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  • List Implementation Needs/Preconditions/Assumptions

  • Define Timeline Milestones/Phases/Scope

    • List Goals/Achievements/Measures for each Milestone/Phase/Stage

    • Define metrics to know how you know you’ve met or missed the mark.

  • Define Interoperability

    • Semantic

    • Syntactic

    • What is the goal for each milestone/phase?

  • List code systems involved and whether precoordinated/post coordinated approach for mapping

    • Same test results may be mapped differently/different code systems depending on requirements in downstream systems. VRE per ELR to public health requirements maps in LIS and ELR message to Public health the Vancomycin antibiotic to LOINC, result value to resistant SCT qualifier code, and organism of Enterococcus faecalis to the SCT organism code. However EHRs receiving these data need to remap/restructure them (often with EHR based remapping table/interface to create CDA document for Healthcare Associated Infection (HAI) reporting to Vancomycin Resistant Enterococcus (VRE) precoordinated SCT organism code. So two different public health systems are receiving two differently structured and encoded lab results via two different messaging HL7 implementation guides.

  • Provide Status Update of existing SHIELD Pilots

  • Proposal/Ideas

    • Phase 0: Assessment of current state

      • Information System Use

        • How many labs use an electronic system (LIS, LIMS, EHR, other portal) to build laboratory orders, results, values?

        • How many labs use paper reporting?

        • How many labs use fax/phone reports?

        • Goal: Get all those use non electronic reporting to electronic reporting.

          • How achieved? Policy? Incentives to purchase/install system? Funding to help labs build, etc.

          • How measured? Within a year, 50% increase with 100% increase in 2 years? What is the gap and how filled?

      • Information System functionality

        • Does Information system have basic lab/informatics/coding/messaging functionality?

          • Codesystems

            • LOINC, SNOMED CT,

            • Does information system support functionality for mapping lab orders and results to current LOINC releases and maintenance

            • Does information system support functionality for mapping qualitative result values, specimen types, specimen sources, organisms, collection procedures, etc. to latest (US or Intl) versions of SCT and maintenance

            • Other code systems: ICD, UCUM, CPT, etc.

            • Goal: Have all LIS/EHR/ information systems with code system support (by when)? How measured? (certification process like EHRs or other measure)?

          • Capability to build/support discrete orders and results and result values for all lab test info

            • Current State: Some LIS/LIMS vendors are unable to support creation of discrete orders and results for all lab data. Some have “workflow items” that are added on to support billing and documentation, but are unable to be mapped to LOINC or SCT as they are not built as orders, results, values. Others have capability for test orders, but they are “suppressed” and not released external to LIS/EHR. More common in microbiology and blood bank areas (i.e. micro antibody susceptibility panel orders, blood bank antigen testing). Will take time to get functionality, so may not be first phase of LIVD implementations.

            • Goal: get all lab data discretely captured, reported (origin, receipt in, sent out).

            • How achieved/measured? Vendor functionality (certification?) Measure of test data that is build discretely as orders/results

          • Discretely captured lab data (i.e. non text blob, pdf reports)

            • Current State: Fair number of lab results/report of record are still not discrete, especially those received from labs via pdf or fax or paper which are scanned/stored as pdfs. At best, these pdfs can support a single LOINC code (path report, lab report), are not very computer processable or semantically interoperable and information therein requires manual work/reading, etc.

            • Assess current state of how much lab data is not very usable as non discrete. Metrics/definitions needed. Assess what is discrete and not encoded (i.e. CAP Cancer Protocols, Genomics reports, some micro/esoteric testing). Assess what % is codified (i.e.) and not codified (individual reports or overall orders/results/values)

            • Goal: Work to make % improvements on discretely capturing and reporting data (some is discretely captured, but still reported as text blob/pdf) in all information systems. Goal : Work to make % improvements on encoding discrete data (precondition here).

            • Note: Won’t be 100%, but perhaps we can get to 70% overall. May want to assess by lab area (chem, hem, micro, blood bank, genomics, cytology, pathology, etc.) as will vary by section. Chem and Hem may get closer to 90% goal, but genomics might be 20% now (harder to get discrete and codify). Pathology may have good discrete coverage, but not as much with encoding (as work in progress). Goals should be realistically achievable. Also some lab data may never be encoded (i.e. no LOINC, not conducive).

      • Issue/Current State: Many LISs and EHRs have test (order and result) naming conventions that differ from the performing lab’s conventions. This contributes to inoperability when these data are shared. The same test may be built/named differently by different physician practices, EHR/LIS/LIMS vendors and combinations there in. If the same result from say LabCorp, Quest, Mayo, etc is named differently in different systems, when they are exchanged via HIEs, sent to public health, FDA, etc, how will end users know whether these tests are the same or different?

        • Most EHRs/LISs/LIMS receive the lab report of record and preserve a “snapshot” to meet CLIA/interface checks requiring it to be the same as the performing lab sent. However, most all receiving systems “remap” the data elements received to their system’s data dictionary and destroy the original message. When these data dictionary terms differ from the performing lab, the name changes occur. This is a huge contributor to variability in test naming conventions.

        • In some cases remapping of LOINCs may occur to a less specific LOINC when an EHR is receiving three lab results (that may not be exactly the same) maps all results/values to their internal database name that is a generic for all three results and may have a methodless LOINC to accommodate not building each out individually in their test data dictionaries. Do recognize physicians/downstream users may not care about the details/methods, etc. but they may be vital in other instances and not lose this valuable information provided by each lab.

        • Current State Assessment: How many lab results, orders preserve the exact naming convention from the performing lab and how many have any type of modification/permutation (identified per orderable or resultable test code)? Would LabCorp, Quest, Mayo, ARUP be able to assess via their interfaces (more than just interface checks) with lab and physicians, hospitals, public health, etc.?

        • May involve definition of source of truth/origin of lab order and result and value. Is a CBC with a Plt the same as without a plt even though named the same way. May involve external/objective source of truth definition.

        • Goal: Get EHR/Downstream systems/users to use the same naming convention for lab orders and results and not modify them. compare performing lab naming with downstream systems (EHR, Public Health, FDA systems) to measure current state and improvements.

  • For later phases (such as needs for FDA, etc.), it would help to understand requirements for assessing devices, test systems, etc. and interoperability needs. My understanding is much of the data is coming from the EHR (not the LIS) and coupled with meds, and other health data, and may have different interoperability needs.

  • Definitions (may need to move to glossary, but pertinent to scope).

    • Lab test order:  Placed by the physician to request a laboratory analysis on a patient specimen using Electronic Health Record (EHR) Clinical Provider Order Entry (CPOE) functionality.  May serve as the order requisition of record per Clinical Laboratory Improvement Amendments (CLIA).

      • Types

        •May be single order(able) such as a Calcium level with a single result(able) of Calcium level

        •May be a panel such as a CBC (Complete Blood count) with results of Hemoglobin, Hematocrit, Platelets, etc.

        •May be a reflexive order such as Urinalysis If (UA If), where a urinalysis is performed. Certain results values may trigger the automatic addition of a culture order to the specimen

        •May be a “tiered” order , profile, or convenience panel whereby a single EHR order (i.e. stroke panel), contains child panel orders (CBC, BMP, PT/INR), each with their own children

      • Terminologies. Non laboratory professionals often refer to this as a procedure, which includes methods of test collection, testing, radiology or cardiac procedures, etc.

        • CMS has some defined panel orders such as BMP, CBC tied to reimbursement, so may need to call these out/use same definitions.

        • Mapped to:

          • (precoordinated) LOINC order codes or both order/observation codes (for single orderable/resultables above), but not observation only codes (as those are for results) (There may be gaps or changes needed to existing LOINC codes if only an observation only LOINC exists for a test order).

          • Nordic Countries code system

          • Japan code system

      • Messaging: Called Observation Request in Health Level 7 version 2.51 (HL7 v 2.51) in OBR-4 message field, Represented by FHIR Service Request.