1. Licensure Requirements for Cosmetic Laser Procedures By: Vickie L. Mickey, CT,CLHRP

2. Who Can Perform Cosmetic Laser Procedures? This is a difficult question to answer! Regulator factors are governed by the: FDA OSHA Individual State Regulations

3. Regulatory Agencies: State Board of Medical License State Board of Nursing State Board of Cosmetology Electrology Licensing Agencies Governmental Radiation & Energy Agencies

4. State Medical Board of Ohio Rule #4731-1-12 (A) A physician licensed may delegate the application of light based medical devices only for the purpose of hair removal and only if all the following conditions are met: 1. The light based medical device has been specifically approved by the United States Food and Drug Administration for the removal of hair from the human body: and

5. 4731-18-03 Cont. The use of the light based medical device for the purpose of hair removal is within the physician’s normal course of practice and expertise: and The physician has seen and personally evaluated the patient to determine whether the purposed application of light based medical device is appropriate; and The physician has seen and personally evaluated the patient following the initial application of light based medical device, but prior to any continuation of treatment in order to determine that the patient responded well to that initial application: and<

6. 4731-18-03 cont. 5. The person to whom the delegation is made is one of the following: (A) A physician assistant registered to chapter 4730. of the Revised Code and the physician has a board approved supplemental utilization plan allowing such delegation; or (B) A cosmetic therapist licensed pursuant to chapter 4731. of the Revised Code: or, (C) A registered nurse or licensed practical nurse licensed pursuant to chapter 4723. of the Revised Code; and,

7. 4731-18-03 Cont. 6. The person to whom the delegation is made has received adequate education and training to provide the level of skill and care required; and, 7. The physician provides on-site supervision at all times the person to whom the delegation is made is applying the light based medical device; and, 8. The physician supervises no more than two persons pursuant to this rule at the same time.

8. 4731-18-03 cont. (B) Not withstanding division (A)(7), the physician may provide off-site supervision when the light based medical device is applied to an established patient if the person to whom the delegation is made pursuant to paragraph (A) is a cosmetic therapist licensed pursuant to chapter 4731. who meets all of the following criteria:

9. 4731-18-03 cont. 1. The cosmetic therapist has successfully completed a course in the use of light based medical devices for the purpose of hair removal that has been approved by the board; and 2. The course consisted of at least fifty hours of training, at least thirty hours of which was clinical experience; and 3. The cosmetic therapist has worked under the on-site supervision of the physician making the delegation a sufficient period of time that the physician is satisfied that the cosmetic therapist is capable of competently performing the service with off-site supervision.

10. 4731-18-03 cont. The cosmetic therapist shall maintain documentation of the successful completion of the required training. (C) The cosmetic therapist, physician assistant, registered nurse or licensed practical nurse shall immediately report any clinically significant side effect following the application of the light based medical device or any failure of the treatment to progress as was expected at the time the delegation was made. The physician shall see and personally evaluate the patient who has experienced the clinically significant side effect or whose treatment is not progressing as expected as soon as practicable.

11. 4731-18-03 cont. (D) For purposes of this rule, on-site supervision requires the physical presence of the supervising physician in the same location (i.e., the physician’s office suite) as the cosmetic therapist, physician assistant, registered nurse or licensed practical nurse, but does not require his or her presence in the same room.

12. 4731-18-03 cont. (F) A violation of division (A) (B) or © of this rule by a physician shall constitute “ a departure from, or the failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established, “ as that clause is used in division (B) (6) of section 4731.22 of the revised code. A violation of division (A) (5) of this rule shall constitute “ violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provision of this chapter or any rule promulgated by the board” as that clause is used in division (B) (20) of section 4731.22 of the Revised Code, to with: section 4731.41 of the revised Code.

13. 4731-18-03 cont. (G) A violation of division (C) of this rule by a cosmetic therapist shall constitute “a departure from, or the failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established “ as that clause is used in division (B) (6) of section 4731.22 of the revised code. A violation of division (C) of this rule by a physician assistant shall constitute a “departure from. Or failure to conform to, minimal standards of care similar physician assistant under the same or similar circumstances, regardless of whether actual injury to patient is established,” as that clause is used in division (B) (19) of section 4730.25 of the Revised Code.

14. Similar Regulatory Board Rules: State Medical Board of Texas Arizona Radiation Regulatory Agency State Medical Board of Florida State Medical Board of New Jersey – Physician only

15. Standards of Practice The Society for Clinical and Medical Hair Removal 1. Compliance with OSHA regulations 2. Eye protection and signage posted. 3. Appointed safety officer. 4. Protocol of high standards, set by the medical director and the practitioner, for the well-being of the patient.

16. Professional Organization Statement: International Guild of Hair removal Specialists supports the Electrologist’s right to expand their scope of practice and we support their use of new technologies as approved by the FDA to further that aim. The use of lasers for hair removal is included within this position statement.

17. Professional Organization Statements: American Society for Dermatological Surgery: A physician who delegates such procedures to licensed or certified non- physician office personnel 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 problems that may occur while the procedure is being performed.

18. Professional Organization Statements Cont. American Society of Laser Medicine and Surgery: 1. Any physician who delegates a procedure to a non-physician must be qualified to do these laser and related procedures themselves by virtue of having received appropriate training in physics, safety, surgical techniques, pre and post operative care, and be able to handle the resultant emergencies or sequelae.

19. ASLMS Cont.: 2. Any licensed medical professional employed by a physician to perform a procedure must have received appropriate documented training and education in the safe and effective use of each system, be a licensed medical professional in their state, and carry adequate malpractice insurance for that procedure.

20. ASLMS cont. 3. A properly trained and licensed medical professional may carry out these specifically designed procedures only under direct, on-site physician supervision and following written procedures and/ or policies established by specific site at which the procedure is performed.

21. ASLMS cont. 4. Since the ultimate responsibility for performing lies with the physician, the supervising physician should be available on-site to respond to any untoward events that may occur.

22. Statements Nationally Consistent Only non-ablative procedures should be delegated to non-physician. Physician and delegate should be adequately trained in the anticipated procedure. Some degree of supervision is required (direct: indirect: on site: off-site)

23. Statements Nationally Consistent WRITTEN PROTOCOLS: Identification of physician authorized to delegate; statement of activities and plan to delegate to follow: statement of method for documenting treatments; statement of communication or feedback to authorizing physician. Delegate completed and document clinical and academic training.

24. Attachment of Government Agencies Electrologist Aesthetician/Cosmetology Laser Governance Responsibilities Nursing