Implementing the Patient Safety and Quality Improvement Act of 2005 Including How to Become a Patient Safety Organization: Interim Guidance (Continued)

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Implementing the Patient Safety and Quality Improvement Act of 2005 Including How to Become a Patient Safety Organization: Interim Guidance (Continued)

SEC. 923 [of the Public Health Service Act]. NETWORK OF PATIENT SAFETY DATABASES.

In General- The Secretary shall facilitate the creation of, and maintain, a network of patient safety databases that provides an interactive evidence-based management resource for providers, patient safety organizations, and other entities. The network of databases shall have the capacity to accept, aggregate across the network, and analyze nonidentifiable patient safety work product voluntarily reported by patient safety organizations, providers, or other entities. The Secretary shall assess the feasibility of providing for a single point of access to the network for qualified researchers for information aggregated across the network and, if feasible, provide for implementation.
Data Standards- The Secretary may determine common formats for the reporting to and among the network of patient safety databases maintained under subsection (a) of nonidentifiable patient safety work product, including necessary work product elements, common and consistent definitions, and a standardized computer interface for the processing of such work product. To the extent practicable, such standards shall be consistent with the administrative simplification provisions of part C of title XI of the Social Security Act.
Use of Information- Information reported to and among the network of patient safety databases under subsection (a) shall be used to analyze national and regional statistics, including trends and patterns of health care errors. The information resulting from such analyses shall be made available to the public and included in the annual quality reports prepared under section 913(b)(2).

SEC. 924 [of the Public Health Service Act]. PATIENT SAFETY ORGANIZATION CERTIFICATION AND LISTING.

CERTIFICATION-
1. INITIAL CERTIFICATION- An entity that seeks to be a patient safety organization shall submit an initial certification to the Secretary that the entity--
  1. has policies and procedures in place to perform each of the patient safety activities described in section 921(5); and
  2. upon being listed under subsection (d), will comply with the criteria described in subsection (b).
2. SUBSEQUENT CERTIFICATIONS- An entity that is a patient safety organization shall submit every 3 years after the date of its initial listing under subsection (d) a subsequent certification to the Secretary that the entity--
  1. is performing each of the patient safety activities described in section 921(5); and
  2. is complying with the criteria described in subsection (b).
CRITERIA-
1. IN GENERAL- The following are criteria for the initial and subsequent certification of an entity as a patient safety organization:
  1. The mission and primary activity of the entity are to conduct activities that are to improve patient safety and the quality of health care delivery.
  2. The entity has appropriately qualified staff (whether directly or through contract), including licensed or certified medical professionals.
  3. The entity, within each 24-month period that begins after the date of the initial listing under subsection (d), has bona fide contracts, each of a reasonable period of time, with more than 1 provider for the purpose of receiving and reviewing patient safety work product.
  4. The entity is not, and is not a component of, a health insurance issuer (as defined in section 2791(b)(2)).
  5. The entity shall fully disclose--
    1. any financial, reporting, or contractual relationship between the entity and any provider that contracts with the entity; and
    2. if applicable, the fact that the entity is not managed, controlled, and operated independently from any provider that contracts with the entity.
  6. To the extent practical and appropriate, the entity collects patient safety work product from providers in a standardized manner that permits valid comparisons of similar cases among similar providers.
  7. The utilization of patient safety work product for the purpose of providing direct feedback and assistance to providers to effectively minimize patient risk.
2. ADDITIONAL CRITERIA FOR COMPONENT ORGANIZATIONS- If an entity that seeks to be a patient safety organization is a component of another organization, the following are additional criteria for the initial and subsequent certification of the entity as a patient safety organization:
  1. The entity maintains patient safety work product separately from the rest of the organization, and establishes appropriate security measures to maintain the confidentiality of the patient safety work product.
  2. The entity does not make an unauthorized disclosure under this part of patient safety work product to the rest of the organization in breach of confidentiality.
  3. The mission of the entity does not create a conflict of interest with the rest of the organization.
REVIEW OF CERTIFICATION-
1. IN GENERAL-
  1. INITIAL CERTIFICATION- Upon the submission by an entity of an initial certification under subsection (a)(1), the Secretary shall determine if the certification meets the requirements of subparagraphs (A) and (B) of such subsection.
  2. SUBSEQUENT CERTIFICATION- Upon the submission by an entity of a subsequent certification under subsection (a)(2), the Secretary shall review the certification with respect to requirements of subparagraphs (A) and (B) of such subsection.
2. NOTICE OF ACCEPTANCE OR NON-ACCEPTANCE- If the Secretary determines that--
  1. an entity's initial certification meets requirements referred to in paragraph (1)(A), the Secretary shall notify the entity of the acceptance of such certification; or
  2. an entity's initial certification does not meet such requirements, the Secretary shall notify the entity that such certification is not accepted and the reasons therefor.
3. DISCLOSURES REGARDING RELATIONSHIP TO PROVIDERS- The Secretary shall consider any disclosures under subsection (b)(1)(E) by an entity and shall make public findings on whether the entity can fairly and accurately perform the patient safety activities of a patient safety organization. The Secretary shall take those findings into consideration in determining whether to accept the entity's initial certification and any subsequent certification submitted under subsection (a) and, based on those findings, may deny, condition, or revoke acceptance of the entity's certification.
LISTING- The Secretary shall compile and maintain a listing of entities with respect to which there is an acceptance of a certification pursuant to subsection (c)(2)(A) that has not been revoked under subsection (e) or voluntarily relinquished.
REVOCATION OF ACCEPTANCE OF CERTIFICATION-
1. IN GENERAL- If, after notice of deficiency, an opportunity for a hearing, and a reasonable opportunity for correction, the Secretary determines that a patient safety organization does not meet the certification requirements under subsection (a)(2), including subparagraphs (A) and (B) of such subsection, the Secretary shall revoke the Secretary's acceptance of the certification of such organization.
2. SUPPLYING CONFIRMATION OF NOTIFICATION TO PROVIDERS- Within 15 days of a revocation under paragraph (1), a patient safety organization shall submit to the Secretary a confirmation that the organization has taken all reasonable actions to notify each provider whose patient safety work product is collected or analyzed by the organization of such revocation.
3. PUBLICATION OF DECISION- If the Secretary revokes the certification of an organization under paragraph (1), the Secretary shall--
  1. remove the organization from the listing maintained under subsection (d); and
  2. publish notice of the revocation in the Federal Register.
STATUS OF DATA AFTER REMOVAL FROM LISTING-
1. NEW DATA- With respect to the privilege and confidentiality protections described in section 922, data submitted to an entity within 30 days after the entity is removed from the listing under subsection (e)(3)(A) shall have the same status as data submitted while the entity was still listed.
2. PROTECTION TO CONTINUE TO APPLY- If the privilege and confidentiality protections described in section 922 applied to patient safety work product while an entity was listed, or to data described in paragraph (1), such protections shall continue to apply to such work product or data after the entity is removed from the listing under subsection (e)(3)(A).
DISPOSITION OF WORK PRODUCT AND DATA- If the Secretary removes a patient safety organization from the listing as provided for in subsection (e)(3)(A), with respect to the patient safety work product or data described in subsection (f)(1) that the patient safety organization received from another entity, such former patient safety organization shall--
1. with the approval of the other entity and a patient safety organization, transfer such work product or data to such patient safety organization;
2. return such work product or data to the entity that submitted the work product or data; or
3. if returning such work product or data to such entity is not practicable, destroy such work product or data.

SEC. 925 [of the Public Health Service Act]. TECHNICAL ASSISTANCE.

The Secretary, acting through the Director, may provide technical assistance to patient safety organizations, including convening annual meetings for patient safety organizations to discuss methodology, communication, data collection, or privacy concerns.

SEC. 926 [of the Public Health Service Act]. SEVERABILITY.

If any provision of this part is held to be unconstitutional, the remainder of this part shall not be affected.'
Authorization of Appropriations- Section 937 of the Public Health Service Act (as redesignated by subsection (a)) is amended by adding at the end the following:
(e) Patient Safety and Quality Improvement- For the purpose of carrying out part C, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2006 through 2010.
GAO Study on Implementation-
1. STUDY- The Comptroller General of the United States shall conduct a study on the effectiveness of part C of title IX of the Public Health Service Act (as added by subsection (a)) in accomplishing the purposes of such part.
2. REPORT- Not later than February 1, 2010, the Comptroller General shall submit a report on the study conducted under paragraph (1). Such report shall include such recommendations for changes in such part as the Comptroller General deems appropriate.

Appendix B: Applicable Provisions of the Patient Safety NPRM

(All of the following provisions are binding during the interim period unless otherwise noted)

Note that some of the language below is not identical to the language in the NPRM. Deletions and other changes were made so that the language below would reflect the statutory language and not including nonbinding language.

Subpart A - General Provisions - 3.20 Definitions - See Section II of this guidance.

Subpart B - PSO Requirements and Agency Procedures

§ 3.102 Process and requirements for initial and continued listing of PSOs.

Eligibility and process for initial and continued listing.
1. Submission of Certification. 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 that meets the requirements of this section, in accordance with the submission requirements at § 3.112. An individual with authority to make commitments on behalf of the entity seeking listing will be required to acknowledge each of the certification requirements, attest that the entity meets each requirement, provide contact information for the entity, and certify that the PSO will promptly notify the Secretary during its period of listing if it can no longer comply with any of the criteria in this section.
2. Restrictions on certain entities. Entities that may not seek listing as a PSO include: health insurance issuers or components of health insurance issuers. An applicant completing the required certification forms described in paragraph (a)(1) of this section will be required to attest that the entity is not subject to the restrictions of this paragraph.
Fifteen general PSO certification requirements. The certifications submitted to the Secretary in accordance with paragraph (a)(1) of this section must conform to the following 15 requirements:
1. Required certification regarding eight patient safety activities. An entity seeking initial listing as a PSO must certify that it has written policies and procedures in place to perform each of the eight patient safety activities, defined in § 3.20. Such policies and procedures will provide for compliance with the confidentiality provisions of Subpart C and the appropriate security measures required by § 3.106 of this subpart. A PSO seeking continued listing must certify that it is performing, and will continue to perform, each of the patient safety activities, and is and will continue to comply with Subpart C and the security requirements referenced in the preceding sentence.
2. Required certification regarding seven PSO criteria. In its initial certification submission, an entity must also certify that it will comply with the additional seven requirements in paragraphs (b)(2)(i) through (b)(2)(vii) of this section. A PSO seeking continued listing must certify that it is complying with, and will continue to comply with, the requirements of this paragraph.
  1. The mission and primary activity of a PSO must be to conduct activities that are to improve patient safety and the quality of health care delivery.
  2. The PSO must have appropriately qualified workforce members, including licensed or certified medical professionals.
  3. 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 entered into 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.
  4. The PSO is not a health insurance issuer, and is not a component of a health insurance issuer.
  5. The PSO must make disclosures to the Secretary as required under § 3.102(d), in accordance with § 3.112 of this subpart.
  6. 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.
  7. The PSO must utilize patient safety work product for the purpose of providing direct feedback and assistance to providers to effectively minimize patient risk.
Additional certifications required of component organizations. In addition to meeting the 15 general PSO certification requirements of paragraph (b) of this section, an entity seeking initial listing that is a component of another organization or enterprise must certify that it will comply with the requirements of paragraphs (c)(1) through (c)(3) of this section. A component PSO seeking continued listing must certify that it is complying with, and will continue to comply with, the requirements of this paragraph.
1. Separation of patient safety work product.
  1. A component PSO must:
2. maintain patient safety work product separately from the rest of the parent organization(s) of which it is a part;
3. No conflict of interest. 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.
(d) Required notifications. PSOs must meet the following notification requirements:
1. Notification regarding PSO compliance with the minimum contract requirement. No later than 45 calendar days prior to the last day of the applicable 24-month assessment period, specified in paragraph (b)(2)(iii) of this section, the Secretary must receive from a PSO a certification that states whether it has met the requirement of that paragraph regarding two bona fide contracts, in accordance with § 3.112 of this subpart.
2. Notification regarding a PSO's relationships with its contracting providers. A PSO must submit to the Secretary a disclosure statement, in accordance with § 3.112 of this subpart, regarding its relationships with each provider with which the PSO has a contract pursuant to the Patient Safety Act if the circumstances described in either paragraph (d)(2)(i) or (d)(2)(ii) of this section are applicable. The Secretary must receive a disclosure statement within 45 days of the date on which a PSO enters a contract with a provider if the circumstances are met on the date the contract is entered. During the contract period, if a PSO subsequently enters one or more relationships with a contracting provider that create the circumstances described in paragraph (d)(2)(i) of this section or a provider exerts any control over the PSO of the type described in paragraph (d)(2)(ii) of this section, the Secretary must receive a disclosure statement from the PSO within 45 days of the date that the PSO entered each new relationship or of the date on which the provider imposed control of the type described in paragraph (d)(2)(ii).
  1. Taking into account all relationships that the PSO has with the provider, other than the bona fide contract entered into pursuant to the Patient Safety Act, the PSO must fully disclose any other contractual, financial, or reporting relationships described below that it has with that provider.
  2. Taking into account all relationships that the PSO has with the provider, the PSO must fully disclose if it is not independently managed or controlled, or if it does not operate independently from, the contracting provider. In particular, the PSO must further disclose whether the contracting provider has exercised or imposed any type of management control that could limit the PSO's ability to fairly and accurately perform patient safety activities and fully describe such control(s).
  3. PSOs may also describe or include in their disclosure statements, as applicable, any agreements, stipulations, or procedural safeguards that have been created to protect the ability of the PSO to operate independently or information that indicates the limited impact or insignificance of its financial, reporting, or contractual relationships with a contracting provider.

§ 3.104 Secretarial actions.

Actions in response to certification submissions for initial and continued listing as a PSO.
1. In response to an initial or continued certification submission by an entity, pursuant to the requirements of § 3.102 of this subpart, the Secretary may -
  1. accept the certification submission and list the entity as a PSO, or maintain the listing of a PSO, if the Secretary determines that the entity meets the applicable requirements of the Patient Safety Act and this subpart;
  2. deny acceptance of a certification submission and, in the case of a currently listed PSO, remove the entity from the list if the entity does not meet the applicable requirements of the Patient Safety Act and this subpart; or
  3. condition the listing of an entity, or continued listing of a PSO, following a determination made pursuant to paragraph (c) of this section.
2. Basis of determination. In making a determination regarding listing, the Secretary will consider the certification submission; any prior actions by the Secretary regarding the entity or PSO including delisting; any history of or current non-compliance by the entity or the PSO with statutory requirements or requests from the Secretary ; the relationships of the entity or PSO with providers; and any findings made by the Secretary ²⁶ in accordance with paragraph (c) of this section.
3. Notification. The Secretary will notify in writing each entity of action taken on its certification submission for initial or continued listing. The Secretary will provide reasons when an entity's certification is conditionally accepted and the entity is conditionally listed, when an entity's certification is not accepted and the entity is not listed, or when acceptance of its certification is revoked and the entity is delisted.
Actions regarding PSO compliance with the minimum contract requirement. When the Secretary receives notification required by § 3.102(d)(1) of this subpart that the PSO has met the minimum contract requirement, the Secretary will acknowledge in writing receipt of the notification and add information to the list established pursuant to paragraph (d) of this section stating that the PSO has certified that it has met the requirement. If the PSO states that it has not yet met the minimum contract requirement, or if notice is not received by the date specified in § 3.102(d)(1) of this subpart, the Secretary will issue to the PSO a notice of a preliminary finding of deficiency as specified in § 3.108(a)(2) and establish a period for correction that extends until midnight of the last day of the PSO's applicable 24-month period of assessment. Immediately thereafter, if the requirement has not been met, the Secretary will provide the PSO a written notice of proposed revocation and delisting in accordance with in § 3.108(a)(3) of this subpart.
Actions regarding required disclosures by PSOs of relationships with contracting providers.The Secretary will review and make findings regarding each disclosure statement submitted by a PSO, pursuant to § 3.102(d)(2) of this subpart, regarding its relationships with contracting provider(s), determine whether such findings warrant action regarding the listing of the PSO, and make the findings public.
1. Determination by the Secretary. Based on the Secretary's review and findings, he may choose to take any of the following actions:
  1. For an entity seeking an initial or continued listing, the Secretary may list or continue the listing of an entity without conditions, list the entity subject to conditions, or deny the entity's certification for initial or continued listing; or
  2. For a listed PSO, the Secretary may determine that the entity will remain listed without conditions, continue the entity's listing subject to conditions, or remove the entity from listing.
2. Release of disclosure statements and Secretarial findings.
  1. Subject to paragraph (3)(ii) of this section, the Secretary will make disclosure statements available to the public along with related findings that are made available in accordance with paragraph (c) of this section.
  2. The Secretary may withhold information that is exempt from public disclosure under the Freedom of Information Act.
Maintaining a list of PSOs. The Secretary will compile and maintain a publicly available list of entities whose certifications as PSOs have been accepted. The list will include contact information for each entity, a copy of all certification forms and disclosure statements submitted by each entity, the effective date of the PSO's listing, and information on whether a PSO has certified that it has met the two contract requirement. The list also will include a copy of the Secretary's findings regarding each disclosure statement submitted by an entity, information describing any related conditions that have been placed by the Secretary on the listing of an entity as a PSO, and other information that this Subpart states may be made public. AHRQ will establish a PSO website (or a comparable future form of public notice) and may post the list on this website.
Three-year period of listing.
1. The period of listing of a PSO will be for a three-year period, unless the listing is revoked or relinquished prior to the expiration of the three-year period, in accordance with § 3.108 of this subpart.
2. The Secretary will send a written notice of imminent expiration to a PSO at least 45 calendar days prior to the date on which its three-year period of listing expires if the Secretary has not received a certification for continued listing.
Effective dates of Secretarial actions. Unless otherwise stated, the effective date of each action by the Secretary pursuant to this subpart will be specified in the written notice of such action that is sent to the entity. When the Secretary sends a notice that addresses acceptance or revocation of an entity's certifications or voluntary relinquishment by an entity of its status as a PSO, the notice will specify the effective date and time of listing or delisting.

§3.108 Correction of deficiencies, revocation, and voluntary relinquishment.

Process for correction of a deficiency and revocation.
1. Circumstances leading to revocation. The Secretary may revoke his acceptance of an entity's certification and delist the entity as a PSO if he determines -
  1. The PSO is not fulfilling the certifications it made to the Secretary that are set forth in § 3.102 of this subpart;
  2. The PSO has not timely notified the Secretary that it has met the two contract requirement, as required by § 3.102(d)(1) of this subpart;
  3. The Secretary, based on a PSO's disclosures made pursuant to § 3.102(d)(2) of this subpart, makes a public finding that the entity cannot fairly and accurately perform the patient safety activities of a PSO; or
  4. The PSO is not in compliance with any other provision of the Patient Safety Act or this Part.
2. Notice of preliminary finding of deficiency and establishment of an opportunity for correction of a deficiency.
  1. If the Secretary determines that a PSO is not in compliance with its obligations under the Patient Safety Act or this Subpart, the Secretary must send a PSO written notice of the preliminary finding of deficiency. The notice must state the actions or inactions that encompass the deficiency finding, outline the evidence that the deficiency exists, specify the possible and/or required corrective actions that must be taken, and establish a date by which the deficiency must be corrected. The Secretary may specify in the notice the level of documentation required to demonstrate that the deficiency has been corrected.
  2. The notice of a preliminary finding of deficiency is presumed received five days after it is sent, absent evidence of the actual receipt date. If a PSO does not submit evidence to the Secretary within 14 calendar days of actual or constructive receipt of such notice, whichever is longer, which demonstrates that the preliminary finding is factually incorrect, the preliminary finding will be the basis for a finding of deficiency.
3. Determination of correction of a deficiency.
  1. Unless the Secretary specifies another date, the Secretary must receive documentation to demonstrate that the PSO has corrected the deficiency no later than five calendar days following the last day of the correction period, that is specified by the Secretary in the notice of preliminary finding of deficiency.
  2. In making a determination regarding the correction of any deficiency, the Secretary will consider the documentation submitted by the PSO, the findings of any site visit that he determines is necessary or appropriate, recommendations of program staff, and any other information available regarding the PSO that the Secretary deems appropriate and relevant to the PSO's implementation of the terms of its certification.
  3. After completing his review, the Secretary may make one of the following determinations:
    1. the action(s) taken by the PSO have corrected any deficiency, in which case the Secretary will withdraw the notice of deficiency and so notify the PSO;
    2. the PSO has acted in good faith to correct the deficiency but the Secretary finds an additional period of time is necessary to achieve full compliance and/or the required corrective action specified in the notice of a preliminary finding of deficiency needs to be modified in light of the experience of the PSO in attempting to implement the corrective action, in which case the Secretary will extend the period for correction and/or modify the specific corrective action required; or
    3. the PSO has not completed the corrective action because it has not acted with reasonable diligence or speed to ensure that the corrective action was completed within the allotted time, in which case the Secretary will issue to the PSO a notice of proposed revocation and delisting.
  4. When the Secretary issues a written notice of proposed revocation and delisting, the notice will specify the deficiencies that have not been timely corrected and will detail the manner in which the PSO may exercise its opportunity to be heard in writing to respond to the deficiencies specified in the notice.
4. Opportunity to be heard in writing following a notice of proposed revocation and delisting. The Secretary will afford a PSO an opportunity to be heard in writing, as specified in paragraph (a)(4)(i) of this section, to provide a substantive response to the deficiency finding(s) set forth in the notice of proposed revocation and delisting.
  1. The notice of proposed revocation and delisting is presumed received five days after it is sent, absent evidence of actual receipt. The Secretary will provide a PSO with a period of time, beginning with the date of receipt of the notice of proposed revocation and delisting of which there is evidence, or the presumed date of receipt if there is no evidence of earlier receipt, and ending at midnight 30 calendar days thereafter, during which the PSO can submit a substantive response to the deficiency findings in writing.
  2. The Secretary will provide to the PSO rules of procedure governing the form or transmission of the written response to the notice of proposed revocation and delisting. The Rules may also be posted on the AHRQ PSO website or published in the Federal Register.
  3. If a PSO does not submit a written response to the deficiency finding(s) within 30 calendar days of receipt of the notice of proposed revocation and delisting, the notice of proposed revocation becomes final as a matter of law and the basis for Secretarial action under paragraph (b)(1) of this section.
5. The Secretary's decision regarding revocation. The Secretary will review the entire administrative record pertaining to a notice of proposed revocation and delisting and any written materials submitted by the PSO under paragraph (a)(4) of this section. The Secretary may affirm, reverse, or modify the notice of proposed revocation and delisting and will make a determination with respect to the continued listing of the PSO.
Revocation of the Secretary's acceptance of a PSO's certifications.
1. Establishing revocation for cause. When the Secretary concludes, in accordance with a decision made under paragraph (a)(5) of this section, that revocation of the acceptance of a PSO's certification is warranted for its failure to comply with requirements of the Patient Safety Act or of this Subpart, the Secretary will establish the time and date for the prompt revocation and removal of the entity from the list of PSOs, so notify the PSO in writing, and provide the relevant public notice required by § 3.108(d) of this subpart.
2. Required notification of providers and status of data. Within 15 days of being notified of the Secretary's action pursuant to paragraph (b)(1) of this section, an entity subject to paragraph (b)(1) of this section will submit to the Secretary confirmation that it has taken all reasonable actions to notify each provider, whose patient safety work product it collected or analyzed, of the Secretary's action(s). Confidentiality and privilege protections that applied to patient safety work product while the former PSO was listed continue to apply after the entity is removed from listing. Data submitted by providers to the former PSO within 30 calendar days of the date on which it is removed from the list of PSOs pursuant to paragraph (b)(1) of this section will have the same status as data submitted while the entity was still listed.
3. Disposition of patient safety work product and data. Following revocation and delisting pursuant to paragraph (b)(1) of this section, the former PSO will take one or more of the following measures:
  1. Transfer such patient safety work product or data, with the approval of the source from which it was received, to a PSO that has agreed to receive such patient safety work product or data;
  2. Return such work product or data to the source from which it was submitted; or
  3. If returning such patient safety work product or data to its source is not practicable, destroy such patient safety work product or data.
Voluntary relinquishment.
1. Circumstances constituting voluntary relinquishment. A PSO will be considered to have voluntarily relinquished its status as a PSO if the Secretary accepts a notification from a PSO that it wishes to relinquish voluntarily its listing as a PSO or the Secretary determines that an implied voluntary relinquishment has taken place because the period of listing of a PSO has expired without receipt of a timely submission of certifications for continued listing.
2. Notification of voluntary relinquishment. A PSO's notification of voluntary relinquishment to the Secretary must include the following:
  1. An attestation that all reasonable efforts have been made, or will have been made by a PSO within 15 calendar days of this statement, to notify the sources from which it received patient safety work product or data of the PSO's intention to cease operations, to relinquish voluntarily its status as a PSO, to request that these other entities cease reporting or submitting any further information to the PSO as soon as possible, and inform them that any data submitted after the effective date and time of delisting, that the Secretary sets pursuant to paragraph (c)(3) of this section, will not be protected as patient safety work product under the Patient Safety Act based upon such submissions;
  2. An attestation that the entity has established a plan, or within 15 calendar days of this statement, will have made all reasonable efforts to establish a plan, in consultation with the sources from which it received patient safety work product or data, that provides for the disposition of such patient safety work product or data consistent with, to the extent practicable, the statutory options for disposition of patient safety work product or data as set out in paragraphs (b)(3)(i) through (iii) of this section; and
  3. Appropriate contact information for further communications from the Secretary.
3. Response to notification of voluntary relinquishment.
  1. After a PSO provides the notification required by paragraph (c)(2) of this section, the Secretary will respond in writing to the entity indicating whether the proposed voluntary relinquishment of its PSO status is accepted. If the voluntary relinquishment is accepted, the Secretary's response will indicate an effective date and time for the entity's removal from the list of PSOs and will provide public notice of the delisting, in accordance with § 3.108(d) of this subpart.
  2. If the Secretary receives a notification of voluntary relinquishment during or immediately after revocation proceedings for cause under paragraphs (a)(4) and (a)(5) of this section, the Secretary, as a matter of discretion, may accept voluntary relinquishment in accordance with the preceding paragraph or decide not to accept the entity's proposed voluntary relinquishment and proceed with the revocation for cause and delisting pursuant to paragraph (b)(1) of this section.
4. Implied voluntary relinquishment.
  1. If the period of listing of a PSO lapses without timely receipt and acceptance by the Secretary of a certification seeking continued listing or timely receipt of a notification of voluntary relinquishment of its PSO status in accordance with paragraph (c)(2) of this section, the Secretary will determine that voluntary relinquishment has occurred and will remove the entity from the list of PSOs effective as of midnight on the last day of its three-year period of listing. The Secretary will take reasonable measures to notify the entity of its delisting and will provide public notice of the delisting in accordance with § 3.108 (d) of this subpart.
  2. The Secretary will request in the notice to the entity that it make reasonable efforts to comply with the requirements of paragraph (c)(2) of this section with respect to notification, appropriate disposition of patient safety work product, and the provision of contact information to the Secretary.
5. Non-applicability of certain procedures and requirements.
  1. A decision by the Secretary to accept a request by a PSO to relinquish voluntarily its status as a PSO pursuant to paragraph (c)(2) of this section or a decision that voluntary relinquishment has occurred pursuant to paragraph (c)(4) of this section does not constitute a determination of a deficiency in PSO compliance with the Patient Safety Act or with this Subpart and no opportunity for corrective action by the PSO is required.
  2. The procedures and requirements of § 3.108(a) of this subpart regarding deficiencies including the opportunity to be heard in writing, and those that are based upon determinations of the Secretary pursuant to § 3.108(b)(1) of this subpart are not applicable to determinations of the Secretary made pursuant to paragraph (c) of this section.
6. Public notice of delisting regarding removal from listing. If the Secretary removes an entity from the list of PSOs following revocation of acceptance of the entity's certification pursuant to § 3.108(b)(1) of this subpart or following a determination of voluntary relinquishment pursuant to §§ 3.108(c)(3) or (c)(4) of this subpart, the Secretary will promptly publish in the Federal Register and on the AHRQ PSO website, or in a comparable future form of public notice, established pursuant to §3.104(d) of this subpart, a notice of the actions taken and the effective dates.

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