Use Case Names
Use Case Name | Use Case Description | Data Flow | Organizations | Systems | Current Mechanism | Data elements needed for this step | Proposed Standards | Available Tools | Notes | |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | lab catalog creation at the lab |
| N/A SM: LIS to everything else? or LIVD to LIS?
This are historic paper catalogs, but most labs now publish electronic version on websites, or have different file structures where they can be downloaded by customers (i.e. EHR for use in CPOE). However, much manual work per ONC/ACLA study/calculator: https://www.healthit.gov/buzz-blog/interoperability/highlighting-advance-interoperability-reduce-costs-lab-tests | IVD vendor
| LIS | spreadsheet | SM: LOINC, units of measure, UDI, Traceability (RM: what data element is tracking this?), RM: Performed test name, test kit identifcation, instrument identifiation, all expected result values, all applicable units of measure, allowable specimen, ordered test name? | LIVD JSON / spreadsheet format | SOLOR / Terminology services LOINC search / RELMA IVD package inserts with info on each assay/aalyte/test | ARP: Is this creation of the CAP/CLIA Specimen Collection Manual, aka laboratory compendium, where each lab distinguishes tests on their menu or something else? If lab compendium, there are CLIA requirements, and eDOS (Electronic Directory of Service) in HL7 v2.51 format or Service Catalog in FHIR provide electronic specifications, but not yet widely adopted. |
| 2 | Lab catalog exchange / setting up CPOE |
| LIS/LIMS to EHR-s | Lab | LIS/LIMS | spreadsheet | Performed test name, test kit identifcation, instrument identifiation, all expected result values, all applicable units of measure, allowable specimen (type, preferred container, min and max volume to submit), ordered test name, applicable ask at order entry question (AOE) / special patient considerations, Billing information | eDOS (V2 messages) = push | NIST tooling for eDOS= https://hl7v2-lab-r2-testing.nist.gov/labs-suite-tool/#/home
LOINC search / RELMA
|
|
| 3 | Test Ordering |
| EHR-S to LIS/LIMS | Lab | LIS/LIMS | paper | Ask at Order (AOE) questions / special patient considerations, test orders, specimen (type, source site, collection method) and collection date/time, prior results if needed, applicable authorization time window, patient information, ordering provider/facility information | LOI (V2 messages) | NIST use cases, tools for LOI = https://hl7v2-lab-r2-testing.nist.gov/labs-suite-tool/#/home |
|
| 4 | Data to and from IVD Instrument |
| IVD to LIS/LIMS | Lab | IVD Instrument (analyzer) |
| order identifier, result value with units of measure if applicable, additional results and graphs / images, instrument identifier (manufacturer, model, instance) | IHE LAW = CLSI AUTO-16 (V2 messages) = LOINC | Gazelle tool for IHE Connectathon = https://gazelle.ihe.net/connectathon.html |
|
| 5 | Result reporting to provider (ambulatory) |
| LIS/LIMS to EHR-s | Lab |
| paper/fax | Echo back all order information (except authorization time window, prior results?) PLUS result value with units of measure if applicable, interpretation, performing organization information, test date, result released date, status flag | LRI (V2 messages) | NIST tool for LRI = https://hl7v2-lab-r2-testing.nist.gov/labs-suite-tool/#/home |
|
| 6 | Result reporting to provider (inpatient) |
| LIS/LIMS to EHR-s | Lab |
| paper/fax | Echo back all order information (except authorization time window, prior results?) PLUS result value with units of measure if applicable, interpretation, performing organization information (may not be needed, since inside same orgnaization), test date, result released date, status flag | LRI (V2 messages) may be |
|
|
| 7 | Result reporting to lab/provider from patient | Patient generated results (i.e. COVID home testing, home pregnancy test, glucose SMB result from meter) | Patient reports result they obtained to provider (preg, covid results/values) or laboratory (glucose SMB collected as AOE on requisition with lab performed value reported back) |
| IVD vendor apps (COVID), patient apps (glucose meter apps trending results), fitness apps (weight, other vitals), etc. etc. | variable. Mostly oral. |
|
|
|
|
| 8 | Result reporting to Patient from lab | Patient receipt of lab results from performing lab
| Performing lab provides to pt via their app, portal, letter, phone, etc. Performing lab provides results to health provider, who provides to patient via phone, provider portal (i.e. EHR), letter, app, etc. | performing lab, health providers | LIS, EHR, performing labs, app developers |
|
|
|
|
|
| 9 | Result reporting to Patient from provider / HIE | Performing lab sends results to provider and/or HIE (precondition) Provider or HIE sends patient lab results. | Performing lab provides results to health provider, who provides to patient via phone, provider portal (i.e. EHR), letter, app, etc. |
|
|
|
|
|
|
|
| 10 | Result reporting to public health from lab |
| LIS/LIMS to PH surveillance system | Lab |
| paper/fax | Test type for analyte detected (Ag vs. Antibody vs. NAAT) Method detail (For NAATs, it’s important to understand what type of NAAT (RT-PCR vs LAMP vs other) Specimen type Complexity (mod/high vs. waived (POC) vs. self-administered) | LRI PH profile component (v2.5.1) ELR IG (R1) HL7v2.5.1 | NIST tool for ELR: https://hl7v2-elr-testing.nist.gov/mu-elr/ |
|
| 11 | Result reporting to public health from provider |
| EHR-s to PH surveillance system | Provider |
| paper/fax | Test type for analyte detected (Ag vs. Antibody vs. NAAT) Method detail (For NAATs, it’s important to understand what type of NAAT (RT-PCR vs LAMP vs other) Specimen type Complexity (mod/high vs. waived (POC) vs. self-administered) | eCR (CDA) |
|
|
| 12 | result use in provider setting | creating flow sheets | ?? Performing lab provides provider results in their EHR. At the doorstep, the lab result of record is preserved to show CMS/CLIA inspectors. HL7 message is remapped into EHR database and original message destroyed. Often performing lab naming conventions are “transformed” to EHR naming conventions. Data are presented to providers depending on EHR functionality/screen view (i.e. flow sheet, results review, graphs, tables, POV), all which may differ in how lab results/data are presented/utilized | Hospital |
|
|
|
|
| ARP: Is this only EHR flow sheets or does it include Problem Oriented View and other “results review” EHR functionality? see
|
| 13 | result use in research (FDA pre-market?) |
| ?? |
|
|
|
|
|
|
|
| 14 | result use in regulation (FDA postmarket) |
| ?? |
|
|
|
|
|
|
|
| 15 | Result reporting from one lab to another (referral lab testing) |
|
|
|
|
|
|
|
|
|
| 16 | Patient Performed Testing (home) | patient collected specimens sent to CLIA lab for drug screening, COVID, genetic/ancestry testing. Kits purchased online and delivered to pt or purchased in pharmacy/store. Unique identifier code for specimen container, is registered to patient email so they receive results. patient collects specimen and mails to vendor/lab. Lab results mailed, emailed back to patient. Public health reportables (i.e. std, covid testing) may not receive patient info (i.e. contact info/address, demographics, AOEs, age) |
|
|
|
|
|
|
| patient collected specimens sent to CLIA lab |
| 17 | Pathologist reporting | For pathology and cancer reporting, AJCC 8th edition/CAP eCC content is collected/reported on specimens per the different Cancer Protocols, including Biomarkers. | Pathologist generated report sent to EHR, and downstream hospital cancer registrar report sent to central cancer registrar reporting (may need to split these into separate use cases) |
| Anatomic Pathology and Laboratory Information Systems to EHRs | CAP eCC for cancer reports, APLIS pathology reports (non cancer) |
| LOINC, SNOMED CT, ICD-O3, other code systems (i.e. HUGO for genomics) |
| Clinical lab tests (i.e. PSA, WBC, CA125, BRCA, Her2, Neu, ER, PR, KRAS, other markers) mapped to LOINC codes in the clinical lab (using LIVD) should flow into the APLIS/path reports, which then should flow into cancer registry reports, mCODE (EHR), etc. and be all aligned on coding. Currently PSA LOINC encoded is entered in text and CAP eCC is being SCT encoded, NAACCR data elements also use LOINC so 3 steps of mapping/remapping/contributing to burdens/inoperability. |
| 18 | HHS/COVID reporting first part | LIS/lab reporting to public health jurisdiction (may overlap with ELR for labs, may not for pt reported results), WATERS connectathon systems, EHRs (cvs, walgreens), home grown systems, IVD vendor systems (i.e. lumira, abbott) | lis, app, ehr to public health | testing entity/ performing lab (traditional/nontraditional) , public health | LIS, EHR, Public Health systems, LIMS, |
| Results, AOEs, etc |
| ELR, Waters Connectathon solutions, APHL template | All original sources of COVID data/results, AOEs |
| 19 | HHS/COVID reporting second part | Public Health agency to CDC/federal agencies for pandemic data needs w lab data | Public Health agency to CDC/federal agencies | Public Health agency, CDC/federal agencies |
|
|
|
|
|
|
| 20 | Electronic Case Reporting (eCR) on e of the standards to use for use case #11 |
| MD EHR to CDC/Public Health | providers | EHR | EHR functionality, CDC FHIR app |
| HL7 ECR guide CDC FHIR app |
| Once this is more pervasive functionality, the extra items in ELR/HHS reporting can be moved to eCR where it is better suited. |
| 21 | Genomics/Molecular reporting | performing lab to EHR -oncology systems. performing lab to public health (where done on reportable condition, such as COVID variant sequencing, infectious diseases | performing lab to EHR -oncology systems (where mCODE used). performing lab to public health (where done on reportable condition, such as COVID variant sequencing), Cancer reporting/systems/cancer registries
| Performing labs, oncology systems, oncologists, | LIS/APLIS, EHRs, CG modules, |
|
| HL7 CG IG, mCODE (receiver/secondary system) |
| Mapping to LOINC/codesystems a bit different for genetic testing. Dr. Alexis Carter can add much more here too |
| 22 | Healthcare Associated Infection (HAI) Reporting | Hospital (EHR) to CDC NHSN. reporting. | EHR to CDC NHSN |
| Hospital (EHR) |
|
| HAI CDA IG |
| Note. remapping of post coordinated results from LIS to EHR occurs in EHR to support CDA IG needs. For example a VRE from LIS (to ELR and EHR) may be a vanc antibiotic mapped to LOINC, the resistant value mapped to SCT qualifier, and SCT org code mapped to Enterococcus faecalis, while HAI CDA requires precoordinated SCT organism code for Vancomycin Resistant Enterococcus to be sent (notice specific organism info lost). |
| 23 | Transfers of Care (TOC) = provider to provider | provider/facility EHR generates a transfer of care doc in CDA which includes LOINC encoded lab results, meds, etc. It is sent with patient when transferred to another (i.e. SNF, rehab, another hospital, long term care facility,) (If patient returns/readmitted, expect the opposite flow would occur from facility to hospital too) |
| hospitals, long tern care (LTC), Skilled Nursing facility (SNF), sub acute rehab hospital, etc. | EHR | some print a paper summary and tuck in the back of the patient’s wheelchair/bed when transferred by ambulance between the entities. Admitting nurse will type in data into receiving EHR system |
| TOC CDA (CCDA) IG |
|
|
| 24 | LIS reporting to HIE | Some labs report from their LIS to an HIE to exchange data with providers, or to send ELR to public health | LIS to HIE | labs, HIEs, providers, public health |
| variable |
|
|
| Some HIEs add LOINC, SCT codes, |
| 25 | Providers reporting lab results to HIEs | Some providers send EHR data to HIEs. Need to confirm, but I think some may order labs this way too. May also involve one provider’s patient results sent to another such as a specialist | EHR to HIE |
|
|
|
|
|
|
|
| 26 | Hospital Lab referral testing (orders) | Referral lab order requests from smaller hospital lab to large lab/academic medical center, public health lab, blood bank (ab testing) or reference lab |
|
|
|
|
|
| If set up electronically HL7 v2.x. some have web portals |
|
| 27 | Consumer performed lab tests (part 1a) | Test kit smartphone reader paired w vendor web portal to collect info form consumer. eventually reported back to pt via consumer portal/app below. |
|
|
|
|
|
|
| UA, Alb/CR, WBC, Neut% LOINCs needed for consumer/app results to distinguish those from health professional performed in EHR |
| 28 | Consumer collected/lab performed lab tests (aka Direct Access Testing, ) part 1b | Consumer collected/lab performed lab tests (aka Direct Access Testing,) | performing lab LIS- > Consumer web portal for results , app, or paper report |
|
|
|
|
|
| Is data discrete or pdf? Is data encoded? Home COVID-19 kits, 23 and me-genetic testing, etc.
|
| 29 | Consumer test results communicated to provider EHR (part 2) | Consumer web portal, scanned/uploaded reports into EHR patient portal, consumer app import into EHR, consumer device to EHR transmission etc |
|
|
|
|
|
|
| Monitoring of pt daily gluc levels w decision support to alert providers of issues or MD manual rvw.
ie.. how are cosumer performed covid tests integrated/received into EHR from home testing? EHRs don’t have capability to receive FHIR app results currently. |
| 30 | more to add in screen shot | 
|
|
|
|
|
|
|
|
|