CMS SOM App. H, Tag V260

9 Personnel (components of the training program)

[A] training program that includes quality testing, the risks and hazards of improperly

prepared concentrate, and bacterial issues [is mandatory].

Operators should be trained in the use of the equipment by the manufacturer or should be

trained using materials provided by the manufacturer.

The training should be specific to the functions performed (i.e., mixing, disinfection,

maintenance, and repairs).

Periodic audits of the operators’ compliance with procedures should be performed.

The user should establish an ongoing training program designed to maintain the operator’s

knowledge and skills.

End of ANSI/AAMI RD52 requirements

Interpretive Guidance § 494.40(a)

The operators of the water/dialysate system equipment are typically trained by the manufacturer

of the equipment, or the training is conducted from materials provided by the manufacturer.

Water treatment service vendors may do the training using materials from the manufacturer.

The facility defines the frequency of audits to evaluate the operators’ compliance: these should

include actual observation of the work: e.g., collecting samples, performing water testing. Audits

should be done at least annually and more frequently if problems are identified.

This tag addresses the content of the training for personnel responsible for the water and

dialysate systems, and audits for compliance with procedures. Whether the personnel

responsible for the water treatment system have been trained is addressed in the Condition for

Personnel qualifications, at V696.

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§ 494.40(b) - Standard: chlorine/chloramines. (1) The water treatment system must include

a component or carbon tank which removes chlorine/chloramine along with a backup

component or second carbon tank in series for chlorine/chloramine removal.

(2)(i) If the test results from the port of the initial component or carbon tank referred to in

section 6.2.5 of AAMI RD52:2004 are greater than 0.5 mg/L for free chlorine or 0.1 mg/L

for chloramines, or equal to or greater than 0.1 mg/L of total chlorine, then the second

component or carbon tank which removes chlorine/chloramine must be tested;

Interpretive Guidance § 494.40(b)

These requirements are duplicative of requirements in AAMI RD52:2004, adopted by reference.

For (b)(1): Refer to V192 for the failure to have primary and secondary carbon tanks for

removing chlorine/chloramines.

For (b)(2)(i): Refer to V197 for the failure to test after the secondary method of removing

chlorine/chloramines when the test results after the primary method indicate breakthrough.