Use an Unusual Event to Reduce Entity Liability
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Spring 2011
The malpractice claims presented in this issue of the Digest raise concerns about the policies and procedures in effect at solo corporations, group practices, and ambulatory surgery centers. Indeed, inadequacies were identified in coordination of care, follow up of noncompliant patients, credentialing, documentation, use of contact lens solutions, appointment scheduling, telephone screening of ophthalmic problems, and instrument sterilization. How can you take action to identify and rectify such problems? Conduct an “event analysis” as soon as you learn of unusual occurrences; focus your analysis on the impact on the patient and the systems or processes involved.
Q The hospital on-call ophthalmologist just informed me that one of my cataract patients developed endophthalmitis. The patient told her he tried to contact our practice three times and finally went to the ER when no one called back. Should I call the patient?
A Yes. This patient needs to know that you care about the complication and want to learn more about the problems he reported in contacting your office. “I’m so sorry to learn that you have a very serious infection in your eye. How are you feeling today?” When you can, move on to the phone issue. “Dr. Jones tells me that you weren’t able to reach our office despite calling three times. Do you feel well enough to tell me more about that?” Keep the focus on the patient: “I can only imagine how upset you must be about not being able to speak with us. Let me assure you that I am going to check with our answering service and find out what happened. May I call you again when I find out?” Notify your partners of the situation, get buy-in on the need to evaluate the system, and identify who will lead the analysis. When you contact the service, remain polite and limit the initial contact to beginning the fact-gathering process. “We’re reviewing our call experience this past weekend. Could you please send us a list with details on all the calls you handled for us?” Ask any physicians covering for the practice to provide you with information on calls they took from the service and/or patients. Review the call documentation for clarity, adequacy, response time, and follow up. Consider expanding the analysis: ask all physicians, office staff, and answering service staff for input on questions, problems, or concerns experienced with after-hours calls during the previous six months.
The goal of the analysis is to determine if the problem was with this particular patient and whether the entire process is safe and reliable. You may identify issues such as a physician who yells at the answering service when contacted, lack of clarity on what to do when a physician does not respond, rapid turnover at the service, or malfunctioning equipment. Go back to the physicians in the group with what you have learned and develop an after-hours policy and procedure. Educate all involved parties, then analyze again. Finally, report back to the patient on your findings and your plan; patients appreciate knowing that their poor experience may lead to improved care for other patients.
Q One of my patients was harmed when her contact lenses were cleaned with the wrong solution. Should I fire the assistant who made this mistake?
A Termination would be indicated only in exceptional cases. Instead, start by providing comfort to the staff member. Inform her that you would like her help identifying what went wrong so it won’t happen again. Call a staff meeting, ask the staff member to explain the incident, and ask other staff to clarify all steps in the process, paying particular attention to ones that could lead to error or harm. Your written team analysis may uncover contributory causes, such as lack of labeling of solutions, similar looking containers, inadequate training, or pressures from an overbooked schedule. Develop a better process to address the causes, write it up, and test it. Modify the procedure as needed.
Q My cataract patient experienced a refractive surprise. When I reviewed the medical record, I found a staff member had made a transcription error that led to implantation of the wrong IOL. Am I expected to review orders on each patient before surgery?
A Not necessarily, but you and your practice need to develop some systematic review process to prevent office-based causes of “wrong IOL.” Use this opportunity to develop an office cataract surgery checklist and staff education program. Include the involved staff member, the technician who performs your A-scans, and your surgery scheduler. Have them map out the care process, and highlight steps that could lead to error or harm. Clarify points at which you will be involved, such as when you verify the results of the A-scan and IOL master. Pay particular attention to key information that needs to be transmitted to the ambulatory surgery center, such as allergies and medical and ocular comorbidities that could impact anesthesia or perioperative care. Eliminate as much transcription as possible by, for example, sending a copy of the A-scan and IOL master results along with the preoperative order. Ensure that the refractive target, type and power of IOL, and operative site are specified. Review and approve the final checklist and educational program before it is presented to the entire staff. Monitor outcomes, and adapt the checklist and process as needed. OMIC risk management staff are here to assist you. Call the confidential Hotline at (800) 562-6642, ext. 641.
Maintaining an Effective Informed Consent Process
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Summer 2011
In nearly all PIOL claims we reviewed, ophthalmologists had lengthy informed consent discussions with patients and asked them to sign detailed procedurespecific forms before surgery; yet, patients alleged lack of informed consent. What happened? Almost inevitably, a breakdown in physician-patient communication occurred after surgery when patients experienced side effects or complications, or did not quickly achieve spectacle independence or the quality of vision they wanted— and for which they paid thousands of dollars out of their own pockets.
Q What information was missing from the initial informed consent discussion in the PIOL claims?
A Ophthalmologists can do a better job of identifying, evaluating, disclosing, and documenting the presence of systemic or ocular comorbidities that could impact the quality of the visual outcome: “As you know, you are a glaucoma suspect. My review of the visual field and OCT results show no signs of active disease, so I feel you are an appropriate candidate for a PIOL. You may be at increased risk, however, for optic nerve damage and vision loss if your intraocular pressure rises during or after surgery, or if you develop swelling and need to be on steroid eye drops for a prolonged period of time. Are you willing to go forward knowing you could have this problem?”
Eye surgeons can also educate patients about areas of clinical uncertainty: “Not all ophthalmologists agree that patients with a monofocal IOL in one eye are good candidates for a premium IOL in the other eye, so I want to talk to you about the drawbacks for you of implanting this type of IOL.”
Q Why do you recommend relating postoperative problems with the consent the patient signed before surgery?
A Although patients hear and read information about potential complications, they tend to emphasize the benefits, minimize the risks, and assume that these problems will not happen to them. When they face disappointing outcomes, some patients may fear that something they did caused it. Others may decide the surgeon was at fault, probably in agreeing to implant the premium IOL rather than insisting on a monofocal one, or in not preventing or better managing the complication. Ophthalmologists can help patients by “normalizing” the outcome: far from being a surprise, perioperative complications are expected in a certain number of cases, despite the best efforts of patients and surgeons alike, and that is why they are discussed before every surgery. When physicians listen to patients’ concerns with empathy rather than defensiveness, they promote emotional healing and strengthen the physician/patient relationship.
Q Should I discuss the extra charges as part of informed consent?
A Unmet expectations and confusion over what services were covered by the extra charges led to dissatisfaction in a number of cases. One patient called her ophthalmologist when she received a bill for toric IOLs from the ASC. Trying to be helpful, a staff member at the practice explained that the ASC orders and provides the IOL. Convinced that the ophthalmologist had double-billed her, she filed a claim alleging fraud (it was dismissed). ASCs already receive $105 for the IOL as part of the surgical fee, so a recent AAO Coding Bulletin on PIOLs advises them to collect the extra fee for the PIOL, both to clarify the billing process for the patient and to avoid the appearance of splitting fees with the surgeon.[1] Ophthalmologists may prevent billing surprises by providing patients with an itemized account of the professional services they will provide and clearly indicating whether the fee covers any additional surgery needed to optimize the quality and precision of the visual outcome. ASCs would be well-advised to provide details about their fees as well as part of the admission process.
Q At what point should I consider refunding the extra amount the patient has paid for a PIOL?
A Some patients may ask for a refund as soon as a problem arises, others may not bring it up at all. If you were not able to implant a PIOL, consider refunding the extra fee right away. If after doing everything you can to improve the refractive outcome and address any complications, the patient still is not satisfied, consider a refund then. Whether or not to offer a refund is a business decision and not an admission of liability. OMIC risk management staff are here to assist you. Call the confidential Hotline at (800) 562-6642, ext. 641.
1. Vicchrilli S. “Coding for Premium IOLs.” AAOE Coding Bulletin. American Association of Ophthalmic Executives, October 2011, www.aao.org.
Surgical Experience: Acquisition and Disclosure
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Spring 2012
Policyholders often call the OMIC Risk Management Hotline to discuss the risks associated with new techniques and technology. They wonder how much training is required and if and how they should talk to patients about their training and experience. The Closed Claim Study in this issue demonstrates that seeking such advice is prudent, as the physician’s level of expertise may become the focus of a malpractice lawsuit.
Q How much experience is needed in order to present oneself as qualified?
A There is no clear-cut answer, but the surgeon will be held to the standard of a reasonably prudent eye surgeon. While physicians are expected to be lifelong learners and continue to hone their skills, the acquisition of new knowledge and skills requires careful preparation. Certainly, any training required or recommended by an equipment manufacturer should be completed, as well as the review of pertinent peerreviewed literature. If the technique or technology is significantly different than that of the surgeon’s experience, additional formal training may well be needed, such as skill transfer classes or practice on cadaver or animal eyes, followed by observation of experienced surgeons and surgical assisting. Once the physician feels ready to treat patients, it would be prudent to ask a senior colleague to serve as proctor (this may even be required in order to obtain privileges at a hospital or ASC). The proctor, an impartial observer with documented training and experience in the skill in question, provides an objective evaluation and is able to attest that the surgeon has demonstrated competency. Finally, the ophthalmologist must feel that he or she is ready to perform the new skill.
Q I have been asked to proctor another ophthalmologist. Are there precautions I should take?
A Yes. First, ensure that you are licensed in the state where the proctoring will take place and have been granted privileges at the facility. Clarify with the credentialing department whether your role will be limited to observing and reporting or whether you are expected to intervene if there is a patient safety risk, and share that information with the physician being evaluated. In addition, ask if proctoring is considered a confidential peer review activity. Confirm that you and the physician whom you will be proctoring have professional liability insurance at adequate limits for the procedure. Ask the surgeon to inform the patient that you will be observing the surgery. Be candid and objective in your evaluation.
Q I just purchased a femtosecond cataract laser. I completed my training from the manufacturer and have been proctored. Do I have a legal duty to tell my patients how many procedures I have done using the laser?
A There is only a small body of case law governing voluntary disclosure of experience during the informed consent discussion, but one of the most famous cases highlights the risks of not discussing experience. A neurosurgeon disclosed the risks of death, stroke, and blindness to a patient who had a basilar aneurysm, stated he had done the procedure to treat it several times, and quoted a mortality rate of 2%. The patient had no prior neurological impairment but was an incomplete quadriplegic after the procedure. During the trial, the surgeon admitted that he had done only two cases, making it seem as if he had inflated his experience. Experts testified, moreover, that he had underestimated the risk: the mortality rate ranged from a low of 11% with very experienced surgeons to a high of 20 to 30% for those surgeons with limited experience. The jury awarded the plaintiff $6.2 million. On appeal, the Wisconsin State Supreme Court ruled that a reasonable person facing the need for an operation to treat a basilar aneurysm would have wanted to know that the neurosurgeon had little experience in the surgery and that the mortality and morbidity rates differed based on experience. In addition to mandating the disclosure, the court felt that the surgeon should have discussed the option of referral to a tertiary care center. In his analysis of the decision, OMIC Vice President Paul Weber noted that there is no clear rule on when the surgeon should talk about comparative risk and that such comparative risk data might not be available. He encouraged ophthalmologists to see the procedure from the patient’s perspective. If, as a patient, the eye surgeon would want to know the level of expertise and experience of the surgeon, he or she should disclose experience (see “Trends in the Duty of Informed Consent” at www.omic.com).
Q What if a patient asks me about how many procedures I have done?
A Here the legal answer is clear. Physicians do have a duty to answer truthfully when asked about their experience and results. When discussing results, it is important to distinguish results from clinical trials or studies from personal experience or that of the entire practice. Overstating one’s results may seem relatively harmless, but it has been construed as false advertising or fraud and has led to settlements of otherwise defensible care.
Practical Application of HIPAA Privacy Rules (Part 1)
Kimberly Wittchow, JD, OMIC Staff Attorney
Digest, Winter, 2003
The April 14, 2003 deadline to comply with the HIPAA Privacy Rules is fast approaching. OMIC enumerated the many components of compliance in its Guide to Implementation of the HIPAA Privacy Standards sent to insureds in November 2002. OMIC has since fielded many questions from insureds about the practical application of the Privacy Rules to their practices. The following are a sample of questions we continue to address.
Q Can I avoid being a Covered Entity under HIPAA if I contract with a billing service to transmit all electronic claims submitted on my behalf?
A No. Submitting even one electronic claim after April 14, 2003, whether directly or through a contracted service, will trigger application of the Privacy Standards to you.
Q Do I have to comply with HIPAA if I am a physician in a small, rural practice?
A Your practice size and location generally do not affect your status under HIPAA. However, you are not a Covered Entity if you maintain either paper or electronic files but do not transmit PHI electronically and have not volunteered to be a Covered Entity by contract or certification. You should be aware though that as of October 16, 2003, Medicare will require practices with 10 or more employees to file claims electronically.
Q Can I post a one page summary of my Notice of Privacy Practices in my office?
A Yes. But in addition, you must post your entire Notice in a clear and prominent location in your office and make it available on your web site. If you make changes, you must post the amended Notice in your office and on your web site, but you do not need to redistribute it to your patients unless they ask for a copy.
Q Can my office staff contact patients before we give them our Notice of Privacy Practices?
A Yes. You must provide the Notice to each patient no later than the date of first service delivery or as soon as practicable in emergencies. Where you contact the patient by telephone to schedule an appointment or collect information in anticipation of a procedure, you can wait to provide the Notice until the patient comes into your office. When you do provide the Notice, you must make a good faith effort to obtain the individual’s written acknowledgment of receipt of the Notice or document your efforts to obtain the acknowledgment and the reason it was not obtained.
Q Can I ask patients to sign a blanket HIPAA Authorization form for any use or disclosure of their PHI?
A No. A HIPAA Authorization is required for certain specific, non-routine uses or disclosures of PHI. Its required use is best defined by the exceptions. You do not need Authorization to disclose PHI to the subject of the PHI, the Department of Health and Human Services, or to people in the patient’s “circle of care.” You also do not need Authorization to use or disclose PHI for payment, treatment, health care operations, as required by law, or for many public health-related activities. In most other situations, Authorization is required. For example, you need Authorization to disclose PHI if you want to sell cataract/IOL outcome data that includes patient identifiable information to IOL manufacturers. You also need Authorization to disclose PHI if the patient is applying for disability insurance and the insurer requests the patient’s medical record to make an underwriting decision.
Q Do I have to enter into Business Associate Agreements with janitorial or other service providers?
A No. Your Business Associates are persons or entities that perform certain functions or activities on your behalf or provide services to you that involve the use or disclosure of PHI. Certain service providers, such as janitors, electricians, and couriers of information, are not Business Associates because their services do not involve the use or disclosure of PHI.
Q Are my patients’ health plan insurers my Business Associates?
A No. When you submit a claim for payment to a health plan and it assesses and pays the claim, you are each acting on your own behalf as Covered Entities and not as Business Associates of one another.
Q How do I find out if my state privacy laws are stricter than HIPAA’s?
A Your state ophthalmic or medical society may have undertaken such an analysis for its members. You also may want to engage legal counsel to advise you on your specific responsibilities under both state and federal privacy laws.
The primary resource for this article was the OCR Guidance Explaining Significant Aspects of the Privacy Rule – Dec. 4, 2002.
Acute Postoperative Endophthalmitis
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Fall 2003
Several policyholders have called with concerns about protocols they use for endophthalmitis prophylaxis before ocular surgery. They have heard rumors that it is below the standard of care not to use the latest topical fluoroquinolones. Currently, there is no basis for this claim. The fact that prevention and treatment of this rare but devastating complication remains the object of ongoing controversy contributes to the confusion. Two sources of information can help allay concerns and provide direction for sound therapeutic choices: OMIC claims experience and evidence-based studies.
Q What is the source of infection in postoperative endophthalmitis?
A In most cases, the causativeorganism is introduced into the eye at the time of surgery. Studies have identified the eyelids and conjunctiva as the primary source, so prophylactic measures are directed there. Other sources of contamination include secondary infection from sites such as the lacrimal system; contaminated eye drops, surgical instruments, intraocular lenses, or irrigation fluids; other agents introduced into the eye; and major breaches in sterile technique.
Q What standards exist for prophylaxis?
A There are currently no definitive standards. The latest evidence-based study by Drs. Cuilla, Starr, and Masket (Ophthalmology, January 2002) gave no prophylactic technique the highest clinical rating; however, an intermediate rating was given to preoperative preparation of the eyelids and conjunctiva with a 5% povidone-iodine solution just before surgery. Because of weak and conflicting evidence, all other reported prophylactic interventions received the lowest recommendation; of these, postoperative subconjunctival antibiotics had greater supporting evidence than the rest.
Q In the absence of standards for prophylaxis, what should I do?
A Base your treatment protocol on sound medical judgment. Tailor your treatment to the patient by taking into account known risk factors such as diabetes or immunosuppression, as well as the risks and benefits of the proposed treatment. Carefully document discussions with the patient, and provide clear, written instructions for pre- and postoperative care. Stay informed by reading peer-reviewed journals, and keep a risk management file of the articles that form the basis for your infection prevention protocol.
Q What is the greatest malpractice risk associated with endophthalmitis?
A Without exception, OMIC claims experience shows that liability arises from a delay in diagnosis or treatment, including a delay in referring the patient to a retina-vitreous specialist.
Q What can I do to reduce the risk of delay in diagnosis?
A If the surgery was complicated (e.g., capsular tear), took a long time, or required extensive instrumentation, you should have a higher index of suspicion for the development of endophthalmitis. Give all patients written discharge instructions stating the symptoms that warrant contacting you (blurred vision, red eye, pain, photophobia). Educate your staff members who handle telephone calls about the risk of endophthalmitis and train them to always ask patients who have these complaints if they have had eye surgery or trauma. Instruct them to schedule emergent appointments for such patients. Use the same screening criteria yourself when fielding after-hours calls (call OMIC for sample screening guidelines and contact forms). Err on the side of patient safety when deciding to treat over the phone versus examining the patient. Document your decisionmaking process in the medical record, especially when the patient calls with symptoms of a possible infection. Obtain a thorough intervalhistory, and perform and document a careful examination, noting the presence or absence of the signs of endophthalmitis (the cardinal sign is intraocular inflammation greater than expected for that point in the recovery process). If in doubt, consult with and/or refer patients to retina-vitreous specialists for cultureand management.
Q Are there other measures I can take to reduce endophthalmitis liability?
A During the informed consentdiscussion, warn patients about the risk of endophthalmitis and the possibility of vision loss. Emphasize the risk if the patient has diabetes, is immunosuppressed, or is having cataract surgery. Have a prudent follow-up plan, especially in symptomatic patients, and ensure that the patient makes the appointment before leaving your office. Diligently follow up on all patients who miss or cancel appointments, again ensuring that they understand that not receiving appropriate treatment could result in blindness. Carefully instruct patients to call you immediately if vision loss, pain, or other ocular problems develop before their next scheduled visit.
