Risk Management

Charting the Perils of LASIK Comanagement

By Richard F. Callaway, Jr., Esq.

Mr. Callaway is a medical malpractice defense attorney and partner in the Houston law firm of Callaway & Brennig. He represents physicians and other health care providers in professional liability claims. The case study presented is not an OMIC case.

[Digest, Fall, 2002]

Beth, a middle aged woman, had worn glasses since she was six years old. She had tried every brand of contact lens on the market from RGP to extended wear without success. LASIK surgery seemed to be the answer to Beth’s problems. For ten years, she had seen an optometrist for her eye care. She genuinely liked the optometrist, so much so that she sought his care even after she sued him. Over the years, the optometrist had diligently compiled a significant patient history, including annual topographies of Beth’s corneas taken since 1995. Although he was not well trained in their interpretation, he used them to fit Beth’s contact lenses. His inability to interpret topographies was no uncommon given the widespread use of non-standardized topographies. Beth’s topographies were stored electronically on the optometrist’s office computer where they were available in sagittal, tangential, and numeric form, but they were not part of Beth’s chart.

Beth’s optometrist thought she was a good candidate for LASIK. No ocular surface diseases, such as keratoconus, had been detected in any of the optometrist’s regular slit lamp examinations. In 1998, he referred Beth to a highly regarded refractive surgeon for preoperative evaluation. Shortly before the appointment, the optometrist transmitted a brief patient history to the surgeon for the six months preceding the referral using a comanagement form provided by the LASIK center where the surgeon operated. He included Beth’s current refraction, information regarding past visual stability, and topographical maps in numeric form taken two weeks before the referral. The maps, one for each eye, were faxed to the surgeon’s office.

The refractive surgeon performed his own preoperative workup. He checked refraction, measure central corneal thickness, and obtained a history of ocular surface and systemic diseases. All tests were within normal range. Topographies were made using a refractive map and revealed a normal cornea. There was no clinical sign of ocular disease on slit lamp examination. Bilateral simultaneous LASIK surgery performed shortly after the preoperative evaluation. Postoperatively, the patient developed iatrogenic keratectasia. Although Beth’s vision was correctable to 20/25 with RGP, she was contact lens intolerant and eventually had to have bilateral corneal transplants. She soon found a lawyer.

Although Beth had orally consented to comanagement, she had not signed an informed consent acknowledging comanagement. Obviously unhappy with the results of LASIK, Beth sued the optometrist and refractive surgeon alleging, in part, negligent screening and failure to explain the plan to “comanage.” In her suit, Beth maintained she had never consented to and had never fully understood comanagement. There was no written informed consent to contradict Beth.

Worse, after suit was filed, the optometrist produced for the first time his complete patient chart containing more than 125 pages of Beth’s history and four years of successive annual color-coded topographical maps in both tangential and sagittal form. The refractive surgeon was shocked to learn this information existed. He was doubly shocked to see successive annual color-coded topographies in tangential and saggital form that were suggestive of an abnormal cornea. In fact, Beth had subclinical pellucid marginal degeneration that could not be detected in the surgeon’s preop workup. Now that suit had been filed, Beth’s entire history came into play.

Comanagement’s Impact on Litigation

In any LASIK lawsuit, comanagement is the simplest issue for lawyers to understand and master. So much has been written about the comanagement question by the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgeons (ASCRS) that lawyers now have a formidable armamentarium of issues and conflicts to exploit. While technical violation of the ethical suggestions and standards contained in the AAO/ASCRS Joint Position Paper may not equate to a violation of the standard of care, the danger is that the issue will get before the jury were the impact can be devastating.

Discovery regarding a patient’s allegations of comanagement leads, inevitably, to a veritable host of litigation horrors, including requests to produce information from patient files concerning fee allocations for the services rendered; inquiries into corresponding increases in comanagement fee and patient load; investigation of the practice protocols of the comanaging optometrist and refractive surgeon; depositions of principals and office personnel; evaluation of the quality and quantity of information in patient charts; and comparison of the surgeon’s comanagement fees with those of other surgeons in the are. The danger in any suit is that the refractive surgeon and the optometrist may be thought of as each other’s agent, as a single entity, or as joint venturers. Liability may attach to the refractive surgeon who has met the standard of care for no reason other than that the comanager is not knowledgeable about recognizing and treating post-LASIK complications or in interpreting preoperative topographies.

Comanagement Chart Audit

To determine the quality and quantity of information in comanagement files, Callaway & Brennig conducted an audit of 179 files from 48 optometrists who referred patients to refractive surgeons throughout 1998. Files were reviewed for information concerning 1) patient histories, 2) corneal topographies, 3) current and past refraction, and 4) preoperative examination. Many of the optometrist practiced in groups, but the groups appear to have had no standard procedures regarding the transmittal of information. Most comanaging optometrists had attended meetings, either individually or in groups, with the refractive surgeons with whom they comanaged. The surgeon’s desire to acquire “all relevant information” was emphasized at all times. Similar requests to furnish “relevant information” were made to office personnel. There was frequent mention of the need for records and conversations between the respective offices of the refractive surgeons and the comanaging optometrists.

Patient Histories

Only 17 of the 170 files contained any historical information about the patient. It has been estimated that the decision to undergo LASIK surgery is an eight-month process from initial consideration to the date of surgery, suggesting there is more patient history in the optometrists’ records than is being sent to the surgeons. The refractive surgeon cannot know whether records exist in a comanagement arrangement; all the surgeon can do is request records.

Corneal Topographies

Of 179 files, 71 (40%) contained topographical maps, 60 of which were of little additional diagnostic value to the surgeon because they were taken less than a month before LASIK surgery. Only 11 charts had corneal topographies more than a month old. More important, the vast majority of topographies (60) were faxed to the referring surgeon, rendering their color-coded features impossible to interpret when they emerged in black and white from the refractive surgeon’s fax machine. Only 10 charts contained color maps; from a historical perspective, these maps were not useful for comparison and detection of abnormality since they were taken within a month of surgery. Only one chart contained a color topographical map that had been made more than a month prior to surgery. Further complicating the problem, review of the files revealed that relatively few comanaging optometrists used topographical maps and scales that were consistent with those used for preoperative evaluation by the refractive surgeon.

One good preoperative topographical map, made by a well-trained person using a good machine, is almost always adequate to detect pathology. For that reason, a long series of topographical maps is not needed to detect most pathologies. The refractive surgeon should do a topographical map as part of the preop evaluation. Where the optometrist has also made topographical maps, those topographies should be transmitted to the surgeon before the preop exam in a form that is legible and with real diagnostic value.

Current and Past Refraction

While 163 files contained information on current, refraction, only 12 supplied information on past refraction. This is a serious omission because stable refraction is a fundamental requirement for LASIK. In the absence of historical information regarding past stable refraction, the refractive surgeon must depend solely on the patient’s word that his or her spectacle prescription has not changed within the last two years.

Preop Exam and Information Sharing

Half of the 179 charts contained information regarding a preoperative examination. It is probable that most optometrists performed slit lamp examinations, but they failed to document those examinations in information sent to the refractive surgeon. Compounding this lack of information sharing was the fact that bilateral simultaneous LASIK generally occurred within a week of the preoperative evaluation by the optometrist, which often was not enough time for the surgeon to receive the patient’s file form the optometrist.

No one can anticipate all the contingencies that might arise in a comanagement arrangement, but standardized procedures designed to ensure the transmittal of relevant patient information would improve comanagement, benefit that patient, and in the event of litigation, assist the comanager and counsel in defending claims of negligent comanagement.

Beth’s case was settled, so we will never knowing if the jury would have penalized the refractive surgeon for not know that a voluminous ten-year chart, including topographical maps stored on computer, existed in the optometrist’s office.

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Protocol for Comanagement of Refractive Patients

The following SLEDOG Protocol for comanaging optometrists and refractive surgeons was developed by Callaway & Brennig

Simple mandatory procedures should be followed and shared with the comanaging optometrist. Each comanager should sign off on the following: refraction, central corneal thickness, pupil size (and how it is measured), ocular surface/systemic diseases, and topography. The refractive surgeon must see the patient for the first postop visit and be clear about the subsequent postop care to be provided by the optometrist.

Letters to comanaging optometrists should be written at the time of referral to request all relevant patient information. Such letters document that a system is in place to retrieve patient information.

Emphasize these simple mandatory procedures at meetings with comanaging optometrists.

Document your file. OMIC provides an informed consent form specifically for comanagement situations. The form simply requires the patient to acknowledge the comanagement arrangement.

Office personnel continuity should be maintained at all costs. Not only can a disgruntled former employee significantly strengthen a plaintiff’s case, but an office in turmoil is one that makes mistakes.

Give specific persons in your office responsibility for obtaining information about patients who have been referred by comanaging optometrists. While everyone should be generally aware of your simple mandatory procedures, designate one or two employees with specific responsibility for obtaining records. If a lawsuit is ever filed, their testimony will play better before the jury than the testimony of several employees, none of whom is completely familiar with your procedures and process.