Newborn Blood Spot Standards for newborn blood spot screening
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1 Newborn Blood Spot Standards for newborn blood spot screening Version 1.0 / August 2013
2 About the NHS Newborn Blood Spot Screening Programme The NHS Newborn Blood Spot Screening Programme has responsibility for developing, implementing and maintaining a high quality, uniform screening programme for all newborn babies and their parents. The UK National Screening Committee (UK NSC) recommends that all babies in the UK are offered screening for phenylketonuria (PKU), congenital hypothyroidism (CHT), sickle cell disease (SCD), cystic fibrosis (CF) and medium-chain acyl-coa dehydrogenase deficiency (MCADD). There is a service specification for the NHS Newborn Blood Spot Screening Programme (No.19) available as part of the public health functions exercised by NHS England ( The UK NSC and NHS Screening Programmes are operated by Public Health England. PHE s mission is to protect and improve the nation s health and to address inequalities through working with national and local government, the NHS, industry and the voluntary and community sector. PHE is an operationally autonomous executive agency of the Department of Health. NHS Newborn Blood Spot Screening Programme newbornbloodspot.screening.nhs.uk Crown copyright 2013 You may re-use this information (excluding logos) free of charge in any format or medium, under the terms of the Open Government Licence v2.0. To view this licence, visit OGL or psi@nationalarchives.gsi.gov.uk. Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. Any enquiries regarding this publication should be sent to bloodspot.screening@nhs.net. Published August 2013 PHE publications gateway number: Uncontrolled when printed. To ensure you have the latest version of this document, please view it online. 2
3 Contents About the NHS Newborn Blood Spot Screening Programme 2 Introduction 4 Summary of main changes 7 Standard 1a: Completeness of coverage (CCG responsibility at birth) 9 Standard 1b: Completeness of coverage (movers in) 11 Standard 2: Timely identification of babies with a null or incomplete result recorded on the child health information system 13 Standard 3: Baby s NHS number (or UK equivalent) is included on the blood spot card 14 Standard 4: Timely sample collection 15 Standard 5: Timely receipt of a sample in the newborn screening laboratory 16 Standard 6: Quality of the blood spot sample 17 Standard 7: Timely taking of a repeat blood spot sample 19 Standard 8: CPA (screening) 20 Standard 9: Timely processing of all PKU, CHT and MCADD screen positive samples 21 Standard 10: CPA (diagnosis) 22 Standard 11: Timely receipt into clinical care 23 Standard 12: Timeliness of results to parents 25 Abbreviations 26 Appendix 1: Glossary 27 Appendix 2: Newborn blood spot screening status codes 30 3
4 Introduction The UK National Screening Committee (UK NSC) recommends that all babies in the UK are offered screening for phenylketonuria (PKU), congenital hypothyroidism (CHT), sickle cell disease (SCD), cystic fibrosis (CF) and medium-chain acyl-coa dehydrogenase deficiency (MCADD). All newborn babies up to one year of age are offered screening in order that a small number with the potential to develop disease might be diagnosed and treated and their parents receive support and education. It is a complex programme delivered by a range of different organisations working together. This document presents the revised national standards for the NHS Newborn Blood Spot Screening Programme. It should be read in conjunction with the standards for the NHS Sickle Cell and Thalassaemia Screening Programme ( and the UK NSC generic standards (under development). These revised standards replace standards 1 9 in Standards and Guidelines for Newborn Blood Spot Screening (August 2008) and unless stated in the document have an implementation date of April A summary of the main changes is available on page 7. Generic standards framework The updated standards have been reviewed in keeping with the proposed generic standards framework that has been developed for the eight English non-cancer NHS Screening Programmes by representatives from the programmes, UK NSC Quality Assurance, regional screening leads and antenatal and child health screening teams. The generic standards framework is based on 10 themes: Identify Population Inform Coverage/Uptake Test Diagnose Intervention/Treatment Outcome 4
5 Minimising Harm Staff: Education and Training Commissioning/Governance The aim is, where it is appropriate, to have one generic acceptable/achievable measurement across the programmes. The themes in italics have specific newborn blood spot screening standards. For all other themes the generic standards apply. Format Where appropriate, the revised standards are measured at two levels: achievable and acceptable. As defined by the UK NSC: The achievable threshold represents the level at which the programme is likely to be running effectively; screening programmes should budget for and aspire towards performance at this level. Local constraints may sometimes result in programmes failing to meet this threshold. Service improvement plans should focus on the delivery of a balanced service with as many standards as possible meeting the achievable threshold. The acceptable threshold is the lowest level of performance considered safe. All programmes are expected to exceed the acceptable threshold and to agree service improvement plans that develop performance towards an achievable level. Programmes not meeting the acceptable threshold are expected to implement recovery plans to ensure rapid and sustained improvement. The standards are accompanied by a number of best practice guidelines that should be followed to deliver high quality screening processes and to meet the standards. Data collection and analysis Please note that data may need to be aggregated by a variety of denominator cohorts, eg local authority (or UK equivalent), maternity service, clinical commissioning group (CCG) and newborn screening/specialist laboratory. The cohort of responsibility for child health records departments remains the same: primary care trusts (PCTs) have been mapped to CCGs. PHE is responsible for ensuring that reports on important aspects of screening are available at various geographies (eg local authority) to enable population-based oversight. Please see the data dictionary for exact data requirements this is updated each year. 5
6 Consultation These revised standards were disseminated widely for consultation in early Following consultation further revisions were made and the standards were presented to and approved by the Blood Spot Advisory Group in May Please note that an abbreviation list and glossary are provided at the end of the document. A broken underline indicates that a term is used according to its definition in this glossary. Where terms from the glossary are used without a broken underline, their common English meaning can be assumed. Except where the context determines otherwise, definitions include all forms of the defined term; so tested and testing refer to the definition of test. The newborn blood spot screening status codes are reproduced in Appendix 2. 6
7 Summary of main changes Standard Changes Data collected by Standard 1a: Completeness of coverage (CCG responsibility at birth) Standard 1b: Completeness of coverage (movers in) Standard 2: Timely identification of babies with a null or incomplete result recorded on the child health information system Standard 3: Baby s NHS number (or UK equivalent) is included on the blood spot card Standard 4: Timely sample collection Standard 5: Timely receipt of sample in the newborn screening laboratory Standard 6: Quality of the blood spot sample Standard 7: Timely taking of a repeat blood spot sample Standard 8: CPA standard (screening) Standard 9: Timely processing of all PKU, CHT and MCADD screen positive samples Standard agreed in August 2011 New standard this standard will be piloted using PKU as proxy to ensure that it is realistic Standard agreed in August 2011 No change Change to thresholds Change to thresholds Change to avoidable repeat definition to account for pretransfusion sample protocol Changes to thresholds and definitions to account for changes in screening protocols. Please note that data collection against this standard will be deferred until implementation of the Newborn Blood Spot Failsafe Solution New standard No change Child health records departments Child health records departments (to be piloted) Child health records departments Newborn screening laboratories Newborn screening laboratories Newborn screening laboratories Newborn screening laboratories Maternity services (deferred until implementation of the Newborn Blood Spot Failsafe Solution) Newborn screening laboratories Newborn screening laboratories 7
8 Standard 10: CPA standard (diagnosis) Standard 11: Timely receipt into clinical care Standard 12: Timeliness of results to parents New standard New standard New standard Newborn screening laboratories Newborn screening laboratories and paediatric specialist centres Child health records departments 8
9 Standard 1a: Completeness of coverage (CCG responsibility at birth) Objective To maximise uptake in the eligible population who are fully informed and wish to participate in the screening programme. Measure Tested babies Eligible babies expressed as a percentage Thresholds Definitions Acceptable Equal to or more than 95% of eligible babies are tested for all conditions. Achievable Equal to or more than 99.9% of eligible babies are tested for PKU, MCADD and SCD. Equal to or more than 98% of eligible babies are tested for CHT and CF. Tested babies (numerator) are the total number of eligible babies for whom a conclusive screening result for each of the five conditions was available within an effective timeframe. Eligible babies (denominator) are the total number of babies born within the reporting period, excluding any baby who died before the age of eight days. For the purpose of this standard, the cohort includes babies for whom the CCG was responsible at birth and is still responsible on the last day of the reporting period. The effective timeframe is that a conclusive result for each of the five conditions is recorded on the child health information system by 17 days of age. A conclusive result is one of the following newborn screening status codes: 04 not suspected 05 carrier 06 sickle not suspected, carrier of other haemoglobin 07 not suspected, other disorders follow up 08 suspected 10 S not suspected (by DNA) No other Hb/thal excluded Status code 02 declines are not included in the count for a conclusive result data is collected and reported alongside coverage data to help interpretation. 9
10 Reporting Reported quarterly for key performance indicator (KPI) NB1 using PKU as proxy: Deadlines: 30 September (Q1), 31 December (Q2), 31 March (Q3), 30 June (Q4) Reported annually for babies born in the previous financial year: Deadline: 30 June Data collected by: child health records departments Monitoring performance of: maternity services, newborn screening laboratories and child health records departments Aggregated by: CCG 10
11 Standard 1b: Completeness of coverage (movers in) Objective To maximise uptake in the eligible population who are fully informed and wish to participate in the screening programme. Measure Tested babies Eligible babies expressed as a percentage Thresholds Definitions Reporting Acceptable Equal to or more than 95% of eligible babies are tested for PKU. Achievable Equal to or more than 99.9% of eligible babies are tested for PKU. Please note that this new standard will be piloted using PKU as proxy to ensure that it is realistic. Tested babies (numerator) are the total number of eligible babies for whom a conclusive screening result for PKU is available within an effective timeframe. Eligible babies (denominator) are the total number of babies born within the reporting period and equal to or less than 364 days old. For the purposes of this standard, the cohort includes only babies who have moved in and become the responsibility of the CCG during the reporting period and for whom the CCG remains responsible on the last day of the reporting period. The effective timeframe is that a conclusive result for PKU is recorded on the child health information system equal to or less than 21 calendar days of movement in being recorded on the child health information system. A conclusive result is one of the following newborn screening status codes: 04 not suspected 07 not suspected, other disorders follow up 08 suspected Status code 02 declines are not included in the count for a conclusive result data are collected and reported alongside coverage data to help interpretation. Reported quarterly for key performance indicator (KPI) NB4 using PKU as proxy: Deadlines: 30 September (Q1), 31 December (Q2), 31 March (Q3), 30 11
12 June (Q4) (implementation date Q1 2014) Reported annually for babies born in the previous financial year (data to be collated between two and three months after financial year-end): Deadline: 30 June Data collected by: child health records departments Monitoring performance of: maternity and health visiting services, newborn screening laboratories and child health records departments Aggregated by: CCG 12
13 Standard 2: Timely identification of babies with a null or incomplete result recorded on the child health information system Objective Measure Thresholds Definitions Reporting To maximise uptake in the eligible population who are fully informed and wish to participate in the screening programme. The newborn screening programme relies on regular checks of the child health information system to ensure early identification of babies with a null or incomplete result, within an effective timeframe. Failsafe reports are produced and action taken to follow-up, according to local protocols. Is the child health information system capable of identifying babies with null or incomplete blood spot results within the standard? Acceptable 100% of child health records departments perform regular checks (ideally daily, minimum weekly) to identify babies with null values or status codes 01 specimen received in laboratory or 03 repeat/further sample required, for any of the five conditions, for all babies equal to or more than 17 days and equal to or less than 364 days. Achievable 100% of child health records departments perform regular checks (ideally daily, minimum weekly) to identify babies with null values or status codes 01 specimen received in laboratory or 03 repeat/further sample required, for any of the five conditions, for all babies equal to or more than 14 days and equal to or less than 364 days. There can be flexibility in frequency and age range of reports providing the method complies with the acceptable performance threshold eg daily check of babies equal to or more than 17 days and equal to or less than 364 days; weekly with an age range equal to or more than 11 days and equal to or less than 364 days. Child health records departments are asked to report annually whether they have a system in place that meets the standard: Deadline: 30 June 13
14 Standard 3: Baby s NHS number (or UK equivalent) is included on the blood spot card Objective To maximise accuracy of screening test. The NHS number (or UK equivalent) is a unique identifier that will aid the identification and tracking of babies as they progress through the screening pathway. Since April 2010 it has been mandatory for the NHS number to be used in England, ideally in a bar-coded label with an eyereadable NHS number. Number of samples received with baby s NHS number Number of samples received expressed as a percentage Measure Thresholds Definitions Reporting Number of samples received with baby s NHS number on a bar-coded label Number of samples received expressed as a percentage Acceptable 100% of blood spot cards received by a laboratory include the baby s NHS number. Achievable 95% of blood spot cards received by a laboratory have the baby s NHS number included on a bar-coded label. N/A Reported annually for samples received in the laboratory in the previous financial year: Deadline: 31 July Data collected by: newborn screening laboratories Monitoring performance of: maternity and health visiting services Aggregated by: maternity service, local authority (or UK equivalent) 14
15 Standard 4: Timely sample collection Objective Measure Thresholds Definitions Reporting Supporting guidelines To maximise accuracy of screening test. It is essential to begin the screening process promptly to give each screen positive baby the best possible chance of receiving early treatment. The blood spot sample should be taken on day 5 and in exceptional circumstances between day 5 and day 8 (day of birth is day 0). Number of first samples taken between 5 and 8 days after birth Number of first samples taken (excludes pre-transfusion admission samples) expressed as a percentage Acceptable Equal to or greater than 95%. Achievable Equal to or greater than 99%. This standard excludes pre-transfusion admission samples. Reported annually for samples received in the laboratory in the previous financial year: Deadline: 31 July Data collected by: newborn screening laboratories Monitoring performance of: maternity services Aggregated by: maternity service, local authority (or UK equivalent) The sample should be taken in accordance with the Guidelines for Newborn Blood Spot Sampling: 15
16 Standard 5: Timely receipt of a sample in the newborn screening laboratory Objective Measure Thresholds Definitions Reporting Supporting guidelines To maximise accuracy of screening test. All samples must arrive within the screening laboratory as soon as possible after the sample has been taken. This enables the laboratory to analyse the sample at the earliest opportunity and also reduces the risk of sample deterioration due to prolonged despatch. All samples received within 4 working days of sample collection All samples received in laboratory expressed as a percentage All samples received within 3 working days of sample collection All samples received in laboratory expressed as a percentage Acceptable Equal to or greater than 99% of all samples received within 4 working days. Achievable Equal to or greater than 99% of all samples received within three working days. The day the sample is taken is day 0 for this standard. Reported annually for samples received in the laboratory in the previous financial year: Deadline: 31 July Data collected by: newborn screening laboratories Monitoring performance of: maternity and health visiting services Aggregated by: maternity service, local authority (or UK equivalent) The sample should be taken in accordance with the Guidelines for Newborn Blood Spot Sampling: 16
17 Standard 6: Quality of the blood spot sample Objective Measure Thresholds To maximise accuracy of screening test. To obtain a good quality sample first time. Number of avoidable repeat requests Total number of first blood spot samples received in laboratory expressed as a percentage Acceptable The avoidable rate is less than or equal to 2%. Achievable The avoidable rate is less than or equal to 0.5%. A good quality blood spot sample is one that: is taken at the right time; has all data fields completed on the blood spot card; contains sufficient blood to perform all tests; has not been contaminated; and arrives in the laboratory in a timely manner. Avoidable repeat requests (numerator) is the total number of repeat (second or subsequent) samples requested by the laboratory during the reporting period because the previous sample was: Definitions Taken when the baby was too young (on or before day 4, where day of birth is day 0) (excluding pre-transfusion admission samples) Insufficient blood Unsuitable sample/card (eg on an expired blood spot card, contaminated, in transit for more than 14 days, anticoagulated sample, baby s NHS number and/or other details not accurately recorded on the blood spot card) Blood samples received in laboratory (denominator) are the total number of first blood spot samples received in the laboratory during the reporting period as part of the newborn blood spot screening programme. Reporting Reported quarterly for key performance indicator (KPI) NB2: Deadlines: 30 September (Q1), 31 December (Q2), 31 March (Q3), 30 June (Q4) Reported annually for samples received in the laboratory in the previous financial year: Deadline: 31 July 17
18 Data collected by: newborn screening laboratories Monitoring performance of: maternity and health visiting services Aggregated by: maternity service, local authority (or UK equivalent) Supporting guidelines The sample should be taken in accordance with the Guidelines for Newborn Blood Spot Sampling: 18
19 Standard 7: Timely taking of a repeat blood spot sample Objective Measure Thresholds To maximise accuracy of screening test. In order that treatment and clinical referral targets are met the timely receipt of a repeat/second blood spot sample is imperative. For each category defined: Number of repeat samples taken as defined for individual tests Number of repeat samples requested expressed as a percentage Acceptable Equal to or greater than 95% of repeat samples taken as defined. Achievable Equal to or greater than 99% of repeat samples taken as defined. Definitions A repeat sample from the avoidable repeat category must be taken within three calendar days of receipt of request A second blood spot sample for raised IRT should be taken ideally on day 21 (between day 21 and 28) A second blood spot sample for borderline TSH should be taken between seven and 10 days after the initial borderline sample A second blood spot sample for TSH should be taken from babies born at less than 32 weeks gestation (less than or equal to 31 weeks + six days) when they reach 28 days of age, or day of discharge home whichever is the sooner (day of birth is day 0) Reporting Reported annually for babies born in the previous financial year: Deadline: deferred until 30 June 2014 Data collected by: maternity services (following implementation of the Newborn Blood Spot Failsafe Solution) Monitoring performance of: maternity and health visiting services Aggregated by: maternity service, local authority (or UK equivalent) 19
20 Standard 8: CPA (screening) Objective Measure Thresholds Definitions Reporting To maximise accuracy of screening test. Laboratories undertaking newborn blood spot screening shall be accredited by Clinical Pathology Accreditation (UK) Ltd (CPA), now formally part of the United Kingdom Accreditation Service (UKAS). This shall include the NBS specialist assessment. DNA laboratories shall be a member of the UK Genetic Testing Network (UK GTN) and comply with the quality criteria laid down by the UK GTN Steering Group. The laboratory is CPA accredited. Acceptable The laboratory is CPA accredited (with the specialist assessment of NBS screening by the next full visit). CPA accredits pathology laboratories against a set of defined standards. These standards are allied to international standards for competence in medical laboratories ISO During the newborn screening specialist assessment CPA looks at both the ISO standards and the UK screening specific laboratory standards, as an integrated process. Read more information on the newborn screening laboratory standards included in the CPA assessment at: The assessment comprises a main visit to the laboratory by a team of independent assessors at intervals of every four years, with a surveillance visit by a regional assessor within two years of the main visit. Other visits may be undertaken to assess resolved noncompliances as part of continuing surveillance of enrolled laboratories. Laboratories must make available reports from accreditation services to screening programmes, the national team and commissioners. Laboratory accreditation can be checked at 20
21 Standard 9: Timely processing of all PKU, CHT and MCADD screen positive samples Objective Measure Thresholds Definitions Reporting To facilitate high quality and timely intervention in those who wish to participate. For each condition: Number of positive screening results available and clinical referral initiated within three or four working days Total number of positive screening results available expressed as a percentage Acceptable 100% of babies with a positive screening result have a clinical referral initiated within four working days of sample receipt by screening laboratory. Achievable 100% of babies with a positive screening result have a clinical referral initiated within three working days of sample receipt by screening laboratory. Applies to PKU, CHT and MCADD laboratories shall notify positive screening results in accordance with the Initial Clinical Referral Guidelines and Standards for each condition. This notification initiates the clinical referral of screen positive cases. Reported annually for samples received in the laboratory in the previous financial year: Deadline: 31 July Data collected by: newborn screening laboratories Monitoring performance of: newborn screening laboratories Aggregated by: newborn screening laboratory 21
22 Standard 10: CPA (diagnosis) Objective To maximise accuracy of diagnostic test. Follow up screening and diagnostic tests shall be undertaken in line with the diagnostic protocols. Measure Thresholds Definitions Reporting The laboratory is CPA accredited. Acceptable The laboratory is CPA accredited. CPA accredits pathology laboratories against a set of defined standards. These standards are allied to international standards for competence in medical laboratories ISO The assessment comprises a main visit to the laboratory by a team of independent assessors at intervals of every four years, with a surveillance visit by a regional assessor within two years of the main visit. Other visits may be undertaken to assess resolved non-compliances as part of continuing surveillance of enrolled laboratories. Read more information on the newborn screening and diagnostic laboratory standards included the CPA assessment at Laboratory accreditation can be checked at 22
23 Standard 11: Timely receipt into clinical care Objective Measure To facilitate high quality and timely intervention in those who wish to participate. Babies referred to specialist services are seen by condition-specific standard Total number of screen positive babies referred per condition expressed as a percentage A baby in whom PKU, CHT (on first sample) or MCADD is suspected should attend their first clinical appointment by: Acceptable 100% by 17 days of age Achievable 100% by 14 days of age A baby in whom CHT is suspected on a repeat blood spot sample that follows a borderline TSH should have their first clinical appointment by: Acceptable 100% by 24 days of age Achievable 100% by 21 days of age Thresholds A baby in whom CF is suspected should have their first clinical appointment by: CF suspected: two CFTR mutations detected: Acceptable 95% of babies seen by 28 days of age Achievable 100% of babies seen by 28 days of age CF suspected: none or one CFTR mutation detected: Acceptable 80% of babies seen by 35 days of age Achievable 100% of babies seen by 35 days of age A baby in whom SCD is suspected should be referred and registered with designated healthcare professional by: Acceptable 90% of babies by 8 weeks of age Achievable 95% of babies by 8 weeks of age A baby in whom SCD is suspected should attend local clinic by 3 months of age: Acceptable 90% of babies 23
24 Achievable 95% of babies Screen positive babies should be offered and prescribed penicillin V (or alternative) by 3 months of age: Acceptable 90% of babies Achievable 99% of babies Definitions Reporting N/A Reported annually for babies born in the previous financial year: Deadline: 31 July Data collected by: newborn screening laboratories (anonymised baby level data on all babies in whom a condition is suspected) and paediatric specialist centres Monitoring performance of: all service providers Aggregated by: newborn screening laboratory for PKU, CHT, CF and MCADD and by specialist centre for SCD 24
25 Standard 12: Timeliness of results to parents Objective Measure Thresholds Definitions Reporting To report newborn blood spot screening results which are screen negative for each of the five conditions in a timely manner to parents. Number of screen negative results letters despatched direct to parents from the child health records department by six weeks of age Number of babies that have newborn blood spot screening results which are screen negative for each of the five conditions recorded on the child health records department system within six weeks of birth expressed as a percentage Acceptable 100% A template for the screen negative results letter is available: Where normal results letters are not sent by child health records departments, area teams should provide evidence that the health visitors have given the results to parents and documented this in the PCHR. This could be achieved through local audit. Reported annually for babies born in the previous financial year: Deadline: 31 July Data collected by: child health records departments Monitoring performance of: all service providers Aggregated by: CCG 25
26 Abbreviations CCG CF CFTR CHT CPA DNA IRT ISO KPI MCADD NBS NHS PCHR PCT PHE PKU SCD TSH UKAS UK GTN UK NSC clinical commissioning group cystic fibrosis cystic fibrosis transmembrane conductance regulator congenital hypothyroidism Clinical Pathology Accreditation (UK) Ltd deoxyribonucleic acid immunoreactive trypsinogen International Organization for Standardization key performance indicator medium-chain acyl-coa dehydrogenase deficiency newborn blood spot National Health Service personal child health record primary care trust Public Health England phenylketonuria sickle cell disease thyroid stimulating hormone United Kingdom Accreditation Service UK Genetic Testing Network UK National Screening Committee 26
27 Appendix 1: Glossary This glossary is reproduced in part from the glossary in the UK NSC s Key Performance Indicators for Screening 2013/14 Version 1.12 ( Crown Copyright, 2013) (available at The UK NSC glossary defines terms that are consistent across the Quality Assurance standards/service objectives of all screening programmes. coverage decline diagnosis effective timeframe eligible The proportion of those eligible for screening who are tested. Coverage is a measure of the delivery of timely screening to an eligible population. Low coverage might indicate that: 1. not all eligible people have been offered screening 2. those offered screening are not accepting the test 3. those accepting the test are not being tested A response to an offer which indicates that a screening subject does not wish to proceed with a screening encounter A diagnostic process following a screen positive result to determine whether the subject is an affected case The period of time within which a screening test can be delivered such that a reliable result is most likely to be obtained. The effective timeframe for a test is usually specified in the policy / guidance for the relevant screening programme The population that is entitled to an offer of screening. The criteria for eligibility may be administrative, demographic, clinical, or any combination of these, and may take into account individual circumstances such as time of presentation to the screening service A co-ordinated network of healthcare professionals contracted to or working under the policies and procedures agreed with a single acute Trust, with collective responsibility for the provision of antenatal, intrapartum and postpartum care. A single maternity service may include: maternity service obstetric-led maternity units midwifery-led maternity units units responsible for the management of home births newborn intensive care units special care baby units paediatric intensive care units 27
28 offer refer reporting period result screen negative screen positive screening test total population A formal communication made by the screening service, giving a specific subject a realisable opportunity to be tested within an effective timeframe. An offer or invitation will only count as an offer if: 1. it reaches the subject 2. the subject is capable of understanding and acting upon it 3. the screening service has the capacity to realise it 4. it offers an opportunity of testing within an effective timeframe In the case of newborn screening programmes, the offer of screening is made to a responsible parent/guardian rather than the subject baby The process of securing further diagnosis/specialist assessment following a screen positive test. The date of referral is the first realisable assessment date offered by an appropriate specialist unit to a screening subject following a screen positive result. Allocation to a pending list or a referral subsequently cancelled by the specialist unit is not a referral The defined time period over which activities should be included in an aggregate audit or performance return. A reporting period can relate to any specified period but for routine reports is usually quarterly or annual. Most screening processes occur over a period of days or weeks, to allow a scan or sample to be assessed. In such cases, a single point in the process (such as the screening encounter) should be used to determine whether the process falls within a particular reporting period A formal and completed assessment of the risk of a condition being screened for in a subject, following a screening encounter. Usually a result will be screen positive or screen negative. Insufficient and unassessable indicate a failure to obtain a result, and are not themselves results An indication following a test that the condition being screened for is lowrisk / not suspected in a subject An indication following a test that the condition being screened is highrisk/suspected in a subject Testing people who do not have or have not recognised the signs or symptoms of the condition being tested for, either with the aim of reducing risk of an adverse outcome, or with the aim of giving information about risk A screening encounter leading to the determination of a conclusive result The population that meets the general criteria for inclusion within a screening programme. The criteria for inclusion within a screening programme may be administrative, demographic, clinical, or any 28
29 combination of these. Not everyone in the total population is likely to be eligible for screening (for example, those who present later than it would be possible to test) uptake The proportion of those offered screening who are tested. Uptake is a measure of the delivery of screening in the population to which it is offered. Low uptake might indicate that: 1. those offered screening are not accepting the test 2. those accepting the test are not being tested 29
30 Appendix 2: Newborn blood spot screening status codes This table of newborn blood spot screening status codes is reproduced from Newborn Status Codes v2.0 (available at Screening status code Suggested term displayed in child health system Comment 01 Specimen received in laboratory 02 (Condition screened for) Declined 03 (Condition screened for) Repeat/further sample required Same value applies to all screening tests (ie relates to the blood spot card) Additional data items to be provided with this status code and entered into child health systems electronically or by manual means: date sample taken date sample received in laboratory laboratory identifier Applies to each screening test individually Applies to each screening test individually. It is important for uses of the child health system to understand that this status code indicates that there is not a screening outcome associated with the condition screened for on this sample Two additional data items: Reason for repeat test and Repeat test comment are required where status code 03 applies Reason for repeat test will include the following pick list for all conditions screened for: too young for reliable screening too soon after transfusion (<72 hours) unsuitable sample insufficient sample 30
31 unsatisfactory analysis In addition Reason for repeat test will also include the following additional options for: Sickle: CHT: CF: transfused, repeat four months after last transfusion too premature for testing pre-term borderline result inconclusive Repeat test comment Free text field 04 (Condition screened for) Not suspected 05 (Condition screened for) Carrier 06 Sickle not suspected, carrier of other haemoglobin 07 (Condition screened for) Not suspected; Other disorders follow up 08 (Condition screened for) Suspected Applies to each screening test individually Applies to sickle cell and cystic fibrosis screening tests A free text comments field is required in association with this status code: (Condition screening for) Carrier comment This text field is required to enable additional information to be provided to Child Health if necessary Applies to sickle cell disease screening test only Applies to each screening test individually Applies to each screening test individually 09 (Condition screened for) Applies to each screening test individually 31
32 Not screened/screening incomplete* *this code applies to specimens collected and not analysed/result unreliable and in situations where a specimen is not collected 10 S not suspected (by DNA) No other Hb/thal excluded Additional data item required: Reason for no result will include the following pick list for all conditions screened for: died unreliable result moved out of area not contactable, reasonable efforts made too old for screening** **For CF, if no specimen is collected in this situation and it is a request for a second specimen (previously raised IRT) it is critical that a process is in place to ensure the baby is recalled for follow up Applies to sickle cell disease screening only 32
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