Browsing articles in "Patient Issues"

Duty to Warn Patients Not to Drive

Anne M. Menke, RN, PhD OMIC Risk Manager

The establishment of the physician-patient relationship imposes certain duties upon ophthalmologists. Some—privacy, confidentiality, continuity of care, and reasonable prudence—are well known and much discussed. Other duties, such as reporting and warning obligations, may give physicians pause, especially if they require a breach of confidentiality or disregard for the patient’s express wishes. This Hotline addresses the duty to warn a patient and report to the state if driving ability is impaired.

 Am I liable for any harm done by my patient while driving?

 Ophthalmologists have been sued by patients and third parties who were involved in motor vehicle accidents. Expert witnesses who evaluate these cases for breaches in the standard of care address two issues. First, did the patient have a condition that should have led a reasonably prudent ophthalmologist to warn the patient not to drive? Second, if the patient had such a condition, did the ophthalmologist warn the patient and document the discussion? In our experience, suits have been dropped if the medical record indicates there was no such condition or, if there was, that the ophthalmologist did warn the patient. Conversely, physicians have been held liable for harm to the patient and injured third parties if no such warning was given.

 Based upon my examination, I don’t feel it is safe for my patient to drive. Am I obligated to inform and warn the patient not to drive?

A  Yes. If the patient has a condition that may prevent safe driving, warn the patient and document the discussion. Reasons to conclude a patient shouldn’t drive include conditions characterized by lapses of consciousness (seizures and epilepsy), dementia, and those that result in certain amounts of uncorrectable decreased visual acuity and reduced visual fields, as well as side effects of medications (tranquilizers and pain medications) and substance abuse.1 Some patients may be able to drive only under certain conditions, such as daylight. Others may need to abstain for only a short period; this is usually the case after dilating drops have been inserted for diagnostic and therapeutic procedures. In addition to reminding patients to wear sunglasses, warn them that dilating drops may adversely affect their ability to drive.

 My patient says dilating drops do not impact his driving and refuses to have someone else drive him to my office. May I still administer the drops?

 Yes. Many ophthalmic conditions can only be diagnosed and monitored if the pupil is dilated. As long as you have warned the patient, you may administer the drops.

 I have warned my patient about driving, but she refuses to heed my advice. What else can I do?

 Patients who can no longer drive may fear a loss of independence and worry about imposing upon friends and relatives. It is thus understandable when patients are reluctant to heed a physician’s advice. Repeat the discussion at each visit in the hope of breaking through the patient’s denial. Consider contacting the patient’s primary care physician for help in convincing the patient. You may also discuss your concerns with the patient’s family and friends. The HIPAA web site clarifies that you may speak to family and friends if you have been given permission, if they accompany the patient to visits or are involved in the patient’s care or payment, or if your professional judgment indicates that such a discussion would be in the best interest of the patient.

 Am I required to report a patient’s inability to drive to my state department of motor vehicles (DMV)?

 The American Medical Association advises physicians that “in situations where clear evidence of substantial driving impairment implies a strong threat to patient and public safety, and where the physician’s advice to discontinue driving privileges is ignored, it is desirable and ethical to notify the Department of Motor Vehicles.”3 Some states require physicians to report, others allow but do not mandate reports, while a few consider a report a breach of confidentiality. There could be liability and penalties if a physician does not act in accordance with state laws on reporting and confidentiality. The safest course is to verify the law. Many states clarify driver’s license laws on the DMV web site or provide a link to email the DMV. If you cannot get an answer from the DMV, contact your state medical board, state medical association, or state ophthalmology organization. If you are required to notify the state, do so only after discussing your evaluation and informing the patient that you will be notifying the state. If you are allowed but not mandated to report, consider that in the event of an accident, a jury may find you did not do all you could have to prevent harm to the patient and others if you do not contact the DMV.

When Patients Shouldn’t Drive

Paul Weber, JD, OMIC Risk Manager

Digest, Fall, 2000

Ophthalmologists frequently inquire about their liability if they report a patient whose visual impairment creates a driving hazard. A related issue is whether an ophthalmologist can be held liable to a third party who is injured in an accident caused by a visually impaired patient. Understanding the reporting laws in your state and calling OMIC’s Risk Management Department are important first steps to reducing the potential liability of this complex legal and ethical situation.

Do I have a duty to report a patient to the motor vehicles department (agency may vary from state to state) if that patient’s vision is severely impaired?

A  Many states require physicians to report patients who have epilepsy or disorders characterized by lapses of consciousness. However, in most states it does not appear that physicians have an affirmative duty to report patients who fall below a certain visual acuity or have limited field of vision. There are exceptions, such as Pennsylvania, where the law states that if a patient has a “visual acuity of less than 20/70 combined vision with best correction,” the physician must report that patient to the Pennsylvania Department of Transportation for further evaluation. Contact your state medical society since most associations will have information regarding diseases and conditions that must be reported to state agencies.

If I am not required by state law to report a patient whose visual impairment affects driving ability, but I do so anyway because I believe it is my ethical obligation to protect the public, what are my risks?

A  Some ophthalmologists believe that voluntary reporting of patients violates the confidential doctor-patient relationship and adversely impacts their role as patient advocate. Others worry that patients won’t be honest with their healthcare provider if they fear being reported. On the other side are those ophthalmologists who believe that reporting a visually impaired driver could help prevent a death or serious injury. Many states, such as Florida, California, and Illinois, keep such reports confidential and provide immunity from civil or criminal prosecution to those who provide such information. Prior to voluntarily reporting a patient to a state agency, OMIC insureds are advised to contact the Risk Management Department.

Q  Should I discuss my concerns with the patient or patient’s family before I report the matter to local authorities?

A  You should tell patients first when it is your professional opinion that their vision is so severely impaired that they should not be driving. From a practical standpoint, this may be enough to convince a patient to stop driving. From a legal standpoint, any discussion regarding a visual impairment should be thoroughly documented in the patient’s chart. This documentation will help defend against claims by the patient or others that the patient did not understand the nature or extent of the visual disability.

Discussing the matter with family members is more delicate. Generally, a patient’s medical information cannot be shared with family members without the signed authorization of the patient. However, if a family member is present during the examination, you may simply ask the patient’s permission to discuss the matter in front of the family member(s) and then document that such permission was orally obtained. Although it is a clear breach of confidentiality to discuss such matters with family members without the patient’s permission, you may feel ethically compelled to do so if there is someone who might be able to persuade the patient to stop driving.

Q  Am I liable to a third party if a visually impaired patient causes an accident?

A  Generally, no liability will attach to the ophthalmologist in such circumstances. Most courts opine that allowing third parties to sue physicians would disregard the legal principle of “foreseeable risk of harm” and extend liability limitlessly to treating physicians vis-à-vis third party victims.

An exception to this general rule arises when an ophthalmologist “causes or aggravates” the impairing visual condition. In one OMIC case, a third party claimed he was injured by a patient whose driving was impaired after the ophthalmologist dilated the patient’s eyes. No payment was made to the third party; however, the case serves as a reminder of the need to inform patients about visual impairment following certain treatments or examinations. Another exception to the rule was made in a California case in which a physician allegedly failed to warn a patient that his uncontrolled diabetes made it dangerous to drive. The court stated that liability could be imposed if the injured third party could prove that the physician’s failure to provide this warning was a “substantial factor” in causing the claimant’s injuries. This ruling reinforces the importance of documenting that a patient has been informed of impairments that could affect driving.

Who Can Perform Preop History & Physical Exams?

Anne M. Menke, RN, PhD, OMIC Risk Manager

Digest, Summer 2005

Many patients contemplating eye surgery also have medical conditions that could increase the risk of operative or diagnostic procedures and anesthesia/ sedation. While ophthalmologists are medical doctors, as specialists they generally limit their care and treatment to ophthalmic conditions. Accordingly, most ophthalmologists do not perform the preoperative history and physical examination (H&P) themselves. Instead, they regularly refer the patient to the primary care physician (PCP) for medical clearance. In the past, H&P exams performed by the PCP within 30 days of surgery met the requirements of regulatory and credentialing organizations. In 2002, CMS began mandating a reassessment within 7 days of surgery, and JCAHO recently instructed facilities that the patient’s condition must be updated within 24 hours of the procedure. As a result, ophthalmologists are being asked to either conduct the reassessment themselves or cosign one done by a Certified Registered Nurse Anesthetist (CRNA), Physician’s Assistant (PA), or Nurse Practitioner (NP).

Q  My hospital has asked me to update the patient’s preoperative history and physical examination by conducting a physical assessment prior to surgery. I haven’t done a preoperative H&P since my residency years ago, and I don’t feel competent to do one now. What should I do?

A  There is no way to truthfully sign a reassessment form without conducting a history and physical examination, however brief. Ophthalmologists whose current competency does not include these skills should decline such requests and work with the hospital administration to find alternative solutions, such as those described below.

Q  I have been conducting these reassessments for several years. What are the malpractice risks?

A  The primary purpose of the preoperative evaluation is to determine if the chosen procedure and anesthesia are safe and appropriate for the patient and to help anticipate potential complications related to ophthalmic or medical comorbidities. If a patient experiences an unanticipated outcome, he or she might allege that the reassessment was negligent or failed to detect pre-existing medical conditions. If you conduct these evaluations, make sure your H&P skills are up-to-date.

Q   The ASC where I operate has hired NPs and PAs to reassess patients. Is it risky for me to cosign their evaluations?

No. These are highly trained mid-level practitioners whose scope of practice regularly includes H&P exams. OMIC has analyzed the liability risk for ophthalmologists when CRNAs provide anesthesia care during ophthalmic procedures (“Anesthesia and Sedation Risks and Precautions,” OMIC Digest, Summer/Fall 2004). When physicians supervise CRNAs who are not their employees, they are not necessarily liable for the actions of the CRNA. Courts generally focus on the amount of control the physician exercises over the provider to determine whether the physician should be held liable for the anesthetist’s actions—whether the anesthesia provider is a CRNA or an anesthesiologist. While plaintiff attorneys might argue that the ophthalmologist’s signature on anesthesia orders, evaluations, or records is proof of control, they will need further evidence that the physician directed the actions of the CRNA to win their case. Similarly, simply cosigning the update to the patient’s condition does not make the ophthalmologist liable for the actions or omissions of the NP or PA.

Q  Does my signature imply that I am certifying the reassessment?

A  No. Your signature on a reassessment form acknowledges that the patient’s medical condition has been evaluated but does not imply that you are attesting to the accuracy or thoroughness of the examination in question. Once the NP or PA has completed the history and physical examination, read it and write “Patient reassessed and medically cleared for surgery by ___________ NP/PA” (include the provider’s name and title).

Q  Can the preanesthesia evaluation performed by the anesthesia provider be used to update the patient’s condition?

A  Yes, and many hospitals and surgery centers meet the CMS and JCAHO requirements in this way. Anesthesiologists and CRNAs have considerable expertise in conducting H&Ps, and must evaluate the patient prior to administering sedation or anesthesia. In the “Updates to the Patient’s Condition” question on its web site (www.jcaho.org), the JCAHO states, “In the situation where the patient is going to have surgery within the first 24 hours of admission, the update to the patient’s condition and the preanesthesia assessment (PC.13.20) could be accomplished in a combined activity.”

Follow-up Duty to ER Patients

Anne M. Menke, RN, PhD, OMIC Risk Manager

Digest, Fall 2006

The most frequent Hotline question we receive related to EMTALA concerns follow-up care. EMTALA stipulates that the hospital must provide the patient with a plan for appropriate follow-up care that is geographically and financially accessible to the patient as part of the discharge instructions. It does not, however, state who must provide the post-discharge services, or make the hospital ensure that follow-up care is obtained. Furthermore, once the patient is discharged, EMTALA no longer applies. Regardless of EMTALA’s silence on the who and how of follow-up, hospital emergency rooms routinely send patients to the appropriate specialist for post-discharge care.

 Does serving as an on-call physician create a physician-patient relationship that would require me to provide post-discharge care?

 The legal theory of professional negligence is based upon the duties that arise from the physician-patient relationship. It is not always clear if a physician-patient relation- ship has been established that would impose an ongoing duty to the patient, as the on-call physician’s involvement may include personally examining and treating the patient, speaking only to the ER physician, having his or her name appear on the discharge instructions, being the on-call physician for that day, or simply being part of an on-call panel. Moreover, even if a physician- patient relationship was established, the relationship may be limited to providing stabilizing treatment in the ER rather than obliging the physician to provide ongoing care. Patients may reasonably assume that if you provide emergency care and tell the patient of the need for ophthalmic follow-up care, you will provide it. The same is true if the ER tells a patient for whom you provided a telephone consult to follow up with you, or if your name appears on the discharge instructions. If you do not intend to provide post-discharge care, you need to take certain steps. OMIC policyholders who need help determining their relationship and duties to ER patients are encouraged to call our Risk Management Department.

 One of my patients was seen in the ER. Do I have a duty to provide post-discharge care?

 Yes. If you have a preexisting physician-patient relationship with the individual, you should assume that you are responsible for out- patient follow-up care whether or not you were on call. Obtain the ER record so you know what care was provided.

 If I accept patients for post- discharge care, and they don’t make or show up for their appointment, do I have any follow-up duties?

 You and the patient both face risks in this situation if the patient does not receive the appropriate care. Your name may very well be in the ER record and on the discharge instructions. A plaintiff attorney will likely argue that you have a duty to follow up on this patient; the defense attorney may respond that there was no relationship and that the patient was noncompliant. Ask in writing that the ER fax you the ER record of all patients you saw, were contacted about, or who were referred to you for post-ER follow- up, and get the patient’s name, address, and phone number. Notify your staff of the type of appointment that should be scheduled, and follow-up on missed appointments and test results. For more guidance on this issue, see “Noncompliance” at www.omic.com.

 The ER referred a patient to me for post-discharge care. When she presented to my office, my staff learned that she had an insurance plan we don’t accept. They offered to help her set up a payment plan, but she left without being seen. Can I ask patients to pay for post- discharge care? If they won’t pay, do I have to see them?

 Staff may follow normal protocol with new patients referred for outpatient care, including those referred by the ER. In most practices, this protocol includes determining insurance coverage and informing the patient of charges and financial responsibilities. Patients who have no coverage should be told that you are available to care for them. Many practices allow patients to set up payment plans. Such an offer helps refute allegations of abandonment. Patients have the right to refuse treatment, whether for financial or other reasons. Patients who leave without being seen or who decline fee-based services when making the appointment should be reminded of the need for proper follow-up. See the sample Refusal of Care letter in “The Ophthalmologist’s Role in Emergency Care: On-Call and Follow-up Duties” at www.omic.com.

Obtaining Consent on the Day of Surgery

By Anne M. Menke, RN, PhD

OMIC Risk Manager

Digest, Summer 2007

Helping a patient to understand the risks, benefits, and alternatives of a planned procedure is no easy task. When the consent discussion takes place on the day of surgery, new opportunities for misunderstanding and liability are introduced.

I perform refractive surgery at several laser surgery centers. Sometimes, I meet the patient for the first time on the day of surgery. Can the optometrist who performed the preoperative evaluation obtain the informed consent or do I have to?

 First, for elective surgeries, the discussion should take place before the day of the surgery whenever possible. Some patients who have had surgery the same day as the informed consent discussion have later sued for lack of informed consent, arguing that they were coerced into having the procedure and did not have time to weigh the risks and benefits. Second, organizations such as the AAO and ASCRS consider it the responsibility of the surgeon to determine the patient’s candidacy and obtain informed consent. Third, OMIC policyholders who perform refractive surgery must comply with certain underwriting requirements, such as personally obtaining consent, as a condition of coverage. If the patient cannot be seen until the day of surgery (e.g., either the surgeon or the patient lives far away), but the type of surgery is already determined, taking a few extra steps before the day of surgery will facilitate patient understanding and ensure that consent is both informed and voluntary. Obtain information from the referring physician or directly from the patient per telephone or questionnaire—about the patient’s medical and ocular health in order to rule out contraindications to the procedure and screen for conditions that could affect the safety of the surgery or anesthesia (e.g., significant coronary artery disease, need for anticoagulants, etc.). Next, send the patient a copy of the procedure-specific consent form along with other educational information, and ask the patient to review the materials. At the time of the preoperative visit and consent discussion, address any questions or concerns, and ask the patient to sign the form. Be prepared to postpone the procedure if you are not convinced that the patient fully understands its risks and is committed to proceeding.

Q I perform oculoplastic procedures. Sometimes, on the day of surgery, the patient asks me to perform an additional procedure. Can I safely accommodate the patient’s request?

A This is a risky situation, especially if the procedure is being performed for cosmetic rather than therapeutic reasons. The informed consent discussion should take place when the patient is awake and aware, free from the effects of any medication that could interfere with the patient’s ability to participate in the decision-making process. Therefore, if the patient has already received any sedation, you should either perform only the planned procedure or delay the surgery until the patient can fully participate in the discussion. A change in the requested procedure may well indicate that the patient is having second thoughts about having the surgery or is confused about what he or she really wants. It is usually prudent to postpone the surgery and give the patient time to reconsider. However, if you know the patient well, and you are completely comfortable with proceeding, you should have and document an informed consent discussion, preferably in front of witnesses. Please note that most hospitals and ambulatory surgery centers now have detailed protocols in place to prevent surgical confusion such as wrong patient, site, or procedure. The facility’s policies may prohibit a change in the surgical plan.

Isn’t there a clause in hospital consent forms that authorizes me to do additional procedures? When can I rely upon that instead of obtaining informed consent on the day of surgery?

A This type of consent clause is designed to address situations that arise unexpectedly during surgery, such as when you need to perform a vitrectomy after rupture of the posterior capsule. These events call for immediate treatment to minimize harm to the patient. Indeed, failure to provide such treatment could be considered negligent management of a complication. On the other hand, if the patient has a condition that can reasonably be foreseen to require additional surgical procedures, that eventuality should be discussed during the preoperative visit. For example, patients on medications such as flomax are now known to develop intraoperative floppy iris syndrome or IFIS. Ophthalmologists who operate on these patients must be prepared to adjust their cataract techniques and utilize mechanical expansion devices.1

1. For an update on IFIS, see Chang DA, Managing intraoperative floppy iris syndrome, available on the AAO web site at http://aaophp.aao.org/current_insight/managing_ifis?from=0,0.




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