CMS SOM App. H, Tag V326

494.50(b)(1)

4 Records

4.2 Reprocessing record: complete/available to patient

Records shall be kept that identify the new dialyzer, the date of each reprocessing step, the

person performing the procedure, his or her signature or other identifying mark, and the

results of tests of device performance and safety. This information should be recorded in a

reprocessing log or the patient’s chart, whichever is more convenient. Patients must be

permitted to read records pertaining to the reprocessing and reuse of their own dialyzers.

Interpretive Guidance § 494.50(b)(1)

Each dialysis facility that reprocesses and reuses dialyzers must maintain a record that identifies

at a minimum the following information to be considered complete:

1. Identification of the new dialyzer,

2. Date of each reprocessing step,

3. Identification of the person performing the procedure,

4. Their signature or other identifying mark, and

5. Results of tests of device performance and safety.

This record can be maintained as a reprocessing log, or in the individual patient’s medical

record. A permanent record (paper or electronic) must be maintained to enable tracking each

dialyzer's history and performance testing; information recorded on the dialyzer label must also

be recorded either in a log or in the patient record, as the labels are discarded with the

dialyzers.

The systems in place must allow patients access to the record of use/reprocessing of their

dialyzer while ensuring the privacy of the other patients’ records. If the reprocessing record is

maintained in a reprocessing log, and a patient is requesting access to their records for the

reprocessing and reuse of their dialyzer, records and health information for other patients must

be protected.