A Patient Safety Organization (PSO) is an entity, or a component of one, that the Secretary of HHS has listed under the Patient Safety and Quality Improvement Act of 2005 and its regulation, 42 CFR Part 3. This page is for organizations forming a PSO and seeking initial listing, and for listed PSOs maintaining or renewing their listing. Integral Healthcare Solutions (IHS) drafts your PSO's governance, procedures and listing package; your counsel owns privilege decisions, and your authorized official submits the certification.

Last reviewed: October 2026.

What is a Patient Safety Organization?

The governing texts are the Patient Safety and Quality Improvement Act of 2005 (the "Patient Safety Act") and its implementing regulation, 42 CFR Part 3 (the "Patient Safety Rule"), current eCFR text, together with AHRQ's PSO Program materials, including the Certification for Initial Listing Form. The regulation defines a PSO as "a private or public entity or component thereof that is listed as a PSO by the Secretary" (42 CFR 3.20).

AHRQ runs the listing program. Its "Become a PSO" page is "an informal educational resource for those interested in learning about the requirements for becoming listed as a PSO under the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and its implementing regulation (Patient Safety Rule)" (AHRQ, Become a PSO, last reviewed March 2022).

AHRQ lays out the steps as "Assess Eligibility to Become a PSO"; "Assess Compatibility of Anticipated PSO Operations with Patient Safety Rule Requirements"; "Establish Policies and Procedures for Conducting Patient Safety Activities"; "Select the Prospective PSO Authorized Official (AO)"; and "Prepare to Submit the Certification for Initial Listing Form" (AHRQ).

Who needs it and what triggers it

The buyer is an organization seeking federal PSO listing, or a listed PSO keeping its listing in place. The triggers come from the regulation:

• Forming a new PSO. "Any entity, except as specified in paragraph (a)(2) of this section, may request from the Secretary an initial or continued listing as a PSO by submitting a completed certification form" (42 CFR 3.102(a)(1)).
• Building the patient safety evaluation system and the policies behind it, since the entity certifies it has "written policies and procedures in place to perform each of the eight patient safety activities" (3.102(b)).
• Meeting the contract requirement: "2 bona fide contracts, each of a reasonable period of time, each with a different provider" 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" (3.102(b)(2)(i)(C)).
• Continued listing. "The three-year period of listing of a PSO will automatically expire at midnight of the last day of this period" unless renewed or revoked earlier (42 CFR 3.104(e)(1)), and continued listing certification is due "no later than 75 days before the expiration of a PSO's three-year period of listing" (3.102(a)(3)).

How IHS helps

IHS drafts the PSO's operating documents through its standard process:

1. A gap assessment against 42 CFR Part 3 and AHRQ's listing materials.
2. Questionnaires on mission, provider relationships, workforce and confidentiality, used to build a crosswalk from each listing attestation to the policy and evidence behind it.
3. Drafting of governance documents, policies for each of the eight patient safety activities, confidentiality and security controls, and provider contract templates, for your organization's counsel and leadership to review and approve.
4. A review of the assembled listing package, read the way a reviewer would read it.
5. Drafted certification text for your authorized official to complete and submit to AHRQ.

What you supply: corporate documents, patient safety staff, provider relationships and counsel.

The limit: privilege and confidentiality decisions belong to your counsel. IHS does not guarantee listing or privilege protection. Your authorized official completes and submits the certification, and your organization, not IHS, deals with AHRQ.

What to have ready

Each item ties to 42 CFR Part 3 (current eCFR text, read October 2026) or AHRQ's PSO pages as cited.

• An eligibility check against 42 CFR 3.102(a). Paragraph (a)(2) bars health insurance issuers (and their units, and entities they own, manage or control) and entities that accredit or license health care providers, oversee or enforce health care regulation, act as agents of such entities, or operate a government patient safety reporting system that providers are required by law to report to; a component of the (a)(2)(ii) entities may seek listing as a component PSO under (a)(2)(iii) (3.102(a)).
• Written policies and procedures "to perform each of the eight patient safety activities" listed in 42 CFR 3.20 (3.102(b)).
• Procedures for "The maintenance of procedures to preserve confidentiality" (3.20).
• Security controls for "The provision of appropriate security measures" (3.20).
• Staffing records that support "The utilization of qualified staff" (3.20).
• A described patient safety evaluation system, covering "Activities related to the operation of a patient safety evaluation system" (3.20).
• A prospective authorized official who is "legally authorized to complete the Certification for Initial Listing Form on behalf of the entity seeking listing as a PSO" (AHRQ, Submit Certification).
• A plan for "2 bona fide contracts, each of a reasonable period of time, each with a different provider" in each 24-month period (3.102(b)(2)(i)(C)).
• A listing calendar: the three-year listing term (3.104(e)(1)) and the continued listing certification due "no later than 75 days before the expiration" (3.102(a)(3)).

The introductory call is the place to go through this list against your organization's current documents.

How it compares

What it costs

AHRQ states: "There are no fees to apply for listing" (AHRQ, Become a PSO; Submit Certification). Verify current fees with AHRQ. IHS scopes each engagement after a free introductory call.

What this is not

• This page is not legal advice. Privilege and confidentiality questions under the Patient Safety Act are for your counsel.
• IHS does not guarantee listing by AHRQ or any privilege protection for your patient safety work.
• IHS does not submit the certification or deal with AHRQ for you; your authorized official signs and submits it.

Frequently asked questions

What is a Patient Safety Organization (PSO) and what does federal listing mean?

Under 42 CFR 3.20, a PSO is "a private or public entity or component thereof that is listed as a PSO by the Secretary" (eCFR). An entity is a PSO only once the Secretary has listed it.

Who is eligible to become a PSO, and which organizations are excluded?

"Any entity, except as specified in paragraph (a)(2) of this section, may request from the Secretary an initial or continued listing as a PSO" (42 CFR 3.102(a)(1)). Paragraph (a)(2) bars health insurance issuers (and their units, and entities they own, manage or control) and entities that accredit or license health care providers, oversee or enforce health care regulation, act as agents of such entities, or operate a government patient safety reporting system that providers are required by law to report to; a component of the (a)(2)(ii) entities may seek listing as a component PSO under (a)(2)(iii). Read the exact text of 3.102(a)(2) with counsel.

Can a health system create its own component PSO?

The definition in 42 CFR 3.20 covers "a private or public entity or component thereof," so a component can be listed. The exclusions in 3.102(a)(2) govern whether a component qualifies. Under 3.102(a)(2)(iii), a component of an entity that accredits or licenses providers, or that oversees or enforces health care regulation, may seek listing as a component PSO subject to the separate requirements in 3.102(c)(1)(ii); a unit of a health insurance issuer may not (3.102(a)(2)(i)). Whether your structure qualifies is a question for your counsel.

What are the eight patient safety activities a PSO must have policies for?

They are listed in 42 CFR 3.20 (eCFR). They include "The maintenance of procedures to preserve confidentiality," "The provision of appropriate security measures," "The utilization of qualified staff," and "Activities related to the operation of a patient safety evaluation system." The entity certifies written policies and procedures for each of the eight (3.102(b)).

How do I apply for PSO listing with AHRQ, and is there a fee?

AHRQ's steps run from assessing eligibility through selecting an authorized official to preparing the Certification for Initial Listing Form. The authorized official "must be legally authorized to complete the Certification for Initial Listing Form on behalf of the entity" and certifies the statements are true (AHRQ). AHRQ states: "There are no fees to apply for listing."

How long does AHRQ take to list a new PSO?

The AHRQ pages we reviewed do not state a processing time. They say: "AHRQ will acknowledge the form upon receipt and will contact the applicant shortly thereafter to begin the initial listing process."

What is the two-contract requirement and when must it be met?

A PSO must have "2 bona fide contracts, each of a reasonable period of time, each with a different provider" 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" (42 CFR 3.102(b)(2)(i)(C)).

How long does a PSO listing last, and when is continued listing due?

Three years. "The three-year period of listing of a PSO will automatically expire at midnight of the last day of this period" unless renewed or revoked earlier (42 CFR 3.104(e)(1)). The continued listing certification is due "no later than 75 days before the expiration of a PSO's three-year period of listing" (3.102(a)(3)).

Should we start our own PSO or contract with an existing listed PSO?

Both routes exist. Forming a PSO means meeting the listing, contract and renewal requirements in 42 CFR Part 3; contracting with a listed PSO means checking AHRQ's directory, which AHRQ advises providers to review "to ensure that the entity's PSO certifications have been accepted." The choice turns on your organization's goals and counsel's advice; IHS supports the formation route.