Guidance

Newborn blood spot screening checks and audits

Published 4 July 2018

1. NHS newborn blood spot (NBS) screening programme

The NHS newborn blood spot (NBS) screening programme identifies babies at risk of rare but serious conditions, in order to improve health and reduce mortality and morbidity. The programme aims to:

• provide equal access to high quality screening across England
• offer all eligible babies timely screening
• support people to make an informed choice about screening for their baby
• refer all screen positive babies to diagnostic and clinical care within an effective timeframe
• minimise adverse effects of screening including; anxiety, inaccurate information and unnecessary investigation

2. Screening pathways

NHS screening programmes have defined pathways. They show how the individual undergoing screening moves from one stage of the pathway to the next. Checks are needed at each stage to ensure the individual moves seamlessly and safely through the pathway, unless they choose not to.

If checks are not in place, there is a risk that an individual will not complete the pathway or the pathway will be delayed unnecessarily. Quality assurance of screening programmes includes checking that failsafe procedures are in place and operating effectively.

3. Failsafe in screening programmes

Failsafe processes need to be in place in screening programmes. If something goes wrong, these processes help make sure it can be easily identified at the time and action can be taken to correct it before any harm occurs. To support the concept of failsafe being understood, an example is provided below.

3.1 Example of a screening failsafe process

Baby Russell was born at the local maternity unit and was admitted to the neonatal unit. His condition deteriorated and he was transferred to a level 3 neonatal unit on the morning of day 5. The staff in the first neonatal unit did not take the newborn blood spot sample, as he was being stabilised. The staff in the receiving unit assumed the blood spot sample had been taken by the first neonatal unit, as it was day 5 when the baby was transferred. Administrative staff in the receiving unit had responsibility for checking (daily, Monday to Friday) that all current inpatients were listed on the newborn blood spot failsafe solution (NBSFS) for their site. The person responsible was on annual leave and no one was allocated responsibility for this task.

The missed screen was identified on day 12, when the baby’s record was displayed on the home screen of the NBSFS of the original unit. The original unit then transferred the baby’s record out to the level 3 unit site and a phonecall was made to alert the receiving unit. A blood spot sample was obtained on day 13. The sample reached the laboratory on day 15 and the result was available on day 16. The baby screened positive for congenital hypothyroidism (CHT). An urgent referral was made to the specialist paediatric team which reviewed the baby on day 17. Diagnostic tests were completed and the baby started treatment on day 18.

Timely entry into clinical care for all screen positive babies is vital. It ensures that health benefits are achieved and reduces morbidity and mortality. Standard 11 requires entry into care by day 14 for CHT screen positive babies identified on the first sample.

As an individual practitioner, please consider if:

• you have a systematic process for regular access to, and monitoring of, the NBSFS
• you check that each baby in your care has a sample taken on day 5 and that the sample reaches the laboratory
• you have processes for checking records on transfer of care to another provider, to make sure responsibility for screening is also transferred

There is evidence from screening safety incidents reported that some providers are not checking the status of babies along the screening pathways, or have unclear processes for communicating the need for sampling when transferred from one care setting to another.

Failsafe processes must be timely. They help to identify what is going wrong in real time (as it is happening).

4. Methodology

For each pathway we:

• mapped all the screening safety incidents, including serious incidents reported
• applied findings from peer review quality assurance visits
• used queries received by the PHE screening helpdesk
• listened to a range of stakeholders’ views about risks

This process enabled us to focus on where there are known weaknesses in the pathway.

5. How to use the template

The template outlines:

• what: this is what we recommend you do
• why: these are the reasons why we are recommending this
• how: this is how you might do this
• when: this is how often we recommend you undertake the action/check

As you work through the document you may want to check if:

• you already have local processes in place to regularly undertake these checks
• there are any gaps
• you are carrying out these checks often enough

If the answer is no to any of the above, you can use the last column (Trust response) to develop an action plan.

You can use the completed checks and audits document, any action plan developed and the results of any audits to benchmark services. They can also be used as evidence for quality assurance activities, including peer review visits.

6. Additional audits

We have also included some additional checks and audits that providers could undertake. These audits will help to determine if the whole system is working effectively.

7. Other important resources

This document should be used in conjunction with:

• service specifications
• standards
• handbook
• screening pathway

8. Vignettes

We provide the following vignettes to demonstrate what can go wrong when failsafe checks are not in place or when checks are not robust or timely.

8.1 Movers in

A baby moved to England from another country at 2 months of age. There were multiple visits by health professionals to the family. The need for newborn blood spot screening was identified but not completed. A failure in communication meant the child health records department was not notified about the child moving in. The baby moved out of the country at 9 months of age, so the opportunity to offer screening was missed.

8.2 Missed screen

A baby had a newborn blood spot sample taken on day 7. This sample was insufficient and a repeat sample was taken on day 16. This sample was also insufficient. The second repeat request from the laboratory was not followed up until day 53 and the sample repeated on day 60. This delay meant that the sample was too late to be tested for cystic fibrosis.

8.3 Result letters to parents

Newborn blood spot screening identified a baby with a suspected CHT result. The baby was seen by the clinical specialist team, the result confirmed, and treatment started. The mother attended a follow-up appointment with the consultant paediatrician where she was anxious that her baby may be on treatment unnecessarily, because she had received a results letter stating that all 9 conditions were not suspected. This was investigated and the CHT result was found to be incorrectly recorded as ‘not suspected’ on the child health information system. A ‘normal’ results letter had therefore been sent to the parents in error.

8.4 Babies who spend time on neonatal units and other paediatric wards

A baby was discharged home but later readmitted to a paediatric ward (on day 4). The paediatric ward did not recognise the need to take the day 5 sample. The baby was discharged from hospital on day 10 without completion of newborn blood spot screening. The community midwife completed screening on day 11.

8.5 Transport

A baby on the special care baby unit had the 28-day CHT newborn blood spot sample taken, but the sample was not received by the laboratory. The NBSFS flagged the baby’s record but staff did not take action, as they believed the sample was in transit. The laboratory contacted the unit and the sample was repeated 9 days later.

8.6 Documentation

A newborn blood spot sample was received in the laboratory with a barcoded NHS number label. It was analysed and reported as all conditions ‘not suspected’. Child health identified that the date of birth on the results was incorrect and informed the laboratory. The baby was too young for screening and a repeat sample was requested.

A baby was discharged from hospital without barcoded NHS number labels. The newborn blood spot sample was taken on day 5 and the blood spot card completed by hand. The baby’s NHS number was incorrectly documented and the sample rejected. A repeat sample was requested by laboratory and taken on day 11.