ESRD Licensing in Texas
ESRD Outpatient
Dialysis Facility
Texas Department of State Health
Services

Kathy Perkins, Assistant Commissioner,
Division for Regulatory Services

Renee Clack, Director
Health Care Quality Section

Derek Jakovich, Manager,
Director of Patient Quality Care Unit.

Health Facility Compliance Groups:
Derek Jakovich
Arlington
Craig Jimerfield
Joel Sprouls
Atkin Wilridge
Patrick Waldron
San Antonio
Tyler
Houston
Austin
Contacting your group office

e- mail anyone at DSHS by using their first
name and last name plus @ DSHS.state.tx.us.
i.e. patsy.lemons@dshs.state.tx.us
e-mail is generally the most reliable method of
contacting your group surveyor or program
administrator. Please remember we travel
extensively .
Subchapter A
This includes the general provisions
with 78 definitions to assist facility
personnel in meeting the minimum
standards.
The surveyor will focus on the requirements
to ensure that the facility meets the
minimum standards for licensing.
Compliance with this chapter does
not constitute release from the more
stringent requirement of other
applicable federal, state or local codes
and ordinances.
This chapter shall be followed where
it is more stringent than other codes
and ordinances.
Subchapter B Facility Licensing
117.11 General Requirements for a License
 117.12 Application and Issuance of Initial
License.
 117.13 Application and Issuance of Renewal
License
 117.14 Change in Status
 117.15 Inactive Status and Closure
 117.16 Fees
 117.17 Time Periods for Processing and Issuing
a license

Application and Issuance of an
Initial License - 117.12 ……
The applicant shall comply with the following
before the issuance of an initial license:
 Complete an accurate application 117.12(a);
 Attend a presurvey conference 117.12(b);
 Completed construction with inspections
117.12(c);
 Submit complete reports of water and dialysate
to ensure compliance with 117.32.

All must be completed before the projected
opening date of the facility
Initial survey
DSHS must have your approved 855 (if
conducting a Medicare Survey)
 Unannounced
 Licensing and Medicare (if access to care
approved)
(Must be in compliance with Medicare
Conditions of Coverage for ESRD facilities
before Medicare certification can be
recommended.)

117.18 INSPECTIONS
Schedule design & space survey (Please refer to
117.102(b)(1) Construction Requirements for a
New End Stage Renal Disease Facility, requires a
minimum of 2 construction inspections.)
 Submit the needed water and culture reports
 Secure initial license, DO NOT ADMIT A
PATIENT BEFORE YOU RECEIVE THE
INITIAL LICENSE!
 Admit a patient
 Notify DSHS in writing ready for survey, with
hours of operation, and the services which will
be provided. If requesting home hemodialysis
or peritoneal dialysis, must have a patient at the
time of the survey.

117.18 Inspections
By applying for or holding a license, the facility
consents to entry and inspection of the facility
by the department or representative of the
department.
 The surveyor is entitled to access all books,
records, or other documents maintained by the
facility .
 The facility shall permit the photocopying to a
department surveyor of any records or other
information necessary to verify compliance.

117.18 (c) Inspection
Entrance conference
 Evaluation of compliance
 Exit conference
 Written notice of findings


117.18(d) Process for an ESRD facility to register
a complaint against a Department of State
Health Services surveyor.
117.19 Exceptions to these rules
All facilities are required to maintain
continuous compliance with these rules. A
request for a temporary exceptions to these
rules may be granted for a maximum of 120
days
 The department may conduct a survey prior to
approving an exception.
 Please review. This section contains very
specific instructions regarding the granting of a
temporary exception.

Subchapter C. Minimum Standards
for Equipment, Water treatment and
Reuse, and Sanitary and Hygienic
Conditions117.31-117.33
117.31 Equipment
117.32 Water Treatment, Dialysate Concentrates,
and Reuse
117.33 Sanitary Conditions and Hygienic
Practices
117.31 Equipment
All equipment used by the facility shall be FDA
approved, operated in accordance with the
manufacturer’s direction for use (DFU), and
maintained free of defects. (Please have the DFU for
each piece of equipment, follow the DFU, and have the
DFU be readily available for all staff and the surveyor
to review.)
– Ensure compliance with 117.31 (a)(5) in the event a
patient is injured or dies while dialyzing.
– Maintain documentation on the facility’s equipment
or system repair log 117.31(a)(6).
117.32 Water Treatment,
Dialysate Concentrates and Reuse
The facility owner and medical director shall
each demonstrate responsibility for the water
treatment and dialysate supply systems to
protect hemodialysis patients from adverse
effects.
 117.32(b)(3)(C) This rule shall not apply to
facilities providing only home training and
support services utilizing single patient
devices.


117.32(b)(4) RD52:2004 Edition of AAMI
AAMI
Association for the Advancement
of Medical Instrumentation
3330 Washington Blvd., Suite 400
Arlington, VA 22201-4598
1-800-332-2264
117.32(b)(19)
Microbiological testing of product
water
Routine testing shall be conducted monthly.
 For a newly installed system, or when repairs,
modifications or changes to the configuration has
been made to an existing system, weekly testing
shall be conducted for one month to verify that
levels are within allowed limits. (Components
which are designed to be replaced on a routine
schedule do not require a period of more frequent
testing.)

117.33 Sanitary Conditions and
Hygienic Practices
In accordance with 29 Code of Federal
Regulations, and the Health and Safety Code
Chapter 85;
 Implement the Recommended Infection
Control Practices for Hemodialysis Units at a
Glance found in Recommendations for
Preventing Transmission of Infections Among
Chronic Hemodialysis Patients, Morbidity and
Mortality Weekly Report, Volume 50, Number
RR – 5, April 27, 2001, pages 18-22, developed
by the CDC.

117.33(b) Physical Environment
Develop, implement and enforce policies and
procedures to provide and ACTIVELY monitor
a safe, functional, comfortable, and sanitary
environment.
(This includes patient treatment areas and other
areas. Record in the facility’s safety report or
maintenance log records.)
 Specific procedures for equipment and dialysis
machines. This includes all items at the
dialysis station. The chair, individual personal
television, and the dialysis machine. Clean
any devices attached to the dialysis machine,
intravenous pole, hand sanitizer, prime
buckets, sharps containers, and items hanging
from the pole.

117.33…(d) Hepatitis B
Staff vaccination records maintained
 Prevention requirements for patients. With a
physician’s order, make the vaccine available to
patients, provided that the patient has coverage
or is willing to pay for the vaccination.
 Serologic screening of patients before
admission. (Refer to 117.33(d)(2)(C)(ix) for
direction if status unknown before admission
to the facility.)
 If a direct patient care staff member is assigned
to both Hepatitis negative and Hepatitis
positive patients, the Hepatitis negative
patients must be antibody positive and are to be
seated at the treatment stations nearest the
isolation station.

117.33(d)(2)(C) Isolation
procedures …

If a facility is licensed after the effective date of
February 9, 2009, the facility must have a
separate isolation room unless the facility has
obtained a waiver from CMS to this
requirement. (Refer to 117.12 (a)(3) for
information related to this process.)

Follow the procedures regarding separate
dedicated supplies, which are labeled
“isolation”.
Subchapter D. Minimum Standards
for Patient Care and Treatment
117.41 Governing Body
 117.42 Patient Rights
 117.43 Quality Assessment and Performance
Improvement
 117.44 Indicators of Quality of Care
 117.45 Provision and Coordination of
Treatment and Services
 117.46 Qualifications of Staff
 117.47 Clinical Records
 117.48 Incident Reports

117.41 Governing Body
The governing body is responsible for the
organization, management, control, and
operation of the facility.
 Appointment of a qualified medical director
who is board certified in internal medicine,
nephrology or pediatric nephrology, with at
least 12 months of experience providing care to
patients who receive dialysis.
 A waiver request shall be made through the
Texas Department of State Health Services for
transmission to CMS.

117.41…
Shall ensure qualified staff. This includes the
advanced practice registered nurse, physician
assistant, registered nurse, licensed vocational
nurse, licensed master social worker, registered
dietitian, patient care technician, and other
technical staff. (Refer to 117.45(i)(3) for
physician extenders, and 117.46 for staff
qualifications.)
117.41…
117.41 (i) Develop, implement, and enforce
policies and procedures relating to the facility’s
disaster preparedness plan, to meet the
requirements of 117.45(b)(5).
 117.41(l) Develop, implement, and enforce policies
and procedures regarding disruptive patients or
family members to ensure the health and safety of
patients, personnel, and the public.
 117.41(m) Ensure that personnel are assigned to
assist the social worker when the patient load is
greater than 100 patients (all modalities).

117.42 Patient Rights
Patient rights posted in waiting room
 Interactive patient care conference by team
for care plan development.
 Discharge for medical reasons only (report
discharge for non compliance to State and
Network 14)
 Lighting for nocturnal dialysis – to allow
adequate visual monitoring for patients

117.43 Quality Assessment and
Performance Improvement
Includes the core staff members, medical
director, supervising nurse, dietitian, social
worker, administrator, and chief technician.
 Must establish and monitor the quality
indicators. Must measure, analyze, and track on
a monthly basis. (minimum of 15, and some of
these have sub-sections)
 Must create and implement improvement plans,
evaluate the implementation of the
improvement plans, and continue monitoring
the improvement activities until resolution of
the improvement plan.
QA plan should follow the ESRD Network 14
criteria and standards, as included in these
rules.

117.45 Provision and Coordination of
Treatment and Services
117.45 (a)(1) The plan of care is based on an
interdisciplinary team assessment.
 117.45(a)(6) The plan of care shall be developed
and implemented within 30 calendar days or 13
outpatient dialysis treatments from the patient’s
admission to the facility, and at least annually
thereafter.
 117.45(a)(7) The facility shall monitor the plan
of care at least monthly to recognize and
address any deviations from the plan of care.
(Through progress notes, physician orders, etc.)

117.45 Provision and Coordination of
Treatment and Services…
117.45 (b) Emergency preparedness, transfer
agreements, and written disaster preparedness
plan.
 The facility must incorporate the use of and
participate in the ESRD Network of Texas
disaster preparedness activities.
 Make contact annually with the local disaster
management representative (EOC).

117.45 (d) Nursing Services
One supervising nurse per facility, who is not a
contracted employee.
 Registered nurse in the facility when patients
are PRESENT in the facility.
 The charge nurse is a qualified registered nurse.
 Staffing level shall not exceed 4 patients per
licensed nurse or patient care technician per
patient shift. Table 1 includes the staff to
patient ratios.

117.45 (d) Nursing Services
 (6) If pediatric dialysis is provided, a registered
nurse with experience or training in pediatric
dialysis shall be available to provide care for
pediatric dialysis patients smaller than 35
kilograms in weight.
 (7)(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.
117.45…
117,45(g) Nutrition services
The maximum patient load is 125 patients.
 117.45(h) Social Services
The facility must have specifically assigned
personnel to assist the social worker when the
patient load exceeds 100 patient, including all
modalities. The maximum patient load with
assigned personnel assistance is 125 patients.

Initial contact must be made with the patient by
the RDLD and the LMSW within 2 weeks or 7
treatments from the patient’s admission, and a
completed assessment within 30 days or 13
treatments of the patient’s admission,
whichever occurs later.
117.45…

117.45(i) Medical Services
Shall be seen by a physician on the medical
staff every 2 weeks during the patient’s dialysis
treatment.
117.45(i)(3) Physician Extenders
(i) Evidence of communication with physician
(v) Shall meet the requirements by the Texas
Board of Nursing or the Texas Medical Board
(vi) The physician and the physician extender
shall develop and sign protocols or other
written authorization which are followed, and
will be reviewed and re-signed at least
annually. These will be made available to the
department to review.
117.45….

117.45(j) Home dialysis service.
Staffing level for home dialysis patients 1-20.
Training by a qualified registered nurse, 12
months clinical experience and 6 months
experience in the specific modality.
An initial monitoring visit of the patient’s
home by facility personnel.
117.46 Qualifications of Staff
All staff, whether employees or contractors
shall meet the personnel qualifications, and
demonstrate competencies necessary to serve
collectively the comprehensive needs of the
patients.
 In facilities with similar policies and
equipment, experienced staff may be shared
with another facility after a shorter orientation
period. Documentation of this with current
competency and delegation by the facility’s
medical director to unlicensed technicians.

117.46…
Certification of patient care technicians.
 All dialysis technicians must be certified under
a national commercially available certification
program, within 18 months of being hired as a
dialysis technician.
 Patient care technicians, who were employed
after October 14, 2008 and have not passed the
certification test, cannot provide patient care.

117.46…




Medical Staff: Ensure that the physician extenders
comply with the requirements of their board.
Nursing Staff: Registered nurse designated as charge,
with 12 months of clinical experience, and 6 months in
hemodialysis subsequent to completion of the facility’s
training program.
Dietitian: Must have a current Texas license, be a
registered dietitian, and have a minimum of one year
professional work experience in clinical dietetics after
becoming a registered dietitian.
Social Worker: Must be a licensed social worker and
hold a masters degree. The clause remains for those who
worked for 2 years prior to September 1, 1976.
117.46…




Technical Staff
Must be qualified, through training and experience and
documentation of such education, training, and
experience maintained in their file in the facility.
The training curriculum must include the requirements at
117.46 (f)(3)(B)(ii).
The training course must have objectives and be
approved by the medical director.
EVIDENCE OF TECHNICAL TRAINING FOR ALL
TECHNICAL STAFF, INCLUDING NURSES AND
PCT’S IF THEY ARE RESPONSIBLE FOR WATER
TESTING/OPENING OR CLOSING PROCEDURES ,
ETC.
117.47 Clinical Records
Establish and maintain an accurate record
system, centralized, safe, separate storage,
confidential, no signature stamps, may be
electronic.
 Protection from casual access.
 Alterations to the documents must include an
explanation of the alteration, electronic or
hand-written.

117.48 Incident Reports
Death of a patient
 Hospital transfers
 Conversion of staff or patient to Hepatitis B
 Involuntary transfer or discharge of a patient
 Fire in the facility
 Form available at the Network site, and DSHS site,
which shall be completed by the facility, and sent in
for review by the surveyor. Please include all the
elements requested on the form when sending this to
the department.

Subchapter E: Dialysis
Technicians
117.61
 117.62
 117.63
 117.64
 117.65

General Requirements
Training Curricula and Instructors
Competency Evaluation
Documentation of Competency
Prohibited Acts
Subchapter G: Fire Prevention
and Safety Requirements


117.91 Fire Prevention, Protection, and Emergency
Contingency Plan
117.91(h)(1)or (2) or (3) Requirements for a facility related
to emergency contingency plan
117.92 General Safety
Must have emergency communication system
No fans, or extension cords, training and isolation rooms
shall not be lockable.
Emergency call system in the patient waiting area,
individual restrooms, exam rooms, isolation room,
individual treatment rooms.
117.93 Handling and Storage of Gases and Flammable
Liquids.
Subchapter H: Physical Plant
and Construction Requirements
117.101 Construction Requirement for an
Existing End Stage Renal Disease Facility
 117.102 Construction Requirements for a New
End Stage Renal Disease Facility
 117.103 Elevators, Escalators, and Conveyors
 117.104 Preparation, Submittal, Review and
Approval of Plans and Retention of Records.\


Please direct questions to the Architectural
department in Austin.
Recap…







Approved 855
Submit requested water
reports
Initial license
Admit first patient
Conduct first GB and
QAPI meetings.
Staff credentials
complete.
Ensure compliance with
state and federal
requirements.


Written notification to
zone office that the
facility has admitted a
patient and the hours of
operation.
If request home
hemodialysis or
peritoneal dialysis, must
have a patient and
providing service to that
patient at the time of the
initial survey.
Survey Process
– Entrance conference;
– Tour of the facility ;
– Tour of the water room and the
reuse room;
– Patient interviews;
– Review of the daily logs,
machine maintenance, etc;
– Review of the Governing Body
meetings;
– Review of the facility’s
contracts;
– Staff interviews;
– Chart review;
– Review of QAPI;
– Credentials for all staff;
– Exit conference.
Desired Outcome:
Each facility provides safe patient
care, using qualified staff, with
written evidence of the care
provided by all of the members of
the interdisciplinary team.