research was selected to be included in the qualitative analysis of studies (third stage).
Therefore, the third stage was carried out from an adaptation of the SQUIRE 2.0 protocol.This protocol presents revised standards, to cite new competencies on quality improvement, through a guidance guide.This instrument was selected so that study analysis could be developed in a resolute way, through the competence of items covered in the articles.
An adapted version of SQUIRE 2.0 was used, in which quality criteria were constructed regarding the title, summary, introduction, results and discussion, applied in the analysis of the articles.The original protocol consists of 18 items, some of which are divided into sub-items, completing a total of 40 recommendations.The final version, adapted and summarized, was finalized, with 21 criteria to be applied in each selected article, the score being: total compliance = 1 point; partial = 0.5 point; non-compliance = 0 point (4) .
The 21 criteria to be considered in each study are: 1. Title -indicates that the article concerns an initiative to improve health; 2. Abstract -provides the key information of the text sections and in the structured summary format; 3. Problem descriptiondescribes the nature and importance of the problem; 4. Available knowledge -presents a summary of what literature currently brings about the problem; 5. Objectives -presents research objectives; 6. Method 1-describes the tool and its steps in sufficient detail for others to reproduce it; 7. Method 2 -specifies the team involved in the work, detailing its components; 8. Indicators -uses indicators or criteria to analyze the intervention processes and results through the tool use; 9. Analysis -uses qualitative and/ or quantitative methods to draw conclusions from the data; 10.Ethical considerations -informs formal ethical reviews and/or potential conflicts of interest (4) .
The criteria: 11.Result 1 -presents the initial steps of the tool and its evolution over time, including modifications; 12. Result 2 -presents the details of the process and result (measures); 13.Result 3 -reports factors from the local context that interfered with the interventions; 14.Result 4 -has unintended consequences: unexpected benefits, problems, failures or costs; 15. Discussion -presents strengths of the work, including the relevance for justifying the work and the objective; 16.Interpretation -demonstrates the association (relationship) between the intervention and the results; 17.Interpretation 1 -compares the results with the findings of other publications; 18. Interpretation 2 -highlights the impact of the project on people and health systems; 19.Limitations -presents limits for the generalization of work; 20.Limitations 1 -presents confounding factors (bias or imprecision in the methods or analysis) and reports the efforts to make these limitations inimical; 21.Conclusion -highlights the usefulness and sustainability of the work as well as the potential for spread and other contexts (4) .
Meetings were held to standardize those involved in the study, through debates about the researched tools, interpretation of each topic adapted from SQUIRE 2.0, as well as the pilot use of the instrument to an article, in order to reduce the subjectivity capable of causing bias in the development and results of this study.
The assessment of each article was carried out by two researchers in an impartial and blind manner.Subsequently, the scores of each criterion were compared and, in the event of incompatibilities, a third evaluator was asked for the final agreement of the score.In order to calculate the agreement between the examiners, it was decided to use Kappa index, which obtained a value of 0.97, corresponding to an excellent agreement (11) .For this calculation, the 15 articles and 21 items adapted from SQUIRE 2.0 were considered, totaling 315 items assessed.

RESULTS
The search in the databases resulted in 8,254 articles (Figure 1), through the journals portal of the Coordination for the Improvement of Higher Education Personnel (CAPES -Coordenação de Aperfeiçoamento de Pessoal de Nível Superior) and the Virtual Health Library (VHL), divided into the following databases: 549 at Scopus, 284 at Ebsco, 21 at SciELO, 629 at Web of Science, 267 at MEDLINE, 89 at CINAHL, 4 at Cochrane Library, 1,765 at Science Direct, 284 at PubMed, 25 at IBECS, 07 at BDENF and 4330 Wiley Online Library.No articles were found in the PAHO, WHOLIS and LILACS databases.
Chart 1 presents a summary of selected studies, specifying the author and year of publication, country of study, type of pediatric unit, the tool used to improve quality and their respective bibliographic references, the objective of the study, the methodological trajectory covered in the use of tools, interventions performed, as well as improvement indicators and their results.
Of the 15 articles selected, 11 performed interventions to improve quality in the processes addressed, showing good post-intervention results (16)(17)(19)(20)(21)(23)(24)(25)(27)(28)30) . Of the 11 studies, onl one did not use indicators to measure improvement; however, it showed that the tool and the proposed interventions were effective in giving confidence to professionals (30) .(32) Analyze FMEA in the practice of medication performed in the operating room of a children's hospital, assessing each stage of the treatment process, scoring possible failures and risks.(19) Spain PICU

Italy
Pediatric hospital FMEA Reference is not mentioned. anada

Installation of parents and children of the University
SA Pediatric hospital RCA The Joint Commission, 2009 (41) Establish a reference point to monitor the strength of action plans developed through RCA and its execution rates.Not mentioned.
The information acquired after the implementation of these tools is able to encourage pediatric institutions to start discussions on risk trends, resulting in the formulation of plans to reduce them on a national scale and not only locally (29) .Chart 1 shows the categorization of improvement indicators is observed after the application of these tools.

DISCUSSION
In this scoping review, 53.3% of articles were from the last 6 years (17)(18)(19)(20)22,(25)(26)29) , noting a current temporality of studies, the relevance of this review and the recent application of RCA and FMEA tools in pediatric units. FMEA was chaacterized as the quality tool chosen in most of the articles of this review (80%), being used mainly in studies developed in the USA (17,(23)(24)(28)(29)(30) .
None of the included articles was developed in Brazil.This fact denotes the low number of scientific studies using FMEA and RCA in health research in the country, although the Brazilian National Patient Safety Program (PNSP -Programa Nacional de Segurança do Paciente) encourages and demonstrates the importance of these tools for analysis of errors and, consequently, related incidents patient safety (31) .
A research on the applicability of these tools, developed in the ICU (18)(19)23) , is justified by the various factors that make patients, especially pediatric ones, more vulnerable to errors, among them the complexity of care, highlighting medication administration, in addition to the vulnerability of patients' critical conditions (11,32) .
The topic of drug therapy is one of the most talked about when talking about patient safety and, in the case of children, the administration of drugs needs to be judicious, with an important requirement from the health team, given the specifics in relation to child's age, weight, body surface area, absorption capacity, biotransformation and drug excretion (32)(33) .
Another research carried out in Southern Brazil showed risk situations in pediatric inpatient units after profiling their reports, finding errors associated with the conduct of unnecessarily fasting children, failures in identifying pediatric patients, administrative factors, in addition to associated with medication and allergy caused by wristbands.In this regard, health professionals must commit to promoting the health of this population, guaranteeing their rights during care provision (34) .
A study carried out at the PICU of a university hospital in Italy showed that the use of FMEA increased the reporting rates of incidents related to drug therapy, with a consequent decrease in the severity of errors made, thanks to the improved action plans after using the tool.The authors of this research stated that FMEA was much more than a tool used to avoid errors, i.e., it was also able to change the mentality of the hospital's clinical of Root Cause Analysis, Failures and Effects in pediatric total quality management: a scoping review Lima LA, Silva LCMA, Dantas JKS, Lima MSM, Dantas DV, Dantas RAN.
team, increasing awareness that there is a problem and the need to do something to correct them (18) .All selected articles, which were developed at PICU, worked at FMEA as the main quality improvement tool, showing its influence on the awareness of the health team's errors, in decreasing the severity indexes through the development of effective corrective measures before an error occurs.Thus, the studies stated that FMEA is a useful tool to describe the reliability of a system, to compare alternative projects and to guide the improvement process (18)(19)23) .
Most of the surveys that carried out corrective actions, based on the possible failures that could occur, presented as improvement indicators of RPN.After the development of the actions, the studies compared this number and evidenced its reduction, representing a decrease in the highest risk failure modes identified by FMEA (20,23,27) .
Other research used FMEA as a pre-implementation phase for certain protocols in institutions, such as pain management in children or implementation of clinical practice guidelines.The tool was able to contribute in the identification of the main barriers and in the plan anticipating actions, for a successful implementation, guaranteeing its safety and effectiveness in providing a safer care to pediatric patients (19,25,30) .
A study carried out in a Neonatal ICU, in Iran, identified 68 modes of errors, which were subdivided into seven classes.For this purpose, the FMEA tool was used in order to monitor and calculate RPN.In order to reduce errors in the process, there was a need to take preventive measures related to supervision, planning changes, updating the activity as the greatest need and immediate action.The use of the tool made it possible to identify the possible causes of errors and to carry out an intervention with the team to reduce these errors (35) .
Of the 12 articles that used FMEA, 50% (16)(17)22,25,27,30) have a referential base anchored in DeRosier's tutorial (36) . This highligts the Healthcare Failure Mode and Effect Analysis (HFMEA), an adaptation of FMEA.Of the changes made, the main one was the addition of two stages: risk score and decision tree.This tool was developed by the Veterans Affairs National Center for Patient Safety (VANCPS) in 2001 (36) .Of the twelve articles that used FMEA, only three (22,24,30) used the HFMEA nomenclature.
In 2007, JC determined that health units should conduct an annual investigation of sentinel events using RCA (37) .Even after this determination, it is suggested that the lack of interest in using this tool is due to the fact that it performs retrospective data analysis, being susceptible to failures due to underreporting and incomplete data in medical records, due to memory failures and unclassified reliable (38) .
Analyzing the references found in Chart 1, it is observed that, of the three articles that used RCA as a tool of choice (24,(26)(27) , two endorsed JC.It is believed that the choice of this institution is due to the international recognition of the work developed since 1917, raising the level of quality of care through the accreditation of health institutions, making available publications, such as the book "Root Cause Analysis in Health Care: Tools and Techniques", first published in 2000 (37) .
A research carried out in Queensland, Australia, sought to assess the effectiveness of the implementation of RCA after incidents involving pediatric patients in public hospitals in the country.The study evidenced RCA as a highly effective tool in detecting factors that led to error in the institutions studied, such as: late diagnosis, adverse events in the procedure and medication administration, and errors in patient identification.It was approached that, from the survey of these factors, it became possible to implement actions aimed mainly at physical changes in the structure of hospitals, the standardization of procedures and care and training and staff involvement with patient safety (39) .
Despite this, only two (13.3%) (19,25)introduced team education in the proposed interventions.Health education has become a relevant strategy for work transformations, becoming an environment of critical, reflective, committed and technically competent performance (38) .It is, therefore, an indispensable tool in the construction of professional competence, contributing to the organization of work, having as its main challenge the incentive to develop awareness among professionals about their context, in which each person understands their responsibility in their ongoing training process (40) .Four (26.6%) (20,24,(27)(28) of the 15 articles did not mention the use of indicators, aiming at patient safety, however they describe the tool deployment and the results achieved.
Some studies have reported the limitations in the use of FMEA, such as its subjectivity, its qualitative character, the difficulties in assembling a multidisciplinary team with involvement in the processes and the time spent to achieve the objectives (18,22,25) .Despite this, the use of this tool has been recommended to improve health care in pediatric care (16)(17)(18)(19)(20)(21)(23)(24)(25)(27)(28) .
It is evident, as the main difficulty found by the study, the scarcity of articles related to the theme; therefore, despite the careful search developed by the researchers using different combinations of keywords and descriptors in the fifteen databases selected for the study, it is likely that some studies with high methodological quality have not been found.
Thus, pediatric health care units are seen as an environment to be explored in the search for quality improvement opportunities, using the tools presented here.

Study limitations
The limitations of this scoping review highlight some points to be made: the fact that most articles have presented FMEA as a tool of choice in relation to RCA, it is possible to have restricted the comparison between the tools.Furthermore, the clipping of languages can also be considered as a limitation for the present study.
Moreover, although a variety of topics have been presented using the FMEA tool, there are many other critical processes in pediatric units that have not been addressed and that need to be subjected to quality tools subject to improvement such as: assistance to preterm neonates; transfer of critical pediatric patients to other health units; cardiopulmonary resuscitation in

Table 1 -
Scoring in descending order of the 15 articles assessed through the adapted SQUIRE 2.0 and definition of the cut-off point for the inclusion of articles in the scoping review.Natal, Rio Grande do Norte, Brazil, 2018

of Root Cause Analysis, Failures and Effects in pediatric total quality management: a scoping review
Lima LA, Silva LCMA, Dantas JKS, Lima MSM, Dantas DV, Dantas RAN.Extraction of data from the 15 articles selected for the scoping review referring to author/year of publication, country, type of pediatric unit, tool and references, objective, methodological trajectory, interventions performed and improvement indicators

, Failures and Effects in pediatric total quality management: a scoping review
Lima LA, Silva LCMA, Dantas JKS, Lima MSM, Dantas DV, Dantas RAN.

Failures and Effects in pediatric total quality management: a scoping review
Lima LA, Silva LCMA, Dantas JKS, Lima MSM, Dantas DV, Dantas RAN.