16 Tex. Admin. Code § 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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.