Help patients reduce their risk of falling in your office or ASC

ANNE M. MENKE, RN, PhD, OMIC Risk Manager

In response to the high number of older patients injured in falls each year, the Centers for Disease Control (CDC) developed a program called STEADI: Stopping Elderly Accidents, Deaths, and Injuries. Many of the materials are geared to primary care physicians and include strength, balance, and mobility tests. Ophthalmologists in their offices and staff in ambulatory surgery centers (ASCs) are not likely to perform these tests as part of an eye exam or preoperative evaluation. The information in the documents does, however, contain recommendations that can be implemented by the eye care team.

Q We have a busy practice and see many elderly patients. Is there a real-world tool our staff members can use to determine who is at risk of falling?

A Yes. One simple way to screen for fall risk is to ask the patient three questions proposed by the CDC: (1) Have you fallen in the last year? (2) Do you feel unsteady when you stand up or walk? and (3) Do you worry about falling? Some ASCs skip the CDC’s third question about the fear of falling and instead ask if the patient has a history of dizziness or lightheadedness, which can help identify younger patients who suffer vasovagal episodes in medical settings. Staff can either ask the questions and document the answers or include them on forms the patient completes, such as the one identifying who will drive them home after surgery or their emergency contact information. Any yes answer indicates the need for assistance and should be communicated to all members of the team providing care for the patient.

Q What are the signs of gait or balance problems?

A Certain behaviors that are readily observed can point to unsteadiness and increased fall risk. Ask staff to watch for these behaviors and immediately go to the side of any patient who exhibits them. Using one’s hands to push up off a chair, a sign of weak abdominal or leg muscles, could alert staff to stand next to the patient and provide assistance. Holding onto furniture when walking could indicate a fear of falling or weakness in the extremities. Trouble stepping up to a curb could stem from poor depth perception or muscular problems. Many patients experience urinary urgency and may fall while rushing to the bathroom. Offer these patients assistance to the restroom, especially after sedation or anesthesia. Patients who use mobility aids, such as canes, walkers, and wheelchairs, are easy to notice. It can be hard to know when to help, however. Our claims experience shows that some may value their independence and decline offers of assistance. Respect the patient’s choice but stay with the patient and be prepared to help until she has safely moved to where she is going. It might be surprising to learn that patients who are sad or depressed are at increased risk of falling. Perhaps they are less attentive to their environment and don’t notice obstacles or the approach of steps as readily. Will getting answers to these questions and observing these behaviors prevent falls in ophthalmic practices and surgery centers? From the limited information available in the claims files we analyzed of 41 patients who fell, at least 19 of the patients would have been considered at increased risk for a fall based on their histories or behaviors. Asking the patient if he or she worries about falls or feels unsteady or lightheaded could well have identified more.

Q Are we expected to educate patients about their increased fall risk?

A Just as ophthalmologists and ophthalmic ASCs do not conduct formal gait and balance testing, they are not expected to provide extensive education on fall risk. But the eye care team can advise patients of simple ways to keep themselves safe. Consider placing signs with the following reminders in the lobby or examination lanes. Prevent falls that can occur when standing up from a seated position by suggesting: “stand up slowly” and “stand still a minute after you stand up.” When patients are offered sunglasses and prepare to exit into brighter light, remind them to “take your time” and “wait for your eyes to adjust.”

Q Our office does not have equipment to lift or move heavy patients. We are worried that staff may injure themselves by trying to assist bigger patients.

A These fears are well-founded. The CDC website’s section on workplace safety indicates that the healthcare industry has some of the highest reports of musculoskeletal injuries from what it calls “overexertion.” The single greatest risk factor for overexertion injuries is the manual lifting, moving, and repositioning of patients. According to the CDC, mechanical equipment, not staff, should be used to lift and move patients: there is no safe way to manually lift another adult human being. Let the ophthalmologist or head nurse know if you identify a patient who needs lifting or moving. The patient may need to be sent to a facility with the necessary equipment.

When is a physician–patient relationship established?

PAUL WEBER, JD, ARM, Vice President, OMIC Risk Management/Legal

Plaintiffs who sue for medical malpractice must show that there was a physician-patient relationship that created a legal duty. OMIC has addressed the issue of a duty being established when the physician has not personally seen the patient in the context of on-call coverage for the emergency department, coverage arrangements with colleagues, and new referrals from other physicians. Articles and recommendations related to these situations can be found at www.omic.com. This article reviews an ophthalmologist’s duty to a patient that may arise from appointments with prospective patients and curbside consults.

Q When is a legal duty established between physician and patient?

A Unfortunately, there are no statutes specifically outlining and providing guidance to physicians on the circumstances that create this duty towards the patient. Instead, the legal basis for the physician-patient relationship arises out of court decisions that create precedents and vary by state. While there is no majority consensus, in general, the duty is established when a physician affirmatively acts in a patient’s care by diagnosing or treating the patient, or agreeing to do so. This area of law has evolved over decades so that now a physician-patient relationship may be established even when the physician does not personally see the patient, refuses to see the patient, or is unavailable to see the patient. Once the relationship is entered into, the physician owes a duty to the patient either to continue care or to properly terminate the relationship.

Q Can an appointment establish the physician-patient relationship?

A The general rule is that an appointment by a prospective patient to see an ophthalmologist by itself is not sufficient to establish a physician-patient relationship since an appointment does not necessarily mean the ophthalmologist has affirmatively acted or agreed to diagnose or treat the patient. However, since there is no “majority rule” on these issues, if a prospective patient misses a scheduled appointment, OMIC advises documenting your efforts to contact the prospective patient. Ophthalmologists generally may decline a request for an appointment but should have a policy to inform the prospective patient of the decision not to examine, diagnose, or treat and provide information about other options for care, e.g., the local hospital emergency room, local medical society, etc. When an ophthalmologist has granted an appointment for a specific consultation or procedure within his or her area of expertise, a duty to the patient can arise even prior to actually seeing the patient. However, if upon meeting and examining the patient, it is determined that the anticipated care is not needed or is beyond the ophthalmologist’s area of expertise, the patient should be referred to someone who can provide treatment. Once treatment has begun, regardless of whether it is within the ophthalmologist’s area of expertise, a relationship has been created and withdrawing from care at an unreasonable time or without affording the patient the opportunity to find a qualified provider may make the ophthalmologist liable for a claim of patient abandonment. OMIC insureds are encouraged to call the risk management hotline when they have concerns about withdrawing from care.

Q Can an informal “curbside consult” establish a physician-patient relationship?

A In the recent past, an informal opinion about a patient provided as a professional courtesy to a colleague did not typically establish a physician-patient relationship. Generally, if the patient’s identity was not disclosed, the patient was unaware of the consultation, and the consulting ophthalmologist did not bill for the advice, most courts would not have found a physician-patient relationship. Now, however, courts are increasingly allowing medical malpractice suits to proceed against specialists consulted informally. For that reason, it is important to follow general rules to avoid unintentionally establishing a physician-patient relationship when providing a curbside consult:¹

1. When consulted by other physicians, (a) frame responses in very general terms; (b) suggest several possible answers, noting that all are dependent on the specific circumstances of a particular case; and (c) include disclaimer statements to emphasize that there is no formal consulting relationship.
2. Beware of evaluating test results of any kind and rendering a specific diagnosis.
3. Keep all such conversations/communications short. If contacted by a treating physician a second time, consider suggesting a formal consultation.
4. Document any such consultations with the date of the inquiry, the inquiring physician’s name, the nature of the inquiry, and any advice given. Without a record of the advice given, the consultant will be defenseless should a claim arise regarding the consultation.

These rules are based on the article “A Doctor’s Legal Duty—Erosion of the Curbside Consult” by Kimberly D. Baker of the Federation of Defense Lawyers and Defense Counsel.

Plain Language Concepts in Consent Discussions 

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

The analysis of informed consent claims presented in the lead article indicates that patients often don’t understand the planned surgery. How can busy eye surgeons and their staff better explain the risks of treatment while staying on schedule? How can they know which patients need additional guidance or have misinterpreted what they have been told? Health literacy experts suggest that the use of “plain language” can help. This article will introduce this idea and explore ways it may be used to communicate more effectively. It will also discuss why changes to the informed consent process need to be made with care.

Q What exactly is “plain language”?

A The term is often used to measure the understandability of written material but applies to speaking as well. A document written in plain language allows people to find what they need, understand what they find, and act appropriately on that understanding.¹

Q Are there guidelines for speaking and writing in plain language?

A Yes, there are a number of key principles, such as organizing material so the most important behavioral or action points come first and breaking complex information into understandable portions with one idea per sentence. One simple change you can make to enhance the clarity of messages is to use the active voice to make clear what action needs to be taken and by whom. Instead of “The drops should be used twice a day,” say “You need to put the drops into your eye twice a day.” Another tool is to use lists to make points: “You need to use three different eye drops after your surgery. The first one with the green label treats infection….” Employ “living room” words that patients already know to explain medical terms and include examples and analogies. For instance, “Eyes are usually round like a basketball. Yours is shaped like a football. This shape makes your vision blurry and is called astigmatism.”

Q I appreciate that anxious patients may have a hard time understanding the information I present. What else can I do to help?

A Start by stating the purpose of important parts of your discussion. “We know you have a cataract and that it needs to be removed. Now I need to decide what type of intraocular lens to put in your eye. To do that, I need to ask you some questions about how you use your eyes and what your goal is for the surgery.” Clarifying the key point is especially helpful for patients with complex conditions or those at higher risk. “You need this surgery to treat the hole in your retina. But your vision is already limited. I want to explain how the normal risks of this operation could cause extra problems for you.”

Q How can my staff and I tell if a patient needs additional guidance or has misinterpreted what we said?

A Communication experts suggest using a technique called “teach back” in which patients are asked to restate information in their own words. Suppose you have just finished recommending a combined cataract and glaucoma procedure. Say to your patient, “I want to make sure that I have explained why you need two different surgeries. Please tell me the two problems with your eyes that I am trying to help.” Use the same approach to clarify the goals of the surgery. “I want to make sure that I explained what vision you can expect with this type of lens. Please tell me when you might need to wear glasses.” Invite input from patients who do not seem to be actively engaged in the conversation. When doing so, avoid questions with yes and no answers (“Do you have any questions about your corneal transplant?”). Instead, you and your staff should encourage patients by asking open-ended questions: “We’ve presented a lot of information and may not have explained everything clearly. What questions do you have for me?”

Q How much information should we provide to minimize claims of lack of informed consent?

A Plain language experts feel patients are sometimes given too much information and recommend thinking of “need to know” instead of “good to know.” While this advice makes sense for clear communication, it may be problematic in the legal context of informed consent discussions. The informed consent process and forms serve a dual purpose: to inform the patient and to defend the physician against allegations of lack of informed consent. Physicians who shorten their forms and discussions too much may later be sued for failure to address certain issues. OMIC is actively exploring these issues with the help of plain language and legal consultants. We want to proceed carefully so both patients and physicians are well-served. For now, try incorporating some of these clear language principles into your conversations with patients.

1. “Plain Language: A Promising Strategy for Clearly Communicating Health Information and Improving Health Literacy.” http://www.health.gov/communication/literacy/plainlanguage/PlainLanguage.htm.

Adverse Events in Clinical Research

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

Just as with care provided outside of research, subjects who participate in clinical trials can experience complications from the study intervention. Federal regulations use the term “adverse events” to describe these outcomes and define them in intentionally broad terms. In drug trials, for example, an adverse event would include any adverse change from the patient’s baseline condition, including any abnormal clinical laboratory test value, which occurs during the course of the study, whether related to the study medication or not. Management of adverse events in clinical research raises questions about who provides and pays for care when adverse events occur.

Q When is an investigator required to provide care for adverse events?

A The FDA issued a guidance document for investigators that contains non-binding recommendations.¹ It states that investigators should provide reasonable care for any adverse events related to trial participation. If the investigator does not possess the necessary expertise, the investigator should make sure that the subject is able to obtain the needed care from a qualified practitioner. The care should continue until any emergency condition related to the study intervention is resolved, whether the condition develops during the study or after it ends. The claimant in the Closed Claim Study alleged that the principal investigator (PI) abandoned her by referring her to a hospital after an adverse event occurred instead of performing the needed surgery herself. The PI was a retinal specialist and had the requisite expertise to perform the vitrectomy. The subject, however, was unemployed and without insurance, and the PI, who was an employee of the research center, did not have the authority to provide care in these circumstances. Since endophthalmitis was a foreseeable risk of an intravitreal injection, the PI should have clarified in advance with the research center and the study coordinating center what care she would be authorized to provide in the case of an adverse event. Once she learned that the care she could provide was limited to office-based interventions, she should have identified retina specialists and hospitals willing to provide further care.

Q Who pays for the care in the case of an adverse event?

A Federal regulations governing informed consent stipulate that subjects who face more than minimal risk should be told what compensation and medical treatments, if any, are available for injuries arising from study procedures and where more information may be obtained. The claimant in the Closed Claim Study complained that the consent form contained conflicting information about what care would be provided. The form stated that tests related to the study would be free, but that the subject or subject’s insurance company would be responsible for the costs of study-related treatment, office visits, and general eye care. The consent form then went on to explain that some costs and treatment might not be covered by the subject’s health plan, but if they were not, they would be covered by the study. The claimant informed the investigator at the outset that she had no insurance, and it appears that she believed the study would pay for her care. Her complaint letter did not reference a later section of the consent form, which stated that, in the event of an injury, she would receive medical treatment but would be responsible for the costs and that no money was available to compensate her for an injury. The form did not explain whether the risks detailed in the document were considered an injury. Consent forms can be confusing. The National Cancer Institute developed a research consent form template that meets federal requirements but uses simplified language. It states, in part, “The study sponsors will not pay for medical treatment if you are injured or hurt because you took part in this study. Your insurance company may not be willing to pay for injury from the study. If you have no insurance, you will be responsible for any costs [related to an injury].” The template further explains that if subjects feel an injury was a result of medical error, they keep all of their legal rights to seek payment for an injury even though they were in a study.² Ophthalmologists may benefit from using similar language to ensure that information about adverse events is clearly communicated in the protocol, consent form, and consent process.

1. FDA. “Guidance for Industry: Investigator’s Responsibilities—Protecting the Rights, Safety, and Welfare of Study Subjects.” http://www.fda.gov/downloads/Drugs/…/Guidances/UCM187772.pdf.
2. National Cancer Institute. NCI Consent Form Template. http://www.cancer.gov/clinicaltrials/conducting/simplification-of-informed-consent-docs/.

Improving the Accuracy of Electronic Health Records

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

As the discussion of the two closed claims involving EHR in the lead article shows, records can become unreliable if steps are not taken to confirm the accuracy of the information. In a study that evaluated changes in the medical record of an ophthalmology practice when an EHR was adopted, the authors found that the length of the record increased due to copy-and-paste, copy-and-forward, and all-normal functionalities.¹ They raised concerns that the increased volume of EHR records would make it difficult to distinguish the critical findings from the background data and adversely impact the eye surgeon’s ability to effectively diagnose and treat the patient. An editorial in Ophthalmology described the type of errors that EHRs can introduce, noting that they have created serious and unintended consequences that need to be identified and addressed immediately to ensure the integrity of the EHR.² Risk reduction strategies from these articles and other sources are discussed here.

Q What principles should guide the use of EHR?

A A basic principle is to “document what you do and only what you do.”² Experts stress the importance of unique documentation for each patient encounter and warn that functions such as carry forward can lead to documentation of findings that were not actually seen.¹ This has implications for billing, as noted later.

Q Given the risk of erroneous documentation, may I use functions such as copy forward? If so, what are considered “best practices” for copying and pasting or carrying forward prior entries?

A Yes. Most articles reviewed for this issue of the Digest acknowledge the need for these tools, especially since adoption of EHRs has been shown, at least initially, to negatively impact the physician’s productivity and decrease the number of patients seen in a day. Some documentation guidelines make a very useful distinction between historical data that is unlikely to change (what I will call “stable data”) and information that is expected to change(what I will call “variable data”). Variable data can “only be presumed to be correct at the time the health care team member obtained it.”³ Examples include the chief complaint, review of systems, physical examination, assessment, and plan, all of which will usually be different for each encounter. One organization allows each physician to copy forward his/her own variable data elements, but requires in its EHR policy that the physician edit the data to make them current. Furthermore, the organization prohibits physicians from copying variable data from the note of another physician. Other groups ban any use of the copy-forward function for variable data. Stable data elements include allergies, historical procedures and surgeries, previous medical history, previous developmental history, immunizations, family history, previous social history, and prior reports (pathology, cytology, radiology, procedures, etc.). One institution allows all EHR “authors” to copy stable data elements from prior entries whether or not the current physician obtained the information. It does caution that reports that are not new should be labeled as copies and that current reports should be prominently displayed.

Q Are there other risks besides inaccuracy if information is copied and pasted?

A The authors of the editorial in Ophthalmology noted not only the possibility of documentation errors, but also the risk of billing fraud. Indeed, the Office of the Inspector General of Health and Human Services (HHS) warned that some providers may be using the technology to game the system. For example, notes from office visits in EHR tend to be much longer and more detailed. Some computer programs incorporate the additional data elements into their billing algorithm and may inadvertently code the visit as more comprehensive than it actually was, leading to possible allegations of false claims and billing fraud. In malpractice lawsuits, plaintiff attorneys have also questioned how a physician could have obtained all the information recorded in a visit note in such a short time. Concerned about such billing and documentation issues, one organization asked its software vendor to program the EHR so that all copied data must be reviewed and verified by clicking on a button. If the information is not pertinent to the current visit, the policy states that the physician should not carry it forward into the current record. Physicians who use EHR systems without such a review button can use the free-text feature to indicate in their note that they have confirmed the accuracy of the data that has been carried forward.

1. Sanders DS, Lattin DK, Read-Brown S, Tu DC, Wilson DJ, Hwang TS, Morrison JC, Yackel TH, Chiang MFl. “Electronic Health Record Systems in Ophthalmology: Impact on Clinical Documentation.” Ophthalmology. 2013;120(9):1745-1755.

2. Silverstone DE, Lim MC. “Ensuring Information Integrity in the Electronic Health Record: The Crisis and the Challenge.” Ophthalmology. 2014;121(2):435-436.

3. University of Illinois Medical Center at Chicago Documentation Guideline. Key Content Expert: David Sarne, MD, EMR Documentation Committee, http://chicago.medicine.uic.edu/compliance/comp_ppg/.