Patient Safety Organization Listing Process

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Patient Safety Organization Listing Process

The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorizes the creation of Patient Safety Organizations (PSOs) to reduce the incidence of events that adversely affect patients. A PSO is an entity or component organization whose primary activity is to conduct activities to improve patient safety and the quality of health care delivery.

The Department of Health and Human Services (HHS) issued the Patient Safety and Quality Improvement final rule (Patient Safety Rule) to implement the Patient Safety Act. The Agency for Healthcare Research and Quality (AHRQ) administers the provisions of the Patient Safety Act and Patient Safety Rule (PDF file, 450 KB. PDF Help) dealing with PSO operations. The Patient Safety Act permits almost any entity—an entire organization or a component of an organization, a public or private entity, a for-profit or not-for-profit entity—to seek listing as a PSO. The Patient Safety Rule, however, expands the number of entities excluded from listing. Any entity that is interested in seeking listing as a PSO is strongly encouraged to carefully review the Patient Safety Rule.

AHRQ has prepared PSO forms for organizations that are certifying to become a PSO and for listed PSOs that are seeking to meet the statutory requirements of the Patient Safety Rule. Please contact the PSO Office for any questions about the Patient Safety Rule and the PSO listing process.

To obtain listing as a PSO:

Review the Patient Safety Rule, particularly the criteria for listing.
If your organization meets the criteria, go to the PSO forms. Print, complete, sign, and submit the form PSO Certification for Initial Listing and any required supplemental information. To facilitate the review and processing of the form, please DO NOT alter, modify, or reformat the form in any way.
Submit the PSO Certification for Initial Listing form to the PSO Office as follows:

By e-mail to:

PSO@ahrq.hhs.gov

Attach a single file in .PDF format containing all relevant forms. The subject line of the e-mail should include the name of the form being submitted. No message text is required.

OR

By U.S. mail or similar carrier to:

PSO Office Center for Quality Improvement and Patient Safety Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850

Upon receipt of the PSO Certification for Initial Listing form, AHRQ will send an acknowledgement e-mail to the applicant entity. The form will be reviewed as expeditiously as possible.
The organization will be notified in writing of the HHS Secretary's determination.

After a PSO has been listed by the HHS Secretary, the form PSO Two Bona Fide Contracts Requirement should be submitted as soon as the PSO has met the requirement for two bona fide contracts. The timeline for submitting the PSO Two Bona Fide Contracts Requirement form is described in Section 3.102(a)(1) of the Patient Safety Rule. This form should be e-mailed or mailed to the PSO Office as outlined above in Step #3.

A listed PSO must submit a PSO Disclosure Statement form only if the PSO has entered into a contract with a provider and has other relationships with that provider as outlined in Section 3.102(a)(2) of the Patient Safety Rule. The timeline for submitting the PSO Disclosure Statement form is also described in Section 3.102(a)(2). This form should be e-mailed or mailed to the PSO Office as outlined above in Step #3.

A PSO is listed for a period of 3 years. To renew its listing for an additional 3 years, a PSO must complete and submit a PSO Certification for Continued Listing form before its listing period expires. The PSO must certify that it is performing, and will continue to perform, each of the patient safety activities and that it is complying with, and will continue to comply with, the other requirements of the Patient Safety Rule. This form should be e-mailed or mailed to the PSO Office as outlined above in Step #3. The PSO will be notified in writing of the HHS Secretary’s determination to renew listing.

Note: The PSO's 3-year period of listing will automatically expire at midnight on the last day of the PSO's listing period if AHRQ has not received and approved the organization’s PSO Certification for Continued Listing form.