CMS SOM App. H, Tag V309

494.50(b)(1)

5.2.2 Documentation

Each person performing procedures for the multiple use of dialyzers shall have successfully

completed the dialysis facility’s training course relevant to that person’s task and

demonstrated competence in the area covered by his or her training. Successful completion

of training shall be certified by the medical director or his or her designated representative

and recorded in the trainee’s personnel file along with verification of the trainee having

received the instruction. Retraining is necessary when new procedures are undertaken.

Annual review of competence is required with appropriate retraining if deficiencies are

found.

Interpretive Guidance § 494.50(b)(1)

Facilities may cross-train staff from other positions, such as hemodialysis technicians or clerical

staff, to perform reprocessing. Each person assigned to dialyzer reprocessing must complete all

components of the training and demonstrate competency.

Personnel files should include:

• Evidence that the medical director/designee has certified each of the reprocessing

personnel who have successfully completed the required training;

• Annual competence review and applicable retraining;

• Retraining for any major change in the reuse program (e.g., a change in equipment

or germicide).