Patient Safety Proposed Regulation Aims To Improve Healthcare Quality
A proposed regulation to improve the quality and
safety of healthcare for all Americans by fostering the establishment
of patient safety organizations (PSOs) was introduced by the U.S.
Department of Health and Human Services (HHS).
PSOs are private entities recognized by the
secretary to collect and analyze patient safety events reported by
healthcare providers. They are new and separate from all currently
existing entities that are addressing healthcare quality.
The creation of PSOs has been called for by the
Institute of Medicine and would help improve the quality and safety of
healthcare in several key ways. PSOs would allow for the voluntary
reporting of patient safety events without fear of new tort liability.
In addition, they would encourage clinicians and
healthcare organizations to voluntarily share data on patient safety
events more freely and consistently. Under the proposal, PSOs can
collect, aggregate and analyze data and provide feedback to help
clinicians and healthcare organizations improve healthcare quality.
"Patient safety organizations will help make
healthcare safer for all Americans," HHS Secretary Mike Leavitt said.
"By making it easier for patient safety events to be reported and the
lessons learned from them to be shared more broadly, patients will
ultimately receive safer healthcare."
The authority to list, or formally recognize, PSOs
was established by the Patient Safety and Quality Improvement Act of
While the statute makes patient safety event
reporting privileged and confidential, it does not relieve clinicians
or healthcare organizations from meeting reporting requirements under
federal, state or local laws. However, the statute and the proposed
regulation address an important barrier that currently exists
– the fear of legal liability or sanctions that can result
from discussing and analyzing patient safety events.
The proposed regulation describes how an
organization may become a PSO and explains how clinicians will be able
to report patient safety events confidentially, the limited ways in
which these data will be shared with others engaging in patient safety
work while remaining privileged and confidential and how clinicians
will receive feedback on ways to improve patient safety.
Strong confidentiality provisions are the key to
voluntary reporting, and breaches of these confidentiality provisions
may result in the imposition of civil monetary penalties.
HHS’ Agency for Healthcare Research and
Quality (AHRQ) will administer the rules for listing qualified PSOs.
The HHS Office for Civil Rights will be responsible for enforcing the
confidentiality provisions of the act.
"We know that clinicians and healthcare
organizations want to participate in efforts to improve patient care,
but they often are inhibited by fears of liability and sanctions," said
AHRQ Director Dr. Carolyn M. Clancy. "The proposed regulation provides
a framework for patient safety organizations to facilitate a
shared-learning approach that supports effective interventions that
reduce risk of harm to patients. We want to make the right thing to do
the easy thing to do."
After collecting and analyzing sufficient
non-identifiable data, AHRQ will publish information on national and
regional statistics, including trends and patterns of patient safety
events. This information will be published in AHRQ’s annual
National Healthcare Quality Report.
Address: U.S. Department of Health and Human
Services, 200 Independence Avenue SW, Washington DC 20201; (202)