An Apptis Division

Safety Event Reporting

George E. Ritter, Jr., MD

Senior VP and Chief Medical Officer

SafeCare Systemsgeorge.ritter@safecaresystems.com

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

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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.

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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

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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 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