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FTCA Site Visit Protocol

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Purpose

The Health Resources and Services Administration (HRSA) conducts Health Center Federal Tort Claims Act (FTCA) Program site visits to support its responsibility to ensure compliance with the FTCA deeming requirements found in 42 U.S.C. 233(h) and (q) with particular respect to credentialing and privileging, risk management, claims management, and quality improvement/quality assurance (QI/QA). These deeming requirements are also addressed within the annual FTCA Health Center Deeming Program Assistance Letter (PAL), the FTCA Health Center Policy Manual (PDF - 406 KB), and pertinent chapters of the Health Center Program Compliance Manual. HRSA may conduct FTCA site visits on a regularly scheduled basis, to provide information related to a deeming application, and/or as otherwise determined by HRSA to be needed or appropriate.

Factors that may prompt an FTCA site visit include, but are not limited to , the following:

  • Submission of an initial FTCA deeming application;
  • Documentation submitted on the FTCA deeming application that indicates possible non-compliance with deeming requirements;
  • 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 Award1;
  • The need for follow-up based on prior site visit findings or other identified issues; and/or
  • A history of medical malpractice claims.

FTCA site visits are distinct from Health Center Program Operational Site Visits (OSVs) under section 330 of the Public Health Service Act. FTCA site visits enable HRSA to objectively assess and verify the implementation of FTCA deeming requirements and provide technical assistance (TA) to health centers as needed and appropriate. In contrast, OSVs assess a health center’s compliance with Health Center Program requirements described in the Health Center Program Compliance Manual.2 Health centers that are currently FTCA deemed or applying for initial FTCA deeming may also be assessed during an OSV for compliance with FTCA Program credentialing and privileging, risk management, claims management, and quality improvement/quality assurance (QI/QA) deeming 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 annual FTCA Health Center Deeming PAL and relevant chapters (e.g., chapters 5, 10, and 21) of the Health Center Program Compliance Manual.

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FTCA Site Visit Structure

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

  • Implemented appropriate policies and procedures to reduce the risk of malpractice and the risk of lawsuits arising out of any health or health-related functions performed by the entity;
  • Reviewed and verified the professional credentials, references, claims history, fitness, professional review organization findings, and licensure status of its physicians and other licensed or certified health care practitioners, and, where necessary, has obtained the permission from these individuals to gain access to this information; and
  • Should a history of claims exist, fully cooperated with the Attorney General in defending against any such claims and either has taken, or will take, any necessary corrective steps to assure against such claims in the future.

HRSA uses the deeming 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, and the annual FTCA Health Center Deeming PAL as the basis for determining whether health centers have demonstrated compliance with the statutory deeming requirements of the FTCA Health Center Program. Consultants and/or HRSA staff also may share best practice recommendations or TA on various areas observed during the site visit.

HRSA primarily conducts FTCA site visits between the months of May and October, although they may be conducted at any time throughout the year. Generally, health centers that have been selected for an FTCA site visit will be notified at the beginning of the calendar year. However, in the event that an FTCA site visit is scheduled due to an emergent need (such as a patient safety concern arising from issues with credentialing and privileging, risk management or QI/QA), HRSA may schedule a site visit with the health center at any time.

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FTCA Site Visit Process Overview

Once on site, the health center can expect the team to conduct document reviews, staff and board interviews and facility tours depending on schedules and availability. FTCA site visits are generally conducted in a 2.5-day timeframe. All details are discussed prior to the site visit during the pre-site visit call. The steps below include pre-site and on-site planning activities during a typical FTCA Site Visit.

Pre-Site Activities

  1. HRSA staff notifies selected health center Chief Executive Officer (CEO) and Project Officer (PO) about their health center’s selection.
  2. HRSA will assemble a site visit team to conduct the FTCA site visit. The team generally consists of a 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 the FTCA Document Review Checklist as noted in Section I below, for review prior to the visit.
  5. During the call, consultants will work with the health center to identify appropriate staff to be interviewed onsite.
  6. The health center will update the FTCA Site Visit Agenda as noted in Section II below, and return requested documents to HRSA staff. HRSA will confirm receipt of documents and follow up as needed.

On-Site Activities

  1. While on site, the site visit team will review the previously requested 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 prior to 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 to ensure tasks are completed on time and within the 2.5-day timeframe.
  3. During the site visit, the site visit team will utilize the FTCA Health Center Site Visit Protocol to conduct the on-site analysis. Possible areas of deficiency are identified using the annual FTCA Health Center Deeming PAL, the FTCA Health Center Policy Manual, the annual Health Center FTCA Deeming Application and pertinent chapters of the Health Center Program Compliance Manual (e.g., chapters 5, 10, and 21) to assess and verify implementation of FTCA deeming requirements.
  4. Any identified areas of deficiency are listed in the FTCA Site Visit Report (see below for additional details regarding the report process).
  5. The FTCA site visit will conclude with an exit conference where the site visit team will present any site visit findings to health center staff. At this time, the health center staff will have an opportunity to ask questions and engage in review and discussion of the site visit team’s findings.

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FTCA Site Visit Report

HRSA will develop and share an FTCA site visit report with the health center, typically within 4-6 weeks of the site visit. The report will convey the site visit findings and determinations regarding the health center’s implementation of FTCA deeming requirements.

The report will include both findings of non-compliance, if any, as well as suggestions for improvement. Findings of non-compliance will not affect a health center’s current calendar year FTCA deeming status. However, health centers that are found to be non-compliant with Health Center Program requirements, specifically credentialing and privileging and/or QI/QA, may be subject to enforcement actions under the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, at 45 CFR part 75. These enforcement actions are further described in the Health Center Program Compliance Manual, specifically, Chapter 2: Health Center Program Oversight. In addition, any areas of non-compliance still present at the time of the subsequent calendar year FTCA deeming cycle may result in a negative deeming determination.

The FTCA site visit report will include a description of health center actions required to comply with FTCA deeming requirements and cure any identified deficiencies. The report will note specific dates or deadlines for submission of information and/or documentation to HRSA.

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Section I – Document Review Checklist

The consolidated Document Review Checklist contains documents used to assess compliance with FTCA program requirements during the FTCA site visit. While on-site, the consultant(s) may request additional documentation and information. The consultants may also ask to speak to specific staff members that work in each of the areas listed below.

Many of the documents addressed in this section are requested in advance of the site visit in order for the site visit team to best service the health center. The lead consultant will reach out to the health center to request specific pre-site visit documents. Notification of these pre-site visit documents will occur on or before the pre-site visit call with the health center. Pre-site visit documents will be transmitted to the identified team electronically by the health center. 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 determine which of your health center documents would be most appropriate. In general, the health center is encouraged to prepare any documents related to the areas of review (risk management, QI/QA, credentialing and privileging, and claims management ) in order to demonstrate evidence of health center compliance.

Risk Management Requested Documents

Health Center Provides Pre-Site Visit

  • Risk Management Policy and Operating Procedures
  • Annual Risk Management Report to the governing board. This is the comprehensive report that covers clinical risk management issues including but not limited to, risk management goals, progressing in meeting goals, completed risk management activities, proposed activities, completed assessments, number of incidents, and trainings.
  • Quarterly Risk Management Assessments (within the past 12-24 months)
  • Minutes of Risk Management meetings (within the past 12-24 months)
  • Staffing HIPAA (Privacy) Policy
  • Medical Records Retention Policy
  • Infection Control Policies and Procedure
  • Sterilization Policies and Procedures
  • Adverse Occurrence Policy or Incident Management Policy
  • Patient Complaint Policy and Procedure
  • Safety Protocols Policy and Procedures (i.e., Sharps use/disposal procedures and Emergency plans)

Health Center Provides On-Site

  • Patient Satisfaction Survey Results
  • If applicable, active and resolved patient complaints
  • Medical Record Documentation and Completeness Standards
  • Medical Record Archiving Procedures

Risk Management Training Requested Documents

Health Center Provides Pre-Site Visit

  • Risk Management Training Plan (This plan outlines the trainings that will be required for the current calendar year, health center staff/provider types required to take the trainings, the date the training will occur, the deadline to complete the training. In addition, the plan should outline the process for tracking training progress, and the tools used to ensure adherence.)
  • Record of governing board risk management training (within the past 12 months)
  • Record of staff risk management and safety training (within the past 12 months)

Health Center Provides On-Site

  • Risk Management Training documentation (Including but not limited to training plans, policies and procedures, Sign - in sheets or other tracking documentation.)

Tracking Requested Documents

Health Center Provides Pre-Site Visit

  • Walk-in Patients Policy
  • Specialty Referral Tracking Policy
  • Hospitalization Tracking Policy
  • ER Tracking Policy
  • Diagnostic Tracking Policy (x-ray, labs) and either log or workflow regarding closing loop of patient lab results from health center back to the patient
  • No Show Appointments Policy and Follow-up
  • Phone Triage Policy
  • Urgent Care Visit Triage Policy and Procedure
  • Specialty Referral Tracking Policy

Health Center Provides On-Site

  • Specialist Referral Tracking Log (or other means to demonstrate referral tracking and follow-up)
  • Hospital and ER Referral Tracking Log (or other means to demonstrate tracking and follow-up)
  • Diagnostic Tracking Log (or other means to demonstrate tracking and follow-up)
  • Specialist Referral Tracking Log (or other means to demonstrate referral tracking and follow-up)

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 Committee Meeting Minutes (within the last 12-24 months)
  • Board Minutes (six most current governing board minutes)
  • Health center bylaws
  • Governing board roster
  • Sample clinical performance reports presented to the QI/QA Committee(s) and Board (most recent)
  • Minutes of provider staff meetings (within the past 6 months)

Health Center Provides On-Site

  • Clinical guidelines and references used to develop guidelines/protocols, ( i.e., UpToDate.com specialty guidelines, Academy of Pediatrics, American College of Obstetrics, Gynecology, Academy of Family Practitioners, etc.)
  • Clinical protocols

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, name, and FTE status
  • Provider Contracts, Agreements and Subrecipient Arrangements (if applicable based on service delivery methods on Form 5A)
  • Credentialing and Privileging Policies and Procedures
  • If applicable, contract or agreement with Credentialing Verification Organization (CVO) or other entity if used to perform credentialing functions, such as primary source verification, on behalf of the health center
  • Peer review procedures or other applicable mechanism(s) (results to be available on site)
  • Health center organizational chart(s) with name of key management staff

Health Center Provides On-Site

  • Credentialing and Privileging files available for examination (specific files to be pulled by health center will be determined by consultant team on-site)

  • Documentation the governing board or designee has approved the staff members who are credentialed or re-credentialed and privileged

Claims Management Requested Documents

Health Center Provides Pre-Site Visit

  • Policies and procedures for internal handling, analyzing, and tracking claims or potential claims

Health Center Provides On-Site

  • Document(s) showing evidence the health center informs patients, using plain language, it is a deemed federal Public Health Service employee via its website, promotional materials, and/or within area(s) of the health center visible to patients
  • Claims files for all potential and actual claims

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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 in a flexible and collaborative manner. The FTCA site visit agenda is created based on a standard template that is utilized for all FTCA site visits and from the recommendations and availability of staff that is submitted by the health center. Prior to the site visit, an FTCA staff member will e-mail a copy of the FTCA agenda template 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: In circumstances where the facility tour cannot be accomplished on the first day or from 10:00 a.m. – 11:00 a.m., the health center can reschedule the tour to 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 health center management.
    2. While it is nice to have governing board members attend in person, it is acceptable for members to attend via telephone, skype, or any other means of telecommunication that the health center has available.
  3. In the timeslots slated for interviews with staff, if there are key staff members with limited availability, 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 that the health center determines has an integral role in any of the areas that will be reviewed by the site visit team

Please Note: During the site visit, schedules may change or certain sessions may run longer than intended. In the event that there are required changes, the FTCA staff and the site visit consultants will keep an open line of communication and make any needed adjustments.

Sample FTCA Site Visit Agenda

Day 1

Timeframe Description
  Arrival at Health Center
9:00 – 10:00

Entrance Conference with site visit team, key management staff and board members; Other staff attends at pleasure of CEO

Review of site visit, overview of health center, site visit logistics, information request and schedule

10:00 – 11:00 Tour of Facility
11:00 – 12:00 Begin document review from requested list of on-site documents and files
12:00 – 1:00 Break for Lunch
  Lead Consultant Schedule
1:00 – 2:00 Discuss Credentialing and Privileging - Consultant and Health Center staff
2:00 – 3:00 Discuss Quality - Consultant and Health Center staff
3:00 – 4:00 Discuss Peer Review with Health Center staff
  2nd Consultant Schedule
1:00 – 4:00

Discuss Clinical Tracking with Health Center staff 

Discuss Risk Management – Infection Control, Safety, and Training with Health Center staff

Day 2

Timeframe Description
  Arrival at Health Center
9:00 – 12:00

Continue Risk Management discussion with Health Center staff

12:00 – 1:00 Interview governing board members 
1:00 – 2:00 Claims Management review with Health Center staff

Day 3

Timeframe Description
  Arrival at Health Center
9:00 – 10:30

Completion of site visit team review

10:30 – 12:00 Exit conference with key management staff. Site visit team presents oral report of findings and recommendations.

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Section III – Sample Report

The site visit report will identify HRSA/FTCA compliance determinations for each area of review (credentialing, privileging, risk management, QI/QA, and claims management ). FTCA program requirement issues are monitored with an action plan as noted below in the Sample Compliance Actions section. The site visit team may also identify performance improvement opportunities. Federal representatives and consultants will engage health center staff onsite about areas of improvement as identified during the review process.

Download Sample Report (PDF - 375 KB)

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Section IV - 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 are listed below . Please visit www.ecri.org or call 610-825-6000 ext. 5891 for more information.

Credentialing and Privileging and Peer Review Tools and Resources

Risk Management Tools and Resources

Quality Assurance and Quality Improvement Tools and Resources

Claims Management Tools and Resources

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Section V – Virtual Site Visit Resources

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