| (42) If used, hot water disinfection systems shall
be monitored for temperature and time of exposure to hot water as
specified by the manufacturer. Temperature of the water shall be recorded
at a point furthest from the water heater, where the lowest water
temperature is likely to occur. The water temperature shall be measured
each time a disinfection cycle is performed. A record that verifies
successful completion of the heat disinfection shall be maintained.
(43) After chemical disinfection, means shall be provided
to restore the equipment and the system in which it is installed to
a safe condition relative to residual disinfectant prior to the product
water being used for dialysis applications.
(44) Samples of product water must be submitted for
chemical analysis every six months and must demonstrate that the quality
of the product water used to prepare dialysate or concentrates from
powder, meets §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.
(45) Samples for chemical analysis shall be collected
at the end of the water treatment components and at the most distal
point in each water distribution loop, if applicable. All other outlets
from the distribution loops shall be inspected to ensure that the
outlets are fabricated from compatible materials. Appropriate containers
and pH adjustments shall be used to ensure accurate determinations.
New LSRHs or LSRHs that add or change the configuration of the water
distribution system must draw samples at the most distal point for
each water distribution loop, if applicable, on a one time basis.
(46) Additional chemical analysis shall be submitted
if substantial changes are made to the water treatment system or if
the percent rejection of an RO system decreased 5.0% or more from
the percent rejection measured at the time the water sample for the
preceding chemical analysis was taken.
(47) LSRH records must include all test results and
evidence that the medical director has reviewed the results of the
water quality testing and directed corrective action when indicated.
(48) Only persons qualified by the education or experience
may operate, repair, or replace components of the water treatment
system.
(49) Quality control procedures shall be established
to ensure ongoing conformance to policies and procedures regarding
dialysate quality.
(p) Each LSRH shall set all hemodialysis machines to
use only one family of concentrates. When new machines are put into
service or the concentrate family or concentrate manufacturer is changed,
samples shall be sent to a laboratory for verification.
(q) Prior to each patient treatment, LSRH staff shall
verify the dialysate conductivity and pH of each machine with an independent
device.
(r) The LSRH shall conduct bacteriological testing.
(s) Responsible LSRH staff shall develop a schedule
to ensure each hemodialysis machine is tested quarterly for bacterial
growth and the presence of endotoxins. Hemodialysis machines of home
patients shall be cultured monthly until results not exceeding 200
CFU/ml are obtained for three consecutive months, then quarterly samples
shall be cultured.
(t) Dialysate shall contain less than 200 CFU/ml and
an endotoxin concentration of less than 2 EU/ml. The action level
for total viable microbial count shall be 50 CFU/ml and the action
level for endotoxin concentration shall be 1 EU/ml.
(u) Disinfection and retesting shall be done when bacterial
or endotoxin counts exceed the action levels. Additional samples shall
be collected when there is a clinical indication of a pyrogenic reaction
and/or septicemia.
(v) Only a licensed nurse may use an additive to increase
concentrations of specific electrolytes in the acid concentrate. Mixing
procedures shall be followed as specified by the additive manufacturer.
When additives are prescribed for a specific patient, the container
holding the prescribed acid concentrate shall be labeled with the
name of the patient, the final concentration of the added electrolyte,
the date the prescribed concentrate was made, and the name of the
person who mixed the additive.
(w) All components used in concentrate preparation
systems (including mixing and storage tanks, pumps, valves, and piping)
shall be fabricated from materials (e.g., plastics or appropriate
stainless steel) that do not interact chemically or physically with
the concentrate so as to affect its purity, or with the germicides
used to disinfect the equipment. The use of materials that are known
to cause toxicity in hemodialysis such as copper, brass, galvanized
material, and aluminum is prohibited.
(x) LSRH policies shall address means to protect stored
acid concentrates from tampering or from degeneration due to exposure
to extreme heat or cold.
(y) Procedures to control the transfer of acid concentrates
from the delivery container to the storage tank and prevent the inadvertent
mixing of different concentrate formulations shall be developed, implemented,
and enforced. The storage tanks shall be clearly labeled.
(z) Concentrate mixing systems shall include a purified
water source, a suitable drain, and a ground fault-protected electrical
outlet.
(aa) Operators of mixing systems shall use personal
protective equipment as specified by the manufacturer during all mixing
processes.
(bb) The manufacturer's instructions for use of a concentrate
mixing system shall be followed, including instructions for mixing
the powder with the correct amount of water. The number of bags or
weight of powder added shall be determined and recorded.
(1) The mixing tank shall be clearly labeled to indicate
the fill and final volumes required to correctly dilute the powder.
(2) Systems for preparing either bicarbonate or acid
concentrate from powder shall be monitored according to the manufacturer's
instructions.
(3) Concentrates shall not be used, or transferred
to holding tanks or distribution systems, until all tests are completed.
(4) If an LSRH designs its own system for mixing concentrates,
procedures shall be developed and validated using an independent laboratory
to ensure proper mixing.
(5) Acid concentrate mixing tanks shall be designed
to allow the inside of the tank to be rinsed when changing concentrate
formulas.
(6) Acid mixing systems shall be designed and maintained
to prevent rust and corrosion.
(7) Acid concentrate mixing tanks shall be emptied
completely and rinsed with product water before mixing another batch
of concentrate to prevent cross contamination between different batches.
(8) Acid concentrate mixing equipment shall be disinfected
as specified by the equipment manufacturer or in the case where no
specifications are given, as defined by LSRH policy.
(9) Records of disinfection and rinsing of disinfectants
to safe residual levels shall be maintained.
(10) Bicarbonate concentrate mixing tanks shall have
conical or bowl-shaped bottoms and shall drain from the lowest point
of the base. The tank design shall allow all internal surfaces to
be disinfected and rinsed.
(11) Bicarbonate concentrate mixing tanks shall not
be prefilled the night before use.
(12) If disinfectant remains in the mixing tank overnight,
this solution must be completely drained and the tank must be rinsed
and tested for residual disinfectant prior to preparing the first
batch of that day of bicarbonate concentrate.
(13) Unused portions of bicarbonate concentrate shall
not be mixed with fresh concentrate.
(14) At a minimum, bicarbonate distribution systems
shall be disinfected weekly. More frequent disinfection shall be done
if required by the manufacturer, or if dialysate culture results are
above the action level.
(15) If jugs are reused to deliver bicarbonate concentrate
to individual hemodialysis machines:
(A) jugs shall be emptied of concentrate, rinsed, and
inverted to drain at the end of each treatment day;
(B) at a minimum, jugs shall be disinfected weekly,
and more frequent disinfection shall be considered by the medical
director if dialysate culture results are above the action level;
and
(C) following disinfection, jugs shall be drained,
rinsed free of residual disinfectant, and inverted to dry. Testing
for residual disinfectant shall be done and documented.
(16) All mixing tanks, bulk storage tanks, dispensing
tanks, and containers for single hemodialysis treatments shall be
labeled as to the contents.
Cont'd... |
