Rule 800 Colorado Medical Board for cosmetic lasers

Anyone training in cosmetic lasers or operating them needs to be aware of Rule 800.

RULE 800

COLORADO BOARD OF MEDICAL EXAMINERS

RULES REGARDING THE DELEGATION AND SUPERVISION OF MEDICAL SERVICES TO UNLICENSED HEALTH CARE PROVIDERS PURSUANT TO SECTION 12-36-106(3)(l), C.R.S.

Skipping ahead to page 14 on this document it states:

Definition of “Medical-Aesthetic Services.” “Medical-Aesthetic Services” are medical services in the cosmetic or aesthetic field that constitute the practice of medicine. Such Medical-Aesthetic Services include, but are not limited to: (a) the use of a laser, radio-frequency device, intense pulsed light, or other technique that results in the revision, destruction, incision or other structural alteration of human tissue and/or for hair removal; and (b) the performance of injections of Botox, Collagen, Restylane, or any other substance injected for a primarily cosmetic purpose.

1. As with all delegated medical services, delegated Medical-Aesthetic Services must be of the type that a reasonable and prudent physician would find within the scope of sound medical judgment to delegate. Consequently, delegated Medical-Aesthetic Services should be routine, technical services, the performance of which do not require the special skills of a licensed physician.

2. Off-label use of medications or devices when performing delegated Medical-Aesthetic Services is generally prohibited unless:

a. the delegating physician has specifically authorized and delegated the off-label use, and

b. the off-label use is within generally accepted standards of medical practice.

C. General applicability of other sections. Except as explicitly provided in this Section VI of these Rules, all requirements set forth in other Sections of these Rules apply to delegation of Medical-Aesthetic Services.

D. Additional requirements. In addition to the other provisions of these Rules, the personal and responsible direction and supervision of delegatees performing Medical-Aesthetic Services must include the following:

1. The delegating physician and the delegatee

must have a written agreement documenting and detailing the relationship. This written agreement is attached in Appendix A of these Rules. The written agreement as set forth in Appendix A must be available to the public at the site where the delegated medical services are performed.

2. The delegating physician must maintain a list of all delegatees to whom the physician has delegated Medical-Aesthetic Services. The list must include a comprehensive and specific list of the delegated Medical-Aesthetic Services the physician has authorized the delegatee to perform. The list shall be maintained with documentation of the delegatee’s qualifications to perform the Medical-Aesthetic Services as described in paragraph III(B) of these Rules. Upon request, all documentation maintained by the physician in accordance with this paragraph shall be provided to the Board.

3. The delegating physician is responsible for assuring the qualifications and competence of

the delegatee to perform the delegated Medical-Aesthetic Services as follows:

a. Prior to authorizing a delegatee to perform any Medical-Aesthetic Services, the delegating physician must personally assess the qualifications and competence of the delegatee to perform the Medical-Aesthetic Services. This assessment must include a review the delegatee’s education and training as relevant to performance of the delegated medical service(s). Additionally, this assessment must include, but must not be limited to, initial over-the-shoulder monitoring of the delegatee’s performance of each delegated Medical-Aesthetic Service.

b. On at least an annual basis, the delegating physician must personally reassess the qualifications and competence of the delegatee to perform the Medical-Aesthetic Services. This reassessment must include, but must not be limited to, over-the-shoulder monitoring of the delegatee’s performance of each delegated Medical-Aesthetic Service.

c. The delegating physician must document the initial assessment and follow-up reassessments of the delegatee’s performance of the delegated Medical-Aesthetic Services. Upon request, the delegating physician must provide such documentation to the Board.

4. Medical-Aesthetic Services must be delivered within a facility appropriate to the delegated service provided and listed on the written agreement as set forth in Appendix A.

E. Physician-patient relationship for delegated Medical-Aesthetic Services. The delegating physician’s physician-patient relationship with a patient receiving delegated Medical-Aesthetic Services pursuant to these Rules need not comply with Section IV(E) of these Rules, but must include the following:

1. The delegating physician must ensure that each patient receives all information necessary to give appropriate informed consent for any Medical-Aesthetic Service and that such informed consent is timely documented in the patient’s chart.

2. All patients receiving a delegated Medical-Aesthetic Service must be informed that the delegating physician is available personally to consult with them or provide appropriate evaluation or treatment in relation to the delegated Medical-Aesthetic Services. Upon request, the delegating physician must timely and personally provide such consultation, evaluation or treatment.

3. The delegating physician must assure that the delegatee maintains appropriate patient charts for each patient receiving Medical-Aesthetic Services.

4. At least weekly, the delegating physician must monitor the quality of the services provided by the delegatee through such means as direct observation, review of care, review of outcomes, review of equipment, review of protocols and procedures and review of charts. The weekly monitoring must occur at the site where the delegated services are performed.