Transcript Risk Management - Duke University

Duke University Health System
Orientation 2008
Clinical Research Coordinators
Risk Management &
Clinical Research
Douglas Borg, MHA, ARM, CPHRM, DFASHRM
Director of Insurance
Duke University Health System
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January 25, 2008
Agenda
Risk Management
Insurance Coverage
Exposures Associated with Clinical Research
Legal Climate
Informed consent
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January 25, 2008
What is Risk Management?
Function is to identify, evaluate and control
risk exposures:
Professional liability - malpractice
General liability - premises, equipment
Proactive - Prevention of loss
Reactive - Management of loss
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Proactive Risk Management
Policy and procedure review and
development
Inservice educational programs
On-call assistance
Providing data for performance
improvement
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Reactive Risk Management
Evaluation of incidents when they occur
that either cause harm or have the
potential to cause harm
Claim investigation
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January 25, 2008
Your PL Insurance
Durham Casualty Company, Ltd.
Coverage for work within the Duke Health
System
Does not cover:
 criminal conduct
 civil rights violations
 inappropriate sexual contact/conduct
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Typical Exposures for CRCs
Inappropriate selection of research subjects
Inadequate informed consent
Failure to adequately monitor the patient for
problems related to the research
Failure to remove a patient from a study
Failure to document patient’s participation
Scope of practice issues
Not adhering to Standard of Care
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Addressing the Risk…
Inappropriate selection of research subjects
Don’t pressure
Don’t make overblown promises of success
Don’t minimize risks
Be aware that compensation can be considered
coercive – compensate for travel and time, but
payment must be a fair reflection of the subject’s
expenses and inconvenience for participating
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January 25, 2008
Addressing the Risk…
Inadequate informed consent
Consent document easy to read & understand
(below 8th grade reading level)
Don’t rely on strict adherence to IRB
requirements
Informed consent process is important – if it is
delegated to someone other than the PI, ensure
that their knowledge of the study is adequate,
and evaluate their communication skills
Ask questions to ensure understanding
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Addressing the Risk…
Failure to adequately monitor the patient for
problems related to the research
Safety first
Track & document compliance with required visits
Track & document compliance with study
instructions
Be familiar with signs and symptoms of adverse
reactions to medications or treatment
Don’t hesitate to pull someone out of a study
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January 25, 2008
Addressing the Risk…
Scope of practice issues
Understand your role
Licensure v. Job Requirements
May lead to insurance coverage issues
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January 25, 2008
Addressing the Risk…
Not adhering to Standard of Care
Research-related treatment and procedures must
be managed in accordance with standard of care
It may still be malpractice!
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Limiting Your Liability
Do not practice outside the scope of your
training.
Be familiar with a task before performing.
Ask for assistance.
Be familiar with written policies and procedures.
Practice good documentation.
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Medical Negligence
In general, in NC health care providers must:
Use his/her best judgment
Act with reasonable care and diligence
Act within the standard of care
Violation of any one duty can be negligence
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What is the Standard of Care?
Standard of practice among peer providers
Can be set by:
Expert testimony
Policies and procedures
Textbooks, articles
Does not guarantee perfect outcomes
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Informed Consent
NC Statute is protective where provider acted in accord
with usual standard of practice
Disclose usual and most frequent risks, and most
severe risks even if unlikely
If evidenced in writing, presumed valid consent
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Your Best Defense?
Documentation is critical
Care of the patient
Success of the study
Defense from claims of malpractice
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Proving Your Treatment
Document patient response to treatment
Document refusal of treatment
Use hospital approved abbreviations
Note time of treatment of assessment
Date and time late entries
Document consideration of the whole patient
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Contacting Risk Management
Phone: 684-3277 - During regular business hours
Page:
970-2404 - After hours and weekends
Fax:
681-8618
On-Line Report (SRS) https://srs.duhs.duke.edu/Default.aspx
Email: [email protected]
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