N.J. Admin. Code § 8:43A-24.10

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:43A-24.10 - Water treatment and dialysate

(a) Water treatment equipment, water, and dialysate shall satisfy the requirements specified in the Association for the Advancement of Medical Instrumentation publications entitled, "Water treatment equipment for hemodialysis applications," RD62:2006, " Preparation and quality management of fluids for haemodialysis and related therapies--Part 5: Quality of dialysis fluid for haemodialysis and related therapies," ISO 23500-5:2019, "Hemodialysis systems," RD5:2008, and "Dialysis Fluid Chemical Composition," AAMI TIR72:2017, incorporated herein by reference, as amended and supplemented.

1. Samples shall be taken at the first and last station and at least 10 percent of the stations on a rotating basis within the distribution system to ensure each station is tested semi-annually. A calibrated loop may not be used in microbiological testing of water samples.

2. Water and dialysate samples shall be microbiologically analyzed at least monthly. Water samples shall be taken immediately beyond the last water treatment device and at other locations in each treatment area so as to ensure that water throughout the distribution lines conforms with AAMI standards.

i. The water treatment system must be continuously monitored during patient treatment and be guarded by audible and visual alarms which can be seen and heard in the dialysis treatment area should water quality drop below specific parameters. Quality monitor sensing cells shall be located as the last component of the water treatment system and at the beginning of the distribution system. No water treatment components that could affect the quality of the product water as measured by this device shall be located after the sensing cell.

ii. Chemical analysis of the water shall be performed every six months and following any change in the water system which may cause a degradation of the water quality.

3. The chlorine and chloramine testing shall be done at the start of daily operations and at times no greater than four-hour intervals daily.

4. Each water treatment system shall include reverse osmosis membranes or deionization tanks and a minimum of two carbon tanks in series appropriately used.

5. Preparation of dialysate onsite requires the facility to establish policies and procedures to ensure the safety and efficacy of the dialysate solution. A record of preparation of the dialysate shall be maintained.

6. Water supply systems shall be designed to supply water to the fixtures and equipment at a minimum pressure recommended by the manufacturer during periods when fixtures and equipment are in use.

7. The facility shall have written policies outlining the training, responsibilities, and competencies of staff responsible for maintaining water treatment processing.

8. Written records of analysis procedures and results and of equipment maintenance shall be maintained in the facility daily. Written records of daily analysis procedure results shall be maintained. Daily logs shall include the acceptable parameters for the processes being monitored.

9. Each facility shall maintain records documenting staff responsible for water procedures and monitoring.

N.J. Admin. Code § 8:43A-24.10

Amended by R.2008 d.24, effective 1/22/2008.
See: 39 N.J.R. 2309(a), 40 N.J.R. 702(a).
In the introductory paragraph of (a), inserted a comma following the second occurrence of "water", deleted "(AAMI)" preceding "publications", a comma following " 'Water treatment", "1st Edition," preceding "RD52:2004", "3rd Edition," preceding "RD5:2003" and "as amended and supplemented," preceding "incorporated", substituted "2006" for "2001", and inserted ", as amended and supplemented" at the end.
Notice of readoption with technical change, effective 1/3/2022.
See: 54 N.J.R. 60(a).