CMS SOM App. H, Tag V250

5.6 Dialysate proportioning (dialysate conductivity and pH measurement)

[I]t is necessary for the operator to follow the manufacturer’s instructions regarding

dialysate conductivity and to measure approximate pH with an independent method before

starting the treatment of the next patient.

Interpretive Guidance § 494.40(a)

ANSI/AAMI RD52:2004

5.6 Dialysate proportioning

Injuries related to improper dialysate are rare, but they can and do happen when all procedures

are not followed. Frequently, when the error occurs, several patients have been exposed before

the facility recognizes the mistake. For example, because one of the concentrates is quite acidic

and the other is basic, connecting the wrong concentrates to the machine could result in

dialysate that could harm the patient.

Even though a single concentrate is used to prepare acetate dialysate, conductivity and pH

should be checked, because certain mix-ups involving acid concentrate and other chemicals can

result in an acceptable conductivity and very low pH.

Page 103 of 420

Additional Guidance:

Each machine must be tested for pH using a handheld meter or other appropriate testing device

(i.e., adequately sensitive testing strips) before every dialysis treatment and whenever a different

composition of acid concentrate is used. If the dialysis machine manufacturer requires testing of

conductivity, this must also be tested using an independent testing device prior to each treatment

and before using a different composition of acid concentrate during the same treatment. The

facility must have set limits for the allowable variability of the handheld values from the machine

readings. As new technology evolves, the manufacturer’s guidance related to this requirement

should be followed.

No Tag

(Rev. )

ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)

6 Monitoring

6.1 General

Quality control and quality assurance procedures should be established to ensure ongoing

conformance to policies and procedures regarding dialysate quality. This clause defines

some of the monitoring activities to be conducted at the dialysis facility as part of the

quality assurance process. The test methods described in [AAMI] 6.2 do not represent the

only acceptable methods available, but are intended to provide examples of acceptable

methods. The frequency of monitoring is generally recommended by the equipment

manufacturer. Table 4 can be used as a guideline for setting up a quality assurance

monitoring program in the absence of a manufacturer’s recommendations or to

supplement those recommendations.

Interpretive Guidance § 494.40(a)

This is an informational tag. Expected monitoring is listed under each water system and

dialysate component; there may be some variation from this Table based on specific equipment

in use.

ANSI/AAMI RD52:2004

6 Monitoring

6.1 General

Table 4—Monitoring guidelines for water purification equipment and distribution systems

and dialysate

NOTE—Refer to note below the table for an explanation of the use of Xs in the Specification

column.

Page 104 of 420

Item to monitor What to monitor Special

interval

Normal interval Specification

Sediment filter Pressure drop across the

filter

NA Daily Pressure drop less than XXXX

Sediment filter

backwashing

cycle

Backwash cycle timer

setting

NA Daily—beginning

of the day

Backwash clock set to XX:XX

Cartridge filter Pressure drop across

the filter

NA Daily Pressure drop less than XXXX

Water softener Product water

softness

NA Daily—end of the

day

Hardness as calcium

carbonate

less than 1 grain/gal, unless

otherwise specified by the

manufacturer of the reverse

osmosis equipment

Water softener

brine tank

Level of undissolved

salt in tank

NA Daily—end of the

day

Salt level at XXX

Water softener

regeneration

cycle

Regeneration cycle

timer setting

NA Daily—beginning

of the day

Softener timer set to XX:XX

Carbon

adsorption

beds

Product water free

chlorine and/or total

chlorine between the

beds

NA Prior to beginning

each patient shift

< 0.1 mg/L of total chlorine

Chemical

injection

system

Level of chemical in

the reservoir, injector

function, value of the

controlling parameter

(e.g., pH)

NA Daily Chemical level in reservoir

≥ XXX; controlling parameter

in

range XX–XX

Reverse

osmosis

Product water

conductivity, total

dissolved solids

(TDS), or resistivity

and calculated

rejection

NA According to the

manufacturer’s

recommendations

(continuous

monitors)

Rejection ≥ XX%

Reverse

osmosis

Product and reject

flow rates, and

calculated recovery

NA Daily (continuous

monitors)

Product water flow rate

> X.X gpm; recovery in the

range XX–XX %

Deionizers Product water

resistivity

NA Continuous Resistivity > 1 megohm-cm

Ultrafilters Pressure drop across

the filter

NA Daily Pressure drop less than XXXX

Water storage

Tanks

Bacterial growth and

pyrogens

Weekly, until a

pattern of

consistent

compliance with

limits can be

demonstrated

NA Bacterial count ≤ 50

CFU/mL;

endotoxin ≤ 1 EU/mL

Water

distribution

piping system

Bacterial growth and

pyrogens

Weekly, until a

pattern of

consistent

compliance with

limits can be

demonstrated

Monthly Bacterial count ≤ 50

CFU/mL;

endotoxin ≤ 1 EU/mL

UV light

sources

Energy output NA Monthly Light output > XXX

Ozone

generators

Concentration in the

water

NA During each

disinfection

Ozone concentration > XXX

Hot water

disinfection

systems

Temperature and

time of exposure of

the system to hot

NA During each

disinfection

Temperature not less than

Page 105 of 420

Item to monitor What to monitor Special

interval

Normal interval Specification

water XX °C; minimum exposure

time at temperature ≥ XX

minutes

Dialysate Bacterial growth and

endotoxin in the

dialysate

NA Monthly, rotated

among machines

so that at least

two machines are

tested each month

and so that each

machine is tested

at least once per

year

Bacterial growth ≤50

CFU/mL;

endotoxin ≤ 1 EU/mL

Dialysate Conductivity and pH NA Each treatment Conductivity within ± 5% of

the nominal machine value;

pH in the range 6.9–7.6

NOTE: It is not possible to specify universally acceptable operating ranges for each device listed

in the table, since some of these values will be system-specific. In those cases (denoted by Xs in

the Specification column of the table), the facility should define an acceptable operating range

based on the manufacturer’s instructions or measurements of system performance.