Current through Reg. 49, No. 38; September 20, 2024
(a) A change of
ownership occurs when there is a change in the person legally responsible for
the operation of the facility, whether by lease or by ownership. If a corporate
licensee amends its articles of incorporation to revise its name, this
subsection does not apply, except that the corporation shall notify the
department not later than the 10th calendar day after the effective date of the
name change. The sale of stock of a corporate licensee does not cause this
subsection to apply.
(1) The new owner shall
submit an application for an initial license to the department at least 60 days
before the date of the change of ownership. The application shall be in
accordance with subsections (a) and (b) of this section. The applicant shall
include the effective date of the change of ownership. The new owner shall be
responsible for previous regulatory violations, and shall ensure compliance
with all rules and regulations.
(2)
The inspection required by subsection (h) of this section may be waived by the
department.
(3) When the new owner
has complied with the provisions of subsections (a) and (b) of this section,
the department shall issue a license which shall be effective the date of the
change of ownership.
(4) The
expiration date of the license shall be in accordance with subsection (e)(2) of
this section.
(5) The previous
owner's license shall be void on the effective date of the new owner's
license.
(b) A facility
planning to relocate shall notify the department at least 90 days before the
planned relocation. Relocations shall be within the same geographical area, and
services shall continue to be provided to the facility's existing patient
population.
(1) The facility shall submit an
application for an initial license to the department prior to the date of the
relocation. The application shall be in accordance with subsections (a) - (d)
of this section.
(2) The inspection
required by subsection (h) of this section may be waived by the
department.
(3) The license shall
be effective on the date the facility is determined to be in compliance with
subsections (a) - (d) of this section.
(4) The expiration date of the license shall
be in accordance with subsection (e)(2) of this section.
(5) The previous facility license shall be
void on the effective date of the relocation.
(c) Changes which affect the license.
(1) A facility shall notify the department in
writing at least 30 days before the occurrence of any of the following:
(A) any remodeling, renovations, additions
and alterations, shall comply with the provisions of §
117.101(b)
of this title (relating to Construction Requirements for an Existing End Stage
Renal Disease Facility);
(B) change
in facility name, mailing address, telephone number, or fax number;
(C) planned change of administrator, or
within five working days of an unplanned change of administrator; or
(D) cessation of operation of the
facility.
(2) A facility
shall obtain written approval from the department prior to the utilization of
added services or an increased number of stations. The written request shall be
submitted 30 days prior to the planned change.
(A) For an additional service or increase in
stations, the department may request that the facility provide evidence of
appropriate staffing and policies and procedures which demonstrate the intent
to comply with the applicable requirements, and any other documentation it
determines is necessary to evaluate the request.
(B) For an increase in stations, the facility
shall also be required to submit written evidence that the water treatment
system is of sufficient size to accommodate the increase and maintain a safe
water supply.
(C) The department
may conduct an on-site inspection prior to taking action on the requested
change.
(D) The facility shall
submit a complete chemical analysis of the product water, and reports to verify
that bacteriological and endotoxin levels of product water and dialysate are in
compliance with §
117.32
of this title (relating to Water Treatment, Dialysate Concentrates, and Reuse).
The reports shall be kept on file at the facility and made available to
department staff during the next on-site inspection.
(E) The department shall send the facility
written notice of the approval or disapproval of the requested
change.
(F) As of February 9, 2009,
all existing facilities increasing the number of in-center dialysis treatment
stations shall have an isolation room or be granted a waiver by the Centers for
Medicare and Medicaid Services. The waiver shall demonstrate that there is
sufficient capacity in the geographic area for isolation rooms for hepatitis B
positive patients. A written request for waiver shall be made through the Texas
Department of State Health Services, Health Facility Compliance Group, Mail
Code 1979, P.O. Box 149347, Austin, Texas, 78714-9347 for transmission to
CMS.
(d) The
facility shall submit a complete chemical analysis of the product water, and
reports to verify that bacteriological and endotoxin levels of product water
and dialysate are in compliance with §
117.32
of this title. The reports shall be kept on file at the facility and made
available to department staff during the on-site inspection.
(e) When it is determined that the facility
has complied with subsections (a) - (d) of this section, the department shall
issue the license to the applicant.
(1) The
license shall be effective on the date the facility is determined to be in
compliance with subsections (a) - (d) of this section.
(2) Expiration date.
(A) If the effective date of the license is
the first day of a month, the license expires on the last day of the 23rd month
after issuance.
(B) If the
effective date of the license is the second or any subsequent day of a month,
the license expires on the last day of the 24th month after issuance.
(f) If an applicant
decides not to continue the application process for a license, the application
may be withdrawn.
(g) Denial of a
license shall be governed by §
117.84 of
this title (relating to Disciplinary Action).
(h) During the initial licensing period, the
department shall conduct an inspection of the facility to ascertain compliance
with the provisions of the Health and Safety Code, Chapter 251, and this
chapter.
(1) A facility shall request an
on-site inspection to be conducted after at least one patient has been admitted
and provided services.
(2) A
facility shall be providing services to at least one patient at the time of the
inspection. The department may interview patients at the time of the inspection
in the patient's home or at the facility.
