CMS SOM App. H, Tag V360

494.50(b)(1)

14 Quality assurance (internal standards and clinical outcomes)

The criteria chosen as the internal standards of a facility shall be documented in its policy

and/or procedure manual. Process review should be part of the activity of the individual

carrying out the process, and oversight of that review by another qualified member of the

staff or a group of staff members should affirm, modify, or repeat these observations to

confirm or improve the process.

Clinical outcomes serve as the most important indicator of quality of all dialysis treatment

practices including reuse. Final oversight is the responsibility of the medical director. See

Table 2 for a summary of the audit schedule.

14.1 Records

A record of review, comments, trend analysis, and conclusions arising from QA practices

serve as a foundation for future review and as documentation to external evaluation.

Interpretive Guidance § 494.50(b)(1)

A.14 Quality assurance

The FDA’s 1987 compliance policy guide (7124.16) advises reuse practitioners to establish the

following: (a) adequate device cleaning and sterilization; (b) the lack of adverse effects on

device quality or physical characteristics; and (c) certainty that the device remains safe,

reliable, and effective for its intended use. The [AAMI RDD] Committee believes that

compliance with those recommendations necessitates use of regularly examined reprocessing

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procedures that are based on methods of demonstrated effectiveness and are carried out under

conditions safe to the patient and the personnel.

Table 2—Quality assurance audit schedule

Monthly Quarterly Semi-Annually

Annually

Patient information policy (14.3) X

Equipment manuals and procedures (14.4) X

Equipment maintenance and repair policies

(14.4)

X

Environmental safety (8.1) X

Environmental safety (8.2) X

Environmental safety (8.4) X

Reprocessing supplies (9) X

Water treatment* (11.4.1.5) X

Hemodialyzer labeling (10) X

Reprocessing procedures** (14.8) X X

Procedures for preparation for dialysis

(14.9)

X

* More frequent monitoring may be required initially as described in 11.4.1.5.

**These functions may allow for a less frequent review period, as indicated in their respective

sections, according to the specified circumstances. **

Note: Numbers in parentheses refer to AAMI sections.

Additional Guidance:

The QAPI Condition at § 494.100 (Tag V625) requires the facility’s quality improvement

program to reflect the complexity of the dialysis facility’s organization and the services it

provides. In other words, if a dialysis facility’s services include reuse, reuse audits must be

performed on the required schedule and reported in the QAPI activities. For many of the audits,

there is a two-tier system of review required: the review of the process by the person assigned

(i.e., reprocessing by the reuse technician), and oversight of that review by another person

qualified to do so (i.e., the technical supervisor observing the reuse technician performing

reprocessing).

If the facility participates in a centralized reprocessing program, the QA audits done in the

reprocessing facility must be provided to the patient treatment facility and reviewed as part of

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the QAPI of that facility. Any complaints related to the reprocessing of dialyzers would need to

be reported to the patient treatment facility sending the applicable dialyzers.