Survey protocols and Interpretive Guidelines are established to provide guidance to personnel conducting surveys.  They serve to clarify and/or explain the intent of the regulations and all surveyors are required to use them in assessing compliance with Federal requirements.  The purpose of the protocols and guidelines is to direct the surveyor's attention to certain avenues for investigation in preparation for the survey, in conducting the survey, and in evaluation of the survey findings.

The End Stage Renal Disease (ESRD) facility survey is conducted in accordance with the appropriate protocols and substantive requirements in the statute and regulations to determine whether a citation of non-compliance is appropriate.  Deficiencies are based on a violation of the statute or regulations, which, in turn, is to be based on observations of the ESRD's performance or practices. 

The Interpretive Guidelines include three parts.  The first part contains the survey tag number.  The second part contains the wording of the regulation.  The third part has guidance to surveyors, including additional survey procedures and probes.

The ESRD Survey Procedures

The ESRD survey procedures include three separate survey protocols: A BASIC SURVEY protocol, a SUPPLEMENTAL SURVEY protocol, and an INITIAL SURVEY protocol.  Each survey protocol has a different focus and purpose.

• The BASIC SURVEY protocol is used for recertification surveys, and therefore assumes that the facility is fully established with a performance history.  This survey protocol is designed around survey tasks that involve observing areas and actions, interviewing patients and staff, and reviewing records and documents.  All of these are focused most on patient care and outcomes. 

• The SUPPLEMENTAL SURVEY protocol is initiated when Condition-level (or suspected Condition-level) problems are noted while conducting the BASIC SURVEY.  The SUPPLEMENTAL SURVEY protocol is used to identify underlying problems or structural weaknesses in the operation of the dialysis facility that has or could produce Condition-level deficiencies.  The SUPPLEMENTAL SURVEY is organized around Conditions for Coverage for each respective area covered in the outcome-oriented BASIC SURVEY.  The SUPPLEMENTAL SURVEY can be used in whole or in part to augment the BASIC SURVEY.

• The INITIAL SURVEY protocol is used for first surveys for new ESRD suppliers.  This initial protocol can also be used for facilities that are changing ownership/management or location/services.   These policies and procedures ensure that the facility meets the basic safety and health standards of the regulations.  This survey emphasizes reviewing documents and protocols, observing the site, and interviewing staff.  Because patients do not have a long history with a new facility, patient interviews are not necessarily central to the INITIAL SURVEY protocol.

The Interpretive Guidelines are a reference.  As a reference, the surveyor or the facility may use them to delineate facility performance expectations and the interpretation of those expectations.  Whereas the survey procedures delineate priority areas for surveys, the Interpretive Guidelines address all areas of the regulation.

The Interpretive Guidelines include three parts: 

• The first part contains the survey tag number. 
• The second part contains the wording of the regulation. 
• The third part contains guidance to surveyors, including additional survey procedures and probes.

Downloads
There are no Downloads
Related Links Inside CMS
Appendix H of the State Operations Manual Certification and Compliance for Dialysis Facilities Survey and Certification General Enforcement Information
Related Links Outside CMS
There are no Related Links Outside CMS

Page Last Modified: 10/27/2008 12:56:09 PM
Help with File Formats and Plug-Ins