Cancer Surveillance BranchDivision of Cancer Prevention and Control

National Center for Chronic Disease Prevention and Health Promotion

October 1, 2014

Cancer Pathology and Biomarker Reporting

National Center for Chronic Disease Prevention and Health Promotion

Division of Cancer Prevention and Control

Cancer Pathology Reporting Standards

North American Association of Central Cancer Registries (NAACCR) Volume V: Pathology Laboratory Electronic Reporting (based on HL7 v.2.5.1 and v2.3.1)

NAACCR Volume V Specification

OBR-4: Universal Service ID

NAACCR Volume V Specification

OBR-4: Universal Service ID

NAACCR Volume V Specification

OBX-3: Observation ID

Sample HL7 Message

OBR|1||22222222222|^^^488136^H+E Histology w/Stains^L|||201309191229||||||LEFT NOSE TIP^^CD- 10001293|||1902001837^TOMAR^RASHMI^^^^MD^^^^^^NPI|||||800^735^4087||||F||||||239.2^Neoplasms of unspecified nature of bone, soft tissue, and skin^IC9|

OBX|1|TX|22633-2^Path report.site of origin^LN^502000^MATER^L||Material submitted:.PART A: Shave Biopsy, Left, Nose Tip||||||F|||20130923195248|34D0655205^LabCorp RTP^CLIA|||

OBX|2|TX|22637-3^Path report.final diagnosis^LN^502004^FDIAG^L||*** Diagnosis:A. BASAL CELL CARCINOMA, NODULAR TYPE.THE DEEP AND LATERAL MARGINS ARE INVOLVED.||||||F|||20130923195251|34D0655205^LabCorp RTP^CLIA|||

OBX|3|TX|19139-5^Pathologist name^LN^502006^SIGNED^L||Electronically signed:.A. LEENA LOURDURAJ||||||F|||20130923195253|34D0655205^LabCorp RTP^CLIA|||

OBX|4|TX|22634-0^Path report.gross observation^LN^502007^GROSSD^L||Gross description: .A. Received in formalin is a piece of skin measuring 0.4 x 0.3 x 0.1 cm which is inked, and submitted in toto in 1 cassette.||||||F|||20130923195254|34D0655205^LabCorp RTP^CLIA|||

OBX|5|TX|22635-7^Path report.microscopic observation^LN^502008^MICROD^L||Microscopic: .A. Dermal nodule composed of nests of atypical basaloid keratinocytes surrounded by a myxoid stroma. Peripheral palisading, individual necrotic keratinocytes and mitotic figures are present.||||||F|||20130923195255|34D0655205^LabCorp RTP^CLIA|||

Sample HL7 MessageOBR|1||999714211|48807-2^Bone marrow aspiration report^LN^6^Bone Marrow Morphology^L|||20111005120000|||||||||^PHYSICIAN^REFERRING|^^^^^555^5555552||||||||F|||||||99999999&Alexa&Liliyana&UNKNOWN&M.D.&&&&UNKNOWN

OBX|1|TX|22633-2^Nature of Specimen^LN|1|Bone marrow||||||F|||20111017105722

OBX|2|TX|22634-0^Gross Pathology^LN|1|1) Core: Received in formalin is a core of firm brown bony material measuring 1.0 x 0.2 x 0.2cm entirely submitted in 1 cassette following decalcification. 2) Clot: Received in formalin, clotted material measuring 2.0 x 2.0 x 1.5cm in aggregate, entirely submitted in 1 cassette. 3) Number of slides received: Ten||||||F|||20111017105722

OBX|3|TX|22635-7^Microscopic Pathology^LN|1|Hypercellular marrow for age (70-80%) with maturing trilineage hematopoiesis. The M:E ratio is within normal limits. There is no increase in mononuclear blast-like cells, accentuated paratrabecular immaturity, or abnormally localized immature precursors noted. Megakaryocytes are increased in number and exhibit cytologic atypia. They are pleomorphic, including megakaryocytes with "cloud-like" and hyperchromatic nuclei and they are arranged in tight clusters. No significant lymphoid or plasma cell infiltrates are noted. Reticulin: Diffuse, moderate to marked increase in reticulin fibers. Trichrome stain: focal collagen fibrosis. Iron: Stainable iron is not observed on tissue sample.||||||F|||20111017105722

OBX|4|TX|22637-3^Final Diagnosis^LN|1|1) Hypercellular marrow with maturing trilineage hematopoiesis, increased atypical megakaryocytes, diffuse moderate to marked reticulin fibrosis and focal collagen fibrosis, consistent with primary myelofibrosis (PMF). 2) No increased CD34 positive blasts detected.||||||F|||20111017105722

Cancer Biomarker Reporting

National Center for Chronic Disease Prevention and Health Promotion

Division of Cancer Prevention and Control

Tests Collected for CER Activities BCR-ABL/BCR-ABL2:

Cytogenetic analysis FISH Qualitative RT-PCR Quantitative RT-PCR

HER2/ER/PR: FISH Test Lab Value and Interpretation CISH Test Lab Value and Interpretation IHC Test Lab Value and Interpretation

JAK2 KRAS Microsatellite Instability Chromosome 18q: Loss of Heterozygosity

(LOH)

CER Questions

Are colorectal cancer patients tested for KRAS and are the results used appropriately to determine treatment? What impact does KRAS testing have on 2-3 year survival among colorectal cancer patients?

Are women with breast cancer being tested appropriately for HER2, progesterone receptor (PR), and estrogen receptor (ER) status and treated appropriately?

Are chronic myeloid leukemia (CML) patients being tested for the BCR-ABL2 gene and receiving appropriate treatment according to those results?

Comparison of ER/PR Results from 4 Laboratories

ER PR: % s reported consistently but Ref Range terminology differs % s Reference Ranges Staining

Intensity Fixative Name

and fixative time provided

Clone ID info

Lab A Actual percentages are provided for each by all labs.

of >4% for Positive; 1-4% for Weakly Positive; <1% Negative

Provided when > 0

Clone ID provided

Lab B Actual percentages are provided

of >=1% for Positive; <1% Negative

Provided when > 0

Provides Fixative and Fixation time for ER/PR

Lab C Actual percentages are provided

of >=1% for Positive; <1% Negative

Provided when > 0

Lab D Actual percentages are provided

of >=1% for Favorable; <1% Unfavorable

Provided when > 0

Fixation name is provided & time recorded when times available.

Clone ID provided

Requirements: CAP Guideline ANP .22999 ASCO / CAP Recommendations Arch Path Lab Med Vol 11 January 2007 (pgs 18, 19, 26 & 40) specifically table 14 (please see attachment B)

JAK2 Tests provided by Laboratory A

JAK2 Tests provided by Laboratory B

JAK2 V617F Mutation Analysis JAK2 Exon 12-14 Mutation Analysis

Multiple LOINC Codes for Similar Tests

Sample HL7 Message - Biomarker

OBR|1||08522507240|^^^489470^JAK2 Mutation Analysis, Quant^L|||20130318|||||||00000000||^MENDPARA^S|||||800^735^4087|20130328|||F|||||||

OBX|1|TX|43399-5^JAK2 gene.p.V617F^LN^489471^JAK2^L||The JAK2 V617F mutation is not detected in the provided specimen of this individual. This result does not rule out the presence of the JAK2 mutation at a level below the sensitivity of detection of this assay, or the presence of other mutations within JAK2 not detected by this assay. This result does not rule out a diagnosis of polycythemia vera (PV), essential thrombocythemia (ET) or idiopathic myelofibrosis (IMF) as the V617F mutation is not detected in all patients with these disorders. Results should be interpreted in conjunction with clinical and other laboratory findings for the most accurate interpretation.||||||F|||20130327173353|34D1008914^LabCorp RTP^CLIA|||

Sample HL7 Message – FISH HER2 Breast

OBR|1||482042||||20140312000000|||||||20140318104600||^VanHoose^John||||||20140321152303|||F|||||||^VanHoose^John

OBX|1|TX|22633-2^Nature of Specimen^LN||Paraffin Tissue||||||F||||^CLIA # 10D0998082.

OBX|2|TX|22636-5^Clinical History^LN||Lesions||||||F||||^CLIA # 10D0998082.

OBX|3|TX|22637-3^Final Diagnosis^LN||Negative||||||F||||^CLIA # 10D0998082.

OBX|4|TX|33746-9^Results: Probe Set Detail^LN||Results show a HER2 to centromere 17 ratio of less than 2.0 and an average HER2 copy number of <4.0 signals per cell following a HER2 breast FISH protocol. This is a NEGATIVE result according to the 2013 ASCO/CAP guidelines.||||||F||||^CLIA # 10D0998082.

OBX|5|TX|33746-9^Results: Nuclei Scored^LN||40||||||F||||^CLIA # 10D0998082.

OBX|6|TX|33746-9^Results: Interpretation^LN||Along with fluorescence in situ hybridization (FISH), an H\T\E stained slide was reviewed by a pathologist to identify the target area containing invasive tumor. FISH analysis of 40 interphase nuclei was performed within the marked target area using a dual-probe FISH assay (Abbott Molecular, Des Plaines, IL). Controls performed appropriately. Results show no evidence of HER2 amplification and a HER2/CEP17 ratio of <2.0 with an average HER2 copy number <4.0 signals per tile. This is a NEGATIVE result.\.br\\.br\Reference: Wolff AC, Hammond MEH, Hicks DG, et al. Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. Arch Pathol Lab Med. doi: 10.5858/arpa.2013-0953-SA.\.br\\.br\Note: This HER2 FISH assay was scored on an automated image analysis platform. Two or more independent areas of tumor were analyzed and the technical results underwent a manual technologist review for quality control purposes.||||||F||||^CLIA # 10D0998082.

OBX|7|TX|22638-1^Comments^LN||Please use Automated CPT Code 88367.26 X 2||||||F||||^CLIA # 10D0998082.

Sample HL7 Message - Biomarker

OBR|1||07922505310|^^^483200^HER2 Rx FISH Rx HERmark(R)^L|||20130314||||||VE3001155 1/2|00000000|||||||800^735^4087|20130325|||F|||||||

OBX|1|TX|18474-7^HER2 Ag^LN^483201^HER2^L||2+||||||F|||20130321174419|34D0655205^LabCorp RTP^CLIA|||

OBR|2||07922505310|^^^483200^HER2 Rx FISH Rx HERmark(R)^L|||20130314||||||VE3001155 1/2|00000000|||||||800^735^4087|20130325|||F|||||||

OBX|1|TX|31150-6^HER2^LN^483211^H2FISH^L|| . No HER2-neu gene amplification was observed for this specimen as defined by the 2007 ASCO/CAP guidelines. Multiple areas of tumor were evaluated and the ratio of HER2-neu/control CEP17 hybridization signals was determined to be less than 1.80. Unless otherwise indicated, only invasive tumor is considered for scoring. . FISH results should be interpreted in conjunction with clinical evaluation and other prognostic factors such as tumor size, nodal status, histologic grade, patient age, hormone receptor status, and other known risk factors.||||||F|||20130325162652|34D0655205^LabCorp RTP^CLIA|||

Challenges with collecting Cancer Pathology and Biomarker Data

Laboratories in United States still using text-based reporting

Inconsistent terminologies used across laboratories

Differences in what laboratories include in the reports (genes tested, probes used, qualitative data, quantitative data, etc.)

Test names are not standardized across laboratories

NAACCR Volume V standard may not be able to handle all biomarker data adequately

Data collection is very labor intensive without standardization and use of automated electronic methodology

College of American Pathologists (CAP) Cancer Pathology Protocols and

Biomarker Templates

CAP Checklist for Invasive Carcinoma of the Breast

CAP Breast Biomarker Reporting Template

CAP Electronic Cancer Checklists (eCC)and Biomarker Templates

SNOMED-CT used to encode the eCC CAP Cancer Biomarker Templates need to be

coded using LOINC and/or SNOMED-CT Testing use of Integrating the Healthcare

Enterprise (IHE) Structured Data Capture (SDC) to capture and report data included in the eCC and Cancer Biomarker Templates at 2015 IHE NA Connectathon in January 2015

For more information please contact Centers for Disease Control and Prevention1600 Clifton Road NE, Atlanta, GA 30333Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348E-mail: cdcinfo@cdc.gov Web: www.cdc.gov

Thank you!

Sandy Jones, CDCPublic Health Advisor

770-488-5689sft1@cdc.gov

National Center for Chronic Disease Prevention and Health Promotion

Division of Cancer Prevention and Control

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.