Risk Management Issues in Ophthalmic Plastic Surgery

By Michael J. Hawes, MD, FACS, and Marilys F. Gilbert, RN, Esq.

Digest, Winter, 1993

Oculoplastic surgery, because it is often cosmetic in nature, poses peculiar risk management challenges to the ophthalmologist who may be called upon to bridge the gap between unrealistic patient expectations and surgery’s limitations.

Further complicating the situation is the fact that health insurance carriers frequently consider oculoplastic procedures to be elective surgery and therefore not a reimbursable medical necessity. These factors combine to create a situation which can strain the physician-patient relationship and set the stage for a potentially adversarial relationship.

Frequency versus Severity

In the professional liability insurance industry, frequency refers to the number of claims filed, while severity refers to the indemnity and expenses incurred with the resolution of a claim. High frequency means that many claims are filed, while severity measures the dollar amounts of defense and settlement costs. In recent years, while we have seen claims frequency drop or level off, claims severity has increased.¹

A review of 1,143 claims against ophthalmologists from three sources indicates that only 3.4% or 39 of these claims related to ophthalmic plastic surgery, suggesting that plastics may be a relatively low-risk subspecialty.^2,3,4 (See Figure I.) There were 452 claims filed against OMIC insureds between October 1987 and January 1993, of which 11 involved oculoplastic procedures (2.4%).

Most Frequent Claim Types

Of the 39 oculoplastic claims reviewed, eyelid surgery was involved in more than half of all claims (20), with socket/orbital surgery a close second (16), and lacrimal drainage surgery a distant third (3). (See Figure I.) Further analysis reveals that blepharoplasty, ptosis repair and management of an orbital mass are the procedures most likely to result in a claim. (See Figure II.) A successful blepharoplasty can be quite gratifying to the surgeon and the patient. But as with any type of plastic surgery, a frequent complication is the unhappy postoperative patient. With blepharoplasty implicated in more than one-fourth of all oculoplastic claims, good patient-surgeon communication cannot be overemphasized. This should include a thorough preoperative discussion of the patient’s expectations and the procedure’s limitations.

The need for additional surgery is a frequent complaint from blepharoplasty patients. The surgeon may dampen patient dissatisfaction with blepharoplasty by not charging for revision surgery. Then, even if a lawsuit is filed, having waived these charges may mitigate damages against the surgeon. Other complications which instigated claims included: asymmetry, scarring, wound dehiscence, ptosis and globe perforation during local anesthetic injection.

Ptosis-related claims also are common, representing 18% of the oculoplastic claims reviewed. Reasons cited for these claims included overcorrection, need for multiple surgeries, and postoperative upper lid ectropion.

An equal number of claims resulted from alleged mismanagement of an orbital mass. Dry eye syndrome after removal of a lesion in or near the lacrimal gland, failure to diagnose an orbital malignancy, and post-biopsy ptosis were the bases for these claims.

Certain procedures such as eyelid tumors, eyelid reconstruction, entropion and trichiasis management were not implicated in any of the 39 claims reviewed. These might be considered, at this time, to fall in the “low risk” category for the oculoplastic surgeon.

Severity of Claims

Information about claims severity is necessarily subjective. An insurance carrier must make a judgment in establishing a “reserve” fund to cover the potential indemnity costs related to a claim which may not be resolved for may years. The amount to an indemnity settlement, if any, often is not released, and only limited information is available regarding severity of oculoplastics claims. However, visual impairment or loss tends to arouse a jury’s sympathy and bring about high dollar awards, regardless of the claimant’s age.

Of the 39 claims reviewed, those involving orbital trauma had the greatest severity. One claim was a case of visual loss after orbital hemorrhage. Permanent diplopia following trauma was present in another case. A ruptured globe and orbital foreign body resulted in a claim in a third case. In general, claims involving loss of vision, double vision, or sponges left in the orbit will result in higher indemnity payments than claims of asymmetry after blepharoplasty or ptosis repair. Likewise, management of an orbital mass probably involves more risk of permanent visual or systemic impairment than does eyelid or lacrimal drainage disease management. Exceptions to these generalizations are abundant, however.

There are steps that oculoplastic surgeons and other ophthalmologists can take to avoid or minimize medicolegal problems. Good patient rapport and preoperative discussion are foremost considerations. Adequate testing, informed consent, unaltered medical records, and timely referrals or second opinions on difficult patients or difficult cases are recommended.

Develop a Rapport with Patients

Good rapport with a patient goes a long way to prevent a claim when a complication or unexpected result has occurred. Often the deciding factor in filing a claim is a determination by the patient and family that the physician “really didn’t care” about the patient’s well-being. The patient should perceive his or her well-being as the goal of treatment. The surgeon who doesn’t relate well to a patient on the initial visit should suggest either a second visit or another doctor.

An unkind remark by the physician may result in a suit being filed. Patients who have complications or who are dissatisfied with their results should be seen more frequently than normal and given special attention by their physician, even thought this special consideration may be unpleasant for the physician.

Avoid Surprise Outcomes with Preoperative Discussion

Following lack of rapport, surprise is the next most common factor in a patient’s decision to file suit. Preoperative discussion with a patient and family can be instrumental in avoiding malpractice claims. Evaluation of patient expectations and psychological status can keep the surgeon out of trouble postoperatively.⁵

Patients tend to accept information presented prior to surgery, but are skeptical of the same statements made after a procedure.⁶ For example, ptosis patients should be advised preoperatively that the lid may be too high or too low after surgery, and that additional surgeries may be needed to obtain a satisfactory result. Blepharoplasty patients actually pay more attention to their appearance after surgery and tend to forget their preoperative appearance. Pre- and postoperative photos may help both patient and surgeon be more objective in evaluating results.

Risks and complications, as well as alternative treatments, must be disclosed preoperatively. While it is not practical or even possible to mention every potential complication, generally the most frequent and most severe complications should be mentioned. For example, patients with orbital tumors should be told that, among other things, visual loss, double vision, nerve damage, ptosis, dry eyes, hemorrhage, and tumor recurrence could occur.

The informed consent discussion is the surgeon’s responsibility, and cannot be delegated to a nurse or other employee. However, the patient should be presented with written information about the nature of the procedure, alternatives and complications. Trained personnel in the doctor’s office may answer some follow-up questions about this document, provided the physician is available to offer further counsel when needed. Written pre-and post-op care instructions, which take into account any specific health conditions or contraindications of the patient, should be given to the patient or a family member.

Keep Good Medical Records

It has been said that a jury tends to believe most of what is written in a patient’s record, and little of what a doctor who is being sued says in court. Once a suit is filed, good medical records are a physician’s best defense. Good records are legible. They document informed consent, treatment course and plan, and note review of lab work, diagnostic studies, and any current medications the patient is taking. They record phone calls and missed appointments. These entries should be timely and accurate. Alterations or additions to the record after a suit is threatened or filed are a major mistake, and may automatically result in a loss in a situation which otherwise might be salvaged.

Personally Review Diagnostic Tests

Delay or failure to diagnose a lesion may result in a suit. For example, MR scans or a biopsy may be essential in establishing the correct diagnosis of an orbital tumor. Ideally, the surgeon personally reviews imaging studies with the radiologist and biopsy results with a pathologist. A puzzling or unexpected diagnosis based on an imaging study or biopsy should provoke further studies or review with additional consultants prior to instituting therapy.

Seek Second Opinions for Difficult Situations

Referral of a difficult patient or a patient with a difficult problem can save a physician from a lawsuit. Even though the oculoplastic surgeon may see him or herself as the “end of the line” in a series of referrals, there is usually another physician (perhaps in another city or state) with special expertise on a given problem. Just sending the patient for a “second opinion” may help to defuse an unpleasant situation, provided the second doctor does not make disparaging comments about the referring doctor’s care.

Finally, do not despair. Despite the best efforts of a physician, claims will occur. Such is the risk of practicing medicine in today’s world. Do not view a malpractice claim as a condemnation of your value as a person. Look at it as part of doing business. Contact and cooperate with your insurance carrier, and assure they provide you with the best legal help possible to resolve the situation.

Notes:

1. Gonzalez ML, Emmons DW, Slora EJ(eds). Socioeconomic Characteristics of Medical Practice 1990/91. American Medical Association, Chicago. 1991.
2. Bettman JW. Seven hundred medicolegal cases in ophthalmology. Ophthalmology. 1990;97:1379-84.
3. Kraushar MF, Turner MF. Medical malpractice litigation in ophthalmology: The New Jersey experience. Ophthalmic Surgery. 1986;17:671-74.
4. Gilbert MF. Unpublished data from the files of the Ophthalmic Mutual Insurance Co., San Francisco. 1991.
5. Hawes MJ, Bible HH. The paranoid patient: Surgeon beware! Ophthalmic Plastic & Reconstructive Surgery. American Academy of Ophthalmology, San Francisco. 1990;6:225-27.
6. Bettman JW. Legal considerations. In Stewart WB (ed): Ophthalmic Plastic & Reconstructive Surgery. American Academy of Ophthalmology, San Francisco. 1984:45.

CO2 Laser Skin Resurfacing: Watch Out for Marketing Liability

By Joe F. Arterberry, MD, and Paul Weber, JD

Argus, February 1997

Skin resurfacing with the CO₂ laser is a relatively complex surgical innovation that has captured the attention of the medical community and the public. Much of the public’s fascination can be traced to aggressive marketing of the procedure, which has led many patients to expect superb results without side effects. Unfortunately, such results are not always achievable despite optimal surgical technique and attentive post-treatment care.

The combination of aggressive marketing and high patient expectations sets the stage for costly litigation when patients suffer real or perceived complications following CO₂ laser resurfacing. The most likely allegations relate to inadequate training resulting in suboptimal performance of the procedure, lack of informed consent, and inadequate laser precautions.

In their haste to sell ophthalmologists very expensive laser systems, manufacturers and sales representatives may not emphasize the substantial amount of education and training necessary to perform this procedure properly. At a minimum, education and training should include:

• A solid foundation in the basic science of lasers and laser interaction with tissues.
• An understanding of skin anatomy and wound healing.
• Didactic courses on specific types of CO₂ laser delivery systems.
• Initial CO₂ resurfacing surgical experience under a preceptor or proctor.
• A laser safety course.

The laser operative team also should have proper training and adhere to stringent laser safety precautions, including:

• Following fire precautions (e.g., avoiding alcohol-based prep solutions and topical, flammable anesthetic agents, etc.).
• Wearing glasses with sideshields or goggles.
• Using dulled metallic corneal shields and dulled low- or nonreflective metallic surgical instruments to prevent specular reflections and to protect tissues from accidental photoablation.
• Using an approved smoke evacuator to remove a potentially infectious laser plume.

All documentation of CO₂ laser education, training and safety courses attended by the ophthalmologist and staff should be kept on file. Continuing education is equally important in this area since the technology and the procedures related to it are relatively new and constantly evolving.

Prior to coming to the ophthalmologist’s office, the patient may already have been misinformed about this procedure by glitzy newspaper and magazine ads or television infomercials touting only the benefits of CO₂ laser skin resurfacing. It is the ophthalmologist’s responsibility to determine the patient’s prior knowledge and understanding of this procedure and to give patients accurate and current information regarding its risks, benefits and alternatives. Some of this information can be provided by non-ophthalmologists; however, the responsibility for securing informed consent from the patient cannot be delegated. Commercial videotapes and educational materials are available to begin the informed consent process, and OMIC has developed an informed consent document for CO₂ laser skin resurfacing that can be requested by fax from OMIC’s Risk Management Department at 415-771-7087. It must be emphasized that these videos, brochures and informed consent documents are no substitute for an ophthalmologist’s detailed discussion with the patient. The fact that this discussion took place should be documented by the physician either on the informed consent document or in the patient’s chart.

Patients need to understand that while the initial results of CO₂ laser skin resurfacing have been very promising, long-term results or effects are currently indeterminate. For instance, with every pass of the CO₂ laser spot, a quantifiable thickness of skin is ablated, ranging from 50-150 microns depending upon the laser parameters used, and a varying thickness of dermis is thermally damaged. Therefore, pending completion of clinical studies, it may be prudent to inform heliotropes or “sun-worshippers” about the increased risk of or susceptibility to developing cutaneous malignancies subsequent to their “resurfacing.”

Ophthalmologists who advertise CO₂ laser skin resurfacing need to be particularly careful about how they characterize this procedure. It is difficult to defend in court the ophthalmologist who advertises and markets the procedure as “safe,” “quick,” “effective,” or “gentle” if a patient has one of the known complications of the procedure. Should a lawsuit arise against an ophthalmologist who improperly advertises, a jury could determine that the misleading statements in the advertisements outweigh the force and effect of a thorough discussion of the risks by the ophthalmologist.

In conclusion, if the ophthalmologist approaches CO₂ laser resurfacing methodically and with a compulsive attention to detail and concern for the patient’s well-being, the surgical risk should be minimized.

Nips, Tucks and Lawsuits

By Paul Weber, JD

Digest, Summer 1998

Everyone involved considered the bilateral upper and lower lid blepharoplasty a cosmetic procedure, including the 54-year-old patient who presented to the OMIC insured with complaints of difficulty driving. Three weeks post-op, the patient had epithelial defects, was unable to wear his contact lenses and could not fully close his eyes. He developed corneal ulcers and subsequently sought a repair of cicatricial lower lid ectropion by a subsequent provider. In his suit, the patient claimed that in addition to improperly performing the blepharoplasty, the insured had misrepresented the number of lid surgeries he had performed.

Inflammatory statements such as these are not uncommon in a lawsuit and although they raise credibility issues, these often can be overcome. What could not be overcome in this case, however, was the allegation of poor pre-op examination. The ophthalmologist had failed to take any pre-op photos, had not tested lower lid horizontal laxity, and had not performed a Schirmer’s test. Although he claimed to have measured horizontal laxity during a slit lamp examination, there was no documentation to support this. This lack of thoroughness in performing the pre-op examination bolstered the plaintiff’s claims that the insured lacked the necessary experience to properly perform the procedure. The case settled with a large indemnity payment.

Perhaps it’s the elective and/or cosmetic nature of many oculoplastic procedures that makes proper patient selection and documentation of the patient’s history, physical, pre-op examinations and diagnosis so essential to a good patient outcome and successful defense if a claim is filed. Since many of these patients are experiencing little, if any, demonstrable functional impairment, documentation of the nature of the patient’s problem, both subjectively and objectively, is critical.

Likewise, lack of informed consent is often added to claims of improper performance. Besides a thorough written consent form signed by the patient well in advance of surgery, there are other approaches the ophthalmologist should employ to ensure that the patient is aware of the goals and possible outcomes of the proposed surgery and understands how he or she will be cared for throughout the process.

Be a Teacher

At a session on documentation and patient selection at the annual meeting of the American Society of Ophthalmic Plastic and Reconstructive Surgery, John W. Shore, MD, presented a history and physical form he has developed in his practice. The form includes sections for measuring “eye protective mechanisms” (tear film, basal tear secretions) and horizontal laxity measurements of the lower lids. Had the OMIC insured in this case used such a document, he would have been prompted to document important information that would have made it difficult for the experts and plaintiff to criticize his preoperative evaluation and dispute whether a critical part of the exam was performed.

Dr. Shore describes his approach to patients considering oculoplastic surgery as that of teacher. Beginning with the first visit and continuing throughout, anytime the patient is given patient education materials, it is documented in the chart. Dr. Shore conveniently does this while writing his Impression and Plan for the patient. From a list of nine handouts, Dr. Shore circles those that are given to the patient. Directly below the Handout section of his H&P is a Discussion section. Again, Dr. Shore selects from a list of six possible discussions the one he has with the patient. Logically, the Handout and Discussion sections come at the end of the H&P near Impression and Plan since only after a thorough exam is it possible to determine which discussion to have and which handout to give to the patient.

During discussions with the patient, Dr. Shore finds it helpful to use a diagram of the face and eyes as a “chalkboard” to explain the goals of surgery (see above). He dates and places the diagram in the medical record and gives a copy to the patient. Sometimes it may be necessary to use more than one diagram to explain a procedure, but these diagrams will go a long way toward helping negate claims that the physician did not take the time to discuss and explain the surgical goals and objectives in a manner the patient could understand.

Family Ties

Often, it is just as important to establish rapport with the patient’s family as it is with the patient. Throughout the treatment process, include in your documentation any time a family member is present; e.g., “reviewed goals of surgery with family and patient once again,” “answered all questions; offered to meet with patient and family once again prior to surgery.” Document if the family member also received and was encouraged to read handouts and other written material provided to the patient. This will be helpful because often it is a concerned family member who encourages the patient to seek legal representation when there is a real or perceived problem arising from surgery.

Ensuring that the prospective patient has reasonable expectations should be foremost in the ophthalmologist’s mind throughout the course of treatment. It is important not to overstate expectations. This cannot be emphasized enough given the public’s growing demand for cosmetic oculoplastic procedures such as CO2 laser skin resurfacing, liposuction and laser hair removal. Many patients come to the physician with very high expectations for these cosmetic procedures based upon advertisements featuring glowing patient testimonials or the recommendation of a friend who was pleased with the results of a particular procedure or the skill of a particular surgeon.

The ophthalmologist needs to explore the patient’s motivation and prior understanding of what the procedure can and cannot accomplish, not only as part of the informed consent process but also as part of the patient selection process. Does the patient understand that while most cosmetic procedures will help improve one’s appearance, there are no guarantees? That even when the procedure is executed well, results may not be apparent for months? Or that additional procedures may be necessary to achieve results the patient will be satisfied with? One defense attorney has suggested that patients considering cosmetic procedures be tested following the informed consent process to determine their understanding of the risks and goals of surgery similar to the tests now given to refractive surgery patients.

Damage Control

Complications sometimes arise even when the most meticulous surgical technique and care are provided. When an adverse event occurs, it is important to promptly discuss the problem with the patient and family. Be empathetic and answer their questions. Significant delays in reporting problems will only make the patient and family suspicious. When another health care provider has caused the complication (e.g., an anesthesia mishap), it is important not to lay blame, but to ensure that the patient is kept fully informed by the responsible party about what has occurred and what is being done to remedy the problem.

Document the date and time when complications were disclosed. This disclosure of complications will start the clock ticking with respect to the statute of limitations within which a patient may file a lawsuit. Even when the complication is one that the patient has been informed about prior to surgery, it is important to give greater attention and consideration to this patient. Inform staff that the patient has had a complication and should not be kept waiting for appointments. If a wait is unavoidable, the ophthalmologist should be alerted and personally handle the matter. Calls from these patients and their family members should be given the highest priority. Efforts to keep the patient satisfied with the ophthalmologist’s service is another way of showing empathy for the patient and family. Empathy and understanding will not be construed as an admission of negligence.

Avoid complications by giving patients detailed postop instructions and seeing them as soon as possible when they call with complaints. Remember that postop patients often need support and encouragement because they are still taking medication or are in the healing stage of their treatment, which could have an impact on their final outcome.

Document all telephone conversations with the patient or other health care professionals concerning a patient’s problem. One oculoplastic case had to be settled with a large indemnity payment because the OMIC insured allegedly refused to respond to a call from the ER about a patient who was having postoperative bleeding following bilateral levator aponeurosis repair. Although the insured maintained that the information given to him was not significant enough to warrant an ER visit, he had no documentation to support what had been said.

In summary, oculoplastic surgery must be approached in a thorough and meticulous fashion from pre-operative examination through postoperative follow-up. Good documentation and an ongoing calm, reassuring attitude on the part of the surgeon and the staff will go a long way toward minimizing claims and avoiding adverse outcomes.

Mr. Weber gratefully acknowledges the generous help of oculoplastic specialists John W. Shore, MD, and Michael J. Hawes, MD, for their contributions to this article.

Facials, Fillers, and Physicians: Keeping the “Medi” in Medi-Spa

By Betsy Kelley OMIC Vice President of Product Management

Digest, Spring 2009

Undercover officers in Florida find an unlicensed cosmetologist injecting Restylane and another unlicensed individual performing sclerotherapy at a medical spa. The patients are not seen by a physician, nor are medical exams conducted. The cosmetologist is arrested for the unlicensed practice of medicine and possession of legend drugs with intent to dispense. The medical director is disciplined by the medical board, including a letter of concern, fine, and mandatory community service.1

Another doctor takes over as medical director of a North Carolina medical spa. Before reviewing the spa’s policies and practices, he authorizes the compounding pharmacy to continue supplying a numbing gel used with laser hair removal. Within one month of the doctor’s hiring, a 22-year-old college student dies of poisoning after using the lidocaine she had received from the pharmacy in anticipation of her treatment. The medical director’s license is suspended for six months for failing to ensure that the prescription gel was properly dispensed.2 The former medical director is also charged with unprofessional conduct for setting up the protocols that allowed the clinic to dispense the gel without individual prescriptions and for failing to train staff in its use.3 The resulting wrongful death lawsuit from this case settles for policy limits against each of the multiple defendants.

These publicized incidents illustrate some of the risks physicians take when they establish or agree to serve as medical directors or supervising or prescribing physicians for a medical spa. Physicians must educate themselves about the risks associated with these facilities in order to reduce their likelihood of liability claims, licensure actions, or other adverse consequences. By understanding and addressing these exposures, physicians can not only better protect themselves but also improve patient safety.

Now is the best time to act on this issue. Medical spas are the fastest-growing segment of the spa industry, increasing from 400 medical spas in the united States in 2004 to more than 2,000 by 2007.4 This number will continue to rise. While fewer patients are seeking elective surgery as a result of the economic downturn, many are turning to less expensive substitutes. Patients who previously would have undergone a facelift are now more likely to select skin resurfacing procedures, injections of fillers or Botox, or chemical peels as a more cost-effective alternative. And the lower cost of obtaining these services from non- physician personnel makes medical spas even more attractive. It’s not only patients who are drawn to medi-spas; seeking ways to supplement their declining revenues, some physicians may feel compelled to set up or expand their own medical spa business.

What is a Medical Spa?

A medical spa is a facility that provides a variety of aesthetic medical procedures and traditional spa therapies under the supervision of a physician, generally in a spa-like setting. The spa may be located within a physician’s office, within the physician’s medical building, or in a stand-alone setting. Medical spas may be physician-owned, or depending upon—or in violation of—state laws and regulations, they may be owned by entrepreneurs or franchises. Typically, services are rendered by aestheticians, nurses, or other allied health care professionals under the supervision of a physician who may or may not be on site.

Know the Laws

Although many states do not specifically regulate medical spas, all facilities where medical care is rendered are subject to the same laws and regulations as health care facilities, including those pertaining to corporate ownership and scope of practice. Corporate practice- of-medicine laws determine who must own or supervise the practice, and regulatory boards establish to whom certain activities can be delegated and under what circumstances. Some states may also require that the facility be licensed or certified by the state in which it operates. Other regulations may dictate facility and equipment requirements such as water, restroom, and health and safety requirements. Nonetheless, experts opine that most medical spas today operate in ignorance or violation of these laws and regulations.

Even well-intentioned, law-abiding physicians find scope-of-practice laws complex and confusing, in part because scopes of practice vary widely. Obviously, scope of practice varies among types of licensees within a given state. Physicians moving to a different state may not expect significant differences from state to state for a specific type of licensed practitioner. To make matters worse, different agencies within the same state may take opposing positions.

For example, according to the Alabama Board of Cosmetology, a cosmetologist or aesthetician can inject Botox and dermal fillers under the supervision of an on-site physician. However, that state’s medical board has ruled that cosmetic injections are the practice of medicine and must be performed by a licensed physician. Therefore, while it appears that an Alabama cosmetologist who performs such services under the direction and supervision of a physician would not be sanctioned by his or her licensing board, the supervising physician could be charged with unprofessional conduct and be subject to disciplinary action. When conflicts such as these exist, it would be prudent for the physician to adhere to the most restrictive regulations (see the Hotline for recommendations on how to safely make delegation decisions).

To protect public safety, and provide guidance to practitioners, regulatory boards in some states have established policies clearly defining their position. For instance, several nursing boards have developed policy statements or protocol guidelines regarding aesthetic cosmetic procedures. Other state boards make determinations on a patient-by-patient basis, or provide advice specific to each provider based upon the provider’s training, skills, and experience. Some counsel nursing staff to follow a decision model to determine whether a particular procedure falls within their legal scope of practice. Others indicate that scope of practice determinations will not be made until or unless a complaint against the provider has been filed and even then will depend upon the specific facts of the case.

Managing scope of practice issues is even more complex when one considers that regulations are continually in a state of flux, and new regulations that expand or restrict scope of practice can be passed at any time. Ignorance of local, state, and federal laws and regulations, however, is not an acceptable defense, and failure to abide by them can result in fines, other disciplinary action, or suspension or revocation of licensure. Therefore, it is important for physicians who associate themselves with a medical spa to personally research the applicable requirements and to ensure that the facility is in full compliance. Consult with each of the nursing, cosmetology, physician, and other professional boards as applicable in your state for final governance rules. Establish a policy to review scope of practice laws on a routine basis, perhaps annually or biannually.

Supervision Required

By definition, medical care is part of the practice of medicine, and must be provided by or under a physician’s supervision. This is true regardless of where the care is provided. Thus, while many medical services provided at medical spas can legally be performed by certain types of qualified non- physician personnel, the supervising physician’s role must be evident.

First, the physician must generally prescribe or order medical treatments (see the Hotline for assistance in distinguishing medical treatments that need a physician’s order from cosmetic procedures). In some situations, the physician may also be required to assess and evaluate the patient before ordering the treatment. ultimately, the supervising physician is responsible for the patient and could be held liable for any legal/regulatory violations and patient injuries that occur.

Before procedures can be delegated to non-physician personnel, the supervising physician has a duty to assess the health care provider’s qualifications. The physician should have direct knowledge of each individual’s licensure, training, certification status, knowledge, and experience in each procedure the provider will perform. In addition, the physician should verify that the procedure falls within the provider’s legal scope of practice (licensed staff) or services (unlicensed assistive personnel). No procedure should be delegated to a provider who has not satisfactorily demonstrated current competency in the necessary skills.

In order to adequately supervise the health care providers, the supervising physician must also be competent in each procedure that is performed at the medical spa. Many states have passed laws or regulations stipulating that the supervising physician have the knowledge, skill, and ability to personally perform each procedure. Some states further require that the physician actively perform such procedures in his or her practice.

The minimum level of supervision legally required while the treatment is being rendered varies from state to state and also depends upon the professional designation of the provider who will render services. In some situations, the physician may be required to be in the same room at the time services are rendered; in others, it may be acceptable for the doctor to be elsewhere in the building. In the case of licensed health care providers, the regulatory board may allow the physician to be “readily available,” to be physically available within a specified time frame, or to simply be available by telephone. To increase patient safety, minimize liability exposure, and reduce the possibility of disciplinary action for failing to properly supervise non- physician staff, a qualified physician should be available on site whenever medical services are performed. In addition, the supervising physician should routinely review, date, and sign the medical records. Written protocols clarifying the role and responsibilities of the physician and of non-physician employees will aid in the appropriate delegation of services. Such protocols also provide supporting documentation of the supervision extended should a complaint be filed.

Treat Medical Procedures as Medical Procedures

Members of the public often believe that procedures rendered at medical spas are cosmetic services with guaranteed results rather than medical procedures with risks; they are misled both by having the services provided by non-physician personnel in non- clinical settings and by brochures and advertisements. It is not surprising, then, that patients often fail to understand the risks involved, have unrealistic expectations, and become dissatisfied if complications or side effects occur.

Clients should be treated as patients, and treatments should be handled as the medical procedures they are, regardless of whether services are rendered in a spa or clinical setting, or performed by a physician or allied health care provider. Practically speaking, this means that HIPAA regulations are respected, and a qualified health care provider or physician obtains and documents a medical and medication history and performs a physical examination of each patient before a physician orders treatment. As with any other medical procedure, an informed consent discussion is held with each patient prior to treatment and the patient signs a consent form documenting understanding of the treatment goals and risks. Medical records are maintained that document the initial assessment, course of treatment, informed consent, and postoperative care rendered.

Just as in hospitals, surgery centers, and physician offices, medi-spa facilities and staff be wise to expect and be prepared for the unexpected. While uncommon, serious medical complications and emergent conditions may arise coincident to or as a result of the procedure. Patients have suffered serious burns from laser procedures performed at medical spas and life-threatening allergic reactions to medications. Supply the medical spa with the medical personnel and equipment necessary to monitor patients and deal with any potential complications that may occur. To ensure that patients can obtain prompt emergency care, establish a written transfer agreement with the nearest acute care hospital and train staff on how to respond to an emergency.

Medical spas represent a new source of liability exposure, but the informed physician can minimize risk and improve patient safety by complying with scope of practice and other laws and regulations, providing the appropriate level of supervision, and recognizing that the services rendered are medical procedures subject to the same guiding principles as other medical services.

1. State of Florida Department of Health, DOH Case No. 2007-08728.

2. Avery S. “N.C. board suspends spa doctor.” The News & Observer, September 9, 2005. Retrieved April 21, 2009.

3. Shimron Y. “Doctor linked to numbing-gel death reaches deal.” The News & Observer, August 16, 2007. Retrieved April 21, 2009.

4. “Deadly Beauty Treatments.” In Prevention, March 8, 2007. Retrieved April 21, 2009 from http://www.prevention.com/cda/article/deadly-beautytreatments/46d268f271903110VgnVCM10000013281eac____/lifelong.beauty/anti.aging.arsenal/cosmetic.procedures.

Contact the following resources for additional information about medical spas:

The International Medical Spa Association, www.medicalspaassociation.org.

“The Bottom Line: The Business of Medicine–Medical Spas,” Medical Board of California, http://www.medbd.ca.gov/licensee/medical_spas-business.pdf.

Failure to Diagnose a Brain Lesion in a Referred Patient

 Digest, Fall, 1992

ALLEGATION  Insured ophthalmologist allegedly failed to diagnose an occipital brain lesion.

DISPOSITION  Motion of Summary Judgment was granted.

Background

In malpractice cases where defense counsel believes there are no issues of material fact for a jury to decide, counsel can request that the matter be dismissed prior to trial by filing a Motion for Summary Judgment. A Summary Judgment allows a judge to make an independent ruling on the legal issues in the case. Scrupulous medical records are essential for such motions to prevail.

Case Summary

The patient was a 60-year-old female who initially presented to the emergency department with complaints of dizziness, headaches and blurred vision of several days duration. She was admitted to the hospital for a diagnostic workup to include a CT scan which was reported as normal. She was diagnosed with transient ischemic attack with carotid atherosclerosis and was ultimately discharged.

The family practitioner referred the patient for follow-up to a neurologist, psychiatrist and the insured ophthalmologist. No neuro deficits were found. Initially, the insured treated the patient for wide-angle glaucoma. On a subsequent visit, the insured did a visual field examination which revealed a right homonymous hemianopsia. The insured discussed these findings with the family physician who reviewed the CT scan. A repeat CT scan was not performed at that time.

Three months later, the patient was admitted again as an inpatient for a diagnostic workup. A subsequent CT scan revealed an area of infarct. An alternate diagnosis of tumor was considered, but ruled out given the distribution and involvement of the cortex. Based on this and a cerebral angiogram, the patient was diagnosed with ischemic infarction secondary to ASHD. She was seen then by another ophthalmologist for treatment of her original complaints as presented to the insured. Two months later, the patient was diagnosed with inoperable mass of the occipital area. Suit was filed against all treating physicians.

Outcome

After initial pleadings and discovery, a Motion for Summary Judgment was granted based on the testimony of independent expert physicians who supported the insured’s position. They concluded that the lesion was a non-treatable condition at the time the plaintiff presented to the insured and that the plaintiff’s presenting symptoms were appropriately treated. The insured’s patient records indicated appropriate referral and follow-up with the family practitioner and, as such, adherence to the standard of care. The record keeping of the insured thus became an essential part of the defense and summary judgment for the defendant.

Risk Management Principles and Commentary

Ophthalmologists are often referred patients by another treating physician. As a means of loss control, measures should be instituted to provide for coordination of care. In this day and age of managed care, this is not always possible. However, follow-up and documentation often are key measures in the prevention of losses. The following may assist in this process:

• Obtain a complete medical history from the patient and referring physician.
• Maintain communication with the referring physician. This includes copies of all diagnostic reports and consults of other treating physicians as well as the ophthalmologist’s own conclusions.
• Promptly make referrals to and follow-up with subspecialists when there are suspicions of an unconfirmed diagnosis.