| (14) Deionization systems, if used, shall be monitored
continuously to produce water of one megohm-centimeter (cm) or greater
specific resistivity (or conductivity of one microsiemen/cm or less)
at 25 degrees Centigrade. An audible and visual alarm shall be activated
when the product water resistivity falls below this level and the
product water stream shall be prevented from reaching any point of
use.
(15) Patients shall not be dialyzed on deionized water
with a resistivity less than 1.0 megohm-cm measured at the output
of the deionizer.
(16) A minimum of two DI tanks in series shall be used
with resistivity monitors including audible and visual alarms placed
pre and post the final DI tank in the system. The alarms must be audible
in the patient care area.
(17) Feed water for deionization systems shall be pretreated
with activated carbon adsorption, or a comparable alternative, to
prevent nitrosamine formation.
(18) If a deionization system is the last process in
a water treatment system, it shall be followed by an ultrafilter or
other bacteria and endotoxin reducing device.
(19) The carbon tanks must contain acid washed carbon,
30-mesh or smaller with a minimum iodine number of 900.
(20) A minimum of two carbon adsorption beds shall
be installed in a series configuration.
(21) The total empty bed contact time (EBCT) shall
be at least 10 minutes, with the final tank providing at least five
minutes EBCT. Carbon adsorption systems used to prepare water for
portable dialysis systems are exempt from the requirement for the
second carbon and a 10-minute EBCT if removal of chloramines to below
0.1 milligram (mg)/1 is verified before each treatment.
(22) A means shall be provided to sample the product
water immediately prior to the final bed(s). Water from this port(s)
must be tested for chlorine/chloramine levels immediately prior to
each patient shift.
(23) All samples for chlorine/chloramine testing must
be drawn when the water treatment system has been operating for at
least 15 minutes.
(24) Tests for total chlorine, which include both free
and combined forms of chlorine, may be used as a single analysis with
the maximum allowable concentration of 0.1 mg/liter (L). Test results
of greater than 0.5 parts per million (ppm) for chlorine or 0.1 ppm
for chloramine from the port between the initial tank(s) and final
tank(s) shall require testing to be performed at the final exit and
replacement of the initial tank(s).
(25) In a system without a holding tank, if test results
at the exit of the final tank(s) are greater than the parameters for
chlorine or chloramine described in this subclause, dialysis treatment
shall be immediately terminated to protect patients from exposure
to chlorine/chloramine and the medical director shall be notified.
In systems with holding tanks, if the holding tank tests <1 mg/L
for total chlorine, the RO may be turned off and the product water
in the holding tank may be used to finish treatments in process. The
medical director shall be notified.
(26) If means other than granulated carbon are used
to remove chlorine/chloramine, the facility's governing body must
approve such use, in writing, after review of the safety of the intended
method for use in hemodialysis applications. If such methods include
the use of additives, there must be evidence the product water does
not contain unsafe levels of these additives.
(27) Water softeners, if used, shall be tested at the
end of the treatment day to verify their capacity to treat a sufficient
volume of water to supply the facility for the entire treatment day
and shall be fitted with a mechanism to prevent water containing the
high concentrations of sodium chloride used during regeneration from
entering the product water line during regeneration.
(28) If used, the face(s) of timer(s) used to control
any component of the water treatment or dialysate delivery system
shall be visible to the operator at all times. Written evidence that
timers are checked for operation and accuracy each day of operation
must be maintained.
(29) Filter housings, if used during disinfectant procedures,
shall include a means to clear the lower portion of the housing of
the disinfecting agents. Filter housings shall be opaque.
(30) Ultrafilters, or other bacterial reducing filters,
if used, shall be fitted with pressure gauges on the inlet and outlet
water lines to monitor the pressure drop across the membrane. Ultrafilters
shall be included in routine disinfection procedures.
(31) If used, storage tanks shall have a conical or
bowl-shaped base and shall drain from the lowest point of the base.
Storage tanks shall have a tight-fitting lid and be vented through
a hydrophobic 0.2 micron air filter. Means shall be provided to effectively
disinfect any storage tank installed in a water distribution system.
(32) Ultraviolet (UV) lights, if used, shall be monitored
at the frequency recommended by the manufacturer. A log sheet shall
be used to record monitoring.
(33) Water treatment system piping shall be labeled
to indicate the contents of the pipe and direction of flow.
(34) The water treatment system must be continuously
monitored during patient treatment and be guarded by audible and visual
alarms that 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.
(35) When deionization tanks do not follow an RO system,
parameters for the rejection rate of the membranes must assure that
the lowest rate accepted would provide product water in compliance
with §4.2.2 (relating to Maximum Level of Chemical Contaminants)
of the American National Standard, Water Treatment Equipment for Hemodialysis
Applications, August 2001 Edition published by the AAMI.
(36) An LSRH shall maintain written logs of the operation
of the water treatment system for each treatment day. The log book
shall include each component's operating parameter and the action
taken when a component is not within the facility's set parameters.
(37) Microbiological testing of product water shall
be conducted.
(A) Microbiological testing shall be conducted monthly
and following any repair or change to the water treatment system.
For a newly installed water distribution system, or when a change
has been made to an existing system, weekly testing shall be conducted
for one month to verify that bacteria and endotoxin levels are consistently
within the allowed limits.
(B) At a minimum, sample sites chosen for the testing
shall include the beginning of the distribution piping, at any site
of dialysate mixing, and the end of the distribution piping.
(C) Samples shall be collected immediately before sanitization/disinfection
of the water treatment system and dialysis machines. Water testing
results shall be routinely trended and reviewed by the medical director
in order to determine if results seem questionable or if there is
an opportunity for improvement. The medical director shall determine
if there is a need for retesting. Repeated results of "no growth"
shall be validated via an outside laboratory. A calibrated loop may
not be used in microbiological testing of water samples. Colonies
shall be counted using a magnifying device.
(38) Product water used to prepare dialysate, concentrates
from powder, or to reprocess dialyzers for multiple use, shall contain
a total viable microbial count less than 200 colony forming units
(CFU)/millimeter (ml) and an endotoxin concentration less than 2 endotoxin
units (EU)/ml. The action level for the total viable microbial count
in the product water shall be 50 CFU/ml and the action level for the
endotoxin concentration shall be 1 EU/ml.
(39) Required action for unacceptable results. If the
action levels described at paragraph (6) of this subsection are observed
in the product water, corrective measures shall be taken promptly
to reduce the levels into an acceptable range.
(40) All bacteria and endotoxin results shall be recorded
on a log sheet in order to identify trends that may indicate the need
for corrective action.
(41) If ozone generators are used to disinfect any
portion of the water or dialysate delivery system, testing based on
the manufacturer's direction shall be used to measure the ozone concentration
each time disinfection is performed, to include testing for safe levels
of residual ozone at the end of the disinfection cycle. Testing for
ozone in the ambient air shall be conducted on a periodic basis as
recommended by the manufacturer. Records of all testing must be maintained
in a log.
Cont'd... |
