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Current rule for cancer reporting (move up for ANY reference to current rule):https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170#p-170.315(f)(4)
Cornell Law site for referencing current rule as alernate to above: https://www.law.cornell.edu/cfr/text/45/170.315
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#2 - Need clarification why LRI is listed as a standard under 170.315.(a)2. As currently written, this section does not provide enough clarify about which actor function for a use case requires which standard - this should be split out into specific use cases and describe the standrds for each actor:
Use case provider ordering from laboratory
actor EHR-s uses CPOE and then LOI to create and send orders
if applicable: HIE must receive LOI, perform any transformations / translations and send the modified order using LOI
actor LIS receives and validates LOI order
Use case laboratory ordering from reference laboratory (which could be a PHL or a bloodbank, too)
actor LIS uses CPOE and then LOI to create and send orders
if applicable: HIE must receive LOI, perform any transformations / translations and send the modified order using LOI - there should be a requirement that no content is lost (like specimen details or AOEs)
actor LIS receives and validates LOI order
If intent is to support use of LRI for results coming back after electronic ordering, then
Use laboratory sends results to ordering provider
actor LIS creates result(s) and uses LRI to send result(s)
if applicable: HIE must receive LRI, perform any transformations / translations and send the modified order using LRI
actor EHR-s receives and validates LRI result(s)
Use case laboratory receiving results from reference laboratory
actor LIS creates result(s) and uses LRI to send result(s)
if applicable: HIE must receive LRI, perform any transformations / translations and send the modified order using LRI
actor LIS receives and validates LRI result(s)
Question: Does this include sending a copy to ordering provider?
Question: Does this include an HIE?
could be included in all of these use cases - so should be added into the use cases
For HIEs to be certified HIT, there should be a requirement that no content is lost (like specimen details or AOEs at the data element level or at the content level when mappings are not equivalent)
OTHER USE CASES?
Notes 8/27/2024
Can we use a software to figure out how the data is moving and how the content may have been changed?
<Ana or Ingeborg to provide the names of the implementations where this software has been used and maybe links to a publication that helps better understand the functionality>
this is more for data analysis in intergrated systems
it would require system errors to be reported to a central system
not sure we can call out a specific software in the HTI-2 rule - this is more importnat to include in implementaitons, not sure this can be part of the certification aspect.
From Chat:
We may wish to comment on to emphasize detailed specimen type, source, laterality, procedure for specimen collection are included with the order when collected so it's transmitted to the performing lab and available for PH for reportables whether via ELR or Cancer Reporting, etc.
John Snyder (NLM) 12:49 PM
I only brought up the HIE question because some HIE's provide mapping services between local code systems and from local code systems to LOINC and/or SNOMED. I wasn't sure if this is still a valid middleware layer that should be taken into consideration because the data isn't purely being passed through from source to target.Andrea Pitkus 1:00 PM
What do you consider a system error, how is it modeled, stored, collected and transmitted to achieve what you described?
Sections of interest for this group:
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