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Total Results: 17 records

Showing results for "drug".

1. HHS Guidance | PSO
   pso.ahrq.gov/resources/hhs-guidance
   August 01, 2022 - of 2005—HHS Guidance Regarding Patient Safety Organizations' Reporting Obligations to the Food and Drug … where they or the organization of which they are a part are legally obligated under the Federal Food, Drug … U.S.C. § 301 et seq., and its implementing regulations to report certain information to the Food and Drug … entities that seek to be or are PSOs that: have mandatory FDA-reporting obligations under the Food, Drug

2. 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 - where they or the organization of which they are a part are legally obligated under the Federal Food, Drug … U.S.C. § 301 et seq., and its implementing regulations to report certain information to the Food and Drug … of the Patient Safety Act do not apply to or prohibit a “[d]isclosure by a provider to the Food and Drug … Administration with respect to a product or activity regulated by the Food and Drug Administration. … shall be construed . . . to limit, alter, or affect any requirement for reporting to the Food and Drug

3. Strategies to Improve Patient Safety: Draft Report to Congress for Public Comment and Review by the National Academy of Medicine (pdf file)
   pso.ahrq.gov/sites/default/files/wysiwyg/strategies-to-improve-patient-safety_draft-report.pdf
   December 21, 2021 - Last reviewed September 2018. 75 US Food and Drug Administration. … Medication errors related to CEDR-regulated drug products. … https://www.fda.gov/drugs/drug-safety-and-availability/medication-errors-related-cder-regulated-drug-products … Last reviewed November 28, 2018. 34 https://www.fda.gov/drugs/drug-safety-and-availability/medication-errors-related-cder-regulated-drug-products … Adverse Drug Events: General Medication Topics Table 2.

4. Resources About the Patient Safety and Quality Improvement Act of 2005 | PSO
   pso.ahrq.gov/resources/psqia
   August 01, 2022 - Guidance HHS Guidance Regarding Patient Safety Organizations' Reporting Obligations to the Food and Drug

5. 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, 2025 - PUBL041 119 STAT. 428 PUBLIC LAW 109–41—JULY 29, 2005 ‘‘(D) Disclosure by a provider to the Food and Drug … Administration with respect to a product or activity regu- lated by the Food and Drug Administration … safety work product; or ‘‘(6) to limit, alter, or affect any requirement for reporting to the Food and Drug … Administration information regarding the safety of a product or activity regulated by the Food and Drug

6. PSO: Certification of Continued Listing (pdf file)
   pso.ahrq.gov/sites/default/files/wysiwyg/PSO_ContinuedListing.pdf
   September 30, 2024 - Food and Drug Administration (FDA) reporting requirements under the Federal Food, Drug, and Cosmetic … Act and its implementing regulations (e.g., drug, device, and biological product manufacturers), “

7. Patient Safety and Quality Improvement Act of 2005; Public Law 109–41, July 29, 2005 (pdf file)
   pso.ahrq.gov/sites/default/files/wysiwyg/Patient-Safety-Act-2005.pdf
   January 01, 2005 - PUBL041 119 STAT. 428 PUBLIC LAW 109–41—JULY 29, 2005 ‘‘(D) Disclosure by a provider to the Food and Drug … Administration with respect to a product or activity regu- lated by the Food and Drug Administration … safety work product; or ‘‘(6) to limit, alter, or affect any requirement for reporting to the Food and Drug … Administration information regarding the safety of a product or activity regulated by the Food and Drug

8. Assess Compatibility of Anticipated PSO Operations with Patient Safety Rule Requirements | PSO
   pso.ahrq.gov/become/assess-compatibility
   August 01, 2021 - Requirements Another issue to consider is whether the entity seeking listing is subject to any Federal Food, Drug

9. Patient Safety Organization: Certification for Initial Listing (pdf file)
   pso.ahrq.gov/sites/default/files/wysiwyg/PSO_InitialListing.pdf
   September 30, 2024 - Food and Drug Administration (FDA) reporting requirements under the Federal Food, Drug, and Cosmetic … Act and its implementing regulations (e.g., drug, device, and biological product manufacturers), “

10. Artificial Intelligence (AI) in Healthcare Safety Program: October 2024 Update (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/ai-healthcare-safety-program.pdf
    July 01, 2025 - example, to attempt to prevent major adverse events such as healthcare- associated infections, adverse drug … Within HHS, AHRQ has engaged the Food and Drug Administration to learn more about when AI may be involved … in drug or device events and the Office of the Assistant Secretary for Technology Policy and Office

11. Slide 1 (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/guidance-pswp-provider-obligations.pdf
    May 24, 2016 - collected to comply with external obligations, such as: state incident reporting requirements; adverse drug … event information reporting to the Food and Drug Administration (FDA); certification or licensing records

12. Benefits of AHRQ Patient Safety Organizations (PSOs): Success Stories From Hospital PSO Members (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/OnDemand%20Webinar%20Slides%20-%20June%2010%202015.pdf
    January 01, 2010 - Benefits of AHRQ Patient Safety Organizations (PSOs): Success Stories From Hospital PSO Members Benefits of AHRQ Patient Safety Organizations (PSOs): Success Stories from Hospital PSO Members Webcast June 10, 2015 2:00 – 3:00 pm ET Need Help? • No sound from computer speakers? ► Join us by phone: (855)…

13. Patient Safety Organization (PSO) Listing Guide (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/PSO-listing-guide-2022.pdf
    January 01, 2022 - of 2005—HHS Guidance Regarding Patient Safety Organizations’ Reporting Obligations to the Food and Drug … where they or the organization of which they are a part are legally obligated under the Federal Food, Drug … U.S.C. §301 et seq., and its implementing regulations to report certain information to the Food and Drug … entities that seek to be or are PSOs that: ● have mandatory FDA-reporting obligations under the Food, Drug … Requirements Another issue to consider is whether the entity seeking listing is subject to any Federal Food, Drug

14. Adverse and Temporary Harm Events in Long-Term-Care Hospitals (LTCH) Designated in Office of Inspector General Report1 as Clearly Preventable or Likely Preventable, by Clinical Category (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/oig-list-long-term-care-hospitals-2019.pdf
    January 01, 2019 - bacteremia) leading to septic shock and death with concurrent urinary tract infection (Acinetobacter multi-drug

15. PSO Common Terms and Acronyms | PSO
    pso.ahrq.gov/resources/acronyms
    August 01, 2021 - Food and Drug Administration.

16. Fedregnotice-05242016 (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/fedregnotice-05242016.pdf
    January 04, 2025 - purposes.’’). 16 Some examples of external obligations include: state incident reporting, adverse drug … event reporting to the Food and Drug Administration (FDA), certification or licensing recordkeeping

17. PSO Program - Common Terms and Acronyms (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/pso-program-acronyms.pdf
    October 01, 2022 - Food and Drug Administration.