Patient safety is a specialized field focused on enhancing healthcare quality through the systematic prevention, reduction, reporting, and analysis of medical errors and preventable harm that can lead to negative patient outcomes. Although healthcare risks have long existed, patient safety only gained formal recognition in the 1990s following reports of alarming rates of medical error-related injuries in many countries. The urgency of the issue was underscored when the World Health Organization (WHO) identified that 1 in 10 patients globally experience harm due to healthcare errors, declaring patient safety an "endemic concern" in modern medicine. Robust healthcare management systems are critical to successfully implementing patient safety strategies, ensuring that safety protocols are seamlessly integrated into clinical operations to reduce medical errors. Today, patient safety is a distinct healthcare discipline, supported by an ever evolving scientific framework. It is underpinned by a robust transdisciplinary body of theoretical and empirical research, with emerging technologies, such as mobile health applications, playing a pivotal role in its advancement.
Prevalence of adverse events
Millennia ago, Hippocrates recognized the potential for injuries that arise from the well-intentioned actions of healers. Greek healers in the 4th century BC drafted the Hippocratic Oath, pledging to "prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone." Since then, the directive primum non nocere ("first, do no harm") has become a central tenet for contemporary medicine. However, despite an increasing emphasis on the scientific basis of medical practice in Europe and the United States in the late 19th century, data on adverse outcomes were hard to come by; the various studies commissioned collected mostly anecdotal events. In April 1982, the ABC television program 20/20 entitled The Deep Sleep presented a rising problem in American hospitals. Showing accounts of anesthetic accidents, the producers stated that, every year, 6,000 Americans die or experience brain damage related to these mishaps. In 1983, the British Royal Society of Medicine and the Harvard Medical School jointly sponsored a symposium on anesthesia deaths and injuries, resulting in an agreement to share statistics and conduct studies. Attention was brought to medical errors in 1999 when the Institute of Medicine reported that about 98,000 deaths occur in the United States every year due to medical errors made in hospitals. By 1984, the American Society of Anesthesiologists (ASA) had established the Anesthesia Patient Safety Foundation (APSF). The APSF marked the first use of the term "patient safety" in the name of a professional reviewing organization. Although anesthesiologists comprise only about 5% of physicians in the United States, anesthesiology became the leading medical specialty addressing issues of patient safety.
To Err is Human
In the United States, the full magnitude and impact of errors in health care were not appreciated until the 1990s, when several reports brought attention to this issue. In 1999, the Institute of Medicine (IOM) of the National Academy of Sciences released a report, To Err Is Human: Building a Safer Health System. The IOM called for a broad national initiative focused on several key actions: creating a Center for Patient Safety, expanding the reporting of adverse events, implementing safety programs within healthcare organizations, and increasing involvement from regulators, healthcare purchasers, and professional societies. The majority of media attention, however, focused on the statistics: from 44,000 to 98,000 preventable deaths annually due to medical errors in hospitals, with 7,000 preventable deaths related to medication errors alone. Within 2 weeks of the report's release, Congress began hearings, and President Clinton ordered a government-wide study of the feasibility of implementing the report's recommendations. Initial criticisms of the methodology in the IOM estimates focused on the statistical methods of amplifying low numbers of incidents in the pilot studies to the general population. To this day, there are only a few comprehensive studies on medical errors. A bibliometric analysis in 2020 revealed a steady growth of publications in this area. In 2016, Michael Daniels and Martin A. Makary published a piece in The British Medical Journal that claimed medical error was the third leading cause of death in America at nearly half a million deaths per year. This number has since been debunked, citing flawed and improper methodology in the paper. More recent analysis using data from the 2016 Global Burden of Diseases, Injuries, and Risk Factors (GBD) study obtained an estimate of 123,603 deaths in the United States from 1990 to 2016 due to adverse effects of medical treatment (AEMT), with the mortality rate decreasing over time despite an overall increase in the number of deaths. The experience has been similar in other countries.
In 1992, an Australian study revealed 18,000 annual deaths from medical errors. Professor Bill Runciman, one of the study's authors and president of the Australian Patient Safety Foundation since its inception in 1989, reported himself a victim of a medical dosing error. In June 2000, the Department of Health Expert Group estimated that over 850,000 incidents harm National Health Service hospital patients in the United Kingdom each year. On average, forty incidents a year contribute to patient deaths in each NHS institution. In 2004, the Canadian Adverse Events Study found that adverse events occurred in more than 7% of hospital admissions and estimated that 9,000 to 24,000 Canadians die annually after an avoidable medical error. These and other reports from New Zealand, Denmark and developing countries have led the World Health Organization to estimate that one in ten persons receiving health care will suffer preventable harm.
Psychological safety Psychological safety aims to provide an environment where patients and medical professionals feel comfortable sharing concerns and mistakes without fear of embarrassment or retribution. This enables increased reporting, as well as the sharing of new ideas and honest feedback. A wider variety of information is thus shared throughout the organization, allowing for creativity, innovation, and learning. Psychological safety is believed to lead to better outcomes by providing basis for more informed decisions. Psychological safety has been found to play an important role in both patient safety culture and in enabling quality improvement in the health care setting.
Communication Communication involves distributing relevant information across operational sites to ensure alignment. It also reduces administrative burden by using model-driven instructions, freeing up operational staff and easing procedural demands. This enables consistent execution with minimal but essential feedback, ensuring processes remain both efficient and controlled.
Effective and ineffective communication
The use of effective communication among patients and healthcare professionals is associated with a patient's health outcome. However, scientific patient safety research by Annegret Hannawa et al. has shown that ineffective communication can lead to patient harm. Communication regarding patient safety can be classified into two categories: the prevention of adverse events and the response to adverse events. Effective communication may help to prevent adverse events, whereas ineffective communication may contribute to their occurrence. If ineffective communication contributes to an adverse event, improved communication skills may be applied in response to achieve optimal outcomes for the patient's safety. There are different modes in which healthcare professionals can work to optimize the safety of patients which include both verbal and nonverbal communication, as well as the effective use of communication technologies. Methods of effective verbal and nonverbal communication include treating patients with respect and showing empathy, clearly communicating with patients in a way that best fits their needs, practicing active listening skills, demonstrating cultural sensitivity and awareness, and respecting the privacy and confidentiality rights of the patient. To use appropriate communication technology, healthcare professionals must choose which channel of communication is best suited to benefit the patient. Some channels are more likely to result in communication errors than others, such as communicating through telephone or email (missing nonverbal messages which are an important element of understanding the situation). It is also the responsibility of the provider to know the advantages and limitations of using electronic health records, as they do not convey all the information necessary to understand patient needs. If a health care professional is not practicing these skills, they are not being an effective communicator which may affect patient outcomes. The goal of a healthcare professional is to aid a patient in achieving their optimal health outcome, which entails that the patient's safety is not at risk. The practice of effective communication plays a crucial role in promoting and protecting patient safety.
Teamwork and communication During complex situations, health professionals must communicate clearly and effectively. There are several techniques, tools, and used to improve communication. Any team should have a clear purpose, and each member should be aware of their role and be involved accordingly. To increase the quality of communication between people involved, regular feedback should be provided. Strategies such as briefings allow the team to be set on their purpose and ensure that members not only share the goal but also the process they will follow to achieve it. Briefings reduce interruptions, prevent delays, and build stronger relationships, resulting in a strong patient safety environment. Debriefing is another useful strategy. Healthcare providers meet to discuss a situation, record what they learned, and discuss how it might be better handled. Closed loop communication is another important technique used to ensure that the message that was sent is received and interpreted by the receiver. SBAR is a structured system designed to help team members communicate about the patient in the most convenient form possible. Communication between healthcare professionals not only helps achieve the best results for the patient but also prevents any unseen incidents.
Safety culture
As is the case in other industries, when a mistake or error is made, people look for someone to blame. This tendency creates a blame culture where who is more important than why or how. A just culture, also sometimes known as no blame or no fault, seeks to understand the root causes of an incident rather than just who was involved. In health care, there is a move towards a patient safety culture. This applies the lessons learned from other industries, such as aviation, marine, and industrial, to a health care setting. When assessing and analyzing an incident, individuals involved are much more likely to be forthcoming with their own mistakes if they know that their job is not at risk. This allows a much more complete and clearer picture to be formed of the facts of an event. From there, root cause analysis can occur. There are often multiple causative factors involved in an adverse or near-miss event. It is only after all contributing factors have been identified that effective changes can be made that will prevent a similar incident from occurring.
Disclosure of an incident After an adverse event occurs, each country has its own way of dealing with the incident. In Canada, a quality improvement review is primarily used. A quality improvement review is an evaluation that is completed after an adverse event occurs with the intention to both fix the problem as well as prevent it from happening again. The individual provinces and territories have laws on whether it is required to disclose the quality improvement review to the patient. Healthcare providers have an obligation to disclose any adverse event to their patients because of ethical and professional guidelines. If more providers participate in the quality improvement review, it can increase interdisciplinary collaboration and can sustain relationships between departments and staff. In the US, clinical peer review is used: uninvolved medical staff review the event and work toward preventing further incidents. The disclosure of adverse events is important in maintaining trust in the relationship between healthcare provider and patient. It is also important to learn how to avoid these mistakes in the future by conducting quality improvement reviews or clinical peer reviews. If the provider accurately handles the event and discloses it to the patient and their family, he/she can avoid getting punished, which includes lawsuits, fines, and suspension.
Causes of healthcare error
The simplest definition of a healthcare error is a preventable adverse effect of care, whether or not it is evident or harmful to the patient. Errors have been, in part, and/or attributed to:
Human factors Variations in healthcare provider training and experience, fatigue, depression and burnout. Diverse patients, unfamiliar settings, and time pressures. Failure to acknowledge the prevalence and seriousness of medical errors. Increasing working hours of healthcare personnel. Mislabeling specimen or forgetting to label specimen. States of anxiety and stress put on the healthcare provider.
Medical complexity Complicated technologies, powerful drugs. Intensive care, prolonged hospital stays.
System failures Unsafe communication. Unclear lines of authority or guidelines for physicians, nurses, and other care providers. Complication increasing when the patient to nurse staffing ratio increases to a point where the patient rate is higher than the rate of staff. Disconnected reporting systems within a hospital: fragmented systems in which numerous hand-offs of patients result in errors in examples such as coordination or other general reports due to even minor errors. Drug names that look alike or sound alike. The impression that action is being taken by other groups within the institution. Reliance on automated systems to prevent error. Inadequate systems to share information about errors hamper analysis of contributory causes and improvement strategies. Cost-cutting measures by hospitals in response to reimbursement cutbacks. Environment and design factors. In emergencies, patient care may be rendered in areas poorly suited for safe monitoring. The American Institute of Architects has identified concerns for the safe design and construction of healthcare facilities. Infrastructure failure. According to the WHO, around 50% of medical equipment in developing countries is only partly usable due to a lack of skilled operators or parts. As a result, diagnostic procedures or treatments cannot be performed, leading to substandard treatment. The Joint Commission's Annual Report on Quality and Safety 2007 found that inadequate communication between healthcare providers, between providers and the patient, and between providers and the patient's family members, was the root cause of over half the serious severe adverse events in accredited hospitals. Other leading causes included inadequate assessment of the patient's condition, poor leadership, and/or training. Common misconceptions about adverse events are:
" 'Bad apples', or incompetent health care providers are a common cause for patient harm". Many of the errors are normal human slips or lapses, and not the result of poor judgment or recklessness. "High-risk procedures or medical specialties are responsible for most avoidable adverse events". Although some mistakes, such as those in surgery, are easier to notice, errors occur at all levels of care. Even though complex procedures entail more risk, adverse outcomes are not usually due to error, but to the severity of the condition being treated. However, USP has reported that medication errors during the course of a surgical procedure are three times more likely to cause harm to a patient than those occurring in other types of hospital care. "If a patient experiences an adverse event during the process of care, an error has occurred". Most medical care entails some level of risk, and there can be complications or side effects, even unforeseen ones, from the underlying condition or from the treatment itself.
Nursing burnout and patient safety In the medical field, many things can lead to decreased patient safety. One significant influence on this is nurse burnout, leading to hundreds of thousands of deaths a year and billions of dollars spent when having to rectify a new problem; this is a real issue in the world. On average in the medical field, one out of 20 prescriptions filled contains an error, considering the billions of prescriptions that get filled every year there is a vital amount of error happening. With these errors, not only is there a likelihood of a prescription being wrong, but there is a $3.5 billion price tag that goes with it, covering the amount that people pay each year for litigation costs and extra days that patients need to stay in hospital beds because of mistakes from the hospital. Burnout has been going on for years amongst nurses and other physicians, affecting nearly half of healthcare workers. Burnout has been going on for decades and the term was originally coined by Herbert Freudenberger. Freudenberger was working at a free clinic, and over time mentioned some of the effects that he had seen, such as "emotional depletion and accompanying psychosomatic symptoms... excessive demands on energy, strength, or resources". These burnout symptoms are commonly seen today in hospital settings as nurses feel like they are pushed to the edge. This emotion is not ideal nor wanted for everyone, especially for people who have to look after patients and take care of others who can be in very severe and mortally harmed states. Using what Freudenberger described, there was a scale created to measure the amount of burnout in the healthcare field. Known as Maslach's scale, this measures 1. Workload, 2. Control, 3. Reward, 4. Community, 5. Fairness, and 6. Values. All of these core points work together and the less you have of most of them, the more likely that burnout will occur and cause a major decrease in patient safety. Similarly to Maslach's scale, there is the Conservation of Resources Theory. This theory essentially states that if one of the four pillars are lost, so are safety and control. According to the Journal of Advanced Nursing, "Healthcare organizations and nursing administrations should develop strategies to protect nurses from the threat of resource loss to decreases in nurse burnout, which may improve nurse and patient safety." The amount of nursing professionals that have experienced burnout is said to be around 50%. This number leads to an increased risk of adverse events that should not happen, ranging from 26% to 70% of a higher risk that something negative will happen to the patient.
Safety programs in industry
Aviation safety In the United States, two organizations contribute to one of the world's lowest aviation accident rates. Mandatory accident investigation is carried out by the National Transportation Safety Board, while the Aviation Safety Reporting System receives voluntary reports to identify deficiencies and provide data for planning improvements. The latter system is confidential and provides reports back to stakeholders without regulatory action. Similarities and contrasts have been noted between the "cultures of safety" in medicine and aviation. Pilots and medical personnel operate in complex environments, interact with technology, and are subject to fatigue, stress, danger, and loss of life and prestige as a consequence of error. Given the enviable record of aviation in accident prevention, a similar medical adverse event system would include both mandatory (for severe incidents) and voluntary non-punitive reporting, teamwork training, feedback on performance and an institutional commitment to data collection and analysis. The Patient Safety Reporting System (PSRS) is a program modeled upon the Aviation Safety Reporting System and developed by the Department of Veterans Affairs (VA) and the National Aeronautics and Space Administration (NASA) to monitor patient safety through voluntary, confidential reports. Required training in crew resource management (CRM), which focused on team dynamics both inside the cockpit and outside was introduced in the early 1980s after the tragic mishap of United Airlines 173. CRM is considered an effective means of improving safety in aviation and is utilized by the DoD, NASA, and almost all commercial airlines. Many of the tenets of this training have been incorporated into medicine under the guise of Team Stepps, which was introduced by the Agency for Healthcare Research and Quality (AHRQ). The AHRQ calls this program "an evidence-based teamwork system to improve communication and teamwork skills among health care professionals."
Near-miss reporting A near miss is an unplanned event that did not result in injury, illness, or damage - but had the potential to do so. Reporting of near misses by observers is an established error reduction technique in aviation, and has been extended to private industry, traffic safety, and fire-rescue services with reductions in accidents and injury. AORN, a US-based professional organization of perioperative registered nurses, has put in effect a voluntary near-miss reporting system (SafetyNet), covering medication or transfusion reactions, communication or consent issues, wrong patient or procedures, communication breakdown or technology malfunctions. An analysis of incidents allows safety alerts to be issued to AORN members. AlmostME is another commercially offered solution for near miss reporting in healthcare.
Limits of the Industrial Safety Model Unintended consequences may occur as improvements in safety are undertaken. It may not be possible to attain maximum safety goals in healthcare without adversely affecting patient care in other ways. An example is blood transfusion; in recent years, to reduce the risk of transmissible infection in the blood supply, donors with only a small probability of infection have been excluded. The result has been a critical shortage of blood for other lifesaving purposes, with a broad impact on patient care. Application of high-reliability theory and normal accident theory can help predict the organizational consequences of implementing safety measures.
Technology in healthcare
Overview According to a study by RAND Health, the U.S. healthcare system could save more than $81 billion annually, reduce adverse healthcare events, and improve the quality of care if health information technology (HIT) is widely adopted. The most immediate barrier to widespread adoption of technology is cost despite the patient benefit from better health, and payer benefit from lower costs. However, hospitals pay both higher costs for implementation and potentially lower revenues (depending on reimbursement scheme) due to reduced patient length of stay. The benefits provided by technological innovations also give rise to serious issues with the introduction of new and previously unseen error types.
Types of healthcare technology Handwritten reports or notes, manual order entry, non-standard abbreviations, and poor legibility lead to substantial errors and injuries, according to the IOM (2000) report. The follow-up IOM report, Crossing the Quality Chasm: A New Health System for the 21st Century, advised rapid adoption of electronic patient records, and electronic medication ordering, with computer- and internet-based information systems to support clinical decisions. This section contains only the patient safety related aspects of HIT.
Electronic health record (EHR) The electronic health record (EHR), previously known as the electronic medical record (EMR), reduces several types of errors, including those related to prescription drugs, emergency and preventive care, and to tests and procedures. Important features of modern EHR include automated drug-drug/drug-food interaction checks and allergy checks, standard drug dosages and patient education information. Drug Information at the point-of-care and drug dispensing points helps in reducing errors. Example: India, MedCLIK. Also, these systems provide recurring alerts to remind clinicians of intervals for preventive care and to track referrals and test results. Clinical guidelines for disease management have a demonstrated benefit when accessible within the electronic record during the process of treating the patient. Advances in health informatics and widespread adoption of interoperable electronic health records promise access to a patient's records at any health care site. Still, there may be a weak link because of physicians' deficiencies in understanding the patient safety features of e.g. government-approved software. Errors associated with patient misidentification may be exacerbated by EHR use, but inclusion of a prominently displayed patient photograph in the EHR can reduce errors and near misses. Portable offline emergency medical record devices have been developed to provide access to health records during widespread or extended infrastructure failure, such as in natural disasters or regional conflicts.
Active RFID platform These systems' basic security measures are based on sound identifying electronic tags to ensure that the patient details provided in different situations are always reliable. These systems offer three differently qualified options:
Identification upon request of health care personnel, using scanners (similar to readers for passive RFID tags or scanners for barcode labels) to identify patients semi-automatically upon presentation of the patient with a tag to staff Automatic identification upon entry of patient. An automatic identification check is carried out on each person with tags (primarily patients) entering the area to determine the presented patient in contrast to other patient earlier entered into reach of the used reader. Automatic identification and range estimation upon approach to the most proximate patient, excluding reads from more distant tags of other patients in the same area Any of these options may be applied whenever and wherever patient details are required in electronic form Such identifying is essential when the information concerned is critical. There are increasing numbers of hospitals that have an RFID system to identify patients, for instance: Hospital La Fe in Valencia, Spain; Wayne Memorial Hospital (US); Royal Alexandria Hospital (UK).
Computerized provider order entry (CPOE) Prescribing errors are the largest identified source of preventable errors in hospitals (IOM, 2000; 2007). The IOM (2006) estimates that each hospitalized patient, on average, is exposed to one medication error each day. Computerized provider order entry (CPOE), formerly called computerized physician order entry, can reduce medication errors by 80% overall but more importantly decrease harm to patients by 55%. A Leapfrog (2004) survey found that 16% of US clinics, hospitals, and medical practices are expected to utilize CPOE within 2 years.
Complete safety medication system A standardized bar code system for dispensing drugs might prevent 25% of drug errors. Despite ample evidence to reduce medication errors, complete medication delivery systems (barcoding and Electronic prescribing) have slow adoption by doctors and hospitals in the United States, due to concerns with interoperability and compliance with future national standards. Such concerns are not inconsequential; standards for electronic prescribing for Medicare Part D conflict with regulations in many US states.
Specific patient safety software A standardized, modular technology system that allows a hospital, clinic, or health system to record their Incidents, including falls, medication errors, pressure ulcers, near misses, etc. These systems can be configured to specific workflows, and the analytics behind them will allow for reporting and dashboards to help learn from things that have gone wrong (and right). Some vendors include Datix, RL Solutions, Verge, Midas, and Quantros.
Technological Iatrogenesis Technology-induced errors are significant and increasingly more evident in care delivery systems. This idiosyncratic and potentially serious problem associated with HIT implementation has recently become a tangible concern for healthcare and information technology professionals. As such, the term technological iatrogenesis describes this new category of adverse events that are an emergent property resulting from technological innovation creating system and microsystem disturbances. Healthcare systems are complex and adaptive, meaning there are many networks and connections working simultaneously to produce certain outcomes. When these systems are under the increased stresses caused by the diffusion of new technology, unfamiliar and new process errors often result. If not recognized, over time these new errors can collectively lead to catastrophic system failures. The term "e-iatrogenesis" can be used to describe the local error manifestation. The sources for these errors include:
Prescriber and staff inexperience may lead to a false sense of security; that when technology suggests a course of action, errors are avoided. Shortcut or default selections can override non-standard medication regimens for elderly or underweight patients, resulting in toxic doses. CPOE and automated drug dispensing were identified as a cause of error by 84% of over 500 healthcare facilities participating in a surveillance system by the United States Pharmacopoeia. Irrelevant or frequent warnings can interrupt workflow. Solutions include ongoing changes in design to cope with unique medical settings, supervising overrides from automatic systems, and training (and re-training) all users.
Evidence-based medicine
Evidence-based medicine integrates an individual doctor's exam and diagnostic skills for a specific patient, with the best available evidence from medical research. The doctor's expertise includes both diagnostic skills and consideration of individual patients' rights and preferences in making decisions about his or her care. The clinician uses pertinent clinical research on the accuracy of diagnostic tests and the efficacy and safety of therapy, rehabilitation, and prevention to develop an individual plan of care. The development of evidence-based recommendations for specific medical conditions, termed clinical practice guidelines or "best practices", has accelerated in the past few years. In the United States, over 1,700 guidelines (see example image, right) have been developed as a resource for physicians to apply to specific patient presentations. The National Institute for Health and Clinical Excellence (NICE) in the United Kingdom provides detailed "clinical guidance" for both health care professionals and the public about specific medical conditions. National Guideline Agencies from all continents collaborate in the Guidelines International Network, which entertains the largest guideline library worldwide. The International Standard ISO 15189:2007 for Accreditation of Medical Laboratory requires laboratories to continuously monitor and improve the quality of their facilities. Advantages:
Evidence-based medicine may reduce adverse events, especially those involving incorrect diagnosis, outdated or risky tests or procedures, or medication overuse. Clinical guidelines provide a common framework for improving communication among clinicians, patients and non-medical purchasers of health care. Errors related to changing shifts or multiple specialists are reduced by a consistent plan of care. Information on the clinical effectiveness of treatments and services can help providers, consumers and purchasers of health care make better use of limited resources. As medical advances become available, doctors and nurses can keep up with new tests and treatments as guidelines are improved. Drawbacks:
Managed care plans may attempt to limit "unnecessary" services to cut the costs of health care, despite evidence that guidelines are not designed for general screening, but rather as decision-making tools when an individual practitioner evaluates a specific patient. The medical literature is evolving and often controversial; the development of guidelines requires consensus. Implementing guidelines and educating the entire health care team within a facility costs time and resources (which may be recovered by future efficiency and error reduction). Clinicians may resist evidence-based medicine as a threat to traditional relationships between patients, doctors, and other health professionals since any participant can influence decisions. Failing to follow guidelines might increase the risk of liability or disciplinary action by regulators.
Quality and Safety Initiatives in Community Pharmacy practice Community pharmacy practice is making important advances in the quality and safety movement, despite the limited number of federal and state regulations that exist and in the absence of national accreditation organizations such as the Joint Commission - a driving force for performance improvement in health care systems. Community pharmacies are using automated drug dispensing devices (robots), computerized drug utilization review tools, and, most recently, the ability to receive electronic prescriptions from prescribers to decrease the risk of error and increase the likelihood of delivering high-quality care. Quality Assurance (QA) in community practice is a relatively new concept. As of 2006, only 16 states have some form of legislation that regulates QA in community pharmacy practice. While most state QA legislation focuses on error reduction, North Carolina has recently approved legislation that requires the pharmacy QA program to include error reduction strategies and assessments of the quality of their pharmaceutical care outcomes and pharmacy services. New technologies facilitate the traceability tools of patients and medications. This is particularly relevant for drugs that are considered high-risk and costly.
Quality improvement and safety initiatives in pediatrics Quality improvement and patient safety is a major concern in the pediatric world of health care. This next section will focus on quality improvement and patient safety initiatives in inpatient settings. Over the last several years, pediatric groups have partnered to improve general understanding, reporting, process improvement methodologies, and quality of pediatric inpatient care. These collaborations have created a robust program of projects, bench-marking efforts, and research. Much of the research and focus on adverse events has been on medication errors–the most frequently reported adverse event for both adult and pediatric patients. It is also of interest to note that medication errors are also the most preventable type of harm that can occur within the pediatric population. It has been reported that when pediatric medication errors occur, these patients have a higher rate of death associated with the error than adult patients. A more recent review of potential pediatric safety issues conducted by Miller, Elixhauser, and Zhan found that hospitalized children who experienced a patient safety incident, compared with those who did not, had
Length of stay 2 to 6 times longer Hospital mortality 2 to 18 times greater Hospital charges 2 to 20 times higher In order to reduce these errors, the attention to safety needs to concentrate on designing safe systems and processes. Slonim and Pollack point out that safety is critical to reducing medical errors and adverse events. These problems can range from diagnostic and treatment errors to hospital-acquired infections, procedural complications, and failure to prevent problems such as pressure ulcers. In addition to addressing quality and safety issues found in adult patients there are a few characteristics that are unique to the pediatric population:
Development: As children mature both cognitively and physically, their needs as consumers of health care goods and services change. Therefore, planning a unified approach to pediatric safety and quality is affected by the fluid nature of childhood development. Dependency: Hospitalized children, especially those who are very young and/or nonverbal, are dependent on caregivers, parents, or other surrogates to convey key information associated with patient encounters. Even when children can accurately express their needs, they are unlikely to receive the same acknowledgment accorded to adult patients. In addition, because children are dependent on their caregivers, their care must be approved by parents or surrogates during all encounters. Different epidemiology: Most hospitalized children require acute episodic care, not care for chronic conditions as with many adult patients. Planning safety and quality initiatives within a framework of "wellness, interrupted by acute conditions or exacerbations" presents distinct challenges and requires a new way of thinking. Demographics: Children are more likely than other groups to live in poverty and experience racial and ethnic disparities in health care. Children are more dependent on public insurance, such as the State Children's Health Insurance Program (SCHIP) and Medicaid. One of the main challenges faced by pediatric safety and quality efforts is that most of the work on patient safety to date has focused on adult patients. In addition, there is no standard nomenclature for pediatric patient safety that is widely used. However, a standard framework for classifying pediatric adverse events that offers flexibility has been introduced. Standardization provides consistency between interdisciplinary teams and can facilitate multi-site studies. If these large-scale studies are conducted, the findings could generate large-scale intervention studies conducted with a faster life cycle.
Leaders in pediatric safety and quality The Agency for Healthcare Research and Quality (AHRQ) is the Federal authority for patient safety and quality of care and has been a leader in pediatric quality and safety. AHRQ has developed Pediatric Quality Indicators (PedQIs) with the goal to highlight areas of quality concern and to target areas for further analysis. Eighteen pediatric quality indicators are included in the AHRQ quality measure modules; based on expert input, risk adjustment, and other considerations. Thirteen inpatient indicators are recommended for use at the hospital level, and five are designated area indicators. Inpatient indicators are treatments or conditions with the greatest potential of an adverse event for hospitalized children.
Possible additions to the dataset will address the patient's condition on admission and increase the understanding of how laboratory and pharmacy utilization impact patient outcomes. The goal of AHRQ is to refine the area-level indicators to improve outcomes for children receiving outpatient care and reduce the incidence of hospitalization for those defined conditions.
Collaborations for pediatric safety and quality Numerous groups are engaged in improving pediatric care, quality, and safety. Each of these groups has a unique mission and membership. The following table details these groups' missions and websites.