CMS SOM App. H, Tag V368

494.50(b)(1)

14.9 Preparation for dialysis (audit frequency)

At least quarterly, designated personnel should audit the written procedures and verify

their implementation. At least quarterly, designated staff members should verify the tests

for the presence of germicide and the test for residual germicide by using positive and

negative control solutions, on those products that are not specifically intended for use in

dialyzer reuse germicide indicator tests and which have not been cleared by the FDA.

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Interpretive Guidance § 494.50(b)(1)

This regulation requires at least quarterly audits (observations) of the set-up for dialysis,

including testing for presence of germicide, testing for residual germicide, and verification of the

patient identity with the reprocessed dialyzer.

Responsible staff (e.g., nurse manager, administrator, medical director) must be able to describe

these audits, provide documentation the audits were accomplished, and provide evidence that

any concerns identified were addressed.

Facilities that participate in centralized reprocessing are responsible for performing the audits

of the steps in the reuse process which occur during preparation for dialysis when reprocessed

dialyzers are being prepared for reuse.