FTCA Site Visit Protocol

On this page:

• Purpose
• FTCA site visit
• FTCA site visit process
• Section I – documents for site visit review
• Section II – sample FTCA site visit agenda
• Section III – FTCA site visit report
• Section IV – FTCA site visit sample letter and report
• Section V – action plan
• Section VI – virtual site visit resources
• Section VII – resources

Purpose

FTCA Health Center Deeming Program Assistance Letter (PAL) (PDF - 812 KB)

Health Resources and Services Administration (HRSA) conducts FTCA site visits to assess compliance with program requirements (see 42 U.S.C. 233). FTCA programmatic requirements are addressed in the FTCA Health Center Policy Manual (PDF - 406 KB) and the Health Center Program Compliance Manual. HRSA may conduct a scheduled FTCA site visit and as otherwise needed.

Reasons for scheduling an FTCA site visit include:

• Submission of an initial FTCA deeming application
• Documentation submitted on the FTCA deeming application that suggests possible non-compliance with program requirements
• A history of medical malpractice claims
• A history of repeated conditions, or current conditions, placed by HRSA on the health center’s Health Center Program grant, as documented on the health center’s associated Notice(s) of Award(NoA)
• Follow-up based on findings from prior site visits or other identified issues

FTCA site visits differ from Health Center Program Operational Site Visits (OSVs). Refer to Federal Tort Claims Act (FTCA) Site Visits and the H80 Health Center Operational Site Visits (OSV): A Cross Walk Comparison Reference Guide for Health Centers (PDF). FTCA site visits enable HRSA to objectively assess and verify the implementation of FTCA program requirements and provide technical assistance to health centers as needed. In contrast, OSVs assess health centers’ compliance with the Health Center Program requirements. 

To prepare for an FTCA site visit, HRSA encourages all health centers to review the FTCA Health Center Policy Manual (PDF - 406 KB), the FTCA Health Center Deeming PAL (PDF - 812 KB), chapters (refer to chapters 5, 10, and 21) of the Health Center Program Compliance Manual, and the FTCA Site Visit Protocol.

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FTCA site visit

The FTCA site visit team consists of both HRSA staff and consultants. During an FTCA site visit, the team will typically evaluate whether the health center has:

• Set up proper policies and procedures to reduce the risk of malpractice and the risk of lawsuits
• Reviewed and verified the professional credentials, references, claims history, fitness of duty, professional review organization findings, and licensure status of its physicians and other licensed or certified health care practitioners
• Demonstrated its full cooperation with the Attorney General and the relevant federal attorneys in defending against any pertinent claims of the past, if a history of claims exists, and has taken any necessary corrective steps to ensure against such claims in the future

HRSA uses the programmatic requirements found in 42 U.S.C. 233(h) and (q), as implemented in the FTCA regulations in 42 CFR part 6, the FTCA Health Center Policy Manual (PDF - 406 KB), and the FTCA Health Center Deeming PAL (PDF - 812 KB) as the basis for determining whether health centers have demonstrated compliance with the statutory deeming requirements of the FTCA Health Center Program. Consultants and HRSA staff also may share best practice recommendations on various areas observed during the site visit.

HRSA conducts scheduled FTCA site visits between May and November. Health Centers are notified in advance of scheduled site visits. HRSA may conduct a site visit at any time due to an emergent need, such as a patient safety concern. 

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FTCA site visit process

Once scheduled, the health center can expect the team to conduct document reviews. After the site visit begins, staff and board interviews and facility tours will be conducted. FTCA site visits last 2.5 days. All details are discussed before the site visit during the pre-site visit call. The steps below include pre- and on-site planning activities during an FTCA Site Visit.

Pre-site activities

1. HRSA staff notifies the selected health center's Chief Executive Officer (CEO) and Project Officer (PO) of their health center’s selection.
2. HRSA will assemble a site visit team to conduct the FTCA site visit. The team consists of an HRSA staff member and two consultants.
3. HRSA staff will coordinate and schedule a pre-site visit call with the health center and site visit team to introduce the site visit process and clarify roles, responsibilities, and logistics.
4. Consultants will request specific documents from FTCA Health Center Program Site Visit Document Review (PDF - 176 KB) (as noted in Section I below) for review before the visit.
5. During the call, consultants will work with the health center to identify key staff to interview.
6. The health center will update the FTCA Site Visit Agenda as noted in Section II below and return the requested documents to HRSA staff. HRSA will confirm receipt of documents and follow up as needed.

On-site activities

1. The site visit team will review the health center policies and procedures pertinent to credentialing and privileging, risk management, claims management, and QI/QA with the grantee. This review typically focuses on questions that may have arisen during the team’s review of the documents before arriving on-site.
2. The site visit team will follow the finalized FTCA Site Visit Agenda, as noted in Section II below, while reviewing documents, conducting interviews, and touring facilities.
3. During the site visit, the site visit team will utilize the FTCA Health Center Site Visit Protocol to conduct the site visit analysis. Areas of deficiency may be identified by using the FTCA Health Center Deeming PAL (PDF - 812 KB), the FTCA Health Center Policy Manual (PDF - 406 KB), the Health Center FTCA Deeming Application, and chapters of the Health Center Program Compliance Manual (e.g., chapters 5, 10, and 21) to assess and verify the implementation of FTCA programmatic requirements.
4. Identified areas of deficiency are listed in the FTCA Site Visit Report (see below for more details about the reporting process).
5. The FTCA site visit will end with an exit conference where the site visit team will present preliminary findings to health center staff. The staff can ask questions at this time.

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Section I – documents for site visit review

The FTCA Health Center Program Site Visit Document Review (PDF - 176 KB) contains documents used to assess compliance with FTCA program requirements during the site visit. During the site visit, the consultant(s) may seek more documentation and information and ask to speak to specific staff members.

Documents addressed in this section will be requested before the site visit to allow the site visit team to evaluate the health center documents in advance. The lead consultant will contact the health center to request specific pre-site visit documents. The health center will electronically transmit pre-site visit documents to the identified team. Health centers have varying names for different policies and procedures. Please review the documents and follow up with the site visit team if you need clarification to decide which of your health center documents would be most suitable to submit. Before the site visit, we encourage the health center to review any documents related to the review areas, such as risk management, quality improvement, quality assurance (QI/QA) credentialing, privileging, and claims management.

Below is a sample of the information requested from the health center. The health center will upload through Citrix Sharefile 2-4 weeks before the site visit. View the FTCA Health Center Program Site Visit Document (PDF - 176 KB). Review for a complete list.

Risk management requested documents

Health Center Provides Pre-Site Visit

• Patient Satisfaction Policy and Procedure and Survey Results
• Medical Record Documentation and Completeness Standards
  • Written policies & standards
  • Actual medical record walk-through
• Medical Record Archiving Procedures
  • Written policies & procedures
• Risk Management Plan and policies and procedures that establish the Risk Management Program
• Annual Risk Management Goals and Objectives, Results, and Actions
• Annual Risk Management Report to the governing board
• Risk Manager position description
• Quarterly Risk Management Assessment Policy and Procedures/Processes
• Quarterly Risk Management Assessments (within the past 12) – most recent four quarters
• Minutes of Risk Management meetings (within the past 12 months)
• Staffing HIPAA (Privacy) Policy
• Medical Records Retention Policy
• Infection Control Policies and Procedures, Logs, and Staff Training Records
• Hand Hygiene Policies and Procedures, Logs, and Staff Training Logs
• Sterilization Policies and Procedures, Logs, and Staff Training Records

Risk management training requested documents

Health Center Provides Pre-Site Visit

• Risk Manager Risk Management Training Logs
• Risk Management Training Plan
• Risk Management Training documentation (Including but not limited to training plans, policies, and procedures, Sign-in sheets, or other tracking documentation)
• Record of staff risk management and safety training (within the past 12 months)
• Safety training records, including PPE, safe injections, sharps handling, autoclave, biological spore testing, eye wash, etc.

Tracking requested documents

Health Center Provides Pre-Site Visit

• Walk-in Patients Policy
• Specialty Referral Tracking Policy
• Specialist Referral Tracking Log (or other means to demonstrate referral tracking and follow-up)
• Hospitalization Tracking Policy
• ER Tracking Policy
• Hospital and ER Referral Tracking Logs (or other means to demonstrate tracking and follow-up demonstrating closing the loop of patient lab results from the health center back to the patient
• Diagnostic Tracking Log or other means to demonstrate tracking and follow-up regarding closing the loop of patient lab results from the health center back to the patient
• No Show Appointments Policy and Procedure and Follow-up Procedures and Logs
• Phone Triage Policy
• Urgent Care Visit Triage Policy and Procedure and Logs

Quality improvement and quality assurance (QI/QA) requested documents

Health Center Provides Pre-Site Visit

• QI/QA Plan and/or policy(ies) that establish the QI/QA program
• QI/QA calendar
• QI/QA Director, Manager, Administrator, CMO Job Description (Individuals responsible for QI/QA program)
• QI/QA Committee Meeting Minutes (within the last 12 months)
• Board Minutes (six most current governing board minutes)
• Health center bylaws
• Governing board roster
• Clinical guidelines and references used to develop guidelines/protocols (i.e., UpToDate.com specialty guidelines, Academy of Pediatrics, American College of Obstetrics (OB), Gynecology, Academy of Family Practitioners, etc.)
• Listing of written Clinical Protocols
• Sample quarterly clinical performance reports presented to the QI/QA Committee(s) and Board (most recent) including peer review
• Minutes of provider staff meetings (within the past 6 months)

Credentialing and privileging requested documents

Health Center Provides Pre-Site Visit

• List of clinical staff members with indicated professional designation, including (but not limited to) relevant credentialing/privileging information, such as name, title, specialty, date of hire, most recent credentialing and privileging date, FTE status, and service location
• Provider Contracts, Agreements, and Sub-recipient Arrangements (if applicable, based on service delivery methods on Form 5A)
• Credentialing and Privileging Policies and Procedures
• Credentialing and Privileging files available for examination (specific files to be pulled by the health center will be determined by the consultant team on-site)
• If applicable, a contract or agreement with the Credentialing Verification Organization (CVO) or other entity if used to perform credentialing functions, such as primary source verification, on behalf of the health center
• Quarterly peer review procedures or other applicable mechanism(s) (detailed results to be available on site)
• Documentation that the governing board or designee has approved the staff members who are credentialed or re-credentialed and privileged
• Health center organizational chart(s) with name of key management staff

Claims management requested documents

Health Center Provides Pre-Site Visit

• Policies and procedures for internal handling, analyzing, and tracking claims or potential claims
• Document(s) showing evidence the health center informs patients, using plain language, that it is a deemed federal Public Health
• Service employee via its website, promotional materials, and within area(s) of the health center visible to patients
• Process for securing or deactivating records of all involved clinical providers and clinic operating procedures
• Claims files for all potential and closed claims
• Claims manager or designee position description

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Section II – sample FTCA site visit agenda

Creation of site visit agenda

When creating the agenda for an FTCA site visit, the goal is to work in coordination with the health center flexibly and collaboratively. The FTCA site visit agenda is created based on a standard template utilized for all FTCA site visits and from the recommendations and availability of staff submitted by the health center. HRSA will provide more information during the pre-site visit call. Before the site visit, a copy of the FTCA agenda template will be provided to the health center contact. The health center will edit the agenda in the following ways:

1. Make any changes to the base of the template.
   1. Example: If the facility tour cannot be accomplished on the first day or between 10:00 a.m. and 11:00 a.m., the health center can reschedule it for another date or time.
2. Select an hour timeslot for the team to meet with the governing board.
   1. Please note that the meeting with the governing board does not include other health center staff or management.
   2. While it is nice to have governing board members attend in person, it is acceptable for members to participate via telephone, GoToMeeting, or other means approved by HRSA.
3. In the timeslots slated for interviews with staff, if key staff members are limited, please include specific times those individuals will be available for meetings. The key staff members typically include:
   1. Risk Manager
   2. Quality Coordinator
   3. Chief Medical Officer
   4. Claims Manager
   5. Credentialing Officer and Human Resource Manager
   6. Other staff the health center decides has an integral role in areas under review by the site visit team

Please Note: Schedules may change during the site visit, or specific sessions may run longer than intended. If necessary, the FTCA staff and the site visit consultants will communicate openly and make any needed adjustments.

Sample FTCA site visit agenda

Day 1

Timeframe (EST)	Description
	Start of Health Center Site Visit
09:00 – 10:00 AM	Entrance conference - Key Management and Board Members Introductions, opening remarks, and purpose of the site visit; Review of FTCA agenda and confirm the agenda. Federal Representative(s)– Provides FTCA/BPHC Update Health Center updates, if applicable Health Center Presentation History and significant developments; challenges that have been encountered; Health Center growth opportunities; changes in the healthcare environment (about 10 minutes)
10:00 – 11:00 AM	Health Center Site Visit Tour: The tour begins outside at the front of the building with key staff members (listed in Section II, #3). The tour should include the following: Approach the front desk Empty treatment room Medication room/ storage and management Vaccine storage area and management Isolation room/ contagious disease room Point of care testing (POCT), i.e., glucometer, centrifuges, EKG machines Eye washing stations Laboratory Pharmacy Each clinical area (primary care, OB, dental, pediatrics, behavioral health)
11:15 – 12:00 PM	Breakout Sessions: (Two breakout sessions will run concurrently.) Staff interviews and document reviews Credential and Privliging (C&P) Overview Risk Management (RM) Overview
12:00 – 1:00 PM	Break for Lunch
01:00 – 4:30 PM	Breakout Sessions: (Two breakout sessions will run concurrently.) Staff interviews and document reviews Risk Management Review: Referral, Hospitalization Lab/ Diagnostic Tracking Review of C&P Files
4:30 - 4:45 PM	Debrief for CEO

Day 2

Timeframe (EST)	Description
	Start of Health Center Site Visit
09:00 AM – 12:00 PM	Breakout Sessions: (Two breakout sessions will run concurrently.) Infection Control: Document Reviews, interviews and discussions Risk management review, infection control, clinical tracking, adverse events, and training policy, procedure, & training documents Staff interviews, document review Document Review: Continue the discussion on C&P, etc. Overview of Contractual Agreements
12:00 – 1:00 PM	Break for Lunch
1:00 – 2:00 PM	FTCA Team meeting with Governing Board
2:00 - 4:00 PM	Breakout Sessions: (Two breakout sessions will run concurrently.) Continue with Document Reviews and Interviews. Claims Management Discussion Continue C&P QI/QA/ Peer Review/Re-privileging
4:00 - 4:15 PM	Debrief for CEO (others)

Day 3

Timeframe (EST)	Description
	Start of Health Center
09:00 – 10:00 AM	Breakout Sessions: Break out session (the team will decide) Final Review/ Interviews
10:00 – 11:00 AM	Debrief for CEO
12:00 – 1:00 PM	Exit conference – CEO, Key Staff, and Board Members: FTCA Team and MSCG Consultant to present the following: Summary of the site visit findings – Team Members, FTCA Observer Recommendations – Team Members Next steps– FTCA/BPHC Federal Representative Question and Answers

Section III – FTCA site visit report

HRSA will develop and share an FTCA site visit report with the health center, typically within 6-8 weeks of the site visit. The report will convey the site visit findings and determinations about the health center’s implementation of FTCA programmatic requirements.

The report will include findings of non-compliance. These will not affect a health center’s current FTCA deeming status but may impact future deeming determinations.

The FTCA site visit report will include an action plan (section V Action Plan Response) with a description of health center actions necessary to comply with FTCA programmatic requirements. The action plan will note specific dates or deadlines for submission of information and/or documentation submission to HRSA.

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Section IV – FTCA site visit sample letter and report

Download Sample FTCA Site Visit Letter and Report (PDF - 408 KB)

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Section V – action plan response

The FTCA site visit report will identify HRSA/FTCA compliance determinations for each area of review (credentialing, privileging, risk management, QI/QA, and claims management). The resolution of FTCA program requirement issues is monitored with an action plan response that is sent via EHBs to the health centers after receiving the site visit report. 

The FTCA site visit action plan will consist of five sections, which describe the health center’s areas (elements) of non-compliance and recommendations from the Project Officer (PO). It is important to review and be responsive to the recommendations from the PO by the due date. Please use the link below for further instructions.

• BPHC Federal Tort Claims Act (FTCA) Action Plan for Health Centers Quick Reference Guide (QRG) (PDF - 1 MB)

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Section VI – virtual site visit resources

• FTCA Virtual Site Visits Overview 
• Supplement for FTCA Virtual Site Visits

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Section VII – resources

If your organization is a Federally Qualified Health Center, please email Clinical_RM_Program@ecri.org to request access to ECRI Clinical Risk Management resources. A sample of the tools and resources available through ECRI is listed below. For more information, please visit the ECRI Clinical Risk Management website or call 610-825-6000 ext. 5200. 

Site visit preparation resources

• Federal Tort Claims Act Site Visit Training for Health Centers Presentation (PDF - 1 MB) | Recording | Transcript (PDF - 253 KB)
• BPHC Federal Tort Claims Act (FTCA) Action Plan for Health Centers Quick Reference Guide (QRG) (PDF - 1 MB)
• New FTCA Site Visits and the H80 Health Center Operational Site Visits (OSV): A Cross Walk Comparison Reference Guide for Health Centers (PDF - 288 KB)
• New Risk Assessment and Mitigation Tool: Infection Prevention and Control (IPC)
• New Risk Assessment and Mitigation Tool: Obstetric Services (DOCX - 95 bytes)
• New Risk Assessment and Mitigation Tool: Claims Management (DOCX - 95 bytes)
• FTCA Deeming Application Step-by-Step Guide (PDF - 2 MB)

Credentialing and privileging and peer review tools and resources

• Credentialing Resource Collection (includes sample credentialing policies, step-by-step processes, credentialing application packet and flowcharts, and more)
• Credentialing and Privileging Guide for Health Centers (PDF - 95 bytes)
• Get Safe: Back to Basics: Effective Credentialing
• Get Safe: Credentialing and Privileging Non-Physician Providers and Clinical Staff
• Get Safe: Assessing Clinical Competence
• Get Safe: Peer Review Improves Patient Safety and Quality of Care
• Get Safe: Effective Processes for Granting Clinical Privileges

Risk management tools and resources

• Risk Management Resource Collection (includes sample plan, checklists, dashboard, risk management training tools, risk assessment tools, and more)
• Diagnosis: Test, Referral, and Hospitalization Tracking (includes sample policy, logs, and more)
• Ambulatory Care Risk Management Certificate Program
• E-Learn Courses for Continuing Education Credit
• Get Safe: Developing a Risk Management Training Program
• Get Safe: Handling Patient Complaints: Feedback for Quality Improvement
• Practice Alert: Conducting Risk Assessments: A Checklist

Quality assurance and quality improvement tools and resources

• Quality Improvement/Quality Assurance Resource Center (includes sample QI plans, meeting agendas and minutes, program checklists, and more)
• Webinar: Data-Driven Quality Improvement
• Webinar: A Measure of Quality: Implementing a QI/QA Program
• Webinar: The Use of EHRs for Quality Improvement
• Virtual Conference: Continuous Quality Improvement: Learning from Events
• Get Safe: Employing Data-Driven Quality Improvement Measures
• Get Safe: Using Valid Quality Improvement (QI) Methodologies

Claims management tools and resources

• Event Reporting Resource Center
• Event Response Resource Center
• Infographic: Proactive Management of Potential Claims (PDF - 95 bytes)
• Virtual Conference: After an Event: Understanding the Claims Process
• Virtual Conference: After an Event: Consider the Patient, Provider, and Practice

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