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Cross - Enterprise Screening Mammography - Workflow Definition ( XSM -WD)

Cross - Enterprise Screening Mammography - Workflow Definition ( XSM -WD). White Paper for 2011/2012 Arianna Cocchiglia , Francesca Vanzo, Luca Zalunardo January, 17 th 2012. Enhancing XSM-WD White Paper.

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Cross - Enterprise Screening Mammography - Workflow Definition ( XSM -WD)

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  1. Cross - Enterprise Screening Mammography - Workflow Definition(XSM-WD) White Paper for 2011/2012 Arianna Cocchiglia, Francesca Vanzo, Luca Zalunardo January, 17th 2012

  2. Enhancing XSM-WD White Paper • The first Screening Mammography use case has been defined also from the XDW Workflow Document point of view • It was necessary to delineate one of the implementations in order to create a template to figure out different approaches on the screening service • It is important now to collect information about different screening programs from other countries • It shall be significant to provide a discussion on what is common between those different methods, guidelines,…

  3. The discussion • In the first place we will focus on the clinical point of view and on fostering answers to gather different approaches. In the second part of the discussion we will analyze the technical aspects • In order to effectively facilitate country based approach sharing, the review of the Italian screening process has been delineated from the clinical perspective • Supposing different possible features for each potential step, some questions are listed near the following tasks

  4. The Italian Mammography Screening workflow • Introduction • The Italian Screening program has several recomendations based on the fourth edition of the European guidelines for quality assurance in mammography screening (2006). The current adherence to mammography screening guidelines is based on each Region’s resources • The table displays some of the parameters of the italian regional programs: *National Centre for Screening Monitoring (Osservatorio Nazionale Screening - ONS) and Italian Group for Mammography Screening (Gruppo Italiano Screening Mammografico - GISMa)

  5. The Italian Mammography Screening workflow • Organizational Model Double blind Reading Biopsy,… Second Level Mammography exam [+ +] CS Evaluation [+ -] Third blind Evaluation [- -] Invitation Letter START CS: List of eligible women [+] (After 2 years) [-] Missing Appointment CS: Central Information System

  6. The Italian Mammography Screening workflow • A complete and shared collection of the features concerning different Screening workflows is decisive • For this purpose, we ask you please to communicate us your characteristics on different screening mammography programs, so as to allow us to also create an accurate portrait of a common screening workflow (taking into account different aspects, differences and definitions) • The Cross-Enterprise Screening Mammography Workflow Definition’s elements shall focus on these aspects to offer customizations and to match different workflow requirements • In order to facilitate the sharing of significant details, for each Task of the process, several specific questions are placed in the corresponding slide during this presentation (any other in-deep examinations is well accepted) • Any contribution can be sent to fvanzo@consorzioarsenal.it

  7. The Italian Mammography Screening workflow • Recruitment • The regional screening programs utilize anagraphical systems in order to create lists of women according to several parameters (age, time of previous exams or other clinical events, address, local health authorities, mobile units,…) • Each list is forwarded to the afferent screening mammography unit (See the following slide) • Questions • What guidelines are considered or are mandatory? (international, national, regional) • Who manages the screening? (centrally by the state, region,…) • What are the eligibility requirements and how are the list generated (range of age)?

  8. The Italian Mammography Screening workflow • Recruitment • The person in charge whom receives the list: • inserts the mammography screening appointments data into the RIS worklist in the screening mammography agenda • *acknowledges the Region when it is needed • In some screening programs the RIS contains a mammography dedicated module integrated with the main screening program: in this case there would not be human intervention • the *Region or the Screening Unit sends out the Invitation Letter (depends on the specific program) • Questions • Who actually sends out the recruitment letters? • How is implemented the import of the worklist’s items? • Is the RIS worklist agenda automatically synchronized with a CS? (kind of integration and format of messages,…) • Are different enterprises RIS (LHA, Sites ) involved for the single exam?

  9. The Italian Mammography Screening workflow Transfer of the exam – Transfer to the RIS

  10. The Italian Mammography Screening workflow • Admission • This step gathers the actual patient admission and the mammography exam execution • the RIS is aware of the admission worklist from the previous step • the RIS manages the exam as usual in the radiology workflow (state of the appointment: state of admission, execution,…) • If a woman refuses/misses her scheduled appointment, the RIS state of the exam remains the same (at the end of the day this information shall be comunicated to the Regional Screening or Central Information System) • Questions • How are the worklist ruled/ composed/scheduled? (who and how) • When changes occur on an exam (day of the visit, acquisition modality), is possible to update the exam data without create a new “access number”?

  11. The Italian Mammography Screening workflow • Admission • As usual, the technician: • performs and completes the mammography for the screening patient by selecting her from the modality worklist (if it is integrated with the RIS or entering the data directly on it) and updates the order status by closing the procedure • transmits the study to PACS • basically the examination consists of two standard projections for each breast • images are available for the two specialists interpretation • in some programs, the RIS informs the regional Central System about the availability of the mammograms • Questions • Are there any specifics about the image acquisition? (legal/regulatory  requirements) • How are handled additional information to the order? (anamnestic data,…) • How is handled the recall for the repetition of mammograms? (wrong projections,…)

  12. The Italian Mammography Screening workflow • Double Reading Evaluations • In most of the italian programs each healthcare enterprise’s RIS is combined with a mammographic module (integrated with the Regional observatory on screening) • two expert radiologists interpret the mammograms and sumit the reports and the pre-formatted screening report • the parallel double reading can also be sequential in some italian programs (task pool scheduling of the evaluation) • Questions • What is the level of expertise of the mammography radiologist who will interpret the images? (n. of mammograms readings per year, supervisor presence,…) • How is organized the reading chain in other MS Program? (single, double reading) • How is handled the double blind reading? • Is there any diagnosis tool (CAD, …)? Double blind reading

  13. The Italian Mammography Screening workflow • Double Reading Evaluations • Screening reports (inserted with the RIS) are mainly pdf and CDA • The reports are digitally signed before the sumbission (p7m, pdf, xml detached or enveloping or enveloped) • For each exam there should be two distinct reports, otherwise in many implementations, actually only one unique report is provided: • the first radiologist produces the first version and the last radiologist adds her/his interpretation to it (the inclusion of the previous contribute is performed by the RIS: the second radiologist shall not see the first report) and signes all • The regional observatory collects two boolean responses and timing stats • Questions • What is/are the format/s of the report? (DICOM SR Template 4200 “Breast Imaging Report” modifications, legacy solutions) • What kind of digital signature is/are used specifically in screening reports?

  14. The Italian Mammography Screening workflow • Example of legacy applications • Questions • How are handled the screening applications? (integration with the RIS, manual entering of results, pre-compiled schemas,…) • Are there any other steps in your program? (ask for further mammogram,…)

  15. The Italian Mammography Screening workflow • Example of legacy applications

  16. The Italian Mammography Screening workflow • CS Evaluation • The Central Information System or the local screening mammography unit, collects and evaluates the two boolean results: • If both reports are negative the CS sends a letter including the negative result to the patient and the process ends • If both reports are positive the CS will compose an “Alert” letter including instructions and the second level of the screening process starts • If the two results are discordant (one positive, one negative) in most of the programs, the CS re-schedules one blind reading in another worklist for a third evaluation. In this case we have another “Evaluation task” • Questions • Are there implementations with “consensus conference” instead of a system evaluation? • What happens in normal, abnormal, suspicious cases?

  17. The Italian Mammography Screening workflow • END • The CS/screening unit receives the [- -] results and sends the letter with the negative result to the patient, also informing her, that the next screening appointment will be scheduled after two years from this one • Questions • Who does send out the “negative result” letter? • What is the screening frequency in negative cases?

  18. The Italian Mammography Screening workflow • Second Level • The CS/screening unit receives the [+ +] results and then: • notifies the result to the radiology department in order to schedule another appointment (for biopsy, ultrasound,…) • sends the “Alert” letter to the patient which includes the data of the next appointment and the kind of examinations or contact information • The XSM-WD is not intended to handle the Second Level (which is managed by the department workflow) • Questions • How is recorded the result of the screening? • Is the second level manually triggered or not?

  19. The Italian Mammography Screening workflow Further orders requests

  20. The Italian Mammography Screening workflow • Evaluation 3 • A third expert radiologist interprets the mammograms and sumits the last report • In some of the programs, the third radiologist is aware of the previous results: in that case she/he is asked to arbitrate on them (even in this case the number of unnecessary recalls is reduced) • Questions • Are there any implementations where the third evaluation is always recommended? (Supervision report for evaluation purpose when the first two radiologists are not enough expert,…)

  21. The Italian Mammography Screening workflow • Response • The CS/screening unit analyzes the new result and produces the response • If the third report is negative the CS/screening unit sends a letter with the negative result to the patient and the use case ends (also informing her, that the next screening appointment will be scheduled after two years from this one) • If the third report is positive the CS/ screening unit composes an “Alert” letter including instructions and the second level of the screening process takes place • Questions • How is the third reading response managed?

  22. The Italian Mammography Screening workflow

  23. WD of the Italian Mammography Screening program • As shown during the latest t-con, the White Paper relies on of the ITI XDW profile by using the Workflow Document which manages and gathers the process details in the screening path • Workflow and Tasks Informations • Each Task includes: • Input Document References • Output Document References

  24. The Mammography Screening Task Diagram TASK 1: RECRUITMENT • Task 1  4 INPUT …….. OUTPUT - Invitation Letter If a woman misses her scheduled appointment OR OR TASK 2a: ADMISSION TASK 2b: ADMISSION INPUT - Previous Exams - Invitation Letter INPUT - Invitation Letter …………… OUTPUT - Images (KOS Document) - AnamnesticDocument OUTPUT - “No admission” Document END TASK 4: EVALUATION 2 TASK 3: EVALUATION 1 INPUT - Images (KOS Document) - Anamnestic Document INPUT - Images (KOS Document) - Anamnestic Document OUTPUT - Report 1 OUTPUT - Report 2

  25. The Mammography Screening Task Diagram • Task 5  9 TASK 5: CS EVALUATION INPUT - Report 1 - Report 2 OUTPUT - Response Report (--,++,+-) OR OR OR TASK 6a: END (--) TASK 6b: SECOND LEVEL (++) TASK 6c: EVALUATION 3 INPUT - Response Report INPUT - Response Report INPUT - Images (KOS Document) - Anamnestic Document OUTPUT - Letter to Patient END • OUTPUT • - Letter to Patient (“Alert”) • Planning Document • END OUTPUT - Report 3 TASK 7: RESPONSE OR INPUT - Report 3 OR OUTPUT - Response Report (+,-) TASK 9: SECOND LEVEL (+-+) TASK 8: END (+--)

  26. Actors and Transaction XSM–WD Diagram Complete Diagram XDS Lifecycle Management Tools coordinate WorkflowDocumentupdates

  27. Actors and Transaction XSM–WD XDW SpecificActors XDS SpecificActors

  28. XSM–WD in the XDS environment • The complete Actor and Transactions Digram shows several transactions and groupable actors • Since the Workflow Document is meant to be constantly updated with the information conveyed by the XDS transactions, we will consider the XSM-WD Workflow Document from this point of view

  29. Workflow Document: Creation and update • The Content Creator constitutes the first version of the Workflow Document • The Content Updater modifies and adds new data based on the tracking of the screening process • The Content Consumer retrieves the Workflow Document

  30. Workflow Document: Creation • The Content Creator constitutes the first version of a Workflow Document and places it into a new Workflow Context Folder (stored in the Document Repository) which will be a fixed reference for the Workflow Document. This actor shall: • Create a New Workflow Context Folder • Generate the First Version of the XSM-WD Workflow Document with the Description information, the Recruitment Task setting as “Completed” the Task’s status including the Input/Output Document References • Submit the Workflow Document to the Folder stored in the Document Repository

  31. Workflow Document: Update • The ContentUpdater modifies and adds new data based on the tracking of the screening process and provides it to the Document Repository and Registry by a Replace. The Content Updater shall: • Get the only “Approved” version of the Workflow Document in the Folder • Update XSM-WD Workflow Document Description elements • Include the new Task, added to the content of the latest Workflow Document version, with its own Input/Output Document References • Save all changes in a new Workflow Document, setting as “Deprecated” the last one and as “Approved” the current version) • Submit the updated Workflow Document to the Folder (stored in the Document Repository)

  32. Workflow Document: Update • Into the Folder there will be only one Workflow Document with the “Approved” status. All the previous ones are located into the same Folder will have a “Deprecated” status • The case with moreContentUpdaters which modify and add new data using a common latest version of the Workflow Document would succeed only for the first Content Updater who submits it. Infact the other(s) would submit the Workflow Document with the documentUniqueID of a “Deprecated” Workflow Document and this can not be accepted • Example Task 3-4: The second radiologist Content Consumer should always refer to the Evaluation 1 Worflow Document to avoid errors: • The second radiologist will not see the screening Images on his/her worklist until the first one will have finished his/her evaluation • Another etrieve of the “actual” Workflow Document and update of it only at the end of each Evaluation (for these two Tasks)

  33. Workflow Document: Retrieve • The Content Consumer retrieves the Workflow Document, obtains informations from it,… • This actor should retrieve the latest version which coincides with the unique “Approved” version • Input/Output Document references for each Task include: • XDSDocumentEntry.uniqueId • homeCommunityId • Possible queries: • Find the Workflow Folder for a Patient • Get the Workflow Folder in which a particular Workflow Document is stored • Get one or more document referenced in a Workflow Document • …

  34. XSM–WD Workflow Document • The XDM-WD Workflow Document cutomization complies the XDW XML Schema which includes elements from the following standards: • HL7 CDA • OASIS WS-Human Task • The four part Document composition: • See XDW Profile for the detailed description of all WD elements

  35. Screening Mammography Workflow Document • Workflow Document Information: • id : documentId • title : « Screening Mammography Workflow Document » • effectiveTime : … • confidentialityCode : … • languageCode : … • patient : Jane Doe  • author : Dr.Kris  • workflowIstanceId : • workflowDocumentSequenceNumber : « 3 » • workflowStatus : « OPEN » • workflowDefinitionReference : to workflow definition template (urn: OID:…) • XDWdocumentHistory : …  XSM–WD Workflow Document • The XSM-WD Workflow Document at Task 3 “Evaluation 1”: TASK 3: EVALUATION 1 INPUT - images (KOS Document) - anamnestic doc TaskList OUTPUT - Report 1 XDWTask taskData Name : Recruitment id : Status : Completed Date/time : Input : Lists of eligible women Output : Recruitment Letter actualOwner : Dr.Smith … • The main Workflow Document Informations are located in the first part of the structure • Some elements are updated upon on the specific Task: author, workflowDocumentSequenceNumber workflowStatus,… • The following part is composed by the list of the actual and the previous Tasks XSM-WD Workflow Document • Workflow Document Information: • id : documentId • title : « Screening Mammography Workflow Document » • effectiveTime : … • confidentialityCode : … • languageCode : … • patient : Jane Doe  • author : Dr.Kris  • workflowIstanceID: • workflowDocumentSequenceNumber : « 3 » • workflowStatus : « OPEN » • workflowDefinitionReference : to workflow definition template (urn: OID:…) • XDWdocumentHistory : …  taskEventHistory  XDWTask taskData Name : Admission id : Status : Completed Date/time : Input : Invitation Letter, Previous exams Output : KOS Document, Anamnestic Document actualOwner : Dr. White … TaskList  taskEventHistory  XDWTask taskData Name : Evaluation 1 id : Status : Completed Date/time : Input : KOS Document, Anamnestic Document Output : Report 1 actualOwner : Dr. Kris … taskEventHistory 

  36. XSM–WD Workflow Document • The XSM-WD Workflow Document at Task 3 “Evaluation 1”: TASK 3: EVALUATION 1 INPUT - images (KOS Document) - anamnestic doc XDWTask OUTPUT - Report 1 OUTPUT - Report 1 taskData Name : Recruitment id : Status : COMPLETED Date/time : Input : Lists of eligible women Output : Recruitment Letter actualOwner : CS – MS Service … • The taskList element includes all generated Tasks items • The last Task’s actualOwner represents the author for the general information of the Workflow Document taskEventHistory  XDWTask XDWTask taskData Name : Evaluation 1 id : Status : COMPLETED Date/time : Input : KOS Document, Anamnestic Document Output : Report 1 actualOwner : Dr. Kris … taskData Name : Admission id : Status : COMPLETED Date/time : Input : Invitation Letter, Previous exams Output : KOS Document, Anamnestic Document actualOwner : Dr. White … taskEventHistory  taskEventHistory 

  37. Example: taskData Element in XSM-DW <ns3:taskData> <ns2:taskDetails> <ns2:id>3</ns2:id> <ns2:taskType>Requested</ns2:taskType> <ns2:name>Evaluation 1</ns2:name> <ns2:status>COMPLETED</ns2:status> <ns2:createdTime>YYYY-MM-DDTHH:MM:SS.0Z</ns2:createdTime> <ns2:lastModifiedTime>YYYY-MM-DDTHH:MM:SS.0Z</ns2:lastModifiedTime> <ns2:renderingMethodExists>false</ns2:renderingMethodExists> </ns2:taskDetails> <ns2:description></ns2:description> <ns2:input> <ns2:part name="xdw"> <reference uid="urn:oid:1.2.3.4.4.3.2.2.X"/> <!– KOS Document --> </ns2:part> <ns2:part name="xdw"> <reference uid="urn:oid:1.2.3.4.4.3.2.2.Y"/> <!– Anamnestic Document--> </ns2:part> </ns2:input> <ns2:output> <ns2:part name="xdw"> <reference uid="urn:oid:1.2.3.4.4.4"/> <!– Report 1 --> </ns2:part> </ns2:output> </ns3:taskData> XDWTask taskData Name : Evaluation 1 id : Status : COMPLETED Date/time : Input : KOS Document, Anamnestic Document Output : Report 1 actualOwner : Dr. Kris … taskEventHistory  • Work in progress: The entire customization on the Screening Mammography Workflow Document

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