Medical errors and the Institute of Medicine (IOM)
Summary - Part I
Institute of Medicine - IOM-2 Crossing the Quality Chasm
IOM-2 Key Findings
The Institute of Medicine (IOM) released two reports that changed the way the public and healthcare systems think about patient safety and quality of care. These reports were part of a series of reports known as the "Quality of Health Care in American" project, to assess the US healthcare system. The first report, (IOM-1), To Err is Human: Building a Safer Health System, was released in November of 1999 and focused attention on the specific issue of medical errors in the hospital setting. According to the IOM-1 report, to "err is human, but errors can be prevented and safety is a critical first step in improving the quality of care." The report summarizes major findings on patient safety, provides key definitions and a framework to discuss medical errors, and makes recommendations for changes by government and healthcare providers and associations. The executive summary (.pdf) (303 KB) of this report may be downloaded or the entire report may be viewed online. (See Key Documents: Kohn 1999).
The IOM panel released a second report, Crossing the Quality Chasm – A New Health System for the 21st Century in March 2001 (IOM-2). This second report recommends a sweeping redesign of the health care system to improve quality of care and provides a suggested framework and key steps to accomplish this goal. This executive summary may also be downloaded or the full document may be viewed at the National Academy press site. (See Key Documents: Crossing the Quality Chasm).
Additional IOM reports on patient safety have been published by the National Academy Press since these two initial groundbreaking reports, for example "Preventing Medication Errors, 2007." This series of reports from the IOM are available at the NAS Web site: http://lab.nap.edu/nap-cgi/discover.cgi?term=iom reports&restric=NAP.
The first report,
Institute of Medicine IOM-1 First Do No Harm
IOM-1 key findings
An estimated 44,000 to 98,000 people die each year in hospitals as a result of medical errors; medication errors alone account for an estimated 7,000 deaths annually. Even the lower estimate (44,000) suggests that medical errors are the eighth leading cause of death, higher than motor vehicle accidents (43,458) or breast cancer (42,297). These numbers were derived predominantly from two studies, one conducted in New York and the other in Colorado and Utah (see References: Brennan 1991, Thomas 1999). However, controversy exists as to the exact magnitude of adverse outcomes associated with medical errors. This is illustrated by two editorials that appeared in the July 5, 2000, issue of the Journal of the American Medical Association. In one, McDonald and others questioned the validity of the IOM-1 estimates and suggested that the numbers were exaggerated (see Resources: McDonald 2000). In the other, a recognized leader in the field indicated that the numbers may actually underestimate the true burden caused by medical errors (See Resources:Leape 2000).
Total annual costs of preventable adverse events (ie, medical errors resulting in injury) are estimated to be between $17 billion and $29 billion per year. Over one-half of these expenditures are for direct health care costs, such as longer stay or treatment. The increased costs of preventable adverse drug events affecting hospitalized patients are about $2 billion per year.
The IOM-1 report also pointed out that not all costs can be directly measured. Examples of such costs include loss of trust in the system, physical and psychological discomfort for patients, lost work productivity among patients who require extra care, loss of morale and frustration among healthcare workers at not being able to provide the best care possible, and lower levels of health of the population served.
A recurring theme in the report is that the majority of medical errors do not result from individual recklessness, but rather from basic flaws in the way health systems are organized. Some of these are only too well demonstrated by sentinel events reported to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Examples include:
- Access to toxic drugs: Availability on patient care units of certain full-strength drugs that are toxic until diluted (eg, potassium chloride) has resulted in deadly mistakes.
- Illegible writing: Misinterpretation of orders in medical records has resulted in administration of drugs to which patients have known allergies.
- Coordination of care. Continuity of care has been shown to suffer when several healthcare practitioners manage the same patients, since all involved practitioners may not have complete information about the medicines prescribed or the patient's illnesses.
The IOM-1 report provides definitions of key terms so that a standard framework can be used for discussing issues related to medical errors and patient safety. These terms are defined as follows:
- Safety: freedom from accidental injury.
- Error: the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim; not all errors result in injury. In an effort to thoroughly consider all of the relevant issues related to medical errors, the Quality Interagency Coordination task force (QuIC) report expanded the IOM-1 definition to read as follows: An error is defined as the failure of a planned action to be completed as intended, or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems.
- Adverse event: an injury resulting from a medical intervention (ie, not due to the underlying medical condition of the patient).
- Preventable adverse event: an adverse event that was attributable to a medical error. Negligent adverse events represent a subset of preventable adverse events that satisfy legal criteria used in determining negligence: whether the care provided failed to meet the standard of care reasonably expected of an average physician qualified to take care of the patient in question.
- Types of failure: errors of execution, in which the correct action does not proceed as intended, or errors of planning, in which the original intended action is not correct.
- System: a set of interdependent elements working to achieve a common aim. The elements may be both human and nonhuman (eg, equipment, technologies).
- Human factor: the study of inter-relationships between humans, the tools they use, and the environment in which they live and work.
IOM-1 General categories for medical errors
The IOM-1 report categorized medical errors in the following way:
- Error or delay in diagnosis
- Failure to employ indicated tests
- Use of outmoded tests or therapy
- Failure to act on results of monitoring or testing
- Error in the performance of an operation, procedure, or test
- Error in administering the treatment
- Error in the dose or method of using a drug
- Avoidable delay in treatment or in responding to an abnormal test
- Inappropriate (not indicated) care
- Failure to provide prophylactic treatment
- Inadequate monitoring or follow-up of treatment
- Failure of communication
- Equipment failure
- Other system failure
IOM-1 Medication errors: A large percentage of medical errors are associated with medications. The National Coordinating Council for Medication Error and Prevention (NCCMERP) has approved the following working definitions specifically for medication errors:
- Medication error: Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, or systems including prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.
- Adverse drug event: An adverse drug event is any injury resulting from a medical intervention related to a drug. Examples of such injuries include heart rhythm disturbances, diarrhea, fever, nausea and vomiting, renal failure, mental confusion, rash, low blood pressure, and bleeding.
Medication errors can occur at any stage of medication administration. These include:
- Ordering: wrong dose, wrong choice of drug,
- Transcribing: wrong frequency of drug administration, missed dose because medication is not transcribed,
- Dispensing: drug not sent in time to be administered at the time ordered, wrong drug, wrong dose,
- Administering: wrong dose of drug administered, wrong technique used to administer the drug, and
- Monitoring: not noting the effects of the given medication.
The IOM committee recommended a four-part plan designed to create both financial and regulatory incentives to move closer to a safer healthcare system. The recommendations provide a systematic way to design safety into the process of care. The report also calls for a program assessment after five years to determine progress in achieving a safer healthcare system. There are two additional recommendations that specifically address medication system errors, since they represent a major proportion of the total errors addressed.
The key recommendations of the IOM-1 was a four-part plan and is described below:
1. Create a "Center for Patient Safety within the Agency for Healthcare Research and Quality:" Having a dedicated federal agency that focuses on safety has dramatically improved safety in other industries. Using that model, the committee recommended that Congress create a center for patient safety within the Agency for Healthcare Research and Quality (AHRQ). This center would:
- Set national goals for patient safety.
- Track progress in meeting the identified goals, and issue an annual report to the President and Congress on patient safety.
- Develop knowledge and understanding of errors in healthcare by developing a research agenda, funding Centers for Excellence, evaluating methods for identifying and preventing errors, and funding dissemination and communication activities to improve patient safety.
2. Establish mandatory and voluntary reporting systems: The IOM-1 committee called for both mandatory and voluntary reporting systems:
- The mandatory system should provide for collection of standardized information by state governments on adverse events that result in death or serious harm. According to the report, Congress should designate the National Forum for Health Care Quality Measurement and Reporting as the entity responsible for promulgating and maintaining a core set of reporting standards. Currently, about a third of the states have their own mandatory reporting requirements. The Center for Patient Safety should convene states to share expertise and identify best practices for implementation. The Center should also receive and analyze aggregate reports from states to identify persistent safety issues that require more intensive analysis and/or broader based response.
- The development of voluntary, confidential reporting systems should be encouraged, and participation should be promoted by accrediting bodies.
- The committee stated that information about the most serious adverse events, which result in harm to patients, and which are subsequently found to result from errors, should not be protected from public disclosure. However, the committee also acknowledged that, for events not falling under this category, fears about legal discoverability may severely hamper reporting efforts. Therefore, the committee recommended that Congress pass legislation to protect the confidentiality of certain information. Such protection would encourage the growth of voluntary, confidential reporting systems without fear of litigation and without compromising patients' legal rights.
3. Raise standards and expectations for improvement in safety through the actions of oversight organizations, group purchasers, and professional groups: Performance standards and expectation for healthcare organizations should focus greater attention on patient safety through the following recommendations:
- Regulators and accreditors should require healthcare organizations to implement meaningful patient safety programs with defined executive responsibility.
- Public and private purchasers should provide incentives to healthcare organizations to demonstrate continuous improvement in patient safety.
- Licensing and certifying bodies should implement periodic re-examinations of doctors, nurses, and other key providers for both competence and knowledge of safety practices.
- Professional societies should make a visible commitment to patient safety by establishing a permanent committee dedicated to safety improvement.
- The Food and Drug Administration (FDA) should increase attention to the safe use of drugs in both pre- and post-marketing processes.
4. Create safety systems inside healthcare organizations through the implementation of safe practices at the delivery level: Healthcare organizations must create an environment (ie, a "culture of safety") in which safety becomes a top priority. As part of this process, healthcare organizations should implement proven medication safety practices. Patient safety programs should:
- Provide strong, clear and visible attention to safety.
- Implement non-punitive systems for reporting and analyzing errors within their organizations.
- Incorporate well-understood safety principles, such as standardizing and simplifying equipment, supplies, and processes.
- Establish interdisciplinary team training programs for providers that incorporate proven methods of team training.
Responses IOM-1 government
Responses to IOM-1 White House and QuIC
Shortly after release of the IOM-1 report, President Clinton accepted the major recommendations in principle. A number of subsequent events demonstrated how importantly the White House perceived this issue:
Agency funded to focus on safety: Using presidential authority to make changes unilaterally, Clinton signed a bill, S. 580, the "Healthcare Research and Quality Act of 1999," which authorized appropriations for the Agency for Health Care Policy and Research, and renamed it the Agency for Healthcare Research and Quality. The bill expanded the mission of the agency to include new goals for identifying the causes of preventable healthcare errors and ways of curtailing them.
QuIC task force: By early 2000, the Clinton administration unveiled its full proposal for reducing medical errors. President Clinton charged the Quality Interagency Coordination (QuIC) task force with considering and responding fully to the IOM-1 report. The QuIC taskforce was convened in response to the final report of the President's Advisory Commission on Consumer Protection and Quality in the Healthcare Industry, released in 1998. That report identified medical errors as one of four major challenges that needed to be addressed to improve healthcare quality. The goal of the QuIC task force is to coordinate quality improvement activity among the following agencies: the Departments of Health and Human Services (which includes the AHRQ, the FDA, the Centers for Disease Control and Prevention [CDC], and the Center for Medicare and Medicaid Services [CMS] formerly known as the Health Care Financing Administration [HCFA]); Labor, Commerce, and Defense; the Coast Guard; the Bureau of Prisons; and the Office of Personnel Management. The AHRQ director functions as the operational Chair of the QuIC task force.
QuIC report: The task force's report "Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact" was released in February 2000. The 95-page report provided details on federal approaches to implementing the IOM-1 recommendations, and may be downloaded or viewed online. (See Key documents QuIC)
QuIC's goal: The QuIC report endorsed the IOM-1's goal of reducing the number of medical errors nationwide by 50% over 5 years. The report responds to each of the IOM-1 recommendations and outlines a comprehensive and strategic plan, which includes federal initiatives that are already underway. The report also outlines a series of follow-up activities. For example, in September 2000, AHRQ and QuIC hosted a review from all stakeholders to identify issues that need to be addressed in setting a research agenda.
Center for Quality Improvement and Patient Safety (CQuIPS): The CQuIPS was established within the AHRQ to coordinates and complement other public and private sector initiatives to improve patient safety. The purpose of the Center is to conduct aggressive research into medical errors, convert findings into improved practices, and educate patients about safety.
Federal Patient Safety Task Force: A task force was established in April 2001 within the Department of Health and Human Services to coordinate a joint effort among several department agencies to improve existing systems to collect data on patient safety. The task force was charged to working closely with the states and private sector to develop data to help avert risks to patients. The agencies include the:
- Agency for Healthcare Research and Quality (AHRQ)
- Centers for Disease Control and Prevention (CDC)
- Food and Drug Administration (FDA)
- Center for Medicare and Medicaid Services(CMS) formerly known as Health Care Financing Administration (HCFA)
The goal of this Task Force is to identify the data that healthcare providers, states, and others need to collect to improve patient safety. To start this process, the task force is releasing a contract request to develop a detailed plan on how to integrate the existing reporting systems in a way that minimizes burden, provides those who must submit reports an opportunity to learn, and improves the safety of health care services. AHRQ provides a fact sheet that describes the members and purpose of the task force, and a slide presentation that describes how this might be accomplished. Both resources may be downloaded and or viewed at the AHRQ web site. (See Key Documents AHRQ -New database)
Responses to IOM-1 Congress
106th Congress: Several bills regarding medical error reporting were introduced in the 106th Congress, and included efforts to develop a voluntary, non-punitive error reduction system under the Medicare and Medicaid programs. The most comprehensive bill invoked the Conditions of Participation to amend title XVIII of the Social Security Act. It sought to establish and implement a comprehensive system under the Medicare Program to reduce the incidence of medical errors, among other provisions. No action was taken on these and similar bills and amendments introduced in late 2000.
107th Congress: By May 2001, three new Senate bills were introduced in the 107th Congress that address medical errors and the information systems required to support medical safety programs:
Medical error reporting: Health Care Assurance Act of 2001 (S 24) was introduced by Arlen Specter (R-PA) in January. It amends the Social Security Act to establish a State-based medical error reporting system. Under Title VIII, Safety and Cost-Effective Medical Treatment, it provides for Medical Error reduction and inserts error definitions and state-based reporting programs. It also requires demonstration projects to reduce medical errors, improve patient safety, and evaluate current reporting systems.
Information technology: The Health Information Technology and Quality Improvement Act of 2001(S 705) was introduced April 5th by Charles Schummer (D-NY) to establish a health information technology grant program for hospitals, skilled nursing facilities and home health agencies. It requires Health and Human Services to establish and implement a methodology under the Medicare program for providing hospitals with reimbursement for costs incurred by these hospitals with respect to implementing information technology systems.
Healthcare and professional organizations responded vigorously to the IOM-1 report and the President's call for action. Many professional organizations had been behind the initiative that led to convening the IOM panel, and these same groups have joined together with industries in a concerted effort to address to improve quality and safety in healthcare organizations. A few groups are briefly described below; see Links for an expanded list of safety organizations and an expanded list of organization's resources:
- American Hospital Association (AHA) has formed a quality initiative with the Institute for Safe Medical Practices (ISMP) that involves special effort in the specific area of medication errors. Linked?
- American Medical Association (AMA) has a similar initiative through their National Patient Safety Foundation (NPSF). The AMA has announced their strong support of the IOM-1 report findings. They noted that the report fits their goal to measurably improve patient safety and work toward the goal of fail-safe care processes.
- Institute for Healthcare Improvement (IHI) has focused its energies on implementing "break through technologies" and design concepts to incorporate safer clinical practices.
- Institute for Safe Medication Practices (ISMP) is a nonprofit organization that works to reduce errors in the prescribing and dispensing of medications.
- National Coordinating Council for Medication Error and Prevention (NCCMERP) has provided the basis of many currently used definitions for medication errors.
- Joint Commission on Accreditation for Healthcare Organizations (JCAHO) has strongly endorsed the concept that safety must be systematically designed into healthcare. JCAHO has addressed the issue of sentinel events and requires an examination of underlying system causes. It has also approved a set of new patient safety standards that were incorporated into existing standards; implementation began July 1, 2001. JCAHO has also developed a "safety management profile" for each accredited organization.
- National Forum for Healthcare Quality Measurement and Reporting (NQF) is frequently called the National Quality Forum and is a not-for-profit membership organization created to develop and implement a national strategy for health care quality measurement and reporting. It works with AHQR, AHQA, AMA, ANA, CMS, JCAHO, NCQA and others to identify standard quality measures.
- Partnership for Patient Safety (P4PS) is an umbrella organization that enables other groups to collaborate on furthering a patient safety culture throughout healthcare systems. For example, P4PS has co-sponsored several national major conferences with NPSF, the Premier healthcare alliance, and VHA.
- Department of Veteran's Affairs (VA) led the way on many initiatives, including applying the aviation error and "near miss" reporting process in a healthcare setting
- Premier Inc. (Premierinc.com) is a strategic alliance of more than 1800 US hospitals and other healthcare sites provides an array of products, services and resources to improve quality, safety and reduce cost in healthcare delivery.
Business groups that represent purchasers of healthcare or medical supply companies have proposed initiatives to "jump start" the process and force attention to the issues in a practical manner. Examples include:
Healthcare Leadership Council (HLC) is a business coalition that is composed of chief executives from hospitals, pharmaceutical companies, and medical surgical supply companies. HLC formed a task force in June of 2000 to reduce medical errors. Members of the task force include the chief executives of Abbott Laboratories, Johnson & Johnson, Cleveland Clinic, Voluntary Hospitals of America, (VHA), First Health Group, Mayo Foundation, Tenet Health Systems, and Humana. Premier's chief executive officer is the chair. The task force's objective is to reduce the incidence of medical errors and enhance patient safety by focusing on production and distribution of healthcare products and services, as well as ensuring appropriate levels of patient care at the provider level.
Leapfrog Group (leapfroggroup)is a Washington, DC-based organization sponsored by the Business Roundtable. Founding members include Buyers Healthcare Action Group, General Electric, General Motors, GTE (now Verizon), and the Pacific Business Group on Health. CMS and the US Office of Personnel Management also participate. The Leapfrog Group is also committed to partnering with healthcare providers. The group is planning on making a giant leap in value-based purchasing; their goal is to mobilize employer purchasing power to trigger a breakthrough in the safety and the overall value of healthcare to American consumers. Preferential use and other market reinforcements will be their tools to achieve this goal. For example, the Leapfrog Group is supporting the following "safety leaps" as key elements of healthcare plans:
- Computer Physician Order Entry: Physician orders are enter by computer.
- Evidence-Based Hospital Referral: Patients are guided for elective treatment to hospitals and clinical teams with superior outcomes if valid comparative quality measurement systems exist. If not, such guidance is based on scientific evidence of volume-outcome relationships.
- ICU Physician Staffing: Hospital ICU care is managed by physicians who are: (1) certified (or eligible for certification) in critical care medicine, (2) present during daytime hours, (3) able to provide care exclusively in the ICU, (4) available to return ICU pages promptly when not in the ICU, and (5) committed to relying on certified "effectors" to implement telephone orders.
- National Quality Forum (NQF) Endorsed Safe Practices: The National Quality Forum published Safe Practices for Better Healthcare: A Consensus Report in May 2003. The report endorsed 30 practices that should be universally used in applicable clinical care settings to reduce the risk of harm to patients. Included in the 30 practices are the original 3 Leapfrog leaps: Computer physician order entry, ICU physician staffing and Evidence-based Hospital Referral for certain high-risk procedures. For this new Leap, hospitals' progress on the remaining 27 safe practices is being assessed. After completion of the online Leapfrog hospital survey, each hospital's relative ranking compared with other hospitals will be displayed on the Leapfrog Web site.
Failure to meet these expectations may affect the ability of healthcare provider to contract with major employers for their health benefit packages.
Premier healthcare alliance Premier has responded in numerous ways in addition to being an active member of the Health Leadership Council. It has developed a specific focus on medication management initiatives, and has received an overwhelming response from owner hospitals to continue working in medication error reduction strategies.
IOM-2 key findings - See also IOM-2 Users manual
Crossing the Quality Chasm: A New Health System for the 21st Century is a follow-up report from the IOM panel of the Quality Health Care project. IOM-2 recommends a sweeping redesign of the American healthcare system. It provides overarching principles for specific direction for policymakers, healthcare leaders, clinicians, regulators and purchasers. It offers:
- A set of performance expectations for the 21st century healthcare system.
- A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality.
- Key steps to promote evidence-based practice and strengthen clinical information systems.
- A set of ten new rules to guide patient-clinician relationships:
- Care based on continuous healing relationships: Patients should receive care whenever they need it, and in many forms, not just face-to-face visits. This rule implies that the healthcare system should be responsive at all times (24 hours a day, every day), and that access to care should be provided over the Internet, by telephone, and by other means in addition to face-to-face visits.
- Customization based on patient needs and values: The system of care should be designed to meet the most common types of needs, but have the capability to respond to individual patient choices and preferences.
- The patient as the source of control: Patients should be given the necessary information and the opportunity to exercise the degree of control they choose over health care decisions that affect them. The health system should be able to accommodate differences in patient preferences and encourage shared decision-making.
- Shared knowledge and the free flow of information: Patients should have unfettered access to their own medical information and to clinical knowledge. Clinicians and patients should communicate effectively and share information.
- Evidence-based decision-making: Patients should receive care based on the best available scientific knowledge. Care should not vary illogically from clinician to clinician or from place to place.
- Safety as a system property: Patients should be safe from injury caused by the care system. Reducing risk and ensuring safety require greater attention to systems that help prevent and mitigate errors.
- The need for transparency: The health care system should make information available to patients and their families that allow them to make informed decisions when selecting a health plan, hospital, or clinical practice, or when choosing among alternative treatments. This should include information describing the system's performance on safety, evidence-based practice, and patient satisfaction.
- Anticipation of needs: The health system should anticipate patient needs, rather than simply reacting to events.
- Continuous decrease in waste: The health system should not waste resources or patient time.
- Cooperation among clinicians: Clinicians and institutions should actively collaborate and communicate to ensure an appropriate exchange of information and coordination of care.
Adapted from icanPREVENT. Used with permission of ican, Inc.