State the problem situation in a way that business stakeholders will understand/empathize with it.

Codifying lab data elements with standard codes will support retention of meaning across data exhange partners

Currently the choices for codes are large and require specific knowldege on the side of the laboratorian to select them during test implementation into their LIS

IVD vendors (provide the test information)

Lab (consume LIVD information and set up mapping into the LIS)

Now be specific with real-world objectives that the solution will achieve.

Support correct coding for LOINC and expand to provide correct coding for SCT (qualitative results, specimen types ad maybe methods) and UCUM (units) in the lab, so that exchanged data is represented in standard vocabulary

Details and description of the technology plan and implementation and why.

LIDR Data elements (and where they come from / go through)

Current elements in LIVD - plus: mapping for results, specimen, units

method (with mapping)

The true positive impact that your solution/project will have on organizations, including the minor positives that folks who are peripherally involved may feel. Also stress on any potential process improvements resulting in man-hour savings.

impact on existing processes that will need to be changed, the people that will impact, and how they may be motivated to make the required changes

For it to be useful to IVD vendors, need to ensure that any data that comes off the instrument flows through the system - need request from customers.

Current LIVD file is not broadly used by IVD vendors (other thn IICC members, but even there, not all are freely sharing (some limit to customers / specific projects)

state the key risks and present mitigation plans and checkpoints for management

How quickly can you get this done with the resources available? If management wants a  implementation or go-to-market timeframe, state how additional resourcing/people can help achieve that.

Manual: Person looks up entry based on manufacturer name / model either in web app or in downloaded file (excel)

Automated: During test set up in LIS, system sends query to LIDR based on manufacturer name / model or UDI and retrieves all codes for test: LOINC(s) for performed test / components of a panel (and order, if available), SNOMED CT for the specimen(s) that is (are) included in the LIS set up, UCUM for units when quantitative results, SNOMED CT codes when qualitative results; LIDR may return more than one appropirate LOINC, if LIS does not have all the additional clinical context included in the query for example for challenge tests, so a manual map selection step might still be needed.

State the problem situation in a way that business stakeholders will understand/empathize with it.

Laboratories

Public Health Agencies

Now be specific with real-world objectives that the solution will achieve.

Narrow guidance for ideally single LOINC / SCT encoding for PH reporting

Details and description of the technology plan and implementation and why.

LIDR Data elements (and where they come from / go through)

support for additional FDA attributes like approved setting, type of test (at-home, for serial testing, pooling allowed)

The true positive impact that your solution/project will have on organizations, including the minor positives that folks who are peripherally involved may feel. Also stress on any potential process improvements resulting in man-hour savings.

impact on existing processes that will need to be changed, the people that will impact, and how they may be motivated to make the required changes

state the key risks and present mitigation plans and checkpoints for management

Limiting the LOINC choice is counter-productive to the goal of reporting as granular as possible, so we should support creation of content of reportable conditions, BUT NOT to the level of identifying a single LOINC.

How quickly can you get this done with the resources available? If management wants a  implementation or go-to-market timeframe, state how additional resourcing/people can help achieve that.

Initial goal is a publically available spreadsheet version - maybe a google sheet, that can be crowdsourced

Manual: Person looks up entry based on manufacturer name / model either in web app or in downloaded file (excel)

Automated: PH Surveillance system may query LIDR when receiving results for a specific IVD test - based on manufacturer name / model or UDI and retrieves all allowable codes for test: LOINC(s) for performed test / components of a panel (and order, if available), SNOMED CT for the specimen that is reported, UCUM for units when quantitative results, SNOMED CT codes when qualitative results;

Alternatively PH Surveillance system may query like LIS above to set up filter for reportable conditions with appropriate codes - in this case LIDR may return more than one appropirate LOINC.

State the problem situation in a way that business stakeholders will understand/empathize with it.

Now be specific with real-world objectives that the solution will achieve.

Details and description of the technology plan and implementation and why.

LIDR Data elements (and where they come from / go through)

additional elements around cross-reactivity, details on targets (for PCR, AG testing), positive predictive value etc

The true positive impact that your solution/project will have on organizations, including the minor positives that folks who are peripherally involved may feel. Also stress on any potential process improvements resulting in man-hour savings.

impact on existing processes that will need to be changed, the people that will impact, and how they may be motivated to make the required changes

state the key risks and present mitigation plans and checkpoints for management

How quickly can you get this done with the resources available? If management wants a  implementation or go-to-market timeframe, state how additional resourcing/people can help achieve that.

State the problem situation in a way that business stakeholders will understand/empathize with it.

Now be specific with real-world objectives that the solution will achieve.

Details and description of the technology plan and implementation and why.

LIDR Data elements (and where they come from / go through)

The true positive impact that your solution/project will have on organizations, including the minor positives that folks who are peripherally involved may feel. Also stress on any potential process improvements resulting in man-hour savings.

impact on existing processes that will need to be changed, the people that will impact, and how they may be motivated to make the required changes

state the key risks and present mitigation plans and checkpoints for management

How quickly can you get this done with the resources available? If management wants a  implementation or go-to-market timeframe, state how additional resourcing/people can help achieve that.

Actors

(expected actions)

IVD vendors (provide the test information)

Lab (consume LIVD information and set up mapping into the LIS)

Providers (Consume LIVD and set up mapping in CPOE, including having additional data elements, so can filter external lab results for comparability of results with in-house testing

IVD vendors

LIS vendors

Middleware vendors

EHR vendors

PH lab LIMS vendors

PH agency software vendors (downstream from LIS and LIMS)

Objectives

Now be specific with real-world objectives that the solution will achieve.

Support correct coding for LOINC and expand to provide correct coding for SCT (qualitative results, specimen types ad maybe methods) and UCUM (units) in the lab, so that exchanged data is represented in standard vocabulary

Real world objectives: Uniquely identify each result and result value and combined with panel order details, provide the full meaning of the “test” and permit encoding of each discrete result and order element with LOINC and messaging in HL7 messages to PH as requested. Many LISs unable to support this currently. Most LISs internally build panel order items (to add on for billing and set antibiotics in each panel with open value fields that the IVD vendor provides values upon analysis). However, these are not trasmitted outside LIS to PH, EHR, etc. and thus unavailable for RWD/RWE/PH, etc.

Solution will work to make these essential data elements for the complete meaning of antimicrobial susceptibility testing results to all.

Recommendation

Details and description of the technology plan and implementation and why.

LIDR Data elements (and where they come from / go through)

Current elements in LIVD - plus: mapping for results, specimen, units

method (with mapping)

UDI, LIVD elements. With additional TBD elements needed in LIDR for unique ID of these items.

Impact on People, Process, and Technology - Advantages

The true positive impact that your solution/project will have on organizations, including the minor positives that folks who are peripherally involved may feel. Also stress on any potential process improvements resulting in man-hour savings.

 Moderate impact on IVD vendors. LIVD need to be produced/updated with TBD elements.

Moderate impact on LIS vendors (variable depending on current functionality. some may have high impact if less functionality currently.)

Advantages: lab results and values are interoperable with complete meaning. ability to transmit this info to PH, EHRs, use for research, clinical trials, etc.

Impact on People, Process, and Technology - Challenges

impact on existing processes that will need to be changed, the people that will impact, and how they may be motivated to make the required changes

For it to be useful to IVD vendors, need to ensure that any data comes

Some LIS vendors will need to build their antimicrobial testing as orders and results like other lab results, orders with LOINC mapping functionality.

Some LIS vendors will need to build antimicrobial susceptiblity order panels, and capabilities to incorporate in OBR4 fields/shared LIS/EHR databases in EHR funcitonality for EHR, research and PH reporting and use

Risks and ROI

state the key risks and present mitigation plans and checkpoints for management

 Will need to be broken down into exchange phases as multiple actors at each:

1. IVD info in LIVD

2. IVD info from device to middleware/LIS (in lab interfaces, w IHE LAW?)

3. LIS functionality (receipt, modeling, internal use/representation)

4. LIS outbound exchange/export (internal EHR/LIS database model, and HL7 messaging model) to EHR/PH

5. PH lab LIMS functionality like #3 w LIS

6. PH Agency support to receive (from #3 and #5 depending on which is doing testing/sending ELR results/values)

7. Clinical Trials/Research systems capability to extract /receive from LIS/EHR/health IT systems for RWD/RWE.

Timing

How quickly can you get this done with the resources available? If management wants a  implementation or go-to-market timeframe, state how additional resourcing/people can help achieve that.

 Not me ​Emoji :wink:

Question for each actor involved in each step above.

Actors

(expected actions)

 Any actor/system should have all info for complete meaning of each unique IVD assay.

IVD vendors (provide the test information)

Lab (consume LIVD information and set up mapping into the LIS)

IVD vendors

LIS vendors (both CP and AP)

Middleware vendors

EHR vendors

Hospital based Cancer registry vendors

Central Cancer Registry (PH) vendors

CDC NPCR and NIH SEER software (downstream consumer)

Clinical Trials/Research vendors (cancer research)

NIH NCI clinical trials/ oncology research reporting

Objectives

Now be specific with real-world objectives that the solution will achieve.

Support correct coding for LOINC and expand to provide correct coding for SCT (qualitative results, specimen types ad maybe methods) and UCUM (units) in the lab, so that exchanged data is represented in standard vocabulary

Support unique identification of results and values and which can be trended/displayed, used in calculations, clinican trials, research etc. and which cannot. IVD vendor test kit components and assays are not interchangeable. LOINC does not provide this uniqueness alone. What other fields are needed for LIDR, usage, and interoperability?

Recommendation

Details and description of the technology plan and implementation and why.

LIDR Data elements (and where they come from / go through)

What LIDR elements current/future are needed to support.

Current elements in LIVD - plus: mapping for results, specimen, units

method (with mapping)

Impact on People, Process, and Technology - Advantages

The true positive impact that your solution/project will have on organizations, including the minor positives that folks who are peripherally involved may feel. Also stress on any potential process improvements resulting in man-hour savings.

 IVD vendor minimal (another data element or two?)

LIS vendor (moderate) functionality to collect, store, transmit, receive, use UDI and other data elements

EHR vendors and downstream health IT (moderate) functionality to receive, store, transmit, use UDI and other data elements

Impact on People, Process, and Technology - Challenges

impact on existing processes that will need to be changed, the people that will impact, and how they may be motivated to make the required changes

see above

For it to be useful to IVD vendors, need to ensure that any data comes

Risks and ROI

state the key risks and present mitigation plans and checkpoints for management

 curenttly, EHR and LIS vendors may not realize IVD test systems (CLIA language) may not be interchangeable and build these as the same “test” order or result and comingle results, resulting in bias/impacts to decision makign including patient care and safety risks, but also RWE/RWD decisions including clinical trials, drugs, etc.

Timing

How quickly can you get this done with the resources available? If management wants a  implementation or go-to-market timeframe, state how additional resourcing/people can help achieve that.

Not me ​Emoji :wink:

Dependent on each actor/system.