Guidance

SCT checks and audits

Published 15 March 2017

1. NHS Sickle Cell and Thalassaemia Screening Programme

The NHS Sickle Cell and Thalassaemia Screening Programme aims to:

• ensure a high quality, accessible screening programme throughout England
• support people to make informed choices during pregnancy and ensure timely transition into appropriate follow up and treatment
• improve infant health through prompt identification of affected babies and timely transition into clinical care
• promote greater understanding and awareness of the conditions and the value of screening

2. Screening pathways

Each NHS screening programme has a defined care pathway. The pathways 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 these checks are not in place there is a risk that an individual does not complete the pathway or the pathway is delayed unnecessarily. Quality assurance of screening programmes includes checking these failsafe procedures are in place and are operating effectively.

3. Failsafe in screening programmes

Failsafe is a term used in other industries like engineering and the military but often refers to mechanisms that can return to a safe state automatically. An example would be a failsafe device in a nuclear weapon that deactivates automatically in the event of accident. In screening programmes when we refer to the need to have failsafe processes in place we want to ensure if something goes wrong that it can be easily identified at the time that it is going wrong and action can be taken to correct it before any harm occurs. The concept of failsafe is not widely understood so we provide an example here.

3.1 Example of a screening failsafe process

Mrs Russell books at 8 weeks of pregnancy and accepts HIV screening. Her blood sample is taken and despatched to the screening laboratory.

1. Do you check that you have her results within 8 working days as per national standards?

2. Do you follow up with the screening laboratory if you don’t have a result within 8 working days?

3. Or do you simply wait until her next appointment which might be around 16 weeks?

Let’s assume her blood sample taken at 8 weeks was lost and never arrived in the laboratory. If you only checked her results before her appointment at 16 weeks you would have lost 8 weeks and delayed any potential intervention she may need. Consider what would happen if she was found to be HIV positive on subsequent screening.

We have evidence from screening safety incidents reported that some providers are not checking screening results in line with the above standards and therefore do not discover a screening sample was inadequate/needs repeating or the sample never arrived in the screening laboratory until reporting on key performance indicators three months later.

Failsafe processes must be timely – they help you to identify when and what is going wrong in real time, as it is happening.

4. Methodology

In 2015 the NHS screening programmes reviewed and updated the screening pathways. As a result the accompanying failsafe processes for each pathway is being revised.

For each pathway we:

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

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

5. Using the template

The template outlines:

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

As you work through the template you may wish to check if:

• you already have local processes in place to do these checks
• there are any gaps
• you are doing these checks often enough

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

The completed failsafe document, any action plan developed and the results of any audits can be used as evidence for quality assurance activities including peer review visits.

6. Annual audits

We have also included additional annual audits that providers should undertake. These audits will help determine if the whole system is working effectively.

7. Other important resources

The template should be used in conjunction with:

• service specifications
• standards
• screening pathway
• handbooks for screening and laboratories

8. Vignettes

We provide the following vignettes to demonstrate what can go wrong when there are no failsafe checks in place or when checks are not robust or timely.

8.1 Midwife unable to take screening sample

Woman had booking appointment at 13 weeks gestation but the midwife was unable to take the screening blood sample and the woman was referred to phelebotomy services and had blood taken 2 days later. A week later the midwife noticed that the result for sickle cell screening was not available, took a repeat sample and sent it to the laboratory.

The woman continued to have antenatal care and was seen on 2 separate occasions by 2 different healthcare professionals, neither professional checked the sickle cell screening result. At the next antenatal appointment the midwife noticed that the results were missing and repeated the screening test. The woman was found to be a carrier of C haemoglobin at 20 weeks gestation. The baby’s father was offered screening which he accepted and was found to be a haemoglobin S carrier.

Therefore there is a 25% chance of having an child affected with SC disease.

8.2 Lack of communication to maternity services

A woman booked at 9 weeks gestation, screening for sickle cell and thalssaemia was accepted and she was found to be a beta thalassaemia carrier. These results were not communicated to maternity services and was only followed up by the community midwife after the 16 week antenatal appointment.

8.3 Not following national algorithm

The woman’s screening result reported as carrier for beta thalassaemia in current pregnancy (HbA2 3.7% MCH 26.3) and the baby’s father was therefore invited for screening. The woman was surprised having a previous screening result in her last pregnancy as alpha + thalassamia (no indication for father screening). On investigation it became apparent that the national algorithm was not followed in her previous pregnancy (HbA2 3.5% and MCH 25.9).

Testing algorithms issued Oct 2009 and Oct 2012 both clearly state if MCH<27 and HbA2> or equal to 3.5% - report beta thal carrier and baby’s father testing is required. Local laboratory operating procedures in place at the time of the first report were reviewed and found to be correct. The error was due to a member of staff not following the procedure correctly. Results are input by one member of staff and then checked before authorisation by a different qualified member of staff.

8.4 Not testing the father

Newborn blood spot screening revealed an unexpected neonatal diagnosis of homozygous sickle cell disease. Parents reported having antenatal screening and the father said he was waiting for his results.

The woman had screening for sickle and thalassamia at 9 weeks gestation. Care was transferred to a different provider and the woman was offered genetic counselling, father testing accepted and screening sample taken at 14 weeks gestation. A clerical error occurred with requesting the laboratory testing of the father’s sample. The lack of the father’s results was undetected.

8.5 Incorrect assumptions about the father

Newborn blood spot screening revealed an unexpected diagnosis of sickle cell disease.

Woman booked for antenatal care at 9 weeks gestation and reported that both her and the baby’s father were sickle cell carriers. This was documented in both her handheld records and hospital records. The woman had consultant-led obstetric care for a previous fetal abnormality.

The woman was asked to provide documented evidence of the father’s result as the father was out of the country. This information was not followed up as the screening team was falsely reassured by a negative status report in the previous pregnancy records. They did not realise that the father of the baby was a different partner to the previous pregnancy. The screening database was populated with this incorrect information and there was no further trigger to follow-up the absent sickle status report for the baby’s father.