Guidelines for the Newborn Bloodspot Screening Programme in by MikeJenny

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									                City and Hackney PCT
   Homerton University Hospitals NHS Foundation Trust



      Guidelines for the Newborn
  Bloodspot Screening Programme in
        Hackney and the City




City and Hackney Newborn Bloodspot Screening Steering Group.
Clinical Governance Steering Committee. (CWSH), Homerton University Teaching
Hospital (NHS) Foundation Trust




                                                                               1
2.0    Summary..........................................................................................................................4
3.0    Introduction ......................................................................................................................4
4.0    Development process including the staff involved ...........................................................5
5.0    Aims and objectives .........................................................................................................5
6.0    Target Population.............................................................................................................6
7.0    Audience ..........................................................................................................................6
8.0    Sources of Evidence (& search strategy) .........................................................................7
9.0    Practice recommendations...............................................................................................8
  9.1     Introduction...................................................................................................................8
  9.2     Development of guidelines ...........................................................................................9
  9.3     UK Newborn Screening Programme Centre standards ..............................................10
  9.4     Local procedures ........................................................................................................11
  9.5     Guidelines: Usual (uncomplicated) circumstances .....................................................14
  9.6     Sample despatch to laboratory ...................................................................................16
  9.7     Guidance for neonatal units: where babies are premature or unwell.........................17
  9.8     Checking results and tracking samples ......................................................................20
  9.9     Communicating results ...............................................................................................24
  9.10 Special circumstances................................................................................................26
9.10.1         Repeat/late tests including babies moving into the borough ......................... 26
9.10.2         Hard-to-trace families .................................................................................... 26
  9.11 Retest requests (3rd reminder letters) sent to Director of Public Health.....................27
  9.12 Roles and responsibilities ...........................................................................................30
9.12.1         PCT lead ....................................................................................................... 30
9.12.2         Child Health Records Department................................................................. 31
9.12.3         Midwives........................................................................................................ 32
9.12.4         Health Visitors ............................................................................................... 33
9.12.5         Paediatric Outpatients Blood Clinic ............................................................... 34
9.12.6         Screening Laboratory .................................................................................... 35
9.12.7         Neonatal Unit................................................................................................. 36
9.12.8         GP/Paediatrician ........................................................................................... 37
9.12.9         Sickle Cell and Thalassaemia Service .......................................................... 38
10.0 Appendix one: Method for obtaining blood spot sample ................................................40
11.0 Appendix two: staff list ...................................................................................................42
12.0 Glossary.........................................................................................................................43
13.0 References / Bibliography ..............................................................................................44




                                                                                                                                         2
                 Clinical Practice Guideline

   Newborn Bloodspot Screening – procedures and guidelines


Authors:              Sarah Rees: Public Health Strategist, City and
                      Hackney PCT;
                      City and Hackney Newborn Bloodspot
                      Screening Steering Group.

Version               Four

Version Date          1st Oct 2007


Implementation Date   1st Dec 2007.

Review Date           1st May 2008.


File Reference        City and Hackney PCT:
                      (Health Improvement drive),
                      g:/healthimprovement/New HIMP shared
                      drive/client groups/children and young
                      people/antenatal and postnatal screening/blood
                      spot policy Homerton template.doc

                      Homerton University Teaching Hospital (NHS)
                      Foundation Trust




                                                                       3
2.0 Summary
The following guidance outlines national and local policy relating to the neonatal blood spot
screening programme in Hackney and the City. It describes the aims and purpose of the UK
Newborn Screening Programme including information regarding the conditions screened for
within the programme. It details the six standards outlined by the UK Newborn Screening
Programme Centre, with which all providers of newborn screening services are expected to
comply. The guidance outlines the processes that all staff groups need to follow to ensure that
a high quality screening service is available to all babies in Hackney and the City under the age
of one year, including step-by-step guides for each staff group. The guidance was developed
collaboratively with representation from all staff groups involved in the screening pathway. The
guidance also addresses the issues surrounding the recording of data in the City and Hackney
PCT Child Health I.T. System (CHIA) and proposes interim solutions to these issues. It is
recommended that this guidance be reviewed every six months due to the inclusion of interim
information recording solutions.

3.0 Introduction
The newborn screening programme offers a service to all newborn babies in the UK. The
programme in Hackney and the City screens for a number of potentially very serious but rare
conditions; phenylketonuria (PKU), congenital hypothyroidism (CHT), Sickle Cell disease,
Medium Chain Acyl CoA Dehydrogenase Deficiency (MCADD) and Cystic Fibrosis. It is
important to screen for these conditions very early in life as rapid diagnosis and treatment can
significantly reduce harm to affected infants. Treatment of affected infants with some
conditions, namely PKU and CHT, should be commenced within 21 days from date of birth.

The midwife (or appropriately trained worker e.g. maternity support worker) is responsible for
taking blood samples from the infant’s heel between day five and day eight of life (where date
of birth is day zero). Ideally the sample should be taken on day five as this allows the maximum
time for testing and will ensure that where affected babies are identified, treatment can
commence as early as possible. Samples taken in City and Hackney are then sent to Great
Ormond Street Hospital Laboratory (GOSH) for analysis. Results are returned to the City and
Hackney PCT Child Health Department and recorded electronically in the Child Health Interim
Application (CHIA). Borderline or affected results are referred directly by the laboratory to the
relevant clinicians in order for re-testing and/or treatment to be commenced urgently. The
laboratory also notifies the baby’s health visitor and GP of positive or borderline results.

The health visitor responsible for the baby notifies parents/carers of unaffected results. Parents
must receive all results by the 6-8 week review at the very latest. Where identified, carrier
status for sickle cell disease will be discussed with parents/carers by specialist counsellors
from the City and Hackney Sickle Service. At present the Regional Child Health Coordinator is
deciding on a process for the giving of Cystic Fibrosis carrier results (as the screening process
for CF is designed to avoid detecting carriers of CF, there will be very few – the estimated
annual figure for London as a whole is under 45).

All infants under one year old who are the responsibility of community midwifery or health
visiting services within Hackney and the City must have evidence in their notes of blood spot
screening having taken place (or having been declined). This includes all those who are
registered with Hackney and City GPs (including residents of other boroughs), residents of
Hackney and the City registered with GPs in other areas, infants under one year old moving
into Hackney or the City from other areas and looked-after children who are placed in the
                                                                                                   4
borough or who are the responsibility of Hackney and the City but placed outside the borough
and those Hackney and City residents who are not registered with a GP at all. In cases where
there is no evidence that prior screening has been carried out, arrangements must be made for
the baby to be screened.

The screening programme in Hackney and the City is complex and involves a number of
professional groups including midwives (hospital and community based), neonatal unit staff,
health visiting teams, sickle cell and thalassaemia service staff, specialist nurse counsellors,
information management staff, public health, phlebotomists, laboratory staff, paediatricians and
GPs. As such the programme requires clear guidance to ensure that roles, responsibilities and
processes are explicit. The following guidelines and procedures are intended to support local
delivery of an effective newborn screening service in Hackney and the City. The guidelines are
based in part upon national standards outlined by the UK Newborn Screening Programme
Centre.

Throughout the document, the term “parents” is assumed to include legal guardians and
carers.

4.0 Development process including the staff involved
A working group was formed to oversee the development and implementation of the guidance.
Membership of the group consisted of staff representatives from Homerton Hospital Midwifery,
Homerton Community Midwifery, Homerton Hospital Neonatal Unit, City and Hackney PCT
Health Visiting, City and Hackney PCT Sickle Cell and Thalassaemia Service, City and
Hackney PCT Public Health Department, City and Hackney PCT Child Health Department, City
and Hackney PCT Information Department and the London Region Screening Programme. The
group met regularly to develop pathways and procedures and to make decisions about roles
and responsibilities. The group was also responsible for reviewing draft guidelines and
providing professional guidance and feedback.

5.0 Aims and objectives
The success of the screening programme depends on timely and efficient procedures and
channels of communication between the many different staff groups involved in the process. In
order to facilitate the development of local screening programmes and policies, the UK
Newborn Screening Programme Centre published a set of policies and standards to guide the
work of screening service providers. The aim of the local guidelines in this document is to
provide an outline of local procedures, roles and responsibilities: they are based on the national
policies and standards but include specific local guidance. They are also based in part on the
Westminster PCT Newborn Screening Guidelines1.
The objectives of this guidance are as follows;

•          To ensure that the blood spot screening service in Hackney and the City is effective and
           efficient and to ensure that 100% of the parents of infants under one year old who are
           the responsibility of City and Hackney PCT are given the opportunity for their infants to
           undergo blood spot screening.
•          To ensure that parents are able to make informed choices about screening
•          To ensure that the roles and responsibilities of the various staff groups involved in the
           screening process are clear and to provide guidance to such staff where required.


1
    Dr Ingrid Wolfe, Westminster PCT. (2006).
                                                                                                   5
•      To ensure that the screening programme in Hackney and the City meets the standards
       outlined by the UK Newborn Screening Programme Centre.
•      To ensure that measures are in place to carry out checks making certain that no babies
       have been missed and to ensure that receipt of all samples is acknowledged by Great
       Ormond Street Hospital Laboratory (GOSH).
•      To outline processes for retests or late screens for babies up to one year old (where
       retests are required due to insufficient or inadequate samples, insufficient information on
       blood spot card, prior transfusion, borderline test results, where no evidence of a prior
       screen is available or for any other circumstances necessitating a repeat/late sample).
•      To clarify the roles and responsibilities of midwives and health visitors in relation to late
       tests, and to clarify the point at which responsibility for arranging late screens transfers
       from midwife to health visitor.
•      To minimise the risk of late or missed diagnosis of affected babies.
•      To improve communication between the professional groups involved in screening and
       also to improve communication between professionals and parents.
•      To outline the difficulties currently experienced within City and Hackney PCT due to the
       lack of a fully functioning child health I.T. system and to provide alternative, interim
       solutions until such time as a fully functioning child health I.T. system becomes
       available.

6.0 Target Population
Neonatal screening must be offered to the parents of all infants under one year old who are
either born within the boundaries of City and Hackney PCT, who reside in Hackney or City,
who are registered with Hackney or City GPs, who move into the borough from elsewhere or
who for any other reason fall under the responsibility of City and Hackney PCT. This includes
babies registered with GPs in Hackney and the City but resident in other boroughs and also
includes babies resident in the borough who are not registered with a GP at all. As such, the
target population is all infants under one year old whose care is the responsibility of City and
Hackney PCT, and their parents.

7.0 Audience
This document is aimed at all staff involved in the screening pathway. The staff groups are as
follows;

•      Midwives (hospital and community based)
•      Neonatal Unit staff
•      Health Visitors and members of the health visiting team including health care support
       workers
•      Specialist nurse counsellors within the City and Hackney PCT Sickle Cell and
       Thalassaemia Service
•      Paediatric nurses in the Children’s Community Nursing Team
•      Information Management & Child health staff
•      Starlight Ward staff
•      Public Health staff
•      GPs
•      Paediatricians
•      Paediatric Phlebotomists
•      Staff involved in research using blood spots

                                                                                                   6
8.0 Sources of Evidence (& search strategy)
The guidelines and procedures are based in part on national guidance produced by the UK
Newborn Screening Programme Centre (UKNSPC). The national guidance is the result of
extensive research and consultation and thus the policy and guidance for Hackney has at its
basis the research already carried out by the UKNSPC.


         A     Requires at least one randomised control trial as part of the body of
               literature of overall good quality and consistency addressing the specific
               recommendation)

         B     Requires availability of well-conducted clinical studies but no randomised
               clinical trials on the topic of recommendation


         C     Requires evidence from expert committee reports or opinions and/ or
               clinical experience of respected authorities.      Indicates absence of
               directly applicable studies of good quality




                                                                                              7
9.0 Practice recommendations
9.1             Introduction

The UK Newborn Screening Programme aims to offer universal screening of newborn babies
for a number of serious conditions which if undetected can cause severe illness or disability.
The conditions screened for are listed below 2:

Phenylketonuria (PKU):
Screening for PKU in the UK commenced in 1969. PKU is an autosomal recessive genetic
condition that affects one in 10,000 babies in the UK. Babies affected with PKU are unable to
metabolise phenylalanine and therefore they must be placed on a strictly controlled, low protein
diet. If diagnosis is timely (by 21 days of age), treatment is very effective. Without treatment,
babies develop serious, permanent mental disability.

Congenital Hypothyroidism (CHT):
Screening for CHT in the UK commenced in 1981. Babies affected by CHT produce insufficient
thyroxine. CHT affects one in 4,000 babies in the UK. Babies who screen positive for CHT can
be treated with thyroxine; this treatment is very effective providing it is commenced early
enough (by 21 days of age). Without treatment, babies develop permanent physical and
mental disability.

Sickle Cell disease:
Screening for Sickle Cell disease began in London in 2003. Sickle Cell disease is an autosomal
recessive inherited blood condition that affects haemoglobin. Inheritance of an affected gene
from both parents results in disease and inheritance of only one affected gene results in a
healthy carrier. Blood spot screening identifies both those with disease and healthy carriers.
Sickle Cell disease affects one in 2,500 babies in the UK although the prevalence in London is
likely to be higher due to the diversity of ethnic origin among the population. Untreated babies
are at high risk of death or complications from treatable infections, or from severe acute
anaemia, in the early years of life. Early diagnosis allows affected babies to be treated with
penicillin and prevenar vaccines within the first three months of life.

Medium Chain Acyl CoA Dehydrogenase Deficiency (MCADD):
Screening for MCADD is currently being piloted in locations across the UK, including London.
MCADD is an autosomal recessive genetic condition affecting the breakdown of fat and the
production of energy. It affects one in 10,000 – 20,000 babies in the UK. MCADD can cause
drowsiness, lethargy, vomiting, seizures, coma and death. It has a mortality rate of 20-25%.
Affected babies are treated by prevention of metabolic crisis (avoidance of fasting, close
monitoring of diet and food intake).

Cystic Fibrosis (CF)
CF is an autosomal recessive genetic condition that causes excessive production of sticky
mucus. This leads to digestive problems, recurrent chest infections, lung damage and poor
growth and development. It affects one in 2,500 babies in the UK. Screening allows pre-
symptomatic babies to be identified and there is evidence that early treatment improves health

2
  Information on conditions taken from the National Screening Committee Antenatal and Newborn Screening Programme
resource cards for midwives.
                                                                                                                    8
and may increase life expectancy. Affected babies are treated using a combination of dietary
supplements, medication and physiotherapy. The screening test for cystic fibrosis is designed
to minimise the number of babies who are identified as healthy carriers.


9.2          Development of guidelines
The guidelines were developed as a result of work by the City and Hackney PCT Newborn
Screening Working Group, which met frequently to map the screening pathways and to
establish procedures. Membership of the group is as follows;

Lesley Mountford: Director of Public Health, Public Health, CHPCT
Sarah Rees: Public Health Strategist, Public Health, CHPCT
Marcia Smikle: Service Development Manager, Children and Families, CHPCT
Hannah Vanderpuije: Interim Children and Families Nurse Manager, CHPCT
Rita Newland: Lecturer Practitioner, Health Visiting, CHPCT
Beverley Smalling: Sickle Cell and Thalassaemia Service Director, CHPCT
Virginia Valdez: Community Midwifery Manager, Homerton Hospital
Carolyn Bovelle: Midwife, Homerton Hospital
Jane Kennedy: Consultant Midwife, Public Health, Homerton Hospital
Joan Douglas: Head of Midwifery, Homerton Hospital
Olga Kurtianyk: Operational Manager, Neonatal Unit, Homerton Hospital
Jenny Frost: Operational Manager, Neonatal Unit, Homerton Hospital
Sharon Tricerri: Information Analyst, IM&T Department, CHPCT
Jean Chapple: London Region Child Health Screening Co-ordinator, Westminster PCT
Nadia Permalloo: London Region Antenatal Screening Co-ordinator, Westminster PCT


It is recommended that these guidelines are reviewed every six months, particularly in light of
the obstacles to monitoring blood spot screening caused by the lack of a fully functioning Child
Health I.T. System.




                                                                                                9
9.3           UK Newborn Screening Programme Centre standards
The standards summarised below were published by the UK Newborn Screening Programme
Centre in April 2005 and outline the level of performance that screening programmes are
expected to achieve. Core standards set the minimum performance requirements and
developmental standards set goals for units to be working towards achieving. Within each
standard there are specific guidelines that will be discussed in more detail within this
document.


Standard one: timely sample collection
Core standard: 95% of first samples taken on day 5-8 following birth, ideally on day 5 (where
date of birth is day 0).
Developmental standard: 100% of first samples taken on day 5-8 following birth, ideally on
day 5 (where date of birth is day 0).

Standard two: timely sample dispatch
Core standard: 100% of samples received by laboratory within 4 working days of blood
sample being taken.
Developmental standard: 100% of samples received by laboratory within 2 working days of
blood sample being taken.

Standard three: completeness of coverage
Core standard: Screening test result or decline of screening recorded for 100% of resident
babies alive at day 8.

Standard four: enhanced tracking abilities
Core standard: 95% of blood spot cards received by laboratory to include babies’ NHS
number.
Developmental standard: by April 2006 – 95% of blood spot cards received by laboratory to
have a bar-coded label including the babies’ NHS number.

Standard five: timely identification of babies for whom the laboratory has not received a
decline notification or a blood sample
Core standard: 100% of untested babies (including declines) identified by 19 days of age.
Developmental standard: 100% of untested babies (including declines) identified by 14 days
of age.

Standard six: timely processing of positive screening samples (for PKU and CHT only)
Core standard: 100% of positive screening results available and clinical referral initiated within
4 working days of sample receipt by screening laboratory.
Developmental standard: 100% of positive screening results available and clinical referral
initiated within 3 working days of sample receipt by screening laboratory.




                                                                                               10
9.4          Local procedures
Midwives are responsible for taking blood samples at day 5-8, ideally at day 5, (where day of
birth is day 0) and sending them to GOSH laboratory for analysis. The laboratory then sends
back acknowledgement of sample receipt, test results and notification of declines to the Child
Health Department at City and Hackney PCT so that they can be recorded electronically and
accessed by staff when required. Note – test results are no longer sent electronically from
GOSH which means that currently, Child Health/IM&T are manually inputting data into
CHIA. This causes significant delay in results reaching CHIA. In addition, reports cannot
currently be extracted from CHIA.

Where positive results are obtained, GOSH laboratory staff are responsible for initiating a
timely referral for clinical treatment, as outlined in standard six. The laboratory may also
request that a repeat blood spot sample is taken: this may be for a number of reasons including
previous transfusion, borderline result, inadequate/contaminated sample or insufficient
information recorded on the blood spot card. GOSH will request repeat samples in writing.
Depending on the age of the infant, the midwife (for infants under 28 days old) or the health
visitor (for infants of 28 days – one year old) is responsible for ensuring a repeat sample is
taken and sent to the laboratory within two working days of receipt of request.

If a sample is borderline or positive for Sickle Cell disease, the sample is sent from GOSH to
Central Middlesex Laboratory (CMH) for further analysis. CMH may request a further sample
for a number of reasons including clarification of borderline results and prior transfusion. City
and Hackney PCT Sickle Cell and Thalassaemia Service is responsible for ensuring that
following a sample request from CMH, samples are obtained and sent to the laboratory within
two working days of receipt of request. All babies confirmed as positive for Sickle Cell disease
are referred to City and Hackney PCT Sickle Cell and Thalassaemia Service, where specialist
nurse counsellors provide counselling and support. Parents are counselled and referred to
Homerton Hospital where a liquid sample is taken and analysed. Final results of these tests are
given to parents by the specialist nurse counsellors.

Where repeat samples are required for any reason, GOSH or CMH will send letters to a
number of individuals requesting a repeat sample, except where premature babies require
retesting at the equivalent of 36 weeks gestation, where no reminder letters are sent. In
all cases where it is known that a retest will be required, the midwife is responsible for
arranging the retest or notifying the health visitor that a retest is required and when it is
required.

Great Ormond Street repeat request procedure:
• All requests for repeat samples are sent by GOSH in writing
• 1st request sent to Homerton Community Midwifery Manager by first class post -
   letter and envelope stamped ‘urgent’ in red
• If no response is received by GOSH after 7 days- a second request (reminder) letter is sent
   to the Community Midwifery Manager
• If no response 7 days after sending the reminder – a letter is sent to the CHPCT Director of
   Public Health (DPH)
• If no response is obtained 14 days after sending the letter to the DPH – GOSH write a note
   on the lab computer to close the case.




                                                                                              11
Central Middlesex repeat request procedure:
a. Where a repeat sample is required following transfusion or other reason
• All requests are sent in writing
• The first letter is addressed to City and Hackney Sickle Cell and Thalassaemia Service and
   sent by first class post
• First requests for repeat tests following transfusion are sent out four months from the date
   of the last known transfusion if available, or from date of first sample receipt if not.
• Where no response is received, a second request (reminder) letter is sent to the Sickle Cell
   and Thalassaemia Service six weeks from the date of the original request.
• Where no response is received following the reminder letter, a third letter is sent to the DPH
   six weeks from the date of the second letter.

b. Where a second sample is required confirming borderline/positive results obtained
previously
• Urgent repeat request letters are faxed immediately (and copies sent by post) to City and
   Hackney Sickle Cell and Thalassaemia Service
• Twice-weekly reminder lists are sent to the Sickle Cell and Thalassaemia Service showing
   all outstanding requests. These reminders are issued indefinitely until the repeat sample is
   received.

c. Where a conclusive result cannot be achieved
• Where a conclusive result is not possible on the first screen, a specialist Sickle Cell and
   Thalassaemia Service specialist nurse counsellor will follow up the case. Parents are
   counselled and the baby is referred to Homerton Hospital where a liquid sample is taken
   and analysed. Once received, the final result of this test is given to the parents by the
   specialist nurse counsellor.

Babies of up to one year old who move into the area covered by City and Hackney PCT must
have a screening result (or decline) recorded. Any baby up to one year old whose care is or
becomes the responsibility of City and Hackney PCT must have their records checked to
ensure that they have been screened. Screening must be arranged urgently if there is no
written evidence that screening has taken place - a sample must be taken and sent to GOSH
laboratory within two working days of identifying an unscreened baby. It is the responsibility of
the midwife (for babies under 28 days of age) or health visitor (for babies 28 days and older) to
ensure that these checks are carried out and to ensure that samples are taken where required.
Procedures for arranging late tests/urgent retests are included in the following guidance.




                                                                                                12
Figure 1: screening guidelines – overview of screening pathway




                                                                 13
9.5              Guidelines: Usual (uncomplicated) circumstances
Figure one, above, summarises the usual/uncomplicated screening pathway

1. Prior to birth
Midwives must give the combined information leaflet (including neonatal screening information)
to parents at time of booking or early in the pregnancy. At between 28 and 36 weeks gestation,
parents should be reminded to look at the information concerning screening. Midwives should
discuss with parents the conditions that are covered by the screening process. Where parents
are known to be beta thalassaemia carriers, they must be informed that screening does not
cover this condition.


2. Taking the first sample
Introduction
•       The midwife is responsible for discussing the screening process with parents
        including the point at which results will be made available to them
•       The midwife is responsible for obtaining informed consent prior to sampling
•       The midwife is responsible for taking the sample 5-8 days after birth – ideally on day
        five;
•       The midwife is responsible for taking the sample properly to ensure good quality
        (see appendix one for guidelines on sampling);
•       The midwife is responsible for recording all relevant information (including the date
        of sample and the NHS number) on the blood spot card, in the maternity record
        (whether electronic or paper-based) and in the Personal Child Health Record (Red
        Book).
•       The midwife is responsible for recording the date that the sample was taken and the
        date the sample was sent in the ward or community office diary.


                 Standard One: Timely sample collection
    Core standard: 95% of first samples to be taken 5-8 days after birth – ideally
    on day 5.
    Developmental standard: 100% of first samples to be taken 5-8 days after
    birth – ideally on day 5.

                                     Key points
    •    Day of birth = DAY 0
    •    Sample should be taken on day 5-8 (preferably day 5) regardless of;
                      Medical condition
                      Feeding status
                      Prematurity




                                                                                            14
Guidance
Midwives must check at least 24 hours before the sample is taken that parents have access to
and are familiar with the pre-screening information leaflet 3. The midwife must ensure that
informed consent is sought from parents/carers prior to taking of the sample. The midwife must
discuss the screening procedure with the parents and record any relevant information in the
patient notes. The following areas should be covered in discussions;
• The conditions that will be screened for and how screening can be helpful to babies with
    these conditions;
• The method by which the blood sample will be taken;
• That, depending on the condition tested for, both affected individuals and healthy carriers
    may be identified;
• That screening tests are not 100% accurate;
• That on some occasions a further sample will be required;
• That after testing, blood spots are stored for at least five years for quality assurance and
    public health monitoring purposes;
• That very rarely, parents may be contacted and invited to take part in research. Parents are
    able to opt out of this by asking for “NO RESEARCH CONTACT” to be written on the blood
    spot card at the time the sample is taken;
• That parents will receive the results of the screen by the 6-8 week review at the very latest.

The parent’s decision to accept or decline the screening tests must be recorded in the
maternity notes. Parents may decline screening for one condition but accept for other
conditions. Where one or more of the screening tests are declined, the midwife should explore
with the parents the reason for the decision and offer additional information where required,
without unduly pressurising them.

Where one or more tests are declined, the blood spot card must be clearly marked “DECLINE”
and sent to the laboratory in the usual way, ensuring that all details are included on the blood
spot card. The family GP and the health visitor must be notified in writing, by the Community
Midwifery Manager, where screening for one or all conditions has been declined. A standard
letter should be available for this purpose.

All information must be recorded in full in all relevant sections of the notes including the date
sample taken and the date it was sent. The date of sample and the tests carried out must be
recorded on page 4 of the Red Book.

The taking of samples MUST NOT be delayed for any reason and MUST take place on day 5-8
(ideally day five) regardless of feeding status, prematurity or any other reason. If parents are
out and the midwife is unable to visit in time to collect the sample, the card must be passed to
another midwife who can obtain the sample within the time limits. This may be particularly
relevant to part-time midwives who must ensure that a colleague is able to take the sample on
their behalf.




                                                                                                    15
9.6               Sample despatch to laboratory

Introduction
•       Samples must be dispatched by midwives in an efficient and timely way to avoid
        unnecessary delay and to ensure that where a positive result is suspected, there is
        sufficient time for follow-up action and clinical referral. This means that if required,
        treatment can start at the earliest possible opportunity.



                  Standard Two: Timely sample dispatch
    Core standard: 100% of samples received by laboratory within 4 working days
    of the sample being taken.
    Developmental standard: 100% of samples received by laboratory within 2
    working days of the sample being taken.

                                      Key points
    •    Samples must be sent to GOSH laboratory within 24 hours of being taken
    •    Samples must be sent in pre-paid First Class envelopes specifically provided
         for blood spot cards
    •    The sample must NOT be placed in the internal mail as this causes
         unnecessary delay. Samples must be placed directly in the external post.
    •    Each envelope must contain no more than five blood spot cards – sending
         cards must not be delayed by waiting to fill envelopes and all samples must
         be sent within 24 hours of being taken.
    •    The professional taking the sample must record the date of the sample and
         the date it was posted, for audit purposes.
    •    Maternity units must have robust systems in place to ensure that samples
         have been received by the lab for all babies eligible for screening.

Guidance
Midwifery staff must ensure that samples are sent according to the guidance above. It is vitally
important that samples are dispatched to the GOSH laboratory within 24 hours of the sample
being taken.

Homerton Hospital must have systems in place to ensure that samples for all babies who
should have been screened but whose samples are not received by GOSH have samples
taken urgently. The GOSH laboratory provide daily acknowledgement lists of samples received
and this list should form the basis of daily checking procedures at the Homerton.

Homerton Hospital will retain with the notes the top copy of the blood spot screening card to
ensure that an accurate record of the sample is kept with the notes.




                                                                                                   16
9.7 Guidance for neonatal units: where babies are premature or
    unwell
The guidance below is taken from the London and South East Bloodspot Screening
Advisory Group guidance for neonatal units, published Oct 2006

The procedure for taking blood spot samples from babies in neonatal units is different from the
usual procedure for a number of reasons;

•   Immaturity may mask CHT and therefore premature babies need to be re-screened at 36
    weeks gestational age
•   When babies are transfused, Sickle Cell disease cannot be detected accurately until four
    months from the date of the final transfusion. The baby still needs to be screened for the
    other conditions.
•   Samples cannot be screened for PKU, MCADD and CHT until the 5th day of life

Key points for neonatal units

•   Date of birth is day zero regardless of what time of day the baby was born and
    regardless of prematurity.
•   The full (four circle) blood spot sample should be taken between day 5-8 regardless
    of type of feeding, illness, maturity or medication.
•   If possible blood sampling should be synchronised with blood taking for other
    purposes.
•   All information must be recorded legibly and in full on ALL blood spot cards. NHS
    number MUST be used.
•   Write clearly on the card if the sample is pre-transfusion, repeat sample or any other
    unusual circumstance.
•   Record in the notes that the sample has been taken AND the date it was sent to the
    laboratory.
•   Where two samples are taken, the cards must be stapled together so that GOSH is
    able to treat as one sample.
•   Checks must be carried out to ensure that all babies under one year old who are
    admitted to the unit have been screened and if babies are found to be unscreened (or
    have only had the first, single-spot sample taken), a further sample must be taken
    and sent to the laboratory urgently.

The following procedure is for ALL babies admitted to the neonatal unit prior to the fifth
day of life regardless of condition (where day of birth is day zero):

1. On admission – (pre-transfusion)
Take a single circle blood spot and mark it “pre-transfusion”. This card should be saved with
the notes and will be used to screen for Sickle Cell disease only.

It is the responsibility of neonatal unit staff to check, at admission, the records of all babies
under one year old at admission to ensure that they have been screened fully. If there is no


                                                                                                    17
evidence that sample(s) have been taken and sent to the lab, a repeat sample must be carried
out and sent to GOSH urgently.

2. On day FIVE (where day of birth is day zero)
Take a full (four circle) blood spot. This will be used to screen for PKU, CHT, CF and MCADD.
If the baby has already been transfused after admission but prior to day 5, delay if possible the
four-circle sample until 72 hours after transfusion, to ensure CHT screen is accurate. However
this sample MUST be taken by day 8 of life regardless of circumstances or transfusion status.

Pre-term babies will require a repeat sample at 36 weeks gestational age. This should be done
as a further single spot sample. Write the gestational information and “repeat TSH” on the
blood spot card before sending to the laboratory.

3. When both samples obtained (day 5 – day 8 at the latest)
Once both cards (the single circle for Sickle Cell disease and the four circle for CHT, PKU, CF
and MCADD) have been completed (by day 8 at the very latest), staple both cards together
and send to the laboratory. Both cards MUST be completed in full. As with all other blood spot
cards, they should be sent first class and in a pre-paid envelope, within 24 hours of the second
sample being taken. The sample MUST NOT be sent via the post room.

The cards are sent together to enable the laboratory to treat as a single sample and to reduce
the risk of incorrect data entry at the laboratory due to duplicate data entry.

4. On discharge from the neonatal unit
A record of the blood spot samples that have been taken and when they were taken must be
recorded in the discharge summary and passed to the baby’s GP and health visitor. They must
also be notified (in writing) if a repeat blood spot is required at a later date. This could be for a
number of reasons including prematurity (retest required at 36 weeks gestational age for CHT)
or following transfusion (repeat required 4 months after last transfusion for Sickle Cell disease).

Community neonatal nurses will perform the 36 week blood spot test on all babies discharged
from the neonatal unit before 36 weeks gestation if they live in the area.

Laboratories will not send reminder letters to request repeat samples for pre-term babies. The
neonatal unit are responsible for ensuring that procedures are in place to make certain that all
staff understand when a repeat is required and to make sure that the repeat is taken.

5. When repeat tests are requested by laboratory
These requests must be responded to very urgently – a repeat sample must be obtained and
sent to the laboratory within 2 days of receipt of the request.




                                                                                                  18
Figure 2: Pathway for Neonatal Units

                                       Blood spot screening in neonatal units

                                                               Birth = day ZERO


                                                                  No                        Blood spot normally performed by midwifery staff
   Admitted to neonatal unit within 5 days of birth
                                                                                                by day 5 - check sample has been taken

                            Yes



 Single circle blood spot taken from all babies - for
 sickle cell. Save with notes to be sent with day 5-8
                        sample




                                                                                               At or after 72 hrs post-transfusion, repeat the
            Has baby been transfused?                             Yes                         blood spot screening (at day 5-8). Do not delay
                                                                                            later than day 8 in any circumstances (eg multiple
                                                                                                                transfusions).
                           No


  Full blood spot sample (four spot) to be taken at
                       day 5




                                                      Born at less than 36 weeks gestation?


                                         No                                                   Yes

                        End
                                                                     At corrected gestational age of 36 weeks or
                                                                  over, repeat a single blood spot sample to check
                                                                   for CHT. If baby already discharged, liaise with
                                                                  community nursing team or other relevant staff.


                                                                   If no pre-transfusion blood spot was taken (for sickle cell) a repeat will be
                                                                      required 4 months from the date of the last transfusion - this must be
                                                                                                    arranged.




                                                                                                                                        19
9.8          Checking results and tracking samples

Introduction
•   All babies who are the responsibility of City and Hackney PCT must be offered blood
    spot screening
•   Systems must be in place to ensure that all samples taken are received by the GOSH
    laboratory
•   Systems must be in place to ensure that any untested babies are detected and
    screened urgently
•   Blood spot cards must be completed in full, including NHS number, to ensure that
    correct identification is assured
•   Test results must be recorded in the appropriate locations and in good time

          Standard three: completeness of coverage
Core standard: screening test result or decline of screening recorded for 100%
of resident babies who were alive at 8 days.
No developmental standard.

                                 Key points
•   GOSH laboratory will notify Child Health of all results (including interim
    results) within 24 hours of being available. NB – this is via paper results at
    present as electronic link between GOSH and Child Health is not
    functional.
•   GOSH laboratory will notify Child Health of all declined screening tests
    (including declines for some but not all tests) within 24 hours of being
    known.
•    Results must be available to health visitors by the 6-8 week review at the
    very latest (see “communicating results” section for more detail).
•   The screening result must be recorded by the health visitor in the Personal
    Child Health Record (Red Book)
•   The Child Health department is responsible for carrying out an annual
    coverage count. This should be carried out on 1st April. The count identifies
    the percentage of babies (between 28 days and 1 year of age who are
    resident in the PCT area) with a recorded screening result or decline
    notification.
•   For babies who move into the borough at or under one year of age, written
    evidence of a blood spot screen is required. Where no proof is available it
    should be assumed that the baby is untested and urgent testing should be
    arranged. Depending on the age of the baby this is the responsibility of the
    midwife (for babies under 28 days old) or the health visitor (for babies 28
    days and older). There is a separate section in the policy about urgent
    late tests/retests.



                                                                                     20
           Standard four: enhanced tracking abilities
 Core standard: 95% of blood spot cards received by the laboratory must
 include the babies’ NHS number
 Developmental standard: 95% of blood spot card received by the laboratory
 should have a bar-coded label including the babies’ NHS number

                                   Key points
 •   If possible, bar-code labels should be used
 •   If bar-code labels are not available, the NHS number must be carefully and
     legibly written on to the card. NHS number MUST be on the blood spot card
     in all cases.




 Standard five: timely identification of babies for whom
the laboratory has not received a decline notification or
                     a blood sample

Core standard: 100% of untested babies (including declines) identified by 19
days of age
Developmental standard: 100% of untested babies (including declines)
identified by 14 days of age
9.8.1                              Key points
• The Child Health department is responsible for running daily searches on
    Child Health records to identify any babies without a test result or decline.
    NB – CHIA is currently incapable of supporting these searches – see
    below for temporary manual solutions proposed
• Midwives are responsible for checking the list of babies who should have
    been screened against the acknowledgement of samples received by GOSH
    laboratory to ensure none are missing. They must initiate urgent repeat
    where missing samples are detected.
• Untested babies identified (up to one year of age) must be screened urgently
    – samples must be taken and sent to GOSH within 2 working days.
• The records of babies who move into the area (up to one year of age) must
    be checked to ensure screening has been carried out. If there is no evidence
    that prior screening has occurred, samples must be taken and sent to GOSH
    within 2 working days. It is the responsibility of the midwife (for babies up to
    28 days old) or the health visitor (for babies 28 days and older) to ensure
    that checks are carried out and samples taken where required.




                                                                                       21
Guidance

It is absolutely essential that mechanisms are in place to ensure that all eligible babies are
screened and that regular checks are performed to identify any babies that do not have test
results (or decline) recorded.

All blood spot cards must be completed legibly and in full, and the NHS number must be included
on all cards. If staff are unsure of where to obtain the babies’ NHS number they must ask their
manager for help in locating it. Samples may be rejected and a repeat test required if there is
insufficient information on the card – this may lead to potentially dangerous delays in affected
babies receiving treatment.

The well-documented problems with the current Child Health I.T. system (CHIA) in North East
London mean that regular reports cannot be run from the system and therefore manual solutions
are required. This concern has been recorded on City and Hackney PCT Risk Register as a
potentially serious risk. Any manual solution is likely to be labour-intensive and prone to error.
Alternative solutions, which involve the manual checking of records, have been proposed until a
more efficient method with lower risk is available. There are three layers to the manual system
proposed; one is the responsibility of the midwifery staff at Homerton, the second is the
responsibility of the health visiting staff at City and Hackney PCT and the third is the responsibility
of the Child Health Department at City and Hackney PCT. To reiterate, these checks are labour-
intensive, manual solutions to be replaced by electronic solutions once they become available.

Midwifery check
The Midwifery Department at Homerton Hospital are responsible for ensuring that all babies
under their care (and those under the care of other areas including the Neonatal Unit) who are
eligible for screening have had samples taken and that the GOSH laboratory has received all
samples sent. Serious incidents and near misses have occurred due to failure to detect where
samples have not reached the laboratory. This can be done by checking a list of all babies who
should have been screened against the daily sample acknowledgement list distributed by GOSH.
It is suggested that these checks are carried out very regularly – preferably daily. This will ensure
that any samples sent to the lab and not received are detected and can be retaken within an
acceptable time; a repeat sample should be sent to GOSH within 2 days of identifying an
unscreened baby.

Health visiting check
Health visitors must check the records of all babies under their care to ensure that they have been
screened (or have a decline recorded). Midwives at Homerton will complete a “discharge from
Midwife Care” form at around 10 days which will provide this information. For babies born
elsewhere health visitors will need to check records at the earliest available point.




                                                                                                    22
Child Health check
A temporary post is to be created within the Child Health team which will have responsibility for
carrying out daily checks on all babies under the care of City and Hackney PCT. This will include
the following populations;
1.      All babies resident in Hackney/City and registered with Hackney/City GPs
2.      All babies resident in Hackney/City who are not registered with any GP
3.      All babies who are resident in other boroughs but are registered with Hackney/City
        GP
4.      All babies who are resident in Hackney/City but are registered with a GP in another
        borough

The checks carried out will be based on extracts from the Child Health system. The postholder
will be responsible for carrying out daily checks and for ensuring that samples are taken from
unscreened babies within two working days of their identification. They will also be responsible for
providing annual data to the Newborn Screening Programme Centre.

This post will exist until such time as a functioning Child Health system is able to support daily
checks.


Data monitoring
PCTs are required to submit annual performance data relating to screening. In the absence of a
I.T. solution to reporting, Health Visiting Modern Matrons in City and Hackney are responsible for
collating from their teams a number of data items as follows;

•   Total number of new births
•   Total number of babies screened (or decline recorded)
•   Total number of babies not screened (or no decline recorded)
•   Total number of babies transferred out of area prior to screening
•   Number of “unaffected” results given to parents

Health visiting modern matrons are responsible for maintaining and collating this information from
health visiting teams on a monthly basis.




                                                                                                     23
9.9              Communicating results

Introduction
•       The GOSH laboratory staff are responsible for referring positive test results (for PKU,
        CHT, MCADD and CF) for clinical consultation and treatment
•       Laboratories are responsible for initiating clinical referral by notifying a positive
        screening result (in both writing and verbally by phone) to a designated specialist
        clinician and the GP/Health visitor.
•       Borderline or positive results for Sickle Cell disease are referred to CMH for further
        testing and the City and Hackney Sickle Cell and Thalassaemia Service are notified for
        further action.
•       Parents should be told of positive results as quickly as possible and by a well-informed
        health professional.
•       “Unaffected” results and carrier status for sickle cell disease MUST be given to
        parents/carers by the 6-8 week review at the latest – it is never acceptable to assume
        that “no news is good news”
•       Results must be recorded on page 24 of the Red Book.




        Standard six: Timely processing of positive screening
                results (PKU, CHT, MCADD and CF)

    Core standard: 100% of positive screening results available and CLINICAL
    REFERRAL INITIATED within 4 working days of sample receipt by laboratory.

    Developmental standard: 100% of positive screening results available and
    CLINICAL REFERRAL INITIATED within 3 working days of sample receipt by
    screening laboratory
                                      Key points
    •    Screening laboratories undertake newborn screening analysis and reporting
         on a daily basis (working days only)
    •    The laboratory must notify a positive screening result verbally (by phone) as
         well as in writing (fax/email) and record the date that the referral was made.
    •    Screening registers for PKU and CHT are under development and will
         contain data from this standard




                                                                                              24
Guidance
The key message relating to this standard is that health visitors must give “unaffected” results to
parents by the 6-8 week review at the very latest. Parents will have been informed at the time the
sample was taken when to expect results. Where late screens have been performed (on babies
up to one year of age) it is equally important that “unaffected” results are given to parents within
six weeks of the sample being taken. Positive results are communicated directly by the laboratory.

Procedures for health visitors – communicating “unaffected” results

Health visitors are responsible for ensuring that all “unaffected” results are communicated to
parents/carers by the 6-8 week review at the very latest, or for late samples, a maximum of six
weeks after then sample date. Health visitors are responsible for taking the following steps to
ensure that parents receive results by the 6-8 week check at the latest (or six weeks after the
sample is taken for late tests).

1.    The Child Health team are responsible for sending results to health visitors as soon as they
      are available.
2.    All results that are received are recorded in the team birth book by Health Visiting team.
3.    These results are then given to parents verbally by phone by Health Visiting team.
4.    A letter is also sent out for all normal results, which asks parents to put the letter in the
      child’s red book and to bring to clinic for the 6-8 week review.
5.    During the 6-8 week clinic review, the HV will enter this information in the child’s Red Book.
6.    Monthly reports are generated by health visitors for monitoring purposes, showing the
      number/percentage of results received.




                                                                                                  25
9.10          Special circumstances

9.10.1               Repeat/late tests including babies moving into the borough
All babies up to one year of age who are the responsibility of City and Hackney PCT must have a
recorded screening result (or decline). Please note that as the test for Cystic Fibrosis is only
effective in infants under 8 weeks old, parents must be told that any samples taken from
infants who are over 8 weeks old will not be screened for this condition.

•      For babies under 28 days old, the midwife is responsible for checking the records and
       ensuring that a screen is carried out where there is no evidence of a previous test. The
       midwife is also responsible for taking the sample.
•      For babies 28 days and over, the health visitor is responsible for checking the records
       and ensuring that a screen is carried out where there is no evidence of previous test. The
       health visitor is responsible for organising the screen but is not required to take the sample.
       In these circumstances, the procedure is as follows;

1. The health visitor discusses the test with the parents, obtains their informed consent and gives
   the parent a blood spot card with completed demographic details including NHS number and a
   pre-paid envelope pre-addressed to GOSH. The health visitor must tell parents that they will
   receive the results of the screen within six weeks of the sample date.
2. An urgent appointment for the parent should then be booked by the Health Visitor at Paediatric
   Outpatients Blood Clinic, Homerton Hospital, where a blood sample will be taken. Clinics take
   place on Mondays, Wednesdays and Fridays between 2 and 4pm. The telephone numbers for
   the Blood Clinic are 020 8510 5018 or 020 8510 7425.
3. Health visiting teams need to provide parents with information about where and when to
   attend for sampling.
4. Blood Clinic staff will take the sample and place it in the external post within 24 hours.
5. Positive and borderline results will be processed as usual; “unaffected” results must be given
   to the parents/carers by the health visitor within 6 weeks of sample date.

It is particularly important that any looked-after children in the borough are checked for screening.
This will include babies from other areas who are placed in Hackney or the City (even if
temporarily) and babies from Hackney and the City who are placed outside the PCT area.

9.10.2                  Hard-to-trace families
As with late retests, for babies up to 28 days of age the midwife is responsible and for babies
between 28 days and one year old, the health visitor is responsible. The following steps should be
taken to attempt to locate hard-to-trace families and ensure that babies are screened;
•      Confirm that contact details are correct
•      Attempt to contact the family by telephone
•      Attempt to visit the family in person and leave written messages if required
•      Contact next of kin
•      Inform GP
•      All efforts to make contact should be fully recorded in the appropriate records
•      If after all routes have been exhausted the baby is not found, Social Services should be
       notified of and “unseen child”.

                                                                                                   26
9.11          Retest requests (3rd reminder letters) sent to Director of
              Public Health
Introduction
Retest requests are issued from two sources; GOSH and CMH. Where blood spot retests are
required, a first request is sent to the midwifery team or Sickle Cell and Thalassaemia Service,
requesting a repeat sample. Where no response is received, a second request (reminder) is sent
to the same individual. If there is no response to the reminder a third is sent to the Director of
Public Health at City and Hackney PCT.

Great Ormond Street Laboratory (GOSH) will request samples to screen for all conditions.
They will send requests to the Community Midwifery Manager or to the Neonatal Unit and if no
response is received within seven days they will send a second request (reminder) to the same
person. If no response is received seven days after the 2nd request, a third letter will be sent to the
Director of Public Health at the PCT.

Central Middlesex Laboratory (CMH) will request a sample to screen for Sickle Cell disease
only. They will request retests where the baby has been transfused, where the previous screen
was borderline or for other reasons. They will initially write to the Sickle Cell and Thalassaemia
Service Manager and if no response is received within 3 weeks they will write again to the same
person. If no response is received within three weeks of the second letter, a third letter will be
sent to the Director of Public Health and the PCT.

It is the responsibility of those to whom letters are addressed to act upon them urgently.
Procedures must be in place to ensure that samples are not delayed due to event of staff
sickness or absence. Letters should be received by the DPH rarely if ever.

The following operational guidance outlines the procedures that should be followed by the
DPH representative when a third stage letter is received by the DPH. There are roles in this
section for public health, midwifery, health visiting, neonatal unit and sickle cell service
staff.

Procedure

1. Letters MUST be actioned by the DPH representative on the day they are received – if a
response is delayed this will delay commencement of treatment in affected babies and may lead
to serious, permanent impairment.

2. Details of the retest request should be recorded in the Blood Spot record sheet (g:/new HIMP
drive/clinical topics/maternity/blood spot.xls). This file is password protected – password with
Public Health P.A. A blood spot letter (saved as “blood spot letter” in the file above) should be
completed and sent to the relevant staff member for urgent action.




                                                                                                    27
3. All letters from GOSH:
 Where babies are over 28 days old: The DPH representative must urgently (on the day the
letter is received) phone the PCT Enhanced Modern Matron covering the area in which the baby
is resident requesting a repeat to be sent within two working days. To identify the relevant
Enhanced Modern Matron, find the babies’ GP and check it against the list saved in the g: drive
folder above (Word document is named “staff list for HV practices covered”). A blood spot letter
(as above) must also be sent confirming details, including a photocopy of the laboratory letter.
Enhanced Modern Matron must investigate reason for delay in responding to 1st and 2nd
letters.

Where babies are 28 days old or less: The letter from GOSH will tell you who the 1st and 2nd
letters were sent to. You must ring this person urgently (on the day letter received) and request
that they arrange a blood spot sample to be taken urgently & sent within two working days. A
blood spot letter (as above) must also be sent to the same person including a photocopy of the
laboratory letter. Head of Midwifery/Neonatal Unit manager must investigate reason for
delay in responding to 1st and 2nd letters.

4. All reminders from CMH: The PCT Sickle Cell and Thalassaemia Service Director (Beverley
Smalling) should be urgently (on the day letter received) notified by phone that a repeat must be
sent within two working days. A blood spot letter (as above) must also be sent, including a
photocopy of the laboratory letter. Sickle Cell and Thalassaemia Service Director must
investigate reason for delay in responding to 1st and 2nd letters.

5. You may need to chase up staff to ensure repeat samples are taken but DO NOT email any
patient-identifiable details as this breeches Caldicott guidelines on confidentiality.

6. The original laboratory letter (including envelope), a copy of the blood spot letter and any other
relevant papers should be filed in the yellow blood spot folder (stored in the lockable section of
Sarah Rees’s desk – key with Public Health P.A.).

7. Weekly checks of CHIA by should be carried out on all babies requiring retests to check for
results. Results are sent from GOSH to Child Health and the PCT and are manually entered into
CHIA so can be checked as follows;


   a. Go to the Blood Spot record sheet (as in stage one) and identify all babies where record is
      still “open”. If you do not have access to CHIA, speak to Sharon Tricerri, Information
      Analyst, City and Hackney PCT IM&T Department.

   b. Checking each record at a time, enter the child’s details into CHIA and go to Screening
      Results. The result of the screen should be available on CHIA within 14 days of the sample
      date (this is delayed due to the lack of electronic link between GOSH and CHIA
      systems). There should be a record of the repeat screening in this section. If not, the
      sample needs to be chased up. Contact the relevant staff member (Sickle Cell and
      Thalassaemia Service Manager or Enhanced Modern Matron) to find out more information.




                                                                                                    28
Figure 3: Screening guidelines - fast-track pathway for late tests or retests




                                                                                29
     9.12           Roles and responsibilities
     9.12.1               PCT lead

                                            PCT Lead
                      Responsibility                             Time scale     Additional
                                                                                  notes
Strategic responsibility for screening programme, under the
direction of the Director of Public Health. Includes
responsibility for writing and reviewing policy and guidance.
Managing near misses and clinical incidents including            When         Incidents should
receiving notification of late or missed screens and following   incidents    be reported to the
up as appropriate.                                               occur        PCT and/or
                                                                              Homerton
                                                                              Hospital Clinical
                                                                              Governance
                                                                              Department.
Responding to requests for urgent retests from Great Ormond      When         Procedures for
Street or Central Middlesex laboratories.                        requests     responding to
                                                                 arrive.      letters are
                                                                              included in this
                                                                              guidance.
Chair regular Newborn Screening Meetings to monitor              Quarterly
performance and ensure policy is followed.




                                                                                             30
                                                                                               .
      9.12.2               Child Health Records Department

                           Child Health records Department
                       Responsibility                 Time scale                  Additional
                                                                                    notes
Receive and record birth notifications                         Notifications
                                                               to be
                                                               recorded in
                                                               the Child
                                                               Health
                                                               system within
                                                               2 working
                                                               days of
                                                               receipt
Receive and record acknowledgment of sample receipt from       Reports sent Currently
Great Ormond Street Laboratory                                 daily           acknowledgement
                                                                               lists cannot be
                                                                               recorded in CHIA
                                                                               until results are
                                                                               available
Notify health visitors of screening results                    Results         The laboratory
                                                               should arrive and/or clinical
                                                               with Child      specialist will
                                                               Health by       notify re: positive
                                                               day 10          results
Perform searches on CHIA to identify babies of 14 days or      Daily           This is
over who have no result (or decline) recorded.                                 problematic for
Babies identified through searches as unscreened must be       When            several reasons.
screened urgently – Child Health must notify the Maternity     unscreened      The lack of an
Lead at Homerton Hospital, the Director of Public health and   babies          electronic link
the PCT designated lead for screening.                         identified.     with GOSH
                                                               Must be         means that
                                                               actioned        results are
                                                               urgently to     manually added
                                                               ensure          to CHIA and are
                                                               sample taken not always
                                                               within 2        available at day
                                                               working days 14. Also CHIA
                                                               of discovery. does not at
An annual coverage count is required to calculate the          1st April every present have the
percentage of babies between 28 days and 1 year old with a     year            facility to produce
screening result (or decline) recorded.                                        reports.
Participate in regular Newborn Screening Meetings to monitor   Quarterly
performance and ensure policy is followed.




                                                                                               31
                                                                                                 .
     9.12.3               Midwives
                                            Midwifes
                      Responsibility                             Time scale          Additional
                                                                                       notes
Provide parents with combined information leaflet including      Time of
screening information.                                           booking/early
                                                                 in pregnancy
Remind women to review screening information in leaflet          Between 28 –
                                                                 36 weeks
                                                                 gestation
Notify Child Health Department of birth                          Within one
                                                                 working day
                                                                 of birth
Obtain informed consent prior to taking sample and discuss       Immediately
the conditions covered by the screen.                            prior to
                                                                 sampling
Where screening for one or more conditions is declined, GP       Following
and Health Visitor need to be notified in writing. This should   decline of
be recorded in notes and Red Book.                               screen
Obtain good quality blood spot sample (see appendix one for      Day 5-8 and       Please note
guidance). Ensure that card is fully complete and includes       ideally day 5     sections of
NHS number.                                                      (where date       guidance on
                                                                 of birth is day   premature and
                                                                 0)                transfused babies
Record date sample taken and date sample sent in all             At time of
relevant records including page 4 of the Personal Child          sampling
Health Record (Red Book)
Inform parents that they will be given the results by a health   At time of
visitor at the 6-8 week review at the latest                     sampling
Check list of acknowledgements from Great Ormond Street to       At regular
ensure that all screens have been taken and received by the      intervals –
laboratory                                                       preferably
                                                                 daily
Check records of all babies under one year old to ensure         When              Where
screening has been carried out. Where unscreened babies or       unscreened        unscreened
babies requiring repeats (e.g. premature babies requiring        babies            babies identified
repeats at 36 week’s gestational age) are identified, ensure     identified        sample must be
that samples are taken and processed urgently                                      sent within 2
                                                                                   working days of
                                                                                   discovery
Where requests for repeat blood spot samples are received        When letters
from the laboratory/DPH, to respond urgently and ensure          are received
samples are taken, sent to the laboratory within 2 working       from
days of request and are received by the laboratory.              laboratory
Midwives must complete the “discharge from midwife care”         At discharge
form and ensure that health visitors are given information       from midwife
about when blood spot sample was taken and sent or if it was     care (usually
declined.                                                        10 days)




                                                                                                  32
                                                                                                       .
     9.12.4                  Health Visitors
                                     Health Visitors
                       Responsibility                            Time scale        Additional
                                                                                     notes
Receive birth notification                                   Within 1
                                                             working day
                                                             of birth
Handover from midwife to health visitor including receipt of When baby is
“discharge from midwife care” form (for births at Homerton). 10-28 days of
                                                             age
Baby’s records checked to ensure that all babies less than   As soon as          This must be
one year old (including those who move into the borough from handover is         carried out
elsewhere) have been screened or have decline recorded.      complete.           urgently to
                                                                                 ensure samples
                                                                                 sent within two
                                                                                 days of
                                                                                 identification.
Screening must be arranged for any transfused babies             As required
requiring a re-screen at four months after date of last
transfusion or premature babies requiring test at 36 weeks
gestation age. This information should have been passed
from the midwife/neonatal unit to the health visitor at
handover and should be documented in the notes.
Arrange for any untested babies under one year old identified    When            Positive and
by checks to have screen urgently – the sample should be         untested        borderline results
taken and sent to the laboratory within 2 working days of        baby            will be
request, as follows;                                             identified.     communicated to
• Contact the parent by telephone or arrange a home visit                        GP, Health visitor
• Discussing the need for retest with parents;                                   and relevant
• Ensure informed consent is obtained;                                           clinicians by the
• Providing parents with a blood spot card (completed                            laboratory.
where appropriate – MUST contain NHS number);                                    Parents to be
• Liaising with Paediatric Outpatients Blood Clinic to                           notified of
arrange sampling;                                                                positive results
• Conveying “unaffected” results to parents as soon as they                      face-to-face, by
are available                                                                    well-informed
Obtain results of blood spot screen in advance of 6-8 week       As soon as      health
review and record in Birth Book.                                 results are     professional.
                                                                 available
Convey “unaffected” results to parents/carers by letter and by   6-8 week        Parents asked to
phone/in person. Where late samples are taken, “unaffected”      review at the   bring the letter in
results must be given with 6 wks of sample date.                 very latest     the Red Book to
                                                                                 6-8 week check
Record results in the Red Book                                   As soon as      By 6-8 week
                                                                 possible        check at the
                                                                                 latest
Respond to requests for repeat blood spot sample for babies      On day
of between 28 days and 1 year old. Procedure is as for           request
unscreened babies identified (as above).                         received.

Modern Matrons collate monthly data on births, number            Monthly
screened/not screened, results given and transfers from area
                                                                                                 33
                                                                                                       .
     9.12.5              Paediatric Outpatients Blood Clinic

                        Paediatric Outpatients Blood Clinic
                     Responsibility                  Time scale               Additional
                                                                                notes
Respond to requests from Health Visitors to carry out urgent   Urgent
repeat/late blood spot samples on babies aged 28 days – 1      appointments
year old.                                                      required
Post samples to laboratory (using pre-paid envelopes           Within 24
provided by Health Visitor) in external post                   hours of
                                                               sample being
                                                               taken




                                                                                       34
                                                                                           .
      9.12.6                  Screening Laboratory


                                  Screening Laboratory
                         Responsibility                Time scale                        Additional
                                                                                           notes
Process blood spot cards                                            Within 2
                                                                    working days
                                                                    of receipt of
                                                                    sample
Send out acknowledgement lists of samples received to Child         Lists to be
Health Department and Homerton Midwifery Department.                produced and
                                                                    sent daily.
Initiate clinical referral for positive results                     Within 3           Standard applies
                                                                    working days       to PKU and CHT
                                                                    of receipt of      only. National
                                                                    sample             standards are
                                                                                       awaited for Sickle
                                                                                       Cell disease, CF
                                                                                       and MCADD.
Where positive results obtained, notify the GP and health           As soon as         GPs and health
visitor responsible for the baby.                                   results            visitors must
                                                                    available – at     receive positive
                                                                    same time as       results at the
                                                                    referral           earliest possible
                                                                    initiated.         point to ensure
                                                                                       that they are
                                                                                       available should
                                                                                       parents seek their
                                                                                       advice or support.
Where results are borderline or inadequate, send and urgent
request for a further sample. This is sent to the individual who
sent the first sample.
If not response is received following first letter, second letter   GOSH – 7
is sent to same individual                                          days after 1st
                                                                    letter;
                                                                    CMH – 3
                                                                    weeks after
                                                                    1st letter
If no response is received following second letter, third letter    GOSH – 7
is sent to City and Hackney PCT Director of Public Health.          days after 2nd
                                                                    letter;
                                                                    CMH – 3 wks
                                                                    after 2nd letter
Produce annual report produced showing performance                  Annually
against the six UK Newborn Screening Programme Centre
standards




                                                                                                      35
                                                                                                        .
      9.12.7               Neonatal Unit


                                           Neonatal Unit
                       Responsibility                              Time scale       Additional
                                                                                      notes
Take single circle blood spot at admission, prior to any           On day of      This sample will
transfusion for all babies admitted within five days of birth.     admission      be used to screen
Save card with notes. Blood spot card details must be fully                       for Sickle Cell
competed.                                                                         disease in case
                                                                                  the baby is
                                                                                  subsequently
                                                                                  transfused.
Check the records of all babies (regardless of age) at             At admission   All unscreened
admission to ensure that all samples have been taken and                          babies under 1
send to GOSH. If unscreened (or partially screened e.g. there                     year old must be
has only been a single spot sample taken) babies are                              offered screening
identified, a sample must be taken and sent urgently. .
Take four circle blood spot sample at day five, or 72 hours        Day 5/72       This sample must
after transfusion where baby transfused. Blood spot card           hours post-    be taken by day 8
must be fully completed.                                           transfusion    at the latest
                                                                                  regardless of
                                                                                  transfusion
                                                                                  history.
For babies who were initially sampled at under 36 weeks            36 weeks       This sample will
gestational age, take a single circle blood spot sample at 36      gestational    be used to screen
weeks gestational age.                                             age            for CHT.
For transfused babies where no pre-transfusion blood spot          At handover
was taken, a further sample will be required 4 months after
the date of the final transfusion. This must be made clear to at
point of handover and documented in all records.




                                                                                                36
                                                                                                  .
     9.12.8              GP/Paediatrician
                                  GP/Paediatrician
                     Responsibility                         Time scale        Additional
                                                                                notes
At 6-8 week review and during other contact with infants    Any contact,    GP/Paediatrician
under one year, to check the Personal Child Health Record   including       should check to
(Red Book) to see if a blood spot screen result has been    opportunistic   see if there is a
recorded.                                                   contact, with   blood spot
                                                            baby under      result/record of
                                                            one year old    decline recorded.
                                                                            If no result is
                                                                            available, the
                                                                            GP/Paediatrician
                                                                            should refer
                                                                            parents to their
                                                                            health visitor who
                                                                            is responsible for
                                                                            finding out
                                                                            results.




                                                                                           37
                                                                                             .
 9.12.9                   Sickle Cell and Thalassaemia Service

 Flow Diagram- Neonatal Screening results
 Provided by City and Hackney Sickle Cell and Thalassaemia Service
  1. Specialist Nurse Counsellor (SNC) must check distribution list against results
     received
  2. Fax signed/checked and dated distribution list must be returned to Joan
     Henthorne, CMH
  3. File away distribution list and “repeat sample required” sheets in the appropriate
     folders



          Affected                            Carrier                     Transfused/ other Hb
                                      Hb AS, Hb AC, Hb AD,                      Variant
                                          Hb AE Hb AE                  Requires further blood testing


1. SNC to enter result details    1. CIO to confirm clients              1. Forward result to SNC for
   on New Birth book                 information and do survival            follow-up counselling/re-
2. Check Antenatal records           check via CHIA system                  screening at Centre or hv
   from Homerton Hospital         2. Enter confirmed information         2. If tested, SNC to send
                                     onto database                          blood spot card to CMH in
                                                                            prepaid envelope
                                                                         3. Upon receipt of repeat test
                                                                            result enter details onto
1. CIO to do survival check       1. CIO to prepare appropriate             database
   and confirm result details        letter and attach                   4. Final results regarding
   via CHIA system                   corresponding carrier leaflet          inconclusive result from
2. CIO to enter result details    2. Prepare appropriate                    Homerton Hospital to be
   onto database                     haemoglobinopathy card for             sent to CMH
3. CIO to prepare appropriate        infant. Replace hospital
   parent & Doctor letters to        number with NHS no. on Hb
   be attached including             card
   result to blank green folder   3. Ensure both letter and card       CIO to inform CMH of outcome
4. Folder to be forwarded to         are signed by Specialist          of contact with clients if test not
   SNC for follow-up                 Nurse Counsellor                  done
   counselling and referral       4. All relevant items (ie trait
5. SNC to contact HV for joint       letter, laminated Hb card and
   hv, send notification letter      leaflet) should be sent to
   to GP and appointment             parents of infant
   letter to parents.             5. Update database.
6. SNC to do hv and prepare          Counsellor recorded on
   Paediatric referral form to       database should be SNC
   be sent to RLH                    who signs letter.
7. CIO to ensure that 4 x         6. File away original trait result
   copies of the completed        7. If the sample name is
   Paediatric referral form          different from the registered
   done by SNC should be             name, upon request of a
   made for GP, HV, parents          new card a birth certificate
   and file                          should be produced to
8. CIO to update database            confirm baby’s registered
   with regards to information       name prior to the issue of a
   on Paediatric referral form       new card.
   ie father’s details, date
   letter was sent off, date
   counselled etc
9. Confirmatory result to be
   obtained from RLH by
   SNC and sent off to CMH

                                                                                                             38
                                                                                                              .
Sickle Cell and Thalassaemia flow diagram:
-List of abbreviations

SNC       Specialist Nurse Counsellor
CMH       Central Middlesex Hospital
RLH       Royal London Hospital
CIO       Clerical Information Officer
CHIA      Child Health Interim Application
GP        General Practitioner
Hb        Haemoglobin
HV        Health Visitor
hv        home visit




                                             39
                                              .
10.0 Appendix one: Method for obtaining blood spot
sample 4


The following procedure should be followed only once informed consent has been
obtained from parents/carers.

Obtaining good quality blood spots is of paramount importance – poor quality spots
will be returned, causing unnecessary delay.

1. Complete all boxes on the blood spot card and apply the baby’s barcode label (if
available). If a label is not available the NHS number MUST be handwritten on the card. If
you are unclear about where to identify the NHS number please speak to your manager
who can help you to locate it.

2. Confirm the baby’s name, date of birth and parent’s contact details and record on the
card.

3. Recommend measures to comfort the baby and reduce pain. Feeding and sucking and
engaging the baby through face-to-face contact, voice and touch are beneficial. Topical pain
relief should not be given as it can contaminate the sample. Pre-warming of the foot is not
essential.

4. Disinfecting clean skin pre-test is not necessary. The baby’s heel must be washed with
plain water and must be allowed to dry completely before the sample is taken; if water is
present it will contaminate the sample and may lead to a repeat being required. The test for
cystic fibrosis is dependent on IRT levels which are also present in faeces, hence need for
cleaning prior to sampling.

5. Wash hands and apply gloves.

6. Perform the test using a newborn automated device. Depth of incision to be <= 2.4mm.
Manual lancets must not be used. Arcing devices are recommended as they produce the
best quality spots.

7. Allow the foot to hang to increase blood flow. Before activation, place automated device
firmly against the heel. Heel puncture should be performed on the plantar surface of the
heel, beyond the lateral and medial limits of the calcaneous. Diagonal lines on the
photograph below mark this area. Avoid posterior curvature of the heel.

8. Wait up to 15 seconds to allow blood to flow. Apply the blood drop to one side of the
card. Allow the blood to fill the circle by natural flow, and seep through to the back of the
card. Fill the circle completely and DO NOT layer blood. This is shown in the photograph
below.




4
    Description and images are taken from the UK Newborn Screening Programme Centre Policies and standards, 2005.
                                                                                                                    40
                                                                                                                     .
Figure 4: the photograph below shows the areas of the foot from where
samples should be taken.




Figure 5: the illustration below shows the correct technique for collecting
blood on the blood spot card.




                                                                         41
                                                                          .
11.0 Appendix two: staff list
List of all staff consulted as part of guideline development
First Consultation

Nadia Permalloo: London Region Antenatal Screening Coordinator, Westminster PCT.
Jean Chapple: London Region Child Health Coordinator, Westminster PCT.
Marcia Smikle: Service Development Manager, Children and Families, City and Hackney PCT
Hannah Vanderpuije, Interim Children and Families Nurse Manager, City and Hackney PCT
Rita Newland: Lecturer Practitioner, Health Visiting, City and Hackney PCT
Sharon Tricerri: Information Analyst, Information Management and Technology Department, City
and Hackney PCT.
Joy Ferguson, Child Health Manager, City and Hackney PCT
Lesley Mountford: Director of Public Health, City and Hackney PCT.
Sarah Rees: Public Health Strategist, City and Hackney PCT.
Virginia Valdez: Community Midwifery Manager, Homerton University Hospital NHS Foundation
Trust.
Carolyn Bovelle, Midwife, Homerton University Hospital NHS Foundation Trust.
Beverley Smalling: Sickle Cell and Thalassaemia Service Manager, City and Hackney PCT,
Jane Kennedy: Consultant Midwife (Public Health), Homerton University Hospital NHS Foundation
Trust.
Joan Douglas: Head of Midwifery, Homerton University Hospital NHS Foundation Trust.
Olga Kurtianyk: Operational Manager, Neonatal Unit, Homerton University Hospital NHS Foundation
Trust.
Jenny Frost: Operational Manager, Neonatal Unit, Homerton University Hospital NHS Foundation
Trust.
Gabrielle Laing: Clinical Director/Consultant Community Paediatrician, City and Hackney PCT.
Eleanor Blackman, Health Visiting Enhanced Modern Matron, City and Hackney PCT.
Commissioning of Primary Care Group, City and Hackney PCT.

Final Consultation
Mr. Neville Wathen          Clinical Audit & Effectiveness Lead Trust
Mr. Ed Dorman               Clinical Audit & Effectiveness Lead CWSH
Dr Sade Okutubo             Clinical Audit & Effectiveness Lead SA&CC
Mr Andrew Jenkinson         Clinical Audit & Effectiveness Lead SA&CC
Dr Louise Abrams            Clinical Audit & Effectiveness Lead Med & Rehab
Mr David Baker              Clinical Audit & Effectiveness Lead Therapies
Dr Stephen Burke            Clinical Audit & Effectiveness Lead DES
Dr Shad Husain              Clinical Director CWSH
Dr Simon Harrod             Clinical Director SA&CC
Dr Christine Blanshard      Clinical Director Med & Rehab
Dr Stephen Miles            Clinical Director DES
Ms. Nancy Hallett           Chief Executive, Chair of Clinical Board
Dr. John Coakley            Executive Director
Ms. Tracey Fletcher         Executive Director
Ms. Caroline Clarke         Executive Director
Ms. Pauline Brown           Executive Director
Mr. Guy Young               Executive Director
Mr. Andrew Panniker         Executive Director
Ms. Susan Acott             Executive Director
Ms. Flora Swanborough       General Manager, SA & CC
Ms. Richard Gourlay         General Manager, Med & Rehab
Ms. Felicity Canning        General Manager, DES
Mr. James Everard           General Manager, CWSH




                                                                                            42
                                                                                              .
12.0 Glossary
CF: Cystic Fibrosis. A condition included in the newborn blood spot screening programme in
London since July 2007.

CHIA: Child Health Interim Application. The City and Hackney PCT Child Health electronic
information system.

CHT: Congenital Hypothyroidism. A condition included in the newborn blood spot screening
programme.

CMH: Central Middlesex Hospital. CMH carry out confirmatory screens on samples that are
borderline or positive for haemoglobinopathies.

DPH: Director of Public Health.

GOSH: Great Ormond Street Hospital. GOSH Laboratory is responsible for carrying out
analysis on all blood samples from City and Hackney PCT.

HBOs: Haemoglobinopathies. Includes Sickle Cell disease and thalassaemias.

PKU: Phenylketonuria. A condition included in the newborn blood spot screening
programme.

MCADD: Medium Chain Acyl CoA Dehydrogenase Deficiency. A condition included in the
newborn blood spot screening programme.

UKNSPC: UK newborn screening programme centre. The organisation that oversees the
national screening programme and has responsibility for the newborn screening standards.




                                                                                       43
                                                                                           .
13.0 References / Bibliography
UK Newborn Screening Programme Centre (2005). Newborn blood spot screening in the
UK: Policies and standards. UK Newborn Screening Programme Centre, London.

Woolf, Ingrid (2006). Guidelines for the newborn blood spot screening programme in
Westminster. Westminster PCT.




                                                                                     44
                                                                                      .
                        14.0 Document Progress Sheet
                  This form to be completed by the Lead Clinician at all relevant stages
                Newborn Bloodspot Screening – procedures and guidelines
Policy Title
                         Sarah Rees, Public Health, City and Hackney PCT
Lead
“home”          Development of guidelines approved by “home” Directorate or Expert Group Minutes
Directorate     attached
 Informed
                Date ___________________           Minutes attached yes         / no


Registered
via Clinical    Name: ___________________                     Date: _____________________
Governance
Facilitator


Version         Attach a complete list of those on circulation list
number
_____           Date: _____________________
circulated
                Other Directorate or Expert Groups
Version           Surgery, Anaesthesia and ITU                        Initial: _____________________
number
                  Medicine & Rehab                                    Initial: _____________________
_____           ⌧ Children, Women & Sexual Health                     Initial: _____________________
circulated
                  Diagnostic & Emergency Services                     Initial: _____________________
                  Nursing & Quality                                   Initial: _____________________
                  ELCMHT                                              Initial: _____________________
                  CHTPCT                                              Initial: _____________________
                  Other Please specify                                Initial: _____________________
                Expert Group or Trust Committee
Final Version
number          Group Name ___________________________
_____
approved by     Date ___________________                       Are Minutes attached      yes    / no
Expert
Committee       NB: Clinical Board will not accept any CPG with out minutes verifying “expert”
                committee approval
   OR           Final version of guidelines approved by “home” Directorate

Final version   Group Name ___________________________

_____           Date ___________________                       Are Minutes attached      yes    / no
approved by     NB: Clinical Board will not accept any CPG with out minutes verifying directorate
home            approval
directorate

Sent to
Deputy Head     Submitted to Clinical Board on: _____________________
of Clinical
Governance
                                                by: _____________________


                                                                                                       45
                                                                                                        .
                     15.0 Document Control Summary
Document Title                Newborn bloodspot screening – procedures and guidelines

Author (s) and Grade (s)      Sarah Rees: Public Health Strategist, City and Hackney PCT. City
                              and Hackney Newborn Bloodspot Steering Group.
Department                    Public Health, City and Hackney PCT

Date of Production            1st Oct 2007.

Planned implementation        1st Dec 2007.
date:
Purpose/Aim of                To provide guidance for all staff involved in the newborn bloodspot
Document                      screening programme in Hackney and the city. To ensure that
                              practices are consistent and responsibilities are clear.
Circulated to
NB: Clinical Board will not
accept any CPG without
circulation list

Status

Version Reference

File Reference / Address      File kept on City and Hackney PCT Public Health drive:
 (Trust network/Intranet)     g:/healthimprovement/New HIMP shared drive/client
                              groups/children and young people/antenatal and postnatal
                              screening/blood spot policy_v3.doc
                              Review every six months
Update Frequency

Next Review Date              1st May 2008.

Approved By

NB: Clinical Board will not
accept any CPG without
minutes verifying
local/expert approval

Signatures                    Clinical Director: __________________________

                              Clinical Governance Chair: _____________________

                              Clinical Board Chair: _____________________




                                                                                                46
                                                                                                    .
Newborn Bloodspot Screening – procedures and guidelines

16.0 These guidelines have been approved by the
Directorate of Children Women & Sexual Health




                                                          47
                                                           .

								
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