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Total Results: 81 records

Showing results for "reporting".

1. 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 - are organizationally related to FDA-regulated reporting entities cannot avoid their mandatory reporting … One example of such FDA mandatory reporting requirements is device manufacturers’ medical device reporting … entity or a PSO organizationally related to the FDA- regulated reporting entity. … reporting obligations. … to currently reporting providers and prospective reporting providers that the PSO will disclose certain

2. Fedregnotice-05242016 (pdf file)
   pso.ahrq.gov/sites/default/files/wysiwyg/fedregnotice-05242016.pdf
   January 04, 2025 - National Academy for State Health Policy, ‘‘2014 Guide to State Adverse Event Reporting Systems’’, … Patient Safety Authority, Pennsylvania Patient Safety Reporting System: PA–PSRS (Pennsylvania Patient … Ch 114, Rules Governing the Reporting of Sentinel Events. … external reporting obligations as well as voluntary reporting activities that occur for the purpose … To the extent an obligation only requires reporting and is fully satisfied after that reporting, a

3. PSO Printable List by State | PSO
   pso.ahrq.gov/pso/listed/geographic/printable-list
   7057 Point of Contact Phone: (205) 968-4448 Disclosures & Findings: None Subject to FDA-Regulated Reporting … Contact Email: siorio@americandatanetwork.com Disclosures & Findings: None Subject to FDA-Regulated Reporting … Point of Contact Email: kari@hdnursing.com Disclosures & Findings: None Subject to FDA-Regulated Reporting … Contact Email: lmead@strategicradiology.org Disclosures & Findings: None Subject to FDA-Regulated Reporting … Ferrell Physician Services Subject to FDA-Regulated Reporting Entity Guidance: Yes

4. PSO Printable Lists | PSO
   pso.ahrq.gov/pso/listed/printable-list
   December 22, 2010 - MacCready Point of Contact Phone: (617) 450-5565 Disclosures & Findings: None Subject to FDA-Regulated Reporting … DeDent Point of Contact Phone: (469) 868-2043 Disclosures & Findings: None Subject to FDA-Regulated Reporting … Mullan Point of Contact Phone: (541) 782-8332 Disclosures & Findings: None Subject to FDA-Regulated Reporting … Ferrell Physician Services Subject to FDA-Regulated Reporting Entity Guidance: Yes PSO Initial Listing … Subject to FDA-Regulated Reporting Entity Guidance: No PSO Initial Listing Date and Time: January 14

5. Slide 1 (pdf file)
   pso.ahrq.gov/sites/default/files/wysiwyg/guidance-pswp-provider-obligations.pdf
   May 24, 2016 - The information is prepared by a provider for reporting to a PSO and it is reported to the PSO; 2. … How Information Becomes PSWP (2) For information to become PSWP through the reporting pathway: ► … under the reporting pathway. 11 Background 4. … to the PSO can become PSWP through the reporting pathway. … "collection, management and analysis of information for reporting to or from a PSO

6. PSO Quiz--Answer Sheet (pdf file)
   pso.ahrq.gov/sites/default/files/quiz/pso-quiz-answer-sheet.pdf
   January 01, 2020 - PSO, which includes information that is documented as within a patient safety evaluation system for reporting … Thus, only a copy of such information prepared for reporting to a PSO can be protected.] … It cannot become PSWP through the reporting pathway because it was prepared for a purpose other than … reporting to a PSO. … By contrast, a copy of a written statement prepared for purposes of reporting to the PSO and/or subsequent

7. Assess Compatibility of Anticipated PSO Operations with Patient Safety Rule Requirements | PSO
   pso.ahrq.gov/become/assess-compatibility
   August 01, 2021 - FDA Reporting Requirements Another issue to consider is whether the entity seeking listing is subject … to any Federal Food, Drug, and Cosmetic Act (FDA) reporting requirements. … FDA reporting responsibilities do not change when an entity becomes listed as a PSO or becomes the parent … Being an FDA-regulated reporting entity or organizationally related to an FDA-regulated reporting entity … For example, the PSO may need to enter into a business associate agreement with its reporting providers

8. Working With a PSO: One Approach (pdf file)
   pso.ahrq.gov/sites/default/files/wysiwyg/WorkingWithAPSOOneApproach-20160317.pdf
   January 01, 2016 - Could improve safety, quality, or outcomes of health care; and ■ Assembled or developed solely for reporting … PSES ■ Date and document incoming information upon entry ■ Analyze or deliberate (protected without reporting … PSES) ■ Excluded by definition of PSWP (1); or ■ Collected or developed for purposes other than reporting … PSO, such as: – Corporate and external record-keeping requirements – Inspection, survey, or external reporting … Information qualifying as PSWP reported to the PSO, or accessible by the PSO pursuant to functional reporting

9. About Network of Patient Safety Databases (NPSD) | PSO
   pso.ahrq.gov/common-formats/about-npsd
   November 01, 2024 - Patient Safety Organization Privacy Protection Center (PSOPPC) using the AHRQ Common Formats for Event Reporting … , which is a standardized reporting format using common language and definitions. … NPSD Data Reporting Tools include Dashboards , Chartbooks , and Spotlights .  

10. HHS Guidance | PSO
    pso.ahrq.gov/resources/hhs-guidance
    August 01, 2022 - Patient Safety and Quality Improvement Act of 2005—HHS Guidance Regarding Patient Safety Organizations' Reporting … This guidance applies to all entities that seek to be or are PSOs that: have mandatory FDA-reporting … under the Food, Drug and Cosmetic Act (FDCA) or are organizationally related to such FDA-regulated reporting … Download the HHS Guidance Regarding Patient Safety Organizations' Reporting Obligations to the FDA

11. Patient Safety Organization: Certification for Initial Listing (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/PSO_InitialListing.pdf
    September 30, 2024 - reporting entity? … Food and Drug Administration (FDA) reporting requirements under the Federal Food, Drug, and Cosmetic … entity, including reporting certain information to the FDA and providing FDA with access to particular … NOTE: The Secretary has provided common definitions and reporting formats, known as Common Formats, … Burden Statement Public reporting burden for the collection of information is estimated to average

12. About Common Formats | PSO
    pso.ahrq.gov/common-formats/about
    November 01, 2024 - AHRQ has developed Common Formats for Event Reporting for several healthcare settings and event types … Any comments on the Common Formats versions that are active for reporting can be submitted through the … What Are the Common Formats for Event Reporting (CFER)? … The CFS is designed to provide information that is complementary to that derived from event reporting

13. How To Choose a PSO | PSO
    pso.ahrq.gov/work-with/choose
    November 01, 2020 - insights for rare cases or sentinel events, another relevant question is “how many providers are actually reporting … It is important to also confirm that your contract complies with HIPAA, if you are reporting Protected … AHRQ created the Common Formats (forms using common definitions and reporting formats) to facilitate … the collection and reporting of patient safety events and to improve healthcare providers’ efforts to

14. PSO: Certification of Continued Listing (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/PSO_ContinuedListing.pdf
    September 30, 2024 - Is the component entity an FDA-regulated reporting entity or organizationally related to an FDA-regulated … reporting entity? … Food and Drug Administration (FDA) reporting requirements under the Federal Food, Drug, and Cosmetic … entity, including reporting certain information to the FDA and providing FDA with access to particular … Burden Statement Public reporting burden for the collection of information is estimated to average 18

15. 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 - improve quality, safety and healthcare outcomes • Authorizes establishment of “Common Formats” for reporting … patient safety events • Establishes “Network of Patient Safety Databases” (NPSD) • Requires reporting … ► Reporting a medication with nearly identical labels led to a national change in the label. … 20 Value of the PSO • Before contracting with the PSO, our focus was on reporting actual events … • Collaboration with the PSO IT staff to assist us in moving toward electronic event reporting.

16. How PSOs Help Health Care Organizations Improve Patient Safety Culture (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/npsdpatient-safety-culture-brief.pdf
    September 01, 2016 - One way to drive improved culture is to develop the norm of routine safety event reporting. … In an organization with a strong safety culture that fosters trust, clinicians are comfortable reporting … The resulting increase in reporting of safety events can then lead to improvement in patient safety … With these protections, a PSO offers a safe space for both reporting key staff from five PSOs that … PSOs encourage voluntary patient safety event reporting by offering technical assistance and the

17. PSO Common Terms and Acronyms | PSO
    pso.ahrq.gov/resources/acronyms
    August 01, 2021 - Common Formats – Common Formats is the generic term for the standardized reporting formats, using common … FDA‐Regulated Reporting Entity – This is an entity that is required by law to report information to … The Guidance can be downloaded here:  HHS Guidance Regarding Patient Safety Organizations' Reporting … Obligations to the FDA  (PDF, 0.4 MB) HERF – Healthcare Event Reporting Form (HERF); it is one of … Workforce – For an individual to be considered a member of a PSO's or reporting provider’s workforce

18. Home | PSO
    pso.ahrq.gov/
    PSO Areas of Interest NPSD Data Reporting … Tools See PSO data in action within AHRQ's National Patient Safety Database Data Reporting Tools.

19. PSO Program - Common Terms and Acronyms (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/pso-program-acronyms.pdf
    October 01, 2022 - Common Formats – Common Formats is the generic term for the standardized reporting formats, using common … language and definitions that AHRQ is developing for reporting safety concerns from a variety of health … FDA‐Regulated Reporting Entity – This is an entity that is required by law to report information to the … HERF – Healthcare Event Reporting Form (HERF); it is one of 3 general forms of AHRQ’s Common Formats. … Workforce – For an individual to be considered a member of a PSO’s or reporting provider’s workforce,

20. Patient Safety Organization: Change of Listing Information (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/PSO_ChangeOfListingInfo.pdf
    September 30, 2024 - Changes to Parent Organization(s) Information NOTE: If you are reporting … Burden Statement Public reporting burden for the collection of information is estimated to average