3.1. Risk Identification Tools
The tools for risk identification are classified as (a) reporting systems; (b) safety briefing; (c) safety walkaround; (d) focus group; (e) medical records review; (f) screening; (g); observation (Buscemi 2009
(a) Reporting systems
An efficient reporting system is an essential component of a safety program. It is a structured modality for the gathering of information related to the occurrence of adverse and/or almost-adverse events. The purpose of it is to provide information on the nature of the events and the related causes to learn and intervene with appropriate preventive measures and to disseminate the knowledge and guide specific research in areas deemed to be most critical. Regarding the contents, the system can be:
open, that is, to gather any type of data related to adverse or almost-adverse events referring to the whole of the services;
predefined, that is, to gather all data related to a definite list of events (for example, sentinel events) or to a specific area (for example, drugs).
Regarding the reporting modality, it can occur via a predetermined or free text format, sent via e-mail, phone, electronic filing, or via the web, implementing all proper forms of protection and confidentiality of the reporting. The figure being reported must be specified in the reporting system. In some systems, the reporting is conducted by general management, by operators in others, and some systems even allow relatives, patients, and citizens to report events. Moreover, the reporting system must allow the identification of new and suspected risks, for example, complications associated with the consumption of drugs or new products. Therefore, the data gathering must always be followed by an analysis. However, healthcare organizations may have difficulty adhering to the reporting operations for a variety of reasons:
the belief in a scarce efficacy of the system and resistance to changes;
a defensive attitude;
investment in resources.
The adverse event and almost-adverse event reporting system allows the acquisition of information related to similar cases in other organizations, offering the opportunity to generalize the problem and to develop more efficient solutions. The reporting system is divided into two categories:
learning systems, usually voluntary systems designed to guarantee continuous improvement of the quality of the treatments. The recommendations that are elaborated after careful analysis are useful to redesign and improve healthcare processes;
accountability systems based on the principle of accountability; they are compulsory and are often limited to predefined events, for example, sentinel events. Many accountability systems use disincentivizing mechanisms such as fines and sanctions, and the efficacy of these systems depends on the ability to convince whoever is needed to report and act with consequential measures. These systems may also be considered as learning systems if the information received is analyzed with transparency, and the actions undertaken are spread to all operators.
Many reporting systems developed are placed in one of the two categories, but the objectives of the two systems are incompatible with one another. However, from this choice derives the compulsoriness or the voluntary nature of the system. Interestingly, in Italy, the so-called incident reporting systems have been implemented on a regional level and in healthcare organizations. These systems gather all adverse and almost-adverse events for the analysis and provision of preventive actions.
(b) Safety briefing
The safety briefing is a simple and easy-to-use tool to ensure a culture and a shared approach towards patient safety. It is a method that allows the creation of an environment in which the safety of the patient is the priority; that stimulates the sharing of information regarding potential or real risk situations. It consists of a brief debate, a conversational yet structured discussion regarding the potential risks for the patient that are present in the operational unit. In quantitative terms, it allows an easy measurement of the achievement of safety objectives. The safety briefing must not be punitive; it may refer to a list of safety issues; and it must be easy to use, easily applicable, and usable for all issues regarding patient safety. The briefing should be facilitated by a moderator, who can explain the reasons and the objectives, and be conducted at the beginning of a shift for a maximum of five minutes to involve all operators caring for the patient.
It should begin with the detection of problems, data, and observations (in the absence of a specific situation, it can revolve around potential issues). At the end of the shift, there must be a debriefing (another very short meeting) to investigate whether there have been potentially risky situations during the activity or whether there are questions from the patients or their relatives. The introduction of this method must be tailored to the needs of the operational unit, enabling regularity, continuity, and response to any issues that may arise. The immediate return is the higher accountability in individual behavior, more attention toward patient safety, an improved work environment, and enhanced “teamwork”.
(c) Safety walkaround
This method consists of “visits” mandated by management that those in charge of safety conduct in the operational units to identify, together with the staff, issues linked to safety. The staff are invited to report events, causation or concurring factors, almost-events, potential problems, and possible solutions. An important added value derives from the fact that the information gathered in this process often already has a solution that lies in the description of the event and therefore can often introduce an immediate change to improve the safety and assistance process. The representatives identify some priorities and the healthcare team develops solutions with all staff. The gathering must be anonymous, and the issues that emerge are entered in a database that registers the reports and the subsequent corrective actions.
The organizational modalities entail meetings within the operational units, between the experts and a small group or singular operators, which last a few minutes, in which they gather and stimulate all the reports of what concerns damage or risk situations. However, common barriers to overcome are the fear of the operators being punished or blamed for reporting and mistrust in the subsequent corrective actions; therefore, it is imperative to provide feedback to the operational units, to ensure they understand the importance and the serious consideration with which the reports are dealt with.
Patient safety culture is included in a greater cultural change that provides an open relationship between the various operators and an atmosphere of integration and cooperation. It should be clear to all those that conduct the visit, but most of all to the frontline staff, that the investigational objective is not individual behaviors, rather the system implemented for the safety of the patient. The proposed system stimulates the staff to critically observe behavior and practices to recognize the risks from a different perspective. It is extremely useful that the system is official and recognized. This modality has the advantage of being low-cost, allowing the identification of risks and changes needed in a specific context, and it does not require staff, structures, or infrastructure.
(d) Focus group
The focus group is a typical methodology in social research, particularly applicable in exploratory research, to uncover unknown factors. Introduced long ago into the healthcare system, it is useful to identify all aspects of a problem from people’s experiences and perceptions; therefore, it can be conducted with singular professional figures or with a team, with patients, relatives, and other stakeholders. The discussion, which lasts about half an hour, should be led by a qualified moderator. The efficacy of the focus group depends on the questions, which must be open and allow discussion and maximum interaction. During the discussion, it is possible to let emerge adverse or almost-adverse events, latent insufficiencies, as well as the essential elements concurring in determining the local safety culture, useful to pinpoint the most efficient strategies to introduce in a specific context.
(e) Medical records review
Review of the medical records has represented a cornerstone in studies on errors in healthcare. It constitutes the most used method for the assessment of quality, allowing investigation of decision-making processes and on the observations of the outcome, analyzing compliance with guidelines and protocols. The review can be explicit when the reviewer searches for specific types of data or events or implicit when an expert physician makes a judgement related to an adverse event and/or error, for example, the consequences related to the missing viewing of a laboratory examination or the missing change of therapy after the reporting of adverse reactions. The medical records review process can also be used to monitor the progress made in the prevention of adverse events when, for example, safer practices are introduced and, through the review, their level of implementation is evaluated.
The degree of detection of the events through this process is much discussed and is essentially based on the quality and quantity of the information. Some information, for example, laboratory examinations, prescriptions, and medical reports, are objectively researchable, while not all the phases of the decision-making process are traced in the clinical documentation and therefore remain implicit. Furthermore, the researcher has an opinion that is affected by their specific competence, as well as by other variables. While serious adverse events are almost always reported, minor errors and conditions never are, so almost-adverse events are rarely noted; hence, medical records are useful in preliminary investigations, but they give very limited contextual information. Other limitations to the use of this technique are the high cost, the need for a homogeneous preparation of the researchers, and the drawing of a reading grid. The selection of the medical records to review can be focused on a specific type of event related to critical points of the existing process.
This method identifies possible adverse events using the data available in the healthcare systems. Databases can be researched retroactively or in real-time, or traditional paper archives can be consulted. It is possible to identify the presence of certain events, previously classified as “indicators”, for example, a return in the operating room or repeated hospitalizations for the same problem or the prescription of an antidote in the case of adverse events due to drugs.
Observation to identify errors is a methodology that should be used in a targeted manner and limited in time. It uses an external and expert observer to detect, with the help of grids, the discrepancies between the healthcare processes implemented and the expected standards. The method is mostly used to detect errors in therapy, and observations on drug administration have demonstrated a high number of errors. Observation requires hard work and therefore is high cost; however, it offers very detailed information, which facilitates the comprehension of the not only of the event but also of the process and the dynamics that have led to the event. It is a method that can be used intermittently, when resources allow, to identify and understand the insufficiencies in the systems and to monitor actions leading to improvements.
3.2. Analysis Tools
A clinical risk management program uses different tools for risk analysis, examining events, when they occur, with reactive methods, or analyzing the processes to prevent events, with a proactive modality. Many are possible approaches for the evaluation of the quality and safety of treatments. If the objective is to realize a safe healthcare process, the proactive approach is preferred to the reactive approach. The first category of tools includes root cause analysis, and the second one includes the failure mode and effect analysis (FMEA) and the failure mode and effect criticality analysis (FMECA).
(a) Root Cause Analysis (RCA)
RCA is a tool for the improvement of quality that helps individuals and organizations to identify causes and contributing factors related to an adverse event and develops improvement projects based on the results. RCA was first used in engineering systems, including aviation and the aerospace industry, since these systems require the development of strategies for the knowledge of risk factors. There are databases within the engineering sector that can gather large quantities of information deriving from the application of this analysis technique for further understanding of the causes and contributing factors of adverse events. Therefore, it would be useful to employ such a system in the healthcare sector. RCA is a retrospective analysis that allows for the comprehension and the reasons for the occurrence of an event. It can be applied to all healthcare sectors: hospitals for acute cases, emergency areas, rehabilitation, mental illness, home hospitalization, and in various branches of treatments outside of hospitals. RCA requirements are:
establishment of an interdisciplinary group consisting of experts in the matter;
participation of those involved in the incident;
impartiality in highlighting potential conflicts of interest.
Further requirements that grant the accuracy and the credibility of the RCA are the participation of management and of all those that are most interested in the process and the system, as well as the confidentiality; that is, the information that comes into one’s knowledge must be protected, not disclosed, with levels of data protection established (Wilson et al. 1993
(b) The Failure Mode and Effect Analysis (FMEA) and the Failure Mode and Effect Criticality Analysis (FMECA)
FMEA is a method used to identify weaknesses of a processes via a proactive approach. The objective of its implementation in healthcare systems is to avoid adverse events that might cause damage to patients, relatives, and operators. It is designed to prospectively examine a process to highlight possible weaknesses and redesign it. The method was created in the United States in 1949 in the military field and applied to healthcare settings in the 1990s. It is based on the systematic analysis of a process conducted by a multidisciplinary group, led by a manager, to identify the modalities of the possible failure of a process or project, the reason of the effects that might be obtained, and what could make the process safer. The first investigative phase provides an analysis of the literature, the gathering of the documentation, and possible interviews with the operators. The second phase is the analysis phase, during which the process is subdivided into macro activities, which are analyzed, with singular tasks pinpointing the possible errors (types of error). The error probability is quantitatively evaluated, while the seriousness of its consequences is evaluated qualitatively. To make an “assessment of the risk”, the modality of occurrence of the error or fault (failure mode) and its effect (failure effect) are analyzed, thereby involving both qualitative and quantitative analysis. The analysis of the entire process entails the identification of the areas with an intervention priority, and it incorporates the following four points: (1) breakdown of the process in phases with the elaboration of a flow chart; (2) definition of “what could go wrong” (failure mode); (3) definition of “why” the insufficiency might occur (failure causes); (4) definition of the possible effects (failure effects). The group then assigns a few risk priorities (RPN) or priority index risk (IPR) to each phase that consists of:
detection probability (score from 1 to 10);
seriousness (score from 1 to 10).
This technique may be used before introducing new processes, to modify existing processes; to use, in different contexts, processes that are already consolidated; and, lastly, to prevent the repetition of an event that has already occurred.
The advantages include (a) improvement of the quality, reliability and the safety of the process; (b) identification of critical areas of a process through a logical and structured procedure; (c) the reduction of the time needed to develop a process and the related costs; (d) help in identifying the criticalities; and (e) the supply of a database.
The main limitation of this analysis technique is that insufficiencies are treated as if they were singular units statistically analyzed, while, in the healthcare sector, adverse events are the result of multiple insufficiencies and conditions that are often related (Stamatis 1995
). When further quantitative analysis is added to FMEA to calculate the level of criticality of the problem identified (criticality analysis), with the attribution of a criticality index, the FMECA technique is applied.
(c) Clinical audit
The word audit derives from the Latin word, which means “to hear”, to listen, and to learn, and it was used first in the “financial” framework when landlords asked their administrators to account for the employment of the resources in a given time frame. Audit in healthcare was introduced by Florence Nightingale, a nurse and a statistics expert in 1854, during the Crimean war, addressing the high mortality of patients undergoing surgery. After the application of this method, new strict preventive measures were introduced that reduced mortality rates from 40% to 2%.
The audit allows (a) a guarantee that patients receive the best possible care; (b) an improvement in clinical practice; (c) an improvement of multidisciplinary work; (d) a facilitation of optimization of the available resources; (e) an opportunity for training continuous professional development.
In the specific framework of patient safety, it allows one to (a) identify the risks related to the clinical activity and the organization; (b) identify errors or almost-adverse events; (c) identify the causes and the contributing and concurrent factors of adverse events; and (d) identify the framework of improvement.
Audit consists of a series of meetings in which the team, possibly multidisciplinary and multi-professional, analyses a clinical case or a healthcare path, identifying the differences to predetermined standards or, should they not be available, with the opinion of internal and external experts. The audit employs clinical and administrative documentation and possible evidence to provide discussion with the amplest scope of information. It would be beneficial to identify in a group a moderator that ensures availability of documentation for the related investigation and the efficient conduct of the meetings and related reporting.
The content of the audit can be (a) outcome of clinical activities and healthcare activities; (b) services; (c) resources and their employment; (d) all forms of assistance, either formal or informal; and (e) organizational processes. The general phases of an audit cycle are (1) choice of topic: evaluation of treatments, services, policies, and organizations, the criteria that help in the definition of the priorities that refer to the frequency of the problems, to the seriousness of the consequences, and to the possibility of implementing preventive solutions or measures; (2) the definition of the purpose and the objectives: the purpose and the objectives must be detailed and specific; (3) identification of the standards: the clinical audit is an activity based on the comparison with defined treatment standards and services. The standards must have certain characteristics that can be summarized with the acronym SMART: Specific (related to the topic), measurable (effectively definable), Achievable (with available resources), research based (based on evidence), and timely (updated); (4) gathering and analysis of the data: the data can be gathered with a review of clinical documentation, with interviews of patients and/or staff, with questionnaires or through reporting systems. The data must be gathered using quantitative or qualitative methods, or both, and analyzed using simple descriptive statistical analysis. The analysis and interpretation of data must always have as a reference point, the standard chosen, and reading of the data must allow decisions to be made, analyzing all available options. Finally, an intervention plan is elaborated with recommendations, actions, responsibilities, and timing; (5) monitoring of expected results following the changes introduced: a re-audit phase is conducted only after the changes have been introduced, and it must follow the same plan as the audit, and only the modified fields should be re-audited.
At the end of the audit, a report is written and improvement measures identified. The audit process, to be a safety tool, must become systematic; therefore, measures introduced following audit must be monitored over time. A very delicate phase is the one in which the results are communicated to the operational unit, which must be involved in all improvement measures (Spanò and Tradori 2015