| (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.
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