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2022 Compliatric Continuous Compliance Series - Chapter 10 and 21.pdf

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2022 Compliatric Continuous Compliance Series - Chapter 10 and 21.pdf

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Watch The Webinar Here: https://compliatric.com/continuous-compliance-chapters-10-21/

Compliatric is excited to continue their “Continuous Compliance" Webinar Series based on the existing Health Center Compliance Manual and the most recently updated Site Visit Protocol. Each month, program requirements are reviewed to assist health centers in understanding the various elements and ensuring continuing compliance. Participants will be able to use these webinars to increase their knowledge of the requirements, and go one step further and utilize the program requirements to improve operational excellence.

This month’s webinar will focus on the following chapters:

Chapter 10: Quality Improvement/Assurance
Chapter 21: FTCA Deeming Requirements

Webinar attendee takeaways will include:

· An understanding of the program requirements, which includes updates to the Site Visit Protocol
· Maintaining continuous compliance - not only based on a site visit
· Improving operational excellence for your Community Health Center

Watch The Webinar Here: https://compliatric.com/continuous-compliance-chapters-10-21/

Compliatric is excited to continue their “Continuous Compliance" Webinar Series based on the existing Health Center Compliance Manual and the most recently updated Site Visit Protocol. Each month, program requirements are reviewed to assist health centers in understanding the various elements and ensuring continuing compliance. Participants will be able to use these webinars to increase their knowledge of the requirements, and go one step further and utilize the program requirements to improve operational excellence.

This month’s webinar will focus on the following chapters:

Chapter 10: Quality Improvement/Assurance
Chapter 21: FTCA Deeming Requirements

Webinar attendee takeaways will include:

· An understanding of the program requirements, which includes updates to the Site Visit Protocol
· Maintaining continuous compliance - not only based on a site visit
· Improving operational excellence for your Community Health Center

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2022 Compliatric Continuous Compliance Series - Chapter 10 and 21.pdf

  1. 1. www.compliantfqhc.com Continuous Compliance Series- It’s not JUST an OSV Prep COMPLIATRIC WEBINAR SERIES Presented by: Michelle Layton BSN, MBA marketing@fqhcwebinar.com
  2. 2. Chapter 10 – Quality Improvement/Assurance Chapter 21 – FederalTort Claims Act (FTCA)
  3. 3. Disclaimers  This presentation is not endorsed by Management Strategists Consulting Group (MSCG)  This presentation is not endorsed by the Health Resources Services Administration (HRSA) or the Bureau of Primary Health Care (BPHC)  Not employed by MSCG or BPHC  Independent Consultant who is contracted to conduct Operational SiteVisits (OSV), provideTechnical Assistance and assist health centers with preparation for their OSV  This information should not be considered legal advice Confidentiality Notice: This document is confidential and contains proprietary information and intellectual property of Infidium Healthcare Solutions. Neither this document nor any of the information contained herein may be reproduced or disclosed under any circumstances without the express written permission of the aforementioned party.
  4. 4. Purpose of the Compliatric Series  HRSA’s evaluation of compliance during COVID-19 continues via Virtual Operational SiteVisits (vOSV)  On-site Operational SiteVisits (OSVs) visits are resuming  Provides an overview of the health center program requirements  Provides updates to the SiteVisit Protocol and vOSV Process  Provides tips on “What to Expect” and “How to Prepare”  Provides a reviewer perspective
  5. 5. Purpose of the Compliatric Series  Compliance maintains HRSA funding ◦ Non-compliance can impact other Federal Programs (i.e., FTCA)  Continuous Compliance supports high performing health centers ◦ Eliminates the chaos of having to “prepare” ◦ Develops practices for operational excellence for the health center
  6. 6. Agenda  What has Changed?  Requirements for Compliance  Evaluation of Compliance  Maintaining Continuous Compliance – Factors to Consider  Question and Answer Session – All questions should be directed to marketing@fqhcwebinar.com
  7. 7. What has Changed?
  8. 8. What has Changed? 2021 and 2022  The HRSA Health Center Compliance Manual has NOT changed  The HRSA SiteVisit Protocol HAS changed (specific chapters as of 5/26/2022)  The HRSA Summary of Updates includes: ◦ 2021 updates made to increase effectiveness, clarify, improve consistency and transparency ◦ 2022 updates made to improve consistency with numbering, formatting and grammar ◦ Other minor changes to include additional examples
  9. 9. SiteVisit Protocol Updates Chapter 10 and Chapter 21  Chapter 10 – Quality Improvement/Assurance – NO CHANGE  Performance Analysis  Chapter 21 – FTCA ◦ Risk Management – Element b  Question added to capture training for identified high-risk services ◦ Risk Management – Element e  Clarification of documentation allowed for risk management assessments  Added a Risk ManagementTraining question
  10. 10. SiteVisit Protocol Updates Chapter 10 and Chapter 21  Chapter 21 – FTCA (cont.) ◦ Question 3 – Risk Management  Clarified language to include examples of Risk Management topics ◦ Claims Management – Element d  Additional example provided of claims related documentation ◦ Question 16 – Claims Management  Updated language to reference a health center’s written claims management procedures
  11. 11. Chapter 10 Quality Improvement/Assurance
  12. 12. Requirements for Compliance
  13. 13. Requirements for Compliance Element a: QI/QA Program Policies The health center must have a board approved policy(ies) that establish the QI/QA Program. The QI/QA Program must address the following:  The quality and utilization of health center services  Patient satisfaction and patient grievance processes; and  Patient safety, including adverse events
  14. 14. Requirements for Compliance Element b: Designee to Oversee QI/QA Program The health center designates an individual(s) to oversee the QI/QA Program, established by the board approved policy(ies)
  15. 15. Requirements for Compliance Element c: QI/QA Procedures or Processes The Health Center must have QI/QA Procedures or Processes in place that address the following: ◦ Adhering to current evidence-based clinical guidelines, standards of care and standards of practice ◦ Identifying, analyzing and addressing patient safety and adverse events, including the implementation of follow-up actions ◦ Assessing patient satisfaction ◦ Hearing and resolving patient grievances ◦ Completion of periodic QI/QA assessments a minimum of quarterly ◦ Producing and sharing reports on QI/QA to support decision-making and oversight
  16. 16. Requirements for Compliance Element d: Quarterly Assessments of Clinician Care The health center’s physicians or other licensed health care professionals must conduct QI/QA assessments a minimum of quarterly, using data systematically collected from patient health records.
  17. 17. Requirements for Compliance Element e: Retrievable Health Records The health center must maintain a retrievable health record for each patient. The format and content of the health record must be consistent with Federal and State Laws and Requirements.
  18. 18. Requirements for Compliance Element f: Confidentiality of Patient Information The health center must have systems in place for protecting the confidentiality of patient information and safeguarding information against loss, destruction or unauthorized use, in accordance with federal and state requirements
  19. 19. Evaluation of Compliance
  20. 20. Evaluation of Compliance Review of Documentation: ◦ Policy that establishes the QI/QA Program (QI Plan and Work Plan) ◦ QI Job Descriptions ◦ QI Policies and Procedures (Peer Review, Patient Satisfaction, etc.) ◦ Procedures for maintaining the confidentiality/security of patient health records ◦ Procedures that support tracking of events and grievances
  21. 21. Evaluation of Compliance Review of Documentation (cont.) ◦ QI Reporting Calendar (can be part of work plan) ◦ QI/QA Committee Meeting Minutes ◦ Implementation of Plan, Do, Study,Act (PDSA) Cycles ◦ Board of Directors Meeting Minutes ◦ Quarterly Reports (UDS Measures, Patient Satisfaction, Patient Grievances, etc.) ◦ 5-10 patient samples demonstrating the ability to generate a visit note or summary of care
  22. 22. Evaluation of Compliance Interviews with staff to verify the following: ◦ Roles and responsibilities of QI/QA positions  The health center determines who the appropriate individuals are for interviews  Medical Director, Dental Director, Director of Quality ◦ QI/QA reporting structure ◦ Mechanisms and processes utilized to support reporting
  23. 23. Evaluation of Compliance The QI/QA Plan (QI/QA Policy) must address the following for all services in scope: ◦ Quality and utilization of services ◦ Patient satisfaction and grievances ◦ Patient safety, including adverse events ◦ The use of evidence based clinical guidelines/standards of care ◦ The completion of quarterly assessments, including but not limited to:  UDS clinical performance metrics  Peer Review  Patient Satisfaction  Patient Complaints ◦ Confidentiality of Patient Information
  24. 24. Evaluation of Compliance Peer Review must be completed: ◦ On a “routine and regular basis”  Considered a quarterly assessment per the SiteVisit Protocol ◦ Between providers within the same specialty who are similarly credentialed ◦ In all clinical areas within the health center’s scope of project (i.e., Medical, Dental, Behavioral Health, OB) ◦ Using an industry standard tool that clearly evaluates the quality of services provided and does not only perform administrative review ◦ Using a blinded methodology that ensures confidentiality of patient information
  25. 25. Maintaining Continuous Compliance Factors to Consider Chapter 10
  26. 26. Factors to Consider  The following must be board approved to ensure compliance ◦ QI/QA Plan/Policy ◦ QI/QA Policies (Patient Satisfaction, Peer Review, Complaints, etc.)  If the above are not board approved, they are considered non-compliant under Chapter 19, Board Authority  QI/QA reports must be provided to the Board of Directors on a routine and regular basis for the purposes of management decision making. Active discussion must be clearly documented in the Board of Directors Meeting Minutes
  27. 27. Factors to Consider  An annual evaluation of the previous year’s QI/QA Program should be completed and presented to the Board of Directors  When presenting quality data to the Board of Directors, consider the following: ◦ Language and literacy levels of the board members ◦ Knowledge base (i.e., health care industry) ◦ Format and presentation of reports  Best practice demonstrates reports show trending and benchmarking against internal goals, state averages and national averages
  28. 28. Chapter 21 Federal Tort Claims Act (FTCA)
  29. 29. FTCA Requirements  The FTCA review does NOT factor into compliance  The FTCA review is only completed for health centers that are currently FTCA deemed  FTCA may consider the reviewer’s responses to this section during the deeming/redeeming process  Unresolved conditions for non-compliance in the areas of Chapter 5 – Clinical Staffing and Chapter 10 - QI/QA may impact deeming status
  30. 30. FTCA Requirements Risk Management Element a: Risk Management Program The health center must implement an ongoing health care Risk Management Program to reduce the risk of adverse outcomes that could possibly result in medical malpractice or other health or health related litigation.
  31. 31. FTCA Requirements Risk Management Element b: Risk Management Procedures The health center has risk management procedures that address the following areas for health center services and operations: ◦ Identifying and mitigating the health care areas/activities of highest risk within the health center’s HRSA-approved scope of project, including but not limited to tracking referrals, diagnostics, and hospital admissions ordered by health center providers ◦ Documenting, analyzing, and addressing clinically-related complaints and “near misses” reported by health center employees, patients, and other individuals
  32. 32. FTCA Requirements Risk Management Element b: Risk Management Procedures (cont.) ◦ Setting and tracking progress related to annual risk management goals ◦ Developing and implementing an annual health care risk management training plan for all staff members based on identified areas/activities of highest clinical risk for the health center (including, but not limited to, obstetrical procedures and infection control) and any non-clinical trainings appropriate for health center staff (including HIPAA medical record confidentiality requirements) ◦ Completing an annual risk management report for the board and key management staff
  33. 33. FTCA Requirements Risk Management Element c: Reports on Risk Management Activities The health center provides reports to the board and key management staff on health care risk management activities and progress in meeting goals at least annually and provides documentation to the board and key management staff showing that any related follow-up actions have been implemented
  34. 34. FTCA Requirements Risk Management Element d: Risk ManagementTraining Plan The health center has a health care risk management training plan for all staff members and documentation showing that such trainings have been completed by the appropriate staff, including all clinical staff, at least annually.
  35. 35. FTCA Requirements Risk Management Element e: Individual who Oversees Risk Management The health center designates an individual(s) (for example, a risk manager) who oversees and coordinates the health center’s health care risk management activities and completes risk management training annually.
  36. 36. FTCA Requirements Claims Management Element a: Claims Management Process The health center has a claims management process for addressing any potential or actual health or health-related claims, including medical malpractice claims, that may be eligible for FTCA coverage. In addition, this process ensures:
  37. 37. FTCA Requirements Claims Management Element a: Claims Management Process (cont.) ◦ The preservation of all health center documentation related to any actual or potential claim or complaint (for example, medical records and associated laboratory and x-ray results, billing records, employment records of all involved clinical providers, clinic operating procedures) ◦ Any service-of-process/summons that the health center or its provider(s) receives relating to any alleged claim or complaint is promptly sent to the HHS, Office of the General Counsel, General Law Division, per the process prescribed by HHS and as further described in the FTCA Health Center Policy Manual
  38. 38. FTCA Requirements Claims Management Element b: Claims Activities Point-of-Contact The health center has a designated individua(s) who is responsible for the management and processing of claims- related activities and serves as the claims point of contact.
  39. 39. FTCA Requirements Claims Management Element c: Notice of FTCA Deeming (Informing Patients of FTCA Deeming) The health center informs patients using plain language that it is a deemed federal Public Health Service employee via its website, promotional materials, and/or within an area(s) of the health center that is visible to patients
  40. 40. FTCA Requirements Claims Management Element d: History of Claims: Cooperation and Mitigation If a history of claims under the FTCA exists, the health center can document that it:  Cooperated with the Attorney General, as further described in the FTCA Health Center Policy Manual; and  Implemented steps to mitigate the risk of such claims in the future
  41. 41. Evaluation of FTCA Requirements
  42. 42. Evaluation of FTCA Requirements Review of documentation: ◦ Most recent HRSA-approved deeming application ◦ Risk Management Policies (i.e., ReferralTracking, HospitalTracking, Incident Reports, etc.) ◦ Claims Management Policies and Procedures ◦ Risk ManagementTraining Plan ◦ Documentation of completed training – Including Risk Manager ◦ Quarterly Risk Management Assessments (2)
  43. 43. Evaluation of FTCA Requirements  Review of documentation (cont.) ◦ Committee Meeting Minutes  QA/QI Committee Meeting Minutes  Risk Management Committee Meeting Minutes  Board of Directors Meeting Minutes  Examples of communicating deemed status (i.e., website, patient handout)  Documentation of corrective action for each closed claim within the past five years
  44. 44. Evaluation of FTCA Requirements  Staff interviews with Risk Management and Claims Management Staff to verify process  Discussion with designated staff to verify activities implemented in response to any closed claims in the last five years  Collection of narrative responses to Questions #5 and #6 of the HRSA SiteVisit Protocol
  45. 45. Evaluation of FTCA Requirements Risk Management Policies and Procedures must address the following for all services in the health center’s scope of project: ◦ Areas of high risk ◦ Clinically related complaints, incidents and “near misses” reported by health center patients, staff and other individuals ◦ Claims Management ◦ Risk Management Training for health center staff (Including Risk Manager)  Obstetrics, Infection Control, HIPAA ◦ Quarterly Risk Assessments ◦ Annual reporting to the Board of Directors
  46. 46. FTCA Requirements Factors to Consider Chapter 21
  47. 47. FTCA Requirements Factors to Consider  Risk Management can be a component of the QI/QA Program  Simplify Risk ManagementTraining and incorporate it into the Annual StaffTraining Plan  Health centers who do NOT provide Prenatal, Intrapartum and Postpartum Care directly are NOT required to complete risk management training for relevant staff on obstetrical services  Risk Management Assessments MUST be completed quarterly with a report to the Board of Directors a minimum of annually  Narrative responses to Risk Management questions #5 and #6 have a character limit of 2000.
  48. 48. Resources
  49. 49. Additional Resources Compliatric https://www.compliatric.com/ HRSA Health Center Compliance Manual HRSA Compliance Manual HRSA SiteVisit Protocol HRSA SiteVisit Protocol HRSA 2021 SiteVisit Protocol: Summary of Updates HRSA Summary of Updates ECRI QI and RM Resources ECRI
  50. 50. Questions & Answers

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