Re: Digest for hl7v2-lab-testing@googlegroups.com - 4 updates in 1 topic

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Andrea Pitkus

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Nov 22, 2021, 9:29:07 AM11/22/21
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Emma,

Do you have more information about the types of test results and device(s) utilized for your desired reporting?  It looks like you may be performing biomarkers on urine with the device for prenatal and kidney care.  Is that correct?  There are many types of test result values that can be reported from urine/urine dipstick.   Looks like this is not COVID testing  (and thus regulations around these results wouldn't apply).  

Who is performing the testing (i.e. health professionals and/or consumers)?  Looks like it might be consumer based testing?

Which countries is the testing performed in (US?  Others)  Trying to understand if CLIA or public reporting (i.e. ELR) or other regulatory requirements may apply.

Looks like this is not COVID testing (and thus HHS 

Will you be reporting directly from the device into Epic or involving information systems (i.e. LIS, EHRs, HIEs)?  Are you looking to message from the device directly into EPIC's EHR products or from the device into their LIS product (Beaker) and then into the EHR (as external lab results and not internal lab results built in Beaker too)?   

If you have any package inserts/user guides, it would be helpful as the website is vague on test/reporting details.  It helps us to all understand your use case/scenario better and which other requirements may or may not apply.

Cordially,

--
Andrea Pitkus, PhD, MLS(ASCP)CM
apitkus@gmail.com
Laboratory Informaticist

On Fri, Nov 19, 2021 at 2:08 AM <hl7v2-la...@googlegroups.com> wrote:
"Taylor, Sheryl L. (Fed)" <sheryl...@nist.gov>: Nov 18 03:36PM

Hi Emma,
 
NIST received your inquiry, and we have forwarded it on to a laboratory results interface expert for analysis and response.
 
Thank you,
 
Sheryl
 
National Institute of Standards and Technology
 
 
From: hl7v2-la...@googlegroups.com <hl7v2-la...@googlegroups.com> On Behalf Of Emma Darby
Sent: Wednesday, November 17, 2021 6:20 PM
To: HL7v2 Lab Testing <hl7v2-la...@googlegroups.com>
Subject: Hl7 v2 testing
 
Hi there,
 
I am trying to develop an app that will upload test results from a device to a patients EMR. I have not done this before, and HL7 sounds a bit complex, but is this something that I could do? Then test my application with your lab testing tool? Any help is hugely appreciated. Thanks!
 
Emma
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"Taylor, Sheryl L. (Fed)" <sheryl...@nist.gov>: Nov 18 05:08PM

Hi Emma,
 
Per the laboratory results interface (LRI) expert, your ability to develop an app that will upload test results from a device to a patient's EMR depends on what EMR you want to connect to - that EMR would need to be able to process the LRI message (HL7 Version 2) that your app produces. Currently, LRI is, unfortunately, not widely implemented across EMRs, though the hope is that will change soon.
 
The current NIST LRI conformance testing tool accessible at https://hl7v2-lab-r2-testing.nist.gov/labs-suite-tool/#/home is designed to test HL7 v2 messages for conformance to the different standards. For lab results data exchange, LRI would be the right specification, though the current NIST LRI tool is updated only to the 2016 version of the LRI Implementation Guide (IG).
 
The Association of Public Health Laboratories (APHL) is using the NIST development platform for creating LRI and laboratory order interface (LOI) HL7 v2 testing tools - accessible via the General Validation Tool (GVT) here https://hl7v2.gvt.nist.gov/gvt/#/home under the Tool Scope "APHL". These tools need to be updated to support the currently published IG releases from 2018; and newer IG versions for both LRI and LOI are to be published soon that support more of the pandemic reporting requirements. Then the plan is that these IGs will be built in the NIST Implementation Guide & Authoring Tool (IGAMT), and those profiles will be published in GVT.
 
Thank you for your question.
 
Sheryl
NIST
 
From: Taylor, Sheryl L. (Fed)
Sent: Thursday, November 18, 2021 10:36 AM
To: hl7v2-la...@googlegroups.com
Subject: RE: Hl7 v2 testing
 
Hi Emma,
 
NIST received your inquiry, and we have forwarded it on to a laboratory results interface expert for analysis and response.
 
Thank you,
 
Sheryl
 
National Institute of Standards and Technology
 
 
From: hl7v2-la...@googlegroups.com<mailto:hl7v2-la...@googlegroups.com> <hl7v2-la...@googlegroups.com<mailto:hl7v2-la...@googlegroups.com>> On Behalf Of Emma Darby
Sent: Wednesday, November 17, 2021 6:20 PM
To: HL7v2 Lab Testing <hl7v2-la...@googlegroups.com<mailto:hl7v2-la...@googlegroups.com>>
Subject: Hl7 v2 testing
 
Hi there,
 
I am trying to develop an app that will upload test results from a device to a patients EMR. I have not done this before, and HL7 sounds a bit complex, but is this something that I could do? Then test my application with your lab testing tool? Any help is hugely appreciated. Thanks!
 
Emma
--
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Emma Darby <em...@youcount.io>: Nov 18 11:38AM -0800

Hi Sheryl,
 
Thank you so much for this information! I believe Epic (which is the EMR I
am trying to connect with) does support LRI. They have a standard published
on their website for Incoming Ancillary Results (see attached). Epic also
has an HL7v2 validator that I just found, which seems to use your public
web validator that you have described. I understand that the validator just
checks to see if the messages are formatted and written properly. Do you
have any tools that will verify that the lab results are inputted correctly
as test results in an EMR server? ie. a testing sandbox with a "fake" EMR?
Or how do you think it would be best to verify that the code works? Or is
that what the General Validation Tool is used for (as opposed to the LRI
conformance tool).
 
Thanks again!
Emma
 
On Thu, Nov 18, 2021 at 9:08 AM 'Taylor, Sheryl L. (Fed)' via HL7v2 Lab
Riki Merrick <rikim...@gmail.com>: Nov 18 06:14PM -0500

Hi Emma,
I am confused by your question: Do you have any tools that will verify that
the lab results are inputted correctly as test results in an EMR server?
ie. a testing sandbox with a "fake" EMR? - what exactly are you asking to
test here - that when the app say COVID-19 PCR, that the message put
COVID-19 PCR in the right place in the message? Or that the EMR that has
received the message properly displays the content?
 
Or how do you think it would be best to verify that the code works? - what
code are you talking about here?
 
The GVT validates conformance to structural and to some extent
vocabulary requirements of the chosen specification - e.g. LRI in the
context-free validation tab; for some of our programs APHL has built
vocabulary validation for tests and related result values, but that is not
normally included in context-free validation.
If there are test cases built - and for LRI that is the case - you can use
the context-based validation tab to check for specific values - for example
if the test case calls for a LOINC code for a specific COVID19 PCR test,
the validator will produce an error, if that is not used - while the
context-free validation would only tell you if the code you used followed
the LOINC rules for code construction.
 
Does that help?
Riki
Riki Merrick
Vernetzt, LLC
rikim...@gmail.com
cell: 916.216.0052
skype: riki.merrick
 
 
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--
Andrea Pitkus, PhD, MLS(ASCP)CM
apitkus@gmail.com

Riki Merrick

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Nov 22, 2021, 10:05:18 AM11/22/21
to hl7v2-la...@googlegroups.com
Thanks Andrea for pointing this out.
Emma,
If you are sending results from an IVD to the LIS, use the IHE-LAW profile available here: https://www.ihe.net/uploadedFiles/Documents/PaLM/IHE_PaLM_TF_Vol2b.pdf 

Riki
Riki Merrick
Vernetzt, LLC
cell: 916.216.0052
skype: riki.merrick

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