Message from the Chairman (discussed frequency and types of errors)

Wrong site/wrong IOL surgery

errors continue to plague our profession despite a concerted effort by OMiC to educate insureds and others about the circumstances that lead to such errors and provide risk management recom- mendations to help prevent them.

A recent retrospective study of 42 OMiC claims and 64 new York state cases by John W. simon, MD, et al, published in Archives of Ophthalmology (vol. 125, no.11) addressed the effectiveness of the universal Protocol as a prevention tool. According to the study, even if the protocol were perfectly implemented, 15% of errors would remain. Recent events in Florida, where ophthalmologists have incurred substantial fines and penalties imposed by the state medical board, and the persistence of wrong site/wrong iOL errors has galvanized OMiC and its sponsor, the American Academy of Ophthalmology, to examine what can be done to eliminate these errors.

First, the problem must be put in perspective. Wrong site and wrong iOL errors are very low in frequency, indicating that proper safeguard systems are currently in place and working fairly well. in our 21 years of existence, approximately 4,679 lawsuits, claims, and incidents have been reported to OMiC. Only about 220, or 5%, have been related to “wrong” events. since 1997, the percentage of insureds who have reported a wrong site or wrong iOL matter to OMiC has stayed relatively constant at a median annual average of about 0.5%.

however infrequent, these types of errors have drawn the attention of the public and state and federal policymakers, resulting in fines and licensing sanctions against physicians and non-payment of services by Medicare and other payors. the AAO, OMiC, and other ophthalmic societies are taking a two-prong approach to the problem—education and prevention—via the Academy Practice improvement task Force and a three-year Academy Campaign to eliminate Wrong site/Wrong iOL surgery.

the first charge of the Practice improvement task Force, a group of seven ophthalmologists representing the AAO, ABO, AuPO, and OMiC, is to develop an online CMe activity that will allow ophthalmologists to compare their own practice to those that follow evidence-based performance measures and protocols proven to reduce errors. simple-to-use checklists will help participants adopt the protocols in their own office. Anonymous data collection of pre- and post- education practice activities will enable the task force to evaluate the effectiveness of the practice improvement activity on care outcomes.

the campaign to eradicate “Wrong site surgery and Wrong iOL implantation” in the u.s. within three years is another cooperative group effort of ophthalmologists and is led by Gary s. schwartz, MD. the group will review suggestions drawn from evidence-based medicine to help surgical teams evaluate and improve their own safety systems to eliminate all sources of wrong site or wrong iOL errors, whether operating in an office, hospital, or ambulatory surgery center.

At the state level, the Florida society of Ophthalmology is working with OMiC and the Academy to educate FsO members on wrong site/ wrong iOL surgery prevention. Florida is “ground zero” when it comes to the regulatory impact of system errors, and ophthalmologists in particular have borne the brunt of fines and licensure sanctions. the reason lies principally with the reporting requirements of AsCs and hospitals to the Florida medical board when a wrong site or wrong iOL error occurs in the operating room. the FsO is partnering with the Florida Board of Medicine to develop a statewide regulatory/ disciplinary process to handle and correct the systems that produce such violations.

With the leadership and participation of so many prominent ophthalmic organizations, we hope to make the persistent problem of wrong site/wrong iOL a “never” event.

Joe R. McFarlane Jr., MD, JD OMIC Chairman of the Board

Premium IOLs Come of Age

By Hans Bruhn, MHS OMIC

Senior Risk Management Specialist

Digest, Winter 2009

Patient satisfaction can be difficult to obtain and easy to lose. Despite the initial level of deference and trust a patient usually brings to the physician-patient relationship, that trust can be lost due to miscommunication about the diagnosis or treatment goals. Out-of-pocket expenses, especially if they are significant, can increase patient expectations and set the stage for dissatisfaction or malpractice lawsuits. A current case in point is intraocular lenses (IOLs), judging by the number of calls on this issue to OMIC’s Risk Management Hotline.

Prior to World War II, ophthalmologists and their patients had few lens choices following cataract surgery. The only way to replace the focusing power of the lens once it was removed was with a thick cataract glass (remember the coke bottle glasses that elderly people wore years ago?). Today, cataract patients are fortunate because ophthalmologists can replace the natural lens with an artificial, clear, plastic lens implant.

The use of lens implants became common practice in cataract surgery in the 1970s, but the discovery of these lenses actually occurred years earlier in the late 1940s. Howard Ridley was an ophthalmologist in the Royal Air Force treating former fighter pilots who had sustained eye injuries during the war when bullets striking the plastic canopy of their aircraft caused small shards of plastic to fly into their eyes. Dr. Ridley realized that the polymethylmethacrylate (PMMA) acrylic from the aircraft canopy was made of an inert material that was compatible with eye tissue. In 1949, he replaced a cataractous natural lens with the first artificial plastic lens.

Fast forward sixty years to the wide selection of IOLs now available to ophthalmologists and patients. Ophthalmologists can recommend lenses based on a patient’s individual postoperative vision goals, and patients willing to pay extra can upgrade to “premium” IOLs for even better visual results. But, as with any commodity, availability of a “premium” product has its downside. In the case of premium IOLs, patients may have unrealistic expectations and because patients are personally responsible for the added cost, they may insist upon guaranteed results. Management of expectations is thus critical to satisfaction when helping a patient choose the right IOL.

The choices are numerous. In addition to the standard monofocal lens, patients now have the option of a “multifocal” intraocular lens (the first one was approved by the FDA in 1997). “Multifocals” provide both near and far vision. unfortunately, not all patients are eligible for “multifocals.” Some patients who are fitted with “multifocals” may still need glasses or contact lenses for certain activities, such as those requiring near and extremely crisp, clear vision. In general, however, fewer need glasses and contacts when fitted with “multifocals” than they would with monofocals. Clinical studies have found that cataract patients who choose “multifocals” over monofocals express greater satisfaction and improved quality of life following surgery.

In addition to these benefits, each of today’s available “multifocal” IOLs (ReStor, ReZoom, and Crystalens) have specific limitations that need to be communicated to the patient to reduce the potential for disappointment and dissatisfaction. To appreciate the need to move cautiously with premium IOLs, we’ll examine OMIC’s claims experience with cataract surgery.

Claims Experience Involving IOLs

Issues that surface with patients who undergo cataract surgery with placement of IOLs include the typical complaints of incorrect lens power, size, type, and position. Another source of claims are complications of surgery that were not handled promptly by the surgeon or referred on to a specialist in a timely manner; these include vitreous loss, retained and dropped lens material, stripped descement’s membrane and other corneal problems, and choroidal hemorrhage.

As indicated in Graph 1, cataract surgery claims continue to be the most frequent type of claim against OMIC insureds. The high rate of cataract- related claims reflects the large number of cataract procedures performed each year in the United States. (Claims involving the use of IOLs in cataract surgery are included in the overall cataract column, but claims involving the use of IOLs in refractive surgery are fairly new and few have been reported so far.) While the average indemnity for cataract claims over the past five years ($113,000) is less than the average indemnity for all types of ophthalmology claims ($145,000), the aggregate indemnity for cataract claims is significant given their high volume.

OMIC did experience a decrease in the number of cataract claims between 2005 and 2008 from 27% of all claims to 20% (see Graph 2). Whether this decline will continue during the current economic downturn remains to be seen. We are seeing an uptick in the number of small general ophthalmology claims, possibly the result of patients seeking financial compensation during hard economic times.

In order to decrease the risk of a claim and the amount of settlement or judgment if a claim is filed, the following risk management strategies are recommended for ophthalmologists who do IOL placement.

Manage Patient Expectations

Management of patient expectations with regard to cataract and refractive lens exchange surgeries begins with proper patient selection. Plaintiff attorneys and experts are quick to point out if the patient was a questionable candidate for surgery or if better alternatives existed for the patient’s particular needs.

Know and follow the indications for surgery in the American Academy of Ophthalmology’s “Preferred Practice Pattern on Cataract in the Adult Eye.” Determine the role of the cataract in the patient’s vision loss. Ask about near and distant vision under varied lighting conditions for activities that the patient views as important. Document the functional impairment using the patient’s own words. Consider using a vision-specific questionnaire designed to help ascertain the impact of the cataract on activities of daily living, such as the Activities of Daily Vision Scale (ADVS)1 or the Visual Function Index (VF-14).2

Identify whether there are other possible causes of the patient’s visual problems besides cataracts. Evaluate the patient for medical comorbidities and medications that can influence the choice of anesthesia or affect the outcome of surgery (e.g., Flomax, anticoagulants).

Provide Thorough Informed Consent

In addition to a well documented medical record, a thorough and memorialized informed consent process will enable OMIC to mount a strong defense against a claim. Consent should be given in advance of surgery with time allowed for the patient to review this information and ask questions. Include a thorough discussion of the risks, benefits, alternatives, and complications of surgery and anesthesia. It is important to document the indications for surgery (e.g., for cataract surgery with premium IOLs, the need for near and distance VA and the impact of cataracts on the patient’s daily life). Also disclose and document the impact of ocular and medical comorbidities on the outcome (e.g., removing a cataract will not cure other eye conditions such as glaucoma or AMD).

Your discussion with the patient should address the options for near vision and astigmatism reduction. If the IOL was recently approved, explain that there is a lack of information about long-term outcomes and the possibility of unforeseen complications. Patients should not feel pressured to choose a more expensive IOL option. Explain your rationale for recommending a particular IOL and provide information about it, including labeling information that a reasonable person would want to know.

More importantly, clarify that no guarantees can be made about postoperative visual acuity. Explain that the selection of the proper implant is based upon sophisticated equipment and computer formulas, but is not an exact science, and if the refractive result is considerably different than expected, there may be a need for glasses or contacts, additional refractive surgery, or lens repositioning or replacement. Also explain what will happen if the selected IOL cannot be placed due to problems that may arise during surgery. If the patient is at increased risk for a particular complication, disclose and document that (e.g., infection in a diabetic patient). More information on the informed consent process for cataract and refractive lens exchange surgeries can be found at www.omic.com.

Handle Patient Complaints

Even patients with uncomplicated surgery may present with complaints after surgery. unwanted visual images, residual refractive errors such as astigmatism, and overall poor quality vision may be cause for complaint. Manage these situations by being empathetic and reassuring to the patient. Emphasize that it may take time to adjust to visual changes and that you will be available to the patient throughout this process. If complaints persist, discuss the matter with OMIC’s Risk Management Department.

Monitor Advertising

The ophthalmologist should personally review how IOL implants are being marketed to patients in the practice’s advertising to ensure that patients are receiving “balanced” information on their risks and benefits. This will also help manage patient expectations before the patient presents in your office. OMIC’s Risk Management Department will be happy to assist you in reviewing your advertising.

1. Mangione CM, Phillips RS, Seddon JM, et al. “Development of the ‘Activities of Daily Vision Scale.’ A Measure of Visual Functional Status.” Med Care 1992; 30: 1111-26.

2. Steinberg EP, Tielsch JM, Schein OD, et al. “The VF-14. An Index of Functional Impairment in Patients with Cataract.” Arch Ophthalmol 1994; 112:630-8.

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.