Why Patient Safety?

Making New Jersey a Model for Patient Safety Patient Safety History and Reporting: An Overview August 19, 2003 Princeton, NJ

Martin Hatlie, Esq. President p4ps (www.p4ps.org) Hatlie

 5−2001

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Advancing Patient Safety: Three Fronts of Engagement The Challenges… “Transforming the Internal Environment

’Growing Internal Cultures that Honor Safety & Deliver High Reliability Care

“Transforming the External Environment

’Fostering a New Understanding of Accountability

“More Effectively Managing Knowledge

“Capturing Information & Converting it to Practical Tools

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Why Patient Safety? Why now?

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The IOM Numbers — Medical failure is a public health problem (4th to 8th largest cause of preventable death) — Medical failure is a systems problem. — One percent of hospital patients experience an error

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Advancing Patient Safety: A Snapshot History “ “ “ “ “

Libby Zion Case (Sleep-deprived residents)(1984) Lucian Leape’s “Error in Medicine” article, JAMA (1990) Willie King (“wrong” foot amputated) (1995) Betsy Lehman Case (Dana Farber overdose) (1995-96) Ben Kolb Case (mix-up of meds in the OR) (1995)

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JCAHO Sentinel Event Initiative launched (1996) National Patient Safety Foundation established(1997) IOM Report (To Err is Human) (1999), followed by others… AHRQ support for Patient Safety ($50 million/year since 2000)

“ Linkage to quality, nursing shortage, tort reform, “gag clause” & physician discipline issues (all on the bubble right now…) “ Josie King case (Infant death at Johns Hopkins) (2002) “ Linda McDougal case (Minnesota double mastectomy) (2002) “ Jessica Santillan case (Transplant error at Duke) (2003) Hatlie

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What’s Driving Patient Safety? Progress and Complexity...

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The Patient Safety Paradox We have… ¾New Technological “Miracles” Pushing Health Care Forward ¾Ability to Treat Ever Sicker Populations

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The Patient Safety Paradox But we also have… ¾Increased Process Complexity ¾Escalating Change ¾Information Overload ¾Increased Expectations for Perfect Outcomes ¾New Patient Acuities = New Patient Vulnerabilities

…All of which raise the bar Hatlie

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Another way to look at it... What’s frustrating patient safety?

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The “Old Look” Paradigm ¾ Clinicians are Supposed to be Infallible ¾ Bad Things Happen Only when People Make Mistakes ¾ People/Organizations that Fail are Bad ¾ Blame & Punishment Sufficiently Motivate Carefulness Hatlie

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The “New Look” from Safety Science ¾ Risk of Failure is Inherent in Complex Systems ¾ Risk is always Emerging ¾ Latent Risk is not Foreseeable ¾ People are Fallible…No Matter How Hard They Try Not to Be ¾ Systems are Fallible ¾ Alert, Well-trained Clinicians are Crucial Hatlie

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What is Safety Science? Where Does it Come from?

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Where Does Safety Science Come From ?? ¾ Health Care Research ¾ Systems Analysis, Engineering & Design ¾ Cognitive Psychology ¾ Human Factors/Ergonomics ¾ Sociology & Organizational Behavior ¾ Lessons Learned from other Industries ¾ Quality Improvement ¾ Complexity Theory Hatlie

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Safety as Core Value = PATIENT CENTERED FOCUS Risk Management

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What have we Learned from Safety Science’s New Look?

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The New Look “Rather than being the main instigators of an accident, operators tend to be the inheritors of systems defects…Their part is that of adding the final garnish to a lethal brew whose ingredients have long been in the cooking.” …James Reason, Human Error Cambridge University Press, 1990 Hatlie

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What Have We Learned from Safety Science? ™Systems never run perfectly – they are prone to failure and degradation ™Reliance on vigilance and memory are insufficient to produce reliably good outcomes ™Errors are rarely due to single “bad apple” ™Simplification and Standardization = Very Important Tools ™Errors are inevitable, but prompt “recovery” can greatly reduce adverse events Hatlie

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What is a Safety Culture? How do we build one?

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What is a Safety Culture? How Do We Build One? ¾ Problem - No Precedents in Health Care ¾ Solution? Look at High Reliability Service Organizations ( HRO ) in other industries ¾ HRO’s are engineered to deliver consistently Good Outcomes in Complex & Dynamic Environments Hatlie

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Where Is Safety Science Being Applied ? Other industries: ¾NASA ¾Aviation ¾Nuclear power ¾Military ¾Banking

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How Did Other Industries Achieve High Reliability? HRO Key Attributes… “ “ “ “ “ Hatlie

Honors Safety as a Core Value Reporting Cultures Flexibility in Operation Perceived to be Just Engaged in and dedicated to

Continuous Learning

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Activities of High Reliability Organizations ™Acknowledgement of the Inherent Riskiness of the work ™Leadership, starting with establishing safety = core value ™Auditing and Feedback (i.e. Reporting) ™Process Control ™Appropriate Rewards for Moving Beyond Blame Hatlie

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What are the Roles of Reporting Systems in Advancing Safety? Is Commercial Aviation a Model?

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Auditing Risk In Commercial Aviation ™Accident Investigation o National Transportation Safety Board

™“Close Call” Analysis o Aviation Safety Reporting System

™Reporting/Observation/Inspection o FAA & Corporate Programs

™Simulation Training to grow expertise Hatlie

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Aviation Safety Reporting System (ASRS) ¾ Type A o Death or Damage > $1Million ¾ Type B o Permanent Disability or Damage > $250k ¾ Type C o Lost Time or Damage >$25k ¾ Incidents o Medical Treatment or Damage >$1,000 ¾ Close Calls o “Almost” a Bad Outcome Hatlie

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“The Mishap Diamond”

Weak Risk Auditing Model ¾ A = Death ¾ B = Serious Injury ¾ C = Lost Time ¾ Injury ¾ Incidents ¾ Close Calls

A B C Incidents Close Calls

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The “Mishap Pyramid” Strong Program Model ¾ A = Death ¾ B = Serious Injury ¾ C = Lost Time Injury ¾ Incidents ¾ Close Calls

A B C Incidents Close Calls

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Mandatory vs. Voluntary Reporting… What’s Better?

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Mandatory vs. Voluntary Reporting Voluntary programs are never the whole answer, but they can… ¾ Be an effective early warning system for emerging risk ¾ Produce info on risk that mandatory systems won’t ¾ Serve as an important culture carrier

But don’t… ¾ Park them with the regulator ¾ Under-resource them ¾ Roll them out without public buy-in Hatlie

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Mandatory vs. Voluntary Reporting Mandatory programs can… ¾Establish a baseline for measurement ¾Increase public confidence ¾Help identify research/policy/spending priorities ¾Identify unsafe environments

…But the problem is compliance Hatlie

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Mandatory vs. Voluntary Reporting Mandatory programs fail because of… ¾Fear of punishment ¾Fear of embarrassment ¾Administrative burden, including inconsistency among different reporting systems ¾Lack of feedback to reporters

…All of which must be addressed. Hatlie

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Mandatory vs. Voluntary Reporting Mandatory reporting can be encouraged by… ¾ Auditing adverse events as opposed to errors ¾ Integrating reporting programs to minimize burden ¾ Feeding back ¾ Aligning public policy with the “New Look”

…Massachusetts and Minnesota are the States to watch right now. Hatlie

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How Do We Achieve Alignment with the “New Look” in the External Environment?

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Growing a Safety Culture: The Stakeholders

¾ Consumers ¾ The Clinician/Patient/Family Team ¾ Health Care Administrators including middle, executive & governance layers ¾ Makers & Purchasers of Medical Products ¾ Clinician, Administrative & Patient Educators ¾ Employers, Payors & Managed Care Orgs ¾ Legislators/Regulators/Lawyers ¾ Media ¾ Medical Liability Insurers Hatlie

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Sharp and Blunt Ends Organizations, Institutions, Policies, Procedures Regulations Resources and Constraints Practitioner Knowledge

Goals

Focus of Attention

Errors and Expertise Monitored Process Modified from Woods, et al., 1994

Sharp and Blunt Ends Media, Legislators,Regulators, Lawyers, Accreditors, Educators Employers/Payors & Product Makers Resources and Constraints Health Care Organizations Administrators

Pr. Buyers

Clinicians, Families, Patients

Sharp End Consumers Modified from Woods, et al., 1994

Growing A Safety Culture: Government Roles ¾ Promoting Awareness about Inherent Risk & Systems Thinking ¾ Educating Policymakers about the “New Look” ¾ Consolidating/Integrating Reporting Programs ¾ Feeding Back Lessons Learned from Reported Events ¾ Maintaining the Spotlight to Discourage Complacency

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Advancing Patient Safety: Is the Media Helping or Hurting? ¾ IOM Report, To Err is Human (November 1999) ¾ Boston Globe’s Coverage of Betsy Lehman Case (1995 to present) ¾ Sporadic Coverage of Ben Kolb Case (1995 to present) ¾ Chicago Tribune Series on Nurses (Summer 2000) ¾ Children’s Hospitals of the Twin Cities Marketing and Culture Carrying Strategies ¾ Johns Hopkins & Duke Medical Center Stories (2002/03) ¾ Adverse Events and Tort Reform

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What Can We Do to Make Reporting Systems Work? A Lesson from Aviation: “One reason that an incident reporting system worked in aviation...was that the entire aviation community -- essentially all of the stakeholders, including air passengers -were involved in the process from the beginning and became advocates for the reporting system (as well as severe, but constructive, critics).” …Charles E. Billings, MD, Editorial Arch Pathol Lab Med 1998,121:214-215

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