Introduction

The purpose of this page is to capture the goals and requirements to enhance ELR reporting in the context of the COVID pandemic, and in that context provide clear guidance to all parties in the communication flow to enhance their contributions to enhance the ELR transaction to a Public Health Authority. 

This is meant to be a working document that we rapidly evolve based on latest understanding. Once it is believed to be sufficiently complete and accurate it will be published elsewhere as a guidance document.

Contacts

Hans Buitendijk - Cerner, HL7 Orders & Observations Co-Chair, EHRA Standards & Interoperability Chair

David Burgess - LabCorp, HL7 Orders & Observations Co-Chair

Freida Hall - Quest Diagnostics

Jason Hall - CDC

Janet Hamilton - CSTE

Riki Merrick - APHL, HL7 Orders & Observations Co-Chair, IHE Pathology and Laboratory Medicine Co-Chair

Craig Newman - Altarum, HL7 Public Health Co-Chair

Andrea Pitkus

Dan Rutz - Epic, IHE ???

Kathy Walsh - LabCorp

Michael Waters - FDA

Definitions

Current Challenges

When ELRs are sent to PHA it does not contain sufficient demographic, ask-at-order-entry data, and device information as is necessary to enable further analysis.  While some of that data could be part of a subsequent eCR, if the data is already available at time or order and ELR transmission before an eCR is available (or the next eCR is available) helps accelerate the process.

Through the process from ordering to reporting, there is a need to:

There are numerous challenges along in this flow in terms of data not being able to be collected, not being documented, not using standard vocabulary, not including it in the order, not forwarding certain data, dropping standard vocabulary, not retaining data, not communicating data available to the PHA.  The challenges this guidance is looking at is ensuring that the relevant data can be communicated from ordering provider through a potential intermediary lab to the performing lab and on to PHA as an ELR in a complete, standard, consistent format and vocabulary.

Currently the specific challenges in that area are:

As indicated before, there are many other challenges to ensure that data if fully, accurate, and consistently documented and communicated, including use of encoded standard vocabulary (at least along with any local coding that remains relevant), but that is not addressed here.  Our goal is to provide guidance on how to address the above challenges in the necessary implementation guides that can be deployed as quickly as possible and as consistent as possible across ALL jurisdictions.

We understand that there may be a desire/need to send the original order to PHA directly as well to get earlier insight into certain tests ordered including PHI, particularly during an emergency (as that may invade patient privacy unnecessarily during "normal" situations), but when that interest becomes a requirement, the guidance for the ordering flow is sufficient as the starting point and being extended based on local PHA emergency mandates on how much (or not) PHI is to be removed before forwarding it.  That guidance should be as consistent as possible as well, but we will address that when an actual requirement in any jurisdiction is raised.


Requirements

The following data set is desired to be made available as part of an ELR as much is is available upon placing the order and to the extent that the Laboratory has access to any additions before the ELR is sent.


 

Use this spreadsheet to collect options and comments around the proposed mapping of the HHS elements to various places in Order and result messages.


Straight from today's LIVD call, needs to be cleaned-up and merged with above where appropriate

We agreed, and Michael agreed, that he be added to the e-mail list.  We also agreed to set up a separate Confluence Page to start to pull everything together: flow, guidance, issues, resource references to start.

From the chat to be included in subsequent documentation.

From Andrea Pitkus PhD, MLS(ASCP)CM to Everyone: 01:25 PM
thanks Ed! There are also UDIs for control and QC, which would be out of scope. The other question is how is UDI captured and mapped in LIS. Do LISs need to add functionality so it can be sent electronically?
From Andrea Pitkus PhD, MLS(ASCP)CM to Everyone: 01:33 PM
Pam and I were discussion LDTs. Is there expectation they would have a UDI and how would that be acquired? If not, what is entered when there is no UDI? N/A? Is field blank?
From Andrea Pitkus PhD, MLS(ASCP)CM to Everyone: 01:45 PM
Can we discuss UDI for manual test kits and LDTs (non analyzer performed tests)?
From Ralf Herzog to Everyone: 01:45 PM
Sorry, need to leave today earlier. Wish you all a nice weekend and CU next week Bye Ralf
From Andrea Pitkus PhD, MLS(ASCP)CM to Everyone: 01:45 PM
Tschuss!
From Andrea Pitkus PhD, MLS(ASCP)CM to Everyone: 02:05 PM
 Test I'm thinking of is the ROMA that is a 2 step immunoassay. Ed will check if 1 or 2 UDIs

CLIA 

Data Flow and Guidance

Test Configuration - LIVD

Lab Orders - LOI

Electronic Lab Reporting - ELR


Open Issues


Resources for Background