6. ESRD Licensing in Texas
ESRD Outpatient Dialysis Facility 1

7. 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 San Antonio
Joel Sprouls Tyler
Atkin Wilridge Houston
Patrick Waldron Austin

8. Contacting your group office
e- mail anyone at DSHS by using their first name and last name DSHS.state.tx.us.
i.e.
is generally the most reliable method of contacting your group surveyor or program administrator. Please remember we travel extensively .

9. 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.
The previous set of rules are revised. The process took approximately 3 years to complete this task.

10. 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.
As always the facility shall be held to the higher standard.

11. Subchapter B Facility Licensing
General Requirements for a License
Application and Issuance of Initial License.
Application and Issuance of Renewal License
Change in Status
Inactive Status and Closure
Fees
Time Periods for Processing and Issuing a license
These are the general topics which are important to a facility, in that a facility can not admit a patient before a license is issued.
includes instruction should a facility desire to increase the number of in-center dialysis stations.
is self explanatory
through includes changes to the license, the facility, fees, and the issuance of a license.

12. 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 (a);
Attend a presurvey conference (b);
Completed construction with inspections (c);
Submit complete reports of water and dialysate to ensure compliance with
All must be completed before the projected opening date of the facility

13. 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.)
If you have deficiencies, certification can not be recommended until the department receives your plan of correction

14. INSPECTIONS
Schedule design & space survey (Please refer to (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.

15. 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.

16. 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.
The procedure for the inspection will include…
117.18(d) is the process to follow should a facility desires to register a complaint against a Department of State Health Services surveyor. This is general information, and is included in each rule set for the state.

17. 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.
Please review this section in the event that your facility desires to request a temporary exception to the rules.

18. Subchapter C. Minimum Standards for Equipment, Water treatment and Reuse, and Sanitary and Hygienic Conditions
Equipment
Water Treatment, Dialysate Concentrates, and Reuse
Sanitary Conditions and Hygienic Practices
Topics for this section

19. 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 (a)(5) in the event a patient is injured or dies while dialyzing.
Maintain documentation on the facility’s equipment or system repair log (a)(6).
(a)(5) please note that the Incident report will need to include this information. Include that the qualified technician has checked the dialysis machine, and that the machine did not contribute to the injury or death of the patient. 3 10

20. 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
Please note at (b) (3) (A) and (B) that the minimum flow will need to be achieved, and the technician should be able to describe how the system is monitored to assure at least minimum flow during operation. This is part of RD52:2004, and is a standard in CMS at tag V 211.
Please look closely at (b)(3)(C) A facility will not be required to have a loop should the facility desire PD or home hemo services only.

21. Association for the Advancement of Medical Instrumentation
AAMI
Association for the Advancement
of Medical Instrumentation
3330 Washington Blvd., Suite 400
Arlington, VA

22. 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.)
These are components which are designed to be replaced on a routine basis. This includes the water distribution system, (from RO to the treatment station)

23. 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.
Please ensure that the facility’s policies follow the MMWR, and that staff do follow the procedures.

24. 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.

25. 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 (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.
Attention to staffing for facilities who have an isolation room with a patient who is Hepatitis B positive, less than 12 patients, and patient who do not have antibodies.

26. 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 (a)(3) for information related to this process.)
Follow the procedures regarding separate dedicated supplies, which are labeled “isolation”.

27. Subchapter D. Minimum Standards for Patient Care and Treatment
Governing Body
Patient Rights
Quality Assessment and Performance Improvement
Indicators of Quality of Care
Provision and Coordination of Treatment and Services
Qualifications of Staff
Clinical Records
Incident Reports

28. 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.

29. 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 (i)(3) for physician extenders, and for staff qualifications.)

30. 117.41…
(i) Develop, implement, and enforce policies and procedures relating to the facility’s disaster preparedness plan, to meet the requirements of (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).

31. 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

32. 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.

33. 117.45 Provision and Coordination of Treatment and Services
(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.)

34. 117.45 Provision and Coordination of Treatment and Services…
(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).

35. (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.

36. (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.

37. 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.

38. 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.

39. 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.

40. 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.

41. 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.

42. 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.

43. 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 (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.

44. 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.

45. 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.

46. Subchapter E: Dialysis Technicians
General Requirements
Training Curricula and Instructors
Competency Evaluation
Documentation of Competency
Prohibited Acts

47. Subchapter G: Fire Prevention and Safety Requirements
Fire Prevention, Protection, and Emergency Contingency Plan
117.91(h)(1)or (2) or (3) Requirements for a facility related to emergency contingency plan
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.
Handling and Storage of Gases and Flammable Liquids.

48. Subchapter H: Physical Plant and Construction Requirements
Construction Requirement for an Existing End Stage Renal Disease Facility
Construction Requirements for a New End Stage Renal Disease Facility
Elevators, Escalators, and Conveyors
Preparation, Submittal, Review and Approval of Plans and Retention of Records.\
Please direct questions to the Architectural department in Austin.

49. 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.

50. 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.

51. 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. 28 36