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Describe the SAME test the SAME way ANYWHERE in the Healthcare ecosystem (as defined by/criteria)

Vision:

The performing clinical laboratory will describe/define their test information in accord with regulations (i.e. CLIA, accreditation). All those ordering, resulting and using laboratory tests will support the data needs in their information systems. Information system vendors will provide needed functionality to support the interoperable use (including sending and receipt) of these data in their systems (internal) and systems (external) to which they are connected, including apps, decision support, reporting, and other uses of the data without modification of the data to preserve the intended meaning, coding, and related information. Meaning shall be preserved for consumers and users of the data including for patient care, public health, real world data, real world evidence, research and trials, and other use cases.

Adoption of said requirements should occur in a reasonable timeframe (TBD, 3-5 yrs?) to allow development/roll out of needed functionality, identification and resolution of barriers, plans for implementation, and assessment. The end goal is X% of laboratory data interoperability within 5 years of implementation and X% of laboratory data which is available at the right place, right time, and right meaning within 10years of implementations to help achieve better patient outcomes, by improving the quality, safety, and efficiency of patient care, research, and diagnostics, (reducing health care costs?). (measurable objectives- 10%)

Meetings:

All membership meetings will be open to the public.  The collaborative community encourages applicable content, after confirmation from the author(s), be made publicly available.  Membership meetings are intended to provide updates on recent activities and to coordinate the scope of collective efforts.  Minutes are taken and will be made publicly available.

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The collaborative community is open to all those working in the field who wish to join.  Members are expected to join teleconferences and in-person meetings and to provide input and feedback to inquiries from their colleagues.  Members are free to leave the collaborative community at any time.

Membership shall include representation from:

  1. IVD industry and devices (IICC members, MDIC, AdvaMed, etc)

  2. Information system vendors (LIS, LIMS, PH, EHR, etc)

  3. Laboratories (CAH labs, independent reference labs, PH/govt labs, academic labs, ACLA members, blood banks, physician office labs, etc.) including laboratory professionals

  4. Laboratory Informatics expertise whether from professional organizations (laboratory-CAP, AACC, ASCP, etc., or informatics- AMIA, API, public health- APHL, etc)

  5. Federal Agencies (FDA, ONC, CDC, CMS, NLM, CLIA,

  6. Standards Development Organizations (LOINC, SNOMED CT, HL7, etc.)

  7. TBD- Health Professionals (i.e. MD, RN, PharmD, C suite- CIO, CMIO) utilizing lab data (or more from usability testing)

  8. TBD- Other industry users/generators (consumer devices, big data/cloud vendors, etc.) (do we include these data processors/generators?)

Roles:

Convener:

Committee Chairs:

Current representation from these organizations:

(Shall representation be equitable across orgs. Shall an org have a single vote by its members?)

Charter review and amendments:

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All decisions made by the collaborative community are supported democratically <TBD e.g. through a simple majority vote> (provided that a quorum <TBD - e.g. >50% of voting charter signatories>) with dispute adjudication exercised before the full community.  (Does each org have a single vote or does each member?)

Charter Signatories:

Name

Organization

Date

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