Posters. P3 North west non‐gynaecological cytology EQA pilot CD ROM scheme 2002–2003

The 8th circulation of this scheme was preceded by a CD ROM circulation of selected digital images and presented as individual JPEG file images in a single folder on the CD ROM. The number of images per case ranged from three to eight. The delegates will have an opportunity to assess these themselves prior to uncovering the consensus diagnosis provided by the participants. Of the 76, 29 participants of the scheme provided a completed answer sheet for the image‐based circulation. To date, 19 have now also supplied answers on the actual slide circulation. The same diagnosis on image and slide circulation varied from 5/19 to 19/19 with a mode of 14/19. The case that provided the poorest correlation was because of a generalized undercall of suspicious in a case which achieved almost complete consensus on the slide circulation. It had been the most difficult to photograph. The case that provided the next poorest correlation 11/19 was the case that had the poorest consensus diagnosis on the slide circulation. The two cases that provided the best correlation 18/19 and 19/19 were two cases that provided 100% consensus diagnosis on the slide‐based circulation. Comments were received from 20 participants about the image circulation ranging from ‘great’ to ‘awful’ with the majority of 12 participants not happy for their diagnostic capability to be assessed on such images alone. Two stated that the CD was easier to use on their home computer than their NHS one. In conclusion an image circulation overcomes many of the inherent problems with a slide circulation for EQA purposes and can provide an overall 70% correlation with a slide circulation but a significant number of pathologists do not find this an acceptable method for EQA.     

Toward implementation of a regional quality assurance program in cytopathology: the Hong Kong experience

OBJECTIVE: To develop a local quality assurance program in cytopathology based on circulation of patient specimens on glass slides, with limited resources. STUDY DESIGN: A working group was set up for design and running of the program. Participation is on a laboratory basis. The scope and frequency of testing are defined. Well-documented cases (including gynecologic, nongynecologic and fine needle aspiration cytology) with commonly encountered diagnoses are collected. Consensus concerning the diagnosis, interpretive menu and scoring system is sought before the actual slide circulations using express mail. After returning their answers to the program organizer, the participating laboratories receive immediate feedback on their scores, with reference answers, explanatory notes, "whole-mount" images of glass slides and cumulative responses of peer laboratories for on-site checking. At the end of each year, an electronic file containing representative photomicrographs of all cases examined is provided to individual laboratories for their permanent records and training purposes. RESULTS: The program was launched in mid-2003. There were 24 and 27 participating laboratories from Hong Kong (and Macau) in 2003 and 2004, respectively. To date, >150 well-documented cytology cases are available in the slide pool and ready for circulation. As the revenue is mainly to cover the expenses of express mail, the program can be carried out at a relatively low cost. CONCLUSION: In order to have any cytology quality assurance program accepted by local laboratories, it has to be fair and practical. Strict confidentiality needs to be observed throughout the process. This program emphasizes both performance assessment and educational value. Adequate representation from experienced local cytology workers, detailed documentation support from authorities and assistance from dedicated staff are essential to the success of any external proficiency testing scheme. Regular review and evaluation are also necessary for continuous improvement. The Hong Kong experience can serve as an example of running a glass slide-based cytology quality assurance program in a small region with limited resources.     

External quality assurance for cervical cytology in developing countries. Experience in Peru and Nicaragua

Given interest from the professionals concerned, an external quality assurance scheme for cervical cytology can successfully be introduced in developing countries. This is a very important precondition if screening programs are to be expanded and decreases in mortality from cervical cancer are to occur in developing countries. Nicaragua and Peru have been experimenting with an external quality assurance system adapted from the Scottish and Northern Ireland scheme. It has been received with enthusiasm and acceptance and has helped cytology laboratories in these countries focusing on quality issues. Nevertheless, a successful quality control scheme that is to result in improvements in the quality of professionals' diagnostic skills needs to be accompanied by a remedial program for subperformers.     

Rapid screening: a comparative study

Although rapid screening of negative and inadequate cervical smears is a quality assurance requirement for all UK laboratories, there has been little attempt to standardize the method and laboratories make use of a number of different techniques and times. The aim of this study was to assess the sensitivity of these various techniques by measuring their ability to pick out known false-negative smears. Completed questionnaires from 123 laboratories across England revealed that 52% of laboratories use a "step" technique, 19% use "turret", 15% use random paths and 34% attempt to rescreen the whole slide quickly. Twenty-two percent of laboratories use a mixture of techniques. Timings are also variable, with the majority of laboratories allowing screeners to review slides at a pace decided by themselves but usually between 1 and 2 min. The study involved 120 participants who performed a total of 24 000 rapid screens. The results showed that, of the 90 abnormal slides used in the study, 62 cases (69%) were identified as abnormal or needing review by more than 50% of participants. Overall rapid screening picked out 58% of high-grade squamous abnormalities, 59% of low-grade abnormalities and 72% of glandular lesions. Step screening performed best, followed by whole slide/random and then turret. One minute was the optimum time and there was a significant fall in performance once individuals attempted to rescreen large numbers (>50). The most significant finding was the marked variation in the performance of individuals using the same slide sets.     

Reliability and accuracy of reporting cervical intraepithelial neoplasia (CIN) in 15 laboratories throughout Italy: phase 1 of a national programme of external quality control in cervical screening

This paper reports results of a first phase of a pilot study to assess and improve quality of diagnoses in cervical cytological laboratories located throughout Italy. It represents the first phase of an External Quality Assurance programme (EQA). In the first phase, two sets of cervical smears representing a range of diagnoses were circulated among participating laboratories. Responses were recorded on a standardized form. Participants were asked to assess the adequacy of the smear and formulate a diagnosis. They were also asked to recommend management of the patient on the basis of the smear report and judge the degree of diagnostic difficulty of each slide. Crude index of agreement, unweighted and weighted kappas, diagnostic specific kappas, sensitivity and specificity as well as clinical indices of variability were calculated. In the second phase, two additional sets of slides were circulated after discussion of the first phase. There was striking variability between laboratories, both in terms of diagnoses offered and recommendations for management on individual slides. Assessment of the degree of difficulty of each slide was also very variable. Discrimination between CINII and CINIII was poor, confirming the choice of merging these two categories in the Bethesda classification. However, discrimination between CINI and CINII was also unsatisfactory. The results were discussed in workshops and it was possible to reach a consensus diagnosis in 35 of 40 smears. This study confirms the need for external quality control programmes.     

Technical External Quality Assessment for SurePath® stained liquid-based cytology gynaecological cervical samples using control material – a novel approach

Aims and objective: The Technical External Quality Assessment Scheme (TEQA) introduced in Wales is based on NHSCSP publication No 19 [External Quality Assessment Scheme for the Evaluation of Papanicolaou Staining in Cervical Cytology] which sets out the policies and standard operating procedures for the TEQA of Papanicolaou staining of gynaecological cervical samples. As part of a development plan for the TEQA scheme in Wales, the use of a control sample was introduced to the assessment process – a common control sample can provide a consistent assessment parameter independent of the recommended slide selection process [External Quality Assessment Scheme for the Evaluation of Papanicolaou Staining in Cervical Cytology, NHSCSP Publication No 19, February 2004] enabling direct comparison of staining standards for laboratories within the region; this counters selection variation bias, establishing a process that may be more representative of routine staining results. Methods: A cervical sample was selected in line with the criteria described in publication 19 [External Quality Assessment Scheme for the Evaluation of Papanicolaou Staining in Cervical Cytology, NHSCSP Publication No 19, February 2004]. Thirteen slides were prepared by the scheme facilitator from this anonymized sample. These control slides were subsequently ‘fixed’ but not stained, then distributed to the laboratories participating in the TEQA scheme. The slides were stained using their standard regime, then returned to the facilitator for assessment. The slides showed consistent staining with no significant inter‐laboratory variation, however, the eosinophilic stained components exhibited an artificial colouration, which slightly altered the expected stained appearance; this was thought to be due to ‘cross‐reactivity’ of the spray fixative with the preserving agent. To address this artefact, a further development of control procedures was devised utilizing a pooled control sample procedure. Residual material from a number of similar samples was pooled and distributed in aliquots to participant laboratories for standard processing and staining; the completed slides were returned to the scheme facilitator for assessment. Results: The pooled sample slides were assessed at the next scheduled quarterly TEQA assessment. The overall scoring for these samples produced an acceptable level of Papanicolaou staining for 12 of the laboratories – only one laboratory produced a marginal score. The artefactual presentation of eosinophilia was not seen. Discussion/conclusion: This method of producing control material establishes consistency in the TEQA comparative assessment process, counters selection bias and reduces the time demands associated with slide selection. It may also prove useful in identifying technical problems within laboratories during sample preparation prior to or during staining, including equipment or process faults. This technique is now well established locally as an enhancement of the current TEQA scheme for the assessment of slide staining. We feel that this enhancement could be incorporated as a new initiative in the current National TEQA scheme as a complement to the established selection process.     

Inadequate cervical smears: results of an educational slide exchange scheme

Fifty-six slides, predominantly inadequate and of varying difficulty, were circulated to 12 laboratories as an educationally based slide exchange scheme. Three slides failed to achieve an agreed majority consensus opinion. Seventy percent of participants agreed with the consensus opinion in 80% of slides. Of the slides originally reported as inadequate, the consensus diagnosis was inadequate in 78%, negative in 12% and abnormal in 10%. The latter included two cases of high-grade dyskaryosis. There was good agreement for the two most frequent causes of inadequacy in submitted slides (obscured and poor cellularity). There was poor consistency in reporting the presence or absence of endocervical and immature squamous metaplastic cells, to an extent that questions their use in the assessment of smear adequacy. Three inadequate slides on consensus opinion were associated with subsequent cervical intraepithelial neoplasia (grade III) or invasive squamous cell carcinoma. In the latter case, the slide had originally been reported as negative by the submitting laboratory.     

P‐15COMPARISON OF RESULTS FOR A NON‐GYNAECOLOGICAL CYTOLOGY EQA SCHEME

The problems encountered with a glass slide circulation are legion but timely circulation is a major problem and is an inherent deficiency of our Non‐gynaecological EQA scheme. This applies not only to consultants but also to specialist registrars (SpRs) and technical staff that are not formally included in the circulation list. In 2005 only 7 technical staff and 4 out of 47 SpRs took part on a formal basis, their participation being dependant on access to slides during their cytology attachment. The results for the 2005 circulation have been analysed and despite the small numbers of participating technical staff and SpRs their answers concur with the consultant body. To address the issues of timeliness and circulation problems a pilot teaching set has been developed by SlidePath into a virtual microscope web based circulation and sent to all SpRs in our region. They have recorded their answers and been given immediate access to the consensus consultant opinion with illustrations of follow up histology. A questionnaire was completed to evaluate the scheme. The facility of immediate feedback of consultant consensus is particularly pertinent to the educational element of the scheme and use of virtual microscopy addresses the issue of timely circulation. If further funding was made available technical staff could also be given the opportunity to try this web‐based circulation.     

P-16DEFAULT FROM CYTOLOGICAL SURVEILLANCE OF LOW-GRADE SMEARS: LEVELS OF DEFAULT AND CHARACTERISTICS OF DEFAULTERS IN THE TRIAL OF MANAGEMENT OF BORDERLINE AND OTHER LOW-GRADE ABNORMAL SMEARS (TOMBOLA)

The problems encountered with a glass slide circulation are legion but timely circulation is a major problem and is an inherent deficiency of our Non-gynaecological EQA scheme. This applies not only to consultants but also to specialist registrars (SpRs) and technical staff that are not formally included in the circulation list. In 2005 only 7 technical staff and 4 out of 47 SpRs took part on a formal basis, their participation being dependant on access to slides during their cytology attachment. The results for the 2005 circulation have been analysed and despite the small numbers of participating technical staff and SpRs their answers concur with the consultant body. To address the issues of timeliness and circulation problems a pilot teaching set has been developed by SlidePath into a virtual microscope web based circulation and sent to all SpRs in our region. They have recorded their answers and been given immediate access to the consensus consultant opinion with illustrations of follow up histology. A questionnaire was completed to evaluate the scheme. The facility of immediate feedback of consultant consensus is particularly pertinent to the educational element of the scheme and use of virtual microscopy addresses the issue of timely circulation. If further funding was made available technical staff could also be given the opportunity to try this web-based circulation.     

O-12The use of control samples in the PAPANICOLAOU technical external quality assessment scheme

Technical external quality assessment (TEQA) in Wales is based on NHSCSP publication 19, which sets out policy and procedures for the scheme. The purpose of EQA is to sustain and improve the quality of patient care by promoting a high standard of performance. Following the introduction of liquid base cytology (LBC) technical limitations, particularly in assessing counterstaining, have been noted. LBC provides the means to address these limitations - As part of a development plan for TEQA in Wales, a control sample procedure was introduced to the scheme. A pooled control sample was composed, containing residual material from six 'matched' negative samples, re-suspended in collection fluid. Aliquots of this sample were distributed for processing and staining, to the 13 laboratories registered with the scheme. The slides produced were assessed at a scheduled TEQA assessment in accordance with the standard criteria. Initial overall scoring for these control samples produced acceptable levels of staining for 12 of the laboratories - one laboratory produced a marginal score. Repeat distributions have shown maintained or improved results. This method provides a prospective quality assessment tool, which counters the emphasis on slide selection and eliminates potential selection bias, whilst introducing consistency and improving comparability across participant laboratories. The method may also prove helpful in identifying technical inconsistencies such as equipment or handling errors that may occur during sample processing prior to or during staining. The control process, which is now used routinely in the Welsh TEQA scheme; is considered complimentary to, and not a replacement for, the selection process established in NHSCSP #19. However, we feel that this development could be considered as a new initiative in the National TEQA scheme. The control process is applicable to all LBC systems in current use.     

An assessment of partial rescreening as an internal quality control method for cervical smears

Partial screening was performed on 10 800 cervical smears, comprising 8640 filed negative and unsatisfactory smears and 2160 newly received smears prior to conventional screening. Each slide was screened for 30 s and those considered abnormal were reviewed by standard screening. Partial screening led to the detection of 27 additional infections and 44 additional cytological abnormalities. These detection rates are better than those obtained with the traditional method of rescreening only a proportion of smears. Amongst the smears partially screened before conventional screening, partial screening detected 37-66% of infections and 22-71% of cytological abnormalities. We recommend the use of partial rescreening of all negatively reported smears as a method of internal quality control in cervical cytology laboratories.     

Organisation of cervical cytology screening in Croatia: past, present and future

This presentation highlights strengths and weaknesses of cervical cytology screening in Croatia, with particular reference to the opportunistic screening, the use of conventional Papanicolaou (Pap) test and the analysis of some organizational, educational and performance issues that are associated with it. Its aim is to propose measures to improve the efficacy of cervical cytology screening in order to reduce cervical cancer mortality. Currently, in excess of 450,000 Pap tests/ year are examined at 35 laboratories scattered throughout the country. All of these laboratories use standard operating procedures including internal and external quality control. They employ a total of 68 cytologists and 91 cytotechnologists. The sensitivity of cervical screening in Croatia is 90.0%, specificity 98.6%, positive predictive value 92.3%, negative predictive value 98.1% and overall diagnostic accuracy 97.2%. The high diagnostic accuracy of cervical cytology is attributed to the long-standing tradition of education and training of cytologists (postgraduate MSc course since 1967, independent residency since 1974) and cytotechnologists (since 1968). This tradition spanning more than half a century means that today in Croatia there is a developed network of cytology laboratories staffed by highly competent cytologists and trained cytotechnologists. The high accuracy of cancer detection through Pap tests provides strong evidence in support of cervical cytology screening remaining the basic method of prevention for cervical carcinoma. However, some modifications to the current situation are needed. These relate primarily to opportunistic screening. The current screening coverage rate is 68%, although there is capacity, which would allow for all women at risk, i.e. those aged 25-64, to be screened once in three years. The screening coverage relates mainly to those women visiting gynecological out patient clinics for unrelated conditions. A properly organized and controlled national screening programme should replace this. This should be accompanied by the introduction of alternative, highly sensitive methods of sample collection and preparation, such as are available through the introduction of new technologies, e.g. liquid based cytology.     

O-8Detection of human telomerase gene (TERC) amplification in cervical neoplasia: a retrospective study of 50 patients with normal smears or mild or moderate dyskaryosis

Circulation E of the North West non gynaecological cytology EQA scheme was split into two with one half receiving conventional glass slides and the other half receiving digital images supplied by the SlidePath company over the web. More of the participants eligible participated in the slide half (43/65) than the digital half (17/41).
Similar results were obtained for seven out of ten of the scoring cases and for both the educational cases. However for one case eight of the digital participants could not obtain the images over the web. In the remaining three scoring cases the digital participants were less good at obtaining the correct answer compared to the slide based participants. The use of this virtual microscopy has shortened the circulation length considerably. The digital participants complained about the speed the digital slides appeared on their computers and whilst most agreed that this is the way forward they are still uncomfortable with their performance being marked on their digital submissions. Delegates will have the opportunity of viewing still images taken for each case from this circulation.     

Liquid-based cytology can improve efficiency of cervical smear readers: evidence from timing surveys in two NHS cytology laboratories

OBJECTIVE: Cervical screening programmes in England and Wales were advised by the National Institute for Clinical Excellence in 2003 to adopt liquid-based cytology (LBC) in place of conventional Papanicolaou (Pap) cytology to facilitate laboratory efficiency. Pilot evaluations in England and Scotland monitored daily or weekly workloads of smear readers and concluded that LBC could increase hourly throughput rates. This study, instead, used timing surveys to determine screening rates. METHODS: Two National Health Service cytology laboratories in Manchester and Stockport were partially converted to the LBC ThinPrep process for a cervical screening trial. Three 1-week timing surveys were conducted over 7 months. The surveys covered all LBC-trained staff. The first survey in Manchester also covered staff undertaking conventional Pap screening. The smear readers used timers to record time taken for examining and reporting each slide. RESULTS: In Manchester, in the first survey, nearly 1 minute per slide was saved by the LBC method during primary microscopy. In both laboratories, the mean microscopy time for primary screening of LBC slides was reduced by almost 1 minute between the first and second surveys. There was no difference between the second and third surveys. Microscopy by cytopathologists was also 1 minute per slide quicker with LBC than conventional Pap. The LBC inadequate rates for both laboratories were <2.0%. Organizational factors impacted on the hourly LBC primary screening rates in the laboratories, the rate for Stockport being higher than the rates in the pilot evaluations. CONCLUSIONS: The timing surveys confirm that the LBC ThinPrep technology can improve laboratory efficiency. However, decision-makers should also consider the overall costs and benefits of introducing the technology in screening programmes, including the capital investment and workforce implications.     

Le spermogramme et le spermocytogramme virtuels. Apport de la “toile” au Contrôle de Qualité Externe et à la formation en spermiologie. Le site www.spermionet.com

Semen analysis, especially estimation of sperm motility and morphology, is an important part of infertility investigation. The “Biologie Prospective” Nancy-France website (www.spermionet.com) proposes modern tools for clinical pathologists designed to promote common clinical practice and teaching by Internet. The aim of this study is describe these new techniques of on-line visualisation and diffusion for the study of human semen preparations. The virtual slide allows external quality control of sperm cytology. Video data of sperm motility are acquired by phase-contrast and dark field microscopy. The sequences are then compressed and published on line. The data have been evaluated by more than 480 laboratories. These new tools allow multicentre studies and collaboration based on standardization of semen analysis.     

Development of an incubation system for an inverted microscopy for long-term observation of cell cultures using chamber slides]

Trifunctional bispecific antibodies open up new immunological possibilities in tumour treatment. Prior to clinical application, comprehensive investigations using animal models and in vitro examinations need to be done. To investigate long-term interactions between various immunologically active blood cells and individual tumour cells in the presence of antibodies, we developed an incubation system for experimental cell cultures on an inverted microscope. The system consists of a perspex box with a central moisture chamber with integrated water reservoir, external air circulation heating, and a CO2 supply. The sterile cell cultures are located in the wells of a slide positioned within a depression in the water reservoir. The newly developed incubation system enables continuous observation over the long term of experiments under optimal cell cultures conditions in combination with modern video techniques.     

Slide preparation and sampling as a major source of variability in the mouse micronucleus assay

This paper describes the results of a study in which mouse bone marrow micronucleus assay slides were assessed for homogeneity of micronucleated polychromatic erythrocytes (MPE) among polychromatic erythrocytes (PE). The slides were prepared by 3 distinct methods and several methods of slide reading were assessed. Observations made using our slides were confirmed by re-analysis of slides from 3 independent laboratories. It is concluded that the method of slide preparation and assessment can significantly influence the variability of data obtained from a study. The extent of this variability casts doubt upon the validity of certain assumptions concerning this assay--such as sex differences in MPE incidence, responder variability, etc. Results are discussed within the context of the very recent literature for this assay. Some laboratories appear to have adequate methods of slide preparation and data accumulation, while others do not. Methods to improve the sensitivity of this assay are suggested within the context of the recommendations made by the Gene-Tox review group. In particular, it is suggested that individual investigators present evidence of the adequacy of their data accumulation techniques in order to enhance the value of future studies.     

Intra- and inter-laboratory variation in the scoring of micronuclei and nucleoplasmic bridges in binucleated human lymphocytes. Results of an international slide-scoring exercise by the HUMN project

One of the objectives of the HUman MicroNucleus (HUMN) project is to identify the methodological variables that have an important impact on micronucleus (MN) or micronucleated (MNed) cell frequencies measured in human lymphocytes using the cytokinesis-block micronucleus assay. In a previous study we had shown that the scoring criteria used were likely to be an important variable. To determine the extent of residual variation when laboratories scored cells from the same cultures using the same set of standard scoring criteria, an inter-laboratory slide-scoring exercise was performed among 34 laboratories from 21 countries with a total of 51 slide scorers involved. The results of this study show that even under these optimized conditions there is a great variation in the MN frequency or MNed cell frequency obtained by individual laboratories and scorers. All laboratories ranked correctly the MNed cell frequency in cells from cultures that were unirradiated, or exposed to 1 or 2Gy of gamma rays. The study also estimated that the intra-scorer median coefficient of variation for duplicate MNed cell frequency scores is 29% for unexposed cultures and 14 and 11% for cells exposed to 1 and 2Gy, respectively. These values can be used as a standard for quality or acceptability of data in future studies. Using a Poisson regression model it was estimated that radiation dose explained 67% of the variance, while staining method, cell sample, laboratory, and covariance explained 0.6, 0.3, 6.5, and 25.6% of the variance, respectively, leaving only 3.1% of the variance unexplained. As part of this exercise, nucleoplasmic bridges were also estimated by the laboratories; however, inexperience in the use of this biomarker of chromosome rearrangement was reflected in the much greater heterogeneity in the data and the unexplained variation estimated by the Poisson model. The results of these studies indicate clearly that even after standardizing culture and scoring conditions it will be necessary to calibrate scorers and laboratories if MN, MNed cell and nucleoplasmic bridge frequencies are to be reliably compared among laboratories and among populations.     

The evolution,evaluation and interpretation of antiphospholipid antibody assays

aPA have been observed in a variety of clinical settings, many of which are associated with thrombotic events in the venous, arterial or placental circulation. Although many assays have evolved to detect aPA the most sensitive ones are those that use the following: 1) bovine serum as a blocking and/or diluting supplement, 2) multiple phospholipid antigens (CL, PS and PE), and 3) conjugates to detect several antibody isotypes (IgG, IgA and IgM). The reported variation in aPA detection is significant; therefore, it is important to test a large number of healthy individuals with the aPA ELISA to determine which patient ELISA values are above normal compared to the local population. Inasmuch as individual assays vary this will ensure that an elevated aPA value in one lab is comparable to an elevated aPA value in another laboratory. As laboratories continue to standardize individual assays both internally and externally, concurrence among laboratories should increase.     

The development of the referral outcome diagram and an analysis of laboratory cancer detection rates in the English NHS cervical screening programme – is there an optimum level of detection of CIN 1 and CIN 2 lesions?

Objective: To use routine annual data from the English cervical screening laboratories (KC61 returns) to evaluate individual laboratory return characteristics with particular reference to factors associated with sensitivity and specificity. Methods: A graphical technique has been developed using data on referral to colposcopy and histological outcomes called a referral outcome (ROUT) diagram. The average grade of cervical intraepithelial neoplasia (CIN) detected (the mean CIN score, MCS) is plotted against the odds of a false‐positive referral. Further analysis has been conducted to examine the relationship between the MCS and screen‐detected invasive cancer rate. Results: There are large variations in ROUT diagram positions of individual laboratories and the diagram can be used to identify laboratories for further investigation. These variations are strongly influenced by substantial differences in the rate of low‐grade referrals and the MCS (and positive predictive value) are inversely related to the referral rate for low‐grade cytology (P < 0.001). There is a strong association between high MCS values and increased screen‐detected cancer rates (P < 0.001) particularly above an MCS of 2.2. The data can be re‐formulated in terms of CIN 2 and CIN 3 only where it can be shown that the invasive cancer rate rapidly increases if the numbers of CIN 2 lesions detected drops below 50% of the number of CIN 3 lesions. Given the complexity of cervical screening this may best be viewed as a hypothesis generating observation, best tested by interventional studies. Conclusions: The ROUT diagram represents a new and potentially interesting way of presenting annual return data. The national programme in England needs to balance the prevention of cancer against too many unnecessary referrals to colposcopy and the ROUT diagram, and associated data given in this paper may help toward this. Further research is required including examining the role of referral policy and threshold criteria in influencing low‐grade referrals and the relationship between MCS and cancer detection rate.