Confidentiality/Privacy Issues and Malpractice Claims
Physicians often have questions about sharing protected health information (PHI) with their professional liability carrier or an attorney during the investigation and litigation of a medical malpractice incident, claim, or lawsuit. Confidentiality During Litigation provides general information; please call your professional liability (PL) carrier or your practice attorney if you need more assistance.
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
ER PATIENTS
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.
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.
Q 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?
A 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.
Q 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.
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.