BCG Vaccination in Neonates 4.0

Document Title: ADMINISTRATION OF THE BACILLUS CALMETTE-
GUERIN (BCG) VACCINATION IN NEONATES
Document Reference/Register no: 10007 Version 4.0

Number:
Document type: (Policy/ Guideline/ Guideline To be Midwives,

SOP) followed by: Obstetricians,
(Target Staff) Paediatricians
Ratification Issue Date: 2nd September 2019 Review 1st September 2022
(Date document is uploaded onto the Date:
intranet)
Developed in response to: Intrapartum NICE Guidelines

RCOG guideline
Contributes to HSC Act 2008 (Regulated Activities) Regulations 2014(Part
3); and CQC Regulations 2009 (Part 4)
CQC Fundamental Standards of Quality and Safety: 9,12
Issuing Division/Directorate: Women’s and Children’s Service
Author/Contact: (Asset Sharon Pilgrim, Advanced Neonatal Nurse Practitioner

Administrator)
Hospital Sites: MEHT

(tick appropriate box/es to indicate □ BTUH
status of policy review i.e. joint/ □ SUH
independent)
Consultation: (Refer to page 2)
Approval Group / Committee(s): n/a Date: n/a
Professionally Approved by: (Asset Dr Ahmed Hassan, Date: 2nd September 2019
Owner) Consultant Paediatrician
Ratification Group(s): Document Ratification Group Date: 29th August 2019
Executive and Clinical Directors Date: August 2019 Distribution Intranet & Website.
(Communication of minutes from Method: Notified on Staff
Document Ratification Group Focus
Administration of the Bacillus Calmette-guerin (BCG) Vaccination in Neonates/10007/4.0
Consulted With: Post/ Approval Committee/ Group: Date:

Anita Rao/Alison Cuthbertson Clinical Director for Women’s and Children’s 29th July 2019
Directorate
Alison Cuthbertson Head of Midwifery/ Nursing for Women’s and

Children’s Services
Madhulika Joshi Consultant for Obstetrics and Gynaecology
Dr Hassan Paediatric Consultant
Sam Brayshaw Anaesthetic Consultant
Amanda Dixon Lead Midwife Acute Inpatient Services
Chris Berner Lead Midwife Clinical Governance
Angela Woolfenden Lead Midwife Community Services
Joyce McIntosh Matron Neonatal unit
Claire Fitzgerald Pharmacy
Ruth Byford Warner Library 5th August 2019
Related Trust Policies (to be read in 04071 Standard Infection Prevention

conjunction with) 04072 Hand Hygiene
04225 Examination of the Newborn
06036 Guideline for Maternity Record Keeping including
Documentation in Handheld Records
04089 Prevention and Management of Latex Allergy in
Health care Workers
10004 Safe handling and disposal of sharps policy
Document Review History:

Version Authored/Reviewer: Summary of amendments/ Issue Date:
No: Record documents superseded by:
1.0 Sharon Pilgrim January 2010
1.1 Deb Cobie Appendix C addition; clarification to point 6.3 June 2010
2.0 Sharon Pilgrim July 2013
4.0 Sharon Pilgrim Full review 2nd September 2019
2
INDEX
1. Purpose
2. Introduction
3. Equality Impact Assessment
4. BCG Vaccination in Neonates (0-4 weeks)
5. Referral Pathway
6. Contra-indications for BCG Vaccination
7. Procedure for BCG Vaccination
8. BCG Vaccination Dosage
9. Care post BCG Vaccination
10. Adverse Reactions
11. Documentation
12. Infection Prevention
13. Staff and Training
14. Professional Midwifery Advocates
15. Audit and Monitoring
16. Guideline Management
17. Communication
18. References
19. Appendices
A. Appendix A: Unscheduled Immunisation Consent Form

B. Appendix B: Communication to Child Health Regarding Unscheduled
Immunisations
C. Appendix C: World Health Organisation (WHO) estimates of tuberculosis
incidence by country 2008
D. Appendix D: World Health Organisation (WHO) estimates of Tuberculosis
incidences by Public Health and Environment Local Health Authority and District,
England
E. Appendix E: Preliminary Equality Analysis
3
1.0 Purpose
1.1 To identify infants who have a high risk of acquiring tuberculosis (TB) and who will
therefore require the Bacillus Calmette-Guerin (BCG) vaccination.
1.2 To ensure that those identified as requiring BCG vaccination have a referral for the BCG
outpatient clinic completed prior to discharge from the postnatal or labour ward.
2.0 Introduction
2.1 The Department of Health advises the BCG vaccination for all neonates at higher risk of
TB, with opportunistic vaccination of older children as necessary.
2.2 The BCG immunisation programme is now a risk-based programme, the key part being a
neonatal programme targeted at those children most at risk of exposure to TB, aiming to
protect them in particular from the more serious childhood forms of the disease.
2.3 The BCG vaccine is a live attenuated strain of mycobacterium bovis.
2.4 Neonatal BCG vaccination provides 50-70% protection against all forms of TB and
70- 80% protection against miliary TB and TB meningitis.
3.0 Equality Impact Assessment

3.1 Mid Essex Hospital Services NHS Trust is committed to the provision of a service that is
fair, accessible and meets the needs of all individuals.
(Refer to Appendix E)
4.0 BCG vaccination in neonates (0-4 weeks)
4.1 Infants eligible for BCG vaccination should be identified prior to birth ideally through
maternity services.
4.2 Discuss neonatal BCG vaccination for any baby with increased risk of TB with parents or
legal guardian prior to discharge from the Postnatal or labour ward.
4.3 When BCG vaccination is being recommended, discuss the benefits and risks of
vaccination or remaining unvaccinated with the person (or, if a child, with the parents), so
that they can make an informed decision. Tailor this discussion to the person, use
appropriate language, and take into account cultural sensitivities and stigma.
4.4 In areas with low incidence of TB BCG immunisation should only be offered to:
 All infants living in areas of the UK where the annual incidence of TB is 40/100,000 or
greater;
(Refer to Appendix D)
 All infants with a parent or grandparent who was born in a country where the annual
incidence of TB is 40/100,000 or greater;
4
(Refer to Appendix C, shaded countries)

 All infants of refugees;
 Infants whose parents live in homeless accommodation;
 Infants of Travellers;
 If visiting or having family visit from these areas in the first 6 months after birth;
 Have family history of TB in last 5 years.
4.5 Preferably vaccinate babies at increased risk of TB before handover from midwifery to
primary care. Otherwise, vaccinate as soon as possible afterwards.
4.6 BCG should NOT be given:
 At parental request, unless the infant falls into any of the high risk groups above,
those without any of these risk factors should be advised as to current policy and
given written information. If they still want BCG immunisation they must go through
their GP for an appointment in a paediatric clinic.
5.0 Referral pathway

5.1 Prior to discharge home a referral form with the mother and infants name and registration
number should be completed by postnatal staff and parents told they will be contacted
with an appointment to attend the clinic.
5.2 Infants who are born at St. Peters and William Julian Courtauld (WJC) Midwife-led Units,
St Michael’s Community Hospital should have their details forwarded to the postnatal
team at Broomfield for an appointment.
6.0 Contra-indications to the BCG Vaccine

6.1 The following list outlines the contra-indications to the BCG vaccine
 Mother known to be HIV positive;
 Infants in a household where active TB is suspected or confirmed;
 Infants born to a mother who received Immunosuppressive medication during
pregnancy;
 Generalised skin sepsis;
 Sepsis.
7.0 Procedure for BCG Vaccination

7.1 Obtain consent from the parents using the unscheduled immunisation consent form.
(Refer to Appendix A)
7.2 There is no need for a heaf test prior to immunisation if <12 months of age.
7.3 Neonatal BCG is to be administered by suitably trained nursing staff in a dedicated BCG
clinic run within the maternity department. Prior to the infant attending BCG vaccine
should be prescribed on the relevant prescription chart. The mother’s history and blood
test reports should be checked for HIV status and contraindications for immunisation.
5
7.4 The healthcare professional should decontaminate their hands and wear an apron and
gloves.
(Refer to the Trust guideline for ‘Prevention and management of latex allergy in health
care workers)
7.5 Use an intradermal BCG – draw up 0.05ml of vaccine and administer intradermally
using a 26G needle. Introduce the needle just under the skin over the left deltoid area.
There should be some resistance and it should raise a tense bleb. See Green book.
7.6 Sharps should be disposed of in a sharp’s bin in accordance with the ‘Safe handling and
disposal of sharps policy; register number 10004)
7.6 Remove gloves and apron; and decontaminate hands.
7.7 Record on page 18b of the infant’s child health record booklet (red book).
8.0 BCG Vaccination Dosage

8.1 BCG vaccine 0.05 ml intradermally (not subcutaneous).
9.0 Care Post BCG Vaccination

9.1 A pinhead, dry, red pimple appears after 2-6 weeks and may last several months and
become ulcerated eventually healing into a flat scar.
9.2 In 5-10% of infants there is no visible reaction.

9.3 No special treatment of the skin is required and air should not be excluded with a
dressing.
10.0 Adverse Reactions

10.1 Adverse reactions usually resolve spontaneously.
10.2 Injection site reactions – large ulcers, abscesses commonly caused by faulty injection
technique (i.e. dose given subcutaneously instead of intradermally).
10.3 Keloid scars at injection site (occurrence increases when injection given too high up the
arm.)
10.4 Rare reactions:

 Axillary lymphadenitis;
 Osteitis;
 Osteomyelitis.
10.5 All serious or unusual adverse reactions associated with BCG vaccination including
abscess and Keloid scarring should be recorded and reported using the yellow card
system.
6
11.0 Documentation
11.1 (Refer to the ‘Guideline for maternity record keeping including documentation in
handheld records’. Register number 06036).
11.2 Following the giving of BCG vaccination the prescription chart with the BCG batch no.
and the consent form will be filed in the maternal notes.
11.3 Record in the red child health record booklet page 18b or the unscheduled immunisation
form to include the batch number and date given.
(Refer to Appendix A)
11.4 If the Red book is not available Child Health should be notified via the unscheduled
immunization form. The top copy should be sent to Child Health by the ward clerk in the
designated area, the second copy should be filed in the patient’s/infant’s health care
records and the third copy; along with the consent form should be filed in the patient’s
handheld maternity records.
(Refer to Appendix B)
12.0 Infection Prevention

12.1 All staff should follow Trust guidelines on infection prevention by ensuring that they
effectively ‘decontaminate their hands’ before and after undertaking any patient contact.
13.0 Staff and Training

13.1 Teaching sessions on the identification of the at risk neonate will be available on a
monthly basis to all midwifery staff.
13.2 All medical staff will have training in the identification of at risk infants and the rationale
for treatment of these infants.
14.0 Professional Midwifery Advocates

14.1 Professional Midwifery Advocates provide a mechanism of support and guidance to
women and midwives. Professional Midwifery Advocates are experienced practising
midwives who have undertaken further education in order to supervise midwifery services
and to advise and support midwives and women in their care choices.
7
15.0 Audit and Monitoring

15.1 Audit of compliance with this guideline will be considered on an annual audit basis in
accordance with the Clinical Audit Strategy and Policy (register number 08076), the
Corporate Clinical Audit and Quality Improvement Project Plan and the Maternity annual
audit work plan; to encompass national and local audit and clinical governance.
identifying key harm themes. The Women’s and Children’s Clinical Audit Group will
identify a lead for the audit.
15.2 The findings of the audit will be reported to and approved by the Multi-disciplinary Risk
Management Group (MRMG) and an action plan with named leads and timescales will be
developed to address any identified deficiencies. Performance against the action plan will
be monitored by this group at subsequent meetings.
15.3 The audit report will be reported to the monthly Directorate Governance
Meeting (DGM) and significant concerns relating to compliance will be entered on the
local Risk Assurance Framework.
15.4 Key findings and learning points from the audit will be submitted to the Clinical
Governance Group within the integrated learning report.
15.5 Key findings and learning points will be disseminated to relevant staff.
16.0 Guideline Management

16.1 As an integral part of the knowledge, skills framework, staff are appraised annually to
ensure competency in computer skills and the ability to access the current approved
guidelines via the Trust’s intranet site.
17.0 Communication
17.1 A quarterly ‘maternity newsletter’ is issued to all staff to highlight key changes in clinical
practice to include a list of newly approved guidelines for staff to acknowledge and
familiarise themselves with and practice accordingly. Staff who are on maternity leave or
‘bank’ staff have letters sent to their home address to update them on current clinical
changes.
17.2 Approved guidelines are published monthly in the Trust’s staff newsletter that is sent via
email to all staff.
18.0 References
Immunisation against infectious disease: Tuberculosis: the green book, chapter 32 (2018)
Public Health England
www.gov.uk/government/publications/tuberculosis-the-green-book-chapter-32
National Institute for Health and Clinical Excellence NG33 Tuberculosis (2016)
www.nice.org.uk
8
Appendix A
Unscheduled Immunisation Consent Form
9
Appendix B
Communication to Child Health Regarding Unscheduled Immunisations
10
Appendix C
11
12
13
14
15
16
Appendix D:
17
18
19
20
21
22
23
24
25
26
Appendix E: Preliminary Equality Analysis

This assessment relates to: Administration of the Bacillus Calmette-guerin (BCG) Vaccination in Neonates/10007
A change in a service to patients A change to an existing policy X A change to the way staff work
Something else
A new policy
(please give details)
Questions Answers
1. What are you proposing to change? Full Review
2. Why are you making this change? 3 year review

(What will the change achieve?)
3. Who benefits from this change and how? Patients and clinicians
4. Is anyone likely to suffer any negative No

impact as a result of this change? If no,
please record reasons here and sign and date
this assessment. If yes, please complete a
full EIA.
5. a) Will you be undertaking any Refer to pages 1 and 2

consultation as part of this change?
b) If so, with whom?
Preliminary analysis completed by:
Name Sharon Pilgrim Job Title ANNP Date July 2019
27

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Document Title: ADMINISTRATION OF THE BACILLUS CALMETTE-

GUERIN (BCG) VACCINATION IN NEONATES

Document Reference/Register no: 10007 Version 4.0

Document type: (Policy/ Guideline/ Guideline To be Midwives,

Developed in response to: Intrapartum NICE Guidelines

Author/Contact: (Asset Sharon Pilgrim, Advanced Neonatal Nurse Practitioner

Hospital Sites: MEHT

Approval Group / Committee(s): n/a Date: n/a

Ratification Group(s): Document Ratification Group Date: 29th August 2019

Consulted With: Post/ Approval Committee/ Group: Date:

Alison Cuthbertson Head of Midwifery/ Nursing for Women’s and

Related Trust Policies (to be read in 04071 Standard Infection Prevention

Document Review History:

3. Equality Impact Assessment

4. BCG Vaccination in Neonates (0-4 weeks)

6. Contra-indications for BCG Vaccination

7. Procedure for BCG Vaccination

8. BCG Vaccination Dosage

9. Care post BCG Vaccination

10. Adverse Reactions

12. Infection Prevention

13. Staff and Training

14. Professional Midwifery Advocates

15. Audit and Monitoring

16. Guideline Management

A. Appendix A: Unscheduled Immunisation Consent Form

2.3 The BCG vaccine is a live attenuated strain of mycobacterium bovis.

3.0 Equality Impact Assessment

4.0 BCG vaccination in neonates (0-4 weeks)

(Refer to Appendix C, shaded countries)

4.6 BCG should NOT be given:

5.0 Referral pathway

6.0 Contra-indications to the BCG Vaccine

7.0 Procedure for BCG Vaccination

7.6 Remove gloves and apron; and decontaminate hands.

8.0 BCG Vaccination Dosage

9.0 Care Post BCG Vaccination

9.2 In 5-10% of infants there is no visible reaction.

10.0 Adverse Reactions

10.4 Rare reactions:

12.0 Infection Prevention

13.0 Staff and Training

14.0 Professional Midwifery Advocates

15.0 Audit and Monitoring

16.0 Guideline Management

Unscheduled Immunisation Consent Form

Communication to Child Health Regarding Unscheduled Immunisations

Appendix E: Preliminary Equality Analysis

1. What are you proposing to change? Full Review

2. Why are you making this change? 3 year review

4. Is anyone likely to suffer any negative No

5. a) Will you be undertaking any Refer to pages 1 and 2

Preliminary analysis completed by:

Name Sharon Pilgrim Job Title ANNP Date July 2019

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