Guidance

Infectious diseases in pregnancy screening checks and audits

Published 4 July 2018

1. NHS infectious diseases in pregnancy screening programme

The NHS infectious diseases in pregnancy screening (IDPS) 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
• 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 make sure 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 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

Mrs Russell books and accepts HIV screening at 8 weeks of pregnancy. Her blood sample is taken and dispatched 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. Do you simply wait until her next appointment which might be around 16 weeks?

We will assume that Mrs Russell’s 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 that some providers are not checking screening results in line with the above standards. They therefore do not find out if a screening sample was inadequate, needs repeating or never arrived in the screening laboratory until reporting on key performance indicators 3 months later.

Failsafe processes must be timely. They help to identify when and 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 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 column (trust response) to develop an action plan.

You can use the completed failsafe document, any action plan developed and the results of any audits 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 failsafe checks are not in place or when checks are not robust or timely.

8.1 Midwife unable to take screening sample

A woman had her booking appointment at 13 weeks gestation but the midwife was unable to obtain the screening blood sample and referred the woman to phlebotomy services. She had the blood tests taken 2 days later. A week later the midwife noticed that the woman’s results for infectious diseases were not available, so she took a repeat sample and sent it to the laboratory.

The woman continued to have antenatal care and was seen on 3 separate occasions by 3 different healthcare professionals. No one checked the infectious diseases screening results. At the next antenatal appointment, the midwife noticed that the results were missing and repeated the screening tests again. The woman was found to be HIV positive at 28 weeks gestation.

8.2 Communicating results to maternity services

A woman booked at 9 weeks gestation, screening for infectious diseases was offered and accepted. On the initial screening test, she was found to be HIV positive. This result was communicated to maternity services and subsequently to the woman before the screening laboratory had confirmed the result. The confirmatory test found the woman to be HIV negative. Unfortunately, the false positive result was already communicated to the woman causing her unnecessary anxiety and distress.

8.3 Woman with hepatitis B not seen by hepatologist

The woman’s screening result was reported as hepatitis B positive. The woman was noted to be of high infectivity and referred to the hepatologist to be seen within 6 weeks as recommended by national standards.

The appointment process failed in the hepatology clinic and the woman was never sent an appointment. There were no checks in place to pick up that this had happened and was only discovered when the woman was admitted in labour.

8.4 Baby born to hepatitis B positive mother requiring HBIG but not given

A baby was identified as requiring hepatitis B vaccine and immunoglobulin (HBIG) within 24 hours of birth. A plan was made antenatally, including a paediatric alert. The vaccine and HBIG were ordered and kept in the fridge.

Following delivery, the baby only received the hepatitis B vaccine. There were checks by the screening team and by the paediatricians but both failed to identify this was missed in a timely manner. By the time the missed HBIG was identified it was outside the time frame for having benefit to the infant.