22 TAC §§821.2, 821.3, 821.5 - 821.7, 821.23, 821.25, 821.27, 821.29, 821.39, 821.41, 821.43
The Texas Board of Orthotics and Prosthetics (board) adopts
amendments to §§821.2, 821.3, 821.5 - 821.7, 821.23, 821.25, 821.27,
821.29, 821.39, 821.41, and 821.43, concerning the licensure and regulation
of orthotists, prosthetists, assistants, technicians, students, and orthotic
and prosthetic facilities. Section 821.29 is adopted with changes to the proposed
text as published in the March 5, 2004, issue of the
Texas Register
(29 TexReg 2182). Sections 821.2, 821.3, 821.5 - 821.7,
821.23, 821.25, 821.27, 821.39, 821.41, and 821.43 are adopted without changes
and the sections will not be republished.
The sections are amended to add a definition for safety manager; incorporate
amendments to the Sunset Advisory Commission's Occupational Licensing Model;
ensure that fee increases mandated by the 2003 Texas Legislature are billed
and collected; add a fee to change the safety manager at accredited facilities;
correct citations; add requirement that scaled floor plans for new facility
applications clearly show the location of parallel bars; require the on-site
practitioner in charge to list all facilities where they are the practitioner
in charge and submit a work schedule; require new facility applications to
list the licensee or registrant who is designated as the safety manager; require
that all photographs submitted with facility applications be labeled; require
that labeled photographs of the facility entrance showing wheelchair accessibility
be submitted with new facility applications; require that labeled photographs
of lab and fabrication areas be submitted with new facility applications;
include the authority for emergency suspensions; and add the imposition of
administrative penalties as a disciplinary action. The sections are also amended
to implement House Bill 2985, 78th Legislature, 2003, which added Occupations
Code, Chapter 101, Subchapter G relating to fees; Senate Bill 1152, 78th Legislature,
2003, which amends Government Code, Chapter 2054, to require participation
in Texas Online; Senate Bill 161, 78th Legislature, 2003, which amends Occupations
Code, Chapter 605, relating to emergency suspensions and administrative penalties.
No comments were received during the comment period concerning the proposed
amendments. However, a revision was made due to a staff comment.
Change: Concerning §821.29(c)(1)(H), second sentence, a hyphen was
deleted between the words "in " and "charge" which now reads "practitioner
in charge" for clarity.
The amendments are adopted under Texas Occupations Code, Chapter
605, which provides the Texas Board of Orthotics and Prosthetics with the
authority to adopt rules concerning the regulation of orthotists and prosthetists.
§821.29.Accreditation of Prosthetic and Orthotic Facilities.
(a)
Requirement for practice setting of licensees.
(1)
A person licensed under the Orthotics and Prosthetics Act,
(Act), Texas Occupations Code, Chapter 605, who practices in Texas shall practice
only in facilities accredited under the Act, unless the type of practice is
exempted by the Act, §§605.301 - 605.305, or the facility is exempted
by the Act, §605.260(e).
(2)
A facility shall not be required to achieve accreditation
under this section if the facility or person(s) providing health care services
at the facility do not perform or hold itself or themselves out as performing
or offering to perform prosthetics and/or orthotics as defined in the Act, §605.002,
or §821.2 of this title (relating to Definitions).
(b)
Purpose of facility accreditation. The purpose of accreditation
is to identify for prospective patients, referral sources, and third-party
payers which prosthetic and/or orthotic facilities meet the board'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 these rules, unless the facility is exempted
under the Act, §605.260(e).
(c)
Accreditation application.
(1)
Accreditation applications must include the following information:
(A)
name of the facility;
(B)
street address of the facility (must be in Texas);
(C)
mailing address, if different from the street address;
(D)
if a corporation:
(i)
the name, address, social security number and percentage
of ownership of persons who directly or indirectly own or control 5.0% or
more of the outstanding shares of stock in the facility in a privately held
corporation; or
(ii)
the name and address of the director(s); or
(E)
the name, address, telephone number, and social security
number of the sole proprietor or partners;
(F)
if another type of organization, the type of organization,
the name, address, and telephone number of the owner(s);
(G)
a scaled floor plan indicating the total square feet in
the facility and clearly showing the location of parallel bars;
(H)
the name and Texas license number of the prosthetist, orthotist,
or prosthetist/orthotist who is designated as the on-site practitioner in
charge and his or her notarized signature. If the on-site practitioner in
charge is in charge of more than one facility, a list of all facilities at
which the practitioner is in charge and a work schedule for the practitioner
in charge must be included. A person who holds a temporary or provisional
license or a student registration may not serve as the on-site practitioner
in charge;
(I)
the name and Texas license number of the licensee or registrant
that is designated as the safety manager;
(J)
the name and Texas license number of other licensees of
this Act who practice in the facility;
(K)
the signature of the on-site practitioner(s) in charge
of the facility;
(L)
labeled photographs of each room and hallway clearly showing
wheelchair accessibility and privacy for patients;
(M)
labeled photographs of the facility entrance clearly showing
wheelchair accessibility; and
(N)
labeled photographs of all lab and fabrication areas.
(2)
The board will not consider an application as officially
submitted until the applicant pays the accreditation fee as set out in §821.5
of this title (relating to Fees). The fee must accompany the application form.
(3)
If an individual, partnership, corporation or other entity
owns one or more facilities, the board requires one primary application and
separate addendum pages for additional sites to be accredited.
(4)
The executive director, acting for the board, shall determine
whether the facility complies with the Act and these rules of the rules.
(5)
If the board does not grant accreditation to the entity
that applies to be an accredited facility, the accreditation fee will not
be returned.
(6)
The executive director shall give the applicant written
notice of the reason(s) for the proposed decision and of the opportunity for
a formal hearing. The formal hearing shall be conducted according to the board's
formal hearing procedures in §821.39 of this title (relating to Complaints).
Procedures relating to the notice and request for hearing shall be governed
by the same section.
(d)
Denial of accreditation. An application may be denied for
one or more of the following reasons:
(1)
nonpayment of an accreditation fee;
(2)
failure to submit the required information on the application
form;
(3)
falsification of information on the application form; or
(4)
violation of the Act or rules.
(e)
Requirements for accredited facilities.
(1)
The entire facility building and property must meet applicable
federal, state, and local laws, codes, and other applicable requirements.
(2)
Prosthetic and/or orthotic facilities must apply for accreditation
with the board and pay an accreditation fee by February 1, 1999, or within
60 days of the first patient treatment date, whichever is later.
(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. An accreditation certificate issued by the board is the property
of the board and must be surrendered on demand by the board.
(4)
An accredited facility is subject to random inspection
to verify compliance with the Act and these rules at any time by authorized
personnel of the board. The board may also conduct inspections if a complaint
is received regarding the facility.
(5)
An accredited facility must be under the clinical on-site
direction of a prosthetist, orthotist, or prosthetist/orthotist licensed by
the board in the discipline in which the facility sought accreditation. The
person shall supervise the provision of prosthetics or orthotics in accordance
with the Act and rules and shall be considered the person in charge. To change
the designation of the on-site practitioner(s) in charge, the facility shall
notify the board in writing of the name and license number of the new on-site
practitioner(s) and the date the effective date of the change. The written
notice shall be accompanied by the appropriate fee as set out in §821.5
of this title (relating to Fees). The notice and fee shall be submitted to
the board before the change is effective.
(6)
A facility accredited under the Act is required to comply
with the Act and rules of the board at all times.
(7)
A facility accredited under the Act shall always prominently
display a sign in letters equal to or larger in size or font as the sign provided
by the board to each accredited facility, containing the name, mailing address
and telephone number of the board, a statement informing consumers that complaints
against licensees of the facility may be directed to the board, and the toll-free
telephone number for presenting complaints to the board about a person or
facility regulated or requiring regulation under the Act.
(8)
An accredited facility is required to report to the board
any change regarding the on-site prosthetist, orthotist, or prosthetist/orthotist
who is clinically directing the facility within 30 days after it occurs. The
information provided to the board shall be accompanied by the appropriate
fee as set out in §821.5 of this title (relating to Fees).
(9)
An accredited facility may advertise as a "Prosthetic and/or
Orthotic Facility Accredited by the Texas Board of Orthotics and Prosthetics."
A facility which is exempt or which the board does not accredit may not advertise
or hold itself out as a facility accredited by the Texas Board of Orthotics
and Prosthetics.
(10)
An accreditation issued under these rules shall not be
transferred or sold to another facility or owner. An accreditation issued
under these rules may not be transferred to a different location without written
approval of the executive director.
(11)
An accredited facility must designate at least one licensee
or registrant as the safety manager. The safety manager is responsible for
developing, carrying out, and monitoring the safety program for the accredited
facility. To change the designation of the safety manager(s), the facility
shall notify the board in writing of the name and license number of the safety
manager(s) and the effective date of the change. The written notice shall
be accompanied by the appropriate fee as set out in §821.5 of this title
(relating to Fees). The notice and fee shall be submitted to the board before
the change is effective.
(f)
Change in ownership. 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.
(1)
The new owner of a prosthetic and/or orthotic facility
must receive accreditation within 90 days of the change in ownership.
(2)
The former owner of the facility must return the accreditation
certificate to the board within 90 days of the sale or transfer of the facility
to a new owner.
(g)
Exemptions to accreditation. A facility licensed under
the Health and Safety Code, Title 4, Subtitle B, is exempt from this accreditation.
This includes hospitals, convalescent and nursing homes, ambulatory surgical
centers, birthing centers, abortion centers, continuing care facilities, personal
care facilities, special care facilities, maternity homes, and end-stage renal
disease facilities. These types of facilities are automatically exempt and
are not required to obtain a formal exemption from the board.
(h)
Renewal of accreditation.
(1)
When issued, an accreditation is valid for two years from
the date the initial accreditation was issued.
(2)
An accredited facility must renew an accreditation every
two years by completing a renewal application and submitting the required
fee.
(3)
The renewal date of an accreditation shall be the last
day of the month in which the accreditation was originally issued.
(4)
The board shall not renew the accreditation of a facility
that is violating or has violated the Act or these rules until the facility
has corrected the violation(s) to the satisfaction of the board.
(5)
At least 30 days before the expiration of a facility's
accreditation, the board will send notice to the facility of the accreditation
expiration date and the amount of the renewal fee due and an accreditation
renewal form. Failure to receive a renewal application from the board does
not exempt the facility from renewing its accreditation. A facility that fails
to receive a renewal application by the first day of its renewal month should
contact the board immediately.
(6)
The board shall issue an accreditation renewal to a facility
that has met the requirements for renewal. It shall be affixed to or displayed
with the original accreditation and is the property of the board.
(i)
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 actions proposed by
the executive director on behalf of the board. Additionally, the licensed
prosthetist, orthotist, or prosthetist/orthotist in charge of the facility
may be violating the Act and rules and subject to disciplinary action.
(j)
Reinstatement of accreditation. When a facility fails to
renew its accreditation by the expiration date, the facility is subject to
the procedures and fees as follows:
(1)
If the facility accreditation has been expired for 90 days
or less, the facility may renew by paying the required renewal fee and a restoration
fee that is one-half of the renewal fee.
(2)
If the facility accreditation has been expired for more
than 90 days but less than one year, the facility may renew by paying the
unpaid renewal fees and a restoration fee that is equal to the renewal fee.
(3)
If the facility accreditation has been expired for more
than one year, the facility may not renew the accreditation. The facility
must submit an application for accreditation as described in subsection (c)
of this section in order to obtain board accreditation.
(k)
Disciplinary actions.
(1)
The executive director, on behalf of the board, may propose
disciplinary action against a facility for violation of the Act or rules.
The disciplinary action may include imposition of an administrative penalty,
letter of reprimand, revocation or suspension of the accreditation, probation,
or other appropriate disciplinary action.
(2)
The processing of complaints against accredited facilities
or applicants for accredited facilities is accomplished in accordance with §821.39
of this title (relating to Complaints).
(3)
A revocation or suspension of an accreditation may affect
all facilities accredited under the same name, the same owners, or the same
corporation.
(4)
The executive director shall give the facility written
notice of the proposed disciplinary action and of the opportunity for a formal
hearing. The formal hearing shall be conducted according to the board's formal
hearing procedures in §821.39 of this title. Procedures relating to the
notice and request for hearing shall be governed by the same section.
(l)
Facility cleanliness. The facility shall be constructed
and maintained appropriately to provide safe and sanitary conditions for the
protection of the patient and the personnel providing prosthetic and orthotic
care.
(1)
Patient examination and treatment rooms shall be cleaned
after each patient is seen.
(2)
Hand soap, hand towels or hand dryers must be available
at the sinks used by employees and patients.
(3)
Exam tables must have disposable covers or disinfected
surfaces.
(4)
Appropriate gloves and disinfectants for disease control
must be available in examination rooms and treatment areas.
(m)
Patient waiting area.
(1)
Patient waiting area must be separate from the other areas.
(2)
Chairs with armrests must be provided in waiting room.
(3)
A telephone must be made available for patient use.
(n)
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. Windows
must assure privacy.
(2)
At least one set of parallel bars and a mirror for patient
ambulation trials must be provided in each facility.
(3)
Chairs with armrests must be provided in examination/treatment
rooms.
(o)
Safety.
(1)
Safety equipment (safety glasses or goggles and dust masks)
must be available to persons working in an accredited facility.
(2)
Proper machine use and training must be provided.
(3)
Safety guards on machines must be in place.
(4)
Lab/Fabrication area must be separated from other areas
by walls and/or rigid doors and have adequate ventilation and lighting.
(5)
If smoking is permitted, appropriate policies and procedures
are required to control smoking materials.
(6)
A minimum of one licensee or registrant must be assigned
to each facility to act as safety manager. The safety manager is responsible
for developing, carrying out, and monitoring the safety program.
(p)
Business office area.
(1)
Patient records must 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)
Records must be kept a minimum of five years.
(q)
General.
(1)
Restroom and hand washing facilities must be available
to the patient.
(2)
Facility must have the capabilities to provide casting,
measuring, fitting, repairs, and adjustments.
(r)
Adding a category to a facility accreditation. To add the
prosthetic or orthotic category to a facility accreditation, which is not
expired, suspended or revoked, an application shall be completed and submitted
to the board on a form provided by the board. The application shall be accompanied
by the appropriate fee as set out in §821.5 of this title.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of
the Secretary of State on June 3, 2004.
TRD-200403688
Scott B. Atha
Presiding Officer
Texas Board of Orthotics and Prosthetics
Effective date: June 23, 2004
Proposal publication date: March 5, 2004
For further information, please call: (512) 458-7236