Amblyopia Risk Reduction: Download Recommendations, Treatment Agreement, and Referral Report
Medical malpractice lawsuits for negligent treatment of amblyopia are infrequent, but the risk to the pediatric patient’s vision is extreme. If not treated appropriately by age nine, the child can have permanent vision loss. The main risk issue is noncompliance with patching and follow-up appointments.
See OMIC’s risk management recommendation guide below.
Amblyopia Risk Reduction
See OMIC’s sample treatment agreement, and referral report below.
Sample Amblyopia Treatment Agreement and Referral Report
Pediatric Sedation for Office-Based Procedures
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Summer/Fall 2004
Ophthalmologists are performing an increasing number of diagnostic and therapeutic procedures in office settings. While most of these are done under local anesthesia, some require sedation and analgesia both in order to accomplish the procedure and to ensure the comfort of the patient. There are important safety concerns when care traditionally rendered by anesthesiologists or CRNAs in hospitals with back-up emergency staff and equipment is provided by non-anesthesia personnel in offices. Using administration of chloral hydrate (CH) to pediatric patients as an example, this article will address some of the risks of office-based sedation and offer recommendations for reducing them.
Q The practice I joined administers chloral hydrate to pediatric patients in order to conduct examinations. Is CH considered safe?
A While CH is widely used “off label” for the sedation of infants and toddlers and has a reputation as a safe medication with minimal effects on respiration, an analysis of adverse pediatric sedation incidents found that 13 out of 60 cases resulting in death or permanent neurologic injury involved the use of chloral hydrate alone or in combination with other medications.[1] Factors contributing to the outcomes included overdosage, administration at home, administration by non- medically trained personnel (technicians), and premature discharge from medical observation. Unlike some opioid medications used for sedation, CH has no known reversal agent, and a very long half-life in children (27.8 +/- 21.3 hours in newborns, 9.7 +/- 1.7 hours in toddlers). Without the stimulation of the examination, the sedating effect returned; children suffered respiratory compromise that went unnoticed by the parent, often during the car ride home.
Q Could the deeper level of sedation be prevented by giving the correct dose?
A Not necessarily, since some of the children who were injured had received the appropriate amount. As the American Society of Anesthesiologists’ “Practice Guidelines for Sedation and Analgesia by Non- Anesthesiologists” warns, sedation is a continuum. Four levels have been identified, based upon responsiveness, the airway, spontaneous ventilation, and cardiovascular function: minimal sedation (anxiolysis), moderate (formerly known as “conscious sedation”), deep sedation, and general anesthesia.[2] The Guidelines clarify that since it is not always possible to predict how an individual patient will respond, practitioners intending to produce a given level of sedation should be able to rescue patients whose level of sedation becomes deeper and causes hypoventilation, apnea, airway obstruction, or cardiopulmonary impairment.[3] Proper monitoring can detect these problems, but the training and expertise needed to recognize these complications and rescue the patient from them are usually not part of the skill set of most ophthalmic personnel. Accordingly, CH is usually administered only in the hospital setting. Increasingly, it is being replaced by reversible IV agents that also provide better pain relief.
Q What measures should I take to protect children receiving sedation?
A Ask the anesthesiology department of your local hospital to help you devise an office-based sedation protocol that addresses drug and patient selection criteria, dosing regimen based upon the child’s weight, NPO (nothing by mouth) guidelines, monitoring and discharge criteria, and rescue practices and equipment (see also the ASA and AAP guidelines referenced in the footnotes below). The order for the medication should include the child’s weight, the mg/kg dose, and the total dose to be administered. Never allow pre-procedure administration at home. After the procedure, observe the child in a quiet monitored area, even if he or she seems to be completely awake immediately after completion. This is especially important when using medications with long half-lives (chloral hydrate, promazine, promethazine, chlorpromazine, phenobarbital).[1] Use only qualified personnel whose training and competency include cardiopulmonary assessment, airway management, and resuscitation to monitor the child during and after the procedure and to determine if the child meets discharge criteria. Provide oral and written discharge instructions for the adult accompanying the child home that address expected behavior, eating, warning signs of complications, special instructions in case of an emergency, and how and when to contact you.[2,3]
1. Cote,Charles J et al. “Adverse Sedation Events in 2. Pediatrics: Analysis of Medications Used for Sedation.” Pediatrics 2000: 106; 633-644.
2. American Society of Anesthesiologists. “Practice Guidelines for Sedation and Analgesia by Non- Anesthesiologists,” approved 17 October 2001, available online at https://ecommerce.asahq.org/p-180-practice-guidelines-for-sedation-and-analgesia-by-non-anesthesiologists.aspx See also the ASA “Sedation Model Policy.”
3. American Academy of Pediatrics, Committee on Drugs. “Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures.” Pediatrics, v. 89, n. 6, June 1992. See also American Academy of Pediatrics, Committee on Drugs, “Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures: Addendum.” Pediatrics, v. 110, n. 4, October 2002.
Shared Liability for ROP Screening
By Kim Wittchow, JD OMIC Staff Attorney
Examining premature infants for retinopathy of prematurity (ROP) is an important aspect of ophthalmic care. Ophthalmologists who perform this critical consultative function are providing a tremendous service to these infants and to the neonatal intensive care units (NICU) and supporting institutions that care for them. Because these institutions and ophthalmologists work together to reduce the likelihood that significant ROP will develop, they also should share the medical malpractice liability risk should a case of ROP advance to vision loss or blindness. If you perform ROP screening, you should know how your hospital handles this shared risk and take steps to limit your liability in the NICU.
Hold Harmless/Indemnification
One approach is to ask the hospital to hold you harmless and indemnify you for any liability you incur in performing ROP screening in the NICU. This means the hospital promises to absolve you of any responsibility for damages or other liability and to reimburse you for any loss you suffer arising from your provision of services in the NICU. This would be accomplished by inserting a hold harmless/indemnification clause in your ROP service contract with the hospital. Note, however, that many states limit the types of risks that can be transferred from one party (you) to another party (the hospital). Any indemnification agreement that you and the hospital enter into should be reviewed and/or drafted by legal counsel. Contact OMIC’s Legal/Risk Management Department for sample language.
An additional safeguard is for you to be named an “Additional Insured” under the hospital’s liability policy. This gives you direct access under the hospital’s policy to defense coverage for insured claims whether or not the hold harmless/indemnification provision is legally enforceable. However, “Additional Insured” status should not be obtained in lieu of a hold harmless/indemnification provision because the hospital’s insurance policy may not cover the loss.
Hospital-Provided or Funded Insurance
Another approach is for the hospital to provide you with additional insurance. Again, the specific provisions would be spelled out in your ROP service contract with the hospital. This hospital-provided insurance would coincide with your primary OMIC professional liability insurance. If you negotiate a primary or contributory policy with the hospital, then OMIC and the hospital most likely would share and cooperate in your defense and payment of any (covered) indemnity. (The OMIC policy describes how losses are apportioned when the OMIC policy and other insurance apply to the loss on the same basis.) However, if you negotiate an excess policy with the hospital, the hospital would not generally participate in the defense of the claim unless it is likely you will exceed your primary limits with OMIC. The excess limits would be available, though, if a judgment against you exceeds your policy limits with OMIC. Keep in mind that all determinations of coverage are case specific.
Another alternative is for the hospital to contribute toward payment of your insurance premiums. The AMA reports that hospitals are increasingly helping physicians pay their medical malpractice premiums to ensure that physicians continue to provide services at hospital facilities.
As an OMIC insured, one option for you is to raise your professional lia- bility limits and ask the hospital to reimburse you for the difference in premium. You should seek legal counsel when entering into these arrangements to ensure compliance with federal and state laws regulating hospital payments to physicians.
Damage Caps and Punitive Damages
When considering any of these options, you should be aware of state laws, such as those governing damage caps and the availability of punitive damages awards, because they will affect how much and what type of liability coverage you should seek. For example, if the state’s damage cap is $1 million and you have $2 million per occurrence/$4 million in the aggregate coverage, you can feel more secure that your limits will not be exceeded because of a jury award against you. However, if your state allows punitive damages awards, you might want to negotiate additional insurance from or indemnification by the hospital since the OMIC policy does not cover punitive damages. Your attorney should recommend the most appropriate and viable coverage alternatives and work with the hospital to draft the applicable terms.
You also should note that if a patient files a lawsuit, conflicts of interest may arise between you, the hospital, and other codefendants such as subsequent treating physicians. For example, you might disagree as to whose responsibility it was to provide follow-up ROP exams to a baby you examined once who was then transferred to another facility. In this situation, OMIC might exercise the right to separate counsel for its insured while still focusing on a unified defense.
Failure to Coordinate Follow-up Care Results in Missed ROP Diagnosis
Digest, Summer, 1995
Allegation
Failure to communicate responsibility for scheduling a follow-up examination of a premature baby after discharge led to delayed diagnosis and treatment of retinopathy of prematurity (ROP), resulting in bilateral blindness.
Disposition
Joint settlement was reached with indemnity equally divided among the neonatologist, the ophthalmologist, the hospital, and the attending pediatrician.
Background
Communication between attending and consultant physicians is a critical aspect of patient care. When responsibility for follow-up is not clearly defined between specialties, the patient may be lost to follow-up if there is a communication failure within the health care team.
Case Summary
A premature baby boy weighing 1200 grams (2.6 pounds) was delivered by caesarean section at 29 weeks gestation. An ophthalmology consult was called and the eye examination was noted on the chart as “ROP I nasal and temporal retina, zone 2 to 3, mild. Should resolve. Recheck 4 weeks.” The ophthalmologist used an older staging system in which Stage I refers to abnormal vessel configuration, rather than a pre-demarcation line condition. He later explained that his examination of the infant revealed a pre- Stage I or Stage O condition, which has no staging description according to the “new” classification system for ROP, which became the standard of care in 1984-four years before this baby was born-Stage I ROP is characterized by a demarcation line. Thus, under the newer classification system the findings from this exam would not have qualified for a staging classification. The ophthalmologist later stated that the four-week follow-up recommendation was based on the “lack of a demarcation line” on exam and that he would have set an earlier recheck date had there been a clearer line of demarcation.
It was the policy at this neonatal unit for the neonatologist to make arrangements for any scheduled follow-up visits for patients while they were in the unit. But once a patient was transferred, the individual consultants were expected to follow up on recommended care. No arrangements were ever made for the four-week ophthalmology recheck, and the child was discharged one week before he should have been seen for the recheck. Additionally, the neonatal unit, which usually completed a discharge planning form to check off whether all consults were done and confirm that follow-up was scheduled, never completed a form for this baby so the ophthalmology recheck exam was never scheduled.
Upon discharge, the infant was followed by a pediatrician, who did not examine the baby for ROP and thus was unaware of the condition until she received the hospital’s discharge summary at her office three months later. She then discovered this ophthalmology reference: “It should be noted that the baby was seen by ophthalmology to rule out ROP and that exam was noted as Stage I, although I cannot at this time find the consult note. He should probably follow up with this infant after discharge.” The attending physician immediately referred the baby to the ophthalmologist who diagnosed Stage V ROP. Referral was made to a retina specialist who confirmed the diagnosis and performed two surgeries on the left eye and one on the right. None of the surgeries were successful, and the infant became totally blind.
Analysis
Each institution has its own rules and policies regarding delegation of duties and responsibility for referral and follow-up of patient care. In this case, there was confusion between the ophthalmologist and the neonatologist over who was responsible for the baby’s follow-up care. The referral pattern established between the attending neonatologist and the consulting ophthalmologist was one of the major issues raised by the experts who reviewed this case. The ophthalmologist stated at his deposition that the neonatologist had not wanted him to contact the parents and that she would contact him to request all consultations with the patient. The neonatologist testified that she considered herself responsible for arranging follow-up appointments with consultant physicians while an infant remained in the hospital, but it was the consultant’s responsibility to follow through with a charted follow-up appointment once the infant was discharged. It was not difficult for the plaintiff’s attorney to convince the jury that each of the caregivers in this case had failed in their responsibility to coordinate follow-up care, and that this failure prevented a timely diagnosis of ROP.
Defense of the case against the ophthalmologist was further hampered by reference to both an “old” staging system and a “new” system in his report of the baby’s first eye exam. It was not clear what the ophthalmologist meant by this until he explained his peculiar reference system at his deposition. Even more damaging to the credibility of the recorded findings was expert testimony that the first ophthalmic exam is often inaccurate due to the difficulty of examining a squirming infant. For this reason, a follow-up exam is generally completed within one to two weeks to confirm the initial findings. This set the stage for the plaintiff to allege that the consulting ophthalmologist not only failed to accurately examine the infant and diagnose ROP on the first exam, but also failed to do a timely follow-up.
Risk Management Principlesand Commentary
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. This case points out the need for communication between the ophthalmologist and the parents during the first examination of an infant for ROP. Parents should be educated about the possibility of blindness in their pre-term infant and a reexamination appointment should be made at the time of the first exam. If this appointment is not kept, the ophthalmologist’s office should contact the parents with a timely phone call and registered letter reminding them of the missed appointment and the need for follow-up care.
Delayed Referral for Progressive ROP
By Mary Kasher, MSN, JD
OMIC Claims Manager
Digest, Summer 2001
ALLEGATION Failure to convey urgency and seriousness of infant’s ROP disease caused a delay in referral to a retinal specialist.
DISPOSITION Defense verdict at trial on behalf of insured.
Case Summary
An infant boy was born at 27 weeks gestation, weighing 1247 grams and suffering from intracranial hemorrhages due to prematurity complicated by several neurological injuries. Following a three-month struggle, the baby was discharged from the hospital and referred by the pediatric neurologist to the insured, a pediatric ophthalmologist, to evaluate and follow for ROP. The insured’s impression when she examined the infant two weeks later was apparent grade I to grade II active phase retinopathy of prematurity OU. She recommended further evaluation by a retinal specialist. The baby was still on oxygen at home.
Three months later, examination by a retinal specialist showed grade IV ROP OD. Cryopexy was performed. The left eye demonstrated some dragging of the optic nerve temporally but no evidence of active neovascularization. Over the next two months, the retinal specialist noted some peripheral fibrosis temporally OD but no significant dragging of the retinal vessels. The left eye demonstrated temporal cicatricial changes with dragging of the macula temporally but no evidence of retinal detachment or active proliferation. At the time of the last examination, the retinal specialist believed the baby had full field vision OS but probably some central impairment associated with retinal dragging. Visual acuity OS was in the range of 20/200 to 20/400. The right eye demonstrated light perception only, and the baby’s general activity indicated total blindness in that eye.
Analysis
There were two central issues in the plaintiff’s case against the insured ophthalmologist: (1) Could vision in the baby’s right eye have been saved with earlier treatment by the retinal specialist? (2) Did the insured stress to the mother the seriousness of the baby’s eye condition and the importance of a timely referral to the retinal specialist?
Plaintiff experts argued that the progression from grade I to II to grade IV OD was a direct result of the delay. Defense experts argued that even if the child had been referred in a timely manner, the end result would have been the same. The mother testified that although the insured did tell her about changes in her son’s eyes, she was never told of the urgent need for follow-up. The insured maintained that she instructed the mother to make an appointment with the retinal specialist within the week, but her records did not support this. She also claimed to have dictated a report of the baby’s condition in front of the parents and to have sent a copy to the retinal specialist, but the specialist’s records did not contain this report.
Fortunately, defense counsel found several neonatal nurses from the hospital where the baby was born to testify that the parents of a premature infant with neurological problems would necessarily have been informed of the seriousness of their baby’s condition before discharge and would have been instructed in the importance of follow-up visits. This instruction was well documented in the hospital’s records and helped discredit the mother’s testimony that she was never informed of the seriousness of her baby’s condition. In addition, the retinal specialist was able to reconstruct from his office records a timeline showing that the first call by the mother to make an appointment was more than a month following the last visit with the insured. His records also indicated that the first appointment was a no show and had to be rescheduled, resulting in yet another delay.
Risk Management Principles
This case demonstrates the importance of medical record details. Although the insured’s medical records were well documented in many respects, plaintiff attorneys zeroed in on the absence of a note regarding the conversation with the mother along with the missing copy of a letter dictated to the specialist. Fortunately, the thoroughness of the preceding and subsequent treatment records provided the jury with sufficient evidence of the mother’s noncompliance. This, along with the overall good quality of the insured’s records in general, enabled defense counsel to sway credibility back to the insured. Had the insured documented her instructions to the mother and her referral to the retinal specialist, this case probably would not have gone to trial and the insured would have been spared the expense of time and courtroom anxiety.
