Chapter 9: A Primer on Medical Malpractice Malpractice – What is it? • Error - behavioral matter • Misperception • Mistake • Omission • Substitution • Accident - unplanned event • Malpractice - negligence Negligence • An act that a prudent person would not have done or the omission of a duty that a prudent person would have fulfilled, resulting in injury or harm to another person. – A civil wrong and part of the law of torts. – Founded on the relationship between the actor and the victim Requirements of an Act of Negligence • Legally recognized relationship between the health care worker and patient • Health care worker has a duty of care to the patient • Health care worker breached the duty of care by failing to conform to the required standards of care • The breach of duty was the direct cause of harm, resulting in the patient suffering damages as a result of the harm Malpractice • Negligence that is the proximate cause of injury or harm to a patient resulting from – A lack of professional knowledge, experience or skill that can be expected in others in the profession. OR – From failure to exercise reasonable care or judgment in the application of professional knowledge, experience or skill. Medical Malpractice • The commission or omission of an action causing an injury is shown to arise from the exercise of professional medical judgment • There must be: – A Physician-Patient Relationship – A Duty to Perform Professionally Sources of Professional Standards • Government statutes and regulations • Professional society standards • Voluntary accrediting agency standards • Administrative policies and rule of the facility Theories of Liability • Informed consent • Strict liability • Vicarious liability • Res ipsa loquitur Re ipsa loquitur The thing speaks for itself – Injury would not ordinarily occur in the absence of negligence – Injury was caused by the actions was within the control of the defendant – Injury is not due to any action on the part of the plaintiff – Evidence surrounding the circumstances is mostly within the control of the defendant Hospital Liability for Malpractice • Respondeat superior • Ostensible agency • Staff Privileges – Corporate Negligence – Contributory Negligence Other Liability Theories • Intentional tort • Assault and battery • Libel • Slander • Invasion of Privacy Types of Damages • Compensatory damage • Awards for pain and suffering • Punitive damages Statute of Limitations • The maximum period of time after the patient’s injury during which a lawsuit may be commenced. • Most state have a statutory period between one and three years. • Typically the statutory period is deferred (tolled) during infancy and starts to run only on the patient’s 18th birthday. Common Malpractice Allegations • Surgery/post-op complications • Failure to diagnose cancer • Surgery/inadvertent act ...

1. Chapter 9: A Primer on
Medical Malpractice
Malpractice – What is it?
• Error - behavioral matter
• Misperception
• Mistake
• Omission
• Substitution
• Accident - unplanned event
• Malpractice - negligence
Negligence
• An act that a prudent person would not
have done or the omission of a duty that a
prudent person would have fulfilled,
resulting in injury or harm to another

2. person.
– A civil wrong and part of the law of torts.
– Founded on the relationship between the
actor and the victim
Requirements of an Act of Negligence
• Legally recognized relationship between the
health care worker and patient
• Health care worker has a duty of care to the
patient
• Health care worker breached the duty of care
by failing to conform to the required
standards of care
• The breach of duty was the direct cause of
harm, resulting in the patient suffering
damages as a result of the harm
Malpractice
• Negligence that is the proximate cause of
injury or harm to a patient resulting from
– A lack of professional knowledge, experience

3. or skill that can be expected in others in the
profession.
OR
– From failure to exercise reasonable care or
judgment in the application of professional
knowledge, experience or skill.
Medical Malpractice
• The commission or omission of an action
causing an injury is shown to arise from
the exercise of professional medical
judgment
• There must be:
– A Physician-Patient Relationship
– A Duty to Perform Professionally
Sources of Professional Standards
• Government statutes and regulations

4. • Professional society standards
• Voluntary accrediting agency standards
• Administrative policies and rule of the
facility
Theories of Liability
• Informed consent
• Strict liability
• Vicarious liability
• Res ipsa loquitur
Re ipsa loquitur
The thing speaks for itself
– Injury would not ordinarily occur in the
absence of negligence
– Injury was caused by the actions was within
the control of the defendant
– Injury is not due to any action on the part of
the plaintiff
– Evidence surrounding the circumstances is

5. mostly within the control of the defendant
Hospital Liability for Malpractice
• Respondeat superior
• Ostensible agency
• Staff Privileges
– Corporate Negligence
– Contributory Negligence
Other Liability Theories
• Intentional tort
• Assault and battery
• Libel
• Slander
• Invasion of Privacy
Types of Damages
• Compensatory damage

6. • Awards for pain and suffering
• Punitive damages
Statute of Limitations
• The maximum period of time after the
patient’s injury during which a lawsuit may be
commenced.
• Most state have a statutory period between
one and three years.
• Typically the statutory period is deferred
(tolled) during infancy and starts to run only
on the patient’s 18th birthday.
Common Malpractice Allegations
• Surgery/post-op complications
• Failure to diagnose cancer
• Surgery/inadvertent act
• Improper treatment (birth related)
• Failure to diagnose fracture or
dislocation

7. Most Expensive Settlements
• Improper treatment (birth related)
• Failure to diagnose hemorrhage
• Failure to diagnose myocardial infarction
• Failure to diagnose infection
• Failure to diagnose cancer
Other concerns which
may impact liability
• Unrealistic patient expectations
• Non response to complaints
• Illegible medical records
• Insufficient information in medical
records
• No follow-up on abnormal tests
• Professional miscommunication
Summary

8. • Risk Managers need to be aware of both
professional and facility liabilities
• Malpractice claims can be very complex
• Setting policies and procedures and
following them are important in
minimizing malpractice liability
Chapter 8: Patient Safety Tools:
Integrating Quality and Managing Risk
Why do we talk about Quality
in the Risk Management setting?
• Risk management makes contributions to
quality by assuring that hazards and
injuries are less likely to occur for both
patients and employees.
• Risk management works to prevent
malpractice claims by identifying,

9. analyzing and treating risks which quality
assessment tries to eliminate
Predicting Hazards and Malpractice
• Prediction is not specific in risk management –
can say an event is likely to occur, but not
when or to what extent
• Confounding factor: increased patient
satisfaction tends to correlate to lower
likelihood of legal action by a patient
• Incident Reporting: can assist the risk
manager in identifying causes
Healthcare Acquired Conditions
• Conditions for which, when acquired during
admission in the health facility, CMS will not
reimburse.
• Examples include:
– Foreign object retained after surgery
– Air embolism
– Blood incompatibility
– Pressure ulcer stage III and IV
– Falls and trauma
– Catheter-associated infection
– Manifestations of poor glycemic control

10. Importance of Communication
• Effective communication is a factor in the
likelihood of a patient deciding not to sue a
provider as it has impact on patient
satisfaction
• Informed Consent is the result of effective
communication between the provider and
patient. The patient needs to know the
possible outcomes of treatment, both good
and bad, so as to have proper understanding
and expectations.
What if Unanticipated Outcomes Occur?
• Disclosure of unanticipated outcomes is
mandatory. The ethical question is NOT
should it be disclosed, but how and by whom.
• Risk managers need to plan, prepare and
educate staff to avoid inappropriate disclosure
Enterprise Risk Management (ERM)
• An approach to assessing and addressing risks
from all sources that either threaten the
organization’s objectives or represent opportunities

11. to exploit competitive advantage.
• Categories of Risk
– Operational/Clinical Risks
– Financial Risks
– Human Capital Risks
– Strategic Risks
– Legal/regulatory Risks
– Technological Risks
– Natural Disaster/Hazard Risks
Difference from
Traditional Risk Management
• Traditional Risk Management took a more
clinically focused approach and examined
risks individually.
• With ERM, the Risk Manager has a larger
focus and more strategic position. It
begins with risk identification and

12. determination of the relative importance of
the risk
ERM Process
• ERM utilizes the steps in the traditional
risk management process
– Identify and analyze the exposures to loss
– Examine the feasibility of alternative
techniques
– Select the best technique
– Implement the technique
– Monitor and improve the risk management
program
Quality and Risk Management
• Historically Risk Management and Quality
initiatives were seen as separate.
• Today, organizations utilize a more integrated
approach, recognizing that many risk
management errors are breakdowns in
process (quality) rather than individual error.

13. Quality Management Techniques
• Quality Assurance – a formal, systematic
program by which care given to patients is
measured against established criteria.
• Quality Management – encompasses
monitoring and evaluating quality issues,
followed by changes in the system.
Total Quality Management – W. E. Deming
• TQM focuses on the system not the
individual
– 85/15 rule – 85% of problem is related to
system failure and 15% is the fault of the
people involved
• Three premises:
– Quality is important and can be measured
– People are part of the solution not the
problem
– Change is fundamental and can be managed
Quality Management Techniques

14. • Continuous Quality Improvement (CQI) –
process used to improve their ability to
satisfy customer expectations.
– Directs attention to the fundamental
mechanism that drives a process or system.
– Focuses on techniques to accomplish positive
change by assessing a process that leads to
an intervention.
– Use of sentinel events
Quality Management Techniques
4 Stages for Process Improvement
• Dr. Steven Speer recommends the following
states to assist with process improvement:
– System design and operation
– Problem solving and improvement
– Knowledge sharing
– Developing high velocity skills in others

15. Other Quality Tools from Industry
• Lean Management focuses on reducing waste
and eliminating error in processes.
• Six Sigma focuses on eliminating causes of
defects or error and minimizing variability in
process.
Barriers to Quality
Management Initiatives
• Separation of administrative functions
– CQI implementation can be difficult as physicians
tend to focus on patients not administrative
responsibilities
• Hierarchical and bureaucratic structure makes
empowerment difficult
• Lack of recognition of problem-solving initiative
• Lack of vision of the desired outcome
• Inflexible attitude of “this is how it’s always been
done”
Quality Improvement Teams
• Quality Improvement Teams (QIT) are change

16. agents.
• Can investigate and recommend
improvements, many times in conjunction
with the risk manager who may or may not be
a member of the team.
Customer is Key
• The quality improvement process views the
customer as central to its purpose.
• It is imperative to know who the customer is
and their importance to providing care.
– Note: the customer is not always the patient.
CQI and Labor Relations
• Risk managers should make sure that any QIT
or other CQI program teams are reviewed and
deemed allowable by the NLRA.
– Some teams may be viewed as labor organizations
dominated by the employer if not structured
properly
Determining the Effectiveness
of Risk Management
• There is currently no research to definitively

17. demonstrate the effectiveness of risk
management programs.
• However, risk management programs are
important as adverse events do happen, and
there is a need to investigate and implement
strategies/improvements to minimize the risk
of adverse events recurring.
Program Evaluation
• What are the areas of responsibility or
functions defined for risk management?
• Which information or data are collected and
available within each of these areas of
responsibility or function?
• Can this information or data be categorized
and analyzed systematically to derive
measures of effectiveness?
Use of Standards
• A standard must be reasonable, achievable
and measurable
• Results standards: what is accomplished
• Activity standards: means by which
something is accomplished

18. Evaluation Tools
• Root Cause Analysis
• Failure Mode, Effect and Criticality
Analysis
External Evaluation
• The Joint Commission may evaluate a
healthcare organization’s risk management
program during the accreditation process.
• Third party payers may also evaluate risk
management programs to determine
insurability of the organization.
• Benchmarking with other organizations.
Practice Guidelines
• Practice guidelines can set a standard of care
to help minimize risk
• May be difficult to monitor
• Risk increases as departure from stated
guidelines can be a source of liability

19. High Exposure Issues
• Clinical Activities
• Monitoring
• Medical Records
• Electronic Health Records
• HIPAA
• Credentialing
• Withholding of Treatment
• Disclosure
Summary
• Quality and Risk Management overlap
• Risk Managers can utilize quality
techniques and reports to assess risk and
recommend improvements