Recommendations from the EHR-S Functional Requirements IG: Lab Results Interface

1. Recommendations from the EHR-S Functional Requirements IG: Lab Results Interface Error Handling 7/10/2014

2. Issues • Is there a requirement to have a 1:1 relationship between application level ACKs and the messages? • If yes, then can you mix order control codes within the same ACKs (ORL = LOI question) • If no, you can send multiple ACKs for a message? • Can you mix order control codes in OML?

3. To Do • Verify treatment of hard errors for LRI • Describe best practice • permissible to stop validation on hard error? • continue and report all error if possible? • stop on hard error and no commit of any ORC/OBR • One ACK with “hard error” notification (MSA1=AR) • Partial consumption (e.g. 5 ORC/OBR groups, where only 1 cannot be consumed) • Get one ACK with “combined error” notification • if YES, then use MSA-1 = new code, ERR-4 = ? • Get 5 ACKs • 4 with MSA-1 = AA or AE if soft errors • 1 with MSA-1 = AR • Guidance for use of ERR-7 and ERR-8 • Guidance for use of ERR-3 vs ERR-5 in single ERR segment • Flow diagrams for message processing at each step

4. Message Flow (needs diagram) • Message received at destination • Send system ACK to last hop • Process message for compliance with IG (includes value sets) • No Error – continue • Soft Error – note and continue • Hard Error – Application ACK MSA-1 = AR • Process message for ability to consume and associate • No Error – continue • Soft Error – note and continue • Hard Error – Application ACK MSA-1 = AR • Consume/store message content • Success – Continue • Failure -- Application ACK MSA-1 = AR • Application ACK • MSA-1 = AA (no soft errors) • MSA-1 = AE (soft errors)

5. Acknowledgement Message Structure Guaranteed delivery is required. Where use of an ACK is appropriate for the transport mechanism it should be used as described in this guide. All other acknowledgement methods are beyond the scope of this document (e.g., acknowledgement of batches using the HL7 batch methods). No changes here. Assumption is 1 ACK/message

6. MSA The Message Acknowledgment Segment (MSA) contains the information sent as acknowledgment to the result message received by a Electronic Health Record System. No changes here. Assumption is 1 ACK/message Consider use of MSA-1 to indicate hard error vs soft error

7. Table 0008 Acknowledgement Code Immunization Use

8. Table 0008 Acknowledgement Code Option 1: Creating IG specific codes to indicate hard vs soft error

9. Table 0008 Acknowledgement Code Option 2: Use existing codes to indicate hard vs soft error

10. ERR The ERR segment is used to add error comments to acknowledgment messages – ONE FOR EACH ERROR.

11. Define ERL datatype

12. Table 0357 in ERR-3Message error condition codes (HL7 defined) **From Immunization in HL70357

13. Table 0516 in ERR-4Error Severity (HL7 defined) These definitions are not very helpful Suggestion: Create 2 new codes that indicate HARD ERROR and SOFT ERROR respectively Hard error- Application cannot meaningfully consume the message content – content NOT processed Soft error – application cannot meaningfully consume part of the message content as indicated in ERL, but consumed remainder of message sections

14. Table 533 suggested codes(empty user defined table in base HL7) **From Immunization in HL70357

15. Table 533 suggested codes(empty user defined table in base HL7) **From Immunization in HL70357

16. Example Hard Error 1 ACK message – application level • MSA-1 = AR • ERR-2 = MSH^1^12 • ERR-3 = code for Message Header Error • ERR-4 = E (or code for hard error) • ERR-5 = empty • ERR-7 = Incompatible version of HL7 message • ERR-8 = Cannot process results; call or FAX results See Chapter 2, section 2.9.3 for clarification

17. Example Hard Error 1 ACK message – application level • MSA-1 = AR • ERR-2 = PID^1^3 • ERR-3 = code for Application Error (or would we use 0 = message processed?) • ERR-4 = E (or code for hard error) • ERR-5 = code for cannot match patient ID • ERR-7 = Cannot match patient ID, message content not processed ERR-8 = Cannot match patient ID; message content not processed; call or Fax results

18. Example soft error 1 ACK message – application level • MSA-1 = ACE • ERR-2 = OBX^1^3 • ERR-3 = code for Application Error (or would we use 0 = message processed?) • ERR-4 = W (or code for soft error) • ERR-5 = code for cannot match to local code • ERR-7 = empty • ERR-8 = Resulted test code does not match what is expected based on ordered test; results stored; call to resolve for future results

19. Error Handling Overview Error Handling • As a follow up item to the LRI and LOI IG publications November 2013, the S&I Lab WG analyzed and discussed the various error situations that should be formally addressed with consistent guidance and testing to ensure consistent and robust end-to-end interoperability from the construction of a laboratory order within an EHR to the receipt of results by an EHR. • The topics were originally addressed as two tracks – LOI [item LOI 1.7, LRI [item LRI 1.5] – but were merged into a single conversation and set of decisions reflected in item LRI-1.5, excerpted below. Definitions– NEED TO DEFINE WHAT THE RESPECTIVE MESSAGES FOR THESE LOOKS LIKE (not used in immunization that way) • Hard Error – full stop; suspend processing and notify sender, do not commit info to patient record • Soft Error – notify (as directed) but can continue to process message unless a hard error is encountered prior to end of message processing; may commit error-free data to patient record while continuing to resolve soft errors with sender.

20. Handling of Non-Cardinality Errors Handling of errors other than cardinality failures Categories: length, cardinality, invalid codes (value can’t be found, format, which code sets, etc.), what constitutes ‘hard’ vs. ‘soft’ errors, encourage folks to bring concerns to add to list of categories, anything that keeps the result from getting to the provider, e.g., provider ID, procedure codes, organization code mismatch with provider codes. • Length • which fields are ‘in-scope’? NTE-3, OBX-5 • NTE-3 is tied to cardinality conversation • Adopt consistent failure criteria • if the error results in the inability to file the results to the database, it is a ‘hard’ error, the sender must be notified. • Missing data • only where usage is ‘R’ • Cardinality • See CardinalitySegmentFieldManagement V13.xlsx

21. Order Errors Matching – For Orders (LOI): • Patient • out of scope for orders in ambulatory setting (systems that have no tight coupling, not owned by same organization) • in-patient is not within the LOI IG scope as currently published, but may be addressed in future release • There is no prohibition on a lab sending an error if patient matching fails • Provider • soft error (inform/resolve but don’t stop processing) • copy-to-provider – soft error (inform but don’t stop processing) • new order (ORC/OBR) • Placer Order Number – see missing data • OBR-4 – service identifier – hard error • OBX • OBX-3 – observation ID not match with what expected in OBR-4 – soft error • OBX-5 – inconsistent with what was expected – soft error • cancel order (ORC/OBR) • Placer Order Number – hard error

22. Result Errors Matching – For Results (LRI): • Patient within ordering provider system • No match – hard error back to Lab (how matching occurs or defining confidence levels are not within scope of the IG) • Patient within copy-to-provider system • No match – no expectation that a copy-to-provider system would be able to resolve who the ordering provider is and/or be able to communicate using application-level ACKs • Out of scope for this version, but may be addressed in the future due to complexity • Provider • No match – soft error • Order (ORC/OBR) – Not applicable to copy-to receivers • Placer Order Number – local decision on level of error • OBR–4 – service identifier – hard error for this pair in the event that it is not on the patient record, can continue with other pairs • Does not apply when specimen action code is ‘G’ for reflex testing • Specific data

23. Cardinality Errors Source: two action items, one for LOI, one for LRI re: cardinality errors and test limits for senders and receivers, these were addressed in a single track and resulting artifact noting the agreed upon limits. During discussions errors and omissions in the respective guides were identified and are queued for disposition as errata updates to each guide. • LRI-1.6 Testing of stated and implied cardinality limits • 5/22/2014 - closed on LRI call • Log CR for LRI – change PID-5 (Patient Name) to [1..1] to sync with LOI • See CardinalitySegmentFieldManagementV13.xlsx