Article

Retina Risk Management

Preparation prevents errors.

Related

For retina specialists, the practice of retina can be both breathtaking in what can be accomplished, and at times stressful, as they manage patients with complex, potentially blinding diseases. To offer the best chance of success for patients and practices, this article will discuss several management pearls that can help retina specialists reach their goals. Retina specialists must be diligent to put in place protocols to prevent miscommunication, unrealistic expectations, and errors. Claims related to retinal conditions are third in frequency after cataract and general ophthalmology claims reported to the Ophthalmic Mutual Insurance Company (OMIC) (Figure 1). Detailed and complete documentation of all patient phone calls and encounters remains at the top of the list of priorities for the avoidance of medical claims. Overall, indemnity payments related to retinal conditions average more than $300,000 per claim (Figure 2).

Figure 1. Total number of Ophthalmic Mutual Insurance Company claims per specialty during the period of 2014 to 2018.

Figure 2. Average indemnity payment made for Ophthalmic Mutual Insurance Company claims from 2014 to 2018 in dollars. The total number of claims for which an indemnity payment was made is shown at the end of each bar.

INTRAVITREAL INJECTIONS

Intravitreal injections are now the most frequently performed ophthalmic procedure. These injections have revolutionized the treatment of macular degeneration and diabetic retinopathy. Visual acuity results can be achieved in a way that no other treatment can offer. However, the number of medical liability claims involving intravitreal injections is also steadily rising. A few practice pearls can help reduce the incidence of malpractice claims.

Conduct a time out before performing an injection (a sample protocol is available at www.omic.com/time-out-before-intravitreal-injections ). This does not need to be an awkward process. The technician who has prepped the patient begins by announcing that, “This is Mrs. Jones and we are performing an injection of bevacizumab to the right eye for diabetic macular edema.” Both the patient and the physician confirm this information before the physician proceeds with the injection. The use of povidone-iodine is recommended for the prevention of infection. This should be documented in the medical record. Allow sufficient time for the iodine to sit on the conjunctiva for the antiseptic effect to be complete.1

Software is available to alert to an injection being performed too early for this eye or alerting that the previous injection has not been paid by the patient’s insurance carrier. Many electronic medical records systems are adding this to their capabilities and stand-alone inventory management products are also available.

Jeremiah Brown Jr., MS, MD, is a vitreoretinal specialist at Brown Retina Institute in Texas. Anne M. Menke, RN, PhD, is Patient Safety Manager for Ophthalmic Mutual Insurance Company. Linda Harrison, PhD, is the director of Ophthalmic Mutual Insurance Company Risk Management. Ryan Bucsi is vice president of claims at Ophthalmic Mutual Insurance Company. The authors report no related financial disclosures. Editor’s note: This article is discussed in an episode of The Retina Podcast. Listen at www.retinapodcast.com .

ENDOPHTHALMITIS

Endophthalmitis remains a potentially devastating complication of ophthalmic procedures. While this is a known potential complication of many procedures, other factors often determine whether or not a claim is filed. It cannot be overemphasized that retina specialists must inform patients of the risk of infection following any procedure and the importance of contacting the office for unresolving pain, vision loss, or visual floaters. Delay in diagnosis is frequently the cause of an incident becoming a claim. Office staff should be well educated in the art of triage and the importance of promptly scheduling appointments for patients who have these symptoms. In an OMIC study of endophthalmitis cases from 2006 to 2017, 78% of endophthalmitis claims involved cataract surgery or intravitreal injection.2

Physicians and staff should be prepared to discuss with patients that underlying risk factors may make them more prone to infection. For example, one might explain as follows: “Any kind of surgery can result in an infection. Your underlying diabetes may make it more likely that you will develop an infection, and it may be more difficult for your body to it fight off. These are the things that I want you to watch out for...”

FAILURE TO DIAGNOSE

Failure to diagnose a medical condition continues to be a major cause of medical malpractice liability claims. In a recent OMIC study, 38% of all diagnostic error claims involved retinal conditions. Retinal detachment cases accounted for the vast majority of these claims (79%).3 A couple of issues arise frequently. The first is the need for a prompt dilated retinal examination with scleral depression. Staff should be trained on the importance of promptly scheduling patients who report symptoms of retinal tear or detachment. Once in the office, the examining physician should document that the retinal periphery was examined to the ora in all 4 quadrants. If the retina cannot be seen, other strategies such a B-scan ultrasonography or referral to a retinal specialist should be employed. Lastly, patients should be educated that the condition can change over the next several weeks. While there is not a retinal detachment the day of the exam, one may develop later. Patients should be instructed to come in promptly for new flashes, floaters, or a shadow in their vision. It is often very helpful to schedule a follow-up examination, regardless of new symptoms, because not all patients with retinal tears experience symptoms. Lastly, remember the risk factors for retinal detachment, which include previous retinal breaks, myopia, lattice degeneration, cataract surgery, trauma, and a history of RD in the fellow eye or in the patient’s family.4

RETINAL ISCHEMIA

Management of patients with acute retinal arterial ischemia has undergone a sea change.5 Rather than managing these patients with observation for retinal complications only, all patients with these findings should be referred. According to published guidelines, “acute retinal arterial ischemia, including vascular transient monocular vision loss (TMVL) and branch (BRAO) and central retinal arterial occlusions (CRAO), are ocular and systemic emergencies requiring immediate diagnosis and treatment. Because the risk of stroke is highest within the first few days after the onset of visual loss, prompt diagnosis and triage are mandatory. Eye care professionals must make a rapid and accurate diagnosis and recognize the need for timely expert intervention by immediately referring patients with acute retinal arterial ischemia to specialized stroke centers without attempting to perform any further testing themselves.”6

It is important to develop protocols for where patients will be referred. Not every region will have a stroke center. In these cases, referral to an emergency room at a hospital equipped to diagnose and manage stroke patients would be appropriate. All staff should be aware of the physician’s referral preference so that a call can be made to the ER informing them that the patient is on the way. Remember, these patients should be treated in the same manner as a patient presenting with an acute transient ischemic attack. Lavin et al studied 103 consecutive patients who presented at Vanderbilt University with an acute central retinal artery occlusion.7 They found that central retinal artery occlusion patients had similar risks of subsequent stroke, myocardial infarction, and death as patients with high-risk transient ischemic attack.

RETINOPATHY OF PREMATURITY

The care of premature infants with this potentially blinding retinal disorder presents the opportunity to make a positive impact that will affect this patient’s entire life. However, the risk of permanent vision loss presents challenges that require special office and hospital procedures and protocols to achieve the best possible outcomes. The care of premature infants is complicated. Multiple medical specialists, nurses, and social workers work together to orchestrate each infant’s care. Meanwhile, the parents of these infants are often stressed, overwhelmed, and challenged to coordinate all of the required care. It is not surprising that, without a very strict plan to insure that all necessary care is delivered properly, appointments, screenings, and treatments can fall through the cracks.

The Ophthalmic Mutual Insurance Company has developed an ROP Safety Net Toolkit with protocols to help hospitals and offices prevent lapses in care (omic.com/rop-safety-net ). Key tenets of the ROP toolkit include the assignment of an ROP coordinator at the hospital as well as in the examining physician’s office. The coordinator’s role is to track the care of each infant and verify that no visit is missed. Coordinators must be diligent in the scheduling of ROP exams using the appropriate protocol. The hospital ROP coordinator must ensure that the proper babies are screened at the appropriate time, and that the written orders are carried out as ordered; the coordinator also must organize the ROP exams with the pediatric ophthalmologist and/or retina specialist. It is also critical for the hospital and office ROP coordinators to communicate about infants who need follow-up care on the appropriate dates. The office coordinator must track these patients per established protocol to make sure they are seen in the specified time frame. A final point is the critical importance of having strict transfer-of-care protocols for infants who need treatment when there is no treating ophthalmologist on staff at the neonatal intensive care unit. Once the need for treatment is identified, the treatment must be performed within 72 hours.

CONSIDER GIANT CELL ARTERITIS

Medical malpractice lawsuits involving the care of patients with giant cell arteritis have been costly and in many cases, preventable. Four factors play critical roles in these cases: (1) obtaining a thorough medical history, (2) coordination between specialists, (3) ordering and tracking laboratory studies, and (4) patient noncompliance. It is critical to inquire about non-vision-related symptoms in the setting of acute vision loss in adults over age 50. Symptoms such as fatigue, malaise, headache, night sweats, and jaw claudication should be discussed and all pertinent positives and negatives should be documented. In a review of 18 giant cell arteritis cases reviewed by OMIC, in 15 of 18 cases patients had symptoms other than vision changes.8 However, frequently, the ophthalmologist did not document these symptoms in the history. Testifying experts have opined that the failure to inquire regarding these symptoms resulted in a delay in diagnosis. A checklist developed by Dr. Ron Pelton (omic.com/giant-cell-arteritis-checklist ) is useful for obtaining a thorough medical history.

When patients are sent for temporal artery biopsy, the request should be made urgent. Laboratory studies for erythrocyte sedimentation rate and C-reactive protein should be marked urgent. An in-office mechanism for the follow-up of laboratory studies should be employed to ensure that the testing has been performed and the results are immediately brought to the physician’s attention. Patients who do not follow through with orders for bloodwork or a temporal artery biopsy should be called and a letter sent via regular mail. Failure to comply with these directives should result in a noncompliance letter being sent to the patient. Examples of letters of noncompliance are available on the OMIC website at omic.com/noncompliance-guidelines-with-sample-missed-appointment-letter .

Lastly, one should consider involving a rheumatologist in the care of patients with giant cell arteritis. Tociliizumab, an interleukin-6 (IL-6) receptor antagonist, combined with a 26-week prednisone taper, has been shown superior to a prednisone taper alone in achieving a sustained glucocorticoid-free remission from giant cell arteritis.9

The world of retina is exciting, varied, and emotionally and intellectually rewarding. However, the complexity of retinal disease presents unique management risks and challenges. The management issues presented are a good starting point for retina specialists to review practices and protocols to achieve the best possible outcomes for patients. RP

REFERENCES

  1. Koerner JC, Geroge MJ, Kissam EA, Rosco MG. Povidone-iodine concentration and in vitro killing time of bacterial corneal ulcer isolates. Digit J Ophthalmol. 2018;24(4):24-26.
  2. Menke AM. Endophthalmitis malpractice claims update. The OMIC Digest. 2018;28(2)1-7. Available at: https://www.omic.com/wp-content/uploads/2018/10/Digest-No-2-2018-WEB-FINAL-rw.pdf .
  3. Menke AM. Failure to diagnose retinal detachments. The OMIC Digest. 2017;27(1)1-5. Available at: https://www.omic.com/wp-content/uploads/2017/10/Digest-No-1-10-10-17-entire-for-web-1.pdf .
  4. Flaxel CJ, Adelman RA, Bailey ST, et al. Posterior vitreous detachment, retinal breaks, and lattice degeneration preferred practice pattern. Ophthalmology. 2020;127(1):P146-P181.
  5. Olsen TW, Pulido JS, Folk JC, Hyman L, Flaxel CJ, Adelman RA. Retinal and ophthalmic artery occlusions preferred practice pattern. Ophthalmology. 2017;124(2):120-143.
  6. Biousse V, Nahab F, Newman NJ. Management of acute retinal ischemia. Ophthalmology. 2018;125(10):1597-1607.
  7. Lavin P, Patrylo M, Hollar M, Espaillat KB, Kirshner H, Schrag M. Stroke risk and risk factors in patients with central retinal artery occlusion. Am J Ophthalmol. 2018;196:96-100.
  8. Pelton RW, Menke AM. Giant cell arteritis claims are costly and difficult to defend. The OMIC Digest. 2015;25(3)1,4-5. Available at: https://www.omic.com/wp-content/uploads/2015/09/Digest-No-3-9-2-15-for-web.pdf .
  9. Stone JH, Tuckwell K, Dimonaco S, et al. Trial of tocilizumab in giant-cell arteritis. N Engl J Med. 2017;377(4):317-328.