Moi Lin Ling
Introduction
With the release of the Institute of Medicine's (IOM) report on patient safety, To Err Is Human, several healthcare organizations have responded with the development of patient safety programs. Patient safety refers to the freedom from injury or illness resulting from processes in healthcare [1]. Many patient care processes are interlinked through varied systems involving multiple handoffs. The possibility of medical errors increases with the level of complexity of care. This is not surprising because medicine remains very much an inexact, hands-on endeavor. Patients are at greater risk than nonpatients, and medical interventions are by their nature high-risk procedures with a rather narrow margin for error.
An error is defined as an unintended act, either by omission or commission, or an act that does not achieve its intended outcome [1]. This may either be a near miss or an incident in which the error results in an adverse outcome for the patient. Healthcare organizations are highly complex systems with thousands of interlinked processes that can go wrong. A healthcare-associated infection (HAI) is one of the possible outcomes of processes that did not turn out right. Other incidents considered as healthcare errors include incorrect diagnosis, inappropriate use of tests or treatments, wrong site surgery, medication errors, transfusion mistakes, patient falls, decubitus ulcers, phlebitis associated with intravenous lines, preventable suicides, and so on.
The IOM report estimated that healthcare errors occur in about 3–4% patients with approximately 2 million HAIs occurring annually in United States with an average of each intensive care unit (ICU) patient experiencing two errors a day [1]. HAIs represent a major cause of death and disability worldwide [2]. The World Health Organization (WHO) estimates that more than 1.4 million people worldwide suffer from HAIs at any one time. It also is estimated that 2 million HAIs occur in the United States annually with about 80,000 deaths; in England, an estimated 5,000 HAI deaths occur annually. The economic burden is heavy at an estimated annual cost of US$ 4,500–5,700 million a year in the United States and £1,000 million annually to the National Health Service in the United Kingdom [2].
The Swiss cheese model of system accidents proposed by James Reason [3] gives a good explanation as to how system issues play a key role in patient safety. Defenses, barriers, and safeguards have many holes just like slices of Swiss cheese. Although these systems are to prevent errors, ironically, errors will lead to bad outcomes if the holes are lined up in a manner to allow an adverse event to pass through unstopped. It is not difficult to appreciate this; we are all too familiar with the many system factors that contribute to an HAI. A key process in prevention of surgical site infection (SSI) is the timely delivery of appropriate antimicrobials to a patient at anesthesia induction [4]. This process has many interlinked steps to contribute to a successful timely delivery of SSI prophylaxis: (1) the development of evidence-based guidelines on prophylaxis regime, (2) the collaboration of the anesthesiologist with the surgeon in adhering to the guidelines, (3) the availability of the appropriate antimicrobial at time of need, and (4) the act of administering it by the anesthesiologist at time of induction. A break in any part of this process will lead to noncompliance with the guidelines and then to possible SSI development.
Errors occur because of basic flaws in the systems of a healthcare organization. Hence, in contrast to previous error reviews that assumed that these were the result of bad behavior, incompetence, negligence, or corporate greed, a new approach in the review of incidents is process review in an attempt to identify gaps in the system that need improvement.
Therefore, to improve patient safety, the prevention of errors points to designing safer systems of care. The second IOM report, Crossing the Quality Chasm, recommended that a quality healthcare system be characterized as one that is
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safe, effective, patient centered, timely, efficient, and equitable [5]. The key challenge will be the redesign of health care organizations to meet these expected characteristics.
Building the Safety Culture
Safety culture has been said to be the greatest challenge in the healthcare system: “The biggest challenge to moving toward a safer health care system is changing the culture from one of blaming individuals for errors to one in which errors are treated not as personal failures but as opportunities to improve the system and prevent harm” [5]. The safety culture refers to a state in which there is a willingness to report all safety events and near misses without fear of retribution but with an understanding of accountability [1]. Staff have the ability to speak up when they have concerns. Having the understanding that each is accountable for the safety in the organization, staff want to work in teams to help each perform his or her part well. To allay all fear and anxiety and remove the blame and shame culture, the systems approach is used to analyze safety issues. In this approach, processes are examined to appreciate how they may lead to errors instead of focusing on individual blame. An integrated system is required to support the safe behavior. The organization sets the philosophy and values for an integrated pattern of behavior. Open communication about safety concerns and a nonpunitive environment can come about only when the leaders of the organization make it possible. In building a learning organization, which learns from errors, an organizational change has to happen. Structure, processes, goals, and rewards will have to be aligned with improving patient safety. The patient safety triangle is an illustration that helps appreciate how the patient safety culture can be developed (Figure 47-1).
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Figure 47-1 The interrelationships between infection control, patient safety, and quality. |
The Role of Leaders
Leaders play a key role in developing and shaping the safety culture. They lead the change and are responsible for setting the direction for an organization. Following the example of the Joint Commission on Accreditation of Healthcare Organizations' (JCAHO) annual patient safety goals [6], setting annual goals to include patient safety helps the organization to express its commitment to building a safe environment for its patients. Leaders also lead by setting examples. Its commitment of leaders to patient safety will have to be expressed in action. Resources will have to be provided to enable the program to succeed. Healthcare organizations committed to safety need to appoint a patient safety officer, usually someone of a senior-level position within the organization who will work with both administrative and clinical leaders [7]. This person must have a strong partnership with the chief executive officer to successfully develop and deploy a comprehensive patient safety program as he plays a significant role in supervising the patient safety program. In addition to personnel, other resources may be required (e.g., budget set aside to improve the systems, enable access to safety devices or equipment). The tone is set when senior management conducts a safety walkabout on a regular basis. These executive walkabouts have been demonstrated to be successful in not only building staff confidence in management but, more importantly, engaging staff in giving contributory feedback or suggestions for making a safer environment [8]. Greater synergy is present when the infection control professional joins the patient safety walkabout, which will help to foster closer relationships between the infection control team and the ground staff.
The Patient Safety Triangle: Systems
Systems influence safety. A reporting system of incidents made easy or user friendly helps to ensure good reporting of incidents and near misses. Anonymous reporting has been used to encourage reporting of near misses. The database of incidents from the reporting system is a wealth of information where learning points may be gathered to build a better and safer workplace. Equally important to tracking and monitoring indicators from this database is the analysis of selected critical events or sentinel events. The root cause analysis methodology is a quality tool used in analyzing these sentinel events. The steps for this analysis as recommended by JCAHO may be summarized [9] as follows:
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The final step of evaluation of implementation of improvement measures is an equally important step not to be ignored. This is aided in a system of required feedback on effectiveness of measures implemented within a set time frame by the authority receiving the sentinel event reports.
Fallibility is part and parcel of the human condition. We may not be able to change the human condition, but we are able to change conditions under which people work. Design management entails designing work so that it is easy to do it right but very difficult or almost impossible to do it wrong. Design management is part of change management. Several methods may be adopted:
Although infection control has increased through the years with emphasis on policies and procedures, the use of both the system reviews approach and quality improvement technique can help the organization to move on to achieve a higher level of quality of patient care.
The Patient Safety Triangle: People
People and their behavior determine the safety culture. Healthcare workers (HCWs) have the innate ability to care and express concern for their patients. Closely related to the system issues discussed previously, habits and attitudes may require some modification to help HCWs comply with safe practices. A good example is the practice of hand hygiene. Although there is clear evidence that this is an important and evidence-based practice that limits the transmission of pathogens, the compliance of hand hygiene has not reached a desirable level whether at the best centers or after a hand-hygiene campaign [9,10,11,12,13]. Behavioral change needs to take place. This comes about with the creation of awareness of the problem through education, presentations, posters, seminars, and example setting by leaders in the organization. The public demonstration of examples or role models has been shown to be an effective intervention in improving hand-hygiene compliance [14]. The practice of Patient Safety Leadership Walkrounds™ is another good demonstration of key leaders setting examples [8].
Patients as partners also play a vital part in building patient safety. After all, they are the ones with the greatest interest in making sure the program works because their safety is the issue at stake. Bringing them into the program as partners in safety and quality may appear to be a nonconventional practice; in infection control however, patients and their family members can play a key role in ensuring that HCWs know and comply with the necessary infection control precautions. Their part in pointing out noncompliance or reminding staff of safe practices can bring compliance to the desired level.
Building a patient safety culture may be a long, arduous process. However, adopting a systematic approach will help to bring the organization to a higher level of safety. An initial assessment of existing safety culture helps to know the baseline from which one is starting and from which action plans are made to effect change [15]. More and more healthcare organizations are now conducting regular organizational culture surveys to measure attitudes and practices to determine success in their programs [16]. The Agency of Healthcare Research and Quality (AHRQ) Hospital Survey on Patient Safety is one example of such survey tools when the following dimensions of patient safety culture are measured [17]:
Leaders also need to determine priorities for change. This may be done during the regular annual review of organizational goals. Incorporating patient safety goals as
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part of the organizational goals helps management to keep this clearly visible on the radar screen. In addition, the review needs to lead to actions formulated to effect the necessary change (e.g., quality and safety framework may need to be modified or help systems need to be created). Last, a regular review of progress made in accomplishing the goals helps to complete the cycle of change.
Quality, Infection Control, and Patient Safety
Both patient safety and infection control share the objective of protecting the patient from harm. However, infection control has a larger scope of safety. It includes staff safety or occupational health issues. There is considerable overlap between patient safety and infection control (Figure 47-2). Infection control is a quality program.
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Figure 47-2 Overlap between patient safety and infection control. |
Quality improvement, a science of process management, will help us not only deliver quality care but also enhance patient care. Quality improvement focuses on streamlining, aligning, and improving systems and processes with the goal of eliminating inappropriate variation in process steps and documenting continuous improvement or outcomes [18] (Figures 47-3 and 47-4). Quality improvement uses the application of known systematic methods with means of analysis and measurement to reach a objective conclusions to improve a process. Effective process management will lead to the desired outcomes. This has been seen clearly in good infection control programs in which surveillance, if correctly applied, plays a large part in guiding the organization in assessing its systems in ensuring safety for patients, staff, and the organization. As defined by U.S. Centers for Disease Control and Prevention, surveillance is the ongoing systematic collection, analysis, and interpretation of health data essential to the planning, implementation, and evaluation of public health practice, closely integrated with the timely dissemination of these data to those who need to know [19]. These steps demonstrating surveillance as a data-driven process are similar to the principles of plan, do, check, and act (PDCA) of the quality improvement model [20]. Planning the change involves modifying the current process in patient care practices in some way or perhaps redesigning it completely. A pilot study is usually performed to test the effectiveness of the intervention. This is then closely monitored through continual tracking of the indicators to determine whether the new process has a level of performance and/or random variation that is superior to that displayed by the previous process. Finally, if the pilot is successful, the intervention is implemented on a wider scale; if it is unsuccessful, modification is made and testing is done again using another PDCA cycle.
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Figure 47-3 Problems in an organization's processes or systems. |
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Figure 47-4 Focus of continuous quality improvement. |
Variation is inevitable in practices. However, it is the inappropriate variation that should be removed because it is a quality waste leading to cost. Quality improvement aims at eliminating inappropriate variation through process management with resultant cost savings. Hence, quality controls cost. This effective approach in achieving quality is a workable winning strategy, especially for organizations facing the constant challenge of balancing resources. When applied to infection control programs, the impact is magnified as can be seen in both the physical and cost outcomes.
One of the contributory factors for success in using the improvement model is the inclusion of process
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owners in the improvement process. These process owners have the body knowledge concerning their processes and, hence, will invariably give useful insight to the cause of a problem and good suggestions for improvement. When applied to infection control programs, this powerful technique will help make the quantum leap in the program. Quality improvement teams are formed in response to an identified problem. Process owners use quality tools (e.g., flowcharts, fishbone diagrams, or Pareto charts) in the diagnostic phase of the project to analyze the problem. Testing change using several rapid PDCA cycles helps to ensure success in the implementation of the improvement measures. One can improve only if one is able to measure. Hence, indicator tracking is a key component in any quality improvement program. This process encompasses all components of surveillance: data collection, analysis, interpretation, and feedback. Quality tools such as run charts and statistical process control (SPC) charts have helped other industries in discerning random variation from special cause variation [21,22]. These are excellent objective tools in data analysis and, when used in infection control surveillance, will help the infection control practitioner to respond appropriately to the variation seen and, hence, will assist in better time management. Time and energy can then be directed to teaching, policy development or review, and quality improvement projects. The synergy within these quality improvement teams helps to bring about effective change.
Conclusion
The strong interrelationships among patient safety, infection control, and quality call for close collaboration for optimal results. The application of quality improvement techniques and principles, will greatly enhance infection control programs to achieve the goal of ensuring patient safety and a better quality of care to patients while they are in our facilities.
References