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.
Chapter 10 – Quality
Improvement/Assurance
Chapter 21 – FederalTort Claims Act
(FTCA)

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.
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.
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.
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.
What has Changed?

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.
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.
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.
Chapter 10
Quality Improvement/Assurance

12.
Requirements for Compliance

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.
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.
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.
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.
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.
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.
Evaluation of Compliance

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.
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.
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.
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.
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.
Maintaining Continuous Compliance
Factors to Consider
Chapter 10

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.
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.
Chapter 21
Federal Tort Claims Act (FTCA)

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Evaluation of FTCA Requirements

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.
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.
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.
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.
FTCA Requirements
Factors to Consider
Chapter 21

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.
Resources

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.
Questions & Answers