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Total Results: 71 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. 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 … Subject to FDA-Regulated Reporting Entity Guidance: No Vizient™ PSO PSO Number: P0007 Components

3. PSO Printable Lists | PSO
   pso.ahrq.gov/pso/listed/printable-list
   May 05, 2010 - Martin Point of Contact Phone: (979) 436-0400 Disclosures & Findings: None Subject to FDA-Regulated Reporting … San Point of Contact Phone: (972) 449-0540 Disclosures & Findings: None Subject to FDA-Regulated Reporting … Kettering Cancer Center Memorial Hospital for Cancer and Allied Diseases Subject to FDA-Regulated Reporting … MedExpress Urgent Care of Boynton Beach, LLC Subject to FDA-Regulated Reporting Entity Guidance: Yes … Subject to FDA-Regulated Reporting Entity Guidance: No PSO Initial Listing Date and Time: January 14

4. 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

5. 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

6. 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

7. 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

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. 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.

10. Patient Safety Organization: Certification for Initial Listing (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/PSO_InitialListing.pdf
    February 15, 2022 - 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

11. PSO: Certification of Continued Listing (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/PSO_ContinuedListing.pdf
    February 15, 2022 - 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

12. 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

13. 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,

14. Frequently Asked Questions | PSO
    pso.ahrq.gov/faq
    April 01, 2023 - A provider PSES manages the collection of information for reporting to a PSO. … AHRQ has developed Common Formats for Event Reporting for several healthcare settings and event types … Using the AHRQ Common Formats (common definitions and reporting formats) makes it possible to collect … What are the Common Formats for Event Reporting (CFER)? … What are the Common Formats for Event Reporting–Diagnostic Safety (CFER-DS)?

15. Patient Safety Organization: Change of Listing Information (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/PSO_ChangeOfListingInfo.pdf
    December 17, 2021 - 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

16. Caring Communities Patient Safety Organization, LLC | PSO
    pso.ahrq.gov/pso/caring-communities-patient-safety-organization-llc
    August 07, 2024 - period is 08/07/2024 through 08/06/2026 Disclosures and Findings: None Subject to FDA-Regulated Reporting

17. PSO Program - Common Terms and Acronyms (pdf file)
    pso.ahrq.gov/sites/default/files/pso-program-acronyms.pdf
    March 01, 2017 - 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 … When a PSO is, or is organizationally related to, an FDA‐regulated reporting entity, the Patient Safety … Workforce – For an individual to be considered a member of a PSO’s or reporting provider’s workforce,

18. AHRQ Slide Template 2019-Widescreen (pdf file)
    pso.ahrq.gov/sites/default/files/wysiwyg/working-with-pso-webinar-value-hospitals.pdf
    January 01, 2020 - , health care quality, or health care outcomes and which − The provider assembles or develops for reporting … and receive PSWP, confidentiality and privilege, and ‘How to report to PSO (SBAR format)’: • Event Reporting … Specifications • Definitions and specifications for each measure • Instructions and deadlines for reporting … for improvement o Rapid dissemination of best practices across the industry • Move from a culture of reporting … to one of performance o Reporting is a must o Utilize the data that you must report to gain value from

19. Braden Health PSO | PSO
    pso.ahrq.gov/pso/braden-health-pso
    April 28, 2022 - attestation period is 04/28/2022 through 04/27/2024 Disclosures and Findings: None Subject to FDA-Regulated Reporting

20. BradenHealth, Patient Safety Organization | PSO
    pso.ahrq.gov/pso/bradenhealth-patient-safety-organization
    April 28, 2020 - period is 04/28/2024 through 04/27/2026 Disclosures and Findings: None Subject to FDA-Regulated Reporting