Development of a Technical External Quality Assessment Scheme in Non- Gynaecological Cytology Dr Paul Cross Consultant Cellular Pathologist Queen Elizabeth Hospital Gateshead Tyne and Wear NE9 6SX

Technical EQA in NG Cytology Cytology has been used since Hooke in 1665 Nearly all labs will do some NG cytology, but lack of consistency and common agreement on what is a good preparation for use The quality of the sample is not solely in the hands of the lab itself and much can depend on sample collection No national process to compare and raise technical standards

So what is cytology? Cytology is the study of individual cells to make a diagnosis (“histology without the collagen”) Broad separation into – Gynaecological cytology (cervical smears) – Non-Gynaecological cytology (everything else!) NG Cytology also termed diagnostic cytology Very broad range of samples and techniques Difficult to try and encompass all sites and methods in a single scheme

Does it matter as long as we can tell what it is?

Which is best?

Quality procedures in non-gynaecological cytology laboratories in England and Wales. Egan M, Gray J. Cytopathology Aug;10(4):240-9 Egan MGray J Cytopathology. Telephone survey of all labs in E+W doing NG cytology (n=169/212) The aim was to investigate what concepts of quality applied in this context and to establish what tools and techniques of quality improvement were used. All types of quality assurance and customer focus procedure questioned were undertaken but to a varied extent; three laboratories (2%) used a complete range and three (2%) used no procedure at all. Accreditation was associated with staffing adequacy and use of surveys, but not quality assurance (QA) or user focus. Laboratories with a high priority for quality performed more QA and reported a higher staffing adequacy. “The study suggested that an integrated approach to quality had not been adopted in English and Welsh cytology laboratories and that there may be a need for a more strategic approach with greater availability of EQA, guidelines on quality tools, closer linkage of accreditation and quality procedures and the production of minimum and ideal standards”

Guidance – Gynae vs NG Cytology Gynae NG Cytology

Why are we doing this? “..to help facilitate or improve diagnosis..” Poor performance in a technical EQA scheme can highlight areas that the lab can work on to improve the quality of its NG cytology samples and hence diagnosis Good performance gives re-assurance as to quality of material as compared to peers Sharing of good practice to raise overall standards We have all talked about it for years!!!

What guidance is there now? BSCC Codes of Practice for non-Gynaecological cytology (2009) “There are presently no national quality assurance schemes..It must be acknowledged that further work is required regulating QC and QA in non- gynaecological cytology” RCPath Tissue pathways for exfoliative cytology and fine needle aspiration cytology (2010) – refers to BSCC CoP but no mention of quality as such!

Development of scheme British Association for Cytopathology formed July 2011 by merger of BSCC and NAC Survey by BAC early in 2012 highlighted variation in NG preparation and samples processed Over three quarters of respondent laboratories felt a NG Technical EQA scheme would be use

76% 24%

Development of scheme - 1 Seen as a high priority by BAC who wished to promote development of such a scheme BAC discussion with UK NEQAS CPT who already ran several established technical EQA schemes in cellular pathology which were also CPA accredited/compliant – General Cellular Pathology – Neuropathology – Renal Biopsy – Muscle Histochemistry

Development of scheme - 2 BAC agreed to help develop and pump prime development of an NG Technical EQA scheme Decided to run two pilot runs in 2013 with aim to use these to refine the process and protocols Drew upon existing expertise from BAC and UK NEQAS CPT assessors to draft scheme protocol and scoring

Development of scheme - 3 Invited laboratories to take part in the two pilots Received over 70 expressions of interest Given numbers, ran pilot 1 with 35 labs, and pilot 2 with all labs who had expressed an interest Free to labs for pilot phase All protocols shared with labs and comments invited

Pilot 1 35 labs from UK, Europe and further afield Used submitted urine and ascitic fluid samples All slides scored by two assessors working in pairs Scored using a 5 point scoring scheme Free text and standard comments given as appropriate

Scoring scheme – Pilot 1 Each pair of assessors gave a score out of 5 per cases per stain Scoring basis – 5 – Excellent – 4 - Good – 3 – Pass – 2 – Borderline Fail – 1 – Fail – 0 – No submission

Pilot 2 72 labs took part Used urine and ascitic fluid samples again Scored using a ten point scoring scheme – each assessor provides a score of 5 and scores are added Free text and standard comments used as appropriate

Scoring scheme – Pilot 2 Each pair of assessors score out of 5 (as previously) and combine scores to make score out of 10 Score <5 - A score of less than 5 / 10 is given for poor staining, where the participant has failed to clearly demonstrate the expected results. Score 5/6 – a score of 5 or 6 / 10 is a pass. Whilst the staining appropriately demonstrates the expected staining results, staining is suboptimal and improvements are still required overall. Score 7/8 – a score of 7 or 8 / 10 shows good appropriate demonstration of the expected results, and an acceptable level of quality. Score 9/10 – a score of 9 or 10 / 10 shows excellent appropriate demonstration of the expected results, and a high level of quality

Pilot 2 overall scores

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Preparation typeNumber of labs C/S P+G – x 1 slide of each9 C/S P+G x 2 slides of each5 C/S P+G two pellets per slide x 1 slide each8 C/S P+G two pellets per slide, x 2 slides each1 Thinprep P only one slide5 Thin prep Pap and Giemsa spread – x 1 each7 Thin prep Pap x 1 slide and C/S Giemsa x 1 slide1 C/S Pap and Giemsa spread x 1 each2 Spread P+G x 1 slide each5 C/S G x 1 and Pap C/S slides x22 C/S Pap x1, Giemsa C/S x 2, Giemsa spread x 11 C/S P+G x 1 slide each, P+G spread x 1 slide1 C/S Pap x 1 slide, C/S Giemsa x 2 slides2 C/S Pap x 1 slide, C/S Giemsa x 1 slide, Giemsa spread x 1 slide2 C/S Pap x 2 slides, C/S Giemsa x 1 slide, Giemsa spread x 1 slide1 C/S Pap x 2 slides, Giemsa spread x 1 slide1 C/S Pap x 2 slides, C/S Giemsa x 1 slide1 C/S P+G x 1 slide each, P+G spread x 1 each1 C/S Gimesa one pellet x 1 slide1 Spread P+G x 2 slides of each1 ?Cell block P+G x 1 slide of each2 Range of preparations for ascitic fluid samples

Preparation typeNumber of labs C/S P+G pellet x 1 per slide, x 2 slides each1 C/S Pap x 1 slide19 C/S Pap two pellets per slide, x 2 slides each6 C/S P+G two pellets per slide, x 2 slides each1 Thin prep x 1 slide19 C/S Pap x 2 slides8 C/S P+G x 1 slide each1 Spread Pap x 1 slide2 C/S Pap x 2 slides, Pap spread x 1 slides, C/S Giemsa x 1 slide 1 C/S Pap x 2 slides, C/S Giemsa x 1 slides, Giemsa spread x 1 slide 1 Range of preparations for Urine samples

The H+E issue….. RCPath January 2010 “H&E staining offers no benefits over Papanicolaou staining and should not be used.” Any scheme must reflect the guidance in existence Scheme does not assess H&E cytological material

The next steps NG Technical EQA scheme now adopted by UK NEQAS CPT as a specialist module Will run from late 2013 Will initially run 6x a year (like all other CPT modules) Protocol will develop as more experience gained – join it and help develop it! Development of other NG technical sample EQA areas (e.g. FNA, brush, by site, ?IHC) Full details :

The Future… Need to expand scheme ultimately to include other types of NG cytology preparation and site May run general sample along with specialist site sample (e.g. urine and bronchial brushings) Possible link with IHC EQA (cytology sample/clot sample)? Possible link with interpretative NG EQA cytology scheme? Possible link with veterinary cytology? Lets walk before we run….