Current through Reg. 49, No. 38; September 20, 2024
(a) The applicant shall comply with the
following before the projected opening date of the facility:
(1) the applicant shall submit an accurate
and complete application form;
(2)
the applicant shall submit the appropriate license fee as required in §
117.16 of this
title (relating to Fees); and
(3)
as of February 9, 2009, the applicant for a new facility or for an existing
facility that is increasing the number of in-center dialysis treatment stations
in existing facilities shall have an isolation room or shall provide 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. An applicant may submit a written request
for waiver 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.
(b) The applicant or the applicant's
representative shall attend a presurvey conference at the office designated by
the department. The purpose of the presurvey conference, which is conducted by
department staff, is to review facility staff qualifications, survey documents
and licensure rules, and to provide consultation prior to the on-site licensure
survey. The department staff conducting the presurvey conference is responsible
for making a recommendation regarding the issuance of the initial license. The
department may waive the presurvey conference requirement.
(c) In addition to the document submittal
requirements in subsection (a) of this section, the following shall be
completed prior to the issuance of an ESRD facility license to newly
constructed ESRD facility or ESRD facility from conversion of non-ESRD
building.
(1) Final construction documents
shall be reviewed and approved by the department in accordance with §
117.104
of this title (relating to Preparation, Submittal, Review and Approval of Plans
and Retention of Records).
(2) For
new construction, necessary intermediate inspections and final construction
inspections shall be conducted by the department in accordance with §
117.105(b)
of this title (relating to Construction, Inspections, and Approval of Project)
to determine that the ESRD facility was constructed in compliance with this
chapter.
(3) When an applicant
intends to reopen and relicense a building formerly licensed as a ESRD
facility, an on-site inspection shall be conducted by the department in
accordance with §
117.105
of this title to determine compliance with applicable construction and fire
safety requirements.
(4) A
certificate of occupancy for the project issued by the local building
authority, if applicable and a written approval of the project by the fire
authority.
(5) A complete and
accurate Final Construction Approval form shall be submitted to the
department.
(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 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 or renewal of 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.
