Office for Civil Rights - Patient Safety and Quality Improvement Act of 2005 (PSQIA)

Enforcement of the Confidentiality of Patient Safety Work Product

General Information

The Patient Safety and Quality Improvement Act of 2005 (PSQIA) Final Rule, 42 C.F.R. Part 3, was published on November 21, 2008, and is effective on January 19, 2009. Click here to view the Final Rule.

PSQIA establishes a voluntary reporting system designed to enhance the data available to assess and resolve patient safety and health care quality issues. To encourage the reporting and analysis of medical errors within health care systems, PSQIA provides Federal privilege and confidentiality protections for patient safety work product. Patient safety work product includes patient, provider and reporter identifying information that is collected, created or used for patient safety activities. Civil money penalties (CMPs) may be imposed for knowing or reckless impermissible disclosures of patient safety work product.

OCR has been delegated the authority to enforce the confidentiality protections of the PSQIA. Click here for more detailed information on the Delegation of Authority. Drawing upon its enforcement experience with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, OCR is working in close coordination with the Agency for Healthcare Research and Quality (AHRQ), to develop and operate the PSQIA enforcement program.

OCR's participation constitutes a lead role in fulfilling the Department's mandate to improve patient safety and reduce the incidence of events that adversely affect patient safety.

Activities

OCR's activities will include:

Administering an enforcement program regarding the confidentiality protections, including conducting investigations, taking compliance actions, and making penalty determinations;
Developing, for issuance by the Secretary, regulations regarding such compliance and enforcement program;
Imposing CMPs for confidentiality violations;
Interpreting standards for enforcement and for guidance to Patient Safety Organizations (PSOs) and providers; and
Providing technical assistance and public information in the administration of the enforcement program.

More Information

For more information on PSQIA, see AHRQ's overview.

Last revised: November 21, 2008

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