In this Learnscape, you are presented a negligence case where a patient was given a treatment without expressly consenting to it. You will discuss with the radiologist who worked with the patient and

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In this Learnscape, you are presented a negligence case where a patient was given a treatment without expressly consenting to it. You will discuss with the radiologist who worked with the patient and did not approve of the treatment, and then you will talk to the cardiologist who performed the treatment without the consent of the patient. You will work with Bright Road Chief Counsel to analyze the data and determine Bright Road’s liability in this case.

Work through the simulation. Read Chapter 27 “Managing Patient Expectations Through Informed Consent”. Review the grading rubric.


1. Recommendation

Answer all the questions to help you make your recommendation.    Submit your recommendation.    Save the assessment “Informed_ConsentYourName” as a word document


2. Write a paragraph that explains how informed consent can promote patient safety.

Save this titled “YourNamePatientSafety” as a word document.

In this Learnscape, you are presented a negligence case where a patient was given a treatment without expressly consenting to it. You will discuss with the radiologist who worked with the patient and
Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 1 Failure to Obtain Consent Introduction: In this scenario , you are presented a negligence case where a patient was given a treatment without expressly consenting to it. You will meet with the radiologist who worked with the patient and did not approve of the treatment, and then will talk to the cardiologist who performed the treatment without the consent of the patient. You will work with Bright Road Chief Counsel to analyze the data a nd determine Bright Road’s liability in this case. Characters: 1. Jeff Passmore , General Counsel at Bright Road Health System 2. Dr. Julie Roso , Radiologist at Bright Road 3. Dr. William Fredericks , Cardiologist at Bright Road Locations: 1. Student’s Office 2. General Counsel’s Office 3. Hospital Hallway 4. Hospital Conference Room Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 2 Scene 1: Meeting with Chief Counsel The Student meets with Jeff Passmore, who lays out a high level overview of the lawsuit involving Mr. Davis . The y briefly discuss the key points in a case regarding informed consent. Student is given direction on who to talk to and how to help Jeff determine what the hospital’s liability is in this case. Location Chief Counsel’s Office Scene setup Jeff faces the Student from behind his desk. On -screen charac ters Jeff Passmore Off -screen characters None On -screen text: You might want to take notes on paper as you go. They could help you form your recommendation at the end. On -screen text: Early morning meeting in the Chief Counsel’s office . . . JEFF So , thi s case is a bit different from the some of the other cases we’ve seen recently . Are you ready for a challenge? STUDENT I sure am, Jeff. How is the case different? JEFF With this lawsuit, we’ll be stepping outside of the world of negligence and into the arena of informed consent. Student must choose both options to continue. STUDENT CHOICE 1 So, we performed an unauthorized procedure ? STUDENT CHOICE 2 Can you discuss the specifics of the case ? JEFF RESPONSE 1 Yes, we did. Informed consent is the legal doc trine that protects a patient’s right to know the potential risks, benefits and alternatives of a proposed procedure. A patient has a right to be informed before giv ing consent and the patient has a right to expect the physician will honor the patient’s wi shes. JEFF RESPONSE 2 Yes. Mr. Davis filed a suit against Bright Road because when he underwent a cardiac catheterization, the cardiologist extended the procedure beyond which Mr. Davis did not consent to . STUDENT Was Mr. Harris harmed by the additional treatment ? JEFF Yes. A s I understand it, he will need to be on medications to prevent blood clots and he will need long -term follow -up . However, t he wrongdoing here was the Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 3 fact that the physician did something to the patient that he expressly stated he did not want done. Student can click on any option to proceed. Student must choose both eventually. STUDENT CHOICE 1 Was it an emergency treatment ? STUDENT CHOICE 2 What was the procedure ? JEFF RESPONSE 1 No . It would have been better if it were . That would have allow ed the cardiologist to initiate emergency treatment while an attempt wa s being made to reach the appropriate party for consent , such as the spouse or parent . But, in this case, it was not an emergency. JEFF RESPONSE 2 The cardiologist inserted stents in to Mr. Davis’s arteries during a cardiac catheterization. Student can click on any option to pro ceed. Student must choose all eventually. STUDENT CHOICE 1 Isn’t that a standard part of the surgery? STUDENT CHOICE 2 So, what information would you like me to help gather? STUDENT CHOICE 3 Is there anyone else I should talk to? JEFF RESPONSE 1 I’m not sure if it is a standard part of cardiac catheterization . All I know is that Mr. Davis crossed out the section on his consent form that called for the stents to be added. During surgery his cardiologist, Dr. William Fredericks, added the stents anyway. JEFF RESPONSE 2 We’re trying to determine the hospital’s liability in this case. You can talk with Dr. Fredericks to learn more about what he di scussed with Mr. Davis prior to the procedure . Did the patient fully understand what was being explained ? Was the patient competent and able to make decisions ? These are questions we’ll need answers to. JEFF RESPONSE 3 You can also talk to the radiologist involved, Dr. Julie Roso. She apparently performed the test that indicated blockage in Mr. Davis’s arteries. But, from what I can gather, she wasn’t even in favor of the cardiac catheterization to begin with . Her viewpoint will be important to understandin g the dynamics of this case. STUDENT That should be a good starting point. JEFF Right. Just contact me if you need anything. Thanks! Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 4 Scene 2: Discussion with Radiolog ist The student meets with Dr. Roso , the radiologist who treated Mr. Davis. She provides i mportant first – hand information of the situation, and discusses the right of the patient to hear alternative treatment plans. Location Student’s Office Scene setup Dr. Roso sits in the left chair on the other side of the Student’s desk On -screen characters Dr. Julie Roso Off -screen characters None On -screen text: Your first me eting is with Dr. Julie Roso . . . STUDENT I appreciate you coming by, Dr. Roso. DR. ROSO Sure . So, what can I help you with ? Student can click on any of the three options to continue, but must choose all eventually. STUDENT CHOICE 1 [BRANCHING 1] Can you give some background on your involvement with Mr. Davis’s care ? STUDENT CHOICE 2 [BRANCHING 2] What happened when you explained the results of Mr. Davis’s test to him? STUDENT CHOICE 3 [BRANCHING 3] Do you agree with how Dr. Fredericks handled the situation ? BRANCHING 1 DR. ROSO RESPONSE B1 I was the radiologist who performed the CT scan on Mr. Davis, to determine his risk for heart disease. His cardiologist, Dr. Frederi cks, referred him to me . I had never seen Mr. Davis before this day. Student must choose all three options to proceed. STUDENT CHOICE 1 What were the results of the CT scan ? STUDENT CHOICE 2 Did you have an opinion on the type of treatment Mr. Davis should undergo ? STUDENT CHOICE 3 How long had you been working at the hospital at the time ? DR. ROSO RESPONSE 1 The CT scan for Mr. Davis revealed that there was approximately 30 to 35% blockage in one of his arteries. It’s fairly significant, although it’ s nothing to get too alarmed about. Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 5 DR. ROSO RESPONSE 2 Personally, I’m not a big fan of invasive treatments, unless they are absolutely necessary . Even cardiac catheterization, while a relatively routine procedure , is something that I avoid unless I obser ve a higher percentage of blockage in any of the arteries on the CT scan . In Mr. Davis’s case, I thought at the time that alternatives to catheterization should be tried first, such as a change of diet , exercise, and adding a statin, which is a well accept ed cholesterol -lowering medication. DR. ROSO RESPONSE 3 I’m pretty much the newbie around here compared to a lot of the doctors. I think I’d been at Bright Road for five years at the time of the occurrence with Mr. Davis. Student goes back to the top of the main branch. If other branch es already selected, the conversation continues . BRANCHING 2 DR. ROSO RESPONSE B2 When I explained the results of the CT scan to Mr. Davis, he was pretty calm. Like I said, it’s alarming, but it’s not ear th-shattering news. We immediately discussed how a treatment plan involving some low risk meds and some easy diet changes would be very helpful in preventing the progression of his heart disease. But, I guess he got a different story from Dr. Fredericks. Student must choose both options to proceed. STUDENT CHOICE 1 Were you there when Mr. Davis discussed the test results with Dr. Fredericks , and do you think the patient was competent ? STUDENT CHOICE 2 Did you discuss Mr. Davis’s situation with Dr. Frederi cks privately? DR. ROSO RESPONSE 1 The patient was definitely competent to make his own decisions regarding his care. There was nothing inhibiting that. And, n o, I wasn’t there when the patient reviewed the results of the scan with Dr. Fredericks. I wish I had been, though. Looking back, it seems Mr. Davis had a gut feeling that things would be diffi cult, because he even asked me if I would support him in communicating to Dr. Fredericks that he did not want a cardiac cathete rization and was more adamant tha t he did not want stents placed in his arteries . DR. ROSO RESPONSE 2 Yes, I actually called Dr. Fredericks while Mr. Davis was in my waiting room. The man wouldn’t listen to anything I h ad to say. Sometimes I think he’s a little too eager to perform those costly cardiac catheterizations. Anyway, I had to tell Mr. Davis that his doctor wanted to see him back in his office right away. He was not only recommending the catheterization, but that most likely stents would need to be inserted as well. Needless to say, Mr. Davis was not happy. Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 6 Student goes back to the top of the main branch. If other branch es already selected, the conversation continues . BRANCHING 3 DR. ROSO RESPONSE B3 No, I don’t agree with how he handled it at all. It was as if he bullied Mr. Davis into consenting to the procedure . Student must click both option s to proceed. STUDENT CHOICE 1 How do you know that? STUDENT CHOICE 2 So, Mr. Davis agreed to the cardiac catheterization, but not the stents? Why is that? DR. ROSO RESPONSE 1 I spoke with Mr. Davis afterwards. He told me that, on his way to Dr. Fredericks’ office, he ran into him in the hall. Right there, he said the doctor told him to get ready for a cardiac catheterization and that he already had scheduled it for eleven o’clock the next morning. A bit presumptuous I thought. When he asked Mr. Davis if he had any questions, he asked him why he disagreed with my opinion that catheterization wasn’t necessary. Mr. Davis said that Dr. Fredericks made some evasive remark and that he would review the written report once he got back to his office, but even after he did, he didn’t change his opinion. Mr. Davis went on to say that Dr. Fredericks seemed somewhat disturbed that I offered m y opinion. DR. ROSO RESPONSE 2 Like I said, I think he felt pressured by Dr. Fredericks. He’s a very competent doctor, but he tends to come across as superior, like he knows better and shouldn’t be questioned. We had originally talked about stents and how, with the amount of blockage he had, these were not at all necessary. I think this is why he crossed out that part on the consent form. Oh, and if I remember correctly , Mr. Davis said he recalled reading some news paper articles that indicated cardiologists were sometimes a bit t oo aggressive in their use of stents. So I think he was fairly fearful of that. Student goes back to the top of the main branch. If other branch es already selected, the conversation continue s. STUDENT That leads me to m y last question: How could Dr. Fredericks simply disregard the consent form? DR. ROSO That’s a very good question. I really don’t know. The form becomes part of his file, and I know that we are supposed to review the file extensively before we perform any invasive procedure at the hospital. Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 7 STUDENT Dr. Roso , that’s all I have for now. I ap preciate your time. DR. ROSO Sure . I hope I helped in some way. Scene 3: Meeting with Cardiologist Next, the student meets with Dr. Fredericks, who is dismissive about the incident. Prior to the meeting, the Student gets more information from Jeff on sound alternatives and consent forms. Location Hospital Conference Room Scene setup Student faces Dr. Fredericks who sits on the left side of the table. Student’s laptop is open on the table for the start of the scene. It is closed after the video chat with Jeff ends. On -screen characters Dr. Fredericks, Jeff Passmore (on video chat ) Off -screen characters None On -screen text: Before your meeting with Dr. Fredericks, you chat with Jeff . . . JEFF (on video chat) You raise a great point regarding alternatives. It would be a great idea to discuss with Dr. Fredericks, whether or not he discussed alternative treatment plans with Mr. Davis. STUDENT What happens if it turns out he didn’t? JEFF (on video chat) We ll, it reminds me of the case, Stover versus Surgeons , where the patient wasn’t informed about alternatives to a specific heart valve that a handful of surgeons recommended she receive. The heart valve the surgeon put in was outdated and known to cause tro uble, and there were existing valves that were much better. The patient ended up suffering serious medical complications as a result, and she won the case because medically sound alternatives existed , but were not discussed with her prior to surgery. Student may choose either option. Both options must be chosen eventually. STUDENT CHOICE 1 Isn’t it just the patient’s word over the doctor, whether sound alternatives were discussed? STUDENT CHOICE 2 What about the consent form? Is that a legally binding form? And, if so, was Dr. Fredericks allowed to disregard it? JEFE 1 (on video chat) Well, in our case, it might be difficult to prove, since it’s not a patently obvious omission. Like, in the case of the heart valve, it’s clear that the patient would’ve Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 8 chosen a much safer alternative to the outdated heart valve if only she had been informed about it. JEFF 2 (on video chat) It varies from state to state, but in our case, yes, the hospital form is sufficient evidence of written consent. I looked at the ori ginal form earlier today, and it clearly shows that Mr. Davis crossed out the section about adding stents, and he even had the foresight to initial and date the change he had made, too. The fact that Dr. Fredericks did not follow the wishes of the patient indicated on the form does not bode well for him in this case. STUDENT Speaking of which, it’s just about time for me to meet with him. Thanks for the info, Jeff! JEFF Sure, l et me know how your meeting goes . NOTE: The video chat session end s, and the Student’s laptop appear s closed. On -screen text: Dr. Fredericks is here for your meeting… STUDENT Thank you for coming, Dr. Fredericks. This shouldn’t take too long. DR. FREDERICKS I appreciate that. I have a very busy afternoon. Student can click on either option to proceed, but must choose both eventually. STUDENT CHOICE 1 [BRANCHING 1] Can you tell me if you discussed alternative treatment plans with Mr. Davis? STUDENT CHOICE 2 [BRANCHING 2] Can we talk for a moment about the consent form that Mr. Davis signed? BRANCHING 1 DR. FREDERICKS RESPONSE 1 Yes, I certainly did discuss alternative treatment plans with Mr. Davis. Student can choose either option to proceed. Both must be chosen eventually. STUDENT CHOICE 1 Did you fully explain the risks and benefits of his options? STUDENT CHOICE 2 From his complaint, it’s clear that Mr. Davis didn’t even want the catheterization . Why wouldn’t he have chosen an alternative, then? DR. FREDERICKS RESPONSE 1 Yes, I explained everything he needed to know. I told him his situation was no t grave, but that, if we didn’t act quickly, it could get a lot worse. I mentioned diet and medication, but, frankly, I’ve seen too many patients get into serious trouble because they lack the willpower to Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 9 change their lifestyl e. So, I highly recommended we take care of the situation with a more reliable procedure , a cardiac catheterization. DR. FREDERICKS RESPONSE 2 I don’t know. Perhaps he realized that a doctor might know a little more than a layman like himself in this situa tion, and he decided to trust my recommendation after all. I really can’t tell you what was going on inside his brain at the time. Student goes back to the top of the main branch. If other branch es already selected, the conversation continues . BRANCHING 2 DR. FREDERICKS RESPONSE 2 Yes, I saw the form. What would you like to know about it? Student can choose either option to proceed. STUDENT CHOICE 1 Prior to catheterization , did you see that Mr. Davis had crossed out the section stating that stents would most likely be insert ed , meaning that he objected to the insertion of stents ? STUDENT CHOICE 2 Is there a reason, particularly, why you ignored Mr. Davis’s expressly written wishes in this situation? DR. FREDERICKS RESPONSE 1 Of course. I make it a point to thoroughly review all of my patients’ forms and records before I perform even the most minor of procedures. It’s a matter of pride with me. DR. FREDERICKS RESPONSE 2 This meeting is a waste of my time, frankly. Didn’t I already tell you that Mr. Davis e xpressly trusted me with his care and treatment? I am his doctor. I think I am better suited to determine whether stents were needed or not in this situation, and I clearly, in my professional judgment, believed that they were needed. Now, if you don’t hav e any more questions for me, today, I should be going. Student goes back to the top of the main branch. If other branch es already selected, the conversation continues . STUDENT That’s all I have for today. Thank you, Doctor. DR. FREDERICKS Of course. Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 10 Scene 4 – Follow Up with Chief Counsel In this scene, the student meets with Jeff Passmore to discuss responsibility and lack of consent, as well as the best way to proceed with Dr. Fredericks. Location Student’s office Scene setup Jeff Passmore is sitting across from the student . On -screen characters Jeff Passmore Off -screen characters None On -screen text: You meet with Jeff Passmore to follow up on your progress . . . JEFF So, how did your meeting with Dr. Fredericks go? The Student may choose either option to continue. STUDENT CHOICE 1 Well, Dr. Fredericks didn’t seem to want to take responsibility for what happened. Whose responsibility is it, ultimately, hi s or the hospital ’s? ** STUDENT CHOICE 2 It didn’t go that well. Should the surgery nurse or nurses have taken responsibility and made sure Mr. Davis’s rights were respected per the consent form? JEFF You’re reminding me of a particular case, Mathias versus St. Catherine’s Hospital . In this situation, the defendant did not consent to receive a tubal ligation while under anesthesia for a cesarean section. The patient’s doctor asked for the instrument to perform the procedure and, while the nurses present tried their best to point out that they did not have consent, they did not stop him from performing the procedure. Student must choose both responses to proceed. STUDENT CHOICE 1 How did it turn out? STUDENT CHOICE 2 Can you explain how this relates to our case? JEFF RESPONSE 1 The c ourt granted summary judgment for the hospital fin ding that it was the responsibility of the patient’s physician to ensure the patient’s wishes were followed. The physician is in the best position to know the patient’s wishes and to explain and evaluate th e risks of a particular procedure. With the patient on the procedure table and sedated, it is not a good time to second guess the physician’s decision and hold a formal hearing as to whether or not the physician is going beyond the scope of what the patien t consented to. The Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 11 patient may, for example, after having signed the consent form said, “Dr., do whatever procedure you think is necessary.” The fact that the patient did not change the consent form leaves the physician out on a limb. The most the nurses could do was to remind the physician that the consent form did not authorize additional procedures. JEFF RESPONSE 2 Here’s where our situation is different. Dr. Fredericks may be considered Mr. Davis’s physician, but he’s also an employee of the hospital. I should have made this clearer earlier, p erhaps. By the way he talks; anyone would think that he was still in his own practice . But, Dr. Fredericks left his private practice and joined Bright Road almost a year ago. Student can choose either option to continue. STUDENT CHOICE 1 (incorrect) So, s ince Dr. Fredericks is an employee of the hospital, he is not responsible for checking the consent form . STUDENT CHOICE 2 (correct) So, as both the patient’s physician and an employee of the hospital, Dr. Frederi cks was responsibl e for checking the consent form. JEFF RESPONSE 1 You’re missing the point, here. He is still the patient’s physician, so he is responsible for abiding by the consent form. The question of h is is employ ment helps us determine liability. JEFF RESPONSE 2 Yes, he was responsible. And, because he was an employee of the hospital at the time, then the hospital may be liable for his actions. STUDENT I still don’t know who to believe when it comes to lack of consent involving sound alternatives. JEFF Both sides seem pretty firm in their positions, huh? I had a feeling this might happen. And, it’s not a clearly obvious case, like that of Riser versus American Medical Intern . This was a case where the doctor was ordered to perform one procedure and, without even discussing it with the patient, performed a similar one that had greater risks and a disastrous outcome . It was clear to the court that, had the doctor discussed both options, the patient would’ve chosen the one with less risk. STUDENT So, wha t should I do regarding Dr. Fredericks, then? JEFF When you meet him again, I would make it clear to him where you’re coming from. It’s understandable that someone of his stature would be defensive. But, he needs to know that, as an employee of the hospital now, we are in danger of facing liability on this . H e Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 12 needs to consider the position he has put Bright Road in , and understand how to avoid this in the future . STUDENT It’s hard to get through to him. Any suggestions? JEFF Maybe you could call Dr. Roso into the meeting. She may be younger, but she’s actu ally been at Bright Road longer than he has, right? STUDENT Yes . That’s a good idea, Jeff. JEFF Keep me posted! Scene 5: Next Meeting with Doctors The student meets with both Dr. Roso and Dr. Fredericks to d iscuss the consent form and hospital liability in this and future situations. Location Hospital Conference Room Scene setup Dr. Roso and Dr. Fredericks sit on opposite sides of the table On -screen characters Dr. Julie Roso , Dr. Fredericks Off -screen characters None On -screen text: At your next meeting with both Dr. Julie Roso and Dr. Fredericks . . . DR. ROSO So, the original idea behind consent forms and informed consent was about communication and decision. It’s true, we’re required to disclose risks, benefits and alternatives of a procedure to our patients, but it shouldn’t just be looked at as a way to avoid lawsuits. The goal is to allow patient s make the best possible informed decision about their care and treatment. DR. FREDERICKS I don’t see informed consent as just a way to protect myself from a lawsuit. I was just saying that the forms, the consent forms have become more of legality than anything. STUDENT To Dr. Roso’s point, I think she’s saying that this was not the original in tention, even for the forms. DR. ROSO Right. Our consent forms lay everything out in detail, top to bottom, so , before they undergo a life -changing procedure , our patients can read it thoroughly and make sure this is what they want to do. Hearing it spoken and seeing it explained on paper in front of you can be totally different experiences, with different results. Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 13 Student may click on any option to continue, but must choose all eventually. STUDENT CHOICE 1 So, do you think physicians are seeing this as more of a legality too ? STUDENT CHOICE 2 What can be done to ensure consent forms are given the right amount of attention ? STUDENT CHOICE 3 Is it safe to say that, since Mr. Davis modified the consent form, initialed and signed it, that he was properly informed in this case ? DR. ROSO RESPONSE 1 Unfortunately, yes. I think, especially in this more economically strained time, we’re expected to do more in less time. So, we may not always take the time to go thro ugh the paperwork thoroughly, especially in cases that seem to be cut and dry. DR. FREDERICKS RESPONSE 1 She’s right. I was thinking more about Mr. Davis’s case last night, and, really, I can’t recall whether I saw the consent form before his surgery after all. The more I think about it, the more I think that I relied on our discussions more than the forms. DR. ROSO RESPONSE 2 I think awareness is key. The administration has to make a more effective effort in train ing staff with emphasis on discussing consent forms with the physician prior to proceeding with any invasive procedure . DR. FREDERICKS 2 You’re right. Improving t eam communication s would be more reliable and provide greater accountability, as well . It may be the responsibility of t he doctor, but if everyone works together to ensure the patient’s wishes are being met, I think it will help greatly. DR. FREDERICKS RESPONSE 3 Well, yes, but even beyond that, I think our discussions prior to the surgery implies verbal consent, doesn’t it? DR. ROSO RESPONSE 3 The question is, which one trumps the other, verbal consent or written consent? STUDENT I’m pretty certain that they’ll be able to use the consent form in court to outweigh any conversations you may have had prior , unless you can show proof the patient had changed his mind from what was written on the consent form. That is not always an easy task. It would be better to have the patient sign a new consent form prior to proceeding with an invasive procedure . Even a note in the patient’s record noting the patient’s change of mind prior to undergoing the procedure would have been helpful. Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 14 DR. FREDERICKS You may be right. It is a signed document, after all , and , I made no additional notes in the patient’s record that co ntradicts his wishes . DR. ROSO Again, I think the emphasis moving forward should be on a mindset that respects the patient’s ability to understand their condition, to process the necessary information and then take an active role in the decision process. Some doctors tend to view patients like they’re on some sort of lower level of intellect. DR. FREDERICKS I know. I hate it when I see that. I always try to avoid that in my practice. Well, at least I did when I had my own practice. Student must choose each option to proceed. STUDENT CHOICE 1 Has it been a difficult transition from your practice to being an employee of the hospital? STUDENT CHOICE 2 I think this brings up a good point about the shift in liability from a private practice physician to a member of the hospital ’s employed staff. DR. FREDERICKS RESPONSE 1 Well, I wouldn’t say it’s been too difficult, but, yes, it’s certainly taken some adjustment. There are plenty more rules and regulations that need to be in place here at the hospital, naturally. DR. ROSO RESPONSE 1 True, but I think there is also a better environment of collaboration here, too. We hope that doctors can consider themselves as part of a smooth -running process where everyone works together to the patient’s ultimate benefit . DR. FREDERICKS RESPONSE 2 I think I understand what you’re saying. This situation has certainly opened up my eyes a little more to the fact that I need to shift my mindset over like Dr. Roso mentioned, now that I ’m part of the greater organization here . DR. ROSO It’s a major benefit to me that the hospital has these procedures and well – executed consent forms to help me . And they always have new and talented colleagues like yourself, Dr. Fredericks, for me to work with to provide the best care possible to the patient . DR. FREDERICKS Thank you. I agree. I look forward to taking advantage of this more, like you said. And I appreciate you both taking the time to talk this through. Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 15 Scene 6: Review with Mentor In this scene, the Student meets with Jeff to review the details of Mr. Davis’s case . Jeff will ask questions to help the Student analyze and prepare for writing a recommendation on the hospital’s liability , with emphasis on informed consent . Location Chief Counsel’s Office Scene setup Student faces Jeff who sits at his desk. On -screen characters Jeff Passmore Off -screen characters None On -screen text: Later, you discuss Mr. Davis’s case with Jeff . . . JEFF So, where do we stand with Mr. Davis’s case? STUD ENT I have a lot of good information that I’d like to share w ith you and get your thoughts on. JEFF Great. It sounds like you had a good breakthrough with Dr. Fredericks. What have you learned? Student can click on either option to proceed. Student must choose both eventually. STUDENT CHOICE 1 [BRANCHING 1] Dr. Fredericks was relying heavily on verbal consent. STUDENT CHOICE 2 [BRANCHING 2] The patient was competent, but could’ve benefited from hearing about more sound alternatives. BRANCHING 1 JEFF RESPONSE B1 What are the implications of this, then? Student can choose any option to proceed , but eventually must click all three to continue. STUDENT CHOICE 1 Patient’s rights can be ignored if they’re unable to speak up for themselves. STUDENT CHOICE 2 Verbal consent can’t hold up alone in court, can it? STUDENT CHOICE 3 The hospital is less protected with only verbal consent in place . JEFF RESPONSE 1 That’s a good observation. It seems like Mr. Davis was unable to explain to Dr. Fredericks that he didn ’t want the cardiac catheterization or the stents. In the end, his only recourse was to cross out at least the part about the stents on the consent form. Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 16 JEFF RESPONSE 2 Well, written consent is actua lly not required for every procedure, just the ones tha t pose an unusual risk in one way or another to the patient. There was a case, Siliezar versus East Jefferson General Hospital , where the patient had the procedure explained to her, she agreed to the procedure, but never signed a consent form. Afterwards, the patient tried to sue the hospital, having later regretted the procedure. But, the court sided with the hospital, because, in this case, the explanation of the procedure was sufficient . JEFF RESPONSE 3 I agree that the hospital is less protected. That’s why we have a policy that a consent form must be signed. The question is whether that form is reviewed or not before surgery, to make sure any changes in the patient’s wishes are understood. Student goes back to the top of the main branch. If other branch es already selected, the conversation continues . BRANCHING 2 JEFF RESPONSE B2 Is this what Dr. Roso told you ? Student must choose both options to proceed. STUDENT CHOICE 1 Yes, she confirmed that he not only was competent, but he had asked her to try to talk Dr. Fredericks out of doing the procedure . STUDENT CHOICE 2 Dr. Roso explained alternatives briefly, but that is the duty of t he patient’s physician, right? JEFF RESPONSE 1 See, that’s unfortunate. Mr. Davis obviously didn’t understand his rights as a patient. He could have easily turned down the procedure altogether and gone elsewhere for a second opinion. JEFF RESPONSE 2 Yes, it was Dr. Fredericks’ responsibility to discuss sound alternatives with the patient to the patient’s satisfaction. Of course, since he is an employee of the hospital, we are the ones who will have to answer for his mistake here. Student goes back to the top of the main branch. If other branch es already selected, the conversation continues . STUDENT The hospital needs to provide better training to avoid liability stemming from employee mistakes like Dr. Frederick’s. Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 17 JEFF So, you’re saying the hospital policies are lacking right now ? Or is it just training that needs to be improved? Student can click on any option to proceed. STUDENT CHOICE 1 The y have a good policy requiring a consent form. But, obviously, it didn’t help in this situation. STUDENT CHOICE 2 I think they just need to train better on accountability, making sure the consent form is adhered to. STUDENT CHOICE 3 Employees need to understand the gravity of the consequences of treating patient s without proper consent. JEFF RESPONSE 1 Right. It would’ve certainly helped if Dr. Fredericks an d his procedure team had noticed Mr. Davis’s change to the form. We definitely need to get away from a paper -shuffling mentality, and return to greater attention to detail. JEFF RESPONSE 2 You’re right. As technology changes, as we’re expected to move fa ster, see more patients with the same or better results, it seems a greater emphasis on training is ne cessary . We need training that inform s the staff of the pitfalls and dangers of working in this ev er-changing medical -legal environment. JEFF RESPONSE 3 Definitely. Just like in the case of Ramos versus Pyati , where the doctor performed something out of scope in the middle of surgery, taking a piece of tendon from the patient’s pinky finger to help fix the index finger , the court wi ll not look favorably on doctor s doing more to a patient than they agreed to. Unless, of course, it’s needed to save their lives. STUDENT What happened in the Ramos v. Pyati case? JEFF The court sided against the doctor and with the patient. There was damage involved, since the patient lost some mobility in the finger that the tendon was taken from. And the doctor never discussed this possibility or received consent from the patient prior to surgery. STUDENT How does this relate to our case ? JEFF Remember, as we discussed early on, every patient has a right to allow or disallow any procedure, regardless of whether it is for good or ill, or if the results are beneficial or not. Mr. Davis expressly turned down the insertion of stents during his surge ry, and yet Dr. Fredericks added them anyway. As you probably know, stents have been recalled over the years . Y ou can’t recall an implanted stent. Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 18 STUDENT There’s no way around that, is there? JEFF No. It doesn’t look like it. Even though Dr. Fredericks may think he had verbal consent, the written consent holds up over verbal, any day. Look, I’ve got a conference call in a few minutes. Why don’t you write up your recommendation when you have the chance, and send it to me to look at? STUDENT Will do. Thank s, Jeff. JEFF Oh, one more thing, a lthough we didn’t discuss it here, performing an unw anted procedure could lead to a civil suit for battery. In some cases even criminal charges have been placed against those who have fraudulently for financial gain inserted stents into patients who had no need for them. Luckily we don’t have those issues in this case. Scene 7: Assessment If all previous scenes have been completed, a 10 -question assessment is presented to the student. Answer the following 10 questions to show what you know about health care ethics for equipment purchasing. Good luck! The student answers the questions and then sees the assessment results. Assessment Results Here are your results. Click Continue if you are satisfied with the res ult. Or you can click Try Again if you want to try and improve your score. NOTE: The student can retry the assessment by clicking the Try Again button, or can continue to final scene by clicking the Continue button. Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 19 Scene 8 : Making Your Recommendation In this scene, the Student will write an email to Jeff Passmore with a recommendation on the hospital’s liability in Mr. Davis’s case. The recommendation will include details from the previous conversations to support the Student’s position. Location Stud ent’s Office Scene setup Student is sitting at their desk facing their open laptop and email program . On -screen characters None Off -screen characters None On -screen text: Write an email to Jeff Passmore with a recommendation on the hospital’s liability in Mr. Davis’ case. The recommendation will include details from the previous conversations to support your position. On -screen text: Type your recommendation below on the hospital’s liability in Mr. Davis’s case . Your response should be 250 -500 words in len gth. Be sure to use the notes you’ve ta ken throughout your interviews to back up your position, with emphasis on whether the consent given by Mr. Davis was sufficient enough, prior to surgery. Click Send when you are ready to submit your recommendation. To : Jeff Passmore , Chief Counsel, Bright Road Re: Recommendation on Mr. Davis’s case Body of Email: [Type your recommendations here.] NOTE: Student will be able to fill in their recommendat ion here. NOTE: The student will be given an option to “ Send ” the email afte r writing the recommendation . After the student submits the email, the computer screen fades to the previous view of the student’s office. On -screen text: Your recommendation to Jeff Passmore has been sent! Nice work! Health Care Law Navigate 2 Scenario : Informed Consent February 16, 2018 20 THE END

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