business of Medicine
Onboarding Advanced Practice Clinicians
August 30, 2019
Informed Consent Overview
Informed consent gone right
The patient was an 82 year old male with chronic orthopedic conditions including left knee problems, and left hip avascular necrosis. Knee replacement surgery was discussed with the patient, to be done after medical clearance. Within that period of time, he complained of increasing hip pain instead of knee pain, and was therefore scheduled for hip replacement surgery to be done first. At the time of admission, he changed his mind and decided on knee replacement due to recent increased pain in the knee. X-rays of the hip were ordered to document that there was no urgent need for hip replacement. Informed consent was then obtained for knee surgery to be performed that day. A newly signed informed consent form was witnessed by the patient’s daughter. The appropriate time out protocol was used prior to the surgery, and was documented in the chart.
The plaintiff alleged that the physician performed knee surgery without his knowledge and consent.
This case was closed after the defense was granted a motion for summary judgment.
Risk and Patient Safety Commentary:
Paramount to any informed consent discussion is the fact that more than just a patient’s signature is required. A patient must be given enough information to allow for individual informed decisions. This process involves shared decision making between physician and patient. The form simply formalizes that process. Communication between the physician and patient, and sometimes a significant other,cannot be emphasized enough. In this case, the physician clearly revised the informed consent according to the patient’s wishes, a family member was present to witness and agree, and appropriate documentation was shown in the record prior to surgery. The unique challenge in this case highlights the importance of clear communication between patient and physician. The patient decided on the day of surgery to have his knee replaced instead of his hip, the physician reviewed and obtained a new informed consent from the patient (witnessed by his daughter) for knee surgery, and the physician documented through imaging studies that there was not an urgent need to perform the original hip surgery.
While the outcome of this case was favorable for the physician, lessons learned from this case are applicable:
- Consent issues remain in the top five liability issues in closed claims between 2003-2012[i]
- Always refer to specific state laws regarding informed consent, remembering the following elements are universal in terms of the physician’s informed consent discussion: 1) proposed treatment or therapy, 2) risks and benefits, 3) likelihood of success, 4) treatment alternatives, 5) potential outcome if no treatment.
- Systematic documentation is essential, including checks and balances such as appropriate time-outs prior to the start of surgery.
- Procedure-specific consent forms are often better since they specifically outline the risks and benefits to a particular procedure.
- Informed consent should not be attempted after the patient has received medication such as anxiolytics which could cloud his or her judgement in making informed decisions.
- The opportunity to dispel any unrealistic expectations regarding the operative procedure should occur during the informed consent process, again potentially mitigating liability.
- Ultimately, a good informed consent process is designed to improve and reaffirm the trust relationship between physician and patient, again mitigating the potential for liability if complications occur.
The informed consent process is a pillar of patient engagement. The provider’s role is to offer the patient sufficient information to make informed health care decisions. Although we think of informed consent most often in the context of procedures, equal consideration of the process should be given to any treatment recommendation that carries high severity or a high frequency risks.
Informed consent is not the signing of a document, rather a process that leads to shared decision making between the patient and the provider. The form is merely an affirmation that the process has taken place. In the inpatient setting, hospitals have co-responsibility with providers to ensure that the process has occurred. Hospitals can be negligent for not ensuring that the consent process has taken place, and providers can be held independently liable for failure to obtain informed consent.1
The American Medical Association offers the following guidance on informed consent: “The patient’s right of self-decision can be effectively exercised only if the patient possesses enough information to enable an informed choice. The patient should make his or her own determination about treatment. The physician's obligation is to present the medical facts accurately to the patient or to the individual responsible for the patient’s care and to make recommendations for management in accordance with good medical practice”.2
According to data from the Physician Insurers Association of America (PIAA), medication errors and failure to instruct or communicate with the patient were among the top ten most prevalent factors in medical liability claims. Consent issues ranked among the top five issues associated with closed claims between 2003 and 2012.3
Often, a procedure-specific form is better because it spells out the risks and benefits discussed for the proposed treatment more clearly than a general one. Of course, patients who better appreciate the details of what a proposed treatment entails will be more likely to make smarter decisions about their healthcare, and are apt to be more engaged in self management. Further, when an unexpected result occurs, patients typically stand by their original decision.
Most state statutes specify that proper informed consent requires the provider to inform the patient of the: 1) proposed treatment or therapy; 2) risks and benefits; 3) likelihood of success; 4) treatment alternatives; and 5) potential outcome with no treatment. The risk list need not be exhaustive, but only list things materially likely to occur. Patients should be given plenty of time to review the form (preferably with the help of family and friends), and ask questions of the provider. Every state may have different requirements, so be sure to consult your attorney regarding your state's laws.
The informed consent process remains one of the most important risk management tools physicians have in improving defensibility of claims when adverse events occur. Search in the learning center for state specific informed consent information.
Risk management issues in telemedicine
The use of telemedicine within the healthcare delivery system is experiencing unprecedented growth spurred by Federal support, managed care demands, the decreasing cost of the technology and the opportunity to provide access to medical care to areas of this country where previously unavailable. Using technology that ranges from simple telephones to satellites to state-of-the-art video conferencing equipment and high-tech links, telemedicine has created a variety of applications today in patient care, education, research and public health. However, with the advance in healthcare delivery comes risk to patient care and professional liability exposures to physicians and other healthcare workers. Although not altogether new, these areas of risk and liability exposure have taken on a new look.
- Providers must become comfortable and proficient with the technology they will be using during the telemedicine encounter. Where is everyone involved in the encounter on the learning curve with the technology?
- Minimum requirements for the technology specifications of the equipment used must be established and standardized to fit the type of encounter. For instance, a dermatology consult requires a high-resolution camera and monitor where a psychiatric consult does not. Equipment used for static image consults, such as in radiology, requires certain types of technology. The American College of Radiology has established standards for teleradiology, but who is setting the standard for the type and quality of the equipment being used in other specialties?
- Technology is changing so rapidly that, without minimum standards and specifications, the practice of telemedicine may not evolve congruently among users. A standard which is established by the clinical community which utilizes telemedicine will protect practitioners and patients.
Credentialing and Qualifications
- What are the credentials of the physician or other healthcare provider or who is presenting the patient?
- Who credentialed them, and what are their credentialing criteria?
- Is the working relationship between the two telemedicine healthcare providers compatible? Are styles similar enough that the encounter does not appear to the patient to have any conflict between such providers? Do the practitioners act as a team?
- Has the referring doctor or healthcare provider teleconsultant (‘teleconsultant”) been trained and credentialed in the use of the technology?
- Is the staff at the referring site qualified to handle an emergency during the consult where you are directing treatment? Do you have proper emergency equipment?
- Is the referring physician comfortable with the credentials of the teleconsultant? In the face of an injury brought on by a teleconsultant, the referring physician may be held vicariously li-able for their actions.
- As you have become comfortable with the credentials of physicians you consult with, now you must also become comfortable with the credentials and qualifications of your teleconsultants.
- Do hospitals that host telemedicine sites credential the present-ing physicians and give them some level of privileges? The hospitals could have vicarious liability for physicians practicing in their facility, and the consulting physician should have the assurance the presenting physician is qualified to perform his/her duties.
- In a closed system, it is easy to set the qualifications and guide-lines for those physician and non-physician practitioners working within the system. When telemedicine goes outside of a closed system, you lose control and should be at a higher level of awareness of the qualifications of those with whom you are work-ing. You wouldn’t send your patient to someone without knowing their qualifications; teleconsulting should be the same.
- Under most state laws, the patient does not have to give in-formed consent for a telemedicine encounter. However, with this new system of healthcare delivery, it is important for the patient to have a complete understanding of risks and realistic expectations of the benefits and limitations of telemedicine. Therefore, obtaining informed consent from the patient is advisable.
- Make the patient aware of treatment options to telemedicine, including traveling to the specialist and other acceptable alternatives.
- At this early stage of telemedicine where the public may be skeptical and their level of acceptance is low, the physician may be held to a higher standard, as the courts may view telemedicine as experimental.
- Make sure telemedicine is appropriate for the situation.
- The patient needs to understand what the limits and benefits of telemedicine are in their treatment plan and accept the limitations of telemedicine.
Document the Encounter
- Not only should the exam, findings, treatment and instruction be documented as they would with any patient encounter, the environment used in the telemedicine encounter, including the equipment used and its specifications (i.e., resolution), should al-so be documented.
- All caregivers who treat the patient should generate and maintain a medical record on each patient they encounter.
- The rules for documenting patient care do not change with tele-medicine. The medical record is still the first line of communication to you and subsequent treating practitioners and still the first line of defense in an allegation of professional liability.
When to Proceed & When to Stop
- Don’t be afraid to stop a telemedicine exam or treatment if you, in your professional judgment, believe the patient would be best treated in person. Proceeding with an exam or treatment when there is a high possibility of misdiagnosis or treatment injury is not a new liability exposure.
- However, proceeding with a telemedicine exam when a face-to-face encounter is indicated adds an extra problem when faced with an injury.
Responsibility for Patient Treatment
- As with any consult or referral, discuss and clarify the roles and responsibilities of each practitioner prior to the patient encounter and clarify the arrangement to the patient.
- Who has established the primary patient-physician relationship?
- A referring physician may be held vicariously liable for the negligence arising from the acts of the teleconsultants. This theory of negligent referral is not new as applied to telemedicine, it just emphasizes the need to know your consultant and feel comfortable with their qualifications.
When is the Patient-Physician Relationship Created?
- This is a fundamental issue with telemedicine that continues to be up to interpretation. It must be made clear to all, including the patient, as to who has responsibility for which part of the patient’s care, treatment and follow-up.
- If the teleconsultant acts as an advisor to the treating physician, a relationship with the patient may not have been created. The attending physician is still the one making the treatment deci-sions based on the advisor. If the teleconsultant is actually directing care and treatment of the patient, there is no doubt that a patient-physician relationship exists.
- In most states, the existence of a patient-physician relationship is requisite to creating a legal connection between the parties, and thus a duty.
Personalize the System
- The teleconsultant must put forth an extra effort to establish rap-port with the two-dimensional patient on the monitor.
- The public may be accustomed to viewing TV, but they are not accustomed to real-time interaction.
- Design both the transmitting and receiving rooms to be similar and make reference to objects or charts in the room to give the patient more of a feeling that you are there.
- In some situations, the person uncomfortable with the encounter may not be the patient, but the physician or other practitioners.
Electronic Records and Confidentiality
- As part of a standard procedure, the teleconsultant and the referring physician must explain to the patient how telemedicine and the electronic transfer of medical information work. The safe-guards of confidentiality on the transmission of the actual encounter, any recorded information and any hard copy documents should be explained.
- The patient must be told who is viewing the encounter. If they feel their cyber exam is being viewed by others, they may not be honest during the exam or worse, may not seek care or follow-up.
- Properly designed electronic record systems can provide greater protection for sensitive information than paper-based records.
- Passwords for electronic record systems must be changed regularly and never shared. Employees should be asked to agree to and sign a Confidentiality Agreement.
Standard of Care for the Use of Telemedicine
- At what point will obtaining a telemedicine consult be considered a standard of care and, thus, create a duty? Some say the duty may be created now.
- In Georgia, the requisite standard of care is defined as what is employed by the profession generally under similar conditions and like surrounding circumstances.
- Therefore, if a teleconsultant is available in a rural area through a locally established telemedicine conferencing center, and the resource is not used as other physicians in the community utilize the resource; is this practicing below the standard of care? Is telemedicine, once established and proven effective, another re-source that must be considered and utilized, if applicable, as you would refer to any specialist?
- Telemedicine has the capability to substantially improve access to needed healthcare services and medical expertise. However, the technology of telemedicine has evolved faster than applicable law.
- Physicians and other healthcare workers are subject to the laws, rules and regulations of the state in which they practice. In most states, a physician is considered to be practicing medicine in the state where the patient is located. Therefore, if a physician teleconsults on a patient in another state, he or she will most likely be subject to that state’s jurisdiction and licensure laws. Physicians who teleconsult should consider the following:
- The Federation of State Medical Boards and the American Medi-cal Association has been in discussion as to the numerous licensure issues, but to date nothing has been decided upon toward the adoption of uniform standard and administrative requirements.
- Will he/she have coverage for professional liability claims if they occur from a telemedicine encounter and the suit is filed in an-other state?
- In which venue will the plaintiff be allowed to file the lawsuit? The attorneys will likely choose the location most favorable to the plaintiff.
- At this time it is advisable to be licensed in the state in which he or she resides and the state where the patient is being consulted.
The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.