General Information About Listed PSOs
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 review the Patient Safety Rule.
The Patient Safety Act and Patient Safety Rule provide confidentiality and privilege protections for patient safety work product (PSWP), a term that is defined in the law (see section 921(7) of the Public Health Service Act). One of the ways that PSWP is created is when a health care provider assembles or develops information for reporting to a PSO and then reports the information to a PSO.
- Before submitting information to an entity that claims to be a PSO, health care providers should always verify that the entity is currently listed by the Secretary. If a health care provider submits information to an entity that is not currently listed by the Secretary, the confidentiality and privilege protections of the Patient Safety Act will not apply. There is one limited exception to this general principle. If a PSO is delisted for cause, the Patient Safety Rule enables a provider to continue to submit information to the entity for 30 calendar days after the date and time that its status as a PSO is revoked.
- Health care providers should not submit information to a PSO before the date and time that its listing is effective. To ensure that the list of PSOs is always accurate on a PSO's first day of listing by the Secretary, AHRQ may update the list a day or two in advance. Therefore, the list will prominently display the date and time that the entity's listing as a PSO becomes effective.
- To remain listed, each PSO is required to have two bona fide contracts with different health care providers within each 24-month period following its initial date of listing. To learn more about this requirement, please go to Two Bona Fide Contracts Requirement Information.
- The Patient Safety Act enables health care providers to learn whether the PSO has relationships or obligations with other health care providers that go beyond contracts for the receipt and review of PSWP (i.e., a Patient Safety Act contract). To learn more about this requirement, please go to Disclosure Statement Information.
- AHRQ provides information on each listed PSO — the initial listing date, two bona fide contracts requirements, and disclosure statements — on the AHRQ Web site at http://www.pso.ahrq.gov/listing/psolist.htm.
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.
PSO Listing Process
- Review the Patient Safety Rule, particularly the criteria for listing.
- Review the Patient Safety Guidance (PDF File, 201 KB; PDF Help) regarding PSOs' reporting obligations and the Patient Safety Act.
- 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 email to:
Attach a single file in .PDF format containing all relevant forms. The subject line of the email should include the name of the form being submitted. No message text is required.
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 email to the applicant. 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 emailed 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 emailed 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 emailed 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.
General Information About Delisted PSOs
A PSO can be "delisted" by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule. IMPORTANT: Confidentiality and privilege protections MAY NOT APPLY to information submitted to a delisted PSO. See below for details.
PSO Delisting Process
An entity may be removed from the list of PSOs under three circumstances:
(1) Voluntary Relinquishment — the PSO chooses to voluntarily relinquish its status as a PSO for any reason
(2) Failure to Seek Continued Listing — the 3-year listing period expires without the PSO seeking continued listing
(3) Delisted for Cause — the listing as a PSO is revoked for cause (i.e., noncompliance with the requirements that each PSO must meet)
PSOs Delisted for Cause:
For health care providers, there is one significant difference between entities that are delisted for cause (#3) and the other circumstances (#1 and #2). If a PSO's listing is revoked for cause, health care providers can continue to submit data for 30 calendar days, beginning on the date and time that the entity has had its status as a PSO revoked and ending 30 calendar days thereafter. Data submitted during this 30 day period are treated as PSWP and are subject to the confidentiality and privilege protections of the Patient Safety Act.
PSOs Delisted for Other Reasons:
The Patient Safety Act and Patient Safety Rule DO NOT extend an additional 30 calendar days of protection to information submitted to an entity that allows its listing as a PSO to expire or to an entity that voluntarily relinquishes its status. If a PSO allows its listing to expire, the PSO automatically becomes delisted at midnight (Eastern time zone) on the last day of the posted listing period. If a PSO seeks to voluntarily relinquish its listed status, the Secretary will set a date and time for its delisting. Information submitted to a PSO during its period of listing, and before the date and time of its delisting, will remain protected as PSWP.
Note: The Department of Health and Human Services (HHS) issued the Patient Safety Rule (PDF file, 450 KB; PDF Help) to implement the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), which authorizes the creation of Patient Safety Organizations (PSOs). The Patient Safety Rule became effective on January 19, 2009.
The Agency for Healthcare Research and Quality (AHRQ) administers the PSO provisions of the Patient Safety Act, and the Office for Civil Rights (OCR) is responsible for interpreting and enforcing the confidentiality protections of the Patient Safety Act and the Patient Safety Rule. AHRQ has prepared a form that an organization must use to certify that it meets the requirements to become listed as a PSO and two forms that a listed PSO must use when certifying compliance with other statutory requirements that are incorporated in the Patient Safety Rule. AHRQ has also prepared a form that a PSO seeking continued listing by the Secretary of Health and Human Services must submit before its period of listing expires (i.e., 3 years from its effective date and time of initial listing). Please note that submitting the PDF version of these forms, either via email or as hard copy, is preferred by AHRQ. For questions about the PSO listing process and form submission, please contact the PSO Office. For AHRQ's consideration and processing, all forms must be signed by the PSO's Authorized Official.
Additionally, AHRQ has prepared an information form that listed PSOs are asked to complete and submit annually to the PSO Privacy Protection Center (PSO PPC), and OCR has provided a PSO complaint form that is available on their Web site.
- Form for Entities Seeking PSO Listing:
- Forms for Currently Listed PSOs:
- Other Forms: