The issue of patient safety has become one of the most significant challenges facing the American health care system. Nearly every week, newspaper articles, reports on the radio and television, and articles in the medical literature keep issues of patient safety in the national spotlight. Leaders of our health care system have demonstrated a commitment to improving the quality and safety of care for all Americans. The issue is a high priority for the Department of Health and Human Services Secretary Tommy Thompson and for the Agency for Healthcare Research and Quality (AHRQ).
In its November 1999 report To Err is Human: Building a Safer Health System, the Institute of Medicine (IOM) estimated that between 44,000 and 98,000 Americans die each year as a result of medical errors. It further noted that more individuals die each year from adverse events in the delivery of health care than die from automobile accidents (43,458) and workplace injuries (6,000), and that deaths caused by medical errors exceed the number attributable to breast cancer, the 8th leading cause of death.1 The IOM report quickly elevated awareness of patient safety.
In January 2000, within weeks of the IOM report's release, the Senate Committee on Appropriations began hearings on medical errors and patient safety issues. As a result of those hearings, the Committee directed AHRQ to lead the national effort to combat medical errors and improve patient safety. The Committee specifically directed AHRQ to establish a competitive demonstration program for health care facilities and organizations in geographically diverse locations, including rural and urban areas, to determine the causes of medical errors. These projects were to use a variety of techniques and approaches to reduce such errors; develop models that minimize the frequency and severity of errors; develop mechanisms that encourage reporting, prompt review, and corrective action; and develop methods to minimize paperwork. The Committee further urged AHRQ to prepare and submit an interim report to Congress concerning the results of this medical error reduction demonstration program within 2 years of the commencement of the projects.2
Additionally, in Senate Report 107-84, dated October 11, 2001, the Senate Committee on Appropriations requested that AHRQ describe how it was responding to applicable recommendations in the IOM's report, To Err is Human. AHRQ was asked to respond to a list of specific questions, including:
- How hospitals and other health care facilities are reducing medical errors.
- 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 professional reduce medical errors.
A list of the most common root causes of medical errors was also requested.3
The purpose of this report is to provide the requested Interim Report to the Committee, and to provide a status update on AHRQ's entire Patient Safety Initiative. As the Patient Safety Initiative nears its second full year of implementation, it has already achieved some important milestones.
- In 2001, AHRQ reconstituted the Agency's Center for Quality Measurement and Improvement, as the Center for Quality Improvement and Patient Safety (CQuIPS). This was the initial step in a series of efforts to re-focus and concentrate in one organizational unit activities designed to improve the safety of the health care Americans receive.
- In September 2001, the Agency reviewed and awarded l6 Medical Error Reporting Demonstration Evaluation Grants from a group of 54 applications. Although only 18 months into their funding cycle, interim observations are providing valuable information that can be used as current reporting systems are improved and new databases developed. These observations are not recommendations from AHRQ but merely interim observations by the grantees.
Key issues highlighted by these observations include:
- No single data source is sufficient to gain a complete understanding of medical errors contributing to actual or potential patient injury.
- As medical error reporting improves, error detection rates increase while the severity of errors eventually decreases. It is important that error detection rates be high because errors that go undetected can have disastrous consequences.
- Despite July 2001 patient safety standards from the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) that require hospitals to disclose to patients all unexpected outcomes of care, there appears to be great variability in whether and how medical errors are disclosed. Although there are fears that disclosure may subject providers to increased risk of malpractice litigation, in fact, lack of disclosure has been associated with an increase in malpractice claims being filed because patients cannot obtain information from the health care organization or individual practitioner.
- The ability to identify patient safety problems would be enhanced by the availability of data guidelines and standards, i.e., common taxonomy and standardized data definitions and data elements in reporting systems.
- Alignment of hospital and health care organization human resource policies and procedures with the emerging "just culture" is a task for the hospital or organizational leadership. "Just culture" is defined as reconciling professional accountability and the need to create a safe environment to report medical errors.
- Legal protection of reported data is critical if medical error reporting is to be truly effective in improving patient safety. Effective reporting requires encouragement of health professionals to report medical errors and other threats to patient safety and a prevailing national norm of legal protection of all reported patient safety data. This is an observation of the grantees and not a conclusion or recommendation.
- Medical error reporting systems may be most effective if they are easy to use, but not so simple that the information reported is of limited value to the institution. The balance between the information required of the reporter and the system operator who investigates the reported events is critical to overall success.
- Observations suggest that analyzing the root causes of medical errors is a high priority in improving patient safety. Many of the root causes or errors are not case-, organization-, or domain-specific, but follow common patterns.
AHRQ dedicated more than $165 million dollars to patient safety research over the past 3 years. The more than 100 studies and other activities funded under AHRQ's patient safety research initiative fall into four categories:
- Identifying threats to patient safety: identify medical errors and causes of patient injury associated with the delivery of health care.
- Identifying and evaluating effective patient safety practices: identify, design, test, and evaluate practices that eliminate medical errors and system-related risks and hazards compromising patient safety.
- Disseminating, educating, and implementing to enhance patient safety: disseminate, teach, and implement patient safety best-practices that reduce or prevent actual (or the potential for) patient injury associated with the delivery of health care
- Maintaining vigilance: monitor and evaluate threats to patient safety.
The Department is committed to creating a culture of improvement and safety in the health care system and providing evidence-based tools and resources to achieve that goal, including the development and adoption of more advanced information technology. In a July 2003 address to the National Health Information Infrastructure Conference, Secretary Thompson gave several examples of that commitment. The Food and Drug Administration (FDA) proposed a new rule for bar coding medications that will allow information systems to reduce preventable medication errors. In addition, the Secretary announced that he had requested $65 million for national health information technology:
- $50 million for AHRQ demonstration projects to show how patient safety is enhanced by information technology.
- $12 million for ASPE and AHRQ to support development of standards.
- $3 million for national health information technology coordination.
AHRQ has requested a total of $84 million dedicated to patient safety activities in Fiscal Year (FY) 2004. As indicated, $50 million will be used to help hospitals and other health care providers invest in information technology designed to improve patient safety with a special emphasis on the needs of small and rural communities where penetration has been low. These care providers often don't have the resources or the information needed to implement cutting-edge technology.
The goal is to encourage health care providers to routinely use information technologies such as: computerized physician order entry, computer monitoring to prevent adverse events, automated medication dispensing, computerized reminder systems to improve compliance with guidelines, handheld devices for prescription information, electronic health records, and online support groups for patients.
Additionally, if the budget is approved, AHRQ will spend $12 million of the $84 million devoted to patient safety to promote and accelerate the development and adoption of information technology standards in health care. The limited use of uniform electronic messaging and language standards is a major obstacle to the development and use of health information systems to support quality improvements and patient safety. The remaining funds will be used for continuing many of AHRQ's Patient Safety Portfolio components detailed in Chapter 3.
This Agency Interim Report to the Senate Committee on Appropriations is divided into three major sections:
- AHRQ's Medical Error Reporting Demonstration Evaluation Projects: Key Issues in Identifying Threats to Patient Safety. This chapter summarizes the interim results from the l6 Medical Error Reporting Demonstration Evaluation projects awarded by AHRQ in September 2001. The grants total $23 million per year for FY 2001, 2002, and 2003.
- Efforts to Reduce Medical Errors: AHRQ's Response to the Senate Appropriations Committee. The chapter responds to the specific questions raised by the Senate Appropriations Committee in its report accompanying the FY 2003 appropriation. Responses are provided for all of the questions posed by the Committee.
- AHRQ's Initiative: Breadth and Depth for Sustainable Improvement. This chapter highlights AHRQ's systematic approach to building the foundation for a national Patient Safety Initiative and addresses progress to date as well as strategic direction in the near and long-term.
The Agency believes that, in collaboration with other Federal partners, professional societies and organizations, health care providers, and consumer advocacy organizations, we can improve patient safety, enhance health care quality and ensure that Americans receive the best, safest health care possible.
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