Orders & Observations Conference Call
21 August 2014
+1 770 657 9270, Passcode: 653212#
Attendees:
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2
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9
Name
Kathy Walsh
Riki Merrick
Phil Pochon
Lorraine Constable
Andrea Pitkus
Ron van Duyne
Mark Jones
Organization
LabCorp
Vernetzt, LLC / APHL
Covance
Constable Consulting
IMO
CDC
Orchard Software
Regrets:
Co-Chair: Lorraine Constable
Scribe: Riki Merrick
Agenda/Minutes:
1. Agenda Review
2. Announcements:
3. Approve Minutes from last call = 8/07/2014, approve as distributed Riki Merrick, Ron Van Duyne, no further discussion,
against: 0, abstain: 2, in favor: 4
4. Ballot Reconciliation:
#992 and 991: Email follow up: no response yet
#128: Specimen purity and concentration are specimen evaluations that are performed prior to testing? – Email Follow
up: During DNA/RNA extraction and amplification, the genetic material after each amplification has its
volume, purity and concentration measured to determine if the target has been reached. If not, any
additional round of purification and amplification may occur.
Clem in one sense is correct, in that the protocol will specify the desired purity and concentration.
But it is routine (at least for clinical research labs like Covance) to report the final amplification
results as lab test results (observations on the specimen) to the sponsor company to document that the
target was reached, and thus the "real" testing/storage activity can begin, or that the target was not
obtained, and the (for example) low purity value of the of the final amplification specimen will be the
reason for cancelling the ordered genotyping test.
We currently store and report them as observations.
The main reason for this is that that we do not chose to produce a different specimen ID for each
amplification cycle, which can have its own purity and concentration value set.
At the bench and LIMS levels, it is easier to store, retrieve and report these as observation results, and
to store multiple (time stamped) observation values, than it is to store them as a single specimen
attribute, which then must use an audit trail/change history query approach to retrieve values other than
the final value.
The issue really is around the final values, and is it easier to have the values as specimen attributes as
one use case, (those interested in DNA storage would probably say yes) or as results.
Discussion: If you are in the lab and are working through the processing steps, then tracking these as observations on the
specimen during processing – i.e. results of the process (that’s how the instrument and LIMS would treat it).
For recording the final value indicating we met the purity and concentration needed for testing when you bank / store
/forward the specimen, then recoding it as a specimen attribute is what is required.
Find not persuasive with mod - agree that it can be considered observations on specimen during processing activity.
Clarify the definition to indicate that purity and concentration are specimen attribute in certain situations, i.e. bio-banking Phil Pochon, Riki Merrick, no further discussion, against:0, abstain: 3, in favor: 3
Affirmatives:
#3: Not all risks are biohazards - for example corrosive, flammable - not persuasive Kathy Walsh, Riki Merrick, no further
discussion, against:0, abstain: 0, in favor: 6
#4: This is a condition that is related to the test - so not necessarily only on the specimen - in v2.x = SPM-24, that
vocabulary has insufficient quantity - but in that context the test is associated, so will be covered there. The conceptual
model should represent the proper attributes of the specimen. Attributes that examine characteristics about the specimen
in relationship to the ordered test are out of scope of this model. Considered – Question Answered - Riki Merrick, Kathy
Walsh, no further discussion, against:0, abstain: 0, in favor: 5
#6: Seems to be a typo - Persuasive - Riki Merrick, Mark Jones, no further discussion, against:0, abstain: 0, in favor: 5
#7: Will ensure font reflects where linking is present - but linking is not desired in these cases - will remove the links –
persuasive with mod - Riki Merrick, Kathy Walsh, no further discussion, against:0, abstain: 0, in favor: 5
#28: TOC should properly render - persuasive - Riki Merrick, Kathy Walsh, no further discussion, against:0, abstain: 0, in
favor: 5
#72: We agree that would be useful, but can only accomplish this, if original use case submitter provides the input - will
reach out to Joyce Hernandez - persuasive with mod - Riki Merrick, Kathy Walsh, no further discussion, against:0,
abstain: 0, in favor: 5
#75: Agree to add numbers to the steps listed - persuasive Riki Merrick, Mark Jones, no further discussion, against:0,
abstain: 0, in favor: 5
#77: That comment should have been removed - we did model laterality explicitly both for the target site
(targetAnatomicSiteQualifier) and for the approach site (ApproachAnatomicSiteQualifier) - in fact we have specific
question for comment on page 6 Questions for balloters on whether having it in the model instead of the terminology. –
The commenter indicates that laterality is important, however there is no indication if that should be accomplished in the
model or in the terminology – considered – no action required - Riki Merrick, Ron Van Duyne, no further discussion,
against:0, abstain: 1, in favor: 4
Spreadsheet at end of call (unfiltered):
ballotcomments_HL7
_DAM_SPECIMEN_R1_I1_2014MAY_Consolidated.xls
Next call is in 2 weeks = 9/04/2014 from 12-1 PM EDT
Call adjourned 12:57 PM EDT