More commonly known as the CMS, this agency is under the US Department of Health and Human Services and is responsible for the administration of the End-Stage Renal Disease (ESRD) program. The latest Conditions for Coverage for ESRD facilities were published on April 15, 2008 and went into effect six months later. The CMS rule established the latest conditions for coverage that dialysis facilities must meet to be certified under the Medicare programs in order to receive reimbursements and remain in operation.
One of the four focus areas found in the Interpretative Guidance for ESRD is Patient Safety. That section covers the following topics: Infection Control, Water Treatment, and Concentrate Preparation. The latest document, nearly 300 pages in length, provides point-by-point detail, known as V-Tags, of water quality and treatment equipment for facility surveyors to reference and inspect upon. It is designed to simplify and clarify the inspection process, creating a more level playing field throughout the county.
All of the Conditions for Coverage found in the Interpretative Guidance are based on AAMI RD52:2004 with subsequent reference to AAMI RD62:2001. Alongside the regulation topic there is another column of information that goes beyond the AAMI Standard. This additional wording is intended to provide further explanation and clarification to what is listed.
Despite the fact that ANSI/AAMI has issued revised Standards as of 2014, CMS has not aligned itself with these latest guidelines. Instead, it is assessing water quality, water treatment systems, water components, monitors, and all water related activities to the 2004 standards found in the AAMI RD52 publication. However, the acceptance and promotion to these Standards will serve to increase patient safety, drive awareness of technology, show the need for education, and improve overall system performance.