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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