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Facilitating the achievement of optimal wellness for renal disease patients

 

Survey and Certification of Dialysis Facilities for ESRD Surveyors and Dialysis Providers

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 is in three parts: a computer identifier tag (“V tag”); the wording of the regulation; and the guidance in 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. Download:  ESRD Program Interpretive Guidance - Version 1.1 October 3, 2008 [PDF, 1MB]
  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. Download:  CMS 3427 ESRD Application/Notification and Survey/Certification Report (5/13) [PDF, 171KB]
  3. ESRD Core Survey Field Manual Version 1.6: multiple documents and worksheets; including the ESRD Core Survey Process task descriptions, Core Survey Data Tools Worksheet, Entrance Conference Questions, Observations of Hemodialysis Care and Infection Control Practices checklists, patient roster worksheet, Water Treatment and Dialysate Review Observation & Interview worksheet, Reuse: Observation/Interview Review worksheet, patient and staff interview worksheets, medical record and personnel file reviews, Quality Assessment and Performance Improvement Review worksheet, and more that can be used by surveyors and providers to monitor care. Download:  ESRD Core Survey Field Manual Version 1.6 [ZIP, 8MB]
  4. ESRD Surveyor “Laminates” are abbreviated survey guidance. Listed below are details of laminates currently available. Download:  ESRD Surveyor Laminates [ZIP, 2MB]
  5. Outline of ESRD Core Survey Process: 4-page list of tasks in the ESRD Core Survey process (Version 1.2) REVISED

    ESRD Core Survey Process Triggers: 2-page list of tasks in the ESRD  Core Survey that lead surveyors further investigate or cite (Version 1.4) 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) REVISED

    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 1.45) REVISED

    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) REVISED

    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) REVISED

    Helpful Web Sites for ESRD Surveyors: 2-page listing of recommended Web sites inside and outside CMS (Version 2.0) 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)

    Outline of the Traditional ESRD Survey Process: 4-page list of tasks in the survey process (Version 1.8)

  6. ESRD Survey & Certification Letters 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. Download:  ESRD Survey & Certification Letters [ZIP, 3MB]
  7. 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. Download:  ESRD Frequently Asked Questions, Version 1.3 [PDF, 555KB]
  8. Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule published in the Federal Register on April 15, 2008. Download:  ESRD Frequently Asked Questions, Version 1.3 [PDF, 555KB
  9. ESRD State Operations Manual (New manual is under construction) Download previous manual:

State Operations Manual Appendix H - Guidance to Surveyors: End-Stage Renal Disease Facilities - (Rev. 1, 05-21-04)

Medicare Benefit Policy Manual Chapter 11 - End Stage Renal Disease (ESRD) (Rev. 171, 06-07-13)