South Carolina Board of Medical Examiners

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LLR-BOARD OF MEDICAL EXAMINERS

Approved by the Board: October 18-19, 1999 Board meeting

Amended at the: February 6-8, 2005 Board meeting

February 5-7, 2007 Board meeting

November 3-5, 2007 Board meeting

Service Area: Medical

Subject: Laser and Other Devices

MEDICAL DEVICES/DELEGATABLE MEDICAL ACT

SCOPE OF PRACTICE

Purpose

  • To provide model legislative and regulatory language upon which the state medical board can develop or improve their regulations governing the scope of practice. The goal is to protect patient safety, and ensure that the physicians' manner commensurates with their education and training.

Definitions

  • "Adverse incident" means any patient complication or any unforeseen unintended outcome, or perception by the patient of complications.

  • "Board certified physician" means an ABMS/ABOMS board-certified or board eligible physician licensed by the state to practice medicine.

  • "Cutaneous medicine" means performing any act or procedure that, by its use, can alter or damage living tissue. This includes, but is not limited to, the use of all lasers, light sources, microwave energy, electrical impulses, chemical applications, particle sanding, the injection or insertion of foreign or natural substances, or soft tissue augmentation.

  • "Light-based medical device" means any device such as lasers, light sources, intense pulsed light and microwave energy that has the ability to alter or damage living human tissue.

  • "Non-physician" means any person that may work under the supervision of a licensed physician.

  • "Patient" means any member of the public who is provided access to a procedure performed by a licensed physician or under the supervision of a licensed physician.

  • "Training" means acceptable training programs such as those that conform to ABMS/ABOMS or specialty society standards; or training that pertains to cutaneous medicine, and the physics and safety of light-based devices.

Physician Responsibilities

  • If advertising as board-certified, a physician must specify which ABMS/ABOMS board (s) they are certified by.

  • The physician must examine each patient prior to any initial treatment or prior to authorizing treatment by a non-physician.

  • The physician should examine any significant new problems existing with the patient.

  • The physician must only perform procedures that are within his/her scope of practice based on his/her education and training.

  • When performing or providing supervision for cutaneous medical procedure, a physician must have adequate training in the procedure and the devices used for performing the procedure.

  • The physician must only delegate procedures to non-physicians that are working within their scope of practice based on their education and training.

  • The physician shall develop written office protocols for non-physicians under his/her supervision for non-physicians to follow when using all devices, including light-based medical devices. The written office protocols must be compliant with existing state law. The written protocol should include:

  • The physician (and back-up physician if applicable) responsible for supervision of the non-physician.

  • A statement of activities, decision criteria, and plan the supervised non-physician must follow when performing the light-based procedure.

  • Identification of all devices and settings, including light-based devices, to be used for patients who meet selection criteria.

  • Methods by which all devices, including light-based devices are to be operated and maintained.

  • A description of appropriate care and follow-up for common complications, serious injury, or emergencies.

  • The physician shall provide on-site supervision for all non-physicians under his/her supervision performing cutaneous medical procedures. The physician must be immediately available at all times in the event of complication or emergency.

  • The physician shall notify the patient if the procedure will be performed by a non-physician, and obtain their consent.

  • The physician shall maintain profession and legal responsibility for the patient's care and treatment at all times.

Non-physician Responsibilities

  • Non-physician must only perform procedures under direct supervision that are within their scope of practice, based on their education and training.

  • Non-physicians must have documentation of their training.

  • Non-physicians must be properly licensed (if applicable) by the appropriate state board.

  • Non-physicians must follow written office protocols when performing procedures using all medical devices, including light-based medical devices.

  • Non-physicians must report all adverse incidents to the supervising physician and document them in the patient's chart.

  • Non-physician must satisfactorily complete a documented special education and training program on applicable: laser physics, safety, techniques, and pre and post operative care and laser safety, which includes supervised practice and clinical skill competency.

  • Continuing education for these procedures is ongoing and documented.