Final Rule Issued for Patient Safety Organizations

The U.S. Department of Health and Human Services has issued a final rule
for Patient Safety Organizations (PSOs).

The rule becomes effective on Jan. 19, 2009. It provides final
requirements and procedures for PSOs, new entities, with which
clinicians and health care providers can work to collect, aggregate and
analyze data -- within a legally secure environment of privilege and
confidentiality protections -- to identify and reduce patient care risks
and hazards.

"I expect the final rule and the creation of Patient Safety
Organizations to greatly improve the quality of health care for all
Americans," HHS Secretary Mike Leavitt said. "By making it easier for
clinicians and health care organizations to report and learn from
adverse events without fear of new legal liability, we will be able to
improve our nation's health care systems and minimize factors that can
contribute to mistakes."

Under interim guidance issued on Oct. 8, AHRQ has already listed 15
PSOs. During the remainder of the interim period, these organizations
will maintain their status as PSOs. However, these and other PSOs listed
throughout the interim period are expected to comply with the final rule
once it takes effect.

"The Patient Safety Organization final rule describes the clear, legally
protected framework for how hospitals, clinicians, and health care
organizations can work together to improve patient safety and the
quality of care nationwide," said AHRQ Director Carolyn M. Clancy, M.D.

The listing of PSOs is authorized by the Patient Safety and Quality
Improvement Act of 2005 (Patient Safety Act). The Patient Safety Act is
intended to encourage voluntary, provider-driven initiatives to improve
the safety of health care through the establishment of legal protections
to ensure that providers who report patient safety information do not
incur new legal liability; to promote rapid learning about the
underlying causes of risks and harms in the delivery of health care; and
to share those findings widely, thus speeding the pace of improvement.

The final rule is consistent with many of the provisions of the proposed
rule issued on Feb. 12. However, it also includes new requirements for
PSOs, such as:

* The requirement that a PSO notify providers if the patient
safety work product it submits is inappropriately disclosed or its
security is breached
* Requirements for how a component PSO maintains separation
between itself and its parent organization(s) have been made more
flexible.

The final rule also makes several important changes from those in the
proposed rule regarding the listing and delisting of PSOs and the ways
in which PSOs must comply with statutory requirements, including:

* Expansion in the types of entities and organizations excluded
from listing as PSOs
* Revisions to how PSOs should disclose certain relationships with
health care providers
* Increased flexibility in how PSOs can store patient safety work
product
* Automatic expiration of Departmental listing after 3 years
unless a PSO's listing is continued by the Secretary and
* An expedited delisting process for PSOs in a limited number of
serious circumstances

AHRQ administers provisions dealing with PSO operations, and the HHS
Office for Civil Rights (OCR) enforces confidentiality provisions. The
final rule addresses concerns regarding how providers may efficiently
collect and analyze patient safety event information with privilege and
confidentiality protections while complying with existing reporting
requirements that seek similar information.

"OCR is pleased to partner with AHRQ to protect and ensure the
confidentiality of the information used by providers and PSOs to improve
the safety and quality of patient care nationwide," said OCR Director
Winston Wilkinson.

To read the final rule and access more information about PSOs, including
background on the rulemaking process, visit AHRQ's PSO Web site at
www.pso.ahrq.gov. Additional information about the confidentiality and
disclosure of patient safety work product may be found at OCR's Web site
at www.hhs.gov/ocr/psqia/.

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