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Safety Event Reporting
George E. Ritter, Jr., MD
Senior VP and Chief Medical Officer
SafeCare Systems
[email protected]
An Apptis Division
The Patient Safety Crisis
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44,000 to 98,000 deaths per year
$37.6B in costs per year*
Preventable mistakes cost $17 to $29 billion per year*
Medical errors consume 10-15% of a hospital’s annual
operating budget
800000
Annual Deaths
700000
600000
Medical Errors are a
Leading Cause of
Death
70% of Medical Errors are
Preventable
6%
500000
400000
300000
Potentially
Preventable
Unpreventable
24%
200000
100000
Preventable
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*IOM Report 1999
70%
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• Patient Safety – “Is one of the top priorities
for healthcare”*
• Patient Safety & Quality Improvement Act of
2005
– National Database ($58 million/5 years)
– Vendor Certification and Technical Assistance
• JCAHO Accreditation Mandates
• Leapfrog and other Employer & Payerdriven safety initiatives
• State Medical Error Reporting Laws in 27
states
* HHS Secretary Mike Leavitt, 2005
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Clinical care is a chain of
processes that together
improve a patient’s health.
Each step can be associated with:
variation,
failure, and
errors.
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ORGANIZATION &
MANAGEMENT
CULTURE
FACTORS
INFLUENCING
PRACTICE
Work/
Environment
Factors
Management
Decisions
and
Organizational
Processes
CARE DELIVERY
PROBLEMS
DEFENSES
&
BARRIERS
Unsafe Acts
Team Factors
Individual
(staff) Factors
Task Factors
Errors
Event
Violations
Patient Factors
LATENT
FAILURES
ERROR &
VIOLATION
PRODUCING
CONDITIONS
ACTIVE
FAILURES
An Apptis Division
An Apptis Division
Sound Reasoning
Effective Practices
Reliable Systems
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“This, then, is the basic
meaning of a ‘learning
organization’ - an organization
that is continually expanding it’s
capacity to create its future.”
Peter M. Senge
The Fifth Discipline
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And the Lord said, ‘Behold, they are one
people, and they have all one language;
and this is only the beginning of what
they will do . . . Come, let us go down,
and there confuse their language, that
they may not understand one another’s
speech’.
Genesis 11: 6–7
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Adverse event/outcome
Incident
Unintended consequence
Medical mishap
Unplanned clinical
Unexpected
occurrence
occurrence
Therapeutic misadventure Untoward incident
Peri-therapeutic accident
Bad call
Iatrogenic complication/injury Sentinel event
Hospital-acquired
Failure
complication
Mistake
Near miss
Lapse
Close call
Slip
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Accidents
Errors
Iatrogenic Adverse
Events
Preventable
Adverse
Events
Negligent
Adverse Event
Preventable
Errors
Sentinel Events
Adapted from HoferTP, Kerr EA, Hayward RA (2000)
An Apptis Division
An Apptis Division
Improvement is a process…
External Event
Safety Event Report(s)
or
Unit process data
Risk Management
Office
Performance
Improvement
Office
JCAHO Sentinel Event Alert
Internal Event
Manager or Team Leader
or PI Coordinator
evaluates event
Collaboration
flow diagram constructed
with details and timeline of
event
Nursing &
Physician Peer
Review Programs
Collaboration
multidisciplinary team
formed
Begin tests of change
Plan
event compared to
“nominal” process
redesign process
Plan data
collection
Act
Do
deviations, flaws
determined
subject process steps
to FMEA
Run Chart
Control Chart
Study
collect data
Pareto Analysis
RCA
hold the gains
ask “why?” 3 times
no
brainstorm on ways
to “fix” root causes
Does the process seem
safe?
yes
report as required
Feb 2005
An Apptis Division
An Apptis Division
Safety Reporting Flow:
P-AME Form (Blue)
Med Error (13.305)
incorrect drug selection, dose, dosage form, quantity, route, concentration, rate
illegible prescriptions
failure to administer an ordered dose
wrong dosage form, wrong drug preparation, wrong time, unauthorized drug
improper dose, deteriorated drug, wrong route, wrong site, or wrong rate of adm
monitoring error
P-AME
DHQ
AME form (White)
AME
Pharmacy
Security Report
Incident (9.941)
any event that deviates from the routine care of the patient.
patient injury
visitor injury
property or equipment damage/loss
medical equipment which appears to be broken, damaged malfunctioning
Adverse Event (10.960)
infant abduction, infant discharged to the wrong family
rape by another patient or staff
hemolytic transfusion reaction
surgery on the wrong patient or wrong body part
suicide of a patient
sentinel event
Security
VISITOR INJURY
ACCIDENT, THEFT,
VANDA;OSM
Patient Fall Incident Report
Incident/Occurrence Report
User Facility Report
RM
FDA
DPH
Serious Injury (9.650)
“serious” events that are life threatening, result in death or require a patient to undergo significant
additional diagnostic or treatment measures, or disrupt services, including:
injury, fires, damage to the hospital structure, suicide of a patient, criminal, theft of narcotics,
physical injury to a patient, medication errors, burns, slips or falls, biomedical device or other
equipment failure, surgical errors involving the wrong patient, the wrong side of the body, the
wrong organ or the retention of a foreign object, blood transfusion errors, poisonings, infectious
disease outbreaks, allegations of abuse, any material death within 90 days of delivery or
termination or pregnancy
Medical Device (11.220)
PI Office
An orphan Employee Accident Report
Clin Eng
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The Pathway to
Reporting of
Medical Errors and
Near-Misses
at
Internet Reporting
for all
Interface with
Staff
Partner with
Managers for
near-miss reporting
Redesign the
Interface with
managers
Fix the basics
of
incident reporting
The strategic campaign toward
learning, safety, clinical quality,
and patient confidence and loyalty.
An Apptis Division
Safety Event Reporting - The Solution
Employees
Patients
Visitors
Report:
Anonymous Reporting
Near Misses,
Incidents,
Adverse Events,
High-Risk Occurrences,
Medical Errors
Client
Event
Database
Event Taxonomy
Workflow
Management &
Notification
Decision
Support & EIS
Event
Entry
National
Comparative
Database
Evidence-Based Research &
Universal Medical
Taxonomies
Risk
Module
Web-enabled
Event Reporting
Client Best
Practices
Library
An Apptis Division
An Apptis Division
Safety Reporting Successes:
– Avoid reliance on memory:
• Pre-Op Checklist reorganized to support verification of site,
procedure with patient as well as identify anticoagulation
status
–
Simplify
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Communication procedures for stat anesthesia
Critical test results communication
Pharmacy preparation of IV and high risk meds
Changed surgical consent process after confusion
Standardize:
• PCIS changes for Metoprolol dosing (mgs instead half tabs)
Enhanced standardized labeling of paralytic agents in critical
care
CPOE changes for numerous drugs (Metoprolol) (mgs
instead half tabs)
Standardized microinfuser pumps use
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– Use constraints and forcing functions:
Automatic stop orders for blood draws and indwelling catheters
– Use protocols :
CPOE changes to prevent incorrect ordering of administration of
vancomycin (5 mins. vs. 60-90 min)
Weight based heparin protocols
CVC insertion protocols
Preoperative Antibiotics protocol
– Absorb errors (time lapses and redundancy):
“Time out” to verify site and procedure in OR performed in a
consistent manner to reduce wrong site procedures
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Top Leadership
Priority
Patient Involvement
Non-punitive Culture
Process
Improvement
Sept 2001
Risk Assessment
Sept 2002
Teamwork
Sept 2004
Best Practices
Sept 2003
Recognition
Adverse Event
Analysis
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No Excuses:
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There is an ROI
There are compelling reasons to act now
Errors waste precious resources
Grasp the leadership challenge
We will all benefit from safe, effective,
efficient healthcare
• Fear of disclosure is an excuse
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…hospitals are still dangerous
places to be if you are sick.
…We can't afford this kind of
health care anymore. And we
shouldn't pay for it.
Karen Davis, PhD; President,
The Commonwealth Fund
An Apptis Division
An Apptis Division