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
what are successes and lessons learned/improvements needed?
Indicate which stage/point in total testing process and beyond the requirement/goal/measure is needed/defined, etc. Is it in the:
lab compendium/test menu/directory of service/CLIA specimen collection manual (often online), ?
which is received/integrated/built in the EHR CPOE system test menu for provider orders? used to generate the test order sent to the performing lab LIS
which receives the EHR/other LIS order request and maps it to it’s own LIS built order/naming/mapping, creating assignments to LIS “station/workbench” for manual/automated tests where order and results placeholders are visible in LIS (lacking result values until analysis is performed)
which sends test (result) requests/requests for analyte/assay to be performed to each instrument/routing of specimens via automated tracks to each instrument, etc. using (IHE LAW), interfaces, lab middleware, specimen tracking systems, storage, processing, etc.
which also is received by instrument with specimen info indicating which test(s) is/are performed on the container (specimen, including any preprocessing creating aliquots or derivatives) when at the analyzer/bench.
IVD instrument performs testing/analyzes of container contents (specimen) and generates result values (direct/calculate), IVD instrument sends results and values (and pt info/container ID) across interface to middleware or LIS directly.
Manually performed test results, may be directly entered into LIS/EHR/POCT system (Point of care testing)
LIS may utilize several results as part of a panel to perform calculations/generate ratios/calculated results, etc. (list examples of calculated results)
calcium/creatinine ratio using calcium and creatinine result values from instruments.
24 hr urine calcium rate uses Total volume (ask at order entry question provided by person collecting specimen or measured by laboratory and entered in this LIS result field with its own LOINC), hours of collection (ask at order entry question provided by person collecting or ordering specimen and entered in this LIS result field with its own LOINC), coupled with instrument calcium once received over interface in its own LIS result field with its own LOINC, and used to calculate the 24 hr urine calcium rate in its own LIS field (with own LOINC) and reported to EHR/downstream systems.
Interpretations.
may be pathology interpretation taking into account several test results and their values, such as with CAP Cancer Protocols (i.e. overall diagnosis, interpretation of biomarkers such as er/pr, or interpretations of special stains)
may be panel interpretations.
several biomarkers, molecular or genomics results, with overall disease, VUS, variant etc interpretation
several coag markers in thrombosis risk panel (factor V leiden, factor VII) with overall interpretation provided (hi, low, intermediate risk)
cardiac risk interpretation as part of lipid panel per clinical guidelines risk assessment reported as own result and result value (and encoded accordingly)
LIS results are manually or auto verified and released to downstream systems such as EHR and Public Health.
Note where LIS and EHR are the same vendor system with a shared database traditional HL7 messages are not used in the release process in “sending results from LIS to EHR.” Rather this is performed internally. Several vendors have this structure.
Verification triggers messaging to be created (often HL7 v 2.51, but may be 2.31) Unaware of any LISs with HL7 FHIR functionality (to create data, send, receive) yet. Recommend sticking to 2.51 since part of regulations.
messages sent to public via (per each jurisdiction’s requirements), often via ELR IG. many HL7 versions used and capabilities there in
messages sent to EHR via LRI IG (or not)
messages sent to data warehouses
EHR receives/consumes laboratory report of record (see HL7 EHR-S IG. not widely adopted nor required yet). Once remapping of lab data occurs in EHR database, then lab data are able to be utilized within the EHR for functionality such as:
results review by health professionals
displays
clinical decision support tools
reporting internally
reporting externally to
Public Health for electronic case reporting (eCR)
Public Health (NHSN) for HAI reporting)
Public Health Cancer Reporting (Hospital Cancer Registrar generated from EHR data including pathology/lab data, meds, treatments, etc. )
Clinical Quality Measure Reporting (more detail needed here @ Julia?)
FDA for device monitoring / regulatory reporting / recalls (more detail needed here)
HIEs
Research/Clinical Trials
other EHRs/systems for Transfers of Care (TOC) CDA including labs and LOINCs
Other downstream reporting system use cases on how they consume/utilize lab data (fill in)
Public Health eCR
Public Health ELR (including how reported to CDC/federal agencies for COVID response)
Public Health HAI NHSN
Public Health Cancer Registry Reporting
Hospital Registrar including pathology/laboratory data/genomics/tumor/biomarkers/ NAACCR data elements sent to central cancer registry (usually state public health)
Central Cancer Registry summarizes and sends to CDC NPCR or NIH SEER programs where summarized cancer data reported/utilized
Hospital Quality Measures (how they make it to CMS)
Physician Quality Measures (how it makes its way to CMS)
Payers/Insurance Companies/Medicare (for lab contracts, but also physician quality “assessments”)
Disease Registries
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.
Scoping
Laboratory Areas: Chemistry (including urinalysis), Hematology (including coag), Microbiology, Blood Bank, Pathology, Cytology, Genomics/Molecular, Histology?, Other subspecialties?
Recommend Chemistry and Hematology first, then automated Microbiology, Tumor/Biomarkers, Manual Microbiology, Pathology, Cytology, Blood Bank
Policy and Regulatory Aspects
Which regulatory policies impact lab coding/informatics/reporting (at source/by performing lab/entity)
Public Health ELR
COVID HHS reporting
Which regulatory policies impact lab quality/informatics/lab report of record, etc (impacting lab/source of truth)
CLIA
Accreditation requirements (may be more stringent than CLIA alone): CAP, Joint Commission, AABB, etc,
Which regulatory polices require lab data coding for downstream uses
ONC & CMS: EHRs-HAI, Quality measures, ELR, etc
ONC & CMS: Meaningful Use, 21st Century Cures Act/Promoting Interoperability
FDA (pre/post market regulations)
Non traditional lab testing settings:
Nursing homes (ie. POCT COVID)
Pharmacies (i.e. POCT clinics, COVID)
National Guard pop up sites (COVID)
Home/Consumer collected testing (performed in CLIA lab) (ie. COVID, drug testing, genomics testing)
Home/Consumer collected testing (performed by consumer w device) (i.e. COVID, home pregnancy test, home urine dipstick manual/device interp, home WBC)
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 Japanese 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.
Lab test result: Detection or measurement of an analyte in a patient specimen. Reported back to the provider in response to their order request.
Terminologies. Non laboratory professionals often refer to this as an observation.
Mapped to:
LOINC observation only or both order/observation codes (for single orderable/resultables above), but not order only codes (as those are for orders)
Messaging: Called Observation (or procedure) in the HL7 v 2.51 OBX-3 message field
Note some define observation as both the result and result value
Lab test result value: Value or response of a lab test result. Can be qualitative, quantitative, narrative, short answer such as an organism, etc.
Terminologies. Some may call this the observation
Mapped to:
SCT qualifier value for ordinal/qualitative values
SCT organism code for organisms
quantitative results usually not mapped
Messaging:
Called Observation Value in the HL7 v 2.51 OBX-5 message field
Interpretations may be messaged in HL7 v 2.51 OBX-8 message field
Note one LIS vendor reports 50% of lab customers report antibiotic susceptibilities as mm in OBX 5 with Interpretation of Susceptible, Intermediate, Resistant in OBX 8 field, while other 50% report just the Interpretation in OBX 5 field
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