Transitions to Surveys with New ESRD Regulations

1. Transitions to Surveys with New ESRD Regulations What does the future hold? Conditions of Coverage Water Standards

2. What are some of the major changes?

3. Reasons for Change • Changes in technology • Water treatment: more complex • Changes in dialysis equipment • Changes in staffing, practice, equipment & training needs.

4. Implementation for Facilities • Understand the new regulations. • Identify the changes required in policy and procedures to satisfy the intent of the new regulations. • Ensure the implementation of new regulations by monitoring staff practice and other audit tools. • Identify the areas in need for staff training.

5. Water and Dialysate • Adoption of AAMI RD52:2004 for water treatment system. • Strict requirements for labeling and monitoring the water treatment system, dialysate preparation and distribution.

6. Water and Dialysate (continued…) • Association for the Advancement of Medical Instrumentation (AAMI) has set the standards for the quality of water used in the preparation of dialysate. • Environmental Protection Association (EPA) has set the standard for levels of chemical contamination in safe drinking water.

7. Water Purification Storage System • The layout of the water purification system must provide easy access to all components of the system including all pressure gauges, flow meters and sampling ports. • User must label major water system components in a manner that identifies the device, its function, verification of performance and the action taken in the event of an unacceptable range. • Critical alarms associated with the ionizer exhaustion or low water levels in a storage tank must be configured to sound an alarm in the water treatment room as well as patient treatment area.

8. Feed Water Components • Back flow preventer device • Temperature blending valve • Mixes the cold city water with the heated water and must be maintained at the temperature between 77 & 80 degrees Fahrenheit to prevent the damage to Reverse Osmosis system (RO) membranes. • Booster pump - Maintain pressure and flow of water into the water treatment system.

9. Water Treatment System • Main components of water treatment system • Sediment Filter (multi-media) • Softener • Primary and Secondary carbon tanks • Reverse Osmosis system • Deionizer tanks

10. Sediment Filter • Multimedia filter commonly selected as sediment filters. • Located at or near the beginning of hemodialysis system • Intended to remove relatively coarse particulate materials from incomming water. • Cleaned by periodic backwashing

11. Softeners • Softener is a cylinder containing insoluble beads called resin. • Prevent hot water deposits from damaging sensitive reverse osmosis membranes. • During operation exchange between calcium and magnesium ions from hard water and sodium ions in the resin occur. • Replacement of sodium ions occur by a process known as regeneration which involves the exposure of the resin beads to a saturated sodium chloride solution. • Softeners that automatically regenerate include a brine tank from which saturated sodium chloride solution is drawn into the tank during regeneration through a control valve.

12. Carbon Tanks • Two carbon tanks must be installed in series with a sample port following the first bed and the second bed. • Principle means of removing both free chlorine and chloramine. • Removal of free chlorine to a maximum level of 0.5 mg/L and chloramine maximum level of 0.1 mg/L. • Carbon tanks contain granular activated carbon with a minimum iodine number of 900. • Each carbon bed shall have a minimum empty bed contact time of 5 minutes at the maximum flow rate through the bed.

13. Chemical Injection System • May be used in the pre-treatment section to supplement physical purification of water. • Consists of a reservoir filled with chemical to be injected, a metering pump and a mixing chamber located in the main water line. • Must also include a means of verifying the concentration of any residuals arising from the addition of chemicals to the water are reduced to safe levels at the point of use.

14. Reverse Osmosis System • Consists of a series of semi permeable membranes, a pump, and various flow pressure controls. • Reverse osmosis system removes dissolved inorganic solutes as well as bacteria and bacterial endotoxins. • Must be operated within its designed parameters and directions for use set by the manufacturer. • Conductivity or total dissolved solids (TDS) must be monitored in the feed water and product water streams to ensure the membranes ability to remove dissolved inorganic solutes. • Flow meters are used in the product water and reject water streams to monitor the output of the RO system. • Pressure gauges are installed to monitor the pressure at various points in the system.

15. Deionization • An exchange process that removes both an-ions (negatively charged ions) and cat-ions (positively charged ions) from water. • This process does not remove bacteria or bacterial endotoxins. • Must be used along with carbon tanks and an ultra filter must be placed downstream of the deionizer tanks. • Can be used as the primary means of purification in the event of RO failure or as a polisher following reverse osmosis system. • The quality of water product from DI is monitored by resistivity monitors (minimum resistivity of 1 megohm – cm or greater). • Resistivity monitor following the final deionizer bed must be connected to an audible and visible alarm in the dialysis treatment. • DI system must divert low quality water to drain when the final bed has a resistivity below 1 megohm-cm.

16. Water Storage & Distribution • Two types of water distribution systems: • Direct feed systems • Indirect feed systems • Materials used in the product water distribution system must provide the least favorable environment for bacterial proliferation and prevent leaching of dangerous chemicals into the water.

17. Water Storage & Distribution (continued…) • Direct feed: • Water flows directly from the last stage of purification system to the point of use. • Offers the least favorable environment for bacterial proliferation. • Indirect feed: - Water flows from the end of purification system to a storage tank.

18. Storage Tank • Must have a conical or bow shaped base • Should drain from the lowest point of the base • Should have a tight fitting lid and be vented through a hydrophobic 0.2 micron air filter • Must be installed with internal spray mechanism to facilitate effective disinfections and rinsing of the storage tank.

19. Bicarbonate Mixing & Storage Systems • Bicarbonate delivery pipe should be color coated blue at the point of use. • Storage times for bicarbonate concentrate should be minimized • Procedures should be developed and demonstrated to ensure proper mixing of the concentrate. • Bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. • Mixing of fresh bicarbonate concentrate with unused portions of concentrate from a pervious batch is not recommended • Bicarbonate concentrate delivery system must be rinsed clean at the end of treatment and disinfected at least weekly. • Bicarbonate concentrate jugs must be rinsed with treated water and stored inverted at the end of each treatment day • Reusable concentrate jugs must be disinfected at least weekly

20. Acid Concentrate Distribution Systems • Delivery piping should be labeled and color coated red at the point of use. • Delivery piping must indicate the type of acid concentrate it delivers at the point of use. • System must be closed to prevent non bacterial contamination and evaporation. • Reusable acid concentrate jugs must be clearly labeled with the type of acid it contains.

21. Bacteriology of Water and Dialysate • Water samples for bacteriology testing must be collected directly from outlets taps located in different parts of the water distribution system on a monthly basis. • Disinfection of sample taps not recommended. • Dialysate samples must be collected from at least 2 dialysis machines monthly and from enough machines so that each machine is tested at least once per year. - Sample must be collected from a dialysate port of the dialyzer, if possible.

22. Recommended AAMI limits • AAMI maximum acceptable limit: • 200 colony forming units • 2 endotoxin units • AAMI action levels: • 50 colony forming units • 1 endotoxin unit

23. Maximum Level of Contaminants • The water used to prepare the dialysate is analyzed for the levels of chemical contaminants. • Water analysis report must be within normal range according to the standards set forth by AAMI recommendations.

24. Personnel • Patient Care Techinician • High school diploma or equivalency • Certification from a state or national program. • New employees to be certified within 18 months of hire (as of 10/14/08). • Existing employees to be certified within 24 months starting 4/4/08. • Complete any required additional training (approved by the Medical Director and Governing Body) specific to the assigned job responsibilities, which may include monitoring the water treatment system and preparation of dialysate. • Undergo vision testing for color blindness if the job responsibility involves testing for chlorine/ chloramine in water using color comparisons.

25. Personnel (continued…) • Chief Technician • Currently no certification required. • Must be certified by the manufacturer of the dialysis machines to be able to maintain them. • Must have training (approved by the Medical Director and Governing Body) to monitor and maintain the water treatment system.

26. Responsibilities of Medical Director • Ensure that all staff adhere to policy and procedures. • Ensure that the water treatment system is monitored and maintained in a manner to provide safe patient care. • Ensure that personnel responsible for the monitoring and maintenance of water treatment system are adequately trained to carry out their assigned duties.