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Anesthesia and Sedation Risks and Precautions

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By Carol Poindexter, JD, and Kimberly Wittchow, JD

Ms. Poindexter is a partner with the international law firm of Shook, Hardy and Bacon LLP specializing in health law.

Ms. Wittchow is OMIC’s staff attorney.

Digest, Summer/Fall 2004

Use the Download option in the toolbar above view the chart titled “Monitoring and Recovery Equipment for Office-Based Anesthesia” mentioned in this article.

Advances in science, technology, and training, combined with reimbursement pressures by third party payors, have had the effect of moving the vast majority of ophthalmic procedures from hospitals to freestanding ambulatory surgery centers (ASCs) and office-based facilities. While this change has generally benefited ophthalmologists and their patients, there are concerns about compromised patient safety and increased physician liability when sedation and anesthesia are administered outside the hospital setting. The first section of this article outlines several risk avoidance practices that can help ophthalmologists, especially those operating in office-based settings, maximize patient safety and minimize sedation and anesthesia-related liability risks.

In some cases, sedation or anesthesia may be administered by an anesthesiologist or other qualified anesthesia provider, such as a certified registered nurse anesthetist (CRNA). Federal and state guidelines often require that in hospital and ASC settings, the treating surgeon supervise the CRNA. The second section of this article addresses the surgeon’s supervisory role and how it affects liability risk.

While hospitals and ASCs are typically closely regulated by accrediting agencies, the office-based surgical setting is currently only regulated in a handful of states. If surgeons do not follow reasonable and published guidelines for office-based surgery and sedation, there is an increased risk that procedures may be performed in settings lacking the appropriately educated and trained clinical staff and/or sufficient equipment and emergency protocols to handle adverse reactions to sedation or anesthesia or other emergencies that may arise. Administering sedation and anesthesia without adequate experience or equipment can have devastating consequences.

Precautions for In-Office Procedures The decision to perform a procedure in an office-based setting should only be made after careful evaluation. The surgeon is responsible for conducting or reviewing an appropriate physical exam and formulating and prescribing a written patient-specific plan for sedation or anesthesia care that addresses fasting requirements and treatment locale. Because it is impossible to accurately predict how each patient will respond to sedation or anesthesia of any type, and given the fact that the physician and office staff may be called upon to rescue the patient if an adverse reaction occurs, all staff should be thoroughly trained in emergency treatment protocols. The surgeon and other clinical support staff should be certified in Basic Life Support (BLS); Advanced Cardiac Life Support (ACLS) or Pediatric Advanced Life Support (PALS) certification is ideal.

To address patient safety con- cerns, the physician must have an adequate number of competent, professional staff members available to monitor the patient during the sedation. The person responsible for monitoring the patient during the procedure cannot be the same one performing it. This person should be familiar with the medications used; know how to recognize airway obstruction and correct it; know how to monitor the required para- meters, recognize abnormalities in them, and intervene; and be able to manage ventilation with a self- inflating bag valve mask. Additionally, all staff members who will be involved in patient care duties must meet all licensure and certification requirements; have sufficient experience to perform their duties; and be supervised by the operating surgeon or other licensed physician throughout the peri, intra, and postoperative/anesthesia periods.

Upon completion of the surgical procedure, the ophthalmologist who administered or medically directed the sedation should evaluate the patient prior to transferring the care to a qualified licensed nurse. The nurse assuming care of the patient should be qualified to identify surgical and sedation or anesthetic complications that might occur during the postoperative period. The patient should be sent home only after discharge criteria are met and in the company of a competent adult. (For more information on office-based sedation, see Hotline article.)

Supervision of CRNAs at Hospitals and ASCs In ASC and hospital settings, ophthalmologists are often required to supervise nurse anesthetists and sign various anesthesia-related orders, evaluations, and reports. This has raised questions about the ophthalmologist’s exposure to claims based on the actions of the CRNA.

Under federal law, it is a condition of participation in the Medicare and Medicaid programs for ASCs that a non-physician anesthetist be under the supervision of the operating physician. The requirement for hospitals varies slightly in that a CRNA must be under the supervision of the operating practitioner or an anesthesiologist who is immediately available if needed.

States may request that their ASCs and hospitals be exempted from this supervision requirement. According to the American Association of Nurse Anesthetists’ web site, however, the only states that had opted out of the federal supervision requirement as of November 2004 were Alaska, Idaho, Iowa, Kansas, Minnesota, Montana, Nebraska, New Hampshire, New Mexico, North Dakota, Oregon, and Washington. If your state is not on this list, there is likely a state law that either mirrors or expands upon the federal provision. See your state government, state medical society, or nurse anesthetists’ association web sites for more information.

Proving Supervision Has Occurred

The Centers for Medicare & Medicaid Services (CMS) do not define or specify how to prove supervision. Nevertheless, having the supervising physician sign certain anesthesia orders, evaluations, or records may be the simplest way for the ASC or hospital to confirm that supervision has occurred.

It is OMIC’s understanding that the role of the treating physician, in 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. It is less common, however, for the surgeon to sign the anesthesia record. If asked to do so, the ophthalmic surgeon may wish to clarify with the ASC or hospital the reason for this requirement, since proof of the surgeon’s presence and/or supervision during the procedure should be ample from the aforementioned signed orders, co-signed pre-op evaluation, and/or operative records.

Liability for the Actions of CRNAs

Depending on state law, you may be held vicariously liable under the doctrine of “respondeat superior” for the actions of nurse anesthetists who are your employees. Also termed the “master-servant rule,” this doctrine holds that an employer is liable for the employee’s wrongful (or negligent) acts committed within the scope of employment.

If you supervise nurse anesthetists who are not your employees, however, you are not necessarily liable for their actions. 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 (whether the anesthetist is a CRNA or an anesthesiologist). The fact that you sign certain anesthesia orders, evaluations, or records might be used by a plaintiff’s attorney to attempt to prove control, but without further evidence, it would doubtfully be sufficient.

Similarly, the fact that you 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 you 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:

Do you 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 he or she 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.

Is there a written contract describing the relationship of the parties? Do you provide the nurse anesthetist with benefits, such as insurance, a pension plan, vacation pay, or sick pay? Is his or her compensation subject to withholdings for income taxes, unemployment, or workers’ compensation? Whether under contract or not, an employee often will receive benefits and his or her compensation is subject to withholdings.

An ophthalmologist’s supervision of one portion of the nurse anesthetist’s provision of services is not determinative of the nurse anesthetist’s employment status. Rather, it is only one of many factors used to determine the nature of the relationship.

OMIC’s policy covers its insureds for liability arising from the supervision of nurse anesthetists (subject to all policy conditions and exclusions). It is your decision whether to seek less responsibility for CRNA supervision at ASCs or hospitals.

Message from the Chairman: Retrobulbar and Periorbital Ocular Blocks

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One of the many benefits of the close relationship between OMIC and the Academy is the ability to coordinate our efforts to address legal, regulatory, and quality of care issues of common concern. Recently, OMIC and the Academy joined forces to stop legislation that would have adversely affected ophthalmic practice in two states.

In March, OMIC responded to a request from Academy EVP/CEO, David Parke, MD, to help the Washington Academy of Eye Physicians and Surgeons (WAEPS) respond to a proposed state Medical Quality Assurance Commission (MQAC) regulation that would characterize retrobulbar and periorbital ocular blocks as anesthesia “where significant cardiovascular or respiratory complications may result.” Such a characterization would require every ophthalmology office that administers anesthetic blocks to undergo an accreditation or certification process similar to that of the Accreditation Association for Ambulatory Healthcare. Clearly, the process would not only be burdensome, but also extraordinarily expensive and unnecessary as ophthalmologists have been administering these anesthetic blocks in their office practices for decades with no significant risk to patients.

As is often the case, this rule was “hidden” in a larger regulation pertaining to office-based surgery. When it appeared likely the regulation would pass, WAEPS contacted the Academy for assistance, and Dr. Parke asked OMIC for claims data related to the use of local blocks in office-based surgery. His response to MQAC stated:

“…complications of retrobulbar injection in the outpatient office setting are extraordinarily rare. A survey by the largest medical malpractice carrier in ophthalmology (Ophthalmic Mutual Insurance Company) found only one case in a 21-year review of its claims data bank of a cardiovascular event from a retrobulbar injection performed outside of the operating room. This is in a period of time when literally millions of such injections were performed. This indicates that the risk is very small.”

Having compelling evidence-based data is of extraordinary benefit when dealing with regulatory agencies. With the support of the Academy, the Washington Medical Association, and other concerned organizations, WAEPS was successful in having the rule taken off the hearing calendar and reevaluated with more input from ophthalmology.

OMIC also worked closely with Academy Secretary for State Affairs, Dan Briceland, MD, to help the West Virginia Academy of Ophthalmology (WVAO) fight an optometry bill that would have allowed optometrists to perform glaucoma surgery. OMIC has extensive experience in this area. Over 300 optometrists are directly insured by OMIC, and approximately 35% of its 4,100 insured ophthalmologists employ or contract with an optometrist. In a letter drafted for WVAO to present to West Virginia legislators, OMIC pointed out the risk to patients:

“OMIC engages in an ongoing process of assessing the risk of optometrists performing ‘surgery.’ Based on an objective risk assessment, OMIC is not willing to extend liability coverage to any optometrist who performs laser surgery or any therapeutic ophthalmic laser procedure.”

The letter noted that only one state (Oklahoma) allows optometrists to perform surgical or therapeutic laser procedures.

“OMIC’s decision to not extend this coverage to optometrists is based on the lack of data available on this liability risk, as well as the company’s assessment that there is also an absence of data to properly underwrite, determine a premium rate, and have the expertise to administer claims arising from surgical or therapeutic laser procedures performed by optometrists.”

After a hard-fought battle, the WVAO was able to defeat the bill and stop the expansion of optometry into glaucoma surgery.

Richard L. Abbott, MD OMIC Chairman of the Board

Ocular Anesthesia Claims: Causes and Outcomes

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Anne M. Menke, RN, PhD, and James J. Salz, MD

Anne Menke is OMIC’s Risk Manager. Dr. Salz is a member of OMIC’s Claims and Risk Management Committees.

Digest, Winter 2006

To view the charts mentioned in this article use the Download button on the toolbar above.

Ocular anesthesia presents challenges for both the ophthalmologist and anesthesiologist. Each must address patient anxiety about eye surgery, including concerns about eye pain or movement during surgery, and possible vision loss. When determining the appropriate anesthesia to use, physicians must take into consideration possible multiple medical comorbidities in elderly patients and the particular anesthesia risks for pediatric patients, especially those who may be premature or have congenital syndromes. Following application of the anesthetic agents, they may need to manage intraocular pressure or respond to cardiovascular events precipitated by oculocardiac reflexes.

OMIC recently conducted a review of claims related to anesthesia and sedation in order to identify issues that can be addressed through proactive risk management. The results of this study are summarized in this article and in an online course. The study was a retrospective analysis of 18 years of OMIC claims experience (1987-2005). While OMIC’s database includes incidents reported by physicians on a precautionary basis, only actual malpractice claims – defined as written demands for money and lawsuits – were included. Cases were located by searching for anesthesia- and sedation-related words in allegations and through codes assigned to these procedures, such as retrobulbar or peribulbar injections. Therapeutic injections were excluded. At times, information was available only from case summaries, not from medical records. As these results show, very few of the thousands of patients who undergo ophthalmic procedures sue their provider for professional negligence in the administration of anesthesia or sedation.

Out of 2,474 OMIC claims during this 18-year period, only 78, or 3%, were related to anesthesia and sedation. Of the 65 closed anesthesia/sedation claims, 43, or 66%, were closed without any indemnity payment to the plaintiff. Claims resolved without any payment to the plaintiff (former patient) for several reasons: (1) the claim was not pursued by the plaintiff,often after OMIC denied it for lack of merit; (2) the physician was dis- missed from the lawsuit through legal action; this was most common when he or she did not administer the anesthesia; or (3) a jury, medical review panel, or arbitrator sup- ported the physician’s care.

In 22 of the 65 closed cases, the plaintiff was awarded money as a result of settlements or plaintiff ver- dicts at trial or arbitration. While the frequency of anesthesia claims is low, both the percentage of claims result- ing in payments and the severity of the indemnity awards were higher than OMIC’s overall claims averages (see Table 1). Defense costs for these 65 closed claims, however, were some- what lower than OMIC’s overall aver- age ($34,574 vs. $39,324) and median ($21,688 vs. $26,223) cost per case.

Types of Anesthesia Resulting in Claims

Complications of orbital injection anesthesia accounted for the over- whelming majority of anesthesia/ sedation-related claims against OMIC insureds (69 claims), while general and topical anesthesia accounted for only 5 and 4 claims, respectively. Sedation was an issue in 5 of the 69 orbital claims. Retrobulbar anesthesia was administered in 49 cases: 32 times by ophthalmologists, including one ophthalmology resident, 14 times by anesthesiologists, and 3 times by Certified Registered Nurse Anesthetists. Of the 16 peribulbar blocks, 9 were given by eye surgeons and 6 by anesthesiologists. The only O’Brien block was injected by an ophthalmologist; the type of orbital anesthesia was not specified in 3 claims. Of note, there were no claims resulting from sub-Tenon’s blocks.

Complications of Ocular Anesthesia

The complications resulting from retro- and peribulbar blocks in the OMIC cases correlate closely with those reported in the medical literature 1,2 (see Table 2). Perforation was the most likely complication, followed by cardiovascular events and hemorrhage. Sedation-related problems were the primary issue in two settled claims. In one case, the plaintiff alleged that her pain and anxiety were inadequately controlled, resulting in a $450,000 indemnity payment on behalf of the ophthalmologist. In the second, the ophthalmologist ordered a nurse to administer sublingual Procardia and oral Valium to an elderly patient, who suffered a series of strokes after she was discharged with a blood pressure significantly lower than upon admission. Neither the ophthalmologist nor the nurse was aware of the “black box” warning associating sublingual Procardia with severe hypotension and stroke. The ophthalmologist and ambulatory surgery center each contributed $375,000 toward the settlement.

In all 4 closed general anesthesia claims, the ophthalmologists were dismissed from the lawsuits despite complications that included adult respiratory distress syndrome, intraoperative choking with a post- operative CVA, and death due to aspiration. The authors do not have information on the outcome for the anesthesia providers in these claims. Failure to control pain and/or movement was the allegation in 2 open topical anesthesia claims, while inadequate pain relief allegedly led to hypertension and hemorrhage in 2 closed topical anesthesia claims. In the closed cases, a cataract surgery claim closed without payment, while a combined cataract/trabeculectomy case settled for $150,000. Both plain- tiff and defense experts criticized the use of topical anesthesia for trabeculectomy and felt surgery was not indicated in the first place, as the patient did not have glaucoma.

Standard of Care Was Met But Other Issues Arose

Eye surgeons who meet the standard of care expect to successfully defend their treatment. Nonetheless, in 6 of the 22 paid indemnity cases, the plaintiff prevailed even though OMIC’s Claims Committee, claims associates, and defense experts were fully supportive of the care provided. Three of these cases were settled at the request of the insured physician due to the ophthalmologist’s health issues, nervousness, or desire to compensate the patient for lost wages. In another, an unwitting dictation mistake concerning the timing of a perforation following a retrobulbar unduly complicated the defense. In 2 instances, the plaintiff attorneys made side deals with the anesthesia providers just before trial in order to pressure the ophthalmologists to settle, even though the anesthesiologists were felt to be responsible for the plaintiffs’ injuries. The anesthesiologist was dismissed in one of these cases and the anesthesiology group made a nominal payment, leaving the ophthalmologist as the sole defendant. After similar maneuvers in the other case, a new theory of negligence was introduced against the ophthalmologist. When the medicine is complicated, the venue is plaintiff-oriented, the outcome is poor, and the ophthalmologist is the only defendant left, a settlement within policy limits can be a prudent move to protect the insured’s personal assets.

Concerns About Care

During the informed consent discussion, ophthalmologists warn patients about the complications associated with anesthesia and the patient’s particular surgery. If a complication occurs but is promptly recognized and appropriately managed, the outcome is considered to be a maloccurrence rather than malpractice or negligence. A single concern about an aspect of care can usually be explained to a jury. Multiple concerns about care still do not constitute negligence, but they can greatly strengthen a plaintiff’s case and persuade a jury to give the plaintiff, rather than the physician, the benefit of the doubt. Three of OMIC’s 22 cases that closed with indemnity payments fall into this category. In the first case, lack of indications for surgery, failure to communicate to the anesthesiologist the difficulties of a wide and long eye, and criticisms about the lack of documentation of a staphyloma led to a settlement. In the second case, a settlement was reached because there was no documented consent, the cause of the injury to the optic nerve could not be ascertained, and the postoperative management was subpar. Question- able indications for a second surgery coupled with scanty documentation and a difficult venue led to a settlement in the third claim.

Negligence

Physician negligence was felt to be the cause of the plaintiff’s injury in 13 of the 22 cases that resulted in an indemnity payment. Table 3 indicates the point in the care process at which the skill, judgment, or expertise of the insured was not that of a reasonably prudent ophthalmologist, which is generally the standard experts use when evaluating a case.

Lawsuits may be mitigated by applying risk management principles at every step of care, from determining the proper procedure to making appropriate care decisions after maloccurrences, and documenting that care clearly and completely. Careful informed consent discussions about anesthesia choices, clear communication with other providers, and an empathetic response to patient concerns and questions can also significantly reduce the likelihood of claims. Please see the document “Ophthalmic Anesthesia Liability” at www.omic.com.

Finally, while the actual choice of anesthesia or its administration was less frequently a concern, physicians should consider substituting sub-Tenon’s for orbital injection anesthesia when appropriate, given its significantly lower risk profile. OMIC’s online “Ophthalmic Anesthesia Liability” course, nearing completion, will feature a video demonstrating this technique.

1. Stead SW and Bell SB, Focal Points: Ocular Anesthesia, The Foundation of the American Academy of Ophthalmology, March 2001: Vol. XIX, No. 3.

2. Anesthesia Alternatives for Ocular Surgery, American Academy of Ophthalmology, 2001.

What You Should Do Now To Protect Your Patient’s Eye Health Information

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Not long ago, eye health information was stored almost exclusively in tattered folders on dusty shelves in a back room of the ophthalmologist’s medical office. Not anymore. Use of full or partial electronic medical record (EMR) systems increased 270% among ophthalmologists between 2005 and 2010. Nearly half of all ophthalmic practices now use some form of electronic record keeping and many use email and other web-based services to transfer medical information.

For all their efficiency and convenience, electronic filing systems present new liabilities for ophthalmologists, including violations of privacy regulations such as HIPAA and the new HITECH Act. Potentially damaging events include malicious virus attacks, accidental data breaches, or even an intentional act of sabotage by a disgruntled employee. Recent studies reveal that many private medical offices have failed to implement security features required under HITECH, highlighting a need for greater security of personal medical information. The lack of continuity between various electronic medical information and record systems and new technology that allows sensitive information to be wirelessly transferred to portable devices such as iPads and smart phones will probably complicate security challenges going forward. Should a breach occur, even if not intentional, costs related to data recovery, patient notification of privacy breaches, and financial credit monitoring, could add up very quickly, and the time required to manage these issues is likely to distract staff from their normal responsibilities. In recent months, policyholders have reported potential claims related to various breaches of sensitive patient health information, including lost and/or stolen laptops and unauthorized release of data over the internet.

Recognizing these emerging exposures and the potential threat posed to our insureds, cyber liability coverage is added under the BRPP supplementary benefit of OMIC’s policy. Visit https://www.omic.com/policyholder/benefits/

What it Covers

Privacy Violations. Reimburses you for fines and penalties associated with breach of federal, state, or local statutes related to personal medical or financial information, including HIPAA, Gramm-Leach-Bliley Act, HITECH, FTC and Fair Credit Reporting Act. Also responds to general allegations by patients of violations or release of their private information.

Network Security. Reimburses you for damages related to inadvertent transmission of harmful viruses, unauthorized access to sensitive information stored on computer systems, prevention of authorized access to computer systems, and failure to prevent identity theft or credit/debit card fraud.

Data Interference. Reimburses you for damage to sensitive data you maintain through intrusion of computer systems and electronic communication devices without your knowledge, whether intentional, malicious, reckless, or negligent.

Patient Notification. Reimburses you for costs related to patient notification of privacy breaches, including all reasonable legal, public relations, advertising, IT forensic, call center, credit monitoring, and postage expenses incurred.

Data Recovery. Reimburses you for all reasonable and necessary expenses required to recover and/or replace patient data that is compromised, damaged, lost, erased, or corrupted.

Additional coverage is available through Lloyds of London underwriters administered through NAS Insurance Agency. If you would like to purchase excess limits above the $50,000 limit provided in your OMIC policy, please contact Dana Pollard at (877) 808-6277 or dpollard@nasinsurance.com.

Risk Management Tips

Breaches of information are usually unintentional; however, you can take steps to protect yourself from both negligent and malicious events involving employees or third parties. Although no data security policy will be 100% effective, following are some areas to focus on when planning, developing, and implementing your office protocol for the privacy and security of patient information.

• Make sure electronic health records, and any other electronic data systems you use in the practice, are protected with vigorous virus and data protection software and that the software is updated automatically whenever a new version is released.

• Perform a regular back-up of all sensitive data and store in a secure area with a third party and/or off site.

• Use encryption services whenever possible and make sure passwords are changed on a regular basis.

• Limit access of private health information to medical office staff when the information is not necessary for their particular job function by storing on separate computers in a separate area away from any systems on which they are able to engage in personal electronic communications.

• Install tracking software to log and monitor each time a staff member accesses or retrieves sensitive information.

• Distribute and rotate duties in such a way that prevents any one person from having complete access to a patient’s health record.

OMIC participated in the eRisk working group. For more information on other risks associated with electronic recordkeeping, please see here.

OMIC’s Top 10 – Claims Payments

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OMIC continues to outperform multispecialty carriers in every tracked industry statistic regarding defense of ophthalmic claims. The cumulative average settlement for ophthalmology (OMIC vs. industry) was $151k to $185k in 2010. OMIC beat the industry in every year of the past decade, as well as since inception of the company. Only 3 cases have exceeded $1M in the history of OMIC. See below for OMIC’s top 10 settlements and verdicts since 1987.

OMIC’s Top 10