1. An Attorney’s Perspective: Prevention of Wrong Site Surgery Troy R. Rackham, Attorney At Law

2. Troy R. Rackham

3. Disclosure Information AORN’s policy is that the subject matter experts for this product must disclose any financial relationship in a company providing grant funds and/or a company whose product(s) may be discussed or used during the educational activity. Financial disclosure will include the name of the company and/or product and the type of financial relationship, and includes relationships that are in place at the time of the activity or were in place in the 12 months preceding the activity. Disclosures for this activity are indicated according to the following numeric categories: 1. Consultant/Speaker’s Bureau: 2. Employee 3. Stockholder 4. Product Designer 5. Grant/Research Support : 6. Other relationship: 7. Has no financial interest : None Speaker: Troy R. Rackham, JD Discloses no conflict Planning Committee: Ellice Mellinger MS, BSN, RN, CNOR Discloses no conflict

4. Objectives 1. Discuss communications skills to avoid wrong side – wrong site injuries 2. Describe ways in which wrong side – wrong site injuries present themselves legally 3. Identify ways that wrong side – wrong site surgeries can present licensing and other complications

5. Stories

6. Case Study # 1 A 65-year-old woman was admitted to the day-surgery unit at this hospital for release of a trigger finger of the left ring finger. - Approximately 3 months earlier, the patient was seen in the orthopedic clinic at this hospital because of pain and stiffness in the ring finger of the left hand. - She reported that the finger intermittently “got stuck” in flexion. - History of coronary-artery and carotid-artery atherosclerosis, hypertension, diabetes mellitus, hyperlipidemia, and hypothyroidism. - Past surgical history included a cholecystectomy. - Medications included nitroglycerin and nitrate preparations, metformin, levothyroxine, simvastatin, acetylsalicylic acid, and vitamins. - She had no known allergies. She spoke only Spanish.

7. Case Study # 1 On examination, there was tenderness in the palm at the base of the left ring finger over the A1 pulley of the flexor tendon sheath and a slight flexion contracture of the proximal interphalangeal joint of the left ring finger. There was snapping of the left ring finger with flexion and extension. Motor and sensory function and tendon balance were normal, and there was no angular or rotational deformity. A diagnosis of idiopathic trigger finger (stenosing tenosynovitis) was made. Conservative treatments failed. The risks, benefits, limitations, and alternatives of operative and nonoperative treatment were discussed. The patient decided to proceed with surgery. Ten days later, the patient was admitted to the day-surgery unit, and carpal- tunnel-release surgery was performed without complications. Immediately after completing the procedure, the surgeon realized that he had performed the incorrect operation.

8. Case Study # 1 What happened? Surgeon performed a carpal-tunnel release on the patient, rather than a trigger-finger release Multifactoral: - Stress on the day-surgery unit was high because several other surgeons were behind schedule. - Multiple patients with similar procedures - Decision made to move this patient to a different room - Difficult experience with a previous patient earlier that day - There was no tourniquet, so the circulating nurse had to leave the room to get one, which distracted her from the patient and made her fall behind on her documentation. - Skin antisepsis caused the marking to be wiped off the limb - No formal time-out took place before the procedure was begun - There was a change in the nursing team in the middle of the procedure

9. Data Regarding Wrong-Site and Wrong-Side Errors and Root Causes for those Errors

10. Is there a problem with WSS?

11. “Never Events” Wrong-site surgery is included in the list of adverse events, also known as never events (i.e., hospital-acquired conditions), originally described by the National Quality Forum and later adopted by Medicare. Wrong-site surgery is a never event that is non- reimbursable

12. Sentinel Events A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase, "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response. The Joint Commission reviews organizations' activities in response to sentinel events in its accreditation process.

13. Sentinel Events

14. Where are these events happening?

15. Sentinel Events Injuries from these events

16. Wrong Site Summits In 2003, The Joint Commission, AAOS, American College of Surgeons, and other organizations held a summon on wrong-site surgeries. Another summit was held in 2007. Recommend the Universal Protocol

17. Universal Protocol Conduct a pre-procedure verification process Mark the procedure site before the procedure is performed Perform a time out

18. To Err is Human Why do these errors occur? - Communication gaps - Breakdowns in skill-based behavior - Breakdowns in rule-based behavior - Breakdowns in knowledge-based behavior - Sometimes a mixture

19. Reasons for Errors Why do these errors occur? - Human factors - Communication gaps - Failures in leadership - Failures in skill-based behavior - Breakdowns in knowledge-based behavior - Often a mixture of each of these

20. Definition of Root Causes Human Factors Staffing levels, staffing skill mix, staff orientation, in- service education, competency assessment, staff supervision, resident supervision, medical staff credentialing/privileging, medical staff peer review, other (e.g., rushing, fatigue, distraction, complacency, bias) Communication Oral, written, electronic, among staff, with/among physicians, with administration, with patient or family

21. Definition of Root Causes Leadership Organizational planning, organizational culture, community relations, service availability, priority setting, resource allocation, complaint resolution, leadership collaboration, standardization (e.g., clinical practice guidelines), directing department/services, integration of services, inadequate policies and procedures, non-compliance with policies and procedures, performance improvement, medical staff organization, nursing leadership

22. Definition of Root Causes Operative care Operative care planning, blood use, and/or patient monitoring Information Management Confidentiality, security of information, data definitions, availability of information, technical systems, patient identification, medical records Assessment Adequacy, timing, or scope of; assessment; pediatric, psychiatric, alcohol/drug, and/or abuse/neglect assessments; patient observation; clinical laboratory testing; care decisions

23. Most Frequently Identified Root Causes of Sentinel Events Reviewed by JCAHO

24. Root Cause for Operative/ Post-Operative Events Reviewed by Joint Commission

25. Root Causes for Retained Foreign Objects

26. Root Causes for Wrong-Site, Wrong- Side, Wrong-Procedure

27. Legal Perspective on these Errors

28. Nursing Malpractice Patient Must Establish Four Elements to Prove Medical Negligence 1. Duty (also known as Standard of Care) 2. Breach 3. Causation 4. Damages

29. Duty Duty of the nurse is to provide the level of care required of other similarly situated professional in the same or similar field Requires expert testimony Reasonable skill and care Universal Protocol and other standards usually guide the duty Hospital’s or organization’s policies, procedures also can establish the standard

30. Res Ipsa Loquitur “The Thing Speaks for Itself” Basically a Presumption of Negligence. Required elements: - (1) Injury does not happen without someone’s negligence; - (2) Exclusive control of person or thing causing injury; and - (3) Patient did not voluntarily act or contribute to injury

31. Causation Causation in Fact Substantial Factor “More Likely than Not” that injury was caused by Health Care Provider Provider’s actions do not have to be sole cause Legal Causation — Foreseeability Expert Testimony Usually Necessary

32. Damages Present Economic Damages Medical and other health care expenses Lost earnings in the past Lost time Rehabilitation expenses Other economic losses

33. Damages Future Economic Damages Medical and other health care expenses Life care expenses Permanent injury/ scarring Lost earning capacity Other economic losses in the future

34. Damages Non-economic damages Damages for pain and suffering Loss of enjoyment of life Hedonic damages

35. Professional Discipline

36. In most states, a licensed nurse may be disciplined if: – he “[h]as willfully or negligently acted in a manner inconsistent with the health or safety of persons under his care” – he “[h]as negligently or willfully practiced nursing in a manner which fails to meet generally accepted standards for such nursing practice” – he “[h]as violated the confidentiality of information or knowledge as prescribed by law concerning any patient” Discipline could range from letter of admonition, to financial sanction, to loss of license

37. Techniques for Avoiding Legal Risks With Wrong Side/Wrong Site/ Wrong Procedure Errors

38. Techniques Robust communication among the entire surgical team Strong leadership invested in a culture of safety Avoid distractions Follow Universal Protocol Ensure consistency of staff Stick to the routine Analyze all contributing factors

39. Disclosure When learn of an error, disclose it to patient Disclose what will be done to mitigate against the risk in the future Report events to hospital or organization Follow the quality management protocol Have a system in place to compensate patient for out of pocket expenses Have a system in place for disclosure Properly disclosing an error requires training and experience Should involve the whole care team

40. The end