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The purpose of this section is to:

  • Provide input to initial SHIELD implementation Plan

  • Define the WHAT needs to be done to achieve laboratory data interoperability

  • Set stage for HOW to deliver the “what’s”

  • Set stage for milestones, goals, timeline

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Use Case Scenarios

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Use cases below are meant to provide tangible scenarios where laboratory data is created, stored, exchanged and/or analyzed for purposes of contextualization of laboratory data interoperability

Clinical and Public Health Scenario Use Cases

Patient A, a 65 y/o male, originally seen at a critical access hospital is transferred to the regional health center and admitted for a suspected case of infectious pneumonia and low oxygen levels. The patient also has cirrhosis of the liver.  A respiratory pathogen panel is ordered by the admitting physician to confirm the pneumonia is due to a bacterial infection.   The lab test is ordered in the EHR.  A n/p swab specimen is collected and sent to the micro lab for testing. 

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During the course of laboratory testing, the organism identified along with its susceptibility profile is recorded.  The data are immediately incorporated into the hospital’s antibiogram calculations and will be incorporated into the next publication by the antimicrobial stewardship (ASM) team.  The organism and susceptibility data are further reported to the state department of epidemiology via HL7 message including S/I/R and MIC data along with testing methods for organism identification and susceptibility test results as ESBL-producing Klebsiella pneumoniae are a reportable condition due to the rise in antimicrobial resistance in this species.   Furthermore, isolates of the organism are sequenced and profiled for known or suspected genes associated with antimicrobial resistance as part of a broader AMS discovery and intervention program.

Clinical Scenario 2 Use Case

A third year house staff in emergency medicine is preparing a quality of care project to meet certification requirements of the ACEM.  In collaboration with a dozen of their colleagues at sister institutions they will compare opioid testing results on patients presenting to the ED with recurring abdominal pain.  They wish to be inclusive of any urinary or blood results for any opioid-receptor agonist agent.  They plan to identify whether any testing was done within 24 hours of the ED visit and to classify the results as COMPLETE, NOT DONE, OPIOD PRESENT or OPIOD NOT DETECTED.  The project will evaluate the effects of the screening data on the expense and outcomes of the ED evaluation.

Research Scenario Use Case

A research faculty at U of Anywhere is designing a study to compare the sensitivity, specificity and positive predictive value of two novel screening tests for COVID-19 respiratory infection in patients with diabetes mellitus.  The test strategies are nasal swab for SARS-CoV-2 N gene versus salivary SARS-CoV-2 N gene.  Diabetes mellitus is defined by a history of random non-stimulated blood glucose >= 200mg/dL or Hemoglobin A1C/Hemoglobin ratio >6.5%. The research team plans to conduct this as an observational trial across the N3C network and they are struggling to define the value sets of coded test results which they will incorporate into their SAS query for cohort identification and outcomes assessment.

Quality Use Case

Goal: Earlier and more sensitive detection of laboratory test component (reagent, calibrator, container) deficiencies. Some testing device defects are not readily detectable by existing, standard manufacturing and process controls. Surveillance of aggregated laboratory testing data could speed the detection of such defects, thus decreasing the potential harm. In addition, this higher resolution labeling of test results would facilitate better cleaning of data for additional secondary uses.

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  • Analysis of data grouped by UDIs (and other contextual factors) for changes in aggregate results

Implementation Plan

Info

Presentation slides and extended draft below

Implementation Plan Power Point

Powerpoint
nameImplementationCommitteePlan_20210707_final.pptx

Implementation Plan Word Document

Word
nameImplementation Proposal_7-6-21.docx

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Insert comments, gaps and edits in line in each subsection below

Comments on what needs to be accomplished

Laboratory Interoperability Data Resources (LIDR) - LIVD expansion file management

Data elements needed

Codification of laboratory data requirements

Test and test result harmonization index

Features of LIDR Tooling

Controlled Medical Terminology (Ontology) Unification

Harmonization of LOINC, SNOMED CT and RxNorm on single ontologic model

Publication of harmonized terminology

Clinical Information System Vendor Engagement and HL7 Engagement

Engage CIS vendors regarding management of LIVD encoded data

Engage CIS vendors and HL7 on Data Exchange of LIVD encoded data

IVD Vendor Engagement

Creation of LIVD data elements and population of LIDR database

LIVD Data exchange between instrument and LIS

SHIELD Data Hub for FDA Use

Features needed

Data elements needed

How to populate and maintain

Sustainability Plan

Implementation Approach

Phased Pilot Approach

Prioritization of Lab Tests to Address First

Parallel Processes for Tooling Development