Risk Management Issues in Glaucoma Diagnosis and Treatment
By E. Randy Craven, MD
Digest, Summer, 1994
Glaucoma-related claims and lawsuits arise relatively infrequently. When they do, however, they are more likely to result in indemnity payments, and those payments are likely to be substantially larger than they are for other types of ophthalmic claims.
Using data collected by the Physician Insurers Association of America (PIAA), whose member companies collectively insure more than 100,000 physicians nationwide, this article will explore the nature of glaucoma-related claims and offer guidelines to avoid or minimize the risks associated with these claims. PIAA has collected data on more than 109,000 medical claims and lawsuits in all specialties since January 1, 1985, making its database the most detailed and comprehensive source of medical malpractice loss data currently available.
By comparison, there are only seven claims arising from treatment of glaucoma patients in OMIC’s claims database. While glaucoma cases represent only 1.5% of all OMIC claims, they account for 6% of the ophthalmic claims in PIAA’s database and 7.8% of the 700 medicolegal cases in ophthalmology reviewed by Jerome W. Bettman, Sr., M.D. (Ophthalmology 1990;97:1379-84). The small percentage of OMIC glaucoma claims is probably a reflection of OMIC’s limited claims experience over a relatively short period of time. Therefore, for purposes of analyzing frequency and severity of glaucoma-related claims, the PIAA database is a more comprehensive and reliable source of statistical information.
Claims Frequency and Severity
Figure I compares claims frequency (number) and severity (indemnity payments) of all medical claims in the PIAA database as of December 31, 1993, with all ophthalmology-related claims, all cataract claims, and all glaucoma claims. As Figure I indicates, half of all glaucoma-related claims result in an indemnity payment, and these payments are almost 20% higher than the average ophthalmology indemnity payment. As the chart also shows, although cataract patients file a third of all claims against ophthalmologists, these claims usually settle without an indemnity payment or with a relatively low payment. To date, OMIC has not paid an indemnity to a claimant or plaintiff in any of its glaucoma-related claims. OMIC’s indemnity rate for all types of claims is 24%.
Analysis of Glaucoma-Related Misadventures
At OMIC’s request, PIAA analyzed 194 claims with a diagnosis of glaucoma to determine the nature of allegations (“medical misadventures” alleged) and, if present, associated issues (e.g., informed consent) which prompted or complicated these claims. OMIC also requested that surgical procedures be sorted from medical procedures to ascertain if one area held greater risk.
Figure II lists the types and percentages of “medical misadventures” (a principal departure from accepted practice) alleged in glaucoma claims. Four types of misadventures account for the majority of allegations: diagnostic error (21.7%), improper performance of care (19.1%), medication error (9.8%), and failure to supervise or monitor the case (8.2%).
The most frequent and second most expensive misadventure is a diagnostic error. The most expensive is failure to refer.
Patients and juries take serious issue to vision loss. When claims arise related to diagnostic errors or failure to refer, it may be difficult to explain to a jury how this frequent cause of blindness was not recognized or suspected by the defendant ophthalmologist. Experts will tell the jury that loss of vision from glaucoma may be prevented through early diagnosis and therapy. It is easy, therefore, for the plaintiff’s attorney to show the relation between the breach of duty (diagnostic error) and the cause of damages (blindness or vision loss).
With glaucoma, claims arising from medical treatment outnumber surgery-related claims by more than 50%, and they are more likely to result in an indemnity payment (54% vs. 44%). The average indemnity paid, however, is about the same for medical and surgical procedures, $142,000. (See Figure III.)
Associated Issues in Glaucoma Claims
A major finding in this review was that claims of abandonment by glaucoma patients result in sizeable indemnity payments. Although abandonment was alleged in only slightly more than 1% of all cases, it accounted for the largest average indemnity payment among claims with an associated issue. It is especially important not to let glaucoma patients “slip through the cracks” and out of the practice. If a “glaucoma suspect” becomes noncompliant, difficult to treat or follow, misses appointments, or does not take prescribed medications, the ophthalmologist may be exposed later to claims of abandonment. This risk may be reduced by proper documentation of the missed visits. A jury will want to know what steps were taken to deal with the patient’s noncompliance. Careful documentation in these cases can make the difference between paying nothing and paying half a million dollars.
Detection of glaucoma entails a complete eye examination, including measurement of intraocular pressures, gonioscopy, evaluation of the optic nerve, and visual field testing. Results of these examinations should be recorded in the patient’s chart each time they are performed. Glaucoma suspects should be flagged for more frequent examinations to monitor for changes and informed of the factors that put them at risk for developing glaucoma. They should be told that failure to comply with treatment can result in vision loss. If educational brochures are offered to glaucoma patients, it should be documented in the chart that they received them.
Standardize Record Keeping
The following suggestions may help standardize glaucoma record keeping and management once a patient is diagnosed. First, as previously mentioned, it is important to have a standard way of initially evaluating the patient to establish adequate baseline information. After a complete eye exam, the thought process should shift to the type and stage of the glaucoma.
Once the diagnosis is established, it is necessary to monitor the patient’s progress. This can be done with sequential evaluations of previous office records, but an abbreviated sheet with the glaucoma-pertinent information is also reasonable. In my practice we use a one-page “flow chart” to indicate the date, medications, vision, IOP, gonioscopic findings, optic nerve configuration, and static visual field statistical parameters for each visit. Ten or more visits can be recorded on a single sheet, making it easy to detect changes. (A copy of this flow chart may be obtained by contacting OMIC’s risk management department). The remainder of the examination is documented on the standard SOAP progress record.
Sort Visual Fields Separately for Each Eye
Visual fields should be sorted separately for the right and left eye in reverse chronological order. This allows for a quick comparison of the two eyes, checking for a neurologic defect as well as a progression in an individual eye. A system for documenting the optic nerve shape is necessary to initially stage the level of the glaucoma and to check for progression of the disease.
The type of equipment used for following glaucoma is an important consideration. Mostglaucoma specialists use static perimetry for their initial evaluation and for following the course of the disease. Goldmann perimetry can be helpful for advanced cases. Most ophthalmologists use an estimate of the optic nerve head anatomy based on a drawing or ratio estimate. Some ophthalmologists use photographs to help follow up on cup progression. Newer computerized nerve head analyzers may be helpful but have not yet been accepted as a modality for detecting changes in the nerve.
Establish Treatment Goals
Establishing initial and subsequent treatment goals can be difficult in glaucoma cases. Experience is invaluable in estimating a treatment intraocular pressure goal. If progression occurs, the treatment goal should be reevaluated. If surgery is an option, the patient mustclearly understand the purpose of the surgery and the outcome that can reasonably be expected. Many patients undergo surgery expecting it to improve their vision; this may not be the case with glaucoma surgery.
Physician-patient rapport requires keeping the patient apprised of the stage of the disease, its course to date, and what can be expected in the future. This type of dialogue with the patient helps reduce an ophthalmologist’s risk since a key trigger in lawsuits is the surprised patient who feels betrayed because he or she finds out more might have been done. Obviously, some cases will progress despite treatment, and this possibility needs to be reinforced with glaucoma patients and carefully documented in their chart.
they are prescribed so the patient will be able to recognize potential problems before they become serious. Patient information sheets on the side effects of specific anti-glaucoma medications are available from the American Academy of Ophthalmology and the American Medical Association.
Risk Management Suggestions
In summary, the data collected by all doctor-owned insurance carriers show that glaucoma-related claims result in an indemnity payment more than 50% of the time. By adhering to the following risk management guidelines, ophthalmologists may avoid becoming another casualty of this statistic:
- Begin with a complete diagnostic eye exam.
- Develop a system for glaucoma record keeping and management. Keys to this system include using up-to-date equipment and following a standard method for initially and subsequently evaluating glaucoma patients.
- Once a patient is diagnosed with glaucoma, establish a specific goal for treatment and use accepted parameters to follow the course of the disease.
- Keep glaucoma patients apprised of the progress of their disease. Inform them of the risks and benefits of their treatment, including drug side effects, and document that you did so.
Figure I – Claims Frequency and Severity
 |
Total Claims | Closed Claims | Closed with Indemnity | Average Indemnity |
|---|---|---|---|---|
| All Specialties | 109,427 | 95,474 | 32% | $135,980 |
| Ophthalmology Claims | 3,264 | 2,840 | 30% | $116,138 |
| Glaucoma Claims | 194 | 169 | 50% | $142,088 |
| Cataract Claims | 985 | 881 | 26% | $85,708 |
Figure II – Glaucoma Claims by Medical Misadventure
Figure III – Surgical vs. Medical Procedures
|
Total Claims | Closed Claims | Closed with Indemnity | Average Indemnity |
|---|---|---|---|---|
| All Glaucoma Claims | 194* | 169 | 50% | $142,088 |
| Medical Procedures | 132 | 122 | 54% | $142,076 |
| Surgical Procedures | 58 | 43 | 44% | $142,148 |
* 4 cases indicated no procedure performed
Risk of Using — and Not Using — Antimetabolites in Glaucoma Surgery
By B. Thomas Hutchinson, MD, and E. Randy Craven, MD
Argus, September, 1996
Although the general medical and disease-specific risk factors for glaucoma surgery are well known and discussed as part of the informed consent process, many ophthalmologists do not commonly address the use of operative and postoperative antimetabolites. Their use can mean the difference between success and failure in glaucoma filtration surgery. The surgeon who fails to discuss with the patient the rationale behind the decision faces potential liability if the patient is unhappy with the outcome.
Even when used appropriately, these agents may cause serious postoperative complications and introduce significant risks for the future. Although no definitive criteria have been established for their use in glaucoma filtration surgery, a consensus is evolving as to when they are most valuable.
Mitomycin-C and 5-Fluorouracil, the most commonly used antimetabolites, may significantly benefit eyes expected to have an excessive fibroproliferative response. Examples include previously operated eyes, failure of previous filters in the same or other eye, coexisting uveitis or rubeosis, combined glaucoma and cataract surgery, and risk factors related to the patient’s age and race.
Since most glaucomacologists do not use these agents routinely in every case, it is equally important to tell the patient why they might not be used, for example, in eyes with no unusual risk factors for failure. The ophthalmologist might elect not to use Mitomycin-C in patients who are at added risk for antimetabolites such as the moderate to highly myopic eye, patients with hypotony after previous surgery (with or without antimetabolites), and patients with potentially complicating corneal, retinal or wound healing problems. In today’s medicolegal practice arena, it is perhaps as important to discuss use and nonuse of these modalities as it is to discuss the rationale for and against the surgery itself.
In addition to the usual complications of glaucoma surgery, it is not uncommon for the “antimetabolite bleb,” especially with Mitomycin-C, to provide overfiltration, initially associated with hypotony and often retinal edema. The use of Mytomycin-C may place the eye at additional future risk of late bleb leak and necrosis of avascular tissue as well as a higher incidence of late bleb infection and endophthalmitis. The hypotony and retinal edema now recognized as a more frequent occurrence with antimetabolites do not commonly respond to medical or surgical attempts at correction. Potential complications of using antimetabolites should be discussed with the patient, along with the risk of failure for glaucoma control without using these new modalities.
It is crucial that the patient understand not only the spectrum of glaucoma as a potentially blinding disease but also the likelihood of success with all modalities of treatment consistent with the patient’s particular disease. In making a decision about surgery, there must be ample opportunity to educate and include the patient in the decision-making process about the concept of surgery as well as adjunctive treatments that may be appropriate for a particular patient. Educating the patient about your rationale for deciding whether to use these new and often valuable antimetabolite medications will clearly identify you as the patient’s advocate and reduce the likelihood that you will become adversaries in the future.
OMIC provides model patient information sheets regarding the use of Mitomycin-C and 5-Fluorouracil during glaucoma surgery, which you can give to patients prior to surgery. Fax your request for these documents to the OMIC Risk Management Department, 415 771-1095.
Shield Yourself From Malpractice Claims
Stay Vigilant
A recent analysis of the database of the Physician Insurers Association of America reveals that one of the most common claims in glaucoma is failure to diagnose. This accounts for nearly 22 percent of claims, with plaintiffs receiving judgments about half the time. The average judgment amounts to more than $145,000.
The simple lesson here is that ophthalmologists must always remain vigilant for glaucoma. Whenever you see a new patient with any risk factors, perform gonioscopy and a visual field exam in addition to tonometry and evaluation of the optic nerve, and thoroughly document your findings.
Simplify Your Management
By far the highest number of claims relates to patient mismanagement. Almost 40 percent of claims result from problems characterized as “errors in diagnosis,” “errors in medications” or “failure to monitor.” (See Tables 1 and 2.) In my opinion, the best way to avoid this kind of lawsuit is to standardize your management system. Well-organized protocols and patient records will help you avoid mismanagement claims.
First of all, use a standardized method for initially and subsequently evaluating glaucoma patients. The Academy’s Preferred Practice Pattern for open-angle glaucoma is a good place to start. Create a treatment plan for every single patient, and document it. In the plan, indicate the target IOP, the desired frequency of follow-up visits, and the frequency of visual field tests. If visual progression occurs, then your treatment plan needs to be reassessed.
Consider organizing glaucoma patient charts differently than you do other charts. Set the record up so that you can immediately see the diagnosis, the pressure and field history, and any medication allergies. I use a one-page flow chart that allows me to record the elements of a glaucoma exam for more than 10 visits on the same page, allowing me to detect any changes quickly. This chart is available through OMIC’s Risk Management Department.
I also recommend keeping the visual field printouts loose in the patient’s folder, separated for right and left eye in reverse chronological order. The largest indemnity payment OMIC ever made involved a case in which the fields were stapled into the chart. This prevented the physician from pulling the fields out and comparing them. As a result, he missed a defect in a glaucoma patient that turned out to represent a tumor.
Keep your patients fully up to date on the stage of the disease and the prognosis. If the disease is progressing, make certain the patient knows about it and take appropriate action. If Mrs. Jones’ visual field looks a little worse this year, tell her that you need to temporarily step up the frequency of visual field testing until you get the disease back under control. If it’s her choice not to do a visual field test for another year, that’s fine provided it’s well documented in her chart. (A sample refusal of treatment form to be signed by the patient in these situations can be found in the Appendix.)
Double- and triple-check that your patients are following instructions regarding their medications. Determine at every visit whether there are any new systemic medications which may interact with the topical glaucoma medications. Make sure that there are no new symptoms which might indicate a side effect to a drug.
Manage Surgical Expectations
About a third of all glaucoma claims are related to surgical procedures. Slightly more than 19 percent of cases involve an allegation of an error in the procedure, and another 3 percent of claims are based on failure to recognize a complication following a procedure. These statistics show why it’s critical to make sure the patient has reasonable expectations about the outcome. Many patients expect that glaucoma surgery will improve their vision, and are disappointed when they see no change or even a worsening in their acuity.
Make sure it is understood that filtration involves many different complications, including failed filters and hypotony, which can actually result in worse vision. If a patient begins developing hypotony following the procedure, begin discussing with him or her the possibility that his vision may become blurry, and make sure he knows to contact you immediately if this takes place. Make sure the patient understands that the vision may not come back.
Be sure to discuss the possibility of vitreous loss during cataract surgery for patients with existing filters, since there may be as high as a 15 percent to 20 percent chance that this can occur during surgery. The risk increases in eyes with pseudoexfoliation, with weakened zonules and in cases in which the glaucoma is secondary to trauma. If vitreous loss does occur, I recommend being completely forthright. I tell patients that I had to remove some of the “jelly” in the back of the eye, and then explain whether I think this poses a problem or not. Remember, surprises frequently lead to lawsuits.
Finally, and this should go without saying, obtain an exhaustive informed consent prior to surgery. OMIC has consent forms for all types of glaucoma surgery. (These forms can be found in the Appendix.)
Refer Promptly
Lawsuits alleging failure to refer or a delay in referral are fairly rare, accounting for just 3 percent of cases. However, these cases settle for an average of $245,000. Also, this type of claim may be on the rise due to managed care and the pressure to reduce utilization. The lesson here should be obvious: It is our fiduciary responsibility to refer patients when their disease falls outside the realm of our own expertise. This is the case regardless of the patient’s insurance plan or our financial incentives.
Follow Up
The claim of abandonment is very rare in glaucoma cases, accounting for just 1 percent of all lawsuits. But they can also result in high payouts. A good example of this type of claim is a case I reviewed. It involved an older ophthalmologist who was nearing retirement and a glaucoma patient he had treated for 20 years. For many years, this doctor had treated the patient with medication and had him come back regularly for pressure checks and manual visual field exams. Over the course of several visits, the patient complained that he was not seeing as well, he then failed to return for an appointment for 18 months. The patient went to see a new ophthalmologist, and that MD discovered significant field loss and significant nerve damage. The patient subsequently called his old ophthalmologist and left a message with a technician. Unfortunately, the tech never relayed the message and the patient just assumed that the MD didn’t care. The angry patient sued the MD, claiming that it was the physician’s responsibility to call him and bring him back in for regular visits! Even though the ophthalmologist was using good clinical judgment and doing all the things he should have done, the plaintiff won a sizable settlement.
This case illustrates two important points:
Do your best to avoid losing glaucoma patients to follow-up. It’s amazing but true: If a patient becomes non-compliant, difficult to treat or misses appointments, you can be held liable for patient abandonment. If a patient does miss appointments or presents other problems, be sure to carefully document it.
Do not make patients mad. If the patient described above hadn’t been angered by what he perceived as his doctor’s uncaring attitude, he probably never would have sued.
Here are two final recommendations:
Use up-to-date equipment and testing techniques. If you’re still using Schiotz rather than Goldmann tonometry and a tangent screen rather than an automated perimeter, it may weaken your defense if you are targeted with a lawsuit.
Constantly educate patients about the disease. Many ophthalmologists give patients a brochure on glaucoma, have them watch a video on the disease, and do no more education. I recommend a more balanced approach. Glaucoma is a long-term disease, and most patients forget the details over time. Constant reinforcement helps patients understand the importance of compliance and results in better success overall.
Ultimately, you bear the full responsibility for a glaucoma patient’s care. Know that if a patient gets worse under your watch, your treatment may be called into question, and you may be sued and lose even if you provided state of the art care. The only sure protection against becoming a malpractice statistic is to follow sound risk management guidelines and carefully document all decisions.
Portions of this article previously appeared in “Risk Management Issues in Glaucoma: Diagnosis and Treatment,” Survey of Ophthalmology 1996:40;459.
| Table 1: Comparison of Medical vs. Surgical Claims | ||||
|---|---|---|---|---|
 |
Total Claims | Closed Claims | Closed w/Payment | Average Payment |
| All Glaucoma Procedures | 194 | 169 | 50% | $142,088 |
| Medical Procedures | 132 | 122 | 54% | $142,076 |
| Surgical Procedures | 58 | 43 | 44% | $142,148 |
Reducing the Risks of Ocular Trauma
By Jerome W. Bettman Sr., MD
Argus, April, 1991
Trauma was the fifth most frequent condition implicated in 700 ophthalmology claims collected over several decades by this author as reported in Ophthalmology (97:1379, 1990). Several medicolegal hazards exist because ocular trauma cases are frequently emergencies. The receptionist may not recognize the need for a timely appointment. The ophthalmologist may fail to do a complete workup or to examine the uninjured eye. Records may be incomplete, making the defense of a claim more difficult.
Furthermore, a patient may expect excellent results despite a very severe injury. A number of claims are filed for no reason other than surprise over a poor result because the patient is not made aware that the prognosis is poor.
Case Study
Failure to diagnose a foreign body accounts for a significant number of trauma-related suits and frequently results when the ophthalmologist relies on one modality such as x-rays. In one such case, a 31-year-old male was seen in an emergency room following an incident in which he hit a metal bar with a sledge hammer and a foreign body struck his right eye. Visual acuity was 20/20 OU and a wound was noted in the sclera in the infero-temporal region. The foreign body was seen on x-ray, localized 4 mm behind the globe, and the patient was discharged.
Four months later, the patient was seen by another ophthalmologist because the eye had become irritated and painful and vision was blurred. A B-scan ultrasound disclosed a foreign body imbedded in the retina. The ERG was abnormal and some siderosis was noted. The patient was hospitalized and the foreign body removed from the ciliary body region. The operation included vitrectomy, cryotherapy, a sponge and encircling buckle. Three-and-a-half years after the injury, a posterior subcapsular cataract was removed from the eye by phacoemulsification with no complications. An IOL was not implanted but visual acuity was corrected to 20/40.
The patient successfully sued the emergency room ophthalmologist and roentgenologist for the missed foreign body. The subsequent ophthalmologist, who extracted the cataract, was sued for not implanting an IOL, but this claim was dropped.
Lessons to be Learned
There are several lessons to be learned from this case:
- More than one modality should be used to diagnose or localize foreign bodies. It is estimated that 20 percent of foreign bodies perforate the globe without significant pain and approximately the same number enter through the sclera. If the foreign body is very small, the entrance wound may not be apparent. None of the siderosis claims reviewed by the author was defensible;
- Contrary to traditional teachings, siderosis is reversible if diagnosed before the ERG is extinguished;
- In cases such as the one cited here, the prognosis is generally poor and the patient should be informed of this. An unpleasant surprise often triggers a suit;
- Cataract patients should be made aware that not everyone is a suitable candidate for an IOL implant.
Minor Distractions Lad to Major Problems in the OR
By John W. Shore, MD, FACS
Dr. Shore is a member of OMIC’s Board of Directors.
Digest, Summer 2006.
To view the charts mentioned in this article, go to Minor distractions lead to major problems in OR Summer 2006
It is well known in aviation circles that minor distractions are often the cause of major airline accidents. A perfect example is the December 29, 1972 accident of an Eastern Airline L-1011 with 176 passengers on board that casually and subtly descended 2,000 feet before crashing into the Everglades while the captain and copilot, sitting in their respective seats, and a third crew member tried to troubleshoot a gear warning light malfunction, all the time ignoring audible and visual instrument warnings that the aircraft was about to crash. The aircraft had been forced to break off its approach to Miami International Airport after the nose gear light failed to illuminate, raising concerns about whether the gear was properly lowered for landing. While in a holding pattern at 2,000 feet above Everglades National Park, the captain bumped his control column, leading to the disconnection of the autopilot. With the attention of all three crew members focused on the landing gear and the extinguished light, the aircraft descended unnoticed into the ground. One hundred passengers and crew members perished.
How could such a thing happen, and how does this incident apply to OMIC’s experience with claims involving seemingly simple or minor surgical procedures? Attending to a failed nose gear warning light should not result in the death of 100 people. Likewise, anesthetic injection into a lower eyelid for chalazion removal should not result in penetration of the globe, retinal detachment, and loss of the eye. Yet, this is what happened to a 35-year-old man, who presented with a chalazion in the left lower eyelid. Although the procedure was noted to be “without complication,” the patient returned to the office the following day with complaints of severe left eye pain and visual loss. The patient was referred to a retinal surgeon, who discovered a large corneal abrasion, an inferotemporal chorioretinal scar, and an adjacent retinal defect. Despite several surgeries, the patient’s vision never improved beyond 20/300; the case was settled during pre-trial mediation for $250,000.
When such an outcome occurs, one can usually point to a breakdown in surgical technique (technical performance), distraction, or inattention of the surgeon immediately prior to or at the time of the incident, or complacency among the surgical team because the procedure is “simple” or “minor.” The adage, “fly the airplane first, and then solve the emergency” applies to surgery as well. To put it in surgical terms: focus on the patient, the surgical field, and the task at hand. Don’t be distracted by nearby events. Intuitively, we know from experience that surgeons prepare for, plan, and execute complex or risky cases with great attention to detail. The surgeon is focused on the difficult and challenging technical aspects of the case. The surgical team feels the tension and pressure to perform with a high level of skill. The OR is silent. The surgical team avoids irrelevant discussions that might divert the surgeon’s attention from the task at hand. This is not unlike the situation in the cockpit when pilots are circumnavigating thunderstorms and landing in low visibility. As in surgery, everyone involved has a stake in the outcome and everyone’s attention is directed at bringing the flight (or surgery) to a successful conclusion.
The Dangers of Complacency
We recognize, however, that it is human nature to let one’s guard down in the office treatment room when performing straightforward or routine treatments and even in difficult cases once the critical portions of the case are over. Complacency (and therefore surgical or technical errors) is more likely to develop during “minor” or “routine” cases where the risk is seemingly low and the technical aspects of the case are simple or straightforward. Also, in difficult cases, there is usually good chart documentation of the complex nature of the case, and the risks of the procedure are spelled out in the surgical consent form, often in the surgeon’s own handwriting. In the case of “minor surgery,” the surgeon may pop into the room momentarily to inject the eyelid and return 15 or 20 minutes later and hastily remove an eyelid papilloma or drain a chalazion. If the surgeon’s attention is diverted by a telephone call, or the patient is startled by the surgeon’s beeper just as the needle penetrates the skin, inadvertent, sudden movement may lead to ocular penetration with disastrous results. Because the case is “minor in scope,” there may or may not be a signed consent. Some physicians require only oral consent for minor cases handled in a treatment room setting. The surgeon or nurse may overlook the importance of sending a specimen to the pathology laboratory because the lesion “appears benign.” In other offices, there is no requirement to dictate or even document the performance of “minor” surgical procedures. There may be no written instructions given to the patient at discharge. The patient may be discharged to drive home alone with one eye patched. While everyone recognizes this is not the ideal way to practice, the reality and pressures of a busy clinic or office is the background for distractions that lead to incidents, suits, and even large malpractice awards. It is not until an error occurs that the lack of a signed consent form becomes the key (missing) document in a malpractice case.
These very tendencies towards complacency and inattentiveness were identified years ago as a major contributing cause of aircraft acci- dents and led air carriers and the FAA to adopt the “sterile cockpit” rule. By regulation, there can be no extrane- ous or irrelevant conversation in the cockpit by the aircrew when flying lower than 10,000 feet above ground level. The goal is to have the flight crew totally focused on flying the air- craft during the critical phases of flight. This lesson can be applied to the operating room as well.
“Minor” Oculoplastic Cases
A review of OMIC oculoplastic claims since the company opened for business almost 20 years ago (Table 1) reveals some interesting statistics that reinforce the need to maintain diligence during “minor” eyelid surgery. Surprisingly, some of the largest awards in oculoplastic surgery were those involving such “minor” procedures as eyelid biopsy, papilloma or cyst removal, and punctal cautery. The single largest oculo- plastic award of $975,000 was for visual loss occurring during excision of a chalazion. In fact, of the $8 mil- lion paid by OMIC for oculoplastic claims over 19 years, $1.27 million was paid for incidents that occurred during removal of chalazia (Table 2). Loss of vision due to penetration of the globe with retinal detachment, corneal perforation, and flash fires leading to scarred and poorly functioning eyelids are not expected out- comes of chalazion surgery and such cases are almost impossible to defend. The goal for all should be prevention of such maloccurrences since little can be done after the fact to satisfy a patient or family other than to make financial restitution and settle the claim. Even that is not a satisfactory resolution because the patient has to live forever with severe or total vision loss.
OMIC has paid out $710,000 for claims involving five fires in the surgical setting. Four of the five preventable fires occurred in a treatment room or ASC setting during “simple” or “minor” surgical procedures (Table 3). One such case is presented in this issue’s Closed Claim Study, while the Risk Management Hotline focuses on preventing and managing surgical fires.
Risk Management Tips
How can a physician alter behavior to minimize the risk of an inadvertent error during surgery? Here are some suggestions:
1. Remember that any surgical or diagnostic procedure carries risk. Instruct your staff and make a per- sonal commitment to approach every surgical procedure as a major case. Avoid the term “minor procedure” when talking to patients. Use “straightforward” instead.
2. Adopt the sterile cockpit rule— avoid extraneous conversation and don’t allow distractions to creep into the operating or treatment room. Turn off your beeper and instruct your staff not to call into the treat- ment room during surgery.
3. Do not allow yourself to become rushed because of office or waiting room pressures.
4. Let the patient know what to expect so he/she is not surprised into making a sudden or inadvertent move.
5. Check for allergies before giving an injection or using oral/intravenous drugs in the treatment room.
6. Inject anesthetics slowly and ensure the eyelid or eye is totally anesthetized to minimize patient movement due to sudden or unexpected pain.
7. Apply topical anesthesia to the conjunctiva before making a transconjunctival injection to anesthetize the eyelid or conjunctiva for surgery. A comfortable patient is less likely to move inadvertently.
8. Learn to use regional nerve block techniques while working on eyelids, eyebrows, and cheeks. Infraorbital, anterior ethmoidal, supratrochlear, infratrochlear, lacrimal, and supraorbital nerve blocks allow a surgeon to work with the patient’s anatomy totally anesthetized and free of pain.
9. Use cornea or globe protection for eyelid procedures (metal corneal protective shields).
10. After discussing the procedure with the patient, always have the patient sign a surgical consent form prior to any surgical procedure.
11. Document each treatment room procedure with a dictated or handwritten operative note that conforms to the current standard for surgical documentation.
12. Give written postoperative or wound care instructions to patients prior to discharge, even in the treatment room setting.
13. Be sure the patient is discharged to the care of a competent adult, particularly if there is temporary visual impairment or mental compromise due to sedation.
14. Obtain and follow OMIC’s guidelines, “Office-based Surgery for Adults,” which can be found in the Risk Management Recommendations section of www.omic.com. These recommendations are applicable to surgery in an ambulatory surgical or hospital OR setting as well as in the treatment room.
The same principles apply to major ophthalmic cases; however, errors due to inattention or distrac- tions are less likely to occur because of the surgical setting and absence of office pressures in the treatment room. Nevertheless, it is easy to let one’s guard down towards the end of the case once the stress of the actual surgery is over. Instru- ments are dropped, packing is not removed, and patches are inappro- priately applied in the rush to get the patient to the recovery room. If the surgical team adopts the approach that the case is not over until the patient is safely in the post-anesthesia care unit, mistakes and the chance for adverse events can be minimized. Again, an airline corollary: the flight is not over until the aircraft pulls up to the gate and the passengers disembark!
