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 Revision 2.0 July 23, 2010 Draft 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. 4

Anatomic Pathology Workflow (APW) Order Placer Image Mgmt Acquisition Modality Order Mgmt Order Filler Care WardAnatomic 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 7

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 8

Test cases Specimen model : Usual situation Specimen can be identified by containers ID Gross imaging Virtual slide

Test cases Unusual situation: Tissue Micro Array More 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 11

Order Filler Care WardAnatomic 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 (

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 15

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) 16

Background From 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 17 Goldsmith, J.D., et al., Reporting guidelines for clinical laboratory reports in surgical pathology. Arch Pathol Lab Med, (10): p

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 18

Order Filler Care WardAnatomic 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) 21 Any APSR CDA document content module is composed of a header and a structured body. 3 types of CDA Document Content Modules Generic APSR ( ) Generic Cancer APSR ( ) 20 organ-specific cancer APSR

CDA Section Content Modules (n=6) 22

CDA Entry Content Module (n=5) e.g Diagnosis entry 23 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 24 [0..*] (zero to many response) coded (code, coding system, version, display name) [0..*] (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 25

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 26

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 27

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 28

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) 29

Organizing observations in sections

Relevant AP observations for the entries & their status (O, R, R2) 31 Document Content Modules Anatomic pathology observations APSR cancer APSR breast cancer cervix cancer colon cancer endometrium cancer esophagus cancer kidney cancer larynx cancer lip oral cavity cancer liver cancer lung cancer ovary cancer pancreas cancer pharynx cancer prostate cancer salivary gland cancer skin melanoma cancer stomach cancer testis cancer thyroid cancer urinary bladder Name Lesion site Oxxxxxxxxxxxxxxxxxxxxx Tumor site ORRRRRRRRRRRRRRRRRRRRR …. Histologic type of DCIS OOR2XXXXXXXXXXXXXXXXXXX …. Microsatellite instability OOXXR2XXXXXXXXXXXXXXXXX

AP observation (Coded Descriptor) Generic value set Specimen integrity (all APSRs) – CodeSystem: PathLex – OID: – Value set OID: – Admitted exceptions : Unknown, Asked but unknown, Other 32 displayNamecomment Intact specimenUnopened, Capsule intact, Single intact specimen, Multiple intact, designated specimens (margins can be evaluated)) Non intact specimenOpen, 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: – Value set OID: – Admitted exceptions : Unknown, Asked but unknown, Other 33 displayName No prior treatment No known presurgical therapy - Treatment history not known No 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 displayName Breast excision without wire-guided localization Breast excision with wire-guided localization Total mastectomy (including nipple and skin) 34 SpecimenCollectionProcedure_procedureCode (Breast Cancer APSR) – CodeSystem: PathLex – OID: – Value set OID: – Admitted exceptions : Unknown, Asked but unknown, Other

The CDA Iceberg 35 Pathologist/clinician sees Machine sees

The pathologist/clinician sees… 36

The pathologist/clinician sees… 37

The machine sees…...remainder of the header not shown... <code code=' ' displayName=Pathology report relevant history' codeSystem=' ' codeSystemName='LOINC'/> Relevant information provided by the ordering physician Tissue submitted: left breast biopsy and apical axillary tissue... <code code=' ' displayName= Reason for referral codeSystem=' ' codeSystemName='LOINC'/> Reason for anatomic pathology procedure Breast mass - left breast... 38

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 39

Anatomic Pathology Integration Profiles Dependencies

More information Googlegroup : ihe-anatomic-pathology- Road map & change proposals logy 41

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) 42

Questions?