Managing FTCA Risk-A Key Component of Your Enterprise Risk

presented by:

of

© Feldesman Tucker Leifer Fidell LLP. All rights reserved.

FELDESMANTUCKERLEIFERFIDELL LLP

Bi-State Primary Care Association

May 14, 2013

Managing FTCA Risk, A Key Component of Your

Enterprise Risk Management Program

Martin Bree, Esq.

In partnership with:


www.FTLF.com


Disclaimer

• This training has been prepared by the attorneys of Feldesman Tucker Leifer Fidell LLP. The opinions expressed in these materials are solely their views and not necessarily the view of any other organization.

• The training is designed to assist your health center in developing and implementing effective operations consistent with the expectations of the U.S. Department of Health and Human Services’ (“HHS”) Health Resources and Services Administration’ (“HRSA) Bureau of Primary Health Care (“BPHC”) for Section 330 funded health centers.

• The materials are being issued with the understanding that the authors are not engaged in rendering legal or other professional services. If legal advice or other expert assistance is required, the services of a competent professional should be sought.

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Topics

• History of the Health Center FTCA Program

• Program Benefits

• Principles of Coverage

• Gaps in Coverage

• Application Requirements

• Claims Process

• FTCA Requirements

• Claims Procedure

• Credentialing & Privileging

• Risk Management Principles

• Informed Consent

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Enterprise Risk Management

• Defined by the Risk and Insurance Management Society (RIMS) as “the cultures, processes and tools to identify strategic opportunities and reduce uncertainty. ERM is a comprehensive view of risk from both operational and strategic perspectives and is a process that supports the reduction of uncertainty and promotes the exploitation of opportunities.

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Enterprise Risk Management

• Seven core competencies:

• An ERM-based approach (executive support within culture)

• ERM process management (methods incorporated into culture)

• ERM appetite management (defines boundary of acceptable risk tolerance within the organization)

• Root cause discipline (degree of this discipline applied)

• Uncovering risks (degree of assessment within organization)

• Performance management (degree of executing vision and strategy)

• Business resiliency and sustainability (degree of integration into operational planning)

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Elements of Risk Management

• Risk Identification

• Risk Analysis

• Risk Reduction

• Risk Maintenance

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Risk Identification

• Examples of Incident reporting mechanisms

• Verbal reports

• Paper incident reports

• Electronic incident reports

• Claim

• Performance Improvement activities

• Incident report content

• The facts only

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Risk Analysis

1. Gather information/data

• What happened

• Who was involved

• What caused it

• What was resulting condition to patient or staff

• What was done at time of incident to mitigate impact

2. Analyze information/data

• Severity

• Frequency

• Legal potential

• Cost of more claims like this one

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Risk Analysis

3. Balance costs of various measures against

losses or lack of improvement expected if measures not in

place

• Quality – patient outcome and satisfaction,

community service

• Financial

• Immediate losses

• Cost of fixing – assuming charges

• Subsequent remedial measures if not fixed

• Long term losses

• Increased insurance costs

• Decreased community confidence

• Negative publicity

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Risk Analysis

4. Implement most reasonable solutions

– Action Plan

– Accountability

– Expectations

5. Document logic, decision making

– Performance Improvement

– Statistical Reports

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Risk Reduction

Methods used to reduce future loss.

• subsequent remedial measures

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Risk Maintenance

• AKA Loss Control

• Managing information

• Scope – How much can I handle

• Paper

• Electronic

• Minimum requirements

• Monthly statistical analysis of statistics

• Annual report is a good idea

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The Bottom Line

• What leadership needs to see

• Comprehensive, understandable report to Board of Directors on loss

control and improvement

• What management needs to see

• Continuous, understandable reporting on impact of performance on

loss control and risk management

• What staff needs to see

• Periodic reports showing impact of daily actions on risk management

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The Bottom Line

• What the carrier wants to see

• Early warning system

• Frequency and severity

• Forecasting

• “IBNR” - incurred but not reported

• Process and outcome improvement

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History of the Health Center FTCA Program

• FEDERAL TORTCLAIMS ACT (FTCA)

• What is a tort?

• Civil wrong recognized by law as grounds for a

lawsuit. The civil wrong results in injury or harm

constituting the basis for a claim by an injured

party.

• Several types of torts

• Intentional torts

• Strict liability

• Negligence

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• What is the tort of negligence?

• Medical malpractice is a tort of

negligence

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DUTY BREACH

CAUSATION INJURY


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• Concept of Sovereign Immunity

• Generally the Government is immune

from lawsuit (both civil and criminal

• FTCA is a limited waiver of the

Government’s sovereign immunity

• FTCA permits private parties to sue

the United States in federal court for

torts committed by persons acting

on behalf of the United States.

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• FEDERAL TORTCLAIMS ACT (as

applied to health centers)

• Provides protection for personal

injury, including death, resulting

from the performance of medical,

surgical, dental or related

functions which constitute medical

malpractice.

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History of the FSHCAA(Federally Supported Health Centers Assistance Act)

Federally Support Health Centers Assistance Act (FSHCAA) of 1992 (Pub.L. 102-501) and 1995 (Pub.L. 104-73)

FSCHAA extended FTCA protections under 28 U.S.C. 1346(b), 2401(b), and 2679-81 to eligible health centers funded under the Health Center Program (Section 330) so health centers did not spend grant dollars purchasing costly malpractice insurance.

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History of the FSHCAA(Federally Supported Health Centers Assistance Act)

• Late 1980s – medical malpractice crisis.

• Health centers in certain geographic areas having difficulty finding adequate coverage

• Studies commissioned showed health centers were lower risk for insurers • 1992 Congressional Study determined that in FY 1989,

health centers had paid over $40M in malpractice insurance premiums while less than 10% of that amount had been paid in claims on there behalf (from BPHC presentation)

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History of the FSHCAA (cont.)

• 92 Act unclear in many areas.

• 92 Act set to expire in 1995.

• Congress amended FSHCAA in 1995 to

eliminate gaps and make program

permanent.

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Program Benefits

• Reduction or elimination of professional

liability insurance costs.

• Increases availability of funds for providing

patient care.

• Establishment of the Judgment Fund

• Immunity from lawsuit = better coverage

• Private insurance typically has limits of $1

mil/3mil.

• No limits under FTCA.

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Program Benefits- (from BPHC presentation)

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Principles of Coverage

• FSHCAA - Health Centers are eligible to be deemed

“federal employees.”

• Provides immunity from lawsuit alleging medical

malpractice.

• Plaintiff’s only remedy is claim under Federal Tort

Claims Act (FTCA).

• Health Centers must apply to be “deemed.” If

approved they are “federal employees” for

purposes of medical malpractice.

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• WHO is covered:

• Board members

• All employees, full-time or part-time.

• Full time contract providers(over 32 1/2 hours per

week).

• Part time contract provider of services in the

fields of family practice, ob-gyn, general

internal medicine, or general pediatrics.

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RISK MANAGEMENT TIP

Review provider list to confirm that you do not

have any part-time contracted staff members.

If you do, confirm that they are practicing in the

fields of family practice, ob-gyn, general

internal medicine or general pediatrics.

HRSA/BPHC will use IRS status to differentiate

contractors and employees (1099 vs. W-2)

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IMPORTANT: Contract MUST be between

the deemed health center and the individual

providerNOT the health center and another

corporation (even an eponymous

corporation).

To ensure coverage for contract providers,

there should be a documented contractual

relationship (i.e., a written contract for the

provision of health services) between the

covered entity and the individual provider.

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FTCA coverage functions like an occurrence

based insurance policy. A covered individual

of a deemed health center who retires or

leaves the health center is protected for all

covered activities resulting in allegations of

medical malpractice that occurred while

he/she was working at the health center.

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Volunteers are NOT covered by FTCA.

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• WHAT is covered:

• The activity must be within the approved scope

of project;

• The activity must be within the requirements of

the job description, contract for services, and/or

duties required by the covered entity (scope of

employment); and

• The activity must occur during the provision of

services to the covered entity’s patients and, in

certain circumstances, to non-health center

patients.

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• “Scope of Project”

• Activities listed in Forms 5-A, 5-B and 5-C

• PIN 2008-01, “Defining Scope of Project & Policy

for Requesting Changes”

• FTCA coverage for new services and sites is

dependent on HRSA/BPHC approval of a change

in scope.

• A request for a change in scope should be

submitted for approval.

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• “Scope of Employment”

• Current, written job description that delineates

duties performed on behalf of the covered entity

• “Of sufficient detail to provide clarity in

determining if the individual in question was

acting within the scope of employment and

therefore covered under FSHCAA and the FTCA

• Moonlighting is NOT covered

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• Provision of Services to “Health Center

Patients”

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• Who is a “Health Center Patient”?

• Turns on the establishment of a patient/provider

relationship which occurs when:

• Individuals access care for initial or follow-up visits at

approved sites that are owned or operated by the covered

entity;

• Individuals access care at approved sites even if they are

not permanent residents of the service area or may only

be receiving care temporarily; or

• Health center triage services are provided by telephone or

in person, even when the patient is not yet registered with

the covered entity but is intended to be registered.

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RISK MANAGEMENT TIP

If a physician’s first interaction with a patient is at a

nursing home (that is not a Form 5- Part B site) or

other non-health center site, then that patient is not

considered a health center patient for purposes of

FTCA coverage.

If a health center physician is going to see a patient

at a nursing home, the patient should be seen first

in the health center to establish the patient/provider

relationship and ensure FTCA coverage.

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• No FTCA coverage for care to non-health

center patients.

• Except: • Secretary of HHS has pre-approved certain situations

where care is delivered to non-health center patients.

• These examples must be strictly interpreted. Health

centers must be “painstakingly exact” to make certain

that what they do “fits squarely” within the examples.

• Examples are found in September 25, 1995 Federal

Register Notice (and summarized in PIN 2011-01).

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• Examples of care to non-health center

patients that the Secretary has approved:

• COMMUNITY-WIDE INTERVENTIONS

• School-Based Clinics

• School-Linked Clinics

• Health Fairs

• Immunization Campaign

• Migrant Camp Outreach

• Homeless Outreach

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• Examples of care to non-health center

patients that the Secretary has approved:

• HOSPITAL-RELATED ACTIVITIES

• Periodic Hospital Call

• Hospital Emergency Room Coverage

• COVERAGE-RELATED ACTIVITIES

• After-Hours Cross Coverage

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RISK MANAGEMENT TIP: Document!!!

Page 9 of PIN#2011-01

School-Based Clinics: Written Affiliation Agreement

School-Linked Clinics: Written Affiliation Agreement

Hospital-Related Activities (both periodic hospital call or hospital

emergency room call):

(1) Documentation that call is a requirement in order to

have admitting privileges.

(2) Documentation that the particular provider that the

coverage is a condition of employment at the health center.

Coverage-Related Activities: Documentation that the particular

provider is required by his/her employment contract to provide

periodic or occasional cross coverage.

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Coverage to Non-Health Center Patients

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RISK MANAGEMENT TIP • FTCA NPRM http://www.gpo.gov/fdsys/pkg/FR-2011-02-28/pdf/2011-

3439.pdf

• Coverage in Certain Individual Emergencies

A health center provider is providing or undertaking to provide covered

services to a health center patient within the approved scope of project

of the center, or to an individual who is not a patient of the health center

under the conditions set forth in this rule (already covered exceptions),

when the provider is then asked, called upon, or undertakes, at or near

that location and as the result of a non-health center patient’s

emergency situation, to temporarily treat or assist in treating that non-

health center patient. In addition to any other documentation required for

the original services, the health center must have documentation (such

as employee manual provisions, health center bylaws, or an employee

contract) that the provision of individual emergency treatment, when the

practitioner is already providing or undertaking to provider covered

services, is a condition of employment at the health center.

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http://www.gpo.gov/fdsys/pkg/FR-2011-02-28/pdf/2011-3439.pdf











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Coverage to Non-Health Center Patients

• September 25, 1995 Federal Register Notice

• “painstakingly exact”

• “squarely fit”

• NPRM released

• 76 Federal Register 10825 (February 28, 2011)

• “squarely fit” language repeated

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Additional Activities(pp.10-12 of PIN #2011-01)

(Covered off-site activities)

• Continuity of Care

• Supervision of Non-Health Center Staff (e.g.,

medical students and residents or obstetrical

supervision) while at health center or while treating

health center patients

• Teaching Activities

• Activities under Other Grant Funding

• Clinical Research

• Assisting with Community Events

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Emergency Events (PIN 2011-01 pp. 13-16)

• FTCA coverage within the service area of the health

center

• FTCA coverage outside the service area of the

health center

• FTCA coverage for non-impacted health centers

• There is no FTCA coverage for volunteers even in

emergencies

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Particularized Determination

• Services to non-health center patients ONLY

• The application must provide sufficient detail showing:

• The provision of services to non-health center patients will benefit

patients of the covered entity and general populations that could be

served by the covered entity through community-wide intervention

efforts within the communities served by such entity;

• The provision of the services to non-health center patients facilitates

the provision of services to patients of the covered entity;

• Such service are otherwise required to be provided to non-health

center patients under an employment contract or similar arrangement

between the covered entity and the covered individual.

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Particularized Determination (cont’d)

• Narrative explanation signed by CEO

• Job descriptions/positions

• Relevant agreements/arrangements

• The request must include enough detail to determine:

• What services are provided

• Who provides the services

• Where the services are provided

• Why covered entity personnel are needed to provide such

services; and

• How these services benefit the patients of the covered

entity.

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The Importance of Scope of Project

• Services

• Only services listed in Form 5, Part A in

EHB are covered

• It is not necessary to specify procedures on

Form 5, Part A

• To add a service, a health center MUST go

through the “Change in Scope” process

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RISK MANAGEMENT TIP

Medical Marijuana Programs

• Marijuana is still classified by the DEA as a Schedule 1

drug (defined as having a high potential for abuse and no

medicinal value). Criminal penalties exist for possession,

use, prescription of marijuana.

• Any activity that is illegal under Federal law would be both

outside the scope of project and outside the individual's

scope of employment and therefore, not be protected by

the FTCA.

• No written BPHC policy on medical marijuana. However,

they have been consistent in their answer when asked if

the FTCA would cover participation in state medical

marijuana laws. That answer has been "no".

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RISK MANAGEMENT TIP

• Suboxone therapy must be separately identified as a

service in Form 5, Part A

• Suboxone therapy is now considered to be a “specialty” service

because it currently requires any provider to obtain an additional

certification above the normal scope of their residency training.

• Methadone is still included in the normal scope of

substance abuse services and no other service has been

parsed out of substance abuse therapy.

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The Importance of Scope of Project

• Sites

• With a few exceptions only services provided at

sites within the scope of project (Form 5, Part B)

are covered by FTCA

• Exception (from PIN 2011-01)

• Form 5, Part C, Intermittent and other sites (PIN 2008-

01)

• Only care delivered to existing health center patients at

Form 5, Part C sites is covered by FTCA

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What are the Common Gaps?

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Possible Gaps in Coverage: Patients

• Individuals who self-identify as health center

patients at the hospital or some other non-health

center location when, in fact, they have never had a

health center visit.

• Patients who are auto-assigned to health center

through an MCO but have never been to the health

center before going to the emergency room. (But

see 233(m)(1) Application of coverage to managed

care plans.

• Patients who are seen in nursing homes by health

center providers before being seen in the health

center.

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Common Gaps

• Non-Covered Patients

• Non-Covered Individuals

• Non-Covered Activities

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Possible Gaps in Coverage: Providers

• Health center contracts with providers who, by definition, are

not covered by the FTCA (volunteers, part-time contract

specialists in non-covered fields)

• Cross coverage between two deemed health centers?

• The provider is a part-time employee of the health center

and has his/her own private practice.

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Possible Gaps in Coverage: Activity

• Heath center provides specialty care for

patient that has not been brought into scope.

• The activity is not medical malpractice:

• Defamation

• HIPAA Violation

• Sexual Harassment

• Civil Rights Violation

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Possible Gaps in Coverage: Location

• Health center is providing services in a

location that is not in the health center’s

scope of project. (Form 5 Part B)

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Filling the Gaps

• Is the arrangement clearly defined and documented

in accordance with PIN 2011-01? Does it squarely

fit into one of the examples in the FRN/ NPRM?

• Is the health center trying to cover services to a

non-health center patient? Can you request a

particularized determination? (Page 10, PIN 2011-

01)

• What other kinds of insurance coverage does the

health center have?

• Can the other party bear the expenses of

professional liability coverage?

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Insurance Coverage

• General Liability Coverage

• D&O Liability Coverage

• Automobile Coverage

• Fire Coverage

• Theft Coverage

• Gap Insurance Coverage

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Gap Insurance Coverage

• Wraps around the coverage provided by

FTCA (EXAMPLES of activities that COULD

BE covered):

• Volunteers and part-time contractors

• Activities and locations outside of scope of

project

• Alleged criminal activities

• Coverage for indemnification

• Coverage for contracts with other corporations

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THE DEEMING APPLICATION PROCESS

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How and When to Apply

• All health centers wanting FTCA coverage

must apply annually for it.

• For redeeming, typically applications are due

in April/May for the following calendar year.

• Applications submitted through the Electronic

Handbook.

• Quality Improvement/Risk Management and

Credentialing programs are carefully

reviewed by HRSA.

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Deeming Requirements

• Annual Application via EHB.

• Has implemented appropriate policies and procedures

to reduce the risk of malpractice and the risk of

lawsuits.

• Has properly credentialed all its licensed or certified

health care practitioners in accordance with PIN 2002-

22.

• Has no history of claims filed under the program or if

such claims(s) exist, has cooperated with the DOJ in

defending such claims.

• Will take corrective action to assure claims will not

reoccur.

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RISK MANAGEMENT TIP

• A health center’s deeming application is

discoverable.

• DO NOT INCLUDE PRIVILEGED/

CONFIDENTIAL OR OTHERWISE

PROTECTED INFORMATION IN THE

CLAIMS HISTORY

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FTCA Requirement

42 U.S.C.§233(h)(2) requires review and

verification of “the professional credentials,

references, claims history, fitness,

professional review organization findings, and

license status of its physicians and other

licensed or certified health care practitioners.

That’s “Credentialing and Privileging”


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Credentialing Requirements

• PIN 2001-16: General Statement on BPHC

policy regarding credentialing and privileging

of health center staff.

• “All Health Centers shall assess the credentials of each

licensed or certified health care practitioner.”

• “A Health Center must verify that its licensed or certified

health care practitioners possess the requisite skills and

expertise to manage and treat patients and to perform the

medical procedures that are required to provide the

authorized services.”

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Credentialing Requirements

• PIN 2002-22: Clarification of C&P policy with

significantly more detail:

• Provides definitions.

• Explains credentialing requirements in detail.

• Explains privileging and re-privileging

requirements.

• Allows use of Credentials Verification

Organization (CVO) to perform credentialing.

• Permits temporary privileges but not temporary

credentialing.

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KEY C&P Requirements from 2002-22

• Must credential all licensed or certified health

care practitioners.

• Credentialing process for licensed

independent practitioners (LIP) is rigorous

requiring primary source verification of many

items.

• Credentialing of non-licensed independent

practitioners (e.g. RNs, LPNs, Radiology

techs, ultrasound techs, etc.) requires primary

source verification of license only.

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KEY C&P Requirements from 2002-22

• Credentialing requirements for LIPs:

• Primary source verification of: • Current license.

• Relevant education, training and experience.

• Current Competence.

• Health fitness or ability to perform the requested privileges.

• Secondary source verification of: • Government issued picture I.D.

• DEA registration (as applicable).

• Hospital admitting privileges (as applicable).

• Immunization and ppd status.

• Life support training (as applicable).

• NPDB query

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Privileging

• Privileging is the process that health care

organizations employ to authorize

practitioners to provide specific services to

their patients. (PIN 2001-16)

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PRIVILEGING PROCESS

• From PIN 2002-22: • primary source verification of a course of study from a

recognized and certifying educational institution.

• direct, first hand one-on-one documentation by a

supervising clinician who possesses the privilege of the

particular procedure or management protocol.

• direct proctoring by a qualified clinician possessing a

degree of expertise in the particular procedure or protocol

beyond the level of expertise of most primary care

providers.

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Privileging Process

• Whatever verification procedures used should

be appropriate to the specialty of each

practitioner, the breadth of clinical services

offered by the health center and the particular

circumstances of the clinic’s accessibility to

ancillary and tertiary medical practitioners.

(PIN 2002-22)

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FTCA CLAIMS PROCESS/PROCEDURE

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HRSA Description of the Claims Process

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FTCA Claims Process/Procedure • How the Claims Process Should Work

• The plaintiff files an administrative claim against the United States.

• DHHS reviews the claim and may deny it, pay it or offer a

settlement.

• If DHHS denies the claim, the plaintiff may file a lawsuit.

• If DHHS does not act on a claim within six months, plaintiff may file

suit in federal court.

• When suit is filed, the case is transferred from DHHS to the

Department of Justice (DOJ). DOJ may attempt to settle the suit,

otherwise it will process in litigation against the United States in

federal court.

• If payment is made on an FTCA claim, the Medical Claims Review

Panel determines whether the standard of care was met for

purposes of NPDB reporting.

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FTCA Claims Process

• How the Claims Process Usually Works

• The plaintiff files a medical malpractice lawsuit against the

health center in state court (referred to as a “premature

lawsuit”)

• The health center notifies DHHS Office of General

Counsel (OGC) about the lawsuit and provides OGC with

all of the necessary documentation.

• The health center proceeds in state court (motions to

extend deadlines, etc…) while waiting for the OGC to

verify the applicability of the FTCA to a particular claims.

• The DHHS verifies the applicability of the FTCA to a

claims and refers the case to the DOJ, who assigns an

Assistant U.S. Attorney to the case.

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FTCA Claims Process

• How the Claims Process Usually Works continued…

• The AUSA removes the case to federal court and files a

motion to dismiss the case against the health center.

• The U.S. District Court dismisses the health center from

the case and substitutes the United States as the

defendant.

• The AUSA moves to dismiss the case against the United

States for the plaintiff failing to exhaust his/her

administrative remedies.

• The U.S. District Court dismisses the case against the

United States and the case proceeds as an FTCA claim

as described in the “How the Claims Process Should

Work” slide.

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What is Risk Management?

• Any activity, process, or policy to reduce

liability exposure.

• Engaging your health center in the practice of

identifying, managing, controlling and

monitoring all risks to the organization.

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Risk Management is aDecision-Making Process

(1) Identifying risk and analyzing an organization’s

exposure to loss

(2) Examining alternate risk techniques

(3) Selecting the best techniques

(4) Implementing the technique(s) chosen

(5) Monitoring and making changes as necessary.

George Head, Insurance Institute of America

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Clinical vs. Non-Clinical Risk Management

CLINICAL • Medical Professional Liability

• QA/QI

• Credentialing & Privileging

• Infection Control

• Patient Safety

• Patient & Family Education

• Medication Errors

NON- CLINICAL • Financial

• Emergency Management

• Legal/ Regulatory Compliance

• Information Technology

• Facilities

• Operations (Non-Clinical)

• Human Resources

• Hazard

• Strategy

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A Word About Clinical Risk

Management

• Clinical Risk and Patient Safety

• ECRI Sample Risk Management Plan

• ECRI Clinical Risk Management Resources

http://www.nachc.com/clinicalriskmanagement.cfm

http://bphc.hrsa.gov/ftca/riskmanagement/riskmgmt

.plan.pdf

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http://www.nachc.com/clinicalriskmanagement.cfm

http://bphc.hrsa.gov/ftca/riskmanagement/riskmgmt.plan.pdf

http://bphc.hrsa.gov/ftca/riskmanagement/riskmgmt.plan.pdf


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OIG Report on Risk Management at Health Centers

• 2005 Office of the Inspector General (OIG) Report on Risk Management at

Health Centers

http://oig.hhs.gov/oei/reports/oei-01-03-00050.pdf

• Perspectives from health center officials regarding risk management practices

and the challenges health centers experience in conducting them

• Identified 16 risk management practices and surveyed grantees about their

experience in dealing with them.

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16 Risk Management Practices Identified for Health Centers

• Active Quality Improvement Program

• Appropriate use of clinical protocols

• Clear communication with patients

• Clear communication with providers

• Comprehensive patient medical records

• Credentialing of health care professionals

• Documentation of informed consent

• Formal patient grievance mechanism

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16 Risk Management Practices Identified for Health Centers

• Internal incident reporting system

• Ongoing peer review of patient cases

• Onsite assessment of risks and risk management practices

• Patient tracking system

• Privileging of health care professionals

• Regular patient satisfaction survey

• Regular staff training on risk management

• Up to date policies on risk management

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• Top Three Health Center Risk Management

Practices for Reducing Claims and Ensuring

Safety:

• Credentialing

• Quality Improvement

• Comprehensive Medical Records

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• Most Difficult Risk Management Practices to Conduct:

• Regular Staff Training

• Patient Tracking

• Peer Review

• Reasons for Difficulty in Implementing Risk Management

Practices:

• Lack of Financial Resources

• Lack of FTE Staff Person for Risk Management

• Lack of Training

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Informed Consent

• It is a process, not a form.

• Components of effective informed consent

• Competency

• Barriers to competency:

• Mental Status

• Age

• Sedation

• Illiteracy

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Informed Consent

• Components of effective informed

consent

• Information

• Explanation of patients condition (in layman’s

terms)

• Proposed therapy and rationale

• What will be the results (with no guarantees)

• Significant risks

• Reasonable alternatives

• Option of no treatment

• Answer questions and offer second opinion

• Patient can retract at any time

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Informed Consent

• Components of effective informed consent

• Agreement by patient on treatment plan

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Informed Consent

• Provide Educational Materials

• Documentation

• Previous materials must be retrievable

• Commercial educational material, review before

providing to patient

• Procedure specific consent forms

• Refusal of treatment must be documented

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Questions?

?

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Contact Information

Martin Bree

Feldesman Tucker Leifer Fidell LLP

1129 20th Street, NW

Fourth Floor

Washington, D.C. 20036

[email protected]

Tel. 202.466.8960

Fax 202.293.8103

WWW.HEALTHCENTERCOMPLIANCE.COM

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Managing FTCA Risk-A Key Component of Your Enterprise Risk

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