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Standard Operating Procedure for the Immunisation of Children
Born to mothers testing positive for Hepatitis B in Fife
Signatories to standard operating procedure
This standard operating procedure (SOP) has been agreed by the Clinical Leads for paediatrics and
obstetrics and gynaecology, the Clinical Director of Planned Care and the Director of Public Health.
Information Governance
Database approved by NHS Fife Information Governance Group (IGG) September 2012. The SOP will be
reviewed one year from IGG approval for the first year; three yearly thereafter. The information
governance review will be conducted by the Data Protection & Caldicott Coordinator.
Background
Hepatitis B virus is acquired through contact with blood and body fluids. Most carriers acquire the virus
either perinatallyor by exposure in early childhood. Some people may have acquired it through
intravenous needle sharing or sexual contact. Following hepatitis B infection as an adult, 90% of
individuals clear the virus become immune and are not infectious to others. However, with infection
acquired at birth, up to 90% will not clear the virus and will become chronically infected. If the hepatitis
B e-antigen (HBeAg) is also positive, this means that the patient has viral protein associated with a high
level of infectivity.
Perinatal transmission can be prevented by immunisation. Other members of the family may be
infectious carriers and even if the baby escapes infection at birth, he/she may still be at risk of infection
at a later date. This is why it is extremely important to ensure that babies born to HbsAg positive
mothers are fully vaccinated against Hepatitis B. If the child is vaccinated, breastfeeding is safe.
Immunisation
Babies born to mothers testing positive for hepatitis B surface antigen (HBsAg positive) undergo the
accelerated hepatitis B immunisation schedule. This requires vaccination at 0, 1, 2 and 12 months of age
and a further dose at the same time as the pre-school booster. Immunoglobulin (HBIG) is also given
except where the mother is has antibodies to HBe. Details are available in the ‘Green book’,
Immunisation against Infectious Disease
(www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_079917)
chapter 18.
National guidance
In 1998 the then Department of Health, Scottish Office in NHS MEL (1998) 56 issued guidance for the
Screening of Pregnant Women for Hepatitis B and Immunisation of Babies at Risk. Health Boards were to
ensure, by April 2000, that the following are met:
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
all pregnant women are offered antenatal screening for hepatitis B

all babies born to infected mothers receive a complete course of immunisation starting at birth
and HBV testing at one year of age

co-ordination of the management and delivery of the programme is adequate

local monitoring and audit of the programme are performed
Incidence in Fife
However, the number testing positive appears to be small. Fife Area Labs identified 40 HBV positive
results in 11 mothers attending NHS Fife antenatal clinics over a 7 year period from January 2002 to
December 2008. Six children born to these 11 mothers within Fife received the first vaccination, but
none completed the required course of immunisation (audit Linda Whetren).
The number of women offered antenatal screening and the number who accept or decline screening is
not recorded in Fife. Also, NHS Tayside, which has a comparable population to NHS Fife, identified 18
mothers over a four year period (personal communication). As such, these counts are likely
underestimates. Nevertheless, the low number of cases identified means that hepatitis B may be easily
missed, as most midwives will be unlikely to see a case from year to year.
Actions following recent Audit
Following the recent audit in NHS Fife immunisation for hepatitis B for newborns has been added to the
Scottish Immunisation and Recall System (SIRS).
SOP
This SOP is based upon discussions with local managers and clinicians and the policies published by NHS
Lothian, Greater Glasgow and Clyde, and the audits carried out in NHS Fife and NHS Tayside.
Scope
This SOP is intended to ensure the immunisation and HBV testing at one year of age of children born to
mothers who agreed to antenatal testing for hepatitis B or who have existing hepatitis B. It does not
address the completeness of antenatal screening which is a wider issue. Nor is it concerned with
counselling mothers who test positive for hepatitis B at screening, which is currently arranged between
maternity services and the consultant microbiologist with an interest in blood borne viruses.
In addition, this SOP does not include pre-exposure vaccination of children “at-risk” of hepatitis B whose
mother’s are HBsAg negative. The fact that these at-risk children are not included in this SOP should in
no way deter staff from arranging pre-exposure vaccination as per the guidance provided in chapter 18
of the ‘Green book’, Immunisation against Infectious Disease chapter 18 (pages 168-171)
(www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicy
AndGuidance/DH_079917).
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Process
An overview of the SOP can be seen in Figure 1. Briefly, the process is divided into three phases 1)
identification of mothers with hepatitis B, 2) delivery of children born to these mothers and 3) follow-up.
This SOP focuses mainly on setting out the agreed responsibilities of each service within NHS Fife, and
where communication between the services is required. The specifics for each responsibility, for
example where the serology is tested and by whom, are not detailed.
Personnel
Members of staff from midwifery services, paediatrics, SIRS and microbiology are involved in the
process. However, there will be a lead for this SOP for the midwifery service (hereafter referred to as
midwifery HBV immunisation lead) and from within paediatrics (hereafter paediatrics HBV immunisation
lead) who are key to the co-ordination of the SOP. For this SOP to be sustainable, a replacement must be
named in the event of either withdrawing from the role. The HBV immunisation leads must have a
named deputy to cover sickness and transition if staffing changes.
Responsibilities
Allocation of roles
The Clinical Director for Planned Services is responsible for nominating the midwifery HBV immunisation
lead and their deputy. The overall Lead for Paediatrics is responsible for nominating the paediatrics HBV
immunisation lead and their deputy. The Medical Director for the Operational Division of NHS Fife is
responsible for providing the name of the consultant in infectious diseases with an interest in blood
born viruses. The Director of Public Health is responsible for nominating a Consultant in Public Health
Medicine.
The leads for midwifery and paediatrics will then be responsible for providing their own contact details
to SIRS, microbiology and public health, and to relevant individuals within their own departments.
The delivery of care is outlined in the diagram in this document, which is divided into three sections,
identification of the mother, delivery of the child and follow-up of the child. The steps in this SOP are
performed as mother and child pass through antenatal, post natal and paediatric care. The emphasis of
this document is on how the responsibility to offer and deliver immunisation will be handed-over
between departments during this necessary transfer of care.
Delivery of care
Identification of mother
In the case of a mother identified on screening the consultant microbiologist will notify the midwifery
HBV immunisation lead directly and in the case of a mother known to have hepatitis B the midwife who
sees the mother at the booking visit will notify the midwifery HBV immunisation lead.
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The midwifery HBV immunisation lead or nominated deputy will then record the hepatitis B status in the
notes and add a sticker to the special features section of the note and record the relevant characteristics
in the Midwifery Table within the HBV database.
If the mother is not actively under the management of a secondary care doctor for her hepatitis B then
she should be referred by the midwife to the consultant in infectious diseases with an interest in blood
born viruses.
Delivery of child
Prior to discharging the mother and child home the midwife responsible for the mother and child’s care
will arrange HBIG, arrange the administration of the first dose of the vaccine. The paediatrician or
Advanced neonatal Nurse practitioner who administers the vaccine will inform SIRS of the case (via a
method agreeable to the midwifery service and to SIRS such as letter, secure NHS email and/or phone)
and notify the midwifery HBV immunisation lead.
The midwifery HBV immunisation lead will investigate at 2 weeks post-expected date of discharge, and if
these actions have not been completed they will record a critical incident and arrange a midwifery visit
in order that the above actions can be completed.
If the actions have been completed, the midwifery HBV immunisation lead will note completion of these
actions on the Midwifery Table of the HBV Database and will refer the child to the paediatrics HBV
immunisation lead.
The paediatrics HBV immunisation lead will notify the midwifery HBV immunisation lead that they have
taken over care and will add the child to the Paediatric Table of the HBV Database, and the midwifery
HBV immunisation lead will then record on the Midwifery Table of the HBV database that the midwifery
role has been completed.
Follow-up of the child
The administration of the vaccines will be performed by primary care, in line with the current agreement
with Fife General Practices. Direct oversight of the course of vaccination will be through the standard
call-recall system of SIRS, where invitation letters for each scheduled dose are repeatedly sent until SIRS
is notified that the course of immunisation is complete.
However, the paediatrics HBV immunisation lead will provide additional oversight on this process. The
paediatrics HBV immunisation lead will receive copies of correspondence from SIRS, which will allow him
or her to identify if a scheduled dose has not been completed. In addition the paediatrics HBV
immunisation lead can contact SIRS or Health Protection at NHS Fife to confirm a dose has been
received if they have not received correspondence after the date of a scheduled dose. Where
appropriate the paediatrics HBV immunisation lead will provide additional communication to
parents/GP practices in order to encourage completion of the course of immunisation.
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In addition the paediatrics HBV immunisation lead will arrange any appropriate clinical follow-up of
children born to mothers with hepatitis B and will also arrange serology at >1 year on completion of the
course of immunisation.
Completion
The SOP is complete for a child when immunisation and testing are complete, when the paediatrics HBV
immunisation lead has judged that this goal is unachievable, or if the family has moved residence to
another Health Board Area and an appropriate person has taken over the role of overseeing HBV
immunisation.
Database
Description
The database will comprise two simple flat tables stored as excel spreadsheets, modelled on those used
in NHS Tayside will be used to deliver and monitor the process. The fields in the each database are given
in Table 1.
Storage and backup
The files will be stored on the networked server at “trust-share on 'fahtfs01\data\HBV immunisation”
(on most NHS Fife networked PCs accessible via “T:\HBV immunisation”). As the data are stored within
NHS Fife servers, physical and technical security measures and backup and destruction of data will take
place as per usual NHS Fife policies.
Access to the files will be controlled via restricting access to the directory within which the spreadsheets
are stored on an NHS Fife server, which will be administered by NHS Fife information services through
the use of NHS Fife individual logins and passwords.
Table 1 Fields for Database
Midwifery HBV Table
Paediatric HBV Table
Status of record
Open/closed
Open/closed
Mother’s details
chi
chi
name
name
date of birth
date of birth
Address
Address
Postcode
Postcode
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Child's details
Midwifery HBV Table
Paediatric HBV Table
Phone number
Phone number
estimated date of delivery
estimated date of delivery
date of birth
date of birth
case surname
first name
chi
place delivery
Handover details
date notified to midwifery HBV
immunisation lead
date notified to paediatrics HBV
immunisation lead
date notified to paediatrics HBV
immunisation lead
date accepted by paediatrics HBV
immunisation lead
date accepted by paediatrics HBV
immunisation lead
date notified to alternative
responsible person (if moved out
of area)
date notified to alternative
responsible person (if moved out of
area)
date accepted by alternative
responsible person (if moved out
of area)
date accepted by alternative
responsible person (if moved out of
area)
date discharged from follow-up
HBIG
Immunisation
HBIG required
HBIG required
HBIG given
HBIG given
date 1st imm given
Date 1st imm given
Date SIRS informed
Date(s) 2nd imm scheduled
Accepted by SIRS
Date 2nd imm given
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Midwifery HBV Table
Paediatric HBV Table
Date mother referred to
consultant in infectious diseases
Date(s) 3rd imm required
Date 3rd imm given
Date(s) 4th imm required
Date 4th imm given
Date(s)5th imm required
Date 5th imm given
Number of doses scheduled (once or
more)
Number of doses given
Notes
Serology
Date serology performed
Result
Referral made to consultant in
infectious diseases (if appropriate)
Date referral made to consultant in
infectious diseases
The spreadsheets will not be copied elsewhere, or stored elsewhere than on the drive. Annually, in April
each version of the spreadsheet will be saved in the “archive databases” sub-directory.
Access and governance
The midwifery HBV immunisation lead will maintain the Midwifery HBV table and the paediatrics HBV
immunisation lead will maintain the Paediatric HBV table. Access will be granted on a named person
basis. Access will be provided to the paediatric and midwifery HBV immunisation leads and to each of
their deputies. At a later date access may also be provided to a named NHS Fife employee for the
purposes of auditing, for the duration of the audit. The paediatric and midwifery HBV immunisation
leads will maintain a list of persons who have access to the data which will be stored in the directory
alongside the database.
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The purpose of this database is to allow named staff rapid access to information contained elsewhere
within NHS Fife on a larger scale (e.g. OASIS, SIRS). As such, it is not anticipated that there will be
requests or secondary uses of these data. However, if application is made for secondary uses of these
data or requests for access by individuals to data concerning them, usual NHS Fife procedures will be
followed.
Retention of data
Data will be deleted from the current tables two years after the child has either completed the
immunisation and testing, or it has been determined by the named paediatrician that this is
unachievable. The archive versions of the tables will be stored until each child is 25 years old, as per
NHS Fife policy on the retention of data (GP/R8: Health Records Retention and Destruction. 13 Jan 2011,
available NHS Fife Intranet).
Training
The tables are stored as simple flat sheets to allow users with a basic competence in excel to be able to
use the database without additional training in software. Any person using the database should read
this SOP, which will be stored in the directory alongside the database.
Births outside of Fife
There is the potential that children born to Fife residents but not within an NHS Fife hospital (including
home births) may not have the necessary referrals made (i.e. to SIRS and/or paediatrics). However, the
SOP will allow us to detect if this occurs at the 2 weeks post-estimated delivery review of the case, and
to make the referrals at this time.
Audit
Data on hepatitis B serology results are available from the laboratory information systems and can be
can be used as a check on the SOP. Individuals testing positive can be compared to those recorded on
the Midwifery and Paediatric HBV tables.
In addition, we recently obtained agreement to add the following (mandatory) fields to the post-natal
discharge checklist whose completion will be enforced by the hospital administration software (Oasis):1. Does the mother have hepatitis B? Yes/No
2. Answer Yes – To prevent chronic liver disease and liver cancer it is essential that the child is
vaccinated. Has the first vaccine been given and a referral been made to SIRS?
Consequently Oasis reports can be used as an additional check against these the Midwifery and
Paediatric HBV tables.
Annually, the Public Health department will use laboratory information systems and Oasis to identify the
number of children identified as requiring hepatitis B because of maternal infection. The consultant in
Public Health Medicine responsible for BBV will nominate an individual from within Public Health. The
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named paediatrician and midwife will compare these patients to those identified and recorded on the
maternity and paediatric tables, and will identify and investigate any discrepancies. Cases reported
through clinical governance procedures as critical incidents will also be collated.
Using this information the paediatric and midwifery HBV immunisation leads will ensure that the
effectiveness of these Hepatitis B immunisation procedures has been evaluated, and will provide an
annual report on this evaluation to the Operational Division Clinical Governance Committee.
If children are identified as having missed vaccination/referral/testing, then the reasons will be
ascertained, and will be used to inform updated versions of this SOP.
We will make any necessary to the changes after the first year, and three-yearly thereafter.
Resources
Sample letters are stored within “T:\HBV immunisation\resources”.
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Diagram of SOP
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Appendix current post holders
Consultant in infectious diseases with an interest in blood borne viruses – Dr Bhattacharya
Consultant in Public Health Medicine – Dr Charles Saunders
Data protection Officer - Una Hill
Director of Public health – Dr Edward Coyle
Midwifery HBV immunisation lead – Joyce Leggate
Midwifery HBV immunisation deputy Paediatrics HBV immunisation lead – nomination by Operational Division Clinical Director
Paediatric HBV immunisation deputy – Dr Laura Stewart
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