Public Health Informatics

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  • 1.  Receiving test results-HL7-CLIA issues

    Posted 11-12-2024 11:57 AM

    good morning APHL Listserv, 

    I am interested in feedback from other jurisdictions how you may be addressing HL7 data reporting. We are working with national partners to complete HL7 reporting of their results back to us and are concerned with how we are expected to receive results. What I am told is that our national partner plan to transfer data only via HL7, and not include a "locked" report, i.e., a .pdf file. Per CLIA requirements, "the referring lab (we) must not revise results or information directly...", and being good stewards of health data, prefer to receive data that cannot be susceptible to revision, regardless of no nefarious actors being involved. As manual data entry issues are prone to occur, even with direct integration, we prefer to remove any opportunities. 

    How are programs ensuring CLIA compliance with reference laboratory results? feel free to reach out to me directly. 

    Thank you!


    Greg



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    Gregory Hovan
    Laboratory Director
    Delaware Public Health Laboratory
    Smyrna DE
    (302) 802-5000
    gregory.hovan@Delaware.gov
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  • 2.  RE: Receiving test results-HL7-CLIA issues

    Posted 11-18-2024 11:48 AM

    Hello Greg,

    I wanted to provide a response from APHL after talking to the terminologists on our team. HL7 obviously has the ability to send PDFs, and some PHLs are sending results from reference labs as PDFs in their HL7 result message. To the best of our knowledge, none of the larger labs (Quest, LabCorp, Arup) are sending PDF to clients via HL7. Related to HL7 standards specifically, it would be best practice to ensure that when forwarding the results the OBX-23 and OBX-24 and OBX-25 are appropriately reflecting the performing organization and are not hardcoded to the PHL itself. Otherwise, this sounds like a policy question, with organizational leadership possibly placing restrictions on how the PHL is allowed to send or receive results. Do others have thoughts? Have you encountered similar issues in your jurisdiction?



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    Melanie Kourbage
    Association of Public Health Laboratories
    Bethesda MD
    (240) 485-2747
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  • 3.  RE: Receiving test results-HL7-CLIA issues

    Posted 11-18-2024 12:10 PM

    We receive HL7 results from several different labs, including two other PHLs.  While our LIS does have the ability to both send and receive a pdf report in the HL7 itself, none of our reference labs send pdf via HL7.  All the labs we work with have a pdf version of the report available by fax or with an online portal.  Our LIS enables attaching an external report as the result, displaying the results on our report, or both.  We choose to do both.  We obtain a copy of the testing lab's report and link it to the order as a reportable document.  Our report lists the testing laboratory and address, and a comment indicating their report is attached.  The submitting facility can then see both our version of the report and the testing lab's report. 

     

    I know of labs who choose to only attach the testing lab's report, and labs who only take in the HL7 and display it on their own report.  There are many ways to do this.  The CLIA requirement is met by each lab's policy of how they handle the results they receive.

     

    Our current LIS doesn't allow us to interact with results from interfaced reference labs at all.  We can't enter results or change results.  Our previous LIS would allow us to enter or change results, but we didn't ever change results.  We would only enter results manually if we didn't receive them electronically for some reason.  Having that copy of their report to compare to is how we would satisfy any inspector who questioned that our report was the same as the testing laboratory.

     

     

    Logo  Description automatically generated

    DEPARTMENT OF

    PUBLIC HEALTH &

    HUMAN SERVICES

     

    Kim Varvel, MLS(ASCP)CM

    Data Coordinator/CLSP

    Laboratory Services Bureau/Public Health Laboratory

    PO Box 4369 | 1400 Broadway | Helena MT 59620-2951

    Desk: 406-444-4115 | Fax: 406-444-5527

    kvarvel@mt.gov

     

     






  • 4.  RE: Receiving test results-HL7-CLIA issues

    Posted 11-18-2024 12:14 PM
    We are working on setting up reference laboratory results coming back in from CDC.  They do not include an embedded PDF in their results so we must receive their results into our LIMS and then report the results out on our report.  The process that we have in place puts a disclaimer on the report that says that the results were produced by the sending agency.  We validate their results by sending them copies of the reports we produce during testing and they send us approval to put the tests into production.  We keep these responses in our validation documents. 

    The raw HL7 messages are also stored in our system if we need to investigate any discrepancies between our reports and their results coming in.  These results are automatically processed when we receive the HL7 message so there's little opportunity for results to be manually manipulated unless those records were "unlocked" in our system which would require permissions and be captured in the audit trail.

    Hope that helps.  We have not had a CLIA audit of this process since it has been put in place so I guess I have no feedback directly from CLIA if it is sufficient or not but it should check all their boxes.  But ideally an embedded PDF that is attached to the report going to the customer is the ideal approach.

    --
    Justin Nucci, MSPH
    (he/him)
    Laboratory Data Systems Program Manager
    CO Dept of Public Health and Environment
    8100 Lowry Blvd
    Denver, CO 80230
    Provide feedback to the lab using this survey.
    303-692-3689