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HL7 Files

Owned by Toma Holtzer
Last updated: 23-Oct-2023 by Steffan Stringer (Unlicensed)
3 min read

Summary

HL7 files are used for orders sent by ClinSpark to the lab, and results and optionally confirmation messages sent from the lab to ClinSpark.

The format of these messages is govenerned by HL7 specifications, and IQVIA does not have additional documentation covering these formats, since they are already exhaustively covered by the specs.

Having said that, we can share some notes regarding how ClinSpark interprets and uses these file formats.

Result HL7 Files

  1. We do not accept any embedded binary content, such as PDFs or images. We can consume textual results only.

  2. We look only for result information, and ignore any information in the MSH or PID segments. This is because ClinSpark is already the source of truth for this information, and we do not update any of this core subject data based on results of the lab.

  3. We expect to find the original specimen barcode in ORC-2 and OBR-2, the same value which was passed for that same sample in the HL7 order file from us. This value is used on our end to look up that specimen so that the contained results can be applied properly.

  4. We expect to find LOINC values for the result in OBX-4. We believe this is also standard, but since this may be new to some labs it is worth calling out specifically.

Example

MSH|^~\&||TST||73915240|202204281824|IGNORED_VALUE|ORU^R01||D|2.4|||||| PID|1|96|KS336424T|P003^|TEST^TC3^||19850614|F|||Address```State`ST 66```||^^^|||||^^^C^^^||||||||| ORC|RE|F1559802|KS336424T||CM||||||^^^|^DOCTOR-LASTNAME^DOCTOR-FIRSTN^^^^^^^||||||C| OBR|1|F1559802|KS336424T|899^TSH^^^^|||202203301940|||||||202203311828|S|^DOCTOR-LASTNAME^DOCTOR-FIRSTN^^^^^^^||||^^||202204061900|||F|||||||||||||||||| OBX|1|TX|55080400^TSH^^^^|38765-7||mIU/L|||||F|||202204061900|KS||| NTE|1|R|THIS IS TESTING RESULT SENT AS NTE ONLY. NTE|2|R|NO NUMERIC RESULT VALUE SENT IN OBX.05 NTE|3|R| Reference Range NTE|4|R| NTE|5|R| > or = 20 Years 0.40-4.50 NTE|6|R| NTE|7|R| Pregnancy Ranges NTE|8|R| First trimester 0.26-2.66 NTE|9|R| Second trimester 0.55-2.73 NTE|10|R| Third trimester 0.43-2.91

Order HL7 Files

Order files are also governed by the HL7 specification, and as such we do not duplicate this reference documentation.

A few notes about how we use orders:

  1. Each specimen tube will have a unique barcode. We expect to receive results for that specimen in a result file with the original barcode we sent in ORC-2 and OBR-2

  2. Barcodes are ideally 12 digits in lengh. The first character is a fixed prefix, which is configurable. It can be any alphanumeric character. The next 9 digits are a digit sequence unique to the specimen tube. The last 2 digits represent the container.

  3. A best practice is for ClinSpark to pass study context information about each sample, such as study name, study event name, cohort and subject numbers. These should be visible to the lab techs, to faciliate conversations with the clinical site when there are issues. We can accommodate many ways to do this, it is up to the lab to decide. One common option is to pass this info as NTE values in the order.

Example File

Note that the bulleted values can be set in the ClinSpark UI as follows:

Exported and Printed Copies Are Uncontrolled