IVF Witness - The ‘Newcastle Experience’

Stephen J. HarbottleLead Clinical Embryologist

Centre for Reproductive Medicine & SurgeryAddenbrookes Hospital

Why install IVF Witness?• Human Fertility and Embryology Authority (HFEA)

– UK ‘critical process’ witnessing requirement• ‘Manual’ witnessing is time consuming and distracting

– Concept of ‘Involuntary Automaticity’• Errors can occur because staff saw what they ‘expected to see’.

• IVF Witness automatically confirms any procedure where 2 or more tagged items are brought together– Avoids involuntary automaticity– Improves gamete and embryo security– Documentation, control and governance at critical points– Goes a long way to preventing ‘IVF Mix-ups’

Meeting our requirements• Flexibility in design stage to facilitate bespoke functionality• Provide an effective audit trail

– Date, Time and User stamp every procedure– Mismatch events logged against operator with explanation– Allow audit per user, per day or per any defined time period– Automatically configure and generate witness reports

• Provide effective and accurate documentation • Provide effective training• Provide ongoing support and maintenance

Implementation of the system and its use• IVF Witness seamlessly fitted into bespoke isolator system

– Careful, thorough planning at design stage– 13 terminals linked to a central database– System validated in-house prior to clinical implementation

• IVF Witness is intuitive, simple to configure and reliable– Very easy to use with well designed user interfaces– Touch screen control for real time procedure recording– Customisable levels of access for Administrators and Users– Laboratory and Clinical staff adapted quickly to the system– Operational advantages; improved workflow & efficiency

How does it work?• Radio Frequency Identification (RFID)

– IVF Consumables are ‘tagged’ with an adhesive RFID label which when detected by a tag reader generates a signal

– This signal is detected and used to uniquely assign the item– The allocation is permanently and irreversibly stored– Every time an item enters the read range it is detected and

identified in the database• IVF Witness therefore relies on 3 components;

– RFID Tags– RFID Tag readers– Controlling Software

The hardware – RFID tags

1 2

3 4

1. ICSI Tag2. Standard Tag3. Square Tag4. ID Card

The hardware – RFID tag readers

The software; ‘Lab Manager’ & ‘IVF Witness’

Very easy to use...

1. Log in1. Log in

2. Enter PIN

1. Log in

2. Enter PIN

3. Select Patient

1. Log in

2. Enter PIN

3. Select Patient

4. Allocate Item

1. Log in

2. Enter PIN

3. Select Patient

4. Allocate Item

5. Confirm

1. Log in

2. Enter PIN

3. Select Patient

4. Allocate Item

5. Confirm

6. Complete

Extra Benefits / Features• Defined pathway for the introduction of donor sperm into

cycles and for the sharing or donation of oocytes– Predefines who can and cannot donate or receive donation– Prevents errors or confusion during donor treatment

• Configured to automatically print a series of labels for consumable items used during a treatment cycle– Labels configurable to contain;

• patient name • date of birth • clinic number• type of dish• any other bespoke field

Impact on working practices – our verdict• IVF Witness facilitates independent working;

– saves time– reduces environmental stresses on embryos– minimises distraction

• Improvement in laboratory efficiency• Streamline paperwork for each treatment cycle• Can receive patient demographic information from many

commonly used patient database systems

Patients views• Overwhelming support for implementation of the system

– Impressed that the unit is embracing new technology to prevent laboratory errors

– Confident that embryos resulting from treatment were created with their gametes without risk of error

– Feel that the system affords a sense of ownership of their gametes and embryos throughout the treatment process

– Understand this is an extension to an already robust sample handling and witnessing policies

Will we use IVF Witness in Cambridge?

• Ongoing design and planning process with RI• Integrate IVF Witness cabling into cleanroom infrastructure• Careful selection of hardware to optimise integration

Concluding remarks• IVF Witness;

– is a reliable, safe and effective – reduces risk of ‘IVF mix-ups’– removes pressure from laboratory staff allowing them to concentrate

entirely on one process without interruption or distraction– provides a detailed audit trail of procedures– Integrates with other common software packages to minimise data

entry into more than one system– gives patients the reassurance that everything has been done to

remove the potentially devastating impact of human error during fertility treatment

Thank you for your attention