Quality and Patient Safety
Current
The Agency for Healthcare Research and Quality (AHRQ) is developing
an implementation strategy for the "Patient Safety and Quality
Improvement Act of 2005" [P.L.
109-41], which was signed into law by President Bush on July
29, 2005. The law applies to patient safety data compiled in conjunction
with AHRQ-supported initiatives. It encourages the voluntary reporting
of such data by assuring its confidentiality.
According to AHRQ Director Dr. Carolyn Clancy, the agency will
likely implement the law by building upon existing patient safety
programs. Dr. Clancy expects AHRQ to compile a national inventory
of such patient safety initiatives by releasing a "Request
for Information" in early 2006.
Background
The "Patient Safety and Quality Improvement Act" [P.L.
109-41] is based on AAMC-supported legislation passed by the Senate
during the 108th Congress. It encourages healthcare providers to
promote a "culture of safety" through their voluntary
submission of medical errors data. The data would be used for educational
and research initiatives and analyses supported by the Agency for
Healthcare Research and Quality (AHRQ).
The law promotes voluntary provider participation by creating a
network of Department of Health and Human Services (HHS)-certified
"patient safety organizations" (PSOs) that would collect
and evaluate medical errors data. The new law also assures legal
protections for any medical errors data that is submitted to an
HHS-certified PSO.
To receive and maintain HHS certification, a PSO must fulfill a
range of criteria (e.g., the entity's primary activity is patient
safety improvement, it maintains appropriate staff, and it operates
independent of any providers who contract for services). While a
PSO may be a component of another organization, it must keep the
patient safety data separate and secure from all other business
operations. It must also assure that its mission does not create
a conflict of interest with the rest of the organization. Issuers
of health insurance are not eligible for HHS certification as a
PSO.
Data submitted to an HHS-certified PSO is, in general, privileged
and confidential. This applies to federal, state, and local proceedings.
Civil monetary penalties apply to any person who violates these
standards. However, judges in criminal cases may choose to disclose
certain data when it contains evidence of a criminal act and is
not available from another source. The new law does not limit other
federal, state, or local laws that offer stronger confidentiality
or privilege protections. Accrediting bodies (e.g., Joint Commission
on Accreditation of Healthcare Organizations, state medical boards)
may not take accrediting action against a provider based on the
provider's "good faith participation…in the collection,
development, reporting, or maintenance" of data that is submitted
to HHS-certified PSOs. Similarly, employers may not take adverse
employment action against a provider, based on the data submitted
to such a PSO.
The new law also directs the HHS Secretary to facilitate the creation
of a voluntary database network to collect, share, and analyze non-identifiable
patient safety data. The Secretary may establish common standards
for reporting such data. In addition, the law establishes that the
HHS Secretary will provide technical assistance to PSOs (e.g., annual
meetings to discuss methodology or privacy concerns).
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