Assess Eligibility to Become a PSO
If an entity's mission and primary activity is to conduct activities that are to improve patient safety and the quality of healthcare delivery, it may be eligible to become a PSO.
Some entities are explicitly prohibited from becoming a PSO.
- A health insurance issuer cannot be a PSO; nor can a unit or division of a health insurance issuer; nor an entity that is owned, managed, or controlled by a health insurance issuer.
- The following types of "excluded entities" cannot themselves become a PSO, but they may be able to form a PSO as a component organization:
- An entity that accredits or licenses healthcare providers
- An entity that oversees or enforces statutory or regulatory requirements governing the delivery of healthcare services
- An agent of an entity that oversees or enforces statutory or regulatory requirements governing the delivery of healthcare services
- An entity that operates a Federal, State, local, or Tribal patient safety reporting system to which healthcare providers (other than members of the entity's workforce or healthcare providers holding privileges with the entity) are required to report information by law or regulation.
Component organizations of excluded entities that are eligible to apply for PSO listing (section 3.102(a)(2)(ii)) are subject to certain operational restrictions. They must also make additional attestations and provide related information when applying for listing (sections 3.102(c)(1)(ii) and (c)(4)). The following sections provide more information about the requirements for listing as a component PSO and some related considerations.
Listing as a "Full Entity PSO" vs. "Component PSO" and Determining "Parent Organization(s)"
- owns a controlling interest or a majority interest in a component organization;
- has the authority to control or manage agenda setting, project management, or day-to-day operations; or
- has the authority to review and override decisions of a component organization.
The Patient Safety Rule uses the terms component and parent organizations broadly. For example, if the entity that will apply for PSO listing is owned, managed, or controlled by one or more legally separate parent organizations, it is considered a component organization for purposes of the Patient Safety Rule and would need to apply for listing as such. For more information, see the section on "Determining a PSO's Parent Organization(s)" in "Guides for PSOs and Providers for Determining Parent Organization and Affiliated Providers (July 2021)."
A component organization does not have to be a legal entity to apply for listing as a PSO if it has a parent organization that is a legal entity. For example, the component organization may be a unit or division of its parent organization.
One consideration in deciding whether to form a component organization to apply for PSO listing is that the mission and primary activity of the PSO must be to conduct activities that are to improve patient safety and the quality of healthcare delivery. Although many organizations have quality and safety in their mission statement, few will meet the primary activity criterion and be able to seek listing as a "full entity PSO." For example, a healthcare facility's primary activity is the delivery of care, not the conduct of activities to improve care.
Requirements Specific to Component PSOs
In addition to the 15 general PSO certification requirements (section 3.102(b)), component organizations have further criteria to meet (section 3.102(c)). Essentially, there must be a firewall between the component PSO and the parent organization so that:
- Patient safety work product (PSWP) is maintained separately from and cannot be accessed by the parent organization.
- The workforce of the component PSO does not make unauthorized disclosures of PSWP to the parent organization or anyone who works there.
- The pursuit of the mission of the PSO cannot create a conflict of interest for the parent organization.
- If any individuals or units of the parent organization will assist the component PSO with patient safety activities requiring access to PSWP, written agreements with specific content are required (see FAQ category "Component PSOs and Shared Staffing Agreements.")
There are additional requirements and restrictions on such arrangements if the PSO is a component of an excluded entity:
- With each certification for listing, the entity must include a statement describing its parent organization's role and scope of authority with respect to any excluded activities described in section 3.102(c)(4). A summary must be prominently posted on the PSO's website and published in any promotional materials for dissemination to providers.
- Each certification for listing must include an attestation that the parent organization has no policies or procedures that would require or induce providers to report PSWP to their component organization once listed as a PSO; and that the component PSO will notify AHRQ within 5 calendar days of the date on which the component organization has knowledge of the adoption by the parent organization of such policies or procedures. The certifications must also acknowledge that the adoption of such policies or procedures by the parent organization during the component PSO's period of listing will result in the initiation of an expedited revocation process in accordance with §3.108(e).
- The component organization may not share staff with its parent organization(s). It may, however, enter into written agreements with individuals or units of the parent organization, for assistance with patient safety activities if their responsibilities do not involve any of the excluded activities.
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