Patient Safety Organizations: A Compliance Self-Assessment Guide (continued)

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Table 3: Required Notifications and Submissions by PSOs

Four requirements described below note that the use of specific forms is required. Those forms are available at www.pso.ahrq.gov. The forms must be submitted in their entirety and AHRQ will not accept a form that has been retyped or altered in any way. If you experience difficulty in downloading a form, submit an email to the AHRQ PSO email box (pso@ahrq.hhs.gov) and specify the form(s) you need. Several notification requirements do not require the use of a specific form. As noted below, those notifications can simply be submitted to the AHRQ PSO email box.

The Certification for Initial Listing form requires the individual completing the form to certify that he or she has the authority to make legally binding commitments on behalf of the entity seeking listing (i.e., the Authorized Official). Once listed, the PSO must notify AHRQ if there is a change in its designated Authorized Official. To ensure that the PSO submissions and notifications it receives are valid, AHRQ will expect all submissions and notifications to be sent by the Authorized Official.

Requirement	Required Date
Submission of Certifications By an Entity Seeking Listing as a PSO
Certification for Initial Listing Form The form must be submitted by an entity seeking a 3-year period of listing as a PSO.	The Certification for Initial Listing form can be submitted at any time. The protections of the law are not in place until the entity is listed by AHRQ. The rule does not establish any deadlines for submission. There are no limits on the number of PSOs that can be listed.
Notifications or Submissions Required of Every PSO During Its Period of Listing
Requirement	Required Date
Two Contract Notification A PSO must use this form to attest that it has entered two contracts for receipt and review of patient safety work product with two different providers. [Section 3.102(d)(1)]	No later than 45 calendar days before the end of each 24-month period following the PSO's initial listing date. [PSOs are encouraged to submit the notice as soon as the requirement is met.]
Disclosure Statement A PSO must use this attestation form and attach the required statement to notify AHRQ that the PSO has entered a Patient Safety Act contract with a provider with which it has other types of relationships specified in the rule. This attestation form and a disclosure statement are also required if a PSO subsequently establishes such relationships with a provider with which it has a Patient Safety Act contract. [Section 3.102(d)(2)]	If any of the specified relationships are present when a contract is entered, AHRQ must receive the statement within 45 calendar days of the date the contract is entered. If any of the specified relationships arise during the period the contract is in effect, AHRQ must receive the disclosure statement within 45 calendar days of the date on which a relationship is established.
Changes in the Accuracy of a PSO's Certifications reflected in Initial or Continued Listing Forms [email notification to pso@ahrq.hhs.gov] —If there are changes in the contact information for the PSO: address, telephone, fax, authorized official, point-of-contact, email addresses. —If the PSO begins using another name to market its PSO services (i.e., “doing business as...”). —If another legal entity gains ownership of, or has the ability to control or manage the PSO (e.g., merger). —If the PSO is recognized to be in noncompliance with any of its attestations. [Section 3.102(a)(1)(vi)]	The PSO must promptly notify AHRQ if any of these changes occur. Note that if a PSO enters into a relationship with another legal entity that can now exert control or management over the PSO, or another legal entity develops an ownership interest in the PSO, this may render the PSO's attestations incompatible with the PSO's new organizational structure. A PSO anticipating such changes is encouraged to discuss the changes with AHRQ staff prior to implementation.
Submission of Certifications for Continued Listing by a PSO
Requirement	Required Date
Certification for Continued Listing Form This form must be submitted by a PSO seeking continued listing as a PSO for another 3-year period. [section 3.102(a)(3)]	PSOs must submit this certification form no later than 75 calendar days before the expiration of a PSO's current period of listing.
Notifications Required of PSOs that are Components of an Excluded Entity
Nature of Requirement	Required Date
Notification if an Excluded Parent Organization Induces Providers to Report to its Component PSO [email notification to pso@ahrq.hhs.gov] A PSO that is a component of an excluded entity must attest at listing that its parent organization has no policies or procedures that would require or induce providers to report PSWP to the component PSO. During its period of listing if the PSO has knowledge that its parent organization has adopted such policies or procedures, the PSO must notify AHRQ. [Section 3.102(c)(4)(i)(B)]	AHRQ must be notified within 5 calendar days of the date on which the PSO has knowledge of the adoption of such policies and procedures.
Notifications Required of PSOs for Correction of Deficiencies and Revocation Process
Requirement	Required Date
Opportunity to Question Accuracy of a Preliminary Finding of Deficiency [email notification to pso@ahrq.hhs.gov] After a PSO receives a Preliminary Finding of Deficiency notice, the PSO has an opportunity to question the factual basis of the notice. Unless evidence is received that the finding is factually incorrect, the PSO will be expected to meet the correction timetable in the notice. [Section 3.108(a)(2)(ii)]	The PSO must submit any evidence that the finding is factually incorrect within 14 days of actual or constructive receipt of a notice, whichever is longer. [Note: constructive receipt-In the absence of evidence of the date of receipt of a notice, the notice is presumed to be received 5 calendar days following the date on which it was mailed.]
Notify AHRQ that a deficiency has been corrected. [email notification to pso@ahrq.hhs.gov] A PSO must promptly provide AHRQ with documentation that the deficiency has been corrected. [Section 3.108(a)(3)(i)]	Unless the deficiency notice sets a specific date, AHRQ must receive documentation within 5 calendar days of the last day of the correction period in the notice of deficiency.
Opportunity to Respond to a Notice of Proposed Revocation [email notification to pso@ahrq.hhs.gov] Whenever a PSO receives a notice of proposed revocation, the PSO has an opportunity to submit a substantive written response to the deficiency findings in the notice. [Section 3.108(a)(4)(i)]	A PSO has until midnight, 30 calendar days after the date of actual or constructive receipt of a notice of proposed revocation, to submit a response.
Notification required following a decision to revoke the listing of a PSO [email notification to pso@ahrq.hhs.gov] Following notification of a decision to revoke its certifications and delist a PSO, the former PSO must submit confirmation to the Secretary that it has notified each provider whose PSWP it collected or analyzed of the revocation decision. [Section 3.108(b)(2)(ii)]	The PSO must submit the notification to AHRQ within 15 calendar days of being notified of the revocation decision.

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Table 4: Patient Safety Rule Requirements For Which Attestations Are Required

Patient Safety Rule Text	Initial Listing Form	Continued Listing Form
Patient Safety Activities
42 Code of Federal Regulations, Part 3	An entity attests that it has policies and procedures in place to perform all 8 patient safety activities	A PSO attests that it is (a) currently performing, and (b) will continue to perform, each of the statutorily required patient safety activities throughout the period of continued listing.
Section 3.20, definition of Patient Safety Activities: (1) Efforts to improve patient safety and the quality of health care delivery	Part III, Attestation 1: Does the entity have policies and procedures to improve patient safety and the quality of health care delivery?	Part III, Attestation 1: Undertaking actions to improve patient safety and the quality of health care delivery?
Section 3.20, definition of Patient Safety Activities: (2) The collection and analysis of patient safety work product	Part III, Attestation 2: Does the entity have policies and procedures for the collection and analysis of patient safety work product?	Part III, Attestation 2: Collecting and analyzing patient safety work product?
Section 3.20, definition of Patient Safety Activities: (3) The development and dissemination of information with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices	Part III, Attestation 3: Does the entity have policies and procedures to develop and disseminate information with respect to improving patient safety, such as recommendations, protocols, and best practices?	Part III, Attestation 3: Developing and disseminating information to improve patient safety?
Section 3.20, definition of Patient Safety Activities: (4)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	Part III, Attestation 4: Does the entity have policies and procedures to utilize patient safety work product to encourage a culture of safety, to provide feedback, and to provide assistance to effectively minimize patient risk?	Part III, Attestation 4: Utilizing patient safety work product to encourage a culture of safety, and to provide feedback and assistance to effectively minimize patient risk?
Section 3.20, definition of Patient Safety Activities: (5)The maintenance of procedures to preserve confidentiality with respect to patient safety work product	Part III, Attestation 5: Does the entity have policies and procedures to preserve confidentiality of patient safety work product in conformity with the rule and the authorizing statute?	Part III, Attestation 5: Implementing and maintaining procedures to preserve confidentiality of patient safety work product in conformity with the rule and authorizing legislation?
Section 3.20, definition of Patient Safety Activities: (6) The provision of appropriate security measures with respect to patient safety work product	Part III, Attestation 6: Does the entity have policies and procedures to protect patient safety work product in conformity with the rule and the authorizing statute?	Part III, Attestation 6: Implementing and maintaining security measures to protect patient safety work product in conformity with the rule and the authorizing legislation?
Section 3.20, definition of Patient Safety Activities: (7) The utilization of qualified staff	Part III, Attestation 7: Does the entity have policies and procedures in place to assure the utilization of appropriately qualified staff?	Part III, Attestation 7: Using appropriately qualified staff to improve patient safety and quality of health care delivery?
Section 3.20, definition of Patient Safety Activities: (8) 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.	Part III, Attestation 8: Does the entity have policies and procedures in place to perform the collection, management, and analytic activities related to the operation of a patient safety evaluation system (PSES), including the provision of feedback to participants in a PSES?	Part III, Attestation 8: Performing the collection, management, or analytic activities related to the operation of a patient safety evaluation system (PSES), including providing feedback to participants in a PSES?
PSO Criteria
Patient Safety Rule Text	Initial Listing Form	Continued Listing Form
42 Code of Federal Regulations, Part 3	An entity attests that, upon listing, it will comply with all seven PSO criteria.	A PSO attests that it is (a) currently complying with, and (b) will continue to comply with, each of the PSO criteria throughout the period of continued listing.
Section 3.102(b)(2)(i)(A): 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.	Part III, Attestation 9: Will improvement of patient safety and the quality of health care delivery be both (a) the entity's mission and (b) the entity's primary activity? A "yes" answer attests that both (a) and (b) will be met.	Part III, Attestation 9: Making the improvement of patient safety and the quality of health care delivery (a) the PSO's mission and (b) the PSO's primary activity? A “yes” answer attests that both conditions are met.
Section 3.102(b)(2)(i)(B): The PSO must have appropriately qualified workforce members, including licensed or certified medical professionals.	Part III, Attestation 10: Will the entity's employees or contractors both (a) be appropriately qualified and (b) include licensed or certified medical professionals?	Part III, Attestation 10: Having staff (employees or contractors) who are both (a) appropriately qualified and (b) include licensed or certified medical professionals?
Section 3.102(b)(2)(i)(C): 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 two 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.	Part III, Attestation 11: Will the entity meet the requirement to enter at least two bona fide contracts within 24 months of its initial listing (and meet that test in every subsequent 24-month period)?	Part III, Attestation 11: Meeting the requirement to enter into at least two bona fide contracts within each of the required sequential 24-month periods following initial listing?
Section 3.102(b)(2)(i)(D): The PSO is not a health insurance issuer, and is not a component of a health insurance issuer.	Part III, Attestation 12: Will the entity comply with the prohibition Part III, Attestation 12: that it may not be a health insurance insurer or a health insurance insurer component?	Part III, Attestation 12: Not being a health insurance issuer or a component of a health insurance issuer?
Section 3.102(b)(2)(i)(E): The PSO must make disclosures to the Secretary as required under § 3.102(d), in accordance with § 3.112 of this subpart.	Part III, Attestation 13: Will the entity meet the requirement to fully disclose to the Secretary relationships with contracting providers?	Part III, Attestation 13: Fully disclosing to the Secretary relationships with contracting providers?
Section 3.102(b)(2)(i)(F): 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.	Part III, Attestation 14: Will the entity collect patient safety work product in a standardized manner that permits valid comparisons of similar cases? Note: The Secretary is providing guidance on common definitions and reporting formats, known as Common Formats, which is available at www.pso.ahrq.gov.	Part III, Attestation 14: Using the Secretary's published guidance for common definitions and reporting formats (Common Formats) in its collection of patient safety work product? Using an alternate system of formats and definitions in its collection of patient safety work product that permits valid comparisons among similar providers? Attest that it is not practical or appropriate to comply with the options described in questions 14A or 14B. If the answer is “yes”, attach a separate sheet with a clear explanation of why it is not practical or appropriate for the PSO to comply with those options. If the answer to 14C is “yes”, is the required explanatory statement attached to this form?
Section 3.102(b)(2)(i)(G): The PSO must utilize patient safety work product for the purpose of providing direct feedback and assistance to providers to effectively minimize patient risk.	Part III, Attestation 15: Will the entity utilize patient safety work product for the purpose of providing direct feedback and assistance to providers to effectively minimize patient risk?	Part III, Attestation 15: Using patient safety work product to provide feedback and help to providers in order to minimize patient risk?
Additional Requirements That Apply to All Component PSOs
Patient Safety Rule Text	Initial Listing Form	Continued Listing Form
42 Code of Federal Regulations, Part 3	A component organization attests what it will do if listed.	The PSO attests that it is (a) currently complying with, and (b) will continue to comply with, each of the additional statutory requirements for component PSOs throughout the period of continued listing
Section 3.102(c)(2)(i): A component PSO must maintain patient safety work product separately from the rest of the parent organization(s) of which it is a part, and establish appropriate security measures to maintain the confidentiality of patient safety work product.	Part III, Attestation 16: Will the component entity maintain patient safety work product separately from the rest of the parent organization(s) and establish appropriate security measures to maintain the confidentiality of patient safety work product?	Part III, Attestation 16: Maintaining patient safety work product separately from the PSO's parent organization(s) and has established appropriate security measures to maintain the confidentiality of patient safety work product?
Section 3.102(c)(2)(ii): A component PSO must require that members of its workforce and any other contractor staff not make unauthorized disclosures of patient safety work product to the rest of the parent organization(s) of which it is a part.	Part III, Attestation 17: Will the component entity require that members of its workforce and any other contractor staff not make unauthorized disclosures of patient safety work product to the rest of the parent organization(s)?	Part III, Attestation 17: Requiring that members of its workforce and any other contractor staff not make unauthorized disclosures of patient safety work product to the rest of the parent organization(s)?
Section 3.102(c)(2)(iii): The pursuit of the mission of a component PSO must not create a conflict of interest with the rest of the parent organization(s) of which it is a part.	Part III, Attestation 18: Will the component entity ensure that the pursuit of its mission will not create a conflict of interest with the rest of its parent organization(s)?	Part III, Attestation 18: Ensuring that the pursuit of its mission is not creating a conflict of interest with the rest of its parent organization(s)?
Section 3.102(c)(3), Written Agreements for Assisting a Component PSO in the Conduct of Patient Safety Activities	Note: There is not a corresponding attestation.	Note: There is not a corresponding attestation.
Additional Requirements for PSOs that are Component Organizations of Excluded Entities
Patient Safety Rule Text	Initial Listing Form	Continued Listing Form
Section 3.102(c)(4)(i)(A): A statement describing its parent organization's role, and the scope of the parent organization's authority, with respect to any of the following that apply: accreditation or licensure of health care providers, oversight or enforcement of statutory or regulatory requirements governing the delivery of health care services, serving as an agent of such a regulatory oversight or enforcement authority, or administering a public mandatory patient safety reporting system.	Part II, Attestation C1: Have you attached a statement outlining the role and authority of the parent organization as required by section 3.102(c)(4)(i)(A)?	Part II, Attestation B4: Has the component PSO complied with the requirements of section 3.102(c)(4) of the rule during its current period of listing? Part II, Attestation B5: If the Secretary approves the request for continued listing, will the component PSO comply with the requirements of section 3.104(c)(4) during its period of continued listing?
Section 3.102(c)(4)(i)(B): An attestation that the parent organization has no policies or procedures that would require or induce providers to report patient safety work product to their component organization once listed as a PSO and that the component PSO will notify the Secretary 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, and an acknowledgment that the adoption of such policies or procedures by the parent organization during the component PSO's period of listing will result in the Secretary initiating an expedited revocation process in accordance with §3.108(e);	Part II, Attestation C2: Does the parent organization have policies and procedures in place that would require or induce providers to report patient safety work product to the component if listed as a PSO? [Go to the prohibition in section 3.102(c)(4)(i)(B).] Part II, Attestation C3: If listed as a PSO, will the component notify the Secretary within five calendar days if the parent organization adopts such policies or procedures that would require or induce providers to report patient safety work product to the component? [Go to section 3.102(c)(4)(i)(B).]	Part II, Attestation B4: Has the component PSO complied with the requirements of section 3.102(c)(4) of the rule during its current period of listing? Part II, Attestation B5: If the Secretary approves the request for continued listing, will the component PSO comply with the requirements of section 3.104(c)(4) during its period of continued listing?
Section 3.102(c)(4)(i)(C): An attestation that the component organization will prominently post notification on its website and publish in any promotional materials for dissemination to providers, a summary of the information that is required by paragraph (c)(4)(i)(A) of this section. [Go to Row #20 above]	Part II, Attestation C4: If listed as a PSO, will the component prominently post notification on its Web site, and publish in any promotional materials for dissemination to providers, a summary of the parent organization's role and authority as required by section 3.102(c)(4)(i)(C)?	Part II, Attestation B4: Has the component PSO complied with the requirements of section 3.102(c)(4) of the rule during its current period of listing? Part II, Attestation B5: If the Secretary approves the request for continued listing, will the component PSO comply with the requirements of section 3.104(c)(4) during its period of continued listing?
Section 3.102(c)(4)(ii)(A): The component organization may not share staff with its parent organization(s).	Part II, Attestation C5: If listed as a PSO, will the entity comply with the restrictions of section 3.102(c)(4)(ii)(A) that prohibits the sharing of staff with the parent organization?	Part II, Attestation B4: Has the component PSO complied with the requirements of section 3.102(c)(4) of the rule during its current period of listing? Part II, Attestation B5: If the Secretary approves the request for continued listing, will the component PSO comply with the requirements of section 3.104(c)(4) during its period of continued listing?
Section 3.102(c)(4)(ii)(B): The component organization may enter into a written agreement pursuant to paragraph (c)(3) but such agreements are limited to units or individuals of the parent organization(s) whose responsibilities do not involve the activities specified in the restrictions in paragraph (a)(2)(ii) of this section.	Part II, Attestation C6: If listed as a PSO, will the entity comply with the additional restrictions on contracting with the parent organization in section 3.102(c)(4)(ii)(B) of the rule?	Part II, Attestation B4: Has the component PSO complied with the requirements of section 3.102(c)(4) of the rule during its current period of listing? Part II, Attestation B5: If the Secretary approves the request for continued listing, will the component PSO comply with the requirements of section 3.104(c)(4) during its period of continued listing?

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