IG Ballot Reconciliation – Comment #891
March 6, 2012
Comment 891 reads: SPM.21 and SPM.22 are listed in table 7-1 however the IG specifies these elements as
optional. If these are CLIA requirements they should be required in the IG.
Comments from the IG Analysis and Vocab WG:
17-Nov-2011 The fields do not have to be sent in all cases. Problem is that the conditions are not computable.
OBX.11 may be used, but is not always present. Motion to change the Usage to RE for SPM.21 through SPM.24
and indicate these are required in specific circumstances that must be enumerated. Vocab WG needs to resolve
appropriate vocabulary. Riki Merrick, Austin Kreisler Riki and Megan will also work with Vocab WG to establish
the circumstances when they should be valued.
14-Feb-2012 Vocab WG: For SPM.21, when a test cannot be performed, this field should be populated with the
specimen rejection reason. Riki will gather available value set options for consideration at the next Vocab WG
meeting. For SPM.22-24, will gather value set options for consideration at the next Vocab WG meeting.
NOTE: Footnote 5 at the bottom of the page was reviewed and determined not to apply to these SPM fields.
28-Feb-2012 Vocab WG: Recommend that SPM.21 is the preferred field for communicating canceled test reasons
(HL7490). However, current practice allows for communicating this information in an alternate manner which
meets accreditation requirements. For SPM.22, need to verify if this field is actually a CLIA requirement. Cindy
will follow-up with Riki and Megan to determine conditions under which these fields should be used.
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SPM.21 Specimen Reject Reason
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If a test order is canceled due to specimen rejection SPM-21 should be used to communicate the reason
for cancelation and the reason needs to be retained and displayed in the patient record / incorporated
into any type of report (paper, displayed on screen).
Agreed that SPM.21 should be RE, noting that many lab systems may not have the capability of parsing
out specimen rejection reasons into a discrete field. For this reason, we recommend keeping this field as
“O” in the current version of the guide.
If a laboratory system cannot use SPM-21, then it is necessary to communicate this information
elsewhere, as it is a CLIA requirement. It should be noted, though, that it will indicate noncompliance
with this guide and needs to be negotiated between trading partners.
Recommend IG to point to HL70490 table as the value set for SPM.21 with a note that the content needs
improvement. SNOMED also has terms but the vocabulary is also not complete. Both vocabularies will
need future work to expand the content to maximize their usefulness.
HL7 definition for SPM.21 “Definition: This describes one or more reasons the specimen is rejected for the
specified observation/result/analysis”. In order to accommodate multiple specimen rejection reasons, it
is suggested that cardinality for SPM-21 should be [0..*]
In CLIA requirements section of the IG, indicate that if SPM.21 is not used (since it is an Optional field),
this information must be communicated using OBX and/or NTE segments.
SPM.22 Specimen Quality
The group was not clear on what this field is intended to do and why it was included in HL7 2.5.1. The values in
HL70491 have no definitions and would be very difficult to use. Every specimen is rated when we receive it and
the condition noted if it does not meet the laboratory’s requirements. SPM-24 Specimen Condition should be
used to communicate this information.
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Laboratories currently send as a qualifier attached to the result or as a report comment, so not easily
reported here.
In most situations, this is mainly important for poor specimens that were processed by the lab based upon
their business practices. It is not known if lab systems would have to report the quality of ALL of the
specimens received, which would be cumbersome.
For these reasons, it was recommended that this field should be “O” instead of “RE”
None of the group thought that this field was required for CLIA, so it should be removed from the
Regulatory Requirements section in the IG.
SPM-23 Specimen Appropriateness
It was felt that one of values in HL70492 might be helpful to have – “Inappropriate specimen due to … “. There
could be multiple reasons communicated here and would probably be more useful than SPM-22.
The group recommended that this field be kept as “O”.
SPM.24 Specimen Condition
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SPM.24 might be very useful for communicating specimen condition information that does not meet the
laboratory’s standard for acceptability (HL70493). This is stated in MU phase 1 requirements, however,
currently many labs communicate this information elsewhere in the record.
Agreed that SPM.24 should be RE, noting that many lab systems may not have the capability of parsing
out specimen condition into a discrete field. For this reason, we recommend keeping this field as “O” in
the current version of the guide.
NOTES:
If a lab sends these fields, they should be displayed and supported in the EHR system
If a lab uses any of these fields – they need to be displayed to the provider.
It is recommended that SPM.21 and SPM.24 should be RE in the future as path forward, and a statement to this
effect should be included in the Best Practices section of the IG.