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!

Endophthalmitis and Tass: Claims Results and Lessons

By Anne M. Menke, RN, PhD

Anne Menke is OMIC’s Risk Manager.

Digest, Spring 2006

To see the charts mentioned in this article, choose this PDF link: Endophthalmitis and Tass Claims Spring 2006

Uncomplicated cataract surgery was performed on an elderly woman. At the end of the procedure, the ophthalmologist was informed by the nurse that the sterilization indicator on the instruments had not changed. It was feared that the instruments had been washed but not sterilized. The physician and ASC medical director decided not to inform the patient of the potential problem, opting instead to increase the frequency of topical antibiotics. No signs of infection were noted at the first postoperative visit, but two days later, endophthalmitis developed. Ten days after surgery, the two physicians informed the patient and her family that the same strain of pseudomonas aeruginosa had grown in the eye and the ultrasonic bath water at the ASC, leading them to conclude that problems with sterilization were the likely cause of her endophthalmitis and phthisical eye. The patient’s lawsuit was settled on behalf of the ASC for $650,000.

Poor outcomes such as this make infectious endophthalmitis one of the most feared complications of ophthalmic surgery. Recently, a type of inflammatory response known as TASS, or Toxic Anterior Segment Syndrome, has garnered attention and prompted calls to OMIC’s Risk Management Hotline. While not all adverse events can be prevented, there is much ophthalmologists can do to reduce the incidence of endophthalmitis and TASS. In its review of OMIC’s claims experience and the lessons learned from it, this article offers risk management guidance on more effective prevention, recognition, and response to these sight-threatening conditions.

Since OMIC’s inception in 1987, endophthalmitis has accounted for 6% of claims frequency (150 claims out of 2,559 total) and 5% of claims severity ($3,345,964 in paid indemnity out of $63,191,199 total). Of these 150 cases, 25 remain open; of the 125 closed cases, only 8 were taken to trial, and in all but one, the jury returned a defense verdict. A poll of the jury after the sole plaintiff verdict of $735,000 revealed that the award was in response to the defendant group’s practice of locking up medical records on weekends, thus preventing access to key patient information needed to assess the plaintiff’s condition. Since the practice’s name did not appear on the jury’s form, a settlement on its behalf was effected for the amount of the verdict, and the plaintiff award against the ophthalmologist was vacated.

More than three-quarters (78%) of OMIC’s endophthalmitis cases have closed without an indemnity payment. The percentage of cases that have settled (22%) and the median settlement amount ($75,000) are comparable to OMIC’s overall data. Despite the severity of the outcome for the patient, endophthalmitis settlements have ranged from $9,000 to $735,000 compared to a low of $500 and a high of $1.8 million for all settlements. Reflecting the relative novelty of TASS, allegations in all but 3 of the 150 claims involve an infectious rather than an inflammatory process.

Given the estimated 2 million cataract procedures performed annually in the United States, one might anticipate that cataract surgery would account for 61% of all endophthalmitis cases. Surprisingly, however, only 23% of cataract- related endophthalmitis cases resulted in an indemnity payment.

During the informed consent process for cataract surgery, ophthalmologists routinely disclose this rare complication, and most actively try to prevent its occurrence by treating preexisting conditions such as blepharitis, preparing the eye with povidone iodine, and administering antibiotics. Assuming cataract surgery was indicated in the first place and the endophthalmitis was promptly recognized and treated, experts view this complication as a tragic maloccurrence rather than malpractice. On the other hand, cases of endophthalmitis resulting from trauma are rare (5%), but they result in settlement 57% of the time. Clearly, ophthalmologists who do not administer antibiotics and/or carefully monitor the eye for signs of endophthalmitis after trauma are not supported by defense or plaintiff experts.

Analysis of Risk Issues

It is helpful to analyze the risk issues associated with substandard care by dividing them into four categories. “Clinical” issues include debates in the ophthalmic community on the standard of care and the natural history of the disease or condition. “Systems” issues involve complicated processes of care, such as medications (research, manufacture, distribution, ordering, etc.), equipment, and follow-up and telephone screening methods. Finally, the acts, omissions, and decisions of individual physicians and patients also impact care out- comes. Table 2 indicates the type and frequency of risk issues in OMIC’s endophthalmitis and TASS cases.

Amid ongoing debate of evidence- based guidelines for prevention of endophthalmitis, it is noteworthy that antibiotic administration was not a key issue in any case; nor was patient noncompliance a significant factor. Ophthalmologists have a leadership role to play in addressing the many systems issues that adversely impact care outcomes. In their capacity as users, surgical directors, board members, and owners, they can review equipment maintenance and infection control measures in hospitals and ASCs, focusing particular attention on issues such as flash sterilization, re-use of single-use items, and the ordering, preparation, and use of ophthalmic products, devices, and medications.

Screening Patient Complaints

The two primary issues in OMIC’s endophthalmitis cases—telephone care and the diagnostic process— indicate the need to carefully screen patients who present with ophthalmic complaints, especially postoperatively, and to educate them about which symptoms to report. Each of these identified risks is squarely within physician control and thus can be modified. This issue’s Closed Claim Study illustrates the perils of inadequate screening and failed coordination of care; the Risk Management Hotline advises physicians on how to disclose and investigate sterilization problems or clusters of cases, and prevent TASS. “Telephone Screening of Ophthalmic Problems” provides screening protocols and contact forms for both staff and physicians taking after-hours calls and can be found at www.omic.com.

“A Witty (WIT-D) Approach to Avoiding Mistakes” proposes an easy-to-remember and effective strategy for improving the diagnostic process. Establish a prioritized differential diagnosis in order to rule out the worst case scenario; determine the information you need to obtain during the history and examination, or through studies, to rule that in or out; tell the patient and other healthcare providers to ensure that you are notified of all signs and symptoms that could help establish the diagnosis and determine the treatment plan; and document your decision-making process and follow-up plan.

Endophthalmitis or TASS?

Failure to rule out endophthalmitis has resulted in harm to patients and significant liability exposure for OMIC policyholders. Emerging research indicates that the ophthalmologist should also include inflammatory reactions such as TASS in the differential diagnosis. Indeed, mistaking one for the other could lead not only to a delay in treatment

but may worsen the outcome. Table 3 summarizes some of the distinguishing features. Although this table may be helpful, it can still be difficult or impossible at times to distinguish between endophthalmitis and TASS. For more information see, “Endophthalmitis and TASS: Prevention, Diagnosis, Investigation, Response” at www.omic.com.

1. Carolyn Buppert, “A Witty (WIT-D) Approach to Avoiding Mistakes,” Gold Street 4(6), 2002. See “Risk Management Issues in Failure to Diagnose Cases: A Focus on Traumatic Eye Injuries.”

2. Table compiled from information in Mamalis, Nick et al. “Review/Update: Toxic Anterior Segment Syndrome.” J Cataract Refract Surg Vol 32, February 2006:324-333; Ronge, Laura J. “Toxic Anterior Segment Syndrome: While Sterile Isn’t Clean Enough.” EyeNet, November/December 2002:17-18; and Davis, Brandon L, and Mamalis, Nick. “Averting TASS: Analyzing the Cause of Sterile Postoperative Endophthalmitis Provides Valuable Clues for its Prevention.” Cataract & Refractive Surgery Today, February 2003:25-27.