Step 1. Determine Organizational Eligibility
Is your organization an eligible entity?
Patient safety-focused non-profits, associations, institutes, and educational organizations may be eligible to become a PSO. Certain organizations cannot become PSOs. Excluded organizations are: a health insurance issuer (or component of one); regulatory agencies (or organizations that serve as their agents); accreditation and licensure entities; and entities that administer a Federal, State, local, or tribal patient safety reporting system to which health care providers are required to report by law or regulation.
[Relevant Patient Safety Rule Section: 3.102(a)(2)].
Should your entire organization seek PSO listing or should you apply as a component?
To become a PSO, an entity's primary mission and primary activity must be to conduct activities to improve patient safety and the quality of health care delivery. Although many organizations have quality and safety in their mission statement, few will meet the primary activity criterion. For example, a health care facility's primary activity is the delivery of care, not the conduct of activities to improve care. If you are unclear whether you must create a component organization to seek listing, contact the PSO program before submitting a certification for initial listing form.
If your organization is a subsidiary of another entity and a separate legal entity, are you considered a component?
Yes. For transparency, the Patient Safety Rule uses the term component and parent much more broadly than traditional legal usage. The fact that a subsidiary is a separate legal entity does not change the fact that it must seek listing as a component of the organization that established it. This is also true when another organization finances or exercises control over the entity seeking listing. Accordingly, a component PSO can have more than one parent organization. If there is any question of whether your entity needs to seek listing as a component organization, contact the PSO program before submitting a Certification for Initial Listing form.
If you are applying as a component organization, what additional requirements must be met?
Component organizations have further criteria to meet, in addition to the 15 general PSO certification requirements [see Patient Safety Rule Section 3.102(c)]. Essentially, there must be a firewall between the component organization and the parent organization so that:
- Protected information is maintained separately from the parent organization
- The workforce of the component PSO does not make unauthorized disclosures 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.
Examples of organizations include divisions of state hospital associations and medical societies. There are additional restrictions and limitations if the organization seeking listing is a component of an entity that is ineligible or performs tasks of an ineligible entity. If these limitations apply, contact the PSO Program before submitting certifications for initial listing.
Is your organization subject to FDA reporting requirements?
The Patient Safety Act works in concert with FDA laws promoting patient safety. If a listed PSO has FDA-reporting responsibilities, or an entity within the parent organization of a component PSO has such reporting responsibilities, the PSO must meet those reporting responsibilities. (For more information, please read the Patient Safety Guidance.)
Step 2. Establish Policies and Procedures for Executing Patient Safety Activities
Before an organization is listed as a PSO, it must certify that it has established the policies and procedures needed to perform the eight key patient safety activities specified in the Patient Safety Rule (see Section 3.20). The organization must create a document that serves as a manual for the workforce, one that explains what the rule requires and how to meet those requirements. This document must be completed before submitting certifications for initial listing. (see Policies and Procedures - Topics to Address; PDF File, 76 KB).
There are eight required patient safety activities:
- Efforts to improve patient safety and the quality of health care delivery;
- The collection and analysis of patient safety work product;
- The development and dissemination of information with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices;
- The utilization of patient safety work product for the purposes of encouraging a culture of safety and of providing feedback and assistance to effectively minimize patient risk;
- The maintenance of procedures to preserve confidentiality with respect to patient safety work product;
- The provision of appropriate security measures with respect to patient safety work product;
- The utilization of qualified staff; and
- Activities related to the operation of a patient safety evaluation system and to the provision of feedback to participants in a patient safety evaluation system.
The Patient Safety Rule authorizes AHRQ to conduct reviews (including announced or unannounced site visits) to assess compliance with listing requirements. To help PSOs prepare for a compliance review, AHRQ developed the Patient Safety Organizations: A Compliance Self-Assessment Guide. This guide helps PSOs understand the scope of listing requirements and what compliance may mean for an individual PSO. Using a checklist of questions as a starting point, the guide will help PSOs determine if compliance efforts take into account unique traits for each organization. For instance, each PSO will have to consider its mission, the services and expertise it offers providers, and its model for carrying out patient safety activities.
Step 3. Attest That The Organization Will Comply With Criteria Specified by the Patient Safety Rule
An entity must certify that it will comply with the following seven additional criteria specified in the Patient Safety Rule (Section 3.102(b)(2)(i)):
- The mission and primary activity of the PSO must be to conduct activities that are to improve patient safety and the quality of health care delivery.
- The PSO must have appropriately qualified workforce members, including licensed or certified medical professionals.
- The PSO, within the 24-month period that begins on the date of its initial listing as a PSO, and within each sequential 24-month period thereafter, must have 2 bona fide contracts, each of a reasonable period of time, each with a different provider for the purpose of receiving and reviewing patient safety work product.
- The PSO is not a health insurance issuer, and is not a component of a health insurance issuer.
- The PSO must make disclosures to the Secretary as required under § 3.102(d), in accordance with § 3.112 of this subpart.
- To the extent practical and appropriate, the PSO must collect patient safety work product from providers in a standardized manner that permits valid comparisons of similar cases among similar providers.
- The PSO must utilize patient safety work product for the purpose of providing direct feedback and assistance to providers to effectively minimize patient risk.
Step 4. Apply to Become a PSO
AHRQ has prepared a PSO Certification for Initial Listing Form that an organization must complete to certify that it meets the requirements to become listed as a PSO. Prior to completing and submitting the Certification for Initial Listing form, please contact the PSO Program. Applications can be submitted at any time.