Responding to “Dear Healthcare Provider” Letters
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Winter 2007
Within the last several months, ophthalmologists have received two “Dear Healthcare Provider” letters from drug manufacturers informing them of “important safety information” about medications they administer regularly. Bristol-Myers Squibb sent the first letter on November 22, 2006 at the urging of the food and Drug Administration (FDA).[1] Consistent with a prior warning on the prescribing information, the letter again reminded ophthalmologists that KenalogTM(triamcinolone acetonide) is not approved for intraocular administration. In response to reports of endophthalmitis, eye inflammation, increased intraocular pressure, and visual disturbances including vision loss— all known side effects about which ophthalmologists routinely inform patients—the company added additional prescribing information recommending against administering KenalogTM by intraocular, intraturbinal, subconjunctival, sub-Tenons, retrobulbar, nasal turbinate, and intralesional (about the head) routes. The second “Dear Healthcare Provider” letter was distributed by genentech Inc., manufacturer of AvastinTM (bevacizumab) and LucentisTM(ranibizumab), drugs both widely used for the treatment of age-related macular degeneration (AMD). In its January 24, 2007 letter, the company informed ophthalmologists that the ongoing SAILOR clinical study revealed a higher incidence of stroke in the 0.5-mg LucentisTM dose group compared with the 0.3-mg dose group (1.2% versus 0.3% respective- ly; P = 0.02).[2] These letters have prompted numerous calls to OMIC’s risk management hotline.
Q Can I still administer KenalogTM ?
A It is OMIC’s opinion that, despite the manufacturer’s warning, it remains legal for ophthalmologists to administer KenalogTM (TA) by the routes mentioned in the letter as part of “the practice of medicine.” In the event of a lawsuit, ophthalmologists who are challenged about their use of TA will continue to rely upon expert witnesses, peer-reviewed literature, and well-documented efforts to provide quality care. Moreover, OMIC feels that the ophthalmologist is in the best position to determine how to treat an individual patient and recognizes that “off-label” use of approved medications is a legal and necessary part of the practice of medicine. Accordingly, our professional liability policy provides coverage for such off-label use, including ongoing use of TA.
Q Do I need to tell my patients about the letter?
A Yes. Patients should be informed of TA’s off-label status and told that the manufacturer has recommended against ophthalmic use, but that the FDA and attorneys have confirmed that ongoing use is legal as part of the practice of medicine. They should also be advised of the long-standing and widespread use of TA to treat ocular conditions as described in many peer-reviewed articles, and that the National Eye Institute is conducting clinical trials on its use. OMIC has prepared a sample consent form for TA, available at www.omic.com.
Q The letter from Genentech did not provide any guidance. Am I required to assess a patient’s risk of stroke before I administer LucentisTM? Should some patients get the lower dose, even though only the higher dose has been approved by the FDA?
A The label produced when LucentisTM was approved warns of the theoretical risk of thrombo- embolic events with intravitreal inhibitors of VEGF,[3] a drug class that also includes Macugen and Avastin. Accordingly, the risk management recommendations that precede OMIC’s revised sample consent form advise physicians to consider conditions that increase the risk for such complications. Now that ophthalmologists have been warned of the higher risk of a second stroke in patients with a stroke history, they should specifically elicit and document any history of stroke. The need for a stroke risk consultation with an internist and the dosage amount both depend upon the patient’s overall health, extent of AMD, and risk tolerance. faced with the certainty of visual loss from AMD, some elderly patients may prefer to assume the risk of stroke in order to best preserve their vision. Others may refuse the medication at any dose. Carefully determine and document the patient’s clinical findings and preferences, and ensure that patients who refuse the medication understand the consequences of their refusal. Consider giving patients written instructions about how to contact you and a list of eye symptoms that should be immediately reported to you. Patients considered at high risk for stroke should be educated on its symptoms and directed to call 911 or to proceed to the nearest emergency room if they suspect they are having a stroke.
1. Lewis-Hall, Freda, MD, Senior VP for Medical Affairs, Bristol-Myers Squibb CO. Dear Healthcare Provider. 22 Nov. 2006.
2. Barron, Hal, MD. Senior VP Development, CHief Medial Officer, Genentech, Inc. 24 Jan 2007.
3. The full prescribing information for LucentisTM is available at http://www.gene.com/gene/products/information/pdf/lucentis-prescribing.pdf
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?
A 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.
Q Does serving as an on-call physician create a physician-patient relationship that would require me to provide post-discharge care?
A 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.
Q One of my patients was seen in the ER. Do I have a duty to provide post-discharge care?
A 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.
Q 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?
A 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.
Q 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?
A 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.
Tracking Referrals and Test Results
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Fall 2009
The OMIC claim discussed in this issue’s lead article involved a patient who was never informed of the need for tests. Other claims result from patients who do not follow instructions to see consultants or undergo diagnostic testing. Both scenarios can lead to patient harm and increased liability risk.
Q Whose responsibility is it to order and review tests and disclose the results to the patient?
A This question needs to be explicitly addressed and answered for each patient when more than one physician is involved. If you want to have the results of tests in hand when you first examine the patient, consider developing a form to send to the referring physician. Ask the physician to state the reason and urgency of the appointment being requested and to provide the contact and medical information you need to evaluate the patient. Indicate the tests that should be completed before you will see the patient. Clearly state who will order the tests and verify that the patient has completed them: “Please send the patient for the following tests and contact my office when you have received the test results.” In some situations, you may not know which tests need to be done until you examine the patient. Tests you choose after examination would normally be tracked by your office.
Q Do you have a system you can ecommend to track referrals and tests?
A Yes. When you determine that a patient needs a consultation with a specialist or a diagnostic test, disclose it to the patient, explain the reason for the order, and document your discussion and order. Ask the patient to schedule a follow-up visit or telephone consultation with you before leaving the office so you can review the results and revise the care plan. Next, instruct your staff to enter the information into a tracking system (see sample below). The system can be a follow-up tracking form, logbook, card file, or spreadsheet on the computer. When the report arrives, instruct staff to attach it to the patient’s file and place on your desk for your review. Date and sign the report, indicate any follow-up needed, and place in the medical record. Disclose the results to the patient and document the discussion. Communicate and document the new treatment plan. update the tracking form.
Q What steps do I need to take to ensure that I get the report?
A There are two ways to ensure that patients obtain the requested tests/consultations and you receive a report. First, assign to a reliable staff member the responsibility of reviewing the tracking system on a regular basis. Second, ask staff as part of preparing records for the next day’s patients to review each file to see if any report or result is expected. If the report is not received in the usual time, ask staff to call for results. If you learn that the patient did not present for the test or consultation, ask staff to contact the patient to learn why. Be sure to question patients in a non-judgmental manner: “We called to get the results of your MRI and were told that you had cancelled it. Was there some kind of problem? Could you tell me why you didn’t have this done?”
Q What if patients refuse the recommended care?
A Clarify why the patient is not complying with treatment recommendations. Possible reasons for not scheduling tests or procedures may include financial difficulties, HMO authorization problems, transportation difficulties, child care problems, confusion about the disease or the need for treatment, or fear of the significance of the results of the test, procedure, or consultation. Next, educate the patient about the disease process, treatment recommendations, and consequences of non-compliance. Target the education to the reasons for non-compliance. When possible, identify social service resources that may help. For example, some pharmaceutical companies provide free or reduced-cost medications. Be familiar with the enrollment criteria and process for state and federal assistance, and of transportation services for patients. If treatment is not authorized by the patient’s HMO, act as a patient advocate and appeal the decision. Verify that the patient understands the points being made by asking the patient to explain them back to you in his or her own words. Give written materials whenever possible, and use visual teaching aids, such as videos, charts, diagrams, and models of the eye. If your efforts to educate and clarify the need for treatment are not effective, you may need to terminate the relationship (see “Noncompliance” and “Termination of the Physician-Patient Relationship” at www.omic.com.
Differential Diagnosis: Develop and Disclose It
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Winter 2010
Failure to diagnose is a frequent allegation in medical malpractice lawsuits. OMIC claims analysis and peer-reviewed studies point to some ways to reduce this obstacle to safe, quality patient care.
Q Are there common problems that surface in “failure to diagnose” cases?
A Yes, but they are not what the court system would lead us to believe. Alleging that a patient suffered harm due to a physician’s negligence implies that the diagnosis was missed because of that particular doctor’s shortcomings. In fact, inadequate knowledge or skill was the cause in only 4 of 100 malpractice cases in one study, and all four involved rare conditions. [1] Other cognitive errors, such as faulty data gathering and information synthesis, occurred frequently in the cases studied and were often compounded by faulty systems such as equipment and organizational issues. Cognitive scientists who have analyzed diagnostic errors point out that the way physicians reason, formulate judgments, and make decisions works well most of the time. In some instances, however, cognitive rules of thumb and shortcuts lead to error. Examples include memories of former cases, the way information is presented and framed, obedience to authority figures, and premature closure of the diagnostic process. [2] These cognitive “pitfalls” are inherent in the process itself; another physician may well make the same errors.
Q Do studies of OMIC claims data reveal these cognitive errors?
A Yes. In a recent OMIC study, three conditions were frequently misdiagnosed: retinal detachment, glaucoma, and foreign bodies. Retinal detachment and glaucoma were often missed if the patient had ocular comorbidities that could explain some of the symptoms, leading the ophthalmologist to assume it wasn’t necessary to complete a comprehensive evaluation, including a dilated eye exam. Retained foreign bodies were missed when the physician did not obtain an adequate history or failed to order x-rays to rule out their presence (see Closed Claim Study). Systems issues, particularly office appointment scheduling and follow-up protocols, also contributed to patient harm and led to settlements. When an on-call physician did not notify his staff of a patient due to come in the following morning after an ER consultation, his staff would not schedule the appointment, citing the office policy of declining public aid patients. After the child developed a corneal ulcer and needed a transplant, the practice settled for $1,000,000. Some conditions manifest themselves more clearly with time, and are often correctly diagnosed at the follow-up visit. If the patient does not show up for the visit, and staff do not notify the ophthalmologist of the missed appointment, an opportunity to intervene is lost. (See OMIC’s “Telephone Screening of Ophthalmic Problems” and “Noncompliance” at www.omic.com.)
Q What strategies do cognitive scientists suggest to improve the decision-making process?
A Strategies that encourage physicians to stop and examine their thinking process may help. Two key safety steps are: 1) pause to consider what else could produce the same signs and symptoms, and 2) entertain, however briefly, the worst possible scenario. By developing a differential diagnosis, the ophthalmologist can determine not only when a complete, dilated exam is required, but also when additional tests are needed to rule out vision-threatening conditions. A diagnosis that does not account for all of the signs and symptoms needs to be reconsidered, as does one that leads to a treatment plan that is not effective. When the patient’s course is unexpected, start over by reviewing the record with an open mind and asking questions such as “What else might be going on?” These strategies might prompt additional testing and examination, an expanded differential diagnosis, and a clearer picture. [3]
Q Why do you recommend disclosing the differential diagnosis to the patient? Doesn’t that just confuse the patient?
A In a busy ophthalmic practice, it is easy to overlook the need to obtain a thorough patient history and to rely solely upon the information provided by the patient to you or your staff. The patient’s presenting “complaint” may be misleading or irrelevant unless specific questions are asked, or the patient may have been interrupted before he or she had time to give a full account of all symptoms. Make the patient part of the healthcare team from the beginning of the diagnostic process by allowing sufficient time for the patient to present his or her concerns. Disclose your differential diagnosis and treatment plan. Ask the patient to watch for new symptoms and to contact you if the condition worsens or does not improve before the next appointment.
1. Graber ML, Franklin N, and Gordon R. “Diagnostic Error in Internal Medicine.” Arch Intern Med. July 11, 2005; v. 165: 1493-1499.
2. Redelmeier DA. “The Cognitive Psychology of Missed Diagnoses.” Ann Intern Med. 2005; 142:115-120. For a detailed discussion, see Croskerry P. “Achieving Quality in Clinical Decision Making: Cognitive Strategies and Detection of Bias.” Acad Emerg Med. 2002; v. 9, n. 11: 1184-1204.
3. “Failure to Diagnose Traumatic Eye Injuries” and “Failure to Diagnose Giant Cell (Temporal) Arteritis” at www.omic.com.
