When Policy and Practice Do Not Match…

Janice J. Thalman, MHS,FAARC, RRTDirector, Respiratory CareDuke University Hospital

Outline

Why do we need Conventional Practice– By the Book

Why do we need Non-Conventional Practice– There is no Book

Why must we Manage a Clinical Culture that enables Both?– Writing the Book

Why Conventional?To Err is Human

Preventable Medical Errors Remains the #1 cause of death in America.– Wrong site, wrong drug, wrong gas, wrong

patient One Medical Error Occurs Per Day; Per

Patient 50-50 Chance of Receiving Care that is

Evidence-Based Human error is the downside of having

a brain

To Err is Human

Einstein: “It is difficult to make things fool proof because fools are so damn ingenious. Machines and automated systems are very good at repeatability and reproducibility. Humans get easily bored doing repetitive tasks so frequently, machines and automated systems are used to control repetitive processes… when people are given control over a process, they are likely to experiment;

turning knobs and adjusting things to see

what happens.

Human Behaviors

– Human error: inadvertent action... slip, drift, lapse, mistake, should have done something else

– At -Risk Behavior: Failure to recognize a risk

– Reckless Behavior: choice to consciously disregard a significant risk.

– Knowing violations: Intentionally violates a rule

Why Conventional?Patient Rights 1997 Clinton’s Advisory Commission

on Consumer Protection and Quality in the Health Care Industry

– “Advise on changes in Healthcare and recommend measures necessary to promote and assure value and protection for consumers and workers in the healthcare system…”

Why Conventional? Patient Rights

Information Disclosure Informed Consent EMATALA ( Emergency Medical

Treatment and Active Labor Act ) Participation in Treatment

Decisions

Why Conventional? …Patients Rights

Advanced Directives Protection from Harm-

Safeguards Provider Non-Discrimination Right to Punitive Damages

Why Conventional?Patient Trust The Sick are Emotionally,

Physically and Spiritually Vulnerable

Imbalance of Knowledge and Power

Patients Grant Substantial Power and Discretion Over to Clinicians

Basic Ethical Rules– Do unto others– Do no harm

Why Conventional? Provider Rights To Make Ethical Decisions To NOT Participate in Care

Interventions– If morally repugnant, religiously

prohibited or ethically improper To Refuse to Carry Out an Order

– With valid ethical concerns

Why Conventional? Provider Rights

To Advocate on Behalf of Patients To Take Actions for the Protection

of Your License

Why Conventional? Employer Rights

To Control the workplace To establish rules To Mandate Employment

Agreements To Assure Safety

Why Conventional? Employer Liabilities

1. To Prevent Medical Error

“Should have been appropriate intention to act in a correct fashion,

However, the action taken ( or lack of action taken) is incorrect or improper”

Why Conventional? Employer Liabilities

2. To Perform Within Standards of Care

Deviation from accepted/community recognized standard of care.

** Standard of care can be set nationally or locally or by a plaintiff’s expert

Why Conventional? Employer Liabilities

3. To Assure SoundProfessional Judgment

Best judgment, skill and learning are used to make a clinical path decisions

Care is appropriate to the average member of the practicing profession

Treatment courses taken are ‘equally acceptable approaches’ ”

Why Conventional?Employer Liability

4. To Uphold Just Cause

– The Duty to avoid causing unjustified risk or harm;

– The Duty to produce an outcome – The Duty to follow procedural rule

Case #1The Krazy Kroger Kaper

Case Study #1

EMT, Fred, hired to transport pediatric patients requiring supplemental oxygen

Fred has noted to his supervisor in the past that he has difficulty finding isolates and transport equipment.

Fred’s performance exceeds expectation; he owns his job

RT director receives call from Hospital President “ a member of the RT staff is pushing a baby through the main lobby of the Hospital in a Kroger shopping cart”

Case Study #1

Upon closer examination; the Kroger shopping cart is padded with blankets from the nursery linen cart

An oxygen E –cylinder is secured to shopping cart’s upper rack with IV bands

The infant appears to be happy and snuggly and arriving on-time to radiology.

#1 Why Conventional?Employer LiabilityControl workplace, assure safety, set rules Was the clinical decision one that a

reasonable person would have made? Was this an acceptable standard of

care? Did we employ “ safeguards” for the

patient? Was this ethically appropriate? Does this employee need a straight

jacket or a promotion? Did the local Kroger’s get their cart

back? Why did it occur?

Conventional…Internal Controls;Why Policies ? To Replace Clinical Autonomy with Clinical Practice that can be Monitored

To Provide a framework for orientation and training

To Organize the flow of the work To Safeguard assets To Promote operational efficiency; clarity To Encourage adherence to desired

managerial behaviors

ConventionalInternal controls… Policy Reality

For the Benefit of Auditors and Regulators

Obstacles of Bureaucracy (Require approval at various levels )

Provide a false sense of security Have too many Or Not Written at all Usually out of date Usually contradictory to practice

Why Non-Conventional?

Rules of clinical engagement take place at the bedside

Micromanagement by policy in health care is not an effective

way to practice medicine

Why Non-Conventional?

The 21st century test of a successful organization is how wisely and quickly it can adjust to important, new possibilities and directions

Inventory can be controlled; people must be led and

developed to adjust to the possibilities

Why Non-Conventional?Medicine is Complex

Surprises Discovery Uncertainty

Incomplete info Multidisciplinary Multitasking

Why Non-Conventional?

You can NOT forecast future

External mandates are numerous and continually in motion

Transition from discovery to a better clinical alternative is very, very slow

Non-Conventional to Conventional

Health Care Transition : Evidence Based Medicine Originates for an individual perspective Researches effects of rigorous criteria Obtains “ best available” evidence Provides efficient interventions Clinical Practice Guidelines Based on evidence and expert opinion Assists health providers in clinical decision making Improves professional practices and system efficiency.

In Between Time

Develop the internal ability to adjust to unpredictability

– Flexibility– Reaction speed – Ability for fast reversal of prior

decisions and policies– Individual accountability

Non-Conventional Operations

Develop Thinkers

Clinical thinking Safety thinking Legal thinking Financial thinking Consequence thinking Future Thinkers

Health Care Thinking Steps Benefits of the action Risks of the action

– Systematic examination– Technology; resources; socio-

economics Alternatives to the prospective

action Decision has everyone at the

table Documentation of details and

results

# 2 Case: The Trach-o-matic Right Pneumonectomy Right stump rupture with air leak into

the chest cavity Patient is trached and ventilator

dependent Goal is to ventilate the left lower lobe

and Keep CO2 < 70 Challenge…securing the ET tube in a

precise position

Trach-o-matic

Trach-o-matic #2

Trach-o-matic #3

Trach-o-matic 4

Trach-o-matic

The trach-o-matic was placed just below the carina in the left main stem

The cuff was deflated – inflation caused the tube to move ever so slightly out of position

The trach-o-matic was sutured in place

Trach-o-matic

BENEFIT – RISK Was there a deviation from accepted

standards? Was there intention to act correctly? Was professional judgment assured? Were safeguards put in place? Is the Employer liable for any

negligence or omissions by the employee?

Trach-o-matic

Where We Fell Short Health Care Thinking

– Dangerous situation or condition– Fragile

Altered deviceProduct liability– Product defects– Product used correctly– Product function verified

Cost – Provider time; unanticipated labor demand

Big BooBoo– Communication– Documentation

When to Seek Higher Ground…. When customary clinical chain of

command should not shoulder the accountability

To help establish the risk: benefit ratio

When medical safety is blatant

Case # 3Under Pressure

Monaghan 225 SIMV

Added Gas Collection Reservoir

Added One-way Valve for

Ambient Air

Added O2 Sampling Line

Under Pressure

Avoidance of risk or harm Best clinical decision; Professional

judgment Deviation from standards Altered Device

Under Pressure

Was no device on the market Anesthesiologist, Clinical

Engineering, RT Director, Chamber Experts

Bench Testing Diagram and Operations Manual Comprehensive Educational

Program Abstract

Creating The Culture

Factors Affecting Human Reliability

– Information– Tools– Tasks– Skills– Individuals– Environment– Supervision– Communications– Systems

Legal Gauge MD and Hospital Directors

– Establish policy for Compliance to Guidelines

– Establish policy for Deviation from Guidelines

– Establish medial record documentation requirements.

Protocol for the Un-Done

An organized approach to the assessment of an event at hand– Immediate actions to take– Communication channels– Going forward; competencies– Documentation requirements

Red Rules–A short list of Non-Negotiables

Just Culture

What to do when an employee makes a mistake or otherwise acts inconsistently with corporate policy, procedure or values.

Just Culture

Moving away from judgment of an occurrence

Moving towards evaluation of an occurrence

Designing a system and manage behaviors that will prevent errors

Just Culture

4 concepts 1. Create a Learning culture Lessons Learned

– Must be at local frontline– Support for advancing knowledge– Looking for best outcomes– Recognizes and prepares for risk

…concepts

2. Create an open culture– Balance of system and individual

accountability to support learning and safety

Concepts….

3. Design a safe system– Anticipate non-conventional

approaches– Template that facilities good

decisions– Template that facilities rules for

delivery

Concepts….

4. Manage behavioral choices– Reliable behavior– “safety critical” thinking– Known Organizational values:

Safety ( Always first ) Privacy Dignity Cost control

Conclusion

Why Conventional– Safety and Protection– The Law

Why Non-Conventional– Medicine and Discovery– Info Speed

Managing Both– Culture of Thinkers

Disclaimer

“The events and situations described in the proceeding presentation are a dramatization performed by paid actors and actresses.”

“Any resemblance to the actual place that I work is purely coincidental”