Guidance

Newborn and infant physical examination quality improvement guidance

Published 29 June 2018

Background

The Section 7a NIPE service specification (number 21) requires maternity services to monitor and manage the eligible newborn cohort, screening coverage and outcomes.

PHE Screening commissions the NIPE Screening Management and Reporting Tool (NIPE SMART) IT system to support this.

NIPE SMART enables maternity services to:

• identify the eligible screening cohort
• record screening results
• monitor and manage pathways for the 4 NIPE newborn screening elements

The NIPE Service Specification (No.21) mandates the use of NIPE SMART. It is part of a nationwide failsafe process and quality assurance framework and supports provision of safe and effective local screening services.

Formal rollout of the NIPE screening programme began in 2014. By May 2018, 122 out of 136 maternity services in England were using NIPE SMART. Trusts use NIPE to monitor and manage their cohort of newborn babies and identify any gaps in their local newborn screening pathway. Many of these are managed as serious incidents or screening safety incidents.

A review of the NIPE SMART implementation process in 2017 identified some gaps in the delivery or recording of some elements of the screening pathway.

These included lack of:

• recording all relevant screening pathway activity
• processes to generate and track referrals for screen positive babies
• follow-up of post-screen positive referrals to ensure babies were seen in the recommended timeframe (recorded as an outcome)
• regular checking of failsafe processes

This showed that many screening providers were still implementing and working towards fully embedding day-to-day effective use of NIPE SMART. To support quality improvement, the national NIPE programme team set up a number of quality improvement workstreams.

Purpose

This guidance for screening providers and commissioners on actions that need to be taken includes:

• lessons learned from previous incidents
• evidence of the current position
• issues that can be managed through quality improvement
• issues that meet the national criteria for screening incidents
• best practice guidance

It also includes a summary of the national work to support NIPE implementation and resources for screening providers.

For more information or advice please contact the PHE screening helpdesk [email protected].

NIPE process checklist pilot

The national programme developed and piloted a NIPE process checklist in 2016 that was piloted in 4 NHS trusts. The checklist was based on critical failsafe points, mapped NIPE screening pathways, and gaps that were identified within screening services.

Findings

The pilot found that processes appeared to be in place for referring babies after screen positive findings.

The main issues were related to the lack of systems to:

• check attendance at these appointments
• record outcomes electronically
• audit outcomes

Lessons learned

The national programme identified a number of issues and lessons learned from the pilot process and information gathered from stakeholders. It recommends the following as good practice:

1. NIPE SMART should be embedded in practice. NIPE practitioners who undertake screening and referral are responsible for accurate and timely data entry as soon as possible after the examination is completed.

2. NIPE practitioners are responsible for completing relevant elements of locally agreed policies, such as referral processes and communication of outcome data.

3. A systematic and regular failsafe checking process should be in place. Responsibility for this should be allocated to more than one designated individual.

4. Local multidisciplinary working is essential. This supports good communication, development and delivery of the individual elements of the screening pathway.

5. Performance data should be presented and reviewed at local screening programme boards to offer positive feedback, share good practice and identify any issues of concern at an early stage. NIPE practitioners and those who oversee the NIPE SMART system should be represented at these groups.

6. Trusts need to have a clear understanding of what constitutes a post-referral outcome, as this may take place on the ward before discharge for 2 of the NIPE target conditions.

Changes were made to the NIPE service specification, handbook and standards to provide further clarity regarding lines of responsibility. Commissioners and providers should use these national documents to measure against local NIPE services.

Actions for local screening providers

Those who lead NIPE screening programmes should be aware of national NIPE guidance documents and use them to develop and refine screening services.

NIPE practitioners should be aware of their professional accountability, and roles and responsibilities along the screening pathway.

Examples of best practice initiatives from across the country include:

• designated ultra sonographers entering outcome data directly onto NIPE SMART after hip ultrasound (instead of sending notification by email or letter to the maternity service)
• appointing a hip screening champion; responsible for following up all screen positive hip outcomes and providing accurate data for key performance indicator (KPI) NP2 in line with national standards
• a ‘one stop shop’ for hip ultrasound and orthopaedic appointments
• initiation of local trust ‘did not attend’ (DNA) or ‘was not brought’ policy as required
• non-clinical failsafe officers following up outcome results of screen positive babies and alerting clinical staff as required
• designated individuals overseeing activity and providing day-to-day NIPE SMART cohort management, including failsafe, and ensuring accurate NIPE SMART reports and KPI data submission
• regular review of monthly performance and KPI breach reports enabling timely remedial actions
• ensuring a NIPE presence on local screening programme boards and presenting performance data as a standard agenda item
• demonstration of the use of NIPE SMART at junior doctor induction sessions, usually by NIPE lead or screening midwife
• setting up NIPE SMART password access before the start of the clinical placement

National programme actions

As part of the quality improvement project, the national NIPE programme team undertook work to:

• increase stakeholder engagement
• address issues raised and feedback received from providers and screening quality assurance service (SQAS) teams
• help trusts further understand their roles and responsibilities along the NIPE screening pathway
• support NIPE SMART super users (or designated NIPE leads) by offering more information to help them develop/refine processes
• take all opportunities to reinforce the need for safe and effective screening clinical pathways (whether providers are using NIPE SMART or not)

Support for NIPE SMART super users relates mainly to failsafe checking, data reporting and ensuring the whole of the screening pathway, including post-referral outcomes, is captured on NIPE SMART.

The national programme has also put in place a number of strategies to address the information needs of those responsible for overseeing the NIPE SMART system, and to understand and address screening pathway, data input and reporting issues.

Improving consistency of response to screening incidents

Key performance indicator (KPI) data, SQAS and NIPE programme team visits have highlighted potential gaps in following up screen positive cases and, in particular, gaps in recording outcomes on NIPE SMART.

Lessons learned from incidents show that some screening pathway gaps are service development issues that can be safely managed through quality improvement. Service development issues relate to any elements of the screening programme that need to be reviewed and refined to ensure a safe screening process and pathway.

In some cases, for example, trusts have a screening referral pathway in place, but do not have an established feedback process to collect and record outcomes on NIPE SMART. If a trust can provide evidence that it has a referral process in place and that screen positive babies are referred and seen, then this is a service development issue.

The guidance below aims to improve consistency in managing gaps in the NIPE screening pathway gaps and make sure the response is proportionate. Providers, commissioners and SQAS should still give careful consideration to local circumstances and professional judgement is required.

This section outlines common scenarios that:

• are suspected incidents
• can be managed as service development issues requiring a quality improvement approach

Expected practice

Expected practice is detailed within the national service specification no. 21, the NIPE programme clinical handbook and the NIPE SMART user guide (available in the national documents section of the NIPE SMART system).

Common scenarios and recommended actions

Scenario 1: Outcomes not routinely recorded on NIPE SMART, evidence of screening referral pathway in place

A trust can provide evidence of a screening referral pathway for all 4 conditions but has no local feedback process to check attendance and systematically record outcomes onto NIPE SMART, or alternative recording system.

Examples of evidence to assure the screening referral pathway include:

• documented screening referral policy
• checks that referrals have been made
• ‘did not attend’ (DNA) policies for ultrasound and/or ophthalmology
• documentation of referral follow up in paediatric record
• review of late diagnoses and missed cases

Some trusts may be checking attendance and recording outcomes only for hip screening, which is reported as KPI NP2 (screen positive requiring hip ultrasound by 2 weeks of age).

This should be managed as a service development issue requiring a quality improvement approach.

The trust is expected to have an action plan that includes:

• development of a local systematic process to check if and when the ultrasound or ophthalmology appointment is attended, or that a senior paediatrician has reviewed the baby (in line with national standards)
• electronic recording of screening outcome in an auditable format
• implementation of failsafe checks including the actions in response to monthly performance and KPI breach reports available on NIPE SMART

Recommended action: no further checks or review of individual cases are required.

Screening outcomes will be included on NIPE SMART prospectively. Trusts would be expected to complete this action within 3 months. SQAS should review the action plan and escalate the issue to the trust head of midwifery and chief executive and commissioners if sufficient progress is not made.

Scenario 2: Outcomes not routinely recorded on NIPE SMART, screening referral pathway not fully evidenced

A trust can describe a usual referral pathway for screen positive babies but there is insufficient assurance that this is in place for one or more of the 4 conditions.

The screening referral pathway varies by condition. Babies who are hip screen positive after clinical examination need to have a hip ultrasound scan by 2 weeks of age, or, in the presence of hip risk factors, by 6 weeks of age. Eye screen positive babies need to be seen by an ophthalmologist by 2 weeks of age.

Heart screen positive babies and babies with bilateral undescended testes require review by a senior paediatrician within 24 hours. Confirmation that this review has been completed is the outcome that needs to be recorded on NIPE SMART. This means that for the majority of babies born in hospital, this can be recorded before being discharged home.

To check that the screening referral pathway is in place:

1. Select a random 10% sample of all condition-specific screen-positive cases in the last 6 months. A minimum of 10 cases should be selected. The time period for review can be extended but should not extend beyond 18 months.

2. Review clinical record to determine if babies have been referred on the correct clinical pathway. Hip screen positive should be referred for hip ultrasound scan. Eyes screen positive should be referred for ophthalmology review. Heart screen positive should be reviewed by a senior paediatrician. Bilateral undescended testes should be reviewed by a senior paediatrician.

3. If all babies in the sample have been referred or reviewed this is evidence that there is a screening referral pathway in place. This can be managed as a service development issue requiring a quality improvement approach.

The screening referral pathway needs to be formally documented and the trust needs to complete the expected actions described in scenario 1 (above).

Recommended action: if the review identifies a gap in the screening referral pathway and screen positive babies are not being referred, this is a suspected incident.

Scenario 3: No evidence of clinical referral process for screen positive babies

Some trusts do not have a process in place to identify all screen positive babies (after clinical examination or with presence of hip risk factors) who should be referred. This can be evidence of a systematic failure in the screening referral pathway.

Recommended action: if a screen positive baby is not referred there is potential harm. This should be managed as a suspected screening incident.

Further information about the parameters of any potential review (usual maximum time period 18 months) is available via SQAS.