Effective Date:

Mission:

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. All meetings will follow the decision making practices described below; procedures will follow Roberts Rules.

Regular Meetings:

At least one annual meeting, open to the public and for the entire membership, shall be held in-person or remotely. Notice of regular meetings will be provided at least fourteen days in advance of the meeting.

Committee Meetings:

Committees will establish the cadence of their meetings per group decision and are convened by the committee chair(s). Notice of these meetings will be provided at least 1 week in advance of the meeting.

Special Meeting:

Special meetings may be requested by <charter signatories> at any time; notice of the time and place of each special meeting will be provided at least three days in advance of the meeting

Committees:

Work will be shared among committees, that focus on specific aspects towards furthering SHIELD’s mission.

In Scope:

Supporting standard coding for lab data elements

LOINC

SNOMED CT

UCUM

HL7

metadata around the test kit and instrument that was used for components that created the results

Lab domains:

Focus on IVD lab instrument tests to start with (no LDTs at the moment) - any tests where there is interfacing or data is available via apps (can include those POCT / OTC)

Chemistry

Hematology

Microbiology

Bloodbanking

Identification of harmonized tests - per this definition = https://www.harmonization.net/measurands/

In Scope Activities: Testing Continuum / Ecosystem

Questionable:

Calibration - use of calibration reagents - provide list of “acceptable reagents” of those not yet harmonized to the manufacturers

Identifying a test as an LDT

Out of Scope:

LDTs (not using the manufacturer’s SOP)

POCT / OTC testing that don't use instruments - so anything that cannot provide data to the LIS (could be via apps) and where LIVD can be provided

Claims data (CPT / HCCPS concepts)

Membership:

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, VA, etc)

6. Standards Development Organizations (Regenstrief (LOINC), SNOMED International of National Library of Medicine (SNOMED CT), HL7, IHE, 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?)

9. (TBD) - Patients

Roles:

Convener(s):

Prepares meeting agendas based on input from the community, sets up calls, facilitates the calls and ensures notes / recordings of the meetings are posted. This position is nominated and then elected by the community. The person filling this role needs to be outside of the potential power struggle between federal agencies; ideally a private entity.

Committee Chairs:

For each created committee, the chair(s) perform the role of convener for that specific committee - participation of mulitple chairs is encouraged and labor division is up to the chairs to decide. This position is nominated and then elected by the community.

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:

Goals:

How we measure efficacy of the collaborative community:

Decision Making Practices:

All decisions made by the collaborative community are supported democratically <TBD e.g. through a simple majority vote>, provided that a quorum of <TBD - e.g. >50% of voting charter signatories> was achieved with dispute adjudication exercised before the full community.  (TBD: Does each org have a single vote or does each member? If each member, need to ensure we don't have preponderance of influence.)

Charter Signatories: