1. Who’s who Harry Solomon Jan 2012 HL7 Working Group Cytometry Meeting

2. 2 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Interoperability Standards Development Organizations (SDO’s)

3. 3 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Four level model of “use” in interoperability business process : tasks exchange : mail data record : document terminology : words Workflow Messaging Format Vocabulary

4. 4 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Vocabulary for lab tests and observations Responsive for new tests/measurements Vocabulary for medicine, anatomy, procedures, clinical findings Robust concept model Workflow Messaging Format Vocabulary

5. 5 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting General organization for cytometry; standards committee Focused on cytometry research, small standards group Example standards: Data File Standard for Flow Cytometry (FCS) Minimum Information about a Flow Cytometry Experiment Image Cytometry Experiment Format (proposed) Workflow Messaging Format Vocabulary

6. 6 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Standards for clinical labs Mostly process quality specifications, some interoperability specs Example standards: Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems Laboratory Automation: Data Content for Specimen Identification Point-of-Care Connectivity Workflow Messaging Format Vocabulary

7. 7 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Interoperability standards for healthcare Broadest healthcare standards organization, robust information modeling framework Example standards: HL7 v2 ADT (Patient Demographics), Orders, Observations (Results), Lab Automation Control HL7 v3 Reference Information Model Clinical Document Architecture Electronic Health Record Functional Model Workflow Messaging Format Vocabulary

8. 8 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Interoperability standards for medical imaging Supports bulk binary data, persistent object model, department workflow, universally implemented in radiology Example standards: Microscopic Image, Whole Slide Image Modality Worklist / Performed Procedure Step Storage Commitment Workflow Messaging Format Vocabulary

9. 9 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Integrating the Healthcare Enterprise, a pubilc-private collaboration promoting standards-based interoperability Use cases from professional society participants (CAP, NAACCR) drive implementation guides, Connectathons, demonstrations Example standards: Anatomic Pathology Workflow Profile Physician Reporting to Public Health – Cancer Registry Cross-Enterprise Document Sharing Profile Workflow Messaging Format Vocabulary

10. 10 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Cooperation HL7 cooperative agreements / MoU’s / affiliations with all other SDO’s HL7 & DICOM – Joint Working Group (IIWG/WG-20) meets at 3 annual HL7 WGMs DICOM & LOINC / IHTSDO – DICOM submits proposed concepts for coding

11. 11 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting HL7 v2

12. 12 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting HL7 v2 Messaging Standard: What HL7 Messaging Standard - An Application Protocol for Electronic Data Exchange in Healthcare Environments Enables disparate healthcare applications to exchange clinical and administrative data Defines the data content and provides the layout of messages that are exchanged between applications based upon a particular trigger event

13. 13 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting HL7 Version 2 Messaging SENDING APPLICATION (Patient Administration) RECEIVING APPLICATION (Lab System) ADMIT MESSAGE (ADT) ACKNOWLEDGEMENT (ACK) TRIGGER EVENT: Patient is Admitted! PID attributes SEQ ELEMENT NAME 1 Set ID - Patient ID 2 Patient ID 3 Patient ID List 4 Alternate Patient ID 5 Patient Name 6 Mother’s Maiden Name 7 Date/Time of Birth 8 Sex 9 Patient Alias ETC. ….PID|||12345||Lorenzi^Virginia||19811231|F…

14. 14 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting HL7 specification terms Message - an ordered collection of segments, associated with a trigger event Trigger event - a real world cause for the exchange of data Segment - an ordered collection of data elements that typically share a common subject Specifies whether the data element is required or optional and whether it may repeat. Data element - a unit of exchanged meaning, with a data type and suggested length, and possibly a table of valid values Data types - encoding of meaning in a constrained character string, or constructs of component data types Limited to two levels of defined construct (components, subcomponents)

15. 15 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Example HL7 v2 ADT Message MSH|^~\&|ADMIN|MCM|LABADT|MCM|198808181126|SECURITY|ADT^A01^ADT_A01| MSG00001|P|2.4| EVN|A01|198808181123|| PID|1||PATID1234^5^M11^ADT1^MR^MCM~123456789^^^USSSA^SS||JONES^WILLIA M^A^III||19610615|M-||C|1200 N ELM STREET^^GREENSBORO^NC^27401-1020|GL| (919)379-1212| (919)271-3434||M||PATID12345001^2^M10^ADT1^AN^A|123456789| 9-87654^NC| NK1|1|JONES^BARBARA^K|WI^WIFE||||NK^NEXT OF KIN PV1|1|I|2000^2012^01||||004777^LEBAUER^SIDNEY^J.|||SUR||-||ADM|A0-| Patient William A. Jones, III was admitted on August 18, 1988 at 11:23 a.m. His wife, Barbara K. Jones is a related family member (next of kin). He has been assigned to room 2012, bed 01 on nursing unit 2000. To be attended by doctor Sidney J. Lebauer (ID# 004777) for surgery. Character based, similar to mag tape records

16. 16 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Example HL7 v2 ADT Message MSH|^~\&|ADMIN|MCM|LABADT|MCM|198808181126|SECURITY|ADT^A01^ADT_A01| MSG00001|P|2.4| EVN|A01|198808181123|| PID|1||PATID1234^5^M11^ADT1^MR^MCM~123456789^^^USSSA^SS||JONES^WILLIA M^A^III||19610615|M-||C|1200 N ELM STREET^^GREENSBORO^NC^27401-1020|GL| (919)379-1212| (919)271-3434||M||PATID12345001^2^M10^ADT1^AN^A|123456789| 9-87654^NC| NK1|1|JONES^BARBARA^K|WI^WIFE||||NK^NEXT OF KIN PV1|1|I|2000^2012^01||||004777^LEBAUER^SIDNEY^J.|||SUR||-||ADM|A0-| Message Type – 3 char code for the type of message sent Trigger Event – 3 char code for the real world event causing the message Segment Type – 3 char code for the logical group of information

17. 17 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting HL7 implementation architecture “The Standard is written from the assumption that an event in the real world of healthcare creates the need for data to flow among systems. The real-world event is called the trigger event.” “HL7 does not explicitly support, but can be used with, systems that support store and forward and data broadcast facilities.” HL7 push model issues Handling multipoint ACKs Offline systems Typical implementation with store and forward interface engine

18. 18 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting v2 Table of Contents Chapter 1 - Introduction Chapter 2 - Control (Conformance added v2.5) Chapter 3 - Patient Administration Chapter 4 - Order Entry Chapter 5 - Query (in Chap 2 in v2.2-v2.3.1) Chapter 6 - Financial Management Chapter 7 - Observation Reporting Chapter 8 - Master Files (added v2.2) Chapter 9 - Medical Records (Document Mgmt) (added v2.3) Chapter 10 - Scheduling (added v2.3) Chapter 11 - Patient Referral (added v2.3) Chapter 12 - Patient Care (added v2.3) Chapter 13 - Clinical Laboratory Automation (added v2.4) Chapter 14 - Application Management (added v2.4) Chapter 15 - Personnel Management (added v2.4) Chapter 16 - eClaims (added v2.6) Chapter 17 - Materials Management (added v2.6)

19. 19 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Look at ToC’s for Chapters 3, 4, 7, 13

20. 20 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting HL7 CDA

21. 21 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting HL7 Clinical Document Architecture The scope of the CDA is the standardization of clinical documents for exchange. A clinical document is a record of observations and other services with the following characteristics: Persistence Stewardship Potential for authentication Wholeness Human readability A CDA document is a defined and complete information object that can exist outside of a message, and can include text, images, sounds, and other multimedia content. A CDA is not an isolated finding or measurement, or an aggregation of documents

22. 22 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Key Aspects of the CDA CDA documents are encoded in Extensible Markup Language (XML) CDA documents derive their meaning from the HL7 v3 Reference Information Model (RIM ) and use HL7 v3 Data Types A CDA document consists of a header and a body Header is consistent across all clinical documents - identifies and classifies the document, provides information on patient, provider, encounter, and authentication; allows document management, compilation of an individual patient's clinical documents into an electronic patient record Body contains narrative text / multimedia content (level 1), optionally structured into sections with coded titles and tagged narrative content (level 2), optionally augmented by coded equivalents to narrative (level 3)

23. 23 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting CDA Release 2 Information Model HeaderBody Participants Sections/ Headings Clinical Statements/ Coded Entries Extl RefsContext Doc ID &Type Start Here

24. 24 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting CDA Structured Body Structured Body Section Text Section Text Section Text Section Text Section Text Section Text Entry Coded statement Entry Coded statement Entry Coded statement Arrows are Act Relationships Has component, Derived from, etc. Entries are coded clinical statements Observation, Procedure, Substance administration, etc.

25. 25 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Narrative and Coded Info CDA structured body requires human-readable “Narrative Block”, all that is needed to reproduce the legally attested clinical content CDA allows optional machine-readable coded “Entries”, which drive automated processes Narrative may be flagged as derived from Entries Textual rendering of coded entries’ content, and contains no clinical content not derived from the entries General method for coding clinical statements is a hard, unsolved problem CDA allows incremental improvement to amount of coded data without breaking the model

26. 26 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Narrative and Coded Entry Example

27. 27 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Implementation Guides CDA is a very generic structure focused on human- readable content Great for minimally marked-up documents Not much required to render narrative content Machine processing (more powerful apps) requires standardization of CDA structures and entries Implementation guides for specific clinical uses Templates for documents, sections, entries

28. 28 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting PCC Technical Framework EDR Continuity of Care Document Ancestry HL7 RIM Data Types Vocabulary CDA CRS CCR CCD Clinical Statement Model XDS-MS (R3) C32 APS EDES FSA 2004 - 2006 1998 - 2004 2002 - 2005 2003 – 2007 O&O Domain Model Genomics Domain Model Patient Care Domain Model Other Domain Models 2005 - 2006 2006 - 2007 C37 2006 - 2007 ASIG 1999 - 2007 XDS-MS (R1) 2006 - 2007 2007 - 2008 CDA4CDT 2007 XD*-LAB QED 2007 - 2008 XPHR C83 C80 2008 Inherits from

29. 29 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting CDA Consolidation Need one-stop shop for CDA templates Consolidated CDA implementation guide incorporating HL7, IHE, and Health Story projects Funded by ONCHIT Basis for care coordination interoperability under Meaningful Use Stage 2 incentives (2014) Balloted through HL7 May 2011, Approved as DSTU December 2011

30. 30 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting DICOM

31. 31 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Scope of DICOM Standard The International Standard for Medical Imaging and related information Standard object formats for images, waveforms, derived structured data (measurements and assessments) Workflow management in the imaging department Service-based network protocol over TCP/IP; media interchange

32. 32 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting DICOM Key Features Object-oriented, persistent information objects Tagged data elements, binary encoding Client-server network services, service negotiation Image compression by encapsulation Conformance Statements

33. 33 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting DICOM Image Information Object Definition Patient Module Patient Study Module General Series Module General Study Module Frame of Reference Module General Equipment Module General Image Module Image Plane Module Contrast/ Bolus Module Image Pixel Module Modality Image Module Multi- frame Module … VOI LUT Module SOP Common Module Patient Information Study Information Series Information Image (Instance) Information Patient Name Patient ID Patient Sex Patient Birthdate Study Unique ID Accession Number Study Date/Time Study Description Referring MD Rows/Columns Bits per Pixel Photometric DICOM Composite Information Model Hierarchy

34. 34 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting DICOM Network Services Information object exchange Reliable object storage (commitment) Object repository (PACS) query / retrieve Modality worklist query Performed procedure step status notification Image print Application protocol riding on TCP/IP (at same level as FTP, HTTP)

35. 35 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Data Element Encoding 0020000D hex UI1.2.840.1.113709.9.0.0.5743.14575602.126 hex Study Instance Unique Identifier (0020,000D) Instance UID encoded as “dotted decimal” Data Set Data Element Tag Value Length Value Field optional field - dependent on negotiated Transfer Syntax Value Represen- tation Data Elem. order of transmission Attributes are the logical concepts associated with an information entity Data elements are how attributes are encoded in an information object Similar to TIFF

36. 36 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Part of a DICOM object (0008,0005)CS 30 ISO 2022 IR 13\ISO 2022 IR 87 (0008,0008)CS 22 ORIGINAL\PRIMARY\AXIAL (0008,0016)UI 26 1.2.840.10008.5.1.4.1.1.2 (0008,0018)UI 58 1.2.392.200036.9116.2.6.1.48.12393615.1211874194.564494 (0008,0020)DA 8 20080527 (0008,0021)DA 8 20080527 (0008,0022)DA 8 20080527 (0008,0023)DA 8 20080527 (0008,0030)TM 10 163836.000 (0008,0031)TM 10 164306.390 (0008,0032)TM 10 164039.850 (0008,0033)TM 10 164040.397 (0008,0050)SH 8 5162581 (0008,0060)CS 2 CT (0008,0070)LO 8 TOSHIBA … (7FE0,0010)OW 524288 00 00 00 00 ff ff ff ff 00 0f 4c 4a 49 46 00 01... Tags in increasing numeric order Value length always an even number Attributes related to modules and information model levels NOT contiguous Patient Information Study Information Series Information Image (Instance) Information

37. 37 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting The Service-Object Pair (SOP) Class The unit of interoperability and conformance Service: network function between user (client) and provider (server) Store (transfer), query, move, create, notify … ∴ SOP Classes represent functionality on information objects Store a CT image Store an MR image Find (list) all studies for a patient Find the worklist for a modality Move a set of images Create an image print job Request/Notify the secure storage of images Notify the performance of a procedure step

38. 38 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting DICOM Network Negotiation First step application level handshake in setting up Association (network connection) Agreement on SOP Classes, roles (client/server), image compression, security One message roundtrip (initiator to acceptor and back)

39. 39 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Storage Commitment “Object Storage” is basic DICOM service for network transfer of images – but has no required receiver behavior C-STORE acknowledgment simply means the objects were received whole Objects can be successfully received by an image archive system, but a system failure could cause them to be lost prior to reliable storage Storage Commitment provides an explicit acknowledgment of reliable storage of specific objects The sending system can then safely delete objects from local store, e.g., auto-purge Storage Commitment may incur a substantial delay E.g., after overnight copy to tertiary storage

40. 40 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Storage and Storage Commitment Modality Transmits Images (or other Objects) to PACS: C-STORE transfer of images (acknowledged) Modality Issues Storage Commitment Request to PACS: N-ACTION including List of objects to be committed (acknowledged) PACS Notifies Modality of Success (or Failure) : N-EVENT-REPORT including List of objects committed (acknowledged) PACS Modality ③ ① ① ② ② ③

41. 41 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting DICOM Query/Retrieve Allows a system to query another system for a list of available images (query) Also allows a system to request another system to send images (retrieve) Query Request Retrieve Request Image(s) Send Store Response(s) Retrieve Response Query Match(es) PACS Query/Retrieve SCP Query/Retrieve SCU Workstation

42. 42 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Managed Workflow Concepts PROCEDURE STEP : The smallest unit of managed work in the workflow Scheduled Procedure Step: ‘A unit of work to do’ Performed Procedure Step: ‘A unit of work done’ ORDER : A request for departmental service REQUESTED PROCEDURE :Unit of work resulting in one Report with associated codified, billable acts

43. 43 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Workflow structuring is user oriented ORDER: A request for departmental service (Accession Number) REQUESTED PROCEDURE : Unit of work resulting in one Report with associated codified, billable acts (Requested Procedure ID) PROCEDURE STEP : The smallest unit of managed work in the workflow (modality worklist entry) CLINICIAN OR REFERRING DOC: The Imaging Dept Customer RADIOLOGIST/ PATHOLOGIST : In Charge of producing the Report TECHNOLOGIST In charge of acquiring images, etc.

44. 44 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Simple Workflow One Order – One Procedure – One Study – One Report Acquisition Modality ORDER A request for Departmental Service Imaging Department Set of Codifiable, Billable, Acts One or more series of images Performed Procedure Step Requested Procedure Scheduled Procedure Step Report DICOM Modality Worklist

45. 45 / Harry Solomon / Jan 2012 HL7 Cytometry Meeting Acquisition Modality Multiple Modality Steps ORDER A request for Departmental Service Imaging Department Set of Codifiable, Billable, Acts One or more series of images Performed Procedure Step P1 Scheduled Procedure Step B Requested Procedure Scheduled Procedure Step A Report One or more series of images Performed Procedure Step P2 DICOM Modality Worklist