Primary High Risk HPV

Conversion Training

North Tyneside

September 2019

Primary HPV Screening

New Provider

• Gateshead Health NHS Foundation Trust (GHNT) was the successful bidder for the North lot 2, which covers the North East and Yorkshire area. Over the coming weeks services will be transferred from your current laboratory to Gateshead.

Transfer date for North Tyneside is

7th October 2019 • We aim to complete roll out of HPV primary

screening by 31st December and consolidation of all tests onto the Gateshead site by 31st March 2020 in line will National roll-out.

Informing Patients

(6 weeks before the laboratory

conversion date of 7th October 2019)

women having primary hrHPV

screening will be sent the screening

leaflet “Programme Cervical screening

and Human Papillomavirus (HPV)

testing” and ‘NHS Screening: Helping

you decide’ with their primary hrHPV

invitation letter.

This will help to ensure that women

attending for screening receive the

correct information in time for the

switch from cytology to hrHPV testing.

New National Leaflets –Sept 19

Informing Patients

• It will be the sample taker’s responsibility to confirm that the woman to be tested has received the necessary information and understood it.

• Once this is confirmed, her consent to primary hrHPV testing is implied by the fact that she attends and accepts the procedure.

• You may have ladies attend with their primary hrHPV invitation letter prior to the conversion date. These ladies will either: – have to re-schedule their appointment for after this date if they

want to have a primary HPV test

or

– you will need to inform them that their sample will be a cytology test and hrHPV only performed as Triage or Test of Cure.

Training Resources • There are two national primary hrHPV testing e-learning modules hosted on

the Health Education England e-learning for Healthcare website and are part of a suite of e-learning materials for staff working in NHS screening programmes.

– e-learning for cervical sample takers

– e-learning for colposcopists

• PHE recommend all sample takers should complete the sample taker module but this module may also be useful for colposcopy nurses because women often have questions about hrHPV testing on attendance at colposcopy.

• The colposcopy module was developed by PHE in collaboration with members of the British Society for Colposcopy and Cervical Pathology and it draws on experience from the primary HPV pilot sites. This is for all colposcopists and nurse colposcopists who receive primary hrHPV screening referrals.

• Both e-learning modules take about 20 minutes to complete and a certificate of completion is generated automatically when finished.

e-learning for cervical sample takers https://portal.e-lfh.org.uk/Component/Details/559150

e-learning for colposcopists https://portal.e-lfh.org.uk/Component/Details/559152

HPV Key learning points:

• Go live date 7th October 2019 • Reversal of current protocol – HPV test first with Cytology

triage for HPV positive samples

• Sample taker’s responsibility to confirm that the woman to be tested has received the necessary information and understood it.

• Once confirmed, her consent to primary hrHPV testing is implied by the fact that she attends and accepts the procedure.

• You may have ladies attend with their primary hrHPV invitation letter prior to 7th October 2019.

LBC Technology Change

• As part of the roll-out GHNT will be changing the technology used to collect and process LBC specimens from Surepath to Hologic ThinPrep

• The processing is more automated and makes processing large volumes of work more efficient. Sample ID is improved and avoids bottle-necks during processing which can impact on lab turnaround times. This offers the opportunity to increase service efficiency and the molecular friendly vial is compatible with all HPV systems.

Hologic

Conversion Training

Taking the LBC sample

Equipment - • Speculae – reusable & disposable • Cervex brushes – green handled (latex

free) • Endocervical brushes (if required)

• ThinPrep vials • Gloves • ICE request label/forms • Sample bags/boxes • Leaflets

Taking the LBC sample

• Prepare all equipment before starting the procedure. Note expiry date on sample collection vial. Do not use expired vials.

• Ensure the entire seal is removed from the lid of the vial and discarded.

• Open the vial before starting the procedure

Options for lubricating the speculum • Lukewarm Water: For a patient without physical or physiologic reasons for

needing lubricant, lukewarm water may be used to warm and lubricate the speculum. This

protocol has the least risk to the quality of the sample collected.

• Lubricant Gels: If lubricant must be used due to patient discomfort or other circumstances, lubricant should be used sparingly and applied only to the exterior sides of the speculum blades, avoiding contact with the tip of the speculum.

– When a lubricant is used sparingly and appropriately, it poses little risk to the quality of the sample.

– Use lubricants that do not contain carbomers

– Carbomers tend to promote coagulation of inflammation cells and bacteria, which obscures epithelial cells and renders the test unsatisfactory for interpretation.

– Carbomers also cause blockage of the Hologic filters

– Examples of lubricants that do not contain carbomers:

K-Y Lubricating Jelly®

Surgilube®

Astroglide®

Crystelle®

Lubricant formulations containing carbomers which SHOULD NOT be used include: AquaGel, L-Gel, Aplicare

Appropriate use of lubricant

Transferring the Cervical Sample

• Immediately rinse the brush into the thin Prep vial by pushing it into the bottom of the vial 10 times forcing the bristles apart “MASHING AND BASHING”.

• As a final step swirl the brush vigorously to further release material.

• Check the brush to ensure that no material is

clinging to the fronds.

• DISCARD THE BRUSH HEAD

• Do not leave the brush in the vial

Final Step - Securing The Vial

• Screw the lid on until the black torque marks meet

• Do not over-tighten

• Complete patient details on the ICE request in the presence of the patient

• Place the ICE label with the barcode vertically, on the sample vial (no need to send ICE form)

• Dispose of equipment and waste safely

Please only place cervical samples in this bag

Sending the sample

• Give all relevant clinical details (e.g. HIV status, DES exposure, compromised immunity) on the ICE form when requesting the test. The term RVI (Retro Viral Infection) should now be used to indicate HIV+ve status.

INTERIM

• Place the labelled vial in a clear specimen bag.

• Place into pink bag and SEAL for transportation to the laboratory

Sample Tracking forms

Tracking Forms • Tracking Forms are to be used to ensure chain of custody of

the samples.

– Practice name; today’s date; time

– Attach one ICE label (without the bar code) per sample (or handwrite details) in each box

– Complete number of samples, name & signature

– Courier then collects the pink bags (and may add a signature) and takes it to the laboratory

– There can be multiple tracking forms per pink bag

– The samples are checked on receipt when the bag is opened

– Any queries can be dealt with immediately

• Using the Tracking Form makes it easier to trace samples that may be delayed or missing.

Coming Soon

• New bespoke sample rack

• Courier will scan each sample in the rack negating the need for tracking forms

Hologic Process Any HPV positive samples will

be processed on the ThinPrep

5000 AutoLoader processor

to produce a slide for

microscope screening

ThinPrep® Process In the laboratory

1. Dispersion 2. Cell Collection 3. Cell Transfer

Cytology Slide

Storage of Vials

• Keep the vials upright

• Store at room temperature

• Ensure that they are used in the order that

they are supplied

• Check expiry date

Hologic Key learning points:

• Go live date 7th October 2019 • 5x 360º clockwise with green handled

cervex brush.

• Immediately and vigorously (Mash and Bash) rinse in vial 10x.

• Check brush for remaining material.

• Discard entire brush.

• Ensure details are correct on vial and form.

• Send to lab as soon as possible .

FAQ’s

FAQ’s

ICE • GHNT are implementing a dedicated instance of ICE Desktop to facilitate

requesting and reporting of Primary HPV samples.

• Within a GP or clinic setting this will be integrated with your clinical system. If your surgery or clinic already has a link to ICE for your other diagnostic requesting this new instance will appear as a second option within a dropdown menu.

• Active sample takers will be provided with logon credentials to allow access to the HPV ICE system enabling you to raise requests electronically.

• Surgeries will be allocated a single Zebra label printer to generate sample labels, to facilitate the move to “Paperless 2020”. Existing label or A4 printers can also be configured for use and stationery will be supplied where required.

• You should have already been visited by our IT team to install your label printer review your new trading partner details to ensure the configuration is valid in preparation for receipt of messages.

Ordering on ICE

• PLEASE CHECK THE PATIENT’S CURRENT ADDRESS BEFORE YOU ORDER THE ICE REQUEST. The ICE system will ask the sample taker to confirm the patient address before the request can be submitted. If the address is incorrect this box will pop up:

• PRINT THE LABEL or ICE FORM AT THE TIME OF TAKING THE SAMPLE.

• If the patient is deferred, reorder the request at the new appointment and ‘phone the laboratory to take the original request out of the queue.

• The date of sample cannot be amended; this is taken automatically from the ICE form.

• The ICE queue is regularly reviewed for outstanding requests and practices are contacted if a vial has not been received and there is an ICE request for cervical cytology in the queue.

Pump Prime kits

• You should have had your pump-prime kits delivered.

• Should be enough for 6 weeks.

• Additional kits will be delivered based on volume.

• They should not be used before the go-live date on the kit

• Contain: Thinprep vials

Green Cervex Brushes

Sample bags

Quick Reference guide

Tracking forms

Instruction leaflet

Logistics

• Samples will be collected from your practices and clinics by our QE Facilities courier service.

• The QEF courier will introduce themselves to your practice and deliver pump prime Hologic sample kits, pink transport bags and tracking forms prior to go-live.

• Existing stock of SurePath consumables will be collected by the courier following go-live.

Cascade Training

• All sample takers in the practice should have attended a

Training session or received Cascade Training

• No-one should take ThinPrep samples for primary HPV testing until

they have undergone conversion training

• All new sample takers in the practice should be trained. This includes

nurses, GP registrars, locums and new partners.

• Resources available on CSTD with links to HPV training:

Cascade training

• Video on CSTD website:

• You will receive a Certificate on completion of video. CSTD will be automatically updated to include confirmation of your Conversion.

Cascade Training

• ‘Confirmation of Cascade Training’ sheet to

be completed and returned to:

lbrown10@nhs.net