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David Harlow's Health Care Law Blog

Patient Safety Organization regulations finally finalized

PSO regulations under the Patient Safety and Quality Improvement Act of 2005 have finally wended their way through interminable process and have made it to publication as final regulations in today's Federal Register, effective January 19, 2009.

The introductory commentary on the rule explains that it

create[s] a voluntary system through which providers [may] share sensitive information relating to patient safety events without fear of liability, which should lead to improvements in patient safety and in the quality of patient care. The [rule reflects] an approach to the implementation of the Patient Safety Act intended to ensure adequate flexibility within the bounds of the statutory provisions and to encourage providers to participate in this voluntary program. The . . . rule emphasize[s] that this program is not federally funded and will be put into operation by the providers and PSOs that wish to participate with little direct federal involvement. However, the process for certification and listing of PSOs will be implemented and overseen by the Agency for Healthcare Research and Quality (AHRQ), while compliance with the confidentiality provisions will be investigated and enforced by the Office for Civil Rights (OCR).

AHRQ explains further:

The goals of the Patient Safety Act are to encourage the expansion of voluntary, provider-driven initiatives to improve the safety of health care; 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 Patient Safety Act:

  • Encourages the development of Patient Safety Organizations (PSOs)—organizations that can work with clinicians and health care organizations to identify, analyze, and reduce the risks and hazards associated with patient care.
  • Fosters a culture of safety by establishing strong Federal confidentiality and privilege protections for information assembled and developed by provider organizations, physicians, and other clinicians for deliberations and analyses regarding quality and safety.
  • Accelerates the speed with which solutions can be identified for the risks and hazards associated with patient care by facilitating the aggregation of a sufficient number of events in a protected legal environment.

The integration of state peer review protections, HIPAA protections and PSO confidentiality rules will serve to close some gaps that existed in the patchwork system we have had to date.

All in all, this is a welcome step forward for the further development of evidence-based medicine, taking into account details of negative outcomes and using those outcomes as learning opportunities for the system as a whole without exposing individual providers to additional potential liabilities.  Through the improved protections, these regulatory changes will enable provider organizations to realize more fully the patient care improvement promise of EHRs as well.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

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