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FTCA compliance and preparing for an FTCA specific on site visit
- 1. GW GARFUNKEL WILD, P.C.
A T T O R N E Y S A T L A W
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(516) 393-2200
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© 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
- 2. © 2019 GARFUNKEL WILD, P.C.
2
GW www.garfunkelwild.com
Next FQHC webinar
• Physician Practice Acquisitions
• FQHC-Hospital Relationships
• Employment Issues
• Special Protections for Substance
Abuse Information
• Board Reporting and Board
Minutes
• 340B
Future FQHC Webinar Series Topics Include:
Preparing for an OSV; Practical Tips
Wednesday, January 22, 2020
2:00 PM - 3:00 PM EDT
Please check your email soon for an invite to the webinar.
- 3. GW www.garfunkelwild.com © 2019 GARFUNKEL WILD, P.C.
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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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FTCA Specific Site Visit
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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FTCA Specific Site Visit
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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FTCA Specific Site Visit
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
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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Risk Management- FTCA Specific OSV
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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Risk Management- FTCA Specific OSV
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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Risk Management- FTCA Specific OSV
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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Risk Management- FTCA Specific OSV
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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Risk Management- FTCA Specific OSV
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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Risk Management- FTCA Specific OSV
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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Risk Management- FTCA Specific OSV
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/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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Quality Improvement/Quality Assurance
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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Quality Improvement/Quality Assurance
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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Quality Improvement/Quality Assurance
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
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Quality Improvement/Quality Assurance
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
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)
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Credentialing and Privileging
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 and Privileging
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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Credentialing and Privileging
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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Credentialing and Privileging
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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Credentialing and Privileging
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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Credentialing and Privileging
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
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
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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
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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)
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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
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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
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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
- 65. GW GARFUNKEL WILD, P.C.
A T T O R N E Y S A T L A W
© 2018 GARFUNKEL WILD, P.C.
GW www.garfunkelwild.com
Questions?
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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
- 67. 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.
© 2019 GARFUNKEL WILD, P.C.
GW www.garfunkelwild.com
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