Health Care Quality: Improving Patient Safety by Promoting Medical Errors Reporting (CRS Report for Congress)
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| Release Date |
Revised March 24, 2005 |
| Report Number |
RL31983 |
| Report Type |
Report |
| Authors |
C. Stephen Redhead, Domestic Social Policy Division |
| Source Agency |
Congressional Research Service |
| Older Revisions |
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Summary:
In the 108th Congress, the House and Senate passed competing versions of the Patient Safety
and
Quality Improvement Act ( H.R. 663 , S. 720 ), but the differences between
the two measures were never resolved. On March 9, 2005, the Senate Committee on Health,
Education, Labor, and Pensions unanimously approved S. 544 , which is identical to
S. 720 . The legislation would establish legal protections for data and reports
on medical errors in an effort to encourage voluntary reporting of such information. The patient
safety bills are in response to the 1999 Institute of Medicine (IOM) report To Err Is Human ,
which
concluded that preventable medical errors cause as many as 98,000 deaths a year. The IOM found
that medical errors are primarily the result of faulty systems, processes, and conditions that lead
people to make mistakes. It recommended establishing a national mandatory reporting system to
hold hospitals accountable for serious medical errors, as well as developing voluntary, confidential
systems for reporting errors that result in little or no harm. Analysis of such voluntarily reported data
could be used to identify vulnerabilities in health care systems.
Twenty-two states mandate medical error reporting by hospitals. However, providers are
reluctant to report adverse events in part because they fear that the information will be used in
malpractice litigation. States have sought to allay those concerns by passing laws to protect reported
data from legal discovery and by de-identifying data and receiving reports anonymously. Such
measures risk limiting the usefulness of the data for research and quality management.
There are several national voluntary reporting systems for medical errors, including the Patient
Safety Information System within the Department of Veterans Affairs. Analysis of these and other
voluntary reporting systems -- notably the Aviation Safety Reporting System -- has identified several
design features associated with effective programs. For example, the reporting process should be
user-friendly and the information kept confidential and protected from legal discovery. Also, reports
should be promptly evaluated by experts who are trained to recognize underlying systems causes,
and reporters should receive timely feedback with recommendations for systems-based
improvements.
To encourage voluntary reporting, H.R. 663 would have protected reported
information from legal discovery in civil and administrative proceeding, and from a Freedom of
Information Act request. The bill required the Agency for Healthcare Research and Quality (AHRQ)
to certify patient safety organizations to collect and analyze the information reported by providers.
Such organizations would develop and disseminate recommendations for systems-based solutions
to improve patient safety and health care quality. H.R. 663 also would have required
AHRQ to establish a national database to receive and analyze de-identified information submitted
by patient safety organizations. S. 544 would protect information from use in criminal
as well as civil and administrative proceedings, unless a judge determined that it contained evidence
of an intentional act to directly harm the patient. This report will be updated as legislative events
in the 109th Congress warrant.
