TITLE 16. ECONOMIC REGULATION

§ 118.1. Authority.

This chapter is promulgated under the authority of Texas Occupations Code, Chapter 51, and Texas Health and Safety Code, Chapter 401, Subchapter M.

§ 118.2. Scope.

(a) Except as otherwise specifically provided, this chapter applies to all persons who:

(1) perform or attempt to perform laser hair removal (LHR); or

(2) operate a laser hair removal facility.

(b) This chapter does not apply to the manufacture of LHR devices.

(c) Except for consulting physicians and alternate consulting physicians, this chapter does not apply to a physician or to a physician's employee or delegate acting under Texas Occupations Code, Chapter 157.

(d) A certification issued under this chapter only authorizes a person to perform nonablative cosmetic LHR. The certification does not authorize the person to diagnose, treat, or offer to treat any client for any illness, disease, injury, defect or deformity of the human body.

(e) This chapter applies only to LHR devices used for nonablative hair removal.

(f) A person who receives, possesses, uses, owns, or acquires an LHR device and who does not hold an LHR facility license is subject to the requirements of this chapter, including any requirement applicable to a person who does hold an LHR facility license.

(g) A health professional licensed under another law is not required to hold a certificate issued under this chapter to perform laser hair removal if the performance of laser hair removal is within the scope of that professional's practice as determined by the professional's licensing board.

§ 118.3. Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise.

(1) Act--Texas Health and Safety Code, Chapter 401, Subchapter M.

(2) Adverse event--Any death or serious injury to a client or employee of an LHR facility that is a result of use, misuse, or failure of an LHR device or LHR safety equipment.

(3) Advertising--All representations disseminated in any manner or by any means for the purpose of inducing, or that are likely to induce, directly or indirectly, the purchase of laser hair removal services.

(4) Alternate consulting physician--A physician, licensed in Texas, designated by an LHR facility to be available for emergency consultation with the facility if the consulting physician is unavailable and as appropriate to the circumstances.

(5) Certifying entity--A non-governmental organization approved by the department that administers an examination for obtaining the LHR Professional certification and meets the requirements of §118.50.

(6) Commission--The Texas Commission of Licensing and Regulation.

(7) Consulting physician--A physician, licensed in Texas, who has a written contract with a LHR facility for the purpose of meeting the requirements under Section 401.519 of the Act.

(8) Customer--An equivalent term for "client".

(9) Delegate--The act of a consulting physician or alternate consulting physician to delegate any medical act that a reasonable and prudent consulting physician or alternate consulting physician would find within the scope of sound medical judgement to delegate. The act must be performed by properly trained persons, as specified in Texas Occupations Code, Chapter 157.

(10) Department--The Texas Department of Licensing and Regulation.

(11) Direct supervision--Direct observation by an individual who is physically present in the LHR facility and available to provide immediate assistance if required.

(12) Executive Director--The executive director of the department.

(13) Individual LHR certification--A certification issued by the department to an individual who has met the requirements for individual LHR licensure. The term includes certifications issued by the department for a LHR apprentice-in-training, a LHR technician, a senior LHR technician, and a LHR professional.

(14) Laser hair removal (LHR)--The use of a laser or pulsed light device for nonablative hair removal procedures. For purposes of this chapter, "laser hair reduction" is an equivalent term.

(15) LHR facility--A business location that provides laser hair removal.

(16) LHR facility license--A license issued by the department that allows a person to operate an LHR facility.

(17) Laser hair removal procedure--The removal of hair from one of the four body areas as specified in §118.4.

(18) Laser or pulsed light device--A device approved by the FDA for laser hair removal or reduction. For purposes of this chapter, "LHR device" is an equivalent term.

(19) Licensed health professional--An individual licensed in accordance with Occupations Code, Title 3.

(20) Nonablative hair removal procedure--A hair removal procedure using a LHR device that does not remove the epidermis.

(21) Operate an LHR facility--To do any of the following:

(A) own an LHR facility; or

(B) perform or attempt to perform laser hair removal at an LHR facility as:

(i) an agent of an owner of the LHR facility; or

(ii) an independent contractor of the LHR facility:

(22) Operator--A person who:

(A) owns an LHR facility; or

(B) performs or attempts to perform laser hair removal at an LHR facility as:

(i) an agent of an owner of the LHR facility; or

(ii) an independent contractor of the LHR facility.

(23) Person--An individual or a legal entity.

(24) Physician--An individual licensed to practice medicine in Texas. Only a Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) can serve as a consulting physician or alternate consulting physician.

(25) Serious injury--An injury or illness that:

(A) is life-threatening;

(B) results in permanent impairment of a body function or permanent damage to a body structure; or

(C) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. Permanent means irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage.

(26) Supervision--The physical presence of a senior LHR technician or LHR professional at the LHR facility.

(27) Training Program--A program, approved by the department, that offers the educational requirements for an "apprentice-in-training" for laser hair removal in accordance with Texas Health and Safety Code, Chapter 401, Subchapter M, and this chapter, and follows applicable state laws, including Texas Education Code, Chapter 132.

§ 118.4. Laser Hair Removal Procedure.

(a) A laser hair removal procedure is the removal of hair from one of the following four body areas, conducted during the same or separate appointment by one person:

(1) head and neck;

(2) upper extremities, to include hands, arms (including armpits), and shoulders;

(3) torso, to include front and back (including pelvic region and buttocks); or

(4) lower extremities, to include legs and feet.

(b) The following areas are considered one procedure, regardless of how many individual body parts are treated within that area:

(1) forehead, glabella, cheeks, nose, upper lip, chin, sideburns, ears, front of neck, and back of neck;

(2) hands, fingers, armpits, shoulders;

(3) areolas, chest (man), abdomen, bikini or Brazilian, upper back lower back, buttocks, midline; and

(4) knees, feet, toes

(c) The following areas may be split into right and left sides and count as more than one single procedure if done simultaneously.

(1) Upper arms;

(2) Lower arms;

(3) Upper legs; and

(4) Lower legs.

§ 118.10. LHR Facility--License Requirements and Application.

(a) A separate application must be submitted for each LHR facility license.

(b) A separate LHR facility license is required for each LHR facility.

(c) If a physician owns or operates a facility where only LHR procedures are performed, an LHR facility license is required.

(d) An LHR facility license is not required for the following:

(1) a facility owned or operated by a physician for the practice of medicine;

(2) a licensed hospital; or

(3) a clinic owned or operated by a licensed hospital.

(e) To be eligible for an LHR facility license, an applicant must:

(1) submit a completed application on a department-approved form;

(2) designate an individual who holds an LHR professional certification who will supervise laser hair removal procedures performed at the facility;

(3) designate the consulting physician and alternate consulting physician with whom the facility has a written contract that includes the following:

(A) proper protocols for the services provided by the consulting physician at the facility as specified in §118.13;

(B) a provision for the consulting physician to audit the LHR facility's protocols and operations in accordance with §118.14;

(C) a commitment that the consulting physician will be available for emergency consultation with the LHR facility as appropriate to the circumstances, including, if the physician considers it necessary, an emergency appointment with the client; and

(D) an alternate consulting physician who must be available for the consultation with the LHR facility relating to care for the client if the consulting physician is unavailable; and

(4) submit the fee required under §118.70.

(f) A person must not operate an LHR facility unless the person holds an LHR facility license issued by the department under this chapter, unless exempt as prescribed in §118.10(d).

§ 118.11. LHR Facility--License Term; Renewal.

(a) An LHR facility license issued by the department is valid for two years.

(b) Each applicant for renewal of an LHR facility license must:

(1) complete an application on department approved forms; and

(2) submit the renewal fee(s) specified under §118.70;

(c) If an LHR facility does not submit an application for renewal of the LHR facility license, the LHR facility must on or before the expiration date of the LHR facility license:

(1) end use of all LHR devices; and

(2) submit to the department a record of the disposition of the LHR devices, and if transferred, to whom the devices were transferred, as specified in §118.12(f).

(d) Expiration of the LHR facility license does not relieve the LHR facility owner or operator of the requirements of this chapter.

§ 118.12. LHR Facility--Responsibilities.

(a) An LHR device used for laser hair removal in a LHR facility must follow all applicable federal and state laws and regulations.

(b) An LHR facility must notify the department within 30 days after any change to the following:

(1) business name of the LHR facility;

(2) physical location of the LHR facility;

(3) street address where LHR devices will be used;

(4) LHR professional designated for the facility; or

(5) consulting physician or alternate consulting physician for the facility.

(c) The LHR facility must follow the adverse reporting requirements for device user facilities in Title 21, CFR, Part 803 - Medical Device Reporting. Copies of all reports of adverse events submitted in accordance with Title 21, CFR, Part 803 must be submitted to the department within 24 hours of their initial submission to the manufacturer, FDA or both as determined by the consulting physician in accordance with §118.13.

(d) If an LHR facility loses the services of the consulting physician, the facility may use the alternate consulting physician designated in the contract in accordance with §118.10, and the LHR facility must contract with a new consulting physician within 30 calendar days. If an LHR facility loses the services of both consulting physicians, the LHR facility must immediately cease LHR procedures until the LHR facility establishes a new contractual relationship with a consulting physician and alternate consulting physician. All new contracts must be sent to the department within 30 days.

(e) Each LHR facility must conduct and maintain a physical inventory of all LHR devices in its possession at an interval not to exceed one year. Records of the inventories must be made and maintained in accordance with §118.60, and must include:

(1) LHR device manufacturer's name;

(2) model and serial number of the LHR device;

(3) specific location of the LHR device (for example, room number);

(4) name, title, and signature of the person performing the inventory; and

(5) date the inventory was performed.

(f) Each LHR facility must maintain records of receipt, transfer, and disposal for each LHR device in accordance with §118.60. The records must include the following information:

(1) LHR manufacturer's name;

(2) model and serial number of the LHR device;

(3) date of the receipt, transfer, or disposal;

(4) name and address of person LHR devices were received from, transferred to, or disposed of with; and

(5) name of the individual recording the information.

(g) An operator is responsible for maintaining the LHR facility's compliance with the requirements of the Act and this chapter.

(h) An operator must not claim, advertise, or distribute promotional materials claiming that laser hair removal is free from risk or provides any medical benefit.

(i) An operator must not produce false or misleading advertising regarding the services offered at the facility.

(j) When an LHR facility ends all activities requiring an LHR facility license, the LHR facility must immediately submit to the department:

(1) a written request for termination of the LHR facility license; and

(2) a record of the disposition of the LHR devices, and if transferred, to whom the devices were transferred, as specified in §118.12(f).

(k) A warning sign must be posted in a conspicuous location that is readily visible to a person entering the LHR facility. The warning sign must meet the following requirements:

(1) be of a size with dimensions at least 8 and 1/2 inches by 11 inches;

(2) contain wording with a font size no smaller than size 26;

(3) contain at least the following wording:

(A) Laser hair removal devices emit electromagnetic radiation that is considered to be an acute hazard to the skin and eyes from direct and scattered radiation. Laser hair removal procedures provide no medical benefit and may result in adverse effects.

(B) To make a complaint, contact the Texas Department of Licensing and Regulation, Laser Hair Removal Program at P.O. Box 12157, Austin, Texas 78711, (512) 539-5600, or www.tdlr.texas.gov.

(l) The LHR controlled area must be conspicuously posted with signs or labels as prescribed by applicable federal and state laws and regulations.

(m) An LHR facility license is not transferrable.

(n) Except as provided by subsection (o), an LHR facility must have an LHR professional present to provide supervision of the LHR procedures performed at the facility during the facility's operating hours.

(o) If an LHR facility loses the services of the LHR professional, or the LHR professional is continuously absent for up to 44 calendar days, the LHR facility must not continue to offer LHR services unless the LHR facility has a senior LHR technician present to perform or directly supervise each procedure. By the 45th day after the date the LHR professional leaves or is continuously absent from the facility:

(1) the facility's senior LHR technician must become certified as an LHR professional in accordance with this chapter; or

(2) the facility must hire a new LHR professional.

§ 118.13. LHR Facility--Consulting Physician.

(a) A LHR facility must have a written contract with a consulting physician. The LHR facility's contract with its consulting physician must provide the following:

(1) The consulting physician must be available for emergency consultation with the facility as appropriate to the circumstances, including, if the physician considers it necessary, an emergency appointment with the client. This responsibility may be met through telemedicine in accordance with Texas Occupations Code, Chapter 111;

(2) If the consulting physician is unavailable for an emergency consultation, the alternate consulting physician must be available for the consultation with the facility relating to care for the client;

(3) The consulting physician and alternate consulting physician must have a non-residential primary practice site located within seventy-five (75) miles of the LHR facility; and

(4) The consulting physician must be responsible for reviewing all adverse events, serious injuries, and for determining whether such events are reportable in accordance with applicable laws.

(b) The protocols required in accordance with §118.10 are:

(1) written instructions agreed upon and signed and dated by the consulting physician and the LHR facility operator;

(2) maintained at the LHR facility; and

(3) reviewed and signed by the consulting physician and LHR operator at least annually.

(c) The protocols required in accordance with §118.10, must include at least the following:

(1) the level of licensure which is required for each LHR procedure;

(2) the circumstances or conditions under which each procedure is to be performed;

(3) specific instructions to be followed for individual LHR certification who are working under direct supervision or who are giving direct supervision;

(4) conditions under which emergency consultation is required;

(5) designated settings, in accordance with the manufacturer's instructions, at which the LHR device can be expected to safely remove hair; and

(6) list of medications taken by the client that must be reported to the consulting physician before LHR services are provided or that, if taken by the client, preclude a LHR procedure from being performed.

(d) The requirements in this section do not relieve a consulting physician or another health care professional from complying with applicable regulations prescribed by a state or federal agency.

§ 118.14. LHR Facility--Audits.

(a) The LHR facility must ensure that operations are being conducted in accordance with the protocols established by the contract specified in §118.10. The consulting physician must conduct audits of the LHR facility to verify compliance with the protocol.

(b) The audits must be unannounced, must be conducted at the physical site of the LHR facility, and must be conducted at least quarterly.

(c) The audits may be scheduled in advance if the consulting physician determines that advance notice does not compromise the ability to determine that operations are being conducted in accordance with established protocols.

(d) The audits may be conducted by the consulting physician, another alternate consulting physician or an advanced practice nurse or physician's assistant acting under the consulting physician's delegated authority.

(e) If the audit is conducted by an advanced practice nurse or physician's assistant, the consulting physician must sign the audit.

(f) The consulting physician must make records of audits conducted under the terms of the contract and maintain those records in accordance with the requirements of this chapter. The consulting physician audit records must be maintained in accordance with this chapter.

(g) The record of the audit must include at least the following:

(1) date audit was performed;

(2) name of the LHR facility audited;

(3) assessment of the LHR facility's performance of the protocols established by the written contract; and

(4) signature of the consulting physician, the LHR facility operator, and any other alternate consulting physician or advanced practice nurse or physician's assistant acting under the consulting physician's delegated authority to conduct the audit.

§ 118.20. LHR Individual Certification--Requirements and Application.

(a) All applicants for an individual LHR certification must:

(1) submit a completed application on a department-approved form;

(2) submit the applicable fee specified under §118.70; and

(3) pass a criminal history background check.

(b) An individual must not perform or attempt to perform laser hair removal unless the person holds the appropriate individual LHR certification issued by the department under this chapter, unless exempt as prescribed by §118.2(g).

§ 118.21. LHR Individual Certification--Responsibilities.

(a) An individual LHR certification issued in accordance with this chapter is subject to the applicable provisions of the Act and to the applicable rules and orders of the department.

(b) An individual LHR certification issued or granted under this chapter is not transferrable.

(c) Each certificant must display the LHR certification issued in accordance with this chapter in an open public area of the LHR facility. Copies of an individual's certification document may be made for display in multiple facilities.

(d) Upon request, each certificant must present to the department or the department's representative any certificate issued by the department or the department's representative.

§ 118.22. Certification Term; Renewal.

(a) An individual LHR certification issued by the department is valid for 2 years.

(b) Each applicant for renewal of an individual LHR certification must:

(1) complete an application on department approved forms; and

(2) submit the renewal fee(s) specified under §118.70.

(c) Each applicant for renewal of an individual LHR certification must also successfully pass a criminal history background check.

(d) Expiration of an individual LHR certification does not relieve the license holder of the requirements of this section.

(e) Renewals for LHR professionals must provide proof of current certification.

§ 118.25. Continuing Education Requirements.

(a) General Requirements. Each individual who holds an individual LHR certification issued by the department must obtain eight (8) hours of continuing education (CE) hours per certification term to include the following LHR related topics:

(1) refresher training in the topics specified in §118.26;

(2) LHR technology updates;

(3) applicable regulatory changes; and

(4) other health and safety related topics.

(b) Web-Based Training. The continuing education hours required by this section may be obtained by web-based online training.

§ 118.26. LHR Individual Certification--Apprentice-in-Training.

(a) LHR Apprentice-In-Training Certification Requirements. An applicant for an LHR apprentice-in-training certification must:

(1) be at least 18 years of age.

(2) have at least 24 hours of training in:

(A) LHR device safety;

(B) laser physics;

(C) skin typing;

(D) skin reactions;

(E) treatment protocols;

(F) burns;

(G) eye protection;

(H) emergencies; and

(I) post-treatment protocols.

(3) have an additional 16 hours of training in:

(A) cardio-pulmonary resuscitation (a valid cardio-pulmonary resuscitation certificate may be used to satisfy up to 8 hours of the training required by this subparagraph);

(B) review of client's pre-existing conditions to determine if consultation with a consulting physician is needed for possible diagnosis or treatment;

(C) review of client's previous LHR procedures by another modality;

(D) review of client's current medications to determine if any medications need to be brought to the attention of the consulting physician based on established protocols;

(E) proper signage and posting;

(F) use of an LHR device; and

(G) anesthesia used in conjunction with LHR procedures.

(b) LHR Apprentice-In-Training Certification Submission Requirement. An applicant for an LHR apprentice-in-training certification must submit proof of successful completion of a training program approved by the department covering the topics listed in §118.26(a)(2). An individual must not perform LHR procedures unless under the direct supervision of a senior LHR technician or an LHR professional.

§ 118.27. LHR Individual Certification--Technician.

(a) LHR Technician Certification Requirements. An applicant for an LHR technician certification must meet the following requirements:

(1) hold a current LHR apprentice-in-training certification in accordance with this chapter; and

(2) have performed at least 100 LHR procedures under the direct supervision of a senior LHR technician or an LHR professional in the 12 months prior to the application submission date.

(b) Supervisor requirements. A physician or other licensed health professional must not perform the direct supervision activities of an LHR professional or senior LHR technician in accordance with this section unless that individual meets the requirements of §118.28 and §118.29.

§ 118.28. LHR Individual Certification--Senior LHR Technician.

(a) Senior LHR Technician Certification Requirements. An applicant for a senior LHR technician certificate must meet the following requirements:

(1) hold a current LHR technician certification in accordance with this chapter; and

(2) have directly supervised at least 100 LHR procedures verified by an LHR professional in the 12 months prior to the application submission date.

(b) Verification requirements. A physician or other licensed health professional must not verify the LHR procedures directly supervised by an applicant for a senior LHR technician certificate in accordance with this section unless that individual meets the requirements for a LHR professional specified in §118.29.

§ 118.29. LHR Individual Certification--LHR Professional.

(a) LHR Professional Certification Requirements. An applicant for an LHR professional certification must meet the following requirements:

(1) hold a current senior LHR technician certification in accordance with this chapter;

(2) be certified by a certifying entity approved by the department pursuant to §118.40; and

(3) pass a department approved examination pursuant to §118.40.

(b) LHR Professional Responsibilities. The duties of an LHR professional include, but are not limited to:

(1) ensuring that users of LHR devices are trained in laser safety;

(2) assuming control and having the authority to institute corrective actions, including shutdown of operations when necessary, in emergency situations or if unsafe conditions exist;

(3) ensuring that maintenance and other practices required for safe operation of the LHR devices are performed;

(4) ensuring the proper use of protective eyewear and other safety measures;

(5) ensuring compliance with the requirements in this section and with protocols specified by the LHR facility;

(6) ensuring audits required in accordance with this chapter are conducted;

(7) maintaining records as required by this chapter; and

(8) ensuring that personnel are adequately trained, certified, and are in compliance with this chapter, the conditions of the LHR facility license, and the protocols of the LHR facility.

(c) Supervisor requirements. An LHR professional must ensure that there was direct supervision of the 100 LHR procedures performed by a LHR technician under §118.27 while obtaining the requirements of a senior LHR technician under §118.28.

§ 118.30. Apprentice Training Programs.

(a) Training program requirements. Training required by this chapter must be obtained from a department-approved training program.

(b) Training program application. Training programs must follow all education requirements set out in this chapter.

(1) Training programs must apply on a department approved application for approval.

(2) An application submitted to the department for approval must include the following:

(A) Course syllabus, including topics covered and time allotted for each topic;

(B) Qualifications of instructors;

(C) Verification that exam(s) are administered to assess the student's knowledge of material presented;

(D) The criteria for successful completion of the course; and

(E) A copy of the certification that will be issued upon successful completion of the training program that includes the following information:

(i) Name of the training program;

(ii) A heading or title of training on the certificate that states "Laser Hair Removal 40 Hour Training;

(iii) A statement that the training was completed in accordance with Texas Health and Safety Code, Chapter 401, Subchapter M, and the rules under 16 Texas Administrative Code, Chapter 118;

(iv) The date the training was completed; and

(v) Verification that the training program is in compliance with applicable state laws, including Texas Education Code, Chapter 132.

(c) Individual Eligibility. An individual should determine his or her eligibility to participate in an educational program to obtain an LHR individual certification, as prescribed by Texas Occupations Code §53.152.

§ 118.40. Requirements for Certifying Entities and Examinations.

(a) A certifying entity must meet the following requirements:

(1) apply on a department approved application for approval and follow all education requirements set out in this chapter;

(2) be a non-governmental organization such as a society, association, business, or school with an interest in the field of laser hair removal or whose members participate in or have an interest in the field of laser hair removal;

(3) if a society or association, not restrict its membership due to race, color, religion, age, national origin or disability and also make its memberships available to the general public nationwide;

(4) if a society or association, have a certification program open to nonmembers as well as members;

(5) be an incorporated nationally recognized entity in good standing involved in setting national standards of practice within its fields of expertise;

(6) have an adequate staff, a viable system for financing its operations, and a policy- and decision- making review board;

(7) have a set of written organizational by-laws and policies that provide adequate assurance of lack of conflict of interest and include a system for monitoring and enforcing these by-laws and policies;

(8) have a committee whose members carry out their responsibilities impartially to review and approve their certification guidelines and procedures and advise the organization's staff in implementing the certification program;

(9) have a committee whose members carry out their responsibilities to impartially review complaints against certified individuals and then determine appropriate sanctions;

(10) have written procedures describing all aspects of its certification program including its administration, and maintain records of the current status of an individual's certification;

(11) have procedures to ensure certified individuals are provided due process with respect to the administration of a certification program, including the certification process and the imposition of any sanctions against certified individuals;

(12) have procedures for proctoring examinations, including qualifications for proctors. These procedures must ensure that the individuals proctoring each examination are not employed by the same company or corporation (or a wholly-owned subsidiary of such company or corporation) as any of the examinees;

(13) exchange information about certified individuals with the agency and other certifying entities and allow periodic review of its certification program and related records by the agency; and

(14) provide a description to the agency of its procedures for choosing examination sites and for providing an appropriate examination environment.

(b) To be approved by the department, a certification program must meet the following requirements:

(1) require applicants for certification to:

(A) receive training in the topics specified in §118.26(a); and

(B) satisfactorily complete a written examination covering these topics;

(2) require applicants for certification to provide documentation that demonstrates that the applicant has:

(A) received training in the topics specified in §118.26(a); and

(B) satisfactorily completed a minimum period of LHR apprentice-in-training certification requirements;

(3) include procedures to ensure that all examination questions are protected from disclosure, as prescribed by 16 Texas Administrative Code §60.54;

(4) include procedures for denying an application and revoking, suspending, and reinstating a certificate;

(5) include procedures for notifying each applicant of current guidelines to determine eligibility in the educational program, as prescribed by Texas Occupations Code §53.152;

(6) provide a certification period of at least 3 years, but not more than 5 years;

(7) include procedures for renewing certifications and, if the procedures allow renewals without examination, require evidence of recent full-time employment and continuing education hours as required by this chapter;

(8) provide a timely response to inquiries from members of the public about an individual's certification status; and

(9) issue a certificate of completion that includes:

(A) the issue date;

(B) the expiration date; and

(C) a statement that the certification program was completed in accordance with Texas Health and Safety Code, Chapter 401, Subchapter M, and the rules under 16 Texas Administrative Code, Chapter 118.

(c) An examination administered or used by a certifying entity must be designed to test an individual's knowledge and understanding of at least the topics specified in §118.26(a).

§ 118.50. LHR Devices--General and Operating Requirements.

(a) An LHR device used in an LHR facility must follow all applicable federal and state laws and regulations.

(b) An LHR device used by an LHR facility must be purchased either by a physician (such as the consulting physician or alternate consulting physician) or by an LHR facility pursuant to a written prescription or other order of a licensed physician in Texas.

(c) A prescription or other order from a licensed physician for the purchase of an LHR device must include at a minimum:

(1) the date the physician issued the order;

(2) the name and quantity of the LHR device(s) authorized to be purchased;

(3) the name, address, and telephone number of the registered LHR facility authorized to purchase and own the laser;

(4) the intended use of the device is limited to nonablative laser hair removal;

(5) the name, address, and telephone number of the physician at the physician's usual place of business, legibly printed or stamped;

(6) a statement that the prescription is valid up to twelve (12) months from the date of issue; and

(7) the signature of the authorizing physician.

(d) An LHR device must not be used for LHR procedures unless:

(1) the LHR device is approved for laser hair removal or reduction by the FDA for that purpose; and

(2) the LHR device is operated only at the settings expected to safely remove hair, in accordance with the manufacturer's instructions and protocols established by the consulting physician in accordance with this chapter and other applicable law regulating devices.

(e) Individuals operating each laser presently being used or listed on the current inventory, must be provided with written instructions for safe use, including clear warnings and precautions to be taken when using the LHR device.

(f) Each individual receiving the instructions must document that they have read and understand the instructions. The instructions and the documentation that each individual has read and understands the instructions must be maintained in accordance with §118.60.

(g) A controlled area must be established within a room in which LHR devices are used and the LHR devices must be secure from unauthorized removal.

(h) Each LHR device must incorporate a key-actuated or computer-actuated master control. The key must be removable and the LHR device must not be operable when the key is removed. When the LHR device is not being prepared for operation or is unattended, the controlled area must be secured to prevent unauthorized access.

(i) Protective eyewear must be worn by all individuals using an LHR device and all individuals present, including clients, in the room where an LHR device is being used. Protective eyewear devices must meet the following requirements:

(1) provide a comfortable and appropriate fit all around the area of the eye;

(2) be in proper condition to ensure the optical filter(s) and frame provide the required optical density or greater at the desired wavelengths, and retain all protective properties during its use;

(3) be suitable for the specific wavelength of the laser and be of optical density adequate for the energy involved;

(4) have the optical density or densities and associated wavelength(s) permanently labeled on the filters or eyewear; and

(5) be examined, at intervals not to exceed twelve (12) months, to ensure the reliability of the protective filters and integrity of the protective filter frames. Unreliable eyewear must be discarded. Documentation of the examination must be made and maintained in accordance with §118.60.

(j) Each client must be provided with a written statement outlining the relevant risks associated with LHR procedures, including a warning that failure to use the eye protection provided to the client by the LHR facility may result in damage to the eyes.

(k) Compliance with the written statement requirement specified in subsection (j), does not affect the liability of the LHR facility operator or a manufacturer of a LHR device.

(l) Each LHR facility licensed by the department to offer LHR procedures using LHR devices in accordance with this chapter must confine use and possession of the LHR devices to the location and purpose authorized in the LHR facility application. If an LHR facility operator owns multiple LHR facilities, the operator may transfer an LHR device from facility to facility that the operator owns if each facility is licensed.

(m) An individual must not operate an LHR device with the intent to treat an illness, disease, injury, or physical defect or deformity unless the individual is:

(1) a physician;

(2) acting under a physician's order; or

(3) authorized under other law to treat the illness, disease, injury, or physical defect or deformity in that manner.

(n) A person who violates subsection (m), is practicing medicine in violation of Occupations Code, Title 3, Subtitle B, and is subject to the penalties under that subtitle and under Health and Safety Code §401.522.

(o) An LHR facility must not be used for living or sleeping purposes, or any other purpose that would tend to make the premises unsanitary, unsafe, or endanger the health and safety of the public. A facility that is attached to a residence must have an entrance that is separate and distinct from the residential entrance. Any door between a residence and a licensed facility must be closed during business hours.

§ 118.51. LHR Devices--Stolen, Lost, or Missing.

(a) Each LHR facility licensed by the department must report to the Department of State Health Services - Radiation Control Program a stolen, lost, or missing LHR device within twenty-four (24) hours after its occurrence becomes known to the person.

(b) Each person or facility required to make a report must, within thirty (30) days after making the initial report, make a written report to the Department of State Health Services - Rational Control Program that includes the following information:

(1) a description of the LHR device involved, including the manufacturer, model, serial number, and class;

(2) a description of the circumstances under which the loss or theft occurred;

(3) a statement of disposition, or probable disposition, of the LHR device involved;

(4) actions that has been taken, or will be taken, to recover the LHR device; and

(5) procedures or measures that has been taken to prevent the loss or theft of LHR devices in the future.

(c) After filing the written report, the person must also report additional substantive information on the loss or theft within thirty (30) days after the person learns of such information.

§ 118.60. Records Retention Requirements.

All records required by this chapter must be properly maintained, and made available upon department request, in accordance with the following time requirements for record keeping:

(1) Retain for Three Years:

(A) Audits;

(i) Records of each audit must be maintained.

(ii) The records must include, but not be limited to, the following:

(I) name of the LHR professional;

(II) name(s) of the individual(s) being audited; and

(III) date of the procedure;

(B) Inventory;

(C) Instruction to Individuals;

(D) Protective Eyewear Examination; and

(E) LHR Procedures Performed;

(i) Records of each LHR procedure must be maintained.

(ii) Each record must include, but not be limited to, the following:

(I) client identification;

(II) date of the LHR procedure;

(III) indication that the client was given the notification;

(IV) name of the individual performing the LHR procedure;

(V) type of individual LHR certification possessed by the individual performing the LHR procedure;

(VI) name of the senior LHR technician or LHR professional providing direct supervision, if applicable; and

(VII) manufacturer, model number, and serial number of the LHR device and the settings used to perform the procedure.

(2) Retain until termination or expiration of LHR facility license: receipts, transfers, and disposals under §118.12.

§ 118.61. Disclosures and Confidentiality Requirements.

(a) Except as provided by subsection (b), no person may disclose a client record required to be kept by the department or another authorized agency.

(b) A person may disclose a client record if:

(1) the client or a person authorized to act on behalf of the client requests the record;

(2) the department, the Texas Medical Board, a health authority, or an authorized agency requests the record;

(3) the client consents in writing to disclosure of the record to another person;

(4) the client is a victim, witness, or defendant in a criminal proceeding and the record is relevant to that proceeding;

(5) the record is requested in a criminal or civil proceeding by court order or subpoena; or

(6) disclosure is otherwise required by law.

§ 118.70. Fees.

(a) All fees paid to the department are non-refundable.

(b) The two-year initial licensing fee for a LHR facility license is $900.

(c) The two-year renewal fee for an LHR facility license is $750.

(d) The two-year initial licensure fees and two-year renewal fees for individual LHR certifications are as follows:

(1) LHR professional--$150;

(2) Senior LHR technician--$100;

(3) LHR technician--$70; and

(4) LHR apprentice-in-training--$50.

(e) A duplicate/replacement fee for a license or certification issued under this chapter is $25.

(f) Late renewal fees for licenses and certifications issued under this chapter are provided under §60.83.

(g) A dishonored payment fee is the fee prescribed under §60.82.

(h) The fee for a criminal history evaluation letter is the fee prescribed under §60.42.

§ 118.80. Administrative Penalties and Sanctions.

If an individual or entity violates any provision of Texas Occupations Code, Chapter 51; Texas Health and Safety Code, Chapter 401, Subchapter M; this chapter; or any rule or order of the executive director or commission, proceedings may be instituted to impose administrative penalties, administrative sanctions, or both, in accordance with the provisions of Texas Occupations Code, Chapter 51; Texas Health and Safety Code, Chapter 401, Subchapter M; and any associated rules.

§ 118.81. Enforcement Authority.

The enforcement authority granted under Texas Occupations Code, Chapter 51; Texas Health and Safety Code, Chapter 401, Subchapter M; and any associated rules may be used to enforce Texas Health and Safety Code, Chapter 401, Subchapter M and this chapter.