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Patient safety is a relatively recent initiative in medicine, emphasizing the reporting, analysis and prevention of medical error.

Prevalence of adverse events

The possibility of error in medical treatment and the inherent danger it poses to the patient was recognized as early as 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." 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 was 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 anaesthesiologists comprise only about 5% of physicians in the United States, anaesthesiology became the leading medical specialty addressing issues of patient safety.

To Err is Human

In the United States, the full magnitude and impact of medical errors 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 the president 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 healthcare 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 Health Foundation estimates that over 850,000 incidents harm or nearly harm National Health Service hospital patients in the United Kingdom each year. On average forty incidents a year contribute to patient deaths in each institution.

Causes of medical error

The simplest definition of a medical error is a preventable adverse effect of medical care, whether or not it is evident or harmful to the patient. A conservative average of both the IOM and HealthGrades reports indicates that there have been between 400,000-1.2 million error-induced deaths during 1996 - 2006. 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 prevelance 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 doctors, nurses, and other care providers.
• Complications increase with patient to nurse staffing ratio increases.
• Disconnected reporting systems within a hospital.
• The impression that action is being taken by other groups within the institution.
• Not measuring patient safety initiatives to analyze contributory issues and identify improvement strategies.

Despite common assumptions, avoidable medical adverse events are rarely caused by:

• "Bad apples" or incompetent health providers.
• High risk procedures or medical specialties, although some mistakes, such as in surgery, are harder to conceal.

Efforts to monitor and prevent adverse events

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. Accident investigation is carried out by the National Transportation Safety Board and 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, are subject to fatigue, stress, danger, and loss of life and prestige as a consequence of error. Given avaition's enviable record in accident prevention, a similar medical adverse event system should include non-punative reporting, teamwork training, feedback on performance and an institutional committment to data collection and analysis.

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.

Preventing medication error

Manual order entry abbreviation, legibility, lack of crossreferencing interactions USP--analysis and research on the data it receives through its reporting programs. USP also develops professional education programs, publishes articles on issues related to medication errors, participates in legislative activities, and provides recommendations for official drug standards that will enhance patient safety.

Technology in medical settings

Electronic medical record False security that when technology suggests a course of action, errors are avoided. A 2004 survey by Leapfrog found that 16% of clinics, hospitals and medical practices are expected to be utilizing CPOE within 2 years. CPOE associated with 80% reduction in medication error rate, and 55% reduction in errors with serious potential harm to patients. Computerized prescriber order entry (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 USP. New sources of error introduced by computerized systems include shortcut or default selections that override non-standard medication regimens for elderly or underweight patients, failure to recognize unfamiliar drug names, irrelevant or frequent warnings, prescriber and staff inexperience. Solutions include design, training, unique workflows, meds tied to patient diagnosis and conditions, supervising overrides from auto drug delivery systems.

Evidence-based medicine

Evidence-based medicine Fourth, the studies that are published in medical journals may not be representative of all the studies that are completed on a given topic (published and unpublished) or may be misleading due to conflicts of interest (i.e. publication bias)[6]. Thus the array of evidence available on particular therapies may not be well-represented in the literature. In managed healthcare systems, evidence-based guidelines have been used as a basis for denying insurance coverage for some treatments which are held by the physicians involved to be effective, but of which randomized controlled trials have not yet been published. In The limits of evidence-based medicine, Tonelli argues that "the knowledge gained from clinical research does not directly answer the primary clinical question of what is best for the patient at hand."

Yet we continue to base our clinical decisions on increasingly out of date primary training or the overinterpretation of experiences with individual patients,1 and even dramatically positive results from rigorous clinical studies remain largely unapplied.2 Doctors need new skills to track down the new types of strong and useful evidence, distinguish it from weak and irrelevant evidence, and put it into practice. In this paper we discuss evidence based medicine, a new framework for clinical problem solving which may help clinicians to meet these challenges. Another advantage of evidence based medicine is that it can be learnt by people from different backgrounds and at any stage in their careers. Medical students carrying out critical appraisals not only learn evidence based medicine for themselves but contribute their appraisals to their teams and update their colleagues. At the other extreme, seasoned clinicians can master evidence based medicine and transform a journal club from a passive summary of assigned journals into an active inquiry in which problems arising from patient care are used to direct searches and appraisals of relevant evidence to keep their practice up to date.

The evidence based approach is being taken up by non-clinicians as well. Consumer groups concerned with obtaining optimal care during pregnancy and childbirth are evolving evidence based patient choice. The critical appraisal skills for purchasers project in the former Oxford region involves teaching evidence based medicine to purchasers who have no medical training so that it can inform their decisions on purchasing.27

A third attraction of evidence based medicine is its potential for improving continuity and uniformity of care through the common approaches and guidelines developed by its practitioners. Shift work and cross cover make communication between health workers both more important and more difficult. Although evidence based medicine cannot alter work relationships, in our experience it does provide a structure for effective team work and the open communication of team generated (rather than externally imposed) guidelines for optimal patient care. It also provides a common framework for problem solving and improving communication and understanding between people from different backgrounds, such as clinicians and patients or non-medical purchasers and clinicians.

Evidence based medicine can help providers make better use of limited resources by enabling them to evaluate clinical effectiveness of treatments and services. Remaining ignorant of valid research findings has serious consequences. For example, it is now clear that giving steroids to women at risk of premature labour greatly reduces infant respiratory distress and consequent morbidity, mortality, and costs of care,28 and it is equally clear that aspirin and streptokinase deserve to be among the mainstays of care for victims of heart attack.

Disadvantages

Evidence based medicine has several drawbacks. Firstly, it takes time both to learn and to practise. For example, it takes about two hours to properly set the question, find the evidence, appraise the evidence, and act on the evidence, and for teams to benefit all members should be present for the first and last steps. Senior staff must therefore be good at time management. They can help to make searches less onerous by setting achievable contracts with the team members doing the searches and by ensuring that the question has direct clinical usefulness. These responsibilities of the team leader are time consuming.

Establishing the infrastructure for practising evidence based medicine costs money. Hospitals and general practices may need to buy and maintain the necessary computer hardware and software. CD-ROM subscriptions can vary from £250 to £2000 a year, depending on the database and specifications. But a shortage of resources need not stifle the adoption of evidence based medicine. The BMA provides Medline free of charge to members with modems, and Medline is also available for a small fee on the internet. Compared with the costs of many medical interventions (to say nothing of journal subscriptions and out of date texts), these costs are small and may recover costs many times their amount by reducing ineffective practice.

Inevitably, evidence based medicine exposes gaps in the evidence.4 This can be frustrating, particularly for inexperienced doctors. Senior staff can help to overcome this problem by setting questions for which there is likely to be good evidence. The identification of such gaps can be helpful in generating local and national research projects, such as those being commissioned by the York Centre for Reviews and Dissemination.29

Another problem is that Medline and the other electronic databases used for finding relevant evidence are not comprehensive and are not always well indexed. At times even a lengthy literature search is fruitless. For some older doctors the computer skills needed for using databases regularly may also seem daunting. Although the evidence based approach requires a minimum of computer literacy and keyboard skills, and while these are now almost universal among medical students and junior doctors, many older doctors are still unfamiliar with computers and databases. On the other hand, creative and systematic searching techniques are increasingly available,30, 31 and high quality review articles are becoming abundant. In the absence of suitable review articles, clinicians who have acquired critical appraisal skills will be able to evaluate the primary literature for themselves.

Finally, authoritarian clinicians may see evidence based medicine as a threat. It may cause them to lose face by sometimes exposing their current practice as obsolete or occasionally even dangerous. At times it will alter the dynamics of the team, removing hierarchical distinctions that are based on seniority; some will rue the day when a junior member of the team, by conducting a search and critical appraisal, has as much authority and respect as the team's most senior member.32 BMJ 1995;310:1122-1126 (29 April) Education and debate Evidence based medicine: an approach to clinical problem-solving William Rosenberg, clinical tutor in medicine,a Anna Donald, senior house officer b

Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice. Increased expertise is reflected in many ways, but especially in more effective and efficient diagnosis and in the more thoughtful identification and compassionate use of individual patients' predicaments, rights, and preferences in making clinical decisions about their care. By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient centred clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens. External clinical evidence both invalidates previously accepted diagnostic tests and treatments and replaces them with new ones that are more powerful, more accurate, more efficacious, and safer. Some fear that evidence based medicine will be hijacked by purchasers and managers to cut the costs of health care. BMJ 1996;312:71-72 (13 January) Editorials Evidence based medicine: what it is and what it isn't

Best practices

Practice guidelines

Mandatory reporting

APSF believes that IOM recommendation 5.1 is both premature and too specific in its content. A considerable amount of further study and public debate will be necessary to determine whether any form of mandatory reporting is desirable, and if so, what form it should take. 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 and patient safety.

Health literacy

Communication is essential for the effective delivery of healthcare. Unfortunately, too often there is a mismatch between a clinician's level of communication and a patient's ability to understand. The lack of understanding can lead to medication errors and adverse medical outcomes.   "Health literacy" is an individual's ability to read, understand and use healthcare information to be able to make effective healthcare decisions and follow instructions for treatment. Research has shown that a significant portion of the US population-perhaps as many as one half of American adults-lacks sufficient health literacy to effectively undertake and execute medical treatments. The lack of health literacy affects all segments of the population, although it is more prominent in certain demographic groups.   The impact from low health literacy on both the health of individuals and the entire healthcare system is significant. The strongest predictor of an individual's health status is not a person's age, income, employment status, education, race or ethnic group-it is their health literacy. It is estimated that the economic consequences nationally of low health literacy are between $50 and $73 billion per year.

The "Ask Me 3" program addresses the issue of healthcare literacy. Research has shown that 20 to 50% of patients have little knowledge of their medical instructions at the time they leave a physician's office. The "Ask Me 3" program is designed to bring public and physician attention to this issue, and to improve healthcare literacy by letting patients know they should ask three questions every 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?

Economic consequences and incentives

The current reimbursement system can also work against safety improvement and, in some cases, may actually reward less-safe care, the authors say. For instance, 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.

In testimony before the Senate Committee on Finance on May 17, CMS Administrator Mark McClellan, stated that CMS wants to eliminate payments for “never events.” “Never events” occur when a patient experiences a negative consequence of care that results in unintended injury, illness or death. The Leapfrog Group strongly supports CMS’ position on never events.

“A never event occurs when there is an inexcusable failure in the delivery of health care services,” stated Suzanne Delbanco, CEO, The Leapfrog Group. “The Leapfrog Group’s mission is to reduce preventable medical mistakes and improve the quality and affordability of health care. Paying for never events runs directly contrary to these aims.”

The Leapfrog Group is exploring how to provide support to its members who are interested in ensuring that their employees do not get billed for such an event and who do not wish to reimburse for these events themselves.

In 2002, the National Quality Forum defined 27 events that should never occur within a health care facility. There are six types of never events: surgical events (e.g., surgery being performed on the wrong patient), product or device events (e.g., using contaminated drugs), patient protection events (e.g., an infant discharged to the wrong person), care management events (e.g., a medication error), environmental events (e.g., electric shock or burn), and criminal events (e.g., sexual assault of a patient). The NQF’s report recommends a national state-based event reporting system to improve the quality of patient care. To date, a little more than half of U.S. states have some version of a reporting system for never events.

Pay for Performance

National Medical Error Disclosure and Compensation (MEDiC) Bill

Patient safety organizations

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 notewothy was an impact on attitudes and organizations. Few health care professionals now doubted that preventable medical injuries remained 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 sought to advance the cause of patient safety.

The National Quality Forum

The National Quality Forum (NQF) is a not-for-profit membership organization created in 1999 to develop and implement a national strategy for health care quality measurement and reporting. Membership is open to national, state, regional, and local groups representing consumers, public and private purchasers, employers, health care professionals, provider organizations, health plans, accrediting bodies, labor unions, supporting industries, and organizations involved in health care research or quality improvement. The NQF has focused on several areas: error rates, unnecessary procedures and undertreatment,especially preventive care. Policies are formed through one of four Member Councils: the Consumer Council, Purchaser Council, Provider and Health Plan Council, and Research and Quality Improvement Council.

In 2002, the National Quality Forum defined 27 events that should never occur within a health care facility. There are six types of "never events" (officially called Serious Reportable Events): surgical events (e.g., surgery being performed on the wrong patient), product or device events (e.g., using contaminated drugs), patient protection events (e.g., an infant discharged to the wrong person), care management events (e.g., a medication error), environmental events (e.g., electric shock or burn), and criminal events (e.g., sexual assault of a patient). The NQF’s report recommends a national state-based event reporting system to improve the quality of patient care. To date, a little more than half of U.S. states have some version of a reporting system for never events. More recently, the organization is developing a national consesus on symptom mangement and end-of-life care in cancer patients.

Leapfrog

Staggered by increasing health insurance costs, several large US companies met in 1998 to influence quality and affordability. The resulting Leapfrog Group agreed to base their purchase of health care on principles that "encourage provider quality improvement and consumer involvement". The group was officially launched in November 2000 with the initial focus provided by the 1999 Institute of Medicine report – reducing preventable medical mistakes (the report recommended that large employers leverage their purchasing power for the quality and safety of health care). The "leapfrog" concept involved large advances stimulated by by rewarding hospitals that implement significant improvements (the Leapfrog Hospital Rewards Program). The quality practices mandated are computer physician order entry CPOE, evidence-based hospital referral, intensive care unit (ICU) staffing by physicians experienced in critical care medicine, and a "Leapfrog Safe Practices Score", based on the National Quality Forum endorsed Safe Practices. Additional initiatives now include public reporting of health care quality and outcomes (hospital quality ratings) to influence consumers' choices. Leapfrog now includes more than 170 large private and public healthcare purchasers providing health benefits to more than 37 million employees and retirees., funded by the Business Roundtable, the Robert Wood Johnson Foundation and Leapfrog members.

JCAHO

Founded in 1951, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is an independent, not-for-profit organization that evaluates and accredits nearly 15,000 health care organizations and programs in the United States. An organization must undergo an on-site survey by a Joint Commission survey team at least every three years. The scope of reviews by JCAHO is broad, including hospitals, home care agencies, medical equipment providers, nursing homes, rehabilitation facilities, surgical centers and medical laboratories. Passing a survey is crucial for most organizations, since accreditation by JCAHO is required for paticipation in Medicare and some state and private health care programs. Since the accreditation rate is over 90%, there have been questions raised regarding the effectiveness of these surveys.

In 1997, JCAHO began including outcomes and other performance data into the accreditation process (the "ORYX initiative"). Information gained allowed the Joint Commission’to develop National Patient Safety Goals to promote specific improvements in patient safety. The Goals highlight problem areas in health care and describe evidence-based solutions. Examples include prevention of falls, patient identification, reducing hospital infections and pressure ulcers, and improving hospital staff communication. In addition, the Joint Commission created a "do not use" list of abbreviations in 2004 to avoid acronyms and symbols that lead to misinterpretation.

Identifying sentinel events and analyzing the root causes has been a focus of JCAHO since 1996; the first eight alerts were published in 1998. The Commission defines a sentinel event as "any unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof." The heath care facility experiencing the sentinel event is expected to complete a thorough root cause analysis, make improvements to the underlying processes, and monitor the effectiveness of the changes. Although the cause of most sentinel events is human error, changes in organizational systems will reduce the likelihood of human error in the future and protect patients from harm when human error does occur. Specific causes of sentinel events and the solutions that hospitals then used successfully to reduce risks are publicized by JCAHO annually. Alerts have included issues as varied as wrong site surgery, restraint deaths, transfusion and medication errors and patient abductions.

On 2005, JCAHO established an International Center for Patient Safety to collaborate with patient safety organizations to identify, develop and share safety solutions, conduct joint research, and advocate public policy changes. Educational materials to help patients prevent medical errors, sentinel event alerts and other resources are provide on the internet.

National Center for Patient Safety (AHRQ)

In 2001, the US Congress responded to the IOM recommendation to create a Center for Patient Safety by allocating $50 million annually for patient safety research to the Agency for Healthcare Research and Quality (AHRQ), the lead federal agency for health care safety. The AHRQ organizes patient safety activities, provides grants to other organizations, serves as a clearinghouse for safety information, and publishes guidelines for evidence-based or "best practices". By 2006, the National Guideline Clearinghouse (NGC) contained more than 1,700 disease-specific diagnosis, management and treatment recommendations, developed from current medical literature. The goal of the NGC is to provide health professionals and institutions, health plans and health care purchasers an accessible mechanism for obtaining objective clinical practice guidelines. Adoption of guidelines has been slowed by physician and hospital concern that

Institute for Healthcare Improvement (100,000 lives)

The Institute for Healthcare Improvement, a not-for-profit organisation whose mission is to accelerate the improvement of health care in the US and internationally, launched the "100 000 Lives" campaign in December 2004. The Institute has enrolled over 3,000 US hospitals (over 80% of total US hospital discharges) in this initiative to avoid 100 000 unnecessary deaths in US hospitals over the 18 months from January 2005 to June 2006. Hospitals will implement six evidence-based interventions that are known to significantly reduce harm to patients:

1. Deploy rapid response teams to patients at risk of cardiac or respiratory arrest.
2. Deliver reliable, evidence-based care for acute myocardial infarction.
3. Prevent adverse drug events by reliable documentation of changes in drug orders.
4. Prevent central line infections.
5. Prevent surgical site infections.
6. Prevent ventilator-associated pneumonia.

A life saved is a patient who survived a hospital stay who would have died had he or she received that hospital's pre-campaign (2004) level of care. The campaign estimated that, as of April 2006, participating hospitals had saved over 84,000 lives, and by the end of the capmpaign over 120,000 lives.

The Health Foundation (Safer Patients)

Based in London, England, the Health Foundation is an independent charity that aims to improve the quality of health care for the people of the United Kingdom. The Safer Patients Initiative , one of the Foundation’s quality and performance improvement programmes, targets reducing medication-related adverse events and errors, reducing infections associated with intensive care units or surgery and improving organisational culture, leadership and expertise in measuring improvement. The goal of the initiative is a 50 percent reduction in adverse events per 1,000 patient days for each site. In 2004, The Health Foundation selected four hospitals from across the UK to work on a £4.3 million patient safety improvement programme. These four hospitals continue to show measurable improvements in their patient safety performance, and 16 more hospitals are being selected in 2006 to join the second phase.

External links

Patient Safety Organizations

• The Agency for Healthcare Research and Quality
• The National Quality Forum
• Joint Commission on Accreditation of Healthcare Organizations
• The Institute for Healthcare Improvement
• The Leapfrog Group

Medication errors

• National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP)
• United States Pharmacopeia (USP): Patient Safety and Medication Error Reporting