Inadequate Hand-offs Between Physicians Delays Treatment of Endophthalmitis
By Ryan Bucsi, OMIC Senior Claims Associate
Digest, Spring 2006
ALLEGATION Failure to timely diagnose and treat endogenous endophthalmitis.
DISPOSITION Settled at mediation for $45,000. Primary care physician (PCP) and hospital contributed $25,000, OMIC insured con- tributed $15,000, and on-call physician for the PCP contributed $5,000. On- call ophthalmologist was not named in the lawsuit.
Case Summary
An elderly female patient telephoned the OMIC insured’s office complaining of blurred vision and floaters. The insured was out of town, so the patient was referred to the on-call ophthalmologist, who scheduled a same day appointment. The appointment was cancelled, however, because later that day, the patient was hospi- talized by the physician on-call for the patient’s primary care physician (PCP) for treatment of a systemic infection. Four days later, at the request of the PCP, the hospital contacted the OMIC insured’s office to request a consultation and was informed that he would not be returning to the office for two days. When the insured returned, he contacted the hospital and was told by a nurse that the patient had been diagnosed with conjunctivitis. The following morning, he went to the hospital for his sole examination of this patient. The patient’s left eye was red and painful with an intraocular pressure of 53 and visual acuity of light perception. A slit lamp exam revealed a 30% hypopyon with 4+ cells and flare in the remainder of the anterior chamber. There was no red reflex in the left eye with the ophthalmoscope on the highest setting. The B-scan displayed moderate debris in the vitreous with an attached retina. The insured diagnosed probable endogenous endophthalmitis secondary to E-coli and referred the patient to a retina specialist. The retinal specialist treated the patient in the hospital for two weeks, but after a total retinal detachment, the patient suffered complete loss of vision in the left eye.
Analysis
Multiple opportunities to intervene in a more timely manner in the infectious process were lost because of inadequate “hand-offs” between the attending physicians and their call partners. Instead of cancelling the scheduled office visit with the on-call ophthalmologist, the on-call PCP should have arranged an in-hospital consultation. The on-call ophthalmologist never informed the insured about the patient’s call, cancelled appointment, or hospital admission. Thus, when the insured did finally speak to the hospital nurse, he relied upon the diagnosis of conjunctivitis and did not clarify the patient’s symptoms or recognize the urgency of the situation.
Defense experts noted that a consulting physician should generally see the patient within a couple of days for a non-emergent consultation. They pointed out that the one day delay in treatment would not have improved the outcome of an E-coli infection. The defense was complicated, however, by the hospital consultation request, which identified the reason for the patient’s admission as bacteremia. Arguably, this diagnosis and a report of red eye should have alerted the insured to the possibility of endophthalmitis. The nurse was expected to testify on behalf of the hospital that the complaint of pain and poor vision was communicated to the insured. Given these troubling issues, mediation was arranged and the case was settled.
Risk Management Principles
Careful telephone screening of ophthalmic problems is perhaps the most effective patient safety and risk reduction measure ophthalmologists can take. Neither patients nor other health care providers can be relied upon to provide the information necessary to diagnose an eye condition over the phone. The ophthalmologist must, therefore, be proactive and “drive” the conversation, being sure to ask not only about ocular symptoms but also about the patient’s overall condition. OMIC has prepared sample contact forms that prompt ophthalmologists and their staff to ask about symptoms, prior surgery, medication use, and problems reported to other physicians, and to report contacts with other members of the health care team (see “ Telephone Screening of Ophthalmic Problems” at http:///www.omic.com/resources/risk_man/ recommend.cfm). Ophthalmologists going on or off call should conduct and document “hand-off” discussions and may want to devise an ophthalmic consultation form for referring physicians, including those in the emergency department, so they have the information necessary to determine the urgency of a consultation request.
Risks and Benefits of Writing Off a Patient’s Bill
By Anne M. Menke, RN, PhD
Anne Menke is OMIC’s Risk Manager.
Faced with a medical error, patients want their doctor to do three things: explain what happened, say he or she is sorry that the patient experienced the poor outcome, and assure the patient that steps will be taken to prevent the same thing from happening to others.1 While many physicians want to talk to their patients in this way about errors and other adverse events, they may hesitate to do so for a variety of reasons. Some fear that disclosing errors and complications may prompt a lawsuit. Others may lack the communication skills necessary to respond to a patient’s anger and grief with compassion rather than defensiveness. When other health care providers or organizations are involved, some physicians may feel conflicting loyalties or be concerned about the impact of a disclosure discussion on collegial relationships, referral patterns, or credentialing.
Ophthalmologists calling OMIC’s Risk Management Hotline frequently ask for advice about revealing errors, offering apologies, or waiving fees. OMIC’s approach is founded on the principles of honesty, compassion, and fairness to both the ophthalmologist and the patient, and is designed to help minimize the risk and severity of claims and lawsuits. Over the years, articles in Argus (now published by the American Academy of Ophthalmology as EyeNet) and the OMIC Digest have offered advice on this topic. Dr. Jerome Bettman noted that “when complications arise, honesty is the best policy.” He encouraged physicians to “tell the patient what has happened as soon as possible.” Dr. Byron Demorest advised that “waiving your bill may avert a claim following a poor clinical outcome.” Paul Weber, vice president of OMIC’s Risk Management/Legal Department, reminded insureds, “don’t be afraid to say you’re sorry.”2 OMIC’s claims experience indicates that whatever the event or situation, communicating with the patient or patient’s family about the adverse outcome sympathetically and non- defensively within the shortest appropriate time period may help dispel much of the patient’s anger, confusion, and distrust. A patient’s belief that he or she is not being told the whole story, or is not being given the opportunity to ask the physician questions and vent feelings, often provokes a decision to seek the advice of an attorney and pursue a medical malpractice claim against the ophthalmologist. Indeed, studies have shown that patients who sued their physician often did so because their doctor did not help them understand what happened.
Patients who experience unantici- pated outcomes are often confused about the difference between a poor or unsatisfactory outcome—a maloccurrence—and malpractice. An unanticipated outcome may or may not be the result of error or negligence, and not all errors are the result of medical malpractice. In fact, further investigation into an unanticipated outcome or allegation of negligence may reveal that what initially appeared to be malpractice was actually the result of the disease process itself or an unforeseeable
or unpreventable complication of a risky, or even life- or vision-saving, treatment. To assist policyholders in dealing with patients following unanticipated outcomes, OMIC offers confidential, individual counseling through our Risk Management Hotline at (800) 562-6642, ext. 651. During these conversations, we help the ophthalmologist prepare for disclosure discussions, conduct an event analysis to evaluate the causes of unanticipated outcomes and improve patient outcomes in the future, respond to complaints, and weigh options when faced with a re- quest for a refund. OMIC’s detailed recommendations on “Responding to Unanticipated Outcomes” are available as a document from our web site and are applied to case studies in two presentation formats, a CD and online course. This issue of the Digest illustrates many of these approaches. This article presents how an error, a complication, and unmet expectations were handled by three OMIC policyholders. Policy Issues discusses apologies in rela- tion to OMIC’s policy coverage; the Closed Claim Study examines fee waivers; and the Hotline discusses waivers, refunds, and indemnity payments.
“Taking the High Road” When an Error Occurs A 44-year-old man presented for bilateral LASIK correction of hy- peropia. The next day, he reported significant visual difficulties, which examination revealed were due to high hyperopia and astigmatism. The ophthalmologist explained that the results were not what he expect- ed. He told the patient he wanted to review the records and asked the patient to return the next day. The ophthalmologist contacted OMIC when he discovered that the pa- tient had been treated with another patient’s laser settings. The physician explained that the first patient of the day had cancelled his surgery and that the second patient did not correct staff members when they repeatedly called him by the other patient’s name.
The ophthalmologist planned to tell the patient what had happened and provide treatment to address his visual difficulties at no charge. We agreed with his approach. After unsuccessful trials of contact lens and glasses, the patient underwent refractive lens exchange with im- plantation of a toric lens, followed by bilateral LASIK to treat residual refractive error, all at no charge to the patient. While his UCVA was 20/20 on the first postoperative day, his vision quality later deteriorated.
At that point, the patient not only stopped seeing the surgeon, but sought legal advice.
An independent medical exami- nation confirmed central irregular astigmatism that could not be corrected surgically, and BCVA of 20/80 OD and 20/100 OS. The oph- thalmologist was disheartened that an error had harmed his patient but remained proud of “taking the high road” to stand by his patient and develop better patient identification policies. His honest, compassionate response was acknowledged by the plaintiff and his attorney. The case was settled for $85,000 on his behalf; the refractive surgery center paid $15,000.
Failure to Disclose Is Difficult to Defend As sometimes happens in cataract surgery, a tear occurred in the posterior capsule, allowing a small fragment to drop into the posterior chamber. The ophthalmologist performed a minimal anterior vitrectomy and proceeded to place the IOL in the posterior chamber. Postoperative visual acuity was 20/100, with the IOP elevated at 30. The surgeon prescribed anti-inflam- matory, antibiotic, and pressure- lowering drops. Over the next ten months, the IOP fluctuated from a low of 18 to a high of 38, with VA progressively declining to LP. On the last visit, the patient expressed her unhappiness about the outcome and promised to seek a second opinion.
The patient was true to her word and ultimately filed a lawsuit, dur- ing which she learned for the first time of the intraoperative complica- tion. Defense and plaintiff experts agreed that the surgery was indicat- ed and that the complication itself was evidence of a maloccurrence rather than malpractice. Unfortu- nately for both the ophthalmologist and the patient, they also concurred in their criticism of the surgeon for neither documenting nor disclosing the complication. Furthermore, they noted that the postoperative man- agement was negligent in that no effort was made to find or remove the lost fragment, despite ongoing problems with elevated intraocu- lar pressure and decreasing visual acuity. They felt that an early refer- ral to a retinal specialist could have resulted in a better outcome for the patient. The policyholder agreed, and the patient was compensated $200,000.
As this case demonstrates, physi- cians are often reluctant to inform patients of complications, but patients clearly want to be told. Indeed, one study showed that 98% of patients want to be informed of even a minor error, and the more severe the outcome, the more patients and families desire informa- tion. While 92% of patients thought they should always be told about complications, only 60% of physi- cians thought so. Similarly, 81% of patients said they wanted to know about future adverse outcomes associated with complications, but only 33% of physicians thought patients should be told about such adverse outcomes.3
OMIC policyholders who are unsure about whether and how to disclose an adverse event to a patient can discuss the matter with our risk management specialists. Had OMIC been consulted in this situation, we would have encouraged the oph- thalmologist to approach the patient at her postoperative visit with the following information: “Mrs. Jones, as you noticed, your vision is not what you and I expected, and your eye pressure is high today. Yester- day, there were some problems during the surgery. Part of your lens fell into the back of your eye. If I had removed it, your eye could have been injured. I am putting you on some drops to control the pressure and swelling and prevent an infec- tion. I’ll watch your eye closely. If the pressure doesn’t come down, or your vision doesn’t improve, I’ll want you to see a retina specialist who may need to remove the piece of lens. I’m so sorry this has happened to you. I’m going to do all I can to help you deal with this complication and protect your vision. Do you have any questions?” Such a discussion will not only strengthen the physi- cian-patient relationship and help involve the patient in his or her care, but can also prevent an allegation of fraudulent concealment, which could open the door to punitive damages.
Some Patient Expectations Cannot Be Met A 65-year-old presented to an ophthalmologist with a complaint of droopy upper eyelids. Examination revealed bilateral ptosis and me- chanical upper eyelid entropion. After a detailed informed consent discussion, the patient agreed to a bilateral upper lid blepharoplasty and internal ptosis repair. The surgeon was pleased with the outcome; the patient was not. As she put it, she “missed the face she was born with.” The ophthalmolo- gist responded with patience and compassion as the patient continued to express her discontent. When she wrote a letter threatening a lawsuit and complaint to the Centers for Medicare and Medicaid (CMS) if he did not pay for surgery by another ophthalmologist, the insured called OMIC for assistance. He was disap- pointed that the patient was unhap- py but felt he had provided the best possible care. We agreed with his decision to deny her request and helped him craft a letter in which he stated that while he was sorry she continued to be unhappy about her outcome and the fact that surgery had not met her expectations, he was unwilling to pay for additional consultations or treatment. In response to the patient’s claim letter, OMIC had the case reviewed by an oculoplastics specialist, who felt the surgeon had provided excellent care. The patient’s com- plaint to CMS was similarly dismissed and the patient never filed a lawsuit.
Two of the ophthalmologists dis- cussed in this article had frank but empathetic conversations with their patients about the unanticipated outcomes, while the third chose not to document or disclose the com- plication. All three received written patient complaints or demands for money, two of which resulted in indemnity payments. Talking to patients in a forthright manner will not necessarily prevent claims and lawsuits, but it will help physicians feel they have responded with dignity and professionalism, in accordance with the ethical stan- dards of the American Academy of Ophthalmology and the Ameri- can Medical Association. Such an approach can also decrease the amount the physician may need to pay to compensate the patient if compensation is warranted.
Case Work-Up Results in Denial of Patient’s Cataract Claim
By Ryan Bucsi, OMIC Senior Litigation Analyst
Digest, Winter 2009
ALLEGATION: Negligent performance of cataract surgery resulting in capsular bag dialysis.
DISPOSITION: Claim was denied and patient did not pursue litigation.
Case Summary
This elderly patient presented to an OMIC insured with complaints of decreased vision Ou. upon examination, the patient’s vision was CCVA 20/100 OD and 20/50 OS. The diagnosis of a 3+ senile, nuclear, and brunescent cataract was made OD>OS. Informed consent was obtained and an extracapsular cataract extraction was planned OD. Two weeks later, the OMIC insured performed an extracapsular cataract extraction with an anterior vitrectomy and anterior chamber IOL implant OD. The procedure was complicated by a capsular bag tear that extended rapidly. On postoperative day 1, the patient was stable with eye pain OD with SCVA 20/100. The patient also complained of seeing a lot of “trash” floating around in the eye. By postoperative day 3, the patient’s visual acuity was unchanged with some continuing pain OD. The patient informed the insured that he was extremely unhappy with his surgical outcome and described his vision in the right eye as “looking through a haze with tiny bubbles.”
The patient refused to return to the insured, and on postoperative day 6, self referred to a retinal specialist due to his concerns about decreased visual acuity and a possible retinal tear post cataract surgery. The patient relayed to the retinal specialist that he had heard the OMIC insured state during the cataract surgery that the retina was torn. The retinal specialist diagnosed a vitreous hemorrhage that was likely to resolve and no retinal tears. Secondary corneal edema was diagnosed, but it was noted that it should resolve as the IOP improved. The patient was diagnosed with ocular hypertension OD and treated with Cosopt. A cataract fragment was noted inferiorly; however, it appeared to be cortical so observation was recommended.
Three months postoperatively, the pressures in the patient’s right eye had returned to normal and the vitreous hemorrhage and corneal edema had resolved. The cataract fragments in the right eye had also resolved and visual acuity was corrected to 20/25+1.
Analysis
After his vision improved, the patient wrote to the OMIC insured demanding compensation for the complicated cataract procedure and asked to speak with the insured’s insurance carrier. A representative of OMIC’s claims department telephoned the patient and requested release of all his ophthalmic medical records so a review could be performed by a board certified ophthalmologist. The patient was informed that no settlement negotiations would take place prior to an expert review and if the review was supportive of the ophthalmologist’s care, the claim would be denied. The patient consented and his records were obtained from all treating ophthalmologists and sent to a board certified ophthalmologist for a standard of care review. The expert reviewer determined that there was absolutely no deviation from the standard of care by the insured. The OMIC claims representative telephoned the patient to discuss the points the reviewer had raised in defense of the insured and followed up with a letter denying the claim. The patient did not pursue the matter, and the case was closed without any type of indemnity payment and with minimal expense to OMIC.
Risk Management Principles
The surgeon in this case reacted properly to a known complication of cataract surgery and the patient ended up with good visual acuity. However, even with a poor visual outcome, the ophthalmologist’s approach should remain the same. If this matter had not had the benefit of a supportive standard of care review and the surgeon had not acted appropriately, a small settlement or refund of some of the patient’s out- of-pocket costs might have been recommended. Giving a patient a refund or agreeing to settle a case for a small amount is not an admission of liability, and such settlements can be arranged so they are not reportable to the National Practitioner Data Bank. Often, a partial refund or small settlement will avoid months or even years of litigation. When a small settlement or refund for services is negotiated between an OMIC insured and a patient, OMIC may recommend that the patient sign a full and final release of all future claims. This is not always necessary though, so a discussion with the Claims Department will help identify the best way to handle a particular situation. See the Hotline article.
Retained Mitomycin-C Sponge During Combined Trabeculectomy and Cataract Surgery
Ryan Bucsi, OMIC Senior Litigation Analyst
Digest, Fall 2011
Allegation
Retained foreign body. Failure to remove Mitomycin-C soaked sponge following surgery.
Disposition
Settled for $35,000.
Case Summary
An OMIC insured performed an uncomplicated combined trabeculectomy and cataract removal with lens implantation on the patient’s right eye. On postoperative day one, the patient complained to the insured of pain and blurry vision. During the week one postoperative visit, she informed the insured that she had been using the prescribed medications and the right eye was no longer painful but it itched. One month postoperatively, the patient reported that the eye was okay but complained of blurry vision and problems driving. Approximately two months postoperatively, she reported that vision in the right eye was still blurry. At the three month postoperative examination, the patient complained of soreness in the right eye not helped by artificial tears; the insured diagnosed a tear film insufficiency. The patient was then seen by the insured six times during postoperative months four and five. At the first of these examinations, the patient complained that the right eye felt worse and she could not sleep due to severe pain. The insured diagnosed episcleritis. At the next examination, the insured questioned the etiology of the patient’s severe pain and considered a secondary inflammation for which the patient was advised to continue taking Cosopt. Seven days later the patient reported feeling much better. Two weeks later the patient again reported feeling much better during an examination with the insured. Nodular scleritis was diagnosed. The patient did not show up for her next scheduled examination but at her last visit with the insured she complained that the right eye pain was gradually getting worse. The patient then self-referred to another ophthalmologist, who diagnosed scleritis due to a Mitomycin-C sponge left in the right eye during the insured’s surgery. The second ophthalmologist removed the sponge from the patient’s right eye and also had to perform an additional graft surgery due to sclera that was thinned by the Mitomycin.
Analysis
The ophthalmologist who the patient self- referred to was of the opinion that the foreign body was the cause of the patient’s problems. OMIC was able to retain an expert who opined that there was no evidence that what this treating ophthalmologist found was a sponge since a sponge left in the eye would have caused corneal melting. This expert believed that what was removed was inflammatory debris or human granuloma tissue. OMIC’s defense counsel retained an ocular pathologist to examine three specimens that the second ophthalmologist took from the patient’s eye during the subsequent surgery: specimen A was white tissue, specimen B was sclera, and specimen C was conjunctiva. unfortunately, the ocular pathologist reported that specimen A was not “native to the eye” and was likely a retained piece of sponge used in the surgery by our insured. Since our expert confirmed that the object in question was indeed a piece of sponge, the decision was made to settle the case. Fortunately, the patient did not lose any visual acuity as a result of the retained foreign body and the matter was settled for $35,000.
Risk Management Principles
Accurately accounting for sponges throughout a surgical procedure should be a priority of the surgical team to minimize the risk of a retained sponge. OMIC Director Steven V. L. Brown, MD, suggests this may be accomplished by monitoring the number of sponges placed during surgery and standardizing the size of the sponges. Counting and timing of sponge placement should be noted by both the surgeon and surgical nurse to ensure that all surgical team members are aware of the number of sponges and duration of exposure. Additionally, labeling and laying out the sponges on a tray prior to surgery and then placing them back on the tray after removal will make it extremely obvious that all sponges have indeed been removed. Consider using an 8-0 vicryl suture or Micropatties (manufactured by Pearsalls in the uK) with a tail string in order to provide easy retrieval and visibility of the sponges. For further suggestions on how to reduce the risk of retained surgical instruments, please see the article “Recommended Practices for Sponge, Sharp, and Instrument Counts” in the 2009 issue of Perioperative Standards and Recommended Practices.
Dislocated Lens Fragments Should Be Referred to a Specialist
By Arthur W. Allen, MD
Argus, June, 1993
Phacoemulsification is becoming increasingly popular in the United States. Techniques such as scleral tunnel “self sealing” incisions, small central continuous curvilinear capsulorrhexis, hydrodissection, hydrodelineation and nuclear fracturing have helped speed recovery after surgery. While such techniques have allowed the phaco surgeon to remove harder nuclei more safely, they also have increased the learning curve for surgeons performing this procedure.
These factors contribute to an increasing number of cataract patients who develop rents in the posterior capsule with loss of nuclear fragments into the vitreous cavity. It is well documented that loss of such fragments often leads to secondary glaucoma, uveitis, corneal edema, retinal detachment, discomfort and decreased vision. Anterior segment surgeons risk serious complications by attempting to remove these fragments with various maneuvers such as irrigation or grasping with a cryoprobe or other instruments. A complication that leads to a protracted, painful postoperative course and a poor visual result is a good recipe for a malpractice suit.
Recently, OMIC defended a case in which the posterior capsule broke, resulting in loss of nuclear fragments into the vitreous cavity. The ophthalmologist had previous retinal training but was primarily an anterior segment surgeon. He attempted a vitrectomy to remove the nuclear fragments, but encountered difficulty with a hard nucleus. At that point, he called in a vitreoretinal colleague who took over the case and removed the fragments. Unfortunately, retinal damage had occurred, resulting in poor vision and an unhappy patient who sued the cataract surgeon.
The case ultimately went to trial with a verdict for the plaintiff, primarily because the jury thought the anterior segment surgeon did not have enough practical experience in removing lens fragments to have made such an attempt. In the jury’s opinion, only an experienced vitreoretinal surgeon should have removed the fragments, and the anterior segment surgeon made an error in judgment in attempting to do so himself. The jury’s message was clear: The anterior segment surgeon had no business trying to retrieve lens fragments from the back of the eye even though he had additional retinal training.
How does an ophthalmologist avoid or at least minimize the likelihood of a successful lawsuit if lens fragments are lost during phaco?
Prior to surgery, discuss with the patient all possible complications of phacoemulsification, including rents in the posterior capsule and loss of nuclear fragments into the vitreous cavity, that may possibly lead to secondary complications and the need for further surgery. Sharing this information with the patient prior to surgery may help decrease the patient’s shock or surprise if such an untoward event occurs. Documenting that this conversation took place may be used as evidence that the patient made an informed decision to go ahead with the procedure. The patient also should understand that there are procedures to remedy most complications.
Several articles in the literature have documented the highly successful removal of retained lens fragments, using a three-port vitrectomy approach by experienced vitreoretinal surgeons. Because these lens fragments always come to rest at the posterior aspect of the eye, either on the macula or in the area of the optic nerve, it can be hazardous for an inexperienced surgeon to try and remove these hard fragments from the surface of the retina. The experienced surgeon, however, is usually able to perform the vitrectomy, aspirate the lens fragments, and retract them to the midvitreous cavity where they can be emulsified.
The legal issue that arises when lens fragments fall into the posterior aspect of the eye is this: should the anterior segment surgeon attempt to retrieve them or refer the patient to an experienced vitreoretinal surgeon? When prevailing professional standards require that particular services be performed by a specialist, the general ophthalmologist who fails to seek the aid of a specialist and undertakes to perform those services will not automatically be held liable for every untoward result; rather, he or she will be subject to the standard of care that the law imposes on specialists. In effect, the duty recognized in many jurisdictions may be a duty either to seek the assistance of a specialist or to have and exercise the same degree of knowledge and skill that is required of a specialist. In the case discussed above, the jury apparently was not persuaded that the anterior segment surgeon had either the same degree of knowledge or skill as a vitreoretinal surgeon and/or exercised such skill.
Interestingly, there seems to be no contraindication for continuing with surgery and placing an anterior or posterior chamber lens in an eye following a complication in which lens fragments have entered the vitreous cavity. Indeed, it has been shown that the final visual result is better in eyes in which an intraocular lens has been placed than in eyes in which one has not. Although immediate removal of the lens fragments is not necessary, the patient should be referred promptly to a specialist for evaluation and, if necessary, surgical removal of the fragments.
In summary, the fact that the capsule breaks and the nucleus is lost posteriorly does not inherently pose a risk for the retina or the eye. It is the maneuvers done by the cataract surgeon to retrieve these fragments that often lead to irreparable retinal damage or poor visual results.
As a general rule, anterior segment surgeons should not attempt to remove the nuclear material, but should simply clean up the anterior segment, put in an appropriate intraocular lens, and allow the fragments to be taken care of by a specialist in this field. Eyes handled by a three-port closed vitrectomy have an excellent chance of achieving good visual acuity. Patients who ultimately achieve good vision are less likely to be angry and sue than are patients who experience complications and a poor visual result.
