ENDOSCOPIC ADVERSE EVENTS: IT HAPPENS EVENTUALLY.IS INFORMED CONSENT ENOUGH?

Transcription

1 ENDOSCOPIC ADVERSE EVENTS: IT HAPPENS EVENTUALLY.IS INFORMED CONSENT ENOUGH? John BAILLIE, MB ChB, FRCP, FACG Carteret Medical Group, Morehead City, NC LAWYERS ARE WAITING FOR THE OPPORTUNITY TO SUE YOU October

2 An adverse or undesired event is not necessarily evidence of error or malpractice; Adverse events can be minimized, but not completely avoided; Life is full of Adverse Events.. October

3 An adverse or undesired event is not necessarily evidence of error or malpractice; Adverse events can be minimized, but not completely avoided; All procedures carry some risk; Informed consent is the sharing of risk with the patient. In the event of malpractice litigation, the plantiff s counsel lhas to show that tyou have deviated from the Standard of Care ; The Standard of Care is what a reasonable and prudent physician would have done in the same circumstances ; The Standard of Care is defined by the practice of experts in your local area October

4 Pre-procedure defenses: Know the national standards for endoscopic practice (i.e. professional society guidelines); Know how your local/regional experts handle difficult cases ( = local standard of care); Do not get creative when performing endoscopy in a community setting. Leave experimentation to experts in large centers, who do this under study protocols and have appropriate back-up. Pre-procedure defenses: Make sure you have sufficient training and experience to safely undertake the procedure; Keep up with changing patterns of care relating to procedures (e.g. pancreatic stenting to prevent post-ercp pancreatitis in high-risk cases); Read the clinical and endoscopy journals and attend local/regional/national courses run by the major professional societies. October

5 Pre-procedure defenses: Get to know some experts, esp local ones to whom you refer cases. Being able to show at deposition and at trial that you keep up with developments in your field and regularly attend meetings for CME is evidence of being a thoughtful htf and conscientious physician. i When in doubt, ask! Any expert worth his/her salt will take your call if you need urgent advice! Pre-procedure defenses: Therapeutic cases should be planned out ahead of time, and alternatives considered (e.g. plastic vs metal stents, standard vs needle knife papillotomy). Do not attempt procedures or use equipment or techniques that require supervised training which you have not received. October

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7 Pre-procedure defenses: Take time to get to know the patient and his/her family. Avoid doing procedures on patients whom you have only just met, and whose medical records you have only glanced at. Especially for advanced procedures, see the patient far enough in advance to arrange additional testing, pre-anesthetic screening, etc. Pre-procedure defenses: If you are concerned about the safety or appropriateness of a proposed procedure, you are probably right; It is wise to seek a second opinion in such cases, which may be from a gastroenterologist or a surgeon in your hospital; - After an adverse event, having consulted ahead of time with colleagues confirms your caution. October

8 Pre-procedural defenses: A well-executed Informed Consent may be your best defense against litigation in the event of an adverse event; Many states do not require that Informed Consent be in writing, but from the legal perspective, if it is not tdocumented din writing, it never happened. Never, ever alter a consent form after the event!: it is fraudulent, and destroys any legal defense. October

9 Pre-procedural defenses: Informed consent should not be delegated to nonphysician extenders, or residents and fellows; Consent should include discussion of the common risks of the procedure, with an estimate of their frequency in the physician s practice; Consent should include a discussion of the alternatives, including not doing anything. Pre-procedural defenses: The physician is not obliged to proceed with a procedure if he/she considers it unsafe, marginally indicated or unlikely to succeed; However, if the patient requires a different intervention to deal with an acute problem that will not resolve on its own (e.g. biliary obstruction), the physician is obliged to facilitate the patient s referral for it without delay. October

10 Pre-procedure defenses: Whenever possible consent should be obtained well ahead of the procedure, and not immediately before, especially for advanced procedures with high risk; Consent should be witnessed, and the presence of a family member is especially useful. Pre-procedure defenses: The type of sedation required should be decided d ahead of time. About 50% of cases nationally are now done with either MAC (propofol) or general anesthesia (intubated). Anesthesiologists and CRNAs do not like the semiprone position for ERCP if only MAC is being used. Very obese patients should be intubated for safety, and may have to be done lying supine. October

11 Pre-procedure defenses: Regardless of what some papers in the literature claim, for most endoscopists the supine position adds a degree of difficulty to ERCP. Never promise anyone a quick and easy procedure if this position is being used (Actually, never promise this at any time! You never know what you are going to find that could slow you down, like a big diverticulum). During procedure defenses: Ensure that everyone in the room knows what is planned, and what equipment is required (this is what Time-Outs are for!). Used customized checklists so important issues aren t missed (e.g. have antibiotics been given?, was the Lovenox held?) Empower everyone in the room to speak up! Do not take phone calls or answer pages during a procedure: have you staff take messages. October

12 During procedure defenses: Make sure that t endoscopy trainees are continuously supervised while holding the scope. Do not leave the room to take calls or deal with other issues (e.g. discharging the last patient), leaving trainees unsupervised. Bad things can happen in your absence. Consider instituting a sterile cockpit approach to chat in the endoscopy room: no social chit-chat or other goofing around from start to finish. October

13 During procedure defenses: Most airlines now prohibit their pilots from engaging in any discussion below 10,000 feet that is not for the sole purpose of conducting the flight. The climb-out and approach-to-landing are the two most critical parts of any flight. It has been shown that distractions due to social chitchat during those periods are a common cause of incidents and accidents. October

14 After an adverse event: When an adverse event has occurred, be honest with the patient and the family about it avoid the temptation to minimize the problem; In many states, it is OK to say you are sorry the problem has occurred (i.e. this cannot be used as an admission i of guilt in legal l proceedings); But avoid self-flagellation in the aftermath! After an adverse event: Statements t t in front of family like the needle knife just slipped I didn t mean to cut that deep or someone must have changed the power settings on the cautery unit when I wasn t looking.. are not helpful, and potentially damaging, when it comes to defending a claim of medical malpractice. Support staff must be educated not to offer their opinions regarding causation. October

15 After an adverse event: How you handle the adverse event is as important as the informed consent. Document, document, document! A detailed record is very helpful when it comes to defending a malpractice suit. Consult, consult, consult! Get your colleagues involved (esp a surgeon if surgery may be needed). October

16 After an adverse event: Try not to leave colleagues to look after your patients with complications; A busy and/or disinterested colleague, or one with less experience than you in managing the adverse event, can compound the problem; Consider delaying weekend or vacation plans in the wake of a serious complication. After an adverse event: If you do have to leave town, put a detailed d note in the chart describing the management plan, preferably after a case conference with your consultants; Indicate in the record that you will be available 24/7 for consultation, and leave your cellphone number. Call in daily to check on progress; have that call identified in the record by a nurse or colleague. October

17 After an adverse event: Do not write long, exculpatory summeries after the event: these are obvious attempts to avoid blame and will be used against you in legal proceedings; Never, ever, change anything written in the record: ink can be dated d by forensic techniques. If you do this and it is discovered, the case becomes indefensible. After an adverse event: Work with your hospital s Risk Management office, which is there to minimize the damage. Many physicians fear Risk Management when an adverse event occurs, but if they are doing their job, they will help to reduce the risk of a subsequent malpractice suit. October

18 After an adverse event: The family may request a meeting to discuss the adverse event. This can defuse anger and win over hostile relatives, but expect it to be an uncomfortable experience. An independent witness should be present; typically, y, this will be a representative of the hospital from Risk Management. After an adverse event: Difficult as it is in the wake of a bad outcome, you should avoid emotional discussion with colleagues, as you will be asked under oath whom you talked to after the event, and they may be called to testify for the plaintiff in court: Yeah, Jim called me in a terrible state: he said he d really screwed up a case. October

19 Adverse Events: Management Pearls Risk Management for Gastroenterologists What can I do to avoid complications of ERCP? > Stop doing ERCP (or don t start) October

20 Adverse Events: Management Pearls Risk Management for Gastroenterologists What can I do to avoid complications of ERCP? > Stop doing ERCP (or don t start) > Limit your practice to low-risk procedures October

21 Adverse Events: Management Pearls Risk Management for Gastroenterologists What can I do to avoid complications of ERCP? > Stop doing ERCP (or don t start) > Limit your practice to low-risk procedures > Get additional training/experience (e.g. pancreatic duct stenting, needle knife papillotomy) October

22 Adverse Events: Management Pearls Risk Management for Gastroenterologists Practice evidence-based Medicine Keep up with CME Know the practice guidelines relevant to your practice; get to know your local experts. Have a Quality Improvement/Assurance program / regularly review adverse events Adverse Events: Management Pearls Risk Management for Gastroenterologists Do a risk-benefit calculation whenever you undertake a complex or risky procedure; Spend time getting really good informed consent in writing; Consider referring patients to tertiary centers for high-risk procedures. October

23 Adverse Events: Management Pearls Risk Management for Gastroenterologists A well-executed written informed consent is your best defense against a malpratice suit Generally, this duty should not be delegated to others (including extenders) Be honest about your failure/complication rates when getting consent Adverse Events: Management Pearls Risk Management for Gastroenterologists What to do in the event of an adverse outcome ( complication ) Be honest with the patient and his or her family do not try to minimize the seriousness of a major complication i October

24 Adverse Events: Management Pearls Risk Management for Gastroenterologists Document, document, document Consult early and often (esp a surgeon if there may be a surgery in the patient s future) If you are in the community, consider getting the patient to a referral center early, esp if intensive care is required. Adverse Events: Management Pearls Risk Management for Gastroenterologists Do not write long exculpatory notes in the record that are obviously added after the event NEVER, NEVER, NEVER change or delete any entry in the record ink can be dated, and if you are shown to have altered to record, it s a home run for the plaintiff s lawyers Make sure that your support staff are in the loop and know how to deal with approaches by family October

25 Adverse Events: Management Pearls Risk Management for Gastroenterologists CARELESS TALK COSTS LIVES, and careless talk causes litigation. Many lawsuits have been triggered by ill-considered critical remarks made to patients or their families by support staff. Educate your staff in the etiquette of managing queries from patients and their relatives about adverse events, but you can t forbid them from talking to them. Adverse Events: Management Pearls Risk Management for Gastroenterologists Call in daily to find out how the patient is doing and have your colleagues document that you have done so. If the person managing the case is you, get together with your consultants and come up with a management plan. Document it in the chart. Revisit it regularly. October

26 Adverse Events: Management Pearls Risk Management for Gastroenterologists It s OK to say you are sorry the way things worked out. But don t flagellate yourself in front of the deceased s family and friends. The family may request a meeting with you to discuss what happened. Although an uncomfortable process, it may head off lawsuit later. Make sure you have a witness present; this is often someone from Risk Management. October