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Written Statement


National Summit on Medical Errors and Patient Safety Research

Panel 4: Reporting Issues and Learning Approaches

Testimony of Marie Dotseth, Minnesota Department of Health

The first National Summit on Medical Errors and Patient Safety Research was held on September 11, 2000, in Washington, DC. Sponsored by the Quality Interagency Coordination Task Force (QuIC), the Summitís goal was to review the information needs of individuals involved in reducing medical errors and improving patient safety. More importantly, the summit set a coordinated and usable research agenda for the future to answer these identified needs.

Individuals were selected by the Agency for Healthcare Research and Quality (AHRQ) to testify at the summit as members of the witness panels. Each submitted written statements for the record before the event, documenting key issues that they confront with regard to patient safety as well as questions to be researched. Other applicants were invited to submit written statements.

Disclaimer and Copyright Statements


With the 1999 release of the Institute of Medicine Report, To Err is Human: Building a Safer Health System1, the issue of medical errors and patient safety was introduced to the public. Although this problem is not a new one, it was never before an issue which attracted public attention, as the medical community preferred to address it privately and quietly. The Institute of Medicine report quotes now famous statistics: 44,000 to 98,000 people die each year in the United States as a result of medical errors at a cost of between $17 and $29 billion to society ($8.8 billion in direct health care costs). Between 2.9 and 3.7 percent of hospitalizations involve an adverse event.2 The accuracy of these numbers has been hotly debated by various members of the medical community, who cite poor study methodology and vague differences between preventable and non-preventable adverse events as causing an artificial inflation of the problem. This is often done in an attempt to de-emphasize or detract from the severity of the problem. For example, Dr. Troyen Brennan stated in an April article in the New England Journal of Medicine that the two studies which these numbers are based on (one based on data from NY, the other on data from Utah and Colorado) were not ever meant to determine "whether the injuries were caused by error. Indeed, there is no evidence that such judgements can be made reliably."3 A counter to this argument is made by Janet Corrigan, one author of the Institute of Medicine report. She points out that in fact these numbers are probably understating the problem if anything, because they only look at errors in the inpatient, hospital setting and exclude long-term care, emergency room and ambulatory care facilities. Medication errors, for one, have been found to occur at higher rates (as high as 18%) in the ambulatory care setting.4 This point leads to the conclusion that if anything, the Institute of Medicine report is underestimating the true extent of this problem. Debates about the accuracy of the numbers obscure the larger point that patients are dying needlessly due to a flawed system. At this time it appears that while all stakeholders agree that there is a problem (albeit not to what extent it exists), there is vast disagreement on what constitutes an appropriate response to this serious problem.

As the public demands action and answers, policymakers are placed in an increasingly difficult situation. There is concern that policymakers may be compelled to act in response to public demand, and may do so based on incomplete or poor information. The dearth of research on the topic of patient safety leaves policymakers and other officials incapable of offering any definitive answers to an anxious public. Furthermore, limited information on the successes and failures of existing initiatives and responses often means that policymakers are unable to effectively evaluate all the different policy options facing them. This results in the outward appearance of a lack of cohesive initiatives to address the issue of patient safety, and means that in actuality, any initiatives undertaken are inefficient. The Institute of Medicine report recommends that "a nationwide mandatory reporting system (should) be established that provides for the collection of standardized information by state governments about adverse events."5 The report goes on to recommend that such systems encompass ambulatory and institutional settings, as well as hospitals. Given the lack of data and research presently available on existing systems, states are largely on their own if they choose to adhere to this recommendation and establish a mandatory reporting system. States expressed their main concerns with reporting systems in the National Academy for State Health Policy report, "State Reporting of Medical Errors and Adverse Events: Results of a 50-State Survey". The NASHP report found that states cite under-reporting and inadequate resources as the two greatest concerns with their current reporting systems. Other concerns include protection from discovery, effectiveness of reporting to improve quality, lack of trained staff, and political pressure to block action. States asked for technical assistance in the form of lessons learned from other states, use of data to improve patient safety, development of a uniform reporting system, designing protections/incentives for reporting, and definition of medical errors/adverse events. States suggested many things central to an effective reporting system including accuracy, confidentiality, standardization, on-line systems with guaranteed security, strong sanctions for attempts to block investigations, and ability to obtain and evaluate preventive plans to eliminate reoccurrence.6 All of these various concerns and suggestions point to the serious need for improvement in current reporting systems across the country.

The Minnesota Department of Health is dedicated to improving patient safety in the state of Minnesota, but the plethora of questions and doubts about reporting systems seriously hinders any attempts at efforts to ameliorate this problem. Furthermore, there is very little information available about alternatives to a mandatory reporting system for preventable adverse events. Given the focus of the Institute of Medicine on a nationwide mandatory reporting with a complementary voluntary system, and the delegation of the implementation of such a system to the states, the Minnesota Department of Health focuses its research needs on information about reporting systems. There are many political and logistical questions which must be addressed with regard to the establishment of an effective reporting system, possibly the most pressing of which is how to ensure continuous quality improvements at the health care delivery level as a result of the data collected by any such system. Our research proposal includes three major concerns: elements necessary to a successful reporting system, the effect of tort laws on reporting levels, and assurance of quality improvements at the care delivery level as a result of reporting. It is our hope that such information would help us develop a coherent policy response to the issue of patient safety and allow us to support proven initiatives capable of adequately addressing this issue.

1. Kohn, Linda T et al (eds.). To Err is Human: Building a Safer Health System. National Academy Press, 1999; page 2.

2. Ibid, pages 1-5.

3. Brennan, Troyen "The Institute of Medicine Report on Medical Errors—Could it do Harm?" N Engl J Med 2000 342(15):1123-5.

4. Gandhi TK. Burstin HR. Cook EF. Puopolo AL. Haas JS. Brennan TA. Bates DW. "Drug complications in outpatients." Journal of General Internal Medicine. 15(3):149-54, 2000 March.

5. See note 1.

6. Rosenthal, J et al. "State Reporting of Medical Errors and Adverse Events: Results of a 50-State Survey." National Academy for State Health Policy; April 2000.

What elements are necessary for a successful reporting system?

"Clearly, a need exists for accurate information on state systems that are designed to collect, report, and use data on medical errors and adverse events."7

National Academy for State Health Policy

Although the Institute of Medicine has recommended establishing a nationwide mandatory reporting system, they did not provide a set of data-backed guidelines by which to do so. There are currently several states with reporting systems, and several other industries use reporting systems to improve safety and quality, but they have not yet been closely examined to distill their strong and weak points. Different sources place the count of states with mandatory reporting systems already in place as of the time of the publishing of the Institute of Medicine's report to be anywhere from eighteen to twenty-three. The National Academy of State Health Policy released a preliminary study on the nature and extent of current state reporting systems in place for medical errors which determined that "fifteen states require mandatory reporting from general and acute care hospitals, as defined by the Institute of Medicine or by the state in a way that encompasses all or part of the Institute of Medicine's definition."8 The major reason for this discrepancy is the fact that states have different requirements for reporting: some require the reporting of serious incidents, others reportable incidents, others occurrences, and still others adverse occurrences. Furthermore, different states require reporting from different entities (for example only from nursing homes or long term care facilities, where abuse and/or neglect has traditionally been a serious issue). The states all have different degrees of protection for the information, and utilize different reporting forms with various time-lines for submission. These differences make it hard to pinpoint the exact number of functioning reporting systems which address the issue of patient safety, as defined by the Institute of Medicine report.

7. See note 6.

8. See note 6, Executive Summary.

Definitional Issues

This points to a serious problem facing the implementation of any mandatory reporting system, especially one that is nationwide: the lack of any standardized definition for medical error. This lack of a clear definition has been one of the general challenges in the discussion around medical error to date. In addition, the use of the term "error" has caused some concern within the medical and health care profession, which by and large prefers the term patient safety. The lack of a clear definition of medical error has seriously complicated attempts by states, as well as private accrediting bodies such as the Joint Commission on Health Care Accreditation, to gather data on these events. The lack of a standard definition for medical error or adverse event constitutes a major barrier to state reporting systems' effectiveness and comparability. There is general agreement that, in order to collect meaningful data which can be readily analyzed, a definition must be agreed upon and the specific events to be reported must be carefully defined. This lack of a standard definition is a universal concern among all the stakeholders involved with this issue.

Following are several different examples of current definitions for medical error, highlighting the challenge to policymakers attempting to address this issue. The Joint Commission on Accreditation of Healthcare Organizations defines sentinel event (the closest they come to medical error) as "any unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof."9 The Institute of Medicine report defines medical error as "failure of a planned action to be to be completed as intended or the use of a wrong plan to achieve an aim."10 Errors can be of either execution or planning, or of omission or commission (a familiar concept in healthcare quality that of the over- and under-use of services). The Institute of Medicine report relied heavily on literature within the behavioral science field to arrive at its definition.

Lucien Leape points out that the Institute of Medicine report defines medical error as something that requires awareness (an error is generally something that a person does not intend to do). Errors may be made due to problems in medical professional training or because of flaws in the flow of information within a healthcare facility, in which case the mistake or error might be made without any awareness on the practitioner's part. Each of these constitutes a separate systems failure and should be addressed, but Leape seems to imply that the type of error in which there is immediate recognition by the practitioner is the type addressed in the Institute of Medicine report.11

The recent National Academy for State Health Policy report did not define medical error in one specific way; rather, it enumerated a list of specific incidents that might constitute medical error. In this way they hoped to overcome the comparison problems associated with the lack of a standardized definition. This report found that no states currently have a definition for the term medical error; two states do have a definition for the term adverse event; seven states do not rely on a definition for a reportable event, rather they enumerate the types of events which must be reported; and finally, six states have a definition for a term similar to adverse event but both the term and definition vary greatly.12 The lack of a clear definition for reportable events might constitute the single largest challenge to instituting an effective reporting system at the state level and therefore is one of the most critical research questions for the Minnesota Department of Health.

9. Joint Commission on Accreditation of Healthcare Organizations. Preventing Sentinel Events in the Environment of Care. 2000; Page 3.

10. See note 2.

11. Lucien Leape, AHRQ conference call series on medical error , May 18, 2000.

12. See note 6.

Mandatory vs. Voluntary Reporting

A second issue of great concern when considering the implementation of state-level reporting systems is that of mandatory versus voluntary reporting. The Institute of Medicine report recommends establishing a system which is comprised of both mandatory and voluntary parts, however there are many concerns among the medical community over the effectiveness of a mandatory reporting system, four of which are raised here.

First, if the current culture of secrecy within the medical profession fails to change, there will be problems with under-reporting in any mandatory reporting system, thus minimizing its effectiveness. It is important to help address this problem by ensuring that any sanctions resulting from a reporting system not be focused on individuals. Research needs to focus specifically on how best to structure sanctions for non-reporting so systems, not individuals, are targeted. At the same time, it is critical that the sanctions are strong enough to effectively encourage high levels of reporting.

A second concern with mandatory reporting is the issue of privacy. Reports on medical error will likely include several different affected parties, including the physician or healthcare provider, the patient, the hospital or other place of service, and the payer. Traditionally, information collected by the state or federal government has been accessible under freedom of information laws unless specifically protected. Many who have written on this topic, for example the Institute of Medicine and the National Academy for State Health Policy, advocate the release of at least some portion of reported information to the public. With the variety of interests involved, it is a challenge to develop systems which protect information adequately while still releasing it in some useful form to the general public or providing helpful feedback to payers or providers for quality improvement purposes. Research on this point needs to address the best balance between public and private information within a reporting system in order to maximize the system's effectiveness.

A third concern with mandatory reporting systems is one over regulatory and reporting overlap. If and when reporting systems are established by states, it will be important to ensure that these systems are compatible with existing systems and with one another, and will not require multiple reporting in different formats for the federal and state government or for private accrediting organizations. Research needs to address how best to establish systems so providers and care givers are not forced to make duplicate filings to several regulatory oversight agencies or bodies. Consideration of the reporter's time will ensure a far higher level of compliance. Finally, as with anything else, there is the issue of cost. It appears that setting up a mandatory reporting system will require a significant investment on the part of the state. The state of New York, which established the New York Patient Occurrence Reporting and Tracking System (NYPORTS) reporting system in 1998, reports that their Web-based system is run using existing staff, required an initial investment of $160,000 and needs $20,000 in maintenance per year.13 This represents an unusual example of a state able to implement a major initiative in an extremely cost-effective way. As this investment is unusually low, it is likely that the type of resource investment most states will face might be a potential stumbling block in the implementation of a comprehensive reporting system while staying within tight budget restraints. However, it will be critical to consider these costs in the context of the cost savings of reporting systems. An extremely useful piece of information would be cost-benefit research conducted on existing systems to compare the total costs to the state and the private sector with the savings associated with systems changes stemming from error reduction and related quality improvements.

It is clear that before mandatory reporting is considered the clear-cut policy option for states attempting to take action on the issue of patient safety, more research must be done to ensure the overall effectiveness of such systems. Study should be undertaken on voluntary systems as well, such as the system for the reporting of sentinel events operated by the Joint Commission on the Accreditation of Healthcare Organizations. Comparisons should be made between mandatory and voluntary reporting and research should be pursued to determine how mandatory or voluntary reporting bears on the preceding four concerns specifically. The Institute of Medicine, with its recommendations for a dual reporting system, provides an excellent framework for beginning to investigate the appropriate balance between voluntary and mandatory reporting.

The state reporting systems in Massachusetts and New York would provide excellent opportunities for evaluation of current systems' strengths and weaknesses. New York has had an extensive system in place for the mandatory reporting of medical errors since 1998, and they are finally starting to develop an adequate database. This data can be accessed by hospitals or providers (de-linked from identifying information) for comparison purposes. The New York system punishes for non-reporting in the form of embarrassment, fines and a consultation to bring quality up to standard. New York gave an extensive breakdown of their state costs, which were surprisingly not too high—the major expense was the establishment of the Web-based reporting system, and this was contracted out. They use their existing staff to maintain and run the system. New York recently opted to include root cause analysis for the roughly 1,000 serious incidents reported to them which require the long form and an investigation, an upgrade which cost them $50,000. The most important lesson they have learned is the critical nature of the definitions of medical error in effective reporting. The New York system received between 20,000 and 25,000 reports last year alone, and is considered a relatively successful example of a current system, even given its punitive and mandatory nature. Furthermore, the ease of their Web-based reporting system is most certainly contributing to the high level of reporting.14 Further examination of the NYPORTS system could provide valuable lessons learned and contribute to best practice guidelines.

A second system that deserves research and consideration is that operated in Massachusetts. Massachusetts was one of the very first states to respond to the issue of reporting medical errors, or "serious incidents" as termed in their 1986 legislation on the topic, long before the Institute of Medicine report was published. "Hospitals must report fire, suicide, serious criminal acts, pending or actual strike, serious physical injury resulting from accident or unknown cause, and other serious incidents that seriously affect the health and safety of patients."15 According to this law, serious incidents include equipment malfunction or user error, medication errors, surgery errors, and blood transfusion errors. Hospitals are required to report serious physical injury or harm to a patient resulting from accident or unknown cause to the Department of Public Health immediately by phone. A written report must be filed within one week for "any serious incident which seriously affects the health and safety of patients".16 The Department of Public Health maintains the right to investigate more thoroughly any incident as it sees fit. Massachusetts is unique in that it also has a reporting system in place whereby all health care providers are required to report "injuries and accidents" to their Patient Care Assessment Coordinators.17 The risk management program mandated through Massachusetts General Laws ch.111 §203 is termed the Qualified Patient Care Assessment Program (QPCAP) and requires at minimum the establishment of a hospital governing board entitled the Patient Care Assessment Committee. This Committee must name a coordinator to oversee operation of the Committee. Furthermore, all hospitals must report "major incidents" to the Board of Registration in Medicine. All individuals or institutions "shall not be liable in a suit for damages by reason of having furnished such information, opinion, counsel or services."18 This information is not available to the public. Once again, closer examination of this dual system would provide valuable information about the effect of public disclosure on reporting levels, as well as the difference between reporting to the Department of Public Health and the Board of Registration in Medicine.

Information and best practice guidelines for reporting are clearly needed by the states. Research in this area is necessary if the recommendations of the Institute of Medicine report are to be adhered to in the most effective fashion.

13. Fred Heigel, AHRQ conference call series on medical error, May 24, 2000.

14. See note 13.

15. 105 CMR 130.331.

16. Ibid.

17. 243 CMR 3.07(3)(a).

18. M.G.L. ch.111, § 203.

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