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1 Pregnancy and Newborn Screening: Newborn Hearing Draft Standards June
2 We are committed to equality and diversity. We have assessed these draft standards for likely impact on the nine equality protected characteristics as stated in the Equality Act 2010 and defined by age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, and sexual orientation. A copy of the impact assessment is available upon request from the Healthcare Improvement Scotland Equality and Diversity Advisor. Healthcare Improvement Scotland 2018 First published June 2018 This document is licensed under the Creative Commons Attribution-Noncommercial- NoDerivatives 4.0 International Licence. This allows for the copy and redistribution of this document as long as Healthcare Improvement Scotland is fully acknowledged and given credit. The material must not be remixed, transformed or built upon in any way. To view a copy of this licence, visit 2
3 Contents Introduction 4 How to participate in the consultation process 6 Summary of pregnancy and newborn screening standards: newborn hearing 7 Pregnancy and newborn screening standards: newborn hearing 8 Standard 1: Eligibility and coverage 8 Standard 2: Test performance and referral for diagnostic audiology assessment 11 Standard 3: Timeliness of diagnostic audiological assessment 13 References 15 Appendix 1: Development of the pregnancy and newborn screening standards 16 Appendix 2: Membership of the Pregnancy and newborn screening standards project group 17 Appendix 3: Possible screen outcomes 19 3
4 Introduction Background to the pregnancy and newborn screening standards Screening is offered to groups of the population to identify people who may be at an increased risk of a particular condition. Pregnancy screening is offered to help women make informed choices about their health and the health of their unborn baby during pregnancy. Newborn screening is offered to enable parents/carers make informed choices about the health of their newborn baby It is important that informed decisions are made in partnership with healthcare professionals at the respective stage of the screening programme. 1 Information on pregnancy and newborn screening, including national information produced by NHS Health Scotland, is provided to women throughout their pregnancy and following the birth of the baby. Healthcare Improvement Scotland supports NHSScotland s screening programmes by developing new and, where appropriate, revising existing standards or indicators. Following a request from the National Services Division (NSD) of NHS National Services Scotland and Scottish Government, Healthcare Improvement Scotland is revising the Clinical Standards for Pregnancy and Newborn Screening (October 2005). Newborn hearing screening The newborn hearing test is a simple test undertaken in the first few weeks after a baby is born; sometimes it takes place before the baby leaves the maternity unit. A trained healthcare professional undertakes the hearing screen and this can be done in one of two ways: a small, soft earpiece will be placed in the outer part of the baby s ear, or three small sensors will be placed on the baby s head and neck. A small, soft earpiece or headphone will be placed in or over the baby s ear. 2 A complete screen includes: babies who had a conclusive screening result, and babies who were referred to an audiology department because a newborn hearing screening result was inconclusive or contraindicated. Scope of the newborn hearing standards These standards apply to newborn hearing screening and cover: eligibility and coverage test performance and referral for diagnostic audiology assessment, and timeliness of diagnostic audiological assessment. These newborn hearing standards should be read alongside the general standards for pregnancy and newborn screening. The general standards are available on the Healthcare Improvement Scotland website ( 4
5 Newborn and infant physical examination (Public Health England, Newborn and Infant Physical Examination Screening Programme Handbook. 2016/2017) 3 is not covered in the suite of Scottish pregnancy and newborn screening standards. Revising the Healthcare Improvement Scotland Pregnancy and Newborn Screening Indicators (November 2013) and developing Key Performance Indicators (KPIs) are outwith the remit of this project. 4 Format of the standards All our standards follow the same format. Each standard includes: a statement of the level of performance to be achieved a rationale providing reasons why the standard is considered important a list of criteria describing the required structures, processes and outcomes what to expect if you are a person receiving care what to expect if you are a member of staff, and what the standards mean for organisations, including examples of evidence of achievement. Within the standards, all criteria are considered essential or required in order to demonstrate the standard has been met. The implementation of these standards will be for local determination. More information about the development of the standards is set out in Appendix 1. Terminology Wherever possible, we have incorporated generic terminology which can be applied across all health settings. The terms woman, women and individual are used within the standards to refer to the person or people receiving care or support. The term parent(s)/carer(s) is used within the standards to refer to the parent, caregiver or guardian who assumes legal parental responsibility for the newborn. The first antenatal contact can be defined as the first appointment with the midwife or hospital. Implementation These standards support NHS staff to assess and support quality improvement in NHSScotland pregnancy and newborn screening services. 5
6 How to participate in the consultation process We welcome feedback on the draft standards and will review every comment received. We may use several different methods of consultation during the development of the draft standards, including: wide circulation of the draft standards to relevant professional groups, health service staff, social care staff, voluntary sector organisations and individuals targeted engagement with the public (such as people who use services and carers) and service providers (including staff at the point of care), and an online survey tool ( For more information, please contact: Wendy McDougall Project Officer Healthcare Improvement Scotland Delta House 50 West Nile Street Glasgow G1 2NP Phone: Submitting your comments Responses to the draft standards should be submitted using our online survey tool. The consultation closes on Thursday 2 August If you would like to submit your comments using a different format, please contact the standards and indicators team on the address provided above. Consultation feedback At the end of the consultation period, all comments will be collated and the project group will respond to each comment received on the suite of draft standards. The response will explain how the comments were taken into account in producing the final standards. A summary of the responses to the consultation will be made available on the Healthcare Improvement Scotland website ( and from Wendy McDougall, Project Officer. The suite of pregnancy and newborn screening final standards will be published in winter
7 Summary of pregnancy and newborn screening standards: newborn hearing Standard 1: Standard 2: Standard 3: All newborn babies are offered newborn hearing screening for their baby. All newborn hearing screening is high quality, maximising effectiveness at each stage of the screening process and minimising harm. All newborn babies requiring audiological assessments are referred and seen in a timely manner. 7
8 Pregnancy and newborn screening standards: newborn hearing Standard 1: Eligibility and coverage Standard statement All eligible newborn babies are offered newborn hearing screening. Rationale Babies are offered newborn hearing screening and, with written consent from a parent(s) of the baby, are tested within an agreed timeframe. 5 Coverage can be defined as a measure of the delivery of screening to an eligible population. 5 Note: Corrected age is the calculation of the baby s actual age in weeks minus the number of weeks the baby was preterm. Criteria 1.1 NHS boards have systems and protocols in place to ensure all newborn babies: are registered within the NHS board of residence this is recorded on the Child Health Information System (CHIS), and have processes in place with child health/screening department to identify and follow-up children with no recorded screening outcome. 1.2 NHS boards have systems and protocols in place for newborn hearing screening, which includes: offering screening at the most appropriate time timescales and methods for communication of the result providing opportunities to discuss with parents/carers the results, further management and/or further testing, and processes for follow-up diagnostic assessment. 1.3 Protocols are in place to undertake delayed screening for babies who are: ill, or born prematurely. 1.4 For pre-term babies, a minimum of 97% of babies will complete newborn hearing screening by 4 weeks corrected age 6. 8
9 1.5 Each NHS board has systems and protocols in place to identify and ensure appropriate management for: all babies who do not attend for screening, and all resident babies who were born outwith their NHS board area. 1.6 Each NHS board has a failsafe protocol for all resident babies to ensure that follow-up action is taken where newborn hearing screening has been accepted but no result has been recorded. What does the standard mean for the parent/carer of the screened baby? Parents/carers will: - be offered newborn hearing screening at the appropriate time - be advised of the newborn hearing screening options - receive information in a language and format appropriate to their needs, and in sufficient time to allow for informed choice - be offered the opportunity to discuss newborn hearing screening and results with an appropriate healthcare professional and all decisions will be respected, and - have their baby s newborn hearing test completed within the agreed timescales. What does the standard mean for staff? Staff can demonstrate knowledge of: - the eligibility criteria for newborn hearing screening - the patient pathway - the process for opt-in and opt-out for newborn babies, and - benefits and risks of screening. Staff will: - provide information and support to parent(s)/carer(s) that is sensitive and respects their choices, and - ensure decisions to accept or decline screening and/or referral for appropriate assessment is recorded and shared appropriately. What does the standard mean for the NHS board? The NHS board will: - have an effective system in place to ensure all babies are offered newborn hearing screening within agreed timescales - regularly check CHIS to identify babies with a null or incomplete result, and - monitor the newborn hearing screening pathway to ensure it is timely. 9
10 Practical examples of evidence of achievement (NOTE: this list is not exhaustive) Monitoring reports detailing completion of the screening pathway within an agreed and defined reporting period. Protocols for eligibility and invitation to the pregnancy and newborn screening service. Evidence that a baby undergoes screening if the parent/carer wishes their baby to have screening. Examples of training documents. 10
11 Standard 2: Test performance and referral for diagnostic audiology assessment Standard statement All newborn hearing screening is high quality, maximising effectiveness at each stage of the screening process and minimising harm. Rationale Newborn hearing screening is a process which may involve up to three screening stages. There are two different screening protocols in operation in Scotland. One protocol uses only Automated Auditory Brainstem Response (AABR) testing and can have up to two stages: a first AABR followed by a second if clear responses are not obtained on the initial test. The second protocol uses Automated Otoacoustic Emission (AOAE) testing followed by AABR if required. It can have up to three stages: a first AOAE followed by a second if clear responses are not obtained on the initial test, with an AABR being performed if clear responses are not obtained on the second AOAE. A hearing screening record should be updated for every baby at each stage of the screen. 5 Complete screens are the total number of eligible babies for whom a decision about referral or discharge from the screening programme is made. Criteria 2.1 The proportion of babies who have a no clear response in one or both ears during the first otoacoustic emissions (AOAE1) hearing test is in line with national guidance The proportion of well babies who have a no clear response in one or both ears during the second otoacoustic emissions (AOAE2) hearing test is in line with national guidance The proportion of well babies who have a no clear response in one or both ears during the first automated auditory brainstem response (AABR1) hearing test is in line with national guidance All babies with a screen identified as no clear response in one or both ears are referred for diagnostic assessment in line with national guidance On completion of the screening process, the proportion of babies requiring referral for diagnostic audiology assessment is in line with national guidance. 6 11
12 What does the standard mean for the parent/carer of the screened baby? Parents/carers will: - receive high quality newborn hearing screening for their baby - receive information in a language and format appropriate to their needs - be fully informed and involved in all aspects of the screening process and given a full explanation if further hearing screening tests are required - be offered the most appropriate care, and/or management in the event of a request to return for a further appointment on completion of the hearing screening process, and - be offered the opportunity to discuss the newborn hearing screening result with an appropriate healthcare professional to allow them to make an informed choice that will be respected. What does the standard mean for staff? Staff can demonstrate: - the patient pathway - how to access the CHI number for all babies undergoing screening, and - what is needed to collect high quality samples for processing. What does the standard mean for the NHS board? The NHS board will: - ensure that standards of care for the delivery of screening are in place and are monitored for compliance with national standards and guidance, and - ensure continuing professional development relevant to staff roles is monitored and access is provided to approved training. Practical examples of evidence of achievement (NOTE: this list is not exhaustive) Reports from the screening management systems detailing referrals from each stage of the screen. Exception reports. 12
13 Standard 3: Timeliness of diagnostic audiological assessment Standard statement All babies requiring audiological assessments are referred and seen in a timely manner. Rationale Babies with a no clear response result in one or both ears, or incomplete result (see Appendix 3) are referred for immediate onward referral for audiological assessment. 5 Audiological assessment and follow-up of babies is in line with national guidance. 6 Timely referral and assessment is essential in order to ensure that any babies with a permanent significant hearing loss or impairment are identified at the earliest possible age enabling appropriate support and management for the child and family and to give babies the best chance of reaching their full developmental potential. Criteria 3.1 Babies who require diagnostic assessment are offered an appointment that is within 4 weeks of screen completion or by 44 weeks gestational age. 3.2 Babies who require diagnostic assessment attend for assessment within 4 weeks of screen completion or by 44 weeks gestational age. What does the standard mean for the parent/carer of the screened baby? Parents/carers will be: - offered newborn hearing screening at the appropriate time - fully informed and involved in all aspects of the screening process - offered the most appropriate care, and/or treatment in the event of a positive result, and - offered the opportunity to discuss newborn hearing screening with the appropriate healthcare professional and all decisions will be respected. What does the standard mean for staff? Staff can demonstrate knowledge of the: - skills to undertake auditory assessment in line with professional competency frameworks, and - referral pathways and processes in the event of a refer response on completion of the newborn hearing screen. 13
14 What does the standard mean for the NHS board? The NHS board will: - ensure that standards of care for the delivery of screening are in place and are monitored for compliance with national standards and guidance - ensure continuing professional development relevant to staff roles is monitored and access is provided to approved training - ensure that audiology departments have the capacity to provide timely appointments to all babies referring from the newborn hearing screen, and - ensure there is appropriate capacity to assess and treat within appropriate timescales. Practical examples of evidence of achievement (NOTE: this list is not exhaustive) Audit of timescales of appointment offered and attendance at audiology department recorded. Exception reports. 14
15 References 1. NICE. Antenatal care for uncomplicated pregnancies [cited 2018 Mar 22]; Available from: 2. NHS Inform. Newborn hearing test [cited 2018 May 08]; Available from: 3. Public Health England. Newborn and infant physical examination screening programme handbook [cited 2018 May 24]; Available from: 4. Healthcare Improvement Scotland. Pregnancy and Newborn Screening [cited 2018 Apr 05]; Available from: child/pregnancy newborn_screening.aspx. 5. Public Health England. NHS public health functions agreement Service specification no. 20 NHS Newborn Hearing Screening Programme [cited 2018 Mar 22]; Available from: 6. Public Health England. NHS Newborn Hearing Screening Programme - Standards 2016 to [cited 2018 May 21]; Available from: chment_data/file/685452/nhsp_standards_2016_-_17.pdf. 15
16 Appendix 1: Development of the pregnancy and newborn screening standards The pregnancy and newborn screening standards have been informed by current evidence, best practice recommendations and developed by group consensus. Development activities To ensure each standard is underpinned with the views and expectations of both health and social care staff, third sector representatives, individuals and the public in relation to pregnancy and newborn screening information has been gathered from a number of sources and activities, including: a scoping meeting in September 2016 with a subset of development group members a scope engagement exercise in October 2016 literature review and equality impact assessment, and three standards development group meetings between September 2017 and February A project group, chaired by Dr Surindra Maharaj, Consultant Obstetrician, NHS Lanarkshire, was convened in September 2017 to consider the evidence and to help identify key themes for standards development. Membership of the project group is set out in Appendix 2. Quality assurance All project group members were responsible for advising on the professional aspects of the standards. Clinical members of the project group were also responsible for advising on clinical aspects of the work. The chair was assigned lead responsibility for providing formal clinical assurance and sign-off on the technical and professional validity and acceptability of any reports or recommendations from the group. All project group members made a declaration of interest at the beginning stages of the project. They also reviewed and agreed to the project group s Terms of Reference. More details are available on request from hcis.standardsandindicators@nhs.net Healthcare Improvement Scotland also reviewed all of the standards documents as a final quality assurance check. This ensures that: the standards are developed according to agreed Healthcare Improvement Scotland methodologies the standards documents address the areas to be covered within the agreed scope, and any risk of bias in the standards development process as a whole is minimised. For more information about Healthcare Improvement Scotland s role, direction and priorities, please visit: 16
17 Appendix 2: Membership of the Pregnancy and newborn screening standards project group Name Position Organisation Dr Surindra Maharaj (Chair) Karen Boyle Consultant Obstetrician Newborn Hearing Screening Manager in Glasgow 17 NHS Lanarkshire NHS Greater Glasgow and Clyde Dr Theresa Carswell Screening Coordinator NHS Ayrshire & Arran Dr Alison Cozens Consultant in Paediatric Inherited Metabolic Medicine NHS Lothian Dr Peter Fowlie Consultant Paediatrician NHS Tayside Elaine Gardiner Programme Lead MSc Medical Ultrasound/ Diagnostic Imaging Lecturer Belinda Henshaw Lyn Hutchison Senior Programme Manager, Quality Assurance Senior Programme Manager Glasgow Caledonian University Healthcare Improvement Scotland National Specialist and Screening Services Directorate (NSD) NHS Lothian Linda Kerr Child Health Systems Manager Dr Peter Kiehlmann General Practitioner NHS Grampian Rachel Le Noan Policy Officer Down's Syndrome Scotland Morag Liddell Neonatal Nurse Specialist NHS Greater Glasgow and Clyde Kelly Macdonald Dr Ann MacKinnon Programme Manager, Standards and Indicators Team Associate Specialist (Paediatric Audiology)/ Newborn Hearing Screening Manager Healthcare Improvement Scotland NHS Tayside Wendy McDougall Project Officer, Standards and Indicators Team Healthcare Improvement Scotland Dr Louisa McIlwaine Consultant Haematologist NHS Greater Glasgow and Clyde Karen McIntosh Scottish Co-ordinator Antenatal Results & Choices Paul McIntyre Consultant Virologist NHS Tayside Sarah Manson Fiona Mundell Senior Policy Manager, National Screening Programmes Lead Midwife, Fetal Medicine & Antenatal Screening Scottish Government NHS Highland
18 Name Position Organisation Paula O Brien Administrative Officer, Standards and Indicators Team Healthcare Improvement Scotland Fiona Paton Senior Health Visitor NHS Dumfries & Galloway Elaine Pirrie Fetal Services & Early NHS Ayrshire & Arran Pregnancy Lead Midwife Dr Andrew Powls Consultant Neonatologist NHS Greater Glasgow and Clyde Catherine Shearing Principal Grade Clinical NHS Lothian Scientist Laboratory Sarah Smith Principal Healthcare Scientist Laboratory NHS Greater Glasgow and Clyde Tasmin Sommerfield Consultant in Public Health Medicine/Screening Coordinator NHS Lanarkshire David Steel Rev Hugh M Stewart Margaretha van Mourik Programme Associate Director Patient representative/ public partner Consultant/Lead Genetic Counsellor National Specialist and Screening Services Directorate (NSD) Healthcare Improvement Scotland NHS Greater Glasgow and Clyde 18
19 Appendix 3: Possible screen outcomes Pregnancy and Newborn Screening Draft Standards: Newborn Hearing June 2018 The screening outcomes for a complete screen within the newborn hearing screening information systems are as follows. Screening result clear response Screening outcome no follow-up required no clear response incomplete targeted follow-up required bilateral referral unilateral referral baby/equipment reason equipment malfunction equipment not available lack of service capacity screening contraindicated baby unsettled The screening outcomes indicating that a referral to audiology department is required are as follows. Screening result no clear response Screening outcome bilateral referral incomplete unilateral referral baby/equipment reason equipment malfunction equipment not available lack of service capacity screening contraindicated baby unsettled 19
20 You can read and download this document from our website. We are happy to consider requests for other languages or formats. Please contact our Equality and Diversity Advisor on or Healthcare Improvement Scotland Edinburgh Office Gyle Square 1 South Gyle Crescent Edinburgh EH12 9EB Glasgow Office Delta House 50 West Nile Street Glasgow G1 2NP
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