Putting “Management” Into Risk Management
Proactive policies for keeping your patients safe.
LESLIE GOLDBERG, ASSOCIATE EDITOR
Timely updating of patient information and informed consent documents, appropriate handling of ROP cases, safe use of fluorescein angiography, avoiding delays in performance, and staying in compliance — all are important issues that your practice must have a handle on to keep you from having to face possible litigation.
This article will provide numerous ideas — many of them directly recommended by Ophthalmic Mutual Insurance Company (OMIC) — on how to create and enforce protocols to prevent you from becoming entangled in a lawsuit.
IT STARTS WITH AN AUDITING PROCESS
Risk management begins with a thoughtful and well-planned auditing process. It is absolutely critical to know what your practice is already doing that offers protection from litigation and in what areas it needs to improve to reduce the chances of a future lawsuit.
Regular self-audits may be a good start, but if a surgery center is also part of the practice, it is wise to join ASC-related professional associations, while also proactively seeking accreditation from an agency that is recognized by Medicare. As a member of one or more of these organizations, a practice can take advantage of participating in useful external benchmarking exercises designed to identify “best practices.”
Among the organizations offering external benchmarking opportunities are the Outpatient Ophthalmic Surgical Society, the Accreditation Association for Ambulatory Health Care, the Joint Commission, and the American Association for Accreditation of Ambulatory Surgical Facilities. Additionally, more specialized associations exist for operating room nurses and administrators.
Bradley C. Black, MD, in private practice in Jeffersonville, IN, has conducted a number of seminars on preventing and dealing with patient emergencies. His practice administrator Sarah Cwiak, MBA, COE, formed the “Insuring No Harm Committee,” which first brainstormed, and then implemented, numerous ideas to prevent patient emergencies in the office.
Some of the safety steps taken as a result of the committee's efforts included installing no-slip mats around urinals and toilets and securing frames, flat screens, and anything hanging on the wall so that if a patient became disoriented and needed to lean on the wall, nothing would fall. In addition, patients were walked to their cars in inclement weather and technicians were trained to turn lights in exam rooms up before exiting rooms with patients.
One retina specialist in the northeastern United States says that as his practice has grown larger and busier, the staff has implemented a system of checks and balances for the key elements of their protocols. He says that it is important that these checks and balances don't become cumbersome. Keeping risk management policies as streamlined as possible is important so no one feels that they are rushing, which can easily lead to mistakes. The practice has a policies and procedures manual that includes protocols for technicians to follow, which helps to keep everyone knowledgeable and up to date.
DATA UPDATES AND PREVENTIVE STEPS
Here's how one practice prevents errors in collection of patient data.
Dr. Black's practice revisited how its health histories were taken and gave the staff some new questions to draw needed information from patients. The practice also had a local pharmacy tech come and talk about the importance of finding out all drugs that patients are using. Staff members also began asking leading questions like, “Are you on any drugs that can make you drowsy?” Finally, the practice developed a check sheet for all surgical procedures. This allows techs to systematically go over steps pre- and postop.
In an ASC setting, additional preventive steps are required, such as limiting patient movement during surgery and double-checking for all medical and contact allergies. In the office setting, Ms. Cwiak advises that all staff members who interact with patients should have CPR training at a minimum and Advanced Cardiac Life Support training as the ideal. The practice should also have a wheelchair on site. Doctors should be trained in the use of defibrillators and epinephrine pens, which should be easy to access in an emergency. It might also be wise to have a tracheotomy kit in case a patient's airway becomes blocked from a severe allergic reaction. It's a good idea to conduct mock drills to practice these emergency procedures.
In an ASC, where the risk of serious patient emergencies is greater than in the office setting, a fully equipped “crash cart” with ACLS-recommended contents and appropriate staff training are musts (Figure 1).
IMAGE COURTESY OF BRADLEY C. BLACK, MD
Figure 1. Re-enacting treatment of a severe allergic reaction to fluorescein dye.
Risk management specialists from OMIC and other medical liability insurers emphasize that all practices need to have sound risk management strategies in place. When properly implemented, these relatively simple strategies can significantly reduce the odds of being sued for medical malpractice.
Following are policies that risk management specialists from OMIC say can serve as the foundation of a risk management plan. A number of other specific practice-protecting ideas may be found under the “Risk Management Recommendations” icon at www.omic.com. Sample in formed consent forms are also available on the OMIC Web site.
■ Have thorough and specific informed consent documents. Malpractice suits involving medical disorders of the retina have become more common, specifically those involving diabetic retinopathy and macular degeneration. Informed consent plays a major role in helping retina patients under stand the consequences of failing to receive treatment and accept the sometimes less-than-perfect results of treatment.1
Out-of-date patient information materials and informed consent documents can increase the risk of a medical malpractice suit. This is especially important when using off-label medications. All patients receiving off-label medications or treatments should be closely monitored. OMIC provides a list of consent forms on its Web site at www.omic.com/resources/risk_man/forms.cfm.
■ Document all patient interactions. Risk specialists caution that the increased use of cell phones and other mobile devices has made it somewhat more difficult for physicians to document all patient inquiries received. However, it is the lack of documentation that puts physicians at risk when patients make claims of malpractice that cannot be adequately refuted.
Improper telephone screening is a source of potential malpractice claims, says OMIC, which is why it is critical that individuals answering the telephone be trained to recognize possible emergencies and schedule such patients appropriately. Documenting the details of a telephone conversation with a patient is as important as documenting the findings of an office examination. Recollections of what was discussed weeks and months later are unreliable and open to dispute without notations in the patient's record.
■ Clearly delineated roles for ROP. Although claims against ophthalmologists for mismanagement of ROP are relatively infrequent, indemnity payments for these claims can be high due to the young age of the plaintiffs and the significant loss of vision that can result even with treatment, says Anne M. Menke, RN, PhD, OMIC Risk Manager.
The table below helps to clarify the roles of each task in the ROP care process, both in the hospital (or other healthcare facility) and during outpatient care (see Table 1).
TABLE COURTESY OF OMIC
To help promote patient safety and minimize the potential liability exposures associated with the critical activities with treating ROP patients, OMIC offers risk management recommendations, as well as a sample consent form for laser surgery.
■ Use of intravenous fluorescein angiography. As stated in the OMIC article “Legal Issues Arise When Unlicensed Ophthalmic Personnel Administer IV Fluorescein,” by Jean Hausheer Ellis, MD, and Paul Weber, JD, “Medical malpractice lawsuits arising from administration of intravenous fluorescein angiography — one of the most commonly performed procedures in the ophthalmic office — are relatively rare but can be expensive when they occur.”
The article states that in 1993, a $475,000 settlement was made against a non-OMIC ophthalmologist whose patient suffered an anaphylactic reaction and died after injection of sodium fluorescein. Other important medicolegal issues surrounding FA include informed consent and emergency response capabilities.
OMIC's Web site has a sample informed consent for angiography and a wall chart listing reactions and treatment to IV fluorescein. (See sidebar by David Khorram, MD.)
■ Communicate with patients and colleagues. Clear and complete communication with patients, staff, and colleagues is a must if errors and misunderstandings are to be avoided.
It has been shown that patients are reluctant to sue a doctor they like, especially a physician who takes the time to explain medical issues and answer all questions.
Managing patient expectations is of the utmost importance; doctors should even consider having patients write down in advance of the procedure where their expectations are in terms of improved vision. If the patient's expectations are too high, the physician needs to correct those expectations to more realistic ones that the patient can accept.
In terms of communicating with staff and colleagues, it's a given that all staff members should be regularly evaluated for competence in the skills that are critical to their specific jobs. Practices must also devise a system that ensures that all messages are received clearly and in a timely manner. One of the great advantages of electronic medical records is the easy accessibility of the patient record from even remote sites and the elimination of errors caused by sloppy or illegible handwriting.
■ Injections. Although the majority of issues here have existed for a long time and have been addressed before, the role (and risk) of injections have greatly changed recently because of the huge population of patients coming back for anti-VEGF injections. The chances of injecting the wrong eye or using the wrong syringe grows exponentially with the increased number of patients coming into a practice.
“My clinic has a procedure person and a scribe who is with me throughout the procedure,” says Phoenix's Pravin Dugel, MD. He enforces the following process in his practice to ensure that no errors are made: First, the tech will confirm with the patient which eye is having the procedure and what needs to be done. The tech will label that. Then the procedure person will double check and ask the same questions again. He will then tape over the eye that is to be done and the tape remains on the entire time. There is then a time out period and the scribe will recheck the whole thing again with the tape on. Dr. Dugel then asks and gets verbal confirmation from the patient that the correct eye has been taped.
“It may seem like a lot, but it only takes one mistake,” says Dr. Dugel. “High volume makes it necessary to go through all these procedures routinely.”
Following sound risk management procedures does not mean being fearful that every patient who walks in the door is a potential litigant. Studies have shown that patients are extremely reluctant to sue a physician with whom they connect on a personal level, so being wary, distant and overly cautious can actually work against you. Once you have the right risk management procedures in place, you can go through the day knowing that you have done everything possible to protect your practice, your reputation, and your pocketbook. RP
- Jerome W. Bettman Sr., MD, and Monica L. Monica, MD, PhD. Risk Management Issues in Medical Retina Disorders. Digest; Fall, 1994.
- Bearelly et al. Anaphylaxis Following Intravenous Fluorescein Angiography in a Vitreoretinal Clinic: Report of 4 Cases. Can J Ophthalmol. 2009;44: 444-445.
|Preparing for Anaphylaxis From Fluorescein Angiography|
The biggest risk we need to be prepared for in retina practices is anaphylaxis from fluorescein angiography. A publication this past summer showed the incidence of anaphylaxis is one per 350 fluoresceins.2 Because anaphylaxis can be life threatening, and because it is treatable, we must train our staff to recognize it — and our retina practices must be prepared to deal with it.
Anaphylaxis is a multisystem allergic reaction. The severity of the reaction is difficult to predict at its outset, and the internal medicine literature advocates treating it early with subcutaneous or intramuscular epinephrine (1:1000). Anaphylaxis can involve four major organ systems: respiratory, cardiovascular, gastrointestinal and cutaneous. Involvement of any two of these organ systems meets the definition of anaphylaxis. So if a patient has itching and shortness of breath, the internal medicine literature advocates treating with epinephrine. I think many of us are hesitant to give epinephrine in our practices because of the potential risks in our patients with diabetes and cardiac disease. But it's certainly worth having epinephrine on hand. It's also important to have a protocol in place.
In developing protocols for our practice, I consulted with other retina specialists to see what protocols they had in place. At hospital-based practices, the most common protocol was “call the code blue team.” Most private practices I spoke to don't have written protocols. In developing ours, I sought the advice of my colleagues in internal medicine, emergency medicine and anesthesia. Among these specialties, they advocated a wide range of reasonable approaches. If you have easy access to a 911 team, then your protocol can be minimal — administer diphenhydramine, maybe epinephrine, and monitor blood pressure. If, however, you want to be more complete, because of a slower anticipated response time, your protocol could include administering oxygen or IV fluids, monitoring oxygen saturation and a cardiac tracing, and having available an airway, bag and an automatic external defibrillator.
Our protocol is primarily a checklist that includes several sections: preparation, which includes checking the blood pressure and pulse, reviewing drug allergies, pregnancy, and any history of prior cardiac or respiratory problems. Most of these data are already on the chart, so this portion of the checklist is a sort of a “time out” to review things before injecting the fluorescein.
The second portion of the checklist addresses things that must be available prior to injecting: Personnel —which is an MD in the office; Equipment — which, in our case, is a cardiac monitor, and bag and mask; Supplies — such as IV fluid, needle, tape and gauze; Drugs — we stock oral and IV diphenhydramine, and IM/SQ epinephrine (1:1000); and Paperwork — the consent form, the symptoms checklist, and treatment flowsheets.
The protocol in our practice is symptom-based. For example, if there is nausea or vomiting, the protocol directs staff to provide an emesis basin, support, and monitor the patient for 30 minutes. In the event of mild hives or itching, the protocol calls for notification of the MD, the administration of oral diphenhydramine 25-50 mg, and monitoring until symptoms improve. For more severe hives or itching, we administer the drug IV.
In the event of the onset of respiratory symptoms, our protocol calls for us to record oxygen saturation and blood pressure, to call 911, to prepare the epinephrine for possible administration, and to get the doctor in the emergency room on the phone for guidance while awaiting arrival of the emergency team. Our entire protocol is available online at TheRetinaBlog.com.
The truth is that severe symptoms are rare, and fortunately, death from fluorescein angiography is reported to be only 1/220,000. But it is prudent to be prepared to deal with the more severe symptoms in the unlikely event they arise.
In terms of training, I think we physicians have to periodically review the management of anaphylaxis, and an excellent review is available in the article, “Office Approach to Anaphylaxis: Sooner Better than Later” by Stephen F. Kemp, which appeared in the Amercian Journal of Medicine (2007) 120, 664-668.
I do think it's reasonable for nonphysicians to administer fluorescein, under the supervision of a physician.* In our case, it means that they have shown their ability to administer FA successfully 10 times under direct physician observation. After that, a physician must be present in the office and available to deal with any emergencies during administration. In our office, all staff (including doctors) maintain current CPR certification.
* OMIC warns that allowing unlicensed staff to inject may be illegal. See their risk management recommendations on FAs.