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Universal Neonatal Hearing Screening Scottish Implementation April 2001 1. Introduction 1.1 Permanent congenital hearing impairment (PCHI) is a condition affecting about 1.1 per thousand live births. On the basis of some 57,000 live births per annum, one may anticipate some 60-65 new cases of PCHI per annum in Scotland. It is more common than other conditions routinely screened for at birth such as congenital hypothyroidism (1 in 25,000) and Phenylketonuria (1 in 14,000). Universal neonatal hearing screening (UNHS) is more health-effective in the detection of hearing impairment in children than present screening methods, the infant distraction test (IDT) and targeted neonatal hearing screening. Evidence-based health technology assessment has demonstrated conclusively that the detection and treatment of permanent congenital hearing impairment (PCHI) before 6 months of age results in substantially greater speech acquisition with consequent benefits that are likely to be life-long in duration and include social and psychological well-being, educational achievement and employment prospects. UNHS offers detection of PCHI at or shortly after birth with a greater degree of accuracy and completeness of population coverage than present screening methods and at an overall cost per case of PCHI detected less, or at worst equal to present funding levels. Background 1.2 In December 1999 the Children’s Sub-Group of the National Screening Committee (NSC) recommended the introduction of UNHS. Although the recommendation was based on robust evidence from international and UK studies, the NSC recognised that there were issues and concerns surrounding the feasibility and management of the service which merited exploration through piloting. 1.3 In July 2000 the Department of Health announced its intention to pilot Universal Neonatal Hearing (UNHS) to replace the Infant Distraction Test (IDT). At this time, the Scottish Executive Health Department asked National Services Division (NSD) to conduct a review of the resource implications associated with implementing such a programme in Scotland and options for its introduction. Specific issues to be taken into account were to include: the high number of initial false positive tests anticipated NSD/E15/4/6\FinalReport-April2001 1 the programme’s ability to cope with early discharge of babies from hospital the lack of national validation criteria, quality standards, performance management and monitoring criteria. the ability of the paediatric audiology service and deaf educators to cope with the service implications. Approach to Task 1.4 The Medical Director and the Nursing and Quality Adviser of NSD have undertaken the review with assistance from the screening team at NSD and Medical Officers at SEHD. We have sought to determine existing practice in Scotland and the resources that are available at present with a view to considering what additional resources will be needed for UNHS to be successfully implemented in Scotland. 1.5 Visits have been made to several audiology departments around Scotland to gather information on current practice and to gauge professional opinion. A questionnaire was sent to Directors of Public Health and copied to Commissioners of Child Health Services in Health Boards and Medical Directors of Trusts at the end of January 2001. The information obtained from responses has been of assistance in the review process and is summarised in section 4. 1.6 From these enquiries it became apparent that the greatest concerns regarding the impact of UNHS implementation, in terms of resources, were not in relation to the screening process itself but to the potential burden on professional audiology staff who would be seeing children at an earlier age and, perhaps, in greater numbers than at present. There was concern that this could have implications for the numbers, recruitment, retention and training of the professional groups concerned (audiologists and audiological scientists). For this reason, it was considered necessary to explore with providers of higher education, Scotland’s teaching and training capability in these areas. 2. Current Situation in England 2.1 Invitations were issued to Health Authorities in October 2000 to apply to become a pilot site. A selection panel with members chosen from professional and voluntary bodies was established and selected 20 sites to participate in the pilot. It is a requirement that pilot sites use the oto- acoustic emission (OAE) test as the primary screening test. 2.2 The 20 sites selected should afford a cross section in terms of demographics and present position with regard to hearing screening. The pilots will commence in four stages. The first stage is scheduled to begin in April 2001, with the other cohorts coming on stream in July, September and November this year. NSD/E15/4/6\FinalReport-April2001 2 2.3 Central funding is available for equipment, information technology, training and project management. Funding is not available for the provision of service. 2.4 The Institute for Hearing Research (IHR) at the Medical Research Council are leading project management and implementation work and the National Deaf Children’s Society are developing information leaflets for parents for use and evaluation at the pilot sites. 2.5 A limited tendering exercise has been undertaken for the evaluation of the project. This has recently been awarded to Professor John Bamford of Manchester University. 3. OAE versus AABR as the screening test 3.1 Although the English pilot sites are required to use OAE as the primary screening test, one Scottish audiology service (serving Highland and the Western Isles) is of the clear view that AABR represents a better option, at least in the circumstances of their service. This service has secured funding under the Remote and Rural Areas Resource Initiative (RARARI) to pilot UNHS using AABR as the primary screening test. This initiative is under way. Consideration, therefore needs to be given to the relative resource implications and benefits of these two approaches to primary screening. a. Oto-acoustic Emissions (OAE) OAE testing is a non-invasive test, which tests the function of the hearing receptor organ, or cochlea, but does not test the functionality of the connections between the cochlea and the hearing centres in the brainstem. The test can be performed at the bedside and a pass or fail response is recorded. OAE has a sensitivity (ability to correctly identify babies who truly have hearing deficit) of 100%. The specificity (ability to correctly identify babies with normal hearing) of OAE is, however, reported as being 82-87%. The false positive rate for OAE is particularly high in babies less than 48 hours old when the ear canals may be blocked with material left over from birth. Babies who “fail” the screening test require to undergo further investigation with a consequent impact on specialised resources as well as the potential for distress and worry for parents For every 1000 babies tested, 130 to 180 will require further testing out of which one will be found to be suffering from PCHI. Nevertheless, OAE is, for the present, regarded by the National Screening Committee as the established primary screening test and is mandatory for centres participating in the English pilot project. b. Automated Auditory Brainstem Response (AABR) Automated Auditory Brainstem Response is an elaboration of a conventional (ABR) system. Both systems rely on careful NSD/E15/4/6\FinalReport-April2001 3 application of electrodes and earphones. This makes for a more complex process than oto-acoustic emission testing but information on the whole auditory system is obtained including the functionality of connections to the hearing centres in the brainstem. Ambient noise (electrical and acoustic), physiological noise and movement can affect the response so that more care needs to be taken in carrying out the test than is the case with OAE. The primary difference between automated ABR and conventional ABR is in the interpretation of the response. Conventional ABR provides objective information but interpreting the output requires professional expertise and judgement on the part of an audiology clinician. Automated ABRs depend on an internal algorithm that interprets the incoming signal and determines if the response is a 'pass' or a 'fail' by statistical techniques. AABR testing can be performed with portable equipment. This equipment has not been widely used in the United Kingdom to date but is claimed by its proponents to be the test of choice in 80% of USA hospitals offering UNHS. The sensitivity and specificity of the AABR test are claimed by commercial manufacturers of AABR machines to be 99.96% and 98.7 respectively although it is not wholly clear what they are using as their proxy for the true hearing status of subjects examined. In contrast, the National Screening Committee quote sensitivity and specificity rates of 89% and 82-87% respectively for conventional ABR but do not address the role of AABR as a screening tool at all. 3.2 Both tests are safe, simple and inexpensive although AABR has higher start-up costs because of the higher capital cost of the equipment required. By contrast, OAE may pose a greater burden on skilled staff who carry out confirmatory diagnostic testing if it turns out to be the case that the technique has a significantly higher specificity than AABR and requires second level screening by ABR and formal confirmatory testing, both being performed by skilled professionally trained staff. 3.3 In any event, Scotland has an established UNHS pilot service based on AABR covering Highland and the Western Isles. Whether or not the funding of this programme is transferred from RARARI to a UNHS masthead, it would seem sensible to ensure that the experiences gained in this pilot, currently funded to run for 3 years, should be included in the overall evaluation of an initial phase of UNHS introduction in Scotland. It is all the more important that this should be encouraged in the light of the fact that the English pilot does not afford such an opportunity. 4. Survey of Health Board-based Children’s Hearing Services 4.1 A questionnaire – a copy of which is attached as Annex 1 - modified from one used as part of the information gathering exercise undertaken in England to identify the state of preparedness of Health Authorities for the introduction of UNHS, was circulated to Directors of Public Health in the 15 Scottish Boards. It was recognised that the NSD/E15/4/6\FinalReport-April2001 4 Island Boards receive the greater part of their specialist children’s hearing services from mainland Boards and it was not anticipated that the former would submit responses. Of the mainland Boards, 10 submitted consolidated responses and one (Argyll & Clyde HB) submitted 3 responses from discrete service elements within their Board area. The responses are summarised in a set of tables at Annex 2. 4.2 Two clear messages emerge from these analyses. Firstly, there are wide variations in the way that services are configured across Scotland; secondly, there is strong evidence of care and thought in the arrangements for the delivery of services and co-ordination with other agencies in most areas described. 4.3 Targeted neonatal hearing screening is reported in 7 Boards although the coverage of births is patchy. For example, in Greater Glasgow some maternity hospitals but not all have instituted targeted neonatal screening. 4.4 Should a centrally co-ordinated UNHS programme be instituted, there will be a need for a substantial measure of harmonisation of the arrangements that link such a programme to other parts of NHSScotland and to other agencies. This would take the form of agreed common policies, protocols and standards. 5. Workload Needs Assessment 5.1 There were 57,000 live births in Scotland in 1998. This was the lowest number recorded since civil registration commenced in 1855 and represented a drop of 11,500 annual births since 1980. Unpublished figures indicate that the number of births fell further in 1999 and 2000. For the purposes of planning, the number of live births to be screened is taken to be 57,000 per annum, distributed as per the distribution by Health Board-based service in 1998. This may be on the high side in the light of recent figures. Similarly, the sensitivity and specificity of OAE testing are taken to be 100% and 82-87% respectively. 5.2 Table 1 shows the impact of introducing OAE-based UNHS, by individual Health Board-based service in terms screening and confirmatory tests. NSD/E15/4/6\FinalReport-April2001 5 Table 1 Health Board-based Service Primary Screens Confirmatory Tests Argyll & Clyde 4600 690 Ayrshire & Arran 4,000 600 Borders 1000 150 Dumfries & Galloway 1,500 225 Fife 2,500 375 Forth Valley 3,200 480 Grampian* 6,400 960 Greater Glasgow 10,200 1530 Highland** 3,200 480 Lanarkshire 6,600 990 Lothian 8,800 1320 Tayside*** 5,300 795 Scotland 57300 8595 Note: * includes Orkney & Shetland ** includes Western Isles and Moray *** includes parts of Fife 5.3 The population to be screened is represented by the annual number of live births and this is assumed, for the purposes of planning, to remain constant irrespective of whether or when UNHS is introduced. Impact of UNHS on current service 5.4 Screening currently takes the form of the infant distraction test, carried out by Health Visitors in the community as part of an overall child surveillance programme, augmented in most areas by targeted neonatal hearing screening carried out by audiology staff for the most part. The impact of transferring this work to a new cadre of semi-skilled screeners will be to: a. release a Health Visitor resource which, although valuable to the NHS as a whole, will have little utility in terms of neonatal hearing; b. release an Audiologist resource which will be available to service any additional burden on audiology services consequent on the introduction of UNHS. 5.5 To be fully effective, confirmatory testing should be carried out at about 44 weeks gestation (4 weeks of age in a full term birth; somewhat later in premature births). For this reason, it is important that waiting times do not develop for confirmatory testing. It is a prerequisite of establishing UNHS, therefore, that there is a clear path from screening to confirmatory testing and that confirmatory testing is fully resourced by Health Boards and Trusts from the outset. NSD/E15/4/6\FinalReport-April2001 6 5.6 Targeted neonatal hearing screening has been shown to pick up some 50% of PCHI so that, in areas where targeted screening takes place, the additional cases ascertained in the neonatal period by UNHS are likely to double the burden of confirmatory testing in this stage. 5.7 The effects of the introduction of UNHS are as follows: a. a cohort of children who would have failed targeted neonatal hearing screening will be ascertained by UNHS within the same timeframe as currently applies; this is likely to represent around 50% of all neonatal ascertainments (ie around 7-8% of births) becoming candidates for confirmatory testing. b. a further cohort of children of about the same size (ie 7-8% of births), who would have been ascertained by IDT at age 6+ months will be ascertained in infancy. c. Over the first 6 months or so of a new UNHS programme, there will continue to be referrals from IDT testing of births in the 6 months prior to the introduction of the programme. The number of such referrals will vary depending on the local “fail” rate of IDT. This can vary in different services between 10 and 20% of children tested. On this basis, one would expect a continuation of referrals from IDT at around 10-20% of monthly births each month for 6 or so months. 6. Staffing Implications Screening 6.1 The screening tests are not complex and can be carried out by staff who have no special knowledge or skills in hearing science but who are good with babies and can assimilate the basic training required. It is not critical whether they have other clinical skills or not. The OAE screening test is more time consuming than the AABR test and can take up to 40 minutes per child, requiring the baby to be settled or asleep during the test. AABR is quicker and less demanding of the child’s level of activity. The level of resource and cost attaching to screening will depend on the staff group recruited to the task in specific settings. This may range from midwives or other professional care workers to lay staff recruited and trained specifically for the task depending on local circumstances. Phlebotomists come to mind by way of an example of the latter approach. This is more likely to be implemented in large maternity units where the number of births would justify the necessary pool of 2-3 trained individuals. While the objective should be to carry out screening in hospital (i.e. prior to discharge) wherever practicable, there will need to be failsafe arrangements to pick up the minority of cases where this is not achieved. This could be achieved through the community midwife service. NSD/E15/4/6\FinalReport-April2001 7 Confirmatory testing 6.2 Confirmatory testing is a skilled task, requiring the personal involvement of a senior medical technical officer (audiologist) or clinical scientist. The extent to which the introduction of universal screening will pose temporary or permanent additional burdens on this staff group depends on the number of babies who “fail” the screening test(s) and the time taken to carry out diagnostic testing in each case. It is clear that the introduction of UNHS in infancy will at the very least impose strains in the system consequent on the fact that, for a period of time, two cohorts of children will be coming through for confirmatory testing, those screened under the new programme and those tested by the current distraction test at 6-9 months. This situation will prevail during the period of rollout of UNHS nationally and for about 6-12 months after its completion. The impact in any particular Health Board area or unit of hearing services will be of the order of 6– 12 months. Follow-up 6.3 Once a child has been confirmed as having a hearing loss they will require ongoing care from their local paediatric audiology department from the age of about three months when they can be fitted with hearing aids. If the child has a profound hearing loss they may be a suitable candidate for cochlear implantation. This operation is ideally performed before the child is five years of age. Support from Rehabilitation Specialists 6.4 Depending on the severity of the hearing loss the child may require the support of rehabilitation specialists (e.g. teacher of the deaf, speech & language therapist). The child’s level of hearing impairment will also help determine their educational requirements, which may be in a main stream school with or without assistance from a teacher of the deaf, or in a school for the deaf. Training 6.5 Staff with no previous audiological training can carry out initial screening. They need a familiarity with the equipment used which can be acquired through on the job training and they require to comfortable handling small babies. Experience and training in speaking to parents is essential. 6.6 Confirmation testing is a skilled task and requires the skills of a Clinical Scientist with Physiological Measurement experience or an Audiologist trained in physiological measurement. NSD/E15/4/6\FinalReport-April2001 8 Clinical Scientist 6.6.1 The Clinical Scientist is responsible for carrying out the second level of diagnostic testing and interpreting the data (also audit and calibration). Funds for Clinical Scientists training (Clinical Physicists and Audiological Scientists) in Scotland are channelled through NSD. There are distinct differences between the two professions. 6.6.2. Clinical Physicists must have an Honours Degree in a Physical Science and a MSc in Clinical Physics. MSc Courses are available at Glasgow and Aberdeen Universities. Graduates are then required to undertake professional training at an accredited centre (there are several in Scotland) for two years and sit IPEM (Institute of Physics and Engineering in Medicine) examinations for the IPEM Diploma. This is usually followed by a programme of Advanced Training and Responsibility (PATR). 6.6.3. Audiological scientists usually have a first degree in a science subject and are then required to undertake an MSc in Audiology followed by a year’s clinical work. MSc courses in Audiology are not available in Scotland. Graduates then sit the examination for Certificate in Audiological Competence (CAC), which is organised by the British Association of Audiological Scientists. Any trainee registering for the CAC must now undertake their training at an accredited centre. This requires there to be at least one audiological scientist of grade 17 or above working in the centre. Previously this training was provided in Aberdeen but they no longer have a sufficiently senior scientist in their department. Although Lothian University Hospitals NHS Trust have senior scientists working in their adult audiology department, the paediatric service is provided by Audiologists and this does not meet the requirements for accreditation as a training centre. Audiologist 6.6.4 Confirmatory testing and hearing-aid fitting is usually carried out by a Medical Technical Officer in Audiology (i.e. an Audiologist). Some senior audiologists are also responsible for physiological measurement. At present audiologists’ education involves a broad based training to National Certificate or Higher National Certificate with a minimum of two years clinical placement. Although there are at present six schools offering audiological training in the UK, there are none in Scotland following the closure of the Glasgow School of Audiology several years ago. A BSc in audiology is planned as the future basic qualification for audiologists. NSD/E15/4/6\FinalReport-April2001 9 6.7 Recently both Queen Margaret University College in Edinburgh and Glasgow Caledonian University have expressed an interest in providing the BSc course for Audiologists should a need be confirmed and funding be available but no firm plans have as yet been established. 7. Resources 7.1 The primary resource issue associated with introducing Universal Neonatal Hearing Screening is one of ensuring the availability of sufficient skilled staff to cope with a short-term increase in confirmatory testing during the first 6 - 12 months of the introduction of UNHS in an area. 7.2 The introduction of UNHS will however release some offsetting resources in terms of the health visitors previously performing the IDT on all children, except those covered by targeted neonatal screening, and the audiologists currently involved in performing the targeted neonatal screening. 7.3 The same audiological resource will be required for those children who have a PCHI that would have been identified with targeted screening and those failing the IDT in the six months following the introduction of UNHS. 7.4 Additional resource will however be required from the introduction of UNHS for trained, but not highly skilled staff, to perform the neonatal screening tests on the expected 57,000, or fewer, babies born annually in Scotland. Whilst individual Health Boards and Trusts will want to determine the best approach to provide this service, it can be assumed that major maternity hospitals will need to employ two to three part time staff at a grade comparable to phlebomists. 7.5 In summary, additional audiological resource will initially be required to perform confirmatory testing on those children who fail UNHS but who would not have been included in targeted screening. Once the backlog of children born after the introduction of UNHS and who have failed their IDT have had their confirmatory tests performed, the only additional audiology input required will result from the fact that children with a hearing loss will be identified earlier and will benefit from audiological care from about the age of three months as opposed to the current situation where they would be identified after their IDT. 7.6 Although the exact amount of additional funding needed for audiologists is difficult to quantify it can be assumed to be minimal and should be able to be offset by no longer having audiologists involved in first line targeted screening. NSD/E15/4/6\FinalReport-April2001 10 8. Implementation of a National Screening Programme for Universal Neonatal Hearing Screening 8.1 There are two elements to the implementation of UNHS as part of a UK initiative: Getting the infrastructure in place to support neonatal screening in general – this can be done in conjunction with the introduction of screening for PKU / hypothyrodism; Getting a national UNH screening programme in place – keeping in step with developments in England and rest of UK. 8.2 Key Steps are: Quality Infrastructure for neonatal screening i) Organisational arrangements - Create QA/support teams at National/Regional level. - Create provider networks to co-ordinate delivery of screening programme. ii) Guidelines - Create national template for screening protocols. - Give advice on how guidelines can be easily accessed iii) Training - Include training co-ordinator in QA team - Launch initial training package focussing on guidelines /communications. - National training co-ordinator to lead review of existing material - Increase budget for screening training iv) Information - Create national template for good information in several languages. - Use co-ordinator network to kite mark standards. v) Audit - Encourage national use of same audit systems Creating a Screening Programme for Universal Neonatal Hearing Screening i) Universal access - Replace all existing targeted screening services with UNHS to ensure available to all. - Review services to ensure universal access achieved. ii) Screening Test - Develop QA standards and organisation - Train staff and recruit where necessary - Introduce UNHS test as standard within 4 days of birth. - Ensure test results in 7 days in all current services. iiii) Confirmatory test - Ensure all current services give confirmatory audiology test promptly. - Ensure sufficient supply of audiologist sessions. iv) Patient follow up and support - Ensure monitoring and follow up systems in place in existing services as well as expand to all patients. - Ensure counselling available in each provider network. NSD/E15/4/6\FinalReport-April2001 11 8.3 The Department of Health in England is currently considering detailed proposals concerning costs and organisational structure for introducing the Programme across the English regions. 9. Organisational Arrangements in Scotland 9.1 The following structure is recommended: Central Co-ordination and Monitoring 9.2 The Scottish Screening Programmes Central Co-ordinating Unit (CCU) in NSD should be responsible for the co-ordination and monitoring of the Scottish Universal Neonatal Hearing Screening Programme, using the quality standards recommended by the NSC and the Clinical Standards Board for Scotland (when developed). 9.3 NSD would work with the service to establish and support the following infrastructure to achieve this: The development of standard national information returns which would allow monitoring of the programme. This would be in association with the Information & Statistics Division who already collect information on neonatal care. The introduction of a core training scheme for staff involved in testing and supporting parents. This would be delivered by a centrally appointed lead training co-ordinator and supported locally by lead audiologists. The national training co-ordinator would be funded on a sessional basis. The establishment and support of a quality assurance structure comprising the following key groups: Midwives Group Audiologist Group/ Facilitators Group provide core training Paediatrician Group NSD/E15/4/6\FinalReport-April2001 12 9.4 The following staff are required to provide this support: Universal Neonatal Hearing Screening Infrastructure Costs A programme co-ordinator 0.5 wte A&C Grade 7 £25,000 A Quality Assurance Director /training co-ordinator (1-2 sessions per week ) £10,000 Administrative/Secretarial support 0.5 wte A&C Grade 4 £12,000 Local training provision £10,000 Statistician/Data collection £12,000 Travel, subsistence, meetings costs £10,000 Scottish contribution to UK initiatives* £20,000 Setup costs for IT System £65,000 Total (recurring) £99,000 Total (non recurring) £65,000 *This includes the development of guidance and participation in UK meetings NHS Boards 9.5 It is recommended that Health Boards appoint a designated co- ordinator to ensure the delivery of neonatal and antenatal screening services in each Board area. The co-ordinators should meet regularly to discuss the antenatal and neonatal programmes and to review monitoring data. This is already the arrangement for breast and cervical screening and the regular meetings of the co-ordinators group provide a constructive national forum. It is proposed that individual co- ordinators are not required for each antenatal and neonatal screening programme. There are generic elements which require these programmes to be co-ordinated together. 9.6 While this will involve some sessional commitment for public health departments, this could be funded from within existing resources as the Boards already have this responsibility, although it is not currently co- ordinated across Scotland. Trusts 9.7 It is recommended that Trusts should allocate the required resources to support the recruitment of semi skilled staff and training of existing staff in maternity services to undertake UNHS tests. No change is recommended to audiology services although Trusts will be required to participate in the Quality Assurance Programme. 9.8 The number of additional staff estimated to be needed across Scotland is the equivalent of 35 WTE semi skilled staff. This assumes that major maternity units will need 2-3 staff (but not fully allocated to hearing screening) and that DGH maternity units will need some additional staff but fewer in number, making use of existing staff who could be trained to undertake the tests as appropriate. In smaller and rural maternity units it is assumed that the tests will be undertaken by existing midwives, suitably trained. NSD/E15/4/6\FinalReport-April2001 13 There will also be an equipment requirement to the extent of approximately 2 OAE screening machines per maternity hospital and one (or more in larger Health Board areas) per primary care Trust. In addition, there is a recurring cost attributable to maintenance, calibration and consumables which has been estimated at 10% of the equipment purchase costs. 9.9 The service costs are estimated to be: Recurring: 35 WTE x around £15,000 (salary plus overheads) £525,000 Maintenance, Calibration and consumables £70,000 Total £655,000 Non-recurring: 70 OAE machines @ £10,000 £700,000 The Scottish Executive 9.10 It is recommended that a National Advisory Group is established for neonatal and antenatal screening to bring together the work of the CCU at NSD, the Boards and the Trusts and to advise the Department on policy and on any issues that may arise. Timescales 9.11 The National Deaf Children’s Society (NDCS) have stated that by 2003 there should be nationwide introduction and full implementation of UNHS. Pilot sites have already been established in England. 9.12 It is recommended that the Scottish Universal Neonatal Hearing Screening Programme is introduced in two phases: I A bidding process should take place over the summer of 2001 to identify, say 2, pathfinder services (in addition to the Highland initiative) would permit a start in these 2 services in April 2002 or earlier if feasible. These pathfinder services would provide an opportunity to develop and document quality guidelines in preparation for wider rollout, in conjunction with English pilots and the Clinical Standards Board for Scotland. II Rollout to the whole of Scotland to cover all Scottish births from April 2003. At this stage, full implementation will need to be associated with the introduction of a quality assurance structure and means of monitoring follow-up and surveillance of children tested neonatally. 9.13 To ensure central co-ordination from the outset, it is recommended that the co-ordinator, and the QA Director/training co-ordinator are appointed from Autumn 2001. NSD/E15/4/6\FinalReport-April2001 14 10. Conclusions and recommendations 10.1 On the basis of some 57,000 live births per annum, one may anticipate some 60-65 new cases of permanent congenital hearing impairment (PCHI) per annum in Scotland. 10.2 Universal neonatal hearing screening (UNHS) is more health-effective in the detection of hearing impairment in children than present screening methods, the infant distraction test (IDT) and targeted neonatal hearing screening. 10.3 UNHS offers detection of PCHI at or shortly after birth with a greater degree of accuracy and completeness of population coverage than present screening methods and at an overall cost per case of PCHI detected less, or at worst equal to present funding levels. The high number of false positive tests with current screening methods should therefore reduce. 10.4 While the objective should be to carry out screening in hospital (i.e. prior to discharge) wherever practicable, there will need to be failsafe arrangements to pick up the minority of cases where this is not achieved. This could be achieved through the community midwife service. There will therefore be a need for training of community midwives in the screening test for the programme to be able to cope with early discharge of babies from hospital. 10.5 From the survey undertaken, the greatest concerns of professional staff in Scotland regarding the impact of UNHS implementation were not in relation to the screening process itself but to the potential burden on professional audiology staff who would be seeing children at an earlier age and, perhaps, in greater numbers than at present. This report concludes that the prime impact of the introduction of UNHS is to reduce the age at which deafness is ascertained. The number of deaf children diagnosed will not change. As a result the impact on the paediatric audiology service is significant only in the first six to twelve months of after the introduction of UNHS. 10.6 There will be no long-term impact on the ability of the paediatric audiology service and deaf educators to cope with the service implications. 10.7 Although the English pilot sites are required to use OAE as the primary screening test, one Scottish audiology service (serving Highland and the Western Isles) is of the clear view that AABR represents a better option, at least in the circumstances of their service. Consideration, therefore needs to be given to the relative resource implications and benefits of these two approaches to primary screening. NSD/E15/4/6\FinalReport-April2001 15 10.8 Whether or not the funding of this programme is transferred from RARARI to a UNHS masthead, it would seem sensible to ensure that the experiences gained in this pilot, currently funded to run for 3 years, should be included in the overall evaluation of an initial phase of UNHS introduction in Scotland. It is all the more important that this should be encouraged in the light of the fact that the English pilot does not afford such an opportunity. 10.9 Targeted neonatal hearing screening is reported in 7 Boards. There are wide variations in the way that services are configured across Scotland but there is strong evidence of care and thought in the arrangements for the delivery of services and co-ordination with other agencies. 10.10 Should a centrally co-ordinated UNHS programme be instituted, there will be a need for a substantial measure of harmonisation of the arrangements that link such a programme to other parts of the Health Service and to other agencies. There is currently a lack of national validation criteria, quality standards, performance management and monitoring criteria. Introduction of UNHS would need to be associated with the development of agreed common policies, protocols and standards. This will need central co-ordination and it is recommended that a QA lead is identified and allocate to the CCU in NSD. 10.11 The impact of switching hearing screening from the infant distraction test, carried out by Health Visitors in the community as part of an overall child surveillance programme, to UNHS will be to: - release a Health Visitor resource which, although valuable to the NHS as a whole, will have little utility in terms of neonatal hearing; - require the employment and/or training of staff in maternity units to undertake the test before babies are discharged from hospital; - require training of community midwives in the new test for babies who are discharged early from hospital; - release an audiologist resource which will be available to service any additional burden on audiology services consequent on the introduction of UNHS. 10.12 The primary resource issue associated with introducing Universal Neonatal Hearing Screening will however be one of ensuring the availability of sufficient skilled staff to cope with a short-term increase in confirmatory testing during the first 6-12 months of the introduction of UNHS in an area. NSD/E15/4/6\FinalReport-April2001 16 10.13 Consideration needs to be given as to whether a staged approach is needed to minimise the short-term impact of the introduction of UNHS. This could involve geographical staging by introducing UNHS in some areas initially on a pilot basis. There will however be a limit to the extent to which skilled audiological resources can be shifted geographically to alleviate pressures. 10.14 Alternatively, introduction could be universal from the outset but this would need to be undertaken only in the context of a clear plan as to how additional sessions of audiology could be provided for 6-12 months during the transition to UHNS while both methods of screening are undertaken in parallel. 10.15 The numbers involved are small and the impact on audiology is therefore likely to be able to be contained within current staffing levels albeit that provision will be need to be made to free up some other audiological workload on a short term basis. 10.16 There will need to be training and recruitment of staff to undertake the initial screening test. The lead time for this is largely dictated by the recruitment process since training is not onerous. 10.17 The numbers of additional staff required is estimated to be 35 WTE. The recurring costs are estimated at £655,000. In additional central co- ordination will be required together with IT and local training support at an estimated costs of around £100,000, bringing the total recurring cost of the programme to around £755,000 a year. 10.18 These recurring costs equate to £133,000 per 10,000 children screened, or £12,700 per case of PCHI detected. 10.19 In addition, capital costs anticipated to be around £765,000 before discount. 10.20 It is recommended that introduction is planned in two steps – initially in, say 2, pathfinder sites with subsequent rollout to all Scotland. The initiative should be supported by nationally co-ordinated training of staff. The timescale should take into account developments in England and the lead time to train staff, recruit staff where necessary and develop guidelines, standards and protocols to ensure equitable high quality provision across all of Scotland. NSD/E15/4/6\FinalReport-April2001 17
"Universal Neonatal Hearing Screening"