Patient Safety and Quality Improvement Act of 2005

• Abstract
• Characteristics of this policy
• Purpose and process analysis
• Expected outcome
• References

Abstract

Legislation was recently implemented to address many of the key issues highlighted in ?To Err is Human,? as The Patient Safety and Quality Improvement Act of 2005, was signed by President George W. Bush on July 29, 2005. The bill amends Title IX of the Public Health Service Act to provide for the improvement of patient safety and to reduce the incidence of events that adversely affect patient safety.

Neue Entwicklungen

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

Protections against the use of reported data may now encourage physicians to disclose information on errors and near misses to PSOs. 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 recently enacted Patient Safety and Quality Improvement Act until further data is available.

Purpose and process analysis

Current Process Stages

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

Initiators of idea/main actors

• Regierung: In the ensuing years the emergence of a bipartisan effort to facilitate reporting of errors is a testament to the enduring influence of ?To Err is Human? and is reflected by the passage of the Patient Safety and Quality Improvement Act of 2005.

Stakeholder positions

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)

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. 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. (#1)

The bill amends Title IX of the Public Health Service Act to provide for the improvement of patient safety and to reduce the incidence of events that adversely affect patient safety, representing a continuing effort on the part of national legislators to facilitate wide-scale reporting and analysis of medical errors. The law establishes procedures for voluntary confidential reporting of medical errors to independent patient safety organizations (PSOs), which would submit the information to a national database for recommendations on reducing medical errors. The Department of Health and Human Services (HHS) will certify these organizations and maintain the medical error database. According to proponents of the bill, data on adverse events will be analyzed and fed back into quality improvement initiatives led by HHS and the PSOs. (#3)

A critical component of the bill protects reports generated by PSOs in that reported information cannot be used in malpractice cases; however, in certain cases, a court could determine that the information can be used as evidence in a criminal proceeding if it is not available from an alternative source. The bill also includes measures to protect health care providers who report this information and designates the patient safety data as "privileged and confidential." (#3)

The sponsors of the bill asserted that these legal protections will create an incentive for doctors to report incidents in which an error was committed. By withholding patient safety data from being used in civil or administrative proceedings, supporters of this bill claim that the bill will 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). According to the signed bill, certain disclosure of patient safety data is permitted by a PSO including: voluntary disclosures of non-identifiable data, disclosures of data containing evidence of a wanton or criminal act to directly harm the patient, disclosures necessary to carry out a patient safety organization or research activity, and voluntary disclosures for public health surveillance. (#3)

The version of the bill formerly considered by the House of Representatives contained a series of measures that would also harness the safety-enhancing capacities of health information technology (IT) systems. The bill had initially sought to simultaneously 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 proposed legislation included a series of grants designed to help practitioners and hospitals purchase electronic prescribing systems and other safety-related IT measures. A committee vote on July 20, 2005 eliminated the provisions in the bill that would authorize $25 million in grants annually for fiscal 2006 and 2007 for technology upgrades to help doctors and hospitals avoid medical errors.

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.

On June 6, 2005, the AMA submitted another letter, signed by more than 100 state and national speciality organizations urging Congressional leaders to pass the patient safety bill. (#6)

Actors and positions

Regierung
Senate	sehr unterstützend		stark dagegen
House of Representatives	sehr unterstützend		stark dagegen
Department of Health and Human Services	sehr unterstützend		stark dagegen
current    previous

Influences in policy making and legislation

Efforts to create a piece of legislation in response to the priority items regarding patient safety addressed in the IOM report have been ongoing for the past five years. In 2003, the House passed a version of this bill and subsequently, the Senate passed one in 2004. Both versions would have allowed the use of medical error information in civil court cases, but the House bill would have allowed its use in criminal proceedings. 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 (#7). The House of Representatives, however, did not name its delegates to the conference committee, leaving the differences unresolved as the 108th congressional session came to a close. The differences were never resolved and House members and Senators disagreed on who was to blame for the holdup.

On March 8, 2005, Sen. James M. Jeffords, I-Vt., introduced S 544 (now the public law enacted on July 29, 2005) and the Senate Health, Education, Labor and Pensions Committee approved the bill on March 9 by voice vote. The full Senate passed the bill July 21 by unanimous consent. The House cleared it for the president's signature on July 27. President Bush signed the Patient Safety and Quality Improvement Act into law on July 29. (#3)

Though differences existed 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 to implement legislation that encouraged provider participation in error reporting systems ultimately received bipartisan support. (#8)

Legislative outcome

Enactment

Actors and influence

Regierung
Senate	sehr groß		kein
House of Representatives	sehr groß		kein
Department of Health and Human Services	sehr groß		kein
current    previous

Positions and Influences at a glance

Adoption and implementation

A key actor involved in the implementation of the Patient Safety and Quality Improvement Act is the Department of Health and Human Services (HHS). The provisions outlined in the bill will be governed by the HHS Agency for Healthcare Research and Quality (AHRQ). The role of this agency in supporting this legislation will be the following:

• Certify Patient Safety Organizations (PSOs)
• Establish and maintain national patient safety database.

The bill also requires a study by the HHS Secretary on a strategy for reducing errors, in response to the information gathered through these reporting efforts and collected by the database. The Institute of Medicine (IOM), largely an impetus for the creation of this legislation also has a role in reviewing the report from HHS to provide critical feedback for further adoption of monitoring measures. The Government Accountability Office (GAO) will also conduct an effectiveness study. (#3)

Other key actors to implementation are health care providers, in that they report medical error information. Safeguards must be in place to assure providers that the information they report will remain privileged and confidential, given persistent concerns over legal consequences.

Monitoring and evaluation

The patient safety database would provide a convenient mechanism for measuring the effect of the bill's attempt to encourage reporting. 

Provisions of the bill also require a study by HHS on strategies for reducing medical errors, based on the data collected from the mechanisms implemented by the approved legislation. A draft report is due no later than 18 months after enactment of any network of patient safety databases. The draft report will be open for public comment and submitted to the Institute of Medicine for review. One year later, a final report is due to Congress. The bill also requires the Government Accountability Office to conduct a study on the effectiveness of the bill no later than Feb. 1, 2010. (#3)

Expected outcome

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 (PSOs) (#9). The CBO estimated that the Act would cost $58 million to implement from 2006 to 2010.

An important component of the implementation process is to ensure the security of information provided to PSOs. This requires 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 is crucial to ensuring successful implementation.

A number of hurdles to the goal of increased voluntary reporting clearly still remain. Many physicians are 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 (#10).

Impact of this policy

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

An accurate assessment remains difficult at this point, given that while the efforts to enact the legislation have proven successful, further data resulting from the use of these reporting measures is necessary. A concern raised in the first report {5(2005)} of the usefulness of anonymous data persists; however, system-wide change due to increased attention and scrutiny of medical errors is inevitable to a certain extent. 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, the act represents a worthy attempt to achieve the quality improvement agenda laid out in "To Err is Human."

References

Sources of Information

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

2. "President Signs Patient Safety and Quality Improvement Act of 2005," Office of the Press Secretary, The White House, July 29, 2005.

3. Hopkins, Cheyenne. CQ BillAnalysis Brief: Patient Safety and Quality Improvement Act of 2005, Congressional Quarterly, August 16, 2005.

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. AMDA Fact Sheet on S. 544: Patient Safety and Quality Improvement Act of 2005. www.amda.com/federalaffairs/factsheets/congress109/s544.htm

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

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

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

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

LINKS:

• Congressional Quarterly: www.cq.com
• The Institute of Medicine: www.iom.edu
• The Joint Commission on Accreditation of Healthcare Organizations: www.jcaho.org
• Agency for Healthcare Research and Quality: www.ahrq.gov
• National Committee for Quality Assurance: www.ncqa.org

Reform formerly reported in

The Patient Safety and Quality Improvement Act Process Stages: Strategiepapier, Gesetzgebung, Idee, Pilotprojekt

Author/s and/or contributors to this survey

Jennifer Fenley, Reviewed by Anne-Marie Audet, M.D.

Empfohlene Zitierweise für diesen Online-Artikel:

Jennifer Fenley, Reviewed by Anne-Marie Audet, M.D.. "Patient Safety and Quality Improvement Act of 2005". Health Policy Monitor, October 2005. Available at http://www.hpm.org/survey/us/c6/3