A “Watchful Eye” on ROP

Paul Weber, JD, ARM VP Risk Management/Legal

Digest, Winter 2010

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

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

The Concept

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

An Interdisciplinary Approach

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

The Role of the ROPC Nurse

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

Double Check System and Filing

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

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

Caregiver Education

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

Outpatient Coordination

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

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

Unit-wide Orientation and Monitoring

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

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

The “Watchful Eye” and OMIC

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

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

Reducing Your Risk of Hypodermic Perforations

By Jerome W. Bettman Sr., MD, and Byron H. Demorest, MD

Argus, December, 1991

Cases of hypodermic perforation of the eye during lid or orbital injections have been recorded in the literature more frequently than one might imagine, indicating how easily such incidents can occur. The sharp disposable needles currently used for injections around the eye may penetrate the sclera unless special care is taken. When such complications do occur, it is imperative to provide appropriate follow-up treatment promptly.

A review of two case histories illustrates this complication. A 68-year-old insulin dependent diabetic man with eight diopters of myopia was being prepared for a cataract extraction. After an uneventful akinesia, retrobulbar injection of Xylocaine was given using a 27-gauge disposable 1-1/4 inch needle. The patient complained of pain and decreased vision. The eye was extremely soft and the surgeon could not see a red reflex. Ultrasound disclosed a hemorrhagic choroidal detachment and later, a retinal detachment. After the blood cleared, a scar in the posterior fundus was seen, apparently the result of perforation by the retrobulbar needle.

In the second case, a prophylactic subconjunctival injection of 40 mg. of gentamicin was given following an uncomplicated cataract extraction with an implant. The patient complained of severe pain and inability to see. The cornea was hazy and the pressure elevated. Several days later, marked retinal ischemia and a cherry red spot were seen in the macula. Vision was light perception. Weeks later, the optic nerve was pale. Vision was NLP.

Penetration of the eye with a retrobulbar needle can happen even to a very skilled and competent surgeon. One can only evaluate where the needle tip is by the angle that the syringe is held, the amount of needle in the orbit and a sense of resistance. Orbital relationships, the length of the globe, and the resistance of the tissue all vary. A myopic eye is longer than a hyperopic eye. An inflamed eye is soft. The globe may be enophthalmic or exophthalmic.

A globe perforation is a complication that may be successfully defended if care is taken to follow up on the side effects, including intraocular hemorrhage, optic nerve atrophy, and arterial or venous occlusions. Unfortunately, death from presumed injection into the optic nerve sheath has also been reported. These problems may occur with the use of either sharp disposable or so-called “dull” retrobulbar needles. Excellent surgeons often use one or the other and neither is considered substandard.

Medicolegal hazards are also associated with penetration during subconjunctival or subtenons injections. Fortunately, this is easier to avoid. During the past several decades, articles have publicized the fact that a subtenon or subconjunctival needle should be moved extensively before any fluid is injected. Such movement provides the assurance that the needle is not engaged in the sclera.

If penetration of the globe should occur, the eye must be treated as it is following any traumatic injury. The patient should be examined with ultrasound when indicated, intraocular infection should be avoided by proper use of antibiotics, and vitreous hemorrhage must be managed even with vitrectomy if needed to prevent retinal detachment or loss of the globe. Timely referral to the appropriate specialist is advised and the patient must be informed of the nature and severity of the complication.

In conclusion, penetration of the globe with a hypodermic needle is relatively common. Liability from perforation following retrobulbar injections can usually be successfully defended if reasonable care, proper documentation and informed consent have been followed. Fortunately, perforation from subconjunctival or subtenons injections is easier to avoid if proper precautions are taken.

Risk Management Issues in Ophthalmic Plastic Surgery

By Michael J. Hawes, MD, FACS, and Marilys F. Gilbert, RN, Esq.

Digest, Winter, 1993

Oculoplastic surgery, because it is often cosmetic in nature, poses peculiar risk management challenges to the ophthalmologist who may be called upon to bridge the gap between unrealistic patient expectations and surgery’s limitations.

Further complicating the situation is the fact that health insurance carriers frequently consider oculoplastic procedures to be elective surgery and therefore not a reimbursable medical necessity. These factors combine to create a situation which can strain the physician-patient relationship and set the stage for a potentially adversarial relationship.

Frequency versus Severity

In the professional liability insurance industry, frequency refers to the number of claims filed, while severity refers to the indemnity and expenses incurred with the resolution of a claim. High frequency means that many claims are filed, while severity measures the dollar amounts of defense and settlement costs. In recent years, while we have seen claims frequency drop or level off, claims severity has increased.¹

A review of 1,143 claims against ophthalmologists from three sources indicates that only 3.4% or 39 of these claims related to ophthalmic plastic surgery, suggesting that plastics may be a relatively low-risk subspecialty.^2,3,4 (See Figure I.) There were 452 claims filed against OMIC insureds between October 1987 and January 1993, of which 11 involved oculoplastic procedures (2.4%).

Most Frequent Claim Types

Of the 39 oculoplastic claims reviewed, eyelid surgery was involved in more than half of all claims (20), with socket/orbital surgery a close second (16), and lacrimal drainage surgery a distant third (3). (See Figure I.) Further analysis reveals that blepharoplasty, ptosis repair and management of an orbital mass are the procedures most likely to result in a claim. (See Figure II.) A successful blepharoplasty can be quite gratifying to the surgeon and the patient. But as with any type of plastic surgery, a frequent complication is the unhappy postoperative patient. With blepharoplasty implicated in more than one-fourth of all oculoplastic claims, good patient-surgeon communication cannot be overemphasized. This should include a thorough preoperative discussion of the patient’s expectations and the procedure’s limitations.

The need for additional surgery is a frequent complaint from blepharoplasty patients. The surgeon may dampen patient dissatisfaction with blepharoplasty by not charging for revision surgery. Then, even if a lawsuit is filed, having waived these charges may mitigate damages against the surgeon. Other complications which instigated claims included: asymmetry, scarring, wound dehiscence, ptosis and globe perforation during local anesthetic injection.

Ptosis-related claims also are common, representing 18% of the oculoplastic claims reviewed. Reasons cited for these claims included overcorrection, need for multiple surgeries, and postoperative upper lid ectropion.

An equal number of claims resulted from alleged mismanagement of an orbital mass. Dry eye syndrome after removal of a lesion in or near the lacrimal gland, failure to diagnose an orbital malignancy, and post-biopsy ptosis were the bases for these claims.

Certain procedures such as eyelid tumors, eyelid reconstruction, entropion and trichiasis management were not implicated in any of the 39 claims reviewed. These might be considered, at this time, to fall in the “low risk” category for the oculoplastic surgeon.

Severity of Claims

Information about claims severity is necessarily subjective. An insurance carrier must make a judgment in establishing a “reserve” fund to cover the potential indemnity costs related to a claim which may not be resolved for may years. The amount to an indemnity settlement, if any, often is not released, and only limited information is available regarding severity of oculoplastics claims. However, visual impairment or loss tends to arouse a jury’s sympathy and bring about high dollar awards, regardless of the claimant’s age.

Of the 39 claims reviewed, those involving orbital trauma had the greatest severity. One claim was a case of visual loss after orbital hemorrhage. Permanent diplopia following trauma was present in another case. A ruptured globe and orbital foreign body resulted in a claim in a third case. In general, claims involving loss of vision, double vision, or sponges left in the orbit will result in higher indemnity payments than claims of asymmetry after blepharoplasty or ptosis repair. Likewise, management of an orbital mass probably involves more risk of permanent visual or systemic impairment than does eyelid or lacrimal drainage disease management. Exceptions to these generalizations are abundant, however.

There are steps that oculoplastic surgeons and other ophthalmologists can take to avoid or minimize medicolegal problems. Good patient rapport and preoperative discussion are foremost considerations. Adequate testing, informed consent, unaltered medical records, and timely referrals or second opinions on difficult patients or difficult cases are recommended.

Develop a Rapport with Patients

Good rapport with a patient goes a long way to prevent a claim when a complication or unexpected result has occurred. Often the deciding factor in filing a claim is a determination by the patient and family that the physician “really didn’t care” about the patient’s well-being. The patient should perceive his or her well-being as the goal of treatment. The surgeon who doesn’t relate well to a patient on the initial visit should suggest either a second visit or another doctor.

An unkind remark by the physician may result in a suit being filed. Patients who have complications or who are dissatisfied with their results should be seen more frequently than normal and given special attention by their physician, even thought this special consideration may be unpleasant for the physician.

Avoid Surprise Outcomes with Preoperative Discussion

Following lack of rapport, surprise is the next most common factor in a patient’s decision to file suit. Preoperative discussion with a patient and family can be instrumental in avoiding malpractice claims. Evaluation of patient expectations and psychological status can keep the surgeon out of trouble postoperatively.⁵

Patients tend to accept information presented prior to surgery, but are skeptical of the same statements made after a procedure.⁶ For example, ptosis patients should be advised preoperatively that the lid may be too high or too low after surgery, and that additional surgeries may be needed to obtain a satisfactory result. Blepharoplasty patients actually pay more attention to their appearance after surgery and tend to forget their preoperative appearance. Pre- and postoperative photos may help both patient and surgeon be more objective in evaluating results.

Risks and complications, as well as alternative treatments, must be disclosed preoperatively. While it is not practical or even possible to mention every potential complication, generally the most frequent and most severe complications should be mentioned. For example, patients with orbital tumors should be told that, among other things, visual loss, double vision, nerve damage, ptosis, dry eyes, hemorrhage, and tumor recurrence could occur.

The informed consent discussion is the surgeon’s responsibility, and cannot be delegated to a nurse or other employee. However, the patient should be presented with written information about the nature of the procedure, alternatives and complications. Trained personnel in the doctor’s office may answer some follow-up questions about this document, provided the physician is available to offer further counsel when needed. Written pre-and post-op care instructions, which take into account any specific health conditions or contraindications of the patient, should be given to the patient or a family member.

Keep Good Medical Records

It has been said that a jury tends to believe most of what is written in a patient’s record, and little of what a doctor who is being sued says in court. Once a suit is filed, good medical records are a physician’s best defense. Good records are legible. They document informed consent, treatment course and plan, and note review of lab work, diagnostic studies, and any current medications the patient is taking. They record phone calls and missed appointments. These entries should be timely and accurate. Alterations or additions to the record after a suit is threatened or filed are a major mistake, and may automatically result in a loss in a situation which otherwise might be salvaged.

Personally Review Diagnostic Tests

Delay or failure to diagnose a lesion may result in a suit. For example, MR scans or a biopsy may be essential in establishing the correct diagnosis of an orbital tumor. Ideally, the surgeon personally reviews imaging studies with the radiologist and biopsy results with a pathologist. A puzzling or unexpected diagnosis based on an imaging study or biopsy should provoke further studies or review with additional consultants prior to instituting therapy.

Seek Second Opinions for Difficult Situations

Referral of a difficult patient or a patient with a difficult problem can save a physician from a lawsuit. Even though the oculoplastic surgeon may see him or herself as the “end of the line” in a series of referrals, there is usually another physician (perhaps in another city or state) with special expertise on a given problem. Just sending the patient for a “second opinion” may help to defuse an unpleasant situation, provided the second doctor does not make disparaging comments about the referring doctor’s care.

Finally, do not despair. Despite the best efforts of a physician, claims will occur. Such is the risk of practicing medicine in today’s world. Do not view a malpractice claim as a condemnation of your value as a person. Look at it as part of doing business. Contact and cooperate with your insurance carrier, and assure they provide you with the best legal help possible to resolve the situation.

Notes:

1. Gonzalez ML, Emmons DW, Slora EJ(eds). Socioeconomic Characteristics of Medical Practice 1990/91. American Medical Association, Chicago. 1991.
2. Bettman JW. Seven hundred medicolegal cases in ophthalmology. Ophthalmology. 1990;97:1379-84.
3. Kraushar MF, Turner MF. Medical malpractice litigation in ophthalmology: The New Jersey experience. Ophthalmic Surgery. 1986;17:671-74.
4. Gilbert MF. Unpublished data from the files of the Ophthalmic Mutual Insurance Co., San Francisco. 1991.
5. Hawes MJ, Bible HH. The paranoid patient: Surgeon beware! Ophthalmic Plastic & Reconstructive Surgery. American Academy of Ophthalmology, San Francisco. 1990;6:225-27.
6. Bettman JW. Legal considerations. In Stewart WB (ed): Ophthalmic Plastic & Reconstructive Surgery. American Academy of Ophthalmology, San Francisco. 1984:45.

CO2 Laser Skin Resurfacing: Watch Out for Marketing Liability

By Joe F. Arterberry, MD, and Paul Weber, JD

Argus, February 1997

Skin resurfacing with the CO₂ laser is a relatively complex surgical innovation that has captured the attention of the medical community and the public. Much of the public’s fascination can be traced to aggressive marketing of the procedure, which has led many patients to expect superb results without side effects. Unfortunately, such results are not always achievable despite optimal surgical technique and attentive post-treatment care.

The combination of aggressive marketing and high patient expectations sets the stage for costly litigation when patients suffer real or perceived complications following CO₂ laser resurfacing. The most likely allegations relate to inadequate training resulting in suboptimal performance of the procedure, lack of informed consent, and inadequate laser precautions.

In their haste to sell ophthalmologists very expensive laser systems, manufacturers and sales representatives may not emphasize the substantial amount of education and training necessary to perform this procedure properly. At a minimum, education and training should include:

• A solid foundation in the basic science of lasers and laser interaction with tissues.
• An understanding of skin anatomy and wound healing.
• Didactic courses on specific types of CO₂ laser delivery systems.
• Initial CO₂ resurfacing surgical experience under a preceptor or proctor.
• A laser safety course.

The laser operative team also should have proper training and adhere to stringent laser safety precautions, including:

• Following fire precautions (e.g., avoiding alcohol-based prep solutions and topical, flammable anesthetic agents, etc.).
• Wearing glasses with sideshields or goggles.
• Using dulled metallic corneal shields and dulled low- or nonreflective metallic surgical instruments to prevent specular reflections and to protect tissues from accidental photoablation.
• Using an approved smoke evacuator to remove a potentially infectious laser plume.

All documentation of CO₂ laser education, training and safety courses attended by the ophthalmologist and staff should be kept on file. Continuing education is equally important in this area since the technology and the procedures related to it are relatively new and constantly evolving.

Prior to coming to the ophthalmologist’s office, the patient may already have been misinformed about this procedure by glitzy newspaper and magazine ads or television infomercials touting only the benefits of CO₂ laser skin resurfacing. It is the ophthalmologist’s responsibility to determine the patient’s prior knowledge and understanding of this procedure and to give patients accurate and current information regarding its risks, benefits and alternatives. Some of this information can be provided by non-ophthalmologists; however, the responsibility for securing informed consent from the patient cannot be delegated. Commercial videotapes and educational materials are available to begin the informed consent process, and OMIC has developed an informed consent document for CO₂ laser skin resurfacing that can be requested by fax from OMIC’s Risk Management Department at 415-771-7087. It must be emphasized that these videos, brochures and informed consent documents are no substitute for an ophthalmologist’s detailed discussion with the patient. The fact that this discussion took place should be documented by the physician either on the informed consent document or in the patient’s chart.

Patients need to understand that while the initial results of CO₂ laser skin resurfacing have been very promising, long-term results or effects are currently indeterminate. For instance, with every pass of the CO₂ laser spot, a quantifiable thickness of skin is ablated, ranging from 50-150 microns depending upon the laser parameters used, and a varying thickness of dermis is thermally damaged. Therefore, pending completion of clinical studies, it may be prudent to inform heliotropes or “sun-worshippers” about the increased risk of or susceptibility to developing cutaneous malignancies subsequent to their “resurfacing.”

Ophthalmologists who advertise CO₂ laser skin resurfacing need to be particularly careful about how they characterize this procedure. It is difficult to defend in court the ophthalmologist who advertises and markets the procedure as “safe,” “quick,” “effective,” or “gentle” if a patient has one of the known complications of the procedure. Should a lawsuit arise against an ophthalmologist who improperly advertises, a jury could determine that the misleading statements in the advertisements outweigh the force and effect of a thorough discussion of the risks by the ophthalmologist.

In conclusion, if the ophthalmologist approaches CO₂ laser resurfacing methodically and with a compulsive attention to detail and concern for the patient’s well-being, the surgical risk should be minimized.

Nips, Tucks and Lawsuits

By Paul Weber, JD

Digest, Summer 1998

Everyone involved considered the bilateral upper and lower lid blepharoplasty a cosmetic procedure, including the 54-year-old patient who presented to the OMIC insured with complaints of difficulty driving. Three weeks post-op, the patient had epithelial defects, was unable to wear his contact lenses and could not fully close his eyes. He developed corneal ulcers and subsequently sought a repair of cicatricial lower lid ectropion by a subsequent provider. In his suit, the patient claimed that in addition to improperly performing the blepharoplasty, the insured had misrepresented the number of lid surgeries he had performed.

Inflammatory statements such as these are not uncommon in a lawsuit and although they raise credibility issues, these often can be overcome. What could not be overcome in this case, however, was the allegation of poor pre-op examination. The ophthalmologist had failed to take any pre-op photos, had not tested lower lid horizontal laxity, and had not performed a Schirmer’s test. Although he claimed to have measured horizontal laxity during a slit lamp examination, there was no documentation to support this. This lack of thoroughness in performing the pre-op examination bolstered the plaintiff’s claims that the insured lacked the necessary experience to properly perform the procedure. The case settled with a large indemnity payment.

Perhaps it’s the elective and/or cosmetic nature of many oculoplastic procedures that makes proper patient selection and documentation of the patient’s history, physical, pre-op examinations and diagnosis so essential to a good patient outcome and successful defense if a claim is filed. Since many of these patients are experiencing little, if any, demonstrable functional impairment, documentation of the nature of the patient’s problem, both subjectively and objectively, is critical.

Likewise, lack of informed consent is often added to claims of improper performance. Besides a thorough written consent form signed by the patient well in advance of surgery, there are other approaches the ophthalmologist should employ to ensure that the patient is aware of the goals and possible outcomes of the proposed surgery and understands how he or she will be cared for throughout the process.

Be a Teacher

At a session on documentation and patient selection at the annual meeting of the American Society of Ophthalmic Plastic and Reconstructive Surgery, John W. Shore, MD, presented a history and physical form he has developed in his practice. The form includes sections for measuring “eye protective mechanisms” (tear film, basal tear secretions) and horizontal laxity measurements of the lower lids. Had the OMIC insured in this case used such a document, he would have been prompted to document important information that would have made it difficult for the experts and plaintiff to criticize his preoperative evaluation and dispute whether a critical part of the exam was performed.

Dr. Shore describes his approach to patients considering oculoplastic surgery as that of teacher. Beginning with the first visit and continuing throughout, anytime the patient is given patient education materials, it is documented in the chart. Dr. Shore conveniently does this while writing his Impression and Plan for the patient. From a list of nine handouts, Dr. Shore circles those that are given to the patient. Directly below the Handout section of his H&P is a Discussion section. Again, Dr. Shore selects from a list of six possible discussions the one he has with the patient. Logically, the Handout and Discussion sections come at the end of the H&P near Impression and Plan since only after a thorough exam is it possible to determine which discussion to have and which handout to give to the patient.

During discussions with the patient, Dr. Shore finds it helpful to use a diagram of the face and eyes as a “chalkboard” to explain the goals of surgery (see above). He dates and places the diagram in the medical record and gives a copy to the patient. Sometimes it may be necessary to use more than one diagram to explain a procedure, but these diagrams will go a long way toward helping negate claims that the physician did not take the time to discuss and explain the surgical goals and objectives in a manner the patient could understand.

Family Ties

Often, it is just as important to establish rapport with the patient’s family as it is with the patient. Throughout the treatment process, include in your documentation any time a family member is present; e.g., “reviewed goals of surgery with family and patient once again,” “answered all questions; offered to meet with patient and family once again prior to surgery.” Document if the family member also received and was encouraged to read handouts and other written material provided to the patient. This will be helpful because often it is a concerned family member who encourages the patient to seek legal representation when there is a real or perceived problem arising from surgery.

Ensuring that the prospective patient has reasonable expectations should be foremost in the ophthalmologist’s mind throughout the course of treatment. It is important not to overstate expectations. This cannot be emphasized enough given the public’s growing demand for cosmetic oculoplastic procedures such as CO2 laser skin resurfacing, liposuction and laser hair removal. Many patients come to the physician with very high expectations for these cosmetic procedures based upon advertisements featuring glowing patient testimonials or the recommendation of a friend who was pleased with the results of a particular procedure or the skill of a particular surgeon.

The ophthalmologist needs to explore the patient’s motivation and prior understanding of what the procedure can and cannot accomplish, not only as part of the informed consent process but also as part of the patient selection process. Does the patient understand that while most cosmetic procedures will help improve one’s appearance, there are no guarantees? That even when the procedure is executed well, results may not be apparent for months? Or that additional procedures may be necessary to achieve results the patient will be satisfied with? One defense attorney has suggested that patients considering cosmetic procedures be tested following the informed consent process to determine their understanding of the risks and goals of surgery similar to the tests now given to refractive surgery patients.

Damage Control

Complications sometimes arise even when the most meticulous surgical technique and care are provided. When an adverse event occurs, it is important to promptly discuss the problem with the patient and family. Be empathetic and answer their questions. Significant delays in reporting problems will only make the patient and family suspicious. When another health care provider has caused the complication (e.g., an anesthesia mishap), it is important not to lay blame, but to ensure that the patient is kept fully informed by the responsible party about what has occurred and what is being done to remedy the problem.

Document the date and time when complications were disclosed. This disclosure of complications will start the clock ticking with respect to the statute of limitations within which a patient may file a lawsuit. Even when the complication is one that the patient has been informed about prior to surgery, it is important to give greater attention and consideration to this patient. Inform staff that the patient has had a complication and should not be kept waiting for appointments. If a wait is unavoidable, the ophthalmologist should be alerted and personally handle the matter. Calls from these patients and their family members should be given the highest priority. Efforts to keep the patient satisfied with the ophthalmologist’s service is another way of showing empathy for the patient and family. Empathy and understanding will not be construed as an admission of negligence.

Avoid complications by giving patients detailed postop instructions and seeing them as soon as possible when they call with complaints. Remember that postop patients often need support and encouragement because they are still taking medication or are in the healing stage of their treatment, which could have an impact on their final outcome.

Document all telephone conversations with the patient or other health care professionals concerning a patient’s problem. One oculoplastic case had to be settled with a large indemnity payment because the OMIC insured allegedly refused to respond to a call from the ER about a patient who was having postoperative bleeding following bilateral levator aponeurosis repair. Although the insured maintained that the information given to him was not significant enough to warrant an ER visit, he had no documentation to support what had been said.

In summary, oculoplastic surgery must be approached in a thorough and meticulous fashion from pre-operative examination through postoperative follow-up. Good documentation and an ongoing calm, reassuring attitude on the part of the surgeon and the staff will go a long way toward minimizing claims and avoiding adverse outcomes.

Mr. Weber gratefully acknowledges the generous help of oculoplastic specialists John W. Shore, MD, and Michael J. Hawes, MD, for their contributions to this article.