Public Meetings and Teleconferences on Patient Safety Organizations
(PSOs)
March 13, 2006, Issues: Operation of a Component PSO
The Patient Safety and Quality Improvement Act of 2005 establishes additional criteria—Section 924 (b)(2)— that must be met by any entity seeking to be a PSO that is a component of another organization:
- The entity maintains patient safety work product separately
from the rest of the organization, and establishes appropriate security
measures to maintain the confidentiality of the patient safety work product.
- The entity does not make an unauthorized
disclosure under this part of patient safety work product to the rest of
the organization in breach of confidentiality.
- The mission of the entity does
not create a conflict of interest with the rest of the organization.
Issues for Discussion:
- While all PSOs must maintain the security and confidentiality of the protected
patient safety work product, requirements (A) and (B) above add requirements
for security and confidentiality of patient safety work product from the
parent organization. We would welcome comments on how a PSO
that is a component of a provider organization would operate within these
restrictions and the types of changes that such providers might need to
make in their existing safety and quality improvement operations to meet
these requirements.
- With respect to requirement (C), the conflict of interest restriction, we
would welcome comments on:
- The types of situations, activities, or mission of a parent organization
that would pose a conflict with a PSO's mission.
- Differences, if any, in the level of concern when the parent organization
is a health care provider or not.
- The types of structural arrangements that might mitigate concerns
regarding conflicts of interest.
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