Federal Tort Claims Act (FTCA) Deeming Requirements

• Risk management policies and related operating procedures or protocols, including but not limited to those that address:
  • Tracking referrals, diagnostics, and hospital admissions ordered by health center providers;
  • Incident reporting for clinically-related complaints; and
  • “Near misses.”

  Note: Health centers may have distinct “risk management” operating procedures OR these may be included or integrated within other health center operating procedures or protocols (for example, Human Resources, Quality Improvement/Quality Assurance, Admin, Clinical, Infection Control).

• Claims management process policies and procedures.
• Most recent HRSA-approved FTCA deeming application.
• Risk management training plan and documentation of completed training.
• Documentation of the last two quarterly risk management assessments of health center activities designed to reduce the risk of adverse outcomes in areas of clinical high risk that could result in medical malpractice or other health or health-related litigation. 
• Board meeting minutes from within past 12 months that include the status of risk management activities.
• Reports presented to the board and key management staff within the past 12 months on risk management activities and progress in meeting risk management goals.
• Examples of methods used to inform patients of the health center’s deemed status (for example, website, promotional materials, statements posted within an area of each health center in-scope site that is visible to patients).
• For health centers with closed claims from within the past 5 years under the FTCA: For each closed claim, documentation of steps implemented to mitigate the risk of such claims in the future (for example, targeted staff training, improved records management, implementation of new clinical protocols). 

• Element a: Risk Management Program
• Element b: Risk Management Procedures
• Element c: Reports on Risk Management Activities
• Element d: Risk Management Training Plan
• Element e: Individual who Oversees Risk Management

Element a: Risk Management Program

The health center has and currently implements an ongoing health care risk management program to reduce the risk of adverse outcomes that could result in medical malpractice or other health or health-related litigation and that requires the following:

• Risk management across the full range of health center health care activities;
• Health care risk management training for health center staff;
• Completion of quarterly risk management assessments by the health center; and
• Annual reporting to the health center board which includes: completed risk management activities; status of the health center’s performance relative to established risk management goals; and proposed risk management activities that relate and/or respond to identified areas of high organizational risk.

Element b: Risk Management Procedures

The health center has risk management procedures that address the following areas for health center services and operations:

• Identifying and mitigating the health care areas/activities of highest risk within the health center’s HRSA-approved scope of project, including but not limited to tracking referrals, diagnostics, and hospital admissions ordered by health center providers;
• Documenting, analyzing, and addressing clinically-related complaints and “near misses” reported by health center employees, patients, and other individuals;
• Setting and tracking progress related to annual risk management goals;
• Developing and implementing an annual health care risk management training plan for all staff members based on identified areas/activities of highest clinical risk for the health center (including, but not limited to, obstetrical procedures and infection control) and any non-clinical trainings appropriate for health center staff (including Health Insurance Portability and Accountability Act (HIPAA) medical record confidentiality requirements); and
• Completing an annual risk management report for the board and key management staff.

Element c: Reports on Risk Management Activities

The health center provides reports to the board and key management staff on health care risk management activities and progress in meeting goals at least annually, and provides documentation to the board and key management staff showing that any related follow-up actions have been implemented.

Element d: Risk Management Training Plan

The health center has a health care risk management training plan for all staff members and documentation showing that such trainings have been completed by the appropriate staff, including all clinical staff, at least annually.

Element e: Individual who Oversees Risk Management

The health center designates an individual(s) (for example, a risk manager) who oversees and coordinates the health center’s health care risk management activities and completes risk management training annually.

• Review the risk management policies and related operating procedures or protocols.
  Note: Health centers may have distinct “risk management” operating procedures OR these may be included or integrated within other health center operating procedures or protocols (for example, Human Resources, Quality Improvement/Quality Assurance, Admin, Clinical, Infection Control). 
• Review the health care risk management training plan. 
• Review the training documentation to verify that appropriate staff, including all clinical staff, completed risk management training at least annually. 
• Review the documentation of last two quarterly risk management assessments that address one or more areas of risk.
• Review the board meeting minutes from within past 12 months that include the status of risk management activities.
• Review the reports presented to the board and key management staff within the past 12 months on risk management activities and progress in meeting risk management goals.
• Interview the health center individuals (for example, health center risk manager) who oversee and coordinate the health center’s risk management activities on implementation of related policies, procedures, training, assessment, reporting, and follow-up actions.
• Interview other health center clinical leadership and individuals as necessary. 

2. Does the health center currently have at least one individual (for example, a “risk manager”) who oversees and coordinates the health center’s risk management activities? 

   Response is either: Yes or No

   If No, an explanation is required.

3. IF YES: Does this individual(s) complete risk management training annually? 

   Response is either: Yes or No

   If No, an explanation is required, including stating what follow-up actions, if any, the health center has or will implement to ensure that the individual(s) completes training. 

4. Do the health center’s risk management policies or procedures apply to all services and sites within the health center’s scope of project?

   Response is either: Yes or No

   If No, an explanation is required.

5. How does the health center identify and mitigate areas and activities of highest patient safety risk? Describe if and how this informs or aligns with the health center’s overall risk management program. For example, staff training, establishment of risk management goals, and changes in clinical safety practices.

   An explanation is required, including one to two examples.

6. Did the health center provide examples and documentation of how it analyzes and addresses clinically-related complaints and “near misses” reported by health center employees, patients, and other individuals? 

   Response is either: Yes or No

   If Yes OR No, an explanation is required, including describing the examples.

7. Did the health center provide documentation of its last two quarterly risk management assessments?

   Response is either: Yes or No

   If No, an explanation is required.

8. Did the health center provide a report, presented to the board and key management staff within the past 12 months, on the status of risk management activities and progress in meeting risk management goals? 

   Response is either: Yes or No

   If No, an explanation is required.

9. Has the health center implemented follow-up actions based on its risk management assessments and its reporting to the board and key management staff?

   Response is either: Yes or No

   If No, an explanation is required.

10. Does the health center’s training plan require risk management training for relevant clinical staff on obstetrical services?

    Notes:

    • A FTCA-deemed health center that provides obstetrical services through FTCA-deemed providers (health center employees or individual contractor providers) is required to include obstetrical training as part of the health center risk management training plan to demonstrate compliance.
    • A FTCA-deemed health center that provides prenatal and postpartum care through FTCA-deemed providers (health center employees or individual contractor providers) is required to include obstetrical training as part of the health center risk management training plan to demonstrate compliance. This applies regardless of whether the health center provides labor and delivery services through FTCA-deemed providers (health center employees or individual contractor providers).
    • For FTCA-deemed health centers that only provide obstetrical services through contracts with provider organizations or formal written referral agreements, the health center is required to ensure that the risk management training plans, credentialing, and privileging of each of the provider organizations and referral providers include obstetrics.
    • In addition, regardless of the provision of obstetrical services, if a FTCA-deemed health center has contact with reproductive age patients for other clinical services through FTCA-deemed providers (health center employees or individual contractor providers), the health center is required to include obstetrical training as part of the health center risk management training plan to demonstrate compliance.
    • Select “Not Applicable” if the health center provides all obstetrical services, including prenatal and postpartum care, to patients only through contracts with provider organizations or formal written referral agreements AND if the health center does not have contact with reproductive age patients for other clinical services through FTCA-deemed providers (health center employees or individual contractor providers).

    Response is: Yes, No, or Not Applicable

    If No, an explanation is required as to why such trainings are not included in the training plan.

11. Does the health center’s training plan require risk management training for clinical staff on infection prevention and control for all departments?

    Response is either: Yes or No

    If No, an explanation is required.

12. Does the health center’s training plan require training for all relevant staff on HIPAA medical record confidentiality requirements?

    Response is either: Yes or No

    If No, an explanation is required.

13. Does the health center’s training plan require risk management training in areas that the health center has identified as high-risk services?

    Response is either: Yes or No

    If No, an explanation is required.

14. Does the health center have documentation that all relevant staff completed training according to the health center’s annual risk management training plan?

    Response is either: Yes or No

    If No, an explanation is required, including stating what follow-up actions, if any, the health center has or will implement to ensure all relevant staff complete training.

• Element a: Claims Management Process
• Element b: Claims Activities Point-of-Contact
• Element c: Informing Patients of FTCA Deemed Status
• Element d: History of Claims: Cooperation and Mitigation

Element a: Claims Management Process

The health center has a claims management process for addressing any potential or actual health or health-related claims, including medical malpractice claims, that may be eligible for FTCA coverage. In addition, this process ensures:

• The preservation of all health center documentation related to any actual or potential claim or complaint (for example, medical records and associated laboratory and x-ray results, billing records, employment records of all involved clinical providers, clinic operating procedures); and
• Any service-of-process/summons that the health center or its provider(s) receives relating to any alleged claim or complaint is promptly sent to the HHS Office of the General Counsel, General Law Division, per the process prescribed by HHS and as further described in the FTCA Health Center Policy Manual (PDF - 406 KB).

Element b: Claims Activities Point-of-Contact

The health center has a designated individual(s) who is responsible for the management and processing of claims-related activities and serves as the claims point of contact.

Element c: Informing Patients of FTCA Deemed Status

The health center informs patients using plain language that it is a deemed federal PHS employee¹ via its website, promotional materials, and/or within an area(s) of the health center that is visible to patients.

Element d: History of Claims: Cooperation and Mitigation

If a history of claims under the FTCA exists, the health center can document that it:

• Cooperated with the Attorney General, as further described in the FTCA Health Center Policy Manual; and
• Implemented steps to mitigate the risk of such claims in the future.

• Interview designated individuals responsible for claims management. 
• Review the claims management process policies and procedures. 
• Review the claims management and claims history section of the FTCA application.
• Review the examples of language used to inform patients that the health center is a deemed federal PHS employee. 
• For health centers with closed claims from within the past 5 years under the FTCA: For each closed claim, review the documentation of steps implemented to mitigate the risk of such claims in the future.

15. Does the health center currently have at least one individual who: 
    • Is responsible for the management and processing of claims-related activities; and
    • Serves as the claims point of contact?

    Response is either: Yes or No

    If No, an explanation is required.

16. Did the health center provide documentation of their claims management procedures that include the following: 
    • Preservation of claims-related documentation (for example, medical records and associated laboratory and x-ray results, billing records, employment and scheduling records of all involved clinical providers, clinic operating procedures); and 
    • Prompt communication with HHS Office of the General Counsel, General Law Division about any actual or potential claim or complaint? 

    Response is either: Yes or No

    If No, an explanation is required.

17. Does the health center inform patients using plain language that it is a deemed federal PHS employee via its website, promotional materials, or within an area of each health center in-scope site that is visible to patients?

    Response is either: Yes or No

    If No, an explanation is required.

18. Does the health center have a history of closed claims under the FTCA within the past 5 years? 

    Response is either: Yes or No

    If Yes, for each closed claim, an explanation is required describing what corrective steps the health center has taken to prevent such claims in the future.