Standard Operational Procedure: Use and Maintenance of ... protocols and... · Standard Operational...

Standard Operational Procedure: Use and Maintenance of Newborn

Hearing Screening Equipment (MAT-SOP-022)

Approval Approval Group Job Title, Chair of Committee Date Maternity & Children’s Services Clinical Governance Committee

Chair, Maternity Clinical Governance Committee

4th January 2019

Change History

Version Date Author, job title Reason 1.0 November

2018 Ali McMasters, Local Manager Newborn Hearing Screening Programme

Trust requirement

1.1 June 2019 Ali McMasters, Local Manager Newborn Hearing Screening Programme

Live change to include use & maintenance of NN resus equipment pg 9/10

Author: Ali McMasters Date: June 2019 Job Title: Local Manager Newborn Hearing Screening

Programme Review Date: January 2021

Policy Lead: Group Director Urgent Care Version: V1.1 June 2019 V1.0 ratified 4/1/19

Location: Policy hub/ Clinical/ Maternity / Professional guidelines/ MAT-SOP-022 This document is valid only on date last printed of 13

Standard Operating Procedure: Use & Maintenance of NBHS Equipment (MAT-SOP-022) June 2019

QUALITY PROCEDURE 1. Describes the processes within the newborn hearing screening team regarding

Quality assurance (QA) checks, calibration and day to day use and maintenance of newborn hearing screening equipment. It also describes the process for making manual changes to Smart 4 Hearing (S4H) and changing screening outcomes.

Prepared by: Ali McMaster, Local Manager Date of first issue: January 2019 This version checked by: Jo Young, Team Lead Signature/date: This version authorised by: Gill Valentine (Director of Midwifery) Signature/date: Location of copies:

Location of Copies No of copies 1 Quality Manager 1

2 File copy (electronic-Policy Hub) 1

3. Community Midwives 1

Document review:

Review date Reason for Review Reviewed by Signature

DOCUMENT AMENDMENT • Amendments may only be made on the electronic copy to ensure all formally issued

location copies are maintained to the updated requirements. • Amendments (changes of up to a sentence in length) must be performed by senior

members of staff only. • Major changes (changes of greater than a sentence in length) must result in immediate

review of procedure. No. Date Page

No Amendment Authorised by:

1 14/6/19

Author: Ali McMasters Date: January 2019 Job Title: Local Manager Newborn Hearing Screening


Policy Lead: Group Director Urgent Care Version: V1.0 ratified 4/1/19 Location: Policy hub/ Clinical/ Maternity / Professional guidelines/ MAT-SOP-022 This document is valid only on date last printed of 13


1. SCOPE AND PURPOSE 1.1 Quality Management Procedures (QMPs) are formal authorised documents

detailing the procedures to be followed in the accomplishment of various tasks. Note procedures may also be referred to as Standard Operational Procedures (SOPs).

1.2 This QMP describes the processes within the newborn hearing screening team

regarding QA checks, calibration and day to day use and maintenance of newborn hearing screening equipment. It also describes the process for making manual changes to S4H and changing screening outcomes.

2. AUTHORISED STAFF

2.1 Team Lead (TL) of the Newborn Hearing Screening Programme (NHSP).

2.2 Local Manager (LM) of the Newborn Hearing Screening Programme.

2.3 Senior Screener and screeners within the Newborn Hearing Screening Programme under supervision and following suitable training.

3. SPECIMEN REQUIREMENTS

N/A

4. EQUIPMENT & SPECIAL SUPPLIES 4.1 Public Health England (PHE) Newborn Hearing Screening Programme (NHSP) provide national operational guidance regarding equipment. 4.2 See: https://www.gov.uk/government/publications/newborn-hearing-screening-programme-nhsp-operational-guidance/5-equipment

5. REAGENTS, STANDARDS OR CALIBRANTS, IQC MATERIALS AND PROCEDURES

N/A




https://www.gov.uk/government/publications/newborn-hearing-screening-programme-nhsp-operational-guidance/5-equipment

https://www.gov.uk/government/publications/newborn-hearing-screening-programme-nhsp-operational-guidance/5-equipment


6. PROCEDURE

QA Checks 6.1 NHSP national operational guidance 5, Equipment, paragraph 7.1 - Equipment

Quality Assurance (QA) checks, states that:

“There is a series of visual checks, probe checks and QA checks designed to identify faults or problems with the equipment. They must all be performed before the equipment is used to screen babies. If the equipment fails any of the checks it must be removed from service until the fault is investigated and rectified.”

6.2 Individual screeners are responsible for carrying out all QA checks on each piece of screening equipment they use, before screening commences. The outcome of these checks must be recorded in the daily equipment checks spreadsheet: W:\Maternity\Antenatal Clinic\Newborn Hearing\NHSP\ DAILY EQUIPMENT CHECKS. It is important to note any duplicated QA checks including reasons for repeating the checks, as well as recording anything out for the ordinary or equipment faults in the comments section at the time that they occur.

6.3 The QA checks results are uploaded daily into the national IT system (S4H), along with the screening results. The LM will ensure adherence to the QA check regime to ensure that babies are only screened using equipment that has completed appropriate QA checks. This ensures that QA checks have been completed and uploaded for every piece of equipment used to screen any baby – see NHSP Audit/Failsafe Schedule MAT-SOP-021.

6.4 NHSP national operational guidance 5, Equipment, paragraph 7.1 - Equipment Quality Assurance (QA) checks details what and how the various checks that must be carried out. Also see Appendix 1 for more details.

Calibration 6.5 NHSP national operational guidance 5, Equipment, paragraph 2.3 Calibration and

maintenance, states that:

“This should be carried out as per equipment specifications, through normal procurement methods. NHSP providers are responsible for ensuring appropriate calibration and maintenance of their screening equipment.”





6.6 There are two pieces of newborn hearing screening equipment currently in use at the RBFT:

Otoport Return to Otodynamics for calibration every 3 years and recondition batteries (drain fully and then recharge) every 12 months – details are recorded on the spread sheet: W:\Maternity\ AntenatalClinic\ NewbornHearing\NHSP\ EQUIPMENT INFORMATION\ OTOPORT\ ‘Otoport Log for Machines Jan 18 – allocation & calibration’.

Algo 3i Return Acoustic Transducer Assembly (ATA) cables to HC Life for calibration every 12 months. Details are recorded on the spread sheet: W:\Maternity\Antenatal Clinic\Newborn Hearing\NHSP\EQUIPMENT INFORMATION\ALGO3i\Algo Log for Machines Jan 18 calibration’.

6.7 A delegated screener is responsible for ensuring that all newborn hearing screening equipment has up to date calibration records on file. Records should be checked on a weekly basis and equipment must be sent to the relevant manufacturer with care to allow a sufficient time buffer to allow time for quotes to be provided and internal financial sign off to be given.

Use and Maintenance of Screening Equipment 6.8 The Otoport is used to carry out the Automated Otoacoustic Emission (AOAE)

screen and the Algo 3i is used to conduct the Automated Auditory Brainstem Response (AABR) screen.

Otoport - AOAE 6.9 Relevant patient data is accurately entered into the Otoport and after observing the

ear canal to ensure it is patent and assess the size, an appropriate sized disposable ear tip is selected by the screener. The largest tip that fits comfortably in the ear should be used in order to minimise noise and maximise emissions. The tip is attached to the probe and inserted into the baby’s ear ensuring a snug fit and securing with a quarter turn. Once the fit is established, the leads are up and away from baby and the environmental factors are conducive, the screen can begin.

6.10 The machine sends soft clicks (35 decibels which is the level of quiet speech) to the cochlea in the inner ear. The hair like cells in the cochlea will move in response to the clicks and create and echo which is picked up by the microphone in the probe. The machine then provides a result of clear response (CR) or no clear response (NCR). NCR can be due to; fluid or debris still present in the ear canal following the





birth, baby becomes unsettled during screen; environment becomes noisy during screen or a hearing loss.

6.11 This process is repeated on both ears and the appropriate paperwork completed to accurately record the outcome and other relevant information, such as risk factors.

6.12 If necessary, e.g. screening conditions deteriorate, the screen can be paused midway, but if the earpiece is removed or falls out, the screen must be incompleted. It is possible to refit the earpiece up to 3 times. It is not appropriate to refit the earpiece if the baby is unsettled or the environment is noisy – simply wait until conditions are more suitable to screen.

Downloading from the Otoport 6.13 Screeners must download data from their equipment to S4H (via our intermediate

software – Otolink) when they have completed their screens for the day. The system then matches this data to the correct patient record and the screener can set outcomes etc. See Appendix 2 for further details.

Maintenance and Cleaning of the Otoport 6.14 The Otoport is robustly constructed but is a precision instrument so should be

handled with care. If any faults are identified with the machine that cannot be resolved by the newborn hearing screen team, the LM should be informed and the equipment removed from use immediately. The faulty equipment should be sent to the relevant manufacturer for investigation and if necessary repair/replacement.

Ear Tips 6.15 The ear tips are disposable and should be discarded after each baby is screened.

The same ear tip can be used for both ears unless there is fluid or debris present, if the screen is painful - consider infection and prevent cross contamination, or if a different sized tip is required for each ear.

Probe 6.16 The probe is a precision assembly and care should be taken throughout in its

handling and cleaning. The casing should be cleaned with a Clinell wipe before screening begins in the morning and subsequently, after each baby is screened and left to dry taking care that no moisture gets into the tubes (couplers). If debris or moisture gets into the couplers they must be replaced and the Otoport re-calibrated before using for any further screening. Couplers tubes should be changed at regular intervals (i.e. at least every 3 months) to prevent contamination.





Cable and Instrument 6.17 The Cable should be cleaned with a Clinell wipe (from the patient end down). The cable should be cleaned with a Clinell wipe before screening begins in the morning and subsequently, after each baby is screened and left to dry. The Otoport itself should not come into contact with the patient being screened but should be cleaned before screening begins in the morning and subsequently, after each baby is screened using a Clinell wipe. Do not allow liquid to enter the Otoport and do not immerse in fluid.

The cable and ear piece should be kept loosely coiled attached to the Otoport when not in use to reduce the risk of dust or damage to the couplers.

6.18 See Appendix 3 for details of how to change a coupler.

Algo 3i - AABR 6.19 Note - not all babies will require an AABR. The machine is calibrated to screen babies >34 weeks gestation.

6.20 Baby must be asleep or settled and this screen can take up to 30 minutes. Patient data is entered into the Algo3i and disposable earphones (red for right and blue for left) are placed over the baby’s ears and sensors are placed on the nape of the neck (white), shoulder (green) and forehead (black). Ensure there is more than a 2cm gap between the nape and shoulder sensors. Good skin preparation with sufficient prep gel prior to sensor placement (particularly on the forehead) ensures that impendence levels remain low and similar. Once the earphones and sensors are in place and the environmental factors are conducive, the screen can begin.

6.21 It is possible to pause the screen if screen conditions deteriorate temporarily and then carry on when conditions improve. If ‘not complete’ results are obtained on one or both ears, one further AABR screen can be carried out.

6.22 The machine sends a soft click stimulus at 35 decibels and each click evokes a series of identifiable brain waves from the auditory brainstem. Each click coupled with a response to that click is called a "sweep". If a REFER result is obtained, the screener will refer baby to Audiology for diagnostic testing.

Downloading from the Algo 3i 6.23 Screeners must download data from their equipment to S4H (via our intermediate

software – Audible for MRC) when they have completed their screens for the day. The system then matches this data to the correct patient record and the screener can set outcomes etc. See Appendix 4 for further details.





Maintenance and Cleaning of the Algo3i 6.24 The Algo 3i is robustly constructed but is a precision instrument so should be

handled with care. If any faults are identified with the machine that cannot be resolved by the newborn hearing screen team, the LM should be informed and the equipment removed from use immediately. The faulty equipment should be sent to the relevant manufacturer for investigation and if necessary repair/replacement.

Ear phones 6.25 6.25 The earphones are disposable and should be discarded after each baby is

screened.

Sensors 6.26 The sensors are disposable and should be discarded after each baby is screened.

Cable and Instrument 6.27 The Cables should be cleaned each day before a screening session, and after each

baby has been screened with a Clinell wipe (from the patient end down).The Algo 3i itself should not come into contact with the patient being screened but should be cleaned each day before a screening session, and after each baby has been screened using a Clinell wipe.

Storage of Equipment 6.28 At the end of each shift, the screening equipment should be placed in the lockers in

the screening office. This will offer the best protection in the event of a leak or other building maintenance issue.

Out-Patient Clinics 6.29 Screening equipment should be brought back to the Royal Berkshire Foundation

Trust (RBFT) screener’s office as soon as possible after completion of an out-patient clinic i.e. that afternoon or the following morning. In exception circumstances, if the screener in question is unable to return the equipment in a timely fashion, it may be necessary to make arrangements for another member of the team to collect it. In the interim, the equipment should be should be securely stored indoors and never left in a car boot.





Consumables 6.30 A delegated screener is responsible for ordering appropriate levels of consumables,

such as different sized ear tips, couplers etc. to ensure service needs can be met. However all member of the newborn hearing screening team are responsible for monitoring consumable stock levels and alerting the designated screener if an order need to be placed, allowing adequate time for request, sign off and delivery.

Manual Changes to S4H Screen Results 6.31 NHSP national operational guidance Appendix: Reports Guidance, paragraphs 2.3

and 2.6 detail how Local Manager should investigate any instances where manual changes have been made to imported test results or test method of entry is different from screening equipment data quality (SEDQ). A local log has been set up to record details of any such instances, e.g. if a screen result has been assigned to the wrong ear. See: W:\Maternity\Antenatal Clinic\Newborn Hearing\NHSP\Log of changes to import results & manual entries on S4H.

6.32 Manual changes should only be made on S4H by the Senior Screener or Local Manager. Once the changes have been made, the screener in question should add a casenote on S4H to confirm that they are in full agreement with the changes made.

Manual Changes to ‘Screening Outcome’ on S4H 6.33 In some circumstances, it may be necessary to manually change the default

‘screening outcome’ set by S4H e.g. despite a clear response screen result, a parent requests an audiological referral due to family history.

6.34 Manual changes should always be accompanied by a full explanation in a casenote on S4H and the Local Manager/NHSP Audiologist should be informed via email.

Use and Maintenance of Neonatal Resuscitation Equipment 6.35 Four neonatal resuscitation equipment kits bags have been set up for each of the 4

out-patient clinic sites used by the newborn hearing screening team. The contents of the bags have been listed and the list must be updated by the relevant screener if any equipment is used and replaced.

6.36 The screener who is rota’d to run any given clinic, must ensure that they take the correct kit bag with them to the clinic. As we don’t have dedicated rooms or





secure storage at these sites, the kit bags must be returned to the screener’s office when not in use.

6.37 The neonatal resuscitation equipment kit in each bag must be checked weekly by the screeners and a physical log completed to evidence these checks. The printed logs will be retained and stored in the screener’s office. Blank logs are available at: W:\Maternity\Antenatal Clinic\Newborn Hearing\NHSP\EQUIPMENT INFORMATION\NEONATE RESUS EQUIPMENT\ RBH NHSP Neonatal Resus Equipment Check Log.

6.38 The neonatal resusictation equipment will be used in accordance with the Trust’s Maternity Lifesaving Guideline entitled ‘Neonatal Resus’.

APPENDIX 1: NHSP Equipment QA Checks

QA test Description Correct outcome Notes QA 1 (Cavity) AOAE

Probe is placed in a cavity. Checks for artefacts which could be misinterpreted as a response in a real ear. Performed to ensure that the equipment could detect a deaf ear

NCR/cavity OK If CR this equipment would not refer a baby with PCHI Any babies screened following a QA1 CR and discharged on that screening result will need to be recalled

QA 2 (Occlusion) AOAE

Ear piece is occluded. Checks earpiece and cover are correctly assembled

NCR/Occlusion OK If ear piece not assembled correctly equipment could refer babies unnecessarily

QA 3 (Real Ear) AOAE

Detects a clear response from a hearing ear

CR/real ear OK. In the absence of anyone who usually has CR their usual expected result is acceptable

Checks equipment can correctly detect a CR if not could refer babies unnecessarily

QA 4 (Click) AABR Checks both speakers are emitting stimulus and electrode connectivity

Stimulus (clicks) can be heard/recorded

If clicks are not emitted, or electrode connectivity is poor equipment could refer babies unnecessarily.

Visual check AOAE and AABR

Overall condition of equipment looking for damage/cracks/weak or worn parts

N/A May affect equipment performance

Probe check AOAE Checks the speaker and microphone are working correctly

Pass/probe OK If stimulus level is too low or the microphone is not picking up the stimulus could refer babies unnecessarily





APPENDIX 2: Downloading from the Otoport

• Ensure the Otoport is switched OFF.

• Connect Otoport to designated PC or laptop using cable provided.

• OTOLINK will open automatically in the computer. Note how many ‘screens’ and ‘patients’ are recorded. Is this correct?

• Synchronise the computer and Otoport ‘Date and Time’ using the green arrow button.

• Press ‘download’ button.

• Successful download is confirmed by number of ‘screens’ and ‘patients ’is ‘0’ and a confirmation of successful data transfer.

• Disconnect the Otoport. It is now empty and ready to use again.

If download is not successful then you will see a message “cannot establish a connection with S4H web services”. When you receive this message the data you have transferred will be removed from your Otoport and will be found on the software on your PC. To view this data you will need to DOUBLE LEFT click on the ‘DATA VIEWER’ icon on your desktop. Results of the screens you have attempted to download will be stored here until the next time you download from the same computer when the data should be automatically uploaded. If you are having trouble downloading please contact IT and note the PC asset number that you attempted to download on. To check your Otoport after an unsuccessful download:

• GO to’ RECORDS’ menu on the OTOPORT and select

• Find ‘SUMMARY’ which should show you

• PATIENTS 0

• RECORDS 0

If data is still on your OTOPORT try downloading again on your PC.





APPENDIX 3: How to Change a Coupler

Equipment required Remove lid from body Hold lead on flat surface and

push body down

Remove and dispose of Attach new couplers Align couplers and old couplers replace body carefully

Re-attach lid to body Press lid firmly to secure

NOW CALIBRATE THE MACHINE before using it for screening again.

Record the coupler change and calibration

checks on the ‘Daily Equipment Check’ Log





APPENDIX 4: Downloading from the Algo 3i Screeners must download the data from their equipment to S4H (via our intermediate software –Audible for MRC) when they have completed their screens for the day. The system then matches this data to the correct patient record and the screener can set outcomes etc.:

• Turn Algo on (login)

• Data management (ok)

• Synchronize with PC (ok)

• Go to desk MRC (on desk top)

• Sign in (rbh_******) password (1****6)

• Go to first icon (device data import)

• Select device (A3i)

• Get infrared ready and line up with window on the left side of Algo press next on desktop then quickly press ok on Algo (they will now connect to each other)

• Algo will now transfer data to desktop

• Go to second icon at the top (transmit screen to S4H)

• Select and press start (please make sure all data has transferred and fail count is 0, if not please report to the Band 4 or Local Manager)

• This is now complete close everything down and set outcomes on S4H.




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