Cancer Pathology and Biomarker Reporting
Cancer Surveillance Branch
Division of Cancer Prevention and Control
National Center for Chronic Disease Prevention and Health
Promotion
October 1, 2014
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^^CD10001293|||1902001837^TOMAR^RASHMI^^^^MD^^^^^^NPI|||||800^735^4087||||F||||||239.2^Neoplasm
s 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 Message
OBR|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 blastlike 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
Lab A
Actual percentages are
provided for each by all
labs.
of >4% for Positive; 14% for Weakly Positive;
<1% Negative
Provided when >
0
Lab B
Actual percentages are
provided
of >=1% for Positive;
<1% Negative
Provided when >
0
Lab C
Actual percentages are
provided
Actual percentages are
provided
of >=1% for Positive;
<1% Negative
of >=1% for Favorable;
<1% Unfavorable
Provided when >
0
Provided when >
0
Lab D
Requirements:
Fixative Name
and fixative time
provided
Clone ID info
Clone ID
provided
Provides Fixative and
Fixation time for
ER/PR
Fixation name is
provided & time
recorded when times
available.
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)
Clone ID
provided
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 HER2neu/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
Thank you!
Sandy Jones, CDC
Public Health Advisor
770-488-5689
sft1@cdc.gov
For more information please contact Centers for Disease Control and Prevention
1600 Clifton Road NE, Atlanta, GA 30333
Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348
E-mail: cdcinfo@cdc.gov
Web: www.cdc.gov
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.
National Center for Chronic Disease Prevention and Health Promotion
Division of Cancer Prevention and Control