Ординатура / Офтальмология / Английские материалы / Risk Prevention in Ophthalmology_Kraushar_2008

palpebrae superioris have also been affected. Spontaneous recovery is usual but not guaranteed. The highest concentrations of local anesthetics should not be employed as they have been shown to be myotoxic. Caution must be used to avoid extraocular muscles during injection. Ophthalmologists have been successfully sued for this complication.14

General Anesthesia

Complications arising during the administration of general anesthesia are not necessarily directly attributable to substandard technique. Some may be coincidental, and others may not be as likely without general anesthesia. It is common for surgeons to be named for vicarious liability in lawsuits regarding general anesthesia problems involving their patients.

For example, a patient undergoing cataract extraction, bucked on the endotracheal tube during surgery and developed a choroidal hemorrhage and retinal detachment. The surgeon was included in the suit but the claim against her was dropped after a year of discovery. The anesthesiologist settled the claim because of an insufficient level of anesthesia. The claim against the ophthalmologist was added to the total of claims against her by the insurance company and her premium was increased the following year.

The most common injury is corneal abrasion and, although it seldom has serious complications, insurance payments have been made for this problem.

Patients in the cataract age group generally have a higher incidence of significant systemic disease, which can lead to problems in the use of general anesthesia.1 Most medical complications of general anesthesia in ophthalmology patients are from coexisting disease, mostly cardiac. For this reason, the ophthalmologist must be familiar with the patient’s medical history. It is strongly advisable to obtain preoperative medical clearance for patients with significant medical problems. Documentation of these reports should be kept in the patient’s medical record. Communication between the surgeon and the internist-consultant should include a discussion of the expected duration of the surgery and the medications to be used before, during and after the operation.1

As an example, an eighty-two year old woman with no significant medical history was admitted to the hospital for outpatient scleral buckle surgery under general anesthesia for a pseudophakic macula-on retinal detachment. An internist examined her at the hospital for preoperative medical clearance and noted a bruit over the left carotid artery. He advised the vitreoretinal surgeon report this finding to the patient’s family physician in order that Doppler studies could be scheduled a few days after the surgery. In the recovery room, the patient was noted to have suffered a stroke. It was postulated that an embolus had broken off the carotid atheroma as a result of extension of the neck during anesthetic intubation (Beauty Parlor Stroke Syndrome15). A lawsuit was brought against the anesthesiologist, the ophthalmologist, and the internist. After fifteen

Because serious complications from anesthesia may cause blindness or death, it is not surprising that analyses previously cited reveal a significant risk of high indemnification for infelicitous results. Not all complications are manifestations of negligence. There will be differences of opinion regarding the use of local or general anesthesia, the agents used and the gauge, and the sharpness and length of needles used for local injection. These will depend upon the choice of the surgeon and the patient, as well as mitigating or jeopardizing circumstances.

While the ophthalmic surgeon may be named in the lawsuit if his or her patient suffers a complication from general or local anesthesia administered by another person, the primary responsibility for the defense will rest with the anesthesiologist or CRNA. In this circumstance, the ophthalmologist’s defense will be stronger if he or she can document preoperative medical clearance if there was a preexisting medical problem that may have played a part in the complication. Familiarity of the credentials and experience of the nonophthalmic person administering a local anesthetic will enable the ophthalmologist to make a more informed decision regarding the capability of this practitioner.

Awareness of possible hazards and meticulous attention to detail with obviate most local anesthesia problems. In the event of a complication from local anesthesia administered by the ophthalmic surgeon it is of paramount importance that he or she to dictate a contemporaneous operative note. The content should state that the appropriate means were used to minimize the risk of the complication, the fact that the problem was diagnosed in a timely manner and that it was managed properly. These facts will tend to dissuade a plaintiff’s attorney from advising litigation and will strengthen the defense of any subsequent litigation. Advanced preparation for rare emergencies, such as apnea and cardiac arrest, may well avert disaster.

In recent years the specialty of ophthalmology has experienced myriad improvements in diagnostic capability, medical technology and surgical expertise all of which have decreased operating time, patient morbidity and dramatically improved outcomes. Ophthalmologists must guard against taking the possibility of complications too lightly and remember that most of their surgical patients are of advanced age and are likely to have significant medical conditions. There is always a risk that even a ten minute cataract operation with topical or local anesthesia on a patient in this age group still carries the threat of serious injury.1

References

1.Kraushar, M.F., Turner, M.F. Medical malpractice litigation in cataract surgery. Arch Ophthalmol 1987;105:1339–1343.

2.Gild, W.M., Posner, K.L., Caplan, R.A., Cheney, F.W. Eye injuries associated with anesthesia. Anesthesiology 1992;76:204–208.

3.Wilson, F.M. II. Adverse external ocular effects of topical ophthalmic medications. Survey of Ophthalmology 1979;24:57–58.

4.Smith, G.B., Hamilton, R.C., Carr, C.A. Ophthalmic Anesthesia, A practical handbook, 2nd edition, London, Sydney, Auckland. Arnold, 1996, pp 139–140.

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5.Donlon, J.V., Jr., Doyle, D.J., and Feldman, M.A. Anesthesia for Eye, Ear, Nose and Throat Surgery, in R.D. Miller (ed), Miller’s Anesthesia, 6th ed., volume 2, Philadelphia, Elsevier, Churchill, Livingstone, 2005, Chapter 65, 2527–2537.

6.Hamilton, R.C. Complications of ophthalmic regional anesthesia, In Kumar, C.M., Dodds, C., Fanning, G.L. (eds). Ophthalmic Anesthesia, Lisse, Netherlands, Swets & Zeitlinger, 2002, pp. 181–196.

7.Rubin, A.P. Complications of local anaesthesia for ophthalmic surgery. British Journal of Anaesthesia 1995;75:93–96.

8.Kay, M.C., Kay, J. Complications of Anesthesia for Ocular Surgery, in Charlton, J.F., Weinstein, G.W. (eds). Ophthalmic Surgery, Complications, Prevention and Management, Philadelphia, J.B. Lippincott Company, 1995, pp. 87–93.

9.Watson, D. Hyaluronidase, British Journal of Anaesthesia 1993;71:422–425.

10. Kraushar, M.F., Seelenfreund, M.H., Freilich, D.B. Central retinal artery closure during orbital hemorrhage from retrobulbar anesthesia. Trans Amer Acad Ophthalmol and Otolaryngol 1974; 78:65–70.

11.Kraushar, M.F., Cangemi, F.E., Morse, P.H. Prevention of accidental intraocular injection following inadvertent needle perforation of the eyeball. Ophthal Surg 1996;27:405–406.

12.Reese, A.B., Carroll, F.D. Optic neuritis following cataract extraction. Arch Ophthalmol 1958;45: 659–662.

13. Katsev, D.A., Drews, R.C., Rose, B.T. An anatomic study of retrobulbar needle path length. Ophthalmology 1989;96:1221–1224.

14. Smith, G.B., Hamilton, R.C., Carr, C.A., op. cit. pp. 148–180.

15.Weintraub, M.I. Stroke after visit to the hairdresser. Lancet 1997;350:1777-1778.

16.Smith, G.B., Hamilton, R.C., Carr, C.A., op. cit. p. 226.

to time—how to handle a posterior capsular break, a small pupil, vitreous loss, or a dropped nucleus—and these refinements have allowed good visual results even when these situations or others like them arise. Even in cases with a poor visual outcome, a good physician–patient relationship can often prevent a future malpractice action.

Complications that develop during surgery are characterized by their episodic and somewhat unpredictable nature and can be defended in most cases (if dealt with properly) as being inherent to the practice of medicine. There are other types of problems that are much more difficult to defend, and these are errors of process that allow seemingly preventable events to occur. Some of these errors are quite obvious: wrong patient, wrong eye, wrong lens inserted. Others, such as poor measurement techniques, number transpositions, unreasonable expectations, and poor documentation of events, are not always so clear until it is too late. Managing this type of issue (preventing errors rather than dealing with their consequences) falls into the area of risk management. It deals with the analysis of large numbers of events and determination of if and when mistakes were made and how best to prevent them from occurring again. Although risk management techniques were originally developed to save insurers money, the primary beneficiaries of this process when applied to the medical field are ophthalmologists and their patients in terms of better outcomes and reduced stress and anxiety. The tools required are simple in concept and inexpensive to implement. They involve both common sense and learning from the experiences, both good and bad, of others.

“An Ounce of Prevention Is Worth a Pound of Cure”

A recent case with which I was involved will show just how important risk management issues can be. Some details in this case, as in the others discussed later in the chapter, have been altered slightly to protect the identity of the physicians involved, but the basic facts remain unchanged. A very skilled young ophthalmologist had scheduled several cases at a facility he did not often use. He brought with him one member of his own team who was familiar with his surgical routine, but she ended up serving as first assistant on all the cases and was therefore unavailable to work with the operating room personnel provided by the facility. The three cases went like clockwork with no surgical complications, and it was only at the first postoperative visits that it was discovered that all three patients had received the wrong power implants, including one patient who received a 29D lens instead of a 20D implant. In addition to potential malpractice litigation, the mistake resulted in state licensure action against the physician. Defending these actions caused a major disruption in the physician’s life and practice. This is an example of “perfect surgery” complicated not by technical inadequacy but rather by a cascade of preventable mistakes.

How in the world could this have happened? In retrospect, it was easy to see. No one individual took charge to be certain that things were being done correctly, because everyone else assumed that someone else was doing so. It was in fact nonmedical process issues that went awry leading to medical liability consequences. The physician

was “too busy” with surgical concerns to be sure that the powers were correct and did not consider this to be part of his responsibility. The first assistant assumed someone else had checked the powers as was done at the facility where the physician usually worked, so she did not inquire. The circulating staff, unfamiliar with the surgeon’s routine, did not know that the physician recorded the specific lens power in a set place in the medical record and expected the staff to look there before handing him the appropriate lens. They assumed that the lenses, which were all in the operating room on a table and not marked with patient identifiers, were stacked in the right order based on the operating room schedule, and they simply worked their way down the pile.

At every point along the way, any of the individuals involved could have stopped this disaster from happening. Either the surgeon or the first assistant, knowing that they were operating with a crew unfamiliar with their routine, could have asked the circulating staff if they had checked the lens power against the chart record. The circulating staff, unfamiliar with that same routine, could have asked the surgeon how they were supposed to know which lens was intended for which patient. Each lens could have been clearly labeled with the correct patient’s name, or only one lens at a time could have been placed in view with the rest laid aside until the proper patient was in the room. There was no system in place that everyone understood, no process that required the “could have” possibilities discussed above to become the “must be” actions required to ensure an error-free environment. This was a risk management failure of major proportions.

Much of the information in this chapter is related to similar risk management issues as they apply to cataract surgery and is based on the knowledge and experience gained from reviewing hundreds of cataract-related malpractice cases like the one above coupled with over 25 years as a practicing anterior segment surgeon. The suggestions that follow are general in nature rather than indicating, for example, which specific antibiotic (if any) should be used for preoperative prophylaxis.

Many of the recommendations are personal opinions, and no attempt is being made, and no inference should be taken, that the standard of care for cataract surgery is being defined in this discussion. The standard of care is actually determined by the community of ophthalmologists, not a single individual, and will evolve as progress is made in the field. It is important that ophthalmologists follow the literature closely and stay abreast of the current best practices as they pertain to cataract surgery. That is the arena in which the standards of care are defined.

General Risk Management Issues

OMIC has available on its website (www.omic.com) a large volume of risk management materials that all ophthalmologists, not just OMIC insureds, are free to access and download. These include articles on risk management and specific informed consent documents for many of the issues that are covered in this chapter.

There are several areas that are important but not specific for cataract surgery. One is a legible medical record that accurately documents the events that have

taken place in the care of the patient. The medical record should be contemporaneously generated and contain sufficient detail so that it can be used in a court of law if necessary to reconstruct the events that occurred. Entries should contain identifiers so that the individual responsible for the information (physician, nurse, technician) can be determined, and all entries should be initialed to attest to their accuracy. Electronic medical records are wonderful for many things, but they often contain errors that are repeated from examination to examination or boilerplate language that continues to be inserted long after it is relevant (such as a description of a cataract long after it has been removed), so they need to be reviewed closely.

Never alter the medical record under any circumstance for any reason. This is particularly important following a complication at surgery. There is often the temptation to do this to document what “really happened,” but a very defensible case can be rendered indefensible by this action even if the intent was to clarify the situation rather than to obscure the facts. Attorneys spend a lot of time comparing various copies of records obtained at different times, and, once the honesty of the physician can be questioned, it is virtually impossible to win a case in front of a jury. Corrections or addenda when required should be clearly marked with the date, time, and identity of the person making the entry and should leave the original record intact.

Careful and accurate communication with patients when complications develop is also critical. A truthful description of what occurred and how it was dealt with is not an admission of fault. All communications should be documented in great detail in the medical record, and any questions the patient asked and the answers provided should be included. Second opinions regarding treatment of complications should be obtained sooner rather than later and in all instances when the patient requests one.

Informed consent for surgery needs to be well documented in the record and should be obtained, when possible, well before the date of surgery. Informed consent is a process (not merely a form that the patient signs) in which the operating surgeon needs to be intimately involved. Educational videos, other educational tools, and office personnel can be used to expedite the process, but the responsibility for being certain that adequate informed consent has been obtain remains with the operating surgeon. It is best if the document signed by the patient is procedure specific, with the actual risks and potential benefits clearly spelled out rather than a general “consent for surgery form” used by multiple specialties at a facility.

The operative report must be an accurate record of what actually took place during each specific case. Increasingly, however, “predictated” operative reports that add the specific patient name, date, and eye treated to a previously created template that describes a typical case are being used. This type of documentation is not ideal under any circumstance (two surgeries are rarely totally identical) but may suffice in an uncomplicated case. However, if the surgery is complicated, they should not be used (even if amended by hand), because they rarely contain enough detail to be useful if litigation ensues. It is extremely important in complicated cases to have an exquisitely detailed operative report that describes what happened as well as both the actions and thought processes that went into treating the com-