End Stage Renal Disease (ESRD)

1

• End Stage Renal Disease (ESRD)
• http//www.hcfa.gov/medicare/esrdpage.htm
• http//www.hcfa.gov/quality/qlty2D5d.htm
• Standard Information Management System (SIMS)
• http//www.simsproject.com
• http//www.esrdnetwork6.org
• Vital Information Systemto Improve Outcomes in
  Nephrology (VISION) HCFA / ESRD E-Reporting
  based on HL7 v3 XML Technology
• XML based Data Collection / ETL Toolsoon
  http//www.metaintegration.net/HCFA
• Contacts _at_ HCFA Contacts _at_ Meta Integration
• Cyrus Karimian CKarimian_at_hcfa.gov Bill Le
  Clair leclair_at_metaintegration.com
• Denis Stricker DStricker_at_hcfa.gov Christian
  Bremeau bremeau_at_metaintegration.com

2
HCFA ESRD Network SOWBackground

• The Statement of Work (SOW) delineates the
  activities to be conducted by each End Stage
  Renal Disease (ESRD) Network Organization
  (Network) to meet the requirements of section
  1881(c) of the Social Security Act the Health
  Care Financing Administration's (HCA's) Health
  Care Quality Improvement Program (HCQIP) and
  other directives related to improving the quality
  of care of patients with ESRD.
• The statute, regulations, the ESRD Network
  Organizations manual, and other HCFA instructions
  provide additional detail concerning Network
  functions, activities, and responsibilities.

3
HCFA ESRD Network SOWGoals

• Improve the quality of health care services and
  quality of life for ESRD beneficiaries
• Improve data reliability, validity, and reporting
  among ESRD providers/facilities, Networks and
  HCFA (or other appropriate agency)
• Establish and improve partnerships and
  cooperative activities among and between the ESRD
  Networks, Peer Review Organizations (PROs), State
  Survey Agencies, ESRD providers/facilities, ESRD
  facility owners, and professional groups.

4
HCFA ESRD Network SOWInformation Management

• The Network shall be required to utilize
  theStandard Information Management System
  (SIMS)to support Network data processing,
  information management and reporting contractual
  requirements to HCFA.
• HCFA is redesigning the current Renal Beneficiary
  and Utilization System (REBUS).
• The new system will be named the Renal Management
  Information System (REMIS).
• The Network shall be required to utilize REBUS or
  REMIS as directed by HCFA.

5
HCFA / ESRD / SIMSResponsibilities

• The Network's responsibilities for data
  processing, information management and reporting
  are
• To have sufficient system capacity with the
  appropriate computer hardware and software to
  carry out its contractual responsibilities
• To effectively manage the collection, validation,
  storage and use of data, including data provided
  by HCFA, for review, profiling, pattern analysis,
  and sharing with the HCFA RO and State Survey
  Agency for use in its ESRD Medicare survey and
  certification activities
• To ensure timely and accurate reporting by the
  providers/facilities
• To maintain an ESRD patient and facility database
  and ensure the integrity and accuracy of the
  databases and
• To ensure the quality and accuracy of the data
  submitted to HCFA for inclusion in the ESRD
  Program Management and Medical Information System
  (PMMIS) and the United States Renal Data System
  (USRDS).

6
HCFA / ESRD / SIMS System Capacity

• The Network shall maintain a system that provides
  the capacity to meet its contractual
  responsibilities for data collection, validation,
  entry, retrieval, profiling, analysis, and
  reporting, and for electronic data interchange.
  The system, at a minimum, shall utilize and
  consist of the following
• SIMS software, and program documentation, for the
  entry and transmission of the HCFA ESRD forms
  described in section C.5.E.
• HCFA approved software for the entry and
  transmission of clinical performance measures
  described in section C.2.C.
• Internet enabled electronic mail capability
  compatible with HCFA, including the ability to
  send and receive attachments
• Dial-in capability for connection to REBUS and
  HCFA compatible web browser access for connection
  to REMIS
• Office automation software compatible with the
  HCFA standard
• HCFA supplied or other statistical software for
  data analysis and profile analysis including
  profiling patients and facilities by county to
  facilitate disaster planning and other studies
• Provisions for disaster recovery of the databases
  and data system and
• Sufficient hardware to run the above software
  applications.

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HCFA / ESRD / SIMSDatabase Management

• The Network shall maintain a patient database
  containing the minimum/ critical data elements
  listed in the Draft ESRD Network Organizations
  Manual instructions. The Network shall perform
  the following tasks related to its patient
  database
• The Networks shall consistently update the SIMS
  central repository based on data received from
  the providers/facilities. HCFA will receive a
  data feed from the SIMS central repository on a
  regularly scheduled basis to obtain an update of
  the Networks patient data for REBUS/REMIS.
• Upon notification from HCFA either by hardcopy or
  electronically through REBUS/REMIS, update the
  Network's patient database with valid changes to
  important data elements (e.g., beneficiary name,
  date of birth, Health Insurance Claim Number
  (HICN) and Beneficiary Identification Code
  (BIC)).
• Through SIMS, the Network shall also maintain a
  facility database containing the minimum data
  elements listed in the Draft ESRD Network
  Organizations Manual instructions. HCFA has the
  capacity to create data files and labels, and to
  verify data for the national listing, directly
  from the SIMS system. HCFA will give the Networks
  two weeks notice prior to taking these actions so
  that Networks can properly schedule their system
  updates for the date the file is created.

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HCFA / ESRD / SIMSCollection, Validation
Maintenance of HCFA ESRD Forms (Introduction)

• The Network shall obtain completed HCFA ESRD
  forms from each ESRD provider/facility in the
  Network area. The Network will also include all
  voluntarily submitted forms from the non-Medicare
  Department of Veterans Affairs (DVA) facilities,
  and other institutions such as prisons and
  nursing homes. These forms contain patient
  specific information necessary for the operation
  of the national ESRD program. The HCFA ESRD forms
  and their facility computer generated equivalents
  include the following
• HCFA-2728-U4 - ESRD Medical Evidence Report
  Medicare Entitlement and/or Patient Registration
  (completed on each incident ESRD patient)
• HCFA-2744 - ESRD Facility Survey (completed
  annually)
• HCFA-2746 - ESRD Death Notification (or
  computerized facility generated Death
  Notification form) (completed within 30 days of
  the date of death)
• HCFA-820 - In-Center Hemodialysis (HD) Clinical
  Performance Measures Data Collection Form and
• HCFA-821 - Peritoneal Dialysis (PD) Clinical
  Performance Measures Data Collection Form.

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HCFA / ESRD / SIMSCollection, Validation
Maintenance of HCFA ESRD Forms (VISION)

• It is anticipated theVital Information System
  to Improve Outcomes in Nephrology (VISION)
  project will be rolled out during this contract
  period, with National Implementation slated for
  the first quarter of calendar year 2001. However,
  until such time as the HCFA requires electronic
  reporting from all dialysis facilities for all
  patients, it will be on a voluntary basis. At
  that time, the Networks will be responsible for
  validating the data from the facilities.
• Monitoring the accuracy and completeness of
  reports, and the validation of facility-level
  patient data are critical roles in assuring the
  integrity of the patient tracking system.
  Similarly, capturing data forms on all incident
  cases requires a mechanism for cross-checking so
  facilities can query and detect unreported forms.
  As VISION is implemented, the activities
  specified below will need to be retained in a
  format that is consistent with migration from
  hardcopy to electronic reporting.

10
HCFA / ESRD / SIMSCollection, Validation
Maintenance of HCFA ESRD Forms (Activities)

• The Network shall conduct activities to ensure
  that the data required on the forms are
  collected, completed, and validated in accordance
  with Draft ESRD Network Organizations Manual
  instructions, and the ESRD Program Instruction
  Manual for Renal Providers. These activities
  include the following
• Review forms received for accuracy and
  completeness and return to the provider/facility
  (or otherwise query the provider/facility) for
  correction or completion of those forms with
  missing or inaccurate data.
• Receive and process the ESRD Medical Evidence
  Report, Medicare Entitlement and/or Patient
  Registration form (HCFA-2728-U4).
• Process and transmit the information on HCFA-2728
  and HCFA-2746 forms directly to the HCFA Data
  Center via SIMS.
• Process and transmit the information on the
  HCFA-2744 form directly to the HCFA Data Center
  via SIMS by the fifth working day in April.
• Transmit corrections on the HCFA-2744 form by
  hard copy or through SIMS by the third Friday in
  May.
• Maintain a file of all HCFA ESRD hardcopy forms
  that are processed for at least two years.

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HCFA / ESRD Data FlowThe big picture
Social SecurityAdministration(SSA)
End Stage Renal Disease (ESRD) Facility
Transforming the ESRD Reporting Process to
HCFAfrom Paper Forms to HL7 v3 XML based
E-reporting
End Stage Renal Disease (ESRD) Facility
Health CareFinancingAdministration(HCFA)
End Stage Renal Disease (ESRD) Facility
ESRD Medical Information SystemFacility
SurveyPart One DialysisPart Two Kidney
Transplants Form HCFA-2744
ESRD Medical Evidence ReportMedicare Entitlement
And/Or Patient RegistrationForm HCFA-2728-U3
FacilitySpecific InformationForm SIMS-???
PatientSpecific InformationForm SIMS-???
In-Center Hemodialysis (HD)Clinical Performance
Measures Data CollectionForm 2000, Form HCFA-820
Patient DeathForm HCFA-2746
Peritoneal Dialysis (PD)Clinical Performance
Measures Data CollectionForm 2000 Form HCFA-821
ESRD Beneficiary Selection(Home Patients
Only)Form HCFA-382
Dialysis Facility (DF)Clinical Performance
Measures Data CollectionForm 2000 Form HCFA-???
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HCFA / ESRD Data FlowThe SIMS front end
End Stage Renal Disease (ESRD) Facility
SIMS Networks(geographicallydistributed)
End Stage Renal Disease (ESRD) Facility
End Stage Renal Disease (ESRD) Facility
Network 01
SIMS
Health Care Financing Administration
(HCFA)
Network 02
End Stage Renal Disease (ESRD) Facility
End Stage Renal Disease (ESRD) Facility
SIMS
End Stage Renal Disease (ESRD) Facility
ReportingHCFA(Paper)Forms

Integrated SIMS Repository (Master)

HCFA Internal Databases
Network 20
End Stage Renal Disease (ESRD) Facility
End Stage Renal Disease (ESRD) Facility
SIMS
End Stage Renal Disease (ESRD) Facility
Integrated SIMS Repository (Shadow)
HCFA-2728-U3
HCFA-2746
HCFA-2744
OvernightUpdates
Replication
IBM Model 2.04 Databases
MS SQL Server Databases
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HCFA / ESRD Data FlowInside HCFA Today
Health Care Financing Administration
(HCFA)
Social SecurityAdministration(SSA)

MS SQLServer
Integrated SIMS Repository (Master)
IBM Model 2.04
REBUS Renal Beneficiary and Utilization System
Integrated SIMS Repository (Shadow)
IBM Model 2.04
HCFA Main Database
14
HCFA / ESRD Data FlowInside HCFA Tomorrow
Health Care Financing Administration
(HCFA)
Oracle Business Intelligence (BI) Knowledge
Management (KM) Solutions Data Warehousing Data
Mining OLAP
AuxiliaryESRD Specialized Databases
Very limited and primitive had-hoc query and
reports on the IBM mainframe (no need for legacy
software migration,replaced by Oracle BI KM
tools DW, DM, OLAP).
Oracle 8i
Updates ETL
Legacy Migration ETL
IBM Model 2.04
Oracle 8i
Legacy ESRD Database REBUS Renal
Beneficiary and Utilization System (to be
shutdown)
New ESRD Database REMIS "Renal
Management Information System"
Updates ETL
IBM Model 2.04
HCFA Main Database
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HCFA / ESRD Data FlowLong Term Objective
Do they havea database ?
Health CareFinancingAdministration(HCFA)
End Stage Renal Disease (ESRD) Facility
MS SQL Server
Data Extraction, Transformation Load
(ETL) Electronic Data Interchange (EDI)over
Secure Internet (based on XML)
RDBMS ?
SIMS
Home Made or Commercial Product
Are they connectedon internet / dialups ?
Is HL7 v3XML Ready ?
How about the securityof the medical information
?
16
HCFA / ESRD Data FlowThe VISION Data Collection
Tool(Vital Information System to Improve
Outcomes in Nephrology)

• Manual Entries of HCFA Forms
• Automatic Import (ETL from ESRD Facility
  Database)
• Automatic Export (ETL to HCFA SIMS)
• Form Editing, Browsing, Queries, Printing, etc.

HCFA-2744
HCFA-2728-U3
HCFA-2746
End Stage Renal Disease (ESRD) Facility

VISION Data Collection Tool(Windows Standalone
Utility)
Health CareFinancingAdministration(HCFA)

Graphical User Interface (GUI)(Windows Visual
Basic)
Graphical User Interface (GUI)(Windows Visual
Basic)
Graphical User Interface (GUI)(Windows MFC
Visual Basic)
MS SQL Server
MS Access DB
RDBMS ?
SIMS
ETL
ETL
VISION (similar to SIMS)
Home Made or Commercial Product
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HCFA / ESRD Data FlowETL 1 2 VISION
Import/Export of HL7 v3 XML Based HCFA
Documents
VISION Data Collection Tool(Windows Standalone
Utility)
Meta Integration? Works Data Extraction,Transfor
mation Load (ETL)
Graphical User Interface (GUI)(Windows Visual
Basic)
Graphical User Interface (GUI)(Windows Visual
Basic)
Graphical User Interface (GUI)(Windows MFC
Visual Basic)
Generation Maintenance of theData Movement
Components(C based, Windows PlugPlay)
XML Files
MS Access DB
Import
HL7 v3 XML basedHCFA-2728-U3
Data Movement Component
Export
Data Movement Component
VISION (similar to SIMS)
Import
Data Movement Component
HL7 v3 XML basedHCFA -2744
Export
HL7 v3 XML basedHCFA -2746
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HCFA / ESRD Data FlowETL 3 HCFA / SIMS Import
of HL7 v3 XML Based HCFA Documents
Meta Integration? Works Data Extraction,Transfor
mation Load (ETL)
Health CareFinancingAdministration(HCFA)

Generation Maintenance of theData Movement
Components(C based, Windows PlugPlay)
XML Files
MS SQLServer
HL7 v3 XML basedHCFA-2728-U3
Import
Data Movement Component
SIMS
Import
Data Movement Component
HL7 v3 XML basedHCFA -2744
Import
HL7 v3 XML basedHCFA -2746
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HCFA / ESRD Data FlowETL 4, 5, ESRD
Facility Export of HL7 v3 XML Based HCFA
Documents
Meta Integration? Works Data Extraction,Transfor
mation Load (ETL)
Generation Maintenance of theData Movement
Components(C based, Windows PlugPlay)
End Stage Renal Disease (ESRD) Facility

XML Files
Any RDBMSvia ODBC
HL7 v3 XML basedHCFA-2728-U3
Export
Home Made or Commercial Product
Data Movement Component
Export
Data Movement Component
HL7 v3 XML basedHCFA -2744
Export
HL7 v3 XML basedHCFA -2746
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HCFA / ESRD Data FlowGenerating Data Movement
Components HL7 v3 XML based HCFA Documents
Meta Integration? Works Data Extraction,Transfor
mation Load (ETL)
(step 1) Model Converter (Import Bridges)
Database SchemaLogical Model (ERwin, Rose,
etc.)Physical Model (DDL)
METADATALEVEL
HL7 v3 XML DTDbasedHCFA-2728-U3
(step 2) Model Mapper
(step 3) Data Bridge Builder
MS Access DB
VISION (similar to SIMS)
HL7 v3 XMLbased HCFA-2728-U3
HCFA-2728 HL7 v3 XML to VISION Data Movement
Component
DATALEVEL
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HCFA / ESRD Data FlowIntroducing VISION phase 1
End Stage Renal Disease (ESRD) Facility
End Stage Renal Disease (ESRD) Facility
Health Care Financing Administration
(HCFA)
Network 01
End Stage Renal Disease (ESRD) Facility
SIMS
Network 02
End Stage Renal Disease (ESRD) Facility
SIMS
End Stage Renal Disease (ESRD) Facility
End Stage Renal Disease (ESRD) Facility
ConventionalReporting HCFA(Paper)Forms

Integrated SIMS Repository (Master)

Network 19
End Stage Renal Disease (ESRD) Facility
SIMS
End Stage Renal Disease (ESRD) Facility
End Stage Renal Disease (ESRD) Facility
Integrated SIMS Repository (Shadow)
VISIONData CollectionTool(WindowsStandaloneUt
ility)
Network 20
E-Reporting HyperShipSecuredTransport U.S.
PostalOfficeCertified !
SIMS
HCFA-2728-U3
HCFA-2746
HCFA-2744
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HL7 DevelopmentEnvironment
Interaction Model
Interaction Model
Interaction Model
Unused?
DomainInformation Models(DIM)
ReferenceInformation Model(RIM)
Refined Message Information Model(R-MIM)
Message Object Diagram
Message Object Diagram
Message Object Diagram
Harmonization Process
HierarchicalMessageDescriptions(HMD)

• The HL7 Development Environment is composed of
• A repository called RIM implemented on
  Microsoft Access
• Represents the master copy of all HL7 metadata,
• Contains RIM tables as well as R-MIM, HMD, more?
• Can be populated from Rational Rose(with
  referential integrity, and version management))
• But contains more information than in Rose?
• Can export to Rose
• A toolset called RoseTree implemented with
  Visual Basic

HL7 v2.x(Encoding- Rules 7) ER7
HL7 v3.x(XML DTD)Messages
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HL7 v3 XML Based HCFA DocumentsDocument/Message
Construction

• Goal
• Build HL7 XML documents/messages for HCFA forms
• Use Message Development Framework Version 3.2
  April 1999
• Use RoseTree
• RIM095 with no modifications
• Use standard coding schemes
• LOINC codes (Logical Observation Identifiers,
  Names and Codes ) for identifying laboratory and
  clinical observations.
• ICD-9 (International Classification of Diseases)
• Fortunate that USAM 2.4 (Unified Service Action
  Model) existed

24
HL7 v3 XML Based HCFA Documents Current Message
Choices

• What about the current documents
• Patient Record Architecture Framework
• Not enough RIM information
• Not all the information seems to be in the RIM
  (i.e.,Clinical_Document_Header with Patient
  relationship)
• Closest to what we need but timeliness is an
  issue
• Could not find other documents dealing with
  documents

25
HL7 v3 XML Based HCFA Documents Classes Used
Clinical_document(1) Clinical_document_header
(1) Authentication(0..1)
Healthcare_document_authenticator(1)
Person(1..n) Person_name(1)
Service(0..n) Target(0..n)
Material(1) Master_patient_service_l
ocation(1) Dependent_Service(1..n)
Service(1) Healthcare_provider_organiza
tion(1) Master_patient_service_loca
tion(1) Patient(1) Person(1)
Person_name(1) Employee(0..n)
Person_Employment(0..n) Administrative_patien
t_death(1)
Master_patient_service_location (from previous
box) Patient(1) Patient_Encounter(0.
.n) Service(0..n)
Target(0..n) Material(0..1)
Master_patient_service_lo
cation(0..1) Dependent_Service(0..n)
Service(1..n)
Consent(1) Consent.Actor(1)
Consent.Witness(0..1)
Master_healthcare_benefit_product(0..1)
Insurer(0..1) Organization(1)
Material(0..n) (Statistical)
Target(0..n) Service(0..n)
(statistical)
Service is an Observation, Procedure,
Condition_node, Medication, or Supply
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HL7 v3 XML Based HCFA Documents Status

• Lessons learned
• The RIM is fairly complete found no needs
  create new relationships or to create new
  attributes
• It is sometimes hard to choose a path when
  several paths are possible and valid (Services
  for example)
• Yes/No questions require interpretation
• Members of HL7 are very cooperative
• Waiting on
• Statistics not yet defined
• Used Xeena tool from IBM (free validating XML
  editing tool)