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Ocular Anesthesia-Related Closed Claims from Ophthalmic Mutual Insurance Company 2008–2018
Journal Pre-proof Ocular Anesthesia-Related Closed Claims from Ophthalmic Mutual Insurance Company 2008-2018 Michael Morley, MD, ScM, Anne M. Menke, RN, PhD, Karen C. Nanji, MD, MPH PII:
S0161-6420(19)32371-1
DOI:
https://doi.org/10.1016/j.ophtha.2019.12.019
Reference:
OPHTHA 11043
To appear in:
Ophthalmology
Received Date: 12 November 2019 Revised Date:
13 December 2019
Accepted Date: 18 December 2019
Please cite this article as: Morley M, Menke AM, Nanji KC, Ocular Anesthesia-Related Closed Claims from Ophthalmic Mutual Insurance Company 2008-2018 Ophthalmology (2020), doi: https:// doi.org/10.1016/j.ophtha.2019.12.019. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Inc. on behalf of the American Academy of Ophthalmology
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Ocular Anesthesia-Related Closed Claims from Ophthalmic Mutual Insurance Company 2008-2018
Michael Morley, MD, ScM1* Anne M. Menke, RN, PhD2* Karen C. Nanji, MD, MPH3
*
These authors contributed equally to this manuscript.
1
Ophthalmic Consultants of Boston, Harvard Medical School, Boston, MA Ophthalmic Mutual Insurance Company, San Francisco, CA 3 Massachusetts General Hospital, Harvard Medical School, Boston, MA 2
Address correspondence to: Michael Morley MD, ScM, Ophthalmic Consultants of Boston 50 Staniford St., Suite 600 Boston, MA 02114 [email protected] 617-367-4800 x 6083
47
Abstract
48
Purpose: To evaluate the types of anesthesia-related closed claims and their contributing
49
factors, using data from Ophthalmic Mutual Insurance Company (OMIC).
50
Design: Retrospective analysis of pre-existing data
51
Participants: Plaintiffs who filed a professional liability claim or suit (written demand for
52
money) against OMIC-insured ophthalmologists, ophthalmic practices, and/or surgicenters in
53
which the surgical case occurred.
54
Methods: Plaintiff claims were collected from the OMIC database from 2008-2018 using search
55
queries for terms associated with known complications of ophthalmic anesthesia.
56
Main outcome measures: Number and types of anesthesia-related injuries and claims, who
57
administered the anesthesia, the outcomes of the claim or suit, cost to defend, and payments
58
made to plaintiffs.
59
Results: Sixty-three anesthesia related claims or suits were filed by 50 plaintiffs. Anesthesia-
60
related injuries included globe perforation (n=17), death (n=13), retrobulbar hemorrhage (n=7),
61
optic nerve damage (n=4), vascular occlusions (n=2), pain (n=2), eye or head movement
62
resulting in injury (n=2), and one case each for numbness, diplopia, and tooth loss during
63
intubation. All but 1 patient who died had pre-existing, significant co-morbidities. Two deaths
64
were related to brainstem anesthesia.
65
Regarding the type of anesthesia in the closed claims, retrobulbar and peribulbar anesthesia
66
were the most common types (n=16 each ), followed by local infiltration around the lids and
67
facial nerve (n=6), topical anesthesia (n=5) and general anesthesia (n=5). In two cases, the
68
exact type of anesthesia was unknown but not general. The 5 topical with sedation anesthesia2
69
related claims were due to inadequate pain control (n= 2), ocular movement resulting in
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capsular rupture (n= 2), or death (n=1) allegedly related to excessive, or inadequate monitoring
71
of, sedation. There were 5 claims related to general anesthesia including 4 deaths and 1 tooth
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loss during intubation. Sedation was alleged to be a factor in 5 cases resulting in death.
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Anticoagulants were a factor in 3 retrobulbar hemorrhage cases.
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Conclusions: While claims and suits were infrequent given the large number of insured
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ophthalmologists and the large number of surgical cases requiring various types of anesthesia
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performed over the 10.5-year study period, severe injuries can occur.
77 78
3
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Introduction
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Ophthalmic surgery typically yields good outcomes and is well-tolerated by the vast majority of
81
patients. The safety of the various ocular surgery anesthesia options contributes to the
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excellent safety profile of ophthalmic surgery. However, severe injuries related to ocular
83
anesthesia do occur, 1-4 and these injuries can result in medical malpractice claims made against
84
the ophthalmologist, ophthalmology practice, anesthesiologist, nurse anesthetist, or the
85
surgical facility in which the surgery occurred. A better understanding of the frequency and
86
types of anesthesia-related claims may help to guide safety efforts to prevent patient harm
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during ophthalmic surgery. Ophthalmic Mutual Insurance Company (OMIC) insures over 5,300
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ophthalmologists, or about half of the ophthalmologists in private practice in the USA, as well
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as their surgicenters and practices, making this data set helpful in evaluating anesthesia-related
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complications that result in malpractice claims. 5 The purpose of this paper is to evaluate the
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types of anesthesia-related closed claims and their contributing factors, using data from OMIC.
92 93
Methods
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This is a retrospective analysis of closed (i.e., resolved) claims made against OMIC insureds for a
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ten-year period from 6/1/2008-12/31/2018. A claim is defined as a written notice or demand
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for money or services, including the institution of a lawsuit or arbitration proceeding. Our data
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do not include open claims, i.e., claims that are filed but not yet resolved. Claims were
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identified by author AMM searching the OMIC claims database for terms related to anesthesia
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and complications from anesthesia including anesthesia, retrobulbar, peribulbar, topical, and
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general anesthesia, globe perforation, perforation, penetration, death, bleeding, hemorrhage, 4
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optic nerve, diplopia, double vision, stroke, heart attack, myocardial infarction, pain,
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movement, and retrobulbar hemorrhage. Cases were selected if there was an allegation in the
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claim of injury related to anesthesia or if the injury was clearly related to the administration of
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anesthesia. All cases were then reviewed independently and then compared by 2 authors
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(AMM and MGM) to confirm if there was an anesthesia-related complaint or injury.
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Disagreements were resolved by consensus. We did not review patients’ medical records; the
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data analyzed were the claims data summary and litigation files collected by OMIC Senior
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Litigation Analysts and defense attorneys. Our data did not include claims regarding eye injuries
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that may be anesthesia-related but occurred during non-ocular surgeries (e.g., anterior
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ischemic optic neuropathy occurring during spine surgery, corneal abrasions occurring in
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general anesthesia cases, etc.)
112 113
Statistical analysis
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This study is a descriptive study with counts of individual events, means and ranges, or
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proportions of total events presented. Because a single injury to a plaintiff may result in more
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than 1 claim, data pertaining to claims use a denominator of number of claims and data
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regarding injuries are presented with a denominator of number of patients. Comparisons
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between groups were not performed. The rate of anesthesia-related ocular injuries was not
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calculated given the lack of a denominator for total number of surgeries performed during the
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time period.
121 122 5
123
Results
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The demographics and descriptive data are presented in Table 1. Fifty patients submitted a
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total of 63 claims or suits against OMIC-insured defendants including ophthalmologists, their
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ophthalmology practices, and the surgical facilities in which the procedure took place. Plaintiffs
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submitted an average of 1.26 claims with the surgeon, the surgeon’s practice, and/or the
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surgicenter named as defendants. The average age of the plaintiff was 58 years old. Plaintiffs
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gender included female (n =26, 51%), male (n= 21, 41%) and unknown (n=4, 8%). On average,
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claims were filed 378 days (range 1-832 days, average 1.0 years) after the precipitating event,
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and closed 1,290 days (range 433-3722 days, average 3.6 years) after the event.
132 133
Types of anesthesia resulting in injuries
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Table 2 lists the data collected from our review of anesthesia-related closed claims cases.
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Retrobulbar (n=16) or peribulbar (n=16) anesthesia were used in 32 (64%) of the plaintiff
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injuries. Local anesthesia injected into the lids or periocular region was used in 6 (12%) cases.
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General anesthesia was associated with 5 (10%) of the cases. Topical (eyedrop) anesthesia was
138
used in 5 (10%) cases. In two cases, the anesthesia type was uncertain but was not general (i.e.,
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peribulbar, retrobulbar, local, or topical). In the 17 globe perforations, 10 patients received
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retrobulbar anesthesia, 5 patients received peribulbar anesthesia, and 2 received an uncertain
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type of anesthesia.
142 143
Administration of the retrobulbar and peribulbar blocks
6
144
Ophthalmologists administered the peribulbar or retrobulbar injection in 27 of 32 (84%) peri-
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or retrobulbar anesthesia-related closed claim cases, while anesthesiologists administered 3
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(9%) and CRNAs administered the injection in 2 (6%) cases. Of the 17 cases with globe
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perforation, ophthalmologists performed the block in 12 (70%) while anesthesiologists
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performed the block in 3 (18%), and a CRNA performed the block in 2 (12%).
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Types of surgical cases/specialty resulting in claims
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Cataract surgical procedures (n=24, 48%) were the most common type of case generating a
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claim, followed by retina procedures (n=12, 24%) including vitrectomy and scleral buckle
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surgery, laser procedures (n=5, 10%), oculoplastic cases (n = 4, 6%), pterygium (n = 3, 6%),
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strabismus surgery (n=1, 2%) and chalazion incision and drainage (n=1, 2%). Four of the closed
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claim injuries occurred in an office setting, 18 occurred in surgical settings (i.e., a hospital or
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surgicenter operating room) and the remaining 18 case locations were not specified but
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presumed to be in an operating room based on claim type.
158 159
Types of Injuries
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Globe perforation was the most common plaintiff injury in our data set accounting for 17 (34%)
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plaintiff injuries. Deaths accounted for 13 (26%) of the plaintiff injuries. Retrobulbar
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hemorrhage resulting in blindness accounted for 7 (14%) of the injuries. Three of the plaintiffs
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with retrobulbar hemorrhage were on anticoagulants, (1 warfarin, 1 apixaban, and 1 case
164
involved a combination of aspirin and clopidogrel). One plaintiff with bleeding had a low
165
platelet count discovered after the injury. Optic nerve injuries or perforation occurred in 4 (8%) 7
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of the plaintiffs. All 4 optic nerve injuries resulted in post-operative pallor and legal blindness.
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Additional injuries included vascular occlusions (n=2, 4%), movement of the eye or head during
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surgery resulting in capsular rupture (n=2, 4%), and post-operative pain (n=2, 4%). Numbness,
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diplopia, and tooth loss (n=1 each, 2% each) comprised the remaining injuries. There were no
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wrong-sided or wrong type of anesthesia claims.
171 172
Of the 13 deaths, most plaintiffs had known medical problems including diabetes mellitus (DM),
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(N=4, 31%), atherosclerotic cardiovascular disease (ASCVD)(N=1, 8%), or a combination of DM,
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hypertension (HTN), ASCVD, or pulmonary edema (N=5, 38%). Despite the presence of these
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conditions, all of the plaintiffs were classified as American Society of Anesthesiologists (ASA)
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Physical Status III, defined as severe systemic disease with substantive functional limitations
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from one or more moderate to severe disease. None were given the higher category IV of
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severe systemic disease that is a constant threat to life.6 Three patients (23%) had a past
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medical history that was not recorded in the OMIC database. Four of the 13 plaintiffs who died
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had general anesthesia, 6 had retro- or peribulbar anesthesia, 1 had topical anesthesia with
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sedation, and 2 were unknown but they did not have general anesthesia. In two of the deaths
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following injection of retrobulbar anesthesia, the plaintiff suffered immediate respiratory arrest
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and loss of consciousness. One case was attributed to brainstem anesthesia based on clinical
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assessment. In the other case, the postmortem toxicology evaluation determined the cause.
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The other deaths were attributed to cardiovascular disease (CVD, congestive heart failure,
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pulmonary edema, myocardial infarction) or cerebrovascular (stroke) conditions; most of these
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patients had known coexisting DM or CVD. General anesthesia injuries included 3 deaths and 1 8
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tooth loss during intubation. The 38 cases with needle-based anesthesia (retrobulbar (n=17),
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peribulbar (n=16), and local anesthesia (n=6)) led to globe perforation (n=17), death (n=6), optic
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nerve injury (n=4), bleeding (n=7), diplopia (n=1), numbness (n=1), and central retinal artery
191
occlusion (n=2).
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Indemnity payments and claim disposition
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Sixteen of the 63 claims (25%) resulted in a payment to the plaintiff (indemnity payment) and
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48 (75%) had no payment as the suit was either successfully defended or dismissed.
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Perforations were the most common and most expensive injury resulting in a payment in 6
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claims averaging $271,000 (range $20,000-$585,000). Death was the second most common
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outcome resulting a payment in 5 claims averaging $73,500 (range $20,000-$160,000.) There
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were 4 payments for retrobulbar hemorrhage cases averaging $92,500 (range $29,999-
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$200,000.) Indemnity payments averaged $158,678 (median $75,000, range $15,000-
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$585,000.) Of the 16 claims resulting in a payment, 14 were negotiated lump sum settlements,
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1 was a negotiated annuity payment, and 1 case resulted from a plaintiff verdict at trial.
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Of the 48 claims that settled with no payment, twenty-three claims were closed with no
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payment before a lawsuit was filed, 4 lawsuits were closed after defense verdicts at trial, 5
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were dismissed without prejudice, i.e., they could be refiled), 3 were dismissed for lack of
206
prosecution, 1 case was dismissed in summary judgement (i.e., decided by a judge not a jury),
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and 12 were dismissed for other various reasons.
208 209
Discussion 9
210
Closed malpractice claims can be a useful quality improvement tool for identifying safety issues,
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patterns and trends of injury, and strategies for prevention of related patient injuries.7 The
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OMIC closed claims data reveal that anesthesia-related claims are relatively rare, with 63 closed
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claims from 50 plaintiffs over 10.5 years despite the large number of surgeries performed
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across the country each year by OMIC-insured ophthalmologists, practices, and surgicenters.
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Anesthesia-related claims represented 2.8% (63/2227) of all total OMIC claims from 2008 to
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2018 when the number of OMIC-insured ophthalmologists rose from 3939-5291. This number
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is down from 3.2% of all claims in 1987-2005 (78/2474) during which time the number of OMIC
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insured ophthalmologists rose from 877-3939.
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While the low number of malpractice claims indicates that ophthalmic anesthesia care is
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generally safe, there are important lessons that can inform a continuous process of
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improvement aimed at maximally reducing the number of patient injuries.
222 223 224
Anesthesia-related complications can lead to severe injuries that have a devastating impact on
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the plaintiff.1,2 Globe perforations were the most common injury in the cohort, accounting for
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34% of defendant injuries. Patients with globe perforation injuries frequently had severe vision
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loss or loss of the eye. The number of globe perforations in our data diminished in the 5.5 years
228
from 2013 to 2018 compared to the first 5 years of the study period, from 2008 to 2012. The
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decreased number of globe perforations may be due to chance alone given the small numbers,
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but it is notable that a switch to topical anesthesia occurred in many cataract practices during
10
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this same time period. 8,9 Prospective trials are required to assess and compare the incidence
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of ocular injury and surgical outcomes with various anesthesia techniques.
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Thirteen patients died, accounting for 26% of complications and the second most untoward
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event. Death occurred following retrobulbar, peribulbar, topical, and general anesthesia, as well
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as sedation. Most of the plaintiffs who died had a known medical history of conditions such as
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DM with end organ damage, CVD (e.g., hypertension, atherosclerotic cardiovascular disease,
238
myocardial infarction, congestive heart failure), or pulmonary disease. In two patients,
239
respiratory arrest, unresponsiveness, and death occurred immediately after a retrobulbar
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block, and brainstem anesthesia was determined to be the etiology. Retrobulbar hemorrhage
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(n=7) occurred both in patients taking anticoagulants (n=3) and those not taking anticoagulants
242
(n=4). The anticoagulants included anti-coagulant cascade inhibitors (warfarin, apixaban) and
243
anti-platelet drugs (aspirin and clopidogrel.)
244 245
The standard of care for medical clearance of patients undergoing ophthalmic surgery is slowly
246
evolving, with a focus on “optimizing risk reduction” instead of a blanket “medical clearance”.
247
There are increasing data to suggest that routine pre-operative medical evaluation and testing
248
of cataract surgery patients are, in some cases, unnecessary. The Centers for Medicare and
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Medicaid Services recently eliminated the requirement that all patients undergoing surgery in
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an ambulatory surgery center have a history and physical exam documented in the chart within
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30 days of the procedure. 10 The new proposal requires that surgicenters create a written policy
252
defining which patients require pre-operative medical evaluation (i.e., history and physical
11
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exam and lab testing) and allowing patients who are deemed low risk for operative
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complications to skip this testing. There are data to support this change given the limited
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benefit and high cost of this requirement for the vast majority of patients.11,12 When the patient
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has significant medical comorbidities, however, it may be prudent, from both a clinical
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standpoint as well as a risk management standpoint, to refer the patient to the primary care
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physician, cardiologist, endocrinologist, or other appropriate medical specialist prior to surgery.
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Engaging these physician consultants and using their expertise to optimize the patient’s general
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health status before surgery may optimize the patients’ cardiovascular or pulmonary (or other)
261
systems to lower risk. Ophthalmologists may prefer to do the preoperative evaluation
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themselves in some situations, especially given the difficulty of obtaining timely medical
263
evaluations and the lack of access in some locations to subspecialty care.
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Fully preventing death related to ocular surgery and ocular anesthesia is not possible in the
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population undergoing eye surgery given the age and co-morbidities. Cataract surgery in elderly
266
patients, and retinal cases involving patients with advanced diabetes-related co-morbidities,
267
carry intrinsic risks that cannot be completely eliminated. It is obviously important to pre-
268
operatively optimize the patient’s systemic health status with control of blood pressure,
269
coronary artery disease, blood sugar, pulmonary disease, and diabetic renal disease. But there
270
are significant obstacles to accomplishing this in many locations and situations. Some elderly
271
and sick patients have intrinsically unpredictable and unstable medical conditions. Some
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ophthalmic surgery is urgent which places time constraints on medical evaluation and
273
stabilization. While there is more time before elective surgeries such as cataract removal,
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patients may not be willing to invest the time, money, and effort to improve their health. 12
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Ophthalmologists and primary care physicians may be falsely reassured by the low risk of
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complications and the unproven value of routine labs and history and physical examinations in
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the majority of patients but there are subsets of patients with serious co-morbidities or active
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medical problems who do benefit from preoperative testing and management. Moreover,
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delaying surgery and making it more time consuming and expensive carries potentially negative
280
consequences such as falls.
281
Two of the deaths appeared to be related to brainstem anesthesia, and both followed
282
retrobulbar anesthesia administered by an ophthalmologist. One plaintiff who could not keep
283
still for an A scan received the injection in the office. No licensed staff member was present to
284
monitor the response to the injection, and emergency response equipment was limited. CPR
285
was initiated while staff called 911. Paramedics arrived quickly and intubated the patient. The
286
defense’s toxicology expert felt that the medication was injected into the optic nerve. The
287
second case occurred in a surgery center where the anesthesia care was provided by an
288
anesthesiologist. While the ophthalmologist wondered if he had inadvertently given brainstem
289
anesthesia, the experts focused on the anesthesiologist whom they opined had over-sedated
290
the patient with propofol and inadequately monitored the response to the anesthesia and
291
sedation.
292
Retrobulbar hemorrhage was the third largest category of injury. Three of the plaintiffs with
293
retrobulbar hemorrhage injuries were taking antiplatelet medications (e.g., clopidogrel) or
294
clotting inhibitors (e.g., warfarin, apixaban, but 4 of 7 patients with retrobulbar hemorrhage
295
were not taking these medications. Continuing anti-coagulant treatment before and during eye
296
surgery is more common with phacoemulsification cataract surgery compared to other 13
297
surgeries, and with topical anesthesia compared to retrobulbar or peribulbar anesthesia.
298
Discontinuing anti-coagulants in the peri-operative period can lead to life-threatening
299
cardiovascular and neurological complications but continuing the anticoagulants elevates the
300
risk of injuries from hemorrhage. The surgeon needs to consult with both the physician who is
301
managing the patient’s medical condition(s) and the patient to address the associated risks of
302
each approach during the informed consent discussion. OMIC has created consent forms that
303
help patients understand the complexity of managing anti-coagulants during the perioperative
304
period. They provide a clear explanation to patients of the risks associated with both stopping
305
and continuing anticoagulants. Planning for urgent treatment of retrobulbar hemorrhage with
306
lateral cantholysis might help mitigate some injuries but extensive intraocular or retrobulbar
307
hemorrhage can be difficult to manage and can lead to a poor clinical outcome.
308 309
As expected, there were more ocular anesthesia claims from high volume procedures. Thus,
310
cataract surgery was most common surgical procedure noted in the closed claims followed by
311
retina surgery, including vitrectomy. General ophthalmological procedures, oculoplastics
312
procedures, strabismus surgery, and miscellaneous surgical procedures account for the
313
remaining cases.
314
Seventy-five percent of the claims or suits closed with no indemnity payments, which compares
315
favorably to industry standards.1 The cases that resulted in indemnity payments were nearly all
316
negotiated settlements; only one of the five cases that went to trial resulted in a plaintiff
317
verdict. Of note, the percentage of claims that were anesthesia-related in the OMIC database
318
(3%) is lower than the percentage in the literature for general surgical specialties (4%). 14
319 320 321
Our review of OMIC’s malpractice claims data supports recent recommended strategies to
322
lower the anesthesia-related risk to patients undergoing ocular surgery. 1-4,8,13 First, use the
323
least invasive form of anesthesia possible, weighing carefully the need for needle-based
324
anesthesia, which can lead to globe perforations and retrobulbar hemorrhage. 1,2 Some
325
ophthalmic surgical cases and patients require needle-based anesthesia, but some can be
326
managed with less invasive forms of anesthesia such as topical anesthesia. Second, obtain or
327
perform preoperative evaluations with the goal of optimizing the patient’s health. Consult with
328
primary care physicians and medical specialists, if available, for patients with serious systemic
329
diseases such as cardiovascular, endocrinological, renal, hematologic, rheumatologic, or
330
pulmonary diseases. Inform patients with conditions such as DM and CVD which are known to
331
increase mortality of the risk-reducing advice given by medical specialists. Clarify that it is
332
impossible to eliminate all risk, and the goal is to minimize risk. Consult with the patient’s
333
primary care or cardiologist to determine the safest plan for managing the peri-operative anti-
334
coagulants and use a specific consent form for those patients who take anti-coagulants to
335
document discussion regarding the risks of both maintaining and stopping the use of
336
anticoagulants. 14 Include in the procedure-specific consent form the rare but serious risks of
337
anesthesia (e.g., death, globe perforation, orbital and ocular hemorrhage, and optic nerve
338
injuries). OMIC has procedure-specific consent forms available on its website. 15 Consider
339
performing known medically high-risk cases in a hospital setting where higher levels of
340
emergency back-up are available compared to a surgicenter setting. Be prepared to manage 15
341
complications such as brainstem anesthesia with CPR or bag valve mask respirations or vision-
342
threatening retrobulbar hemorrhage by superior and inferior lateral canthal tendon cantholysis
343
to relieve increased orbital pressure. Communicating with anesthesia providers about patients
344
on anticoagulants and those with high myopia (i.e., long axial length) can be helpful. Consider
345
doing a cut-down block in these situations, in which peribulbar anesthesia is administered via a
346
blunt cannula through a small conjunctival peritomy after the patient is prepped and draped.
347
Confirm that new anesthesia providers who perform blocks are well trained, monitored during
348
their early cases in a facility, and can consult with other anesthesia providers in difficult cases.
349
Calmly address patients who have pain, anxiety, or movement during surgery and clarify with
350
the anesthesia team the need for additional sedation. Keep in mind that, although rare, local
351
infiltration of anesthesia to lids can result in globe perforation. Finally, maintaining vigilance
352
and situational awareness, especially during any type of periocular injection, including lid
353
anesthesia, may help mitigate the chance of a complication. A seemingly innocuous injection of
354
anesthesia for a laser procedure or a chalazion incision and drainage can be complicated by
355
globe perforation as was seen in several of our closed claims.
356
Our paper has several limitations. First, analyzing malpractice claims differs greatly from a
357
retrospective analysis of clinical data or an epidemiological study. Medical experts who provide
358
opinions about a malpractice claim know the plaintiff’s outcome and are participating in an
359
adversarial process. Plaintiffs typically testify to the impact of the alleged harm on their daily
360
life, providing information that is not readily available in the medical record. This process can
361
introduce multiple confounders, biases, and allegations concerning the severity of injuries. The
362
profitability of a case and the willingness of the plaintiff and his/her lawyer to pursue litigation 16
363
impact whether a claim or suit is filed or not, as well as the claim resolution. The nature of the
364
physician-patient relationship may incite or inhibit the filing of a claim or lawsuit irrespective of
365
the clinical outcome of a procedure. For these reasons, retrospective closed claim data must be
366
interpreted with these limitations in mind. While it is not a statistically valid source of
367
epidemiological data, the information is still valuable and actionable.
368
A second limitation is that there is uncertainty about the exact cause for some of the injuries
369
reported here. In particular, the role of sedation or over-sedation, is hard to quantify. For
370
example, in one case, a patient who received topical anesthesia as well as intravenous sedation
371
died and there was an allegation of over-sedation. Attributing an injury to the anesthesia, or to
372
the sedation medications which are frequently administered in conjunction with non-general
373
anesthesia cases, or to progression of a patient’s underlying medical condition is sometimes
374
difficult, especially in retrospection. Similarly, post-operative optic nerve injury can in some
375
cases be directly attributed to an optic nerve sheath penetration and hemorrhage but in some
376
cases may be related to optic nerve diseases such as ischemic optic neuropathy. Ophthalmic
377
surgical patients frequently have risk factors for increased mortality including advanced age as
378
well as co-existent medical problems such as DM, HTN, or ASCVD.
379
A third limitation of our study is that our data also do not include claims that may have been
380
made against non-OMIC insured entities such as the anesthesiologist, nurse anesthetist, the
381
anesthesiology group contracted to provide anesthesia services, or the hospital. Thus, our study
382
likely underestimates the number of anesthesia-related closed claims cases.
383
17
384
In summary, anesthesia-related claims are uncommon but serious anesthesia-related injuries
385
do occur. The population of patients undergoing ophthalmic surgery includes elderly and sick
386
patients making some morbidity and mortality unavoidable. Strategies described herein may
387
help to reduce potential complications and help to maximize patient safety and minimize
388
professional liability exposure of ophthalmologists, anesthesia providers, surgicenters, and
389
medical practices.
390
This study adheres to the Declaration of Helsinki.
391
The authors have no financial or other conflicts of interest to declare.
392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407
References 1) Nanji, K.C., Roberto, S.A., Morley, M.G. and Bayes, J., 2018. Preventing adverse events in cataract surgery: recommendations from a Massachusetts expert panel. Anesthesia & Analgesia, 126(5), pp.1537-1547. 2) Roberto, S.A., Bayes, J., Karner, P.E., Morley, M.G. and Nanji, K.C., 2018. Patient harm in cataract surgery: a series of adverse events in Massachusetts. Anesthesia & Analgesia, 126(5), pp.1548-1550. 3) Nanji, K, Morley, M, Betsy Lehman Center for Patient safety, Improving Patient Safety in Cataract Surgery, Published September 2016, https://betsylehmancenterma.gov/initiatives/cataract-surgery-initiative Accessed 11/12/19 4) Pennsylvania Patient safety Advisory, Pennsylvania Patient Safety Reporting System (PAPSRS) Patient Safety Advisory—Vol. 4, No. 1 http://patientsafety.pa.gov/ADVISORIES/Pages/200703_18.aspx Accessed 7/27/2019 5) Ophthalmic Mutual Insurance Company 2018 Members Report. Ophthalmic Mutual
408
Insurance Company, https://www.omic.com/wp-content/uploads/2018/10/2018-
409
Members-Report.pdf Accessed 2/19/19
410
6) American Society of Anesthesiologists Physical Status Classification
411
https://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-
412
system. Accessed September 15, 2019 18
413 414 415 416
7) Anesthesia Quality Institute. American Society of Anesthesiologists, About Closed Claims https://www.aqihq.org/ACCMain.aspx accessed 7/21/19 8) Karen Posner, PhD, Lori Lee, MD, Anesthesia malpractice claims associated with eye
417
surgery and eye Injury- highlights from the anesthesia closed claims project data request
418
service https://www.aqihq.org/closedclaimsPDF/Click%20here%20for_5PDF
419
American Society of Anesthesiologists November 2014, 78;11 28-30 2014
420
Accessed 2/19/19
421
9) Severe adverse events associated with local anaesthesia in cataract surgery: 1-year
422
national survey of practice and complications in the UK Richard M H Lee, John R
423
Thompson and Tom Eke Br J Ophthalmol published online September 24, 2015
424
10) Centers for Medicare and Medicaid Services Omnibus Burden Reduction Conditions
425
Participation Final Rule. https://www.cms.gov/newsroom/fact-sheets/omnibus-burden-
426
reduction-conditions-participation-final-rule-cms-3346-f
427
428
11) Keay,l., Lindsley, K., Katz, J., Schein, O., Routine preoperative medical testing for
429
cataract surgery. Cochrane Database Syst rev 2019 Jan 8; 1: CD007293.doi:
430
10.1002/14651858.CD.007293.pub4
431
12) Chen, CL, Lin, GA, Bardach, NS, et al Preoperative medical testing in Medicare patients
432
undergoing cataract surgery. NEJM 2015 Apr 16; 372(16):1530-8. Doi:
433
10.1056/NEJMsa1410846
19
434 435 436 437 438 439
13) Menke, A., Salz, J., Ocular Anesthesia-Related Claims: Causes and Outcomes. OMIC Digest 2006 16(1): 1-5 14) Menke, A, Ophthalmic Mutual Insurance Company, OMIC consents- anticoagulants https://www.omic.com/anticoagulant-consent 15) Menke, A, Ophthalmic Mutual Insurance Company, Consent forms for cataract surgery anesthesia https://www.omic.com/risk-management/consent-forms/
440
441
20
1 2
Table 1 Table 1: Summary of Demographics of Closed Claims Data 2008-2018 Number of plaintiffs (N) Number of claims or suits (N)
50 63
Plaintiff age in years (mean, range)median?
58.0, (2-81)
Gender, N (%) Female 26 (52%) Male 21 (42) Uncertain 3 (6%)
3
Time to open claim from occurrence in days; (mean, range) 380 (1-832) Time to close claim from occurrence in days; (mean, range) 1299 (433-3722) Table 1 Legend: Summary of demographics of closed claims data.
1 2
Table 2 Table 2: Summary of Closed Claims data 2008-2018 Types of plaintiff injuries (N)
(N)
(%)
Globe perforation Death Retrobulbar hemorrhage Optic nerve injury Vascular occlusion, pain, movement during surgery resulting in injury Numbness, diplopia, tooth loss total
17 13 7 4 2 each, 6 total
34% 26% 14% 8% 4% each, 12% total
1 each, 3 total 50
2% each, 6% total 100%
Type of anesthesia (N)
Retrobulbar Peribulbar Local infiltration Topical General Unknown, but not general Total
16 16 6 5 5 2 50
32% 32% 12% 10% 10% 4% 100%
Administrator of all retrobulbar or peribulbar anesthesia blocks (N=32)
Ophthalmologist
27
85%
Anesthesiologist CRNA Total
3 2 32
9% 6% 100%
Retrobulbar Peribulbar Peri or RB- uncertain type
10 5 2
59% 29% 12%
Ophthalmologist Anesthesiologist CRNA
12 3 2
70% 18% 12%
Types of blocks associated with globe perforation (n=17)
Administrator of blocks in perforation cases (n=17)
Location of Procedure Hospital inpatient OR Office based laser or minor procedure room Hospital based surgicenter Non-hospital based surgicenter Location not recorded
1 4
Cataract/IOL surgery Retina surgery (vitrectomy/SB) Laser surgery Lid surgery/oculoplastic Pterygium surgery Strabismus Total procedures
24 12
48% 24%
5 5 3 1 50
10% 10% 6% 2% 100%
9 18 18
Procedure type (N)
Disposition (N)
Closed with payment Settled with annuity 1 Settled with lump sum 14 Plaintiff verdict- trial 1 Closed without payment Dismissed Without prejudice With prejudice Lack of prosecution Judgement defensemotion summary judgement Defense verdict-trial
3 4 5 6
2% 22% 2%
24
38%
5 10 3 1
8% 16% 5% 2%
4
6%
Total disposition 63 *101% Table 2 Legend: Summary data regarding the closed claims cases in the OMIC database, 2008-2018. *Percentage > 100 due to rounding.
2
Actionable steps to Minimize Anesthesia-Related Complications in Ocular Surgery Number Steps Comment 1 Maintain situational awareness of the location of Anesthesia injections to the the needle tip when performing even a “simple” eyelid or peribulbar or periocular anesthetic injection. retrobulbar space can occur less than a millimeter from the globe. 2 Use the least invasive method of anesthesia when Topical anesthesia, while possible. not always possible, lowers chance of perforation and other needle-related complications. 3 Consider medical consultation for patients with Primary care or specialty active systemic diseases. consultations to optimize health can benefit the anesthesia team, the eye surgeon, and the patient. 4 Manage perioperative anticoagulants in concert Both stopping and with the patients’ doctors. maintaining anticoagulants in the perioperative period carry risk. Help the patient understand the risks. 5 Consider using a hospital based OR for patients who Hospitals have significantly may require medical support or resuscitation. more resources to manage complex or unstable medical patients compared to free standing surgicenters. 6 Be prepared to manage anesthesia related Surgicenter or office-based complications such as retrobulbar hemorrhage (e.g., settings will have the lateral canthotomy) or brainstem anesthesia (e.g., equipment to manage these CPR with bag mask respirations). complications. Prompt recognition is critical. 7 Communicate with anesthesia providers in cases of Notifying anesthesia of a high myopia with elongated globes. posterior staphyloma may help reduce perforations. 8 Review all new anesthesia providers’ experience New providers should be and expertise in administering periocular blocks. monitored to assure quality and safety. 9 Consider conjunctival cut down and blunt cannula Potentially lower risk of injection of anesthetic in elongated eyes. globe perforation in high risk eyes.
10
Optimize surgical consent forms to inform patients Informs patients and about anesthesia risks documents risk discussions. Table 3: Actionable steps to minimize anesthesia-related complications in ocular surgery.
S0161-6420(19)32371-1
DOI:
https://doi.org/10.1016/j.ophtha.2019.12.019
Reference:
OPHTHA 11043
To appear in:
Ophthalmology
Received Date: 12 November 2019 Revised Date:
13 December 2019
Accepted Date: 18 December 2019
Please cite this article as: Morley M, Menke AM, Nanji KC, Ocular Anesthesia-Related Closed Claims from Ophthalmic Mutual Insurance Company 2008-2018 Ophthalmology (2020), doi: https:// doi.org/10.1016/j.ophtha.2019.12.019. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2019 Published by Elsevier Inc. on behalf of the American Academy of Ophthalmology
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Ocular Anesthesia-Related Closed Claims from Ophthalmic Mutual Insurance Company 2008-2018
Michael Morley, MD, ScM1* Anne M. Menke, RN, PhD2* Karen C. Nanji, MD, MPH3
*
These authors contributed equally to this manuscript.
1
Ophthalmic Consultants of Boston, Harvard Medical School, Boston, MA Ophthalmic Mutual Insurance Company, San Francisco, CA 3 Massachusetts General Hospital, Harvard Medical School, Boston, MA 2
Address correspondence to: Michael Morley MD, ScM, Ophthalmic Consultants of Boston 50 Staniford St., Suite 600 Boston, MA 02114 [email protected] 617-367-4800 x 6083
47
Abstract
48
Purpose: To evaluate the types of anesthesia-related closed claims and their contributing
49
factors, using data from Ophthalmic Mutual Insurance Company (OMIC).
50
Design: Retrospective analysis of pre-existing data
51
Participants: Plaintiffs who filed a professional liability claim or suit (written demand for
52
money) against OMIC-insured ophthalmologists, ophthalmic practices, and/or surgicenters in
53
which the surgical case occurred.
54
Methods: Plaintiff claims were collected from the OMIC database from 2008-2018 using search
55
queries for terms associated with known complications of ophthalmic anesthesia.
56
Main outcome measures: Number and types of anesthesia-related injuries and claims, who
57
administered the anesthesia, the outcomes of the claim or suit, cost to defend, and payments
58
made to plaintiffs.
59
Results: Sixty-three anesthesia related claims or suits were filed by 50 plaintiffs. Anesthesia-
60
related injuries included globe perforation (n=17), death (n=13), retrobulbar hemorrhage (n=7),
61
optic nerve damage (n=4), vascular occlusions (n=2), pain (n=2), eye or head movement
62
resulting in injury (n=2), and one case each for numbness, diplopia, and tooth loss during
63
intubation. All but 1 patient who died had pre-existing, significant co-morbidities. Two deaths
64
were related to brainstem anesthesia.
65
Regarding the type of anesthesia in the closed claims, retrobulbar and peribulbar anesthesia
66
were the most common types (n=16 each ), followed by local infiltration around the lids and
67
facial nerve (n=6), topical anesthesia (n=5) and general anesthesia (n=5). In two cases, the
68
exact type of anesthesia was unknown but not general. The 5 topical with sedation anesthesia2
69
related claims were due to inadequate pain control (n= 2), ocular movement resulting in
70
capsular rupture (n= 2), or death (n=1) allegedly related to excessive, or inadequate monitoring
71
of, sedation. There were 5 claims related to general anesthesia including 4 deaths and 1 tooth
72
loss during intubation. Sedation was alleged to be a factor in 5 cases resulting in death.
73
Anticoagulants were a factor in 3 retrobulbar hemorrhage cases.
74
Conclusions: While claims and suits were infrequent given the large number of insured
75
ophthalmologists and the large number of surgical cases requiring various types of anesthesia
76
performed over the 10.5-year study period, severe injuries can occur.
77 78
3
79
Introduction
80
Ophthalmic surgery typically yields good outcomes and is well-tolerated by the vast majority of
81
patients. The safety of the various ocular surgery anesthesia options contributes to the
82
excellent safety profile of ophthalmic surgery. However, severe injuries related to ocular
83
anesthesia do occur, 1-4 and these injuries can result in medical malpractice claims made against
84
the ophthalmologist, ophthalmology practice, anesthesiologist, nurse anesthetist, or the
85
surgical facility in which the surgery occurred. A better understanding of the frequency and
86
types of anesthesia-related claims may help to guide safety efforts to prevent patient harm
87
during ophthalmic surgery. Ophthalmic Mutual Insurance Company (OMIC) insures over 5,300
88
ophthalmologists, or about half of the ophthalmologists in private practice in the USA, as well
89
as their surgicenters and practices, making this data set helpful in evaluating anesthesia-related
90
complications that result in malpractice claims. 5 The purpose of this paper is to evaluate the
91
types of anesthesia-related closed claims and their contributing factors, using data from OMIC.
92 93
Methods
94
This is a retrospective analysis of closed (i.e., resolved) claims made against OMIC insureds for a
95
ten-year period from 6/1/2008-12/31/2018. A claim is defined as a written notice or demand
96
for money or services, including the institution of a lawsuit or arbitration proceeding. Our data
97
do not include open claims, i.e., claims that are filed but not yet resolved. Claims were
98
identified by author AMM searching the OMIC claims database for terms related to anesthesia
99
and complications from anesthesia including anesthesia, retrobulbar, peribulbar, topical, and
100
general anesthesia, globe perforation, perforation, penetration, death, bleeding, hemorrhage, 4
101
optic nerve, diplopia, double vision, stroke, heart attack, myocardial infarction, pain,
102
movement, and retrobulbar hemorrhage. Cases were selected if there was an allegation in the
103
claim of injury related to anesthesia or if the injury was clearly related to the administration of
104
anesthesia. All cases were then reviewed independently and then compared by 2 authors
105
(AMM and MGM) to confirm if there was an anesthesia-related complaint or injury.
106
Disagreements were resolved by consensus. We did not review patients’ medical records; the
107
data analyzed were the claims data summary and litigation files collected by OMIC Senior
108
Litigation Analysts and defense attorneys. Our data did not include claims regarding eye injuries
109
that may be anesthesia-related but occurred during non-ocular surgeries (e.g., anterior
110
ischemic optic neuropathy occurring during spine surgery, corneal abrasions occurring in
111
general anesthesia cases, etc.)
112 113
Statistical analysis
114
This study is a descriptive study with counts of individual events, means and ranges, or
115
proportions of total events presented. Because a single injury to a plaintiff may result in more
116
than 1 claim, data pertaining to claims use a denominator of number of claims and data
117
regarding injuries are presented with a denominator of number of patients. Comparisons
118
between groups were not performed. The rate of anesthesia-related ocular injuries was not
119
calculated given the lack of a denominator for total number of surgeries performed during the
120
time period.
121 122 5
123
Results
124
The demographics and descriptive data are presented in Table 1. Fifty patients submitted a
125
total of 63 claims or suits against OMIC-insured defendants including ophthalmologists, their
126
ophthalmology practices, and the surgical facilities in which the procedure took place. Plaintiffs
127
submitted an average of 1.26 claims with the surgeon, the surgeon’s practice, and/or the
128
surgicenter named as defendants. The average age of the plaintiff was 58 years old. Plaintiffs
129
gender included female (n =26, 51%), male (n= 21, 41%) and unknown (n=4, 8%). On average,
130
claims were filed 378 days (range 1-832 days, average 1.0 years) after the precipitating event,
131
and closed 1,290 days (range 433-3722 days, average 3.6 years) after the event.
132 133
Types of anesthesia resulting in injuries
134
Table 2 lists the data collected from our review of anesthesia-related closed claims cases.
135
Retrobulbar (n=16) or peribulbar (n=16) anesthesia were used in 32 (64%) of the plaintiff
136
injuries. Local anesthesia injected into the lids or periocular region was used in 6 (12%) cases.
137
General anesthesia was associated with 5 (10%) of the cases. Topical (eyedrop) anesthesia was
138
used in 5 (10%) cases. In two cases, the anesthesia type was uncertain but was not general (i.e.,
139
peribulbar, retrobulbar, local, or topical). In the 17 globe perforations, 10 patients received
140
retrobulbar anesthesia, 5 patients received peribulbar anesthesia, and 2 received an uncertain
141
type of anesthesia.
142 143
Administration of the retrobulbar and peribulbar blocks
6
144
Ophthalmologists administered the peribulbar or retrobulbar injection in 27 of 32 (84%) peri-
145
or retrobulbar anesthesia-related closed claim cases, while anesthesiologists administered 3
146
(9%) and CRNAs administered the injection in 2 (6%) cases. Of the 17 cases with globe
147
perforation, ophthalmologists performed the block in 12 (70%) while anesthesiologists
148
performed the block in 3 (18%), and a CRNA performed the block in 2 (12%).
149 150
Types of surgical cases/specialty resulting in claims
151
Cataract surgical procedures (n=24, 48%) were the most common type of case generating a
152
claim, followed by retina procedures (n=12, 24%) including vitrectomy and scleral buckle
153
surgery, laser procedures (n=5, 10%), oculoplastic cases (n = 4, 6%), pterygium (n = 3, 6%),
154
strabismus surgery (n=1, 2%) and chalazion incision and drainage (n=1, 2%). Four of the closed
155
claim injuries occurred in an office setting, 18 occurred in surgical settings (i.e., a hospital or
156
surgicenter operating room) and the remaining 18 case locations were not specified but
157
presumed to be in an operating room based on claim type.
158 159
Types of Injuries
160
Globe perforation was the most common plaintiff injury in our data set accounting for 17 (34%)
161
plaintiff injuries. Deaths accounted for 13 (26%) of the plaintiff injuries. Retrobulbar
162
hemorrhage resulting in blindness accounted for 7 (14%) of the injuries. Three of the plaintiffs
163
with retrobulbar hemorrhage were on anticoagulants, (1 warfarin, 1 apixaban, and 1 case
164
involved a combination of aspirin and clopidogrel). One plaintiff with bleeding had a low
165
platelet count discovered after the injury. Optic nerve injuries or perforation occurred in 4 (8%) 7
166
of the plaintiffs. All 4 optic nerve injuries resulted in post-operative pallor and legal blindness.
167
Additional injuries included vascular occlusions (n=2, 4%), movement of the eye or head during
168
surgery resulting in capsular rupture (n=2, 4%), and post-operative pain (n=2, 4%). Numbness,
169
diplopia, and tooth loss (n=1 each, 2% each) comprised the remaining injuries. There were no
170
wrong-sided or wrong type of anesthesia claims.
171 172
Of the 13 deaths, most plaintiffs had known medical problems including diabetes mellitus (DM),
173
(N=4, 31%), atherosclerotic cardiovascular disease (ASCVD)(N=1, 8%), or a combination of DM,
174
hypertension (HTN), ASCVD, or pulmonary edema (N=5, 38%). Despite the presence of these
175
conditions, all of the plaintiffs were classified as American Society of Anesthesiologists (ASA)
176
Physical Status III, defined as severe systemic disease with substantive functional limitations
177
from one or more moderate to severe disease. None were given the higher category IV of
178
severe systemic disease that is a constant threat to life.6 Three patients (23%) had a past
179
medical history that was not recorded in the OMIC database. Four of the 13 plaintiffs who died
180
had general anesthesia, 6 had retro- or peribulbar anesthesia, 1 had topical anesthesia with
181
sedation, and 2 were unknown but they did not have general anesthesia. In two of the deaths
182
following injection of retrobulbar anesthesia, the plaintiff suffered immediate respiratory arrest
183
and loss of consciousness. One case was attributed to brainstem anesthesia based on clinical
184
assessment. In the other case, the postmortem toxicology evaluation determined the cause.
185
The other deaths were attributed to cardiovascular disease (CVD, congestive heart failure,
186
pulmonary edema, myocardial infarction) or cerebrovascular (stroke) conditions; most of these
187
patients had known coexisting DM or CVD. General anesthesia injuries included 3 deaths and 1 8
188
tooth loss during intubation. The 38 cases with needle-based anesthesia (retrobulbar (n=17),
189
peribulbar (n=16), and local anesthesia (n=6)) led to globe perforation (n=17), death (n=6), optic
190
nerve injury (n=4), bleeding (n=7), diplopia (n=1), numbness (n=1), and central retinal artery
191
occlusion (n=2).
192 193
Indemnity payments and claim disposition
194
Sixteen of the 63 claims (25%) resulted in a payment to the plaintiff (indemnity payment) and
195
48 (75%) had no payment as the suit was either successfully defended or dismissed.
196
Perforations were the most common and most expensive injury resulting in a payment in 6
197
claims averaging $271,000 (range $20,000-$585,000). Death was the second most common
198
outcome resulting a payment in 5 claims averaging $73,500 (range $20,000-$160,000.) There
199
were 4 payments for retrobulbar hemorrhage cases averaging $92,500 (range $29,999-
200
$200,000.) Indemnity payments averaged $158,678 (median $75,000, range $15,000-
201
$585,000.) Of the 16 claims resulting in a payment, 14 were negotiated lump sum settlements,
202
1 was a negotiated annuity payment, and 1 case resulted from a plaintiff verdict at trial.
203
Of the 48 claims that settled with no payment, twenty-three claims were closed with no
204
payment before a lawsuit was filed, 4 lawsuits were closed after defense verdicts at trial, 5
205
were dismissed without prejudice, i.e., they could be refiled), 3 were dismissed for lack of
206
prosecution, 1 case was dismissed in summary judgement (i.e., decided by a judge not a jury),
207
and 12 were dismissed for other various reasons.
208 209
Discussion 9
210
Closed malpractice claims can be a useful quality improvement tool for identifying safety issues,
211
patterns and trends of injury, and strategies for prevention of related patient injuries.7 The
212
OMIC closed claims data reveal that anesthesia-related claims are relatively rare, with 63 closed
213
claims from 50 plaintiffs over 10.5 years despite the large number of surgeries performed
214
across the country each year by OMIC-insured ophthalmologists, practices, and surgicenters.
215
Anesthesia-related claims represented 2.8% (63/2227) of all total OMIC claims from 2008 to
216
2018 when the number of OMIC-insured ophthalmologists rose from 3939-5291. This number
217
is down from 3.2% of all claims in 1987-2005 (78/2474) during which time the number of OMIC
218
insured ophthalmologists rose from 877-3939.
219
While the low number of malpractice claims indicates that ophthalmic anesthesia care is
220
generally safe, there are important lessons that can inform a continuous process of
221
improvement aimed at maximally reducing the number of patient injuries.
222 223 224
Anesthesia-related complications can lead to severe injuries that have a devastating impact on
225
the plaintiff.1,2 Globe perforations were the most common injury in the cohort, accounting for
226
34% of defendant injuries. Patients with globe perforation injuries frequently had severe vision
227
loss or loss of the eye. The number of globe perforations in our data diminished in the 5.5 years
228
from 2013 to 2018 compared to the first 5 years of the study period, from 2008 to 2012. The
229
decreased number of globe perforations may be due to chance alone given the small numbers,
230
but it is notable that a switch to topical anesthesia occurred in many cataract practices during
10
231
this same time period. 8,9 Prospective trials are required to assess and compare the incidence
232
of ocular injury and surgical outcomes with various anesthesia techniques.
233 234
Thirteen patients died, accounting for 26% of complications and the second most untoward
235
event. Death occurred following retrobulbar, peribulbar, topical, and general anesthesia, as well
236
as sedation. Most of the plaintiffs who died had a known medical history of conditions such as
237
DM with end organ damage, CVD (e.g., hypertension, atherosclerotic cardiovascular disease,
238
myocardial infarction, congestive heart failure), or pulmonary disease. In two patients,
239
respiratory arrest, unresponsiveness, and death occurred immediately after a retrobulbar
240
block, and brainstem anesthesia was determined to be the etiology. Retrobulbar hemorrhage
241
(n=7) occurred both in patients taking anticoagulants (n=3) and those not taking anticoagulants
242
(n=4). The anticoagulants included anti-coagulant cascade inhibitors (warfarin, apixaban) and
243
anti-platelet drugs (aspirin and clopidogrel.)
244 245
The standard of care for medical clearance of patients undergoing ophthalmic surgery is slowly
246
evolving, with a focus on “optimizing risk reduction” instead of a blanket “medical clearance”.
247
There are increasing data to suggest that routine pre-operative medical evaluation and testing
248
of cataract surgery patients are, in some cases, unnecessary. The Centers for Medicare and
249
Medicaid Services recently eliminated the requirement that all patients undergoing surgery in
250
an ambulatory surgery center have a history and physical exam documented in the chart within
251
30 days of the procedure. 10 The new proposal requires that surgicenters create a written policy
252
defining which patients require pre-operative medical evaluation (i.e., history and physical
11
253
exam and lab testing) and allowing patients who are deemed low risk for operative
254
complications to skip this testing. There are data to support this change given the limited
255
benefit and high cost of this requirement for the vast majority of patients.11,12 When the patient
256
has significant medical comorbidities, however, it may be prudent, from both a clinical
257
standpoint as well as a risk management standpoint, to refer the patient to the primary care
258
physician, cardiologist, endocrinologist, or other appropriate medical specialist prior to surgery.
259
Engaging these physician consultants and using their expertise to optimize the patient’s general
260
health status before surgery may optimize the patients’ cardiovascular or pulmonary (or other)
261
systems to lower risk. Ophthalmologists may prefer to do the preoperative evaluation
262
themselves in some situations, especially given the difficulty of obtaining timely medical
263
evaluations and the lack of access in some locations to subspecialty care.
264
Fully preventing death related to ocular surgery and ocular anesthesia is not possible in the
265
population undergoing eye surgery given the age and co-morbidities. Cataract surgery in elderly
266
patients, and retinal cases involving patients with advanced diabetes-related co-morbidities,
267
carry intrinsic risks that cannot be completely eliminated. It is obviously important to pre-
268
operatively optimize the patient’s systemic health status with control of blood pressure,
269
coronary artery disease, blood sugar, pulmonary disease, and diabetic renal disease. But there
270
are significant obstacles to accomplishing this in many locations and situations. Some elderly
271
and sick patients have intrinsically unpredictable and unstable medical conditions. Some
272
ophthalmic surgery is urgent which places time constraints on medical evaluation and
273
stabilization. While there is more time before elective surgeries such as cataract removal,
274
patients may not be willing to invest the time, money, and effort to improve their health. 12
275
Ophthalmologists and primary care physicians may be falsely reassured by the low risk of
276
complications and the unproven value of routine labs and history and physical examinations in
277
the majority of patients but there are subsets of patients with serious co-morbidities or active
278
medical problems who do benefit from preoperative testing and management. Moreover,
279
delaying surgery and making it more time consuming and expensive carries potentially negative
280
consequences such as falls.
281
Two of the deaths appeared to be related to brainstem anesthesia, and both followed
282
retrobulbar anesthesia administered by an ophthalmologist. One plaintiff who could not keep
283
still for an A scan received the injection in the office. No licensed staff member was present to
284
monitor the response to the injection, and emergency response equipment was limited. CPR
285
was initiated while staff called 911. Paramedics arrived quickly and intubated the patient. The
286
defense’s toxicology expert felt that the medication was injected into the optic nerve. The
287
second case occurred in a surgery center where the anesthesia care was provided by an
288
anesthesiologist. While the ophthalmologist wondered if he had inadvertently given brainstem
289
anesthesia, the experts focused on the anesthesiologist whom they opined had over-sedated
290
the patient with propofol and inadequately monitored the response to the anesthesia and
291
sedation.
292
Retrobulbar hemorrhage was the third largest category of injury. Three of the plaintiffs with
293
retrobulbar hemorrhage injuries were taking antiplatelet medications (e.g., clopidogrel) or
294
clotting inhibitors (e.g., warfarin, apixaban, but 4 of 7 patients with retrobulbar hemorrhage
295
were not taking these medications. Continuing anti-coagulant treatment before and during eye
296
surgery is more common with phacoemulsification cataract surgery compared to other 13
297
surgeries, and with topical anesthesia compared to retrobulbar or peribulbar anesthesia.
298
Discontinuing anti-coagulants in the peri-operative period can lead to life-threatening
299
cardiovascular and neurological complications but continuing the anticoagulants elevates the
300
risk of injuries from hemorrhage. The surgeon needs to consult with both the physician who is
301
managing the patient’s medical condition(s) and the patient to address the associated risks of
302
each approach during the informed consent discussion. OMIC has created consent forms that
303
help patients understand the complexity of managing anti-coagulants during the perioperative
304
period. They provide a clear explanation to patients of the risks associated with both stopping
305
and continuing anticoagulants. Planning for urgent treatment of retrobulbar hemorrhage with
306
lateral cantholysis might help mitigate some injuries but extensive intraocular or retrobulbar
307
hemorrhage can be difficult to manage and can lead to a poor clinical outcome.
308 309
As expected, there were more ocular anesthesia claims from high volume procedures. Thus,
310
cataract surgery was most common surgical procedure noted in the closed claims followed by
311
retina surgery, including vitrectomy. General ophthalmological procedures, oculoplastics
312
procedures, strabismus surgery, and miscellaneous surgical procedures account for the
313
remaining cases.
314
Seventy-five percent of the claims or suits closed with no indemnity payments, which compares
315
favorably to industry standards.1 The cases that resulted in indemnity payments were nearly all
316
negotiated settlements; only one of the five cases that went to trial resulted in a plaintiff
317
verdict. Of note, the percentage of claims that were anesthesia-related in the OMIC database
318
(3%) is lower than the percentage in the literature for general surgical specialties (4%). 14
319 320 321
Our review of OMIC’s malpractice claims data supports recent recommended strategies to
322
lower the anesthesia-related risk to patients undergoing ocular surgery. 1-4,8,13 First, use the
323
least invasive form of anesthesia possible, weighing carefully the need for needle-based
324
anesthesia, which can lead to globe perforations and retrobulbar hemorrhage. 1,2 Some
325
ophthalmic surgical cases and patients require needle-based anesthesia, but some can be
326
managed with less invasive forms of anesthesia such as topical anesthesia. Second, obtain or
327
perform preoperative evaluations with the goal of optimizing the patient’s health. Consult with
328
primary care physicians and medical specialists, if available, for patients with serious systemic
329
diseases such as cardiovascular, endocrinological, renal, hematologic, rheumatologic, or
330
pulmonary diseases. Inform patients with conditions such as DM and CVD which are known to
331
increase mortality of the risk-reducing advice given by medical specialists. Clarify that it is
332
impossible to eliminate all risk, and the goal is to minimize risk. Consult with the patient’s
333
primary care or cardiologist to determine the safest plan for managing the peri-operative anti-
334
coagulants and use a specific consent form for those patients who take anti-coagulants to
335
document discussion regarding the risks of both maintaining and stopping the use of
336
anticoagulants. 14 Include in the procedure-specific consent form the rare but serious risks of
337
anesthesia (e.g., death, globe perforation, orbital and ocular hemorrhage, and optic nerve
338
injuries). OMIC has procedure-specific consent forms available on its website. 15 Consider
339
performing known medically high-risk cases in a hospital setting where higher levels of
340
emergency back-up are available compared to a surgicenter setting. Be prepared to manage 15
341
complications such as brainstem anesthesia with CPR or bag valve mask respirations or vision-
342
threatening retrobulbar hemorrhage by superior and inferior lateral canthal tendon cantholysis
343
to relieve increased orbital pressure. Communicating with anesthesia providers about patients
344
on anticoagulants and those with high myopia (i.e., long axial length) can be helpful. Consider
345
doing a cut-down block in these situations, in which peribulbar anesthesia is administered via a
346
blunt cannula through a small conjunctival peritomy after the patient is prepped and draped.
347
Confirm that new anesthesia providers who perform blocks are well trained, monitored during
348
their early cases in a facility, and can consult with other anesthesia providers in difficult cases.
349
Calmly address patients who have pain, anxiety, or movement during surgery and clarify with
350
the anesthesia team the need for additional sedation. Keep in mind that, although rare, local
351
infiltration of anesthesia to lids can result in globe perforation. Finally, maintaining vigilance
352
and situational awareness, especially during any type of periocular injection, including lid
353
anesthesia, may help mitigate the chance of a complication. A seemingly innocuous injection of
354
anesthesia for a laser procedure or a chalazion incision and drainage can be complicated by
355
globe perforation as was seen in several of our closed claims.
356
Our paper has several limitations. First, analyzing malpractice claims differs greatly from a
357
retrospective analysis of clinical data or an epidemiological study. Medical experts who provide
358
opinions about a malpractice claim know the plaintiff’s outcome and are participating in an
359
adversarial process. Plaintiffs typically testify to the impact of the alleged harm on their daily
360
life, providing information that is not readily available in the medical record. This process can
361
introduce multiple confounders, biases, and allegations concerning the severity of injuries. The
362
profitability of a case and the willingness of the plaintiff and his/her lawyer to pursue litigation 16
363
impact whether a claim or suit is filed or not, as well as the claim resolution. The nature of the
364
physician-patient relationship may incite or inhibit the filing of a claim or lawsuit irrespective of
365
the clinical outcome of a procedure. For these reasons, retrospective closed claim data must be
366
interpreted with these limitations in mind. While it is not a statistically valid source of
367
epidemiological data, the information is still valuable and actionable.
368
A second limitation is that there is uncertainty about the exact cause for some of the injuries
369
reported here. In particular, the role of sedation or over-sedation, is hard to quantify. For
370
example, in one case, a patient who received topical anesthesia as well as intravenous sedation
371
died and there was an allegation of over-sedation. Attributing an injury to the anesthesia, or to
372
the sedation medications which are frequently administered in conjunction with non-general
373
anesthesia cases, or to progression of a patient’s underlying medical condition is sometimes
374
difficult, especially in retrospection. Similarly, post-operative optic nerve injury can in some
375
cases be directly attributed to an optic nerve sheath penetration and hemorrhage but in some
376
cases may be related to optic nerve diseases such as ischemic optic neuropathy. Ophthalmic
377
surgical patients frequently have risk factors for increased mortality including advanced age as
378
well as co-existent medical problems such as DM, HTN, or ASCVD.
379
A third limitation of our study is that our data also do not include claims that may have been
380
made against non-OMIC insured entities such as the anesthesiologist, nurse anesthetist, the
381
anesthesiology group contracted to provide anesthesia services, or the hospital. Thus, our study
382
likely underestimates the number of anesthesia-related closed claims cases.
383
17
384
In summary, anesthesia-related claims are uncommon but serious anesthesia-related injuries
385
do occur. The population of patients undergoing ophthalmic surgery includes elderly and sick
386
patients making some morbidity and mortality unavoidable. Strategies described herein may
387
help to reduce potential complications and help to maximize patient safety and minimize
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professional liability exposure of ophthalmologists, anesthesia providers, surgicenters, and
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medical practices.
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This study adheres to the Declaration of Helsinki.
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The authors have no financial or other conflicts of interest to declare.
392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407
References 1) Nanji, K.C., Roberto, S.A., Morley, M.G. and Bayes, J., 2018. Preventing adverse events in cataract surgery: recommendations from a Massachusetts expert panel. Anesthesia & Analgesia, 126(5), pp.1537-1547. 2) Roberto, S.A., Bayes, J., Karner, P.E., Morley, M.G. and Nanji, K.C., 2018. Patient harm in cataract surgery: a series of adverse events in Massachusetts. Anesthesia & Analgesia, 126(5), pp.1548-1550. 3) Nanji, K, Morley, M, Betsy Lehman Center for Patient safety, Improving Patient Safety in Cataract Surgery, Published September 2016, https://betsylehmancenterma.gov/initiatives/cataract-surgery-initiative Accessed 11/12/19 4) Pennsylvania Patient safety Advisory, Pennsylvania Patient Safety Reporting System (PAPSRS) Patient Safety Advisory—Vol. 4, No. 1 http://patientsafety.pa.gov/ADVISORIES/Pages/200703_18.aspx Accessed 7/27/2019 5) Ophthalmic Mutual Insurance Company 2018 Members Report. Ophthalmic Mutual
408
Insurance Company, https://www.omic.com/wp-content/uploads/2018/10/2018-
409
Members-Report.pdf Accessed 2/19/19
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6) American Society of Anesthesiologists Physical Status Classification
411
https://www.asahq.org/standards-and-guidelines/asa-physical-status-classification-
412
system. Accessed September 15, 2019 18
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7) Anesthesia Quality Institute. American Society of Anesthesiologists, About Closed Claims https://www.aqihq.org/ACCMain.aspx accessed 7/21/19 8) Karen Posner, PhD, Lori Lee, MD, Anesthesia malpractice claims associated with eye
417
surgery and eye Injury- highlights from the anesthesia closed claims project data request
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service https://www.aqihq.org/closedclaimsPDF/Click%20here%20for_5PDF
419
American Society of Anesthesiologists November 2014, 78;11 28-30 2014
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Accessed 2/19/19
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9) Severe adverse events associated with local anaesthesia in cataract surgery: 1-year
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national survey of practice and complications in the UK Richard M H Lee, John R
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Thompson and Tom Eke Br J Ophthalmol published online September 24, 2015
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10) Centers for Medicare and Medicaid Services Omnibus Burden Reduction Conditions
425
Participation Final Rule. https://www.cms.gov/newsroom/fact-sheets/omnibus-burden-
426
reduction-conditions-participation-final-rule-cms-3346-f
427
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11) Keay,l., Lindsley, K., Katz, J., Schein, O., Routine preoperative medical testing for
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cataract surgery. Cochrane Database Syst rev 2019 Jan 8; 1: CD007293.doi:
430
10.1002/14651858.CD.007293.pub4
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12) Chen, CL, Lin, GA, Bardach, NS, et al Preoperative medical testing in Medicare patients
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undergoing cataract surgery. NEJM 2015 Apr 16; 372(16):1530-8. Doi:
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10.1056/NEJMsa1410846
19
434 435 436 437 438 439
13) Menke, A., Salz, J., Ocular Anesthesia-Related Claims: Causes and Outcomes. OMIC Digest 2006 16(1): 1-5 14) Menke, A, Ophthalmic Mutual Insurance Company, OMIC consents- anticoagulants https://www.omic.com/anticoagulant-consent 15) Menke, A, Ophthalmic Mutual Insurance Company, Consent forms for cataract surgery anesthesia https://www.omic.com/risk-management/consent-forms/
440
441
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1 2
Table 1 Table 1: Summary of Demographics of Closed Claims Data 2008-2018 Number of plaintiffs (N) Number of claims or suits (N)
50 63
Plaintiff age in years (mean, range)median?
58.0, (2-81)
Gender, N (%) Female 26 (52%) Male 21 (42) Uncertain 3 (6%)
3
Time to open claim from occurrence in days; (mean, range) 380 (1-832) Time to close claim from occurrence in days; (mean, range) 1299 (433-3722) Table 1 Legend: Summary of demographics of closed claims data.
1 2
Table 2 Table 2: Summary of Closed Claims data 2008-2018 Types of plaintiff injuries (N)
(N)
(%)
Globe perforation Death Retrobulbar hemorrhage Optic nerve injury Vascular occlusion, pain, movement during surgery resulting in injury Numbness, diplopia, tooth loss total
17 13 7 4 2 each, 6 total
34% 26% 14% 8% 4% each, 12% total
1 each, 3 total 50
2% each, 6% total 100%
Type of anesthesia (N)
Retrobulbar Peribulbar Local infiltration Topical General Unknown, but not general Total
16 16 6 5 5 2 50
32% 32% 12% 10% 10% 4% 100%
Administrator of all retrobulbar or peribulbar anesthesia blocks (N=32)
Ophthalmologist
27
85%
Anesthesiologist CRNA Total
3 2 32
9% 6% 100%
Retrobulbar Peribulbar Peri or RB- uncertain type
10 5 2
59% 29% 12%
Ophthalmologist Anesthesiologist CRNA
12 3 2
70% 18% 12%
Types of blocks associated with globe perforation (n=17)
Administrator of blocks in perforation cases (n=17)
Location of Procedure Hospital inpatient OR Office based laser or minor procedure room Hospital based surgicenter Non-hospital based surgicenter Location not recorded
1 4
Cataract/IOL surgery Retina surgery (vitrectomy/SB) Laser surgery Lid surgery/oculoplastic Pterygium surgery Strabismus Total procedures
24 12
48% 24%
5 5 3 1 50
10% 10% 6% 2% 100%
9 18 18
Procedure type (N)
Disposition (N)
Closed with payment Settled with annuity 1 Settled with lump sum 14 Plaintiff verdict- trial 1 Closed without payment Dismissed Without prejudice With prejudice Lack of prosecution Judgement defensemotion summary judgement Defense verdict-trial
3 4 5 6
2% 22% 2%
24
38%
5 10 3 1
8% 16% 5% 2%
4
6%
Total disposition 63 *101% Table 2 Legend: Summary data regarding the closed claims cases in the OMIC database, 2008-2018. *Percentage > 100 due to rounding.
2
Actionable steps to Minimize Anesthesia-Related Complications in Ocular Surgery Number Steps Comment 1 Maintain situational awareness of the location of Anesthesia injections to the the needle tip when performing even a “simple” eyelid or peribulbar or periocular anesthetic injection. retrobulbar space can occur less than a millimeter from the globe. 2 Use the least invasive method of anesthesia when Topical anesthesia, while possible. not always possible, lowers chance of perforation and other needle-related complications. 3 Consider medical consultation for patients with Primary care or specialty active systemic diseases. consultations to optimize health can benefit the anesthesia team, the eye surgeon, and the patient. 4 Manage perioperative anticoagulants in concert Both stopping and with the patients’ doctors. maintaining anticoagulants in the perioperative period carry risk. Help the patient understand the risks. 5 Consider using a hospital based OR for patients who Hospitals have significantly may require medical support or resuscitation. more resources to manage complex or unstable medical patients compared to free standing surgicenters. 6 Be prepared to manage anesthesia related Surgicenter or office-based complications such as retrobulbar hemorrhage (e.g., settings will have the lateral canthotomy) or brainstem anesthesia (e.g., equipment to manage these CPR with bag mask respirations). complications. Prompt recognition is critical. 7 Communicate with anesthesia providers in cases of Notifying anesthesia of a high myopia with elongated globes. posterior staphyloma may help reduce perforations. 8 Review all new anesthesia providers’ experience New providers should be and expertise in administering periocular blocks. monitored to assure quality and safety. 9 Consider conjunctival cut down and blunt cannula Potentially lower risk of injection of anesthetic in elongated eyes. globe perforation in high risk eyes.
10
Optimize surgical consent forms to inform patients Informs patients and about anesthesia risks documents risk discussions. Table 3: Actionable steps to minimize anesthesia-related complications in ocular surgery.