Jan 2012 HL 7 Working Group Cytometry Meeting

Jan 2012 HL 7 Working Group Cytometry Meeting Who’s who Harry Solomon

Jan 2012 HL 7 Cytometry Meeting Interoperability Standards Development Organizations (SDO’s) 2/ Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Four level model of “use” in interoperability Workflow business process : tasks Messaging exchange : mail Format data record : document Vocabulary terminology : words 3/ Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Workflow Messaging Format Vocabulary for lab tests and observations Vocabulary Responsive for new tests/measurements Vocabulary for medicine, anatomy, procedures, clinical findings Robust concept model 4/ Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Workflow Messaging Format General organization for cytometry; standards committee Vocabulary 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) 5/ Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Workflow Messaging Format Standards for clinical labs Vocabulary 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 6/ Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Workflow Messaging Format Interoperability standards for healthcare Vocabulary Broadest healthcare standards organization, robust information modeling framework Example standards: • HL 7 v 2 ADT (Patient Demographics), Orders, Observations (Results), Lab Automation Control • HL 7 v 3 Reference Information Model • Clinical Document Architecture • Electronic Health Record Functional Model 7/ Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Workflow Messaging Format Interoperability standards for medical imaging Vocabulary 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 8/ Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Workflow Messaging Format 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: Vocabulary • Anatomic Pathology Workflow Profile • Physician Reporting to Public Health – Cancer Registry • Cross-Enterprise Document Sharing Profile 9/ Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Cooperation HL 7 cooperative agreements / Mo. U’s / affiliations with all other SDO’s HL 7 & DICOM – Joint Working Group (IIWG/WG-20) meets at 3 annual HL 7 WGMs DICOM & LOINC / IHTSDO – DICOM submits proposed concepts for coding 10 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting HL 7 v 2 11 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting HL 7 v 2 Messaging Standard: What HL 7 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 12 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting HL 7 Version 2 Messaging TRIGGER EVENT: Patient is Admitted! T) D (A E S E M T G SA ) I M D A SENDING APPLICATION (Patient Administration) RECEIVING APPLICATION (Lab System) T EN M E DG E L OW AC KN …. PID|||12345||Lorenzi^Virginia||19811231|F… K C A ( PID attributes SEQ 1 2 3 4 5 6 7 8 9 ELEMENT NAME Set ID - Patient ID List Alternate Patient ID Patient Name Mother’s Maiden Name Date/Time of Birth Sex Patient Alias 13 / Harry Solomon / ETC.

Jan 2012 HL 7 Cytometry Meeting HL 7 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) 14 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Example HL 7 v 2 ADT Message MSH|^~&|ADMIN|MCM|LABADT|MCM|198808181126|SECURITY|ADT^A 01^ADT_A 0 1| MSG 00001|P|2. 4| <cr> EVN|A 01|198808181123||<cr> PID|1||PATID 1234^5^M 11^ADT 1^MR^MCM~123456789^^^USSSA^SS||JONES^WIL LIAM^A^III||19610615|M-||C|1200 N ELM STREET^^GREENSBORO^NC^274011020|GL| (919)379 -1212| (919)2713434||M||PATID 12345001^2^M 10^ADT 1^AN^A|123456789| 9 -87654^NC|<cr> NK 1|1|JONES^BARBARA^K|WI^WIFE||||NK^NEXT OF KIN<cr> PV 1|1|I|2000^2012^01||||004777^LEBAUER^SIDNEY^J. |||SUR||-||ADM|A 0 -|<cr> 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 15 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Example HL 7 v 2 ADT Message MSH|^~&|ADMIN|MCM|LABADT|MCM|198808181126|SECURITY|ADT^A 01^ADT_A 0 1| MSG 00001|P|2. 4| <cr> EVN|A 01|198808181123||<cr> PID|1||PATID 1234^5^M 11^ADT 1^MR^MCM~123456789^^^USSSA^SS||JONES^WIL LIAM^A^III||19610615|M-||C|1200 N ELM STREET^^GREENSBORO^NC^274011020|GL| (919)379 -1212| (919)2713434||M||PATID 12345001^2^M 10^ADT 1^AN^A|123456789| 9 -87654^NC|<cr> NK 1|1|JONES^BARBARA^K|WI^WIFE||||NK^NEXT OF KIN<cr> PV 1|1|I|2000^2012^01||||004777^LEBAUER^SIDNEY^J. |||SUR||-||ADM|A 0 -|<cr> Segment Type – 3 char code for the logical group of information Message Type – 3 char code for the type of message sent Trigger Event – 3 char code for the real world event causing the message 16 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting HL 7 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. ” “HL 7 does not explicitly support, but can be used with, systems that support store and forward and data broadcast facilities. ” HL 7 push model issues • Handling multipoint ACKs • Offline systems Typical implementation with store and forward interface engine 17 / Harry Solomon /

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

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

Jan 2012 HL 7 Cytometry Meeting HL 7 CDA 20 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting HL 7 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 21 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Key Aspects of the CDA documents are encoded in Extensible Markup Language (XML) CDA documents derive their meaning from the HL 7 v 3 Reference Information Model (RIM ) and use HL 7 v 3 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) 22 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting CDA Release 2 Information Model Header Participants Start Here Doc ID &Type Body Context Sections/ Headings Clinical Statements/ Extl 23 / Harry. Refs Solomon / Coded Entries

Jan 2012 HL 7 Cytometry Meeting CDA Structured Body Arrows are Act Relationships • Has component, Derived from, etc. Entries are coded clinical statements • Observation, Procedure, Substance administration, etc. Structured Body Section Text Section Text Entry Coded statement 24 / Harry Solomon /

Jan 2012 HL 7 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 25 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Narrative and Coded Entry Example 26 / Harry Solomon /

Jan 2012 HL 7 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 27 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Continuity of Care Document Ancestry 2003 – 2007 Clinical Statement Model 2002 - 2005 CDA 1999 - 2007 O&O Genomics Domain Patient Care Domain Model Other Model Domain Models 2005 - 2006 ASIG Inherits from 2004 - 2006 CCR 1998 - 2004 HL 7 RIM Data Types Vocabulary CRS 2005 - 2006 XDS-MS 2006 - 2007 (R 1) 2006 - 2007 CCD C 32 2007 XD*-LAB CDA 4 CDT C 37 2008 C 83 2006 - 2007 PCC Technical Framework 2007 - 2008 FSA C 80 2007 - 2008 QED 2006 - 2007 XPHR 2007 - 2008 APS 2007 - 2008 EDES 2006 - 2007 XDS-MS (R 3) 2006 - 2007 EDR 28 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting CDA Consolidation Need one-stop shop for CDA templates Consolidated CDA implementation guide incorporating HL 7, IHE, and Health Story projects Funded by ONCHIT Basis for care coordination interoperability under Meaningful Use Stage 2 incentives (2014) Balloted through HL 7 May 2011, Approved as DSTU December 2011 29 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting DICOM 30 / Harry Solomon /

Jan 2012 HL 7 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 31 / Harry Solomon /

Jan 2012 HL 7 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 32 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting DICOM Image Information Object Definition DICOM Composite Information Model Hierarchy Patient Information Study Information Series Information Image (Instance) Information Patient Name Patient ID Patient Sex Patient Birthdate Patient Module Study Unique ID Accession Number Study Date/Time Study Description General Frame of General Referring MD Rows/Columns Series Reference. Equipment Bits per Pixel Module Photometric Image Contrast/ Image General Bolus Pixel Plane Image Module General Study Module Modality Image Module Multiframe Module Patient Study Module VOI LUT Module … SOP Common Module 33 / Harry Solomon /

Jan 2012 HL 7 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) 34 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Data Element Encoding Data Set order of transmission Data Elem. Data Element Value Tag Representation Value Length Data Elem. Attributes are the logical concepts associated with an information entity Data elements are how attributes are encoded in an information object Value Field optional field - dependent on negotiated Transfer Syntax 0020000 Dhex UI Study Instance Unique Identifier (0020, 000 D) 26 hex 1. 2. 840. 1. 113709. 9. 0. 0. 5743. 14575602. 1 Instance UID encoded as “dotted decimal” Similar to TIFF 35 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Part of a DICOM object (0008, 0005) CS 30 ISO 2022 IR 13ISO 2022 IR 87 (0008, 0008) CS 22 ORIGINALPRIMARYAXIAL (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 Patient Information Study Information Series Information Image (Instance) Information Tags in increasing numeric order Value length always an even number Attributes related to modules and information model levels NOT contiguous … (7 FE 0, 0010) OW 524288 00 00 ff ff 00 0 f 4 c 4 a 49 46 00 01. . . 36 / Harry Solomon /

Jan 2012 HL 7 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 37 / Harry Solomon /

Jan 2012 HL 7 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) 38 / Harry Solomon /

Jan 2012 HL 7 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 39 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Storage and Storage Commitment Modality Transmits Images (or other Objects) to PACS: ① C-STORE transfer of images (acknowledged) Modality Issues Storage Commitment Request to PACS: ② N-ACTION including List of objects to be committed (acknowledged) PACS Notifies Modality of Success (or Failure) : ③ N-EVENT-REPORT including List of objects committed (acknowledged) Modality PACS ① ② ③ 40 / Harry Solomon /

Jan 2012 HL 7 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) Workstation Query Request PACS Query Match(es) Retrieve Request Image(s) Send Query/Retrieve SCU Store Response(s) Query/Retrieve SCP Retrieve Response 41 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Managed Workflow Concepts ORDER : A request for departmental service REQUESTED PROCEDURE : Unit of work resulting in one Report with associated codified, billable acts 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’ 42 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting Workflow structuring is user oriented ORDER: A request for departmental service (Accession Number) CLINICIAN OR REFERRING DOC: The Imaging Dept Customer REQUESTED PROCEDURE : Unit of work resulting in one Report with associated codified, billable acts (Requested Procedure ID) RADIOLOGIST/ PATHOLOGIST : In Charge of producing the Report PROCEDURE STEP : The smallest unit of managed work in the workflow (modality worklist entry) TECHNOLOGIST In charge of acquiring images, etc. 43 / Harry Solomon /

Simple Workflow Jan 2012 HL 7 Cytometry Meeting One Order – One Procedure – One Study – One Report ORDER A request for Departmental Service DICOM Modality Worklist Scheduled Procedure Step Requested Procedure Imaging Department Performed Procedure Step One or more series of images Acquisition Modality Report Set of Codifiable , Billable, Acts 44 / Harry Solomon /

Jan 2012 HL 7 Cytometry Meeting ORDER A request for Departmental Service Multiple Modality Steps DICOM Modality Worklist. Imaging Department Scheduled Procedure Step A Requested Procedure Scheduled Procedure Step B DICOM Modality Worklist Performed Procedure Step P 1 One or more series of images Performed Acquisition Procedure Step P 2 Modality Report Set of Codifiable , Billable, Acts One or more series of images Acquisition Modality 45 / Harry Solomon /