Anatomic Pathology Domain (PAT)

Co-chairs : C.Daniel (France), M.Garcia-Rojo (Spain) ,T.Schrader (Germany)APSR Supplement : F.Macary (France), M.Kennedy (US), D.Booker (US)

Overview

• Intra hospital integration profiles– Anatomic Pathology Workflow (APW)

• Ordering and performing anatomic pathology examinations

• Community– Anatomic Reporting for Public Health (ARPH)

• Sending anatomic pathology reports to public health organizations

– Anatomic Pathology Structured Report (APSR)• Sharing/exchanging structured anatomic pathology reports

as CDA documents

Organization of Anatomic Pathology Technical Framework

20102010 20112011

Revision 2.0 July 23, 2010Draft for Trial Implementation

2010 Supplement for Trial Implementation

Anatomic Pathology Workflow (APW)

• Establishes the integrity of basic pathology data acquired for examinations being ordered for an identified patient

• Defines the actors and transactions involved in– Ordering and reporting aspects of the workflow

• Order entry, report creation and transmission.

– Imaging aspects of the workflow• Image acquisition, storage and distribution among

multiple systems.

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Anatomic Pathology Workflow (APW)

Order Placer

Image Mgmt

Acquisition Modality

Order Mgmt

Order Filler

Care Ward Anatomic Pathology Laboratory

Hospital

Image Archive/Image Manager

(PACS)

Order result tracker

Report Mgmt

APW actors & transactions

Standards used• HL7 v2.5

– OML^O21/ORL^O22 (PAT-1, 2 &4)– ORU^R01 + report (PAT-3)

• DICOM– DICOM 2003 PS 3.4: Modality Worklist SOP Class (PAT-5 & 6) – DICOM 2007 PS 3.4: Storage Service Class– DICOM 2007 PS 3.4: Storage Commitment Push Model SOP

Class– DICOM 2007 PS 3.4: Query/Retrieve Service Class– Supplément 122 : Specimen Identification and Revised

Pathology SOP Classes

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Test cases

• Different « subspecialties »– Surgical pathology (4 cases)– Biopsies (2 cases)– Cytopathology (2 cases)– Autopsy (1 case)– TMA (1 case)

• Complex relationships specimen/container– 1 specimen per container– Several specimen per container

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Test casesSpecimen model : Usual situation

Specimen can be identified by containers’ ID

Gross imaging

Virtual slide

Test cases Unusual situation: Tissue Micro

ArrayMore than one derived specimen on slide coming from the different blocks coming from different parts and from different patients

Anatomic Pathology Reporting to Public Health (ARPH)

• Joint initiative : IHE AP, HL7 AP, NAACCR (North American Association of Central Cancer Registries), CDC (Centers for Disease Control).

• Defines the actors and transactions involved in anatomic pathology reporting to public health organizations.

• Global Perspective of Cancer Surveillance– International Association of Cancer Registries

• 241 Registries (Voting Member) from all 6 continents– North American Association of Central Cancer Registries

• All Canadian Provinces• All US States• All US Territories and Jurisdictions

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Order Filler

Care Ward Anatomic Pathology Laboratory

Report Sender

Hospital

Anatomic Pathology Reporting to Public Health (ARPH)

Healthcare community

Report Receiver

Public Health Report Mgmt

Report Sender

Anatomic Pathology Laboratory

Clinics

ARPH actors & transactions

Standards used• HL7 v2.5

– ORU^R01 message (PAT-10) • LOINC• SNOMED CT• NAACCR*

– Standards for Cancer Registries Volume V: Pathology Laboratory Electronic Reporting v3.0

– Search Term List• International Classification of Diseases, 10th rev

(and 9th rev)*NAACCR - North American Association of Central Cancer Registries (www.naaccr.org)

Anatomic Pathology Structured Report (APSR)

• Joint IHE and HL7 anatomic pathology initiative • Content integration profile standardizing Anatomic

Pathology Structured Report (APSR) using HL7 CDA – APSR as CDA documents including Anatomic Pathology

observations bound to images or regions of interest – Shared or exchanged within a community of care providers

using existing integration profiles defined by IHE Information Technology Infrastructure

• Unique opportunity to share/exchange Anatomic Pathology Structured Reports that are semantically interoperable at an international level

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Scope• APSR for surgical pathology

– 22 CDA templates • Generic APSR template

– All fields of anatomic pathology (inflammatory, vascular, traumatic, metabolic diseases as well as cancer)

• Generic cancer APSR template• 20 organ-specific cancer APSR templates

– “Traditional” anatomic pathology observation using light microscopy (including immunohistochemistry, FISH, etc)

• Further cycles– Forensic (autopsy, toxicology)– Special ancillary techniques (flow cytometry, cytogenetics,

electronic microscopy)– Research (TMA, etc)

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BackgroundFrom clinical document models…

• Recent recommendations for required, preferred, and optional elements for any APR of surgical pathology, regardless of report types [Goldsmith 08]

• National initiatives– Anatomic Pathology SR (Netherlands, Germany, Australasia)– Cancer APSR

• US - CAP (College of American Pathologists)– 67 cancer checklists and protocols (October 2009)

• France - SFP (French society of pathology) – INCa (French National Cancer Institute)

– Minimum data sets for cancer APSR in 20 locations (85% of new cancers in France) (required by accrediting bodies)

• Australasia– 6 templates for cancer APSR

• UK Royal college

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Goldsmith, J.D., et al., Reporting guidelines for clinical laboratory reports in surgical pathology. Arch Pathol Lab Med, 2008. 132(10): p. 1608-16.

Background … to IT templates

• Non healthcare IT standard– CAP electronic Cancer Checklist

• Healthcare IT standard– CEN archetypes

• Australia

– HL7 CDA• Most reliable standard for clinical document templates• Existing implementation guides for the APSR ?

– Netherlands, Germany

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Order Filler

Care Ward Anatomic Pathology Laboratory

Document Source

Hospital

Anatomic Pathology Structured Report (APSR)

Healthcare community

Document Repository

Document sharing

Anatomic Pathology Laboratory

Clinics

Document Source

APSR actors & transactions• Content (Anatomic Pathology Structured Report) is

created by a Content Creator consumed by a Content Consumer.

• Sharing or transmission of content from one actor to the other – XDS, XDM and XDR Integration Profiles, described in

Volume 3 of the Anatomic Pathology Technical Framework.

CDA Document Content Module (n=22)

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Any APSR CDA document content module is composed of a header and a structured body.

3 types of CDA Document Content Modules Generic APSR (1.3.6.1.4.1.19376.1.8.1.1.1) Generic Cancer APSR (1.3.6.1.4.1.19376.1.8.1.1.2) 20 organ-specific cancer APSR

CDA Section Content Modules (n=6)

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CDA Entry Content Module (n=5)e.g Diagnosis entry

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Diagnoses on all specimens that are delivered to the pathology reported separatly

Additional pathologic finding(s), results of ancillary studi(es) & images

In case of cancer, this section includes the cancer checklists

Anatomic Pathology Observation

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[0..*] <value> (zero to many response)coded (code, coding system, version, display name)

[0..*] <qualifier> (post coordinated expression)

numeric (integer or real, unit)textual

Anatomic pathology observation codes (n=68)

• Specimen weight• Specimen size

– Largest/additional dimension• Specimen integrity• Macroscopic type• Lesion/tumor site• Lesion/tumor focality• Lesion/tumor size

– Largest/additional dimension

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Anatomic pathology observation codes (n=68)

• Histologic type of– Morphologic abnormality– In situ neoplasm

• DCIS (Architectural pattern, Necrosis)• LCIS

– Infiltrating malignant neoplasm• Histologic grade

– Gleason– Nottingham

• Glandular/Tubular Differentiation• Mitotic Count• Nuclear Pleomorphism

– World Health Organization (WHO) Grading System

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Anatomic pathology observation codes (n=68)

• Margins involvement by– Lesion– Adenoma – Dysplasia– Carcinoma in situ

• DCIS• Melanoma in situ

– Infiltrating malignant neoplasm• Invasive carcinoma• Invasive melanoma

• Margin site• Distance of lesion/tumor from closest uninvolved margin

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Anatomic pathology observation codes (n=68)

• Number of lymph nodes– Examined– Involved

• with isolated tumor cells (< = 0.2 mm and < = 200 cells)• with macrometastases (>0.2 cm)• with micrometastases (>0.2 mm to 0.2 cm and/or >200 cells)

• Lymph node metastasis size• Lymph node capsule involvement• Lymph node site• Lymph-vascular invasion• Perineural invasion• TNM Descriptors : pT, pN, pM• Teatment effect

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AP ancillary technique observation codes (n=12)

• Estrogen Receptor• Progesterone Receptor• HER2/neu (FISH/immunoperoxidase studies)• Immunohistochemistry Study for Mismatch Repair

– Proteins-MLH1, Proteins-MLH2, Proteins-MLH6, Proteins-PMS2

• Mutational analysis – BRAF V600E, KRAS

• Microsatellite instability• Epidermal growth factor receptor (EGFR)

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Organizing observations in sections

<text>

AP <entry>

human-readable part

machine-readable part

specimen information <organizer> a specimen

problem <organizer> a problem observed

1..1

0..*

1..1

0..*

0..*

AP ancillary technique <observation>0..*

clinical laboratory <observation>0..*

one to six AP sections

specimen collection <procedure>1..1

0..*

procedure, target site, specimen type, …

has as sub-observation

AP <observation>

1..6

<structuredBody>1..1 Body of the report

<ClinicalDocument> Header of the APSR, delivers contextualinformation.

non-AP <section>

AP <section>

0..*

Relevant AP observations for the entries & their status (O, R, R2)

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AP observation (Coded Descriptor) Generic value set

• Specimen integrity (all APSRs)– CodeSystem: PathLex – OID: 1.3.6.1.4.1.19376.1.8.2.1– Value set OID: 1.3.6.1.4.1.19376.1.8.5.2

– Admitted exceptions : Unknown, Asked but unknown, Other

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displayName commentIntact specimen Unopened, Capsule intact, Single intact

specimen, Multiple intact, designated specimens (margins can be evaluated))

Non intact specimen Open, Capsule ruptured specimen, Multiple non designated specimens, Fragmented, Morcellated)(margins cannot be evaluated with certainty)

AP observation (Coded Descriptor) Generic value set

• Treatment effect (all cancer APSRs)– CodeSystem: PathLex – OID: 1.3.6.1.4.1.19376.1.8.2.1– Value set OID: 1.3.6.1.4.1.19376.1.8.5.10

– Admitted exceptions : Unknown, Asked but unknown, Other

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displayNameNo prior treatmentNo known presurgical therapy - Treatment history not knownNo residual tumor (complete response, grade 0)Marked response (grade 1, minimal residual cancer)Moderate response (grade 2)No definite response identified (grade 3, poor or no response)

AP observation (Coded Descriptor) Specific value set

displayNameBreast excision without wire-guided localizationBreast excision with wire-guided localizationTotal mastectomy (including nipple and skin)

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• SpecimenCollectionProcedure_procedureCode (Breast Cancer APSR) – CodeSystem: PathLex – OID: 1.3.6.1.4.1.19376.1.8.2.1– Value set OID: 1.3.6.1.4.1.19376.1.8.5.2

– Admitted exceptions : Unknown, Asked but unknown, Other

The CDA Iceberg

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Pathologist/clinician sees

Machine sees

The pathologist/clinician sees…

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The pathologist/clinician sees…

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The machine sees…<ClinicalDocument xmlns='urn:hl7-org:v3'> <typeId extension="POCD_HD000040" root="2.16.840.1.113883.1.3"/> <!-- conformance to a generic APSR content module --> <templateId root='1.3.6.1.4.1.19376.1.8.1.1.1'/> <!-- conformance to a cancer APSR content module --> <templateId root='1.3.6.1.4.1.19376.1.8.1.1.2'/> <!-- conformance to a breast cancer content module --> <templateId root='1.3.6.1.4.1.19376.1.8.1.1.2.1'/> ...remainder of the header not shown ... <component> <structuredBody> <component> <section> <templateId root='1.3.6.1.4.1.19376.1.8.1.2.1'/> <code code='22636-5' displayName=’Pathology report relevant history' codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/> <title>Relevant information provided by the ordering physician</title> <text> Tissue submitted: left breast biopsy and apical axillary tissue </text> <entry> ... </entry> <component> <section> <templateId root='1.3.6.1.4.1.19376.1.8.1.2.1'/> <code code='42349-1' displayName= ‘Reason for referral’ codeSystem='2.16.840.1.113883.6.1' codeSystemName='LOINC'/> <title>Reason for anatomic pathology procedure</title> <text>Breast mass - left breast</text> <entry> ... </entry> </section> </component> <component>

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APSR content profile

• Unique opportunity to share/exchange Anatomic Pathology Structured Reports that are semantically interoperable at an international level

• Machine-readable format usable for– Decision support– Clinical data warehouses– Clinical research, epidemiology

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Anatomic Pathology Integration Profiles Dependencies

More information

• Googlegroup : ihe-anatomic-pathology-committee@googlegroups.com

• Road map & change proposalshttp://wiki.ihe.net/index.php?

title=Anatomic_Pathology

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Contributors to the IHE Anatomic Pathology Technical Framework

• Practicing pathologists – Dominique Henin, MD, PhD (ADICAP, AP-HP, Paris, France); Fréderique Capron, MD, PhD

(ADICAP, AP-HP, Paris, France); Bettina Fabiani, MD (ADICAP, AP-HP, Paris, France); Jean-Marc Guinebretière, MD (Centre René Huguenin, ADICAP, France); Marcial García Rojo, MD, PhD (Hospital General de Ciudad Real, Ciudad Real, Spanish Society of Health Informatics-SEIS, Spain); Ernesto Moro (Universidad Rey Juan Carlos, Madrid, Spanish Society of Pathology-SEAP, Spain); Thomas Schrader, MD, PhD (La Charité, Berlin, Germany); John Gilbertson, MD (Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, United States); Bruce A. Beckwith, MD (Laboratory Medicine Department of Pathology, Salem, United States); Luis Goncalves, MD (Hospital de Evora, Portugal); Ikuo Tofukuji, MD (Takasaki University of Health and Welfare, Japan), David Booker (HL7 AP, CAP).

• Informatics technology professionals– Karima Bourquard, PhD (GMSIH, Paris, France); Christel Daniel, MD, PhD (AP-HP, INSERM,

ADICAP, Paris, France); Vincenzo Della Mea, PhD (Department of Mathematics and Computer Science, University of Udine, Udine, Italy); François Macary (GMSIH, Paris, France); Carlos Peces (SESCAM, Spain); Miguel Angel Laguna, PhD (HGCR-SESCAM, Spain); Eric Poiseau, PhD (IHE, France), Mary Kennedy (HL7 AP, CAP), Wendy Scharber (CDC-Contractor), Lori A. Havener (NAACCR)

• Vendors– Didier Adelh (Samba Technologies); Jean-Christophe Cauvin, PhD (Medasys, Gif/Yvette, France);

Emmanuel Cordonnier (Etiam, Rennes, France); Jacques Klossa, PhD (Tribvn, Chatillon, France); François Lecertisseur (Technidata); Damien Mazoyer (Infologic); Takashi Okuno (Olympus Medical Systems); Harry Solomon (GE, Chicago, United States)

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Questions?