Kan. Admin. Regs. § 100-27-1

Current through Register Vol. 43, No. 49, December 5, 2024

Section 100-27-1 - Supervision of light-based medical treatment

(a)

(1) The phrase "class III or class IV device" shall mean a medical instrument that meets either of the following conditions:

(A) Is a class IIIa, class IIIb, or class IV laser product as defined by 21 C.F.R. § 1040.10, as in effect on March 31, 2000; or

(B) emits radiation in a continuous wave of more than one milliwatt or at a pulsed rate of more than five milliwatts.

(2) The phrase "immediately available" shall mean that the licensee either is physically present in the same building or can be present at the location where the service is performed within five minutes.

(3) "Licensee" shall mean a person licensed to practice medicine and surgery or osteopathic medicine and surgery in this state.

(4) The phrase "light-based medical device" shall mean any instrument that produces or amplifies electromagnetic radiation at wavelengths equal to or greater than 180 nanometers, but less than or equal to 1.0 X 106 nanometers, for the purpose of affecting the structure or function of any part of the living human body.

(5) The phrase "physically present" shall mean that the licensee is capable of constant, direct communication and is in the same office within the building where the service is performed throughout the entire time during which the service is performed.

(b) A licensee shall not authorize another person to perform a professional service using a light-based medical device unless either the licensee is immediately available or, except as limited by subsection (c), there is a written practice protocol signed by the licensee and the person performing the treatment that requires all of the following:

(1) The person performing the treatment will not provide any service for which the person is not competent by training, education, and experience.

(2) The person receiving the treatment is required to give consent to the treatment, after being informed of the nature and purpose of the treatment, risks, and expected consequences of treatment, alternatives to light-based medical treatment, and identification of the treatment as a medical and surgical procedure.

(3) The person performing the treatment is required to inform the person receiving the treatment of the licensee's identity, emergency telephone number, and practice location, if different from the location at which the treatment is performed.

(4) Each treatment is required to be performed only at a location that the licensee maintains for the practice of the branch of the healing arts for which the licensee is licensed.

(5) Each treatment provided while the licensee is not physically present is required to be performed within written operating parameters.

(6) Creation of an adequate patient record is required.

(7) The licensee is required to review the patient record and authenticate this review within 14 days following the treatment.

(8) The person performing the treatment is prohibited from delegating the use of the light-based medical device to another person.

(c) A licensee shall not authorize another person to perform a professional service using a class III or class IV device or an intense pulsed-light device substantially equivalent to a laser surgical device as defined by 21 C.F.R. § 878.4810, as in effect on January 16, 1996, unless either of the following conditions is met:

(1) The licensee is physically present.

(2) The licensee is immediately available, and there is a written protocol signed by the licensee and the person performing the treatment that meets the requirements of paragraphs (b)(1) through (b)(8).

(d) This regulation shall not apply to an order by a licensee to any appropriate person for the application of light-based medical devices for phototherapy in the treatment of hyperbilirubinemia in neonates.

(e) This regulation shall not apply to any of the following:

(1) Any person licensed under the healing arts act to practice chiropractic who engages in light-based physiotherapy;

(2) any licensed physical therapist who provides treatments as authorized by law; or

(3) any licensed occupational therapist who provides treatments as authorized by law.

Kan. Admin. Regs. § 100-27-1

Authorized by K.S.A. 65-2865; implementing K.S.A. 2005 Supp. 65-28,127; effective June 1, 2001; amended March 22, 2002; amended Sept. 15, 2006.