Thinprep Imager Feasibility Study

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Thinprep Imager Feasibility Study

• Anne Park
• Project Manager
• 17.0609

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Who am I?

• 30 years experience in cytology
• Started in Perth Royal Infirmary
• Based in Ninewells now for lt6 years
• Senior Biomedical Scientist lt6 years
• Project Manager 21st July 08

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Cervical Cytology Laboratory Review

• Commissioned by Scottish Govt.
• Steering Group 1st Meeting May 2007
• Chair John Burns
• Remit
• To oversee the review of provision of laboratory
  services for the Cervical Cancer Screening
  Programme and to provide a report with
  recommendations for the future to NHS Scotland
  and the Scottish Government.

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Cervical Cytology Laboratory Review

• Drivers
• Effect of technology including Imager
• Manpower planning
• Declining coverage
• Effect of HPV Vaccination
• Effect of HPV testing

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No of Smears Processed 2002-2007
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Cervical Cytology Laboratory Review

• Decision to look in depth at the national options
  for delivery
• Tribal Consultants Appointed June 2008
• Options Status Quo through single/multicentre,
  networking etc
• Due to report 2009

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Imager Feasibility Study

• Commissioned by the Review Group
• Scottish Government resourced
• 80,000 samples (5050 split between manual and
  imager arms)
• Commitment to roll out across Scotland if
  successful (exit strategy)
• Contract signed with Hologic after a European
  tender exercise
• Project went live in September 2008 and due to
  last 9 months to 1 year
• Final report by late 2009

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Terms of reference

• To conduct the feasibility study and report the
  findings to the Cervical Cytology Laboratory
  Review Group.
• Specifically
• to ensure the quality and standards for the
  Cervical Screening Programme are met during the
  study
• to advise if the technology meets the needs of
  the Cervical Screening Programme

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What could the feasibility study deliver

• To assess the likelihood that the Imager will
  realise the claimed benefits within a Scottish
  Cohort
• Increased High and Low grade abnormality
  detection
• Reduction in the false negatives without
  increasing false positives
• Reduction in workflow time
• Staff support

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Quality

• ThinPrep Plus Imaging increases the sensitivity
  of cytology

Publication Increase in HSIL with ThinPrep Plus Imaging
Roberts et al 2006 22
Miller et al 2007 42
Lorano et al 2006 38
Davey et al 2007 15
Chivukula et al 2007 13
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Feasibility Study hub and spoke arrangements

• Cohorts
• 3 Aberdeen.
• 5 Dundee
• 11 Inverness
• 4. Glasgow Royal Infirmary
• 7 Glasgow Southern General
• 10 Greenock

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THINPREP IMAGING SYSTEM - MULTICYTE
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Protocol

• Manual arm
• Standard full manual primary screen
• Rapid review/preview
• Abnormals referred to checkers
• Abnormals reported by Advanced Practitioner/Cytopa
  thologist
• V
• Imager arm
• Imaged and 22FOVs reviewed
• Rapid review/preview IQC
• Abnormals full screen/(autoscan)
• Abnormals reported by Advanced Practitioner/Cytopa
  thologist

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Slide selection for imaging

• A minimum of 80,000 (40,000 manual and 40,000
  imager) cases over 6 sites, in 2 hub and spoke
  groupings
• Half of lab workload for time period
• In batches by accession number
• 1 50 imaged 51 100 manual

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What should be measured?

• Specificity
• Sensitivity
• Positive Predictive Value
• Productivity
• Colposcopy referral rate
• BMS/Cytology screener/Consultant perceptions
• Costs
• Risks

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What are we recording

• Imaging time
• Screening time and review scope time
• Transport times
• Rejection rate
• Full review/Autoscan rates
• IQC detected abnormals/Imager negative

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Questions we want to answer

• Are the qualitative and quantitative improvements
  published reflected in a Scottish Cohort
• What are the strengths, weaknesses and risks.
  (SWOT)
• What information will it add to future service
  design
• Interface with National Call Recall computer
  system for Scotland (SCCRS)
• Is it the right technology for the Scottish
  screening programme?
• Financial Impact

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The imager

• Analyses objects in each of 2000 images
• Ignores objects that are considered not to be
  nuclei and clusters considered not to be
  epithelial cells
• Sorts nuclei and clusters by integrated optical
  density dependent on amount of DNA present
• Screener is presented with 22 fields of view
  (FOV) on each slide to review using an automated
  Review Scope. Two of these FOV are sheets or
  clusters of cells.
• Location guided system. No Sorting or Ranking

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Staining

• ThinPrep Imager requires standardised stain
  provided by Hologic as part of test
• Requires acclimatisation for screeners
• Only approved staining machines can be used
• Possible adoption as national stain for Scotland

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Stain validation

• Uses archive vials and slides
• Screener review of original slides and duplicate
  slides stained by imager stain.
• Carried out blinded
• 100 slides (25 abnormal, 75 negatives)
• Compare results
• Must meet Positive Percent Agreement target

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Review scope operation

• Must look at entire FOV (but not necessarily
  beyond the FOV)
• Not just centre of field
• Can set and save Autoscan settings for each
  screener
• Can mark a maximum of 30 objects
• Confidence levels in authorising negatives on 22
  FOVs.

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Screening process

• Review scope guides screener to 22 FOVs
• If any thought abnormal, electronically marked,
  scope guides screener through whole slide
  (autoscan)
• Anything abnormal is physically marked using
  scope
• Adequacy and infections assessed during 22 FOV
  screening
• IQC continues as usual
• Review/preview, checking, Advanced
  Practitioner/Cytopathologists use own microscope

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Training Schedule

• Comprehensive programme delivered by Hologic
• 1.5 day programme
• Overcalling was common
• Well received by staff
• Additional support available
• Certificate
• Second phase of training highlighted gaps

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Validation protocol

• CPA compliance
• Use Hologic test slides
• 100 slides (75 neg, 25 BNA)
• Assesses agreement between manual screen and
  review of 22 FOV
• Carried out after training
• Must meet Positive Percent Agreement target

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Issues/challenges encountered

• Transport
• Slide labels
• IQC EQA
• Slow building of confidence levels
• Ergonomics
• Full review/Autoscan facility
• Data security/back-up and integration

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Transport

• Inverclyde and Aberdeen hubs for study
• 2 transport models tested
• Existing transport links in one health board
• New links over health board boundaries
• Boxes, trays, packing
• Coordinates sent on CD (roll out review)
• Paper (or IT) trail for slides in transit

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Labelling

• TPI reads the number printed by T3
• Format 7 over 7, no letters
• May be accession or SCCRS number
• Paper label on front of slide only
• Labelling on back of slide if validated during
  pilot this will be roll out protocol
• T2 slides require printed label for TPI

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EQA

• Technical
• Local solutions not appropriate
• Join the Hologic scheme
• Interpretive
• Scottish system no longer sustainable
• Adopt a modified NHS Cervical Screening Programme
  model

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Internal quality control

• Rapid pre-view/review v FOV review
• Jury still out
• The potential weak link!
• Are we checking screener or imager performance?
• Scotland doing rapid pre/rescreen
• USA doing 10 rescreen

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Confidence/Trust levels

• Long learning curve for some screeners
• Partly dependant on pre-imager staining
• Variation in screener review times depends on
  existing manual times
• Consultant led review sessions vital
• Hologic led review sessions
• Practice makes perfect!

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Ergonomics

• Review scope is ergonomic but..
• Can only adjust height of head
• Not as ergonomic as existing microscopes
• Existing RSI symptoms
• One size fits all!
• New desks and spacers solved many issues
• Manual RS to the rescue!

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Autoscan facility

• Any slide requiring full review must go through
  autoscan
• Can adjust speed and motion
• Can slow the process down
• Variable screener/lab referral for autoscan
• Variation reflects existing screener/lab profiles
• Part of the learning curve

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Integration of Multicyte

• CD transfer not the final solution
• Can download data at hub and email (within secure
  NHS) to spoke where CD can be burned
• Back up of imager data
• Direct transfer of data from hub to spoke is the
  aim but Hologic need roll out commitment

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Very early unvalidated data

• HG/LG disease at least equal to comparator
• Average screening time productivity gain
• Phase one - 20 .
• Screener perceptions survey 86 response rate.
  
• Negative opinion on 22FOV
• Abnormality present it is picked up on 22FOV
• HG/LG false negative rate comparable
• Referral for checking rates comparable

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Imager Feasibility Project Timelines
Stage Timeline
Scoping of Feasibility Study December 2007
OJEU for procurement of Imaging System March 2008
Project Manager Specification/AFC Grading/Advert May 2008
Project Initiation Document May 2008
Contract Award for Imager Feasibility Study June 2008
Detailed specification of protocols June 2008
Project Manager Appointment June 2008
Staining machine delivery, stain conversion and validation Jun - Aug 2008
Imager delivery and placement Aug Sep 2008
Review of initial process October 2008
Completion of practical element September 2009
Delivery of draft report to Feasibility group October 2009
Final report to review group December 2009
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Phase Two

• Improve screener perception
• Full review of all abnormal slides on manual
  microscope
• 10,000 slides on each arm
• Report - phase one and two
• Testing of Manual plus microscope
• Phase two - 32 Screening time productivity gain
  (Very early data)

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Long learning curve..

• Issues will arise at the beginning that appear to
  be show-stoppers
• Dont panic!
• Dont make hasty decisions based on early
  results/feedback
• Limit the numbers trained at the beginning
  (37-30)
• Consolidate then cascade!

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Take home message

• Meticulous planning
• Be prepared for early difficulties
• Record everything!
• Think about alternatives to CDs
• Ergonomic issues
• Slow confidence building