The Criminalization of Adverse Events. Joy Schank, MSN Caroline E. Fife, MD,

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1 The Criminalization of Adverse Events Joy Schank, MSN Caroline E. Fife, MD,

2 Patient wanted to die at home and niece agreed to care for her Advanced Alzheimer s Called 911 Cause of death: Sepsis due to infected decubitus ulcers/physical neglect 2 No blood cultures WBC normal Photos - no signs of sepsis

3 DA prosecuted patient for neglect 3 year prison sentence (23 year max was possible) 7 year s probation Kristine was 42 years old 3 year prison sentence (23 year max was possible) 7 year s probation She was handcuffed after trial no chance to see her 4 children youngest 4 3

4 Article - Kennedy Terminal Ulcer Google search

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6

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8 Aunt essentially homeless Escaped from nursing home Advanced Alzheimer s Pulled out PEG left out Praise from home health Deemed hospice candidate Family physician Developed pneumonia

9 Felony charges 2-10 years Up to $100,000 fine 2 trials

10 Plea deal offered to one Plead guilty Testify against other No time but $10,000 fine

11 Night before 2 nd trial Offered plead guilty No time $10,000 fine Family said take deal

12 Dr. Anna Pou Cancer Surgeon LSU School of Medicine 34 patients died at Memorial Medical center died during storm

13 Allegations of euthanasia Louisiana AG requested 1 count of second degree murder 9 counts of murder conspiracy Grand Jury failed to indict

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15 Crime: Involuntary Manslaughter Commission of lawful act with criminal negligence Failure to perform legal duty with criminal negligence Sentenced to 4 years imprisonment 15

16 Prosecutors argued Dr. Murray veered significantly from acceptable medical practice: 16 administering the propofol not having proper monitoring equipment failing to call 911 right away not keeping records of administering propofol

17 Los Angeles County district attorney said that he hoped the trial would send a message to other unscrupulous, corrupt doctors who help fuel patients reliance on powerful drugs. To the extent that someone dies as a result of their playing the role of Dr. Feelgood, they will be held accountable. 17

18 Criminalization of clinical care Primarily state law driven Primarily focused on elder care & LTC Criminalization of nonclinical activities Primarily federal in nature Part of criminalization trend 18

19 Legal Standard #1: A crime is committed when A person acts in a reckless way that creates a high risk of death or great bodily injury; and A reasonable person would have known that acting in that way would create such a risk. Legal Standard #2: A crime is committed when: A person acts, and from his or her standpoint the act or at the time of its occurrence involves an extreme degree of risk considering the probability and magnitude of the potential harm to others; and The person has actual subjective awareness of the risk involved but never theless proceeds with consciences indifference to the rights, safety or welfare of others. 19

20 Legal Standard #1: Nevada Definition of Criminal Negligence A person acts in a reckless way that creates a high risk of death or great bodily injury; and A reasonable person would have known that acting in that way would create such a risk. Legal Standard #2: Texas Definition of Civil Gross Negligence A person acts, and from his or her standpoint the act or at the time of its occurrence involves an extreme degree of risk considering the probability and magnitude of the potential harm to others; and The person has actual subjective awareness of the risk involved but never theless proceeds with consciences indifference to the rights, safety or welfare of others. 20

21 Typical approach focused on: Abuse Neglect Mistreatment 21

22 22 Homicide by Bed Sores

23 23 Most pressure sores are preventable and are caused by faulty care

24 24 Pressure sores are entirely preventable

25 Hawaiian nursing home operator convicted of manslaughter after resident dies of infection caused by pressure ulcers With the introduction of criminal prosecution for gross neglect, a new weapon against poor nursing care has appeared.

26 Are Pressure ulcers Never Events?

27 Pressure ulcers are found under Subpart (F)(b) "Hospital Acquired Conditions" Subpart (F)(c) "Serious Preventable Events section begins AFTER pressure ulcers are discussed (SPEs are the Never Events )

28 1. Leaving an object in the patient 2. Performing the wrong surgery (wrong body part, wrong patient, wrong procedure) 3. Air embolism following surgery 4. Incompatible blood products

29 "We acknowledge the commentators' concern that some pressure ulcers are unavoidable. However, we believe improved screening to identify pressure ulcers upon admission will increase the quality of care." Pressure ulcers are only identified as: high volume and high cost conditions. All CMS really says about Pressure Ulcers are: Pressure ulcers are an important hospital-acquired complication. Prevention guidelines exist and can be implemented by hospitals.

30 Pressure ulcers are NOT never events as far as CMS is concerned. CMS considers them reasonably preventable hospital acquired conditions Why do we need to fight the misconception of pressure ulcers as never events?

31 31

32 NQF s list of serious reportable events includes both injuries caused by care management (rather than the underlying disease) and errors that occur from failure to follow standard care or institutional practices and policies. Care Management Events Stage 3 or 4 pressure ulcers acquired after admission to a healthcare facility 32

33 Strict liability is a well established concept in products liability law and certain areas of criminal law. It essentially means "liability without fault". If strict liability applies in connection with an event, you are liable, even if you acted reasonably or in an exemplary fashion (e.g. sex with a minor even if you did not know they were a minor) One of many concerns we have with the misconception that pressure ulcers have been classified as never events is that an attorney might convince a judge to apply the same standard to health care providers, convincing the judge that liability exists regardless of conduct, simply because the "never event" itself happened.

34 Texas penal code section 22.04: it is a crime to Intentionally, knowingly, recklessly, or with criminal negligence by omission Cause to a child elderly or individual or disabled individual Serious bodily injury, serious mental deficiency, impairment injury, bodily injury or 34 exploitation

35 Texas Health and Safety Code Section Criminalizes knowing failure to report that a nursing home resident s physical health or mental welfare Has in the past been or May in the future be Adversely effected by abuse or neglect 35

36 Legal Standard #1: Nevada Definition of Criminal Negligence A person acts in a reckless way that creates a high risk of death or great bodily injury; and A reasonable person would have known that acting in that way would create such a risk. 36

37 Resident does not develop pressure sores unless the individual s clinical condition demonstrates that they were unavoidable. The definition for unavoidability is, The resident developed a pressure ulcer even though the facility had evaluated the resident s clinical condition and pressure ulcer risk factors: defined and implemented interventions that are consistent with resident needs, resident goals, and recognized standards of practice; monitored and evaluated the impact of the interventions; and revised the approaches as appropriate.

38 Criminalization trend will continue Vulnerable patients as a % will increase Motivations to prosecute will grow Educate & act now to manage/minimize risk 38

39 Malpractice coverage does not help you You will pay for your defense If you plead out, you will have a felony conviction Lose your license? Lose your practice 39

40 Be aware as a profession Know your state statues on protection of vulnerable people (children and elderly) Who is your counsel? Develop a game plan for your institution (and yourself) 40 Examples of documentation with cross reference to statute which will reduce the likelihood that a prosecutor will interpret what happened as neglect Ensure that documents do not create red flags in an uneducated legal mind (forms not filled out, sniping between caregivers)

41 What is the #1 thing that should NEVER HAPPEN IN A HOSPITAL, according to Consumer Reports? #1. Bedsores. These painful wounds, usually on the ankles, back, buttocks, hips, or other bony areas, can develop if a patient is left in one position too long. Frequent repositioning and special pads, cushions, and mattresses can prevent them.

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43 Statement 1: Physiologic changes that occur as a result of the dying process (days to weeks) may affect the skin and soft tissues and may manifest as observable (objective) changes in skin color, turgor, or integrity, or as subjective symptoms such as localized pain. These changes can be unavoidable and may occur with the application of appropriate interventions that meet or exceed the standard of care. 43

44 1983 first described 1989 in literature 1877 in literature Decubitus Ominosus Dr. Jean-Martin Charcot Dr. Charcot s research not known to Kennedy nor reported in modern literature

45 In a recent transmittal from CMS, the KTU can now be used to avoid reporting a pressure ulcer as a quality measure in Long-Term Care Hospitals (LTCHs).

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