New Jersey Administrative Code › Title 8 - HEALTH › Chapter 43A - MANUAL OF STANDARDS FOR LICENSING OF AMBULATORY CARE FACILITIES › Subchapter 24 - RENAL DIALYSIS › Section 8:43A-24.10 - Water treatment and dialysate

Current through Register Vol. 56, No. 14, July 15, 2024
(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.