CYPOL002 THE CYTOLOGY LABORATORY HANDBOOK

CYTOPATHOLOGY DEPARTMENT HANDBOOK Cytology Department Royal Stoke University Hospital Floor 2, Main Building Newcastle Road Stoke-on-Trent ST4 6QG Tel: 01782 674951

This laboratory handbook is issued under the authority of:

Lead BMS, Cytology Department

Issue Date January 2017 Review Interval 24 months Authors Sarah Fish

CYPOL002- Cytopathology department handbook Issue Date: January 2017 Review Interval: 24 months Revision No.:012 Author: S.Fish Authorised by: AR/DD/AS Page 1 of 10 CYPOL002 THE CYTOLOGY LABORATORY HANDBOOK

Cytopathology Department Handbook Amendment Pages

AMENDMENTS PROCEDURE

This document may be reviewed and re-issued electronically without notice. The University Hospital of North Midlands website should be checked regularly to ensure that up to date information is utilised. Details of current amendments must be registered in the amendment table below. Under no circumstances must sections within this manual be defaced in any way. Hand-written amendments are not permitted.

Amend Date Section Page Issue no. Details Sign 6/11/2014 All All 008 Updated to include new KF hospital names and SF reformatted for easier use 7/04/2015 General information 4 009 Phone number updated. KF Karen Frost now Acting Lead BMS. Section 1 6 Protection of personal information Vaginal lubricants 7 Sample taker PINs. 9 26/10/2015 Section 1. 6 010 Comment about patient KF consent added 7 E-mail address for call/recall updated. 23/12/2015 Contact details 4 011 Dr Stephens and Dr KF Sheldon added. 5 Division updated. Section 1 9 Allocation of PINs 30/01/2017 Section 2 012 Non-gynae is now under SF the management of Histology - removed

Contents

CYPOL002- Cytopathology department handbook Issue Date: January 2017 Review Interval: 24 months Revision No.:012 Author: S.Fish Authorised by: AR/DD/AS Page 2 of 10 CYPOL002 THE CYTOLOGY LABORATORY HANDBOOK

Page Amendment history 2 General laboratory information 4 Contact details 4 Telephone numbers 4 Medical staff 4 Senior laboratory staff 4 The location of the laboratory 4 Laboratory hours 4 Complaints 5

Section 1. Cervical cytology

1.1 Introduction 5 1.2 Clinical information 6 1.3 Guidance on preparing cervical specimens 6 1.4 Clinical advice 7 1.5 Completion of the request form and labelling of the vial 7 1.5.1 Request form 7 1.5.2 Vial details 8 1.6 Transportation of specimens 8 1.7 Acceptance policy 8 1.8 Screening frequency 9 1.9 Sample taker PINs 10

CYPOL002- Cytopathology department handbook Issue Date: January 2017 Review Interval: 24 months Revision No.:012 Author: S.Fish Authorised by: AR/DD/AS Page 3 of 10 CYPOL002 THE CYTOLOGY LABORATORY HANDBOOK

GENERAL LABORATORY INFORMATION Contact Details Telephone Information

Cytology laboratory (results and general information) 01782 674229 / 674951

Internal enquiries ext. 74229 / 74853 Fax [email protected] 0843 636 5116 Medical staff: Dr Nichola Cooper, Consultant Pathologist, Cytology Clinical Lead 01782 674840

Dr Gill Douce, Consultant Pathologist, Hospital Based Programme 01782 674843 Coordinator & Network Manager

Senior laboratory staff: Sarah Fish, Acting Lead BMS [email protected] 01782 674229 Joanne Parkes, Consultant BMS [email protected] 01782 674229 Angela Randall, Consultant BMS [email protected] 01782 674229 Steven Bird, Consultant BMS [email protected] 01782 674229

THE LOCATION OF THE LABORATORY The Cytology laboratory and screening room is situated within the Pathology department at the Royal Stoke University Hospital in the Main Building on Floor 2. The Cytology department processes approximately 95,000 cervical cytology samples per annum. It is part of the Pathology Directorate which in turn is part of the Children’s, Women’s and Diagnostics division. The laboratory provides a service to the NHS Cervical Screening Programme for the UHNM (University Hospitals of North Midlands) and surrounding General Practitioners in Staffordshire, Shropshire and Cheshire.

LABORATORY HOURS Monday to Friday, 8.00am to 5pm.

COMPLAINTS.

CYPOL002- Cytopathology department handbook Issue Date: January 2017 Review Interval: 24 months Revision No.:012 Author: S.Fish Authorised by: AR/DD/AS Page 4 of 10 CYPOL002 THE CYTOLOGY LABORATORY HANDBOOK

If you have any complaints about the service the department provides please contact the Acting Lead BMS on the number or email above. Patients should contact PALS ON 01782 676450/676455/676435.

SECTION 1. CERVICAL CYTOLOGY 1.1 Introduction Cervical specimens are taken as part of the NHS cervical screening programme (NHSCSP). Approximately 95,000 cervical cytology requests are processed by the cytology laboratory each year with specimens being processed from practices in the North Staffordshire CCG, Stoke CCG, South Staffordshire CCG, Mid Cheshire CCG, East Cheshire CCG and Shropshire CCG areas.

Since 1st January 2011 98% of cervical cytology specimens must be reported within 14 days of the specimen being taken.

The cytology department implemented NHSCSP, Human Papilloma Virus (HPV) Triage and Test of Cure pathways in March 2012. The HPV test is performed within the Virology department of the RSUH (Royal Stoke University Hospital), which is CPA accredited. Information on the cervical screening programme including a number of publications can be found on the NHSCSP website: https://www.gov.uk/guidance/cervical-screening-programme-overview

The West Midlands Cancer Screening Quality Assurance Reference Centre which is now part of Public Health England, produce a Cervical Sample Taking Resource Pack and toolkit.

All personal information received is covered by the Data Protection Act. All staff members within the department have received confidentiality training. Personal information is recorded on a secure computer system only accessible by laboratory staff.

1.2 Clinical Information

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When receiving a cervical specimen, it is important that sufficient relevant clinical information is given. Relevant clinical information includes: Any previous abnormal specimens Any previous treatment Details of any hormones including contraception IUCD in situ Any symptoms of abnormal bleeding Whether the patient is pregnant/post natal

This will help in the interpretation of the cervical specimen and also ensure that the correct follow up management is given.

1.3 Guidance on Preparing Cervical Specimens Individuals taking cervical specimens must have attended a specimen taker course and completed their training log book, including a visit to the laboratory for a tour and general overview. Before taking specimens they must register as specimen takers with the laboratory. A cervical sample taking resource pack and toolkit is available within GP practices and hospital clinics for guidance on taking the specimen. By presenting herself for cervical screening, the patient has consented to the procedure. Once the specimen is taken, the head of the sampling device (cervical broom) must be removed from the handle by a simple flicking with the thumb while the head is within the vial. The vial must be labelled with the patient’s surname, forename and date of birth and/or NHS number. Ensure that the lid on the vial has been tightened.

If a brush specimen is also taken (for example the patient has a stenosed os due to previous treatment or the patient has had a previous endocervical abnormality) the head of this sampling device must be removed by utilising the brush remover that is present within the pack. The brush head must be placed into the same vial as the cervical broom specimen. Please note on the request form if a brush and a broom sample have been taken.

A brush specimen must not be used in isolation- a cervical broom specimen must be taken as well.

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Please note that use of a vaginal lubricant e.g. Replens may affect HPV testing leading to an inadequate result.

1.4 Clinical Advice Clinical advice from a Consultant Pathologist/Consultant BMS is available. Please telephone during normal working hours.

1.5 Completion of the request form and labelling of the vial.

1.5.1 Request form.  All cervical cytology specimens should be accompanied with a pre-populated Open Exeter form. Once you have completed the HMR101 form – editable, please click on A5HMR101PDF(2009) before printing. Ensure you complete all sections highlighted below.

 Information on the Open Exeter- NHS cancer screening programmes can be accessed via Google.

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 If you do not have access to Open Exeter or are not registered to use Open Exeter, please contact your local Call & Recall centre:  Shropshire and Staffordshire ([email protected])  Cheshire ([email protected])  Please ensure that your unique cytology specimen takers PIN or NMC/GMC code is recorded on the request form. This is constantly monitored within the laboratory and information is shared with the regional screening and immunisation leads.  Requests will be accepted on handwritten HMR101 forms if you are unable to access the patient record but please remember to include previous screening history.

There should be a minimum of two legible and correct patient identifiers to link a form and vial that arrive together. There should be a minimum of three legible and correct patient demographics to identify a patient and match them with any existing record on the pathology system.

1.5.2 Vial details Identifier Minimum identifying requirement for cervical samples 1 Patients full name i.e. first name and surname. 2 Patients date of birth. 3 Preferred third identifier: NHS number. Acceptable third identifier: patients address.

The liquid based cytology vial should contain at least two patient identifiers i.e. the patient’s forename and surname, date of birth and /or NHS number.

Insufficient labelling of request forms and/or specimen vials may result in disposal of the specimen. When a specimen is disposed of there is a wait period of at least 12 weeks before a repeat sample can be taken – this is in order to allow the cervical epithelium to regenerate.

1.6 Transportation of Specimens The HMR101 request form and specimen vial should be placed in a specimen bag and then a pink transport bag. All cervical specimens being transported in the pink bag should be listed on the proforma so that any anomalies can be dealt with upon receipt of the pink bag, which should be sealed once all samples have been placed in it. Please record the number of samples sent on the

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front of the bag. Please do not place any other specimens for Pathology into the pink bag as we cannot guarantee they will be passed on in a timely manner, so this could be detrimental to the test. Samples should be sent to the laboratory ASAP to facilitate 14 day turnaround times. Samples taken on a Friday afternoon will keep over the weekend at room temperature. Under no circumstances must a cervical sample vial be refrigerated

1.7 Acceptance policy. The department follows the West Midlands Regional Policy for Acceptance of Cervical Cytology Samples (Publication No: CG10/02). Errors relating to specimens taken as part of the cervical screening programme are recorded and reported to Screening and Immunisation leads and the Hospital Based Programme Coordinator.

The main points are: Major discrepancies:  Unlabelled vial (these are always rejected as we cannot confirm which patient the vial belongs to – please take extra care)  No broom in vial  Insufficient patient identifiers between vial and form  Mismatched vial and form  Woman aged under 24 years and 6 months  Woman aged over 65 years  Vault samples from GPs (these are only accepted from Gynae & Colp clinics)  Forms without vials  Vials without forms  Samples received too early after a previous test (please check Open Exeter if you are unsure whether the patient is due for her test).  Vial in poor condition - Leaked vial, Out of date vial, Damaged vial

These may lead to the sample being rejected of discarded. The sample taker will be informed by letter of these samples. If you require any further information, please contact the department as above.

1.8 Screening frequency. The screening intervals set by NHSCSP for routine samples in England are:

Aged 25-49: every 3 years Aged 50-64: every 5 years

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Routine recall is indicated by ‘A’ on the HMR101 form.

Patients with a prior abnormality should have repeat tests as recommended – these will be given the code ‘R’ on the HMR101 form.

Patients with a negative HPV result may be given the ‘R’ code due to a recommended repeat of 36 months – this ensures the patient is called back for a repeat test as follow-up in 3 years, but is not deemed as a ‘normal recall’.

When a patient has a suspended recall, indicated by an ‘S’ code, they have been under the care of colposcopy and the follow-up interval should be provided by colposcopy. Please check ‘Cervical Cytology Reports’ on Open Exeter which will show the true recall date and may have further information in the ‘notes’ section.

Please note: samples must not be taken less than 12 weeks after an inadequate result.

1.9 Sample taker PINs.

All sample takers should have a personal identification number (PIN) which is registered with the department. Sample takers based in Staffordshire may have been issued with codes during their training. Those that have not been issued with a code and sample takers based in Cheshire or Shropshire, will use their GMC or NMC code. Please note that you should not use another person’s PIN code or allow another person to use yours. If someone is acting in a training capacity (for registrars who will only be taking a couple of samples) please make that clear on the request form. Trainees sample takers from Shropshire and Staffordshire will be allocated a trainee PIN by the Screening and Immunisation team. Once trained, the laboratory will allocate a permanent PIN. GMC and NMC codes are usually used with a T prefix for trainees. All PINs (trainee and permanent) for Cheshire, are allocated by the Screening and Immunisation team. The laboratory keeps a record of discrepancies on forms and vials as well as issuing inadequate rates. These are audited via the PIN code.

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