As the largest funder of dialysis therapy in the United States, the Centers for Medicare & Medicaid Services (CMS) requires that providers comply with certain performance criteria to ensure the safety of patients with end-stage renal disease (ESRD). However, there are differences between CMS requirements and a suite of International Organization of Standardization standards adopted by the Association for the Advancement of Medical Instrumentation (AAMI).
To help explain the key differences, as well as how facilities can respond, AAMI has released "Dialysis Water and Dialysate Recommendations: A User Guide." The guide’s editor, Glenda Payne, is director of clinical services for Nephrology Clinical Solutions. Previously, she was a member of the CMS core faculty for training surveyors responsible for surveys of dialysis facilities.
“Altogether, this work makes an important contribution to reducing conflict between the surveyors and the surveyed and will help advance the cause of patient safety,” wrote Richard Ward, past user co-chair of the AAMI Renal Disease and Detoxification Committee, in the guide’s forward.
The idea for the updated resource came as a result of an evolution in AAMI standards. In 2008, CMS published a major revision of its conditions for coverage to incorporate almost all of ANSI/AAMI RD52:2004, Dialysate for hemodialysis. However, in 2011, AAMI adopted a suite of standards that revised RD52. Subsequently, AAMI issued Technical Information Report 43,2011, Ultrapure dialysate for hemodialysis and related therapies, which revised and replaced RD52. These changes meant the CMS conditions for coverage no longer mirrored AAMI standards.
“Discrepancies involve both performance criteria, such as the maximum allowable levels for bacteria and endotoxin in water and dialysate, and recommended approaches to maintaining compliance with the fluid quality standards, with the current AAMI standards emphasizing compliance through the development and implementation of a facility-specific quality management program,” according to the document.
To help reduce confusion, the guide provides a table of differences that defines the discrepancies between the CMS regulation and interpretive guidance and the newer suite of standards that AAMI adopted. “I hope this guide will help all dialysis providers move to the use of higher quality water, and thus provide better quality treatment for dialysis patients,” says Payne.
The publication is available for $205, or $120 with AAMI member discount, as a book or in PDF format. Purchasers can also buy both the book and PDF as a set for $310, or $185 with AAMI member discount. To purchase the guide, visit: http://www.aami.org/news/2014/070814_Press_Dialysis_User_Guide.html.