Final Rule Issued For Patient Safety Organization, US Department Of Health

Main Category: Public Health
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 23 Nov 2008 - 1:00 PDT

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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 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 http://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 http://www.hhs.gov/ocr/psqia

HHS