CCR Standard Development and Maintenance

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CCR Standard Development and Maintenance

• CCR Developers and Users Conference
• June 15, 2005
• Claudia Tessier, CAE, RHIA
• Co-Chair, ASTM E31 Workgroup on CCR
• Executive Director, Mobile Healthcare Alliance

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ASTM International

• International Standards Development Organization
  (SDO)
• ANSI Accredited SDO
• Formed in 1898 oldest SDO in US
• Private sector, not-for-profit organization
• Purpose is to develop and deliver standards and
  related information in response to market needs

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ASTM Provides Standards Forum for More than 100
Industries

• Healthcare Informatics
• Medical Devices
• Bio-Genetics
• Petroleum
• Steel
• Rubber
• Plastics
• Paint
• Metals
• Chemicals

• Environment
• Road and Paving Materials
• Thermal Insulation
• Cement and Concrete
• Textiles
• Medical Devices
• Consumer Products
• Livestock, Meat, and Poultry Evaluation Systems
• And more

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ASTM Standards Development Key Principles

• Key stakeholders represented
• Consensus process
• Neutrality and openness
• Balance of interests
• Ensure due process
• Standards maintenance

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ASTM E31Committee on Health Informatics

• Since CCR work began, membership has grown to
  over 400
• Subcommittees include
• E31.20 Security and Privacy
• E31.22 Healthcare Documentation
• E31.28 EHR
• Total membership now over 100
• CCR Workgroup
• Nonmember distribution list over 300

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CCR Unique Standards Development Effort

• Consortium of not-for-profit sponsoring
  organizations
• ASTM International
• Massachusetts Medical Society
• HIMSS
• American Academy of Family Physicians
• American Academy of Pediatrics
• American Medical Association
• Patient Safety Institute
• American Health Care Association
• National Association for the Support of LTC
• Mobile Healthcare Alliance (MoHCA)
• Additional sponsoring organizations pending

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Sponsors represent

• ANSI-recognized standards development
  organization
• Over 400,000 practitioners
• Over 13,000 IT professionals
• Over 12,000 institutions in the long-term care
  community that provide care to over 1.5 million
  elderly and disabled

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Other Stakeholders

• Other medical specialties
• Members of other SDOs, e.g., HL7
• Other professional associations
• Other health-related associations
• Technology experts
• Vendors
• Healthcare practitioners
• Provider institutions
• Government agencies, federal and state
• State departments of health
• Consultants
• Patients and patient advocates
• International members
• Health plans
• Others

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NHII Conference June 2003

• Physicians and other clinicians sometimes
  provide patient care without knowing what has
  been done previously and by whom, resulting both
  in wasteful duplication and in clinical decisions
  that do not take into account critical data
  related to patient health.

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So, how to create consensus?

• Complex Task
• First major standard involving medical
  specialties along with wide range of other
  stakeholders
• First major healthcare standard addressing
  content
• Had to overcome some negative perceptions of ASTM
  E31

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In the beginning

• Late 2002, E31 meeting Tampa FL
• Decision to create PCRF workgroup within ASTM
  E31.28
• Early 2003 Discussions and communications with
  stakeholders
• MMS becomes first co-sponsor
• Spring Summer 2003
• HIMSS joins MMS as a co-sponsor
• Planning meeting July 2003 with government
  representatives and other select stakeholders
  agreement that CCR is needed
• AAFP becomes a sponsor
• Plan Standardize a core dataset of patient
  information to be shared when a patient is
  referred from one provider to another (PCRF)

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And then 2003 - 2004

• Concept paper and FAQs
• Work on draft standard begins
• Draft specification
• Core data elements
• What to include, what not to include
• Consensus process
• Stakeholder input
• Editorial process
• Team approach between meetings
• Formal consensus occurs at ballot time
• Additional sponsorships and meetings
• AMA, AAP, PSI, AHCA, NASL, MoHCA
• Meetings in Boston, Kansas City, Florida, DC

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Ballot process

• Voting privileges
• Members of ASTM E31.28 and Main Committee
• Fast tracked, so both votes in tandem
• Requires 60 response rate, 90 affirmative vote
• 30-day ballot
• Ballot reconciliation meeting
• Quorum 8 of committee/subcommittee membership
• Affirmative with or without comment
• Abstention with or without comment
• Negative with rationale

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Spring 2004 First ballot

• April 2004 Ballot passed after resolving
  negative votes
• Withdrawn with or without editorial change and
  changed to affirmative or abstention with or
  without comment
• Found nonpersuasive with or without editorial
  change (requires 2/3 positive vote)

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Spring Fall 2004

• As standard spec was prepared for publication
• Work continued on improving CCR
• Increasing interest/demand for xsd and
  implementation guide, initially planned as
  separate standards
• Over time, decision made to prepare
  single-package standard
• Specification
• Data elements spreadsheet
• .xsd
• Implementation Guide

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VTAG

• Formed Vendor Technical Advisory Group
• In response to vendor community seeking more
  organized opportunities for input
• Planned to post work on website
• Scheduled 3-4 conference call meetings
• Worked on xsd and Implementation Guide
• Minimal involvement, waning participation

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Preparing for second ballot

• New sponsors, expanding membership, growing
  nonmember interest and database
• Preparing package for ballot
• Revised standard specification
• Revised data elements spreadsheet
• XSD
• Implementation Guide

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Second ballot March April 2005

• Ballot reconciliation meeting April 28
• Some affirmative and abstention votes with
  comments
• Several negative votes, some essentially
  duplicates of one another
• All issues addressed at April 28 were resolved
• Insufficient time to address all negative votes

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Second Ballot - continued

• Second meeting on June 8
• Remaining negative votes addressed and resolved
• Important Agreed to note that in electronic
  version, XML is required, either the specified
  XML or that developed through joint efforts of
  ASTM and other SDOs
• Timetable for release of CCR established
• June 17 All editorial input from negative votes
  to be submitted to Claudia
• July 1 Red-lined specification to be posted on
  Yahoo site
• July 15 Resolution of editorial changes
• July 22 Final draft to ASTM to prepare for
  publication
• September Release of CCR standard

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Maintenance and Next Steps

• ASTM has review calendar for standards
• Amend, withdraw, or renew as is
• Can do earlier revision
• Potential for extensions, e.g., long-term care,
  HIV, pediatrics and other medical specialties
• Assess needs do they require extension?
• If yes, development will follow usual ASTM
  standards development process and balloting
• If not, can use CCR core data set
• Harmonization work with HL7
• Other harmonization work with other SDOs,
  including NCPDP, X12, etc.

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Maintenance and Next Steps

• Potential for specification for paper CCR display
  format
• Expanding international interest
• Europe, Asia, Canada
• ASTM International has established relationships
  worldwide
• New CCR Technical and Clinical Work Group
• New CCR Acceleration Task Group
• Other possibilities

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How can you become involved

• Join ASTM E31 and its EHR subcommittee E31.28
• Dues are 75 per year and include free access to
  standards
• Purchase standard as nonmember price not set
  yet, but probably around 50
• Be added to CCR nonmember distribution list
• Have your organization consider becoming a
  co-sponsor
• Join the Technical and Clinical Work Group
• Join the CCR Acceleration Task Group
• Participate in meetings, website, etc.

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CCR Technical Clinical Work Group

• Development and editorial and change management
  of the CCR standard.
• At least two co-chairs
• Email discussion list for people to participate
  to the development process and to be advised of
  scheduled conferences, calls, and meetings.
• Periodic TCWG calls in between scheduled
  face-to-face meeting.
• Shared workspace on the web (either part of the
  ASTM web site or separate currently Yahoo)
  where standard developers and interested parties
  with appropriate rights of access can find
• Current and prior versions of the standard(s),
  schema(s), and associated tools (XSLT, etc.).
• Presentations, discussion, and reference
  materials.
• Scheduled call and meeting minutes.
• Call and meeting schedules.

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Thank you!

• For more information on the CCR
• Claudia Tessier, CAE, RHIA
• 202-659-2699
• ctessi_at_attglobal.net