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pso.ahrq.gov/become/assess-compatibility
August 01, 2021 - Below are examples of just a few of the Patient Safety Rule requirements that need to be considered when … in section 3.212) ); and the security requirements ( section 3.106 ). … PSWP may only be permissibly disclosed if the contemplated disclosure fits all of the requirements of … to any Federal Food, Drug, and Cosmetic Act (FDA) reporting requirements. … See HIPAA Security Rule requirements for information.
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pso.ahrq.gov/sites/default/files/wysiwyg/pso-listing-guide-2022.pdf
January 01, 2022 - Requirements Specific to Component PSOs
In addition to the 15 general PSO certification requirements … Page 31
https://pso.ahrq.gov/faq/staffing-and-personnel-requirements
https://pso.ahrq.gov/faq/staffing-and-personnel-requirements … https://pso.ahrq.gov/faq/additional-requirements
https://pso.ahrq.gov/faq/additional-requirements
https … Security Requirements
(Section 3.106 of the Patient Safety Rule)
Application
Row Security
Requirements … These
requirements must
Has the PSO established security standards that meet the requirements of this
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pso.ahrq.gov/sites/default/files/wysiwyg/PSO-listing-guide-2022.pdf
January 01, 2022 - Requirements Specific to Component PSOs
In addition to the 15 general PSO certification requirements … Page 31
https://pso.ahrq.gov/faq/staffing-and-personnel-requirements
https://pso.ahrq.gov/faq/staffing-and-personnel-requirements … https://pso.ahrq.gov/faq/additional-requirements
https://pso.ahrq.gov/faq/additional-requirements
https … Security Requirements
(Section 3.106 of the Patient Safety Rule)
Application
Row Security
Requirements … These
requirements must
Has the PSO established security standards that meet the requirements of this
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pso.ahrq.gov/become/assess-eligibility
August 01, 2021 - Eligibility to Become a PSO
Assess Compatibility of Anticipated PSO Operations with Patient Safety Rule Requirements … accredits or licenses healthcare providers
An entity that oversees or enforces statutory or regulatory requirements … The following sections provide more information about the requirements for listing as a component PSO … Requirements Specific to Component PSOs
In addition to the 15 general PSO certification requirements … There are additional requirements and restrictions on such arrangements if the PSO is a component of
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pso.ahrq.gov/sites/default/files/wysiwyg/saguide.pdf
September 01, 2009 - , and other regulatory requirements) are addressed in Table
1. … The requirements listed in Table 4 parallel
those in Table 1. … Additional Requirements That Apply to All Component PSOs
The following requirements (Rows #16–#19) only … All component PSOs also must meet requirements applicable to all PSOs (Rows #1–#15). … Several notification requirements do not require the use of a specific
form.
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pso.ahrq.gov/sites/default/files/wysiwyg/PSO_Voluntary_Relinquishment.pdf
January 03, 2022 - entity’s certification submission and determines that
it meets the applicable statutory and regulatory requirements … A PSO can be “delisted” by the Secretary if: (a)
the PSO no longer meets the requirements of the Patient … The
requirements for seeking voluntary relinquishment can be found at section 3.108(c) of the Patient … PART III: ATTESTATIONS REGARDING DISPOSITION REQUIREMENTS … as well as the terms of its business associate
agreements and all applicable HIPAA requirements.
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pso.ahrq.gov/faq
April 01, 2023 - with the Patient Safety Rule's disposition requirements for PSWP? … The disposition requirements for PSWP preempt any conflicting state requirements for disposition of information … Listing Process and Requirements
Who can seek listing as a PSO? … What are the requirements to be a PSO? … Are there additional requirements for a component organization?
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pso.ahrq.gov/sites/default/files/wysiwyg/guidance-pswp-provider-obligations.pdf
May 24, 2016 - Later Developing Requirements
6
Background
1. … Later Developing Requirements (2)
1. … Later Developing Requirements (3)
2. … Later Developing Requirements (4)
3. … Later Developing Requirements (4)
Resources
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pso.ahrq.gov/become
March 01, 2022 - Eligibility to Become a PSO
Assess Compatibility of Anticipated PSO Operations with Patient Safety Rule Requirements … Become a PSO is an informal educational resource for those interested in learning about the requirements … Eligibility to Become a PSO
Assess Compatibility of Anticipated PSO Operations with Patient Safety Rule Requirements
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pso.ahrq.gov/become/establish-policies
August 01, 2021 - Eligibility to Become a PSO
Assess Compatibility of Anticipated PSO Operations with Patient Safety Rule Requirements … policies and procedures must include and provide for compliance with the confidentiality and security requirements … also requires the applicant to certify that, if listed as a PSO, it will also comply with the seven requirements … Eligibility to Become a PSO
Assess Compatibility of Anticipated PSO Operations with Patient Safety Rule Requirements
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pso.ahrq.gov/sites/default/files/wysiwyg/what-is-the-role-of-ao.pdf
July 01, 2021 - commitments on behalf of the entity—referred to as “Authorized Official” or AO—to complete
certain requirements … entities excluded from listing as a PSO;
• Certify that the entity meets all 15 general PSO certification requirements … AHRQ during the PSO’s period of listing if:
o the PSO cannot comply with any of its attestations or requirements … In general, these above requirements are captured in the Certification for Initial Listing form. … entity must notify AHRQ…
The AO must understand the basic concepts of the Patient Safety Rule and the requirements
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pso.ahrq.gov/become/submit-certification
August 01, 2021 - Eligibility to Become a PSO
Assess Compatibility of Anticipated PSO Operations with Patient Safety Rule Requirements … calls with the AHRQ PSO team provide an informal opportunity to discuss specific questions about the requirements … Eligibility to Become a PSO
Assess Compatibility of Anticipated PSO Operations with Patient Safety Rule Requirements
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pso.ahrq.gov/sites/default/files/wysiwyg/Role%20of%20AO_July%202016_FINAL.pdf
July 01, 2016 - of the entity – referred to as “Authorized Official” or “AO” – to
complete certain requirements … listing as a PSO;
Certify that the entity meets all 15 general PSO certification requirements … period of
listing if:
o the PSO cannot comply with any of its attestations or requirements … In general, these above requirements are captured in the Certification for Initial Listing … is to be sure you understand
the basic concepts of the Patient Safety Rule and the requirements
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pso.ahrq.gov/sites/default/files/wysiwyg/what-is-the-role-of-ao-june-2017.pdf
January 01, 2017 - commitments on behalf of the entity—referred to as “Authorized Official” or AO—to complete
certain requirements … entities excluded from listing as a PSO;
• Certify that the entity meets all 15 general PSO certification requirements … AHRQ during the PSO’s period of listing if:
o the PSO cannot comply with any of its attestations or requirements … In general, these above requirements are captured in the Certification for Initial Listing form. … must notify AHRQ…
The AO must understand the basic concepts of the Patient Safety Rule and the requirements
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pso.ahrq.gov/sites/default/files/wysiwyg/PSO_InitialListing.pdf
February 15, 2022 - This form sets forth the requirements that all entities seeking listing as a PSO must certify they meet … of health care services;
- An agent of an entity that oversees or enforces statutory or regulatory
requirements … Food and Drug Administration (FDA) reporting
requirements under the Federal Food, Drug, and Cosmetic … of health care services;
An agent of an entity that oversees or enforces statutory or regulatory
requirements … health care providers; oversight
or enforcement, including as an agent, of statutory or regulatory requirements
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pso.ahrq.gov/sites/default/files/wysiwyg/fda-guidance-pso.pdf
December 01, 2010 - For example, FDA-regulated device manufacturers
who are subject to FDA medical device reporting requirements … The FDA Exception
The confidentiality requirements of the Patient Safety Act do not apply to or prohibit … Entities that wish to be component PSOs must meet these criteria as well as additional
requirements … One of these additional
requirements is the requirement that “the mission of the [component PSO] does … The PSWP that is
relevant depends upon the specific FDA requirements relating to the entity.
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pso.ahrq.gov/sites/default/files/wysiwyg/PSO_ContinuedListing.pdf
February 15, 2022 - This form sets forth the requirements that all PSOs seeking continued listing must certify they meet … attesting that the PSO remains
in compliance with all of its prior attestations and the applicable requirements … of health care services;
- An agent of an entity that oversees or enforces statutory or regulatory
requirements … b) will continue to comply throughout
the period of continued listing, with each of the additional requirements … Food and Drug Administration (FDA) reporting
requirements under the Federal Food, Drug, and Cosmetic
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pso.ahrq.gov/sites/default/files/wysiwyg/PSO_Disclosure.pdf
October 12, 2022 - consisting of this form and the accompanying attachment for each
provider to which the disclosure requirements … Office to discuss the nature of your
disclosure or to clarify any issues or concerns about disclosure requirements … attachment must include the following substantive information in two parts in sufficient detail
to meet the requirements … ) that create,
or contain, any of the types of relationships that must be disclosed based upon the requirements … ______________________
(fill in date)
Required Attachment: A disclosure statement that meets the requirements
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pso.ahrq.gov/become/select-authorized-official
August 01, 2021 - Eligibility to Become a PSO
Assess Compatibility of Anticipated PSO Operations with Patient Safety Rule Requirements … Eligibility to Become a PSO
Assess Compatibility of Anticipated PSO Operations with Patient Safety Rule Requirements
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pso.ahrq.gov/resources/acronyms
August 01, 2021 - Section 3.208 of the Patient Safety Rule describes the continued privilege and confidentiality requirements … First, when information meets all of the applicable requirements of the definition of PSWP, any copy … While, if the pertinent Patient Safety Rule requirements are met, the copy in the PSES is protected, … Patient safety work product that contains protected health information (PHI) is subject to the requirements … For details on what information can, and cannot, become PSWP, the applicable process and purpose requirements