Sterilization Breakdowns in Endophthalmitis/TASS

Anne M. Menke, RN, PhD, OMIC Risk Manager

Digest, Spring 2006

The malpractice case featured in this issue’s lead article stemmed from a series of breakdowns in the facility’s sterilization process. When notified of the problem, the physician consulted with the ASC’s medical director and together they decided not to alarm the patient until they knew the facts. By not warning the patient of the symptoms to watch for, they arguably missed an opportunity to diagnose the problem earlier.

Q  Should I tell my patient of potential problems with sterilization?

A  Yes for several reasons. Patients have a need and a right to know about their own condition and can help monitor the development of symptoms. Such disclosure of adverse events is best understood as a continuation of the informed consent process begun before the surgery. Moreover, communicating with the patient sympathetically and non-defensively within the shortest appropriate time period may help dispel much of the anger, confusion, and distrust that complications may engender, while preventing allegations of fraudulent concealment that could extend the statute of limitations or allow for punitive damages. Stick to the currently known facts, avoiding speculation or blame. As more information becomes available, share it with the patient and document it in the medical record.

Q  How should I proceed if I suspect a cluster of endophthalmitis or TASS cases?

A  You will need to coordinate with the facility, your staff, and your patients in order to respond effectively. All patients operated on that day need to be notified of the events, screened for symptoms, and educated about when and why to contact you. The facility needs to sequester all involved materials, interview staff, and evaluate equipment, devices, solutions, medications, and the sterilization process. The investigation will help locate the responsible organism or toxic agent, ascertain liability, and determine what steps to take to remedy any identified problems.

Q  What specific information do I need to collect for the investigation?

A  Nick Mamalis, MD, of the Intermountain Ocular Research Center at the University of Utah has developed an Excel-based protocol that can be used for individual or clustered cases of infectious or sterile endophthalmitis. Detailed information about each patient’s pre- and postoperative course, the facility, equipment, supplies, medication preparation, and sterilization technique are compiled, entered into the spreadsheet, and sent to the center for review. Research fellows are available for on-site evaluations, and charge only airfare and nominal expenses. In response to more than 80 TASS cases nationwide, the AAO and ASCRS announced in May 2006 that an ad hoc committee chaired by Dr. Mamalis had been established to help determine the causes. Ophthalmologists with TASS cases are urged to complete two short questionnaires about the products involved during cataract surgery and the actual process of cleaning and preparing instruments and patients for surgery and forward them to Dr. Mamalis. The protocols and questionnaires are available on the OMIC web site, via email at  Nick.mamalis@hsc.utah.edu or by calling (801) 581-6586.

Q  What measures can I and the ASC take to prevent TASS?

A  While it can be very difficult to pinpoint the cause of TASS, pH, preser- vatives, and cleaning solutions are often implicated. Dr. Mamalis suggests a whole team approach to the order- ing, cleaning, sterilizing, and preparation of all instruments, viscoelastic, medications, and irrigation solutions to ensure proper pH, osmolality, and non-toxicity. Avoid re-use, especially of cannulas and damaged instruments. Rinse I/A tips and phaco hand pieces at the conclusion of each cleaning step with sterile, deionized water through both ports. Replace ultrasound water baths daily. Change the steam auto- clave sterilizer at least weekly. Take care with wound construction and avoid ophthalmic ointment and patches with clear corneal incisions.[1]

Q  Does the OMIC endophthalmitis claims study identify specific ways that physicians can minimize their liability?

A  Yes. Treat preexisting blepharitis. Screen for and stabilize medical conditions, such as immunosuppression or uncontrolled diabetes, that could adversely impact the patient’s healing process. Use povidone iodine to prepare the eyelid, carefully construct the wound, and check for leakage. Base your choice of antibiotic prophylaxis on current peer-reviewed recommendations. Provide written discharge instructions on wound care, signs and symptoms to report, and contact information. Carefully screen complaints from postoperative patients and evaluate the need to personally examine the patient. Following possible breaks in sterilization or clusters, consider examining or talking to the patient daily until infection/TASS has been ruled out or effectively treated.

1. Mamalis, Nick et al. “Review/Update: Toxic Anterior Segment Syndrome.” J Cataract Refract Surg Vol 32, February 2006:324-333.

Coumadin and Ocular Anesthesia

By Paul Weber, JD

Digest, Spring 1998

Recently, I took an incident report from an insured who stopped a patient’s Coumadin five days prior to surgery. Two days after surgery, the patient suffered a devastating stroke. The specific risks of discontinuing Coumadin were not discussed with this patient prior to surgery. It was the first time an incident of this kind was reported to OMIC, although the question of whether to stop Coumadin prior to cataract (or intraocular) surgery has come up a number of times. Quite often, an important risk management issue such as this one will raise both clinical and legal issues. When this occurs, we are fortunate to be able to collaborate on the clinical issues with ophthalmologists from OMIC’s Board and Committees.

In this case, Risk Management Committee Chairman Dean C. Brick, MD, a cornea specialist in Tucson, addressed the prevalent clinical issues. We realize this is a controversial topic and would appreciate hearing from our readers on this one.

Q  Should I discontinue a patient’s Coumadin prior to cataract (or intraocular) surgery?
A  This is a difficult situation since Coumadin puts both patient and surgeon at increased risk. If you continue the patient on Coumadin, you risk being sued if the patient develops bleeding problems. If you discontinue the Coumadin and the patient suffers a stroke, you may be sued for not advising the patient of the risks involved in stopping the medication. Two critical decisions must be made in these patients.

The first is whether the patient needs to be maintained on full doses of Coumadin prior to and during surgery. In many cases, patients are on Coumadin for prophylactic reasons and may safely discontinue it for a few days prior to surgery to allow the INR to decrease but not to a normal level. This option should be discussed with the primary care physician monitoring the patient’s anticoagulant and the discussion and decision reviewed with the patient and documented in the chart. If the decision to stop Coumadin is made, routine technique and anesthesia (including retrobulbar anesthesia) are appropriate.

Q  What surgical technique or anesthesia should I use in patients whose anticoagulant cannot be discontinued or decreased such as those with artificial heart valves?
A  This leads to the second critical decision: Should you change your technique of surgery or anesthesia? If a patient’s INR remains significantly elevated prior to surgery, the patient faces the risk of retrobulbar hemorrhage following retrobulbar or peribulbar anesthesia as well as the possibility of a more severe suprachoroidal hemorrhage. It might seem that topical anesthesia would be the technique of choice in these cases; however, OMIC has had two cases of suprachoroidal hemorrhage associated with topical anesthesia in which the patients complained of pain during surgery. It was alleged that the patient’s pain and discomfort resulted in elevated blood pressure and hemorrhage. Even though there are still risks of complications, topical anesthesia is probably the technique of choice for such patients provided the physician and anesthetist are experienced with its application.

If not, the surgeon should refer the patient to a surgeon who is experienced with this technique or modify his or her technique to fit the circumstances.

Q  If after weighing the options, it is decided that injectable anesthesia is the technique to use on a patient, how can I minimize the risk of complications?
A  Use a Greenbaum cannula or blunted needle to administer the anesthetic. A prolonged massage following the injection will prevent the formation of a large hemorrhage, which would compromise circulation to the globe or optic nerve. Closely observe the patient for signs of hemorrhage prior to, during and after surgery. Provide instructions before the patient leaves the hospital on how to recognize the signs of hemorrhage and how to contact you if any of these symptoms occur. Always be prepared to respond to emergencies. There are health risks to the patient and concomitant liability risks to the surgeon with any decision in situations like this. Discuss all the options and risks with the patient and document the reasons for the final decision in the chart.

Anesthesia and Sedation Risks and Precautions

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.