SECTION 114.29. Accreditation and Inspection of Facilities

(a) The purpose of accreditation is to identify for prospective patients, referral sources, and third-party payers which prosthetic or orthotic facilities meet the department's requirements. This section is adopted under the Act, §605.260. All facilities where orthotics and prosthetics are provided by persons licensed or registered under this title must be accredited under the Act, unless the facility is one to which the accreditation requirement does not apply in accordance with §605.260(e) of the Act.

(b) The accreditation requirement is inapplicable to the following facilities:

(1) A facility licensed under the Health and Safety Code, Title 4, in accordance with §605.260(e) of the Act. These facilities include hospitals, convalescent and nursing facilities, ambulatory surgical centers, continuing care facilities, assisted living facilities, and end stage renal disease facilities; or

(2) Any facility that does not hold itself out as performing or offering to perform orthotics or prosthetics, and at which persons providing health care services do not perform or hold themselves out as performing or offering to perform orthotics or prosthetics.

(c) Accreditation application. The application shall be completed and submitted to the department on a department-approved form. The application shall be accompanied by the appropriate fee.

(1) A new application for accreditation is required for:

(A) a new facility;

(B) a new location or branch of existing, affiliated facilities;

(C) a new location of an existing facility that is relocating;

(D) a facility adding the prosthetic or orthotic category to an accreditation that is not expired, suspended or revoked;

(E) a facility for which the accreditation has expired or has been terminated; and

(F) an existing facility that has been transferred to new ownership, regardless of prior accreditation status.

(i) A change of ownership of a facility occurs when there is a change in the person(s) legally responsible for the operation of the facility, whether by lease or by ownership.

(ii) The new owner of a prosthetic or orthotic facility must apply for accreditation within ten business days after the change in ownership.

(2) The application for accreditation must include:

(A) a scaled floor plan of the facility indicating the total square feet in the facility and clearly showing the location of parallel bars;

(B) labeled photographs of each room and hallway clearly showing wheelchair accessibility and privacy protections for patients;

(C) labeled photographs of the facility entrance clearly showing wheelchair accessibility; and

(D) labeled photographs of all laboratory and fabrication areas.

(3) If a person applies for accreditation of more than one facility owned by that person, the department requires one primary application and separate addendum pages for additional sites to be accredited.

(4) If the department does not grant accreditation to the entity that applies to be an accredited facility, the accreditation fee will not be returned.

(5) The department shall give the applicant written notice of the reason(s) for the proposed decision if the facility fails to obtain accreditation.

(d) Personnel requirements for accredited facilities. Accredited facilities shall have the following staff and shall comply with the following conditions:

(1) Practitioner in charge.

(A) An accredited facility must be under the on-site clinical direction of a practitioner licensed by the department in the discipline(s) for which the facility is accredited. The practitioner in charge shall supervise the provision of prosthetics or orthotics in accordance with the Act and rules.

(B) A person who holds a temporary license or a student registration may not serve as the on-site practitioner in charge.

(C) To change the designation of the on-site practitioner(s) in charge, the facility shall provide notice in the manner prescribed by the department of the new on-site practitioner(s) and the effective date of the change within thirty (30) days after the change is effective.

(2) Residency program director. Facilities providing professional clinical residencies shall have a residency program director to provide direct and indirect supervision of residents. The program director shall be on site as appropriate in accordance with the responsibilities in §114.30. The program director must be a Texas licensed practitioner whose license is in the same discipline in which the professional clinical residency is being conducted.

(3) Safety manager. An accredited facility must designate at least one person as the safety manager.

(A) The safety manager shall develop, carry out, and monitor the safety program for the accredited facility.

(B) To change the designation of the safety manager(s), the facility shall provide notice in the manner prescribed by the department of the new safety manager(s), and the effective date of the change within thirty (30) days after the change is effective.

(e) General requirements for accredited facilities.

(1) A facility may not provide services until the department has approved the accreditation.

(2) The facility building and property must meet all applicable federal, state, and local laws, codes, and other requirements.

(3) An accredited facility must display the accreditation certificate in a prominent location in the facility where it is available for inspection by the public.

(4) An accreditation certificate issued by the department is the property of the department and must be surrendered on demand by the department.

(5) A facility accredited under the Act shall prominently display a consumer complaint notice or sign that complies with the requirements of §114.70(d).

(6) An accredited facility may advertise as a "Prosthetic and/or Orthotic Facility Accredited by the Texas Department of Licensing and Regulation." A facility that is exempt or that is not subject to the Act, or that the department does not accredit may not advertise or hold itself out as a facility accredited by the department.

(7) An accreditation issued under this chapter may not be transferred or sold to another facility, location, or owner.

(8) An accredited facility must display the license certificates of its practitioners in a prominent location in the facility where they are available for inspection by patients, and by the public upon request.

(9) An accredited facility must display a visible sign with its hours of operation, including:

(A) hours of normal business operation, and when appropriate;

(B) information regarding temporary closure, including holidays, or for periods during business hours, including specific dates and times of the closure and emergency contact information.

(10) An accredited facility shall have the equipment, tools, and materials to provide casting, measuring, fitting, repairs and adjustments of orthoses and prostheses, as applicable.

(f) Failure to achieve accreditation. Facilities that fail to achieve accreditation as required by the Act and the rules are noncompliant with the Act and rules and are subject to disciplinary action.

(g) Facilities failing to renew the accreditation by the expiration date are subject to the late renewal fee schedule applicable to licensees in §60.83 of this title (relating to Late Renewal Fees)

(h) Facilities shall be inspected in accordance with Texas Occupations Code, Chapter 51, and the inspection rules under 16 Texas Administrative Code, Chapter 60, Subchapter H.

(i) Facility cleanliness. The facility shall be constructed and maintained appropriately to provide safe and sanitary conditions for the protection of the patients and the personnel providing prosthetic and orthotic care.

(1) Licensees shall wash their hands with hand sanitizer or soap and water before providing service to each patient.

(2) Patient examination and treatment rooms shall be cleaned after each patient.

(3) Hand sanitizer or hand soap and hand towels or hand dryers must be available at the sinks used by employees and patients.

(4) Exam tables shall either be covered in a material that can be disinfected and shall be cleaned and disinfected after providing service to each patient or the facility must use disposable covers that are one-time use and that are replaced after providing service to each patient.

(5) Appropriate gloves and disinfectants for disease control must be available in examination rooms and treatment areas.

(6) Facilities shall keep the floors, walls, ceilings, shelves, furniture, furnishings, and fixtures clean and in good repair. Any cracks, holes, or other similar disrepair not readily accessible for cleaning shall be repaired or filled in to create a smooth, washable surface.

(7) Plumbing fixtures, including toilets and wash basins, shall be kept clean. Any disrepair not readily accessible for cleaning shall be repaired or filled in to create a smooth, washable surface.

(8) Facilities shall have suitable plumbing that provides an adequate and readily available supply of hot and cold running water at all times and that is connected for drainage of sewage and for potable water supply.

(9) Facilities shall not be utilized for living or sleeping purposes except as applicable to patients, and may not be used for any other purpose that would tend to make the premises unsanitary, unsafe, or endanger the health and safety of the public.

(j) Patient waiting area.

(1) Patient waiting areas must be separate from other areas.

(2) Chairs with armrests must be provided in waiting rooms. Chairs without armrests or with or without wheels must be provided upon patient request.

(k) Examination/treatment rooms.

(1) Rooms in which patients are seen must maintain privacy and have permanent, floor-to-ceiling walls or dividers and rigid doors that can be closed. Windows must be covered in a way that assures privacy.

(2) At least one set of parallel bars and a mirror that is affixed to the wall or a mirror with a free standing base for patient ambulation trials must be provided in each facility.

(3) At least one chair with armrests shall be available for use in each examination/treatment room. Chairs without armrests or with or without wheels must be provided upon patient request.

(l) Safety.

(1) Safety equipment, including safety glasses or goggles and dust masks, shall be available to persons working in an accredited facility.

(2) Proper machine use training shall be provided to staff. The facility shall maintain records documenting training, listing the name of the staff person and the date of training for each machine.

(3) Safety guards on machines shall be in place in accordance with the manufacturers' specifications.

(4) Laboratory/Fabrication areas must be separated from other areas by walls or rigid doors and have adequate lighting.

(5) If smoking is permitted, policies and procedures to control smoking materials shall be clearly posted.

(6) Facilities shall provide access to at least one accessible restroom with handwashing facilities located on or adjacent to the premises of the facility. Chemical supplies shall not be stored in restrooms or other areas accessible to the public or to patients.

(m) Business office area.

(1) Patient records shall include accurate and current progress notes.

(2) Patient records must be kept private.

(3) Patient records shall not be made available to anyone outside the facility without the patient's signed consent or as required by law.

(4) All patient and facility records that are required to be retained or made available shall be kept for a minimum of five years.

Source Note: The provisions of this §114.29 adopted to be effective October 1, 2016, 41 TexReg 4467; amended to be effective September 1, 2018, 43 TexReg 5362; amended to be effective May 1, 2022, 47 TexReg 2524; amended to be effective January 15, 2023, 48 TexReg 42