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Re: Consent for Vag deliveryFrom: ainsron (ainsron@sbcglobal.net)Tue Jun 6 11:28:43 2006
JCAHO be damned or not, the process of informed consent is defined by the courts, not be JCAHO. They may be the messenger, but they do not create the laws. I apologize for the length of the following, but it is the summary of a recent discussion on Informed Consent that came from my malpractice carrier: Informed Consent 1. A competent patient has the right to decide what will happen to his or her body with regard to medical care. That right has two separate aspects: a. First, a patient has the right to consent or refuse consent to any recommended medical procedure. b. Second, a patient has the right to sufficient information to make that consent meaningful. c. A violation of the first aspect is considered an intentional tort, battery or fraud; a violation of the second is considered negligence. 2. Battery may be found not only when a physician provides a non-consensual treatment, but also when a physician exceeds the scope of the patient's consent, i.e., performs an additional procedure in the course of providing the procedure to which consent has been obtained. A physician who withholds or misrepresents a material risk or other material information related to a medical procedure may be liable for fraud and intentional infliction of emotional distress. Unless an emergency requiring additional or different treatment occurs in the course of providing treatment to which the patient has consented and obtaining the patient's consent to the other treatment is impracticable, a physician would be well-advised to obtain the patient's consent before performing the other treatment. 3. California law requires the physician to disclose all information which is "material to the patient's decision of whether to proceed," that is, "that which the physician knows or should know would be regarded as significant by a reasonable person in the patient's position when deciding to accept or reject the recommended procedure," supplemented as necessary in cases in which "the physician knows or should know of a patient's unique concern or lack of familiarity with medical procedures." (Truman v. Thomas, 1980) 4. There are only four exceptions to the informed consent requirement, the scope of these exceptions is relatively narrow and physicians who rely on any of these exceptions would be will advised to document in the patient's chart the reasons why the exception is invoked: a. Emergency situations, b. Patient requests not to be informed c. "Therapeutic privilege, and d. Testing of blood or patient samples to determine exposure to AIDS or communicable disease. 5. In order for a patient's informed consent to be valid, two criteria must be satisfied: a. The consent must be voluntary, the patient may withdraw his consent at any time before the proposed procedure has been initiated b. The patient must have decision-making capacity. 6. Patients must be given enough information in lay terms to make a knowledgeable decision regarding the recommended medical procedure. The Supreme Court has specifically mentioned three areas which should be discussed: a. The nature of the recommended treatment; b. The risks, complications and expected benefits of the recommended treatment, including its likelihood of success; and c. Any alternatives to the recommended treatment, including the alternative of no treatment and their risks and benefits. d. The California Supreme Court also ruled that is important to disclose the patient's diagnosis or life expectancy, although there is no duty as a matter of law to disclose such information in all or certain categories of cases. e. To date, there has been no conclusive California Court ruling as to whether or not physicians have a duty to disclose personal background information (such as HIV status, drug or alcohol abuse, frequency of complications) or their level of expertise to a patient as part of the informed consent process. 7. Informed consent is part of the process by which the caregiver and the person receiving the care begin to understand the various risks and benefits of the procedure, either with surgery or during the entire course of care. 8. The duty to inform and explain rests with the physician who will be performing the procedure. As a general rule, the physician should not delegate this duty to a nurse admission clerk, receptionist or any non-physician. 9. Informed consent or shared decision making is something that is not simply mandated by law, it is the right thing to do for patients. Physicians need to have discussions with their patients at an appropriate time and location. They also need to provide the patient with the necessary information and the material risks, alternatives, benefits, etc concerning their treatment or procedure. They need to make certain that the patient understands the information being discussed. They should not simply speak to the patient, but make certain that the patient provides feedback and understands what is being said. The physicians should then get the appropriate forms signed, make the right note in the chart, and then continue with the practice of medicine. If there is a complication, having taken all of these steps, they will have done one of two things: they will have prevented a claim or, at the very least, will have provided the foundation for a defense for the defense attorney and for the experts in defining the case against them on informed consent. 10. The informed consent process is a long one, not necessarily taking place all at one sitting. 11. With elective procedures, the process usually begins far in advance of the procedure because basically the patient is taking on acceptance of care. 12. The first step in the process of the mutual understanding is just one step and is the most important, both for understanding and for the ethical management of the illness. 13. The second step is to document that the patient has received this information and understands it; then documentation of that process must be placed in the medical record, where it can be reviewed at a later time if necessary. 14. The attending surgeon or attending physician should be the one who is obtaining consent from the patients; it should not be the responsibility of the nurse or medical assistant. The discussion and the consent form must be handled by someone who is knowledgeable about the procedure and the surgery, if applicable. It is important under non-emergency circumstances to have the form signed at some preceding time during the discussion with the attending physician. 15. The hospital consent is frequently delegated to someone who is part of the team. It should not be delegated to someone who is not part of the team. At that point, meaningful discussions have already taken place. The hospital form is the last of a series of several encounters about consent; not to diminish its importance, but certainly at that point, someone who is part of the team could get the form signed. 16. Physicians have a duty to discuss with the patient the material risks of a specific procedure or treatment that is being recommended, the expected benefits of the treatment, and the possible alternatives, including the option of doing nothing. a. Informed consent is a legal concept that dates back to a 1914 New York state court. In 1972, the U.S. Court of Appeals for the District of Columbia confirmed the importance of the "patient's right of self-determination" and held that physicians must disclose all risks that potentially affect a patient's decision about a course of treatment. It is important to understand that informed consent law varies significantly from state to state, with approximately half of the states holding to a "reasonable professional" standard and the other half holding to a "reasonable patient" standard. b. You should be prepared to handle situations in which informed consent must be obtained from a person other than the patient. It is important to understand the specific requirements that apply to patients who are under age or who have legal guardians, as well as adult patients with diminished capabilities. c. With informed consent, physicians have a duty to discuss the following items with their patients: the material risks of a specific procedure or treatment that is being recommended; the expected benefits of that proposed treatment; and the possible alternatives, including the option of doing nothing. d. Patients should also know the potential effects of a treatment, especially if it may affect the patient's ability to drive or operate large machinery. e. A physician should inform a patient if the physician subsequently learns about dangers posed by a prior treatment or procedure, especially if steps can be taken to avert the potential harm. f. Patients need to know what might happen if they did nothing rather than undergo the treatment or procedure. g. This is the duty of the physician. It is not non-delegable. h. A physician has no obligation to advise a patient about treatment which is not available in California, even if the treatment is available in another state. i. A physician has no obligation to disclose unapproved treatments. j. The fact that there are other reputable schools of thought concerning a proposed treatment may also be material information that should be disclosed to the patient in obtaining informed consent to a procedure. However the California Court of Appeals has rejected the contention that a physician has a duty as a matter of law to inform a patient of other possible views of other healthcare providers and rejected the general duty of disclosure concerning a treatment or procedure the physician does not recommend. 17. In informed consent discussions, the physician describes for the patient the nature of the illness or condition. Although many patients already have great understanding, they should be asked about what they think is going on and how they think the issue needs to be addressed. 18. By asking patients these questions, physicians will gain a good understanding of what the patients know about the process to come 19. The surgeon will describe the procedure, what the operation consists of, and what the patient will immediately encounter with respect to pain, discomfort, nausea, and vomiting. The surgeon will then point out that some procedures carry rather great risks. Many surgeons emphasize the great risks early such as dying or disability because then everything else begins to be compared with the greatest risks. Then the lesser risks the long-term necessity for taking medication over a period of time, the potential discomforts, risk of infection, the weakness induced by the various drugs, etc can be brought into the discussion either at that sitting or at subsequent sittings, because this is a long process for such a complicated issue. For simpler procedures, simpler operations, this can be shortened, of course. 20. The inclusion of death as a possible complication of a procedure or treatment does not relieve the physician of obligations to discuss less severe risks. In examining consent forms, there are specific things to look for. Was there a specific mention of the risk that is now an issue in the case? If it is a laceration of an adjacent organ, for example, was that specifically mentioned in the consent form? If so, it is very unlikely that an attorney would get involved in pursuing an informed consent case. However, many of the consent forms being used are rather generic. They include catchall phrases and sentences that say something like "I acknowledge that my doctor has told me about all of the risks and pitfalls of the procedure." This is a very generic statement as opposed to one that specifically lists certain risks that can occur with this particular procedure. Some have used the argument that if the informed consent form lists death as one of the potential complications but does not mention something less final, yet that less final complication occurs, then everything is subsumed in death. Therefore, why would anything else need to be mentioned? The average juror might see the inclusion of death as a self-serving sort of catchall to relieve the doctor of talking about the specific risks that patients would need to know if they were about to undergo colonoscopy, open heart surgery, gastric bypass, etc. What are the real, specific things they would need to know? I do not believe that inclusion of death subsumes and relieves the physician of obligations to talk about anything else because the average juror probably would not look at things that way. 21. Physicians must use an element of discretion in determining which specific risks to include on a consent form. In using a consent form, doctors must decide if they want to use the generic form or a more specific form. The generic form basically says that the physician has informed the patient of all of the risks and alternatives to the surgery. These forms are rather open ended for testimony as to what was or was not said. A more specific consent form itemizes all the risks. The itemized list can be very helpful to the physician because it specifically covers the risks that may materialize during surgery that may lead to the patient's injury. In those cases, the physician probably feels a sense of protection from an informed consent case. However, if the itemized list is used and a risk occurs during surgery that was not on that specific menu, the physician has left himself (or herself) open to the argument from the plaintiff's attorney that the specific complication was not listed on the form and, therefore, probably was not discussed. The generic consent form in which specific complications were not mentioned leaves it a little more open ended for testimony at trial about what was or was not said; that can benefit either the doctor or the patient in any given case. Physicians may struggle with the question of where to start and end when listing potential complications. The guidance from the courts refers to something called "material risks," but there is no break line test to determine what that is. There is always going to be an element of discretion with physicians. They have to use their best judgment and say, "These are the material risks. I have listed them for you." If something else happens, physicians are left with the argument that the complication was so rare and so unforeseen that they did not even think to discuss 22. Informed consent is usually an ongoing discussion between the physician and the patient, especially with elective procedures in which patients will be seen over the course of time. 23. A physician cannot satisfy the requirement of informed consent merely by using a printed form, no matter how complete, a discussion and documentation of the discussion is essential, the consent form is used only in conjunction with that discussion. 24. When patients are given a consent form, they should take the form home, read it, and bring back any questions or concerns they might have. Physicians should then complete the process with a note in the chart. At many institutions, physicians use procedure-specific forms. For example, if the patient is going to undergo a cholecystectomy, a special form is used for that procedure. The specific risks are listed on the form for that particular procedure, which is available for physicians to give to their patients. Physicians should also use the form during their discussion with the patients, which is the basis of informed consent. Patients should take the form home, read it, and bring back any questions or concerns they might have. Physicians should then complete the process with a note in the chart and the physician has one of two ways of documenting that discussion: (1) the short or succinct side of what was talked about and the risks and benefits discussed, or (2) a note in the chart that would accompany the specific form. If physicians use the short form of the note, they should make sure they have a routine. That way, if there is ever a question about what they did or did not say, they can sit in front of a jury or judge or at a deposition and credibly testify, "I know I told Mr. Smith about points 1, 2, 3, and 4 because I tell every one of my patients whose gallbladder I am going to remove that these are the risks they face." That will give physicians some credibility when they say that because the note itself is brief and succinct. 25. When possible, a family member should be present with the patient during the informed consent discussion to help the patient understand what is being discussed and to verify what the physician did or did not say. It is important that another family member (or someone else if a family member is not available) be involved in the consent discussion with the patient. That person may either agree with or have another viewpoint on what went on during the discussion. It is important from the patient's standpoint, in particular, to have someone else present. Patients do not go into surgery with the idea that they may file a legal claim down the road. Unfortunately, if another family member is not present during the discussion and the patient dies during surgery from a risk that may or may not have been disclosed, the patient has no witness to verify what the doctor did or did not reveal about the risks or alternatives to the procedure. There are also other more immediate reasons for having a family member present. Often one person in the family is more medically attuned, is more inquisitive by nature, and is perhaps the person the patient looks to for support. Having that person there to either pose a question or filter an answer from a physician can be beneficial to both sides. From a medical perspective, it is important that a patient has an advocate or a family member there to ask questions that the patient either has not thought of or is uncomfortable asking. That person can also ensure that the information being relayed is received and understood and can perhaps relate to the patient, in plain English, what is going on or is to be expected. 26. There are times when a surgeon will have to sit down and discuss the situation quickly and then immediately take the patient off to the operating room. This may lead to many misunderstandings because of the anxiety of the urgent situation. When the opportunity arises, physicians should raise the issue and discuss the alternative treatments that might be available. In most cases, there are multiple options, and in discussing the problem with the patient, physicians are essentially getting consent for the next stage in the process. This is very important because then, at the time of the documentation that the discussions have taken place, physicians can ask the patients once more what they understand about the risks and benefits of this procedure and get a good idea about their level of understanding. Then when they are asked to sign a paper that lists many of the complications in detail, they understand in general that this is a documentary phase. 27. The timing of the informed consent discussion is not as critical as the fact that the discussion takes place in the privacy of the doctor's office. The informed consent discussion should not take place as the patient is being wheeled into the operating room. The patient may be in a state of anxiety or may have been premedicated. It important that physicians take time to sit in their office and discuss the situation with the patient ahead of time. Patients are a little more skeptical of what was or was not said if the consent discussion takes place in the holding area before surgery. If it takes place in a doctor's office in a private setting, one on one, it is more likely that the physician did have a full and complete discussion with the patient. Most discussions that take place in the office for elective procedures are such that, given the surgeons' typical schedule, they are occurring usually within a week of the procedure. Patients should be given some time to think about what was discussed. If the discussion took place 6 months prior to surgery, that is a different matter. However, the location of the informed consent discussion is more important than the timing. 28. Level of Detail. Every possible complication that could occur should not be addressed in the informed consent discussion; only those that are deemed a material risk should be included. There is, unfortunately, no definitive line to say that "anything that is more than 1% probability must be disclosed and anything less than that does not have to be." The physicians must use a great deal of discretion in knowing what to emphasize in the discussion. Of course, if death is discussed as a possibility, everything thereafter seems to be lesser of a potential problem. 29. Postoperative Complications. People often assume that if they survive the operation, they are over the hump, which may not be true. Operative deaths or immediate postoperative deaths are very rare in almost any medical procedure. It is important to recognize that complications may begin after the operation. Patients often do not realize that things may not have gone perfectly after the operation or that, in the course of getting better, they may get worse first. Explain to patients that in the course of recovery, there is always a risk of problems, and that we cannot guess what they are all going to be. We will do our very best to prevent them, but in the course of prevention of certain kinds of complications, we may encounter complications of the prevention procedure. 30. In an informed consent discussion, physicians should question patients about their concerns regarding treatment. Most physicians want to reassure the patients that they are getting the best possible care and that the ultimate outcome is going to be favorable. In the majority of therapeutic endeavors, there is some relief of the patient's concerns. For example, in patients with cancer, physicians cannot promise them that they will be cured by their operation. Physicians often must tell their patients that they may require more therapy and that, even though their chances are good and a lot better than they used to be, the outcome is not always going to be perfect. Making this balance is extremely complicated, and, in urgent situations, it is virtually impossible to convey in truth. That is why the serial conversation is so important, because each conversation helps the physician realize how much the patients understand with respect to the problems that might arise during the therapeutic process. Asking patients what worries them is sometimes useful. Reading their faces is critical. Patients would like to deny that they are actually going to have any trouble. Many patients have faith that they are going to do very well, and warnings or advice concerning potential complications should not lead them to reject the procedure that is being recommended to them. Therefore, asking what worries them is very helpful. Although physicians can reassure patients that they are going to do their very best to make that happen, they cannot promise that things are going to be perfect because they rarely are. 31. In emergency situations in which a victim is brought to the emergency department and requires immediate attention, consent is implied. Informed consent for emergency procedures is a little different. In these instances, informed consent is still needed but it is implied. If a trauma victim is brought to the emergency department in critical condition and needs a particular surgery or treatment, physicians cannot wait until the patient regains consciousness to sign a consent form. They obviously have to do what is necessary to treat the patient. In those cases, consent is implied. Physicians cannot wait for a form to be signed or a conversation to take place with a trauma victim; they must do what is necessary without delaying any needed surgery or treatment for the patient. Usually these types of cases are team processed. If a patient comes in after an automobile accident and desperate measures need to be performed, part of the team will inform the family or find significant others who are involved with the patient. These team members will later explain to the family members what treatment was necessary and why it was necessary to do it without going through the usual processes in gaining informed consent. 32. During informed consent discussions, a third party should be present to witness the signatures of both the patient and the physician on the consent form. Consent forms should not be pre-signed by the physician. With a procedure-specific form, it may be tempting to go ahead and sign the forms and put them away to use later on. That is not a good practice and should not to be done. The forms should be signed by the physician and the patient during the informed consent discussion with a witness present for the patient's signature. The witness is not witnessing the discussion of informed consent but only the signatures on the form, verifying that the discussion has taken place. Pre-signed forms lead to deception. They are an invitation to trouble or a perception that the discussion actually never took place. It is very important to mutually witness each other's signatures--the doctor and the patient with the witness present. Another thing that should be included on the consent form, when appropriate, is bilaterality. In cases of back surgery, the particular level of the spine should be specified. Then when the patient comes into the operating room and the discussion takes place between the surgeon, anesthesiologist, and circulating nurse, the appropriate person can match up the consent form with the scheduling. This verifies that the patient knows exactly what is to be done. These things are important and are mandated to be on the consent forms. 33. Special consent requirement apply to sterilization, hysterectomy, breast, prostate and gynecological cancers, electroconvulsive therapy, psychosurgery, and certain experimental procedures. Numerous laws and regulations govern human experimentation and investigational use of drugs and devices. Ronald E. Ainsworth, MD, FACOG -----Original Message----- From: ob-gyn-l@obgyn.net [mailto:ob-gyn-l@obgyn.net] On Behalf Of RModugno@aol.com Sent: Tuesday, June 06, 2006 8:56 AM To: Multiple recipients of list OB-GYN-L Subject: Re: Consent for Vag delivery In a message dated 6/6/2006 10:47:52 A.M. Eastern Standard Time, ainsron@sbcglobal.net writes: However, according to JCAHO, the hospital initiated consent form does not document informed consent. It has to be initiated and signed by the physician/CNM. I am arguing this point. Of course the hospital-initiated consent is informed consent - our hospital consent form complies with the state requirements for informed consent - and that's all that really matters - JCAHO be damned! :+) Soon they'll be saying that you don't need anti-depressants to treat postpartum depression, just vitamins, diet and exercise! Robert Modugno MD MBA FACOG Marietta, GA
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