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Universal Neonatal Hearing Screening

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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

								
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