Core - Pathology

As of January 2016, all pathology should be submitted to the NDRS in structured xml. These reports will include all the data as prescribed below and would be submitted to the NDRS directly from the pathology Laboratory Information Management Systems (LIMS). Once the pathologist has completed and signed off each report, they can be submitted either individually or as a monthly batch of data. There is a separate pathology schema for submissions which come directly from the pathology LIMS.

There is no expectation therefore for providers to double enter these data by non-clinical MDT coordinators trying to read a pathology report and transcribe the relevant information correctly into their local cancer information system. As a result, all pathology data items have been removed from the main COSD data set and can only be reported via the pathology departments and this data set.

Pathological diagnosis and grade (where applicable) are recorded on biopsies and may be amended after surgical resection (if appropriate), when pathological staging should also be available. Full text pathology reports should be submitted to include these data items if structured coded extracts are not available. In addition, there may be more than one pathology section completed for each record.

To carry the pathology details. The core data set includes general pathological items which are applicable to all tumour sites unless otherwise stated, and site specific pathology items (relating to stage components). These core and site specific items are a subset of the RCPath cancer data sets which have been approved as professional standards by the college.

All the data items across the data set were aligned exactly with the ‘RC Path – Core’ pathology data items. This has created additional changes to both data item names, descriptions and/or the attribute lists, where these were different in COSD. It is expected that these changes will help improve the data quality and ascertainment, whilst reducing the burden of double reporting.

Where structured reporting systems are not available for pathology, it is expected that many of the relevant data items will be included in the free text pathology report.

Important notes:

• all pathology data items are prefixed with a lowercase ‘p’, for example ‘pCR0780’
• these reports should be sent to the NDRS through pre-agreed methods of submission
• the regional Data Liaison Managers can support Trusts with this, and any testing required for new reporting of data
• this is especially important when a new system is implemented, or an upgrade rolled out by a supplier or Trust IT team

A patient may have any number of pathology reports, and there may be more than one pathology report per specimen.

The following tables contain all the data items in the Core - Pathology section of the data set, and are applicable to most tumours. Certain data items are mandatory to improve data quality, however most are required but must be reported if applicable to the specimen and/or tumour.

May be multiple occurrences per record (0..*)

Start of section - Consultant (Pathology Test Requested By)

End of section - Consultant (Pathology Test Requested By)

Start of section - Consultant (Pathologist)

End of section - Consultant (Pathologist)

Start of section - Topography/Morphology SNOMED

Topography/Morphology Choice 1..2

Choice 1

Start of repeating item - Topography (SNOMED) Pathology

End of repeating item - Topography (SNOMED) Pathology

End of Choice - Choice 1

Choice 2

Start of repeating item - Morphology (SNOMED) Pathology

End of repeating item - Morphology (SNOMED) Pathology

End of Choice 2

End of Topography/Morphology Choice

End of section - Topography/Morphology SNOMED

Start of repeating item - Primary Diagnosis (ICD Pathological)

End of repeating item - Primary Diagnosis (ICD Pathological)

Note the following data item has been retired from v5.0:

• Microsatellite Instability (MSI) Testing

Investigation Result Date

Record the date on which an investigation was concluded, for example: the date the result was authorised.

Service Report Identifier

A unique identifier of a service report.

Notes:

• it is possible that some legacy data may not have all the required mandatory fields
• the recommendation is for Trusts to update their data to meet the new requirements and improve/enrich their data submissions, or not upload the legacy data items in the new record (if that data is not available)

Pathology Observation Report Identifier

This is the local identifier of an observation report.

Notes:

• this differs from the Service Report Identifier as it identifies the specific RC Path Form used
• multiple of these could be contained within a Service Report (where there are multiple tumours are identified/taken)

Service Report Status

The status of the service report.

Notes:

• the next 2 data items are now a multiple selection group and are mandatory within the group
• there may be one occurrence per 'CORE – Pathology Details' section

Professional Registration Issuer Code – Consultant (Pathology Test Requested By)

This is a code which identifies the professional registration body for the consultant or health care professional who requested the pathology test.

Professional Registration Entry Identifier – Consultant (Pathology Test Requested By)

This is the registration identifier allocated by a Professional Registration Body for the consultant or health care professional who requested the pathology test.

Organisation Site Identifier (Pathology Test Requested By)

The ‘Organisation Identifier’ of the organisation site at which the care professional, who requested the diagnostic test request for suspected cancer, is based.

Sample Collection Date

The date that a sample collection takes place or the start of a period for sample collection. This is the same as the date the Sample is taken.

Sample Receipt Date

Date of receipt of a sample by a laboratory.

Organisation Identifier (of Reporting Pathologist)

The ‘Organisation Identifier’ of the organisation at which the authorising pathologist is based.

Notes:

• the next 2 data items are now a multiple selection group and are mandatory within the group
• there may be one occurrence per 'CORE – Pathology Details' section

Professional Registration Issuer Code – Consultant (Pathologist)

This is a code which identifies the professional registration body for the consultant or health care professional who authorises the pathology report.

Professional Registration Entry Identifier – Consultant (Pathologist)

This is the registration identifier allocated by a Professional Registration Body for the consultant or health care professional who authorises the pathology report.

Specimen Nature

The nature of the specimen taken during a clinical investigation.

Note:

• where none of the above options are applicable, ‘Not known’ maybe selected

Important note:

• the next 3 data items form a section, which has a two choice group, all data items are mandatory within the group.

SNOMED version

The version of SNOMED used to encode ‘Morphology (SNOMED) Pathology’ and ‘Topography (SNOMED) Pathology’.

Note:

• versions of SNOMED prior to SNOMED CT ceased to be licenced by The International Health Terminology Standards Development Organisation (IHTSDO) after April 2017 other than for historical content

Important note:

• the next 2 data items form a 2-choice menu and at least one of the following choices must be provided per submission (1..2)

Choice 1

Topography (SNOMED) Pathology

This is the topographical site of the tumour as categorised by SNOMED International / SNOMED CT, multiple codes may be submitted.

Choice 2

Morphology (SNOMED) Pathology

This is the morphology of the tumour as categorised by SNOMED International / SNOMED CT, multiple codes may be submitted.

Diagnosis (ICD Pathological)

The ICD diagnosis is based on the evidence from a pathological examination, multiple codes may be submitted as it is a repeating data item.

Notes:

• where the ICD10 code only has 3 characters, for example C01, please add “X” as a ‘packing digit’ to meet the validation rules (such as C01.X, C07.X, C73.X)
• in addition, the reporting format excludes the decimal CXX.X or DXX.X, all xml reports must be recorded as CXXX or DXXX

Tumour Laterality (Pathological)

‘Tumour laterality’ identifies the side of the body for a tumour relating to paired organs within a patient based on the evidence from a pathological examination.

Pathology Investigation Type

The type of pathology investigation procedure carried out.

Pathology Report Text

The full text from the pathology report, which is required by Registries to calculate diagnosis, staging and additional observational findings/details.

Lesion Size (Pathological)

The size in millimetres of the diameter of a lesion, largest if more than one, if the histology of a sample proves to be invasive.

Notes:

• for COSD reporting purposes, this data item can be submitted to 2 decimal places
• this data item is not applicable for Haematology diagnosis
• please see Skin site specific data set for further information on collecting this data item, including the site specific values to be used

Grade Of Differentiation (at Diagnosis)

This is the definitive grade of the Tumour at the time of patient diagnosis.

Notes:

• the default labels for these fields 'well differentiated', 'moderately differentiated' and 'poorly differentiated'
• these are nationally assigned ‘general’ descriptions used within COSD, the correct grade will be applied by the NCRAS upon processing the data
• not required for prostate or testicular cancer or haematological diagnoses

The following mapping table can be used to map other (site-specific) invasive grades, into the main 'Grade of Differentiation (At Diagnosis)' field:

Cancer Vascular or Lymphatic Invasion

An indication of the presence or absence of unequivocal tumour in lymphatic and/or vascular spaces.

Note:

• this data item is not applicable for Haematology diagnosis

Perineural Invasion

This data item is now centralised in CORE, as this is relevant to many tumours. Is there perineural invasion (invasion into perineurium of nerve bundles- PNI)

Excision Margin

An indication of whether the excision margin was clear of the tumour and if so, by how much. Where there is more than one measurement, record the closest or closest relevant margin. Where actual measurements are not taken use options 01, 05 or 06.

Notes:

• codes 07, 08 and 09 are only applicable for skin cancers, they have been included to align with the RCPath data sets for skin diagnoses
• this data item is not applicable for Haematology diagnosis

Excision Margin (Circumferential)

This data item is now centralised in CORE, as this is relevant to many tumours. Identify whether circumferential margin is involved. (Involved equals 1mm or less, not involved equals greater than 1mm).

Synchronous Tumour Indicator

An indicator of the presence of multiple tumours at a tumour site.

Note:

• this data item is not applicable for Haematology diagnosis

Number of Nodes Examined

The number of local and regional nodes examined.

Note:

• this data item is not applicable for CNS, Haematology or Lung diagnosis

Number Of Nodes Positive

The number of local and regional nodes reported as being positive for the presence of tumour metastases.

Note:

• this data item is not applicable for CNS, Haematology or Lung diagnosis

Sentinel Lymph Nodes Examined Number

This data item is now centralised in CORE, as this is relevant to many tumours. Record the number of sentinel lymph nodes examined.

Sentinel Lymph Nodes Positive Number

This data item is now centralised in CORE, as this is relevant to many tumours. Record the number of sentinel lymph nodes positive.

Post SLNB Completion Lymphadenectomy - Nodes Examined Number

This data item is now centralised in CORE, as this is relevant to many tumours. Post Sentinel Lymph Node Biopsy (SLNB) completion lymphadenectomy (not always done), number of nodes examined.

Post SLNB Completion Lymphadenectomy - Nodes Positive Number

This data item is now centralised in CORE, as this is relevant to many tumours. Post Sentinel Lymph Node Biopsy (SLNB completion lymphadenectomy (not always done), number of nodes positive.

Important notes:

• the COSD Core TNM Staging data items below are not applicable for CNS, Gynaecological, Haematological, Skin and most CTYA diagnoses
• see site specific data sets for further information on collecting applicable stage data, including the site specific values to be used for TNM where relevant

TNM Coding Edition

The TNM Coding edition in use.

Note:

• European Neuroendocrine Tumour Society (ENTS) v4 has been added to this list of TNM coding editions reportable through COSD, to improve data quality

TNM Version Number (Pathological)

The AJCC, UICC or ENETS version number used for Tumour, Node and Metastasis (TNM) staging for cancer diagnosis.

T Category (Pathological)

‘T Category (Pathological)’ is the code which classifies the size and extent of the primary tumour based on the evidence from a pathological examination.

N Category (Pathological)

‘N Category (Pathological)’ is the code which classifies the absence or presence and extent of regional lymph node metastases based on the evidence from a pathological examination.

M Category (Pathological)

‘M Category (Pathological)’ is the code which classifies the absence or presence of distant metastases based on the evidence from a pathological examination.

TNM Stage Grouping (Pathological)

‘TNM Stage Grouping (Pathological)’ is the code which classifies the combination of tumour, node and metastases into stage groupings based on the evidence from a pathological examination.

Neoadjuvant Therapy Indicator

Indicator of whether the pathological stage was recorded after the patient had received neoadjuvant therapy (i.e. chemotherapy or radiotherapy prior to surgery).

Note:

• if this is ‘Yes’ the pathology stage fields should NOT be prefixed with the letter ‘y’

Ki-67 Indicator

Indicate if a Ki-67 staining was done on the sample.

Ki-67 Result

Record the percentage of tumour cells that are positive for Ki-67, on a scale of 0 to 100.

MLH1 Nuclear Expression Intact

Is MLH1 immunohistochemistry nuclear expression intact?

PMS2 Nuclear Expression Intact

Is PMS2 immunohistochemistry nuclear expression intact?

MSH2 Nuclear Expression Intact

Is MSH2 immunohistochemistry nuclear expression intact?

MSH6 Nuclear Expression Intact

Is MSH6 immunohistochemistry nuclear expression intact?