FTCA compliance and preparing for an FTCA specific on site visit

GW GARFUNKEL WILD, P.C.
A T T O R N E Y S A T L A W
Great Neck, NY
(516) 393-2200
Hackensack, NJ
(201) 883-1030
Stamford, CT
(203) 316-0483
Albany, NY
(518) 242-7582
© 2019 GARFUNKEL WILD, P.C.
Federal Tort Claims Act (FTCA) Compliance
and Preparing for an FTCA Specific
On-Site Visit
November 20, 2019
Co-sponsored by
Jeffry Adest
jadest@garfunkelwild.com
Sandra Jensen
sjensen@garfunkelwild.com

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The Federal Tort Claims Act
 In the event an FQHC is subject to a malpractice or health related
claim, the Federal Tort Claims Act (FTCA) will generally provide
coverage for such claim
 Employees and certain contractors of eligible FQHCs may be
deemed to be Federal Employees qualified for protection under
the FTCA
 Deemed FQHC grantees are immune from medical malpractice
lawsuits resulting from the performance of medical, surgical,
dental, or related functions within the approved scope of project

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FTCA Deeming Requirements
 Eligible FQHCs must submit an original deeming and annual re-deeming
application to the U.S. Department of Health and Human Services, Health
Resources and Services Administration (HRSA), Bureau of Primary Health
Care (BPHC)
 The FTCA Application in most cases follows the requirements contained
in HRSA’s Compliance Manual and is broken down into 4 sections:
 Risk Management
 Quality Improvement/Quality Assurance
 Credentialing and Privileging
 Claims Management

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FTCA Deeming
 Historically, HRSA has approved deeming and re-deeming applications
submitted by FQHCs
 Recently HRSA has started to reject applications if policies and other
documents uploaded do not meet its requirements
 An FQHC should not rely on HRSA’s approval of FTCA deeming and re-
deeming applications as indication that the FQHC meets all FTCA
requirements. HRSA has found deficiencies on site visits and FTCA
Specific OSVs on documents that were submitted as part of the FTCA
application and approved

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HRSA ISSUES NEW FTCA SPECIFIC SITE VISIT
PROTOCOL
 In January, 2019 HRSA issued a Federal Tort Claims Act Site
Visit Protocol
 The FTCA Site Visit Protocol and FTCA Specific On-Site Visit
reviews greatly expand on or include new requirements than
those contained in the Compliance Manual and in the FTCA
Application Program Assistance Letter (PAL)
 FTCA Specific Site Visit Protocol can be found at:
https://bphc.hrsa.gov/programrequirements/svguide.html

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FTCA Specific Site Visit
 HRSA has begun conducting site visits specifically focused on
FTCA compliance
 Site visits are conducted over a 2.5 day period and assess
compliance with:
 Risk Management
 QA/QI
 Credentialing and Privileging
 Claims Management

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 Factors that may prompt an FTCA Specific Site Visit:
 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 on
an FQHC’s award;
 The need for follow-up based on an OSV; and/or
 A history of medical malpractice claims

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 Process:
 Pre-Site Activities: specific documents will be requested
for review prior to the visit and an agenda will be
established. HRSA assembles a site visit team consisting
of one staff member and two consultants
 On-Site Activities: document reviews, staff and
Governing Board interviews, facility tours (inspections)

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 Exit Interview and Report: exit interview will outline the
findings and within 4-6 weeks, HRSA will provide an FTCA site
visit report setting forth the findings and determinations
regarding compliance. Corrective action will be required for
findings of non-compliance
 Findings of non-compliance do not impact current calendar
year deeming status except that FQHCs that are found non-
compliant with credentialing and privileging or QI/QA may be
subject to enforcement actions

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OSV vs. FTCA Specific OSV
 HRSA OSVs review compliance with the Compliance Manual
requirements and pay particular attention to policies and
operating procedures as set forth in your policies
 FTCA Specific OSVs reviews both policy AND process. Focus
on how you implement your policies

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RISK MANAGEMENT

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Risk Management
 The FQHC must designate an individual responsible to oversee the Risk
Management Program
 The Risk Manager must complete annual health care risk
management training
 HRSA explained that it expects to see a progression in training.
For example, the Risk Manager has first completed Level I
training from ECRI, followed up by Level II the next year
 The Risk Manager’s position description must include risk
management activities
 Risk Manager’s job description must clearly state that risk
management activities are a part of the Risk Manager’s daily
responsibilities.

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Risk Management
 The FQHC has to attest that it has Risk Management Program to
reduce the risk of adverse outcomes that could result in medical
malpractice or other health or health-related litigation
 An FQHC’s program must address:
 Risk management across the full range of FQHC activities including:
• Triage (including telephone triage)
• Scheduling (sick visits, walk ins)
• Missed Appointments
• Intake
• Tracking and Follow-up

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Risk Management- FTCA Specific OSV
 FQHCs must be able to produce and have implemented
policies and procedures on: Walk-In Patients, No Show
Appointments, Phone Triage, Urgent Care Triage
 Walk-in Patients Policy
 Should have appointments available for walk in patients
 Review process within all Departments in the FQHC
 No Show Appointments Policy
 Follow- up on patients who have failed to present for a
scheduled appointment

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 Phone Triage Policy
 Process for handling patient calls
 Urgent Care Triage Policy
 Process for handling patients with possibly emergent conditions
 Should include process for patients who telephone with urgent
issues
 Must be able to show that you implemented these
policies
 Consider what each of your Departments do/processes
applicable to each

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Risk Management
 Risk Management Program, cont’d:
 Risk Management Training for all staff;
 Completion of quarterly risk management assessments;
and
 Annual reporting to the Board
 FTCA Specific OSV: The Board is expected to receive risk
management training as well. FQHCs will also have to
prove that the Board received this training

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Risk Management
 FQHCs are required to have in place the following policies:
 Referral Tracking Policy
 Hospitalization Tracking Policy
 Diagnostic Tracking Policy (x-ray and labs)
 HRSA has made available a Technical Assistance Resource document that
sets out the elements that should be included in tracking policies. It is
available at the following link:
https://bphc.hrsa.gov/sites/default/files/bphc/ftca/healthcenters/ftca-
deeming-app-tracking-checklist-cy-19.pdf

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Risk Management
 Hospital Tracking Policy Requirements
 HRSA requires that a hospital tracking system include:
• Patient information
• Date of admission or visit
• Date of notification
• Reason for visit, if known
• Documentation received
• Documentation requested (including dates requested)

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 Hospital Tracking
 Identify what Departments send patients to the hospital from
the FQHC
 How do you track this?
 Who is notified?
 Tracking log and processes will be reviewed
 Staff responsible for tracking hospital admissions/ER visits may
be asked to provide a demonstration of tracking process

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Risk Management
 Referral Tracking Policy Requirements
 An FQHC’s referral tracking policy must include the following
elements:
 Defining referral type (e.g., specialist referral, patient initiated referral,
etc.)
 How it was initiated (e.g., by whom and the process, such as a form or
processing by a referral department)

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Risk Management
Referral Tracking Policy Requirements, cont’d
 Referral tracking:
 Frequency of follow- up
 Who is the party responsible for follow-up
 Documentation of follow-up activities
 Patient follow-up
 Status reports
 Patient Compliance

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Risk Management
Referral Tracking, cont’d
 The referral tracking policy must also include documentation in the
patient’s medical record of the following:
 Follow-up efforts
 Missed referral appointments
 Frequency of attempts
• (e.g., attempts to obtain documentation from referred-
to provider)
 Attempt methods

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Referral Tracking
 Reviewers want to see a process for urgent referrals vs.
routine referrals
 Must be able to show a log or other means to track referrals
 Staff responsible for tracking referrals may be asked to
provide a demonstration of the process
 Although not required by the Compliance Manual, Site
Reviewers may ask how the FQHC tracks referrals made to
FQHC providers

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Risk Management
 Diagnostic/Lab Test Tracking Policy Requirements
 An FQHC’s policy must track BOTH radiology testing and lab testing.
 Tracking elements include:
• Patient information
• Date the test was ordered
• Ordering provider
• List of tests ordered
• Date test results were received
• Provider who reviewed the results
• Follow-up recommended by the provider
• Communication of results to patient

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Risk Management
Diagnostic/Lab Test Tracking Policy Requirements, cont’d
 Other issues to address in the policy:
 How to communicate the results to the patient
 Procedures to contact a back-up provider
 Documentation of patient contact attempts
 Tracking and monitoring critical values
 Incorporating audits of how the policy is implemented into QI/QA

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Risk Management
Diagnostic/Lab Test Tracking Policy Requirements, cont’d
 The tracking policy must define normal, abnormal and critical
values for each lab and provide a time frame to communicate
the results back to the patient
 HRSA required that all results, including normal results, be
communicated back to the patient

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Diagnostic Tracking
 Must be able to show a log or other means to track
diagnostic orders
 Staff responsible for tracking may be asked to provide a
demonstration of the process
 Reviewers will check to see whether providers are following
the policy (e.g., whether there are any outstanding results
not reported to the patient)
 Critical values are an important focus of reviewers. Process
must include home visit or other means of notifying a patient
if telephone contact is not made

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Risk Management
 FQHCs must have implemented risk management operating
procedures
 Operating procedures must include:
 Identifying the areas/activities of highest risk
 Mitigating those high risk areas/activities, including
through:
• Establishing or using clinical protocols
• Medical Staff supervision
 FTCA Specific OSV: FQHCs will have to submit for review
Department-specific clinical protocols

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Risk Management
Operating procedures requirements, cont’d:
 Documenting, analyzing and addressing clinically related
complaints, incidents and “near misses”
 Setting and tracking progress related to annual risk
management goals
 Developing and implementing an annual health care risk
management training plan
 Completing an annual risk management report for the
Board and key management staff

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 Incidents are a focus of the FTCA OSV
 FQHCs have to submit their Incident Management Policy.
Individual incident reports/forms will be reviewed
 The Incident Management Policy should tie in to Claims
Management
 Ex. Review incidents to determine whether a litigation hold should be
issued

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Risk Management
 An FQHC had to attest that it has implemented an annual risk
management training plan that incorporates:
1. Obstetrical procedures (e.g., Continuing education for electronic
fetal monitoring, and dystocia drills)
 FQHCs that provide obstetrical services through FQHC providers
need to include obstetrical training as part of the risk
management training plan. Includes FQHCs that provide
prenatal and postpartum care even if they do not provide labor
and delivery services
2. HIPAA medical record confidentiality requirements
3. NEW: Specific trainings for group of providers that perform various
services that could lead to risk (e.g., dental, pharmacy, family
practice)

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Risk Management
Annual Risk Management Training Plan, cont’d
4. Infection control (e.g., Blood Borne Pathogen Exposure
protocol, Infection Prevent and Control policies, Hand
Hygiene, Dental Equipment Sterilization)
• Dental Equipment Sterilization training was a new
requirement this year

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Risk Management
 Staff attendance and completion of training must be tracked
 Completion of training must be part of performance reviews and
credentialing and privileging
 The FQHC must have a process for handling those staff who fail to
complete the required training
 Risk Manager must complete annual health care risk management
training
 FTCA Specific OSV: All documents, including the training log will be
reviewed. Reviewers may ask to see the personnel/credentialing files for
staff who failed to complete the required training.

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Risk Management
 Risk Management Assessments
 FQHCs must complete quarterly risk management assessments.
While the need to complete assessments is not new, FQHCs had to
now upload them as part of their FTCA application this year.
 Examples:
 Data/Trends
 Reports
 Risk Management Committee minutes

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Infection Control & Sterilization Policies and Procedures
Infection Control is a major focus of an FTCA OSV. Policies and procedures
must match your actual process. Site Reviewers will conduct facility
inspection/tour to observe/interview staff on infection control practices
 Staff may be asked to know/demonstrate appropriate hand hygiene
and use of PPE
 Equipment should be in working order and staff should know how to
use it
 Staff must show competency with use of eye wash station and hand
hygiene
 Review your policies and procedures carefully!

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Governing Board Requirements
 Overall responsibility for risk management
 Authorizes approval of the Risk Management Plan
 Receives and reviews the annual risk management report on:
 Completed risk management activities
 Status of the FQHC’s performance in relation to meeting its risk
management goals
 Proposed risk management activities that relate or respond to
identified areas of high organizational risk
 Makes any recommendations on follow up
 This year, FQHC’s had to upload the most recent report to the Board
which incorporates all of these elements, including evidence that related
follow up actions have been implemented
 FQHCs were required to upload proof that the board received and
reviewed the report (e.g., board minutes signed by the board
chair/secretary)

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Annual Report to the Board
 Expands on what is to be included in the annual report.
 In addition to outlining risk management goals, progress in
meeting goals and proposed activities, HRSA indicated that
they expect this to be a comprehensive report which includes
 Completed risk management assessments;
 Number of incidents;
 Risk management trainings;
 Patient grievances;
 Claim information, etc.
 Should include charts/tables outlining trends over the past year

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QUALITY IMPROVEMENT/QUALITY ASSURANCE

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Quality Improvement/Assurance
 Chapter 10 of the Compliance Manual requires that FQHCs
have an ongoing quality improvement/assurance (QI/QA)
system that includes clinical services and clinical
management and maintains the confidentiality of patient
records
 FQHCs must have board-approved policies (e.g., a QI/QA
Plan) that demonstrates that it established a quality
program. The policies must address:
 Quality and utilization of FQHC services;
 Patient satisfaction and patient grievance processes; and
 Patient safety, including adverse events

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Quality Improvement/Assurance -FTCA Specific OSV
 FQHCs should review QI/QA Committee structure
 All Departments within an FQHC’s scope of project should be
included in the QI/QA system, including OB, Dental, Behavioral
Health and specialties
 Ideally, a member of each Department should be on the QI/QA
Committee
 If not, need to incorporate QI/QA into the Department and have
reports of activities presented to overall QI/QA Committee
 FQHCs will also be required to submit provider staff meeting
minutes

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Quality Improvement/Quality Assurance
 The FQHC must have QI/QA operating procedures that address:
 A process for assessing patient satisfaction;
 A process for hearing and resolving patient grievances;
 Completion of periodic QI/QA Assessments on at least a
quarterly basis and a process for modifying FQHC services
based on findings of the QI/QA Assessments; and
 Producing and sharing reports on QI/QA to support decision-
making and oversight by key management staff and by the
governing board regarding the provision of FQHC services

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Quality Improvement/Assurance -FTCA Specific OSV
 FQHCs should be implementing patient satisfaction and
patient grievance processes. Patient satisfaction results and
patient grievances will be reviewed
 Ensure you maintain proper documentation
 Should be discussed during QI/QA Committee meetings and
incorporated into minutes
 Any corrective action taken should be included in the
minutes

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 QI/QA assessments must be completed on a quarterly
basis which include assessing:
 Provider adherence to current evidence based clinical
guidance, standards of care, and standards of practice
in the provision of services; and
 Identification of patient safety and adverse events
and implementation of follow up actions, as
necessary

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 The Compliance Manual clarified that QI/QA Assessments
must:
 Be done by physicians or other licensed health care
professionals under supervision of physicians; and
 Use data systematically collected from patient records to
ensure compliance with clinical guidelines, standards of
practice and utilization of services

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Quality Improvement/Assurance
FTCA Specific OSV
 Peer Review is a focus of the FTCA OSV
 All providers in each in-scope Department must have gone
through peer review
 The Board should be informed of peer review results
 FQHCs must submit their clinical protocols for review
 Clinical protocols should be Department-specific
 FQHCs must have clinical protocols even if utilizing
Up-To-Date or other online resource

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 FQHCs must ensure that the QI/QA Director’s Position
Description includes the following as part of the job duties:
 Ensuring implementation of and updating QI/QA
operating procedures
 Completion of QI/QA Assessments
 Monitoring QI/QA outcomes
 The job description also had to clearly state that the QI/QA
activities are a part of the individual's daily responsibilities

48
 FQHCs must implement a certified EHR system for all FQHC
patients
 Attest that it has systems and procedures in place for
protecting the confidentiality of patient information and
safeguarding information against loss, destruction or
unauthorized use
 FTCA Specific OSV: FQHCs must submit their policies and
procedures regarding medical records and patient
confidentiality, including: HIPAA Policy, Medical Record
Completeness Standards, Medical Record Retention and
Archiving Policies

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QI/QA
Governing Board Requirements
 A QI/QA report must be provided to the Board and key
management staff
 Board meeting minutes must document that the report was
shared with and discussed by the Board to support decision-
making and oversight regarding the provision of FQHC
services, and that any follow up actions have been taken
 The Compliance Manual requires that the QI/QA policy/plan
be reviewed by the Board at least every 3 years

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CREDENTIALING AND PRIVILEGING

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Credentialing and Privileging
 FQHCs must have in place a credentialing and privileging process
and operating procedures that meet the requirements set forth in
the Compliance Manual
 This year’s FTCA PAL specified that if procedures are missing any of
the required elements, it would be interpreted as the FQHC not
implementing the missing components
 FQHCs policies and procedures must include all the required
personnel listed in the Compliance Manual:
 Licensed Independent Practitioners (LIPs)
 Other Licensed or Certified Practitioners (OLCPs)
 Other Clinical Staff providing services on behalf of the FQHC
(OCSs)

52
FTCA Specific OSV
 Unlike a HRSA OSV where FQHCs may choose in advance which
credentialing/privileging files will be reviewed, for an FTCA OSV,
the reviewers will ask for a list of all staff (LIPs, OLCPs and OCSs)
and will let the FQHC know on the first day of the OSV which files
must be presented for review
 Compliance Manual requirements will be reviewed as well as
review of whether the FQHC is complying with their own policies
and procedures

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 Credentialing elements include verification of:
 Current licensure, registration or certification using primary
sources
 Education and training of initial credentialing
 Primary source verification for LIPs
 Primary or secondary for others
 Completion of NPDB query
 DEA registration
 Identification
 Basic Life Support

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 Privileging elements include verification of:
 Fitness for duty, immunization and communicable disease status
 For initial privileging- verification of current clinical competence
through training, education and if available, references
 For renewal of privileges- verification of current clinical competence
through peer review or other methods (ex., supervisory performance
reviews); and
 A process for denying, modifying or removing privileges based on
assessments of clinical competence and/or fitness for duty

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FTCA Specific OSV
 The Credentialing and Privileging policy must specify:
 Which providers are subject to verification of DEA registration.
 The different categories of personnel who must have BLS
 What immunizations/ tests are required of practitioners
 References should relate to quality of work performed, and be
given by an individual who is either a peer or a supervisor
 Reference shouldn’t be from a subordinate

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 The FQHC must maintain files or records for clinical staff that
contain documentation of licensure and credentialing verification
and recording of privileges
 If the FQHC contracts with provider organizations, or has formal,
written referral arrangements with other provider organizations,
the contracts or formal referral arrangements contain provisions
that:
 Ensure that the providers are licensed, certified or registered
through a credentialing process; and
 Ensure that the providers are assessed as competent and fit through
a privileging process
 FTCA Specific OSV: FQHCs have to submit the provider contracts for
review to determine compliance with this requirement

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Compliance Manual requirements, cont’d
 FQHCs have the flexibility to determine who has approval authority
for credentialing and privileging of clinical staff
 FTCA Specific OSV: If the Governing Board has delegated
approval authority, reviewers want to see that the Governing
Board is at least made aware that privileges were granted
 Verification of current clinical competence can be done via peer
review OR other comparable method (e.g., supervisory performance
reviews)

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CLAIMS MANAGEMENT

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Claims Management
 FQHCs must have a claims management process for addressing
claims, including medical malpractice claims. The claims
management process must include:
 Preservation of all health center documentation related to any actual
or potential claim or complaint (e.g., medical records, laboratory and
x-ray results, billing records, employment records of all involved
clinical personnel, clinic operating procedures); and
 Any service of process/summons received relating to an alleged
claim or complaint is promptly sent to the HHS, Office of General
Counsel

60
Claims Management
FTCA OSV:
 Claims management files will be reviewed. Reviewers will look to
see whether the files are complete and evidence cooperation
with/notice to the HHS Office of General Counsel
 All documentation should be maintained, including envelopes
 Claims Management process should include a review of incidents
and a determination of whether a litigation hold should be issued
on incidents that could be considered a potential claim.
 Claim files should be tracked
 Root cause analysis should be done to determine the cause of the
allegations

61
Claims Management
 An FQHC must inform patients using plain language that it is a
deemed federal Public Health Service employee via its website,
promotional materials, and/or within an area of the FQHC that is
visible to patients
 The Compliance Manual clarified that FQHCs have flexibility in
determining how to inform patients of their deemed status
 FTCA OSV: However, reviewers will look to see whether the method
an FQHC chooses will actually reach its patients (e.g., placing the
notice on the FQHC’s website but the community doesn’t generally
access the internet)

62
FTCA Specific OSV
Highlight of (Some) Documents Reviewed
• Credentialing & Privileging Policy
• List of Clinical Staff Members
• Credentialing & Privileging files for LIPs,
OLCPs and OCSs
• Governing Board or proof of appropriate
delegated approval authority
• Supervisory evaluations/sign-off
• Form 5A
• Provider Contracts
• Peer review Procedures
• Peer Review reports
• Performance Evaluations
• Governing Board minutes
• Organizational Chart
• Risk Management Policy
• Risk Management Report
• Quarterly Risk Management Assessments
• Risk Management meeting minutes
• Patient Satisfaction Survey Results
• HIPAA policy
• Notice of Privacy Policy
• Medical Records Retention Policy
• Infection Control Policy
• Sterilization Policies
• Patient Complaint Policy
• Incident Management Policy
• Active and resolved patient complaints
• Medical Record Documentation Standards

63
FTCA Specific OSV
Highlight of (Some) Documents Reviewed
• Safety Policies and Procedures
• Risk Management Training documentation
• Records of staff risk management Training
• Records of staff training on safety
• Record of Governing Board training on Risk
Management
• QI/QA Plan
• QI/QA Meeting Minutes
• Governing Board meeting minutes
• Clinical Protocols
• Clinical Guidelines and references used to
develop guidelines and protocols
• Minutes of provider staff meetings
• UDS
• No Show Appointment Policy
• Phone Triage Policy
• Urgent Care Visit Triage Policy
• Specialist Referral Tracking Policy and Log
• Hospitalization Tracking Policy and Log
• Diagnostic Tracking Policy and Log
• Claims Management Policy
• Documentation of Internal Claims
Investigation
• Claim files for all potential and actual
claims

64
FTCA Specific OSV
 Recommendation- Prepare early for an FTCA OSV!
 Go through your policies and procedures and make sure they
contain the required elements -AND- that they follow what
your staff is actually doing
 Ensure staff are following Infection Control requirements
 Monitor for Infection Control and maintain logs (e.g., periodically
observe appropriate hand washing and use of PPE)
 Incorporate all Departments into QI/QA and peer review.
 Implement all requirements of your Risk Management Plan
and maintain appropriate documentation to show reviewers

GW GARFUNKEL WILD, P.C.
A T T O R N E Y S A T L A W
Questions?

66
Contact Information
Jeffry Adest
Garfunkel Wild, P.C.
Partner/Director
(516) 393-2270
jadest@garfunkelwild.com
Sandra Jensen
Garfunkel Wild, P.C.
Partner
(518) 242-7582
sjensen@garfunkelwild.com
Dave Monaghan, MHA
Compliatric
(888) 878-8897
dmonaghan@compliatric.com

350 Bedford Street
Suite 406A
Stamford, CT 06901
(203) 316-0483
677 Broadway
7th Floor
Albany, NY 12207
(518) 242-7582
111 Great Neck Road
Suite 600
Great Neck, NY 11021
(516) 393-2200
411 Hackensack Ave.
5th Floor
Hackensack, NJ 07601
(201) 883-1030
67
Although this document may provide information concerning potential legal issues, it is not a substitute for legal advice from qualified counsel. Any opinions or conclusions provided in this
document shall not be ascribed to Garfunkel Wild, P.C. or any clients of the firm.
The document is not created or designed to address the unique facts or circumstances that may arise in any specific instance, and you should not and are not authorized to rely on this content as a
source of legal advice and this seminar material does not create any attorney-client relationship between you and Garfunkel Wild, P.C.
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FTCA compliance and preparing for an FTCA specific on site visit