Ординатура / Офтальмология / Английские материалы / Risk Prevention in Ophthalmology_Kraushar_2008

The case points out the importance of a thoroughly understood practice pattern among these participants. While “immature retina” arguably should have been understood by the neonatologist as not eliminating the possibility of ROP, especially because a short interval repeated screening was recommended, there should be an established understanding among the involved physicians regarding what meaning such an ophthalmologic description conveys.

There should be further understanding of whether responsibility for follow up is shared by the ophthalmologist or remains with the nursery or the subsequent pediatrician during the stage of screening, however many sessions are required before terminating scrutiny. Because the latter two coordinate all care during and following discharge, logic suggests that the responsibility best remains with them, but this is entirely a local determination. However, at the point where any degree of ROP has been detected, the capacity to address the matter has gone beyond the primary care givers, and it would be difficult for the pediatric ophthalmologist to deny some share of responsibility while being in the better position to carry out the necessary treatment or to secure this service from a colleague.

In the case described above, no ROP was evident at the first screening, but through a misunderstanding of the result, follow up was not arranged appropriately through no fault of the ophthalmologist. What then constituted his risk? It was that there was no system in place within his office for spotting compliance failures and assisting in efforts at rectification.

Other opportunities for a break in the system can occur. It is important that when medical considerations prevent the ophthalmologist from accomplishing the screening, this should be documented in the chart and some type of reminder should exist for restoring the infant to the schedule. When the screening ophthalmologist is not the person responsible for treatment, this too increases the possibility of a communication failure and gives a further responsibility to ensure compliance when the referral for treatment arises.

It is best to memorialize this or any other variation of understanding in a document freely available and universally adopted, but consistent custom and practice will govern in the alternative. Be aware that these understandings fix the working relationships at a particular institution, but no agreement to assign responsibility for any aspect of care elsewhere from where the facts of the specific case indicate it should lie will immunize against liability for negligence. The patient is not bound by arrangements between the involved physicians.

Final Thoughts

Try to accomplish an entire examination in one visit; it limits what might otherwise “fall through the cracks” if the patient does not return. You might avoid missing a retinal lesion, causing what may otherwise appear to be a routine strabismus problem or one that explains why an infant with supposed amblyopia is not improving with adequate occlusion.

Although it may seem clear that a tearing infant has lacrimal obstruction, always harbor a suspicion of congenital glaucoma. No ophthalmologist, especially not a pediatric ophthalmologist, should overlook this possibility.

Surgical overand undercorrection of strabismus occurs frequently enough. Avoid characterizing these as complications, because they are within the spectrum of foreseeable outcomes, even though disappointing. Your informed consent procedure should establish this view.

Your informed consent discussions should include risks, benefits, and alternatives respecting the proposed treatment, but full disclosure still leaves room for you to rank the alternatives. Remember also to present not only the alternatives but also their risks and benefits as well as those of your preference. As to risks, the discussion is not complete without giving some idea of the likelihood of any risk materializing. I have seen several instances of adults with strabismus unduly discouraged from improving their self-image and business/social acceptance through surgery by an exaggerated estimate of the risk of intractable postoperative diplopia. Surely this unusual complication should be revealed, but in proper perspective relative to the likelihood of achieving the anticipated benefits.

References

1.Tenuto v. Lederle Laboratories, et al. 90 N.Y.2d 606; 687 N.E.2d 1300; 665 N.Y.S.2d 17 (N.Y. Ct. App. 1997).

2.Tarasoff v. Regents of University of California, et al. 13 Cal.3d 177; 529 P.2d 118; 118 Cal. Rptr. 129 (Sup. Ct. Cal. 1974).

3.Sawh v. Schoen. 215 A.D.2d 291; 627 N.Y.S.2d 7 (N.Y. A.D. 1st Dept. 1995).

4.Thomas v. Corso. 265 Md. 84; 288 A.2d 379 (Md. Ct. App. 1972).

5.Hertle RW, Dell’ Osso LF, FitzGibbon EJ, Yang D, Mello SD. Horizontal rectus muscle tenotomy in children with infantile nystagmus syndrome: a pilot study. JAAPOS 2004;8(6):539–548.

6.Cowan DH. Innovative Therapy v. Experimentation. 21 Tort&Ins. L.J. 1986;21:619–623.

7.American Academy of Pediatrics, Section on Ophthalmology, American Academy of Ophthalmology, American Association for Pediatric Ophthalmology and Strabismus. Screening examination of premature infants for retinopathy of prematurity. Pediatrics 2006;117(2):572– 576. Erratum in Pediatrics 2006;118(3):1324.

Figure 20.4 Total settlement by ophthalmic subspecialty

Refractive Surgery Claims by Procedure

Radial Keratotomy

The OMIC experience with RK claims has been surprisingly favorable. Figure 20.5 shows the incidence of refractive claims by procedure from 1989 through 2002. There were only a handful of RK claims up to about 1996 when PRK was approved by the U.S. Food and Drug Administration (FDA). Very few surgeons continued performing RK after 1996, and it is generally accepted that it was a transitional procedure with many associated problems. The size of the optical zone, number of incisions, direction of the incisions, metal versus diamond blades, amount of myopia, patient age, incision depth, crossing incisions, peripheral re-deepening, and postoperative cortisone drops were all subjects of great debate—without much hard science to settle the questions.

The RK procedure itself weakened the peripheral cornea and unusual results— so called “overand underresponders”—were common. It was performed by hand, usually in a private office, with relatively inexpensive equipment after attending RK courses, which were readily available from both corporate and private sponsors, and with little regulation controlling the equipment or the surgeons. The procedure caused anywhere from 3 to 4 to 32 to 64 permanent scars in the cornea. Glare and star bursting around lights at night were considered to be not complications but instead expected postoperative events. Optical zones were generally only as small as 3.0 mm, but some surgeons made them as small as 1.0 mm in an attempt to push the limits of the operation to include more potential patients.

With all of these known problems, why was the OMIC experience generally favorable? The answer is that OMIC implemented underwriting requirements and provided risk management support specific to RK. In order to be covered for

experience by Abbott et al.2 These conclusions and the discussion they generated are discussed in detail in the literature review; the risk management section provides recommendations on how to minimize the risk of a lawsuit regardless of surgical volume and how to safely comanage patients.

Laser In Situ Keratomileusis

In 1996, PRK became the first laser vision correction procedure to be approved by the FDA. Although it was deemed safe and effective, it never became popular with the general public because it was associated with significant discomfort and delayed visual recovery. Patients’ experiences with LASIK were different: the combination of minimal discomfort and rapid visual recovery provoked a “WOW!” reaction from patients who responded enthusiastically to the almost immediate improvement in their vision and near complete visual recovery by the morning after surgery. Bilateral simultaneous surgery became very popular, and the number of LASIK procedures escalated dramatically. Within a couple of years of its introduction in the United States in 1996–1997, more than a million LASIK procedures were being performed, and ophthalmologists began to advertise widely, and at times aggressively, in order to attract patients.

Soon enough, stories of complications emerged, which is hardly surprising given that LASIK is a technologically more difficult procedure requiring more surgical skill than PRK. In addition, early microkeratomes were difficult to assemble, maintain, and use. Figure 20.1 details the OMIC claims incidence between 1995 and 2004, when LASIK claims rose from 7 in 1998 to a peak of 55 in 2002. This uptick in claims frequency correlates with the increases in both the number of LASIK procedures being performed and the number of ophthalmologists insured by OMIC, which rose from 1,700 members in 1996 to 2,968 insureds in 2002. A similar spike was noted in cataract claims over that time period. Figure 20.6 clarifies, however, that the LASIK frequency trend was short-lived. Although the number of policyholders continued to climb, LASIK claims kept decreasing; as of June 2006, there were only four.

Figure 20.7 details the average indemnity payment per LASIK claim between 2001 and 2005, which ranged from $31,000 to $56,000—except for 2003. That year, there were 12 claims and a much higher average settlement of $156,000, largely due to two significant awards. In one case, a patient underwent bilateral simultaneous surgery and later developed corneal ectasia with irregular astigmatism, ghosting, and best-corrected visual acuity of 20/30. The patient’s topography indicated form fruste keratoconus. Most refractive surgeons consider this a contraindication to LASIK surgery. Photorefractive keratectomy might be an option if the surgeon provides the patient with information about the possible increased risk for postoperative problems associated with ectasia. The insured surgeon in this case, however, did not review the topography, disclose the presence of form fruste keratoconus to the patient, or have the patient sign a procedure-specific informed consent document. The case settled for $250,000.

Average LASIK Settlement

as of July 1, 2005

Figure 20.7 Average laser in situ keratomileusis settlements

That same year, another patient sustained a buttonhole flap complication in the first eye, allegedly resulting from a violent head movement during the microkeratome pass. The flap was repositioned without ablation of the bed, and surgery on the second eye was cancelled. The patient developed central corneal haze and irregular astigmatism with best-corrected vision of 20/40. As in the prior case, there were questions about the patient’s candidacy and the consent. No preoperative pachymetry was performed, and subsequent examinations revealed that the patient had a “thin” cornea.

The patient’s consent for surgery must be both voluntary and informed. To the dismay of some surgeons, the legal standard is what a prudent layperson would need to know in order for the choice to be informed, not what the surgeon feels is necessary. The surgeon in question first met the patient on the day of surgery but did not document a discussion of the risks and benefits, so the plaintiff argued he was not informed. Moreover, the informed consent document was signed immediately before the procedure, allowing the plaintiff to argue that the consent was coerced instead of voluntary. As readers have no doubt surmised, the patient’s care was comanaged. In addition to limited contact before the surgery, the ophthalmologist examined the patient only on the first postoperative day; subsequent examinations were performed by the comanaging optometrist. Documentation problems surfaced, as no documentation of the head movement could be found. While both the surgeon and the operating room technician confirmed the incident during depositions, the other standard of care concerns led to a settlement of $450,000. In response to these cases, OMIC modified its refractive surgery underwriting requirements pertaining to the role the surgeon must play in determining patient candidacy and informed consent (see the risk management discussion at the end of the chapter).

Figure 20.8 charts OMIC’s LASIK trials between 2000 and 2006. In five cases, the jury returned defense verdicts. The only two plaintiff verdicts occurred in 2006. In the first case, a loss of suction during the microkeratome pass led to