Laser Hair Removal Program Administrative Rules

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LASER HAIR REMOVAL
Administrative Rules of the Texas Department of Licensing and Regulation
16 Texas Administrative Code, Chapter 118
(Effective November 1, 2017)

TABLE OF CONTENTS

118.1. Authority
118.2. Purpose
118.3. Scope
118.10. Definitions
118.20. Prohibitions
118.30. Laser Hair Removal Facility Certificate--Requirements and Application
118.31. Laser Hair Removal Facility--Responsibilities
118.32. Laser Safety Officer--Designation and Responsibilities
118.33. Laser Hair Removal Individual Certificate--Requirements and Application
118.34. Laser Hair Removal Professionals and Senior Laser Hair Removal Technicians--Auditing and Supervision Requirements
118.35. Continuing Education Requirements
118.40. License Terms; Renewals
118.50. Requirements for Certifying Entities and Examinations
118.60. Consulting Physician--Responsibilities and Protocols
118.61. Consulting Physician--Audits of LHR Facility Protocols and Operations
118.70. Laser Hair Removal Devices--General and Operating Requirements
118.71. Laser Hair Removal Devices--Stolen, Lost, or Missing
118.80. Fees
118.90. Administrative Penalties and Sanctions
118.91. Enforcement Authority
118.100. Records Retention Requirements
118.110. Disclosures and Confidentiality Requirements

118.1. Authority. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

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

118.2. Purpose. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

(a) This chapter establishes requirements for:

(1) radiation safety in the use of lasers or pulsed light devices for hair removal procedures;

(2) laser hair removal (LHR) facility operations, training and qualifications for persons performing LHR procedures, customer notification, consulting physicians, enforcement, penalties, and responsibilities of the registrant, laser safety officer (LSO), certified individuals, and consulting physicians;

(3) the registration of LHR facilities and the certification of individuals who perform or attempt to perform LHR procedures.

(b) No person may operate a LHR facility except as authorized in a certificate of LHR registration issued by the department in accordance with the requirements of this chapter.

(c) No person may perform or attempt to perform LHR except as authorized in a certificate issued by the department in accordance with this chapter.

118.3. Scope. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

(a) Except as otherwise specifically provided, this chapter applies to all persons who operate a location that provides LHR procedures using LHR devices and to all persons who perform or attempt to perform LHR procedures using LHR devices.

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

(c) A LHR device used for nonablative hair removal procedures shall meet the applicable performance standards for light-emitting products specified in Title 21, Code of Federal Regulations (CFR), §1040.10 and §1040.11.

(d) Except for 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.

(e) A certificate issued in accordance with this chapter only authorizes a person to perform nonablative cosmetic LHR. The certificate issued in accordance with this chapter does not authorize an individual to diagnose, treat, or offer to treat any client for any illness, disease, injury, defect or deformity of the human body.

(f) This chapter applies only to LHR devices used for nonablative hair removal. Lasers or pulsed light devices used for any other purpose shall comply with the requirements of 22 TAC §289.301 (relating to Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices).

(g) A person who receives, possesses, uses, owns, or acquires LHR devices prior to receiving a certificate of LHR registration is subject to the requirements of this chapter and 22 TAC §289.301.

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

(i) The qualifications for eligibility for an applicant for a senior LHR technician certificate who is a licensed health professional shall be established by the entity that issues licenses for that health profession.

(j) Training programs complying with the requirements of §118.33(e), are also subject to certain requirements of 22 TAC §289.226 (relating to Registration of Radiation Machine Use and Services).

(k) A LHR device categorized by the United States Food and Drug Administration (FDA) as a prescription device shall meet the requirements for prescription use specified in Title 21, CFR, §801.109. For purposes of this chapter:

(1) the requirements for a consulting physician specified in §118.30, shall satisfy the requirement for supervision by a physician specified in Title 21, CFR, §801.109; and

(2) the requirement for a consulting physician to establish protocols for a LHR facility in accordance with §118.30, shall satisfy the requirement for a prescription for use as specified in Title 21, CFR, §801.109.

(l) A LHR device shall be purchased by or on the order of a physician, in accordance with Title 21, CFR, §801.109 and 118.71.

118.10. Definitions. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

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

(1) Act--Texas Radiation Control Act, Health and Safety Code, Chapter 401.

(2) Adverse event--Any death or serious injury, as that term is defined in Title 21, CFR, §803.3, to a client or employee of a LHR facility that is a result of use, misuse, or failure of LHR devices 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) Applicant--A person seeking a certificate of LHR registration or individual LHR certificate, issued in accordance with the provisions of the Act and the requirements in this chapter.

(5) Certificate of LHR registration--A form of permission given by the department to a LHR facility applicant who has met the requirements for LHR registration certification. For purposes of this chapter, "certificate of LHR registration" is an equivalent term for "facility license" as specified in Health and Safety Code, §401.510.

(6) Certified individual--Any individual issued an individual LHR certificate by the department.

(7) Commission--The Texas Commission on Licensing and Regulation.

(8) Consulting physician--A physician who has a contract with a LHR facility.

(9) Contract--A written legal document between a consulting physician and the operator of a LHR facility.

(10) Customer--For purposes of this chapter, “client’ is an equivalent term for “customer”.

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

(12) Direct supervision--Direct observation by a senior LHR technician or a LHR professional of LHR procedures performed by a LHR apprentice-in-training. Direct supervision shall include the following:

(A) the physical presence of senior LHR technician or LHR professional at the LHR facility;

(B) the availability of the senior LHR technician or LHR professional to give immediate assistance if required; and

(C) the direct observation by the senior LHR technician or LHR professional of LHR procedures performed by a LHR apprentice-in-training.

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

(14) Individual LHR certificate-- An individual who has met the requirements for individual LHR certification. The term includes certificates issued by the department for a LHR professional, a senior LHR technician, a LHR technician, and a LHR apprentice-in-training.

(15) 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.

(16) Laser hair removal facility--A business location that provides laser hair removal.

(17) Laser hair removal procedure--The removal of hair from one of the four body areas specified below, conducted during the same or separate appointment. Each area is considered one procedure, regardless of how many individual body parts are treated within that area:

(A) head and neck;

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

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

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

(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) Laser safety officer (LSO)--An individual who has knowledge of and the authority and responsibility to apply appropriate laser radiation protection rules, standards, and practices, and who shall be specifically authorized on a certificate of LHR registration.

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

(21) Living quarters--Any area used as a place of abode with provisions for sleeping, cooking, and sanitation.

(22) Mobile LHR facility--A business location self-contained within a vehicle that provides LHR procedures within the vehicle and meets all the requirements of this section.

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

(24) Operator--The owner of a LHR facility, an agent of an owner, or an independent contractor of a LHR facility.

(25) Person--Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, local government, any other state or political subdivision or agency thereof, or any other legal entity, and any legal successor, representative, agent, or agency of the foregoing.

(26) Physician--An individual who meets the definition in Texas Occupations Code, Title 3, Subtitle B, Chapter 151.

(27) Registrant--Any facility issued a certificate of LHR registration by the department. For purposes of this chapter, "certificate of LHR registration" is an equivalent term for "facility license" as specified in Health and Safety Code, §401.510.

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

118.20. Prohibitions. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

(a) The department may prohibit the use of LHR devices that pose a significant threat or endanger occupational or public health and safety, in accordance with §118.2.

(b) A person shall not operate a LHR facility unless the person holds a certificate of LHR registration issued by the department in accordance with this chapter.

(c) An individual shall not use LHR devices to perform or attempt to perform LHR procedures unless the person holds the individual LHR certificate issued by the department in accordance with this chapter.

(d) An individual shall not operate a laser hair removal 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.

(e) A person who violates subsection (d), 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.

(f) A person shall not operate a LHR facility from a person's living quarters. A LHR facility shall be separated from living quarters by complete floor to ceiling partitioning and shall contain no access to living quarters.

118.30. Laser Hair Removal Facility Certificate--Requirements and Application. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

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

(b) A separate certificate of LHR registration is required for each LHR facility.

(c) A certificate of LHR registration for a LHR facility 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.

(d) A certificate of LHR registration is required for a facility owned or operated by a physician that performs only LHR procedures.

(e) A certificate of laser registration issued in accordance with 22 TAC §289.301 may be required for the entities specified in subsection (c) that own, possess, or use lasers for purposes other than LHR.

(f) An applicant for a facility certificate of LHR registration shall complete a department-approved application which must include:

(1) a qualified LSO designated on each application form pursuant to §118.32;

(2) a qualified LHR professional(s) designated on each application form;

(3) A copy of a written contract with a consulting physician which includes the following:

(A) proper protocols for the services provided by the consulting physician at the facility as specified in §118.60;

(B) a provision for the consulting physician to audit the LHR facility's protocols and operations in accordance with §118.61;

(C) a commitment that the consulting physician shall 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) a designated physician who shall be available for the consultation with the LHR facility relating to care for the client if the consulting physician is unavailable;

(4) the required fee prescribed under §118.80.

(g) An application for a LHR facility shall be signed by an operator and LSO.

118.31. Laser Hair Removal Facility--Responsibilities. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

(a) The LHR facility registrant must notify the department in writing of any changes that would render the information contained in the application for LHR registration or the certificate of LHR registration inaccurate.

(b) Notification is required within thirty (30) days of the following:

(1) change in business name of the LHR facility;

(2) change in physical location of the LHR facility;

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

(4) change in LSO;

(5) loss or change of the LHR facility's LHR professional; or

(6) loss or change of the LHR facility's consulting physician.

(c) The LHR facility registrant shall comply with 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 shall 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 §118.60.

(d) If the LHR facility registrant loses the services of the consulting physician, the registrant may use another physician(s) who has been designated in the contract in accordance with §118.30. If the LHR facility registrant loses the services of both designated consulting physicians, the LHR facility registrant shall immediately cease LHR procedures until the LHR facility registrant establishes a contractual relationship with a consulting physician.

(e) Each registrant shall conduct a physical inventory of all LHR devices in its possession at an interval not to exceed 1 year. Records of the inventories shall be made and maintained in accordance with this chapter, and shall 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 registrant shall maintain records of receipt, transfer, and disposal for each LHR device in accordance with this chapter. The records shall 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) A LHR operator is responsible for maintaining the LHR facility's compliance with the requirements of the Act and this chapter.

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

(i) A LHR operator shall not produce false or misleading advertising regarding the services offered at the facility. An advertisement of services using lasers for hair removal shall be deemed to be false or misleading if it is inaccurate or misleading in any particular regarding representations made or suggested or failure to reveal material facts with respect to consequences which may result from the use of such services.

(j) When a LHR facility registrant decides to terminate all activities involving LHR devices authorized under the facility certificate of LHR registration, the registrant shall immediately:

(1) request termination of the facility certificate of LHR registration in writing; and

(2) submit to the department a record of the disposition of the LHR devices, and if transferred, to whom the devices were transferred.

(k) Each facility certificate of LHR registration issued in accordance with this chapter shall be subject to the applicable provisions of the Act and to the applicable rules and orders of the department.

(l) No certificate of LHR registration issued or granted under this chapter shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, to any person.

118.32. Laser Safety Officer--Designation and Responsibilities. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

(a) LSO qualifications shall be submitted to the department with the completed LHR facility application and shall include at least the following:

(1) educational courses related to laser radiation safety or a LSO course; or

(2) familiarity with and experience in the use of LHR devices; and

(3) knowledge of potential laser radiation hazards and laser emergency situations.

(b) A LSO must perform the following duties, including but 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 registrant;

(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 complying with this chapter, the conditions of the facility certificate of LHR registration, and the protocols of the registrant.

118.33. Laser Hair Removal Individual Certificate--Requirements and Application. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

(a) All applicants for an individual LHR certificate shall:

(1) complete an application on department approved forms;

(2) submit the applicable fee(s) specified under §118.80;

(3) successfully pass a criminal history background check.

(b) Laser Hair Removal Professional Certificate Requirements. An applicant for a LHR professional certificate shall meet the following requirements:

(1) be certified by a certifying entity approved by the department pursuant to §118.50;

(2) meet the requirements for a senior LHR technician certificate in accordance with this chapter; and

(3) pass a department approved examination pursuant to §118.50.

(c) Senior Laser Hair Removal Technician Certificate Requirements. An applicant for a senior LHR technician certificate shall meet the following requirements:

(1) meet the requirements for a LHR technician certificate in accordance with this chapter; and

(2) have directly supervised at least 100 LHR procedures within 12 months, as audited by a LHR professional. An individual shall not supervise LHR procedures without audit by a LHR professional until:

(A) 100 LHR procedures within 12 months have been directly supervised, as audited by a LHR professional; and

(B) an individual senior LHR technician certificate has been issued by the department in accordance with this chapter.

(d) Laser Hair Removal Technician Certificate Requirements.

(1) An applicant for a LHR technician certificate shall meet the following requirements:

(A) meet the requirements for a LHR apprentice-in-training certificate in accordance with this chapter; and

(B) have performed at least 100 LHR procedures within 12 months under the direct supervision of a senior LHR technician or a LHR professional.

(2) An individual shall not perform LHR procedures unsupervised until:

(A) 100 LHR procedures within 12 months have been performed under the direct supervision of a senior LHR technician or LHR professional; and

(B) an individual LHR technician certificate has been issued by the department.

(e) Laser Hair Removal Apprentice-in-Training Certificate Requirements.

(1) An applicant for a LHR apprentice-in-training certificate shall meet the following requirements:

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

(i) LHR device safety;

(ii) laser physics;

(iii) skin typing;

(iv) skin reactions;

(v) treatment protocols;

(vi) burns;

(vii) eye protection;

(viii) emergencies; and

(ix) post-treatment protocols;

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

(i) 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);

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

(iii) review of client's previous hair removal procedures by another modality;

(iv) 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;

(v) proper signage and posting;

(vi) use of a LHR device; and

(vii) anesthesia used in conjunction with LHR procedures.

(C) shall not perform LHR procedures unless under the direct supervision of a senior LHR technician or a LHR professional; and

(D) shall be at least 18 years of age.

(2) Training required by this section shall be obtained from a department approved training program registered with the department in accordance with the following:

(A) A department approved training program is defined as a radiation service in accordance with 22 TAC §289.226(b).

(B) A radiation service shall be registered in accordance with 22 TAC §289.226(j).

(C) A training program specified in this section shall meet the requirements of 22 TAC §289.226(a), (j)(1), (j)(2), (j)(3)(C), (k), (l), (m)(1)(A), (m)(4) - (7), (o) - (r), and (t)(1)(A).

(D) For purposes of this section, the responsibilities of a radiation safety officer specified in 22 TAC §289.226(j) may be fulfilled by a LSO.

(3) Training programs must apply on a department approved application for approval and must comply with all education requirements set out in this chapter.

(4) An application submitted to the department for approval shall 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;

(E) a copy of the certificate that will be issued upon successful completion of the training program; and

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

(f) Each individual LHR certificate issued in accordance with this chapter shall be subject to the applicable provisions of the Act and to the applicable rules and orders of the department.

(g) No individual LHR certificate issued or granted under this chapter shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, to any person.

118.34. Laser Hair Removal Professionals and Senior Laser Hair Removal Technicians--Auditing and Supervision Requirements. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

(a) A physician or other licensed health professional shall not perform the auditing activities of a LHR professional in accordance with §118.33(c), unless that individual meets the requirements for a LHR professional specified in §118.33(b).

(b) A physician or other licensed health professional shall not perform the direct supervision activities of a LHR professional or senior LHR technician in accordance with §118.33(d), unless that individual meets the requirements of §118.33(b) and §118.33(c).

(c) A LHR professional shall audit and ensure that there was direct supervision of the 100 LHR procedures performed by a LHR technician while obtaining the requirements of §118.33(c)

118.35. Continuing Education Requirements. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

(a) Each individual who holds an individual LHR certificate issued by the department shall obtain eight (8) hours of continuing education hours per certificate term to include, but not limited to, the following:

(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) The continuing education hours required by this section may be obtained by web-based online training or a home-study training program.

118.40. License Terms; Renewals. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

(a) A facility certificate of LHR registration or individual LHR certificate issued by the department is valid for 2 years.

(b) Each applicant for renewal of a facility certificate of LHR registration or individual LHR certificate shall:

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

(2) submit the renewal fee(s) specified under §118.80;

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

(d) If a registrant does not submit an application for renewal of the facility certificate of LHR registration, the registrant shall on or before the expiration date specified in the facility certificate of LHR registration:

(1) terminate 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.

(e) Expiration of the facility certificate of LHR registration or individual LHR certificate does not relieve the registrant of the requirements of this section.

(f) Documentation of successful completion of the continuing education requirements shall be submitted with each application for renewal of an individual LHR certificate.

118.50. Requirements for Certifying Entities and Examinations. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

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

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

(2) if a society or association, make its membership available to the general public nationwide that is not restricted because of race, color, religion, age, national origin or disability;

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

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

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

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

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

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

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

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

(11) have procedures for proctoring examinations, including qualifications for proctors. These procedures shall 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;

(12) 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

(13) 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 shall meet the following requirements:

(1) require applicants for certification to:

(A) receive training in the topics specified in §118.33(e); 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 §118.33(e); and

(B) satisfactorily completed a minimum period of on-the-job training.

(3) include procedures to ensure that all examination questions are protected from disclosure;

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

(5) provide a certification period of not less than 3 years nor more than 5 years;

(6) 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; and

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

(c) An examination administered or used by a certifying entity shall be designed to test an individual's knowledge and understanding of at least the topics specified in §118.33(e).

118.60. Consulting Physician--Responsibilities and Protocols. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

(a) The consulting physician shall 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.

(b) If the consulting physician is unavailable for an emergency consultation, another designated physician shall be available for the consultation with the facility relating to care for the client.

(c) The consulting physician and designated physician shall have a primary practice site located within seventy-five (75) miles of the LHR facility.

(d) The consulting physician shall be responsible for reviewing all adverse events and for determining whether such events are reportable in accordance with Title 21, CFR, Part 803.

(e) The protocols required in accordance with §118.30 shall be:

(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.

(f) The protocols required in accordance with §118.30, shall include at least the following:

(1) which LHR procedures require a particular level of individual LHR certification;

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

(3) specific instructions to be followed for individual LHR certificate holders 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 should 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.

(g) 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.

118.61. Consulting Physician--Audits of LHR Facility Protocols and Operations. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

(a) The consulting physician shall conduct audits of the registrant's LHR facility to ensure that operations are being conducted in accordance with the protocols established by the contract specified in §118.30.

(b) The audits shall be unannounced, shall be conducted at the physical site of the LHR facility, and shall 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 designated 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 shall sign the audit.

(f) The consulting physician shall 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 shall be maintained in accordance with this chapter.

(g) The record of the audit shall 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 designated physician or advanced practice nurse or physician's assistant acting under the consulting physician's delegated authority to conduct the audit.

118.70. Laser Hair Removal Devices--General and Operating Requirements. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

(a) No person shall make, sell, lease, transfer, or lend laser hair removal devices unless such devices, when properly placed in operation and use, meet the applicable requirements of this 22 TAC §289.301.

(b) A LHR device used in a LHR facility shall comply with all applicable federal and state laws and regulations.

(c) A person who adulterates or misbrands a LHR device under Health and Safety Code, §431.111 or §431.112 violates Health and Safety Code, Chapter 431. The Department of State Health Services - Radiation Control Program may investigate a person accused of adulterating or misbranding a LHR device.

(d) A LHR device used by a LHR facility may be purchased either by a physician (such as the consulting physician or other designated physician for emergencies) or by a LHR facility pursuant to a written prescription or other order of a licensed physician in Texas.

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

(1) the date of the order's issue;

(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.

(f) A LHR device shall 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.

(g) Except as provided by subsection (h), a LHR facility shall have a LHR professional or a licensed health professional present to provide supervision of the LHR procedures performed at the facility during the facility's operating hours.

(h) A LHR facility may continue to perform LHR procedures after the facility's LHR professional leaves the facility or is continuously absent for up to forty-four (44) days if a senior LHR technician is present to perform or directly supervise each procedure. Not later than the 45th day after the date the facility's LHR professional leaves or is continuously absent from the facility:

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

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

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

(j) Each individual receiving the instructions shall document that they have read and understand the instructions. The instructions and the documentation that each individual has read and understands the instructions shall be maintained in accordance with this chapter.

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

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

(m) Protective eyewear shall be worn by all individuals using a LHR device or all individual present, including clients, in the room where a LHR device is being used. Protective eyewear devices shall 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 shall be discarded. Documentation of the examination shall be made and maintained in accordance with this chapter.

(n) Each client shall 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.

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

(p) Each certified individual shall display the certificate of LHR registration 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.

(q) A warning sign shall be posted in a conspicuous location that is readily visible to a person entering the LHR facility. The warning sign shall 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.

(r) The LHR controlled area shall be conspicuously posted with signs or labels as designated by the following:

(1) Title 21, CFR, §1040.10;

(2) ANSI Z136.1-2000, Safe Use of Lasers; and

(3) IEC standards 60825-1 and 60601-2-22.

(s) Records shall be made of each audit conducted. The records shall be maintained in accordance this chapter. The records shall include, but not be limited to, the following:

(1) name of the LHR professional;

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

(3) date of the procedure.

(t) Records shall be made of each LHR procedure and maintained in accordance with this chapter for inspection by the agency. Each record shall include, but not be limited to, the following:

(1) client identification;

(2) date of the LHR procedure;

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

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

(5) type of individual LHR certificate possessed by the individual performing the LHR procedure;

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

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

(u) Each person registered by the department for use of LHR devices in accordance with this chapter shall confine use and possession of the LHR devices to the location and purpose authorized in the facility certificate of LHR registration. If a LHR facility operator owns multiple LHR facilities, the operator may transfer a LHR device from facility to facility that the operator owns if each facility is registered.

118.71. Laser Hair Removal Devices--Stolen, Lost, or Missing. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

(a) Each person registered by the department shall report to the Department of State Health Services - Radiation Control Program a stolen, lost, or missing LHR device within seventy-two (72) hours after its occurrence becomes known to the registrant.

(b) Each person required to make a report shall, 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 have been taken, or will be taken, to recover the LHR device; and

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

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

118.80. Fees. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

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

(b) The two-year initial certification fee for a facility certificate of LHR registration is $900.

(c) The two-year renewal fee for a facility certificate of LHR registration is $750.

(d) The two-year initial certification fees and two-year renewal fees for individual LHR certificates 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 registrations and certificates issued under this chapter are $25.

(f) The fee for a criminal history evaluation letter is the fee prescribed under §60.42 of this title (relating to Criminal History Evaluation Letters).

(g) A dishonored/returned check or payment fee is the fee prescribed under §60.82 of this title (relating to Dishonored Payment Device).

(h) Late renewal fees for registrations and certificates issued under this chapter are provided under §60.83 of this title (relating to Late Renewal Fees).

118.90. Administrative Penalties and Sanctions. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

If an individual or entity violates any provision of Texas Occupations Code, Chapters 51 or 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 and Texas Health and Safety Code Chapter 401, Subchapter M and any associated rules.

118.91. Enforcement Authority. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

The enforcement authority granted under Texas Occupations Code, Chapters 51 and 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.

118.100. Records Retention Requirements. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

All records required by this chapter shall be properly maintain in accordance to the following time requirements for records keeping:

(1) Retain for Three Years:

(A) Audits (§118.61);

(B) Inventory (§118.31);

(C) Instruction to Individuals (§118.70);

(D) Protective Eyewear Examination (§118.70); and

(E) LHR Procedures Performed (§118.70).

(2) Retain until termination or expiration of Certificate of LHR Registration receipts, transfers, and disposals (§118.31).

118.110. Disclosures and Confidentiality Requirements. (New Section adopted effective November 1, 2017, 42 TexReg 4815)

(a) Except as provided by subsection (b), the registrant or any other person may not disclose a client record required to be kept by the department, the Department of State Health Services, or another authorized agency.

(b) The registrant or any other 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 prohibited by law.