IHE Laboratory

1. 1 IHE Laboratory François Macary, AGFA Healthcare IHE Laboratory cochair

2. 2 Laboratory Technical Framework General scope: Ordering and performing clinical laboratory tests. In vitro testing Microbiology included. Anatomic pathology excluded. Sharing of laboratory reports (both ambulatory & acute care settings)

3. 3 Primary membership (sponsors & contributors) Biomedical scientists in professional societies SFIL (Fr) In discussion: CAP (US) National Healthcare IT bodies GMSIH (Fr) JAHIS (Jp) HIMSS (US) In discussion: CHCF (US) Contributing countries: France, Japan, Italy, UK, Germany, US Basically LIS & AM vendors, Analyzers manufacturers

4. 4 Summary of integration profiles Workflow Integration Profiles: Laboratory Scheduled Workflow (LSWF) Laboratory Information Reconciliation (LIR) Laboratory Device Automation (LDA) Laboratory Point Of Care Testing (LPOCT) Laboratory Code Sets Distribution (LCSD) Laboratory Specimen Label Workflow (LSL) Content Integration Profiles Sharing Laboratory Reports (XD*-LAB)

5. 5 Sharing Laboratory Reports: XD*-LAB

6. 6 Purpose Sharing laboratory reports Access to lab results in a patient-centric manner Retrieval of historical lab results by providers of care To improve coordination of care A content profile. A lab report: Presents a set of releasable laboratory results to be shared as “historical information”. Is human-readable, shared between care providers of various specialties and the patient (e.g. through a PHR) Contains machine readable coded entries (decision support, bio-surveillance) The clinical laboratory report is a final report that comes out after the fulfillment workflow has been achieved. It is intended first for human readers: care providers who will share this document within an electronic health record or a personal health record. It may contain fine grained coded data that can be integrated in the EHR or in the practitioner’s database. At this point in time, all clinical laboratory specialties are in scope except blood banks (this profile only addresses the blood bank testing like the report of an ABO group for a blood receiver) and pathology which manages different kinds of reports (mixing bulk text and large images). Pathology has its dedicated domain in IHE. The report uses CDA R2, constraining it with a set of templates at level 2 (human readable part) and level 3 (fine grained coded data).The clinical laboratory report is a final report that comes out after the fulfillment workflow has been achieved. It is intended first for human readers: care providers who will share this document within an electronic health record or a personal health record. It may contain fine grained coded data that can be integrated in the EHR or in the practitioner’s database. At this point in time, all clinical laboratory specialties are in scope except blood banks (this profile only addresses the blood bank testing like the report of an ABO group for a blood receiver) and pathology which manages different kinds of reports (mixing bulk text and large images). Pathology has its dedicated domain in IHE. The report uses CDA R2, constraining it with a set of templates at level 2 (human readable part) and level 3 (fine grained coded data).

7. 7 Value Proposition Use case 1: Hospital lab report [CIS ? RHIO ? EHRs] Most significant lab reports shared at discharge time. Use case 2: Private lab report [LIS ? RHIO / PHR] Final report shared by a private laboratory Use case 3: Lab report shared by physician [EHR ? PHR] Results received from a reference laboratory. Report shared by physician. Use case 4: Lab report automatically shared [LIS ? RHIO] A laboratory, systematically and automatically shares its final reports with a regional healthcare network. Use case 5: Hospital’s cumulative report [CIS ? RHIO] At discharge time a hospital physician selects the most significant lab results and builds a cumulative report shared in a health info exchange .

8. 8 CDA Release 2 from HL7 v3 normative edition HL7 V3 Laboratory Result Event RMIM <entry> template based on a restriction of LAB “Result Event” RMIM. LOINC subset of test codes, alternatively SNOMED CT

9. 9 A CDA document is a kind of XML document

10. 10 clinicalDocument/code Multi-disciplinary lab report (LOINC or SNOMED) Single discipline lab report (e.g. chemistry) (LOINC) recordTarget The patient effectiveTime Time the report was issued confidentialityCode Normal, restricted, very restricted interpreted by defined policies Lab contextual data in the header (1)

11. 11 Lab contextual data in the header (2) author A human (e.g. a physician) A system (e.g. LIS, EHR, …) custodian The organization operating the Content Creator legalAuthenticator The verifier of the report who legally authenticated it authenticator A verifier who is not he legal authenticator

12. 12 Lab contextual data in the header (3) inFulfillmentOf/order the Order (Group) that was fulfilled participant typecode=“REF” The ordering physician for the lab act. documentationOf/serviceEvent The act documented serviceEvent/statusCode “active” = preliminary, “completed” = final serviceEvent/performer The fulfiller lab (person and organization)

13. 13 Human-readable body: Two levels of sections A laboratory report has its results sorted by “specialty” sections. Within a specialty section, the results may be organized by “reported item” sections (battery, specimen study, individual test). The relationship between reported item and specialty is not constrained: Left up to the Document Source Actor. Each leaf section of the body is derived from a level 3 <entry> The xmlStructuredBody of the lab report, for the level 2 human-readable part, is composed of two levels of sections: At the top level, “specialty” sections (20 sections or so that come from the US Lab Claim Attachment). At the leaf level, “promised item” sections. A promised item is an item (battery, study, test) that was actually promised (either ordered or reflex). This profile does not constrain the relationship between “promised item” and “specialty”. For instance it does not say whether a urine glucose should be sorted below the URINALYSIS specialty section or below the CHEMISTRY specialty section. This relationship varies from country to country and even from a healthcare organization to another. Yet, it might be further constrained in the national extensions of this profile.The xmlStructuredBody of the lab report, for the level 2 human-readable part, is composed of two levels of sections: At the top level, “specialty” sections (20 sections or so that come from the US Lab Claim Attachment). At the leaf level, “promised item” sections. A promised item is an item (battery, study, test) that was actually promised (either ordered or reflex). This profile does not constrain the relationship between “promised item” and “specialty”. For instance it does not say whether a urine glucose should be sorted below the URINALYSIS specialty section or below the CHEMISTRY specialty section. This relationship varies from country to country and even from a healthcare organization to another. Yet, it might be further constrained in the national extensions of this profile.

14. 14 A specialty section may also be itself a leaf section… The xmlStructuredBody of the lab report, for the level 2 human-readable part, is composed of two levels of sections: At the top level, “specialty” sections (20 sections or so that come from the US Lab Claim Attachment). At the leaf level, “promised item” sections. A promised item is an item (battery, study, test) that was actually promised (either ordered or reflex). This profile does not constrain the relationship between “promised item” and “specialty”. For instance it does not say whether a urine glucose should be sorted below the URINALYSIS specialty section or below the CHEMISTRY specialty section. This relationship varies from country to country and even from a healthcare organization to another. Yet, it might be further constrained in the national extensions of this profile.The xmlStructuredBody of the lab report, for the level 2 human-readable part, is composed of two levels of sections: At the top level, “specialty” sections (20 sections or so that come from the US Lab Claim Attachment). At the leaf level, “promised item” sections. A promised item is an item (battery, study, test) that was actually promised (either ordered or reflex). This profile does not constrain the relationship between “promised item” and “specialty”. For instance it does not say whether a urine glucose should be sorted below the URINALYSIS specialty section or below the CHEMISTRY specialty section. This relationship varies from country to country and even from a healthcare organization to another. Yet, it might be further constrained in the national extensions of this profile.

15. 15 Lab report structure This profile applies constraints to the 3 levels of CDA Level 1 (header) is basically constrained by realms. This profile just spots the lab data in the header. For level 2 (the human readable body), we defined : one template for the top-level “specialty” section, without narrative block and four templates for the leaf “promised item” sections, each of which having a mandatory narrative block. At level 3 (the fine grained coded data) we have four “entry” templates corresponding to the 4 “promised item” templates. And below these we use four “observation” templates, and one additional template for the battery containing the antibiotic sensitivity of an isolate, in microbiology.This profile applies constraints to the 3 levels of CDA Level 1 (header) is basically constrained by realms. This profile just spots the lab data in the header. For level 2 (the human readable body), we defined : one template for the top-level “specialty” section, without narrative block and four templates for the leaf “promised item” sections, each of which having a mandatory narrative block. At level 3 (the fine grained coded data) we have four “entry” templates corresponding to the 4 “promised item” templates. And below these we use four “observation” templates, and one additional template for the battery containing the antibiotic sensitivity of an isolate, in microbiology.

16. 16 Rendering of a single specimen battery (1) For “promised item” templates, the basic shape is: Optional paragraph element (setting the context of the study) A table element (containing all the observations Optional footnotes containing comments of the results Optional paragraph element (conclusion, global interpretation) For “promised item” templates, the basic shape is: Optional paragraph element (setting the context of the study) A table element (containing all the observations Optional footnotes containing comments of the results Optional paragraph element (conclusion, global interpretation)

17. 17 Rendering of a single specimen battery (2) For “promised item” templates, the basic shape is: Optional paragraph element (setting the context of the study) A table element (containing all the observations Optional footnotes containing comments of the results Optional paragraph element (conclusion, global interpretation) For “promised item” templates, the basic shape is: Optional paragraph element (setting the context of the study) A table element (containing all the observations Optional footnotes containing comments of the results Optional paragraph element (conclusion, global interpretation)

18. 18 A possible rendering for microbiology

19. 19 Another possible rendering for microbiology

20. 20 LOINC subset for test codes Chemistry ……………………………………………………………. Hematology ………………………………………………………..... Toxicology and drug monitoring ……………………………….. Virology and serology …………………………………………….. Parasitology and micology ………………….…………………… Bacteriology ………………………………………………………… Immunology and cell mark ……………………………………….. Patient and specimen findings ………………………………….. 873 tests 284 tests 194 tests 374 tests 158 tests 387 tests 278 tests 30 measures

21. 21 Thank you. Questions…