IAAS Recommendation Report

Standardisation Committee for Care Information (SCCI)

30 April 2014 Agenda Item:09

For: (insert action/decision/info)

IAAS Recommendation Report

IAAS Recommendation Report

ISB 1513 Maternity Services Data Set (Amd 45/2012)

30

April 2014 SCCI meeting

Document filename: ISB 1513 Amd 45/2012 RR (Change)

Directorate / Programme Operations & Technical Services

Independent Assurance & Advice Service (IAAS)

Document Reference

Author Lindsey Blake Status Final

Document Management

Revision History

Version Date Summary of Changes

0.1 02.04.14 First version for comment

0.2 11.04.14 Second version post IAAS discussion 0.3 12.04.14 Edit for clarity

0.4 14.04.14 Further IAAS changes 0.5 14.04.14 IAAS amendments 1.0 15.04.14 Following QA comments

Reviewers

This document must be reviewed by the following people: author to indicate reviewers Reviewer name Title / Responsibility Date Version

IAAS Assurance 14.04.14 V1.0

Approved by

This document must be approved by the following people: author to indicate approvers

Name Date Version

IAAS Head of Operations 15.04.14 V1.0

Document Control:

The controlled copy of this document is maintained in the HSCIC corporate network. Any copies of this document held outside of that area, in whatever format (e.g. paper, email attachment), are considered to have passed out of control and should be checked for currency and validity.

1 Introduction

This report presents the recommendations of the Independent Assurance & Advice

Service (IAAS) in respect of the release detailed below, for submission to the

Standardisation Committee for Care Information (SCCI).

1.1 Standard contact information

Standard

SRO Kathy Farndon, Head of Information Standards and Information Governance, NHS England

Sponsor Phil Walker, Head of Information Governance & Standards Policy, Department of Health

Project/Programme Lead

Netta Hollings, Programme Manager, Mental Health and Community Care, HSCIC

1.2 Standard and release summary

Standard

Number ISB 1513

Title Maternity Services Data Set

Stage Change

Description Background

The Maternity Services Data Set (MSDS) forms part of an overall Maternity and Children’s Data Set (MCDS) that has been developed as a key driver to achieving better outcomes of care for mothers, babies and children.

The MCDS incorporates the following individual information standards:

 Maternity Services Data Set (MSDS)

 Children and Young People’s Health Services (CYPHS) data set

set

The MSDS is a patient-level data set that captures key information at each stage of the maternity service care pathway including mother’s demographics, booking appointments, admissions and re-admissions, screening tests, labour and delivery along with baby’s demographics, admissions, diagnoses and screening tests.

In Scope

This standard mandates the central flow of administrative and clinical information for secondary uses purposes. The standard defines an ‘output specification’ based on extracts from existing clinical systems. Additional supplementary guidance on definitions and technical

aspects for monthly data submissions to a central data warehouse are provided to support the implementation of the standard and can be found here:

http://www.isb.nhs.uk/library/standard/81

http://www.hscic.gov.uk/maternityandchildren/maternity

All NHS funded Maternity Services providers are required to conform to this standard.

Out of Scope

The following areas are exceptions to the MSDS scope:

 Existing clinical data collection standards within the maternity care pathway.

 System functionality or design: whilst the standard provides details of ‘what’ and ‘how’ data should be submitted, it does not stipulate any standard on the functionality or design of local clinical and operational systems, although if data is easy to collect and synchronise with care pathways it will improve the quality of the data provided.

 Activities undertaken after discharge from Maternity Services.

 Non-NHS funded services provided by independent organisations.

 Services rendered outside England.

 Paper records, see note below.

 Independent midwives and private providers, who are not required to make submissions unless commissioned by the NHS.

Paper Records

The standard does not provide financial cover for local procurement to support the transcription of paper records or purchase of IT systems to sustain the data submission. Therefore, where data requirements are predominantly recorded on paper and not transcribed to any electronic form, services are not required to make submissions of those data groups in the first instance. However, organisations are encouraged to make provision for IT solutions and should, at their own cost, progress the procurement/enhancement of electronic systems that meet this specification as early as possible.

Release

Release Number Amd 45/2012

Title Version 1.5

Description This release of the standard introduces minor changes in relation to the maternity data set. These are:

 Addition of data items relating to maternity currencies.

 Addition of data items relating to date capture for specific events.

 Re-formatting the data set Output Specification; XML has replaced the bespoke segment structure.

 NHS number is now a required item and the Local Patient ID is mandatory. Renaming of data items to conform to the NHS Data Model and Dictionary.

Applies to Organisation Types

The MSDS will be used in all organisations providing Maternity Services, and the standard applies to all NHS commissioned

Maternity Services in England, including Acute Trusts and Foundation Trusts actively involved in the maternity care pathway (antenatal, intrapartum and postnatal/postpartum episodes). This also includes private services commissioned by the NHS, although data submission will only be made by NHS Trusts.

Services

The standard must be read and used by all NHS funded Maternity Service providers, and related services that have an active

involvement in the maternity care pathway, including:

 Obstetric Services.

 Midwifery Services.

 Radiology Services.  Pathology Services.  Gynaecology Services.  Neonatal Services.  Community Providers. Professionals

The standard primarily, but not exclusively, applies to the following professionals:

 Maternity Services administrative personnel.

 Obstetricians.

 Midwives.

 Neonatologists.

 Paediatricians.

 Information and IT Professionals.

IT Systems

The standard predominantly, but not exclusively, relates to the following electronic information systems:

 Patient Administration Systems (PAS).

 Commercial and National Maternity Systems.

 Radiology Systems.

 Pathology Systems.

 Neonatal Systems.

Data Subjects

The standard primarily aims to capture information on three data subjects:

 Pregnant women.

 Women’s partners (or father of the baby).

 Babies.

Data will be captured for women and babies presenting for any part of the maternity care pathway. It is not necessary for the woman or baby to have a ‘full data record’.

Legal basis This is a change to an existing Collection. Given the significance of the changes it requires a Direction from NHS England under Section 254 of the Health & Social Care Act 2012.

1.3 Milestone dates

Milestones

Type Planned Estimated Achieved

End of Change stage 24/04/2013 30/04/2014 Implementation start date 01/05/2014 01/05/2014 Full conformance date 01/11/2014 (system suppliers). 01/05/2015 (care providers). 01/11/2014 (system suppliers). 01/05/2015 (care providers). Post implementation review 30/11/2015 30/11/2015

1.4 IAAS position statement

IAAS

IAAS recommends APPROVAL with CONDITIONS for this release. Suggested conditions

1. The SRO is able to confirm acceptance of the outstanding risks demonstrated by the number of data items not returned during testing.

2. The SRO is able to confirm that the implementation programme will be supported to enable the extended implementation plan to be successfully implemented.

3. Funding is confirmed as released for this standard.

4. A Direction is issued under Section 254 of the Health & Social Care Act

Summary of evidence

Background:

The Maternity Data Set has had a challenging history, with significant delays in the development of the first release. Similar delays have impacted on the development of the changes proposed, particularly related to financial

approvals. These delays have resulted in several suppliers being unable, (or unwilling without an Information Standards Notice), to make changes to systems in advance of formal notification of these requirements. Throughout the appraisal of changes to this standard, (both historical and current), a number of concerns were identified and mitigations to associated risks were agreed by the Information Standards Board (ISB). In making a decision on this standard, SCCI need to consider those concerns, associated risks and

recommended mitigations (see risk log below).

Data items and testing:

The maternity data set requirement necessitates a collection of data items that may not be available in all settings, or for all cases. Such data items are “required” i.e. must be returned if available. In addition, the NHS Number has been changed from “Mandated” to “Required” as not all expectant mothers have an NHS No. This has been compensated by changing the extended local patient identifier from “Required” to “Mandated”.

For many of the new data items, the scope of testing has been limited. The rationale put forward, (that was agreed by the Maternity Programme Board and subsequently by the ISB), is that the ability to test the new data items fully is not possible due to the number of systems involved that do not have a solution to this requirement and the need for an Information Standards Notice to

engage the supplier community.

Testing has been completed which shows that the ability to flow data that is available can be achieved in a number of settings. The case has been made that this standard is needed to improve the quality of data flowing. To achieve to? this end a significant number of the data items in this standard are optional. The agreed approach is to monitor and support the flow of these data items, then review and update requirements to “Required” or “Mandated” as

appropriate at a future date.

ISB supported this position, whilst requiring that the developer established a clear baseline by testing at least three different supplier solutions, proving that all information available could flow to the HSCIC.

The test results prove the schema works, and that the access tool developed to enable services to populate the schema reduces burden and is well

regarded by the test sites.

There is a significant risk related to the less than complete returns of new data items. The proposal is to mitigate this by a two stage implementation.

It should be noted that the testing evidence is clear and honest, setting out the difficulties and challenges of securing test sites in this arena and securing system supplier compliance with requirements relating to new data items.

Recommendation:

The updated Maternity Services Data Set (MSDS) Data Set is proposed to be mandated for local collection by providers from 1st April 2015 with the first national submission commencing 1st May 2015. System suppliers are required

to be fully compliant with the standard from 1st November 2014.

Based on the history of this standard, as summarised above, the developers have made a case, supported by their project board, to undergo a phased implementation. This is for two purposes:

 HSCIC's data repository set up can be put in place – this requires a release of funding.

 Extra support can also be provided to support data flow (schema and use of conversion tool) which may mean adjustments to the tool to meet variations in settings.

The importance of this standard combined with the lengthy delays resolving finance issues (which effectively disengaged system suppliers) and the proposal by developers to extend and more proactively support

implementation are reasonable mitigations for the risks raised.

The ISB position, and one that is now supported by IAAS, is that while this standard has not demonstrated full implementability of all data items, the mitigation plan through implementation, linked with the exposed risks being accepted by the SRO means it should be supported.

Comments

IAAS would recommend a review of the compliance with this standard as well as a benefits realisation report to be completed within six months of full

implementation and, ideally, that interim compliance reports are produced after first and third national submissions.

Appendix: Risks and issues

The following risks are raised by IAAS:

#

Description

Type (R/I)

Owner

Proposed mitigation

1.

Funding has not been released from NHS England to the MCDS projects.

R

30.04.14.

2.

End to end data flow has not been proven in testing.

R SRO 07.04.14: The phased implementation

programme should mitigate any risks for full implementation and compliance. The SRO must also be willing to accept the risk demonstrated by the number of data items not returned during testing. These are conditions of approval.

3. Early identification of issue in testing

The Community and Mental Health Testing Team raised a concern that the ‘Complicating STIs at Booking’ data group contains the full appointment date of a pregnant woman’s initial booking appointment, as well as the maternity complicating STI diagnosis for the mother. This could potentially identify a mother if a low volume of booking appointments were sent through in a single submission.

R Developer 13.02.14: It was agreed that, as the HSCIC

is a Safe Haven, it would be acceptable for the full ‘Appointment Date (Formal Antenatal Booking)’ to be sent by the providers as long as the HSCIC converted this to the

‘Appointment Month (Formal Antenatal Booking)’ before including it in any reports or extracts.

The ‘Appointment Date (Formal Antenatal Booking)’ would then be replaced by ‘Appointment Month (Formal Antenatal Booking)’ in the next release of this standard.

4.

All records for a mother and a baby are linked through their Local Patient Identifier within the submission file. Whilst the mother’s and baby’s NHS number should be supplied wherever it is known, the project accepts that there may be occasions where the NHS number is not known.

R Developer 20.01.14: The capture of the NHS number is

vital as this is the only identifier that allows the mother and baby to be tracked across different organisations or across a single organisation when multiple Local Patient Identifiers have been used for a mother and/ or baby.

Although this is not a mandated field, as not all mothers and babies have NHS numbers, data quality reports will be produced to identify the completeness of this field. In cases where a mother’s NHS number is unavailable (which may be because the mother or baby does not possess one) data providers must submit a null NHS number and [07] Number not present and trace not required in NHS NUMBER STATUS INDICATOR (MOTHER)/(BABY). To be addressed at next release.

5.

As the Maternity data set is an output data set that only re-uses clinical data, SNOMED CT has previously been deemed to be not required for this data set.

R

revisit the position for the next release to see how SNOMED CT can be implemented.

6.

schema

The approach which is being taken by the developer in relation to the design of the XML schema is not one which the NHS Data Dictionary team would recommend. The ’non-validated’ XML schema version, which is

R

relating to data and data quality. The ideal is that data quality is resolved before the data is submitted. The HSCIC also has a duty to report on data quality. In this case, following discussions with sponsors, SRO, and

developers, the relative immaturity of the sector in data collections terms poses a

intended by the developers to be the only one released for operational use, includes no data item or data group validation, and does not utilise the multiple repeating data item functionality available. In our view this negates the business benefits of using XML and will encourage poor data quality both initially and long-term.

greater risk of non-reporting. The agreed solution for this release is a non-validated schema; with data quality checked on receipt at HSCIC and reported back to the relevant Trust to resolve and resubmit.

This mitigates the risk on data quality and assists the Trusts to improve their data quality.

The schema will be reviewed for the next release.