Gloucestershire Cervical Screening Programme Guidelines

Transcription

1 Gloucestershire Cervical Screening Programme Guidelines February Cervical Screening Programme Guidelines Page 1 Version: 6.0 Issued: February 2014

2 Notes: Please note that this extensive document contains internal and external hyperlinks and is best viewed on line. If you are reading a paper copy the on line version can be accessed at.. Contents Page Number 1. Introduction to Cervical screening 6 Aims and objectives Overview of the current programme Responsibilities within the local programme General guidance 2.Training and Guidelines for taking cervical cytology samples Sample Taker training 2.2 Before and after taking a cervical cytology sample 2.3 Taking a cervical cytology sample 2.4 Taking an endocervical brush sample 2.5 Inadequate/unsatisfactory result guidelines 2.6 General 3.Colposcopy service and direct referral 18 4.Gloucestershire Call, Recall and Follow-up policy General guidance routine call and recall 4.2 Inadequate cytology samples 4.3 Negative Cytology Samples: Call and recall Following borderline cytology Following diagnosis and/or treatment of CIN1 Following treatment of CIN2/3 or CGIN Following hysterectomy 4.4 Management of results from samples containing infection or endometrial cells 4.5 Low grade cytology: Borderline changes in squamous, metaplastic or endocervical cells and Mild dyskaryosis 4.6 High grade cytology moderate and severe dyskaryosis Cervical Screening Programme Guidelines Page 2 Version: 5.2 Issued: March 2012

3 4.7 Severe dyskaryosis? invasive and? endocervical neoplasia 4.8? non cervical disease 5. Interpreting laboratory reports Cervical cytology on women under Cervical cytology on virgins Cervical cytology for women who have undergone Gender Reassignment Cervical cytology in pregnancy Cervical screening for women in High Risk groups 41 General guidance risk factors Immunosuppressed women D.E.S. exposure 11. Ceasing guidelines Age 11.2.i Automatic 11.2.ii At GP s Request 11.3 No Cervix 11.4 At woman s request 11.5 Lack of Mental Capacity 11.6 Other categories 12. Administration Good practice guidelines for surgeries 47 Call/Recall Woman eligible for cervical screening invitation process flowchart Ceasing further guidelines for completion of paperwork 13. Guide to invitation and result letters Clinical governance issues in the Cervical Screening Programme 53 Gloucestershire Cervical Screening Programme Guidelines, Page 3

4 Appendices Page Number Appendix1 Membership of Cervical Screening Steering group 56 Appendix 2 List of literature 60 Appendix 3 Reasons for inadequate results 63 Appendix 4 Failsafe mechanisms 65 Appendix 5 Post-hysterectomy follow-up 68 Appendix 6 Ceasing forms and letters: GP request to cease a woman from the cervical screening programme. 6.2 Disclaimer Form to cease a woman who lacks mental capacity or to defer her next test due date (double sided). 6.3 Disclaimer Form to cease a woman with severe learning disabilities or to defer her next test due date (double-sided). 6.4 Letter to patient ceased from Programme under Mental Capacity Act Disclaimer form (patient request to permanently cease) provided at patient s request by SBS this includes an option to defer rather than cancel only (See Appendices 6.2 and 6.3 for women who lack mental capacity) 6.6 Letter to patient ceased from Programme at patient s request 6.7 Letter to patient ceased from Programme because of absence of cervix 6.8 Letter to patient automatically ceased from Programme following DNA 6.9 Letter to patient automatically ceased from Programme following a test Appendix 7 Colposcopy Protocol Colposcopy Protocol and failsafe for?endocervical Neoplasia 7.2 Colposcopy Appointment Letters 7.3 Colposcopy Clinic Patient Leaflet 7.4 Colposcopy Guidelines for Women fitted with an IUD or IUS 7.5 Colposcopy Clinics Appendix 8 Laboratory policy on labelling of specimens and completion 101 of request forms 8.1 Pathology Minimum Data Set for Transfusion and Blood Grouping Requests 8.2 Pathology Minimum Data Set for all Departments. 8.3 Other Mandatory Data for all Departments 8.4 Additional Department Specific Requirements Appendix 9 Patient pathways Triage (low grade cytology) and high grade cytology 9.2 Test of cure Gloucestershire Cervical Screening Programme Guidelines, Page 4

5 Appendix 10 NHSCSP report grades and further action codes 107 Appendix 11 Gloucestershire Cervical Screening Programme letter texts Invitation letters (for samples processed at Glos lab) 108 Appendix 12 Glossary of terms 182 Appendix 13 LBC sample taker checklist 183 Gloucestershire Cervical Screening Programme Guidelines, Page 5

6 1. Introduction to Cervical Screening Back to index Aims and Objectives National picture Cervical screening is a national programme commissioned by Public Health England (PHE) under Service Specification no.25 Cervical Screening. Many healthcare professionals are involved in the Cervical Screening Programme General Practitioners, Contraception and Sexual Health (CASH) staff, nurses, pathologists, laboratory staff, gynaecologists, administration staff and all strive to deliver the national screening programme aims. These are: To reduce the number of women who develop cervical cancer (incidence) and To reduce the number of women who die from cervical cancer (mortality). The programme produces an annual report; the 2013/14 report can be read here. Regional picture Delivery of the Gloucestershire programme is overseen by the Bath, Gloucestershire, Swindon and Wiltshire Local Area Team (LAT) under the guidance of the Screening and Immunisation Lead (SIL) Local picture Administration Screening programme administration including Call and recall Result letters Are delivered by Shared Business Services (SBS) The Gloucestershire Cervical Screening Programme screens all eligible women resident in Gloucestershire who are registered with an NHS GP - including a dummy GP - on the NHAIS system. Sample taking Sample taking is the cornerstone of the screening programme. Collection of high quality samples underpins all other elements of the programme. Samples are collected from surgeries and clinics and are delivered to the laboratory by transport managed by the laboratory. Whilst GP surgeries delivers the majority of the Gloucestershire Cervical Screening Programme Guidelines, Page 6

7 primary care element of the service sample taking and counselling some is also delivered by Gloucestershire Care Services (CGS) in CASH clinics. Four Welsh practices that have Gloucestershire patients registered send their samples to the Gwent laboratory in Newport. These are Mount Pleasant Practice and Vauxhall Surgery in Chepstow, and Dixton and Chippenham Surgery in Monmouth. Laboratory services Most samples are processed in the Gloucestershire Pathology Laboratory which is located at Cheltenham General Hospital and is hosted by Gloucestershire Hospitals NHS FT. (GHNHSFT) The laboratory provides the following services: Cytology screening High Risk Human Papilloma Virus (HR HPV) testing Histopathology Colposcopy, gynaecology and Oncology services Women requiring colposcopy will be referred by the laboratory to colposcopy or, in rare cases where non cervical disease is suspected, gynaecology. Colposcopy clinics are currently provided at: Cheltenham General Hospital Cirencester Hospital Gloucestershire Royal Hospital Stroud General Hospital All are hosted by GHNHSFT. Women requiring assessment and/or treatment of cancer are referred to Oncology and at this point are no longer part of the programme. Oversight GHNHSFT Within GHNHSFT there is a Hospital Based Programme Co-ordinator (HBPC) whose role is to ensure that the cervical cytology, histology and colposcopy services within the Acute Trust function as an integrated service. LAT A county steering group under the Chairmanship of the SIL runs the local cervical screening programme. The group has representatives from all the professions involved in this programme as follows: Gloucestershire Cervical Screening Programme Guidelines, Page 7

8 Bath, Gloucestershire, Swindon and Wiltshire Local Area Team: Screening and Immunisation Lead (SIL) Screening and Immunisation Co-ordinator (SIC) Shared Business Services (SBS): Primary Care: General Practitioners: Gloucestershire Care Services Acute Unit: (GHNHSFT) Lead cytopathologist Cytology lead BMS S and W Region: Screening Call/Recall manager LMC representative CASH clinical lead Hospital Programme Co-ordinator Lead colposcopists Quality Assurance Team A full list of Steering Group members and their contact details can be found in Appendix 1. The Steering Group oversees the running of the programme. Its role is: To set local policy and guidelines; To monitor the performance of the programme in the county against these and national standards; To produce an annual report. S&W Quality Assurance team Programme quality is monitored by the Quality Assurance Team (QAT) at regional level. This is a multidisciplinary body with representation from all the professions involved in this programme. Its roles are: To monitor local services and to ensure compliance with national standards To record untoward incidents and ensure appropriate action is taken to address issues that may arise. To provide, via the training school in Bristol, a laboratory external quality assurance scheme To offer advice and support to local programmes. Overview of the Current Programme National guidance requires that all eligible women aged years are included in the programme. Women in this age group are eligible for screening if they have a cervix; they are called at regular intervals for screening, which uses cytology to detect asymptomatic pre-cancer. National guidance is that women are called from 24 years and 6 months and Gloucestershire Cervical Screening Programme Guidelines, Page 8

9 then recalled every 3 years until the age of 49. Women aged between 50 and 64 are called every 5 years. The programme aims to achieve at least 80% coverage of eligible women. The Gloucestershire programme currently uses the Thin Prep LBC system marketed by Hologic. A structured approach is dictated by the use of this technology please see the section on sample taking for further instructions. From 1 st April 2012 High Risk Human Papilloma Virus (HR HPV) testing using the existing cytology sample has been implemented in the Gloucestershire programme for: Triage of low grade cytology results. Test of cure Currently Hybrid Capture 2 (HC2) is used as the HR HPV testing system other systems are currently being investigated as suitable to take forwards as the initial 3 year contract expires in March With triage of low grade results following morphological assessment for cytological abnormality women with high grade cytology are referred immediately for colposcopy. If cytology suggests low grade disease borderline or mild dyskaryosis - a HR HPV test is performed. If this is positive then colposcopy is indicated and actioned under the colposcopy direct referral scheme but if negative then the woman is returned to routine recall. For Test of Cure (TOC) following treatment of cervical pre-malignant disease a cytology sample is taken at 6 months. Following morphological assessment a woman with persistent high grade disease is referred back for colposcopy; a woman with negative or low grade cytology has a HR HPV test performed. If this is negative then the woman is returned initially to a 3 yearly recall regardless of age then to routine recall no further cytological follow-up. If this is positive then the woman is referred back to colposcopy. Note that both triage and TOC will be applied retrospectively to women with sporadic screening attendance records. The laboratory notifies cervical cytology and linked HR HPV results and associated recall intervals to the screening database run by SBS. This is updated based on this information and is then used to generate result letters to women. The recall due date is also set using this information and using this each week the screening database issues a prior notification list (PNL) to notify Surgeries of the names of women due for cytology call or recall. If the cytology sample was negative this notification is sent after 3 or 5 years as described above. The laboratory issues results on a daily basis to both sample takers and SBS, who ensure that result letters are issued to the women daily, together with the appropriate national leaflet with non-negative results. If the cytology sample is abnormal the laboratory will make a recommendation based on HR HPV and management pathways unless the woman is already with a Consultant in which case an appropriate clinical management decision will be made. An abnormal cytology result does not mean that cancer of the cervix has been detected. The changes seen may be Gloucestershire Cervical Screening Programme Guidelines, Page 9

10 due to a simple condition such as infection which can be easily treated or which may resolve of its own accord; HR HPV triage is used to determine appropriate management. If pre-malignant change or, rarely, evidence of a possible malignancy is detected, the woman will be recommended for referral to a colposcopist via the direct referral system. Changes are confirmed at colposcopic examination. If these are confined to the ectocervix (outside the canal) then relatively minor treatment on an outpatient basis (usually loop diathermy excision of the transformation zone LLETZ) can deliver a high cure rate. Note that it is the responsibility of sample takers to counsel the woman - including HR HPV testing - appropriately at sample taking. See the section under sample taking. To do this in an informed manner it is essential that there is a clear understanding of the woman s screening history and current place in any of the pathways. Use of Open Exeter request forms is a great aid to this but when colposcopy referral has already taken place particularly outside Gloucestershire it is essential to provide the laboratory with that information on the request form. Sample takers also have a responsibility to ensure that a result is received for each sample sent to the laboratory. Cancer biology High risk human papilloma virus (HR HPV) is implicated as the trigger in almost every case of cervical cancer. However the natural biology of cervical cancer is such that progression from the earliest abnormality to cancer is not inevitable and in most cases is slow, taking between five and fifteen years. This allows time for detection within the screening programme and treatment to take place. The combination of the call and recall system, close surveillance following abnormal results and appropriate referral for treatment will help ensure continuing reduction in the occurrence of cervical cancer. The main reasons why the Gloucestershire programme is successful are: The robust and professional team approach of all health care professions involved in the local programme. The co-operation shown by the women of Gloucestershire in responding to call requests via their GP until now. However, there is no room for complacency. The hard-won success will only continue if: local women continue to give wholehearted support to the programme. healthcare professionals monitor and evaluate their work with audit and quality control. adequate funding for the cervical screening programme is maintained. Gloucestershire Cervical Screening Programme Guidelines, Page 10

11 Responsibilities within the Local Programme National and local guidelines define clear responsibilities within the programme. These can best be described as follows: Primary Care For samples taken in the practice: To complete and return Prior Notification Lists, as necessary, within appropriate timescales. To send 2 nd reminder on receipt of First Non-Responder cards in line with QoF. To ensure women due for screening are given appointments within appropriate time scales To ensure that the screening pathway is clearly understood for each woman. To ensure that when samples are taken appropriate counselling is given with particular regard to HR HPV testing and notification of results. To ensure that samples are correctly labelled and that the correct request form is fully completed with all relevant details (see Section 2). To ensure a result is received from the laboratory for all samples taken. On receipt of the result, to review the result and the adequacy of the cytology sample in the light of clinical information (see Section 4). To ensure that appropriate follow-up is taking place, including referral when required outside the colposcopy direct referral scheme. To perform clinical assessment of women presenting with significant symptoms and refer under two week wait rule when warranted. Additionally, for samples taken outside the surgery on women registered within the practice: To ensure that appropriate follow-up is taking place. Acute unit and other clinical settings For samples taken in CASH, colposcopy clinics or other clinical settings e.g. Gynaecology Outpatient Clinics To ensure that when samples are taken appropriate counselling is given with particular regard to HPV testing and notification of results. To ensure that samples are correctly labelled and that the correct request form is fully completed with all relevant details (see Section 2). To ensure a result is received from the laboratory for all samples taken. On receipt of the result, to review the result and the adequacy of the cytology sample in the light of clinical information (see Section 4). To ensure that appropriate follow-up is taking place, including referral when required outside the colposcopy direct referral scheme. Gloucestershire Cervical Screening Programme Guidelines, Page 11

12 Additional points for Colposcopy clinics To provide a colposcopy service within current national guidelines. To ensure that results of all procedures are notified to the women and their GPs. To provide failsafe for women awaiting repeat colposcopy including tracking of subsequent investigations and notification to the Screening Commissioner of women who fail to attend for subsequent re- assessment. To provide discharge information to ensure the screening database is updated appropriately in the light of colposcopy discharge information. To supply statistical data from the colposcopy element of the screening programme Additional points for CASH and gynaecology outpatient clinics To robustly review screening history and obtain screening samples where screening is due. To assess clinical presentation and ensure appropriate referral to colposcopy when warranted by symptoms. Laboratory To report all samples within national guidelines. To apply HR HPV tests within triage and TOC protocols To relay the result to the clinician responsible for taking the sample and to the woman s GP if the sample was not taken in the surgery. To transfer the results of all cytology and HR HPV tests (where applicable) to the screening database. To provide failsafe for women who are referred for further investigations, including tracking of subsequent investigation and notification to the Screening Commissioner of women who fail to attend for initial assessment. To communicate with sample takers and update failsafe based on their responses. To supply statistical data from the laboratory element of the screening programme. Additional points for HBPC To co-ordinate and oversee programme delivery within the acute Trust. To ensure provision of sample taker training and updates To ensure provision of governance and performance information relating to sample takers, including a sample taker register. To ensure robust provision of MDTs. To act as point of contact for screening programme issues from other areas of the programme. SBS To run a call and recall system from the NHAIS screening database ensuring all eligible women are included in the Programme. To send PNL to practices prior to first invitation letter to the patient. To issue invitation and first reminder letters, with appropriate leaflets. To send non-responder cards to the practice if no response after two invitations. To issue result letters so women receive results within 14 days in line with national targets. To maintain up to date records of all cytology and HR HPV test results. To amend recall due dates based on colposcopy discharge information. To monitor women who are suspended from the screening programme. Gloucestershire Cervical Screening Programme Guidelines, Page 12

13 To forward screening histories to the relevant local NHAIS screening database when a woman moves out of the district. To supply statistical data from the screening database element of the screening programme. Local Area Team To provide co-ordination of the programme (the role of a screening commissioner), including the implementation and monitoring of service level agreements within the local screening programme To provide access to Public Health expertise as required by the screening programme General Guidance Cervical cytology is a screening test and should not be used as a procedure for investigating clinical symptoms. When clinical symptoms such as vaginal discharge and/or bleeding are present they should be investigated and treated appropriately. A negative cytology result must not preclude the investigation of symptomatic women by other appropriate means. Specifically, if there is a clinical suspicion of invasive disease, then the woman should be referred to a gynaecologist notwithstanding the cytology result. The guidance given in this Yellow Folder will assist health professionals to provide consistent information and clinical care to women in Gloucestershire. If a woman is reluctant to have a cervical cytology sample then her views should be respected. The woman should remain on the call/recall system rather than being ceased completely from the screening programme. See Appendix 6 for relevant paperwork. The Gloucestershire laboratories will no longer process samples taken outside national screening programme guidelines. Please ensure you are clear as to why cytology is required before taking the sample as rejection by the laboratory may lead to governance issues. If unsure, please discuss the taking of such samples beforehand with laboratory staff. See Appendix 1 for contact details. Gloucestershire Cervical Screening Programme Guidelines, Page 13

14 2. Training and Guidelines for Taking Cervical Cytology samples Back to index 2.1 Sample Taker Training Back to index All unqualified sample takers must attend and complete a suitable sample takers course before they can take samples. Newly employed and qualified sample takers must inform the lead sample taker of their qualifications before going on the register. Training for sample takers is currently provided by GHNHSFT although it is recognised that other training may also be accessed. Training is in two parts: a theoretical course plus a period of practical training. The theoretical training is delivered by professionals with relevant experience and the content for the course is in line with the NHSCSP sample taker training recommendations. Practical training takes place in the practice or clinic where the trainee is based and is overseen by a clinical assessor with local support from a mentor in the practice or clinic. Trainees visit a colposcopy clinic and a cytology laboratory during the training. Trainees must complete a portfolio of evidence. All training is completed within 6 months Once trained, to remain on the register sample takers should attend a minimum of one half day s training every 3 years. Update training will address the following issues: current developments in the cervical screening programme both nationally and locally, recent literature to sample taking, sampling devices and women s needs, change to local screening policies and procedures, Personal learning needs. The laboratory holds a list of sample takers on behalf of the LAT with details of when the sample takers completed a recommended course and attendance at update sessions. The laboratory feeds quality data on sample taking back to the LAT every 12 months on a rolling 12 month basis based on the 12 months to the end of August. This means that data should be available to tie in with QOF audits. 2.2 Before and after taking a cervical cytology sample Back to index These guidelines are derived from those developed for training purposes and cover aspects of sample taking in detail. Before taking a sample it is essential that the sample taker clearly understands the reason why the sample is being taken. Failure to follow this guidance can result in inappropriate counselling and subsequent governance issues. Whilst discussion with the woman as to her screening history is always advisable and to be recorded on the request form when significant the record as recorded on the Open Exeter system and printed out on the pre-populated request form is the one that the laboratory will use to determine recall and/or management. Gloucestershire Cervical Screening Programme Guidelines, Page 14

15 AIM: To take an adequate cytology sample from the cervix, transfer it to a sample vial to fix it as soon as possible with due regard to the potential for cross-infection, and complete a request form. Avoiding Cross Infection The control of cross infection is the responsibility of the nurse/doctor taking the sample. Areas of most risk are: the light Lubricant tube please note KY Jelly or water are the only acceptable lubricants Before taking a sample or starting your clinic ensure that the lights have been cleaned with an alcohol-impregnated wipe. Remember to leave all fixtures or items used in a clean state following any procedure. Vaginal swabs and pelvic examinations These do not form part of the cytology procedure and must not compromise the quality of the cytology sample. If one or both of these procedures need to be carried out then another pair of gloves can be put on after step 12 of the procedure has been completed (see Taking a Cervical Cytology sample page 16). The speculum may have been fixed open and left in the vagina at step 9 Profuse vaginal discharge If this is present then an HVS can be taken and a small cotton wool swab can be used to mop up the discharge avoiding contact with the cervix. Choice of sampling device The only sampling device approved for use with the Thin Prep system is the Cervex broom. Devices such as the Aylesbury or Oxford spatula used for conventional Pap smears are not appropriate for liquid based cytology. The Cervex broom is a better sampler and in particular is more likely to penetrate and sample the os and endocervical canal in women with a difficult presentation. In the vast majority of cases the use of a single Cervex broom will sample the entire cervix, including the transformation zone(tz), adequately. There are a few cases where either the use of a second sampler may be appropriate: A second broom if the TZ extends beyond the reach of a broom with its extended central bristles inserted in the os An endocervical brush following a LLETZ procedure if the os is stenosed or there are other difficlties. When using additional sampling devices it is essential that the request form is clearly completed to reflect this. Multiple samples taken with different devices should be transferred to the same pot unless if the samples are from different anatomical sites e.g. 2 cervices in which case they should be clearly labelled as such. Chaperone Please refer to policies regarding chaperones for intimate procedures. Preparing for the consultation The room environment should be warm, well lit, private and comfortable. Gloucestershire Cervical Screening Programme Guidelines, Page 15

16 Counselling and consent It is essential that the woman is correctly counselled before a sample is taken. This must include the application of HR HPV testing, notification of results and the colposcopy direct referral system should this be required. Before taking a sample ensure that the woman consents to the procedure. The sample taker must ensure that the woman has the capacity to consent to the procedure and that consent is valid. Please refer to consent guidelines within your Organisation. Due consideration for language or learning disabilities should be maintained. Guidance is available online at The standard national leaflet (available on line in several languages at is sent out with every invitation letter but it is essential that it has been understood The procedure should have been explained in the leaflet sent out with the invitation, but it is the sample taker s responsibility to ensure that this has taken place. Every woman should be informed of: the purpose of cervical screening (to identify woman with changes in their cervical epithelium who are at risk of developing cancer in the future) and its limitations (it cannot diagnose cancer or infection and is not 100% perfect). the likelihood of a normal test (about 92%). the meaning of a normal test result (low risk, not no risk). the likelihood of an inadequate test (1-4%) and why this may occur (plug of mucus in the cervix prevents sampling from TZ, insufficient pressure applied to the brush when specimen collected or insufficient epithelial material transferred from brush to collection vial). the importance of reporting any abnormal bleeding or discharge to an appropriate health professional. when and how test results will be made available. A result letter will be issued by the screening programme. the result letter only contains the screening result. Whilst in most cases this will be negative there may be circumstances such as the presence of infection or endometrial cells that warrant further clinical investigation. These will be dealt with by the sample taker or GP as appropriate but will not be mentioned in the screening programme result letter the colposcopy direct referral system should also be explained; if the sample result generates a requirement for colposcopy referral then the appointment letter from colposcopy, with supporting leaflets, may be the first notification that the woman receives of her sample result. Ensure the details on the request form are correct and match with those in computer/paper notes and the woman has verified them as correct. Taking a clinical history Ensure screening history is correct (date of last test, any abnormal results, if so, when, where, result, any treatment including histology results and follow up, any previous HR HPV tests). Document 1 st day of Last Menstrual Period (LMP) (mid cycle best time to take sample), any abnormal bleeding (postcoital, intermenstrual and postmenopausal, consider Gloucestershire Cervical Screening Programme Guidelines, Page 16

17 referral to a gynaecologist)), any unusual discharge, any contraception used (including insertion of IUD/IUS) and if less than 12 weeks post natal. You should not take a sample in the following circumstances unless you think the woman will not re-attend: during menstruation, if the woman is pregnant (unless never had a cervical sample or more than 3 years without cervical screening), less than 12 weeks postnatal if there is infection/discharge present (treat the infection and sample two weeks later). Documentation Documentation of procedure in patients notes should include informed consent obtained, LMP, visualisation of cervix, 360 sweep, sampling of TZ, any problems with sampling the cervix and all clinical details (unusual bleeding, discharge etc.). Documentation should be in line with Trust and professional documentation policy. 2.3 Taking a Cervical Cytology sample Back to index Equipment An examination couch, preferably a rise and fall type to facilitate ease of use for the patient and safer use by the sample taker. A good light source to ensure clear view of cervix. Disposable covers for beds and pillows or wipe clean pillows. Blankets must not be used due to cross infection risk. Test request forms, preferably pre-printed Open Exeter Black ball point pen Information leaflets for women Packaging for transporting LBC samples Examination tray/ trolley laid up with: selection of disposable specula or reusable CSSD individual trays/dishes disposable gloves, preferably powder and latex free cervex broom/endocervical brush Single use lubricating jelly (KY or similar) sponge forceps, small cotton wool balls tissues sample collection vial (ensure in date) Procedure: Explain clearly to the woman what you are going to do during the procedure and what to expect. Women having the test for the first time may need a more detailed explanation, including an explanation of the speculum and the sampling device. Women need to know that they will have to remove their underwear and that the speculum will be inserted into their vagina. Ask the woman if she would like to use toilet facilities before you start. 1. Produce HMR101 cytology form using Open Exeter. Check identity of patient against pre-printed form. Gloucestershire Cervical Screening Programme Guidelines, Page 17

18 Full name, address and postcode Any previous name Name and address of GP Name and address of sample taker if not GP Sample taker code Date of last LMP Date of last test Contraception/hormones/IUCD Any other relevant history 2. Assemble tray/dish with speculum, vial and brushes. 3. Note expiry date on sample collection vial. Do not use expired vials. Record the patient s full name and date of birth on the collection vial. Remove plastic seal and lid from sample vial. 4. Advise and help woman into dorsal/lateral position. 5. Position and switch on examination light. 6. Wash hands and put on gloves. 7. The speculum should be warmed prior to insertion. Warm water is sufficient; however in the event of severe vaginal dryness in post menopausal women a minimum amount of KY jelly may be used. Avoid lubricating the tip of the speculum as this may contract the cervix and have an adverse effect on the quality of the sample. No other lubricant should be used as they can have an adversely affect sample processing. Gently insert speculum into vagina to obtain view of complete cervix. If albeit rarely on visualising the cervix there is any question in the sample taker s view that the cervix may be grossly abnormal eg craggy and rough and that cancer may be a possibility then assistance and advice must be sought from a medical colleague. 8. If there is a plug of mucus in the cervix, or if there is excessive inflammatory exudate present then this can be dealt with by gently moving to one side with forcep and cotton wool. Insert the central bristles of the brush into the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix. Push gently, and rotate the brush in a clockwise direction 5 times. In order to ensure good contact with the ectocervix, the plastic flonds of the cervix brush are bevelled for clockwise rotation only. 9. Rinse the brush immediately (before you remove the speculum) in the vial by pushing it into the bottom of the vial 10 times, forcing the bristles apart. Firm pressure is essential or the cells will cling to the broom. As a final step, swirl the brush vigorously to further release material. Inspect the brush to ensure no material remains attached, remove any by passing the brush over the edge of the vial. Discard the brush. Gloucestershire Cervical Screening Programme Guidelines, Page 18

19 10. Put the lid back on the vial. Tighten so that the black torque line on the cap passes the black torque line on the vial. Do not over tighten. 11. Gently release the lock on the speculum and slowly remove and dispose of speculum appropriately. 12. Provide tissues for woman to wipe herself; she can now leave the couch. 13. Remove gloves and dispose of appropriately. Wash your hands. 14. Add information about how taken in clinical details box on HMR101 request form. 15. Inform woman about how and when she will receive the results of her and council on direct referral system. 16. Complete the request form with any further clinical details Cervix visualised 360 sweep five times appearance of cervix details of additional sample if used date sample taken 17. Put vial and return with completed form, in the appropriate envelope or specimen bag, to the Cytology Laboratory as soon as possible. Check name, DOB are recorded on vial, check HMR101 form is complete. 2.4 Taking an Endocervical Brush Sample Back to index An endocervical brush cytology sample should only be taken in the following circumstances, and then only after a cervix broom sample : Where there is difficulty in inserting the brush into the os. When requested by the laboratory or colposcopy clinic. Procedure: 1. Gently insert the brush into the os and rotate 360 degrees slowly. 2. Ensure the lower bristles remain visible when sampling the endocervical canal. 3. Press the sample brush against the side of the vial to facilitate transfer of cells from the brush into the preservative. 4. Both samples should be placed in the same vial. Note on the request form that both a broom and brush have been used to obtain the sample. 2.5 Inadequate/Unsatisfactory Cervical Guidelines Back to index See Section 13 for details of clinical governance issues around inadequate rates. Gloucestershire Cervical Screening Programme Guidelines, Page 19

20 Factors that will be considered when a sample is reported are the number of squamous and/or endocervical cells present and the amount of epithelial material harvested and transferred to the vial. Taking, transferring and fixing a cervical cytology sample is a multi-step process and problems can occur at any of the steps. However, an inadequate result may not necessarily be the fault of the sample taker. The reason why a sample was reported as inadequate is always stated on the report. This should facilitate obtaining a repeat that is satisfactory. The possible causes of inadequate samples and suggested solutions are summarised in the table in Appendix 3. Gloucestershire Cervical Screening Programme Guidelines, Page 20

21 2.6 General Back to index It is the responsibility of the sample taker to visualise the cervix to ensure that the whole of the transformation zone has been sampled. It is important to record on the request form and in the woman s notes how the sample was taken and the visualisation of the cervix. The sample taker ultimately determines what is an adequate sample based on the clinical history, the appearance of the cervix and the cytology report. Under National Guidelines issued in the ABC 2 document (NHSCSP Publication No 1. Achievable standards, benchmarks for reporting & criteria for evaluating cervical cytopathology (May 2000) ), the importance of the amount of transformation zone material in determining the adequacy of a is greatly reduced. Transformation zone material is required in a sample that was taken to follow up a previous report of either borderline endocervical abnormality or glandular dysplasia, or following treatment for glandular dysplasia. Local laboratories will continue to report the presence or absence of transformation zone material in all cervical samples from women under 50, but this will not be used as a laboratory parameter to establish adequacy. Sample takers may take it into consideration, however, when assessing the adequacy of a sample and it will still be used as a criterion in assessing practice nurses on the cervical cytology training course. If the cytology sample taker wishes to repeat a cytology sample because they have not satisfactorily seen the cervix and the cytology sample lacks cytological evidence of transformation zone sampling, the repeat sample should be taken after three months, with an explanation of the reason for the request. Sample taking is summarised in the LBC sample check list in appendix 13. A copy of this should be displayed in clinic rooms as an Aide Memoire. Gloucestershire Cervical Screening Programme Guidelines, Page 21

22 3. Colposcopy Service Back to index The colposcopy service is managed by the Gloucestershire Hospitals NHS Foundation Trust with clinics held in hospitals at Gloucester, Cheltenham, Stroud and Cirencester. Guidelines for management and follow-up of the different common abnormal cytology sample results have been agreed across the county by clinicians and laboratories (Appendix 9). Colposcopy Direct Referral Scheme A copy of every cervical cytology sample report generated by the laboratories with a recommendation for referral for colposcopy is sent directly to the colposcopy department. On receipt, the colposcopy department allocates an appointment at the nearest appropriate hospital to the patient based on the available information. A letter individualised to the particular cytology sample abnormality and HR HPV result (Appendix 7) is selected to be forwarded to the patient. An information leaflet (Appendix 7) explaining the cytology sample result, the colposcopy examination and most usual method of treatment is enclosed with the appointment letter. The successful application of this scheme has ensured that the number of nonattendances in the colposcopy clinic is kept to a minimum and the time interval from the laboratory issuing the cytology sample result to the patient being seen in colposcopy has been substantially reduced. The service aims to meet the national standard waits for appointments of: Within 2 weeks for possible invasion or glandular neoplasia. Within 2 weeks for women referred with high-grade cytology (severe). Within 4 weeks for women referred with high grade cytology (moderate). Within 6 weeks for all other referrals. Direct referral by the laboratory occurs after: Three consecutive inadequate cytology results. One borderline in endocervical cells cytology result AND positive HR HPV result One borderline cytology result in squamous or metaplastic cells AND positive HR HPV result One mild dyskaryotic cytology result AND positive HR HPV result One moderate, severe or? invasive cytology result. The national HPV testing algorithm can be found here Gloucestershire Cervical Screening Programme Guidelines, Page 22

23 Cases excluded from the scheme are: Those where a referral to a general gynaecologist rather than a colposcopist is appropriate e.g. presence of endometrial cells. Cytology samples taken by a gynaecologist. Colposcopy Clinic The clinic offers a see and treat policy for patients with high grade cytology samples where the colposcopic appearance is in agreement. Treatment is generally by diathermy loop excision under local anaesthetic. Management of colposcopically confirmed low grade abnormalities is generally by continued cervical cytology surveillance in the first instance. Biopsy and loop diathermy specimens taken in colposcopy are sent to the laboratory for histological assessment and reporting. The histology report is sent to the colposcopist. It is the colposcopist s responsibility to notify the patient and GP of the outcome of the colposcopy episode within four weeks. Women referred for colposcopy are temporarily suspended from the NHS SBS recall system and the laboratories provide a failsafe mechanism for follow up until the patient has had the recommended number of negative cytology samples and returned to NHS SBS recall. It is the responsibility of the colposcopy clinic to inform the patient, GP and laboratory as to who is to do the first follow up cytology sample. The laboratory will advise on the frequency of subsequent cytology samples along agreed guidelines. A copy of the colposcopy clinic timetable is found in appendix 7 Twice a month a multidisciplinary team meeting for colposcopy will be held. Discrepancies in colposcopy findings, cytology and histology will be reviewed and difficult management decisions will be discussed. A Hospital Based Cervical Screening Coordinator meeting is held on a quarterly basis as are Colposcopy, Histology and Cytology departmental meetings are also held on regular basis. Gloucestershire Cervical Screening Programme Guidelines, Page 23

24 4.Gloucestershire Call, Recall and Follow-Up Policy Back to index 4.1 General Guidance Routine Call and Recall Back to index Women currently within screening programme parameters are included in the call and recall programme run by SBS. Exceptions are: Women who are suspended whilst under the care of a gynaecologist Women ceased following a hysterectomy Women for whom a decision is made, by the woman or Care Team where there is lack of capacity, to withdraw from the programme (see Section 10 Ceasing Guidelines). This call/recall status is determined by the result of the woman s latest cytology and HR HPV results (when HPV testing is available) although this may be modified by the laboratory if additional information is to hand. A guide to good practice for GP surgeries involved in call and recall of women is to be found in Section 11. The call/recall process is initiated by SBS from the NHAIS screening database. A PNL is produced and accessed by the practice electronically via Open Exeter. This will consist of women resident in the county whose cytology sample test due date is in 10 weeks time. The PNL should be checked by the practice and if the woman is not to be invited, or if her details should be changed, SBS must be notified within 3 weeks of receipt of the PNL. SBS will then issue the invitation, and where necessary, the first reminder letter. Failsafe mechanism. All areas of call, recall and follow-up have a failsafe mechanism so that in the unlikely event of system failure there is a back up in place. Responsibility for this is detailed in Appendix 4. Routine Call and Recall Routine call Women are first called into the programme from 24 years and 6 months to ensure screening by their 25 th birthday. SBS will notify the GP via the PNL that a woman is due for her first call 10 weeks before her 25 th Birthday. Routine recall age 25 to 49. Women with a negative cytology sample history have repeat cytology screening every 3 years. SBS will notify the GP that a woman is due for recall via the PNL 10 weeks before her next test due date. Routine recall age 50 to 64. Women with a negative cytology sample history have a repeat cytology sample every 5 years. SBS will notify the GP that a woman is due for recall via the PNL 10 weeks before her next test due date. Please note that the 50 th birthday is the cut off point for the recall change a woman having a cytology sample on the day before her 50 th birthday will be recalled in 3 years, whereas a woman having a cytology sample on her birthday will be recalled in 5 years. Gloucestershire Cervical Screening Programme Guidelines, Page 24

25 4.2 Inadequate Cytology samples Back to index Guidance Note that samples must not be repeated before 3 calendar months have elapsed as this time interval is required for the cervical epithelium to regenerate. A first report of an inadequate cytology sample, for any reason as stated in Appendix 3 will attract a request for a repeat cytology sample in 3 months time. A second report of an inadequate cytology sample will attract another request for a repeat cytology sample in 3 months. The recall status of the woman will not change. In post menopausal women with an atrophic cervix the laboratory will recommend a course of local oestrogen treatment if clinically appropriate. A third report of an inadequate cytology sample will trigger referral to colposcopy via the direct referral system for assessment and cytology sample. The woman will remain on the laboratory failsafe system and will be suspended from routine recall as she is now under the care of a gynaecologist. An adequate cytology sample and colposcopic assessment will remove the woman from laboratory failsafe and return her to routine recall or trigger other appropriate management action. Under national guidelines it is not acceptable to review and amalgamate consecutive inadequate cytology samples. Each must be considered and reported in its own right. When repeating an inadequate cytology sample please ring code 5 in box 17 of the HMR101 national cytology form. Failsafe for inadequate cytology samples For cytology samples requiring an early repeat the NHAIS screening database provides the primary recall and failsafe. For third consecutive inadequate cytology samples triggering colposcopy referral, the woman is suspended from screening recall and is placed on the laboratory failsafe system. The Colposcopy failsafe system applies if subsequent visits are required within the episode. The woman will appear on the suspended list sent to practices by SBS, initially according to the interval for the repeat cytology sample set by the laboratory and then every 3 months until the woman returns to routine recall. See Appendix 4 for a schematic representation of failsafe within the Gloucestershire Cervical Screening Programme. Gloucestershire Cervical Screening Programme Guidelines, Page 25

26 4.3 Negative Cytology Samples Back to index General Guidance Negative cytology samples can be divided into 5 categories: Call and recall. Negative during surveillance of cytological low-grade cytological abnormalities untreated biopsy confirmed CIN1. Negative after diagnosis and treatment of CIN and CGIN TOC will be applied following treatment of CGIN (if completely excised) and CIN. Negative after treatment of CGIN (If incompletely excised) and cervical cancer (if cervix is retained). Negative vault cytology samples note that call and recall does not apply to vault samples, a woman with no cervix is ceased from the screening programme. A cytology sample reported as negative can be assumed to be adequate unless there are factors known to the cytology sample taker that would require it to be categorised as inadequate. These are defined in Section i Call and Recall Call: Women will be included in the Screening Programme at age 24 years and 6 months. Their first invitation will be received at around age 24 years and 7 months This first call cytology sample is the only cytology sample for which code 1 in box 17 of HMR101 (national cytology form see Appendix 6.8) should be ringed by the cytology sample taker. Recall: Women between the ages of 25 and 49 with a negative cytology sample will be recalled in 2 years and 10.5 months (6 weeks prior to test due date. Women between the ages of 50 and 64 will be recalled in 4 years and 10.5 months (6 weeks prior to test due date). In both cases Code 2 in box 17 of HMR101 should be ringed by the cytology sample taker. Failsafe for negative call and recall cytology samples For subsequent negative cytology samples the NHAIS screening database handles recall. Failsafe is provided by surgeries checking that all cytology samples taken have been reported. See Appendix 4 for a schematic representation of failsafe within the Gloucestershire Cervical Screening Programme. 4.3.ii. Negative Cytology sample following diagnosis ONLY of CIN1 A woman with histologically diagnosed CIN1 requires 2 negative results at 12 and 24 months post diagnosis. If these are both negative then routine recall can resume. Failsafe for negative call and recall cytology samples Gloucestershire Cervical Screening Programme Guidelines, Page 26