North Tyneside Primary High Risk HPV Conversion Training - September 2019 - Cervical Screening Training

North Tyneside
         Primary High Risk HPV
          Conversion Training

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