CMS SOM App. H, Tag V308

494.50(b)(1)

5.2 Training

5.2.1 Curriculum

The dialysis facility’s physician or director shall establish a training course for the persons

performing hemodialyzer reprocessing. A written document should give details about the

curriculum and, in particular, address the potential risks to patients and staff members of

not following correct procedures. The curriculum should include at least the following

information:

• the facility’s specific reprocessing procedure, including a rationale for each step;

• basic documentation requirements of the program;

• the operation and maintenance of the facility’s specific equipment for

reprocessing hemodialyzers and, if appropriate, the dialysis systems and

components;

• microbiology with respect to aseptic technique, the collection and handling of

samples, and personnel safety precautions for infectious hazards;

• the risks and hazards of multiple use of hemodialyzers;

• the consequences of not performing tasks properly;

• the risks and hazards associated with toxic substances used in reprocessing

hemodialyzers, proper handling of these substances, and procedures for

handling spills and proper disposal of toxic substances;

• the use and location of protective eyewear, respirators, masks, and special

clothing;

• emergency procedures as required by the facility; and

• the principles of dialysis, emphasizing the characteristics of the hemodialyzer

and the effect of reuse on these characteristics.

Interpretive Guidance § 494.50(b)(1)

Page 122 of 420

Available training materials must include all required topics and be congruent with the

processes observed.