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1. Patient Safety Organization: Disclosure Statement (pdf file)
   pso.ahrq.gov/sites/default/files/wysiwyg/PSO_Disclosure.pdf
   October 12, 2022 - https://pso.ahrq.gov/sites/default/files/wysiwyg/Patient-Safety-Rule-2008.pdf https://pso.ahrq.gov

2. Patient Safety Organization: Two Bona Fide Contracts Requirement (pdf file)
   pso.ahrq.gov/sites/default/files/wysiwyg/PSO_BonaFideContracts.pdf
   January 21, 2021 - Yes No https://pso.ahrq.gov/ https://pso.ahrq.gov/sites/default/files/wysiwyg/Patient-Safety-Rule

3. PSO: Certification of Continued Listing (pdf file)
   pso.ahrq.gov/sites/default/files/wysiwyg/PSO_ContinuedListing.pdf
   February 15, 2022 - street address) City State Zip Code Phone Extension (if applicable) https://pso.ahrq.gov/sites/default/files … Yes No https://pso.ahrq.gov/sites/default/files/wysiwyg/PSO_Disclosure.pdf https://pso.ahrq.gov … /sites/default/files/wysiwyg/PSO_Disclosure.pdf https://www.psoppc.org/psoppc_web/publicpages/commonFormatsOverview

4. Patient Safety Organization: Change of Listing Information (pdf file)
   pso.ahrq.gov/sites/default/files/wysiwyg/PSO_ChangeOfListingInfo.pdf
   December 17, 2021 - Address Phone Extension (if applicable) Reason for change(s) https://pso.ahrq.gov/sites/default/files

5. Patient Safety Organization: Certification for Initial Listing (pdf file)
   pso.ahrq.gov/sites/default/files/wysiwyg/PSO_InitialListing.pdf
   February 15, 2022 - Zip Code Phone Extension (if applicable) https://pso.ahrq.gov https://pso.ahrq.gov/sites/default/files … from PSO) Phone Extension (if applicable) Email Page 2 of 8 https://pso.ahrq.gov/sites/default/files … https://pso.ahrq.gov/sites/default/files/wysiwyg/PSO_Disclosure.pdf … https://www.psoppc.org/psopps_web/publicpages/commonFormatsOverview https://pso.ahrq.gov/sites/default/files

6. Patient Safety Organization: Request For Voluntary Relinquishment (pdf file)
   pso.ahrq.gov/sites/default/files/wysiwyg/PSO_Voluntary_Relinquishment.pdf
   January 03, 2022 - Address City State Zip Code Phone Extension (if applicable) https://pso.ahrq.gov/sites/default/files

7. Patient Safety Organizations: A Compliance Self-Assessment Guide (pdf file)
   pso.ahrq.gov/sites/default/files/wysiwyg/saguide.pdf
   September 01, 2009 - If the PSO merges patient safety work product with non-patient safety work product files, and the

8. Choosing a Patient Safety Organization (pdf file)
   pso.ahrq.gov/sites/default/files/wysiwyg/pso-brochure.pdf
   March 01, 2020 - Choosing a Patient Safety Organization Choosing a Patient Safety Organization Background You are committed to making healthcare safer and better for your patients. One of the challenges to achieving this goal is the concern that patient safety information that you or your organization create as part of the ca…

9. PSO Program - Common Terms and Acronyms (pdf file)
   pso.ahrq.gov/sites/default/files/pso-program-acronyms.pdf
   March 01, 2017 - PSO Program - Common Terms and Acronyms                                                                                                                                                                                                                                                                                 …

10. Choosing a Patient Safety Organization: Tips for Hospitals and Health Care Providers (pdf file)
    pso.ahrq.gov/sites/default/files/Choosing%20a%20PSO.pdf
    August 01, 2012 - Choosing a Patient Safety Organization: Tips for Hospitals and Health Care Providers Background The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) authorized the creation of Patient Safety Organizations (PSOs). It encourages clinicians and health care organizations to voluntarily report to…

11. Choosing a Patient Safety Organization: Tips for Hospitals and Health Care Providers (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/ChoosingPSO_2016.pdf
    January 01, 2016 - Choosing a Patient Safety Organization: Tips for Hospitals and Health Care Providers Background Your organization is committed to making health care better and safer for your patients. But achieving this goal is no small feat. You and your staff must collect data, identify quality and safety problems, design impr…

12. Fedregnotice-05242016 (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/fedregnotice-05242016.pdf
    January 04, 2024 - 32655 Federal Register / Vol. 81, No. 100 / Tuesday, May 24, 2016 / Rules and Regulations 1 Institute of Medicine, ‘‘To Err Is Human: Building a Safer Health System’’, 1999, page 86. 2 42 CFR 482.21(a)(2). 3 As of November 2014, 26 states and the District of Columbia had adverse event reporting systems, and Te…

13. Patient Safety and Quality Improvement Act of 2005; Public Law 109–41, July 29, 2005 (pdf file)
    pso.ahrq.gov/sites/default/files/Patient%20Safety%20Act%20PDF.pdf
    January 01, 2024 - Patient Safety and Quality Improvement Act of 2005; Public Law 109–41, July 29, 2005 PUBLIC LAW 109–41—JULY 29, 2005 PATIENT SAFETY AND QUALITY IMPROVEMENT ACT OF 2005 VerDate 14-DEC-2004 11:17 Aug 05, 2005 Jkt 039139 PO 00041 Frm 00001 Fmt 6579 Sfmt 6579 E:\PUBLAW\PUBL041.109 APPS10 PsN: PUBL041 119 STAT. 424 P…

14. PSO Program - Common Terms and Acronyms (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/pso-program-acronyms.pdf
    October 01, 2022 - PSO Program - Common Terms and Acronyms Page 1 of 6 PSO PROGRAM: COMMON TERMS AND ACRONYMS [Note: Terms used in the Patient Safety Act or Rule are summarized here solely for convenience and may be defined in the statute or rule. You should always rely on the actual definition when making any determination. The …

15. U.S. Department of Health and Human Services Guidance Regarding Patient Safety Organizations' Reporting Obligations and the Patient Safety and Quality Improvement Act of 2005 (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/fda-guidance-pso.pdf
    December 01, 2010 - its implementing regulations, device manufacturers are required to establish and maintain MDR event files … and complaint files, and must also establish and maintain procedures for receiving, reviewing, and … any authorized FDA employee, at all reasonable times, to access, to copy, and to verify MDR event files … Thus, FDA may inspect facilities and any adverse event/complaint files, including files containing PSWP … related to its products, including files containing PSWP that it creates or receives as a PSO or that

16. PSO Quiz--Question Sheet (pdf file)
    pso.ahrq.gov/sites/default/files/quiz/pso-quiz-questions.pdf
    January 01, 2020 - PSO Quiz--Question Sheet QUIZ —QUESTION SHEET Page 1 of 3 Question 1 of 12 A PSO that changes its Authorized Official is expected to notify AHRQ of the change no later than when the PSO submits its next certifications for continued listing. Choose one: True False Question 2 of 12 A PSO should notif…

17. Working With a PSO: One Approach (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/WorkingWithAPSOOneApproach-20160317.pdf
    January 01, 2016 - Working With a PSO: One Approach Working With a PSO: One Approach PSWP Protected Patient Safety and Quality Information Information Triaged by Provider PSOPPC NPSD Information Eligible to Become PSWP ■ Could improve safety, quality, or outcomes of health care; and ■ Assembled or developed solely for reportin…

18. PSO Quiz--Answer Sheet (pdf file)
    pso.ahrq.gov/sites/default/files/quiz/pso-quiz-answer-sheet.pdf
    January 01, 2020 - PSO Quiz--Answer Sheet QUIZ —AN…

19. Patient Safety Organization (PSO) Listing Guide (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/pso-listing-guide-2022.pdf
    January 01, 2022 - /wysiwyg/NPRM-2008.pdf https://pso.ahrq.gov/sites/default/files/wysiwyg/Patient-Safety-Rule-2008.pdf … https://pso.ahrq.gov/sites/default/files/wysiwyg/pso-policies-procedures-topics-to-address.pdf https … sites/default/files/wysiwyg/fda-guidance-pso.pdf https://pso.ahrq.gov/sites/default/files/wysiwyg/fda-guidance-pso.pdf … /sites/default/files/wysiwyg/PSO_BonaFideContracts.pdf https://pso.ahrq.gov/sites/default/files/wysiwyg … /files/wysiwyg/Patient-Safety-Rule-2008.pdf https://pso.ahrq.gov/sites/default/files/wysiwyg/Patient-Safety-Rule

20. Patient Safety Organization (PSO) Listing Guide (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/PSO-listing-guide-2022.pdf
    January 01, 2022 - /wysiwyg/NPRM-2008.pdf https://pso.ahrq.gov/sites/default/files/wysiwyg/Patient-Safety-Rule-2008.pdf … https://pso.ahrq.gov/sites/default/files/wysiwyg/pso-policies-procedures-topics-to-address.pdf https … sites/default/files/wysiwyg/fda-guidance-pso.pdf https://pso.ahrq.gov/sites/default/files/wysiwyg/fda-guidance-pso.pdf … /sites/default/files/wysiwyg/PSO_BonaFideContracts.pdf https://pso.ahrq.gov/sites/default/files/wysiwyg … /files/wysiwyg/Patient-Safety-Rule-2008.pdf https://pso.ahrq.gov/sites/default/files/wysiwyg/Patient-Safety-Rule