The Department of Cellular Pathology Requires a Core Lab to Remain on the Frenchay Site

North Bristol NHS Trust, Department of Cellular Pathology

Cellular Pathology: Proposal for future services at Frenchay Hospital

1. Introduction

(a) For several years, the Department has sought to rationalise its services in such a way that supports specialist reporting and provides an effective, efficient service meeting the needs of users. In November 2009, the first moves to achieve this took place when after considerable discussion and planning, the Southmead Hospital laboratories transferred into the Lime Walk Building. The intention has always been that, once new equipment obtained through the Managed Laboratory Service contract became available the bulk of the service provided from Frenchay would also move to the Southmead site.

In making this change, it has always been agreed that between 2010 and 2014, the Department of Cellular Pathology requires a laboratory presence on the Frenchay site to support a number of key elements of the clinical services that will continue to be provided from the site. These can be summarised as follows and are reproduced from a paper dated August 2008;

(a) Provision of a diagnostic Fine Needle Aspiration (FNA) service to the Breast Care Centre at Frenchay Hospital. This is a component of the ‘One-stop’ clinic which runs three days per week for women who are being investigated for breast lumps. The laboratory receives a FNA sample, which it then accessions, stains and provides a rapid report back to the clinicians. Anticipated turnaround time through the laboratory is 20 minutes and the department usually receives 10 – 15, but up to 20, such samples per clinic day and some may arrive on other days on an ad hoc basis.

(b) Intra-operative frozen section service, primarily in support of the breast surgeons. This is an element of the department’s work that has increased in recent years as changes in practice means that the sentinel lymph nodes are required to be checked for the presence of tumour. In the event that tumour is found, further surgery will follow. Between 5 and 8 samples are received per week and the results need to be back with the surgeon within 15 minutes of receipt to minimise risk to patient and to prevent unnecessary delays in the operating schedules.

In addition, frozen section requests may be received from other specialties particularly Plastic Surgery, and these may arrive at any time during the week.

Receipt of fresh breast tissues (lumpectomies, wide excisions and mastectomies) so that they can be examined, sampled and treated in such a way as to optimise fixation. This is important since the subsequent investigations include semi-quantitative assessments using immunohistochemical and molecular techniques that rely on having excellent preservation of a number of tissue antigens. The demonstration of these components which provide information back to the clinicians about the suitability of various treatment regimes eg Herceptin, for a particular patient.

The surgeons will also turn up in the department with specimens, particularly needle localisations, requesting that they be checked to ensure that tumours have been fully excised

The alternatives are to either send the Southmead in a fresh state or to send with the entire specimen placed into formalin. With either approach, fixation of key components of the tissue will be delayed and so risk sub-standard demonstration of tissue components.

Due to the requirements to meet the timescales of the service users, the frequently unpredictable arrival of frozen sections coupled with the amount of work, it was always

File: 0a6a50e5d5e2c1249c853b226289e417.doc Date: 20 October 2010 Author: Dr K Denton, Mr AR Heryet Page 1 of 10 North Bristol NHS Trust, Department of Cellular Pathology

accepted that it would be necessary to base at least one Consultant Pathologist at Frenchay at all times. They would need to be supported by two BMS / MLA staff to prepare samples, screen the Cytology, send work on to Southmead and to prepare the MDT.

(b) In all discussions about centralisation and reconfiguration of services within the Trust and within Bristol, it has always been agreed that the work described above would need to be provided from a pathology laboratory on the hospital site from where the clinical services are being delivered. The view of the clinical professionals at the various Trusts is that to do anything different would introduce significant clinical risks for patient care

(c) Centralisation of services will provide a better opportunity for the department to retain its CPA accredited status. The assessment visit carried out in March 2010 highlighted a number of issues relating specifically to the equipment and occupied space at Frenchay. These were forecast to be raised but, given the department’s intention to reconfigure the service within a short time-frame, the department did not feel it necessary to take any remedial action ahead of the visit.

(d) This paper follows on from documents produced earlier in 2010-2011 that described the options to bring about greater centralisation of Cellular Pathology services on to the Southmead Hospital site. That document examined the costs implications and risks of each option.

(e) The department now seeks to move all aspects of its service with the exception of a hot lab facility. Mindful of some of the likely objections, this paper seeks to clarify the scope of the service that will remain, identify any risks and quality issues and establish ways in which the department might mitigate against those risks and maintain service quality.

(f) Gastro-intestinal surgery and medicine are currently carried out at Frenchay but all specimens are transferred to Southmead for dissection and reporting. The pathologists attend the MDTs at both sites

2. Proposed Cellular Pathology service, Frenchay Hospital

2.1 The Department of Cellular Pathology is proposing to transfer the majority of services that are currently provided from the Frenchay Hospital site to Southmead. It is intended to retain a service on the Frenchay Hospital site that enables, (a) The provision of a diagnostic Fine Needle Aspiration (FNA) service to the ‘One-stop’ clinic run by the Breast Care Centre at Frenchay Hospital. This runs three days per week for women who are being investigated for breast lumps. (b) An Intra-operative frozen section service, primarily in support of the breast surgeons. In addition, frozen section requests may be received from other specialties particularly Plastic Surgery, which may arrive at any time during the week. (c) Receipt of fresh breast tissues (lumpectomies, wide excisions and mastectomies) so that they can be examined, sampled and treated in such a way as to optimise fixation. (d) Cut up and reporting of specimens to maximise the use of consultant PAs (e) Support for breast skin and GI MDT meetings

2.2 All other laboratory work to be carried out at Southmead Hospital.

2.3 Where the capacity of the lab and consultant staff at Frenchay is exceeded fixed tissues will to be transferred to Southmead Hospital for cut-up and processing .

3. Required resources

3.1 Equipment

Requirements are as shown here,

Processors Embedding Microtomes Stainer Coverslipper Cryostat Centres 0 0 0 0 0 2

3.2 Staff

Requirements are as shown here,

Band 2/3 Band 5/6 Band 7 BMS Medical Clerical / Consultant MLA BMS Secretary Audit 1 1 1 1 0 1 - 2

(a) Two Consultants Pathologist to be at Frenchay at all times. The second breast pathologist to be available on site at Frenchay for booked nodal frozen section and one stop clinics. Clinicians to review whether they can plan to do these operations in designated session. (see accompanying document) (b) One-stop clinics will be supported by a two pathologists on site. Where a second breast pathologist is not available a second review will occur before MDT i.e. before management decision. Histology reports would also be available at this time. Clinicians to inform patients that the result is a preliminary diagnosis. (c) All staff to be based at Southmead and rostered to support the Frenchay laboratory. Number of staff on site will vary from day to day according to likely workload.

3.3 Accommodation

(a) Requirements are as follows,

Cut-up room with downdraft bench and space for specimen storage Area for cytology preparation of fluid samples to include safety cupboard, centrifuge and cytospin Area for Cryotomy, staining and coverslipping Screening room 2 Consultant offices Sample reception Storage for consumables, blocks, slides, reports

Room 016 – Cut-up, frozen sections, (17.8m²) Room 003 – Cytology preparation, staining / coverslipping (8.0m²) Room 014 – Consultant’s office (12.5m²) Room 005 – BMS office and microscopy including screening (9.4m²)

(b) It is recognised that space could be freed at Frenchay providing opportunity for use by other services

4. Risk Assessment

Description Action already taken / required 1 Delays getting specimens between There has been an improved inter-site transport to sites facilitate movement of specimens. (There have been no incidents concerning loss of delay in

specimens attributable to the interlaboratory service in the last year. There have been delays where the case has gone to the pathologist with the wrong expertise. ) 2 Equipment: Some items at Frenchay Service contracts are now in place for items due to be replaced and would now in use at FHY be out of use had the whole service been delivered from Southmead 3 Supply of consumables Senior BMS staff able to order directly through MES contract or via Eros 4 Staff availability Robust and flexible rotas to be established 5 Cases for MDT not being made Close liaison between sites and between the available department and the breast MDT coordinators. This has not been a problem for the GI cases which are stored on one site but has been a problem for lymphoreticular disease because the cases may be filed on either site.

5. Quality Aspects of Breast Pathology at North Bristol Trust

1. The Breast cancer service at North Bristol Trust is of a very high quality and pathology is an important part of this service.

2. There is a requirement to move parts of Cellular Pathology from Frenchay Hospital to Southmead Hospital to deliver quality in all sub- specialist areas.

3. This department fully accepts that essential patient safety of the Breast pathology service must be maintained and this document summarises the means with which it will be achieved against the specific concerns that have been raised.

4. A number of concerns have also been raised by other surgical specialities with regard to moving services from Frenchay and these are also addressed below.

Current Service Concerns raised Proposed solution Practice elsewhere Patient safety maintained 1. Breast biopsies Women having a biopsy Moving processing to Southmead, samples  Most laboratories work to a 48 Yes taken up to 5pm on on Wednesday afternoon taken on Wednesday am will be available. hour turnaround Wednesdays are will wait 7 days for their Samples from Wednesday pm will not.  No national standards for available for Breast case to be discussed in Numbers for Weds pm are very low. timeliness of this part of the MDT Thursday am. the Breast MDT meeting Clinicians to manage patient expectations. cancer management pathway exist 2. One-stop clinic A report by only one Two pathologists would be on site nearly  Proposal is entirely in keeping Yes cytology reports pathologist might be less all the times. Where two breast pathologists with RCPath guidance on dual are dual reported accurate are not available, a second review would reporting by 2 pathologists at occur before MDT i.e. before management  The RCPath Cytology sub- the time of the decision. Histology reports would also be committee has confirmed that clinic available at this time. Clinicians to inform one stop clinics are reported by a patients appropriately (i.e. that the result is single pathologist in most centres In addition all first a preliminary diagnosis) diagnoses of malignancy are checked by a second pathologist at the time of reporting. File: 0a6a50e5d5e2c1249c853b226289e417.doc Date: 20 October 2010 Author: Dr K Denton, Mr AR Heryet Page 5 of 10 North Bristol NHS Trust, Department of Cellular Pathology

3. Frozen section Current sensitivity is very Although this service is currently in excess  The use of frozen sections in this Yes of lymph nodes for high. Reporting by a of all national specifications (and indeed of setting exceeds all national micro-metastasis single pathologist may the funded service at its introduction in quality specifications are dual reported decrease sensitivity. 2008) it is accepted that any decrease in  There is no national requirement by two This would lead to sensitivity would result in potential harm to for any frozen section to be dual pathologists. patients needing to patients who would need further surgery. reported Reported sensitivity undergo a second This service needs to be maintained but  However in view of the is high. surgical procedure kept under review. excellence of the service and the risk to patients of further surgery Second pathologist to be available on site after a false negative report, this at Frenchay for booked nodal Frozen service should be supported section. Clinicians to review whether they  A molecular method for detecting can plan to do these operations in micro-metastases is under designated sessions. development. There is no evidence currently that double reporting of frozen sections is a significant improvement on a single experienced pathologist reporting alone.

Issues relating to Plastic Surgery

4. No very urgent Existing turnaround times can be monitored Proposal is entirely in keeping with Yes time pressures and improved from Southmead. RCPath guidelines on reporting identified for histology reporting. 5. Occasional OAt least one pathologist would be on site at Proposal is entirely in keeping with Yes ‘one stop’ out all times. However, second review would RCPath guidelines on reporting patient FNA’s are occur before MDT i.e. before management taken. decision. Clinicians to inform patients appropriate (i.e. preliminary diagnosis) 6. Intra-operative There is no evidence that double reporting Entirely in keeping with RCPath Yes FNA’s or FS are improves sensitivity. The issues are different Guidelines on Quality Assurance in taken and to the issues in breast nodes for micro Histopathology reporting currently dual metastasis. Two pathologists will be based at reported. Frenchay to continue with this service. In the File: 0a6a50e5d5e2c1249c853b226289e417.doc Date: 20 October 2010 Author: Dr K Denton, Mr AR Heryet Page 6 of 10 North Bristol NHS Trust, Department of Cellular Pathology

event of only one person being available there is a video link to Southmead 7. Liaison about Sometimes surgeons bring the specimen to No problems encountered in the Yes macro specimens the lab to explain resection margins in detail. orientation of GI specimens. A pathologist will be based at Frenchay at all times so this should not be a problem. A video link to Southmead is available. 8 turn around Thereis a concern that The current turn-around time for plastic These times need to be improved times any movement of surgery cases reported at Frenchay is 8 days but there is no evidence that the specimens across site at Southmead is 6 days. For all cases movement of specimens to will increase turn-around except breast and urology which are site Southmead will affect the time to times for reports specific the turn round times are 9 and 8 reporting. days respectively.

Issues related to other services eg Gastro-intestinal

8. Intra-operative Occasional frozen sections are requested by Yes frozen section the GI team. Since a pathologist will always be based at Frenchay this should not be a problem as it is usually a question of mesothelial proliferation or metastasis. If it is a question of surgical margin involvement (even more rarely requested) one of the GI team can arrange to be present

Summary of existing service provision

 3 consultants and supporting lab staff are based on the Frenchay site but are part of a single North Bristol department  All staff contracts include the need to work on either site and many staff have moved or regularly work on both sites.  Pathology specimens or prepared slides are frequently moved between sites. In recent months all Gastro-intestinal pathology and all primary care samples have been relocated to Southmead from Frenchay.  Although the policy has been for dual reporting as described, with only three consultants it has not always been possible to provide it, especially during periods of leave.

6. Implementation

The Department of Cellular Pathology is proposing to transfer the majority of services that are currently provided from the Frenchay Hospital site to Southmead. A ‘Hot Lab’ facility to cover frozen sections, one-stop breast clinics and some specimen cut-up will remain on site. Earlier documents prepared by the department have outlined the rationale for the move, the risks to service and the means by which those risks might be addressed.

The work required to facilitate the move is relatively small and could be achieved, as a minimum, approximately one month after agreement to proceed. The key issues are to be considered are provided below.

Ref Description To be completed Additional support Responsibility 0 Trust Agreement to move service As soon as possible CD, MD KD 1 Inform all departmental and Pathology Sciences staff of As soon as move is agreed ARH, KD move with timescales 2 Inform all service users (including externals) of change As soon as move is agreed 3 Establish with the Clinical Director, General Surgery when As soon as move is agreed lists and clinics will run. This to optimise staffing provision at Frenchay. 4 Provide formal notice of move to staff As soon as possible but at least HR ARH one month prior to move 5 Complete an inventory of equipment, consumables, CMcK, CDA archived and other items to transfer and identify to precisely where it will transfer. Decide what needs to remain at Frenchay and what can be disposed. 6 Identify any items that need to be moved to Southmead ahead of the date of main transfer to ensure that there is no break in quality of service provision. Identify any items that need to be left until last or need to move early on date of main move. 7 Arrange for a removals company to provide quotation Projects team CMcK, CDA 8 Agree date for transfer Removals Co 9 Identify any changes to department at Southmead that Estates may be required to accommodate the additional work, equipment and staff 10 Ensure free access to laboratories for move Parking services, Security, File: 0a6a50e5d5e2c1249c853b226289e417.doc Date: 20 October 2010 Author: Dr K Denton, Mr AR Heryet Page 8 of 10 North Bristol NHS Trust, Department of Cellular Pathology

Pathology Sciences staff 11 Contact equipment suppliers in the event that specialist As appropriate equipment needs to move 12 Arrange to, IM&T - transfer IT assets to Southmead - make new phones and numbers available - establish video-conferencing facility between Southmead and Frenchay laboratories 13 Agree who will be coordinating move at each end 14 Once date of move is set, - establish precisely when work will cease to be processed at Frenchay - decide what staffing resource is required at Frenchay on day of move 15 Inform relevant services in Trust of change Estates, Payroll 16 Review and test cross-site transport systems to ensure ?Transport service needs are met especially with regards transfer of and slides for reporting / MDT meetings and wet specimens 17 Agree suitable staffing level for Frenchay site 18 Agree mechanism for ensuring an audit trail for specimens CMcK moving to Southmead 19 Implement all operational changes identified as being CMcK, CDA necessary to provide a smooth flow of work through the department as previously agreed and documented. 20 Rotas for BMS and Clerical staff to include any None CDA commitment in Cytology 21 Rotas to enable Consultant cover of breast pathology work 22 All specialist teams of pathologists involved (includes skin, GI, head & neck) to agree rotas. 23 Relocate any items within the department at Frenchay At time of move / post-move 24 Remove all unwanted items from department Post-move Removals Co 25 Decontaminate areas of department that are not in use Post-move

Notes & Comments:

4 The equipment that is to transfer is already established and does not include any laboratory capital items 16 Likely to be 2 x Consultant, 1 x MLA, 1 x BMS Band 5/6, 1 x Band 7 BMS. This may change depending upon service needs 10 Only likely to be Dako Autostainer in the event that the Leica Oracle system has not been brought into use

Andrew Heryet Laboratory Manager Cellular Pathology Karin Denton Head of Cellular Pathology Nicholas Rooney Head of Pathology Sciences 10-11-10

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