The Patient Safety and Quality Improvement Act

• Abstract
• Purpose of health policy or idea
• Characteristics of this policy
• Political and economic background
• Purpose and process analysis
• Expected outcome
• References

Featured in half-yearly report: G-politik in Industrieländern 5

Abstract

Patient safety legislation currently under consideration would encourage voluntary reporting of medical errors and facilitate the adoption of information systems. The aims of the bill are to: create a national patient safety database; protect submitted information from legal discovery and thereby encourage reporting on adverse events; Assess penalties to anyone releasing identifiable information reported to PSOs.

Purpose of health policy or idea

In the past half-decade, interest in patient safety has risen to unprecedented levels in the United States. The release of the 1999 Institute of Medicine (IOM) report, "To Err is Human," drew attention to the high frequency of medical errors and prompted calls for system-wide reform. Among the top priorities cited by the authors were the need for increased capacity to gather information on adverse events and wider use of information technology. (#1)

Legislation currently under consideration in Congress, The Patient Safety and Quality Improvement Act, addresses many of the key issues highlighted in "To Err is Human." The Act represents a continuing effort on the part of national legislators to facilitate wide-scale reporting and analysis of medical errors. It would create a national patient safety database for use in analyzing national and regional medical statistics and identifying trends in medical errors, and would allow health care providers to voluntarily report medical errors to public and private "patient safety organizations" (PSOs). The Department of Health and Human Services (HHS) would certify these organizations and maintain the medical error database. According to proponents of the bill, data on adverse events would be analyzed and fed back into quality improvement initiatives led by HHS and the PSOs.

A critical component of the bill would protect reports generated by PSOs from being used in malpractice lawsuits or accreditation actions, with financial penalties assessed for the disclosure of identifiable information submitted to a patient safety database (#2). (The Senate version would disallow the use of information reported to PSOs in litigation or accreditation under all circumstances, while the bill that has been considered in the House of Representatives would allow this data to be used in certain, limited circumstances). (#3)

Sponsors of the legislation assert that these legal protections would create an incentive for doctors to report incidents in which an error was committed. Because of the adversarial nature of medical malpractice proceedings and the attendant risk of heavy financial penalties, health care providers have become reluctant to share information on adverse events, including accounts of minor injuries or "near misses" (#1). This reluctance has a chilling effect on quality improvement efforts that rely on collecting and analyzing data on such events. By withholding patient safety data from being used in civil or administrative proceedings, supporters claim that the bill would realign incentives toward a process of continuous quality improvement (#4). Critics, however, claim that loopholes in the bill could let providers curb public access to information about death rates, surgery volume and other data that are used to compile report cards on provider performance (#5).

The version of the bill formerly considered by the House of Representatives, which is expected to be revived during the current Congress, contains a series of measures that would harness the safety-enhancing capacities of health information technology (IT) systems. The bill attempts to lay the groundwork for an interconnected electronic health information infrastructure by allowing national authorities to set standards for the electronic exchange of health information. The legislation would also establish a series of grants designed to help practitioners and hospitals purchase electronic prescribing systems and other safety-related IT measures.

Despite their proven benefits, the high costs and level of commitment required to adopt computer-based systems, as well as a lack of standards and financial incentives, cause many providers to continue to rely on hand-written record-keeping and prescribing (#6, #7, #8). Industry observers claim that health care entities invest in IT at less than half the rate of those in other industries. The series of grants made available through this legislation would give incentives to these providers for adoption of computerized health information systems, which have been cited for their contribution to improving the safety and quality of health care. (#9, #10, #11)

Main points

Main objectives

To define and establish Patient Safety Organizations (PSOs); to generate data on minor medical errors and near misses for use in quality improvement efforts; to diffuse health information technology (IT) across the health sector, and ensure the efficacy and interoperability of health IT.

Type of incentives

Financial incentives include grants for the purchase of electronic health record (EHS) systems, computerized physician order entry (CPOE) and other health IT programs. Incentives for voluntary reporting include the exemption of data provided to  PSOs from legal discovery.

Groups affected

Patients, Providers, Hospitals

Innovationsgrad	traditionell		innovativ
Kontroversität	unumstritten		kontrovers
Strukturelle Wirkung	marginal		fundamental
Medienpräsenz	sehr gering		sehr hoch
Übertragbarkeit	sehr systemabhängig		systemneutral

For comments see below Expected Outcome.

Political and economic background

The release of the 1999 Institute of Medicine (IOM) report, "To Err is Human," propelled patient safety into the national spotlight in the United States. Revealing that hospital errors cost as many as 98,000 lives every year, the report called for comprehensive changes in health care delivery and oversight, and set the ambitious goal of reducing error-related deaths by 50% in five years. In addition to revealing the scope of the problem, its authors called for a fundamental change in the way that medical mistakes are viewed, not simply as the consequences of individual underperformance, but as by-products of flawed systems. (#1).

 Recognizing that this systematic focus required analysis of how systems function (and malfunction), the IOM panel highlighted the importance of voluntary error reporting systems, which allow for the analysis of "near misses" as a way to prevent future harms. The report recommended that government agencies and professional organizations encourage provider participation in error reporting systems, and called for the passage of enabling legislation that would protect reported information from legal discovery. In the ensuing years policymakers have made several attempts to increase the reporting of medical errors. On the whole, however, these efforts have been compromised by the often conflicting functions of reporting systems: on the one hand, they can be used to hold providers accountable for performance; on the other, they can generate information that leads to systematic safety improvements. The recent negotiations over the Patient Safety and Quality Improvement Act reflect the importance of striking a balance between the goals of immediate accountability and long-term, system-wide quality improvement.

 Despite remaining hurdles, the emergence of a bipartisan effort to facilitate reporting of errors is a testament to the enduring influence of "To Err is Human." On the health IT front, another IOM publication, "Crossing the Quality Chasm" (2001) has laid the groundwork for the kind of national initiative called for in the House version of the Patient Safety and Quality Improvement Act. (#12) Taking on the systems perspective promoted in "To Err is Human," this report highlighted the importance of computer-based information systems in facilitating safe, coordinated, and patient-centred care. The report noted, among other things, the virtues of IT from a safety standpoint, citing evidence on the role of automated order entry systems in reducing errors in drug prescribing and dosing. (#13, #14)

Change based on an overall national health policy statement

The Institute of Medicine Report,

Purpose and process analysis

Current Process Stages

	Idee	Pilotprojekt	Strategiepapier	Gesetzgebung	Umsetzung	Evaluation	Veränderung/Richtungswechsel
Implemented in this survey?

Origins of health policy idea

In the mid-1990s, the Department of Veteran's Affairs embarked on an ambitious quest to improve the performance of its Health Service. Then Undersecretary for Health Kenneth Kizer led an effort to change the organizational culture of the System, instituting a regime of continuous quality improvement. This involved the adoption of a systems approach that emphasized prevention and eschewed punishment. New standards were issued to VA providers for reporting minor errors and near misses, with the understanding that data would be used strictly for the purposes of improving patient safety (#15).

 In 1999, a new National Center for Patient Safety (NCPS) was created within the Department of Health and Human Services to manage data on patient safety, perform root cause analyses (RCA) of reported incidents, and report on safety issues to the public (#16). In collaboration with NASA, the Center created a voluntary external reporting system, (The Patient Safety Information System, or "SPOT"). This system was patterned after the much-lauded Aviation Safety Reporting System (ASRS), a voluntary, non-punitive program that is run by NASA and is credited with dramatically improving airline safety. During his testimony in support of the Patient Safety and Quality Improvement Act, Dr. James Bagian, NCPS director, claimed that error reporting within the VA went up 30-fold after the initiation of the continuous quality improvement regime in 1997 (for "close-call" reporting, Dr. Bagian reported a 900-fold increase). Bagian went on to extol the virtues of voluntary reporting systems, emphasizing the importance of protecting physicians from punishment (#4).

 Reporting systems also exist at the state level. Currently, 21 states have regulatory systems that require the reporting of medical errors (#17). The success of these efforts varies greatly. Systematic underreporting of errors by providers and unwillingness on the part of states to release data to the public are cited as major barriers to effectiveness. However, recent trends suggest that states are learning from the failures that have, to date, plagued such efforts. Among states introducing new mandatory reporting systems, there is a trend toward doing so through statutory, rather than regulatory, means. Increasingly, these systems contain robust protections of reported data that prevent the identification of mistakes made by compliant reporters. Instead of releasing incident-specific information that may be harmful to providers, thereby exacerbating the problem of underreporting, states are now more likely to release data only in aggregate form. These trends are all reflected in the Patient Safety and Quality Improvement Act, in particular its provisions protecting against the use of reported data in civil and administrative action.

The VA Health Service has also shown leadership in the adoption of computerized health information systems. Recognizing the agency's unique position as large, single-payer system with its own facilities and physician staff, quality improvement experts sought to create a fully-functional electronic health information infrastructure. This effort culminated in creation of the Computerized Patient Record System (CPRS), which supports clinical decision-making by organizing patients' health information and providing a forum for electronic communication between clinicians, their colleagues, and their patients (Perlin, 2004). Among other benefits, the system allows physicians to receive reminders and alerts when vital follow-up measures are required, and allows real-time prescription drug order checking. In an article published last year in the New England Journal of Medicine, VA officials reported dramatic improvements in the safety of its patient population after the adoption of the CPRS (#15). The VA system continues to draw praise from policy analysts in the United States and abroad, and is cited as a model for future efforts at improving patient safety.

Initiators of idea/main actors

• Regierung

Approach of idea

The approach of the idea is described as:
renewed: The idea originated in the late 1990s

Stakeholder positions

On September 20, 2004, a letter of support was sent to the House of Representatives, with the endorsement of the American Medical Association (AMA) and the American Hospital Association (AHA), along with that of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the National Patient Safety Foundation (NPSF), and a number of state medical societies. Both the AMA and the AHA had previously issued statements in support of the bill.

Actors and positions

Regierung
Government Agencies	sehr unterstützend		stark dagegen
Providers	sehr unterstützend		stark dagegen
Scientific Community	sehr unterstützend		stark dagegen

Influences in policy making and legislation

During the last legislative session, Congressional Republicans appeared eager to move this legislation forward. After the passage of Medicare prescription drug legislation last year, Republicans anticipated being able to campaign on their health care record in 2004 (#18). However, poor press and negative public opinion have plagued the drug assistance law, leaving the party to explore other avenues for health care reform. Last year also saw the House of Representatives and Senate address tort reform legislation, intended to reign in rising medical malpractice premiums by capping awards for non-economic damages. Although the House passed its bill on March 13, 2004, the Senate version fell far short of the 60 votes needed to move the bill through (#18).

These failures appeared to open a unique window of opportunity for patient safety legislation. Assurances that reported data would be protected from use in legal proceedings prompted medical interest groups to support the legislation. Two of the most influential of these groups, the American Medical Association (AMA) and the American Hospital Association (AHA), issued statements backing the bill during the last congressional session. The House version of the bill passed by a margin of 418-6 last year, but the road was more difficult in the Senate, where some Democrats expressed concern over the reach of the new protections. A group of Senators held up passage of the bill until they were assured that evidence currently available to patients under the legal discovery process would remain so. This issue is a difficult one for Democrats, who have fought to make some error reports admissible in criminal trials (#19). At the same time, the party has advocated for system-wide efforts to improve patient safety, an expressed goal of this legislation.

In July 2004, Republican Judd Gregg of New Hampshire, chairman of the Health, Education, Labor and Pensions (HELP) Committee and Democrat Edward Kennedy, the panel's ranking minority member, negotiated a series of key compromises that allowed the bill to proceed to the full Senate chamber. Most crucial was an agreement to allow reports to be admitted into evidence in cases where the court determines they show an intention to harm (#19). Ensuring that data would be admissible in such circumstances, and that the law would not restrict access to information that is currently admissible, paved the way for Democrats to support the initiative without the risk of upsetting key constituent groups (such as the American Trial Lawyers Association). The Senate passed the bill in late July 2004, and appointed delegates to a conference committee for resolution of the differences in the two versions (#20). However, the House of Representatives did name its own delegates to the conference committee, leaving the differences unresolved as the 108th congressional session came to a close. Despite this setback, the bill has been reintroduced during the current session. Though differences exist in the versions considered by the two chambers (including the extent to which reported events will be subject to legal and administrative discovery and the inclusion of the House provisions on information technology), the effort continues to enjoy bipartisan support. (#24)

Legislative outcome

pending

Actors and influence

Regierung
Government Agencies	sehr groß		kein
Providers	sehr groß		kein
Scientific Community	sehr groß		kein

Positions and Influences at a glance

Adoption and implementation

According to a recent Congressional Budget Office (CBO) assessment of the legislation, primary responsibility for implementation of the Patient Safety and Quality Improvement Act would rest with the Agency for Health Care Research and Quality (AHRQ). The Agency would be charged with establishing and maintaining the national database on adverse events, as well as certifying and overseeing the work of Patient Safety Organizations (#25). The CBO estimated that the Act would cost $58 million to implement from 2006 to 2010.

Clearly, an important component of the implementation process would be ensuring the security of information provided to Patient Safety Organizations. This would require secure information systems, as well as strong protections against the use of information on adverse events in civil or administrative proceedings. The ability of responsible agencies and individuals to follow up on the bill's promise to protect reported data-through measures such as ensuring the security would be crucial in ensuring successful implementation.

Even if data security can be maintained successfully, a number of hurdles stand in the way of the goal of increased voluntary reporting. Many physicians would be likely to maintain their reluctance to release any information on adverse events or near misses. Fear of tort liability is far-reaching, and may continue to dampen reporting. Despite these risks, research has shown that regulation can be a useful tool in driving patient safety efforts (#21).


The fragmentation of the American health care system poses a unique challenge to government-led efforts aimed at increasing the use of information technology. A number of countries are currently working on expanding their electronic information infrastructure, many of them under circumstances that are far more favourable than those facing American policymakers. Countries with highly centralized and integrated health systems, such the United Kingdom, are well positioned to implement standards, ensure interoperability and speed diffusion. In the US, policymakers face the challenges of constructing a convincing business case for patient safety, aligning incentives toward the adoption of information technology systems, and setting useful standards for the content and operability of electronic medical record systems (#22). Purchasers of health care technology, including physicians, are reluctant to make large investments in IT, fearing that benefits will be outweighed by the considerable costs of such innovations (#23) Though the VA's experience displays the positive potential, from the perspective of increasing patient safety, of investing in technology, few systems can exert the kind of control on the practice environment as can the VA's Health Service.

Monitoring and evaluation

The patient safety database would provide a convenient mechanism for measuring the effect of the bill's attempt to encourage reporting. Grants awarded for the purchase of health IT would be monitored and evaluated on an ongoing basis.

Expected outcome

Protections against the use of reported data may encourage physicians to disclose information on errors and near misses to patient safety organizations. As for the larger goal of using that information to analyze errors, identify system failures and transform results into meaningful quality improvement efforts, it is difficult at this point to assess the likely impact of the Patient Safety and Quality Improvement Act. Despite favourable accounts of anonymous reporting (particularly in the Veterans Health System), the effectiveness of these mechanisms is not fully understood.

What can be said of the VA's anonymous reporting system is that it came as part of an overarching strategy of continuous quality improvement. This regime of CQI has succeeded, in large part, due to strong leadership that has taken on the difficult work of using research results to reengineer clinical practice protocols. Similarly strong leadership will be required if the initiative in question is to succeed in its ultimate goal of informing quality improvement.

Despite concerns about the impact of the Act, the goal of learning more about why systems fail is an important one. By looking for the roots of patient safety problems, rather than expending more resources to identify "bad apples," the Act represents a worthy attempt to achieve the quality improvement agenda laid out in To Err is Human.

Impact of this policy

Qualität	kaum Einfluss		starker Einfluss
Gerechtigkeit	System weniger gerecht		System gerechter
Kosteneffizienz	sehr gering		sehr hoch

Difficult to assess at this point. More research must be done to determine the usefulness of anonymous data.

References

Sources of Information

1. Institute of Medicine. To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press 1999.

2. "Senate HELP Approves Medical Errors Bill Intended to Help Doctors Improve Safety," Congressional Quarterly Healthbeat, March 9, 2005.

3. Thomas - The Patient Safety and Quality Improvement Act of 2004: http://thomas.loc.gov/cgi-bin/bdquery/z?d108:H.R.663

4. Patient Safety: Instilling Hospitals with a Culture of Continuous Improvement: Hearing Before the U.S. Senate Committee on Governmental Affairs. 108th Congress. (testimony of James Bagian, MD)

5. "Medical Error Bill Heading to Conference Committee," Congressional Quarterly Healthline, July 22, 2004.  

6. Doolan DF, Bates DW. Computerized physician order entry systems in hospitals: mandates and incentives. Health Affairs 2002;21(4):180-188.

7. Metzger J, Turisco F. Computerized physician order entry: a look at the vendor marketplace and getting started. Washington, DC: Leapfrog Group, December 2001. (Accessed September 29, 2004, at www.leapfroggroup.org/media/file/Leapfrog-CPOE_Guide.pdf).

8. Audet AJ, Doty MM, et al. Information technologies: when will they make it into physicians' black bags? Medscape General Medicine 2004;6(4).

9. Bates DW, Gawande AA. Improving safety with information technology. New England Journal of Medicine 2003;348:2526-3254.

10. Testimony on the President's Fiscal Year 2005 Budget Request for AHRQ: Hearings Before the House Subcommittee on Labor -HHS-Education Appropriations. 108th Congress. (testimony of Carolyn Clancy, MD).

11. Institute of Medicine. Key Capabilities of an Electronic Health Record System (Letter Report - Committee on Data Standards for Patient Safety; Board on Health Care Services). Washington, DC: National Academy Press 2003.

12. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press 2001.

13. Bates DW. Using information technology to reduce rates of medication errors in hospitals. British Medical Journal 2000;320:788-791.

14. Bates DW, Teich JM, Lee J, et al. The impact of computerized physician order entry on medication error prevention. Journal of the American Medical Informatics Association 1999;6(4):313-321.

15. Jha AK, Perlin JB, Kizer KW, Dudley RA. Effect of the transformation of the Veterans Affairs health care system on the quality of care. The New England Journal of Medicine 2003;348(22):2218-2227.

16. VA National Center for Patient Safety Fact Sheet.

17. National Association for State Health Policy. "How States Report Medical Errors to the Public: Issues and Barriers" Accessed (16 February 2005): www.nashp.org/_docdisp_page.cfm?LID=F5F19A94-DB2F-4C5B-B05876BE2038E891

18. "As Third Senate Cloture Vote on Medical Malpractice Fails, GOP Vows to Keep Issue Alive," Congressional Quarterly Healthbeat, April 10, 2004.

19. "Senate HELP Approves Bill Seeking to Cut Medical Errors," Congressional Quarterly Healthbeat, July 23, 2003.

20. "Medical Errors Legislation Still Waiting to Regain Momentum for Conference," Congressional Quarterly Healthbeat, October 15, 2004.

21. Devers KJ, Pham HH, Liu G. What is driving hospitals' patient-safety efforts? Health Affairs 2004;23(2):103-115.

22. Brailer DJ. Perspective: translating ideals for health information technology into practice. Health Affairs Web Exclusive, May 25, 2004.

23. Poon EG, Blumenthal D, Jaggi T, Honour MM, Bates DW, Kaushal R. From the field; overcoming bariers to adopting and implementing computerized physician order entry systems in U.S. hospitals. Health Affairs 2004;23(4):184:190.

24. Thomas - The Patient Safety and Quality Improvement Act of 2005: http://thomas.loc.gov/cgi-bin/bdquery/z?d109:s.00544

25. "CBO Estimates Cost of Patient Safety Bill At $58 Million from 2006-2010," Congressional Quarterly Healthline, April 8, 2005.

Author/s and/or contributors to this survey

Jonathan Wittenberg ? The Commonwealth Fund; Reviewed by Anne-Marie Audet, M.D.

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Jonathan Wittenberg ? The Commonwealth Fund; Reviewed by Anne-Marie Audet, M.D.. "The Patient Safety and Quality Improvement Act". Health Policy Monitor, May 2005. Available at http://www.hpm.org/survey/us/c5/1