Risk Management

Retinopathy of Prematurity Requires Diligent Follow-up Care

By Byron H. Demorest, MD

Digest, Summer, 1995

Although claims against ophthalmologists for mismanagement of retinopathy of prematurity (ROP) are relatively infrequent, indemnity payments for these claims can be very high due to the young age of the plaintiffs and the significant loss of vision that often results.

OMIC has found that malpractice exposure is a constant threat for physicians who examine pre-term babies for ROP. Not many babies with progressive ROP are missed, but when a case is misdiagnosed or lost to follow-up, the subsequent indemnity payment for this misadventure is usually significant. A blind child presented to a jury panel elicits an extreme sympathetic response and the feeling that “someone must pay” for this tragedy.

Nationally, settlements of other carriers over the $1 million range are common, even when the ophthalmologist is only partially or peripherally involved. Sometimes these high indemnity payments are shared among the hospital, the neonatologist, the pediatrician, and the ophthalmologist, but the loss of practice time with subsequent diminution of income can be very expensive for the physician involved in a long jury trial. More important is the fact that infants may be unnecessarily blinded if they are lost to follow-up during their immediate neonatal period.

In seven years of operation, OMIC has received four claims and lawsuits against insured ophthalmologists for alleged mismanagement of infants with ROP. A review of 771 ophthalmic cases by Jerome W. Bettman Sr., MD, included 34 claims involving ROP misadventures, or 4.5% of the total. Dr. Bettman noted that “the risk of suits against ophthalmologists has increased with the rise of cryotherapy” and that “an important factor in these claims has been a lack of adequate communication.”¹

The following review of OMIC claims illustrates how problems related to diagnosis or treatment of ROP can occur and outlines suggestions for the proper follow-up and care of all infants with ROP.

Case One: Delay in Referral of Infant with ROP

A pre-term boy was born following a precipitous delivery, weighing 1200 grams. He had a cerebral hemorrhage and needed a ventilator and oxygen therapy during the first three weeks of life. The child had a stormy course in the hospital and required resuscitation on two occasions.

After things stabilized somewhat, the neonatologist requested that the ophthalmologist examine the baby’s eyes at three months of age. The ophthalmologist noted Stage I to Stage II ROP in both eyes and suspected microcephaly and optic nerve hypoplasia. Two weeks later, the ophthalmologist examined the baby again and felt that the ROP was progressing. Since the child was being discharged from the hospital, the ophthalmologist told the parents he would like their son to be seen by a retinal specialist and gave them the name of one.

Unfortunately, the parents delayed making the appointment and when they did call the retinologist, they did not indicate that there was any urgency. When the baby was finally seen by the vitreo-ophthalmologist at five months of age, he had Stage IV ROP. Cryotherapy was done with some resolution of the ROP, but the child progressed to a complete detachment in one eye and a large retinal fold across the macula with scarring and cicatrization in the temporal periphery of the good eye.

The family sued the first ophthalmologist, stating they did not realize the urgency of the retinal referral and alleging that the first ophthalmologist “dropped the ball,” thus allowing their child to become blind. A court trial resulted in a defense verdict for the first ophthalmologist because it was noted that the baby’s visual prognosis had been extremely poor anyway due to hypoplasia of both optic nerves. It was also felt that the parents carried much of the blame since they did not immediately consult the retinal specialist after they had been referred.

The lesson here is that when referring a patient to another doctor, a call should be made to that physician’s office to secure the appointment. Responsibility for making the referral appointment should not fall entirely on the parents. Documentation indicating the need for the referral should be forwarded to the second doctor along with a copy of the record of the patient’s previous history and eye examinations.

Case Two: Failure to Diagnose ROP

A girl was born pre-term following a precipitous delivery, weighing only 1000 grams. The baby was delivered in a rural hospital, but did remarkably well on minimal oxygen therapy. The child did not need any support other than oxygen, and the oxygen was discontinued at the end of three weeks of age.

When the baby was two months of age, the pediatrician in charge of the neonatal unit asked a general ophthalmologist to examine the baby’s eyes. The ophthalmologist, who was not accustomed to evaluating infants with ROP, noted that the baby’s pupils dilated very poorly in spite of repeated attempts with mydriatics and cycloplegics. His comment on the examination at two months of age was “unable to dilate well-retinas seen poorly-apparent Stage I ROP-return in six months.”

The baby went home and the parents noted that the child did not see well. She did not look at her mother directly and seemed to look out of the corner of her eyes in order to see light. When she was four months of age, the parents felt the baby needed to be seen by a specialist. They traveled across the state to see a retinal specialist at the university hospital, where bilateral Stage V ROP was noted. The child became blind, and the parents sued the initial ophthalmologist.

Individuals who examine babies for retinopathy of prematurity, whether they be general ophthalmologists, pediatric ophthalmologists, or retinologists, should be well versed in the development of the disease. Myotic pupils, shallow anterior chambers, and an inability to examine the retina well are findings frequently seen in advanced ROP.

Case Three: A Child Lost to Follow-up Care

An 18-year-old unmarried woman, who had concealed her pregnancy from her parents, gave birth to a 34-week gestation infant, precipitously, at home in her own bed one morning at 3 a.m. She cleaned up the bathroom, wrapping the baby in a towel, while she washed the sheets and remade her bed. Three hours after the birth, she presented the baby to the emergency room of a local hospital. The baby was immediately placed in the neonatal intensive care unit where it required oxygen and subsequent intubation with ventilation. The baby had a stormy neonatal course during the first two weeks of life.

At one month of age, an ophthalmologist was called to examine the child. He found Stage I ROP and recommended follow-up in two weeks. The baby became ill and needed surgery to correct a severe enterocolitis. The baby was transferred to another hospital and lost to follow-up.

The general ophthalmologist sent the mother a routine postcard notice indicating that the two-week follow-up appointment had not been kept. The notice did not indicate the possible severity of the baby’s eye problem nor was a follow-up phone call ever made to the mother. No other attempt was made to track the baby.

At four months of age, the baby was finally seen by another ophthalmologist who diagnosed Stage V ROP with total retinal detachments and dense retrolental membranes. The mother sued the hospital, the neonatologist, and the first ophthalmologist for lack of care.

Recommendations for Monitoring ROP Patients

The following recommendations were developed in the mid-1980s by the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity chaired by Earl A. Palmer, MD, and funded by the National Eye Institute.

• With all pre-term infants, a careful delineation of the responsibilities of the hospital, the neonatal ICU, the neonatologist, and the ophthalmologist must be developed. Eligible infants are those with a birth weight under 1600 grams or with greater than 30 days’ exposure to supplemental oxygen.
• It should be the responsibility of the neonatologist to identify all eligible infants in the nursery and set the appropriate timing for the initial ROP exam. Each week, the neonatologist should make a list of all eligible infants who require a fundus examination. An order for this examination should be placed in the baby’s medical record and the ophthalmologic consultant should be notified. Additionally, the patient’s family should be informed of the nature and possibility of ROP. When an eligible infant is discharged from the hospital, an outpatient ophthalmology appointment should be made and instructions given to the patient’s family about ROP. If an eligible infant is transferred out of the neonatal unit to another medical institution, it should be documented on the transfer note that the infant requires further follow-up examination for ROP.
• If an eligible infant is no longer at risk for ROP and is discharged, the family should be given instructions regarding the importance of a repeat eye examination when the child is 8 to 12 months of age because of the increased incidence of other eye diseases in premature infants. The neonatologist should have the family read and sign a document informing them of the complications that may occur in premature infants, particularly with regard to the development of ROP. (See Appendix for sample form provided by Lawrence M. Kaufman, MD, PhD.)
• It should be the responsibility of the ophthalmologist to perform ROP rounds as required by the neonatologist. The ophthalmologist should order the administration of dilating drops prior to visiting the nursery. An ROP consult or progress note should be made on the baby’s hospital chart, and the history and examination results kept in the ophthalmologist’s own records in the office so the baby is not lost to follow-up. When treatment for ROP is necessary, the ophthalmology consultant should either perform the treatment or refer the baby to a vitreo-retinal expert for cryotherapy or laser surgery.
• It should be the responsibility of the NICU/nursery/hospital to keep a list of those babies who are candidates for developing ROP, including the patient’s name, medical record number, birthdate, birth weight, gestational age, and date of the initial ROP exam.
• The nursery should instill all eye drops for the ophthalmologist and stamp the medical record when the drops have been given. An ROP progress note should be kept in the record. Educational materials informing parents about the possibility of their premature infant developing ROP should be made available to them by the neonatal ward.

Notes:

1. Bettman JW and Demorest BH. Practice Without Malpractice in Ophthalmology: A Compendium of Risk Management Essays. Ophthalmic Mutual Insurance Co., San Francisco. 1995:55-56.