Transition to SurveysTransition to Surveyswith New ESRD Regulationswith New ESRD Regulations

What Does the Future Hold? What Does the Future Hold?

ObjectivesObjectives

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

• Describe the implementation challenges Describe the implementation challenges for surveyors & facilitiesfor surveyors & facilities

• Discuss major changes from the current Discuss major changes from the current to the new regulationsto the new regulations

2

The Long JourneyThe Long Journey

3

The ESRD Regulation TimelineThe ESRD Regulation Timeline

• 1976: First ESRD regulations published1976: First ESRD regulations published

• 70’s-90’s: Technical updates70’s-90’s: Technical updates

• 1994: Community Forum Meeting to begin 1994: Community Forum Meeting to begin

complete rewrite of ESRD regulationscomplete rewrite of ESRD regulations

• 2008: New ESRD regulations published2008: New ESRD regulations published

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1994 Community Forum: Outcome1994 Community Forum: OutcomeChange in Regulatory FocusChange in Regulatory Focus

FromFrom ToTo

First, paper First, paper reviewsreviews

First, safety reviews First, safety reviews –WaterWater–ReuseReuse–Infection controlInfection control–Physical environmentPhysical environment

StructureStructure OutcomesOutcomes

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1994: Change in the Survey Process1994: Change in the Survey Process

From a focus From a focus on:on:

To a focus on:To a focus on:

• PoliciesPolicies• Procedures Procedures • Personnel Personnel

recordsrecords

• Reviewing dataReviewing data• Observing careObserving care• Interviewing patientsInterviewing patients• Interviewing the people Interviewing the people

doing the workdoing the work

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1994: Change in the Survey Process1994: Change in the Survey Process

From a focus onFrom a focus on To a focus onTo a focus on

StructureStructure OutcomesOutcomes

• Practices: water Practices: water treatment results, dialysis treatment results, dialysis adequacyadequacy

• Data: Dialysis Facility Data: Dialysis Facility ReportsReports

• Community-set minimum Community-set minimum standardsstandards

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Common Themes on the Common Themes on the Long JourneyLong Journey

• CMS & Kidney Community partnershipCMS & Kidney Community partnership

• Survey process is driven by outcomes & Survey process is driven by outcomes &

data, not structure & paperdata, not structure & paper

• Striving for consistency & common Striving for consistency & common

understandings understandings

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Rationale Behind the ChangesRationale Behind the Changes

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Rationale for ESRD Regulation ChangesRationale for ESRD Regulation Changes

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

• Needed to drive improvements in careNeeded to drive improvements in care• Critical if CMS moves to value-based pricing Critical if CMS moves to value-based pricing

(aka, Pay for Performance)(aka, Pay for Performance)• Necessary if CMS moves to bundled Necessary if CMS moves to bundled

reimbursement for ESRD carereimbursement for ESRD care

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Reasons for ChangeReasons for Change

• Changes in technology Changes in technology – Water treatment: more complex Water treatment: more complex – Changes in dialysis equipmentChanges in dialysis equipment

• Differences in care deliveryDifferences in care delivery– 1970’s: few technicians; regulations are 1970’s: few technicians; regulations are

silentsilent– 2008: technicians provide most direct care; 2008: technicians provide most direct care;

public is demanding regulationpublic is demanding regulation

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Reasons for ChangesReasons for Changes• Evidence Based Practice: ESRD community Evidence Based Practice: ESRD community

coming to consensus on minimum standards of coming to consensus on minimum standards of carecare– RPA’s Adequacy of Dialysis ReportRPA’s Adequacy of Dialysis Report– K/DOQI GuidelinesK/DOQI Guidelines– Fistula First Breakthrough Initiative Fistula First Breakthrough Initiative

• QAPI: accepted process of quality assessment QAPI: accepted process of quality assessment across provider typesacross provider types

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

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Final ESRD Final ESRD Regulations Regulations

FinallyFinally Published! Published!

April 3, 2008April 3, 200813

Posted for ViewingPosted for Viewing

http://www.cms.hhs.gov/CFCshttp://www.cms.hhs.gov/CFCsAndCoPs/downloads/ESRDAndCoPs/downloads/ESRDdisplayfinalrule.pdfdisplayfinalrule.pdf

(In Word = 625 pages)(In Word = 625 pages)

Targeted “Publish” Date: Targeted “Publish” Date: April 15April 15

The Implementation BeginsThe Implementation Begins

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What are the Effective Dates What are the Effective Dates for these Rules?for these Rules?

New Conditions for CoverageNew Conditions for Coverage 6 months6 months

10-14-0810-14-08

Life Safety Code andLife Safety Code and

Separate room for HBsAg+ Separate room for HBsAg+ patientspatients

300 days300 days

2-9-092-9-09

Certification of technicians hired Certification of technicians hired after 10-4-08after 10-4-08

18 months 18 months from hirefrom hire

Certification of existing Certification of existing technicianstechnicians

24 months24 months

4-15-104-15-10

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New Rules Require New Data New Rules Require New Data InfrastructuresInfrastructures

• The Survey & Certification data system, The Survey & Certification data system,

ASPEN, must be updatedASPEN, must be updated

• The automated ESRD data software, The automated ESRD data software,

STAR, must be updatedSTAR, must be updated

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New Rules Require New Interpretive New Rules Require New Interpretive GuidanceGuidance

• Interpretive Guidance (IG) is CMS’ interpretation Interpretive Guidance (IG) is CMS’ interpretation of the Rule ; provides clarification to surveyors & of the Rule ; provides clarification to surveyors & providersproviders

• Community input was sought for this guidance:Community input was sought for this guidance:– Draft document posted on the web & emailed Draft document posted on the web & emailed

to 10,000 CMS listserv subscribersto 10,000 CMS listserv subscribers– Community Forum in December 2007 for Community Forum in December 2007 for

patients, professionals (all disciplines), patients, professionals (all disciplines), providers, suppliers, organizationsproviders, suppliers, organizations

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Interpretive GuidelinesInterpretive Guidelines

18

Implementation Challenges: Implementation Challenges: Surveyors & FacilitiesSurveyors & Facilities

• Effective Date? 10-14-2008Effective Date? 10-14-2008• Lots of time? Lots of time? NOTNOT

19

New Rules Require New & Updated New Rules Require New & Updated ProductsProducts

• New Survey ProtocolNew Survey Protocol• New training courses & training New training courses & training

materialsmaterials• Updated Frequently Asked QuestionsUpdated Frequently Asked Questions• Updated STAR (automated ESRD Updated STAR (automated ESRD

survey process)survey process)• Updated communications websitesUpdated communications websites

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Implementation for FacilitiesImplementation for Facilities

1.1. Read the whole document (preamble & Read the whole document (preamble & rule)rule)

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

3.3. Identify staffing, practice, equipment, & Identify staffing, practice, equipment, & training needstraining needs

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

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What are some of the major changes?What are some of the major changes?

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Infection ControlInfection Control

• From one tag to a Whole ConditionFrom one tag to a Whole Condition

• Adopts Adopts

– CDC’s 2001 CDC’s 2001 Recommendations for Recommendations for Prevention of Infections in HemodialysisPrevention of Infections in Hemodialysis

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

23

Infection ControlInfection Control

• HepatitisHepatitis

– All new facilities must have a separate All new facilities must have a separate room room

• Must report issues to Medical Director & Must report issues to Medical Director & QAPIQAPI

24

Water & DialysateWater & Dialysate

• Adopts AAMI RD52:2004 as regulationAdopts AAMI RD52:2004 as regulation

• Written for the userWritten for the user

• Specifics & required monitoring detailed Specifics & required monitoring detailed

for all water treatment componentsfor all water treatment components

• Separate requirements for water treatment Separate requirements for water treatment

for home hemo under Care at Home for home hemo under Care at Home

ConditionCondition25

DialysateDialysate

• For the first time, specific regulations for For the first time, specific regulations for dialysatedialysate

• AAMI RD52:2004 addresses acid & AAMI RD52:2004 addresses acid & bicarbonate concentrate: bicarbonate concentrate:

– LabelingLabeling

– MixingMixing

– DistributionDistribution

– UseUse

26

Water & DialysateWater & Dialysate

• From ~8 tags to about 175 tags! From ~8 tags to about 175 tags!

• Very detailed & thoroughVery detailed & thorough

• Most questions will now have a regulatory Most questions will now have a regulatory

answer answer

• Use RD52:2004 to update facility policy & Use RD52:2004 to update facility policy &

practice for water treatment & dialysate practice for water treatment & dialysate

preparation & distribution preparation & distribution 27

ReuseReuse

• Adopts AAMI RD:47:2002/2003Adopts AAMI RD:47:2002/2003

• Requires reuse be suspended if a Requires reuse be suspended if a

cluster of adverse patient reactions is cluster of adverse patient reactions is

associated with reuseassociated with reuse

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Physical EnvironmentPhysical EnvironmentLife Safety Code (LSC) Requirements: Life Safety Code (LSC) Requirements: • Must meet provisions of NFPA 2000Must meet provisions of NFPA 2000• Grandfather clause for current facilities in non-Grandfather clause for current facilities in non-

sprinklered buildings if built prior to 1/1/2008sprinklered buildings if built prior to 1/1/2008• State fire safety codes may be used in lieu of State fire safety codes may be used in lieu of

LSCLSC• Specific provisions of LSC may be waived in Specific provisions of LSC may be waived in

some casessome cases

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Physical EnvironmentPhysical Environment

• Every facility must have an AED Every facility must have an AED oror a defibrillator a defibrillator

(& ACLS qualified staff)(& ACLS qualified staff)

• All equipment maintained & operated according All equipment maintained & operated according

to manufacturer’s directionsto manufacturer’s directions

• Emergency preparedness for staff & patients, Emergency preparedness for staff & patients,

including disaster prep—get to know your local including disaster prep—get to know your local

Emergency Ops CenterEmergency Ops Center

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Patients’ RightsPatients’ Rights

To be treated with respect & dignity and to:To be treated with respect & dignity and to:• Receive information on Receive information on allall modalities, modalities,

including those not provided at the current including those not provided at the current facilityfacility

• Receive alternative scheduling options Receive alternative scheduling options [from other facilities] for working patients[from other facilities] for working patients

• Receive necessary services listed in the Receive necessary services listed in the Plan of CarePlan of Care

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Patients’ RightsPatients’ Rights

• Be informed of the right to have an Be informed of the right to have an advance directiveadvance directive

• Be informed about transfer & Be informed about transfer & discharge policiesdischarge policies

32

Patient AssessmentPatient Assessment• ComprehensiveComprehensive• Interdisciplinary teamInterdisciplinary team• Initial completed within the latter of 30 days or Initial completed within the latter of 30 days or

13 HD treatments13 HD treatments• Components required include anemia, Components required include anemia,

adequacy, access, bone disease, nutrition, adequacy, access, bone disease, nutrition, psychosocial status, home dialysis, transplant psychosocial status, home dialysis, transplant status, functional status, rehabstatus, functional status, rehab

• FYI: ANNA/NKF have developed a toolFYI: ANNA/NKF have developed a tool

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Patient AssessmentPatient Assessment

• Comprehensive reassessment within 3 Comprehensive reassessment within 3 months of completion of the initial months of completion of the initial assessment for all patientsassessment for all patients

• Adequacy assessed Adequacy assessed

– monthly for HD;monthly for HD;

– every 3 months for PDevery 3 months for PD

• Stable patients require annual reviewStable patients require annual review

34

Patient AssessmentPatient Assessment

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

• Extended or frequent hospitalizations;Extended or frequent hospitalizations;• Marked deterioration in health status;Marked deterioration in health status;• Significant change in psychosocial needs; orSignificant change in psychosocial needs; or• Concurrent poor nutritional status, Concurrent poor nutritional status,

unmanaged anemia and inadequate dialysis.unmanaged anemia and inadequate dialysis.

35

Plan of CarePlan of Care

• No “cookie-cutter” approach allowedNo “cookie-cutter” approach allowed

• Must address identified needs = Must address identified needs = individualized! individualized!

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

• Update: within 15 days of each re-Update: within 15 days of each re-assessmentassessment

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Major Change: No LTPMajor Change: No LTP

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

• Requirements for patients to be informed of Requirements for patients to be informed of all modalities (transplant & therapies not all modalities (transplant & therapies not offered at their current clinic) are addressed offered at their current clinic) are addressed under: under: – Patients’ RightsPatients’ Rights– Patient AssessmentPatient Assessment– Plan of CarePlan of Care

37

Care at HomeCare at Home

• Separate Condition for home therapiesSeparate Condition for home therapies

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

• Training required for patient described in Training required for patient described in detaildetail

• Water treatment / dialysate separately Water treatment / dialysate separately addressed, including newer technologiesaddressed, including newer technologies

38

Home Dialysis in Residential InstitutionsHome Dialysis in Residential Institutions

• Interim: home dialysis in residential Interim: home dialysis in residential

institutions will be addressed in Survey institutions will be addressed in Survey

& Certification Letter& Certification Letter

• Long-Term: future rules will address Long-Term: future rules will address

this areathis area

39

QAPIQAPI

• Condition levelCondition level• Interdisciplinary teamInterdisciplinary team• Process continuous & on-goingProcess continuous & on-going• Outcome focused: use community accepted Outcome focused: use community accepted

standards as targetsstandards as targets• Include patient satisfaction, infection control, Include patient satisfaction, infection control,

medical injuries & medication errorsmedical injuries & medication errors• Plan/Do/Check/Act: Close the loop!Plan/Do/Check/Act: Close the loop!

40

Special Purpose Renal Dialysis FacilitiesSpecial Purpose Renal Dialysis Facilities

• ForFor– Vacation campsVacation camps– Facilities providing services in Facilities providing services in

emergenciesemergencies

• Approved for a maximum of 8 monthsApproved for a maximum of 8 months

41

Laboratory ServicesLaboratory Services

• Dialysis facility must provide or make Dialysis facility must provide or make

available appropriate lab servicesavailable appropriate lab services

• Lab services must meet CLIA Lab services must meet CLIA

regulations regulations

42

PersonnelPersonnel• Defines individual qualifications:Defines individual qualifications:

– Medical DirectorMedical Director– Nurses: nurse manager, home training Nurses: nurse manager, home training

nurse, charge nurse, staff nursenurse, charge nurse, staff nurse– DietitianDietitian– Social WorkerSocial Worker

• Defines group qualifications:Defines group qualifications:– Patient care techniciansPatient care technicians– Water treatment system techniciansWater treatment system technicians

43

PersonnelPersonnel

Patient Care Technician Patient Care Technician • High school diploma or equivalencyHigh school diploma or equivalency• Complete a (defined) training course, Complete a (defined) training course,

approved by Medical Director & Governing approved by Medical Director & Governing Body; under direction of RNBody; under direction of RN

• Be certified by a State or national programBe certified by a State or national program– New employees: within 18 months of hire New employees: within 18 months of hire

date (starts after 10/4/08) date (starts after 10/4/08) – Current employees: within 24 months of Current employees: within 24 months of

4/4/084/4/0844

Medical DirectorMedical Director

• Accountable to the Governing BodyAccountable to the Governing Body

• Responsible for patient care and Responsible for patient care and

outcomesoutcomes

• Responsible for effective QAPI and Responsible for effective QAPI and

Infection Control programsInfection Control programs

45

Medical DirectorMedical Director

• Responsible to assure all staff, physicians Responsible to assure all staff, physicians

& non-physician providers “adhere” to all & non-physician providers “adhere” to all

policiespolicies

• Must be engaged in any involuntary Must be engaged in any involuntary

patient transfer or dischargepatient transfer or discharge

45

Medical RecordsMedical Records

• Traditional rules on completeness & Traditional rules on completeness &

protection of medical recordsprotection of medical records

• Transfer requested records to the Transfer requested records to the

receiving facility within one day receiving facility within one day

46

Governance: RN PresenceGovernance: RN Presence

““An RN, who is responsible for An RN, who is responsible for

the nursing care provided, is the nursing care provided, is

present in the facility at all present in the facility at all

times that in-center dialysis times that in-center dialysis

patients are being treated.”patients are being treated.”

47

Governance: Patient Involuntary Governance: Patient Involuntary DischargeDischarge

Specific requirements Specific requirements – Reassess the patientReassess the patient– Involve the Medical Director Involve the Medical Director – Contact another facility and attempt to placeContact another facility and attempt to place– 30 days notice unless threat to safety30 days notice unless threat to safety– Notify the Network and the State AgencyNotify the Network and the State Agency

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

48

Governance: Electronic Data SubmissionGovernance: Electronic Data Submission

As of 2/1/09, every facility must As of 2/1/09, every facility must

electronically submit data on all electronically submit data on all

patients, including data on clinical patients, including data on clinical

performance measures, to CMS.performance measures, to CMS.

CROWN WebCROWN Web

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What Does the Future Hold?

and Lots of good work for youLots of good work for us!

50

Thank You for...Thank You for...

• Partnering with CMS to enhance & inform the Partnering with CMS to enhance & inform the

survey & certification worksurvey & certification work

• Providing data & outcomes to guide & direct Providing data & outcomes to guide & direct

our workour work

• Improving consistency by helping us build Improving consistency by helping us build

Interpretive Guidelines with common Interpretive Guidelines with common

understandingsunderstandings

51

* * Remember, the rules were only Remember, the rules were only published Thursday…published Thursday…

52

Helpful CMS WebsitesHelpful CMS Websites

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

• ESRD Center ESRD Center http://www.cms.hhs.gov/center/esrd.asp

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