An Apptis Division
Safety Event Reporting
George E. Ritter, Jr., MD
Senior VP and Chief Medical Officer
SafeCare [email protected]
An Apptis Division
The Patient Safety Crisis
• 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
70% of Medical Errors are Preventable
Potentially Preventable
Unpreventable
70%
24%
6%
70%
24%
6%
PreventablePreventable0
100000
200000
300000
400000
500000
600000
700000
800000
Ann
ual D
eath
s
Medical Errors are a Leading Cause of
Death
*IOM Report 1999
An Apptis Division* HHS Secretary Mike Leavitt, 2005
• 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 & Payer-driven
safety initiatives
• State Medical Error Reporting Laws in 27 states
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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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ManagementDecisions
and Organizational
Processes
Unsafe Acts
Errors
Violations
Work/Environment
Factors
Team Factors
Individual(staff) Factors
Task Factors
Patient Factors
ORGANIZATION &MANAGEMENT
CULTURE
FACTORSINFLUENCING
PRACTICE
CARE DELIVERYPROBLEMS
Event
DEFENSES &
BARRIERS
LATENT FAILURES ERROR &
VIOLATIONPRODUCINGCONDITIONS
ACTIVEFAILURES
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 Unintended consequence Unplanned clinical
occurrence Therapeutic
misadventure Peri-therapeutic accident Iatrogenic
complication/injury Hospital-acquired
complication Near miss Close call
Incident Medical mishapUnexpected
occurrenceUntoward
incidentBad callSentinel eventFailureMistakeLapseSlip
An Apptis Division
Errors
Iatrogenic AdverseEvents
PreventableErrors
NegligentAdverse Event
PreventableAdverseEvents
Sentinel Events
Accidents
Adapted from HoferTP, Kerr EA, Hayward RA (2000)
An Apptis Division
An Apptis Division
Safety Event Report(s)
multidisciplinary team formed
JCAHO Sentinel Event Alert
Manager or Team Leader or PI Coordinatorevaluates event
External Event
Risk Management Office
Nursing & Physician Peer
Review Programs
flow diagram constructed with details and timeline
of event
event compared to “nominal” process
Collaboration Collaboration
deviations, flaws determined
RCA
ask “why?” 3 times
brainstorm on ways to “fix” root causes
subject process steps to FMEA
Plan
Act Do
Study
Does the process seem safe?
redesign process
report as required
hold the gains
Begin tests of change
Improvement is a process…
Feb 2005
no yes
Performance Improvement
Office Internal Event
or
CollaborationUnit process data
collect data
Plan data collection
Run Chart
Control Chart Pareto Analysis
An Apptis Division
An Apptis Division
Med Error (13.305)
Serious Injury (9.650)
Adverse Event (10.960)
Incident (9.941)
Medical Device (11.220)
Pharmacy
DHQ
Security
RM
FDA
DPH
Clin Eng
any event that deviates from the routine care of the patient. patient injury visitor injury property or equipment damage/lossmedical equipment which appears to be broken, damaged malfunctioning
“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
infant abduction, infant discharged to the wrong familyrape by another patient or staffhemolytic transfusion reaction surgery on the wrong patient or wrong body partsuicide of a patientsentinel event
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
AME
P-AME
VISITOR INJURYACCIDENT, THEFT, VANDA;OSM
PI Office
Safety Reporting Flow:Safety Reporting Flow:P-AME Form (Blue)
AME form (White)
Security Report
Incident/Occurrence ReportPatient Fall Incident Report
User Facility Report
An orphan -Employee Accident Report
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Fix the basicsof
incident reporting
Redesign the Interface with
managers
Internet Reportingfor all
Interface withStaff
Partner withManagers for
near-miss reporting
The Pathway to Reporting of
Medical Errors and Near-Misses
at
The strategic campaign towardlearning, safety, clinical quality,and patient confidence and loyalty.
An Apptis Division
Evidence-Based Research & Universal Medical
Taxonomies
Client Best PracticesLibrary
PatientsEmployees
Visitors
Workflow Management &
NotificationClientEvent
Database
NationalComparative
Database
Event Entry
Risk Module Risk
ModuleNear Misses,Incidents,Adverse Events, High-Risk Occurrences, Medical Errors
Report:
Decision Support & EIS
Decision Support & EIS
linkages
Anonymous Reporting
Web-enabled Event Reporting
Event Taxonomy
Safety Event Reporting - The SolutionSafety Event Reporting - The Solution
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• 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
An Apptis Division
– 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 LeadershipPriority
Non-punitive Culture
Risk Assessment
Best Practices
Adverse EventAnalysis
Recognition
Teamwork
ProcessImprovement
Patient Involvement
Sept 2001
Sept 2002
Sept 2003
Sept 2004
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No Excuses:
• 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