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Section 5 management of smear results web:layout

Classification systems for reporting cytology Formats in which smeartakers may receive reports Aim of sectionThe aim of this section is to provide an overview of the key issues relating to the management ofsmear results including the classification systems for reporting cytology, the management oflaboratory recommendations and considerations for primary care when interpreting, communicatingand recording results.
CervicalCheck, in consultation with laboratory specialists, has agreed recommendations for themanagement of the range of possible smear test results. In the national programme every eligiblescreening smear will carry a management recommendation. The EU recommended guidelines for bestpractice is a turnaround time of ten days in laboratories.
Classification systems for reporting cytology 5.2.1 Bethesda and BSCC TerminologiesSmear reporting uses either the Bethesda System of Classification (TBS) or the British Society for ClinicalCytology (BSCC) CIN terminology. Bethesda terminology is used in most other countries outside of the UKand Ireland. Although the BSCC or CIN terminology has been most commonly used to date in Irishlaboratories, smeartakers registered with CervicalCheck need to be familiar with both terminologies.
Most cancers of the cervix develop from abnormal epithelial changes in the cervix. These changes are called Cervical Intraepithelial Neoplasia (CIN). CIN is a term used in histology where a biopsy is analysed. The equivalent term in cytology where individual cells are viewed is dyskaryosis. Dyskaryosis is identified in the cells as nuclear changes. Histology will determine the degree of CIN in tissue biopsies. Laboratory reports equate mild dyskaryosis with CIN 1, moderate dyskaryosis with CIN 2 and severe dyskaryosis with CIN 3. Page 1 of 14
Table 5.1 Cytology Terminology Translation Table Table 5.1 provides a breakdown for both BCSS terminology and Bethesda terminology andillustrates a direct correlation between both terminologies and the management recommendationsof these reported results.
5.2.2 Overview of the Bethesda System of Classification (TBS)The Bethesda model, first developed in 1988, was modified in 2001 to take into account the results of new research and the previous years’ experience with the terminology. The Bethesda terminology relates to cytology and recognises the need to move away from terminology that suggests an inevitable progression from CIN 1 through to CIN 2, CIN 3 and to cancer. Such progression is now recognised to be a rare event. CIN 1 reflects an infective process. Progressionto more significant disease is related to persistent HPV infection over many years.
The Bethesda classification also aims to unify terminology thereby improving patient management.
The dysplasia/CIN spectrum has been simplified in the Bethesda system as low grade and highgrade squamous intraepithelial lesion (LSIL and HSIL) whereas CIN recognises three grades CIN 1,CIN 2 and CIN 3. 5.2.3 Overview of the British Society for Clinical Cytology (BSCC) The BSCC classification is a grading system that allows the cytologist to classify the varying degreesof dyskaryotic changes in the cells of the sample. There are three grades within this system i.e.
mild, moderate and severe dyskaryosis. Mild dyskaryosis is the least severe category of changewith increasing degree of abnormality through moderate to severe dyskaryosis.
In March 2002, the BSCC held a Terminology Conference at which a number of changes wererecommended with a view that these changes would bring Bethesda and BSCC reporting closertogether. However, these changes have yet to be agreed by other professional bodies and noimplementation date has yet been proposed. The European Guidelines for Quality Assurance inCervical Screening 2007 state that results should be ‘translatable to Bethesda’ (Herbert et al, 2007).
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Formats in which smeartakers may receive reports Table 5.2 Bethesda 2001 System Terminology for Reporting the Results of Cervical Cytology Satisfactory for evaluation (note presence/ absence of endocervical /transformation zone component.) Unsatisfactory for evaluation. (specify reason) • Specimen rejected/not processed (specify reason) Specimen processed and examined, but unsatisfactory for evaluation of epithelial abnormality because of (specify reason) Negative for Intraepithelial Lesion or Malignancy Negative for Intraepithelial Lesion or Malignancy Fungal organisms morphologically consistent with Candida species Shift in flora suggestive of bacterial vaginosis Bacteria morphologically consistent with Actinomyces species Cellular changes consistent with Herpes simplex virus Other non neoplastic findings (optional to report; list not inclusive)• Reactive cellular changes associated with Glandular cells status post hysterectomy Epithelial cell abnormalities squamous cell • Atypical squamous cells of undetermined significance (ASC-US) Atypical squamous cells cannot exclude HSIL (ASC-H) Low grade squamous intraepithelial lesion (LSIL) encompassing: HPV/mild dysplasia/CIN 1 High grade squamous intraepithelial lesion (HSIL) encompassing: moderate and severe dysplasia, CIS/CIN 2 and CIN 3 Atypical glandular cells (AGC) (specify endocervical, endometrial or not otherwise specified) Atypical glandular cells, favour neoplastic (specify endocervical or not otherwise specified) Endocervical adenocarcinoma in situ (AIS) Other (list not comprehensive)Endometrial cells in a woman 40 years of age.
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Table 5.3 Possible Smear Results from a Laboratory using BSCC/CIN Terminology Most unsuitable LBC specimens are likely to be attributed to too few squamous cells present in the preparation, occurring more commonly in post-menopausal women and where insufficient pressure was used to harvest cells duringsmeartaking. Smears may also be deemed unsatisfactory because the reading is compromisedby the presence of excess blood, menstrual debris, polymorphs or bacteria.
Normal includes simple inflammatory changes.
Cellular appearances that cannot definitely be described as normal.
Cellular appearances consistent with origin from CIN 1 (Mild dysplasia).
Cellular appearances consistent with origin from CIN 2 (Moderate dysplasia).
Cellular appearances consistent with origin from CIN 3 (Severe dysplasia/carcinoma in situ).
Cellular appearances consistent with origin from CIN 3 but with additional features which suggest the possibility of invasive cancer.
Equivocal glandular cell changes are reported on cytology as BNA (gl), although the relative rarity of glandular neoplasia should make this unusual. Cellular appearances suggesting pre-cancer or cancer in the cervical canal, the endometrium or extra-uterine site. Pre-malignant change in the endocervical epithelium is commonly referred to ascervical glandular intra-epithelial neoplasia (CGIN) Page 4 of 14
Other comments on smear reports from laboratories using BSCC Terminology Trichomonas, Candida and Herpes simplex can be identified.
Produces cellular appearance which may be described as koilocytosis and dyskeratosis. Varying nuclear changes will be present which may be indistinguishable from dyskaryosis.
These are cells from the columnar epithelium of the cervical canal. During its formation, the transformation zone will include similar epithelium. Samplingof the TZ will yield columnar (glandular) cells prior to completion of the metaplastic process.
Endocervical cells are not essential for an adequate smear, except infollow- up smears where the previous abnormality was seen in endocervicalcells.1 Normal cells from the transformation zone (TZ).
Evidence of TZ cells is not a requirement on its own for a satisfactory sample. However, it is the responsibility of the smeartaker to make every effort to sample the whole of the TZ.1 A normal process of cell disintegration. The normal breakdown of cells due to the presence of lactobacilli when the vaginal environment is acidic. Most common in the second half of the menstrual cycle and in women on progesterone-only contraceptives, also common in pregnancy.
Cells derived from the endometrial lining of the uterine cavity. Shed during menstruation and in some other circumstances.
Cellular changes present in some degree in many smears which are not evidence of CIN.
The presence of inflammatory changes on a smear result should not be managed by repeat smear testing. Page 5 of 14
5.4.1 Specimen adequacy and results using the Bethesda system (TBS)The Bethesda system requires at least 5,000 cells on a liquid based preparation for adequacy. Commentsmay be given on the report about inflammatory exudates. Women should be referred for colposcopy afterthree consecutive inadequate smears. The consensus opinion is that invasive cancers may be associatedwith inflammatory processes and contact bleeding. Women with persistent inadequate samples shouldundergo colposcopy to exclude invasive cancer. Table 5.4 Specimen adequacy and results using the Bethesda system (TBS) NILM is the report given to a negative smear. However, it may contain a text report comment on numerous variants of benign cellular findings e.g. atrophic changes or the presence of organisms.
LSIL cannot be distinguished from transient HPV infection by cytology alone, which is the rationale for surveillance to identify the minority that progress to high grade Despite apparently successful treatment of HSIL, published studies show that this group of women remain at higher risk of cervical cancer than women who never have had an abnormality (Strander, 2007). In view of this, the colposcopist will determine the frequency of smears post-treatment.
This category has been shown to be associated with approximately 10 per cent of high grade lesions on biopsy (Arbyn, 2004).
This is a subgroup of atypical / borderline changes in which the changes are suspicious of HSIL and occasionally cancer. It is sometimes used when the abnormal cells are so few that the diagnosis is uncertain. It is important to remember that a normal smear result does not rule out an invasive cancer and if clinically suspicious, urgent referral for a gynaecologicalopinion is recommended. The diagnosis of invasive cancer requires a histologicalbiopsy but there are cytological changes that suggest the possibility of invasion.
TBS recognise the importance of reporting such changes and define a separatecategory for the commonest type of invasive cancer i.e. squamous cell carcinomaor for changes in which the cell type of invasive cancer is not evident. Page 6 of 14
Glandular lesions are less common than their squamous cell counterparts but form an important group as they are more difficult to detect by cytology screening andmore difficult to recognize at colposcopy.
AGC on a smear is frequently associated with a clinically significant diagnosis.
This category is used when the cell changes are thought to favour glandular neoplasia but are insufficient for a firm diagnosis. The higher rate of invasive cancer diagnosis within two years of a report of glandular abnormality justifies referral to colposcopy as the management recommendation. (NHMRC Guidelines,2005).
Defined as replacement of endocervical glandular epithelium by cytologically malignant cells. (AIS) is confined to the surface of the cervix.
Endometrial cells in a woman over 40 years of age. The presence of these cellsindicates an increased risk for endometrial cancer of 0.2 per cent. (NHMRC Guidelines, 2005).
Women should be referred for colposcopy if they have three test results reported as abnormal at any grade in a ten year period even if returned to routine recall on one or more occasions in that period.
The doctor may be the only person to recognise this situation.
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The following outlines the various processes in communicating different types of results.
The doctor with clinical responsibility will receive a copy of the result from the laboratory. CervicalCheck will send a letter to the womaninforming her that no abnormality has been detected. This letter willalso indicate when the next smear will be due. This is calculated on thebasis of the smear test result and the clinical information provided onthe Cervical Cytology Form. A further letter will be sent when the nextsmear is due. A report is sent to CervicalCheck and the smeartaker by the laboratory.
CervicalCheck will send a letter to the woman advising her that the result has been reported unsatisfactory and that she will need to returnfor another smear. Two reminders will be sent to the woman ifCervicalCheck does not receive notification that a further smear has beentaken. A ‘not normal’ result is sent to the doctor with clinical responsibility.
CervicalCheck will send a letter to the woman advising her that her smear has been reported as needing follow up and to contact her doctor take a closer look at theneck of the womb. This is a The doctor with clinical responsibility is responsible for taking the appropriate action. A face to face consultation is recommended.
CervicalCheck provides a leaflet explaining colposcopy which may be helpful for the woman. In the event of the woman failing to attend forfollow up, CervicalCheck will send two reminder letters to the woman Where a referral to a colposcopy clinic is indicated, a colposcopy referral form should be completed and a copy of the smear result should be attached. It is very important to provide adequate counselling at this point. The role of this counselling is not only to provide information regarding the follow-up procedure but also to identify those women who are at risk of not attending the colposcopy clinic. which is then viewedthrough the microscope. The manner in which a woman is told about an abnormal test will affect her likelihood to attend colposcopy and her ability to cope with any treatment or follow-up. The information provided should be clear and provides magnification sothat any abnormal areas Women who receive abnormal results should be offered an opportunity to speak with the general practitioner to discuss the implications of the result. Patients often assume that an abnormal result means cancer andit is important to re-iterate the pre-malignant nature of the cellularchanges seen on the smear. The fact that this is a treatable conditionshould also be underlined.
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An accurate system of recording results should be in place and records should be updated • For all the follow-up contacts related to the smear result Smear results should be recorded in the woman’s medical record so that her results are immediately clear tothe healthcare professional when she attends the practice for other reasons. This will ensure an efficientfailsafe mechanism and is particularly relevant if there was a failure to attend for follow-up. A trackingsystem should also be put in place to ensure the following• All smears have been sent to the laboratory All results have been received by the laboratory All the laboratory recommendations are followed The system can be either manual or electronic as follows: Manual records can be organised utilising a The procedure for entering cervical smears will manual logbook. A designated person in the vary depending on the software package being clinic should be responsible for checking that the utilised. Current GP software allows recording of logbook is completed at each stage and that all smear test results and the production of reports the appropriate actions have been taken.
listing smears taken, results received and smearsdue during certain defined periods. Practices Alternatively, an A5 card can be used as a should contact their technical support or the local separate record card with the details from the GP IT tutor for further information.
smear form submitted to the laboratory copied onto the card. All cards should be kept until all Appropriate advice should be provided to all actions required are performed. These records clinical people involved in the screening can be divided into the following categories: designated person should be responsible for ensuring that everybody has the necessarycompetence to enter data in the system correctly.
A manual record-keeping system for these cardscan be created using small storage boxes withalphabet dividers. At least two boxes are used:1. Smear done - awaiting result2. Result received and acted upon Additional, separate boxes may be of value for‘Action Taken’ and ‘Smear Fee Received’ in largerpractices. The forms can be moved from one boxto the other as appropriate. One person in thepractice should be responsible for managing thissystem.
In addition to record keeping within the clinical context, recording personal information on computer or instructured manual files carries with it legal responsibilities under the Data Protection Acts, 1988 and 2003(see Appendix 5).
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(Please attach a copy of the referring cytology smear result form as necessary) Referral Smear Details:Cytology Lab Accession Number Page 11 of 14
Under the Data Protection Acts, 1988 and 2003, the following eight rules must be followed when recordingdata: 2. Keep it only for one or more specified, explicit and lawful purposes 3. Use and disclose it only in ways compatible with these purposes 5. Keep it accurate, complete and up-to-date 6. Ensure that it is adequate, relevant and not excessive 7. Retain it for no longer than is necessary for the purpose or purposes 8. Give a copy of his/her personal data to an individual, on request.
Source: Office of the Data Protection Commissioner website (www.dataprotection.ie) If in any doubt about the implications of this legislation, a legal adviser or the Data Protection Commissionershould be contacted.
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Arbyn, M., Buntinx, F., Van Ranst, M., Paraskevaidis, E., Martin-Hirsch, P., Dillner, J.,(2004): Virologic VersusCytologic Triage of Women with Equivocal Pap Smears: A Meta-Analysis of The Accuracy to Detect HighGrade Intraepithelial Neoplasia J Natl Cancer Inst 2004 96 280 -93 British Society for Clinical Cytology (2003) Taking Cervical Smears, 3rd Edition. BSCC, London.
Daniel, A., Barreth, D., Schepansky, A., Johnson, G., Capstick, V., Faught, W. (2005): Histologic and ClinicalSignificance of Atypical Glandular Cells on Pap Smears. International Journal of Gynaecology and Obstetrics,Vol.91, No 3, 238-242 Herbert, A., Bergeron,C., Wiener,H., Schenck, U., Klinkhamer, P., Bulten, J., Arbyn, M. (2007): EuropeanGuidelines for Quality Assurance in Cervical Cancer Screening: Recommendations for Cervical CytologyTerminology. Cytopathology 18 (4) , 213–219 doi:10.1111/j.1365-2303.2007.00469.
IARC (2008): European Guidelines for Quality Assurance in Cervical Screening, 2nd Edition, Office for OfficialPublications of the European Community. Luxembourg: European Commission.
NHS CSP Achievable Standards, Benchmarks for Reporting & Criteria for Evaluating Cervical Cytopathology,2nd Edition Solomon, D., Davey, D., Kurman, R. et al.(2002): The 2001 Bethesda System: Terminology for ReportingResults of Cervical Cytology. JAMA 2002 287:2140-1 Strander, B., Andersson-Ellström, A., Milsom, I., & Sparén, P. (2007): Long Term Risk of Invasive Cancer AfterTreatment for Cervical Intraepithelial Neoplasia Grade 3: Population Based Cohort Study. BMJ 335;1077.
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