Endophthalmitis/TASS Recommendations and AAO/ASCRS Reports
Anne M. Menke, R.N., Ph.D.
OMIC Risk Manager
DISCLAIMER: This information is intended solely to provide risk management recommendations. It is not intended to constitute legal advice and should not be relied upon as a source for legal advice. If legal advice is desired or needed, an attorney should be consulted. This information is not intended to be a modification of the terms and conditions of your OMIC policy of insurance. Please refer to your OMIC policy for these terms and conditions.
Uncomplicated cataract surgery was performed on an elderly woman. At the end of the procedure, the ophthalmologist was informed by the nurse that the sterilization indicator on the instruments had not changed. It was feared that the instruments had been washed but not sterilized. The physician and ASC medical director decided not to inform the patient of the potential problem, opting instead to increase the frequency of topical antibiotics. No signs of infection were noted at the first postoperative visit, but two days later, endophthalmitis developed. Ten days after surgery, the two physicians informed the patient and her family that the same strain of pseudomonas aeruginosa had grown in the eye and the ultrasonic bath water at the ASC, leading them to conclude that problems with sterilization were the likely cause of her endophthalmitis and phthisical eye. The patient’s lawsuit was settled on behalf of the ASC for $650,000.
Poor outcomes like this make infectious endophthalmitis one of the most feared complications of ophthalmic surgery. Recently, a type of inflammatory response known as TASS, or Toxic Anterior Segment Syndrome, has garnered attention and prompted calls to OMIC’s Risk Management Hotline. While not all adverse events can be prevented, there is much ophthalmologists can do to reduce the incidence of endophthalmitis and TASS. In its review of OMIC’s claims experience and the lessons learned from it, this article offers risk management guidance on more effective prevention, recognition, and response to these sight-threatening conditions.
ENDOPHTHALMITIS/TASS CLAIMS EXPERIENCE
Since OMIC’s inception in 1987, endophthalmitis has accounted for 0.6% of claims frequency (150 claims out of 2,559 total) and 5% of claims severity ($3,345,964 paid indemnity out of $63,191,199 total). Of these 150 endophthalmitis cases, 25 remain open; of the 125 closed endophthalmitis cases, only 8 were taken to trial, and in all but one, the jury returned a defense verdict. A poll of the jury after the sole plaintiff verdict of $735,000 revealed that the award was in response to the defendant group’s practice of locking up medical records on weekends, thus preventing access to key patient information needed to assess the plaintiff’s condition. Since the practice’s name did not appear on the jury’s form, a settlement on its behalf was effected for the amount of the verdict, and the plaintiff award against the ophthalmologist was vacated.
More than three-quarters (78%) of OMIC’s endophthalmitis cases have closed without an indemnity payment. The percentage of cases that have settled (22%) and the median settlement amount ($75,000) are comparable to OMIC’s overall data. Despite the severity of the outcome for the patient, endophthalmitis settlements have ranged from $9,000 to $735,000 compared to a low of $500 and a high of $1.8 million for all settlements. Reflecting the relative novelty of TASS, allegations in all but 3 of the 150 claims involve an infectious rather than an inflammatory process.
Table 1. Indemnity Payments by Type of Case
TYPE OF CASE
TOTAL CLOSED
CLAIMS
CLOSED WITHOUT INDEMNITY
CLOSED
WITH
INDEMNITY
SETTLEMENT
RANGE
MEDIAN
SETTLEMENT
Cataract
77
59
18
$9,000 – 735,000
$75,000
Retina
23
19
4
$58,000 – 101,476
$75,000
Cornea
14
13
1
$300,000
Trauma
7
3
4
$24,999 – 248,000
$31,000
Glaucoma
2
2
0
Endogenous
1
0
1
$15,000
Uveitis
1
1
0
Given the estimated 2 million cataract procedures performed annually in the United States, it is hardly surprising that cataract surgery would account for 61% of all endophthalmitis cases. Less expected, however, is that only 23% of cataract-related endophthalmitis cases resulted in an indemnity payment. During the informed consent process for cataract surgery, ophthalmologists routinely disclose this rare complication, and most actively try to prevent its occurrence by treating preexisting conditions such as blepharitis, preparing the eye with povidone iodine, and administering antibiotics. Indeed, assuming cataract surgery was indicated in the first place and the endophthalmitis was promptly recognized and treated, expert witnesses view this complication as a tragic maloccurrence rather than malpractice. On the other hand, cases of endophthalmitis resulting from trauma are rare (6%), but they result in settlement 57% of the time. Clearly, ophthalmologists who do not administer antibiotics and/or carefully monitor the eye for signs of endophthalmitis after trauma are not supported by defense or plaintiff experts.
ANALYSIS OF RISK ISSUES
It is helpful to analyze the risk issues associated with substandard care by dividing them into four categories. “Clinical” issues include debates in the ophthalmic community on the standard of care and the natural history of the disease or condition. “Systems” issues involve complicated processes of care, such as medications (research, manufacture, distribution, ordering, etc.), equipment, and follow-up and telephone screening methods. Finally, the acts, omissions, and decisions of individual physicians and patients also impact care outcomes. The following table indicates the type and frequency of risk issues in OMIC’s endophthalmitis and TASS cases.
Table 2. Incidence of Risk Issues in Endophthalmitis/TASS Cases
Clinical 4
• Antibiotics
o Route
o Timing
Systems 32
• Telephone care (16)
o After-hours (12)
o Staff (4)
• Sterilization (6)
o Not done (2)
o Ultrasound bath contaminated
o Cracked irrigation bottle
o Saline flush contaminated
o Donor tissue not cultured
• Equipment malfunction (3)
• Product liability (2)
• Access to medical records (1)
Physician 57
• Diagnostic process (18)
o Diagnosis did not account for symptoms
o Exam elements
• Documentation (7)
o Missing
o Late
o Altered
• Surgery not indicated or contraindicated (6)
• Treatment (6)
• Follow-up interval (5)
• Referral delay (5)
• Informed consent and disclosure (4)
• Coordination of Care with PCP (3)
• Supervision of OD (2)
• Discharge instructions (1)
Patient 5
• Noncompliance
Amid ongoing debate of evidence-based guidelines for prevention of endophthalmitis, it is noteworthy that antibiotic administration was not a key issue in any case; nor was patient noncompliance a significant factor. Instead, systems issues and physician-driven processes predominate. The remainder of this document provides risk management recommendations targeted at these issues.
CAUSES AND PREVENTION OF ENDOPHTHALMITIS/TASS
Systems for ordering, cleaning, sterilizing, and maintaining ophthalmic equipment and products were a factor in 11 OMIC cases. Our claims experience confirms the research findings of Dr. Nick Mamalis and his colleagues at the John Moran Eye Center/Intermountain Ocular Research Center of the University of Utah. Funded by a grant from ASCRS (American Society for Cataract and Refractive Surgery), the ophthalmologists at the Center have been evaluating endophthalmitis and TASS for the past 15 years, searching for what causes these conditions and what steps should be taken to prevent them. In their work on TASS, they found that preparations of BSS, antibiotics, anesthetics, and other medications were not the correct pH and/or osmolality, or that they contained endotoxins or preservatives that triggered anterior segment inflammation. Numerous problems during the cleaning and sterilization of instruments were also noted, such as the use of enzymatic cleaners and inadequate rinsing.
In their capacity as users, surgical directors, board members, and owners, ophthalmologists have a leadership role to play in addressing these systems issues that adversely impact care outcomes. They can review equipment maintenance and infection control measures in hospitals and ASCs, focusing particular attention on flash sterilization, re-use of single-use items, and the ordering, preparation, and use of ophthalmic products, devices, and medications. Table 3 summarizes the causes of endophthalmitis and TASS and the actions needed to prevent them.
Table 3. Steps Ophthalmologists Can Take to Reduce the Incidence of Endophthalmitis/TASS
TASS
ENDOPHTALMITIS
CAUSE
Noninfectious reaction to toxic agent present in:
• BSS solution
• Antibiotic injection
• IOL
• Endotoxin
• Residue
• Preservative
Failure to correct
• pH
• Osmolality
Bacterial, fungal, or viral infection
PREVENTION
• Whole team approach to ordering, cleaning, sterilizing, and preparation of instruments, viscoelastic, medications, and irrigation solution to ensure proper pH, osmolality, non-toxicity
• Avoid re-use, especially of cannulas and damaged instruments
• Rinse I/A tips and phaco hand pieces at conclusion of each cleaning step with sterile, deionized water through both ports
• Replace ultrasound water baths daily
• Change the steam autoclave sterilizer at least weekly
• Careful wound construction
• Avoid ophthalmic ointment and patches with clear corneal incisions
• Treat preexisting blepharitis
• Eyelid preparation with 5% povidone iodine
• Perioperative antibiotics
• Careful wound construction
• Avoid ophthalmic ointment and patches with clear corneal incisions
• Discharge instructions on wound care, signs and symptoms to report, contact information
• Careful telephone screening of ophthalmic complaints
SCREENING OF PATIENT COMPLAINTS KEY TO IMPROVED CARE
The two primary issues in OMIC’s endophthalmitis cases—telephone care and the diagnostic process—indicate the need to carefully screen patients who present with ophthalmic complaints, especially postoperatively, and to educate them about which symptoms to report. Each of these identified risks is squarely within physician control and thus can be modified. “Telephone Screening of Ophthalmic Problems” (in the Risk Management Recommendations section of www.omic.com) provides screening protocols and contact forms for both staff and physicians taking after-hours calls.
“A Witty (WIT-D) Approach to Avoiding Mistakes” proposes an easy-to-remember and effective strategy for improving the diagnostic process. Establish a prioritized differential diagnosis in order to rule out the worst case scenario; determine the information you need to obtain during the history and examination, or through studies, to rule that in or out; tell the patient and other health care providers to ensure that you are notified of all signs and symptoms that could help establish the diagnosis and determine the treatment plan; and document your decision-making process and follow-up plan. More information is available in “Failure to Diagnose Cases: Focus on Traumatic Eye Injuries,” available in the Risk Management Recommendations section of www.omic.com).
ENDOPHTHALMITIS OR TASS?
Failure to rule out endophthalmitis has resulted in harm to patients and significant liability exposure for OMIC policyholders. Emerging research indicates that the ophthalmologist should also include inflammatory reactions such as TASS in the differential diagnosis. Indeed, mistaking one for the other could lead not only to a delay in treatment but may worsen the outcome. The following table summarizes some of the distinguishing features and the recommended treatment. Although this table may be helpful, it can still be difficult or impossible at times to discriminate between endophthalmitis and TASS.
Table 4. Differential Diagnosis : TASS or Endophthalmitis?
TASS
ENDOPHTHALMITIS
Onset
12-24 hours
4-7 days
Signs/Symptoms
*distinguishing feature
• Blurry vision
• Pain: none, or mild to moderate
• Corneal edema: diffuse, limbus to limbus*
• Pupil: dilated, irregular, nonreactive*
• Increased IOP*
• Anterior chamber: mild to severe reaction with cells, flare, hypopyon, fibrin
• Signs and symptoms are limited to anterior chamber*
• Gram stain and culture negative
• Decreased VA
• Pain (25% have no pain)
• Lid swelling with edema
• Conjunctival injection
• Hyperemia
• Anterior chamber: marked inflammatory response with hypopyon
• Vitreous involvement
• Inflammation in entire ocular cavity*
Treatment
• Rule out infection: culture anterior chamber
• Intensive corticosteroids
• Monitor IOP closely for signs of damage to trabecular meshwork and side effects of steroids
• Watch closely for next few hours for signs of bacterial infection
• Culture anterior chamber and vitreous
• Intravitreal and topical antibiotics
• Vitrectomy
DISCLOSURE OF A STERILIZATION BREAKDOWN
The malpractice case featured earlier in this document stemmed from a series of breakdowns in the facility’s sterilization process. When notified of it, the physician consulted with the ASC’s Medical Director and together they decided not to alarm the patient until they knew the facts. By not warning the patient of the symptoms to watch for, they arguably missed an opportunity to diagnose the problem earlier.
As we note in “Responding to Unanticipated Outcomes” (available in the Risk Management Recommendations section of www.omic.com), ophthalmologists are well-advised to tell patients about complications as well as potential problems with sterilization. Patients have a need and a right to know about their own condition, and can help monitor for the development of symptoms. Such disclosure of adverse events is best understood as a continuation of the informed consent process begun before the surgery.
Moreover, communicating with the patient sympathetically and non-defensively within the shortest appropriate time period may help dispel much of the anger, confusion, and distrust that complications may engender, while preventing allegations of fraudulent concealment that could extend the statute of limitations or allow for punitive damages.
When talking to patients, stick to the currently known facts, avoiding speculation or blame. Use language such as this: “I was informed by the nurse at the end of the procedure that one of the sterilization indicators on the instruments had not changed color. This means that the instruments may not have been sterile. If they were not sterile, you are at an increased risk for an infection. The surgery center is evaluating what happened, and I will share information with you as it becomes available. For now, I want to go over with you the medication you are on to prevent an infection, and what symptoms to report to me.”
Document all disclosure conversations in the medical record, noting the names of all family or staff members present. Unless the ASC informs you that certain information is confidential, you can document facts disclosed to you about the investigation and note them in the record. As more information becomes available, share it with the patient and document it.
RESPONSE TO A CLUSTER OF ENDOPHTHALMITIS OR TASS CASES
An effective response depends upon careful coordination and cooperation among the facility, surgeon, and patient. OMIC policyholders are urged to call our risk management department for confidential assistance as soon as possible. The facility should contact all affected surgeons, and document the notification efforts. Ophthalmologists in turn need to call all patients operated on that day or during that period, and notify them of the events, screen for symptoms, and educate them about when and why to contact the physician.
As in any disclosure discussion, the physician should stick to the facts and avoid speculation or blame: “I don’t want to alarm you, but I felt you should know that several patients have contracted a serious infection OR experienced a serious reaction after their cataract surgery two days ago. You may or may not have this infection/reaction. To find out, I’m going to ask you some questions, go over your medications and explain what I want you to watch out for.” Document the discussion, instructions, and follow-up plan in the patient’s medical record.
Until endophthalmitis or TASS is ruled out and the patient’s condition has stabilized, see or speak with the patient on a regular basis. Some ophthalmologists call their patients daily during the at-risk period to both gather accurate information and to reassure the patient. Pay particular attention to follow-up periods for patients whose surgery falls right before a weekend or holiday. Encourage them to call you to report symptoms or ask questions.
The facility needs to sequester all involved materials, interview staff, and evaluate equipment, devices, solutions, medications, and the sterilization process. All aspects of the investigation should be carefully documented. The investigation will help locate the responsible organism or toxic agent, ascertain liability, and determine what steps to take to remedy any identified problems. Dr. Mamalis’s group developed an Excel-based protocol that can be used for individual or clustered cases of infectious or sterile endophthalmitis. The protocol is in an Excel format that allows reporting of multiple cases in one document; it is available on the OMIC website, via e-mail nick.mamalis@hsc.utah.edu, or by calling 801.581-6586. Detailed information about each patient’s pre- and postoperative course, the facility, equipment, supplies, medication preparation and sterilization technique are entered into the spreadsheet, compiled, and then sent to the Center for review. Research fellows are available for on-site evaluations, and charge only airfare and nominal expenses.
DECIDING WHEN TO POSTPONE OR RESUME SURGERY AT A SURGICAL FACILITY
Faced with a cluster of either endophthalmitis or TASS cases, both the surgical facility and the individual surgeon will need to decide whether or not it is safe to proceed with other scheduled ophthalmic cases at that location. Ophthalmologists who have an ownership interest in an ambulatory surgical facility may also be involved in these deliberations, and should act as patient advocates promoting quality care. Patient safety should be the driving factor, and all parties must feel confident that the causative factors have been identified and addressed. At times, the surgery center may need the assistance of outside consultants such as Dr. Mamalis or legal counsel in order to conduct the investigation and make the decision to cancel or resume procedures. OMIC’s Risk Manager can be a valuable resource.
Most elective cases can be postponed. Patients may be inconvenienced but will appreciate that you are working to ensure the best outcome for their eye condition. For urgent and emergent ones, you will need to find an alternative facility. If you do not have privileges at other facilities, you will need to refer the patient to an ophthalmologist who does. Contact the affected patients: “The _____ surgical facility is evaluating a potential safety issue. For your protection, your surgery will be postponed OR your surgery will need to be done at ___________ surgical facility. Since I do not operate at that facility, would you like for me to refer you or do you have another ophthalmologist you would like to see for your surgery?”
When the causes of the endophthalmitis or TASS have been identified and addressed, the surgeon and facility may want to notify patients of the prior problem. A sample letter is included at the end of this document.
AAO AND ASCRS REQUEST PHYSICIANS’ HELP TRACKING TASS
In response to over 80 TASS cases nationwide, the AAO (American Academy of Ophthalmology) and ASCRS announced the formation of a task force to help determine the causes and share best practices. Chaired by Dr. Mamalis, it includes Dr. Henry Edelhauser from Emory University, Dr. Arjun Srinivasan from the Centers for Disease Control, Dr. Walter Hellinger (Epidemiologist from Mayo Clinic), Dr. Sam Masket, President of the ASCRS, and members of the ophthalmic product industry.
Ophthalmologists with TASS cases are urged to complete the two short questionnaires that follow about the products involved during cataract surgery and the actual process of cleaning and preparing instruments and patients for surgery and forward them to Dr. Mamalis.
A preliminary report on over 100 cases was communicated to AAO and ASCRS members on June 22, 2006. There is no single cause, but potential sources have been identified. These include pre-operative non-steroidal anti-inflammatory drugs; intracameral anesthetics that remain in the anterior chamber longer due to ophthalmic visco surgical devices (OVD), or those that have been improperly dosed, mixed, or injected; epinephrine stabilized by bisulphites or other preservations added to balanced salt solutions (BSS); and reusable cannulas or viscoelastic that retain residues, enzymatic detergents, or ultrasonic cleaners.
High surgical volume can put pressure on the sterilization process, leading to inadequate rinsing and incomplete cycles. Cases reported on OMIC’s Risk Management Hotline point to an inadequate supply of instruments and a reliance on flash sterilization, which was designed to quickly reprocess instruments that had been dropped or contaminated, not those that have been used and need to be cleaned.
OMIC policyholders who have additional questions or concerns about this issue may call our risk management department for assistance at (800) 562-6642, extension 652.
Product Questionnaire Page 1 of 3
Cataract surgical center contact:
Name of center: _______________________
Contact person: ______________________
Telephone number: ____________________
Fax number: _________________
Address: __________________
___________________
On behalf of the American Society of Cataract & Refractive Surgery, please return to:
Nick Mamalis, MD
Intermountain Ocular Research Center
John A. Moran Eye Center
University of Utah
Salt Lake City, Utah 84132
Fax# (801) 581-3357
Please indicate below the products and procedures which were used during surgeries that were followed by cases of TASS in the year 2006.
Preoperative topical mydriatic: ____________________ (trade name)
Preoperative topical cycloplegic: ___________________ (trade name)
Preoperative topical NSAID: _____________________ (trade name)
Preoperative topical cleaning agent (eg Ocusoft, Baby Shampoo): _______________ (trade name)
Preoperative topical anti-septic (circle one): Betadine 5% (ophthalmic) / Betadine 10% /
Phisohex / Chlorhexidene 2% / Other:_____
Preoperative topical antibiotic (w/o concentration): ___________________ (trade name)
Preoperative topical anesthetic (w/o concentration): ___________________ (trade name)
Intracameral anesthetic: Yes No
Intracameral anesthetic preservative free: Yes No
Retrobulbar or peribulbar anesthetic block: Yes No
Flexible iris retractor: Yes No
Intraocular miotic (circle one): Miostatin / Miochol / Other:_____________ (trade name)
Viscoelastic #1 (circle one): Discovisc / Duovisc / Provisc / Viscoat / Cellulgel / Healon
/ Healon GV / Amvisc+ / Other: ___________ (trade name)
Page 2 of 3
Contact tel # (from pg. 1): ____________
Viscoelastic #2 (circle one): Discovisc / Duovisc / Provisc / Viscoat / Cellulgel / Healon
/ Healon GV / Amvisc+ / Other: ___________ (trade name)
BSS (500cc) intraocular irrigant (circle one): AMO / Acorn / Cytosol / Alcon / Baxter /
Other: __________________ (trade name)
Topical (15cc) irrigant (circle one): AMO / Acorn / Cytosol / Alcon / Baxter /
Other: _________
Epinephrine added to BSS: ________________________ (trade name & concentration)
None added
Intraocular antibiotic #1 added to BSS: ___________________________ (trade name)
Intraocular antibiotic #2 added to BSS: ___________________________ (trade name)
Intracameral antibiotic #1: ________________________ (trade name)
Intracameral antibiotic #2: ________________________ (trade name)
Incision (circle one): Clear cornea / Scleral tunnel / Other: __________________
Suture of incision: Yes No
Type of Blade/Knife (circle one): Reused non-diamond / Reused diamond /
Disposed after each case
Blade/Knife Brand (circle one): ASICO / Alcon / Sharpoint / Rhein / Other: ________
Phaco delivery system (circle one): Legacy / Infinity / Sovereign / White Star /
Millenium / Other: ____________________
Phaco tip reused: Yes No
Phaco tubing reused: Yes No
I/A tip reused: Yes No
Insertor tip reused: Yes No
Insertor reused: Yes No
Cartridge for loading IOL to insertor: Alcon / AMO / White Star / Bausch & Lomb
Other: ____________________________
Other cannulated equipment reused: Yes No
Custom Pack (circle one): Alcon / Allegiance / Cardinal / Medline / Other: __________
Page 3 of 3
Contact tel # (from page 1): ____________
IOL Type (circle one): Silicon / Acrylic hydrophilic / Acrylic hydrophobic / PMMA /
Other: _______________________
IOL Manufacturer: Alcon / AMO / Bausch & Lomb / Staar / Other: ______________
Capsule staining (select one): Trypan blue / ICG / Other: _______________________
Post-operative topical antibiotic: _____________________ (trade name)
Post-operative topical steroid: ______________________ (trade name)
Post-operative topical NSAID: _____________________ (trade name)
Instrument Re-processing Questionnaire Page 1 of 2
Cataract surgical center contact:
Name of center: _______________________
Contact person: ______________________
Telephone number: ____________________
Fax number: _________________
Address: __________________
___________________
On behalf of the American Society of Cataract & Refractive Surgery, please return to:
Nick Mamalis, MD
Intermountain Ocular Research Center
John A. Moran Eye Center
University of Utah
Salt Lake City, Utah 84132
Fax# (801) 581-3357
1. How many operating rooms do you use on days of cataract surgery? ____
2. How many cases of cataract surgery do you perform on an average day? ____
3. Have you observed a pattern to your cases of TASS (surgical case of day, surgery day of week, OR number)? Y, N
4. How many trays of cataract surgical equipment do you have? ____
5. Do you have a written protocol which specifies the time, duration, detergents, enzymatics, type of water (tap vs sterile) and rinsing for cleaning the following re-used equipment:
Phaco handpiece Y N Don’t Know Not reused
Volume of water used to flush handpiece: _______
Phaco tubing Y N Don’t Know Not reused
I/A tips Y N Don’t Know Not reused
Have you had occluded I/A tips? Y N
Insertor Y N Don’t Know Not reused
Other cannulated equipment Y N Don’t Know Not reused
Forceps for loading IOL Y N Don’t Know Not reused
6. Is any of your re-used equipment cleansed with enzymatic detergents?
Y N Don’t Know
7. Is any of your re-used equipment cleansed or rinsed in an ultrasonic bath? Y, N
Page 2 of 2
Contact tel # (from pg. 1): ____________
8. If you use an ultrasonic bath, is it cleaned:
Between each use ≥Once daily ≥Once weekly <Once weekly
Don’t Know
9. Is re-used cataract surgical equipment separated from non-ophthalmologic surgical equipment through all steps of cleaning before sterilization?
Y N Don’t Know
10. Which method is used for sterilizing your re-used equipment:
Autoclave
ETO (ethylene oxide gas)
Plasma gas
Glutaraldehyde
Other: ___________________________
11. If you sterilize your equipment with an autoclave, please indicate all that apply:
Regular inspection & cleaning documented Y N Don’t Know
Recent operational problems Y N Don’t Know
Steam produced by facility-wide boiler Y N Don’t Know
Steam produced only for autoclave Y N Don’t Know
NOTE: This is a sample disclosure form intended for use once the causes of the infection or toxic reaction have been identified and addressed, and the responsible parties at the ASC have determined that it is safe to proceed with surgery. Modify it for the particular clinical situation and circumstances. For example, in some cases, the Infection Control Committee may be involved instead of public health officials.
____________________________ Surgery Center
Consent and Disclosure About Endophthalmitis or TASS Cases
I have been advised that on _____________________, patients undergoing cataract surgery at _______________ Surgery Center contracted a serious bacterial/fungal/viral infection OR experienced an inflammatory reaction in their eye and that some of these patients are still under care for their condition. I understand that public health officials and outside medical experts have reviewed this matter and believe it is safe to proceed with surgery. I have been given the opportunity to ask questions regarding these infections/inflammatory reactions, the investigation into them, my surgery, and any other questions I have had, and my questions have been answered to my satisfaction. Accordingly, I desire to and consent to undergoing surgery at _______________________ Surgery Center at this time.
Date: _________________________
Patient’s signature_______________________________________
Debunking the Exploding Cataract: Why You Shouldn’t Sell Surgery
By Michael R. Redmond, MD
[Argus, March, 1992]
A patient presents to the ophthalmologist’s office with a cataract and 20/40 Snellen visual acuity. Visual acuity with medium glare is recorded as 20/100. Cataract surgery is performed and goes well, but the patient develops a retinal detachment soon after surgery. Complications ensue and the final visual acuity is light perception. The patient sues the cataract surgeon on the basis that the surgery was unnecessary in the first place.
A young father, himself postop twice for strabismus surgery, has his son in the pediatric ophthalmologist’s office for the child’s strabismus follow-up. Allegedly, the ophthalmologist initiates a discussion and tells the father that he, the father, needs additional strabismus surgery and that it can be done simply and without problems. Postoperative restrictions develop, corneal exposure with keratitis ensues and the father endures additional surgeries without total relief. He sues the ophthalmologist alleging, among other things, lack of informed consent.
Were the surgeries marketed too vigorously? Expectations set too high? Were the surgeries themselves trivialized, potential complications minimized or not even discussed? Were the patients “solicited” for surgery?
In today’s medical milieu, the ophthalmologist must avoid any hint of pressure on the patient or the family to undergo an elective procedure. Physicians are required to inform patients about the therapeutic (surgical) alternatives available and the urgency or elective nature of a procedure, but they must avoid “selling” their services. If a patient is pressured to undergo an elective procedure and a less than satisfactory result occurs, the patient is much more likely to become angry and initiate a malpractice action. Under these circumstances, the patient is unlikely to admit to recalling discussions of risks and alternatives, but will likely remember assurances, trivializations and encouragement to undergo surgery.
Documentation and informed consent are two cornerstones of risk prevention and management. An ophthalmologist can never do too much in these areas but can easily, all too often, do too little. Because what an ophthalmologist does every day may become routine, the multiple complaints the patient expresses (e.g., headlight glare, inability to read, people not knowing whether or not the strabismus patient is looking at them) are not always recorded adequately in the chart. If the records do not substantiate the ophthalmologist’s claims, a jury is likely to doubt his or her credibility and may begin to suspect a lapse not only in charting but also in professional judgment and/or ethics. The ophthalmologist should also record anything of importance, i.e., test results, consultations and family members present.
Informed consent must include an understanding between the patient and the physician, not simply discussion and signing a piece of paper. The proper relationship and rapport between patient and physician can thus be established.
Ethically, an ophthalmologist should never pressure or cajole a patient to have an elective procedure. Such pressure could turn into a malpractice liability. Communicate, document and inform but never “sell.” After all, cataracts really do not explode.
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.
Phacoemulsification: Use Careful Patient Selection
By Reginald J. Stambaugh, MD
Argus, August, 1993
Surgical removal of a cataract, when performed under the right conditions and using the proper technique, can be extremely rewarding for the patient. If complications occur and patient expectations are not achieved, however, the result can be disastrous for both patient and surgeon. Therefore, proper preoperative evaluation by the operating ophthalmologist is critical.
Improvements in technique, equipment, instruments and implants have driven the number of cataract extractions up to unprecedented levels in recent years, resulting in closer public scrutiny of the procedure and those who perform it. Further, misleading advertising promises for “painless, instantaneous vision” have contributed to unrealistic expectations in many patients. The result is that it is imperative for the ophthalmologist, who may be held legally liable for the outcome, to carefully evaluate patients before performing surgery.
Preoperative evaluation by the surgeon should assess not only the physical findings of the patient, but also the realistic needs of the patient. These needs are determined by such factors as the patient’s occupation, age, overall health, lifestyle, recreational activities and family obligations. The surgeon must consider whether surgery will improve the patient’s vision and whether improved vision will meet the patient’s needs and improve the patient’s quality of life. If the answer is yes and there are no physical contraindications, the ophthalmologist may feel comfortable recommending surgery.
Phacoemulsification has become the procedure of choice for many cataract surgeons. Ophthalmologists who have made the transition to phaco know it is not a simple procedure nor one without complications, and they have developed a healthy respect for the learning curve involved in perfecting this technique. Once the surgeon’s skill is established, patient selection becomes the most important risk management consideration for the surgeon.
Visual acuity should always be the primary criterion in preoperative evaluation. Determination of the glare factor may or may not be significant. While inflammation, infection, corneal scars, macular or retinal deterioration, optic nerve disease, etc., are generally accepted contraindications to ocular surgery, there are other less decisive factors to consider such as corneal endothelium, anterior chamber depth, size of the dilated pupil, grade of the nucleus and posterior capsule status.
Corneal decompensation with poor results can be prevented in selected cases, but even with improvements in technique, the stage of the nucleus and integrity of the capsule continue to be important criteria in the selection of phaco candidates. When emulsifying the nucleus, problems with the endothelium and posterior capsules, both critical structures, can produce complications, as experienced surgeons know.
Age of the patient is an important factor. The procedure is quite different in young patients who have minimal nuclear changes and a stronger posterior capsule that can tolerate more manipulation before rupturing.
Having done phacoemulsification and intraocular lens implants since 1975, including 10 years of specular microscopy and endothelium study, I have become more conservative in my selection of surgical candidates. Although the success rate of phaco is high, poor results in a patient with unreasonable expectations can result in the filing of a malpractice claim, even if the procedure is done properly. Given our litigious society and the competitive marketplace in which we practice, legal disasters may be avoided only if ophthalmologists remember that they are entrusted with their patients’ care, and evaluate each one’s needs, physical findings and expectations with integrity.
Uveitis: Proceed with Caution and Proper Documentation
By Dean C. Brick, MD
[Argus, May, 1996]
Successful diagnosis and management of patients with uveitis requires vigilance and patience. The diagnosis may be difficult and obscure; treatment may be prolonged, marginally effective, and fraught with potential complications or side effects. Often the uveitis, which itself may be visually devastating, is caused by a systemic disease whose diagnosis and treatment cannot be overlooked. These factors create unique risk management problems for the ophthalmologist and underscore the need for proper documentation, thorough informed consent, and use of consultants.
Averting Claims of Failure to Diagnose
Failure to diagnose is one of the most common assertions in uveitis-related claims and lawsuits. Proper documentation of an adequate patient history and physical will help avoid this claim, particularly in cases of severe or recurrent uveitis, which can result in vision loss or other complications.
In these instances, the usual history taken by a technician or a physician is inadequate. Since remembering all the important questions to ask a uveitis patient may be difficult, use a detailed, uveitis-specific questionnaire which the patient can fill out in the waiting area. Using a yes-no format makes it easy for the ophthalmologist to review the questionnaire and pose further questions, and can alert the physician to the need to perform a dermatological exam, serology test for toxocara, or other physical or laboratory examinations.
Then, record an appropriate physical exam, which should include the examination of any other organ systems, if indicated, as well as significant negative findings in the ophthalmological exam. Again, the ophthalmologist may use a uveitis-specific eye examination form, with space for recording a descriptive diagnosis: recurrent, anterior, non-granulomatous iridocyclitis, for example, or focal necrotizing retinochoroiditis. In some instances, a specific diagnosis may be possible, such as Fuch’s heterochromic cyclitis.
Next, formulate and record a differential diagnosis list. It need not be exhaustive or necessarily include the ultimate correct diagnosis; however, it demonstrates that the ophthalmologist attempted to formulate a diagnosis and ordered indicated laboratory tests, which helps counter claims of failure to perform a thorough workup.
When laboratory tests are performed, the ophthalmologist should review all results before placing them in the chart. At this point, if the diagnosis remains enigmatic and the potential for visual loss is severe, consider referring the patient to a consultant. This helps prevent claims of delayed referral to a specialist.
Treatment Complications Can Trigger Lawsuits
Uveitis treatment is frequently associated with severe side effects and complications. High doses and prolonged treatment with systemic steroids and strong immunosuppressant drugs can lead to informed consent-related claims. To help counter these claims, document in the chart that the risks and benefits of treatment were discussed and that the patient received medication information handouts. Again, collaborating with an internist or a specialist is valuable in defending a decision to use potentially risky therapy and for monitoring strong or prolonged immunosuppressant drug therapy.
Finally, the interval between examinations should correlate with the severity of the disease and the potential for complications. Following these guidelines and maintaining a caring, supportive attitude for patients will help reduce the risks of treating these difficult cases.
To obtain a copy of a uveitis-specific history form, contact OMIC’s Risk Management Depart- ment by fax, 415-771-7087.
