Public Meetings and Teleconferences on Patient Safety Organizations (PSOs): Topics

Topic 1. Provider–Patient Safety Organization (PSO) Relationships, Contracts, Disclosures

The Patient Safety and Quality Improvement Act of 2005 distinguishes between information at the provider site that is covered by the confidentiality and privilege protections and information that is not. The statute specifically states that "information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system" (PSES) is not protected (i.e., it is not considered Patient Safety Work Product). Therefore, the scope and boundaries of the PSES are critical for determining what is protected under the Act.

It would be useful to better understand:

The range of patient safety activities that providers envision undertaking within their PSES and which activities and products they expect a PSO to provide.
Whether providers envision contracting with more than one PSO and the issues such arrangements might raise including, specifically, whether they plan to report a given patient safety event to only one PSO or to more than one PSO.
The relationship of a Patient Safety Evaluation System to, and its impact on, a provider’s current quality/safety improvement, risk management or other systems.
Practical approaches to delineating protected information (whether oral, written, or otherwise recorded).

Topic 2. Statutorily Required Disclosures

Section 924 of the Patient Safety legislation requires prospective PSOs to certify that they will fully disclose to the Secretary:

(i) any financial, reporting, or contractual relationship between the entity and any provider that contracts with the entity; and
(ii) if applicable, the fact that the entity is not managed, controlled, and [is] operated independently from any provider that contracts with the entity.

The Secretary is required, under section 924(c), to consider these required PSO disclosures in making public findings on whether a prospective PSO can fairly and accurately perform the patient safety activities of a patient safety organization. The Secretary must then use these public findings in determining whether to accept the entity's initial certifications and any subsequent certifications submitted, or to deny, condition, or revoke the listing of the entity as a PSO.

We are seeking comments on:

The circumstances in which relationships with a provider would raise concerns that a PSO could fairly and accurately perform its required functions.
The specific information that the Secretary needs to review in order to make the required determination about PSO relationships with providers. We are interested in limiting the potential burden placed on PSOs while meeting the requirements of the statute. A variety of perspectives—financial, accounting, corporate, legal, ethical, consumer—are encouraged.

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Current as of March 2006

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