Overview of Site Visit Process

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

Division of Community HIV/AIDS Programs Clinical

Windows User

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:

• 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).


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

Reducing new HIV infections

Increasing access to care and improving

health outcomes for

PLWHA

Reducing HIV-related

disparities and health

inequities

Achieving a more

coordinated national

response to the HIV epidemic


Parts A,B,C,D, and F, and the Minority AIDS Initiative

Ryan White HIV/AIDS Program• Metropolitan Areas affected by HIV/AIDSPart A

• States and US Territories• AIDS Drug Assistance Program (ADAP)Part B

• Early Intervention Services and Capacity Development Part C

• Women, Infants, Children and Youth (Part D)Part D

• Dental, Education/Training, Planning, Capacity Development and Demonstrations, Minority AIDS Initiative

Part F

Ryan White HIV/AIDS Program Administration

• Division of Metropolitan HIV/AIDS ProgramsPart A

• Division of State HIV/AIDS ProgramsPart B

• Division of Community HIV/AIDS Programs

Part C, D and F

Dental

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 ProgramPart F / Dental

• Expands access to oral health care for PLWHA while training additional dental and dental hygiene providers

Dental Reimburse

ment Program

• Provides oral health services to PLWHA via cooperative projects with community-based providers of oral health services

Community Based Dental

Partnership Program

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

MonitoringSite Visits

DCHAP Site Visits

Types of Site Visits DescriptionComprehensive •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 ProgramCompliance Monitoring

Monitoring Calls

Review of RW Programmatic Reports

Review of Fiscal Reports

Comprehensive Site Visits

Diagnostic Site Visits

HRSA/HAB conducts ongoing

review and monitoring of

grantees

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 4 Weeks Prior to Scheduled Site VisitPre-Site Visit Conference Call Held with the Project Officer, Consultants, and Grantee

Minimum of 8 Weeks Prior to Scheduled Site VisitProject Officer Confirms Date and Time of Pre-Site Visit Conference Call with Consultants and Grantee

Minimum of 10 Weeks Prior to Scheduled Site Visit Consultants are identified and site visit materials are emailed to Consultants

Goal of Site Visit Timeline continued

By 4 Weeks Following Completion of Site VisitProject Officer Releases Completed Site Visit Report to Grantee

Within 4 Weeks of Completion of Site VisitSite Visit Report Approved by Project Officer, Branch Chief, Clinical Reviewer, and Deputy Director of DCHAP

Within 2 Weeks of Completion of Site VisitSite Visit Report Submitted by Team Leader to Project Officer

Within 1 Week of Completion of Site VisitSite Visit Report Submitted by Consultants to Team Leader

Pre-Site Visit Prep1. 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 Officer2. 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 ActivitiesRole 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 ActivitiesRole of Team Leader

Confirms travel arrangements, arrival and departure times with Consultants

Makes him/herself available by phone or email to the other Consultants and Grantee’s staff

Facilitates Pre-Site Visit Conference Call

Responsible for working with PO, Grantee, and Consultants to finalize the Site Visit Agenda

Team Leader

Pre-Site Visit ActivitiesRole of Team Leader

Pre-Site Visit Conference Call• Facilitates the Pre-Site Visit Conference Call (re-

iterate 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 ActivitiesRole 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 ActivitiesRole 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 ActivitiesRole 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 ActivitiesRole 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 ActivitiesRole 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 ActivitiesRole 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 Pre-Exit and/or Exit Conference.

Post-Site Visit ActivitiesRole 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 ActivitiesRole 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 ActivitiesRole 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.


• 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.”)

• 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.).


• 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.


• 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 websitesReason – to familiarize the Consultant with our services and brand

Site Visit Assessment ToolWhat’s Old? What’s New?

Site Visit Categories•4 – Administrative•5 – Fiscal•8 – Clinical

Site Visit RequirementsWe 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 ToolWhat’s Old? What’s New?

Fiscal – reference tools 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 requirementReason – 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 GlanceSection I: Administrative

1 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.

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

2 Data ReportingGrantee 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

3 System CoordinationGrantee 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

4Accessibility,

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 Glancecontinued

Section II: Clinical

5HIV 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

6 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

7Other 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.

8 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 Glancecontinued

Section III: Fiscal

9 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

12Sliding 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

Snapshot of a RequirementRequirement 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

Yes/Met No N/A

Partially Met

Not Met

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?

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: Comprehensive ____ Diagnostic ____ Technical Assistance____

Purpose of Visit: 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

Partially Met

Not Met

•All elements of a Requirement are met.

•No findings or recommendations should be included within the Site Visit Report under the specific Requirement.

•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.

•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 RequirementsPart 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 AdministrationHIV/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 visitVerify the Grantee’s program is

in compliance

with the Ryan White Legislative

Requirements.

Verify integration

of oral health care,

mental health care,

and specialty services

within HIV primary careEnsure

highest quality HIV clinical care

and compliance with HHS

Guidelines.

Develop a Technical

Assistance Plan to

address any program

deficiencies.

Clinical ReviewElements

All elements of the Site Visit

Assessment Tool are important.

Sequence Find sequence that works for you, may

not necessarily be in numerical order.

“Must do” • Quality Improvement

(QI/CQM)• Medical Record Review • HIV Core Medical Services

now included in chart review tool

Interviews Clinical PersonnelConsumer Panel

Core Site Visit Requirements At A GlanceSection II: Clinical

5HIV Counseling, Testing,

Referral, and Patient Enrollment

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

6 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

7 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.

8 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

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


Requirement 6: HIV Medical Carecontinued

• 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.


Requirement 6: HIV Medical Carecontinued

• 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.


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.


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 CareAdditional 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.


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

should identify

his/herself as a medical provider:

sometimes that opens the door for

consumers to talk about their care

Clinical Consultant

has vital role in asking/

probing about model of

care, clinical services,

access (e.g. to meds), 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 Reviewcontinued

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 ReviewPatient 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 Reviewcontinued

Patient Information ID # ___ age____ gender

Cervical cancer screening PM, B

If patient is female, was a pap smear result documented?

Hepatitis B & C screening G, PM

Are Hepatitis B & C serology results documented since enrollment?

IMMUNIZATIONS

Hepatitis B vaccination G, PM

Is completion of the HBV vaccine series documented since enrollment? If no, please explain

Influenza vaccine PM Was influenza vaccine documented for the most recent season?


HIV CARE

PCP prophylaxis G, PM If CD4 cell count <200, was PCP prophylaxis prescribed? If no, was reason documented?

Antiretroviral therapy HHS Was ART offered to the patient? If yes, list medications.

Adherence counseling PM

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 Information ID # ___ age____ gender

Oral exam PM, B Was oral health care documented (visit to dental professional or oral exam by primary care provider)?

Tobacco cessation PM If the patient is a smoker, was tobacco cessation counseling delivered?

Mental health screening G, PM Was patient referred or given a MH screening since enrollment?

Substance abuse screening G, PM Was patient referred or given a SA screening since enrollment?

Conception counseling

If female of reproductive age, was the patient offered preconception counseling?

HIV risk counseling PM Was safer sex discussed?

Notes

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)

• Tracking of missed appointments / retention in care

• Linkage of case management records or documentation of Core Medical Services within primary medical records

Evaluate Electronic

Health Record

system or paper

medical record for:

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.

mailto:[email protected]

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 [email protected]

HHS/HRSA/HAB/DCHAP301-443-0493




Overview of Site Visit Process

Documents

Transcript of Overview of Site Visit Process