a Site Visit? - TARGET Center

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Overview of Site Visit Process
Ryan White HIV/AIDS Program
Part C, D, and F-Dental
Department of Health and Human Services
Health Resources and Services Administration
HIV/AIDS Bureau
Clinical
Division of Community HIV/AIDS Programs
Webinar Goal
To increase the knowledge of Consultants and Project Officers on
how to effectively assess and report on the HRSA/HAB/DCHAP’s
Ryan White HIV/AIDS Program Part C, D, and F-Dental grantees
provision of comprehensive, high quality healthcare for people living
with HIV/AIDS, compliance with legislative and programmatic
requirements, and the National HIV/AIDS Strategy.
Webinar Objectives
By the end of the webinar, participants will:
• Become familiar with all applicable Federal statutes and regulations
relative to the administration of grants.
• Increase knowledge of how to properly use the Site Visit Assessment
Tool.
• Compare and contrast the Ryan White HIV/AIDS Program Parts
A,B,C,D, and F, and Minority AIDS Initiative.
• Describe the reasons for conducting a site visit and how to prepare
for pre and post site visit activities.
• Identify “What’s New?” with the 2013 Site Visit Assessment Tool.
• Increase knowledge of the site visit process.
• Apply tools to write a concise and comprehensive report.
Webinar Outline
• Overview of HRSA/HAB
• Authorities that Govern Site Visits
• Ryan White HIV/AIDS Program Parts A,B,C,D, and F,
and MAI
• Monitoring Site Visits
• Site Visit Roles and Responsibilities
• Team Member Professional Standards
• Site Visit Assessment Tool
• Site Visit Reporting Criteria
• Tips for Writing a Concise and Comprehensive Report
Health Resources and Services
Administration (HRSA)
Vision
Healthy Communities, Healthy People
Mission
To improve health and achieve health equity through
access to quality services, a skilled health workforce,
and innovative programs.
HIV/AIDS Bureau
Vision
Optimal HIV/AIDS care and treatment for all.
Mission
Provide leadership and resources to assure access to
and retention in high quality, integrated care and
treatment services for vulnerable people living with
HIV/AIDS and their families.
Authority
The site visit process is governed by:
•
•
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•
•
Ryan White HIV/AIDS Legislation
Title XXVI of the Public Health Service Act
HAB Policy Notices
National HIV/AIDS Strategy
Funding Opportunity Announcement
Ryan White HIV/AIDS Legislation
Congress enacted the Ryan White Comprehensive AIDS Resources
Emergency (CARE) Act in 1990 to improve the quality and availability
of care for low-income, uninsured, and underinsured individuals and
families affected by HIV disease. The CARE Act was amended and
reauthorized in 1996, 2000, and 2006; in 2009 it was reauthorized as
the Ryan White HIV/ AIDS Treatment Extension Act of 2009 (Public
Law 111–87).
Ryan White HIV/AIDS Program
Administered by the U.S. Department of Health and Human Services
(HHS), Health Resources and Services Administration (HRSA),
HIV/AIDS Bureau (HAB), the Ryan White HIV/AIDS Program works
with cities, states, and local community based organizations to
provide services to over 559,000 people each year who do not have
sufficient health care coverage or financial resources to cope with HIV
disease. The majority of Ryan White HIV/AIDS Program funds
support primary medical care and essential support services. A
smaller but equally critical portion is used to fund technical
assistance, clinical training, and research on innovative models of
care.
Title XXVI of the Public Health Service Act- examines the authority
of the government at various jurisdictional levels to improve the health
of the general population within societal limits and norms.
HAB Policy Notices- provide updates from HAB regarding
clarification of legislation and policies.
Funding Opportunity Announcement (FOA)- explains the
availability of a Federal grant funding opportunity and application
process and is released through Grants.gov.
National HIV/AIDS Strategy Goals
Increasing access to
Reducing new HIV
care and improving
infections
health outcomes for
PLWHA
Reducing HIV-related
disparities and health
inequities
Achieving a more
coordinated national
response to the HIV
epidemic
Ryan White HIV/AIDS Program
Parts A,B,C,D, and F, and the Minority AIDS
Initiative
Ryan White HIV/AIDS Program
Part A
• Metropolitan Areas affected by HIV/AIDS
Part B
• States and US Territories
• AIDS Drug Assistance Program (ADAP)
Part C
• Early Intervention Services and Capacity
Development
Part D
• Women, Infants, Children and Youth (Part D)
Part F
• Dental, Education/Training, Planning, Capacity
Development and Demonstrations, Minority AIDS
Initiative
Ryan White HIV/AIDS Program
Administration
Part A
• Division of Metropolitan HIV/AIDS Programs
Part B
• Division of State HIV/AIDS Programs
Part C, D and F
Dental
• Division of Community HIV/AIDS Programs
Ryan White HIV/AIDS Program
Part A
• Emergency assistance to Eligible Metropolitan Areas
(EMAs) and Transitional Grant Areas (TGAs) that are
most severely impacted by the HIV/AIDS epidemic
• Award made to Chief Elected Official
• Funding allocations determined by Planning Council
• Part A funds distribution:
• 2/3 by formula – based on the number of living cases of HIV
(non AIDS) and AIDS
• 1/3 supplemental – competitive grant process
Ryan White HIV/AIDS Program
Part B
• Base Grant - Provides grants to all 50 States, the District of
Columbia, Puerto Rico, Guam, U.S. Virgin Islands, 6 Pacific
jurisdictions to pay for care for people living with HIV/AIDS
• For jurisdictions with >1 percent of nation’s HIV/AIDS cases,
match required $1 state: $2 federal
• Funds distributed by formula based on HIV/AIDS cases
• Award made to Chief Elected Official
• AIDS Drug Assistance Program (ADAP) pays for:
• Medications to treat HIV disease
• Insurance continuation for eligible clients
• Services that enhance access, adherence, and monitoring of
drug treatment
Part C EIS Overview
• Purpose: To provide comprehensive continuum of
outpatient HIV primary care in a service area.
• Required Services:
•
•
•
•
HIV counseling, testing, and referral
Medical evaluation and clinical care
Other primary care services
Referrals to other health services
• Medical Model of Care:
• Assess
• Treat
• Refer
Part D WICY Overview
Purpose: To provide family-centered primary medical care to
women, infants, children, and youth (WICY) living with
HIV/AIDS when payments for such services are unavailable
from other sources.
Ryan White HIV/AIDS Program
Part F / Dental
Dental
Reimbursement
Program
• Expands access to oral health care for
PLWHA while training additional dental
and dental hygiene providers
Community Based • Provides oral health services to PLWHA
via cooperative projects with communityDental Partnership
Program
based providers of oral health services
Minority AIDS Initiative (MAI)
• Goal: To help reduce the disproportionate impact of
HIV/AIDS and address disparities by:
• Increasing the number of persons from racial and ethnic
minority populations receiving HIV care, and
• Increasing the number of persons from racial and ethnic
minority populations who stay in care.
• MAI funds awarded are noted under the grant specific
terms section of the Notice of Award (NoA) which
establishes the final funding for the budget period.
Ryan White HIV/AIDS Treatment Extension Act of 2009 (Public Law
111-87,October 30,2009), §2693
Monitoring
Site Visits
DCHAP Site Visits
Types of Site Visits
Description
Comprehensive
•Conducted to review a Program’s
ability to meet the legislative and
programmatic requirements of the
Ryan White HIV/AIDS Program
•Newly awarded and established
grantees who have not had a site visit
within the last five years are a priority
Diagnostic
•Conducted to identify and clarify any
programmatic deficiencies for grantees
who are exhibiting challenges within
one or more of the three core areas:
clinical, fiscal or administrative
Technical Assistance
•Conducted to offer appropriate
support to enhance a grantee’s
capacity to provide high quality, cost
competitive health care and services
Ryan White HIV/AIDS Program
Compliance Monitoring
Monitoring Calls
HRSA/HAB
conducts ongoing
review and
monitoring of
grantees
Review of RW Programmatic
Reports
Review of Fiscal Reports
Comprehensive Site Visits
Diagnostic Site Visits
Why Do We Conduct Site Visits?
1. Support DCHAP’s mission to provide grantee oversight
in the delivery of comprehensive high quality HIV
primary and oral health care.
2. Verify the grantee’s program is in compliance with the
Ryan White Legislative & Programmatic requirements.
3. Ensure highest quality HIV clinical care and
compliance with HHS Guidelines.
4. Ensure administrative and fiscal integrity.
5. Identify technical assistance needs to address any
program deficiencies.
What Can “Trigger” a Site Visit?
-
Need for an initial site visit
for newly awarded grantee
or comprehensive site visit
for established grantee
- Low score on recent
competitive application or
lack of progress reflected
within non-competing
report
- Habitual and problematic
staff turnover for grantee
- Lack of communication
with Project Officer
- Continually failing to meet work
plan objectives
- A sense on the part of the
Project Officer/Branch Chief
that “something’s just not right”
with the grantee’s program
- Media attention
- Known financial problems
- Problematic spend-down
patterns and/or multiple years
with unobligated balances
- Draw down restrictions
Goal of Site Visit Timeline
Minimum of 10 Weeks Prior to Scheduled Site Visit
Consultants are identified and site visit materials are emailed to Consultants
Minimum of 8 Weeks Prior to Scheduled Site Visit
Project Officer Confirms Date and Time of Pre-Site Visit Conference Call with Consultants and Grantee
Minimum of 4 Weeks Prior to Scheduled Site Visit
Pre-Site Visit Conference Call Held with the Project Officer, Consultants, and Grantee
Goal of Site Visit Timeline
continued
Within 1 Week of Completion of Site Visit
Site Visit Report Submitted by Consultants to Team Leader
Within 2 Weeks of Completion of Site Visit
Site Visit Report Submitted by Team Leader to Project Officer
Within 4 Weeks of Completion of Site Visit
Site Visit Report Approved by Project Officer, Branch Chief, Clinical Reviewer, and Deputy Director of DCHAP
By 4 Weeks Following Completion of Site Visit
Project Officer Releases Completed Site Visit Report to Grantee
Pre-Site Visit Prep
1. Pre-Site Visit Preparation
•
Copy of most recent applicable Funding Opportunity Announcement (FOA)
• Most recent Competing Application and Non-Competing Progress Report
• Most recent Ryan White Services Report (RSR)
• Three most recent Federal Financial Reports
• Current line item budget and justification
• Copies of any previous Site Visit Reports (as applicable)
• Most recent A-133 Audit
2. Team Pre-Site Visit Conference Call
• Team Leader, Consultant Team Members and Project Officer.
3. Pre-Site Visit Conference Call with the Grantee
How Does Grantee Prepare for the Site Visit?
1. Extensive instructions from their Project Officer
2. Materials provided to grantee:
• Site Visit Assessment Tool
• Pre-Site Visit Conference Call Agenda
• List of “Materials to be Available” for review on-site
• Sample Site Visit Agenda
• “Site Visit Evaluation Form”
3. Site Visit Agenda jointly developed with Team
Leader
Site Visit
Roles and Responsibilities
Pre-Site Visit Activities
Role of Project Officer
• Internally initiates
the site visit within
HAB
• Establishes the site
visit date, Pre-Site
Visit Conference
Call(s), and
prepares packet
• Communicates
with the Team the
purpose of the site
visit
Pre-Site Visit Activities
Role of Team Leader
Confirms travel arrangements,
Makes him/herself available by
arrival and departure times with
phone or email to the other
Consultants
Consultants and Grantee’s staff
Team Leader
Facilitates Pre-Site Visit
Responsible for working with
Conference Call
PO, Grantee, and Consultants
to finalize the Site Visit Agenda
Pre-Site Visit Activities
Role of Team Leader
Pre-Site Visit Conference Call
• Facilitates the Pre-Site Visit Conference Call (reiterate purpose, introduce Team, and ensure that a
review of the site visit process is presented to the
grantee).
• Ensures the grantee will arrange for a confidential
Consumer Panel interview (preferably during a lunch).
• Ensures the grantee’s necessary staff and
subcontractors (if applicable) are available for
interviews during the site visit.
Pre-Site Visit Activities
Role of Team Members
 Responsible for making personal travel arrangements
with contractor.
 Reads the Pre-Site Visit Informational Packet.
 Responsible for participating on the Pre-Site Visit
Conference Call.
 Makes him/herself directly available by phone or
email to the other Consultants and to the grantee’s
staff.
On-Site Activities
Role of Project Officer
• Opens the entrance conference by clarifying the purpose
for the site visit; roles of the Team; and introduces the
Team.
• Provides information on questions related to: HRSA/HAB
policy; Program Guidance and Expectations; HAB/Division
of Grants Management Operations (DGMO) approved
budgets; and HRSA/HAB updates.
• Available to Consultants as they obtain information.
On-Site Activities
Role of Project Officer (cont)
• Holds “check-in” meetings with Team Leader and Consultants
throughout the visit.
• Provides clarification on questions that arise.
• Actively participates in Pre-Exit and Exit Conferences
(provides closing remarks and “next steps”).
On-Site Activities
Role of Team Leader
Serves as “lead reviewer,” getting directions to sites and
facilities, etc.
Serves as a mediator in discussions or when disagreements
arise. The “lead reviewer” is responsible for ensuring that the
Site Visit Team completes a review that meets the spoken and
written instructions of the Project Officer.
Facilitates meetings and handles on-site team logistics (e.g.
rental car, when applicable).
On-Site Activities
Role of Team Leader (cont)
“Checks in” with the Project Officer and Team Members on a regular
basis to ensure that the site visit is progressing as expected or to
make needed adjustments to the agenda.
Usually serves as the facilitator of the Consumer Panel meeting.
Ensures the preparedness of the entire Team for the Pre-Exit and/or
Exit Conference.
Provides feedback as necessary to Team Members.
On-Site Activities
Role of Team Members
 Participates in the following meetings: Entrance
Conference, Consumer Panel, Pre-Exit and/or Exit
Conference.
 Efficiently conducts review of materials and staff
interviews.
 “Checks-in” with the Project Officer and Team
Leader on a regular basis.
 Is fully prepared to make their remarks at the PreExit and/or Exit Conference.
Post-Site Visit Activities
Role of Team Members
• Submit written report to Team Leader within
one week of completion of site visit.
• Provide any clarification or edits as
requested.
Post-Site Visit Activities
Role of Team Leader
• Compiles and submits final Site Visit Report
within two weeks of completion of site visit.
• Contacts Team Members for edits requested
by Project Officer.
Post-Site Visit Activities
Role of Project Officer
• Reviews and provides feedback to Team
Leader on Site Visit Report.
• Assures the completion and release of the
Site Visit Report to the grantee within four
weeks of the conclusion of the site visit.
• Monitors completion of grantee’s Corrective
Action Plan and provides technical assistance
when necessary.
Contractor and Project Officers Roles
The Contractor is responsible for issuing all
reimbursement for consultants’ out of pocket
expenses and honorariums for site
visits. Honorariums are issued by the
contractor upon final approval of the Site Visit
Report by the Project Officer. All
communication concerning consultant
reimbursement should be sent to the
Contractor.
Team Member
Professional Standards
Confidentiality
CONFIDENTIALITY:
As a Consultant, you must fully understand the confidential nature of the site
visit discussions related thereto and agree:
(1) to return all copies of review-related materials;
(2) to erase all electronic review-related materials;
(3) not to discuss these materials or the site visit review proceedings with any
individual except the staff of Health Resources and Services Administration
(HRSA) and Grants Management Officials; and
(4) to refer all inquiries made concerning any aspect of the review
proceedings to the HRSA Project Officer in charge of the review.
Team Member Professional Standards
• Maintain utmost degree of professionalism at all times.
• Strike a balance in decorum. Avoid opposite extremes
- being condescending or being overly-friendly.
• Avoid expressing personal opinions on the policies
and procedures of DHHS, HRSA, or HAB. Avoid
personal biases (“That’s not how WE do it at OUR
clinic.”)
Team Member Professional Standards
• Refrain from conducting personal business on Federal
time.
• Avoid even the slightest PERCEPTION of a “Conflict
of Interest.”
• Never market personal consulting services or products
(e.g. books you have authored, etc.).
Team Member Professional Standards
• Refrain from accepting significant gifts, meals,
drinks, etc. from grantees. Items of nominal value
(e.g. t-shirt, pens, button, coffee mug, etc.) are
permissible.
• If the Consumer Panel is during lunch (optimal), the
Team Members are expected to contribute their
portion of the cost of the meal.
Team Member Professional Standards
• Be respectful of the time and availability of the grantee’s
staff, consumers, Board Members, and subcontractors.
• Be thorough in your review with as little disruption of the
grantee’s workplace as possible.
• Be respectful of your fellow Team Members’ time and
efforts.
• Be fully prepared for Pre-Exit and Exit Conferences.
• Be respectful of the grantee’s organizational culture!
• Frame your closing remarks to be sensitive to the culture of
the grantee.
Site Visit Assessment Tool
Site Visit Assessment Tool
What’s New?
Name – Site Visit Assessment Tool
Core Site Visit Requirements At A Glance
Introduction page
Mission, Vision, and respective websites
Reason – to familiarize the Consultant with our
services and brand
Site Visit Assessment Tool
What’s Old?
What’s New?
Site Visit Categories
•4 – Administrative
•5 – Fiscal
•8 – Clinical
Site Visit Requirements
We have identified a separate authority and
resource for each requirement for a total of:
•4 – Administrative
•4 – Fiscal
•4 – Clinical
MIS – included as a separate category at the end
of each module
MIS – we have integrated MIS into all
requirements
Improvement options
All improvement options were removed.
Reason – to place focus on legislative authorities
and essential elements versus citing grantees for
trivial issues. This approach will lead to a more
streamlined report and concise corrective action
plan.
Site Visit Assessment Tool
What’s Old?
Fiscal – reference tools
What’s New?
A separate document that will accompany the
Site Visit Assessment Tool with reference
material.
Resources added below each requirement.
Reason – to assist Consultants in identifying
materials for review
No sub-categories
Sub-categories added under each requirement
Reason – for relative ease in reviewing the tool
by grouping similar subject matter
Findings – potential for numerous findings
Consultants will identify findings based on 12
requirements. Each finding will not be
addressed individually within the report.
Reason – provide a more tailored approach to
the exit conference, report, and corrective
action plan. Project Officer can provide more
targeted TA based on respective requirement.
Core Site Visit Requirements At A Glance
Section I: Administrative
1
2
3
4
Sections 2601-2692 of title XXVI of
the PHS Act; 42 USC §300ff-11,
§300ff-111; 45 CFR 74; 45 CFR 92;
2 CFR 215; HHS Grants Policy
Statement (2007); HAB Policy Notice
11-02
Administrative Structure
and Management
Grantee maintains a fully staffed management and clinical
team as appropriate for the size and needs of the program.
The organization has established appropriate oversight and
authority over all aspects of the program.
Data Reporting
Grantee has systems which accurately collect and organize
data for program reporting and which support management
decision making.
Section 2664 (a), Section 2671 (c),
and Section 2691 (b) of title XXVI of
the PHS Act; 42 USC §300ff-64,
§300ff-71, and §300ff-101; FOA
Grantee makes efforts to establish and maintain
collaborative relationships with medical and support
providers.
Section 2651 (e) and Section 2671
(c) of title XXVI of the PHS Act; 42
USC §300ff-51 and §300ff-71; HAB
Policy Notice 12-01
System Coordination
Accessibility,
Confidentiality, and Cultural
Competency
Grantee has policies and procedures that address
HIV/AIDS related confidentiality and program processes
that include limiting access to passwords, electronic files,
medical records, faxes and release of client information.
Grantee adheres to accessibility and National Standards
on Culturally and Linguistically Appropriate Services
(CLAS).
Section 2652 (a) (2) and Section
2661 (a) of title XXVI of the PHS Act;
PL104-191 HIPPAA; CLAS
Standards
Core Site Visit Requirements At A Glance
continued
Section II: Clinical
5
6
7
8
HIV Counseling, Testing,
Referral, and Patient
Enrollment
Grantee maintains formal linkages to HIV Counseling,
Testing, Referral, and partner counseling either on site or
from other sources that are available and accessible to the
targeted population(s).
Section 2651 (e) (1) (A) and (B),
Section 2661 (a) and (b), and Section
2662 (a) and (b) of title XXVI of the
PHS Act
HIV Medical Care
Grantee provides a comprehensive continuum of outpatient
HIV primary care services within a targeted area that
attempts to link persons with HIV disease as early in the
course of infection as possible and retain them in medical
care. Program must reflect a medical model of care that
remains abreast of clinical advances in which providers
can assess, treat, and refer patients.
Section 2651 (c) (3), (e) (D) and (E) of
title XXVI of the PHS Act
Other Services to Support
HIV Clinical Outcomes
Grantee ensures access, either directly or via referral, to
oral health care, adherence counseling, outpatient mental
health care and substance abuse treatment, nutritional
services, and specialty medical care. Formal
arrangements such as contracts or memoranda of
agreements are established with appropriate providers as
applicable.
Section 2651 (c) (3), (d) of title XXVI of
the PHS Act.
Clinical Quality
Management Program
Grantee has established a clinical quality management
(CQM) program that assesses the extent to which HIV
health services are consistent with performance standards
as defined by HHS benchmarks and quality indicators.
Grantee’s CQM program includes an evaluation
component that measures performance and continuously
plans, implements, evaluates, and incorporates strategies
to improve delivery of care.
Section 2664 (a) (3), (g) (5) and
Section 2671 (f) (2) of title XXVI of the
PHS Act
Core Site Visit Requirements At A Glance
continued
Section III: Fiscal
Ryan White Budget and
Use of Funds
Grant Funds are budgeted and expended for approved
activities in alignment with applicable Federal legislation
and program requirements.
Section 2664 (g), Section 2651 and
Section 2671 of title XXVI of the PHS
Act; 2 CFR Parts 215, 220, 225, and
230; 45 CFR Part 92; and OMB
Circular A-133
10
Fiscal Management and
Oversight
Grantee maintains accounting and internal control systems
appropriate to the size and complexity of the organization
reflecting Generally Accepted Accounting Principles
(GAAP) and separates functions appropriate to
organizational size to safeguard assets, maintain financial
stability, and account for the appropriate expenditure of
Ryan White funds.
Section 2664 (g) of title XXVI of the
PHS Act; 2 CFR Parts 215, 220, 225,
and 230; 45 CFR Part 92; and OMB
Circular A-133
11
Third Party
Reimbursement: Billing,
Collections, and Program
Income Reporting
Grantee has systems in place to identify and maximize
collections and reimbursement for its costs in providing
health services, including written billing, credit and
collection policies and procedures, and how such revenue
is invested in the Ryan White funded program.
Section 2652 (b) and Section 2664 of
title XXVI of the PHS Act; 2 CFR 215
and 45 CFR 92
12
Sliding Fee Discounts and
Annual Cap on Charges
Grantee has a system in place to determine eligibility for
patient discounts and maintains legislative Sliding Fee
Scale and Annual Cap on Charges to ensure no one is
denied services based on an inability to pay.
Section 2652 (b) and Section 2664 of
title XXVI of the PHS Act; 2 CFR 215
and 45 CFR 92
9
Snapshot of a Requirement
Requirement 3: System Coordination
Authority: Section 2651 (e) and Section 2671 (c) of title XXVI of
the Public Health Service Act; 42 USC §300ff-51 and §300ff-71;
HAB Policy Notice 12-01
Resources: 1) Contracts/MOAs; 2) SOPS; and 3) EHR/EMR
Management
Does the program have collaborative relationships with other health
care providers, other community centers, other RW providers, as
well as local, state, and private organizations providing similar or
complimentary services in the community?
Yes/Met
No
Partially
Met
N/A
Not Met
Site Visit Report
Title XXVI of the PHS Act as amended by the Ryan White
HIV/AIDS Treatment Extension Act of 2009 (Ryan White
Program)
Site Visit Report
Grantee Information:
Grantee Name:
Grant Number:
Type of Visit:
Purpose of Visit:
Comprehensive ____
Diagnostic ____
Technical Assistance____
The purpose of this site visit was to assess grantee’s compliance with the
legislative and programmatic requirements of the Ryan White Part [C Early
Intervention Services (EIS)] Program. The site visit team reviewed the clinical,
fiscal, Management Information Systems (MIS), administrative and support
services of the HIV program operations.
[State Reason that prompted this particular site visit]
Date(s) of Visit:
Project Officer:
Consultant(s):
Overview of Grantee Organization: Include brief summary of organizations’ model of care, hours of
operations, services provided, client demographics, third party payors, summary of chart audit review, and
consumer panel.
Defining Use of Met / Partially Met /
Not Met
Met
•All elements of a Requirement are
met.
•No findings or recommendations
should be included within the Site
Visit Report under the specific
Requirement.
Partially Met
•Not all elements of the
Requirement are met.
•Include findings and
recommendations that were not
met within the Site Visit Report
under the specific Requirement.
Not Met
•All elements of a Requirement are
not met.
•Include findings and
recommendations within the Site
Visit Report under the specific
Requirement and reflect a “must”
in this case.
Site Visit Report
Sample of a Requirement
Section I. Administrative
3. System Coordination: Grantee makes efforts to establish and maintain collaborative relationships with medical and
support providers.
Authority: Section 2651 (e), and Section 2671 (c) of title XXVI of the Public Health Service (PHS) Act; 42 USC §300ff-51 and
§300ff-71; HAB Policy Notice 12-01
Met/ Partially Met/Not Met:
Finding(s):
Recommendations:
Tips for Writing a Concise and
Comprehensive Site Visit Report
• Limit “overview” to one page (Refer to Site Visit Report for an
example)
• Limit total pages to 10.
• If a Requirement is not met or partially met provide a short description
of finding(s) and recommendation(s).
• Only include findings related to the Requirements.
Remember to:
Communicate with the Project Officer
Follow the site visit template
Tailor the report to the findings discussed in the Exit
Conference
Produce a clear and concise report
Meet the Site Visit Report deadline of two weeks
following conclusion of the site visit.
Questions should be emailed to
David Pitman at
[email protected]
FY 2013 Clinical Requirements
Part C HIV Early Intervention Services (EIS)
Part D Grants for Coordinated HIV Services and Access to
Research for Women, Infants, Children, and Youth (WICY)
Part F – Dental
Presented by:
Department of Health and Human Services
Health Resources and Services Administration
HIV/AIDS Bureau
Division of Community HIV/AIDS Programs
Purpose
The following webinar is offered in support of the Health
Resources and Services Administration’s (HRSA), HIV/AIDS
Bureau (HAB), Division of Community HIV/AIDS Programs
(DCHAP), 2013 Site Visit Assessment Tool.
Webinar Goal
• To increase HRSA/HAB/DCHAP’s Ryan White Part C, D, and F
Consultants’ and Project Officers’ knowledge of how to effectively
assess and report on the grantee’s provision of comprehensive,
high quality healthcare for people living with HIV/AIDS;
compliance with legislative and programmatic requirements; and
the National HIV/AIDS Strategy.
• To learn to effectively assess compliance and report findings
based on clinical practices required by legislation.
Learning Objectives
At the conclusion of this presentation, participants should:
•Be familiar with the clinical requirements governing Ryan
White Parts C, D, and F-Dental awards.
•Be prepared to test grantee compliance with Ryan White
Parts C, D, and F-Dental clinical requirements.
•Understand how to accurately identify and report clinical
findings.
•Be prepared to conduct a thorough chart review.
Webinar Outline






Purpose of the Clinical Site Visit
Overview of Clinical Requirements
Potential Resources
Common Clinical Findings
Consumer Panel
Chart Review Process
Purpose of the Clinical site visit
Verify the Grantee’s
Verify integration of
program is in
oral health care,
compliance with the
mental health care,
Ryan White
and specialty
Legislative
services within HIV
Requirements.
primary care
Ensure highest
Develop a Technical
quality HIV clinical
Assistance Plan to
care and compliance
address any program
with HHS Guidelines.
deficiencies.
Clinical Review
Elements
Sequence
All elements of the Site Visit
Find sequence that works
Assessment Tool are
for you, may not necessarily
important.
be in numerical order.
“Must do”
Interviews
• Quality Improvement (QI/CQM)
• Medical Record Review
• HIV Core Medical Services now
included in chart review tool
Clinical Personnel
Consumer Panel
Core Site Visit Requirements At A Glance
Section II: Clinical
5
6
7
8
Grantee maintains formal linkages to HIV Counseling,
Testing, and Referral, and partner counseling either on site
or from other sources that are available and accessible to
the targeted populations(s).
Section 2651 (e) (1) (A) and (B),
Section 2661 (a) and (b), and Section
2662 (a) and (b) of title XXVI of the
PHS Act
Grantee provides a comprehensive continuum of outpatient
HIV primary care services within a targeted area that
attempts to link persons with HIV disease as early in the
course of infection as possible and retain them in medical
care. Program must reflect a medical model of care that
remains abreast of clinical advances in which providers
can assess, treat, and refer patients.
Section 2651 (c) (3), (e) (D) and (E) of
title XXVI of the PHS Act
Other Services to Support HIV
Clinical Outcomes
Grantee ensures access, either directly or via referral, to
oral health care, adherence counseling, outpatient mental
health care and substance abuse treatment, nutritional
services, and specialty medical care. Formal
arrangements such as contracts or memoranda of
agreements are established with appropriate providers as
applicable.
Section 2651 (c) (3), (d) of title XXVI of
the PHS Act.
Clinical Quality Management
Program
Grantee has established a clinical quality management
(CQM) program that assesses the extent to which HIV
health services are consistent with performance standards
as defined by HHS benchmarks and quality indicators.
Grantee’s CQM program includes an evaluation
component that measures performance and continuously
plans, implements, evaluates, and incorporates strategies
to improve delivery of care.
Section 2664 (a) (3), (g) (5) and
Section 2671 (f) (2) of title XXVI of the
PHS Act
HIV Counseling, Testing, Referral,
and Patient Enrollment
HIV Medical Care
Requirement 5: HIV Counseling, Testing,
Referral, and Patient Enrollment
• HIV counseling, testing, referral, and partner counseling
should be available for high risk targeted service
populations either via Part C or D funding or by other
sources.
• Linkages and formal referral mechanisms should be established
with HIV testing programs, community providers, and support
service agencies.
• Part C funding should not be used for routine HIV testing in
general patient populations.
• Counseling, testing and referral programs must assure
the confidentiality of patient information.
Reference: Funding Opportunity Announcement
Requirement 5: HIV Counseling, Testing,
Referral, and Patient Enrollment
continued
Additional Areas to Consider:
• Does counseling include the provision of HIV risk
assessment and education on HIV transmission?
• Is prevention with HIV positive persons counseling
available and documented?
• Are partner notification services available?
Requirement 6: HIV Medical Care
• Comprehensive continuum of HIV care including primary
medical care and, when applicable, perinatal care must be
offered.
• Medical care should be provided according to the latest
HHS Guidelines and include:
• Periodic medical evaluations
• Appropriate treatment of HIV infection
• Prophylactic and treatment interventions for complications of HIV
infection, including opportunistic infections, opportunistic
malignancies, and other AIDS defining conditions
Reference: Funding Opportunity Announcement
Requirement 6: HIV Medical Care
continued
• Testing must be available to confirm the presence of HIV
infection (Viral Load) and status of immune system (CD4).
• Ongoing prevention services must be accessible.
• Diagnostic and therapeutic measures, according to HHS
Guidelines, for preventing and treating the deterioration of
the immune system and related conditions must be
provided.
Reference: Funding Opportunity Announcement
Requirement 6: HIV Medical Care
continued
• Patients should be involved and fully educated about their
medical needs and treatment options.
• Diagnosis, prophylaxis, treatment, or referral for persons
co-infected with TB, Hepatitis B and C, and STI should be
available.
• Systematic tracking of referrals, including documentation
of outcomes, must be implemented.
• After-hours and weekend clinical coverage must be
available for medical and dental services.
• Continuing education opportunities must be provided to
EIS program staff.
Reference: Funding Opportunity Announcement
Additional Areas to Consider
•
What is the model of care?
• What is the number of service sites?
• What Core Medical Services are being provided?
• Is HIV specialty care segregated from primary care?
• Is there continuity of care?
• Are there adequate hours to assure access?
• What services are available after hours?
• Are there linkages with community providers and support
service agencies to ensure access to EIS services for all
RW eligible persons in the service area?
Requirement 7: Other Services to
Support HIV Clinical Outcomes
• Ensure access to oral health care, adherence counseling,
outpatient mental health care, outpatient substance abuse
treatment, nutritional services, and specialty medical care
either:
• On site
• Via contract
• Via memoranda of agreement
• All practitioners for these services should have
experience working with HIV and the target populations.
Reference: Funding Opportunity Announcement
Requirement 7: Other Services to
Support HIV Clinical Outcomes
continued
Additional Areas to Consider:
• Are referrals to these services fully integrated with the
delivery of HIV primary medical care?
• Do the programs monitor the quality of these services?
• Is there access to medical case management and
specialty care?
• Is there access to drug discount programs via 340B or
Manufacturer Assistance Programs?
• Are services available to support PLWHA to achieve their
medical outcomes? i.e. transportation
Oral Health Care
Additional Areas to Consider:
• Are patients in the program getting oral health care
services?
• Do primary medical care providers screen/detect for
oral diseases?
• Are oral health referrals documented by primary care
medical providers?
• Is oral health care part of the Clinical Quality
Management Program’s performance measures?
Requirement 8: Clinical Quality
Management Program
• A Clinical Quality Management (CQM) Program should be
established to:
- Assess the extent to which HIV medical care is consistent with the
most recent HHS Guidelines.
- Develop strategies to ensure access to and the quality of HIV
services.
• Ensure process for measuring performance, planning, implementing,
and evaluating improvement strategies.
• Subcontracts, if applicable, must include provisions regarding
monitoring and CQM.
• Programs must involve consumers in the development,
implementation, and evaluation of services and activities.
Reference: Funding Opportunity Announcement
Requirement 8: Clinical Quality
Management Program
continued
Additional Areas to Consider:
• Are quality goals measurable and achievable?
• Is there a tracking mechanism in place that leads to
process improvements?
• Does the program track retention in care?
• Does the program track viral suppression?
Potential Resources
•
•
•
•
•
•
•
•
•
•
•
HHS Guidelines
Clinical Policies and Procedures and Practice Protocols
Contracts and Memoranda of Agreements
Medical Record Review (request staff assistance for navigating EHR)
Case Management Notes
Staffing Plan
Personnel Interviews – Medical Director, Providers, and Staff
Consumer Panel
CQM Plan and CQM Meeting Minutes
DCHAP Chief Medical Officer and Chief Dental Officer
HAB Performance Measures website
Common Unmet Findings for
Requirements 5-8
• Compromised confidentiality
• Lack of Clinical Quality Management Program or clinical
performance measures
• Insufficient access to primary medical care or Core
Medical Services (Part C)
• Consumers in Part D program not informed about/given
access to clinical research trials
• No current site-specific clinical protocols
Common Unmet Findings for
Requirements 5-8
continued
• Inadequate documentation of HIV clinical care &
monitoring
• Inadequate after-hours or emergency coverage
• Lack of health maintenance or primary care services for
HIV positive patients
• Inadequate access to specialty care depending upon
region and availability
• Inadequate tracking of referrals and missed appointments
in the medical case management records
Consumer Panel
Team Leader
usually provides
guidance as to
Team Member
roles
Clinical Consultant
Clinical Consultant
should identify
has vital role in
his/herself as a
asking/ probing
medical provider:
about model of
sometimes that
care, clinical
opens the door for
services, access
consumers to talk
(e.g. to meds),
about their care
and quality of care
CHART REVIEW
Selecting Charts for Review
Select charts to be
reviewed by clinical
consultant to include
some patients with
CD4 < 200, some in
200 – 500 range, and
some > 500 cells/mm.
Request a list of all
active patients by
medical record
number or other
identifier (no names),
with gender, age,
latest CD4 count and
Viral Load
Make sure that at least
3 – 5 charts are
chosen per provider
and from each site
and include newly
enrolled (< 1 yr.) and
established patients
Sources for
Chart Review Elements
G
HHS Adult and Adolescent HIV/AIDS Care Guidelines
(2012)
PM HRSA HIV/AIDS Performance Measures (2009-2011)
PC HIV Primary Care Guidelines (2009)
B Bartlett’s Medical Management of HIV (2010)
HHS HHS Indicators for monitoring HHS-funded HIV
services (2012)
IOM IOM Monitoring HIV Care in the United States (2012)
NQF National Quality Forum
Chart Review - Systems-Level Review
Clinical Quality Measures:
- Retention in medical care
- Viral load suppression
- Hepatitis B vaccination
- Pneumocystis pneumonia
prophylaxis
Systems-Level Review
continued
Access to Care and Quality Management:
- Waiting Time for Initial Access to
Outpatient/Ambulatory Medical Care PM
- Urgent Visits
- Referrals
- Quality Management Program PM
Patient Level Review
Patient Information
ID # ___ age____ gender
Date most recent visit
What was the date of the most recent visit at this site?
Notes on retention in
medical care
Has the patient been evaluated by a medical provider once in
each 6-month period in the past 24 months? HHS
LABS
CD4 G, PM
List the most recent CD4 value with the date
Viral load G, PM
List the most recent viral load value with the date
Lab bundle date (CBC,
Chemistry, LFTs) G
Did patient receive CBC with differential, basic chemistry, AST,
ALT, and Total Bilirubin at least 2 times, at least 3 months apart?
Lipid screening G, PM
Did patient have a lipid panel? If fasting, please note.
STI screening bundle
PM, B
Did patient receive a serologic test for syphilis/RPR and
genitourinary test for gonorrhea and chlamydia? If no, then
check documentation on sexual history or clinic
policy/procedures.
Patient Level Review
continued
Patient Information
Cervical cancer
screening PM, B
Hepatitis B & C
screening G, PM
ID # ___ age____ gender
If patient is female, was a pap smear result documented?
Are Hepatitis B & C serology results documented since
enrollment?
IMMUNIZATIONS
Hepatitis B
vaccination
Is completion of the HBV vaccine series documented since
enrollment? If no, please explain
G, PM
Influenza vaccine
PM
Was influenza vaccine documented for the most recent season?
Patient Level Review
continued
HIV CARE
PCP prophylaxis
G, PM
Antiretroviral therapy
HHS
Adherence counseling
PM
If CD4 cell count <200, was PCP prophylaxis prescribed?
If no, was reason documented?
Was ART offered to the patient? If yes, list medications.
If patient was prescribed ART, was (s)he assessed and/or
counseled for adherence at least 2 times before/after ART
initiation? (Includes counseling from any health care provider)
PRIMARY CARE
Allergies
Were drug allergies documented?
Blood pressure
screening PC
Was blood pressure tested?
BMI NQF
Was BMI documented, and if abnormal, was follow-up plan
documented?
Patient Level Review
continued
Patient Information
Oral exam PM, B
Tobacco cessation PM
Mental health
screening G, PM
Substance abuse
screening G, PM
Conception
counseling
HIV risk counseling PM
Notes
ID # ___ age____ gender
Was oral health care documented (visit to dental professional or
oral exam by primary care provider)?
If the patient is a smoker, was tobacco cessation counseling
delivered?
Was patient referred or given a MH screening since enrollment?
Was patient referred or given a SA screening since enrollment?
If female of reproductive age, was the patient offered
preconception counseling?
Was safer sex discussed?
Tips for Reviewing Charts
 Attempt to get a broad sampling of charts
 Don’t just tick off boxes; see if the flow of care makes
sense, is it effective?
 Remember – goal of therapy is viral suppression!
 Ask for charts of women currently pregnant or post
partum within last year
 If Part D program, in addition to primary care charts for
adult women, request:
 Pediatric charts of varying ages (including HIV exposed infants)
 Adolescent charts – both perinatally and behaviorally infected
 Prenatal charts
Chart Review
• Plan to review a good sampling of charts (approx. 10 – 15)
during a 2 day visit for either Part C or Part D.
• If the visit is for a multiply-funded site (Parts C and D) for at
least 3 days, attempt to review at least 20 charts with 10 for the
Part D (WICY) population.
• Assessment of the chart review findings should be correlated
with the site-specific clinical protocols.
• Include number of charts reviewed and number of charts with
HIV-1 VL < 200 copies/ml on Site Visit Report.
Management Information Systems (MIS)
Evaluate
Electronic
Health
Record
system or
paper
medical
record for:
• Tracking of missed
appointments / retention in
care
• Linkage of case
management records or
documentation of Core
Medical Services within
primary medical records
Questions should be emailed to
David Pitman at
[email protected]
Next Steps
Please note that successful completion of this webinar is one
qualifying component for selection as a HRSA/DCHAP Site Visit
Consultant.
1) Within two business days, an email will be sent to all
participants that will include a Consultant Questionnaire and
a Post Test Exam.
2) Please return a signed scanned copy of the completed Post
Test Exam and Questionnaire along with a current resume/CV
to David Pitman at [email protected] within two business
days of receipt of the email.
Contact Information
Karen Gooden, Co-Chair DCHAP Site Visit Workgroup
[email protected]
Sandra Lloyd, Co-Chair DCHAP Site Visit Workgroup
[email protected]
John Fanning, DCHAP Senior Policy Advisor
[email protected]
HHS/HRSA/HAB/DCHAP
301-443-0493