Use of lasers and other modalities affecting living tissue
 

Rules and compliance

Board Rules, Chapter 540-X-11:


Rules do not apply to:

  • persons licensed to practice chiropractic, dentistry, occupational therapy, optometry or physical therapy if the device that affects living tissue is used exclusively for the practice of those branches of the healing arts.
  • persons practicing "body art" as defined by the Department of Public Health.
  • persons using these devices in hospitals as defined in Ala. Code 22-21-20.

FAQs

Q: What is required of physicians using lasers/other devices?
A: Supervision (section .05), written protocols (section .06), educational requirements (section .07), quality assurance (section .11), equipment safety (section .12), safe use of lasers (section .13), registration, reporting requirement.

Q: Are there any forms provided by the Board for the required written protocols and/or quality assurance program?
A: No, each practice is expected to develop its own protocol and quality assurance program pursuant to sections .06 and .11.

Q: To whom may a physician delegate laser/other devices procedures?
A: A Level 1 Delegate or a Level 2 Delegate.

Q: What training is required for physicians and Level 1 Delegates?
A: Sixteen hours of basic training, maintenance of competence (section .07).

Q: What training is required for Level 2 Delegates?
A: Academic training, sixteen hours of documented initial training, completion of at least ten procedures of preceptee training (section .08)

Q: What if the delegating physician is unavailable to supervise a delegate?
A: Arrangements should be made for an alternative physician to provide the supervision. The alternate physician must have the same training as the primary supervising physician and must affirm in writing to the Board that the physician is familiar with the protocols in use at the site, will be accountable for adequate supervision.

Q: Can a physician petition the Board to allow delegates to use lasers/other devices for ablative procedures?
A: No. Only physicians may use these devices for ablative procedures.

Q: What's the difference between "ablative" and "non-ablative?"
A: The terms "ablative" and "non-ablative" are distinctions commonly used by the American College of Surgeons and other medical specialties when referring to lasers/pulsed light treatments. According to ACOS: "An ablative treatment is expected to excise, burn, or vaporize the skin below the dermo-epidermal junction. Non-ablative treatments are those that are not expected or intended to excise, burn, or vaporize the epidermal surface of the skin. Any procedures that can damage the eye (cornea to retina) are ablative and should only be performed by a licensed physician." Source: American College of Surgeons.


FAQs - specific procedures/modalities

Q: Is electrocautery covered under these rules?
A: Yes, electrocautery may be used by a Level 1 or Level 2 delegate under direct physician supervision.

Q: Is the use of pulsed and thermocoagulation radiofrequency lesioning governed under the rules?
A: Yes. Pulsed and thermocoagulation radiofrequency lesioning is a modality that affects living tissue, and as such, a physician using it is required to register with the Board.

Q: Is the use of hyfrecators, thermage or cryotherapy governed under the rules?
A: No. A physician utilizing hyfrecators, thermage and cryotherapy, as these modalities currently exist, is not required to register with the Board.

Q: Is the use of radiofrequency endovascular procedures governed under the rules?
A: Yes. Radiofrequency endovascular procedures are ablative and the physician is required to register with the Board; however, because the procedure cannot be delegated, there is no requirement for written protocols or quality assurance.

Q: Is the use of microwave machines (Urologix, Theramatrix and Prolieve) governed under the rules?
A: Yes. Procedures using these machines are considered "other modalities affecting living tissue," and all rules apply.


Terms and definitions

  • "lasers and other modalities": lasers, pulsed light devices, or any energy source, chemical or other modality that affects living tissue (for skin, anything below the stratum corneum), whether applied for surgical, therapeutic or cosmetic purposes.
  • "non-ablative": includes any laser/intense pulsed light treatment or other energy source, chemical or modality that is not expected or intended to remove, burn, or vaporize tissue. This includes treatments related to laser hair removal.
  • "physician registration": required of physicians who use or offer to use a laser/pulsed light device in any facility other than a hospital. (registration form)
  • "reporting of adverse events": all events related to a procedure that resulted in hospitalization or third degree dermal injury must be reported to the Board. (reporting form)
  • "Level 1 Delegate":  a mid-level practitioner who is authorized in a written job description or collaborative protocol to use a specific laser/other device for non-ablative procedures, as designated in the written job description or collaborative protocol and who has met the educational requirements for a Level 1 Delegate.
  • "mid-level practitioner":  an assistant to physician, as defined in Ala. Code 34-24-290, or an advanced practice nurse.
  • "Level 2 Delegate":  any person, other than a Level 1 Delegate, who has met the educational requirements for Level 2 Delegates.
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