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Transition to Surveys with New ESRD Regulations. What Does the Future Hold? . Objectives. Demonstrate understanding of the background & rationale for changes to the current ESRD regulations Describe the implementation challenges for surveyors & facilities

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Presentation Transcript

Demonstrate understanding of the background & rationale for changes to the current ESRD regulations

Describe the implementation challenges for surveyors & facilities

Discuss major changes from the current to the new regulations


the esrd regulation timeline
The ESRD Regulation Timeline
  • 1976: First ESRD regulations published
  • 70’s-90’s: Technical updates
  • 1994: Community Forum Meeting to begin complete rewrite of ESRD regulations
  • 2008: New ESRD regulations published


common themes on the long journey
Common Themes on the Long Journey
  • CMS & Kidney Community partnership
  • Survey process is driven by outcomes & data, not structure & paper
  • Striving for consistency & common understandings


rationale for esrd regulation changes
Rationale for ESRD Regulation Changes

Increasing realization of the need for regulatory support for an outcomes focus across provider types

Needed to drive improvements in care

Critical if CMS moves to value-based pricing (aka, Pay for Performance)

Necessary if CMS moves to bundled reimbursement for ESRD care


reasons for change
Reasons for Change

Changes in technology

Water treatment: more complex

Changes in dialysis equipment

Differences in care delivery

1970’s: few technicians; regulations are silent

2008: technicians provide most direct care; public is demanding regulation


reasons for changes
Reasons for Changes

Evidence Based Practice: ESRD community coming to consensus on minimum standards of care

RPA’s Adequacy of Dialysis Report

K/DOQI Guidelines

Fistula First Breakthrough Initiative

QAPI: accepted process of quality assessment across provider types

Electronic data submission required to keep pace with growing ESRD population & need for current data


posted for viewing
Posted for Viewing



(In Word = 625 pages)

Targeted “Publish” Date: April 15

new rules require new data infrastructures
New Rules Require New Data Infrastructures
  • The Survey & Certification data system, ASPEN, must be updated
  • The automated ESRD data software, STAR, must be updated


new rules require new interpretive guidance
New Rules Require New Interpretive Guidance
  • Interpretive Guidance (IG) is CMS’ interpretation of the Rule ; provides clarification to surveyors & providers
  • Community input was sought for this guidance:
    • Draft document posted on the web & emailed to 10,000 CMS listserv subscribers
    • Community Forum in December 2007 for patients, professionals (all disciplines), providers, suppliers, organizations


interpretive guidelines
Interpretive Guidelines

Thanks for Your Help!


implementation challenges surveyors facilities
Implementation Challenges: Surveyors & Facilities

Effective Date? 10-14-2008

Lots of time? NOT

Federal Register

April 15, 2008


new rules require new updated products
New Rules Require New & Updated Products
  • New Survey Protocol
  • New training courses & training materials
  • Updated Frequently Asked Questions
  • Updated STAR (automated ESRD survey process)
  • Updated communications websites


implementation for facilities
Implementation for Facilities

Read the whole document (preamble & rule)

Review current practice (& policies) to be sure they meet rules

Identify staffing, practice, equipment, & training needs

Develop documentation tools to match the new rules (logs, audit tools, chart forms)


infection control
Infection Control

From one tag to a Whole Condition


CDC’s 2001 Recommendations for Prevention of Infections in Hemodialysis

CDC’s 2002 Guidelines for the Prevention of Catheter-Related Infections


infection control25
Infection Control


All new facilities must have a separate room

Must report issues to Medical Director & QAPI


water dialysate
Water & Dialysate

Adopts AAMI RD52:2004 as regulation

Written for the user

Specifics & required monitoring detailed for all water treatment components

Separate requirements for water treatment for home hemo under Care at Home Condition



For the first time, specific regulations for dialysate

AAMI RD52:2004 addresses acid & bicarbonate concentrate:






water dialysate28
Water & Dialysate

From ~8 tags to about 175 tags!

Very detailed & thorough

Most questions will now have a regulatory answer

Use RD52:2004 to update facility policy & practice for water treatment & dialysate preparation & distribution


  • Adopts AAMI RD:47:2002/2003
  • Requires reuse be suspended if a cluster of adverse patient reactions is associated with reuse


physical environment
Physical Environment

Life Safety Code (LSC) Requirements:

  • Must meet provisions of NFPA 2000
  • Grandfather clause for current facilities in non-sprinklered buildings if built prior to 1/1/2008
  • State fire safety codes may be used in lieu of LSC
  • Specific provisions of LSC may be waived in some cases


physical environment31
Physical Environment
  • Every facility must have an AED or a defibrillator

(& ACLS qualified staff)

  • All equipment maintained & operated according to manufacturer’s directions
  • Emergency preparedness for staff & patients, including disaster prep—get to know your local Emergency Ops Center


patients rights
Patients’ Rights

To be treated with respect & dignity and to:

  • Receive information on all modalities, including those not provided at the current facility
  • Receive alternative scheduling options [from other facilities] for working patients
  • Receive necessary services listed in the Plan of Care


patients rights33
Patients’ Rights
  • Be informed of the right to have an advance directive
  • Be informed about transfer & discharge policies


patient assessment
Patient Assessment
  • Comprehensive
  • Interdisciplinary team
  • Initial completed within the latter of 30 days or 13 HD treatments
  • Components required include anemia, adequacy, access, bone disease, nutrition, psychosocial status, home dialysis, transplant status, functional status, rehab
  • FYI: ANNA/NKF have developed a tool


patient assessment35
Patient Assessment
  • Comprehensive reassessment within 3 months of completion of the initial assessment for all patients
  • Adequacy assessed
    • monthly for HD;
    • every 3 months for PD
  • Stable patients require annual review


patient assessment36
Patient Assessment

Assessments and plan of care done monthly for “unstable patients,” examples include:

  • Extended or frequent hospitalizations;
  • Marked deterioration in health status;
  • Significant change in psychosocial needs; or
  • Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis.


plan of care
Plan of Care

No “cookie-cutter” approach allowed

Must address identified needs = individualized!

Initial: within 30 days or 13 outpatient hemodialysis treatments of admission

Update: within 15 days of each re-assessment


major change no ltp
Major Change: No LTP

No expectation for a long term program or “signature” of transplant surgeon

Requirements for patients to be informed of all modalities (transplant & therapies not offered at their current clinic) are addressed under:

Patients’ Rights

Patient Assessment

Plan of Care


care at home
Care at Home

Separate Condition for home therapies

Care at home must be equal in quality to care provided in-center

Training required for patient described in detail

Water treatment / dialysate separately addressed, including newer technologies


home dialysis in residential institutions
Home Dialysis in Residential Institutions
  • Interim: home dialysis in residential institutions will be addressed in Survey & Certification Letter
  • Long-Term: future rules will address this area



Condition level

Interdisciplinary team

Process continuous & on-going

Outcome focused: use community accepted standards as targets

Include patient satisfaction, infection control, medical injuries & medication errors

Plan/Do/Check/Act: Close the loop!


special purpose renal dialysis facilities
Special Purpose Renal Dialysis Facilities
  • For
    • Vacation camps
    • Facilities providing services in emergencies
  • Approved for a maximum of 8 months


laboratory services
Laboratory Services
  • Dialysis facility must provide or make available appropriate lab services
  • Lab services must meet CLIA regulations


  • Defines individual qualifications:
    • Medical Director
    • Nurses: nurse manager, home training nurse, charge nurse, staff nurse
    • Dietitian
    • Social Worker
  • Defines group qualifications:
    • Patient care technicians
    • Water treatment system technicians



Patient Care Technician

  • High school diploma or equivalency
  • Complete a (defined) training course, approved by Medical Director & Governing Body; under direction of RN
  • Be certified by a State or national program
    • New employees: within 18 months of hire date (starts after 10/4/08)
    • Current employees: within 24 months of 4/4/08


medical director
Medical Director

Accountable to the Governing Body

Responsible for patient care and outcomes

Responsible for effective QAPI and Infection Control programs


medical director47
Medical Director

Responsible to assure all staff, physicians & non-physician providers “adhere” to all policies

Must be engaged in any involuntary patient transfer or discharge


medical records
Medical Records
  • Traditional rules on completeness & protection of medical records
  • Transfer requested records to the receiving facility within one day


governance rn presence
Governance: RN Presence

“An RN, who is responsible for the nursing care provided, is present in the facility at all times that in-center dialysis patients are being treated.”


governance patient involuntary discharge
Governance: Patient Involuntary Discharge

Specific requirements

Reassess the patient

Involve the Medical Director

Contact another facility and attempt to place

30 days notice unless threat to safety

Notify the Network and the State Agency

FYI: Network “DPC” program contains tools to help prevent involuntary discharges


governance electronic data submission
Governance: Electronic Data Submission

As of 2/1/09, every facility must electronically submit data on all patients, including data on clinical performance measures, to CMS.



what does the future hold

What Does the Future Hold?

Opportunity to improve patient outcomes


Lots of good work for you

Lots of good work for us!


thank you for
Thank You for...
  • Partnering with CMS to enhance & inform the survey & certification work
  • Providing data & outcomes to guide & direct our work
  • Improving consistency by helping us build Interpretive Guidelines with common understandings



* Remember, the rules were only published Thursday…



helpful cms websites
Helpful CMS Websites

ESRD Open Door Forum listserv http://www.cms.hhs.govAboutWebsites/20EmailUpdates.asp

ESRD Center