Informed Consent Revisited

By Paul Weber, JD
OMIC’s vice-president of risk management

Digest, Summer, 2001

Poor informed consent continues to be a frequent and serious allegation in claims and lawsuits against ophthalmologists. Despite the availability of procedure-specific informed consent documents from OMIC, an alarming number of insureds still do not use them and simply rely on the hospital or surgicenter’s consent form to cover their exposure. Unfortunately, these generic documents focus on the risks of anesthesia and rarely address ophthalmic-specific risks. Informed consent documentation is so critical to the successful defense of a malpractice claim that it bears revisiting.

Q  What is the risk of not obtaining informed consent from a patient?
A  The courts in most states have decided that if a physician performs a procedure or provides care without first informing the patient of the risks, complications, and alternatives and the patient has a known complication or side effect, the doctor must pay damages. (In some states, this decision has been codified into a statute.) This legal doctrine provides another avenue for patients to sue their physician and is often used in conjunction with claims of improper performance. The law in most states provides that: (1) In providing medical services, a physician must get informed consent; (2) Informed consent occurs after disclosure by the physician of factors a “reasonably well qualified” physician would disclose under similar circumstances; (3) Failure to obtain informed consent is negligence; (4) Expert testimony is needed to prove the sufficiency of disclosed risks/alternatives.

Q  What must the plaintiff prove to prevail in an allegation of informed consent?
A  The plaintiff must prove that: (1) The physician failed to inform the patient of the risks/alternatives another physician would have disclosed; (2) If these risks/alternatives were disclosed, a reasonable person would not have submitted to the procedure; (3) The patient was injured; (4) Failure to disclose these risks/alternatives was cause of injury.

Q  What steps can I take to ensure that the patient is properly informed?
A  The process of informed consent begins when the patient is first seen and given information to read and/or a video to view about his or her condition and its treatment. For risk management purposes, it is important to document that the patient received this information and/or viewed a video to help refute a claim of lack of informed consent.

Q  When does informed consent “happen”?
A  Some experts suggest that informed consent is an ongoing process rather than a seminal event. However, for medicolegal purposes, it is essential the ophthalmologist have a personal discussion with the patient about the risks, benefits, and alternatives to treatment and personally answer the patient’s questions. Only after this discussion can the patient give his or her informed consent. It is this discussion and subsequent patient agreement that constitutes “informed consent.” What comes next is the documentation or memorializing of the patient agreement.

Q  Why is a procedure-specific informed consent document so important? Why isn’t a simple note in the chart sufficient?
A  Without a document signed by the patient listing the risks specific to the procedure, the jury will be confronted with two entirely different versions of what was discussed. Unfortunately, it is quite rare that handwritten chart notes are as comprehensive as a procedure-specific informed consent document. However, such a note in the patient’s chart coupled with a procedure-specific informed consent document presents a formidable defense. Also document whenever the ophthalmologist spends a significant amount of time with a patient discussing a procedure, including how much time was spent. This helps refute claims that the physician was “in and out” of the room and did not seriously address the patient’s concerns.

Q  What are some strategies surrounding the actual signing of the informed consent document?
A  The patient should sign the document after having the discussion with the ophthalmologist. Many of these documents state that “the doctor has answered my questions.” This assumes that a discussion has taken place so if the patient signs the document before the discussion, it is inaccurate and may diminish the document’s effectiveness. Ask the patient to initial each page of a multi-page document or even specific paragraphs to avoid allegations that the patient was shown only the last page to sign and not given a chance to review the document in its entirety. Encourage the patient to take the document home prior to signing to digest the information and review it with a family member if necessary. The patient also may be given a copy of the document to keep.

Bridging Language Barriers

By Paul Weber, JD

OMIC’s vice-president of risk management

Digest, Winter 2001

 In August 2000, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) published guidelines for compliance with Title VI of the 1964 Civil Rights Act as it applies to persons who speak little English, or have limited English proficiency (LEP). Title VI assures that no person shall be discriminated against on the basis of color, race or national origin under any program that receives federal monies, including Medicare and Medicaid. The OCR guidelines mandate the policies and procedures for identifying individuals with limited English proficiency and the steps for providing “effective communication” in the form of language assistance and interpreter services.

Q How do I determine whether my practice is in compliance with federal guidelines?
A First, assess the number of LEP patients your practice treats on a regular basis and all the primary languages spoken by these patients. Involve all front and back office staff in the assessment process to ensure that you include the complete range of languages spoken by patients in your practice. Even if your practice cares for a large number of Spanish speaking patients, don’t assume Spanish is the only language for which you might have to provide assistance. In many areas of the country, there is no one dominant foreign language spoken. Document this assessment process.

Q How will my practice comply with federal guidelines if my patients speak many different foreign languages?
A Among other factors, the OCR takes into account the size of the practice and the frequency with which other languages and LEP patients are encountered. The OCR emphasizes flexibility, focusing on the “end result” and whether the practice has taken steps to ensure that LEP patients have access to the physician’s services. If 30% or more of the patients seen in your practice are Spanish speaking, clearly you will want to ensure that the practice has an ample number of Spanish speaking staff and physicians and/or interpreter services available. It’s also important to provide written information, such as informed consent documents, in a patient’s spoken language. If you do not treat many patients who speak a particular foreign language, you may be able to arrange with a community organization to have an interpreter available in person or by phone during patient consultations. Document these arrangements and whether there are delays or other service-related problems with respect to LEP patients.

Q Can a patient’s family member or friend be used as an interpreter?
A The OCR requires the provider to first inform the LEP patient of the right to receive free interpreter services and permits the use of family and friends only after such offer of assistance has been declined and documented. This is to protect the privacy of patients who might not want to reveal personal health information in the presence of family members or friends and to ensure that the interpreter is sufficiently proficient in both languages. Since inaccurate or incomplete interpretation of an ophthalmic problem could cause serious harm, do not rely exclusively upon a patient’s family member or friend to serve as an interpreter.

Q Does the OCR provide specific guidance on this matter?
A Given the diversity of patient populations and ophthalmic practices, problems and ambiguities are inevitable. OCR provides technical assistance to health care providers to ensure that LEP persons can access their services. OCR will help identify successful practices and strategies used by other providers as well as sources of federal reimbursement for translation services.

Q Who is responsible for paying for interpreter services?
A In certain instances, the physician may be forced to pay for interpreter services. The AMA has been joined by nearly 40 state and specialty medical societies (including the American Academy of Ophthalmology) in objecting to shifting this cost burden to the physician.

Q What if it is determined that my practice is not in compliance with federal guidelines?
A OCR will investigate whenever it receives a complaint or report that alleges possible noncompliance with Title VI. If noncompliance is found, OCR will send a letter of findings to the practice setting out the areas of noncompliance and the steps that must be taken to correct them. OCR must attempt to secure voluntary compliance through informal means. If the matter cannot be resolved informally, OCR must secure compliance through (a) termination of federal assistance after the practice has been given an administrative hearing, (b) referral to the Department of Justice for injunctive relief or other enforcement proceedings, or (c) any other means authorized by law.

For more information about Title VI guidelines, visit the HHS OCR web site at 

http://www.hhs.gov/ocr/civilrights/resources/specialtopics/lep/index.html

 http://www.cvrc.state.nm.us/NM%20Electronic%20Materials/LEP%20Guidance.pdf

Assuring Safe Passage Through the Healthcare System

By Anne M. Menke, RN, PhD

OMIC Risk Manager

Digest, Fall 2009

During our recent OMIC Forum on “Shared Care” at the AAO annual meeting, Dr. Steven Brown presented the following case involving four competent, experienced physicians. A primary care physician (PCP) referred an elderly gentleman to a comprehensive ophthalmologist (CO) for evaluation of a grey spot in his eye. After diagnosing a melanoma, the CO referred the patient to a retina specialist for confirmation and treatment options. The retina specialist offered the patient a choice between radiation and enucleation, and reported back that the patient chose enucleation. The CO then referred the patient to an oculoplastic surgeon for the procedure, which was completed two weeks after the initial ophthalmological evaluation. So far, the patient had received timely, effective, well-coordinated care. Nonetheless, when the patient died from metastatic disease that was diagnosed by his PCP eight months after his eye was removed, his family requested the medical records and concluded that the care was negligent. They reached their conclusion after finding a report from the retina specialist to the CO, advising him of the need for tests to monitor for metastasis. The family proceeded to sue the PCP, CO, and oculoplastic surgeon, alleging failure to follow-up and coordinate care. Investigation revealed that all three physicians knew the patient was at risk for metastatic disease, and knew which tests to order to monitor for it. Yet no one took the responsibility to clarify who was in charge, and none of them ordered the necessary tests. The oculoplastic surgeon testified that he had explained the need for follow-up to the patient but did not provide his recommendations in writing or document them in his record. No doubt the patient was not able to truly hear these care instructions while facing a new diagnosis of cancer and recovering from an enucleation.

Patient “Hand Off” A Critical Moment In Care

The Joint Commission (TJC) receives regular reports of medical errors that occur at the hospitals, ambulatory surgery centers, and other healthcare organizations that it accredits. By analyzing the problems, TJC hopes to understand not only which errors occur but more importantly what causes them. What TJC determined echoes the findings of the OMIC case. The top factor contributing to medical error was not lack of knowledge or technical skills or inexperience. Rather, it was problematic communication: the information conveyed during care was incomplete, inaccurate, and/ or misinterpreted. Ineffective communication occurred in 70% of “sentinel events,” a term TJC uses for incidents that have the most serious outcomes. Just as with the OMIC case, fully half of the time, the harmful communication breakdown occurred during a “patient hand off.”1

Patient safety experts, aware of the dangers of the hand off, have focused attention on ways to ensure communication and coordination of care during the moments when patients transition from one provider, facility, or unit to another. “Lost in Transition: Challenges and Opportunities for Improving the Quality of Care” points to our fragmented American healthcare system as the cause: decreasing numbers of primary care physicians, increasing numbers of patients with more than one disease who require diagnostic tests and specialists, and a payment system that does not reimburse physicians for the time it takes to communicate with one another and coordinate care.2

A literature review of care transitions found that patients referred to a specialist arrived 49% of the time with no information about the patient. The consultants apparently responded in kind, as the referring physicians complained that even four weeks after the consultation, 25% had not received a report back. PCPs said they were not notified that patients had been hospitalized and rarely received discharge summaries. The few that came were inadequate for directing care. Patients received even less information. Those sent for tests said that 17% of the time the physician had not received the results by the time of the office visit scheduled to discuss them. More than 75% of physicians report not informing patients when test results are normal, and 33% do not even disclose abnormal results. The author concluded that, “Care among multiple providers must be coordinated to avoid wasteful duplication of diagnostic testing, perilous polypharmacy, and confusion about conflicting care plans.”3

To help ophthalmologists coordinate care and follow up on referrals, test results, and appointments, OMIC developed a tracking system, which is discussed in the Hotline article and presented in detail in our document, “Noncompliance: A Frequent Prelude to Malpractice Lawsuits,” available in the risk management recommendations section at www.omic.com. A tracking system is only effective, however, if all physicians involved in the care of a patient are clear on who is in charge of ordering, interpreting, communicating, and acting upon the results of tests and consultations. As the OMIC case demonstrates, sending a letter with the proper recommendations does not lead to safe care if the message is not received and acknowledged. A more active process is required. Several new regulations imposed on healthcare facilities have been adopted to force physicians, nurses, and other caregivers to better coordinate care and hand off patients. The first is medication reconciliation, the second is standardized hand-off discussions; each will be addressed in turn.

Reducing Errors from Medication Changes

OMIC claims experience and the studies discussed so far show that patients and providers alike appear to be inadequately prepared for their role in the next phase of care. This is particularly true with changes to medications, which occur regularly when patients undergo diagnostic/surgical procedures, are diagnosed with new conditions, or are hospitalized. Too many times, neither the patient nor the prescribing physician has accurate and complete information about the patient’s current medication regime. The stage is thus set for errors and adverse drug events that result in patient harm, hospitalization, increased costs, and allegations of medical malpractice.

Take anticoagulants, for example, which are among the top three classes of drugs involved in medication errors. Ophthalmologists who are planning procedures with a high risk of bleeding, such as blepharoplasty, routinely inquire about prescription and over-the-counter drugs that influence the clotting cascade, and make changes to the drug regimen preoperatively. OMIC claims studies have shown, however, that patients misremember which medications they are taking, misrepresent—often when faced with financial problems—when they last had clotting studies done by their primary care physician, or do not think to report recent cardiac procedures, such as the placement of stents. Failure to confirm dosages, test results, and the intended change in medication with PCPs and cardiologists, failure to confirm that a patient has indeed stopped medications as directed, and failure to provide comprehensible, written instructions on how and when to restart medications have all led to malpractice lawsuits. Adverse medication events such as these indicate the need for an explicit process of “medication reconciliation” at key transition moments, such as a new diagnosis, admission for surgery, or discharge from a healthcare facility. This step is now a “National Patient Safety Goal” that facilities must meet in order to maintain accreditation by organizations such as TJC and AAAHC.4 And while time consuming, the process works: studies show that medication reconciliation decreases medication errors by 70% and adverse drug events by 15%.2

Tools to Improve the Quality of Hand Offs

One study of hand offs looked at the accuracy of information exchanged by nurses during shift change. Twelve fictitious patients were created, and nurses passed on information during five consecutive hand overs.

Oral communication resulted in the loss of all data. Note taking during hand off reduced data loss to 31%. It was only when a standardized form was combined with oral exchange of information that data loss was minimal.5 Studies such as this convinced many organizations, including the Institute of Medicine, the Department of Defense Patient Safety Program (DOD), Kaiser Permanente, and AORN (Association of periOperative Registered Nurses) to produce tools to better structure patient hand offs. These teams learned that standardized hand offs shifted the focus from the people involved in the exchange (often hierarchical) to the patient, and led to common expectations about what was going to be communicated, how the communication would be structured, and the required elements. Most importantly, the process requires two-way conversation in which critical information is verified and clear responsibility for ongoing care is established.

The toolkit jointly developed by the DOD and AORN is particularly useful to ophthalmologists as it focuses on team building and was developed specifically for perioperative care.6 It provides information on several standardized hand-off formats (see TALK TO ME IN SBAR and I PASS the BATON). Ophthalmologists would be well advised to become familiar with these hand-off processes, now that the Joint Commission, in National Patient Safety Goal 2E, requires facilities to implement a standardized approach to hand offs. TJC has clarified its expectations: hand offs must be interactive, allowing for participants to ask and answer questions; they must include accurate, current information; interruptions during hand offs should be minimized; they must include a process for verification of the received information, including read back or repeat back if needed; and other necessary patient information should be available for review.7 It will no doubt take time to hone the hand-off process, but the effort will clearly result in safer care and less liability.

1. JCAHO. “Improving Hand-off Communications: Meeting National Patient Safety Goal 2E.” Joint Perspectives on Patient Safety 2006; 6(8): 9-15.

2. Coleman EA and Berenson RA. “Lost in Transition: Challenges and Opportunities for Improving the Quality of Care.” Ann Intern Med 2004; 140: 533-536.

3. Bodenheimer, Thomas. “Coordinating Care—A Perilous Journey Through The Healthcare System.” New England Journal of Medicine 2008; 358: 10.

4. Several resources provide medication reconciliation tools. The Agency for Healthcare Research and Quality has a primer available at http://www.psnet.ahrq.gov/primer.aspx?primerID=1. The Institute for Healthcare Improvement has a tool to help review medical records to catch medication errors and develop an effective reconciliation process; this tool is available at www.ihi.org.

5. Pothier D, Monteiro P, Mooktiar M, Shaw A. “Pilot study to show the loss of important data in nursing handover.” British Journal of Nursing 2005; v.14, n.20.

6. The toolkit, which includes slide presentations, sample tools, and forms developed for perioperative use, is available at www.aorn.org.

7. The Joint Commission’s National Patient Safety Goal on hand-off communication can be found at www.jointcommission.org.

Payment Issues: Avoid Delays in Treatment

Hans Bruhn, MHS, OMIC Senior Risk Management Specialist

Digest, Winter 2011

By the time a patient is referred and examined by an ophthalmic specialist, he probably has already been seen by a primary care physician and a general ophthalmologist. Most health insurers require patients to go through a referral process before they can be seen by a specialist. This can be problematic if the patient’s eye condition requires rapid diagnosis and treatment by the specialist. Critical care can also be delayed when patients do not have health insurance and cannot pay out of pocket for these services. When delays in critical care result in less than desired or poor outcomes, some patients will file a claim against the specialist and all referring health care providers, alleging failure to provide timely treatment.

Q  Can I withhold care because of a patient’s inability to pay (including co-pays)?

A  This is always a tricky situation. Ophthalmologists may be required to collect co-pays or deductibles by third party insurers. If emergent care is needed, we recommend separating payment issues from decisions about care. Proceed with providing as much care as possible and sort out the financial issues after the patient is stable. This will avoid delays in treatment and reduce the risk of a claim. Notify the insurance company of the urgent care situation and the patient’s inability to pay the co- payment. The insurance company may allow you to waive the co-payment; however, waiving fees without first checking with the insurer can jeopardize your provider contract. You should make a reasonable effort to work out a payment plan with the patient; document your efforts and the results.

You may have less control over the situation in a surgical facility or hospital setting that requires payment up front as a condition of admission. But before you send the patient elsewhere, act as the patient’s advocate. Explain to the facility the urgent nature of the required treatment and ask if it will work out a payment plan with the patient. If not, promptly refer the patient to another facility that may be willing to do so. If all attempts fail, it may be necessary to refer the patient to the local emergency room, where federal law mandates that treatment be provided. Throughout this process, keep the patient informed about your efforts on his behalf. This will help reduce the likelihood that you will be perceived by the patient as withholding care. Document carefully.

Q  During follow-up, I noted that a patient I first saw in the ER needed surgery. Since I am not part of her HMO, I promptly called her primary care physician to secure a referral to a participating ophthalmologist, but the PCP was out of town. What action should I take?

A  Advise the patient about the situation (PCP is not available; surgery is needed and you are not in her insurance provider network). If the patient elects to pay out of pocket, get that in writing and proceed with care. If not, help the patient find another provider to assume care. Contact her HMO directly and request a referral to another ophthalmologist. Once another provider is identified, contact that new physician and facilitate transfer of care along with patient authorization and your recommendation for surgery. Advise the patient of your actions and document accordingly.

Q  A patient that I have been treating since June 2008 has developed a serious corneal ulcer (OS), possibly fungal. I prescribed Natamycin drops, but the patient has not gotten the drops and has canceled follow-up appointments because of the cost. The patient is blind in his right eye, and now his left eye is compromised with this serious condition. Am I obligated to continuing seeing him?

A  Contact the patient and tell him of your concern. Explain that many patients are having trouble affording care and ask if his financial situation is keeping him from getting the care he needs. Advise him of the seriousness of his eye condition, including the consequences of not using the drops you prescribed and not coming in for exams. Given the urgency of the situation in this functionally monocular patient, encourage him to come in to see you so you can conduct an exam and provide care, including drops, if possible. If the patient is still reluctant to see you, ask if there are any relatives to assist him. Offer to set up a payment plan for incurred medical expenses. As a last resort, advise the patient to go to the nearest emergency room for care. If the patient refuses, document your discussion and send a letter reiterating your recommendations and explaining again the consequences of not getting care. If the patient does not respond to your discussions and letter, consider sending OMIC’s “noncompliance” letter, which gives the patient one last chance to come in for care before the physician-patient relationship is terminated.

Contact OMIC’s Risk Management department for assistance or visit our web site, www.omic.com, for our recommendation “Discontinuing Treatment for Financial Reasons and Noncompliance Guidelines.”

Ensure Coverage for Your Refractive Surgery

By Kimberly Wittchow

OMIC Legal Counsel

Being specialists in the underwriting and management of risk for the

practice of ophthalmology, OMiC makes sure that all insureds are individually reviewed and approved for their unique practices. therefore, OMiC’s policy excludes all refractive surgery until the company has had an opportunity to review the credentials and experience of ophthalmologists in the performance of each type of refractive surgery. Once approved, these services are covered at full policy limits by endorsement to the policy. no additional premium is charged for this coverage. however, coverage applies only to the specific procedure(s) added by endorsement. if an insured who has been approved for one type of procedure would like to perform other types of refractive surgery, he or she must apply and undergo under- writing review and approval for each additional type of procedure.

OMiC’s refractive surgery endorse- ments all have a common condition for coverage to apply: the procedure must be “performed within OMiC’s underwriting requirements or any exceptions to the requirements granted in writing by OMiC.” specific procedures have their own require- ments, and there is also an overall set of refractive surgery requirements applicable to all. these requirements, which address patient selection criteria, informed consent processes, and post- operative care, among other issues, must be met in order for a claim to be covered. All applicants for refractive surgery receive these requirements, and, in their supplemental application, they warrant and represent that they will abide by these rules and deviate from them only after approval on a case-by-case basis from OMiC. to view OMiC’s most current underwriting requirements for refractive surgery, go to the Refractive surgery information page of OMiC’s web site (accessible from the “Favorites” section of OMiC’s home page or by selecting “Products,” then “Professional Liability”) and select the procedure of your choice within the supplemental refractive surgery questionnaires.

the reasons for these requirements are threefold. Performance of refrac- tive surgery procedures within these parameters, based on sensible medical practice and sound risk management principles, should reduce the likeli- hood of unanticipated outcomes, and consequently, claims. they also protect the insured if a claim does arise, as procedures performed within the requirements are more defensible. the requirements also protect the company and its member-insureds, since more defensible claims protect the financial solvency of the company and there- fore enable OMiC to continue to operate for the benefit of all insureds.

the requirements were implemented by OMiC’s Board of Directors, under the guidance of the underwriting Committee, composed entirely of ophthalmologists, including refractive surgery specialists. they are continually reviewed and updated as necessary, with nearly all revisions to date expanding coverage. OMiC’s requirements with respect to patient selection are never more restrictive than the FDA on-label requirements and are generally more permissive. information gleaned from past refractive surgery claims, input from defense attorneys, and studies such as the one discussed in this issue’s lead article by Anne Menke, together with personal experience and expertise, all help our Board develop OMiC’s refractive surgery requirements. On occasion, the Board also seeks outside input from respected leaders in the refractive surgery community before implementing requirements.

in addition to the underwriting requirements for refractive surgery procedures, OMiC also has specific postop care requirements found in the policy itself in section iii. Common

exclusions, A.16. For coverage to apply, the insured must meet these conditions: (a) the insured operating ophthalmologist or an on-call or locum tenens ophthalmologist must perform the patient’s postoperative care throughout the patient’s recovery period; (b) the insured operating ophthalmologist must (i) refer the patient to a licensed ophthalmologist or other licensed physician as appropriate and (ii) obtain the patient’s informed consent for planned comanagement prior to surgery; or (c) the insured operating ophthalmologist must (i) arrange for a portion of the outpatient postoperative care to be rendered by a non-physician provider who is clinically competent and lawfully able to provide that care and (ii) obtain the patient’s written informed consent for planned comanagement prior to surgery. such delegated postoperative care must be provided under the insured operating ophthalmologist’s supervision. in addition to this postop care exclusion, which applies to all ophthalmic surgeries, the refractive surgery requirements oblige the operating surgeon or a designated ophthalmologist to perform the first postop visit. together, OMiC believes these requirements best protect the insured operating ophthalmologist while providing flexibility in the provision of postoperative care by comanaging providers. since the operating ophthalmologist is ultimately responsible for the outcome of his or her surgery, we want to facilitate his or her oversight, or proper delegation of the management, of postoperative care.

OMiC’s Board is constantly balancing patient safety, claims defensibility, and its fiduciary duty to insureds with the company’s desire to cover insureds for their growing expertise in new and modified procedures. so far, we’re confident we’ve gotten it right since OMiC’s claims experience is significantly better than the industry average. if you have any questions or comments about OMiC’s refractive surgery requirements, please contact your underwriter.