WIRRAL UNIVERSITY TEACHING HOSPITAL CYTOLOGY NHS CERVICAL SCREENING PROGRAMME INFORMATION PACK FOR SAMPLE TAKERS

Transcription

1 Author J. Evans BMS 3 Authoriser A. Bamber Page 1 of 16 WIRRAL UNIVERSITY TEACHING HOSPITAL CYTOLOGY NHS CERVICAL SCREENING PROGRAMME INFORMATION PACK FOR SAMPLE TAKERS

2 Author J. Evans BMS 3 Authoriser A. Bamber Page 2 of Contact Us Cytology is a processing and High Risk Human Papilloma Virus (HPV) testing site for Wirral & West Cheshire and accepts Surepath Liquid Based Cytology (LBC). Find us: Cytology is based in the Histopathology building at Arrowe Park. All visitors should access the department via the main reception. Wirral UniversityTeaching Hospital Upton Wirral CH49 5PE. Telephone enquires: Fax: joanneevans1@nhs.net Hours of Opening: 8.00am-5.00 pm Monday to Friday (except bank holidays). Consultant Cytopathologists: Dr V Thonse Consultant Biomedical Scientist Angela Randall Cellular Pathology Manager Andrew Bamber Cytology Manager & Hospital Based Coordinator Joanne Evans

3 Author J. Evans BMS 3 Authoriser A. Bamber Page 3 of WIRRAL UNIVERSITY TEACHING HOSPITAL CYTOLOGY DEPARTMENT 2.1 The Wirral Cytology Centre is a UKAS accredited department and all cervical Liquid Based Cytology (LBC) samples are processed and screened following NHS Cervical Screening Programme guidelines and the regional Quality Assurance Reference Centre recommendations. The department participates in the regional gynaecological and technical EQA schemes and the performance of all screening staff is assessed quarterly as per NHSCSP guidelines. The management and staff within the department are committed to providing a quality service to our users. We aim to continually improve our service through internal audit and feedback from users. If you do have a complaint or concern about any aspect of the service, this should be addressed to the Lead Biomedical Scientist on or the Cellular Pathology Manager on TRANSPORT AND LBC KITS LBC kits are distributed for Wirral from Main stores at Clatterbridge Hospital only. They can be contacted on Ext LBC kits cannot be ordered through the IPROC/NHS Supplies system but ordered by using the LBC form code KSD300 for a box of 25 vials. For the West Cheshire region, supplies are distributed from the Histopathology Department at the Countess of Chester Hospital and they can be contacted on Please be aware that LBC kits have an expiry date and it is the sample takers responsibility to ensure that there is stock rotation and to check the vials they are using are not passed the expiry date. 2.3 REQUEST FORMS AND VIALS Request form: Either the WROCS (if Wirral), ICE (West Cheshire) or Exeter download order forms are to be used. If HMR101 forms are used please ensure the request is completed in full with all information legibly

4 Author J. Evans BMS 3 Authoriser A. Bamber Page 4 of 16 Information relating to previous histology biopsies (punch, LLETZ/loop, cone etc) with histology grade and date of biopsy, as well as details of any treatment are ESSENTIAL to ensure correct patient management is given. NHS number: The NHS number MUST be used whenever it is available as this is the unique patient identifier. In addition, the full forename, surname and date of birth MUST be given. PIN codes: The laboratory has changed over to using the GMC and NMC number as the sample taker PIN code. The laboratory is required to do this for clinical governance purposes. All Smear takers should register their GMC/NMC numbers, the date and location of last smear taker update course with the laboratory at wih-tr.cytology@nhs.net. A database is being compiled which will in the future be used in the rejection of specimens that have been received from non-registries. Under no circumstances should anyone else s smear taker code be used on a Cervical Cytology form Sample: The label on the sample vial must record the forename (or initial), surname and date of birth and ideally the NHS number (if known) to allow matching of the vial with the request form. After collection and labeling, the sample and request form should be placed in separate sections of the plastic specimen bag before dispatch to the laboratory. This specimen should be placed in the large White Histopathology sample bags currently being supplied to surgeries. 2.4 REPORT GENERATION AND DISTRIBUTION The laboratory issues electronic reports to GPs/sample takers and screening agencies. Those who do not have electronic links will be issued with paper copies. If a smear has been taken for example at the Family Planning Clinic a copy of the report will be sent to the registered GP. Direct Referral The department implements a direct referral policy on any specimen reported as Low grade (HPV Detected) or worse. Any test reported as Suspected Invasive carcinoma or Suspected Glandular neoplasia requires Urgent referral for further investigation. The Laboratory will refer the patient but the patient will not receive a result letter through the post so it is the responsibility for the GP to contact the

5 Author J. Evans BMS 3 Authoriser A. Bamber Page 5 of 16 patient and relay the result. It is suggested this is done urgently as the patient will receive a phone call from the Colposcopy department regarding an Urgent Referral appointment The Laboratory will only contact the GP about results if a specimen is reported?6 Glandular Neoplasia (Non-Cervical ). This is due to the current letter system were the patient will receive. Glandular neoplasia (Non cervical) Routine Recall. A failsafe system is in place to ensure that the report has been received and that the patient has received a referral appointment. 14 day turnaround The laboratory aims to report the majority of tests within 8 days from receipt of the sample excluding samples that require HR-HPV testing. 3. RECALL AND INAPPROPRIATE SAMPLES 3.1 RECALL INTERVALS Routine 3 yearly recalls between the ages of 24 years, 6 months to 49 years inclusive Routine 5 yearly recalls between the ages of 50 to 64 years inclusive Cease cervical cytology at age 65 years; only screen those who are currently on follow-up for a previous cervical abnormality. However the Laboratory will not currently reject any smear taken over the age of INAPPROPRIATE AND OUT OF PROGRAMME SAMPLES Cervical Cytology samples are not justified in any of the following situations: On taking or starting to take an oral contraceptive On insertion of an intrauterine contraceptive device (IUCD) On taking or starting to take hormone replacement therapy (HRT) In association with pregnancy In women with genital warts In women with a vaginal discharge In women with pelvic infection In women who have had multiple sexual partners In women who are heavy cigarette smokers

6 Author J. Evans BMS 3 Authoriser A. Bamber Page 6 of SYMPTOMATIC WOMEN Women with symptoms of cervical cancer should be referred to colposcopy. Cervical cytology is not an appropriate investigation for: Post coital bleeding Intermenstrual bleeding Postmenopausal bleeding Persistent Vaginal discharge 4. ACCEPTANCE CRITERIA The policy has been based on the following principles: 1. Cervical cytology in primary care settings is a screening tool for apparently healthy women. Cytology screening does not have a role for women who present with symptoms. 2. Women should only be screened when they are due or overdue for a cytology test. The women will be invited by the Primary Care Support (previously known as the call / recall service). Women who are overdue for a cytology test should remain a priority and screened opportunistically. 3. Any inadequate specimens that have been identified should not be retested before 3 months following the inadequate cervical screening. This allows for the cervix to be appropriate to retest and adequate cervix sample for the screening test. Out of scope samples, from women less than 24.6 years. Out of scope samples from women over 65 unless woman unscreened, missed last invitation at 60 or is in follow up for previous abnormal Out of scope vault samples from women with total hysterectomy for non-cervical malignancy or benign conditions. Out of scope samples from women more than 3 months before their next test due date (Including post HPV test). Vial received without a form. Form received without a vial. Vial is unlabeled. Vial is only partially labelled Patient details and vial do not match. Insufficient patient details on the form. Patient details differ from cytology record

7 Author J. Evans BMS 3 Authoriser A. Bamber Page 7 of 16 Valid GMC/NMC not provided on the form. GMC/NMC not registered with the laboratory. The sample is in poor condition. Form/vial illegible VAGINAL VAULT SAMPLES Women who need vaginal vault cytology following surgery are no longer included in the NHS Cervical Screening Programme (NHSCSP). The latest national recommendation supported by the North West Cervical Screening Quality Assurance Reference Centre (QARC) is that Vault Cytology should be performed at colpscopy and therefore women requiring this should be referred to colposcopy or remain at colposcopy until all necessary vault smears have been taken. THE LABORATORY WILL NOW REJECT ANY VAULT SAMPLE TAKEN IN PRIMARY CARE AS PART OF THE ACCEPTANCE POLICY. PLEASE CONTACT THE LABORATORY IF YOU HAVE ANY QUERIES ON TERMINOLOGY AND MANAGEMENT OF PATIENTS 5.1 ABC 3 TERMINOLOGY The new, ABC 3 terminology has been used by the laboratory since June Negative Borderline nuclear changes in squamous cells Borderline nuclear changes in endocervical cells Low grade dyskaryosis High grade (Moderate) High grade (Severe)? Invasive Squamous Carcinoma? Glandular neoplasia of endocervical type? Glandular neoplasia (non cervical) - The patient will receive a result letter stating:

8 Author J. Evans BMS 3 Authoriser A. Bamber Page 8 of 16?Glandular neoplasia (non cervical) Routine Recall. The GP will be informed by phone and a copy of the result will be faxed. It is the responsibility of the GP to refer the patient to Gynecology. The laboratory will continue to implement Failsafe. 5.2 CERVICAL SMEAR MANAGEMENT OF SAMPLES TAKEN IN PRIMARY CARE (NOT HR HPV TESTED) Inadequate Negative Borderline Low grade High Grade (Moderate/Severe) Invasive or? Glandular neoplasia Repeat cytology in 3 months 3 Inadequates Refer to Colposcopy Routine recall Repeat in 6 months/ 3 Borderlines within 10 years refer to Colposcopy Refer to colposcopy Refer to colposcopy Refer to colposcopy 5.3 FOLLOW UP AFTER TREATMENT INVASIVE CERVICAL CANCER WOMEN WITH RESIDUAL CERVIX If conservative treatment for cervical cancer has been performed, leaving a residual cervix, cytological follow up is recommended. Cervical cytology should be taken six and 12 months after treatment, followed by annual cytology for the next nine years before return to routine recall to 65 years. Test of Cure (TOC) utility of HPV testing has not been applied to cases of stage 1A1 and 1A2 Cervical Cancer

9 Author J. Evans BMS 3 Authoriser A. Bamber Page 9 of 16 FOLLOW UP OF STAGE 1A2/1B1 If Conservative Management for IA2/IB1 disease was by simple or radical trachelectomy, cytological follow up is determined by the management policy of the gynecological oncologist. VAULT SMEARS ALL VAULT SMEARS ARE TO BE TAKEN AT COLPOSCOPY. For women on routine recall: Suggest cancel recall. Where there is no CIN or invasive cervical cancer on histology. For women not on routine recall: Take a vault sample at 6 months, then suggest cancel recall if negative. For fully excised CIN/CGIN Suggest cancel recall after 2 subsequent negative cytology tests at 6 months and 18 months after surgery. For incomplete or uncertain excision of CIN 1: Follow-up vault cytology at 6 and 12 and 24 months. Follow-up continues until age 65 or until 2 years after surgery (whichever is later) For incomplete or uncertain excision of CIN 2, CIN 3 or CGIN: Follow-up vault cytology at 6 and 12 months, then annual follow-up for a total of 10 years. Follow-up continues until age 65 or until 10 years after surgery (whichever is later) For invasive cervical carcinoma (no radiotherapy) Follow-up to be determined by the gynaecologist or oncologist Follow-up after radiotherapy: No need for follow-up vault cytology unless specialist opinion indicates otherwise. For endometrial /ovarian carcinoma: Suggest cancel recall unless specialist opinion indicates otherwise Women who have undergone subtotal hysterectomy will have their cervix in situ and so must remain within the NHSCSP, Women who have undergone radical hysterectomy for cervical cancer: In general, cytological follow-up is not recommended in the assessment of these women but

10 Author J. Evans BMS 3 Authoriser A. Bamber Page 10 of 16 decisions regarding this small group of patients should be determined by the gynaecological oncologist who carries out the procedure. Women who have undergone radiotherapy for the treatment of cervical cancer: Cervical or vaginal vault cytology should not be performed on women who have undergone radiotherapy as part of their treatment. 6 HIGH RISK (HR) HPV TESTING The cytology department currently tests for HR HPV in house using the Roche 4800 Cobas system. The Cobas 4800 system uses Real-time Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single run. Cobas is capable of specifically identifying HPV strains 16 and 18 while concurrently detecting the rest of the high risk types (31,33,35,39,45,51,52,56,58,59,66 and 68) at levels that are clinically relevant.β-globin is used as an internal control to assess the cellularity of the sample to ensure any results are adequate and false negatives are not issued. What is human papillomavirus (HPV)? There are around 100 types of HPV (human papillomavirus) Most do not cause significant disease in humans Certain high-risk subtypes (notably 16 & 18) have been confirmed as agents causing cervical cancer High-risk types (HR-HPV) do not produce visible symptoms (such as genital warts) Almost all cervical cancers (99.7%) contain HR-HPV DNA HR-HPV infection is common, especially in women under 35yrs In most cases infection is transient and cleared by the woman s immune system Around 20-30% of women do not clear the virus and are at most risk of CIN that may eventually develop into cervical cancer How is HPV acquired? HR-HPV infection is very common. It is generally accepted that cervical HR-HPV infection is acquired through sexual contact. This can occur between men and women and between partners of the same sex. The epidemiology of cervical cancer has for many years indicated increased risk in women who have had multiple partners or onset of sexual activity at a young

11 Author J. Evans BMS 3 Authoriser A. Bamber Page 11 of 16 age. This suggested that a sexually transmitted agent was involved in cervical carcinogenesis, which we now know to be HR-HPV. Some men and women state that their current partner has been their only sexual partner. Theoretically, if two virgins form a faithful sexual relationship there should be no opportunity to acquire HR-HPV. Yet we know that some women who describe their relationship this way do test HR-HPV positive. HR-HPV infection can persist for many years and it is not possible to be sure when HR-HPV was acquired or what its true source was. The HR-HPV types most often associated with cervical cancer are usually symptomless in both partners. This can be a difficult area, but a gentle explanation of the facts as we understand them usually suffices. If a woman who has had only one sexual partner acquires cervical HR-HPV, be cautious about suggesting that this indicates infidelity. How long can HR HPV infect for? HR-HPV infection of the cervix usually occurs early in the sexual lives of women. We know this because HRHPV positive rates are about 50% in women at the age of 20. In most women, the HR-HPV infection is cleared, usually within a year, and protective antibodies may develop to prevent future infection by the same HR-HPV type. However, this does not always happen and it is not uncommon for women to acquire a subsequent infection with a different type of HR- HPV. In some women (probably 20 30%) HR-HPV infection persists and may last for years. The longer the virus persists, the greater the risk of subsequent cellular abnormalities. How can HR-HPV cause cancer? HR-HPV is found in 99.7% of cervical cancers. It contains several genes that can disturb the mechanisms regulating normal cell division, which then becomes uncontrolled. It is thought that infection with HR-HPV may not be sufficient to cause cancer and that other factor, such as smoking, may play a part. Can HPV infection be treated? At present there is no effective treatment for the HR-HPV virus but, as stated, the immune system usually clears most HR-HPV.

12 Author J. Evans BMS 3 Authoriser A. Bamber Page 12 of 16 Why test for HPV? HR-HPV testing is already used in the NHS Cervical Screening Programme in HPV triage and HPV test of cure. In HPV triage, women with low-grade abnormalities are tested for HPV. Those with a positive result are referred for colposcopy, whilst those who are HR-HPV negative can be safely returned to routine recall. In HPV test of cure, women who have been treated for cervical intraepithelial neoplasia (CIN) are tested for HR-HPV after six months. Those who have normal, borderline, or low-grade cytology and who also test negative for HR-HPV are at very low risk of significant residual disease. They are therefore not screened again for three years. The HPV primary screening pilot will use HPV testing instead of cytology as the first test to be performed on the cervical screening sample. HPV testing is more sensitive than cytology for high-grade CIN. Its high negative predictive value also extends the period for which women are protected by screening, meaning that it might eventually be possible to screen women less frequently How is HPV testing being used? Testing is currently being used in the NHSCSP in England for triaging women with low-grade cytological abnormalities. Women who test positive for HR-HPV are quickly referred for colposcopy whilst women who are HR-HPV negative are returned to routine recall HR-HPV testing is also being used as a test of cure for women who have been treated for CIN. A negative HR-HPV test result 6-months after treatment in women with a cytology sample reported as negative, borderline or low-grade dyskaryosis indicates a low risk of significant residual disease. This means the woman does not need to return for a repeat test for a further 3 years. HPV testing women with mild or borderline test results can speed up referral to colposcopy and avoid referral when HPV is not found How is the HR-HPV test done? HR-HPV testing is performed on the sample taken for a cervical screening test. Where cytology triage is indicated; a slide will be prepared and examined under the microscope for abnormal cells.this will be carried out on the same sample so there is no need for a woman to return for a

13 Author J. Evans BMS 3 Authoriser A. Bamber Page 13 of 16 second test. Both tests will be processed at the same laboratory and all results will be issued as part of a single report with a management recommendation provided. To ensure that eligible women have the benefit of the Test of Cure HPV test following treatment for CIN; please could all sample takers provide details of previous treatment i.e. the histological grade of CIN, the type of biopsy e.g. punch biopsy, LLETZ or cone biopsy and/or the type of treatment. This is important if the treatment was ablative as there will be no histology report available. The presence of Invasive disease is particularly important as this precludes Test of Cure. If the laboratory gives a management of keep at colposcopy (S), it means that colposcopy will then decide the patient s recall therefore it can change. In conjunction with the Cytology result, Colposcopy will assess the examination notes and any results from treatment performed to make a management decision.

14 Author J. Evans BMS 3 Authoriser A. Bamber Page 14 of 16

15 Author J. Evans BMS 3 Authoriser A. Bamber Page 15 of 16 To ensure that eligible women have the benefit of the Test of Cure HPV test following treatment for CIN; please could all sample takers provide details of previous treatment i.e. the histological grade of CIN, the type of biopsy e.g. punch biopsy, LLETZ or cone biopsy and/or the type of treatment. This is important if the treatment was ablative as there will be no histology report available. The presence of invasive disease is particularly important as this precludes Test of Cure. If the laboratory gives a management of keep at colposcopy (S), it means that colposcopy will then decide the patient s recall therefore it can change. In conjunction with the Cytology result, Colposcopy will assess the examination notes and any results from treatment performed to make a management decision.

16 Author J. Evans BMS 3 Authoriser A. Bamber Page 16 of 16