AHRQ's Patient Safety Initiative: Building Foundations, Reducing Risk
Chapter 2. Efforts to Reduce Medical Errors: AHRQ's Response to Senate Committee on Appropriations Questions
In Senate Report 107-84, the Committee on Appropriations directed AHRQ to provide a report detailing the results of its efforts to reduce medical errors. It indicated that the report should specifically provide information on:
- How hospitals and other health care facilities are reducing medical error.
- How these strategies are being shared among health care professionals.
- How many hospitals and other health care facilities record and track medical errors.
- How medical error information is used to improve patient safety.
- What types of incentives and/or disincentives have helped health care professionals reduce medical error.
- The most common root causes of medical errors.
- The effectiveness of State requirements in reducing medical errors.3
The following information responds to these issues and draws on interim results from AHRQ's 16 reporting demonstration grants, as well as the literature and other AHRQ efforts.
How are Hospitals and Other Heath Care Facilities Reducing Errors?
Changes in organizational culture, the involvement of key leaders, the education of providers, the establishment of Patient Safety Committees, the development and adoption of safe protocols and procedures, and the use of technology are all essential elements in hospital and health care facilities' efforts to reduce medical errors and improve patient safety. A broad range of approaches follows, with special focus on strategies selected by AHRQ grantees as having special promise for efficacy and ease of implementation.
Changes in Organizational Culture
Several grantees point to changes in organizational culture, particularly creating a positive safety culture, as an essential element in making care safer for patients. These changes primarily focus on human resources management procedures and practices relative to the supervision and discipline of individuals reporting events to institutions and leadership. Organizations found that to encourage reporting of medical errors, it was important to adopt a culture that eliminated the blame and shame associated with medical errors. When such changes were made and employees believed that they would not be punished if they reported medical errors, harm, no harm, or near miss events, the organizations often found that their reporting rates increased—in some instances remarkably so.
Involvement of Key Leaders
When organizational leadership, both administrative and clinical, actively engages in patient safety improvement, it has an exceptionally beneficial impact on all employees and staff of the organization. An example of this involvement is an Executive Safety Round. This is a routine visit to clinical units by an organization's senior leaders to discuss patient safety issues. This technique is increasingly used to involve senior leadership in actively promoting safety and discovering the risks and hazards to patients within the process of care.
Education of Providers
Provider education is used nationwide to orient professionals about various aspects of patient safety and how errors are identified. Education is also often used to introduce or reinforce safe practices that are proven to eliminate or minimize harm to patients. Some AHRQ-supported researchers note that the process of collecting and analyzing medical error information also results in increased patient safety.
When key personnel are trained in and understand the use of root cause analysis, the quality of information obtained from the medical error reporting systems is enhanced. Root cause analysis (RCA) is an error analysis technique for determining the contributing causes of adverse events that have already happened. It takes into account the severity and likelihood of occurrence of the adverse event to ensure that significant problems are addressed and then identifies contributing factors and mitigating actions. Failure modes and effects analysis (FMEA) is a proactive analysis technique for identifying potential failure modes, determining their effect on the product or service under examination, and identifying actions to mitigate the failures. While RCAs focus on what went wrong, FMEAs focus on what could go wrong.
When complete root cause analysis is performed, a more precise corrective action can be implemented in that the types of changes that are initiated move away from the usual employee counseling to the modification of organizational processes and procedures. Being able to link corrective actions to root causes is much more effective.
Establishment of Patient Safety Committees
Many organizations participating in reporting systems, particularly in Georgia, describe establishing special patient safety committees made up of physicians, nurses, pharmacists, and other health care providers to examine medical error reports. The establishment of these committees helps the organizations identify more effective corrective actions and to implement safe procedures that involve all stakeholders. Interdisciplinary safety committees also seem to help bring attention to patient safety issues and facilitate the adoption of safe practices.
Development and Adoption of Safe Protocols and Procedures
Health care facilities and hospitals report that they have been able to develop and adopt safe protocols and procedures to effectively reduce medical errors. These protocols and procedures are often similar to those developed by the Institute of Safe Medication Practices (ISMP). For example, two AHRQ grantees have participated in activities of the Wisconsin Patient Safety Institute, which developed a Medication Safe Practices Manual to help guide safe medication use. Examples include alerts for medications with a high potential for harm if not managed appropriately and guidelines on the use of standard abbreviations.
Technology is being used as a tool to reduce errors and improve safety (e.g., through the use of computerized physician order entry and infusion pumps). However, we know that use of technology must be implemented and monitored carefully to prevent the introduction of new errors and to ensure that the intended solutions are indeed achieved.9 One AHRQ grantee has found medical device use errors occur that can be attributed to design problems and lack of user training. Another AHRQ grantee has found that the introduction of a computerized order entry system was itself a cause of stress and error.
How Do Health Care Professionals Share Strategies?
Health care professionals use a variety of methods to share strategies focused on reducing medical errors. The communication channels reported commonly include:
- Committee and task force meetings: quality improvement and patient safety.
- Reports—print and electronic issued annually, quarterly.
- Newsletters—video and teleconferencing.
- Regional and local conferences.
- Training programs, e.g., www.MERS-TM.net.
- Individual consults.
Information is most often shared in two forms:
- Results of the types of errors reported.
- Case studies of events and prevention strategies or practices that eliminate risks and hazards embedded in the process of care.
General patient safety information is often shared as well (e.g., best practices).
Communication occurs within individual hospitals or health care systems or more broadly across health delivery systems. For example, nine grantees report that they are sharing medical error reduction strategies outside of their project, but within their health care delivery systems. Six report sharing such strategies with other professionals outside their health care delivery systems. These sharing activities often take the form of special rounds or conferences, as well as one-on-one communication between patient safety officers. As the number of patient safety officers in hospitals grows, so does the network of informal and formal sharing.
States play a vital role in patient safety nationwide. In the past decade, numerous State and regional patient safety cooperatives and partnerships have been established and the number is growing. In several geographic areas such as Pittsburgh, Chicago, Dayton, and Madison, effective partnerships for patient safety and quality improvement have been established. Many of these partnerships or cooperatives address corrective actions that may be used to implement safe procedures. Interdisciplinary safety committees also help bring attention to patient safety issues and facilitate the adoption of safe practices.
How Many Hospitals and Other Health Care Facilities Record and Track Medical Errors?
The exact number of hospitals and other health facilities that record and track medical errors, as well as types of reporting that is occurring, is unknown at this point, or at least not documented to any degree of accuracy. More importantly, little is known as to how and in what manner hospitals use the information they do collect as a patient safety management tool. However, virtually every hospital in the country has in place some form of medical error reporting system because the current JCAHO requirements provide that some form of patient safety event reporting must be in place to track, at a minimum, a variety of events, such as falls and the use of restraints. Depending on the individual State, many hospitals may be tracking other required information, such as surgical errors, infections, and other information as required by various professional organizations and various components of the Federal government. However, many of these systems are operated independently of one another and data may be infrequently shared.
Event Reporting Survey Instrument
To obtain the information needed to address this question, AHRQ, in cooperation with other Federal agencies, developed and pilot tested a hospital survey instrument. This event reporting survey instrument collects information on the extent to which hospitals are reporting events and using the information to improve patient safety.
How Is Medical Error Information Used to Improve Patient Safety?
In September 2001, as part of AHRQ's overall evaluation efforts and in conjunction with our partners in the Quality Interagency Coordination Task Force (QuIC), a contract was issued to develop patient safety measures. It is essential that AHRQ obtain baseline information on how health care facilities actually track patient safety events and so a survey is being developed to gather baseline information on hospital patient safety event reporting. Since there is currently no comprehensive data on how hospitals use medical error reporting information a survey will determine how patient safety event reporting is utilized by institutions as a patient safety or error management tool. However, it is even more important to obtain information on how institutions are actually using patient safety event reporting data to improve their systems and reduce the risks of health care associated injury to patients. Medical error reporting information is being used in various ways including:
- Surveillance and Monitoring. At a minimum, most institutions are tracking and trending the various types of events that are occurring given JCAHO requirements. They also maintain frequency and sometimes rates of occurrence data for specific types of events for risk management and JCAHO accreditation purposes.
- System Changes. Organizations have made a number of system and procedural changes based on data generated from event reporting systems. For example, medication use has changed based on this data (e.g., patient notification in regard to harm, use of medications with high potential for harm if not managed appropriately, and infection control related to CDC's National Institute of Statistical Sciences data).
- Organizational Changes. A number of health care organizations found that some of their policies and procedures with respect to medical error reporting needed to be changed to improve the information reported. Many hospitals used incident or event reporting more as a personnel management tool rather than as a safety or quality improvement tool. Changes in personnel policies are often required to make information appropriate for patient safety use rather than providing documentation for justifying disciplinary actions.
What Incentives and/or Disincentives Have Helped Health Care Professionals Reduce Medical Errors?
A culture of reporting where information is confidential and non-discoverable is the most significant incentive to reduce medical errors.10 Support from opinion leaders of professional organizations is also considered very helpful to promote the culture of safety. For example, recognition by the Georgia State legislature, acknowledging certain hospitals' patient safety efforts provided an extremely important incentive for continued and expanded efforts. In one Health Maintenance Organization (HMO) network, participating physicians were provided an increased reimbursement for providing counseling and patient information. Because carrying out these tasks requires additional clinician time, the cost is reimbursed if it is recorded in the chart or electronic medical record.11
Timely feedback from reporting systems is a critical incentive to continue to report medical errors and to monitor patient safety improvements. Reporters need to know what was done with the information they provided, ensuring that it was acted upon.
One grantee found that the greatest disincentive to reporting is the fear of litigation. Both organizations and individual practitioners continue to report fear of litigation as a major disincentive to reporting medical errors and identifying threats to patient safety. For organizations and providers to commit to addressing patient safety, they must be confident that information that is recorded in reporting and analyzing errors will remain confidential.
Most Common Root Causes of Medical Errors
The demonstration project grantees identified a diverse group of factors that cause medical errors. The factors can generally be group into eight categories and how these factors contribute to medical errors is described below:
- Communication problems represent the most common cause of medical errors noted by the error reporting evaluation grantees. Communication problems can cause many different types of medical errors and can involve all members of a health care team. Communication failures (verbal or written) can take many forms, including miscommunication within an office practice as well as miscommunication between different components of the health care system or health care providers working different shifts. These problems can occur between health care providers such as primary care physicians and emergency room personnel, attending physicians and ancillary services, and nursing homes and patient services in hospitals. Communication problems can result in poorly documented or lost information on laboratory results, diagnostic testing, or medication information, and can occur at any point along the communication chain. Communication problems can also occur within a health care team in one location, between providers at different locations, between health care teams and other non-clinician providers (such as labs or imaging centers), and between health care providers and patients.
Inadequate information flow can include problems that prevent:
- The availability of critical information when needed to influence prescribing decisions.
- Timely and reliable communication of critical test results.
- Coordination of medication orders at points of interface or transfer of care.
Information flow is critical between service areas as well as within service areas in health care. Often, necessary information does not follow the patient when he or she is transferred to another service or is discharged from one component or organization to another.
- Human problems relate to how standards of care, policies, or procedures are followed. Problems that may occur include failures in following policies, guidelines, protocols, and processes. Such failures also include sub-optimal documentation and poor labeling of specimens. There are also knowledge-based errors where individuals do not have adequate knowledge to provide the care that is required for any given patient at the time it is needed.
- Patient-related issues can include improper patient identification, incomplete patient assessment, failure to obtain consent, and inadequate patient education. While patient related issues are listed as a separate cause by some reporting systems, they are often nested within other human and organizational failures of the system.
- Organizational transfer of knowledge can include deficiencies in orientation or training, and lack of, or inconsistent, education and training for those providing care. This category of cause deals with the level of knowledge needed by individuals to perform the tasks that they are assigned. Transfer of knowledge is critical in areas where new employees or temporary help is often used. The organizational transfer of knowledge addresses how things are done in a particular organization or health care unit. This information is often not communicated or transferred. Organizational transfer of knowledge is also a critical issue in academic medical centers where physicians in training often rotate through numerous centers of care.
- Staffing patterns/work flow can cause errors when physicians, nurses, and other health care workers are too busy because of inadequate staffing or when supervision is inadequate. Inadequate staffing, by itself, does not lead directly to medical errors, but can put health care workers in situations where they are much more likely to make an error.
- Technical failures include device/equipment failure and complications or failures of implants or grafts. In many instances equipment and devices such as infusion pumps or monitors can fail and lead to significant harm to patients. In many instances inadequate instructions or poorly designed equipment can lead to patient injury. Often technical failure of equipment is not properly identified as the underlying cause of patient injury, and it is assumed that the health care provider made an error. A complete root cause analysis often reveals that technical failures, which on first review are not obvious, are present in an adverse event.
- Inadequate policies and procedures guiding the delivery of care can be a significant contributing factor in many medical errors. Often, failures in the process of care can be traced to poorly documented, non-existent, or clinically inadequate procedures.
How Effective are State Reporting Systems?
AHRQ was charged with exploring the effectiveness of existing State reporting systems related to medical errors, as well as developing recommendations for State reporting systems. Projects funded in FY 2001 have made considerable progress in evaluating State reporting systems and developing State guidance. AHRQ, in cooperation with the California Health Care Foundation, the Commonwealth Fund, and the Robert Wood Johnson Foundation, commissioned studies by the National Academy for State Health Policy (NASHP). The following reports have been issued:
- Patient Safety and Medical Errors: A Road Map for State Action (NASHP, March 2001).12 This report provides State executive and legislative branch officials with a framework for considering how they might coordinate with government and private stakeholders to address medical errors and patient safety in their States. The report outlines mechanisms to estimate the number of medical errors that occur and actions that States can take to improve patient safety in their roles as purchasers, providers, regulators, educators, conveners, and policymakers. This report outlines actions that States can follow to improve reporting and ways to improve feedback from the data received.
- State-based Mandatory Reporting of Medical Errors: An Analysis of the Legal and Policy Issues (NASHP, March 2001).13 This report explores data issues associated with mandatory reporting systems, potential interactions between mandatory reporting and malpractice litigation, the potential uses of publicly available mandatory reporting system data, and arguments for and against protections for such data. The report shows that, far from being an all or nothing proposition, legal protections and system design features may be used together, in varying degrees, to protect reporting system data from public disclosure and legal discovery. The report recommends that States determine the goals of their reporting system and design appropriate measures to protect data to improve reporting. Failure to clearly identify the purpose of the reporting systems may reduce their effectiveness.
- Current State Programs Addressing Medical Errors: An Analysis of Mandatory Reporting and Other Initiatives (NASHP, January 2001).14 This report examines how eight States with mandatory reporting requirements for hospital incidents administer, oversee, and enforce their requirements. The report presents the status of event reporting across the country and reviews the strengths and weakness of different reporting systems.
- Improving Patient Safety: What States Can Do About Medical Errors (NASHP, June 2000).15 This paper synthesizes a meeting of key policy officials in June 2000 at the NASHP's Flood Tide Forum II. The brief examines current Federal, congressional, and State activities; proposes roles for States; and identifies actions that foundations and others could take. The report addresses ways in which State reporting systems can be made more effective with more uniform policies, procedures, and reporting formats.
While it is premature to draw conclusions about the effectiveness of State reporting systems, AHRQ is funding several demonstration projects that include State systems. Georgia, Massachusetts, and New York are testing traditional active reporting systems. Utah, Missouri, and Wisconsin are evaluating the use of discharge data for identifying risks and hazards to patient safety.