Patient safety is a relatively recent initiative in healthcare, emphasizing the reporting, analysis and prevention of medical error and adverse healthcare events. The frequency and magnitude of avoidable adverse events was not well known until the 1990s, when reports in several countries revealed a staggering number of patient injuries and deaths each year. Patient safety initiatives include application of lessons learned from business and industry, advancing technologies, education of providers and the public, and economic incentives. A large number of organizations internationally promote patient safety issues.
Prevalence of adverse events
Unforeseen bad outcomes of medical treatment cause harm to patients; Greek healers knew this in the 4th Century B.C., when the Hippocratic Oath pledged to "prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone." 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 and the various studies commissioned collected mostly anecdotal events.
In the United States, the public and the medical specialty of anesthesia were shocked in April 1982 by the ABC television program 20/20 entitled The Deep Sleep. Presenting accounts of anesthetic accidents, the producers stated that, every year, 6,000 Americans die or suffer 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 to conduct studies. By 1984 the American Society of Anesthesiologists had established the Anesthesia Patient Safety Foundation. The APSF marked the first use of the term "patient safety" in the name of 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. Likewise in Australia, the Australian Patient Safety Foundation was founded in 1989 for anesthesia error monitoring. Both organizations were soon expanded as the magnitude of the medical error crisis became known.
To Err is Human
In the United States, the full magnitude and impact of errors in health care was 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 effort to include establishment of a Center for Patient Safety, expanded reporting of adverse events, development of safety programs in health care organizations, and attention by regulators, health care purchasers, and professional societies. The majority of media attention, however, focused on the staggering statistics: from 44,000 to 98,000 preventable deaths annually due to medical error, 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. However, subsequent reports emphasized the striking prevalence and consequences of medical error. In July 2004, Healthgrades, a leading health care ratings organization, published a study, Patient Safety in American Hospitals, concluding that there were over one million adverse events associated with Medicare hospitalizations during 2000-2002, resulting in up to 195,000 accidental deaths per year in American hospitals.
The experience has been similar in other countries.
- Ten years after a groundbreaking Australian study revealed 18,000 annual deaths from medical errors, Professor Bill Runicman, 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.
- The Department of Health Expert Group in June 2000 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 over 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.
Causes of health care errors
The simplest definition of a health care error is a preventable adverse effect of care, whether or not it is evident or harmful to the patient. A conservative average of both the Institute of Medicine and HealthGrades reports indicates that there have been between 400,000-1.2 million error-induced deaths during 1996 - 2006 in the United States. These casualties have been, in part, attributed to:
- Human Factors
- Variations in provider training & experience, fatigue.
- Diverse patients, unfamiliar settings, time pressures.
- Failure to acknowledge the prevalence and seriousness of medical errors.
- Medical complexity
- Complicated technologies, powerful drugs.
- Intensive care, prolonged hospital stay.
- System failures
- Poor communication, unclear lines of authority of physicians, nurses, and other care providers.
- Complications increase as patient to nurse staffing ratio increases.
- Disconnected reporting systems within a hospital: fragmented systems in which numerous hand-offs of patients results in lack of coordination and errors.
- The impression that action is being taken by other groups within the institution.
- Reliance on automated systems to prevent error.
- Not measuring patient safety initiatives to analyze contributory issues and identify improvement strategies.
- Cost-cutting measures by hospitals in response to reimbursement cutbacks.
Common misconceptions about adverse events are:
- "Bad apples" or incompetent health care providers are a common cause. (Although human error is commonly an initiating event, the faulty process of delivering care invariably permits or compounds the harm, and is the focus of improvement.)
- High risk procedures or medical specialties are responsible for most avoidable adverse events. (Although some mistakes, such as in surgery, are harder to conceal, errors occur in 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.)
Initiatives in patient safety
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.
- 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.
- 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 settings
Handwritten reports or notes, manual order entry, non-standard abbreviations and poor legibility lead to substantial errors and injuries, according to the 1999 Institute of Medicine (IOM) 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, electronic medication ordering, with computer- and internet-based information systems to support clinical decisions. According to a study by RAND Health, the US healthcare system could save more than $81 billion annually, reduce adverse healthcare events and improve the quality of care if it were to widely adopt health information technology. The most immediate barrier to widespread adoption of technology is cost: patients benefit from better health, and payers benefit from lower costs; however, hospitals pay in both higher costs for implementation and lower revenues due to reduced patient length of stay.
The Electronic health record (EHR), previously known as the Electronic medical record (EMR), reduces several types of errors, including those related to prescription drugs, to preventive care, and to tests and procedures. Important features of modern EHR software include automatic drug-drug/drug-food interaction checks and allergy checks, standard drug dosages and patient education information, such as describing common side effects. Recurring alerts remind clinicians of intervals for preventive care and 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. A 2005 report noted that medical practices in the United States are encountering barriers to adopting an EHR system, such as training, costs and complexity, but the adoption rate continues to rise (see chart to right). Since 2002, the National Health Service of the United Kingdom has placed emphasis on introducing computers into healthcare. As of 2005, one of the largest projects for a national EHR is by the National Health Service (NHS) in the United Kingdom. The goal of the NHS is to have 60,000,000 patients with a centralized electronic health record by 2010. The plan involves a gradual roll-out commencing May 2006, providing general practices in England access to the National Programme for IT (NPfIT), the NHS component of which is known as the "Connecting for Health Programme". However, recent surveys have shown physicians' deficiencies in understanding the patient safety features of the NPfIT-approved software.
Prescribing errors are the largest identified source of preventable errors in hospitals. A 2006 report by the Institute of Medicine estimated that a hospitalized patient is exposed to a medication error each day of his or her stay. Computer physician order entry (CPOE) reduces the medication error rate by 80%, and by 55% for errors with serious potential patient harm. A 2004 survey by Leapfrog found that 16% of US clinics, hospitals and medical practices are expected to be utilizing CPOE within 2 years. In addition to electronic prescribing, a standardized bar code system for dispensing drugs could prevent a quarter of drug errors. Consumer information about the risks of the drugs and improved drug packaging (clear labels, avoiding similar drug names and dosage reminders) are other error-proofing measures. Despite ample evidence of the potential to reduce medication errors, competing systems of barcoding and electronic prescribing have slowed adoption of this technology by doctors and hospitals in the United States, due to concern 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.
- 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 was identified as a cause of error by 84% of over 500 health care facilities participating in a surveillance system by the United States Pharmacopoeia.
- Irrelevant or frequent warnings can interrupt work flow.
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 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 patient's 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.
- 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.
- Managed care plans may attempt limit "unnecessary" services to cut the costs of health care, despite evidence that guidelines are not designed for general screening, rather as decision-making tools when an individual practitioner evaluates a specific patient.
- The medical literature is evolving and often controversial; 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.
The types and methods of public reporting across countries have been reviewed.
- The Danish Act on Patient Safety passed Parliament in June 2003, and on January 1, 2004 Denmark became the first country to introduce nation-wide mandatory reporting. The Act obligates frontline personnel to report adverse events to a national reporting system. Hospital owners are obligated to act on the reports and the National Board of Health is obligated to communicate the learning nationally. The reporting system is intended purely for learning and frontline personnel cannot experience sanctions for reporting. This is stated in Section 6 of the Danish Act on Patient Safety (as of January 1, 2007: Section 201 of the Danish Health Act): "A frontline person who reports an adverse event cannot as a result of that report be subjected to investigation or disciplinary action from the employer, the Board of Health or the Court of Justice." The reporting system and the Danish Patient Safety Database is described in further detail in a National Board of Health publication.
- United Kingdom
- The National Patient Safety Agency encourages voluntary reporting of health care errors, but has several specific instances, known as "Confidential Enquiries", for which investigation is routinely initiated: maternal or infant deaths, childhood deaths to age 16, deaths in persons with mental illness, and perioperative and unexpected medical deaths. Medical records and questionnaires are requested from the involved clinician, and participation has been high, since individual details are confidential.
- United States
- The 1999 Institute of Medicine (IOM) report recommended "a nationwide mandatory reporting system … that provides for … collection of standardized information by state governments about adverse events that result in death or serious harm." Professional organizations, such as the Anesthesia Patient Safety Foundation, responded negatively: "Mandatory reporting systems in general create incentives for individuals and institutions to play a numbers game. If such reporting becomes linked to punitive action or inappropriate public disclosure, there is a high risk of driving reporting "underground", and of reinforcing the cultures of silence and blame that many believe are at the heart of the problems of medical error…"
- Although 23 states established mandatory reporting systems for serious patient injuries or death by 2005, the national database envisioned in the IOM report was delayed by the controversy over mandatory versus voluntary reporting. Finally in 2005, the US Congress passed the long-debated Patient Safety and Quality Improvement Act, establishing a federal reporting database. Hospitals reports of serious patient harm are voluntary, collected by patient safety organizations under contract to analyze errors and recommend improvements. The federal government serves to coordinate data collection and maintain the national database. Reports remain confidential, and cannot be used in liability cases. Consumer groups have objected to the lack of transparency, claiming it denies the public information on the safety of specific hospitals.
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 JCAHO - a driving force for quality in hospitals. 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 for error and increase the likelihood of delivering high quality of 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.
Health literacy is an individual's ability to read, understand and use healthcare information to make decisions and follow instructions for treatment. A study of 2,600 patients conducted in 1995 by two US hospitals found that between 26-60% of patients could not understand medication directions, a standard informed consent or basic health care materials. This mismatch between a clinician's level of communication and a patient's ability to understand can lead to medication errors and adverse medical outcomes. The lack of health literacy affects all segments of the population, although it is disproportionate in certain demographic groups, such as the elderly, ethnic minorities, recent immigrants and persons with low general literacy.
According to a 2004 Institute of Medicine report, low health literacy negatively affects the outcome of healthcare. These patients have a higher risk of hospitalization and longer hospital stays, are less likely to comply with treatment, are more likely to make errors with medication, and are more ill when they seek medical care.
Identifying patients at risk due to low health literacy is productive. Health behaviors such as correct medication use, taking advantage of health screening and effective preventive measures such as exercise and smoking cessation improved when low literacy patients were given visual aids, easy readability brochures or videotapes. Several tests of health literacy have been developed to validate research studies, but a practical, three-minute assessment can be completed in a doctor's office.
Once identified, low health literacy patients benefit from providing limited but clear information at each visit, avoidance of medical jargon, using illustrations of important concepts and confirming information by a "teach back" method. A program called "Ask Me 3" is designed to bring public and physician attention to this issue, by letting patients know that they should ask three questions each time they talk to a doctor, nurse, or pharmacist:
- What is my main problem?
- What do I need to do?
- Why is it important for me to do this?
Pay for performance (P4P)
Pay for performance systems link compensation to measures of work quality or goals. As of 2005, 75 percent of all U.S. companies connect at least part of an employee's pay to measures of performance, and in healthcare, over 100 private and federal pilot programs are underway. Current methods of healthcare payment may actually reward less-safe care, since some insurance companies will not pay for new practices to reduce errors, while physicians and hospitals can bill for additional services that are needed when patients are injured by mistakes. However, early studies showed little gain in quality for the money spent, as well as evidence suggesting unintended consequences, like the avoidance of high-risk patients, when payment was linked to outcome improvements. The 2006 Institute of Medicine report Preventing Medication Errors recommended "incentives...so that profitability of hospitals, clinics, pharmacies, insurance companies, and manufacturers (are) aligned with patient safety goals;...(to) strengthen the business case for quality and safety."
In the United Kingdom, the National Health Service (NHS) began a major pay for performance initiative in 2004, known as the Quality and Outcomes Framework (QOF). General practitioners agreed to increases in existing income according to performance with respect to 146 quality indicators covering clinical care for 10 chronic diseases, organization of care, and patient experience. Unlike proposed quality incentive programs in the United States, funding for primary care was increased 20% over previous levels. This allowed practices to invest in extra staff and technology; 90% of general practitioners use electronic prescribing, and up to 50% use electronic health records for the majority of clinical care. The first data show that substantially increasing physicians’ pay based on their success in meeting quality performance measures works. The 8,000 family practitioners included in the study earned an average of $40,000 more by collecting nearly 97% of the points available.
In the United States, Medicare has various pay-for-performance ("P4P") initiatives in offices, clinics and hospitals, seeking to improving quality and avoid unnecessary health care costs. The Centers for Medicare and Medicaid Services (CMS) has several demonstration projects underway offering compensation for improvements:
- Payments for better care coordination between home, hospital and offices for patients with chronic illnesses. In April 2005, CMS launched its first value-based purchasing pilot or "demonstration" project- the three-year Medicare Physician Group Practice (PGP) Demonstration. The project involves ten large, multi-specialty physician practices caring for more than 200,000 Medicare fee-for-service beneficiaries. Participating practices will phase in quality standards for preventive care and the management of common chronic illnesses such as diabetes. Practices meeting these standards will be eligible for rewards from savings due to resulting improvements in patient management. The First Evaluation Report to Congress in 2006 showed that the model rewarded high quality, efficient provision of health care, but the lack of up-front payment for the investment in new systems of case management "have made for an uncertain future with respect for any payments under the demonstration."
- A set of 10 hospital quality measures which, if reported to CMS, will increase the payments that hospitals receive for each discharge. By the third year of the demonstration, those hospitals that do not meet a threshold on quality will be subject to reductions in payment. Preliminary data from the second year of the study indicates that pay for performance was associated with a roughly 2.5% to 4.0% improvement in compliance with quality measures, compared with the control hospitals. Dr. Arnold Epstein of the Harvard School of Public Health commented in an accompanying editorial that pay-for-performance "is fundamentally a social experiment likely to have only modest incremental value."
- Rewards to physicians for improving health outcomes by the use of health information technology in the care of chronically ill Medicare patients.
- Disincentives: The 2006 Tax Relief & Health Care Act of 2006 required the HHS Inspector General to study ways that Medicare payments to hospitals could be recouped for "never events", as defined by the National Quality Forum, including hospital infections. In August 2007, CMS announced that it will stop payments to hospitals for several negative consequences of care that result in injury, illness or death. This rule, effective October 2008, would reduce hospital payments for eight serious types of preventable incidents: objects left in a patient during surgery, blood transfusion reaction, air embolism, falls, mediastinitis, urinary tract infections from catheters, pressure ulcer, and sepsis from catheters. Reporting of "never events" and creation of performance benchmarks for hospitals are also mandated. Other private health payers are considering similar actions; in 2005, HealthPartners, a Minnesota health insurer, chose not to cover 27 types of "never events". The Leapfrog Group has announced that will work with hospitals, health plans and consumer groups to advocate reducing payment for "never events", and will recognize hospitals that agree to certain steps when a serious avoidable adverse event occurs in the facility, including notifying the patient and patient safety organizations, and waiving costs. Physician groups involved in the management of complications, such as the Infectious Diseases Society of America, have voiced objections to these proposals, observing that "some patients develop infections despite application of all evidence-based practices known to avoid infection", and that a punitive response may discourage further study and slow the dramatic improvements that have already been made.
Pay for performance programs often target patients with serious and complex illnesses; such patients commonly interact with multiple healthcare providers and facilities. However, pilot programs now underway focus on simple indicators such as improvement in lab values or use of emergency services, avoiding areas of complexity such as multiple complications or several treating specialists. A 2007 study analyzing Medicare beneficiaries’ healthcare visits showed that a median of two primary care physicians and five specialists provide care for a single patient. The authors doubt that pay-for-performance systems can accurately attribute responsibility for the outcome of care for such patients.
Liability protection for disclosing errors
Ethical standards of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the American Medical Association (AMA) Council on Ethical and Judicial Affairs, and the American College of Physicians Ethics Manual require disclosure of the most serious adverse events. However, many doctors and hospitals do not report errors under the current system because of concerns about malpractice lawsuits; this prevents collection of information needed to find and correct the conditions that lead to mistakes. As of 2006, twenty US states have statutes allowing doctors and health care providers to apologize and offer expressions of regret without their words being used against them in court. Pennsylvania, Florida, and Nevada have also passed laws mandating written disclosure of adverse events and bad outcomes to patients and families. In September 2005, US Senators Clinton and Obama introduced the National Medical Error Disclosure and Compensation (MEDiC) Bill, providing physicians protection from liability and a safe environment for disclosure, as part of a program to notify and compensate patients harmed by medical errors. This national approach is modeled after a University of Michigan Hospital System program that has reduced the number of lawsuits against the hospital by half and has decreased the average litigation cost.
Numerous organizations, government branches, and private companies conduct research studies to investigate the overall health of patient safety in America and across the globe. Despite the shocking and widely publicized statistics on preventable deaths due to medical errors in America’s hospitals, the 2006 National Healthcare Quality Report assembled by the Agency for Healthcare Research and Quality (AHRQ) had the following sobering assessment:
- Most measures of Quality are improving, but the pace of change remains modest.
- Quality improvement varies by setting and phase of care.
- The rate of improvement accelerated for some measures while a few continued to show deterioration.
- Variation in heath care quality remains high.
The Health Grades study in April 2006 determined that over 3% of hospitalized Medicare patients experienced adverse events, and that the total number of patient safety incidents has been increasing since 2001.
Organizations advocating patient safety
Several authors of the 1999 Institute of Medicine report revisited the status of their recommendations and the state of patient safety, five years after "To Err is Human". Discovering that patient safety had become a frequent topic for journalists, health care experts, and the public, it was harder to see overall improvements on a national level. What was noteworthy was the impact on attitudes and organizations. Few health care professionals now doubted that preventable medical injuries were a serious problem. The central concept of the report—that bad systems and not bad people lead to most errors—became established in patient safety efforts. A broad array of organizations now advance the cause of patient safety. Template:Patient safety organizations
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