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SEGURAN AN A EM SA SA DE CURSO E OFICINA DE TRABALHO SOBRE GERENCIAMENTO DE RISCO E SEGUR

Sao Paulo - SP, Brazil Nov. 5 7, 2007

Risk Management in Healthcare


Frank R. Painter, MS, CCE
Clinical Engineering Internship Program Director University of Connecticut Healthcare Technology Consultant

Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

ACCE

American College of Clinical Engineering Professional society of Clinical Engineers

Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Risk Versus Safety


Safety & Risk; opposite sides of the same coin

If risk goes up, safety goes down If risk goes down, safety goes up Everyone likes safety; no one likes risk
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Risk Versus Safety

Risk management identifies risks, analyzes risk data and mitigates risk Safety programs manage that risk through education, maintenance, design, and personal protective equipment
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Understanding Safety

Safety = The level of risk you are willing to accept Safety is freedom from danger, risk or injury Safety is subjective
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Understanding Risk

Risk is the possibility of suffering harm or loss Probability of an event Severity of an event Risk = Probability x Severity Risk is measured in numbers
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Generally acceptable Acceptable considering the benefit S e v e r i t y

Risk Acceptance

Probability
Generally unacceptable
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Managing Risk

Reduce the severity

Reduce the probability

Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Healthcare Risks

Medication Errors Wrong Site Surgery Hospital Acquired Infections Managing Multiple Alarms Patient Restraints Electromagnetic Interference Patient Falls Surgical & ICU Fires Electrosurgical Burns
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Managing Risk
ASSESS RISK
identify, name and categorize risks

ANALYZE
estimate the likelihood and loss of each outcome, under all alternative choices or decisions

MONITOR
monitor risk prevention activities and modify as needed

EVALUATE
compute risk exposures and determine which risks pose the greatest threat, and how they might be averted

CONTROL
take actions to avoid/minimize risks

PLAN ACTION
avoid/minimize risks

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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Unusual Conditions in Hospitals Increase Risk


Functions 24 x 7 Multiple functions; patient care, cafeteria, clinical lab, laundry, etc Hospital equipment varied and complex Hazards affect healthy staff as well as severely ill & immobile patients Hazards mean fires, infections, security issues, chemicals and the like Hazards vary with equipment and applications Hazards constantly changing
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Integrated Safety (Tobey Clark) Program

Patient Safety
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Employee Safety

Risk Management

Environmental Safety

Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Hospital Risk Management Programs

One component of an overall quality control program Historically, treated as separate process Recently integrated into quality assurance and patient safety activities Risk managers, safety officers, quality assurance, & patient safety All integrated at some level
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Hospital Risk Management


(continued)

Risk is an exposure to the chance of injury or financial loss Risk Managers reduce liability & costs by managing risks Accident data analysis Constant systems improvements to reduce risk
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Risk Management

Insurance policies
Malpractice Liability Errors & Omissions

Claims management Risk reduction strategies Incident investigation


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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Risk Management Tools


Administrative support Hazard identification Hazard evaluation Training Controls Communications Record keeping Program review & improvement Total involvement
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

JCAHO

Environment of Care Standards


Safety Management Security Management Hazardous Materials & Waste Management Emergency Management Life Safety (Fire Safety) Management Medical Equipment Management Utility Systems Management Safety Committee & Safety Officer
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

JCAHO

Patient Safety Standards


Annual FMEA (Failure Mode and Effect Analysis) Sentinel Events RCA (Root Cause Analysis) National Patient Safety Goals
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Clinical Engineers as Risk Managers

By definition, clinical engineers apply engineering and managerial skills to the advancement of health care. Engineering education
Scientific method (cause and effect) Analysis of systems and processes (identify root causes)
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Clinical Engineers as Risk Managers

Knowledge:
How technology works How hospitals work How the human body works How the human mind works How to investigate an accident How to work with people How to write technical reports
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Engineering & Risk Reduction

Contributions to risk reduction and patient safety:


Medical equipment planning Medical equipment inspection Medical equipment maintenance Training medical equipment users

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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Engineering & Risk Reduction


Management of recalls & hazard alerts Analysis of maintenance records Review of near miss events Incident investigation User Training Quality Improvement
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Systems Approach to Reducing Medical Device Risk


Assure safety of systems & processes Modify systems & processes as recommended by the team Investigate failures
Identify root causes Modify the systems to prevent future failures Benefit from past failures
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Manufacturers

Know their devices Use FMEA in design Use human factors engineering and usability testing in design Keep a complaint file Listen to feedback and improve the design
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Healthcare Workers

Device training
How it works What can go wrong What happens when it goes wrong

Report problems without fear of punishment or ridicule. Competency assessment


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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Patients and Family


Device Training

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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Clinical Engineers

Device Training Service and inspection Investigate problems Provide feedback to healthcare workers Advise administration

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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Administration

Know devices in general


Costs, risks, supplies, maintenance

Support training and improvement Support non-punitive problem reporting Provide record keeping Share information Have a plan
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Government

Regulate medical device quality Create systems to share information Facilitate open communications Publicize trends Encourage quality healthcare systems Acknowledge good performance

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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Risk Management Summary

Safety must begin at the top---Ministry of Health, Local Health Authorities , and hospital administrators---but must be implemented by motivated staff members Risk management must be fully integrated into our health care culture, systems and processes
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

Risk Management Summary (continued)

Investigation of accidents, incidents and near hits can provide information that will allow improvements in systems and processes Clinical Engineers are valuable team members
Educated, trained and experienced in accident investigation, they can provide the identification of the root causes of failed systems
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Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007

perguntas

&

comentrios
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