The 13 ROP malpractice cases reviewed here represent the largest series in the literature. It is the only series not based on the files of malpractice insurance companies, and where the author personally reviewed the entire medical record in each case, and in which the review was conducted by a physician experienced in the clinical care and research of ROP.
These 13 cases likely represent a large majority of the ROP-related cases over the 8-year span from 1999–2006. Only 6 additional cases were identified in a literature and legal database search in this time period. Due to the vagaries of court reporting procedures, there may be undiscovered cases that completed disposition. However, it is unlikely that such potentially unidentified cases would be numerous. Therefore this sample is highly representative if not exhaustively inclusive.
The characteristics of these 13 cases are described in and . It is notable that the cases arise from a wide geographic distribution. If one includes the cases from the literature review (), the geographic distribution remains diverse, but there are coincidences. Three of 19 are from Texas, 2 of 19 are from California, 2 of 19 from New Jersey, 2 of 19 from North Carolina, and 2 of 19 from Illinois. Eleven of 19 are from just 5 states. This could be simple coincidence, or it might relate to the general litigiousness of the location.
and list the dispositions and awards in each case. In evaluating the dispositions and awards, it is important to remember that our court system is an adversarial one. Conflicting evidence is presented, and fallible people must weigh that evidence. They do so not only based on merit, but on how well that evidence was presented and interpreted by attorney and expert witness. It is not just the presentation of fact, but how the facts are presented. Since evidence is conflicting and presenting talent is variable, the jury has a difficult and unpredictable task. It is a big gamble for each side to depend on the jury verdict. In addition, it is a big gamble to depend on the size of the jury award. Each side dislikes accepting these risks, and they minimize these risks by negotiating a settlement. So, court settlements are at least as much about containing risk as they are about merit. And a settlement can occur at any point: pretrial, during or after testimony, and some even past verdict but preaward, as in 3 of these cases.
The dispositions of ROP malpractice reflect these tendencies. Of the 13 cases, 10 concluded with settlements. One was dismissed, and two went to jury verdict and resulted in dramatically large awards, one of which was partially vacated on appeal. So the 10 settlements provided each side with contained and predictable results, hopefully somewhat based on merit.
It is useful to examine the birth weight and gestational age of each of these infants with serious ROP and determine if various screening protocols would have captured these infants who obviously needed acute screening. The 14 infants involved in this series cannot be used to determine appropriate screening eligibility criteria. However, they do represent infants with serious ROP and can serve to test inclusion criteria. The 2006 consensus screening guidelines are very much based on the 2002 evidence-based criteria derived from CRYO-ROP and LIGHT-ROP and the design parameters from ET-ROP. Since screening protocols have changed over the years, it is reasonable to continue to test their applicability. includes each infant’s birth weight and gestational age at birth. Ten of the 14 infants were under 1000 g at birth. The twins in case 5 were 1170 and 1406 g at birth. But two of the infants (cases 7 and 12) were over 1500 g at birth. One of these two had a gestational age at birth of 28 weeks, and one was 30 weeks.
Applying the joint statement screening guidelines published in 2006, all of these infants would be eligible for acute ROP screening.29,30
These guidelines recommended screening infants with birth weights less than 1500 g or gestational ages of 30 weeks or less. So the two infants over 1500 g would be included based on gestational age.
However, these two infants would not have met the systematic inclusion criteria of all other screening protocols. The 2001 consensus guidelines suggested 1500 g and/or 28 weeks.50
Case seven would therefore be missed. Although the screening guidelines published by the American Academy of Ophthalmology, American Academy of Pediatrics, and American Association for Pediatric Ophthalmology and Strabismus represent the most frequently quoted standard in court, many other published works may offer differing guidelines. Again, case 7 and even case 12 would not meet the suggested eligibility criteria in several recent publications.51–55
However, the criteria of others would have captured them in a systematic way.56–58
This series represents infants with serious ROP and proves that serious ROP can occur in older, bigger babies in the United States. It is comforting to know that each of these infants would fit under the evidence-based screening protocols that were based on CRYO-ROP and LIGHT-ROP and the 2006 consensus guidelines, which were predominantly based on that study. On the other hand, it is very disquieting to know that authors suggesting screening protocols based on cost-effectiveness, such as Lee and coworkers, would indeed fail to screen 3 of these 14 infants.55
If the primary goal of screening is to recognize infants with potentially blinding, serious ROP, then the 2002 evidence-based guidelines and the 2006 consensus guidelines do just that.
We can now turn to the specific issues of care that arise from an analysis of the medical records in these 13 cases. is a summary of all the relevant medical care issues and their frequency of occurrence in this series of 13. is the author’s educated judgment of negligent error and negligent harm for each case and each defendant, which is a necessary part of any medical issue assessment.
NEONATOLOGY/PEDIATRIC CARE ISSUES
The first and perhaps most dramatic issue in its implications at trial is a failure of the neonatology/pediatric team to refer an infant for appropriate ophthalmologic consultation. This can most egregiously involve an infant who simply “falls through the cracks” and never receives a timely examination. An example of this is case 2. The initial consultation request was clearly late, the initial eye examination noted disease beyond threshold, ie, disease outside the optimal intervention point, and a poor outcome resulted. The relevant issues involved only the neonatology team. No ophthalmologic issues were present. And there is no reasonable defense. This child was negligently denied a timely examination, and directly related harm was the result.
This type of egregious negligence is unusual. Typically this failure to refer allegation occurs in more disputable ways. An initial referral can fail to be made in a timely manner, ie, well beyond the recommended age for the conduct of the initial examination. But the later-than-recommended eye examination finds serious ROP that is not outside the acceptable intervention window, ie, still at threshold or better. Case 6 is an excellent example. The initial eye examination occurred at PMA 35 weeks and CA 8 weeks, clearly later than recommended. However, the ROP detected was not beyond threshold, and appropriate treatment was provided. Negligent referral may have been present and a poor outcome occurred, but that harm was not negligent, since treatment occurred at threshold and this infant could reasonably be placed in the group of eyes that can have an expected poor outcome despite adequate treatment. The court settlement reflected the strength of the defense here. How this case came to litigation and why a settlement was acceptable to the defense relates to other issues, ie, zone III centered disputes, which will be covered subsequently.
Another failure to refer issue can relate to hospital transfers. Eye examinations may occur if indicated at the initial admitting hospital nursery, but subsequent eye examinations do not occur after transport to another geographic hospital location. Case 1 is an example of this. Although there are applicable ophthalmologic issues in this case, it is apparent that no eye examination occurred or was ordered by the second receiving hospital. On merit review, this was a negligent error of omission.
Probably the most frequent situation relating to the failure to refer issue is the failure to obtain ophthalmologic consultation as an outpatient following discharge from the hospital. This occurred in cases 1, 5, 8, and 12. Four of the 13 cases involve a lack of outpatient eye examinations. These 4 have other contributory elements, but clearly this is a critical time for at-risk infants and their caregivers. Case 12 is particularly illuminating, since no real ophthalmology issues are involved. Although the ophthalmologist was a defendant, no error was made. In this case the infant had an appropriate eye examination at 32 weeks PMA and 4 weeks CA, but was discharged 8 days later. The second eye examination did not occur until 44 weeks PMA. The neonatologists vigorously defended their attempts to schedule an appropriate outpatient examination, and some of those efforts were documented. The pediatrician, however, never addressed the issue despite several office visits with the child. The result was predictable. Negligence occurred, negligent harm resulted, and a large award was made. Even if the parents share the blame, as they did in this case and in case 5, every responsible party shares in the obligation to ensure timely eye examinations.
There are several lessons from this care issue of appropriate referral.
- No infant can be allowed to “fall through the cracks.” Eligible infants must be referred.
- Appropriate referral is the responsibility of the admitting nursery, the transferring nursery, the receiving nursery, the discharging staff, and the receiving pediatricians, as well as the parents themselves.
- No caregiver should provide care for these infants or accept such infants into their practice unless they are familiar with the ROP screening eligibility requirements. Ignorance of these by ordinary pediatricians who accept such at-risk infants is no excuse or defense, as seen in case 12.
- Assuming appropriate knowledge is present and appropriate actions are taken, proper documentation of that knowledge and effort is critical. Knowing a baby needs an examination and informing a parent of this is little defense without solid documentation.
- Parents must be appropriately informed of the necessary actions and potential consequences.
- Recognize that human error can occur. Develop a system that includes all parties and various checks and balances to ensure proper tracking and referral. Eliminate sources of human error when possible by the use of such a systems approach. Several publications have detailed suggestions for successful referral.59–61
All involved parties should periodically assess and reassess their particular success in this area.
The additional neonatology issues involving allegations of failure to educate or failure to properly oversee involve the same elements as above. The parents must be involved and educated appropriately, this activity should be documented in some way, handouts can be useful, and the need should be reinforced if noncompliance is occurring. And institutions do have an obligation to ensure that their staff members are providing appropriate care, especially when a cross-departmental protocol such as screening is involved.
Before leaving the area of greatest concern to neonatology and turning to the ophthalmologist, it is appropriate to comment on the oxygenation controversy. None of the 13 cases subject to this thesis had supplemental oxygen utilization as a critical factor. However, given a poor treatment result when all other care is clearly appropriate, this could become an element of dispute.
A 2006 publication in this area62
in stating that the optimal level of oxygenation for infants after premature birth is yet unknown. However, observational studies are suggesting that reduced oxygenation may reduce ROP in some way.62–66
The bottom line is we still do not know.12
More and better data are needed. Malpractice based on allegations of negligent oxygenation is not supportable unless some outlandish events took place. There is no reliable evidence-based data upon which to base such an allegation.
OPHTHALMOLOGIC CARE ISSUES
These are more complex, since they are more disease-based and hence more involved with physician judgment. again lists the medical care issues and a large number of them do relate to the examining ophthalmologist. Although failure to refer or request initial consultation is an exclusively neonatal/nursery issue, the ophthalmologist can become involved in follow-up appointment disputes relating solely to administrative or clerical functions as opposed to recommendations based on a disputed medical exam.
Issue 1: Follow-up
Six of 13 cases involved an allegation about failure to properly follow an infant by the ophthalmologist. However, these usually involve disputes between the ophthalmology recommended follow-up interval and the acceptable standard of care. Hence, they relate to potential errors of examination and diagnosis. Only one case of alleged failure to follow was purely administrative, and that is case 5. The initial eye examination was requested and performed appropriately on twin 1. Twin 2 was discharged prior to the examination. Despite the 2-week follow-up recommended by the ophthalmologist, no examination was performed until 4 months later. Several factors involved negligence here, including parental behavior. But was the examining ophthalmologist liable for ensuring that the family keeps an initial outpatient appointment? The trial court said yes, but this was reversed on appeal. On merit analysis, there was no ophthalmologic error in this case.
The ophthalmologist is exclusively a consultant in the hospital nursery. As such, the ophthalmologist is unaware of the hospital course of these infants following their examinations. These infants may remain in the hospital and have further consultations, they may be transferred, they may develop medical conditions that preclude safe examination and thus be discretionarily delayed by the neonatal team, or they may be discharged. Frequently the ophthalmologist never has an opportunity to meet the parents and relies on the neonatal team to communicate examination findings. In addition, name changes often occur after discharge. Baby Smith may become Mary Jones and the ophthalmologist has no way of tracking these events.
For these reasons and more, it is not in the best interest of the infant to have the ophthalmologist play a role in initial outpatient follow-up compliance. The ophthalmologist has no reasonable opportunity to do this effectively. Assigning such a role, even a shared role, is a recipe for noncompliance. This responsibility must be assumed by the primary care givers if it is to be at its most reliable. This does not apply to outpatient visits subsequent to the initial visit, when a more traditional physician-patient relationship exists.
Issue 2: Resident Care
An area of concern that is very pertinent occurred in 2 of the 13 cases. Unsupervised resident ophthalmologic examinations represent a major risk. Cases 1 and 8 involve just such unsupervised examinations. In case 1 a resident examination noted the incompatible findings of a “ridge” and a diagnosis of stage 1. “Plus” disease was also noted, yet a 2-week follow-up was recommended. Such incompatible results strongly support negligent examinations. If harm results, malpractice is clear.
Residents are by nature students and not work substitutes. Attending physician educators and hospitals must recognize this. However, they are capable of performing examinations and procedures consistent with their level of training under the direct or indirect supervision of licensed physicians. The resident performance in these two cases does not live up to these criteria. They clearly did not have an acceptable knowledge of ROP, their examinations under these documented conditions were not adequately supervised (eg, paired examinations did not occur), and they were incapable of deciding on their own when they needed help. Resident involvement in ROP screening must be rigorously defined and supervised.
Issue 3: Diagnosis and Recommendation
The dominant medical care issue for the ophthalmologist is proper diagnosis and follow-up recommendation. Nine of 13 cases alleged negligence in this area. Those not involving residents are cases 3, 7, 9, 10, 11, 12, and 13. Some of these also involve zone III issues and potentially rare events. These are the cases that are the most complex, most affected by examination findings, most involved with physician judgment, and most likely to be averted by sound, reliable, evidence-based medical knowledge.
The natural history of normal retinal vascularization is critical to know when examining infants. Reynolds and coworkers33
examined CRYO-ROP and LIGHT-ROP data to determine the time course of normal vascularization in prematurely born infants. Vascularization reached to within 1 disc diameter of the nasal ora in at least 1 clock hour at a median of approximately 35 weeks PMA. Only 5% of infants achieved zone III vascularization by age 32 weeks PMA. Full vascularization was achieved by 50% at 36 weeks PMA, by 95% at 42 weeks PMA, and by 99% at 43 weeks. Examiners must keep this natural history in mind when assessing the need for follow-up.
Case 3 is an excellent example of the dilemma. An initial, timely examination was performed at 33 weeks PMA and 6 weeks chronologic age. The findings were “normal discs, vessels, without ROP.” A follow-up interval of 6 months was recommended, and bilateral stage 5 ROP was diagnosed at that time. The defense claimed that the examination notes meant that full retinal vascularization was present and that the tractional retinal detachments were not produced by ROP but rather an unknown disorder. Despite defense claims to the contrary, ROP was extremely likely to be the cause. No other diagnosis, such as familial exudative vitreoretinopathy, could be plausibly made. Could ROP retinal detachment occur following full retinal vascularization? No such case exists in the literature. Therefore the conclusion is that the retinas were not fully vascularized and negligence occurred.
What knowledge or experience was necessary to prevent such an occurrence? We know even experienced examiners can fail to agree on retinal findings 100% of the time. This potential examiner error has been described.33
Therefore, experience alone could not be expected to avoid this misdiagnosis. However, we know the natural history of normal retinal vascularization. At 33 weeks PMA, as in case 3, only about 15% of infants would have achieved even full nasal vascularization, with an even smaller percentage reaching the temporal ora.
Was patient 3 one of those very, very few babies with full retinal vascularization at 33 weeks PMA? It is possible, but extremely improbable considering the stage 5 detachments that later occurred. Clearly the examination was in error. This error was not negligent. It is a recognized and understandable event. What was negligent was the 6-month follow-up recommendation, which resulted from a lack of knowledge about the natural history of ROP. It was critical to know at that time, and not just in hindsight, that examination error was more likely than full retinal vascularization in such an immature retina. Repeat examination in 2 to 3 weeks was indicated.
Issue 4: Zone III
The issue of zone III disease merits special attention. Does serious zone III ROP exist? Can zone III disease lead to an unfavorable outcome? What is the relevant pathophysiology? Are there specific sources of misunderstanding about zone III disease?
It is essential to consider the classification of zone III when assessing retinal signs. Zone III is arbitrarily classified according to findings of the nasal retina only. The temporal retina is assumed to mirror the nasal retina. No independent temporal retinal landmarks are used in the international classification. The intent of this classification system is to use readily recognized retinal landmarks to determine the location of normal vascularization or disease. Unfortunately, there are no such landmarks in the midtemporal periphery, and this led to the reliance on nasal only signs. This represents an understandable flaw in the classification system that has directly led to malpractice conflict. How has this happened?
Normal retinal vascularization has been recognized to occur in a radial fashion beginning at the optic nerve. As long as no process interrupts this, the vascularization proceeds symmetrically. However, ROP can interfere with this process. ROP may develop in mid zone II in the temporal retina and yet normal nasal vascularization proceeds. If normal vessels reach within 1 disc diameter of the nasal ora, this temporal zone II disease is now correctly classified as zone III, even though it is still mid zone II on the temporal side and subject to the natural history of zone II ROP. Hence, in the desire of the designers of the international classification for ease of recognition and repeatability, this flaw was introduced.
The critical question to be determined in assigning retinal activity in zone III, then, is whether there was preexisting ROP on the temporal side. And take note that only 1 clock hour of nasal vascularization to the ora is required to denote zone III. Eleven hours may not yet have completed vascularization fully.
A review of CRYO-ROP data with this in mind answers all of our zone III questions. No patient without preexisting ROP in whom retinal vascularization reached zone III ever developed serious disease. One patient (0.2%) in whom ROP was first observed in zone III developed serious ROP.67
But an important exception was noted by Repka and coworkers20
and is explained by the classification flaw. Zone II ROP that later became zone III, ie, temporal only disease, had an unfavorable anatomic outcome in 2 of 200 eyes (1%). Therefore zone III ROP can be serious; it can lead to unfavorable outcomes; and it has led to unrecognized risk that resulted in patient harm, as the following cases will demonstrate.
Cases 7, 9, and 10 are similar but subtly and importantly different. Each involves a dispute surrounding zone III. In case 7, zone III vascularization was noted at 34 weeks PMA, an expected occurrence about 30% of the time.33
Case 9 had ROP of stage 1 in zone III, which could have followed the normal vascularization into zone III in about 15% of infants at 33 weeks PMA. And case 10 noted ROP stage 2, zone III at 36 weeks PMA. If the ROP onset was very recent, then a majority of infants could reach zone III vascularization prior to the onset of stage 2. The mean PMA at which zone III normal vascularization occurs is 34.3 weeks for LIGHT-ROP data and 35.6 weeks for CRYO-ROP data.33
So in each of these cases the percentages of expected zone III findings noted are not beyond possibility.
In case 7, zone III activity was documented twice, first as immature vascularization and then with ROP stage 1 or 2. Examination findings that are found consistently rather than just once are more believable and less error-prone. The screening guidelines recommend just such a reasonable repeat examination.29,30,33
However, infant 7 did go on to serious ROP with a poor outcome. Is this negligent diagnosis or a rare, unpredictable event?
Case 9 similarly noted ROP stage 1, zone III, but did so only once before stage 5 ROP was noted over 7 weeks later. Is this a negligent diagnosis or rare event? The lack of documented follow-up recommendations was a significant factor in this case, as well as an unrepeated examination finding coupled with the high risk of the infant’s birth weight and gestational age.
Finally, case 10 is quite different even though zone III ROP is an issue. Despite a diagnosis of ROP stage 2, zone III, repeated examination occurs 1 week later and threshold ROP is diagnosed and treated. An unfavorable, but potentially expected outcome occurs. Is this negligent or not?
What is the answer in these 3 zone III cases? Case 7 is clearly debatable, but the repeated examinations within acceptable windows coupled with the extremely low risk of such a larger, older infant at birth suggest that a series of rare events is as likely as negligence. Case 9 is less debatable. Although a rare zone III event is possible, there are no mitigating circumstances. Repka and colleagues’ work20
may be relevant here in explaining an outcome consistent with the examination, but the examination may also be negligent. Case 10, on the other hand, diagnosed ROP stage 2, zone III, but repeated an examination in only 1 week. Although surprisingly now at threshold, this sequence of events is highly defensible. The zone III diagnosis may have been in error, but repeated examination in 1 week is the proper response to that possibility. Then the appropriate diagnosis of threshold occurs in time, and unfortunately a poor but potentially expected result occurs. Hence case 7 is probably not malpractice but rather a rare event. Repeated examinations were prudently performed despite an initial finding of zone III. Case 9 is likely malpractice, since the unlikely zone III finding did not stimulate prudent confirmatory examination. And case 10 is not malpractice. Despite a zone III finding, appropriate reexamination was performed, the possible error was caught in a timely fashion, and appropriate treatment occurred.
Issue 5: Documentation
Cases 11 through 13 involve several issues besides just diagnosis. Case 11 demonstrates two issues. The foremost issue is the need for consistency of documentation and the need to act on one’s own recommendations. In case 11 an examination noted “very dilated and tortuous vessels.” No mention was made as to whether this represented plus disease. Accepted nomenclature demands that such a finding be described as plus or pre-plus. Descriptive elements are useful, but proper nomenclature cannot be ignored. Follow-up examination noted findings that were “suggestive of neovascularization,” Again, is this stage 3 ROP or not? One week follow-up is recommended but does not occur for 13 days, at which time threshold ROP is noted. The absence of adequate use of the international classification, coupled with poor documentation in general and failure to take appropriate management actions, is apparent.
Case 11 is highly suggestive of negligent diagnosis, negligent documentation, and negligent follow-up. However, since the patient was diagnosed at a timely point, ie, threshold, no harm resulted from that negligence. The unfavorable outcome was the poor outcome that can expectedly result from proper and timely treatment. This element of negligence without causative harm is also evident in cases 6 and 10. Negligent error occurs in all 3 cases, but ultimately treatment is applied at threshold, nonnegligent harm occurs, and hence no malpractice occurs.
Case 12 alleged ophthalmologist negligence, but the case was essentially all about poor pediatrician/neonatologist referral issues.
Case 13 could be viewed as the ultimate documentation problem. The eye examination notes were lost, and no defense is possible without them. The pediatric notes suggest negligent timing. The issue of diagnosis at threshold or beyond is present, but such woeful record keeping is unlikely to mitigate the plaintiff allegations.
The lessons for the ophthalmologist are clear. They are as follows:
- The examining ophthalmologist should not be responsible for ensuring initial outpatient appointments. It is wise to participate in ROP screenings only when a written protocol or clear oral unwritten understanding exists among all parties that spells this out. Such a protocol or understanding must include a delineation of to whom this responsibility is assigned. An ophthalmologist should make every attempt to ensure that there is no misunderstanding in regards to this. Such clear delineations do not insulate the ophthalmologist from suit, but they should help dramatically in winning such a suit. Clearly a by-product of such action will be improved follow-up compliance and improved care.
- The examining ophthalmologist is unavoidably responsible for outpatient visits subsequent to the initial visit. The initial visit establishes a patient-physician relationship that is no longer purely consultative and is relatively independent of other health care providers. Proper administrative/clerical protocols should exist for tracking and recalling noncompliant families.
- An acute ROP screening eligibility protocol should be adopted in each nursery. The 2006 consensus guidelines would have functioned well in systematically identifying all 14 infants in this case series. However, other protocols have been suggested, and each nursery should actively select criteria for systematic screening eligibility.
- Residents can participate in ROP examination, diagnosis, and management, in a hands-on fashion as part of an appropriate educational experience. They cannot assume sole responsibility for the ROP care of these infants. They cannot be depended on to use their own discretion in determining when paired examinations are necessary. Resident examinations do not require attending repetition of every element. They do require appropriate supervision. ROP screening programs should be extremely cautious of entrusting these examinations to inappropriately supervised residents.
- Examiner error occurs.33 Examining ophthalmologists should keep their own fallibility in mind and prudently reexamine if elements of the case warrant such confirmation.
- Zone III ROP cannot be considered “safe.” The work of Repka and coworkers20 must be considered. Unless one is fully confident that no preexisting temporal zone II disease was present, reexamination is prudent.33
- Normal retinal vascularization proceeds in a predictable way within a fairly tight time frame.19,33 Confirmatory examinations are prudent when there is any doubt about the zone or if the infant is unexpectedly young when zone III or full vascularization is thought to have been reached.
- It should be self-evident, but ophthalmologists should be very familiar with normal and abnormal retinal development and the classification and nomenclature of ROP. The documentation of their findings must be consistent. One cannot mention or draw a ridge and entertain a diagnosis of stage 1 ROP. One cannot mention plus without taking appropriate action.
These lessons have applicability for ophthalmologists caring for any disease in any patient. They broadly relate to a physician’s responsibility in patient education; patient compliance; physician/consultant/patient relationships; appropriate protocols for supervising both clerical staff and medical staff, eg, clerical staff involved in timely patient access; resident supervision; awareness of the potential for physician error and the need for procedures to minimize the impact of that error; finally, a thorough knowledge of the literature and best practices on diseases within one’s scope of practice.
ROP malpractice cases are infrequent but are dramatic, since they involve serious harm with a lifetime effect. Both the settlements and the jury awards are up to 10 times larger than most ophthalmologic cases, respectively. This analysis has identified specific areas of care that constitute the main areas of concern in these cases.
Issues of referral and follow-up, issues of supervision, and issues of diagnosis and management constitute the basis of malpractice allegations in ROP. Issues of referral and follow-up are primarily procedural in nature. All the providers should be active in overseeing what is essentially a clerical function. A medically acceptable screening eligibility protocol must be in place, and it then must be administered appropriately. The ophthalmologist should participate in the selection of the screening eligibility protocol, but it is the responsibility of neonatology to administer it and ensure timely initial consultation request.
As we have documented, follow-up consultations/appointments are more difficult to assure. Several of the 13 cases demonstrate this. Participants should strive for a foolproof procedure. Whenever patient/parent compliance is involved, no system in any area of medicine will achieve 100% success. However, the participants must make all reasonable efforts to ensure compliance. Parental compliance failure will still occur, but if a procedure is effective, such noncompliance will be minimized and will be the result of demonstrably unreasonable parental actions.
Achieving such a system is difficult and fraught with potential error points. Every participant will likely bear responsibility here. It serves the interests of patient and provider alike to view this process in a nondefensive way. The parties most able to effectively and reasonably secure follow-up compliance need to accept this responsibility. As noted before, this is not the ophthalmologist. Clearly, the nursery personnel and the outpatient pediatrician are afforded a much greater opportunity to interact with the family and establish compliance.
But there is a difference between what is practical or even ideal and what is found legally binding. These two at times contradictory elements must be fused by negotiation and planning. Ophthalmologists must not put themselves in legally compromising positions by assuming responsibility that they cannot deliver upon. Conversely, they cannot negotiate the avoidance of a legally unavoidable duty. Begin a dialogue, develop a system-wide protocol, negotiate the ophthalmology role, and get legal advice to ensure success.
The importance of appropriate supervision is much more straightforward than compliance. The involved physicians and the hospital are ultimately responsible for patient care. Nurses, practitioners, residents, and clerical workers are all subject to supervision in some fashion. The examining ophthalmologist can teach residents and fellows and supervise care. ROP examinations are no different than teaching surgery. But the key in any resident learning experience is proper supervision.
Finally, this report has documented recurring difficulties in the ophthalmology role of diagnosis and management. Areas requiring special emphasis are as follows:
- Knowledge of the natural history of normal retinal vascularization
- Knowledge of the natural history of ROP development
- Facility with the international classification
- The subtleties and pitfalls of zone III recognition and disease
- An appreciation of the potential for human error and the ability to act in such a way as to not only minimize such errors, but to minimize the impact of such errors, eg, timely confirmation of unusual findings
- Experience and facility with indirect ophthalmoscopy and scleral depression in tiny infants
Knowledge and experience alone cannot insulate an examiner from malpractice claims. But being forewarned of the critical problem areas as well as the tools necessary to be forearmed can go a long way in helping to provide the highest quality of care. Additionally, an understanding of the pathophysiology involved in diagnostic problem areas; eg, zone III issues, will lead to fewer errors and a lessening of the impact of these errors.