Ординатура / Офтальмология / Английские материалы / Risk Prevention in Ophthalmology_Kraushar_2008

Explanations must be given without blame. If an attempt is made to conceal an error or injury to a patient, one might be guilty of “fraudulent concealment.”3

Disclosure and apology may be coincident but are not identical. Apology is appropriate when facts and evidence reveal a preventable error.3 An apology is not an admission of fault. However, protection against an admission of fault is not invariable, and one must be knowledgeable with respect to the situation in a particular jurisdiction. No statement by a physician or any health care personnel should be made without this information and counsel.

Structure and Effect of Apology

An apology may be defined as an acknowledgment of responsibility for an offense or error that is coupled with an expression of remorse.1 The four components in the structure of an apology are acknowledgment of the offense; explanation or reason for the commission of the offense; expression of remorse, shame, forbearance, humility; and reparation.1

The following are several salutary mechanisms in apology. If the patient feels humiliated, an apology may restore dignity and self-respect. Concern for the wellbeing of the patient and the patient’s family may be communicated through apology. Patients often feel powerless after an offense, but the knowledge that changes are being made to correct the error and prevent future errors may restore a sense of power to the patient.

Some patients and their families are vindictive and wish to witness suffering by those whom they view as the offenders. A physician’s appearance and manner during an apology may help to mitigate this desire on the part of the patient.

Some patients require validation that the offense occurred and that it has become part of his or her history and identity. Especially when infants or children are injured, parents feel variable intensities of guilt and are comforted by the assurance that they are not at fault.

Confirmation of shared values is important for continuing trust in a patient’s relationship with a physician. The patient must know that what he or she feels to be an error is also the opinion shared by those involved in his or her health care. An injured party also desires to feel some hope or promise for the future with knowledge that individuals or institutions responsible for the alleged offense are taking or have taken corrective and preventive measures.

Emotions commonly felt by patients in adverse situations are anger, frustration, helplessness, abandonment, and fear. Physicians must be aware of this and be available and willing to have appropriate and empathic dialogue about the concerns of the patient and the patient’s family.

Reparations may also be a therapeutic part of an apology and do not always require legal intervention. Reparations may take many forms, including facilitating subsequent appointments with physicians, canceling bills, and making a financial settlement.1

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Inadequate Apology

The fact that an apology has been made is insufficient. In fact, an inadequate or cursory apology may worsen a situation. A peremptory “I am sorry” is not enough. Often apologies fail to acknowledge responsibility or attempt to make an excuse or partial excuse in the apologetic statement. Many vague, tangential, or oblique impersonal phrases are invoked in an apology. Examples include such phrases as “I am sorry for what happened” or “mistakes were made.” Conditional statements, such as “if there was an error” or “a mistake was made but” or “these things happen to the best of people,” should not be used. Unacceptable explanations, arrogance, or inadequate reparation may also degrade or negate the effect of an apology.1

Conclusion

An apology when indicated may be regarded as a therapeutic intervention. All too often psychological aspects, which are part of complete patient care, are disregarded. A cleansing or catharsis for both physician and patient may be effected by a proper apology. Previous satisfactory relationships may be enhanced, and damaged relationships may be repaired. Rendering an apology by the physician may provide atonement by diminishing the feeling of guilt and shame and apprehension of retaliation. For the offended patient, receiving an apology may expunge a grudge and abate ineluctable corrosive anger, thereby facilitating forgiveness and reconciliation.1

Despite some evidence that apologies seem to decrease the prevalence of malpractice litigation, there is an understandable hesitancy and lack of certitude on the part of physicans.1,4 This aspect of medical practice should be further explored in that it may ameliorate heretofore insoluble aspects of patient care and medical–legal conflicts. It is a conceivable manner for negotiation between a physician and an injured patient. Furthermore, initiation or enhancement of cooperation between physicians and attorneys may be possible. Even if no formal method or procedure evolves, a greater comprehension of the psychology involved in the perception of injury by the patient may help to modify a physician’s interpersonal behavior and relationships.

References

1.Lazare A. Apology in medical practice: an emerging clinical skill. JAMA 2006;296:1401–1404.

2.Joint Commission on Accreditation of Healthcare Organizations. Standard R1.1.2.2, July 1, 2001. Available at: http://www.jointcommission.org/.

3.Perspectives on Prevention. Minneapolis: Midwest Medical Insurance Company, August 2006, pp. 1–4.

4.Zimmerman R. Doctors’ new tool to fight lawsuits: saying “I’m sorry.” Wall Street Journal May 18, 2004, A1.

Part 2

Risk Management in the Ophthalmic

Subspecialties and Related Fields

The 13 chapters in Part 2 are not intended to be comprehensive recapitulations of “how to do it” with respect to the clinical management of patients with ophthalmic disease. The authors discuss only those problems that arise in the management of diseases in their field that, in their experience as consultants and experts, most commonly lead to litigation, and they offer opinions on how best to maximize risk management. For example, because presbyopia surgery is in its developmental infancy and the optimal procedure for specific candidates has not yet been determined, there is presently no significant track record regarding the malpractice litigation experience. The suggestions offered are not in any way intended to be regarded as establishing a standard of care.

Because some diseases can appropriately be categorized in more than one field there is some overlap of discussion within chapters. While there is variation within these chapters with respect to the spectrum of diseases, there are also similarities in risk management modalities, such as establishing a good physician–patient relationship, having an effective discussion of informed consent, and maintaining adequate documentation. Additionally, many of these chapters have their own unique indications for these same modalities. For example, while informed consent is essential for all fields, it is of even greater importance for elective procedures such as clear lens exchange, cosmetic surgery, or LASIK. Although establishing a good physician–patient relationship can be relatively easily accomplished during the management of long-term problems such as glaucoma and strabismus, it is a more challenging task in the management of acute problems such as trauma and retinal detachment. The concept of documentation is of particular importance in the preoperative evaluation of cosmetic surgical patients.

Based on the advice of noted ophthalmic pathologists, no specific chapter is devoted to the subspecialty of pathology because lawsuits of this nature are uncommon and are typically brought against the ophthalmologist managing the care of the patient, that is, the generalist, retinavitreous surgeon, pediatric ophthalmologist, ophthalmic plastic surgeon, ophthalmic oncologist, and so forth. The discussion of these problems is included in the appropriate subspecialty chapters.

Topical Anesthesia

Some topical anesthetics, especially cocaine, may cause clouding of the corneal epithelium. Idiosyncratic reactions are rare. Cocaine blocks the re-uptake of norepinephrine at nerve terminals causing a sympathomimetic effect. Ocular instillation, even with very low plasma levels, may create severe bradycardia.2,3

Bupivacaine, lidocaine, proparacaine and tetracaine have all been used topically and intracamerally for cataract extraction. Some claim this route of anesthesia is insufficient. Although it lacks akinesia and requires a cooperative patient, it is the method of choice for a large number of cataract surgeons. It is imperative that patients are carefully selected and appropriately counseled for this type of anesthesia, including a thorough discussion of informed consent. Additional sedation is generally required.4

Local Anesthesia

General Considerations

There is greater patient awareness in anticipation of and during procedures performed under local anesthesia than with general anesthesia. Therefore, critical and prolonged preparation is required. No haste should be evident and thorough informed consent should be obtained. If an anesthesiologist is involved, either in the administration or monitoring of anesthesia, he or she should spend time with the patient. Oversedation should be carefully avoided to facilitate patient cooperation. Often, hearing aids and dentures should be left in place for patient comfort. Attention is given to patient transport and positioning. Equipment for and personnel experienced with emergency resuscitation must be readily available.

Risk factors for regional anesthesia include inadequate sedation, a communication barrier, lack of patient cooperation or desire, and patients with spontaneous chronic coughing, shortness of breath while recumbent, a recently operated or inflamed eye, prolonged operations, Parkinsonian head tremor, Alzheimer’s disease, and/or claustrophobia.4 General anesthesia should be considered for such patients.

Complications following injection of local anesthetics are rare and estimated at 1 in 500. Awareness of possible interactions of a patient’s medications and anesthetic agents is paramount. Most reactions occur within 15 minutes of injection and are usually the result of apprehension, pain, oversedation, local anesthetic toxicity, method of needle placement, or injection of local anesthetic. Hypotension, bradycardia, diaphoresis, nausea, and cardiac arrest are usually elicited by fear, pain, or manipulation of the globe. True allergic reactions occur in less than 1% of local injections and are characterized by wheezing, urticaria, and respiratory distress.5-8 With the Nadbath block of the stylomastoid foramen for facial akinesia, the

anesthetic may spread to the vagus, glossopharyngeal, or spinal accessory nerves, causing respiratory distress and dysphagia.

Systemic complications may follow an overdose or intravascular injection of adrenline, which is often combined with the anesthetic to extend the duration of the local block. Hyaluronidase, used to hasten the onset and quality of the block, rarely causes an allergic reaction.9 Respiratory arrest may occur after intravenous sedation.7

Systemic toxicity from local peribulbar 4% xylocaine injection leads to toxic central nervous system dysfunction and cardiac depression. For a 70 kg patient, a total volume of 7.5 mL of 4% xylocaine is safe. For a smaller patient, no more than 5 mL should be given.4

Retrobulbar Hemorrhage

Retrobulbar hemorrhage is estimated to occur in 1 of 700 retrobulbar blocks. Other citations of prevalence range from 0.1% to 1.7% of patients. Predisposing factors are elderly patients and those receiving corticosteroids, aspirin, nonsteroidal antiinflammatory medications, and anticoagulants.4

The mechanical tamponade of the hemorrhage causes increased intraocular pressure (IOP), which may cause central retinal artery compression or occlusion (CRAO). Osmotic diuresis, anterior chamber paracentesis, lateral canthotomy, and decompressive surgery may be required. The IOP should be measured and the optic nerve should be observed for arterial pulsation and pallor. Similar complications may occur following the injection of an excessive volume of anesthesia in the orbit. If the lack of clarity of the ocular media precludes adequate visualization of the optic nerve, an empirical lateral canthotomy may be advisable.10

Penetration or Perforation of the Globe

Whenever any medication is injected near the outside of the eyeball and the tip of the needle cannot be visualized, maximal care must be taken to be as certain as possible that the needle tip is in the desired location prior to injection. Unintended insertion of a needle into the globe (penetration) or through the globe with an entry wound and an exit wound (perforation) is a rare complication. Myopic eyes, often longer than 26 mm, are at greater risk because of the posterior, staphylomatous bulge and the relative thinness of equatorial myopic sclera. Other estimates place high risk eyes at 23.5 mm or greater length. Perforation may occur with either retrobulbar or peribulbar (periconal) blocks. Direct damage by the needle to the fovea or optic nerve may occur. A retinal tear or detachment is also possible. Referral to a retinavitreous specialist is advisable if there is any difficulty completing a thorough examination of the ocular fundus.

Although pain at the time of the block is typical when a needle enters the globe, many patients experience no pain, thus making a timely diagnosis more difficult. Penetration of the globe as opposed to a through and through perforation carries the additional risk of accidental injection of anesthetic into the eye. This will raise the IOP and the person administering the block will sense back pressure on the plunger of the syringe. Even a minimal amount of fluid injection into the eye can increase IOP sufficiently to cause partial or complete CRAO in which case the patient may complain of loss of vision. Another clue may be loss of the red reflex due to a vitreous hemorrhage from a choroidal or a retinal vessel. On withdrawal of the needle, there may be leakage of vitreous from the entry site with attendant hypotony. Every patient who receives medication of any kind by periocular injection in whom a postinjection vitreous hemorrhage is diagnosed should have a prompt, thorough examination of the ocular fundus to rule out the possibility of accidental intrusion of the needle. If the hemorrhage precludes adequate visualization and fails to clear rapidly, serious consideration must be given to the need for pars plana vitrectomy.

The risk of this complication may be minimized by having the patient look in the primary (neutral) position of gaze rather than upward and nasally during retrobulbar injection. When giving peribulbar or retrobulbar injections, it is often forgotten that the globe curves outward in the orbit. Especially with peribulbar anesthesisa, the risk of perforation is enhanced because the injections are often given with the needle inserted straight backward rather than angled away from the globe toward the orbital wall. To avoid unintended intraocular injection of anesthetic, it has been recommended11 that once the practitioner thinks the needle tip is in the proper location and prior to injecting anywhere in the immediate vicinity of the outside of the eyeball, the syringe should be moved in and out as well as circumferentially. An experienced practitioner will be able to discern the difference between motion of the globe caused by traction on Tenon’s capsule as opposed to motion due to traction from an intrascleral needle. The risk of causing a retrobulbar hemorrhage with this maneuver is negligible and the usual consequences are far less dangerous than those of accidental intraocular injection of anesthetic.

An example of this is a twenty-eight year-old male who presented with a temporal pterygium and vision of 20/20 in his right eye (OD). The visual acuity in his left eye (OS) was 20/200 because of amblyopia. The patient underwent removal of the pterygium following a subconjunctival injection of xylocaine 2%. The administration of local anesthesia and surgery were believed to be uneventful. When the patch was removed the following morning, the patient had hand motions vision OD. There was no evidence of retrobulbar hemorrhage, there was no proptosis of the eye, and there was a full range of motion. Examination of the ocular fundus revealed a cherry-red fovea with a pale retina secondary to CRAO from undetected accidental intraocular injection of the anesthetic. Despite immediate referral to a retinavitreous specialist and extensive therapeutic efforts, the visual acuity never improved. At trial there was a multimillion dollar award by the jury.

Because an eye is anesthetized, it does not diminish the risk of inadvertent penetration and a number of cases involving intraocular injection of antibiotic or corticosteroid have occurred. Intraocular Gentamycin may cause irreparable loss of vision.

One situation involved gross misdirection of the needle with tearing of the retina and subretinal injection of corticosteroid beneath the macula. Vision was lost and the claim was settled.

Amaurosis

Temporary loss of vision may occur from anesthetic blocking the optic nerve or being accidentally injected into the eye. Patients having regional blocks, especially retrobulbar, should be warned of loss of vision up to perception of light and, if some vision is retained, it does not mean that the block is ineffective. Patients may also be aware of the microscope light and some movement during surgery.

Atrophy of the Optic Nerve

In the 1950s and 1960s, there were numerous reports in the literature12 of optic atrophy of unknown origin developing six to twelve weeks after cataract surgery. At the time it was commonplace for the ophthalmic surgeon to stand at the contralateral shoulder of the supine patient and direct the patient to look superonasally at him during retrobulbar insertion of the anesthetic needle at the inferotemporal aspect of the orbit. In this manner the upward-inward gaze of the patient brought the posterior part of the globe and the optic nerve inferotemporally to facilitate the location of the needle tip as close to the optic nerve as possible for maximal anesthetic effect. In retrospect, this maneuver increased the risk of needle trauma to the optic nerve and the central retinal artery. This is an additional indication for the patient’s eye to be in the primary (neutral) position of gaze during the insertion of the needle.

Another practice of anesthetic delivery, which has been discontinued, is intraconal injection. It was the aim of this technique to pierce the muscle cone with the needle in order to inject the anesthetic closer to the optic nerve and the ciliary ganglion. This technique had the added putative advantage of requiring a smaller volume of anesthetic and achieving the anesthetic effect faster without having to wait for diffusion of the anesthetic through the muscle cone. However, this technique carried the undesirable risk of placing the needle tip dangerously close to the optic nerve.

Optic atrophy or central retinal artery occlusion may be caused by direct needle tip damage to the optic nerve or the central retinal artery or by injection into or hemorrhage within the optic nerve sheath. The fundus may resemble Purtscher’s retinopathy. If this is suspected, an urgent MRI might identify the problem and optic nerve sheath decompression can be performed. Celerity is essential for effective treatment.

The standard needle provided in most operating rooms is 1.50 inches in length. It has been suggested13 that to avoid the risk of damaging the optic nerve the needle for retrobulbar injection should be no longer than 31 mm or 1.25 inches in length.

Since the difference between a 1.25 inch needle and a 1.50 inch needle may not be readily apparent, it is a good idea for anyone who requests a 1.25 inch needle to check the label on the wrapper prior to injecting. In peribulbar injection, a 5/8 inch needle is sufficient. Needles should never be inserted beyond 25 mm of the orbital rim. While length of the needle is often emphasized, it is knowledge of the anatomy of the orbit and careful attention to technique of injection that is critical.

Damage to the optic nerve may also occur following retrobulbar hemorrhage with or without acute retinal vascular occlusion. The increased orbital pressure may occlude the small nutrient vessels to the optic nerve without signs of retinal vascular occlusion. This complication may lead to late optic atrophy and result in partial to complete visual loss.

Penetration of the Optic Nerve Sheath

The optic nerve has a complete dural cuff extending to the sclera. An injection of an anesthetic agent into this cuff leads to direct spread to the central nervous system via the subarachnoid space. This can lead to protean symptoms and signs, including increased or decreased cardiovascular vital signs, pulmonary edema, drowsiness, vomiting, and contralateral blindness because of reflux of the drug to the optic chiasm or an air bubble in the sheath. Contralateral oculomotor paralysis, facial palsy, deafness, vertigo, aphasia, loss of neck muscle power, vagolysis, shivering, convulsions, respiratory depression or arrest (apnea), neurological deficits, hyperreflexia, hemiplegia, paraplegia, quadriplegia, and cardiac arrest may be seen. If the diagnosis is made in a timely manner and if appropriate life support is instituted promptly and continued until the anesthetic is metabolized, permanent deleterious complications can be avoided.4,5,14

Brainstem Anesthesia

Manifestations of brainstem anesthesia have interconnections with those of injection into the optic nerve sheath. The symptoms usually appear within 8 minutes but vary from immediate to 40 minutes. This complication occurs with either retrobulbar or peribulbar anesthesia. Symptoms and signs of this potentially fatal complication may be amaurosis, gaze palsy (ductional defects), dysphagia, shivering, tachycardia, hypertension, loss of consciousness, dilation of the contralateral pupil, apnea, and cardiac arrest4,5,14 Resuscitation equipment and personnel trained in its use must be available. Alertness and cognizance of this possible complication with institution of early therapy usually leads to full recovery.

An an example, A CRNA administered a retrobulbar block to the right eye of a cataract patient. Within ten minutes, the patient noted bilateral amaurosis and shortly thereafter became apneic and lost consciousness. Following prompt recognition of the problem by the ophthalmologist, the patient was intubated and maintained on life support. When the patient regained consciousness and was extubated, she described