Statement of Jill Rosenthal, MPH, Project Manager, National Academy for State Health Policy, Portland, Maine

Testimony Before the Subcommittee on Health
of the House Committee on Ways and Means

Hearing on Legislation to Reduce Medical Errors

September 10, 2002

Chairman Johnson, Congressman Stark and distinguished Members of the Committee:

My name is Jill Rosenthal and I am a project manager for the National Academy for State Health Policy, a non-partisan, non-profit public policy research organization that works with state governments to help them achieve excellence in their health care policy and practice.

Our organization has been working with the Institute of Medicine and states on the issue of patient safety since 1999. We have provided policy analysis, training, and technical assistance to states as they have attempted to address the Institute of Medicine’s recommendations.

Among the recommendations outlined in the Institute of Medicine report To Err is Human is a call for two types of reporting systems, each designed to address a specific concern. Mandatory reporting was intended for events that cause serious harm or death, as part of a public system for holding health care organizations accountable for performance. Voluntary reporting was intended to complement mandatory reporting by detecting system weaknesses before the occurrence of serious harm. The Institute of Medicine made clear that there is a need for both mandatory, public reporting systems and voluntary, confidential reporting systems.

As envisioned by the Institute of Medicine, a nationwide mandatory reporting system should be established by building on current state systems. The IOM recommended that funding be provided to states for this purpose.

States are the appropriate entities to take on this role because they are on the front line in protecting the public’s health. States have the unique role and legal responsibility to license and provide oversight of health care facilities and professionals. The public looks to state government to ensure that the healthcare system takes necessary measures to ensure care is safe.

Although states have struggled with a lack of resources to implement reporting systems, they are embracing the challenge. Today 20 states have created mandatory reporting systems. More states are considering enacting systems and others would follow if resources were available.

According to state officials, mandatory reporting systems play a vital role in hospital oversight by providing a window into hospital patient safety practices and developing more complete facility profiles. In addition to investigating individual events and ensuring corrective action, many states share reported information with professional licensure boards when professional standards may have been violated, and they issue safety alerts and newsletters to help facilities improve safe practices.

States continually strive to improve their systems. We are currently working with states and the National Quality Forum to compare state lists of types of events with the National Quality Forum’s (NQF) list of Serious Reportable Events in order to help states develop a standardized list of clearly defined events that can be easily implemented and that allows room for state flexibility.

Unfortunately, the bill before you will likely interfere with states’ capacity to meet their obligations.

Without a mandatory system that provides accountability, there will be no check and balance and Congress and the public will have no mechanism to know that voluntary reporting is working to reduce serious medical errors.

Voluntary reporting systems are intended to collect information about events that cause minimal or no patient harm. Events that cause serious harm or death are intended for mandatory systems because these types of events may indicate serious system weaknesses. However, "patient safety data" is so broadly defined in the bill that it applies to all types of events. As a result, the bill creates an additional burden on providers who may be required to report the same events to both state-based mandatory systems and the national voluntary system.

The bill could have a chilling effect on state efforts to collect data for purposes of accountability. If duplication exists, providers will be unlikely to support two separate reporting mechanisms and will likely lobby against state efforts to create mandatory reporting systems even though they have a different scope, purpose, and function than voluntary systems. The bill authorizes funding for the voluntary system but does not address the IOM recommendation to fund state-based mandatory systems.

The bill requires data reported to patient safety organizations to be confidential and privileged. However, the IOM recommended that analyses of individual serious event reports should be made available to the public as part of a public system of accountability. Since the bill requires reporting of serious events in addition to those that cause minimal harm, all events would fall under strict confidentiality protections.

In a later study, the IOM called for health systems to be accountable to the public; to do their work openly; to make their results known to the public and professionals; and to build trust through disclosure, even of the systems’ own problems. According to the IOM, a transparent health care system will improve trust, be more patient-centered, and safer, because patients would have information to make informed decisions about their care. Some organizations, such as the Veteran’s Administration, have increased transparency already. The IOM points out that although many providers fear increased transparency could increase liability, some evidence shows that open disclosure of errors may decrease the likelihood of malpractice loss.

1. Clarify the scope, purpose, and function of voluntary reporting systems as separate and distinct from, and complementary to, state-based mandatory reporting systems. This would reduce duplication and confusion and lay the groundwork to address IOM recommendations. Confidential, voluntary reporting systems should not preempt state public mandatory systems that collect information about events that cause death or serious harm in the 20 states with existing systems or in states that have yet to develop mandatory systems.
2. Recognize the role of state-based mandatory reporting systems as identified in the IOM report: to collect information on specific cases that cause serious harm or death for the purpose of accountability and to collect information that may become known to the public. Certain events, such as those that cause serious harm, death, and criminal events, should not inadvertently or intentionally be given legal protection under a voluntary system.
3. Balance funding for improvement of national voluntary reporting efforts with funding for state-based mandatory systems, as envisioned by the IOM report.

State and federal government need to represent consumers and assure them that the health care system is being held accountable for safety. A public reporting system that provides both a check and balance and public information is needed as is a voluntary system for quality improvement purposes. Without both, we cannot realize the Institute of Medicine’s goals and we fail to provide needed public accountability for patient safety.

National Academy for State Health Policy is a non-partisan, non-profit public policy research organization that works with state governments to help them achieve excellence in their health care policy and practice. Since its inception in 1987, NASHP has provided state health policy leaders with access to timely, unbiased information on pressing healthcare issues. Because NASHP recognizes that responsibility for health care does not reside in a single state agency, department, or branch of government, it strives to foster productive interchange across all lines of authority. Each year, NASHP conducts policy analysis, provides training and technical assistance to states, and – through its publications, annual state health policy conference, media briefings, meetings, and website (www.nashp.org)– disseminates information designed to assist states in the development of practical, innovative solutions to complex health policy issues.

Twenty states have created mandatory reporting systems:

Twenty state licensure and certification agencies require mandatory reporting of adverse events that occur in hospitals. Many of the reporting systems also collect information from ambulatory care centers and psychiatric hospitals. Some collect information from free-standing laboratories and outpatient mental health centers, nursing facilities, and other licensed facilities. For example, Colorado’s reporting system requires reporting from general and acute care hospitals, ambulatory care centers, psychiatric hospitals, freestanding laboratories, freestanding outpatient mental health centers, nursing facilities, and other licensed facilities. Washington State’s reporting system collects information from acute care hospitals only.

States identify and define reportable events in different ways although they require fairly similar data elements to be reported. Facility name, type of incident, and date of occurrence are required by all states. Most states also include patient identification, provider identification, description of the incident, person reporting the incident, action taken by facility, patient outcome/status, and notification of other parties (e.g. professional licensing boards). Some include identification of witnesses as well.

One of the barriers that states face in implementing mandatory reporting systems is identifying an unambiguous and clearly defined list of reportable events. The IOM report called for a nationwide mandatory reporting system that provides for the collection of standardized information by state governments about adverse events that result in death or serious harm. The report urged Congress to designate the National Quality Forum (NQF) as the entity responsible for establishing and maintaining a core set of reporting standards to be used by the states. Through its Serious Reportable Events Project, the NQF used a voluntary consensus standards setting process to develop a set of serious, preventable adverse events that might form the basis for a national state-based event reporting system. Participants identified 27 serious adverse events that should be reported by all licensed healthcare facilities. As suggested in NQF’s report, additional specification may need to be developed to ensure standardized data collection.

The National Academy for State Health Policy (NASHP) is working with the NQF and a group of states (SAFER: State Alliance for Error Reporting) to compare state lists of reportable events with the National Quality Forum’s (NQF) list of Serious Reportable Events in order to determine areas of overlap and areas of difference. The result of the project will be a user’s guide to help states develop a standardized list of clearly defined events that can be easily implemented and that allows room for state flexibility.

Twelve bills dealing with some aspect of error reporting were introduced in seven states during the 2001 state legislative sessions. Of these, six bills (in MA, MD, NY, and PA) would require new types of mandatory reporting or would strengthen existing reporting requirements.

The IOM recommended that errors that are identified through mandatory reporting systems and are part of a public system of accountability should not be protected from discovery. State investigations of individual incidents are available on request in most states. One state makes investigation reports available on the Internet. All reporting systems (8) reviewed during NASHP site visits protect patient specific information. Reporting system officials unanimously support protecting patient confidentiality.

Some states release aggregate data that does not identify the facilities or patients involved in the incidents (de-identified data). Data elements may include the most common injuries, the average number of incidents per facility, or the total number of incidents reported.

States less commonly provide aggregate data that identifies incidents by facility name, in part because underreporting leads to incomplete data, making it difficult to distinguish between facilities that experience more errors and those that report more errors because they are more compliant with reporting requirements. However, some states have considered releasing information on the number, type, frequency, and causes of errors by facility. To do so requires risk adjustments for age, relative illness, and other complex factors so that users can interpret the data accurately. States continue to struggle with developing risk adjustment methodologies that take into account relevant factors that may help explain the frequency of adverse events.

States may choose to change their approach to disclosure over time. Some may choose to release de-identified aggregate data in the early stages of the system’s development and move toward facility-specific data as the system matures, reporting increases, and a risk-adjustment technique is identified.

The overriding reason for mandatory reporting systems is to hold healthcare facilities accountable for preventable adverse events that result in serious injury or death. Accountability is achieved by investigating the event, providing expertise or information to help remedy the problem, and insuring that appropriate changes are made and sustained to avoid the problem in the future. Investigation may be made on-site by clinicians.

A secondary purpose of a mandatory reporting system may be to improve overall quality and patient safety across facilities. Over time as experience and expertise have grown, many state reporting systems have shared lessons learned from individual reporting incidents by aggregating data to identify trends. Some states issue patient safety alerts, distribute newsletters that highlight trends and best practices, and operate websites that can be used by facilities to compare their patient safety history to peer facilities.

To varying degrees, all states share information with professional medical, nursing, and pharmacy boards if reports indicate that a professional violation may have occurred.

Examples:

SUMMARY OF STATE LEGISLATIVE ACTIVITY: 1999 - 2001*

*most recent year available

1 A Virginia bill was not enacted but was implemented in 2000 by request of the Speaker. That bill is counted as an enacted bill for 2000.

2 HI, MA, NY, OK, and WA.

3 CA, FL, HI, IL, MA, MN, MO, NJ, NY, PA, SD, VA, WA, and WV.

4 CA, CT, FL, GA, IL, IN, IA, KY, ME, MD, MA, MI, MN, MO, NV, NH, NJ, NY, OR, PA, VA, and WV.
 

Sharon Conrow Comden and Jill Rosenthal, Statewide Patient Safety Coalitions: A Status Report (Portland, ME: National Academy for State Health Policy, May 2002).

Jill Rosenthal and Maureen Booth, How Safe is Your Health Care? A Workbook for States Seeking to Build Accountability and Quality Improvement through Mandatory Reporting Systems (Portland, ME: National Academy for State Health Policy, November 2001).

Jill Rosenthal, Maureen Booth, and Anne Barry, Cost Implications of State Medical Error Reporting Programs: A Briefing Paper (Portland, ME: National Academy for State Health Policy, May 2001).

Jill Rosenthal and Trish Riley, Patient Safety and Medical Errors: A Road Map for State Action (Portland, ME: National Academy for State Health Policy, March 2001).

Jill Rosenthal et al., Current State Programs Addressing Medical Errors: An Analysis of Mandatory Reporting and Other Initiatives (Portland, ME: National Academy for State Health Policy, January 2001).

Jill Rosenthal, Trish Riley, and Maureen Booth, State Reporting of Medical Errors and Adverse Events: Results of a 50-State Survey (Portland, ME: National Academy for State Health Policy, April 2000).