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!
ER Call: Another Layer of EMTALA Liability
By Tamara R. Fountain, MD
Digest, Fall 2006
Dr. Fountain is a member of OMIC’s Audit, Finance, and Insurance/Marketing Committees. This article, originally published in the Digest in 2001, has been updated to reflect current law.
Fans of the hit television series, ER, are familiar with this scenario: a patient is rushed to the ER in need of life-saving treatment but the specialist on call, be it an OB/GYN or CT surgeon, fails to answer the ER’s page. Drs. Weaver, Carter, and Company are then charged with cracking chests, doing stat sections, and taking other heroic measures to stabilize the patient—all in one entertaining hour, including commercials.
Even Hollywood knows that transferring an unstable patient is against the law. That federal mandate, the Emergency Medical Treatment and Active Labor Act (EMTALA), is part of the Comprehensive Omnibus Budget Reconciliation Act (COBRA) passed by Congress in 1986. This well-intentioned piece of legislation was enacted to discourage hospitals from turning away patients based on their ability to pay. Widening legal interpretation of EMTALA provisions has created a host of accountability and risk management issues for physicians who provide emergency room coverage.
Under EMTALA, any patient who presents to a hospital ER must be afforded an “appropriate medical screening examination to determine the presence of any emergency medical condition.” EMTALA defines emergency medical condition as one in which “the absence of immediate medical attention would…result in placing the person’s health in serious jeopardy, cause serious impairment to bodily functions or cause serious dysfunction to any bodily organ or part.”1 An appropriate medical screening examination need satisfy only two elements to be compliant with EMTALA standards: (1) it should be reasonably expected to identify an emergency medical condition; and (2) it need be directed only at the signs and symptoms described by the patient or identified by the physician—NOT signs and symptoms the physician is not made aware of or might otherwise overlook.2
If the ER physician determines that an emergency medical condition exists (or cannot be ruled out), he or she may refer the patient to the appropriate physician on call for evaluation and management. The on-call physician is not only obligated to answer a page in a “timely fashion” (the definition of which is usually buried in one’s medical staff bylaws) but to evaluate the patient in the ER if requested to do so by the ER physician. The on-call physician must never try to talk the ER doctor out of a request to evaluate the patient. It may sound like the most routine, unequivocal case of conjunctivitis to you over the phone at one o’clock in the morning, but if the ER doctor asks you to come in, you must do so. (By the way, in the real world, those on-call OB/GYN and CT surgeons who failed to respond to their pagers in the ER episode would be subject to EMTALA fines of up to $50,000 each.)
Appropriate Patient Transfers
So you leave your daughter’s piano recital to see a patient in the ER. You diagnose an open globe with vitreous presenting at the wound— a qualifying emergency medical condition. But the hospital’s vitrector is being repaired and there is no surgical eye team available. What should you do? If the hospital’s facilities or ancillary staff are inadequate to treat a patient with an emergency medical condition, a transfer must be effected.
Since EMTALA was enacted to prevent indiscriminate transfer of patients to other facilities, one would expect strict guidelines on what constitutes an acceptable transfer. Federal law defines an appropriate transfer as one in which: (1) the patient has been treated within the capacity of the transferring hospital, thereby minimizing the risks of transfer; (2) a hospital with the space and personnel to care for the patient has been identified and has agreed to the transfer; (3) all records are sent, including informed consent, the transferring doctor’s certification that transfer is in the best interest of the patient, and, if applicable, the name and address of any on-call physician who refused or failed to evaluate the patient; and (4) qualified personnel, equipment, and transportation are utilized to effect the transfer.
Under most state laws, hospitals that are legally obligated to provide emergency care are also obligated to accept a patient transferred from another facility. Not as widely recognized, however, is an EMTALA provision affectionately known as the “snitch rule.” This whistleblower statute obligates the receiving hospital to report any inappropriate transfers to federal authorities. Failure to report such an infraction may invoke the same penalties for the receiving hospital (fines of up to $50,000 and exclusion from Medicare) as are levied on the hospital that initiated the transfer.
While this covers the primary areas of EMTALA’s impact on ER call physicians, there are many gray areas not addressed by its statutes (see Frequently Asked Questions About ER Call and this issue’s Risk Management Hotline, which elaborates on follow-up duties). As legal interpretations and provisions vary from state to state and hospital to hospital, OMIC recommends that ophthalmologists seek the counsel of their hospital medical staff office or our risk management department for further guidance.
1.42 C.F.R. §489.24(b)
2.Reynolds v. Maine General Health 1st Cir, 2000
218F.3d78.
Frequently Asked Questions About ER Call
Q: Do I have to take call at my local hospital if most of my cases are handled in an ASC?
A: It depends. Federal laws do not mandate taking calls, but whether you volunteer, take call as a requirement of medical staff bylaws, or independently contract your services to an ER, once you enter into a formal agreement to provide emergency coverage, you must comply with EMTALA regulations. Some ophthalmologists need hospital privileges as a condition of being a provider in a managed care contract and end up with call coverage as a result of those privileges.
Q: My hospital’s ER is poorly equipped to evaluate and manage eye emergencies. Do I have to come in if I know the patient will be transferred anyway?
A: Yes. You are still obligated to stabilize the patient within the available capabilities of the hospital’s staff and facilities. Once the risks of transfer have been minimized and if you determine that the benefits of transfer outweigh the risks on an unstable patient, you must effect a transfer. Later, you may want to discuss with your department chair or the ER department the need for adequate equipment to properly evaluate and manage common eye emergencies.
Q: I’m on call during a busy clinic day and get called to see a patient in the ER. Wouldn’t it be easier to have the patient come to my office for an evaluation?
A: Yes, but only easier for you. The ER doctor is asking you to come in to see the patient and, instead, you are proposing that the patient come to your office solely for your convenience.
If the patient deteriorates enroute, you will effectively have authorized, by phone, an inappropriate transfer under EMTALA laws. If, however, the ER doctor determines that no emergency medical condition exists, then the patient can be safely discharged from the ER to follow up in your office.
Q: I am an oculoplastics specialist. Do I have to come in for a retinal detachment?
A: Yes. Staff bylaws may spell out the scope of your clinical privi- leges and expertise, but if you take call, it is assumed that you are capable of evaluating ocular problems even if you’re not qualified to treat them.
Again, your job as an on-call doctor is to stabilize the patient and arrange appropriate consultation as needed. Some hospitals arrange call schedules so that various subspecialists provide back-up coverage. If a patient must be transferred to another facility, document that the benefits of a transfer outweigh the risks.
Q: The ER doctor calls and tells me a patient has conjunctivitis and, while I don’t need to come in, the ER doctor wants the patient to follow up in my office. The patient presents the next day with a corneal ulcer, not conjunc- tivitis. Am I in violation of EMTALA laws?
A: No. If you were not asked to come in, the ER doctor is effectively saying that he or she has ruled out (albeit incorrectly) an emergency medical condition based on a screening examination. Case law generally holds that a hospital and its ER physicians are not in violation of EMTALA for failing to treat an emergency medical condition if the facts demonstrate the hospital had no knowledge of the condition despite an appropriate screening examination. The ER doctor still may be liable for failure to diagnose and delay in treatment under regular malpractice laws, however, and such situations may expose the ophthalmologist to malpractice claims. Thus, it is critical to properly document and retain a record of your discussion with the ER doctor.
Q: If I am called in to treat a patient emergently, do I have to provide follow-up care?
A: The emergency transfer laws do not address the issue of follow- up care to patients who have been treated and stabilized in the ER and then discharged. However, a common law duty to the patient may arise since, arguably, a doctor-patient relationship is established by your treatment of the patient in the ER, giving rise to the expectation by that patient that you will provide follow-up care. You should consult your medical staff bylaws, as some specifically address this issue. Some bylaws establish a duty and require the on-call physician to see the patient in follow up and through- out the course of the illness that brought the patient to the ER.
Q: A patient is evaluated and treated in the ER while I’m on call but no one notifies me. The ER doctor discharges the patient to follow up with me the next day. Am I required to see this patient?
A: Not from an EMTALA standpoint. While there would be no EMTALA violation since the patient was presumably stabilized and discharged by the ER, your medical staff bylaws may require you to see the patient. When in doubt, you should accept a patient who presents to your office if the patient was treated in the ER while you were on call. Work with your hospital to establish a protocol for follow-up care.
Q: The ER doctor calls me one night and based on his or her description, I decide to wait to see the patient in my office the next morning. Is this an EMTALA violation?
A: It depends. If the ER doctor asks you to see the patient, you must do so when called, not the next morning. If the ER doctor feels the patient is stabilized and can wait until the next morning and the patient’s condition deteriorates because of the delay, the primary malpractice liability rests with the ER doctor. (EMTALA does not apply in this case because the patient was discharged in stable condition.) If the ER doctor cannot rule out an emergency medical condition, you as the on-call specialist cannot do so over the phone, as an appropriate medical screening exam has not technically been performed. As always, it is critical to document your discussion with the ER doctor.
Q: It’s bad enough that I can be fined by the federal government for EMTALA violations. Can I be sued by the patient too?
A: The federal government may fine both hospitals and individual physicians for EMTALA violations. Additionally, a patient may sue a hospital for EMTALA infractions. A patient may NOT sue a physician for breaking EMTALA laws. However, any doctor or hospital providing emergency room care is subject to civil claims of negligence and medical malpractice.
Unapproved Devices
Ophthalmologists are privy to various treatment alternatives, many of which are tested and employed by their peers around the world long before they are approved for use here in the U.S. Before deciding whether or not to use the newest device available, physicians would be well advised to evaluate the patient safety and professional liability risks.
See OMIC’s checklist Risk Analysis of Unapproved Devices below.
Unapproved Devices
See OMIC’s article below.
When FDA Leaves Doctors To Their Own Devices
Off-label Drugs and Devices
Sample Language For Off-label Consent. Physicians are well-advised to obtain informed consent for off-label devices or drugs.
See OMIC’s sample consent language to incorporate into consent forms as needed.
Off-Label Sample Consent Language
See list of articles and forms about the use of off-label and unapproved drugs and devices below.
Medicolegal Implications of Using Off-label Drugs and Devices
Informed Consent and Elective Procedures
Liability Issues Associated with PRK and the Excimer Laser
When FDA Leaves Doctors to Their Own Devices
Checklist for risk analysis of unapproved devices
Suggested Informed Consent Clauses for Documenting Off-Label PRK
Dilating Drops: Patient Safety and Liability Risks
Dilating drops are used on countless patients daily during diagnostic examinations and surgical procedures. They are essential in order to obtain an adequate view of the retina and fundus. Indeed, failure to perform a thorough examination of the eye could lead to significant patient harm such as delay in diagnosis or failure to diagnose, as well as surgical complications due to poor visibility.
See OMIC’s risk management recommendation guide below.
