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New patient safety proposed regulation aims
to improve Health Care Quality and Patient
Safety
Newswise — A proposed regulation to improve the quality and
safety of health care for all Americans by
fostering the establishment of Patient
Safety Organizations (PSOs) was announced
today 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 health care providers. They are new and
separate from all currently existing
entities that are addressing health care
quality.
The creation of PSOs has been called for by the Institute of
Medicine and would help improve the quality
and safety of health care 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 health care
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
health care organizations improve health
care quality.
“Patient Safety Organizations will help make health care 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 health care.”
The authority to list, or formally recognize, PSOs was
established by the Patient Safety and
Quality Improvement Act of 2005.
While the statute makes patient safety event reporting privileged
and confidential, it does not relieve
clinicians or health care 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 (OCR) will be responsible for
enforcing the confidentiality provisions of
the act.
In addition, the department plans to issue guidance soon that
would allow entities to be listed as PSOs,
consistent with the statute, prior to
publication of the final rule.
"We know that clinicians and health care organizations want to
participate in efforts to improve patient
care, but they often are inhibited by fears
of liability and sanctions,” said AHRQ
Director Carolyn M. Clancy, M.D.
“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.”
Winston Wilkinson, director of OCR, added: “It is essential to
the success of this new voluntary reporting
program that the information exchanged to
address important patient safety issues
remains privileged and confidential.
Provider trust in our enforcement of strong confidential
protections will encourage participation in
the critical work of improving the
understanding of the threats to patient
safety and ultimately improving care for all
patients.”
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.
Members of the public are invited to comment on the proposed
regulation until April 14, and their
feedback will be used to shape the final
regulation.
In addition, AHRQ and OCR are planning to host an audio
conference on Feb. 29 from 2:00 p.m. to 3:00
p.m. EST, to provide additional details and
answer questions about the proposed
regulation.
More information on the audio conference can be found at
http://www.academyhealth.org/ahrq/psoaudio/.
The notice of proposed rulemaking was published in today’s
Federal Register.
The proposed regulation can be viewed on the Federal eRulemaking
Portal at
http://www.regulations.gov/fdmspublic/ContentViewer?objectId=09000064803acce8&disposition=attachment&contentType=html.
The Federal Register notice can also be
accessed via AHRQ’s Web site at
http://www.pso.ahrq.gov/index.html.
Comments can be submitted by any of the following methods:
• Federal eRulemaking Portal:
http://www.regulations.gov/fdmspublic/component/main?main=SubmitComment&o=09000064803acce8
Comments should include the agency name (AHRQ
and/or OCR) and “RIN 0919-AA01.”
• Mail/hand delivery/courier: Center for Quality Improvement and
Patient Safety, Attention: Patient Safety
Act NPRM Comments, AHRQ, 540 Gaither Road,
Rockville, Md. 20850.
Comments sent by facsimile (FAX) transmission or electronic mail
will not be accepted.
Comments received through the eRulemaking
Portal can be viewed online at either of the
Web sites listed above.
All comments received through the eRulemaking Portal, mail, and
hand delivery/courier are available for
public inspection at the AHRQ Information
Resources Center, which is located at 540
Gaither Road, Rockville, Md. 20850.
The Information Resources Center is open from 8:30 a.m. to 5:00
p.m. EST, Monday through Friday.
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