CMS SOM App. H, Tag V358

494.50(b)(1)

13.4 Clinical results (monitoring patient results; Kt/V)

Monitoring of relevant patient results is recommended to ensure that all parameters

relating to hemodialyzer clearance are being met. Specifically, examination of urea

reduction ratio (URR) or Kt/V over time is necessary. The failure of these results to meet

the expectations of the dialysis prescription should be investigated. Deterioration of a

patient’s clinical condition or variability of routine dialysis procedures (heparinization,

ultrafiltration, dose of erythropoietin stimulating agent) [requires] an investigation of all

practices, including reuse. Reports of investigations should be filed in the complaint log.

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Interpretive Guidance § 494.50(b)(1)

AAMI Rationale for the Development and Provisions of this Recommended Practice

A.13.4 Clinical results

Critical assessment of chemistries and the delivered dose of dialysis (Kt/V or urea reduction

ratio), as is done monthly, provides a clear trend line to assess treatment. This scrutiny of the

patient’s treatment and course is the primary confirmation that hemodialyzer performance

anticipated from TCV or other indirect estimation is accurate and adequate. The overall

effectiveness of the entire treatment, not only the clearance of the dialyzers, is measured. No

other measure of the effectiveness of new or reused dialyzers is as clear or relevant. Trend lines

developed from this data characterize the quality of therapy. . . If the practitioner has concerns

for “middle molecules” or other clinical parameters, these factors should also be part of the

assessment of the delivered therapy.

There are many reasons for an apparent reduction in the mass transfer of urea, other than

decreased hemodialyzer clearance as a result of inadequate reprocessing (such as recirculation,

decreased dialysis time or blood flow rate, or an inappropriate dialysis prescription). To

document adequate mass transfer, parallel measurements of pre- and post-creatinine levels are

helpful. When problems develop with any patient or group of patients, monitoring intensity

should be increased, and other methods should be used to analyze the problem and define

corrective action.