Preoperative Medical Assessment
Many patients contemplating ophthalmic surgery have medical conditions that could increase the risk of the procedure and anesthesia/sedation. To prepare for and reduce the risks as much as possible, patients undergo a preoperative medical assessment that usually includes a history and physical examination (H&P). Such an assessment has been mandated by CMS (Centers for Medicare and Medicaid Services). Regulations passed in 2019, however, give surgery centers more flexibility in determining who needs a preoperative H&P and when it must be performed; these new regulations are discussed in Part 2. Ophthalmologists may play a role in these determinations. They may also be performing the H&P themselves. Preoperative medical assessment provides information to guide decision making about the preoperative medical assessment.
Monocular Patient Loses Vision After Vitrectomy
Ryan Bucsi, OMIC Senior Litigation Analyst
This is a recently closed claim study of the Ophthalmic Mutual Insurance Company.
Digest, V24 N1 2014
Allegation
Lack of informed consent of increased risk of bleeding during elective vitrectomy in a patient taking Plavix and aspirin.
Disposition
Case settled for $825,000.
Case Summary
A 77-year-old female patient was referred to an OMIC insured with a history of blindness OS following a stroke several years earlier, as well as diabetes and hypertension. She had previous cataract surgery OD with 20/40 visual acuity and complained of seeing “specks.” The insured diagnosed marked asteroid hyalosis and, although the retina was attached, he recommended a vitrectomy to reduce the floaters. The insured was aware of the patient’s history of stroke and lost vision OS and that she was taking Plavix and aspirin, but he did not have her discontinue these medications prior to surgery. Towards the conclusion of the vitrectomy, the patient developed a bleed that led to a retinal detachment. Unable to isolate the bleed, the insured closed the eye and scheduled a subsequent procedure one week later to remove the blood and reattach the retina using silicone oil. It was noted during this second procedure that there was extensive clotting from the previous procedure.
At this point, the insured consulted with the patient’s primary care physician, who decided to discontinue the Plavix. Two weeks later, a third procedure was performed to remove additional blood. The retina was detached for the removal of blood and reattached at the conclusion of the procedure, again using silicone oil. The insured then consulted with his partner as there was still some blood present in the eye and the retina continued to detach following each surgery. With the insured present, the partner performed a fourth surgery six weeks later in an attempt to remove all the remaining blood and reattach the retina. The surgery was successful in reattaching the retina, but all the blood could not be removed as the patient continued to bleed during the procedure. A final examination revealed a white optic nerve and indicated that blood underneath the retina for a prolonged period of time may have caused damage to the photoreceptors. The patient had nerve atrophy, atrophy of the eye itself, and NLP OD, rendering her completely blind.
Analysis
Our defense experts were split on whether it was within the standard of care to operate on this patient without first consulting her primary care physician about safely taking her off Plavix and aspirin prior to surgery. However, our experts unanimously agreed that a separate informed consent should have been given to the patient specifically detailing the risk of hemorrhage, retinal detachment, and potential loss of sight.
During his deposition, the insured testified that he had no discussions with the patient about an increased risk of bleeding, retinal detachment, and loss of vision because the vitrectomy was done in an avascular area and bleeding was not expected. Our experts disagreed and felt that bleeding was indeed a risk and since the patient had sight in only one eye, there should have been a more thorough review and discussion of all the risks associated with surgery. Indeed, the main weakness of the case was the apparent imbalance between the expected benefit of surgery to remove floaters and the potential risk of blindness in a functionally monocular patient.
Risk Management Principles
The patient history and physical exam were appropriately performed and documented; however, the insured did not take into account that the findings indicated an increased risk for bleeding and retinal detachment, which could lead to blindness in the patient’s remaining good eye. The patient was never informed of these possible complications and did not have the opportunity to make a well-informed decision about moving forward with a procedure that carried significant risks. Additionally, as pointed out by one of OMIC’s defense experts, since this was an elective procedure, a detailed, welldocumented discussion of the risks would have benefited the doctor when complications arose.
OMIC has a sample consent form to use with surgical patients who are taking anticoagulants. See it here.
Ophthalmologists’ Liability for the Actions of CRNAs
Kimberly Wynkoop, OMIC Legal Counsel
Digest, Summer 2012
Sedation or anesthesia for ophthalmic procedures may be administered by anesthesiologists or other qualified anesthesia providers. Ophthalmologists are exposed to legal liability for claims based on the actions of anesthetists, and OMIC’s policy is available to protect ophthalmologists if they do arise.
CRNAs as Employees or Agents
Supervising ophthalmologists may be held vicariously liable for the acts or omissions of the CRNA under various theories of liability. The most common is respondeat superior, Latin for “let the superior respond” or “let the master answer.” Also termed the “master-servant rule,” this doctrine holds an employer or principal liable for the employee’s or agent’s wrongful (or negligent) acts committed within the scope of the employment or agency.
The fact that ophthalmologists are required to supervise nurse anesthetists’ provision of services during a procedure does not, by itself, create an employer-employee relationship, nor does it prevent ophthalmologists from maintaining independent contractor relationships with them (or no formal relationships at all, such as in a hospital setting). The substance of the relationship, not the label, governs the nurse anesthetist’s status as an employee or independent contractor. In order to determine whether a CRNA would be considered an employee, there are several factors to consider.
Does the ophthalmologist have a right to direct and control how the nurse anesthetist does the task for which he or she was hired? An employee is generally subject to the employer’s instructions about when, where, and how to work.
Does the CRNA bill separately for his or her own services? Independent contractors are more likely than employees to have non-reimbursed expenses and to bill separately for their own services. Whether under contract or not, an employee often will receive benefits and his or her compensation is subject to withholdings.
Control Over Independent CRNAs
As a general rule, ophthalmologists are not held liable for the negligent acts or omissions of independent CRNAs, even if—for billing and regulatory purposes—they are deemed to be their “supervisors,” unless the ophthalmologist controls or directs the actions of the anesthesia provider. Courts generally focus on the amount of control the treating physician exercises over the anesthesia provider to determine whether the physician should be liable for the anesthetist’s actions.
To determine if a physician has such control, courts consider who hired, could terminate, and pays the anesthetist, and who has the right to direct the anesthetist in the manner and performance of his or her work. The particular test to determine whether the supervising physician controls the anesthetist’s work varies by state.
In ASC and hospital settings, ophthalmologists are often required, under CMS regulations and/or state law, to supervise nurse anesthetists and sign various anesthesia-related orders, evaluations, and reports. It is OMIC’s understanding that the role of the treating physician, with relation to the provision of anesthesia services, is to (1) determine whether a patient requires the surgery or diagnostic procedure, (2) request that anesthesia be administered, and (3) determine that the patient is an appropriate candidate for the procedure and anesthesia. Therefore, it is not uncommon for the treating physician to be asked to sign perioperative orders for anesthesia, sedation, and anxiolytic drugs and to co-sign the pre-anesthesia evaluation conducted by the nurse anesthetist in addition to signing the record of the operation prepared by the circulating nurse as well as the dictated operative report. The fact that ophthalmologists sign certain anesthesia orders, evaluations, or records could be used by a plaintiff’s attorney to attempt to prove control, but without further evidence, it would probably not be sufficient.
Even if ophthalmologists do not have general control over a CRNA, the “borrowed servant” theory of liability provides that physicians can be held liable if they “borrow” another’s employee and acquire a temporary right of control over the employee that was originally possessed by the lending employer.
Negligent Supervision and Hiring
The supervising ophthalmologist may also be held liable for the CRNA’s actions under the theories of negligent supervision and negligent hiring. Negligent supervision arises from the rationale that physicians conducting professional activities through other professionals such as CRNAs are subject to liability for any injuries caused if the physician is negligent or reckless in supervising such activity. Negligent hiring may be alleged if the ophthalmologist knew or failed to use reasonable care to discover that the CRNA was not competent, fit, licensed, or certified to perform the required duties.
OMIC’s professional liability policy covers ophthalmologists for professional services incidents arising from direct patient treatment provided by “any person acting under the supervision, direction, or control of the insured at the time of the professional services incident, so long as that person was acting within the scope of his or her licensure, training, and professional liability insurance coverage, if applicable.” In other words, OMIC’s policy covers insureds for their liability arising from the supervision of nurse anesthetists, subject to all policy terms, conditions, and exclusions.
Co-Defendant CRNA Denies Responsibility for Failed Resuscitation
OMIC ARTICLES ON ANESTHESIA LIABILITY
- This article appeared in an issue of our Digest devoted to wrongful death claims. The policy article in that issue addresses supervision of CRNAs and liability questions: https://docs.google.com/viewerng/viewer?url=http://www.omic.com/wp-content/uploads/2012/12/Digest-Summer-2012.pdf
- Another issue of the Digest analyzed ophthalmic anesthesia claims: https://docs.google.com/viewerng/viewer?url=http://www.omic.com/wp-content/uploads/2012/12/Digest-Winter-2006.pdf.
- Here are detailed risk management recommendations on ophthalmic anesthesia: http://www.omic.com/wp-content/uploads/2012/04/Anesthesia-Liability.pdf.
Ryan Bucsi, OMIC Senior Litigation Analyst
Digest, Summer 2012
Allegation
Negligent resuscitation resulting in death of 45-year-old father of three.
Disposition
Case settled for $1,775,000 of which CRNA contributed $975,000 and OMIC insured contributed $800,000.
Case Summary
Anon-OMIC-insured ophthalmologist performed cataract surgery on a patient who subsequently developed a hemorrhage OD. The patient was then seen by the insured, who had previously treated his proliferative diabetic retinopathy and bilateral retinal detachments. The insured recommended a vitrectomy under local anesthesia at a surgery center knowing that the patient had tolerated the cataract surgery under local anesthesia. 
During the vitrectomy, a CRNA administered local anesthesia with IV sedation, and the insured performed a retrobulbar block OD. When the patient became agitated and complained of pain, the CRNA provided more sedation after which the patient turned pale and stopped breathing. The CRNA administered oxygen through an Ambubag but O2 saturation did not increase. The insured instructed the CRNA to intubate and 911 was called. Despite intubation, the patient’s O2 saturation did not improve. The CRNA confirmed that the tube was in the trachea but asked the surgeon to listen for breath sounds with him; both the surgeon and CRNA heard breath sounds. When the paramedics arrived, they determined that the CO2 monitor had not changed color indicating the tube was in the esophagus rather than the trachea. This prompted the CRNA to get into a shoving match with one of the paramedics. The paramedic re-intubated the patient and O2 saturations began to go up. The patient was transferred to the hospital where he died eight days later.
Analysis
The plaintiff’s anesthesiology expert had many criticisms of the insured ophthalmologist. He testified that surgery should not have been performed since the plaintiff had low blood sugar and high blood pressure on the morning of surgery. It was this expert’s opinion that, given the patient’s medical condition, general anesthesia should have been used, but if local anesthesia was used, the surgery should have been performed in a hospital or facility where an MD anesthesiologist was available. Since this surgery center did not have an MD anesthesiologist, the expert pointed to the ophthalmologist as the “captain of the ship.” The expert testified that the CRNA did not intubate the patient properly and the insured did not diagnose improper esophageal intubation.
The defense expert disagreed with these opinions and the role of a surgeon in anesthesia care. He insisted that the anesthesia provider is responsible for monitoring the patient during surgery. He testified that the CRNA failed to monitor and communicate a low oxygen level to the insured prior to the patient’s arrest, thus leading to a delay in resuscitation. Unfortunately, the defense expert was not comfortable rendering an opinion on the standard of care related to the decision to perform surgery. The co-defendant CRNA testified at his deposition that he was responsible for providing anesthesia to the patient, but that the insured was the “captain of the ship.” The CRNA admitted that he had not performed an intubation in the five years preceding this case and that he never discussed the risks and complications of anesthesia with the patient because he did not want to scare him. However, he maintained that the intubation was properly done and that the paramedic dislodged the tube. It was defense counsel’s opinion that a jury would award the plaintiff $2.8 to $4 million and hold the OMIC insured 25% to 50% liable. The CRNA settled first for $975,000, and the OMIC insured settled later at mediation for $800,000.
Risk Management Principles
For the OMIC insured, this could be viewed as a case of being in the wrong place at the wrong time. The procedure was performed in a surgery center with a CRNA who allegedly did not properly intubate the patient leading to a prolonged period without oxygen and eventual death. There are several steps insureds can take to minimize the risk of an improper resuscitation in a surgery center. First, find out if there is a peer review process in place to review the competency of CRNAs and anesthesiologists. Inquire about the emergency response measures in place and whether there is anyone else available within the surgery center to assist with resuscitations. Lastly, call 911 immediately when a potentially life-threatening situation arises.
Surgical Experience: Acquisition and Disclosure
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Spring 2012
Policyholders often call the OMIC Risk Management Hotline to discuss the risks associated with new techniques and technology. They wonder how much training is required and if and how they should talk to patients about their training and experience. The Closed Claim Study in this issue demonstrates that seeking such advice is prudent, as the physician’s level of expertise may become the focus of a malpractice lawsuit.
Q How much experience is needed in order to present oneself as qualified?
A There is no clear-cut answer, but the surgeon will be held to the standard of a reasonably prudent eye surgeon. While physicians are expected to be lifelong learners and continue to hone their skills, the acquisition of new knowledge and skills requires careful preparation. Certainly, any training required or recommended by an equipment manufacturer should be completed, as well as the review of pertinent peerreviewed literature. If the technique or technology is significantly different than that of the surgeon’s experience, additional formal training may well be needed, such as skill transfer classes or practice on cadaver or animal eyes, followed by observation of experienced surgeons and surgical assisting. Once the physician feels ready to treat patients, it would be prudent to ask a senior colleague to serve as proctor (this may even be required in order to obtain privileges at a hospital or ASC). The proctor, an impartial observer with documented training and experience in the skill in question, provides an objective evaluation and is able to attest that the surgeon has demonstrated competency. Finally, the ophthalmologist must feel that he or she is ready to perform the new skill.
Q I have been asked to proctor another ophthalmologist. Are there precautions I should take?
A Yes. First, ensure that you are licensed in the state where the proctoring will take place and have been granted privileges at the facility. Clarify with the credentialing department whether your role will be limited to observing and reporting or whether you are expected to intervene if there is a patient safety risk, and share that information with the physician being evaluated. In addition, ask if proctoring is considered a confidential peer review activity. Confirm that you and the physician whom you will be proctoring have professional liability insurance at adequate limits for the procedure. Ask the surgeon to inform the patient that you will be observing the surgery. Be candid and objective in your evaluation.
Q I just purchased a femtosecond cataract laser. I completed my training from the manufacturer and have been proctored. Do I have a legal duty to tell my patients how many procedures I have done using the laser?
A There is only a small body of case law governing voluntary disclosure of experience during the informed consent discussion, but one of the most famous cases highlights the risks of not discussing experience. A neurosurgeon disclosed the risks of death, stroke, and blindness to a patient who had a basilar aneurysm, stated he had done the procedure to treat it several times, and quoted a mortality rate of 2%. The patient had no prior neurological impairment but was an incomplete quadriplegic after the procedure. During the trial, the surgeon admitted that he had done only two cases, making it seem as if he had inflated his experience. Experts testified, moreover, that he had underestimated the risk: the mortality rate ranged from a low of 11% with very experienced surgeons to a high of 20 to 30% for those surgeons with limited experience. The jury awarded the plaintiff $6.2 million. On appeal, the Wisconsin State Supreme Court ruled that a reasonable person facing the need for an operation to treat a basilar aneurysm would have wanted to know that the neurosurgeon had little experience in the surgery and that the mortality and morbidity rates differed based on experience. In addition to mandating the disclosure, the court felt that the surgeon should have discussed the option of referral to a tertiary care center. In his analysis of the decision, OMIC Vice President Paul Weber noted that there is no clear rule on when the surgeon should talk about comparative risk and that such comparative risk data might not be available. He encouraged ophthalmologists to see the procedure from the patient’s perspective. If, as a patient, the eye surgeon would want to know the level of expertise and experience of the surgeon, he or she should disclose experience (see “Trends in the Duty of Informed Consent” at www.omic.com).
Q What if a patient asks me about how many procedures I have done?
A Here the legal answer is clear. Physicians do have a duty to answer truthfully when asked about their experience and results. When discussing results, it is important to distinguish results from clinical trials or studies from personal experience or that of the entire practice. Overstating one’s results may seem relatively harmless, but it has been construed as false advertising or fraud and has led to settlements of otherwise defensible care.
