Use of Lasers and Other Modalities
New Physician Registration Form
- Definitions
- Categories of Procedures
- Delegation and Supervision
- Written Protocols
- Initial Training Requirements
- Procedure and Device Requirements
- Remote Practice Site
- Alternate Physicians
- Quality Assurance
- Equipment Safety
- Registration of Physicians
- Reporting Requirement
- Effective Date
- Continuing Education and Minimum Annual Procedures
INTRODUCTION
- The use in Alabama of “LLBDs”—lasers/pulsed light devices, or any energy source, chemical, or other modality that affects living tissue (when referring to the skin, anything below the stratum corneum), whether applied for surgical, therapeutic, or cosmetic purposes—is the practice of medicine.
- These are guidelines for the use of LLBDs for ablative and non-ablative treatment by physicians. Nothing in these rules shall be construed to relieve the supervising physician of the professional or legal responsibility for the care and treatment of the physician's patients.
- These rules do not apply licensed chiropractors, dentists, occupational therapists, optometrists, or physical therapists if the treatment is used exclusively within their scope of practice.
- These rules apply to removing body art with LLBD but not placing body art as defined by the Alabama Department of Public Health unless it is a part of patient treatment.
- These rules do not apply to the use of LLBDs in hospitals as defined in Ala. Code § 22-21-20.
DEFINITIONS
- Ablative Treatment – Ablative treatment includes any LLBD that is expected or intended to remove, burn, or vaporize tissue extending below the dermal-epidermal junction, as well as any modality that causes coagulation necrosis or pure ablation at or below the dermal-epidermal junction.
- Direct Physician Supervision – Direct physician supervision shall mean that the physician is in the physical presence of the patient being treated and is directly observing a delegate’s use of the modality.
- Energy Source – any therapeutic source that can affect or change living tissue, including varying ability levels to cause trauma and/or scarring.
- LLBD - Lasers and Light/Energy-Based Devices – lasers/pulsed light devices, or any energy source, chemical, or other modality that affects living tissue (when referring to the skin, anything below the stratum corneum), whether applied for surgical, therapeutic, or cosmetic purposes.
- Level 1 Delegate – A Level 1 Delegate is an assistant to physicians (PA), a certified registered nurse practitioner, or registered nurse (RN) authorized in a written job description or protocol to use a specific LLBD for non-ablative procedures, as designated in the written job description or protocol, and who has met the educational requirements for a Level 1 Delegate stated in Board rules.
- Level 2 Delegate – A Level 2 Delegate is a licensed practicing nurse (LPN) or medical assistant to include aestheticians, cosmetologists, and laser technicians authorized in a written job description or protocol to use a specific LLBD for non-ablative procedures, as designated in the written job description or protocol, and who has met the educational requirements for a Level 2 Delegate as stated in Board rules.
- Non-ablative Treatment – Non-ablative treatment includes any LLBD that, although not expected or intended to remove, burn, or vaporize tissue, is intended to cause controlled heat-induced thermal change/injury to produce a result. This includes treatments related to laser hair removal and other devices defined in Board rules.
- On-Site Supervision – On-site supervision means continuous supervision in which the supervising physician is physically present in the same building as the appropriate, properly trained Legal 1 or 2 Delegate who is using an LLBD. All treatments and procedures must be performed under the physician’s direction and immediate personal supervision, and the physician must be immediately available at all times that the Level 1 or 2 Delegate is on duty. The physician retains full responsibility to patients and the Board for the manner and results of all services rendered.
- Locally Remote Supervision – Locally remote supervision means the geographic physical proximity of a delegating physician to a Level 1 Delegate who is performing a non-ablative procedure who is not providing on-site supervision but who is readily available for consultation, evaluation, referral, or direct medical intervention in person or by telemedicine. A locally remote physician’s geographic physical proximity from the patient’s treatment site must not exceed the usual and customary response time of emergency management services for the locality. Locally remote supervision may only be provided by American Board of Medical Specialties or American Osteopathic Association board-certified physicians who have completed post-graduate training in lasers, light-based devices, chemical peels, and any other modality that may be used to perform ablative treatment.
- Physician – A physician licensed by the Medical Licensure Commission of the State of Alabama.
CATEGORIES OF PROCEDURES
- Ablative Laser Skin Resurfacing – These procedures include the use of fractional (partially ablative) and non-fractional (fully ablative) CO2 lasers, fractional and non-fractional Erbium-type lasers (2940nm) used deeper than 100 microns, plasma, and any other laser/device that vaporizes or removes skin beyond the dermal-epidermal junction, both fractional and non-fractional types.
- Non-Ablative Laser Photorejuvenation – These procedures include the use of LLBD for skin resurfacing and rejuvenation that involves targeting certain chromophores with no purposeful vaporization or removal of skin.
- Intense Pulsed Light (IPL) and Broad Band Light (BBL) – These procedures include the use of devices with pulsed light instead of a laser beam to target chromophores (pigment, vascularity, water). IPL devices consist of different levels with a wide range of power/energy and variable settings.
- Photoepilation/Laser Hair Removal, and Vascular Conditions and Lesions, and Pigmentary Conditions or Lesions.
- Photoepilation/Laser Hair Removal procedures include the use of Ruby (694 nm), Alexandrite (755nm), Diode (800nm-810nm), ND:YAG (1064nm) lasers that target chromophore melanin, and IPL/BBL devices (when used solely for hair reduction in appropriate, fair-skinned patients).
- Vascular Conditions and Lesions, and Pigmentary Conditions or Lesions procedures include the use of LLBDs that target a specific individual colored target and are used to treat spider veins, telangiectasias, small non-varicose vessels, rosacea, pigmented spots/lesions such as freckles, lentigines (sun/age spots), melasma, and hyperpigmentation, and benign colored lesions (Seborrheic Keratosis, Actinic Keratosis). LLBDs include ND:YAG, IPL, BBL, Pulsed Dye Laser, KTP, Alexandrite, radiofrequency probe procedures.
- Tattoo Removal – These procedures involve the treatment of all colors of tattoos with Q-switch ND:YAG, Q-switch Ruby, Q-switch Alexandrite, or other nano/picosecond devices used specifically for tattoo removal. These procedures carry a significant risk of complications, burns, and ulcerations.
- Non-Laser Skin Rejuvenation – These procedures use energy sources such as radiofrequency, ultrasound, infrared, and Class III lasers that work on heat-based targeting of skin and collagen. These procedures include any ultrasonic treatments, treatments for skin tightening/fat removal (including cryolipolysis and cryotherapy), and micro-needling.
- Endovascular Radiofrequency and Laser Ablation (EVLA) – These are surgical procedures that may only be performed by physicians.
- Laser-Assisted Liposuction (LAL) and Power-Assisted Liposuction – These procedures involve laser or energy-assisted invasive liposuction with the use of 1064nm, 1320nm, 1440nm, 1444nm, 924/975nm, 1319nm, and ultrasounds. These procedures include VaserLipo, Smart Lipo, Cellulaze, Cool Lipo, Tickle Lipo, Accusculpt, Slim Lipo, ProLipo, CelluSmooth, BodyJet (water-assisted), and variations thereof, and may only be performed by physicians.
- Laser-Assisted Surgery – These procedures involve the use of lasers to assist surgeons with cutting, coagulation, tissue removal and ablation, and other surgical procedures, and may only be performed by physicians.
DELEGATION AND SUPERVISION
- A physician may delegate the performance of non-ablative treatments as defined in Board rules through the use of written protocols to a properly trained Level 1 or 2 Delegate.
- A delegating physician must supervise the performance of all non-ablative treatments delegated to a Level 1 or 2 Delegate, including:
- Ensuring that patients are adequately informed and, prior to treatment, have signed consent forms that outline Risks, Benefits, Alternatives, and Complications, including the disclosure of reasonably foreseeable side effects and complications that may result from the non-ablative treatment, as well as the name of the device and the procedure;
- Responsibility for the formulation or approval of a written protocol that meets the requirements of these rules and responsibility for any patient-specific deviation from the protocol;
- Substantive review and authorization, at least annually, of the written protocol and any patient-specific deviations from the protocol regarding care provided to a patient under the protocol on a schedule defined in the written protocol;
- Ensuring that any Level 1 or 2 Delegate has read and signed the facility’s policies and procedures, written protocols for delegation, and these rules regarding the safe use of non-ablative devices;
- Prompt receipt of information from the Level 1 or 2 Delegate concerning any problem or complication encountered with any treatment;
- On-site or locally remote supervision for non-ablative treatments performed by Level 1 and 2 Delegates consistent with these rules, the training and experience of the delegate performing the procedure, and the risk of harm to the patient;
- Personal evaluation and care for complications that arise; and
- Evaluation of the technical skills of the Level 1 or 2 Delegate performing non-ablative treatments on an ongoing basis by formally documenting and reviewing at least annually the Level 1 or 2 Delegate's ability to perform the following:
- To properly operate the devices and provide safe and effective care; and
- To respond appropriately to concerns, complaints, and complications and untoward effects of the procedures.
WRITTEN PROTOCOLS
“Written protocols” means a physician's order, standing delegation order, standing medical order, or other written order that is maintained on site.
A written protocol must be provided to the Board upon request and must provide, at a minimum, the following:
- A statement identifying the individual physician authorized to utilize the specified device and responsible for the delegation of the performance of the specified procedure, including proof of the physician’s training in accordance with Board rules;
- A statement of the activities, decision criteria, and plan the Level 1 or 2 Delegate shall follow when performing delegated procedures;
- Selection criteria to screen patients for the appropriateness of non-ablative treatments;
- Identification of devices and settings to be used for patients who meet selection criteria;
- Methods by which the specified device is to be operated;
- A description of appropriate care and follow-up for common complications, serious injury, or emergencies as a result of the non-ablative treatment;
- Procedures for obtaining proper consent forms signed by the patient or legal guardian;
- Instructions for maintaining a patient’s chart, which should include, at a minimum, the patient intake form, the executed informed consent, the treatment sheet and progress notes, and before and after instructions;
- Instructions for documentation of a patient’s treatment, decisions made, and a plan for communication or feedback to the authorizing physician concerning specific decisions made.
- Documentation shall be recorded within a reasonable time after each procedure and may be performed on the patient's record or medical chart; and
- Instructions to contact the supervising physician immediately if complications or complaints from the patient arise.
- Written protocols should be signed by both the supervising physician and the corresponding Legal 1 or 2 Delegate.
INITIAL TRAINING REQUIREMENTS FOR PHYSICIANS AND DELEGATES
- These initial training requirements do not apply to any physician who holds a current registration with the Board to use LLBDs as of January 1, 2024.
- Any Level 1 or 2 Delegates currently using LLBDs under supervision of a registered physician as of January 1, 2024, shall not be required to complete the initial training requirements in this section.
- Any physicians who register to use LLBDs after January 1, 2024, will be subject to the initial training requirements.
Physicians and delegates involved in the use of LLBDs must meet the following training requirements before utilizing a device:
- A physician must complete thirty (30) hours of training.
- A Level 1 or 2 Delegate must complete forty (40) hours of training.
- Appropriate training for the use of any device covered by this Chapter shall include the following topics:
- Theory and physics of laser and light/energy-based devices and procedures, including their effect on living tissue, tissue interaction, clinical applications, and pre/post-treatment care;
- Education of skin anatomy and physiology, concerns, conditions, and diseases, including cancer, of the skin, skin type and color, chromophores, targets, general care for the skin, and recognition, management, and reporting of side effects and complications;
- Eight (8) hours of LLBD safety training, and
- Two (2) hours of training on the Board’s rules and regulations.
Appropriate training may be obtained through residency, fellowship, private courses, Board-approved self-study, training under another cosmetic practice, training on-site with a specialty board certified physician, and company-provided or in-service training by device representatives.
PROCEDURE AND DEVICE REQUIREMENTS
Physicians and delegates involved in the use of LLBDs must complete a minimum number of procedure/device-specific training hours, a minimum number of observed procedures, a minimum number of supervised procedures, and a minimum number of cases under supervision as follows:
- Ablative Laser Skin Resurfacing:
- Prior to performing procedures with any category of LLBD, physicians must complete eight (8) hours of training in the device or device category, unless the physician received training on the device in residency, in which case only four (4) hours of training are required.
- Level 1 and 2 Delegates shall not perform these procedures.
- Non-Ablative Laser Photorejuvenation:
- Physicians - eight (8) hours of training on each device unless he or she received training on the device in residency, in which case only four (4) hours of training are required.
- Level 1 Delegates - twelve (12) hours of training on each device, which includes observing the procedure performed by a trained physician and performing ten (10) cases under the direct supervision of a trained physician. After twenty (20) cases have been performed with a physician seeing a patient prior to the procedure, a Level 1 Delegate may treat a patient without a physician seeing the patient at the initial and each subsequent visit.
- Level 2 Delegates - twenty (20) hours of training on each device, which includes observing the procedure performed by a trained physician or Level 1 Delegate, and performing fifteen (15) cases under the direct supervision of a trained physician. After twenty (20) cases have been performed with a physician seeing a patient prior to the procedure, a Level 2 Delegate may treat a patient without a physician seeing the patient at the initial and each subsequent visit.
- Intense Pulsed Light (IPL) and Broad Band Light (BBL):
- Physicians - eight (8) hours of training on each device, unless he or she received training in residency, in which case only four (4) hours of training are required.
- Level 1 Delegates - twelve (12) hours of training on each device, which includes observing the procedure performed by a trained physician and performing ten (10) cases under the direct supervision of a trained physician. After performing twenty-five (25) supervised cases, a Level 1 Delegate may treat patients for subsequent patient visits without direct supervision by the physician after the physician sees the patient in consult. After performing fifty (50) cases, a Level 1 Delegate may treat patients without direct supervision by the physician for the initial consult and patient consent.
- Level 2 Delegates - twenty (20) hours of training on each device, which includes observing the procedure performed by a trained physician and performing fifteen (15) cases under the direct supervision of a trained physician. After performing twenty-five (25) supervised cases, a Level 2 Delegate may treat patients for subsequent patient visits without direct supervision by the physician after the initial patient consult and consent, provided that the physician shall review the device settings for cases 26 through 50 prior to treatment. After performing fifty (50) cases, a Level 2 Delegate may treat patients for the initial treatment visit and subsequent visits without direct supervision by the physician after the physician has seen the patient in consult and consent.
- Photoepilation/Laser Hair Removal, Vascular Conditions and Lesions, and Pigmentary Conditions:
- Physicians - eight (8) hours of training on each device, unless he or she received training in residency, in which case only four (4) hours of training are required.
- Level 1 Delegates - twelve (12) hours of training on each device, which includes observing the procedure performed by a trained physician and performing ten (10) cases under the direct supervision of a trained physician. After performing twenty-five (25) supervised cases, a Level 1 Delegate may treat patients for subsequent patient visits without direct supervision by the physician after the physician sees the patient in consult. After performing fifty (50) cases, a Level 1 Delegate may treat patients without direct supervision by the physician for the initial consult and patient consent.
- Level 2 Delegates - twenty (20) hours of training on each device, which includes observing the procedure performed by a trained physician and performing fifteen (15) cases under the direct supervision of a trained physician. After performing twenty-five (25) supervised cases, a Level 2 Delegate may treat patients for subsequent patient visits without direct supervision by the physician after the initial patient consult and consent, provided that the physician shall review the device settings for cases 26 through 50 prior to treatment. After performing fifty (50) cases, a Level 2 Delegate may treat patients for the initial treatment visit and subsequent visits without direct supervision by the physician after the physician has seen the patient in consult and consent. A solitary pigmented lesion shall be evaluated by a physician prior to any treatment with an LLBD device.
- Tattoo Removal:
- Physicians - eight (8) hours of training on each device, unless he or she received training in residency, in which case only four (4) hours of training are required.
- Level 1 Delegates - twelve (12) hours of training on each device, which includes observing the procedure performed by a trained physician and performing ten (10) cases under the direct supervision of a trained physician. After performing twenty-five (25) supervised cases, a Level 1 Delegate may treat patients for subsequent patient visits without direct supervision by the physician after the physician sees the patient in consult. After performing fifty (50) cases, a Level 1 Delegate may treat patients without direct supervision by the physician for the initial consult and patient consent.
- Level 2 Delegates - twenty (20) hours of training on each device, which includes observing the procedure performed by a trained physician and performing fifteen (15) cases under the direct supervision of a trained physician. After performing twenty-five (25) supervised cases, a Level 2 Delegate may treat patients for subsequent patient visits without direct supervision by the physician after the initial patient consult and consent, provided that the physician shall review the device settings for cases 26 through 50 prior to treatment. After performing fifty (50) cases, a Level 2 Delegate may treat patients for the initial treatment visit and subsequent visits without direct supervision by the physician after the physician has seen the patient in consult and consent.
- Non-Laser Skin Rejuvenation:
- Physicians and Level 1 and 2 Delegates must complete official certifying training by the device manufacturer or be trained by a physician certified by the manufacturer to use the device.
- Level 1 and 2 Delegates must complete eight (8) hours of training on each device, which includes observation of five (5) area-specific treatments by a trained physician and performing ten (10) treatments under the direct supervision of a trained physician. After completing ten (10) treatments under direct supervision, a Level 1 or 2 Delegate may complete ten (10) additional treatments without direct supervision by the physician, provided that the physician reviews the treatment plan and device settings prior to the treatment. After performing twenty-five (25) supervised cases, a Level 1 or 2 Delegate may consult, consent, and treat patients without direct supervision by the physician. Thereafter, treatments may be performed under locally remote supervision.
- Endovascular Radiofrequency and Laser Ablation (EVLA):
- Physicians - eight (8) hours of training on each device within a residency or fellowship program.
- Level 1 and 2 Delegates shall not perform these procedures.
- Laser-Assisted Liposuction (LAL) and Power-Assisted Liposuction:
- Physicians - eight (8) hours of training on each device within a residency or fellowship program.
- Level 1 and 2 Delegates shall not perform these procedures.
- Laser-Assisted Surgery:
- Physicians - sixteen (16) hours of training on each device within a residency or fellowship program.
- Level 1 and 2 Delegates shall not perform these procedures.
REMOTE PRACTICE SITE
- A remote practice site is a practice site at which a Level 1 Delegate may, if authorized by a written job description or collaborative protocol, use LLBDs for non-ablative procedures under locally remote supervision. A Level 2 Delegate shall not use LLBDs at a remote practice site without their supervising physician on-site. Locally remote supervision is not allowed for a Level 2 Delegate.
- The physician shall examine the patient, establish a treatment plan, perform informed consent of the patient, and sign the patient chart prior to a Level 1 Delegate performing the first non-ablative treatment of a patient for a particular disease or condition at a remote practice site.
- Subsequent non-ablative treatments which are a continuation of a treatment plan documented in the patient’s chart may be performed by the Level 1 Delegate at a remote practice site without examination of the patient by the physician before each treatment. If any changes are made to the treatment plan or the treatment plan ends, the physician must re-examine the patient prior to any updated treatment being performed.
ALTERNATE PHYSICIANS
- If a delegating physician will be unavailable to supervise a Level 1 or 2 Delegate as required by Board rules, arrangements shall be made for an alternate physician to provide that supervision.
- An alternate physician must have the same training in performance of non-ablative treatments as the primary supervising physician.
- Any alternate physician providing supervision shall affirm in writing to the Board of Medical Examiners that he or she is familiar with the protocols or standing delegation orders in use at the site, will be accountable for adequately supervising care provided pursuant to those protocols or standing delegation orders, and has the same training in performance of non-ablative treatments as the primary supervising physician.
QUALITY ASSURANCE
- The physician must ensure that there is a quality assurance program for the facility where non-ablative procedures are performed for the purpose of continuously improving the selection and treatment of patients.
- An appropriate quality assurance program shall consist of the following elements:
- A mechanism to identify complications and untoward effects of treatment and to determine their cause.
- A mechanism to review the adherence of delegates to standing delegation orders, standing medical orders, and written protocols.
- A mechanism to monitor the quality of non-ablative treatments.
- A mechanism by which the findings of the quality assurance program are reviewed and incorporated into future standing delegation orders, standing medical orders, protocols, and supervising responsibility.
- Ongoing training to improve the quality and performance of delegates.
EQUIPMENT SAFETY AND SAFE USE OF LASERS
- All equipment used for the purposes stated in the Board rules must be inspected, calibrated, and certified as safe to use according to the manufacturer’s specifications.
- All physicians and delegates who use or operate lasers must comply with any regulations, standards, directives and guidelines for laser safety and use issued by the Occupational Safety and Health Administration, United States Department of Labor.
REGISTRATION OF PHYSICIANS USING LLBDs IN THE PRACTICE OF MEDICINE
- Every physician who proposes to perform any LLBD procedure in Alabama shall register with the Board prior to performing any procedure.
- Registration shall be accomplished on a form provided by the Board.
- After initially registering, it shall be the obligation of the registrant to notify the Board in writing of any change or addition of facility location where LLBD procedures occur or are offered for use.
- Annual registration as a provider of LLBD procedures shall be required and shall be accomplished by electronic means as prompted during the license renewal process.
- Annual registration as an LLBD provider shall be due by January 31 of each year.
REPORTING REQUIREMENT FOR ADVERSE EVENTS
Every physician who performs or supervises the performance of a procedure covered under these rules must report to the Board within three (3) business days the occurrence of all events related to a procedure that resulted in an emergency transfer of a patient to a hospital, unscheduled hospitalization related to the procedure, third-degree dermal injury, or death.
CONTINUING EDUCATION AND MINIMUM ANNUAL PROCEDURES REQUIRED
- Level 1 and 2 Delegates must complete a minimum number of hours of continuing LLBD education and a minimum number of procedures to continue performing LLBD procedures under these guidelines.
- Physicians are exempt from continued LLBD education and an annual minimum number of procedures but must maintain proper training on any procedure or device a Level 1 or 2 Delegate is allowed to utilize.
- If a delegate fails to meet these requirements, he or she must complete the initial training and procedure-specific training set forth in these guidelines.
- Level 1 Delegates must annually complete a minimum of four (4) hours of continuing LLBD education, and Level 2 Delegates must annually complete a minimum of six (6) hours of continuing LLBD education.
- Continuing LLBD education may include AMA PRA Category 1 CME hours, LLBD-specific medical conference hours, online study and courses, and self-study through online webinars, lectures, CME courses, and hours lectured by a physician. Continuing LLBD education obtained may be general for all LLBD procedures and not specific to every procedure performed.
- Continuing education should include training on LLBD theory and physics; skin anatomy and conditions/diseases; LLBD safety; treatment of conditions; recognition, management, and reporting of side effects and complications; and overall use of LLBD procedures to treat patients.
- Level 1 Delegates must complete a minimum of ten (10) total LLBD procedures per year, and Level 2 Delegates must complete a minimum of thirty (30) total LLBD procedures per year.
- Level 1 Delegates must complete a minimum of ten (10) procedures in each procedure category they practice within, and Level 2 Delegates must complete a minimum of thirty (30) procedures in each procedure category they practice within.
Questions? Please email the LLBD Department