STD028

SCCI1577

0.1

SCCI1577 Guidance (NHS Digital)

Guidance

Draft

TBC

STD028-1

Radiology Information Systems MUST be able to capture and/or derive the data items defined within this standard. This includes mapping of local codes to national codes, and the ability to extract this information as envisaged within this standard,

MUST

STD028-2

IT supplier's systems MUST ensure that the increase in burden for providers for capturing and extracting the information defined in the DID Guidance is proportionate.

MUST

STD028-3

IT systems suppliers, when considering potential developments, minimising the burden on providers and supporting good data quality MUST be prioritised.

MUST

STD028-4

IT Systems Suppliers SHOULD review all related documentation to fully understand the background, objectives and scope of this information standard.

SHOULD

STD028-5

With immediate effect, IT Systems Suppliers SHOULD review the DID Guidance to understand the scope and definition of each data item.

SHOULD

STD028-6

As an Output Data Set, the DID is intended to only define “what should be extracted” from local IT systems, not “what should be captured”. A clinical data set will need data items beyond what the DID specifies. While IT Systems Suppliers SHOULD use this data set to support their system development, they SHOULD NOT use the data set exclusively and SHOULD also consider the full requirements of the care setting where it is used. The whole ethos around the DID is to only re-use clinical data, not specify standards for capturing clinical data.

SHOULD

STD028-7

IT Systems suppliers SHOULD provide the ability to extract the required data items from Radiology Information Systems in .xml format without the need for further manipulation of the extracted data.

SHOULD

STD028-8

IT Systems Suppliers SHOULD familiarise themselves with the .xml schema to understand how data items are grouped and formatted for the Data Submission File.

SHOULD

STD028-9

IT Systems Suppliers SHOULD provide tools to enable a ‘data mapping exercise’ to be carried out and where possible complete the mappings to the national codes on behalf of the providers of Imaging Services.

SHOULD

STD028-10

The DID Guidance Document explains the Information Governance issues surrounding the data set. IT Systems suppliers MUST provide a mechanism to allow providers to identify records where patients have objected to the use of their data for secondary purposes or where there is a legal requirement to restrict the flow of identifiable information for a patient.

MUST

STD028-11

IT System Suppliers SHOULD always ensure that any changes resulting from the implementation of the DID are compliant with the safety standards ISB 0129 and ISB 0160.

SHOULD

STD028-12

IT Systems Suppliers SHOULD review the DID Guidance on the NHS Digital website to understand the data validation rules that will be applied upon submission to all incoming Data Submission Files. Any hard validation rules not adhered to will result in the entire Data Submission File being rejected. Soft validation rules not adhered to will generate warnings in the Validation Error Report available on the DID submission portal.

SHOULD

1

From 1st April 2016 providers of Imaging Services as defined in this Information Standard MUST be able to collect the information as defined in this specification for local use

MUST

2

From 1st May 2016 providers of Imaging Services as defined in this Information Standard MUST submit monthly Mental Health Services Data Set submissions centrally as per the instructions in the DID Guidance.

MUST

3

The providers MUST allow time to review and implement corrections to their submission files within the designated window

MUST

4

Providers SHOULD review all related documentation to fully understand the background, objectives and scope to this information standard.

SHOULD

5

NHS Digital will continue to provide a local codes mapping service for Imaging Service Providers where within system mapping would be burdensome. Imaging Services Providers and Data Submitters MUST make sure that local mapping files are uploaded to the DID submission portal as per the instructions in the DID Guidance and MUST ensure mapping files are kept up to date.

MUST

6

As the DID Guidance is intended to only define “what should be extracted” from local IT systems, not “what should be captured”, A clinical data set will need data items beyond what the DID specifies; consequently, providers of Imaging Services SHOULD NOT use this data set to define their clinical and operational data capture. The DID is collected to only re-use clinical data and not specify standards for capturing clinical data.

SHOULD

7

Providers of Imaging Services MUST make submissions only for those data items defined in the DID Guidance and no additional data items should be included.

MUST

8

The DID Guidance Document explains the Information Governance issues surrounding the data set. Caldicott Guardians and the Heads of Information Services MUST review the Information Governance Guidelines within the DID Guidance Document to ensure their understanding is correct: - How data submission, storage and reporting processes handle identifiable and sensitive data items - How consent issues should be best managed This standard does not change what is being collected in DID or the Information Governance issues surrounding the data set.

MUST

9

Providers of Imaging Services MUST make available information and guidance to patients stating that their clinical care data MAY be re-used for the purpose of data analysis and reporting. It MUST be the sole responsibility of the care provider’s Caldicott Guardian to ensure the subject information is withheld where appropriate. Any immediate concerns SHOULD be addressed to the DID Service Team at the NHS DIGITAL or the Health Research Authority (HRA) Confidentiality Advisory Group (CAG).

MUST

10

With immediate effect, providers of Imaging Services SHOULD read the ‘NHS Confidentiality Code of Practice’, ‘Caldicott Report’ and subsequent ‘Information: To share or not to share?’ Information Governance Review (second Caldicott review) for guidance and technical support related to data and information sharing at both operational and secondary use levels.

SHOULD

11

Providers of Imaging Services SHOULD also consult and adhere to the good practice advice and guidance set out in ‘A Guide to Confidentiality in Health and Social Care’ to prevent breaches of confidentiality

SHOULD

12

It MUST be the sole responsibility of the care provider’s Caldicott Guardian to ensure the subject information is withheld where appropriate.

MUST

13

Any immediate concerns regarding Information Governance SHOULD be addressed to the DID Service Team at the NHS DIGITAL or the Health Research Authority (HRA) Confidentiality Advisory Group (CAG).

SHOULD

14

Clinical governance is defined by Department of Health as ‘the system through which NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care, by creating an environment in which clinical excellence will flourish’. As an Information Standard that approves a national patient-level data set: - Governing and audit bodies MAY use the data set to monitor whether providers of Imaging Services are making year on year improvements. - Providers of Imaging Services MAY use the data set to compare and contrast performance to drive service improvements. - The National Cancer Intelligence Network (NCIN) MAY use the data set benchmark GPs. - The Public Health England Cancer Registry MAY use the data set to extend the cancer pathway information. It is therefore clear that the data set can be used for clinical governance purposes.

MAY

15

Providers of Imaging Services SHOULD always seek to understand the context of published national reports and be aware that the information presented depends greatly upon the quality of information submitted. Ongoing efforts SHOULD be made to ensure that data quality is of the highest standard before forming judgements about reports and introducing changes. As an Information Standard that approves a national patient-level data set: - The Public Health England MAY use the data set to estimate exposure to radiation through use of imaging tests for diagnosis, intervention or treatment.

SHOULD

16

Providers of Imaging Services* MUST create a monthly data submission as set out in the DID Guidance.

MUST

17

Providers of Imaging Services MUST be able to: Collate and extract data from local IT (RIS) systems as per the DID Guidance. Structure the data and create a data submission file as per the DID Guidance. - Apply the basic validation rules and ensure that the submission file conforms to these. - Submit the data submission file on the secure DID submission portal using a personal login by authorised personnel only.

MUST

18

Providers of Imaging Services* MUST submit data monthly to the DID, based on a schedule that is available on the NHS Digital DID website.

MUST

19

Providers of Imaging Services* MUST check for error reports, correct errors and make re-submissions at the earliest opportunity. Further details on error correction and re-submissions are explained within the DID Guidance.

MUST

20

*In some circumstances one organisation may submit data to DID on behalf of other providers of Imaging Services. In these cases: - The imaging providers MUST agree who will be responsible for submitting to the DID and avoid submitting duplicate records. - The submitting organisation MUST use the correct ODS Site Code for the imaging activity so that the activity can be mapped to the correct provider.

MUST

21

Data Submitters MUST familiarise themselves with the DID Guidance Document which provides information on how to create a monthly submission file. However, noted below are key requirements of the technical submission architecture:

MUST

22

A submission MUST: Meet the conditions and validation rules explained in the DID Guidance.

MUST

23

Each Data Submission File - SHOULD be in .xml format - MAY be in .csv format if submission in .xml is not possible

SHOULD

24

Each Data Submission File MUST NOT contain duplicate records with the same Radiological Accession Number

MUST

25

Each .xml submission: - MUST conform to the published .xml schema. - MUST contain all Mandatory data items and at least one item from each Mandatory Group for every record as described in the DID Guidance.

MUST

26

Each .csv submission will be converted to .xml by the system before being validated therefore each .csv file: - MUST NOT contain a header row. - MUST be in the correct column order as described in the DID Guidance. - MUST NOT contain any blank rows after the last record. - MUST contain all Mandatory data items and at least one item from each Mandatory Group for every record as described in the DID Guidance. - MUST have all data items formatted correctly to allow necessary leading zeros and correct date formats as described in the DID Guidance.

MUST

27

Providers of Imaging Services MUST include in their submission all eligible completed imaging activity recorded in their RIS.

MUST

28

Providers of Imaging Services SHOULD include in their submission all Required data items where these are available for extraction from their RIS.

SHOULD

29

Existing data validation rules will not be affected by this standard. However, providers of Imaging Services MUST review the DID Guidance on the NHS Digital DID website to understand the data validation rules that will be applied upon submission to all incoming Data Submission Files. Any hard validation rules not adhered to will result in entire submission being rejected.

MUST

30

Where error reports are generated due to non-conformance against validation rules, DID submitters MUST take immediate action and resubmit the corrected file within the submission window.

MUST

31

Data quality issues will be reported back to data submitters on an ad-hoc basis as they arise by the NHS Digital Data Collections team. Providers of Imaging Services and submitters of DID data SHOULD make every effort to resolve inherent systemic errors and address recurring data quality issues.

SHOULD

32

Coverage, Completeness and Quality measures are published monthly on the NHS England Website for DID. Providers of Imaging Services and submitters of DID data SHOULD review these reports regularly and consider how the completeness and quality of their data can be improved.

SHOULD

33

A submission MUST be loaded onto the portal on a monthly basis and as per instructions laid out in the DID Guidance.

MUST

34

Heads of Imaging Services are responsible for capturing the information as part of the on-going care of patients. They MUST: - Familiarise themselves with the DID Guidance to understand what data items are mandated by this Information Standard - Ensure they understand and implement the Information Governance approach adopted for this data set, which can be found in the Consent section of the DID Guidance Document - Explain to operational and clinical staff the importance of capturing data for the DID.

MUST

35

Clinical staff MUST: - Capture the DID data items in an accurate and timely manner. - Understand the deployed IG approach, especially in relation to the handling of sensitive data.

MUST

36

Informatics staff are responsible for producing extracts that conform to the DID Guidance. They MUST: - Familiarise themselves with the DID Guidance to understand what data items are mandated by this Information Standard. - Configure Radiology Information Systems and/or associated data extracts to allow compliance with the standard. - Submit the data to the DID submission portal within the prescribed reporting periods and deadlines. - Review and work with clinicians to resolve data quality issues identified in the output reports. - Ensure they understand and implement the Information Governance approach adopted for this data set, which can be found in the Consent section of the DID Guidance Document.

MUST

STD030

ISB 1556

0.1

ISB 1556 Guidance

Guidance

Draft

STD030-1

DICOM Networking Conformance Requirements

IT system suppliers implementations claiming DICOM network conformance shall:

• conform to the minimum conformance requirements defined in this section;

• provide with the implementation a Conformance Statement structured according to the rules and policies in this Part including Annex A;

• conform to at least one Standard or Standard Extended SOP class as defined in PS3.4; Note Conformance to a Standard or Standard Extended SOP class implies conformance to the related IOD outlined in PS3.3, the Data Elements defined in PS3.6, and the operations and notifications defined in PS3.7.

• comply with the rules governing SOP Class types outlined in Section 7.3;

• accept a Presentation Context for the Verification SOP Class as an SCP if the implementation accepts any DICOM association requests;

• produce and/or process Data Sets as defined in PS3.5; Note Conformance to PS3.5 also implies conformance to PS3.6.

• obtain legitimate right to a registered for creating UIDs (see PS3.5) if an implementation utilizes Privately Defined UIDs (i.e., UIDs not defined in the DICOM Standard);

• support the following communication mode: • TCP/IP (See PS3.8).

MUST

STD030-2

DICOM Media Interchange Conformance Requirements

IT system suppliers implementations claiming DICOM Media Interchange conformance shall:

• provide with the implementation a Conformance Statement structured according to the rules and policies in this Part including Annex A;

• conform to at least one Standard Application Profile as defined in PS3.11;

• support one of the Physical Media and associated Media Format, as specified by PS3.12; • comply with the rules governing SOP Class types outlined in Section 7.3;

• comply with the specific rules governing media storage Application Profile according to their types as specified in Section 7.4. No other types of Application Profiles may be used; - Standard - DICOM PS3.2 2022c - Conformance Page 49

• read as an FSR or FSU all SOP Classes defined as mandatory by each of the supported Application Profiles encoded in any of the mandatory Transfer Syntaxes. • write as an FSC or FSU all SOP Classes defined as mandatory by each of the supported Application Profiles in one of the mandatory Transfer Syntaxes;

• be able to gracefully ignore any Standard, Standard Extended, Specialized or Private SOP Classes that may be present on the Storage Medium but are not defined in any of the Application Profiles to which conformance is claimed. Note There may be more than one Application Profile used to create or read a File-set on a single physical medium (e.g., a medium may have a File-set created with Standard and Augmented Application Profiles).

• be able to gracefully ignore Directory Records in the DICOMDIR file that do not correspond to Directory Records defined in any of the Application Profiles to which conformance is claimed.

• access the File-set(s) on media using the standard roles defined in PS3.10; • produce and/or process Data Sets as defined in PS3.5 encapsulated in DICOM Files; Note Conformance to PS3.5 also implies conformance to PS3.6

• obtain legitimate right to a registered for creating UIDs (see PS3.5) if an implementation utilizes Privately Defined UIDs (i.e., UIDs not defined in the DICOM Standard). An implementation that does not meet all the above requirements shall not claim conformance to DICOM for Media Storage Interchange.

MUST

STD069

DAPB4017

0.1

DAPB4017 Guidance (NHS Digital)

Data Standard - NHS

Draft

STD0069-1

Unified Test List (UTL)

The IT system supplier MUST use the National catalogue of pathology test requests and results, using SNOMED CT. Specified in section 2.5 of DAPB4017 Specification.

MUST

STD0069-2

Units of Measures (UoM)

The IT system supplier MUST use the National set of standardised units of measure, using The Unified Code for Units of Measure (UCUM), aligned with the UTL and HL7 FHIR. Specified in section 2.4 of DAPB4017 Specification.

MUST

STD0069-3

Message Specification

The IT system supplier MUST use the Message specification, using Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR). Specified in section 2.3 of DAPB4017 Specification.

MUST