EHR-S Functional Requirements IG: Lab Results Interface

1. EHR-S Functional Requirements IG: Lab Results Interface Laboratory Initiative 3/24/2014

2. Meeting Etiquette • Remember: If you are not speaking keep your phone on mute • Do not put your phone on hold – if you need to take a call, hang up and dial in again when finished with your other call • This meeting, like all of our meetings, is being recorded • Another reason to keep your phone on mute when not speaking! • Feel free to use the “Chat” or “Q&A” feature for questions or comments • Please announce your name prior to making comments or suggestions during the meeting From S&I Framework to Participants: Hi everyone: remember to keep your phone on mute  NOTE: This meeting will be recorded and posted to the S&I wiki

3. Agenda • Feedback on 2015 NPRM in regards to § 170.315(b)(4) (Incorporate laboratory tests and values/results) • EHR System (EHR-S) Functional Requirements Implementation Guide: Laboratory Results Interface (LRI) • Finish off scope discussion • Start off with use case discussion • Last 10 min: Discussion on how to approach the development of the lab functional profile on the EHR side

4. Feedback on 2015 NPRM • § 170.315(b)(4): • This functionality would require EHR technology to be capable of displaying the following information included in laboratory test reports it receives: (1) the information for a test report as specified in 42 CFR 493.1291(a)(1) through (a)(3) and (c)(1) through (c)(7); the information related to reference values as specified in 42 CFR 493.1291(d); the information for alerts and delays as specified in 42 CFR 493.1291(g) and (h); and the information for corrected reports as specified in 42 CFR 493.1291(k)(2).

5. 42 CFR 493.1291(a)(1) through (a)(3) • (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: • (1) Results reported from calculated data. • (2) Results and patient-specific data electronically reported to network or interfaced systems. • (3) Manually transcribed or electronically transmitted results and patient specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations.

6. 42 CFR 493.1291(c)(1) through (c)(7) (c) The test report must indicate the following: (1) For positive patient identification, either the patient’s name and identification number, or a unique patient identifier and identification number. (2) The name and address of the laboratory location where the test was performed. (3) The test report date. (4) The test performed. (5) Specimen source, when appropriate. (6) The test result and, if applicable, the units of measurement or interpretation, or both. (7) Any information regarding the condition and disposition of specimens that do not meet the laboratory’s criteria for acceptability.

7. 42 CFR 493.1291(d) • (d) Pertinent ‘‘reference intervals’’ or ‘‘normal’’ values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results.

8. 42 CFR 493.1291(k)(2) • (k) When errors in the reported patient test results are detected, the laboratory must do the following: • (2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results.

9. Use case section The following are variations under this use case • Initial Results received • default = Final results • Alternative = Partial • Re-sent results • Partial to final (e.g. new results) • After change in patient information (demographic or clinical) • Result interpretation changed • Result interpretation unchanged • Result needs correction (other reason) • variation = Preliminary to final • Result confirmation request • Receipt of unsolicited result (includes full report for copy to) • Reflex • Add-on (depending on how added) • verbal orders if not documented in EHR) • Rejected specimen • Order canceled = LOI

10. Use case section Questions: • What requirements do we need to cover? • NPRM named items • CLIA regulations and accreditation items • Laboratory/Clinical best practice • Audit trail and persistence of viewed information • What else? • Use cases for translations • Use cases for persistence • Initial information • Transformations • Use cases for display • Reference Report • Summary information • Flow sheet • Graphical information

11. EHR-S lab FP WG • Do we have a lead volunteer to go host this sub-working group? • Or can we have folks review and send comments back asynchronously by specified due dates • Documents to work from: • Draft FP spreadsheet with reference to the PHLab FP • EHR-S glossary • APHL LIMS requirements document may have some items that also apply for EHR-S • Need to create a parking lot document for the lab side for results reporting and order receiving