CMS SOM App. H, Tag V242

6.5 Concentrate distribution (Initial Bicarbonate Monitoring)

Page 97 of 420

Once a bicarbonate distribution system has been activated, dialysate should be monitored

weekly until sufficient data has been obtained to demonstrate consistent compliance with

acceptable levels of contamination. The frequency of monitoring may then be reduced, but

monitoring should be performed at least monthly. If elevated bacteria or endotoxin levels

are found in the dialysate, all systems involved in dialysate preparation, including the

bicarbonate concentrate distribution system should be evaluated and appropriate action,

such as disinfection, should be taken. The frequency of monitoring should then be

increased until it can be demonstrated that the problem has been resolved.

Interpretive Guidance § 494.40(a)

ANSI/AAMI RD52:2004

6.5 Concentrate distribution

Because acid concentrate distribution systems have been shown not to be subject to bacterial

proliferation, it is not necessary to perform bacteria and endotoxin testing on those systems.

Additional Guidance:

Whenever use of a new bicarbonate distribution system is initiated, weekly monitoring of

dialysate should occur for at least four consecutive weekly reports of acceptable levels.

Evaluation of positive culture or endotoxin reports should also consider the number of positives

in relationship to the number of samples taken. For example, if one sample out of 10 has a count

of 53, while the other 9 have no growth, repeating the culture of one or more sites may be the

first action taken. The medical director should be involved in any decisions for determining the

appropriate action(s) to address abnormal culture or endotoxin results, i.e., growth exceeds

permissible standards.