Policy. Cytopathology Clinical Operational Policy. Register No: Status: Public. Contributes to HCC Core Standard number:

Transcription

1 Cytopathology Clinical Operational Policy Developed in response to: Contributes to HCC Core Standard number: Policy Register No: Status: Public Service Needs C7a Consulted With Individual/Body Date General Manager-Pathology Richard Green November 2009 Divisional Manager AT&D Elizabeth Hayes November 2009 Clinical Consultant Histologist Dr Peter Davis November 2009 Professionally Approved By Dr Peter Davis November 2009 Version Number 1.0 Issuing Directorate Pathology Ratified by: Margaret Blackett, Chief Operational Officer Ratified on: 4 th January 2010 Trust Executive Board Date n/a Implementation Date 4 th January 2010 Next Review Date January 2011 Author/Contact for Information Jacqueline Wilks Policy to be followed by (target staff) All Staff Distribution Method Intranet Related Trust Policies (to be read in conjunction with) Infection Prevention, Mandatory Training, Manual Handling, Fire Safety, IT, Patient Safety, Record Keeping Document Review History Review No Reviewed by Review Date It is the personal responsibility of the individual referred to this document to ensure that they are viewing the latest version which will be the document on the intranet 1

2 Index 1. Purpose of Document 2. Aims of the Service 3. Scope of the Service 4. Work Flows 5. Key Relationships 6. Staffing 7. Equipment Requirements 8. Infection Prevention 9. Equality and Diversity 10. Contingency 11. Auditing this Policy 12. Responsibilities 13. References Appendix 1 Cervical Gynaecology Activity Data Appendix 2 Non Gynaecology Activity Data Appendix 3 Cervical Gynaecology Work Flows Appendix 4 Non Gynaecology Work Flows 2

3 1. Purpose of Document 1.1 To describe the service and operational function provided by the department of Cytopathology, part of Cellular Pathology. 2. Aims of the Service 2..1 To provide a full screening and diagnostic cellular pathology service to Mid Essex Hospitals NHS Trust (MEHT), Mid Essex PCT and private healthcare providers including Springfield Hospital and Chelmsford Medical Centre. 2.2 Cytopathology delivers a high quality service by maintaining the standards of the NHS Cervical Screening Programme, the East of England Quality Assurance Cancer Screening Programmes, and Clinical Pathology Accreditation and to report within the Department of Health turnaround times. 3. Scope of the Service 3.1 The allied specialties of Histopathology and the Mortuary are the subject of separate Clinical Operational Policy documents and although interdependent, will not be discussed formally within this document. 3.2 Cytopathology is the branch of pathology which diagnoses disease and conditions through the examination of cell samples in order to produce a report to assist the clinician in making management decisions. 3.3 Non gynaecological cytology is a considered opinion based upon interpretation of microscopic features in the light of the clinical details provided and the findings from other diagnostic modalities such as radiology, chemical pathology, haematology, microbiology and immunology. The cytopathology report provides a diagnosis (where possible), recommendations on need for further investigation (where diagnosis is not immediately possible), and guidance as to further treatment options. 3.4 The cervical screening programme is dependent on exfoliative cytology, using the liquid based cytology technique and microscopic examination to diagnose precancerous and invasive cancers from the female genital tract. Inclusion Criteria 3.5 All cellular material from adults and children treated by Mid Essex Hospitals NHS Trust and according to service level agreements with Mid Essex PCT and Private Healthcare Providers. Cases may be referred in for second opinion or MDT review from other Cytopathology departments within the Essex Pathology Network or further afield. Exclusion Criteria 3.6 Tissue samples, which are processed by Histopathology. 3

4 Staff 3.7 Staff involved are Consultant Histopathologists, rotational Specialist Registrars from the London Deanery, FY2 doctors, Biomedical Scientists (BMS), Medical Laboratory Assistants (MLA) and Medical Secretaries. 3.8 Estimated Activity Cervical Screening 1 st April st March 2008: requests tests 1 st April st March 2009: requests tests Predicted : requests tests Non Gynaecological Cytology 1 st April st March 2008: 2706 requests 7891 tests 1 st April st March 2009: 2471 requests 7383 tests Predicted : 2484 requests 7383 tests Please refer to appendices 1 and 2 for activity data. 3.9 Hours of operation Monday Friday 08:30 17:30. There is no on-call or weekend service. 4. Work Flows 4.1 Work flows for the department are detailed in appendices 3 and Specimens Specimens are delivered by Broomfield hospital transport and hospital porters. Specimens are received from GP Surgeries, Community Clinics, Genito-Urinary Medicine, Theatres, Hospital Wards/ In Patients and Out Patient Departments from all Mid Essex Hospitals and from Springfield Hospital. Specimens are delivered to a common reception in Haematology where they are sorted and the cytology specimens are delivered to Cytopathology via the hospital porters. Flow of work into the department is unpredictable and entirely dependent on clinical activity. 4

5 4.3 Staff Consultant Histopathologists are medically qualified members of the Royal College of Pathologists. Biomedical Scientists are registered practitioners with the Health Professions Council and must hold must hold the NHSCSP Certificate in Cervical Cytology and a Certificate in Liquid Based ThinPrep Cervical Cytopathology or the City and Guilds Cytology Diploma. Cytoscreeners must hold the NHSCSP Certificate in Cervical Cytology and a Certificate in Liquid Based ThinPrep Cervical Cytopathology or the City and Guilds Cytology Diploma. Medical Laboratory Assistants provide support working under the supervision of the Biomedical Scientists Medical Secretaries provide administrative and secretarial support to the cytopathology department. 4.4 Goods Goods deliveries for Cytopathology are received in the Histopathology Office or via the Goods Receiving department. 5. Key Relationships 5.1 Key Operational Requirements Fast, reliable and auditable specimen delivery from primary care, private practice and across all MEHT sites. Adequate laboratory staffing and appropriate skill mix to ensure high quality, rapid turnaround and continuing quality control, audit and training. A dedicated specimen reception capable of handling large numbers of LBC vials. Fully equipped laboratory and high risk room, including equipment and areas for: processing machines, automated and hand staining, cover-slipping, quality control checks and archive storage. A fully equipped screening laboratory, including adequate space and appropriate IT. Individual consultant and technical senior offices. Staff rest area. Staff changing. Department office (secretarial and admin). Copier and printer room. On-site storage of blocks and slides. Off-site long term storage (Provider: Cell Nass) Close location to Histopathology for correlation between sample modalities. 5.2 Key Relationship with other Departments Theatres Endoscopy 5

6 Day Stay Unit Wards Outpatients Department Accident & Emergency Cancer MDT teams Radiology Other pathology disciplines (haematology, chemical pathology, immunology, microbiology) IT Portering Services and Hospital Transport Medical Records Cytopathology has close relationships with GPs and Primary care trusts. Local Private Healthcare Providers (e.g. Springfield Hospital, Chelmsford Medical Centre) 5.3 Specialty specific factors: Quiet time for cervical screening examination and reporting. Production of recall and failsafe letters. Communications: clinicians and their secretaries must be contactable. IT and administrative support is essential to booking in specimens, dealing with enquiries and checking patient histories, typing reports and letters, organising distribution of finished reports, preparing MDT meetings and producing workload data and statistics. 5.4 Key Requirements for Facilities Management ( F.M.) Maintenance contracts with outside providers are in place for cytology equipment. Department requires regular cleaning services and access to the estates maintenance department. There are no catering services within the department; there is a staff rest area. Cytopathology must be consulted before changes are made to parking spaces outside the department used for deliveries, in order to ensure optimum placement of road markings to facilitate access for all user groups. 5.5 Environmental Requirements There is a service level agreement with Domestic services and Estates to ensure environmental conditions remain as standard. Laboratory procedures in place for cleaning and safe handling of substances hazardous to health (COSHH, CPA). Microbiological exhaust hood for high risk pathological specimens. Non-slip flooring in all corridors and laboratory areas. Carpets in consultant and technical staff offices, screening room, administrative office and staff rest areas. Ambience important as staff work long hours direct impact on staff welfare, contentment, sick leave and recruitment/retention. Individual consultant and senior technical staff offices for quiet reporting, case discussion, teaching and management activities. Ergonomic workstations for long periods of microscopy screening. 6

7 Quiet and relaxed environment essential for concentration and the production of accurate reports. 5.6 Way finding Not accessed directly by patients. Porters, clinicians, administrative staff and visitors need to find the department. Signage to cytopathology is unclear from the Broomfield site. 5.7 Security Requirements Data Security The service will be delivered in accordance with and compliance to the Trust s IT Policies Data sharing agreements will be drawn up to cover all data sharing outside the Trust in accordance with the Trust data sharing policy Hospital information/patient data will only be downloaded onto devices provided by the Trust which are encrypted Databases will be registered on the Trust database of databases A data mapping form will be completed for all routine data flows leaving the Trust Patient identifiable information will only be sent out of the Trust from an nhs.net account or other secure route (never from an nhs.uk account) Security for Patients This service is not directly accessed by patients Security for Staff The service will be delivered in accordance with and compliance to the Trust s Lone Worker and Security/Risk Management Policies. The laboratory and office areas are secure from public access, with access control. Computers have non password protected screensavers, in order to allow for continuous use during reporting. Cytopathology meets the requirements of CPA accreditation Medical Records Security If medical records are required within the department they will be managed confidentially at all times and stored securely in locked office or outpatient facility whilst not in use All movement of patient records will be accurately tracked in accordance with the Trust s Case note Tracking Policy All new documentation will be secured into the folder prior to it leaving the department 7

8 5.8 Manual Handling The service will be delivered in accordance with and compliance to the Trust s Manual Handing Policies. 5.9 Fire Safety The service will be compliant with the Trust s Fire Safety Policy, Fire Evacuation Policy and other local fire plans and procedures. (The detail of these items will then be developed as part of the separate Fire Safety Work Programme, as led by the Trust s Fire Officer.) 5.10 ICT Requirements Cytopathology is dependent on ICT. Laboratory Information Management System (LIMS), Sysmed is responsible for booking in, process control, QA, audit, access to patient specimen history, reporting and authorisation, recall and failsafe. Stable servers and reliable IT system, with minimal downtime and maintenance scheduled outside department peak times, outside working hours where possible. Comprehensive pathology system network within the Trust and across the health subeconomy to support GP messaging and the shift to fully electronic requesting. Server hardware will form part of a separate IM&T Operational Policy Storage of additional images. Access to Q-Pulse 5 document control system. Networked PCs, with office based software Histopathology: 17 with Sysmed, plus 3 without Sysmed Cytopathology: 8 with Sysmed Mortuary: 1 without Sysmed Network points required: At least Staffing 6.1 Staffing Profile 6.2 Consultant staff 6.3 The current consultant staffing consists of 6 full time consultants. Laboratory and Administrative Staff Funded Biomedical Scientists Band 8A 1 Biomedical Scientists Band Biomedical Scientists Band 6 2 Cytoscreeners Band Medical Laboratory Assistant Band 3 1 Medical Secretaries Band

9 6.4 Training and Education All staff within Cytopathology attend mandatory Trust training and adhere to NHSLA requirements. Dedicated training officer in place. Consultant and laboratory staff take part in RCPath / IBMS accredited CPD schemes and will be able to demonstrate this. Consultant staff registered with and meet requirements of GMC The department undertakes training of BMS and cytoscreeners staff in conjunction with the University of Essex, the University of Westminster and the Newmarket East of England Cytology Training Centre. 6.5 Facilities Staff refreshments restaurant; league of friends / WRVS coffee shops. Hospital shop. Occupational health. Self referral to Physiotherapy. Lockers/ Lockable filing cabinets for staff personal belongings. 7. Equipment Requirements 7.1 Laboratory: Refrigerator x 1 T2000 x 1 Exhaust hood x 1 Cytospin x 1 Centrifuge x 1 Tissue Tek Coverslipper x 1 Shandon Varistain x 2 Numbering machine x 1 Microscopes x 7 Specialist cabinets x Administrative: Fax machine x 1 Printers x 2 Photocopier / printer x 1 8. Infection Prevention 8.1 The service will be delivered in accordance with and compliance to the Trust s Infection Prevention Policies. 9

10 9. Equality and Diversity 9.1 The Trust is committed to commit to the provision of a service that is fair, accessible and meets the needs of all individuals. 10. Contingency 10.1 Totally dependent on IT contingency strategy to continue activity in the event of software/hardware/power failure In the event of an IT system failure Cytopathology will continue to process current specimens, but booking-in, slide labelling and report generation is no longer possible Role in MAJAX response primarily concerns the Mortuary. 11 Auditing this Policy 11.1 This policy will be audited annually by the General Manager for Pathology; this information will be shared at the bilateral. Updating of this policy will be undertaken by the Clinical and Technical Leads following audit feedback from the General Manager. Revised Policy will be submitted to the Document Ratification Accreditation Group and the submitted to the Trust Board. 12. Responsibilities 12.1 The General Manager for Pathology is operationally and financially accountable for service delivery. The Clinical Team (Consultant Pathologists) will remain professionally accountable for their actions. They will work in conjunction with the General Manager to ensure that the service is delivered within the confines of the agreed budget and operational requirements Chief Executive Officer Director of Delivery Divisional Manager General Manager Pathology Technical Lead Technical and Administrative Teams Medical Director Clinical Director Clinical Lead Consultant Pathologists 10

11 13. References 13.1 MEHT Policies Royal College of Pathologists Institute of Biomedical Science National Association of Cytologists NHS Cervical Screening Programmes East of England Screening Quality Assurance Reference Centre British Society for Clinical Cytology Clinical Pathology Accreditation (CPA) Health and Safety Executive: Control of Substances Hazardous to Health Cytopathology Standard Operating Procedures (SOP) are controlled documents held on the Q-Pulse 5 document control system in accordance with CPA requirements. 11

12 Appendix 1 Gynae Cervical Cytology Workload Requests January February March April May June July August September October November December 12

13 Appendix 2 Non-Gynae Cytology Workload Requests January February March April May June July August September October November December 13

14 Appendix 3 Liquid Based Gynae Cytology Transport to laboratory Specimen received, given a sequential gynae cytology lab number using a time stamp machine and bar code label on request form and specimen vial. Cytology request form taken to the cytology office for entering onto the WinPath system. Work list produced for work to be sent to Colchester Hospital University NHS Foundation Trust. Liquid Based Cytology Vials separated into urgent and non urgent work. Non urgent specimens sent to Colchester Hospital University NHS Foundation Trust for processing on T3000. Urgent work processed at MEHT in cytology high risk room on T2000. Slides produced for both urgent and non urgent specimens. Slides returned from CHUT checked back in. All slides stained at MEHT. Slides labelled with computer generated slide labels. Negative specimens reported by cytoscreeners. Suspected abnormal and inadequates passed to checkers. Abnormal passed to Pathologists for reporting. Results written onto request form and entered onto WinPath system in the cytology office. Reports checked and authorised by cytoscreeners, checkers or pathologists. Reports printed out and sent to sender of specimen. MDT review of cancer cases and audit of Invasive Cervical Cancers for NHS Cervical Screening Programme. 14

15 Appendix 4 Non-Gynaecology Cytology Transport to laboratory Specimen received, the request form is time and date stamped. All non-gynae specimens are processed in the high risk room in the microbiological safety cabinet. The patient details are entered in the daybook and allocated the next specimen number. The non-gynae request form is taken to the cytology office for entering onto the WinPath system. The slides produced are stained and then matched up with the request forms. The slides are labelled with computer generated slide labels. After checking by a BMS the slides and forms are passed to a Pathologist for reporting. Report goes to office for reporting onto the WinPath system. Pathologist checks and authorises report. Report printed out, despatched and available on MEHT Review. MDT review of cancer cases / external referral of selected cases for second opinion. 15