Risk Management

Staggering ROP Awards Scaring Doctors Away

By Paul Weber, JD

OMIC’s vice-president of risk management

Digest, Summer 2001

Screening premature infants for retinopathy of prematurity (ROP) is a valuable clinical task, both for the individual patient and society as a whole, as it can potentially spare a child a lifetime of blindness. Over the past 14 years, OMIC Board and staff members have learned a great deal about liability issues arising from ROP screening and have developed tremendous respect for the ophthalmologists who perform this worthwhile service. Therefore, it is distressing to hear more and more ophthalmologists say they are unwilling to become involved in ROP screening because of the risk of potentially staggering malpractice awards. Some of the reasons behind this growing crisis were succinctly set forth in a 1994 letter from one ophthalmology practice to a local hospital with copies to the state medical and ophthalmic societies explaining why this particular practice would no longer offer ROP examinations in the nursery:

“Guidelines from the Cryotherapy of Prematurity Study must be followed exactly. The timing of the evaluation and follow-up visits are critical. This is often not under the physician’s control (i.e., patient’s family compliance to follow-up visit requests is at times marginal). The risk of liability in these cases is high. The emotional trauma of dealing with any kind of litigation is great.”

This letter was forwarded to OMIC by an insured when he became the only retinal specialist in the region of his rural state to offer ROP screenings as a result of this practice’s decision to stop examining these babies. After much deliberation, this insured also decided to discontinue ROP screenings of premature infants.

Since 1994, the malpractice climate has become decidedly worse for healthcare providers due to both real and perceived problems associated with managed care and HMOs, particularly access to care issues. Health care providers are being severely punished in jury trials for providing “poor quality care” whenever there is a breakdown in the system of communication and follow-up with patients. Add to the general hostile malpractice environment the dissension that exists among expert witnesses (ophthalmologists, pediatricians, neonatologists) concerning responsibility for follow-up with parents after the ROP screening/monitoring is set in motion for missed or canceled appointments or referrals to specialists. Due to a confluence of factors, the exodus of well-trained ophthalmologists who examine premature infants is escalating.

Following a $15 million jury award against two pediatricians and a pediatric ophthalmologist in February 2001 for alleged failure to properly diagnose and treat ROP in twins, several well-trained ophthalmologists stopped performing ROP exams in their local hospitals rather than face unlimited liability risk. The pediatric ophthalmologist, an OMIC insured, was found liable for 15% of the damages awarded to one twin. The case is currently under appeal. Over the past 13 years, OMIC and its insureds have weathered several other serious ROP lawsuits. In Key Clinical Risk Junctures in ROP Disease, Dr. Trese points out several critical “junctures” when the ophthalmologist is exposed to significant malpractice risk. Other junctures bear scrutiny as well. One occurs when the pediatric ophthalmologist refers the ROP patient to another ophthalmologist for treatment. This issue’s Closed Claim Study illustrates the need to carefully document the referral of an ROP patient to another physician or face the possibility of a grueling trial with an uncertain result.

Discharged or Transferred Patients Lost to Follow-Up
Another common scenario occurs when the ophthalmologist examines a premature infant in the hospital, makes a diagnosis of ROP, and schedules a reexamination in two to four weeks. In the meantime, however, the patient is transferred to another facility or discharged to home and lost to follow-up.

In one lawsuit, an ophthalmologist performed an ROP exam, noted that the infant had “Zone 2, immature retinas, and a few clock hours of ridge (stage I) plus disease,” and recommended a reexamination in two weeks. The patient was transferred from the NICU to a lower level hospital with a discharge note of a diagnosis of “early changes of ROP and needs follow-up in two weeks.” The admitting nurse at this hospital did not recognize the importance of ROP and wrote that the patient would need follow-up for ROP as an outpatient, while the attending physician apparently missed the discharge instructions concerning needed follow-up altogether. When the infant was discharged from this facility, the attending physician noted on the discharge summary that the baby was scheduled to have eyes checked for ROP as an outpatient. Less than two weeks after this discharge, the infant was seen by a retinal specialist, who diagnosed stage IV ROP with poor prognosis. The patient became bilaterally blind. The lower level hospital and attending physician settled with an indemnity payment. The defendant ophthalmologist was found to have no liability; however, the cost of defending this case exceeded $100,000.

Experts Disagree Over Who’s Responsible
The issue raised in this case concerned the duty of the physicians and the hospitals regarding follow-up ROP examinations. Among ophthalmologists it may seem reasonable to assume that the NICU will be responsible for follow-up exams while the patient is still in the hospital and that the neonatologist and NICU discharge planner will provide for such follow-up when the patient is discharged or transferred. At trial, however, the standard of care for follow-up becomes a question of fact for the jury to decide based on the expert testimony, which may vary from one ophthalmologist to another. The defense expert will testify that follow-up scheduling is the responsibility of the neonatologist and NICU. The plaintiff’s expert will testify that once the ophthalmologist has examined and established a relationship with the patient, it becomes the ophthalmologist’s responsibility to keep track of when the patient needs to be seen next.

Unfortunately, ophthalmologists who perform ROP exams are increasingly faced with the burden of showing that they have taken extraordinary measures to follow their ROP patients. Ophthalmologists may find the following documents helpful in following the care of their ROP patients: Parents: Read This About Your Premature Baby’s Eyes explains the progression of ROP and advises parents when their baby should be examined. The document is meant to be signed by the parents to signify their understanding of the need for follow-up care. Protocol: Monitoring for Retinopathy of Prematurity (ROP) was provided to OMIC by LAwrence M. Kaufman, MD, PhD.  It provides a useful model for setting up a hospital screenig protocol and delineates the respective responsibilities of the attending neonatologist, ophthalmology consultant, and NICU/nursery discharge-planning nurse.

Both documents are available through OMIC’s web site, www.omic.com.

Key Clinical Risk Junctures in ROP Disease

By Michael T. Trese, MD
Dr. Trese is an OMIC insured and a vitreoretinal specialist in Royal Oak, MI.

Ophthalmologists who perform ROP screenings face five critical junctures in the disease course when malpractice exposure is the greatest:

Schedule timely examinations.
The first juncture is deciding who should be examined and when. Different guidelines are available, such as those of the American Academy of Pediatrics, American Academy of Pediatric Ophthalmology and Strabismus and, soon, the CRYO-ROP Study. Most protocols recommend that infants be screened if they are 1500 grams dry birth weight (some premature infants are born with water retention and are recorded at much higher weight than they should be). Children should be screened at no later than 31 weeks postmenstrual age because the youngest child in the CRYO-ROP Study to reach standard threshold was at 32 weeks postmenstrual age. The hospital NICU should schedule the necessary eye exam; the ophthalmologist should never take responsibility for this. The ophthalmologist is responsible for showing up in the NICU at a regularly scheduled time (weekly or half-weekly as needed) prepared to see all the children who require examination. Each exam should be treated as a new consult.

Understand the tempo of ROP.
The second juncture is to be familiar with the International Classification for retinopathy of prematurity and realize that this is a disease that can progress rapidly but passes through the acute process by 50 weeks postmenstrual age or 10 weeks after the child’s due date. (With today’s methods for dating premature infants, gestational age can be accurately dated to within several days.) It is this variable and possibly rapid course of ROP referred to as RUSH disease that can create problems for the ophthalmologist. This may be best overcome by the ophthalmologist making a regular weekly visit to the NICU to see the children the NICU has scheduled for reexamination.

Get a good view.
The third juncture is to be certain that you can see the fundus well. Whatever the reason for an unsatisfactory view (poor pupil dilation, hazy media, active child, a curtailed exam because of an apneic or bradycardiac child), there is no excuse for generating a bad data point. Without a good view, the examiner cannot determine the frequency of exams or treatment. Although rarely needed for screening, some ophthalmologists find it necessary to examine the baby under anesthesia (EUA) to get a good view. Follow-up exams can be performed every two weeks in an eye where no ROP is present. If ROP is present, weekly or even half-weekly exams may be necessary until the retina is fully vascularized or reaches stage 3 threshold (5 contiguous or 8 discontiguous clock hours of stage 3 ROP with plus disease). When treated ROP is graphed along the postmenstrual age, the peak incidence of stage 3 threshold is about 37 weeks, and the range is 31 to 46 weeks postmenstrual age. Stage 3 threshold is a term borrowed from the CRYO-ROP Study and is also a guideline.

Treatment.
The fourth juncture is to treat the eye at threshold promptly within 72 hours with peripheral ablation. Management beyond stage 3 is rarely discussed as material for lawsuits. There may be times when treatment at a different point would be justified. Reasons for doing so should be documented in the medical record with a drawing and narrative explaining why this variation is appropriate.

Communicate with the family.
The fifth juncture is to document that the child must be examined following discharge from the hospital. The NICU should provide a document to be signed by the parents containing the time and place for a follow-up exam and advising them of the risk of blindness from ROP. The original should be kept in the patient’s chart and a copy provided to the parents. The families of premature infants need great care to guide them through this process. Caring and concern from the ophthalmologist may help avoid a lawsuit even in the face of a bad result.