25 TAC §§117.12, 117.43, 117.45, 117.65
The Texas Department of Health submitted final rules
for 25 TAC, Chapter 117, End Stage Renal Disease Facilities published in the
April 2, 1999, issue of the Texas Register (24 TexReg 2639).
On page 2641, preamble, first column, 3rd paragraph, 7th
sentence, the language should state "a registered nurse who is not the nurse
functioning in the charge role to initiate the initial nursing assessment."
instead of "a registered nurse who is not the charge nurse to initiate the
initial nursing assessment."
Sections §§117.12, 117.43, 117.45, and 117.65
were shown to be adopted without changes. However, the sections should have
been published to show correct language. The sections should read as follows.
§117.12.Application and Issuance of Temporary Initial License and First Annual License.
(a)
Application procedures. This section establishes the application
procedures for obtaining a temporary initial license. All first-time applications
for a license are applications for a temporary initial license. The application
for a temporary initial license is also an application for the first annual
license issued under the requirements in subsection (h) of this section.
(b)
Request for an application. Upon written request, the Texas
Department of Health
(department)
shall furnish a person with an application packet
and a copy of the statute and this chapter.
(c)
Application requirements. The applicant shall submit the
information listed in paragraph (3) of this subsection to the department within
six months from the date the department mails the application packet to the
applicant.
(1)
If the department does not receive the information listed
in paragraph (3) of this subsection within six months from the mailing date,
the applicant must request a new application packet.
(2)
An applicant shall not misstate a material fact on
any documents required to be submitted under this section.
(3)
The following items shall be submitted with the original
application form and shall be originals or notarized copies:
(A)
an accurate and complete application which contains original
signatures;
(B)
the initial license fee;
(C)
information on the applicant including name, street address,
mailing address, social security number or franchise tax identification number,
date of birth, and driver's license number;
(D)
the name, mailing address, and street address of the facility.
The address provided on the application must be the address from which the
facility will be operating and providing services;
(E)
the telephone number of the facility, the telephone number
where the administrator can usually be reached when the facility is closed,
and if the facility has a fax machine, the fax number;
(F)
a list of names and business addresses of all persons who
own any percentage interest in the applicant including:
(i)
each limited partner and general partner if the applicant
is a partnership; and
(ii)
each shareholder, member, director, and officer if the
applicant is a corporation, limited liability company or other business entity;
(G)
a list of any businesses with which the applicant subcontracts
and in which the persons listed under subparagraph (F) of this paragraph hold
any percentage of the ownership;
(H)
if the applicant has held or holds a facility license or
has been or is an affiliate of another licensed facility, the relationship,
including the name and current or last address of the other facility and the
date such relationship commenced and, if applicable, the date it was terminated;
(I)
if the facility is operated by or proposed to be operated
under a management contract, the names and addresses of any person and organization
having an ownership interest of any percentage in the management company;
(J)
a list of management and supervisory personnel, and a job
description for each administrative and supervisory position;
(K)
a notarized statement attesting that the applicant is capable
of meeting the requirements of this chapter;
(L)
a notarized attestation that each dialysis technician on
staff has completed the training and competency evaluation programs. This
attestation may be consolidated with the attestation described in subparagraph
(K) of this paragraph;
(M)
a written plan for the orderly transfer of care of the
applicant's patients and clinical records if the applicant is unable to maintain
services under the license;
(N)
a copy of an approved fire safety inspection report from
the local fire authority in whose jurisdiction the facility is based that
is dated no earlier than 12 months prior to the date of the application;
(O)
an organizational structure of the staffing for the facility;
(P)
if an applicant is a corporation, a current letter from
the state comptroller's office stating the corporation is in good standing
or a notarized certification that the tax owed to the state under the Tax
Code, Chapter 171, is not delinquent or that the corporation is exempt from
the payment of the tax and is not subject to the Tax Code, Chapter 171;
(Q)
the organizational structure of the applicant which includes
written full disclosure of the names and addresses of all owners and persons
controlling any ownership interest in the facility. In the case of corporations,
holding companies, partnerships, and similar organizations, the names and
addresses of officers, directors, and stockholders, both beneficial and of
record, when holding any percent, shall be disclosed;
(R)
the name(s) and credentials of:
(i)
the medical director or at least one physician on staff
at the facility who is qualified to serve as the medical director;
(ii)
the license number(s) of the physician(s); and
(iii)
if applicable, all physician assistants and advanced
practice nurses who will provide services at the facility;
(S)
the following data concerning the applicant, the applicant's
affiliates, and the managers of the applicant:
(i)
denial, suspension, or revocation of an end stage renal
disease facility license in any state; a license for any health care facility
or a license for a home and community support services agency (agency) in
any state; or any other enforcement action, such as (but not limited to) civil
or criminal court action in any state;
(ii)
denial, suspension, or revocation of or other enforcement
action against a facility license in any state, a license for any health care
facility in any state, or a license for an agency in any state which is or
was proposed by the licensing agency and the status of the proposal;
(iii)
surrender of a license before expiration of the license
or allowing a license to expire in lieu of the department proceeding with
enforcement action;
(iv)
federal or state (any state) criminal felony arrests or
convictions;
(v)
federal or state Medicaid or Medicare sanctions or penalties
relating to the operation of a health care facility or agency;
(vi)
operation of a health care facility or agency that has
been decertified or terminated from participation in any state under Medicare
or Medicaid; or
(vii)
debarment, exclusion, or contract cancellation in any
state from Medicare or Medicaid; and
(T)
for the two-year period preceding the application date,
the following data concerning the applicant, the applicant's affiliates, and
the managers of the applicant:
(i)
federal or state (any state) criminal misdemeanor arrests
or convictions;
(ii)
federal or state (any state) tax liens;
(iii)
unsatisfied final judgement(s);
(iv)
eviction involving any property or space used as a facility
or health care facility in any state;
(v)
injunctive orders from any court; or
(vi)
unresolved final federal or state (any state) Medicare
or Medicaid audit exceptions.
(4)
The applicant shall retain a copy of all
documentation that is submitted to the department.
(d)
Application processing. Upon receipt of the application,
including the required documentation described in paragraph (2) of this subsection
and the initial license fee from the applicant, the department shall review
the material to determine whether it is complete and correct.
(1)
The time periods for processing an application shall be
in accordance with §117.15 of this title (relating to Time Periods for
Processing and Issuing a License).
(2)
If a facility receives a notice from the department
that some or all of the information required under subsection (c)(3) of this
section is deficient, the facility shall submit the required information no
later than six months from the date of the notice.
(A)
A facility which fails to submit the required information
within six months from the notice date is considered to have withdrawn its
application for a temporary initial license. The license fee will not be refunded.
(B)
A facility which has withdrawn its application must reapply
for a license in accordance with this section, if it wishes to continue the
application process. A new license fee is required.
(e)
Issuance of a temporary initial license.
(1)
Presurvey conference. Once the department has determined
that the application form, the information required to accompany the application
form, and the initial license fee are complete and correct, the department
shall schedule a presurvey conference with the applicant in order to inform
the applicant or his or her designee of the licensing standards for the facility.
The presurvey conference will be held at the office designated by the department.
All applicants are required to attend a presurvey conference unless the designated
survey office waives the requirement.
(2)
Design and space inspection. The department shall
conduct the design and space inspection described in §117.16(b)(1) of
this title (relating to Inspections) prior to issuance of the temporary initial
license, unless the department waives the requirement.
(3)
Issuance of license. After completion of the presurvey
conference and the design and space inspection described in paragraph (2)
of this subsection, the department:
(A)
will issue a temporary initial license; or
(B)
may deny the temporary initial license if the facility
does not meet the requirements described in this section. The procedures for
denying a temporary initial license shall be in accordance with §117.84
of this title (relating to Disciplinary Action).
(f)
Compliance required. Continuing compliance with the statute
and this chapter is required during the temporary initial license period in
order for a first annual license to be issued.
(g)
Withdrawal from the application process. An applicant may
withdraw its application for a temporary initial license at any time.
(1)
An applicant who decides to withdraw its application for
a temporary initial license during the application review process, shall submit
to the department its written request to withdraw. The department shall acknowledge
receipt of the request to withdraw. The license fee will not be refunded.
(2)
An applicant who decides to withdraw its application
after the department issues the temporary initial license shall return the
license certificate to the department with a written request to withdraw.
The department shall acknowledge receipt of the request to withdraw. The license
fee will not be refunded.
(h)
Issuance of first annual license. The department shall
issue a first annual license to a facility if, after inspection and investigation
during the temporary initial license period, it finds the applicant meets
the requirements of this chapter. An inspection for the purposes of issuing
a first annual license shall be completed in accordance with §117.16(c)
of this title. The first annual license supersedes the temporary initial license
and shall expire one year from the date of issuance of the temporary initial
license.
(1)
If the temporary initial license is issued on the first
day of a month, the first annual license expires on the last day of the preceding
month of the next year.
(2)
If the temporary initial license is issued on the
second or any subsequent day of a month, the first annual license expires
on the last day of the month of issuance of the next year.
(i)
Noncompliance. The department may deny the first annual
license if, after inspection and investigation during the temporary license
period, the department determines that the facility does not comply with the
requirements of the statute or this chapter. Denial of a first annual license
shall be in accordance with §117.84 of this title.
§117.43.Provision and Coordination of Treatment and Services.
(a)
Patient rights. Each facility shall adopt, implement, and
enforce policies and procedures appropriate to the patient population served
which ensure each patient is:
(1)-(11)
(No change.)
(12)
transferred only for medical reasons, for the patient's
welfare or that of other patients or staff members, or for nonpayment of fees.
A patient shall be given 30 calendar days advance notice to ensure orderly
transfer or discharge, except in cases where the patient presents an immediate
risk to others;
(13)
provided protection from abuse, neglect, or exploitation
as those terms are defined in §1.204 of this title (relating to Abuse,
Neglect, and Exploitation Defined);
(14)
provided information regarding advance directives
and allowed to formulate such directives to the extent permitted by law. This
includes documents executed under the Natural Death Act, Health and Safety
Code, Chapter 672; Civil Practice and Remedies Code, Chapter 135 concerning
durable power of attorney for health care; and Health and Safety Code, Chapter
674 concerning out-of-hospital do-not-resuscitate;
(15)
aware of the mechanisms and agencies to express a
complaint against the facility without fear of reprisal or denial of services.
A facility shall provide to each individual who is admitted to the facility
a written statement that informs the individual that a complaint against the
facility may be directed to the department. The statement shall be provided
at the time of admission and shall advise the patient that registration of
complaints may be filed with the director, Health Facility Licensing Division,
Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199,
1-800-228-1570. Correctional institutions shall not be required to include
the 1-800 number in information provided to patients in these facilities;
and
(16)
fully informed of the rights listed in this subsection,
the responsibilities established by the facility, and all rules and regulations
governing patient conduct and responsibilities. A written copy of the patient's
rights and responsibilities shall be provided to each patient or the patient's
legal representative upon admission and a copy shall be posted with the facility
license certificate.
(b)
(No change.)
(c)
Emergency preparedness.
(1)-(5)
(No change.)
(6)
A written disaster preparedness plan specific to each
facility shall be developed and in place. The plan shall be based on an assessment
of the probability and type of disaster in each region and the local resources
available to the facility. The plan shall include procedures designed to minimize
harm to patients and staff along with ensuring safe facility operations. The
plan and in-service programs for patients and staff shall include provisions
or procedures for responsibility of direction and control, communications,
alerting and warning systems, evacuation, and closure. Each staff member employed
by or under contract with the facility shall be able to demonstrate their
role or responsibility to implement the facility's disaster preparedness plan.
(7)
A facility shall have an emergency lighting system
capable of providing sufficient illumination to allow safe discontinuation
of treatments and safe evacuation from the building. Battery pack systems
shall be maintained and tested quarterly. If a facility maintains a back-up
generator, the generator must be installed, tested and maintained in accordance
with the National Fire Protection Association 110, Standard for Emergency
and Standby Power Systems, 1993 Edition (NFPA 110), published by the National
Fire Protection Association.
(8)
A facility shall develop and post a telephone number
listing specific to the facility equipment and locale to assist staff in contacting
mechanical and technical support in the event of an emergency.
(d)
Medication storage and administration.
(1)-(2)
(No change.)
(3)
All verbal or telephone orders shall be received by
a licensed nurse or physician assistant. Orders relating to a specific service
(e.g. dietary services), may be received by the licensed professional responsible
for providing the service (e.g. dietitian) and countersigned by the physician
within 15 calendar days.
(4)-(8)
(No change.)
(e)
Nursing services.
(1)-(3)
(No change.)
(4)
A nurse functioning in the charge role shall be on
site and available to the treatment area to provide patient care during all
dialysis treatments.
(5)
At least one licensed nurse shall be available on-site
to provide patient care for every twelve patients or portion thereof. This
may include the nurse functioning in the charge role required by paragraph
(4) of this subsection.
(6)
(No change.)
(7)
Sufficient direct care staff shall be on-site to meet
the needs of the patients.
(A)
The staffing level for a facility shall not exceed four
patients per licensed nurse or patient care technician per patient shift.
During treatment of eight or more patients, the licensed nurse functioning
in the charge role shall not be included in this ratio.
(B)
For pediatric dialysis patients, one licensed nurse shall
be provided on-site for each patient weighing less than ten kilograms and
one licensed nurse provided on- site for every two patients weighing from
ten to 20 kilograms.
(8)-(9)
(No change.)
(10)
The initial patient evaluation shall be initiated
by a licensed nurse functioning in the charge role or a registered nurse at
the time of the first treatment in the facility and completed by a registered
nurse within the first three treatments.
(f)-(i)
(No change.)
(j)
Medical services.
(1)
(No change.)
(2)
Medical staff.
(A)-(B)
(No change.)
(C)
At a minimum, each patient receiving dialysis in the facility
shall be seen by a physician on the medical staff once every two weeks during
the patient's treatment time. Home patients shall be seen by a physician at
least every three months. The record of these contacts shall include evidence
of assessment for new and recurrent problems and review of dialysis adequacy,
monthly for in-facility patients and quarterly for home patients.
(D)
(No change.)
(E)
Orders for treatment shall be in writing and signed by
the prescribing physician. Routine orders for treatment shall be updated at
least annually.
(i)
Orders for hemodialysis treatment shall include length
of treatment, dialyzer, blood flow rate, dialysate composition, target weight,
medications including heparin, and, as needed, specific infection control
measures.
(ii)
Orders for peritoneal dialysis treatment shall include
fill volume(s), number of exchanges, dialysate concentrations, catheter care,
medications, and, as needed, specific infection control measures.
(F)
(No change.)
(k)
(No change.)
(l)
Temporary and transient admissions.
(1)
Temporary admissions. If a facility dialyzes a patient
who is normally dialyzed in another local facility, the referring and receiving
facilities shall meet the requirements in this paragraph.
(A)
The individual to be treated by the receiving facility
must be a patient of a physician who is a member of the medical staffs of
the referring and receiving facilities.
(B)
The referring and receiving facilities shall establish,
implement, and enforce written policies and procedures for communication of
medical information and transfer of clinical records between facilities.
(C)
The receiving facility shall continuously evaluate staffing
levels and utilize this information in determining whether to accept a temporary
admission for treatment.
(D)
The receiving facility shall obtain the information described
in §117.45(e) of this title (relating to Clinical Records) prior to
providing dialysis. However, if the referring facility is closed when the
patient's need for dialysis treatment is identified, the receiving facility
may provide dialysis with, at a minimum, the following information:
(i)
orders for treatment;
(ii)
hepatitis B status;
(iii)
medical justification by the physician ordering treatment
that the patient's need for dialysis outweighs the need for the additional
clinical information set out in §117.45(e) of this title.
(E)
In the event a temporary patient's hepatitis status is
unknown, the patient may undergo treatment as if the HBsAg test results were
potentially positive, except that such a patient shall not be treated in the
HBsAg isolation room, area, or machine.
(2)
Transient admissions. If a facility dialyzes
a patient who is normally dialyzed in a distant facility, the facility shall
meet the requirements in this paragraph.
(A)
The facility shall continuously evaluate staffing levels
and utilize this information in determining whether to accept a transient
patient for treatment.
(B)
The facility shall obtain the information described in
§117.45(e) of this title (relating to Clinical Records) prior to providing
dialysis. However, if the transient patient arrives unannounced, the facility
may provide dialysis with, at a minimum, the following information:
(i)
evidence of evaluation of the patient by a physician on
the staff of the facility;
(ii)
orders for treatment;
(iii)
hepatitis B status;
(iv)
medical justification by the physician ordering treatment
that the patient's need for dialysis outweighs the need for the additional
clinical information set out in §117.45(e) of this title.
(C)
In the event a transient patient's hepatitis status is
unknown, the patient may undergo treatment as if the HBsAg test results were
potentially positive, except that such a patient shall not be treated in the
HBsAg isolation room, area, or machine.
(m)
Laboratory services. A facility that provides laboratory
services shall comply with the requirements of Federal Public Law 100-578,
Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988). CLIA 1988
applies to all facilities that examine human specimens for the diagnosis,
prevention, or treatment of any disease or impairment of, or the assessment
of the health of, human beings.
(n)
Illegal remuneration prohibited. A facility shall not violate
the Health and Safety Code, §161.191, et seq. concerning the prohibition
on illegal remuneration for the purpose of securing or soliciting patients
or patronage.
(o)
Do-not-resuscitate orders. The facility shall comply with
the Health and Safety Code, Chapter 674 concerning out-of-hospital do-not-resuscitate
orders.
(p)
Audits of billing. A facility shall develop, implement,
and enforce a compliance policy for monitoring its receipt and expenditure
of state or federal funds.
(q)
Student health care professionals. If the facility has
a contract or agreement with an accredited school of health care to use their
facility for a portion of the students' clinical experience, those students
may provide care under the following conditions.
(1)
Students may be used in facilities, provided the instructor
gives class supervision and assumes responsibility for all student activities
occurring within the facility. If the student is licensed (e.g., a licensed
vocational nurse attending a registered nurse program for licensure as a registered
nurse) the facility shall ensure that the administration of any medication(s)
is within the student's licensed scope of practice.
(2)
A student may administer medications only if:
(A)
on assignment as a student of his or her school of health
care; and
(B)
the instructor is on the premises and immediately supervises
the administration of medication by an unlicensed student and the administration
of such medication is within the instructor's licensed scope of practice.
(3)
Students shall not be used to fulfill the requirement
for administration of medications by licensed personnel.
(4)
Students shall not be considered when determining
staffing levels required by the facility.
(r)
Complaint resolution. A facility shall adopt, implement,
and enforce procedures for the resolution of complaints relevant to quality
of care or services rendered by licensed health care professionals and other
members of the facility staff, including contract services or staff. The facility
shall document the receipt and the disposition of the complaint. The investigation
and documentation must be completed within 30 calendar days after the facility
receives the complaint, unless the facility has and documents reasonable cause
for a delay.
§117.45. Clinical Records.
(a)
(No change.)
(b)
A patient's medical history and physical shall be completed
30 days before or within two weeks after admission to the facility. Prior
to the first treatment in the facility, the physician shall inform the nurse
functioning in the charge role of at least the patient's diagnoses, medications,
hepatitis status, allergies, and dialysis prescription. The clinical record
shall include this data.
(c)-(d)
(No change.)
(e)
Prior to providing dialysis treatment of a transient patient,
a facility shall obtain and include, at a minimum:
(1)
orders for treatment in this facility;
(2)
list of medications and allergies;
(3)
laboratory reports. Such reports shall indicate laboratory
work was performed no later than one month prior to treatment at the facility
and include screening for hepatitis B status;
(4)
the most current patient care plan;
(5)
the most current treatment records from the home facility;
and
(6)
records of care and treatment at this facility.
(f)-(j)
(No change.)
§117.65.Prohibited Acts.
(a)
Performance of the following acts by any dialysis technician
who is not a licensed vocational nurse qualified to function in the charge
role is prohibited:
(1)
initiation of patient education; or
(2)
alteration of ordered treatment, including shortening
of the treatment time.
(b)
Performance of the following acts by a dialysis technician
who is not a licensed vocational nurse is prohibited:
(1)
initiation or discontinuation of dialysis via a central
catheter, manipulation of a central catheter, or dressing changes for a central
catheter;
(2)-(3)
(No change.)
(4)
performance of non-access site arterial puncture;
(5)
acceptance of physician orders; or
(6)
provision of hemodialysis treatment to pediatric patients
under 14 years of age or under 35 kilograms.
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 April
14, 1999.
TRD-9902205
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: April 11, 1999
Proposal publication date: October 30, 1998
For further information, please call: (512) 458-7236