1. September, 2005What IHE Delivers 1 Francois Macary, Agfa HealthCare co-chair Lab Technical Committee co-chair Lab Technical Committee Sharing Laboratory Reports XD-LAB

2. 2 Lab TF Integration Profiles Workflow Content Laboratory Scheduled Workflow (LSWF) Laboratory Information Reconciliation (LIR) Laboratory Device Automation (LDA) Laboratory Point Of Care Testing (LPOCT) Laboratory Code Sets Distribution (LCSD) Laboratory Barcode Labeling (LBL) -> 2007 Sharing Laboratory Reports (XD-LAB) V3:CDA V2.5HL7 Subset of LOINC test codes

3. 3 Lab TF Integration Profiles Workflow Content Laboratory Scheduled Workflow (LSWF) Laboratory Information Reconciliation (LIR) Laboratory Device Automation (LDA) Laboratory Point Of Care Testing (LPOCT) Laboratory Code Sets Distribution (LCSD) Laboratory Barcode Labeling (LBL) -> 2007 Sharing Laboratory Reports (XD-LAB) V3:CDA V2.5HL7 Subset of LOINC test codes Sharing Laboratory Reports

4. 4 Scope Sharing laboratory reports Retrieval of historical lab results by the providers of care, in a patient-centric manner Main characteristics of a lab report: Presents a set of releasable laboratory results to be shared as historical information. Usually a final report, shared once the lab order is completed. Occasionally a partial report may also be shared Human-readable, viewed by care providers (physicians, nurses, pharmacists… and even the patient (e.g. through a PHR) Machine-processable (for decision support, bio-surveillance) The results must be represented in both formats

5. 5 CIS Use case 1: Hospital lab report [CIS EHRs] At discharge time, a hospital physician selects the most significant laboratory reports produced during the patient stay, and issues these reports to an Affinity Domain shared by a number of healthcare enterprises and primary care providers. Lab Report Source Lab Report Consumer XD* Dischargetime Lab Reports Hospital Any care setting or care provider

6. 6 LIS Use case 2: Private lab report [LIS PHR/EHR] A private laboratory having signed a final report for a patient, sends this report in an electronic format to the patient record in the regional or national PHR. Lab Report Source XD* Lab Report document Private laboratory Report Signed Lab Report Consumer Any care setting or care provider

7. 7 Use case 3: Lab report published by a GP A physician reviews the results received from a reference laboratory for his patient. The doctor, as requested by the patient, shares this laboratory report in the patients personal health record in an electronic format. Lab Report Consumer Any care setting or care provider Lab Report Source XD* Lab Report document Ambulatory physicians office Resultsreviewed

8. 8 Use case 4: Lab report automatically shared A laboratory, systematically (with some degree of automatism) shares its final reports with a regional healthcare network. LIS Lab Report Source XD* Lab Report Document Laboratory Results completed Lab Report Consumer Any care setting or care provider

9. 9 CIS Use case 5: Hospitals cumulative report [CIS PHR] At discharge time of an inpatient, a hospital physician selects the most significant lab results, produced by one or more laboratories of the healthcare enterprise during patient stay, and issues a cumulative report to the national PHR. Lab Report Source Lab Report Consumer XD* Dischargetime Cumulative Lab Report Hospital Any care setting or care provider

10. 10 Dependencies of XD-LAB towards other profiles Content Creator Content Consumer Share a CDA lab report XDS XDRXDM or Document sharing infrastructure Security infrastructure ATNA CT XD-LAB

11. 11 XD-LAB options ActorOptionsDomain, Volume, Section Content Consumer View Option (1) Document Import Option (1) Section Import Option (1) Discrete Data Import Option (1) PCC TF-2: 3.1.1 PCC TF-2: 3.1.2 PCC TF-2: 3.1.3 PCC TF-2: 3.1.4 Content Creator No option (1) The Content Consumer must support at least one of these options

12. 12 A CDA Release 2 document The header delivers the context: patient, encounter, author, cutodian, documented act… The body can be structured as a tree of nested sections A section may contain a narrative block for the human reader… …and a number of entries containing machine-readable coded data.

13. 13 Constrains the use of elements of the CDA header Delivers guidelines for the layout of the structured body How to build the tree of sections How to organize the narrative block ….. Mandates the structured & coded data ….. and defines a unique template for it. Aligned with HL7 V3 Laboratory result messages Compatible with HL7 v2.5 laboratory result messages XD-LAB constrains CDA R2

14. 14 Key elements in the header clinicalDocument/realmCode universal (no national extension) US extension clinicalDocument/code The kind of document: Either a multi-disciplinary lab report or a single specialty lab report. clinicalDocument/languageCode The main language used in the document (can be superseded by some section) Elements driven by the affinity domain:

15. 15 Key elements in the header = The time the current version was produced = a common identifier to all versions of this document = unique id of the current instance = integer representing the current version (only replacement) = the unique id of the replaced document Replacing a lab report by a new version:

16. 16 Key elements in the header The may be a system (e.g. the LIS) The is the organization in charge with stewardship of the report (replace, deprecate). It is the organization operating the Content Creator Actor (depending on the use case the laboratory, the hospital, the GP ) Authoring and stewardship:

17. 17 Key elements in the header inFulfillmentOf/order = the request received by the laboratory = the ordering physician informationRecipient/intendedRecipient = the list of the other intended recipents Who and what this report is answering to:

18. 18 Key elements in the header documentationOf/serviceEvent = the main act documented by the report (e.g. the laboratory order) = the laboratory who performed the main part or the totality of the tests reported in this document. = the person who has verified and legally authenticated the report, and the organization represented by this person = the other verifiers of the report (e.g. a biologist who performed the clinical validation of the results) The main act: a lab order

19. 19 Key elements in the header = the patient componentOf/encompassingEncounter = the encounter during which the tests documented in this report were produced The patient:

20. 20 Same content binding as PCC Mapping between the metadata of XD* and the header of the CDA document (here the lab report), is defined in PCC TF, volume 2, section 4.1.1

21. 21 The body is structured in two levels of sections Header Reported Item section Specialty section 18767-4: Blood gas 18719-5: Chemistry Electrolytes Na (mmol/l) 141 K (mmol/l) 4.4 Arterial blood gas pO2 (mm Hg)85 pCO2 (mm Hg) 35 Each section carrying results is derived from a mandatory embedded at the end of the section. This entry carries the coded & structured representation of these results, to be imported by the consumer. entry

22. 22 At the international level, this profile is flexible regarding the organization of the body Possibility to use only one level of section, instead of two. The profile provides a list of specialties but does not impose the relationship between specialties and tests The narrative block ( … ) may appear only in a leaf section (which can be a specialty section without sub-section).

23. 23 General rules of representation of lab results in the human-readable body Date/time of the observation (physiologic time = specimen collection) Name of the analyte Value (numeric, textual, coded, graphic, image) Unit (if relevant) Reference range (if known and relevant) Interpretation code (if known and relevant) Specimen type (if not implied by the test) Testing method Zero or more previous results, to facilitate the interpretation (trend) Verifier, if it does not appear in the header Subcontractor lab if this test was not performed by the performer declared in the header

24. 24 4 templates for the leaf sections Single specimen battery Individual test Challenge study (dynamic function test) microbiology These templates are flexible: {paragraph, table, paragraph} The examples shown, are not exclusive.

25. 25 Example: Human readable block Current results Previous results Specialty section

26. 26 Embedded graphics or images …

27. 27 Microbiology: rendering with table germ/antibiotic

28. 28 Microbiology: more traditional rendering

29. 29 The coded & structured data Each leaf section SHALL contain one element at its end, below the block. The block of the section SHALL be derived from the content of the The conforms to a unique template defined in section 9.2 of the supplement.

30. 30 Usable coding systems in the Usable coding systems in the HL7 vocabulary domains (e.g. specimen type, patient gender …) SNOMED CT For test codes: LOINC subset SNOMED CT National terminologies (e.g. in Japan)

31. September, 2005What IHE Delivers 31 Questions… Francois.macary@agfa.com