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Reporting Safety Events

Patient Safety Work Product

What is Patient Safety Work Product?

Patient safety work product (PSWP) includes any data, reports, records, memoranda, analyses (such as root cause analyses), reviews, investigations, or written or oral statements (or copies of any of this material) that:

  • Could improve patient safety, health care quality, or health care outcomes.
  • Are assembled or developed by a provider for reporting to a patient safety organization (PSO) and are reported to a PSO, which includes:
    • Information that is documented as within a patient safety evaluation system for reporting to a PSO, and
    • Such documentation includes the date the information entered the patient safety evaluation system; or
    • Are developed by a PSO for the conduct of patient safety activities.

Patient safety work product does not include:

  • A patient's medical record.
  • Billing and discharge information.
  • Any other original source of patient or provider information.

The patient safety and quality improvement act permits providers to undertake deliberations and analyses of patient safety-related events at their facilities.

These deliberations and analyses become protected immediately from legal discovery as patient safety work product only if these activities are conducted within the provider’s patient safety evaluation system.

See the Electronic Code of Federal Regulations for more information about patient safety work product.