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Dialysis

The Survey and Certification Program certifies ESRD facilities for inclusion in the Medicare Program by validating that the care and services of each facility meet specified safety and quality standards, called "Conditions for Coverage." The Survey and Certification Program provides initial certification of each dialysis facility and ongoing monitoring to ensure that these facilities continue to meet these basic requirements.

This page provides basic information related to survey and certification of dialysis facilities for ESRD surveyors and dialysis providers. It includes links to applicable laws and regulations, and provides resources to support and assess compliance with Federal regulations.

  1. ESRD Program Interpretive Guidance Manual Version 1.1 is formatted as a three column table: a computer identifier tag (“V tag”); the text of the regulation; and the guidance for interpreting the regulation. For ease of navigating the Interpretive Guidance, the Conditions are hyperlinked so you can click on the page number for the Condition in the Table of Contents to navigate to that page.
  2. CMS 3427 ESRD Application/Notification and Survey/Certification Report (5/13): completed by facility and reviewed by the surveyor for Medicare certification/recertification for a new facility, existing facility, expansion of stations/services, relocation, or change of ownership 
  3. ESRD Core Survey Field Manual Version 1.7: This manual contains the ESRD Core Survey Process task descriptions, copies of key laminates, Core Survey Data Worksheet, CMS 3427, Personnel File, a sign to announce the survey, Entrance Conference Questions, Observations of Hemodialysis Care and Infection Control Practices checklists, Patient Roster, Water Treatment and Dialysate Review Observation & Interview worksheet, Reuse: Observation/Interview Review worksheet, Machine/Equipment Maintenance Technician worksheet, patient and personnel interview worksheets, Medical Record Review worksheets, Personnel Record Review worksheet, and the Quality Assessment and Performance Improvement Review worksheet, that can be used by surveyors and providers to monitor care REVISED
  4. ESRD Surveyor “Laminates” are abbreviated survey guidance
    • Outline of ESRD Core Survey Process: 4-page list of tasks in the ESRD Core Survey process (Version 1.3) REVISED
    • ESRD Core Survey Process Triggers: 2-page list of tasks in the ESRD  Core Survey that lead surveyors further investigate or cite (Version 1.5) REVISED
    • Measures Assessment Tool (MAT): 2-page summary of the standards used in assessing compliance with regulatory requirements formatted in 5 columns to include the referenced V tag, the measure, the expected value(s), reference for the value(s), and where the surveyor should find the information during a survey (Version 2.3)
    • Evidence of Recognizing and Addressing (ERA) Interdisciplinary Clinical Care of the Individual Patient: 2-page description of sample findings, what to look for, and why it is important (Version 1.0)
    • End Stage Renal Disease Facilities V-Tags & Identifiers: 3-page list of V-Tags and ASPEN identifiers along with Condition statements from the Interpretive Guidance (Version 1.5)
    • Infection Control/Requirements for Isolation Room or Area: 2-page description of V-tags and descriptors plus requirements for all facilities, existing facilities and new facilities (Version 1.5)
    • Water System Flow Diagram/ Critical Water and Dialysate Requirements: 2-page summary of the ANSI/AAMI RD 62 water and dialysate requirements and a diagram of a typical water system (Version 1.2)
    • Personnel Requirements/National Commercial PCT Certification Organizations: 2-page summary of requirements for staff of a dialysis facility plus information on national commercial dialysis technician certification organizations (Version 1.4)
    • Helpful Web Sites for ESRD Surveyors: 2-page listing of recommended Web sites inside and outside CMS (Version 2.2) REVISED
    • Dialysis Lab Tests At a Glance: 2-page listing of common blood tests for people on dialysis, to include normal values, expected values in someone with kidney disease, and signs/symptoms if values are too high or too low (Version 1.4)
    • Components of Immediate Jeopardy/Guidelines for Citations: -2-page flow chart and guidelines to help the surveyor determine the level of citation (Version 1.1)
    • Principles of Documentation Overview: 2-page adaptation of the Principles of Documentation, the guidance surveyors must use in writing deficiency statements adapted from (Exhibit 7A), in the CMS State Operations Manual (Version 1.0)

5. ESRD Survey & Certification Memos related to dialysis: PureFlow, initial survey, waivers and phase in, Life Safety Code, surveying electronic health records, CMS Approval of State and National Certification Programs for PCTs under the new ESRD Conditions for Coverage, ESRD Program Survey Guidance on PCT Certification, revised Life Safety Code requirements and more

6. ESRD Frequently Asked Questions Version 1.3: provides answers to frequently asked questions asked by surveyors and members of the renal community, all organized by the applicable V Tag. All questions and answers added since the last version are printed in red for easy reference..For ease of navigating the ESRD FAQs, the Conditions are hyperlinked so you can click on the page number for the Condition in the Table of Contents to navigate to that page. Please send your questions about the ESRD Conditions for Coverage or ESRD Survey & Certification to ESRDQuestions@cms.hhs.gov.

7. Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule published in the Federal Register on April 15, 2008

8. ESRD State Operations Manual (under construction)