Transcript CE Risk Management

Risk Management
Frank Painter, CE Program Director
University of Connecticut
June 6, 2015
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Risk Management
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“…an organized effort to identify,
assess, and reduce where appropriate,
risks to patients, visitors, staff, and
organizational assets”
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CE Risk Management Issues
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Device Recalls
Device Tracking/Reporting (SMDA)
Incident Investigations
Medical Technology risks (MRI, laser,
anesthesia, radiation, infection control, etc.)
Alternate parts
EMI interference
Disposal of used equipment
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Principles of Risk
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Absolute safety is generally not achievable
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Zero risk is generally not achievable
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What is sought is a balance between safety,
utility and resources
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Optimal safety is not an automatic byproduct
of overall good intentions…
it requires specific effort!
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Components of risk: Hazards
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Hazards (to people) –
the manner in which a device or
system can cause injury
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Hazards (to things) –
the manner in which a device or system
can cause damage to equipment,
buildings or organization functionality
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Components of risk: Severity
All hazards are not equal
 Different “severities” can be identified
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Minor
Catastrophic
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Components of risk: Probability
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Hazards are not equally likely to occur,
they have a range of probability
Highly unlikely
Highly likely
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Components of risk: Detectability
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Hazards are not equally likely to be
identified before causing harm, they
have a range of probability
Obvious
Unidentifiable
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TJC Sentinel Events
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A sentinel event - an unexpected occurrence
involving death or serious physical or psychological
injury, or the risk thereof (Where a recurrence would
carry a significant chance of a serious adverse
outcome).
Organization must conduct a Root Cause Analysis on
each Sentinel Event.
Organization may voluntarily report Sentinel Events
to the TJC
Certain types of Sentinel Events are required to be
reported (unanticipated death or major loss of function,
suicide, Abduction of a patient, Discharge of infant to
wrong family, Hemolytic transfusion reaction, wrong
site/patient surgery, & a few others)
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FDA Reporting Requirements
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Safe Medical Devices Act (SMDA) of 1990
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Postmarket Surveillance for the monitoring of
products after their clearance to market
Device Tracking for maintaining traceability of
certain devices to the user level.
Medical Device Reporting (MDR) regulation of
December 1995 (for user facilities and
manufacturers)
The MDR regulation provides a mechanism for
FDA and manufacturers to identify and monitor
significant adverse events involving medical
devices
FDA Modernization Act of 1997
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FDA Reporting Requirements
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Users (healthcare professionals) voluntary
adverse event reporting program is called
MedWatch
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used for adverse reactions, product quality
problems & product use errors
The SMDA requires user facilities to report:
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device-related deaths to the FDA and the device
manufacturer;
device-related serious injuries to the
manufacturer, or to FDA if the manufacturer is not
known; and
submit to FDA on an annual basis a summary of
all reports submitted during that period.
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FDA Data
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Manufacturer And User Device Experience
(MAUDE) database
Medsun – A more carefully managed version
An on-line search is available which allows
you to search the CDRH's database information
on medical devices which may have
malfunctioned or caused a death or serious
injury.
MAUDE is scheduled to be updated quarterly
and the search page reflects the date of the
most recent update.
This data is on ECRI’s HD website too.
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Root Cause Analysis
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Retrospective
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probe the reason for problems that occurred
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get to the root of the problem, not the
apparent, surface or proximate cause
(special causes)
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ask - why, why, why
To prevent recurrence
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To create an action plan for improvement
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Root Cause Analysis
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Process for identifying the basic or
causal factors in performance variation
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Focuses primarily on systems and
processes, not individual performance
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No assignment of blame
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Find the factors that enabled the event to
occur
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Root Cause Analysis
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Proximate Causes
Superficial
 Obvious
 Immediate
 Special causes
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Root Causes
Underlying causes
 Causes that lead to the proximate cause
 Common causes
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Proximate Cause Variation
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Proximate causes
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Mechanical Malfunction, intoxicated
employee, flood, hurricane, earthquake
Firing an intoxicated employee who
failed to connect the NIBP line correctly
will not prevent the same special cause
from recurring in the future
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Root Cause Analysis
Do not solve problems by eliminating
proximate causes
 Probe, understand and address
underlying root causes
 Proximate causes in one process are
usually the result of root causes in a
larger system
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Root Cause Analysis
Mechanical breakdown of a piece of
equipment in surgery –> problem with
organization’s PM activities
 Intoxicated employee -> organization’s
screening and hiring practices
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TJC Sentinel Events
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TJC 2014 Patient Safety Goals
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Goal 1 Improve the accuracy of patient identification.
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Minimum of two identifiers
Eliminate transfusion errors
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Goal 2 Improve the effectiveness of communication about test results
among caregivers
 Goal 3 Improve the safety of using medications.
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Labeling
Anti-coagulant therapy issues
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Goal 6 Clinical alarms management
 Goal 7 Reduce the risk of health care-associated infections.
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Follow hand washing guidelines
Implement program for
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MRSA
CLABI
surgical site infections
CAUTI
Reduce procedure mistakes
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Verify the correct procedure and patient
Mark the procedure site
Call time-out
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Resolved Patient Safety Goals
Wrong site-wrong side surgery
 IV pump free flow
 MRI safety
 Surgical fires
 Ventilator safety
 Patient falls
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Failure Modes and Effects Analysis
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Proactive – focuses on the design of the system
to prevent future failures
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Assumes failures will occur
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Analyzes what could go wrong, the likelihood it will go
wrong and the effect if it did
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Faults or problems are anticipated and designed out
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Systematic way to examine the design for possible
ways failure can occur
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Minimizes Probability and effect of failure.
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Disaster Planning
Managing the risks of potential
catastrophic incidents
 Hazard vulnerability analysis
 Emergency preparedness plan
 Planning & Practice = Preparedness
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Incident Investigation
Arrive with the right tools (tool box)
 Document the overall scene – layout
 Document environmental issues
 Document the arrangement of the people
and their roles
 Document the settings, connections and
nearby but apparently uninvolved
equipment
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Incident Investigation
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Incident Investigation
Photograph everything – a good camera
is important & a microscope
 Test the equipment – against know
standard
 Do not fix the equipment – spoliation is
bad
 Write the report – nothing but the facts
 Develop your opinions separately
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Incident Investigation
Work with & report to Risk Manager
 Do things by the book – follow policies
and procedures
 A lawsuit could develop and unproven
opinions and conclusions will become
facts in the mind of opposing lawyers
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CE Risk Management
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In Retrospect
If you have good well thought out policies
and procedures
 If you inspect and repair equipment,
manage recalls and safety issues according
to policies and procedures
 If you work closely with Risk Management
during incident investigations
 Things will go well for CE.
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