Understanding the Patient Safety and Quality Improvement Act

By: Susanne S. Warfield

Posted: May 3, 2010, from the May 2010 issue of

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Finally, a health care clearinghouse is also considered a covered entity, and this includes entities that process non-standard health information they receive from another entity into a standard format or vice versa.¹

Encouraging reporting

The Patient Safety Rule went into effect on Jan. 19, 2009, and it established a voluntary system for Patient Safety Organizations (PSOs) to aggregate and analyze data they receive from health care providers regarding medical errors and other patient safety events so as to improve patient safety. To encourage provider reporting, the Patient Safety Act and Rule includes federal privilege and confidentiality protections for Patient Safety Work Product (PSWP). Information submitted to and developed by these PSOs is protected as a PSWP.

A PSWP is any information that:

• Is assembled or developed by a health care provider for reporting to a PSO that is listed by the HHS Agency for Healthcare Research and Quality (AHRQ) and is documented as being within the provider’s patient safety evaluation system for reporting to a PSO;
• Is developed by a PSO for the conduct of patient safety activities; or
• Identifies or constitutes the deliberations, or analysis of, or identifies the fact of reporting pursuant to a patient safety evaluation system.²

PSWP may identify patients, health care providers and individuals who report medical errors or other patient safety events. PSWP is confidential and may only be disclosed in certain, very limited situations.

For a full description of permissible disclosures, see the Patient Safety Rule section at www.hhs.gov/ocr/privacy/psa/regulation/rule/index.html. Additionally, PSWP remains protected regardless of who holds the information.

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