Orbital Fracture Missed During Eye Exam

By Mary Kasher, MSN, JD

OMIC Claims Manager

Digest, Winter 2002

ALLEGATION  Failure to diagnose orbital fracture in child, resulting in reduced range of motion and double vision.

DISPOSTION  Plaintiff verdict at trial.

Case Summary

A five-year-old boy was referred to the insured ophthalmologist by his pediatrician for a post-trauma eye exam. The child had been fighting with his brother and was pushed to the floor, rubbing his face on the carpet. Examination revealed normal VA in both eyes. The right eye was normal in appearance and movement; the left eye revealed a superficial abrasion to the corneal surface (2+ injection at inner aspect). Palpation elicited no complaints. Observing no restriction of movement, the insured decided not to perform a forced duction test. Antibiotic drops and a firm patch were applied to the left eye, and a follow-up visit was scheduled for the next day.

The following day, the child presented with increased pain and a “pinching” sensation. He would not allow an examination due to the pain. Suspecting a foreign body and wanting to examine the eye carefully, the insured performed an exam under anesthesia. No foreign body was discovered, but a notation was made that the corneal abrasion was healing. The patient continued to improve until five months later when the pediatrician again referred him to the insured because the left eye was not moving properly. The insured confirmed that the left eye did not elevate properly and referred the child to an oculoplastic specialist.

The specialist noted severely restricted movement OS and ordered a CT scan, which showed a fracture of the orbit. On exam, the upward gaze was almost nonexistent and downward gaze was moderately restricted. The eyeball itself was 2 mm depressed. Surgery to release the entrapped muscle was successful, and improvement in both double vision and movement was noted, although the child continued to experience slight double vision in upward and downward gaze. Neither the child nor his parents reported any problems or restrictions in his activities.

Analysis

The central issue in this case was whether the insured’s examination met the standard of care and whether the delay in diagnosing the orbital fracture affected the outcome. The plaintiff expert and three defense experts stated that with the presenting history and symptoms, they would have suspected an orbital fracture and conducted a forced duction test, either at the office visit or under anesthesia. They also felt it was substandard not to order a CT scan or schedule a follow-up visit after the hospital exam. OMIC was able to find one expert who agreed with the insured that the child did not present with characteristics of an orbital fracture because there were no signs of trauma around the eye and no restriction of movement. Also, the child’s persistent pain was more indicative of a corneal abrasion, which the insured diagnosed, than a fracture. This expert further felt it was not unreasonable that the insured did not perform a forced duction exam under anesthesia since his focus was to examine the cornea and retina. Unfortunately, this expert could not say that the delay in treatment had no effect on the final outcome.

Risk Management Principles

OMIC’s Claims Committee recommended a reasonable settlement to avoid what looked to be an almost certain plaintiff verdict; however, the insured insisted on going to trial because he believed his care was appropriate for the child’s presenting symptoms and that the final result was very good given the injury. Unfortunately, the jury did not agree and came back with a plaintiff verdict.

It is important to remember that when a case goes to trial it is not tried before a jury of the physician’s medical peers but before lay people who have little or no medical knowledge or experience. The jury did not appreciate that the child had an excellent overall result and that the measure of damages was very small, or that the insured’s care was reasonable at the time the child presented. The plaintiff attorney, who had the benefit of hindsight, was able to successfully argue that “if only the doctor had done a duction exam or a CT scan, the child would have better sight today.” It created a scenario in the minds of the jurors that was difficult to overcome.

Informed Consent for Minor Patients

By Paul Weber, JD
OMIC Risk Manager

[Digest, Summer, 1999]

The law authorizes parent(s) or guardian(s) of a minor (anyone under the age of 18) to give informed consent for most medical decisions on behalf of the child. Claims by parents alleging treatment of a minor patient without the consent of the parent are relatively rare. OMIC has never handled a claim involving this legal issue, yet questions have come up from insureds concerning informed consent and treatment of minor patients. Laws vary from state to state, but here is a general approach to the situation.

Q Do minors who are undergoing a series of treatments need a signed parental consent each time they are seen at the office?
A If a minor patient needs a series of treatments or exams, it is strongly advised that the parent/guardian sign a consent form prior to the first treatment stating that the minor patient can be treated and examined by the ophthalmologist and staff even if the minor patient is not accompanied by an adult. Of course, if the nature of the treatment or exam changes, a new consent must be obtained.

Q Do both parents have to agree to a proposed treatment/procedure?
A For most medical procedures, it is sufficient to obtain the consent of one parent (in an intact married couple). However, if treatment poses a significant risk to the minor or violates the personal or religious beliefs of one or both parents, it is advisable to obtain the consent of both parents. If the parents disagree about the advisability of the procedure, and the dispute cannot be resolved, it may be necessary for a juvenile court to intervene.

Q Who can give consent when parents are divorced?
A If the parents share joint legal custody, they “share” the right to make health care decisions for their child. Either parent alone may consent to a recommended medical procedure unless the court issuing the order of joint legal custody has specified that the consent of both parents is required for certain, or all, medical decisions. If parents have joint legal custody and are unable to agree about treatment, it may be necessary to obtain a court order before treatment is provided unless there is an emergency. If a parent has sole legal custody, that parent has the sole legal right to make health care decisions for the child.

Q Do legal guardians have the same rights as parents to give consent to treat a minor?
A A legal guardian has the same authority to consent to medical treatment for a minor as a parent would have.

Q  Can a stepparent give consent for a minor?
A  A stepparent does not have the authority to give legal consent to medical treatment for a minor stepchild unless the stepparent has legally adopted the child or been designated a legal guardian.

Q  Can a foster parent give consent for a minor patient?
A  A foster parent may legally give consent to “ordinary” medical and dental treatment for the child, including immunizations, physical exams, and x-rays.

Q  In what situations can minors be treated if their parents or guardian are unavailable?
A  An emergency exception may apply to permit examination and treatment of minors requiring immediate services for alleviation of severe pain or immediate diagnosis and treatment of unforeseeable medical conditions, which if not immediately diagnosed and treated, would lead to serious disability or death. Some state education codes establish qualified immunity for physicians who treat school children during regular school hours for emergency treatment.

Also, a child’s parents or legal guardians may sign a statement authorizing a third party to consent to medical care in the event the child or child’s parents (guardians) will be away from home, such as during vacations. A copy of the authorization signed by the parents or legal guardian should be retained with the child’s medical records.

Q  Are there any exceptions to minors consenting for themselves?
A Some exceptions exist to allow minors to consent to their own treatment; for example, married or divorced minors, minors on active duty in the armed forces, and minors “emancipated” by a court order.

If you have an informed consent question involving a minor patient, please contact Paul Weber at (800) 562-6642, ext. 603 or pweber@omic.com, or fax your question to the Risk Management Hotline at (415) 771-7087.

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.

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.

A “Watchful Eye” on ROP

Paul Weber, JD, ARM VP Risk Management/Legal

Digest, Winter 2010

To view the graphs and tables referenced in this article, go to http://www-test5.omic.com/new/digest/Digest%20Win%2010%20FINAL.pdf

There is no greater liability exposure in ophthalmology than the examination and treatment of premature babies at risk for retinopathy of prematurity (ROP). unlike most care provided by ophthalmologists, ROP is hospital-centered, multidisciplinary care with a very narrow window in which to provide timely examination, treatment, and follow-up. The challenges include providing ophthalmic care to infants who are often very sick, guaranteeing smooth patient discharge or transfer of care, and ensuring that caregivers understand the importance of compliance with follow-up appointments. This patient safety/liability risk is unlike any other that OMIC has grappled with in its 23-year history. The main obstacle has been developing a multidisciplinary, systematic approach to dealing with this unique liability risk. OMIC believes it has found such a system in the St. Luke’s Hospital and Health Network’s Watchful Eye Program for Retinopathy of Prematurity (©2008 St. Luke’s Hospital of Bethlehem, Pennsylvania).

The Concept

The Watchful Eye program is a fairly simple model of hospital- centered care (see conceptual map on page 4). Its premise is the overall management of ROP care by a Retinopathy of Prematurity Coordinator (ROPC). The ROPC participates in and monitors the ROP care of the infant, both as an inpatient and outpatient, until the infant reaches full retinal vascularization and is no longer at risk. OMIC’s own ROP claims analysis and safety net (see “ROP: Creating a Safety Net” at www-test5.omic.com) has pointed out the importance of an ROPC. Identifying the concept of an ROP tracking system and coordinator is clear-cut; however, the Watchful Eye program demonstrates that the commitment and attention to detail required to develop, implement, and monitor results is a complex process that cannot be underestimated.

An Interdisciplinary Approach

The Watchful Eye program was developed by an interdisciplinary team at St. Luke’s Hospital and Health Network in Bethlehem, Pennsylvania. The team included nursing administration, nursing staff, legal counsel, ophthalmology, neonatology, and social services. This type of collaboration is the essential first step in the creation and implementation of an ROP patient safety program. The St. Luke’s team also underscores the fact that high level leadership within the hospital administration is indispensable to ensuring the success of such a program.Besides preventing blindness in premature infants, an important goal of the Watchful Eye program is to reduce St. Luke’s exposure to large losses arising from ROP claims. The leadership of St. Luke’s learned in 2006 of the $20 million dollar judgment against a Pennsylvania hospital and neonatologist who were found to be jointly responsible for discharging an at-risk infant and failing to provide adequate follow-up care—just one of several multimillion dollar ROP verdicts passed down in recent years. For St. Luke’s, the decision was straightforward: allocate the requisite time and money to proactively prevent this type of claim or pay untold millions in damages sometime in the future.

The Role of the ROPC Nurse

There are many more facets to the Watchful Eye program than this article can address. (See “Keeping a Watchful Eye on Retinopathy of Prematurity” in Neonatal Network, Sept/Oct 2008; v. 27, n. 5.) However, the heart of the program is the ROPC, a registered nurse with neonatal nursing experience who is responsible for identifying and tracking infants, assisting the ophthalmologist during the screening exam, and caregiver education. At St. Luke’s, the ROPC is a 16-hour-per-week position. The thorough development of this key position is a feature that underscores the innovative aspect of the Watchful Eye program. The patient safety challenge has always been how to ensure that there is someone who will take responsibility for monitoring the infant until the risk has passed. The ROPC nurse takes full responsibility and is dedicated to the inpatient and outpatient tracking of ROP care of premature babies in the program. until now, inpatient and outpatient tracking and monitoring has been fragmented, leading to tragic injury to the infants and finger-pointing among the healthcare providers and caregivers. In fact, several surveys of ophthalmologists indicate that the liability risk arising from improperly tracking and monitoring ROP care convinces many to simply stop providing ROP services. This exodus of well-qualified, well-trained ophthalmologists creates a public health risk.

Double Check System and Filing

The Watchful Eye program employs a unique and very detailed “double check” strategy and filing system. The double check system ensures that at each step of the process there are two people checking the status of ROP care to be provided. The ROPC is always one of the people involved in the double check system, together with either the neonatologist or ophthalmologist (examining or treating), who follow the infant’s inpatient and outpatient care.

The actual documentation and recording of the double check is carried out through a detailed color coded filing system maintained by the ROPC as an adjunct to St. Luke’s electronic medical record (EMR) system. The ROP filing system is maintained even after the infant is discharged. Only when the infant reaches full retinal vascularization is the ROPC filing closed and scanned into St. Luke’s EMR system. The underpinnings of the double check strategy and filing system again hinges on the ROPC. Without an ROPC, the double check and filing system simply is not viable.

Caregiver Education

In most hospitals, the only healthcare provider who participates at each step of ROP care is the NICu nurse. The ROPC nurse interfaces not only with the neonatologist and ophthalmologist but, most critically, with the parents. The St. Luke’s Watchful Eye program now has an ROPC nurse responsible for the most precarious step in the care continuum: ensuring compliance with the follow-up appointment. The ROPC understands that caregivers are dealing with a needy infant requiring multiple post-discharge appointments and follow-up care. The ROP follow- up appointment is only one of many issues the caregiver must handle. Simply providing a document about the importance of the follow-up appointment is a precarious way to ensure compliance. The Watchful Eye program addresses the importance of follow-up care even before the infant’s first ROP examination in the NICu. As soon as it is determined that the infant needs to be followed for ROP, the ROPC approaches the parents and provides both oral and written information about ROP. The ROPC informs the family that the infant’s first eye exam will be at four weeks of age. The parents are invited to be present for the examination and are fully informed about the procedure. After the exam, the ROPC nurse assists in educating the family about the results.

Outpatient Coordination

When the infant is ready for discharge, the ROPC makes the follow-up appointment at the ophthalmologist’s office. In scheduling the appointment, the ROPC communicates the family’s needs to the ophthalmologist’s appointment scheduler. The ROPC nurse then records the appointment date on a discharge instruction form. Developed by the ROP team, the discharge form provides educational information about ROP and contains this disclosure: “If you fail to keep this (follow-up) appointment, the ophthalmologist and/or St. Luke’s Hospital and Health Network may contact the appropriate legal authorities, as required by law, in an effort to locate your baby and provide treatment.” After the parent signs the form, copies are made for the family, the ophthalmologist, and the hospital records. Again, it must be emphasized that this is only one step in the education and orientation process of the parent/caregiver. This step by itself would be too little too late.

Part of the Watchful Eye program is careful outpatient coordination with the ophthalmologist’s office. As noted above and in the conceptual map on page 4, the double-check strategy and filing system continues after the infant’s discharge from the hospital.

Unit-wide Orientation and Monitoring

 The Watchful Eye program is not an isolated component of care for the premature infant nor is it static. It is a dynamic process that has to be integrated into the infant’s overall care and updated when necessary. This multidisciplinary approach extends beyond the providers active in treating ROP to the NICu unit responsible for the overall care of the premature infant. The entire NICu unit needs to be oriented to the program, including social services, administrative staff, discharge planners, etc.

The process is dynamic in that the principles of continuous quality improvement are applied. An excellent example is a 2008 revision to the Watchful Eye program placing stronger emphasis on ROP education for parents prior to discharge to help them understand the potential risks and consequences of their infant’s condition. This increased emphasis on caregiver education has resulted in better outcomes while maintaining 100% follow-up compliance. The need for ROPC interventions dropped from 23% to 2% and the number of patients requiring surgery decreased from 6% to 2% in the year following this revision (see graph).

The “Watchful Eye” and OMIC

On behalf of the 325 OMIC insureds and other ophthalmologists who screen and treat for ROP, OMIC has been at the forefront of addressing the unique liability risks of ROP for more than two decades. During this time, it has become evident to us that many hospitals are reluctant to create and implement a comprehensive ROP tracking and monitoring program. This frustrates ophthalmologists who would provide ROP care if hospitals were more involved.

OMIC believes the Watchful Eye program presents an opportunity for hospitals, nurses, neonatologists, and ophthalmologists to work together in a collaborative and innovative way to solve this problem. St. Luke’s Hospital and OMIC are in the process of bringing the Watchful Eye program to OMIC insureds and others interested in a comprehensive ROP tracking system. We anticipate a great deal of interest from the AAO, AAPOS, SOOp, and ASRS as we tackle one of ophthalmology’s greatest challenges: preventing blindness in premature infants.