Use of Cutaneous Lasers and Light Sources: Appropriate Training and Delegation

M. Alam, MD¹; J. S. Dover, MD, FRCPC²; K. A. Arndt, MD³

¹Northwestern University Medical School, Chicago, IL, USA
²Yale University School of Medicine, New Haven, CN and Dartmouth Medical School, Hanover, MA, USA
³Beth Israel Hospital and Harvard Medical School, Boston, MA, USA

ABSTRACT

In recent years, there has been increasing concern among physicians, patient advocacy groups, and media watchdogs that laser, light, and cosmetic surgery are being practiced by poorly trained professionals, with resulting preventable injuries to patients. In response, several professional organizations have developed guidelines for the delegation of laser services to nonphysician providers. These guidelines delineate appropriate qualifications for delegating physicians and nonphysician providers, and also describe the circumstances and settings in which delegation is appropriate.

Key Words:
Laser, Cosmetic Surgery, Pulsed Light, Guidelines

Historical Overview

As early as 8-10 years ago, reports documented the increasing tension between dermatologists and electrologists over the training required to perform laser hair removal, with dermatologists advocating for supervision by licensed physicians who are on-site. Some states that do not require licensing for electrologists to administer laser treatments, such as Texas, were of particular concern.1,2 Yet concurrently, data showed that “properly trained” nurses had no greater risk than physicians of inducing undesirable outcomes, such as pigmentation change and blistering after laser hair removal with the long-pulsed alexandrite laser.3 Recent studies suggest that a proportionately greater number of complications are arising from dermatologic care delivered by physician extenders. Nearly 53% of 488 dermatologists surveyed in Texas in 20044 reported seeing a greater number of complications associated with delegation to nonphysicians. Of those surveyed, 33% asserted that they knew of such complications arising in the absence of a supervising physician on-site during treatment delivery. This confirmed earlier results of a survey of 2,400 members of the American Society for Dermatologic Surgery (ASDS) in 2001, which ascribed the preponderance of post-treatment patient complications to “nonphysician operators,” including cosmetic technicians, estheticians, and workers in medical/dental offices who performed procedures for which they were not appropriately trained, or who were inadequately supervised.5 Further studies under the auspices of the ASDS are ongoing. A growing body of evidence suggests that nonphysician provision of laser services and insufficient physician supervision of extenders may be jeopardizing patients, unnecessarily raising complication rates, and leaving dermatologists vulnerable to public censure and legal liability.6,7

Training for Provision of Laser Services: Formal Guidelines and State Regulation

Several professional physician groups have attempted to delineate appropriate training standards for those using lasers on patients. Such standards have typically been embedded in larger position papers on the scope of practice or laser use. Moreover, given that even the physician leadership can differ on exactly how training standards should be implemented, these guidelines tend to be firm in tone, but vague in terms of specific benchmarks for competency.

American Academy of Dermatology

On February 22, 2004, the Board of Directors of the American Academy of Dermatology (AAD) approved a Position Statement on the Use of Lasers, Pulsed Light, Radiofrequency, and Medical Microwave Devices.8 This one-page document notes that physicians using the aforementioned devices must be trained in relevant “physics, safety, and surgical techniques.” Regarding physician and nonphysician roles during delegation of laser procedures, the following precautions should be observed:

A physician who delegates such procedures should be fully qualified by residency training and preceptorship or appropriate course work prior to delegating procedure to licensed or certified nonphysician office personnel and should directly supervise the procedures. The supervising physician shall be physically present on-site, immediately available, and able to respond promptly to any questions or problem that may occur while the procedure is being performed.

Any nonphysician office personnel employed and designated by a physician to perform a procedure must be under the direct supervision of the physician. For each procedure performed, the nonphysician office personnel must have appropriate documented training and education in the physics, safety, and surgical techniques of each system, be properly licensed in their state if required, and be adequately insured for that procedure. The nonphysician office personnel should also be appropriately trained by the delegating physician in cutaneous medicine.

In summary, the AAD document notes that the “Academy endorses the concept that use of properly trained nonphysician office personnel under appropriate supervision allows certain procedures to be performed safely and effectively.” The earlier exhortation that the supervising physician be present on-site is thus balanced by the concession that delegation of laser procedures to nonphysicians is inherently acceptable.

American Society of Laser Surgery and Medicine

The most extensive work in this area has been by the American Society of Laser Surgery and Medicine (ASLMS), which has incorporated the relevant guidelines established by the American National Standards Institute (ANSI) Z136.3 Standard Safe Use of Lasers in Healthcare Facilities.9 Regarding operator qualification in the context of laser safety, ASLMS guidelines include the following clauses:

The laser will be operated only by those who have had training in laser theory, techniques of control, and operation of the laser(s) or IPL.

A program for laser safety training will be made available to ALL personnel working around the lasers. The Laser Safety Officer shall have discretion, according to ANSI standards, in delineating which personnel are required to undergo which levels of training. All of the training shall be documented and kept on file.

ASLMS also further clarifies training requirements in documents on office-based laser procedures10 and nonphysician use of lasers.^11,12

The ASLMS Principles for Nonphysician Laser Use,11 and Educational Recommendations for Laser Use by Nonphysicians,12 reproduced below, are slightly more specific:

Principles for Nonphysician Laser Use

Any physician who delegates a laser procedure to a nonphysician must be qualified to do the procedure themselves by virtue of having received appropriate training in laser physics, safety, laser surgical techniques, pre- and postoperative care, and be able to handle the resultant emergencies or sequelae.

Any nonlicensed medical professional employed by a physician to perform a laser procedure must have received appropriate documented training and education in the safe and effective use of each laser system, be a licensed medical professional in their state, and carry adequate malpractice insurance for that procedure.

A properly trained and licensed medical professional may carry out specifically designed laser procedures only under physician supervision and following written procedures and/or policies established by the specific site at which the laser procedure is performed.

Since the ultimate responsibility for performing any procedure lies with the physician, the supervising physician should be immediately available and shall be able to respond within five minutes to any untoward event that may occur. Ultimate responsibility lies with the supervising physician.

The guiding principle for all physicians is to practice ethical medicine with the highest possible standards to ensure the best interest and welfare of each patient is guaranteed. The ASLMS endorses the concept that use of properly trained and licensed medical professionals, under appropriate supervision, allows certain laser procedures to be performed safely and effectively.

Educational Recommendations for Laser Use by Nonphysicians

Individuals should be trained appropriately in laser physics, tissue interaction, laser safety, clinical application, and pre and post operative care of the laser patient. Prior to the initiation of any patient care activity the individual should have read and signed the facilities policies and procedures regarding the safe use of lasers.

Continuing education of all licensed medical professionals should be mandatory and be made available with reasonable frequency (including outside the office setting) to help ensure adequate performance. Specific credit hour requirements will be determined by the state, and/or individual facility.

A minimum of TEN procedures of precepted training should be required for each laser procedure and laser type to assess competency. Participation in all training programs, acquisition of new skills and number of hours spent in maintaining proficiency should be well documented.

After demonstrating competency to act alone, the designated licensed medical professional may perform limited laser treatments on specific patients as directed by the supervising physician.

American College of Surgeons

Among major specialties approved by the American Council on Graduate Medical Education (ACGME), surgery has been among the most active in promulgating outlines for laser training and use. This broad field is experienced at incorporating and regulating new operative technologies, but the breadth of laser use in surgery limits the specificity of the relevant parts of the American College of Surgeons’ (ACS) Statement on Laser Surgery,13 revised in 2007 from the original statement published in 1991:

Surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is a part of the practice of medicine. Surgery is also the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue, which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles. All of these surgical procedures are invasive, including those that are performed with lasers, and the risks of any surgical intervention are not eliminated by using a light knife or laser in place of a metal knife or scalpel.

The American College of Surgeons believes that surgery using lasers, pulsed light, radiofrequency devices, or other means is part of the practice of medicine and constitutes standard forms of surgical intervention. It is subject to the same regulations that govern the performance of all surgical procedures, including those that are ablative or nonablative, regardless of site of service (that is, hospital, ambulatory surgery center, physician’s office, or other locations). Patient safety and quality of care are paramount, and the College therefore believes that patients should be assured that individuals who perform these types of surgery are licensed physicians (defined as doctors of medicine or osteopathy) who meet appropriate professional standards. This is evidenced by comprehensive surgical training and experience, including the management of complications, and the acquisition and maintenance of credentials in the appropriate surgical specialties (that is, board certification) and in the use of lasers, pulsed light, radiofrequency devices, or other similar techniques.

Individuals who perform laser surgery utilizing lasers, pulsed light, radiofrequency devices, or other techniques should meet the principles of the College in all respects, to include the avoidance of any misrepresentations to the public regarding unfounded advantages of the laser compared with traditional operative techniques. ¹³

Furthermore, the ACS Statement on Issues to Be Considered Before New Surgical Technology is Applied to the Care of Patients, the subsection on “Is the individual proposing to perform the new procedure fully qualified to do so?” includes the following passage:

In order to determine and apply proper indications for a procedure and to select the appropriate patients for applications of the technology, comprehensive knowledge of the disease process and experience in management of patients with the disease is essential. Prompt recognition and management of complications can only be achieved when the individual or team member is fully qualified in all aspects of treatment of the disease.14

American Society for Dermatologic Surgery

Within dermatology, the American Society for Dermatologic Surgery (ASDS) has been most active in developing guidelines for the nonphysician practice of medicine, in particular, the use of lasers. This multi-pronged approach has included alerting state medical boards to the potential hazards to patients, publishing statistical data in the professional medical literature, making information easily available to patients on the Internet, and conducting a public relations campaign to apprise patients of the dangers inherent in receiving laser services from unqualified personnel.

At present, the ASDS guidelines assert that cosmetic procedures, including cutaneous laser procedures, be delivered only by MDs and DOs who have been adequately trained. A qualified physician may delegate some procedures to certified or licensed office personnel (e.g., RN, CMA, LPN, PA, NP) if, and only if, the delegated individuals are properly trained in the specific procedure and the physician remains physically on-site and available to respond in a timely manner to questions or problems that may arise.15

In recognition of the fact that laser hair removal procedures, in particular, are likely to be performed by nonphysicians, the ASDS provides, in the public portion of its web-site, a statement entitled Don’t Get Burned – What You Need to Know About Laser Hair Removal,16 which reads in part:

• Do consult a qualified physician: Regulations for laser use have not kept up with the demand and consumers should be cautious of nonphysicians practicing these procedures in spas/salons. Only a physician who is board-certified in dermatology or another specialty with equivalent training and experience should perform this procedure or the physician can designate another trained technician to perform a procedure as long as he/she is under the direct (on-site) supervision of the physician.
• Do ask questions: What kind of lasers do they use? What kind of training or experience do they have? Can you speak with one of their clients? If the person performing the procedure can’t answer these simple questions, you should walk away.
• Do ensure the physician has experience with different skin types: People of a darker complexion may experience unusual lightening of the skin if an incorrect laser is used at an inappropriate setting.

State Medical Boards

State medical boards have taken notice of the media furor surrounding adverse events resulting from laser use by nonphysicians. The Louisiana State Board of Medical Examiners has begun to require that the use of medical lasers and chemical peeling procedures be under direct supervision by an on-site physician. Similarly, the New York State Board of Medicine has construed laser hair removal by lasers and intense pulsed light devices to constitute the practice of medicine, and hence to be permissible only when performed by a physician or under a physician’s direct supervision. The Massachusetts legislature established a task force within the Board of Medicine to report back to the legislature by May, 2007 with draft standards or regulations on medi-spas.

Practical Issues in Nonphysician Laser Practice: Financial Incentives, Patient Safety, and Adverse Events

From a practical standpoint, the dangers of inappropriate delegation of laser services or nonphysician practice of medicine include:

• impaired patient safety, such as
  • increased frequency of avoidable adverse events
  • failure to treat adverse events appropriately and in a timely manner;
• provision of unnecessary or inappropriate laser services
• over-treatment
• subordination of patient well-being to financial productivity of the practice.17

In the case of laser use in a spa, the financial incentives for delegation are further enhanced by the nature of the business model, which resembles a retail store rather than a medical practice, and to a greater extent than in a physician practice, service providers may be compensated on an incentive basis. There may be no physicians present at most times, and there may even be a dearth of medical personnel. In many spas, services are provided by estheticians and nonmedical, nonphysician providers, who are not inculcated as are physicians and nurses in the need to ensure patient well-being.

Problems that have been commonly seen in unsupervised or nonphysician laser centers have been numerous and varied and include:

• burns associated with excessive treatment levels
• burns and post-treatment hyperpigmentation associated with treatment of tanned individuals
• scarring and hypopigmentation associated with excessive treatment, multiple passes, or cooling excess or failures
• delayed healing, erosions, and ulceration associated with untreated herpes simplex infection or impetigo
• configurate linear and round patterning of the skin associated with improper treatment resulting in tattooing with the laser handpiece
• corneal and retinal injury due to inadequate use of eye protection.

Some of these problems, like hyperpigmentation, will eventually resolve, but hypopigmentation and configurate scarring can be persistent and disfiguring. Rampant infection can result in functional loss, including permanent impairment of facial sensory structures.

The problem of impaired safety is exacerbated by the lack of general dermatologic training among nonphysician providers of laser services. In general, low-level and even some high-level nonphysician providers are trained mostly in the technique of laser service delivery, with lesser training in the management of adverse events, and little or no training in general cutaneous medicine. Adverse events, and especially unusual cases, may be recognized late by such providers, who may then treat them incorrectly. Especially when physician supervision is light, incorrect treatment may continue for some time, until the problem has worsened and permanent sequelae may be inevitable. It is a truism in cutaneous laser therapy that firing a laser handpiece may be the least important portion of the treatment; it is everything but the actual treatment, including patient selection, parameter selection, and recognition and management of undesirable outcomes, that requires judgment and training. In the spa environment or in a poorly supervised laser practice, the pressure to “convert” all consultations into treatments may result in poor patient selection, which in turn may dramatically increase the rate of adverse events.

Incentives for nonphysician providers to maximize revenue generation in a spa or thinly supervised setting can increase the risk of adverse events by:

• hurrying preoperative evaluation and laser treatment.
• encouraging the treatment of patients who may be poor laser candidates.

To the extent that nonphysician providers may have a skewed financial incentive structure, wherein they are more often rewarded for revenue generation than penalized for adverse events and patient dissatisfaction, the impetus to increase business may dominate. The result means greater risk for the patient, and for the ostensibly delegating but possibly off-site physician, who may have medico-legal responsibility for problems accruing from delegated services.

Beyond adverse events, such incentives may lead to unnecessary treatments motivated by the desire to increase financial yield by extending the number of sessions. Indeed, more revenue may be generated by systematically undertreating patients to ensure that they return for more visits. Subtherapeutic treatments may also reduce the risk of adverse events when laser treatments are delivered by minimally trained nonphysician providers. While undertreatment is unlikely to cause irrevocable physical injury, it is a form of fraud that wastes patients’ time and money.

Conclusions

While current guidelines on appropriate cutaneous laser training and delegation are not detailed and comprehensive, some recommendations occur repeatedly in guidelines proposed by various national professional organizations. In particular, it is apparent that:

• optimal laser use occurs when a physician who is trained in a relevant specialty, with additional training for the specific laser to be used, directly performs laser services on an appropriately selected patient.
• laser training of nonphysician providers should be comprehensive and not limited to merely delivering a technical service, but should include theoretical and practical training, and should encompass an understanding of patient selection, adverse events, and appreciation of the limits of this training.
• even when nonphysician personnel are appropriately trained, delegation of laser use should occur in the context of adequate physician oversight under ideally direct, on-site supervision. In medicine, a quest for efficiency or revenue maximization by an individual or corporate entity can never supersede the responsibility to ensure patient safety.
• in medicine, a quest for efficiency or revenue maximization by an individual or corporate entity can never supersede the responsibility to ensure patient safety.

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