Medicine and the Law

1. Medicine and the Law Dominic Reilly, MD Associate Professor, Medicine Associate Medical Director, Risk Management University of Washington, Seattle

2. Medicine and the Law Medical Malpractice Minimizing risk Malpractice insurance Confidentiality Specific laws that impacts on your practice

3. Legal Disclaimer Although the fundamental legal issues in medical practice are relatively uniform, each state has it�s own specific set of laws and regulations, and each medical center and clinic often have their own policies and procedures Please check for the specific details about your state and practice

4. Case 1 You are in the final weeks of your fourth year of medical school. You are in the midst of a rotation in a small town in Eastern Idaho. When you arrive at clinic you find a note in your box telling you that the Risk Management office from Harborview called and want you to call them back ASAP. When you call, the Risk Manager tells you that you have been named in a malpractice claim.

5. Case 1 A young woman had presented to the Emergency Room one evening when you were on call. The patient presented with facial pain, fever and fatigue. She was otherwise healthy except for a history of bulimia. You diagnosed her with acute sinusitis and prescribed amoxicillin. Unbeknownst to you the nurse sent standard ER labs. Her potassium returned at 2.1. You were not aware. After leaving the ED she suffered a cardiac arrest, though survived but was left brain damaged.

6. Medical Malpractice and Tort Law Tort is the law of civil wrongs It provides for compensation when one person is injured by the acts or omissions of another (liability) Professional negligence is a major source of tort law cases Contrary to popular opinion medical students and residents can be named in malpractice cases.

7. Medical Negligence 1. Demonstrate a duty to care for the patient 2. Show that the physician failed to meet the standard of care (i.e. was negligent) The standard of care is established by expert testimony In general, providers are compared to those with similar training, acting in similar circumstances 3. Show that there was an injury 4. Prove that the physician�s negligence caused the injury

8. Case 1 The risk manager tells you that the family is suing you, the attending and the hospital for negligence. She tells you that when you return to Seattle you will need to sit for a deposition. The Risk Managers are still evaluating the facts of the case, but they are considering settling. She informs you that if they settle the case they will be reporting to the National Practitioner Databank.

9. Medical Students and Malpractice It is uncommon for medical students to be named in lawsuits. However, it does occur. Most often it�s a case of being in the wrong place at the wrong time. If a payment over $10K is made on your behalf, that information will be reported to the National Practitioner Databank. This is federally established organization that tracks malpractice actions and practice restrictions placed on medical professionals. This databank can be queried by hospitals, insurers, and others. Fortunately, it only covers licensed providers.

10. More Professional Negligence Failure to warn a patient or others Failure to diagnose Failure to refer or consult when indicated Treating without indication Breaching confidentiality

11. More Professional Negligence Abandonment Being unavailable without replacement Warranty (Promise) If you�ve guaranteed a result or outcome Lack of Informed Consent Based on your judgment what the reasonable patient would want to know Including risks related to medications

12. Case 2 You receive an email from the hospital Medical Director. A famous local celebrity was admitted to the hospital after an injury. The Medical Director wants to know why you logged into the patient�s electronic medical record.

13. Confidentiality All hospitals, including HMC and UWMC have policies and procedures that limit who�s chart you can access. At HMC/UWMC you CAN access: Charts for those patients you care for Your own record You CANNOT access charts of: Anyone else including family members, friends, etc. We track every time the chart is accessed. http://depts.washington.edu/comply/privacy.shtml

14. Confidentiality - HIPAA In 1996 congress passed the Health Insurance Portability and Accountability Act (HIPAA) . This act established penalties for disclosure of protected health information without permission. Protected health information includes all data related to the patient�s care, including diagnoses, treatments, and prognosis. It includes such details as the dates of services, their hospital numbers and other information. Patient�s have a right to privacy. Release of information to other individuals requires the patient�s explicit consent. Release of information to family members/care givers is often provided verbally. For other situations consent must be given in writing.

15. Breaching Confidentiality UCLA - 2008, an administrative staff member was indicted by federal grand jury for selling patient information for celebrities to local media. Conviction could carry penalty of 10 years in prison. California � 2009, Kaiser hospital fined $250K, 15 employees lost their jobs, another 8 disciplined for viewing multip�s records. New Mexico � 2008, two employees fired for posting pictures taken in the emergency department on line. Arkansas � 2008, several employees fired for accessing the record of a TV news reporter.

16. Case 2 Accessing the medical record of a VIP admitted to the hospital. Possible answers to the Medical Director: He/she is my favorite celebrity and I wanted to make sure they were ok I must have forgotten to log out and someone else accessed the chart after I left I was the student on the Infectious Disease team and we were asked to consult on the patient by the Trauma Service. I saw the patient with the Fellow and Attending.

17. Case 3 You are working one morning in the Emergency Room. A woman brings her baby in because he�s been sleepy and hard to arouse. On exam the infant has multiple bruises of varying age and there are small circular injuries consistent with cigarette burns. A CT scan shows a subdural hematoma and a skull fracture. You arrange urgent admission to the Pediatric ICU.

18. Case 3 You and the attending suspect child abuse. You contact the Social Worker and you all agree that Child Protective Services should be called. The patients mother becomes belligerent and tells you that she will �sue you for all of the money you are worth�. The attending, social worker and nurses appear unimpressed. Why?

19. Mandatory Reporting Most states have some reporting requirements 1. Suspected abuse (including financial) of a child or vulnerable adult 2. Injuries sustained by a deadly weapon 3. Coroner�s cases 4. Reportable infectious diseases (e.g., TB, STD�s, meningococcus, infectious diarrhea, AIDS, etc.) http://www.kingcounty.gov/healthservices/health/communicable/providers.aspx 5. Issues related to driving in some states (patient�s should always be warned) With a requirement to report generally comes some protection for liability except for deliberate misreporting.

20. Case 3 In the State of Washington you are protected for any errors in reporting to Child Protective Services RCW 26.44.060 � any person participating in good faith in the making of a report pursuant to this chapter or testifying as to alleged child abuse or neglect in a judicial proceeding shall in so doing be immune from any liability arising out of such reporting or testifying under any law of this state or its political subdivisions. Reporting to Child or Adult Protective Services is a serious matter. But, if your attending agrees that reporting is appropriate you will be protected. You have nothing to fear from the woman�s threats.

21. Permissible Reporting Duty to Warn Extension of statutory duty to protect the patient, any identifiable threatened person, or others in the community from reasonably foreseeable harm Privacy law exemption If the health care provider reasonably believes that disclosure will avoid or minimize an imminent danger to the health or safety of the patient or any other individual You may also share information with any practitioner who you reasonably believe is providing care for the patient

22. Case 4 A 20 y.o. nursing student is brought to the ED by her roommate. She has a h/o type 1 diabetes. For the past 3 days the patient had fevers, chills and a cough. The patient�s family lives in a distant city and the roommate does not have any contact information. On exam the patient is unarousable. The BP is 60/palp, heart rate 145, temperature of 39 C, and 02 sat of 71% on room air. Finger stick glucose is 621. Chest x-ray shows bilateral infiltrates consistent multilobar pneumonia. The nurses are unable to obtain IV access, the attending preps for an urgent subclavian central line.

23. Case 4 During the procedure the patient suffers a pneumothorax. Her BP and Sat�s fall precipitously. A code is called, but despite aggressive resuscitative measures the patient dies in the ED. Two months later her family files a claim against everyone involved (including you) alleging that you did not obtain consent for procedure, and that neither the patient or family would have consented to the procedure if they had known the risks. What is everyone�s risk in this situation?

24. Informed Consent A discussion between the health care provider and the patient that facilitates the patient�s understanding of their: Illness Treatment or procedure needed Benefits of the treatment or procedure Risks Alternatives, including non-treatment and their risks and benefits Potential consequences of no action This happens before the consent form is signed. Make sure you make an additional note describing the conversation.This happens before the consent form is signed. Make sure you make an additional note describing the conversation.

25. Who Gives Informed Consent? Where medical treatment is required for an adult patient who is unable to give informed consent, consent may be given by others. Each state varies, typically involves (in order): Patient�s legal guardian, if they have the power to make healthcare decision An individual to whom the patient has given durable power of attorney that includes healthcare decisions The patient�s spouse One or more adult children of the patient Parents of the patient Adult siblings of the patient NOTE: Consent issues are very state specific WA State LawWA State Law

26. Emergency Exception If a recognized health care emergency exists and the patient is not legally competent to give an informed consent and/or a person legally authorized to consent on behalf of the patient is not readily available, the patient�s consent to required treatment is generally implied.

27. Case 4 20 y.o. with a pneumothorax following a subclavian line The care was appropriate The issue will be one of consent It will also be one of documentation How this case turns out, depends on how well you�ve all documented your actions. If the team tried and failed to reach her family, and/or documented the emergent nature of the procedure, then everyone will likely be fine.

28. Case 5 32 y.o. male with a hx of IVDU admitted for fever and a new murmur. Blood cultures, are drawn, an echo is ordered, a central line is placed and he is started on antibiotics. On hospital day 2 you see him in street clothes standing by the elevator. He is agitated and says he is leaving. When you ask him why he wants to leave, he says, �I need to get out of here� and steps toward the elevator. His central line is visible in his neck. What do you do?

29. Assessing Decision Making Capacity (Competence) A Consent Issue If competent, an adult must give his/her own consent for care Competence is often inconsistently defined There is usually a legal presumption that a person is competent, but this presumption is rebuttable To be capable of informed consent, a patient must have the ability to understand the nature of their condition, the risk and benefits of treatment or non-treatment and the ability to make a reasoned decision (not necessarily a wise decision) based upon this information.

30. Methods for Assessing Consent Capacity Consider using the mini-mental state exam (MMSE) to help ascertain whether the patient has a cognitive impairment If you believe a patient is incapacitated, may seek a second opinion from another physician (e.g., psychiatry or neurology) Document the method used to assess the patient's decision-making capabilities and the results

31. When can the patient be held? In general, may restrain for evaluation if impairment is thought to meet criteria for involuntary mental health treatment (secondary medical care is then allowed). This is decided by the MHP�s. May restrain for medical care if cognitive impairment is thought to be organic, AND is making patient incapable of informed consent, AND requires urgent or emergent medical treatment You would, naturally, involve your attending in this situation

32. Case 5 32 y.o. with IVDU attempting to leave with a central line Attempt to persuade patient to comply with treatment plan (use patient care agreement) or at least to allow removal of the line You may restrain the patient (with assistance) until the presence of cognitive impairment can be determined Otherwise Document refusal of treatment Obtain written informed refusal if possible

33. Case 6 You are paged urgently to the OB floor. One of your patients, an 18 y.o. woman is in premature labor. The patient has a h/o drug use and is trying to leave the ward against medical advice (AMA). You, the obstetrician and the nurses try to persuade her to stay for the sake of her child. She refuses and leaves the ward.

34. Case 6 The child is born prematurely and suffers significant neurologic injury. 20 years later, you and the OB are sued by the child�s guardian for failing to prevent this tragedy. What will be the biggest determinate in this case?

35. Documenting In the Medical Record Date and time all entries Sign every entry with your name and professional title Legibility is a priority Be accurate and objective Avoid assigning blame and don�t criticize another�s care, avoid jousting Most centers do not like you to chart �risk management notified� or �an incident report filed� as it may make the documentation open to discovery The purpose of the medical record is to provide a record of all the elements involved in the medical care over a particular time. This information belongs to the patient. The medical record, assembled in a sequenced format, should allow any subsequent reader, whether immediately, or at any time interval in the future, to reconstruct completely what transpired at the time the medical care was provided. The purpose of the medical record is to provide a record of all the elements involved in the medical care over a particular time. This information belongs to the patient. The medical record, assembled in a sequenced format, should allow any subsequent reader, whether immediately, or at any time interval in the future, to reconstruct completely what transpired at the time the medical care was provided.

36. Case 6 Lawsuit 20 years after premature delivery Even in states with statutes of limitations children can often have the right to sue after they after they attain the age of majority (18 y.o.). The biggest determinant in this case will be the medical record. Who will be able to recall with clarity what happened those many years ago. If you took the time to document your interactions with the patient, you will likely be fairly safe. If nothing was documented, you may have a major problem.

37. Minimizing Risk Keep up to date. Treat only within your area of expertise. Don�t hesitate to consult and/or seek other opinions if uncomfortable, especially if the stakes are high. Document thoroughly. Communicate effectively with patients regarding treatment plans and follow-up. NEVER alter the medical record.

38. Minimizing Risk Be cautious with unfamiliar medications. Write legible prescriptions Get good informed consent and document it Maintain confidentiality Foster teamwork Don�t be afraid to say, �I�m sorry this happened.� Partner with your Risk Manager when necessary

39. Minimizing Risks Be sure test results are reported to the patient and followed up on. Ensure patients have recommended tests/consultations. Make a reasonable effort to contact patients when they are non-compliant and inform them of the potential consequences, and document it. Have medical records available during telephone calls and document telephone communications. Inform patients of potential confidentiality issues with on-line communication, and secure patient data.

40. Documenting in the Electronic Era Avoid excessive copying/pasting from previous notes, they clutter the chart and make it difficult to find good information. The goal is a synthesis of the available information. Acknowledge the sources for your information when copied. Read everything in your note and make sure it accurately reflects the clinical circumstances. Any errors in your documentation may place the patient at risk, and may come back to haunt you. Identify your role on the team (e.g., MS III)

41. Risk Factors for Malpractice Of 280 patients in the Harvard study with an adverse negligent event, only 8 pursued litigation. Utah/CO study 4 suits out of 130 negligent events. Patient factors associated with a suit Anger/revenge Perceived lack of caring Serious injuries, esp. to young or those with dependents Higher socioeconomic status In one study 63% of claims were for minor and/or emotional issues.

42. Physicians and Malpractice Physician characteristics associated with an increased risk of malpractice suit Surgical subspecialty Male ER coverage Hx of patient complaints to medical board or frequent complaints to the practice Board certification (surgical, not medical) Factors associated with decreased risk Female Good communication skills Satisfaction with practice arrangement

43. �No Claims� Behaviors Used more statements of orientation Advised what to expect of an exam Described flow of a visit Laughed and used humor Tended to use more facilitation Solicited the patient�s opinion Checked for understanding Encouraged patients to talk

44. Communication Skills Patient Rapport - empathy, comfort & emotional support Non-verbal communication: Sitting at the patient�s eye level Present a friendly demeanor Watch verbal and non-verbal cues Avoid appearance of inattention (taking phone calls, looking at clock or watch, etc.)

45. Communication Skills Explain treatment in language your patient understands Communicate follow-up plans and instructions Be sure the patient knows whom to contact if there is a problem Be accessible Be honest when discussing risks & benefits (Lack of trust combined with poor outcomes = complaints & claims)

46. Patient Risk Factors for Suit Most suits are generated by financial need, supplemented with anger. Highest risk are: Wage earners/care givers Higher socioeconomic status Children Injuries with high care needs Medical background or family Straightforward error

47. Medical Malpractice Insurance Claims made vs. occurrence policies Occurrence � you are covered for anything that occurred while the policy was in force (this is typically limited to institutions) Claims made � you are only covered while the policy is in force, drop the policy, and the coverage is gone. Most require a �tail� or a �nose� policy to cover your residual risk

48. Medical Malpractice Insurance Most policies have limits for any single claim/total for the year e.g., 1 million/3 million coverage Cost of the policy depends on location, specialty, prior claims At UW, you have unlimited coverage when carrying out assigned responsibilities

49. Cost of Malpractice Insurance

50. UW Insurance Protection Self insured since 1973 Unlimited coverage No deductible Covers all claims made while at the institution No tail coverage required Describe the Health Sciences Risk Management Structure My focus is clinical RM - I am your resource for any potential or imminent concernsDescribe the Health Sciences Risk Management Structure My focus is clinical RM - I am your resource for any potential or imminent concerns

51. UW Insurance Protection What is NOT covered: Claims related to practice/employment prior to any UW appointment Moonlighting Acts of �bad faith� Working outside the system Describe the Health Sciences Risk Management Structure My focus is clinical RM - I am your resource for any potential or imminent concernsDescribe the Health Sciences Risk Management Structure My focus is clinical RM - I am your resource for any potential or imminent concerns

52. What�s Bad Faith As defined by the UW Board of Regents: Acts committed with the willful intention of causing injury or harm Acts that were reckless or malicious in nature Acts committed in willful violation of law or university regulations Acts committed while under the influence of alcohol or a controlled substance Altering the medical record after the fact Describe the Health Sciences Risk Management Structure My focus is clinical RM - I am your resource for any potential or imminent concernsDescribe the Health Sciences Risk Management Structure My focus is clinical RM - I am your resource for any potential or imminent concerns

53. Regulatory and Government Agencies State Licensure- each state sets their own rules and requirements. Have authority to investigate complaints and take actions against providers. Most require ongoing continuing education. Drug Enforcement Agency- authority to prescribe controlled substances Mental Health Professionals (MHPs) � authorized to detain patients for mental health reasons. Peer Review � State/Federal sponsored agencies (i.e., Medicare/Medicaid) contracted to review records and investigate when they have concerns about the quality of care.

54. Washington State Laws Good Samaritan Law � no liability for injury when rendering uncompensated emergency assistance outside of clinical areas. (RCW 4.24.300) Legible Prescriptions - all prescriptions be hand printed, typewritten or electronically generated (NO cursive). A legible prescription is defined as a medication order that can be read and understood by the pharmacist, nurse, or practitioner who must dispense it. Must also include reason for any PRN meds (RCW 69.41.010) HIV Test Counseling � requires pre/post counseling to patients who undergo testing. Most hospitals have specific consent forms and checklists (RCW 246.100.207) 

55. Questions?