When Policy and Practice Do Not Match…

1. When Policy and Practice Do Not Match… Janice J. Thalman, MHS,FAARC, RRT Director, Respiratory Care Duke University Hospital

2. 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

3. 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

4. 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.

5. 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

6. 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…”

7. Why Conventional? Patient Rights • Information Disclosure • Informed Consent • EMATALA ( Emergency Medical Treatment and Active Labor Act ) • Participation in Treatment Decisions

8. Why Conventional? …Patients Rights • Advanced Directives • Protection from Harm- Safeguards • Provider Non-Discrimination • Right to Punitive Damages

9. 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

10. 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

11. Why Conventional? Provider Rights • To Advocate on Behalf of Patients • To Take Actions for the Protection of Your License

12. Why Conventional? Employer Rights • To Control the workplace • To establish rules • To Mandate Employment Agreements • To Assure Safety

13. 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”

14. 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

15. Why Conventional? Employer Liabilities 3. To Assure Sound Professional 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’ ”

16. 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

17. Case #1The Krazy Kroger Kaper

18. 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”

19. 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.

20. #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?

21. 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

22. 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

23. 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

24. 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

25. Why Non-Conventional?Medicine is Complex • Surprises • Discovery • Uncertainty • Incomplete info • Multidisciplinary • Multitasking

26. 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

27. Non-Conventionalto 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.

28. 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

29. Non-Conventional Operations Develop Thinkers • Clinical thinking • Safety thinking • Legal thinking • Financial thinking • Consequence thinking • Future Thinkers

30. 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

31. # 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

32. Trach-o-matic

33. Trach-o-matic #2

34. Trach-o-matic #3

35. Trach-o-matic 4

36. 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

37. 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?

38. Trach-o-matic Where We Fell Short • Health Care Thinking • Dangerous situation or condition • Fragile • Altered device Product liability • Product defects • Product used correctly • Product function verified • Cost • Provider time; unanticipated labor demand • Big BooBoo • Communication • Documentation

39. 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

40. Case # 3Under Pressure

42. Monaghan 225 SIMV Added O2 Sampling Line Added One-way Valve for Ambient Air Added Gas Collection Reservoir

43. Under Pressure • Avoidance of risk or harm • Best clinical decision; Professional judgment • Deviation from standards • Altered Device

44. 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

45. Creating The Culture

46. Factors Affecting Human Reliability • Information • Tools • Tasks • Skills • Individuals • Environment • Supervision • Communications • Systems

47. Legal Gauge • MD and Hospital Directors • Establish policy for Compliance to Guidelines • Establish policy for Deviation from Guidelines • Establish medial record documentation requirements.

48. 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 Protocol for the Un-Done

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

50. 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