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Avoiding Liability Through Good Communication and Documentation By: Lisa Wilson, JD University Legal Counsel Today’s Focus • What does it mean to obtain informed consent • What is the best evidence of informed consent • How to disclose unanticipated outcomes and medical errors Informed Consent Reasons for Informed Consent • Respect individuality, self-determination, autonomy - patient has a right to know and participate in plan of care • Structure and establish the relationship with the patient / family • Enhance outcome – improve cooperation • Comply with the law, accreditation standards and avoid liability Required by common law, state statute, medical licensing standards, and CMS Conditions of Participation The Joint Commission (TJC) requires that charts contain evidence of informed consent Leapfrog and other patient safety organizations Informed Consent Process Includes: • Appropriate person with decision-making capacity • Required information Risks, benefits, alternatives • Use of understandable language • Awareness of cultural differences, literacy, beliefs, language barriers Contact Interpreter Services / Patient Relations • Apply “teach-back” method to confirm understanding Who is Responsible for Obtaining Informed Consent? • The physician performing the procedure is responsible party Statutory Licensure requirements Hospital policy – UWHC Policy #4.17 • Physician may designate others (i.e. nurse, resident) to assist in giving information and obtaining signature Informed Consent Standard Generally, what a reasonable patient would want to know under same or similar circumstances present to make an educated and informed decision What Information Should Be Provided? • Details of the procedure • Risks and benefits of the procedure • Consequences of non-treatment • Alternative, viable medical modes of treatment and the risks/benefits of each Risk Communication • Major emphasis on patient choice • Provide information that aids the decision- making process Use of decision aids • Patient values and preferences vary widely…difficult to predict • Patients who are more engaged and informed are more compliant and have better outcomes Discussing Risks • Display competence, a caring approach, willingness to discuss patient’s own expectations and fears…builds trust • When discussing rates of risk it is suggested to use: absolute rather than relative risk a common denominator information that reflects the individual’s risks • Positive versus negative percentages Johnson v. Kokemoor, 199 Wis. 2d 615 (S.Ct. 1999) Plaintiff diagnosed with basilar bifurcation aneurysm. Defendant clipped aneurysm but Plaintiff rendered an incomplete quadriplegic. B/4 surgery, Plaintiff had asked Defendant whether he had performed same surgery before and he said “several” times. When questioned further, he stated “dozens” and “lots of times.” In fact, Defendant had performed aneurysm surgery on six patients, only twice on basilar bifurcation aneurysm, and never one as large as Plaintiff’s. Johnson v. Kokemoor (cont.) Wisconsin Supreme Court held that Defendant’s relative lack of experience in performing basilar bifurcation aneurysm surgery and fact that other physicians would have substantially different success rate in performing same procedure was something a reasonable person would have wanted to know – choice between alternate, viable medical modes of treatment. What Information Generally Need Not Be Provided? • Information beyond what a reasonably-well qualified physician in a similar medical classification would know • Detailed technical information in all probability the patient would not understand • Risks apparent or known to the patient What Information Generally Need Not Be Provided? (con’t) • Extremely remote possibilities that might falsely or detrimentally alarm the patient Must weigh the seriousness of the risk against likelihood it will happen • Information in an emergency where failure to treat more harmful than treatment • Information in cases where patient is incapable of consenting (surrogate?) Documenting Informed Consent • TJC, CMS, etc require that medical charts contain evidence of informed consent • Two common methods: Signed consent document (v. implied consent) Dictated chart note Signed Consent v. Implied Consent • Signed Consent • Procedures that are more than minimal risk such as those performed in OR; radiotherapy; chemotherapy; dialysis; transfusions; other invasive procedures (such as puncture or incision of the skin or insertion of instrument or foreign material into the body) • List of procedures requiring signed consent form (UWHC Policy #4.17 attachment) • Implied Consent • Generally only for routine, noninvasive or minimally invasive procedures with no more than minimal risk (chart note strongly recommended) Signed Consent Document • Standard forms used by hospital Flexibility in altering forms Procedure specific forms • Form must have date and time when patient or patient’s representative signed and when physician signed • Witness must sign and include professional designation • Must have witness if obtaining telephone consent • Form must be signed by patient or representative and physician prior to surgery / procedure • RNs, NPs & PAs are only allowed to be sole authenticator on form IF they are performing the procedure alone (sign on witness blank) Dictated Chart Note • Use in conjunction with signed consent document, and especially when consent implied • Your best protection against assertion of failure to obtain informed consent • Memories fade over time leaving chart note as only evidence of actual conversation • Document chart note same day as discussion with patient noting general discussion • Signed consent form without chart note may result in contest between patient and physician Ideal Chart Note • Patient’s existing condition • Nature of proposed medical care, its risks and side effects • Benefits of proposed medical care and its outlook for success • Alternative, viable modes of treatment discussed and risks/benefits of each • Significant questions asked by patient and answers given • Patient consented to planned care • Any refusal to receive information • Any refusal to receive recommended care Lawsuits • To recover damages for a failure to obtain informed consent, patient need not show that physician performed below standard of care No hiring of expert witnesses May be easier to prove failure to obtain informed consent than to prove negligence • Patient need only show: A reasonable person would have wanted to know omitted information A reasonable person would have chosen differently based on that information Failure to disclose was cause of injury Lawsuits (cont.) Studies show that patients are less likely to sue, even when there is a bad outcome, if they have had good communication with their physician, leading to a feeling that they received all of the information and that their physician truly cares about their condition Tips to Remember • Ideally, time to obtain informed consent is not on day of procedure • Consent is a process and good consent process reduces risk of claims • Never go back and change a record. If error exists, use appropriate hospital procedures to amend • Never put anything in a chart note that you would not want a judge or jury to see Disclosing Unanticipated Outcomes & Medical Errors Why Disclose Medical Errors? • Ethical to do so when error significantly affects the care of patient (1992 American College of Physicians’ Ethics Manual) • Required by TJC: Patient must be informed about outcomes of care, including unanticipated outcomes (Standard Rl.1.1.2) • Required by UWHC Policy: Physician or designee must clearly explain outcome of treatment or procedures whenever outcome differs significantly from what was anticipated (Policy #4.45). Goals of Disclosure • To support the patient’s right to information about the outcomes of diagnostic tests, medical treatment and surgical intervention. • To acknowledge, identify, reduce and prevent medical errors and improve patient safety. • To create an environment in which patient safety is paramount; in which caregivers feel comfortable bringing unanticipated outcomes to light in order to learn from them and participate in process improvement. Definitions • Unanticipated Outcomes: Result that differs significantly from what was anticipated. May or may not include error. • Medical Errors: Failure of a planned action to be completed as intended or the use of the wrong plan to achieve an aim. Does not include intentional or reckless actions that result in harm to the patient. Known Complications • Known complications are not unanticipated outcomes • Patients should still be informed that a known complication occurred and the consequences • Use same techniques for disclosing unanticipated outcomes and medical errors Experiences with Disclosure • Lexington Kentucky VA Hospital: systematic disclosure since 1987 of accidents and incidents has resulted in reduction of malpractice claims • University of Michigan Health System 2002-2004: annual attorney fees dropped from $3M to $1M 2001-2004: lawsuits and notice of intent to sue fell from 262 to 130 Patient Perceptions/Behaviors • Most patients want their physicians to alert them to even the smallest of errors • Patients’ motivations to sue include anger over feeling they have not been told all needed facts • May resort to use of legal process to find out what happened Provider Perceptions/Behaviors • Fear of litigation prevents many providers from disclosing medical errors • 1991 JAMA article: Wu, et al reported the following rates of disclosure of mistakes by residents: To attending MD 54% To patient/family 24% Who Should Disclose Errors? • Attending physician; other members of care team; patient relations representative; nurse manager • Never make disclosure alone (witness) • Never make disclosure of event that involved someone else without including that person in discussion When Should Disclosure Be Made? • As close to time of event as possible • May not have all facts yet • May only be able to say that it appears an unanticipated event occurred, with brief description of the event, and that an investigation is taking place • Maintain regular follow up with patient / family to keep them informed of progress and provide when will be in contact until investigation is completed and results have been shared. How Should a Disclosure Be Made? • Try to pick a time/place where you won’t be disturbed by phones, pager, etc. • Sit down! • Make eye contact and talk slowly • Don’t be too technical • Pause to allow the patient to process or ask questions • Ask patient if he/she understands • Don’t be intimidated by silence or feel the need to fill it Content of Disclosure • “There is no easy way to say this…” or “I’m sorry to have to tell you this…” • Describe the event truthfully • Discuss what, when, how, consequences • Apologize/Sympathize: “I’m sorry that this happened” and “I understand this must be very difficult for you to hear” • Don’t blame yourself or others! Events are often multi-factorial, involving many mistakes or break downs in process Discussing Consequences • Tell patient what this means in terms of follow up/additional care; quality of life issues; etc. • Tell patient if processes have been changed as a result of the event • If patient asks about bills/compensation, refer to patient relations to deal with Never tell patient he/she will not be responsible for charges! Documenting • Carefully document your discussion with the patient • Include people present (later witnesses) • Include facts you told patient about the event • Include significant questions by the patient and how they were addressed • Do not reference peer or QA review or discussions with risk management/legal Legal Risks • Negligence versus bad outcomes or complications • Standard of care • Availability of evidence • Protection of peer review processes • Financial liability • Admitting liability Theories of Liability • Violation of AMA Code of Medical Ethics Not a law, but would discredit physician • Breach of fiduciary duty Failure to disclose may be fraud (failure to act in patient’s best interest) • Fraudulent concealment (misrepresentation) Intentional injury to the patient’s best interest Extends statute of limitations and involves punitive damages Settlement likely to be more difficult and costly Questions?
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