Breast screening: quality assurance guidelines for breast pathology services

Question 1

1. Introduction

Accepted Answer

The principal objective of these updated guidelines remains the drive for continued improvement in standards of pathology performance in the NHSBSP. The quality of pathology services is central to the delivery of high quality breast screening services, because the definitive diagnosis of cancer and its subsequent classification are determined pathologically.

High quality pathology is also required to distinguish cancer from benign conditions and report histological features of prognostic and predictive significance reproducibly and accurately. This makes sure patients are treated appropriately. However, the full significance of these pathological characteristics can be recognised only if they are reported consistently by all pathologists.

Consistency is optimised if guidelines are adopted by pathologists working in both breast screening programmes and symptomatic breast services, as pathology data are a key element in the effective monitoring in both areas. Although the success of a breast screening programme is ultimately measured by a reduction in mortality in the invited population, statistically significant mortality data do not become available for many years. Other methods can therefore be used to monitor the effectiveness of programmes over the medium term. These include:

the number of tumours detected
the size of tumours
nodal status
other prognostic features, such as histological grade

In addition to their role in monitoring the breast screening programme and supporting patients and their treatment, pathology data contribute to clinical and cancer standards audit, as well as clinical research. The quality of these data depends on the expertise of pathologists and the techniques and reporting methods they employ.

Within the NHSBSP, specimens from screened women often make more demands on pathology resources and expertise than those from symptomatic women. Such samples can be macroscopically and histologically more complex and time consuming to examine. In particular, impalpable lesions may require specimen (and specimen slice) radiography, making the process of examining and reporting a specimen more intricate.

To generate high quality pathological data and achieve the standards required by the NHSBSP, pathologists need:

appropriate managerial and administrative support
access to appropriate equipment and resources
to rely on robust quality assurance (QA) processes, both internal and external

The pathology QA process is led and coordinated by the UK National Coordinating Committee for Breast Pathology (NCCBP) on behalf of NHS England (NHSE) and the Royal College of Pathologists (RCPath). It is part of the larger QA programme involving all professional groups working in the NHS BSP. The QA process for breast pathology operates, and is managed, on a national basis. The pathology Screening Professional Clinical Advisors (SPCAs) are members of the NCCBP.

This guidance is applicable to all laboratories and pathologists providing a breast screening pathology service. This includes those that are outsourced or handled and reported privately (such as third party providers).

Question 2

2. Breast specimen handling and reporting

Accepted Answer

2.1 Standardisation of terminology, diagnostic criteria and use of proformas

A principal objective of the QA programme is to unify the terminology and diagnostic criteria employed in reporting breast lesions. This ensures accurate analysis of datasets. Central to this are the national breast screening system (NBSS) reporting forms that are used to enter data for needle core biopsy, vacuum-assisted specimens (vacuum-assisted biopsies and excisions), surgical specimens and cytopathology.

Synoptic reports that include the RCPath minimum dataset and NHSBSP pathology dataset items must be used for reporting. This ensures comprehensive and consistent provision of pathology data and eases transcription for Administrative and Clerical (A&C) staff and accurate data transfer. This applies not only to NHS BSP systems but to cancer registry and audit datasets such as the National Disease Registration Service (NDRS).

Sample synoptic reports, definitions of terms, and more detailed guidance on using the forms are set out in the NHS BSP/RCPath publication G148 and publication G150, and are therefore not duplicated here.

2.2 Frozen section examination of impalpable lesions

Frozen section examination has now almost entirely been displaced by effective non-operative diagnosis techniques. Diagnostic frozen section examination of palpable lesions should be avoided if at all possible. Only in very exceptional circumstances should frozen section assessment be considered on impalpable lesions, and then only after detailed consultation and agreement between the pathologist and surgeon.

2.3 Quality assurance of non-operative diagnosis

Guidance on the principles and practical aspects of needle core biopsy and fine needle aspiration cytology (FNAC) is provided in RCPath publication G150. These recommendations should be adhered to when reporting such samples.

All specimens should be reported by a named NHS BSP breast screening consultant pathologist, or a trainee pathologist under a named breast screening consultant pathologist’s supervision.

If an individual reports limited numbers of non-operative specimens per year, they should consider whether they are receiving sufficient exposure to maintain expertise. A pathologist should report at least 30 non-operative specimens in a 3-year period. Analysis of results from individuals reporting fewer than this is impossible and in the National Pathology Data Review, those reporting less than 30 needle core biopsy cases in a 3-year period have been excluded.

B3 lesions should be managed in line with the “NHS Breast Screening multidisciplinary working group guidelines for the diagnosis and management of breast lesions of uncertain malignant potential on core biopsy (B3 lesions)”.

The NBSS is able to generate QA statistical reports automatically from non-operative specimens and surgical histology data in the form of biopsy quality assurance (BQA) routines. These permit detailed examination of results at the unit, laboratory and individual level.

The National Pathology Data Review provides comparative non-operative biopsy data on individual pathologist performance (for those reporting sufficient numbers of cases), as well as by laboratory and screening service, on an annual basis. Pathologists should review their own results. The Screening Quality Assurance Service (SQAS) can be approached for additional advice e.g. regarding outlier status.

For details of non-operative peformance standards see RCPath publication G150

2.4 Quality assurance of the macroscopic examination of specimens

Timely transfer of surgical pathological samples to the laboratory to enable appropriate and accurate fixation, dissection, processing, embedding, sectioning and staining procedures is mandatory.

Careful macroscopic examination of surgical specimens is a vital part of the screening process. Before undertaking macroscopic examination, the pathologist should make sure they are aware of all relevant clinical details (from the request form or electronic information systems).

Specimen handling should be undertaken only by:

pathologists involved in the breast screening service (and who meet the requirements of a breast screening pathologist and are experienced in breast dissection)
appropriately trained biomedical scientists (BMSs/Advanced Practitioners)
trainee histopathologists under breast pathology consultant supervision

Detailed guidance on the macroscopic examination of diagnostic and therapeutic surgical biopsies, including wide local excisions, mastectomies and lymph node specimens, can be found in RCPath publication G148.

Laboratory standard operating procedures (SOPs) for handling and reporting breast specimens must be well documented. A copy of the laboratory SOP for breast specimens must be provided as part of the supplementary documents attached to the pathology questionnaire for a QA intervention.

2.5 Quality assurance aspects of specimen radiography facilities

Immediate specimen radiography of surgical specimens from impalpable lesions will be assessed in the operating theatre to confirm that they include the radiological abnormality.

Whilst smaller specimens may then be all embedded and examined histologically, larger specimens may benefit from x-ray examination of the sliced tissue. Such further specimen (and specimen slice) radiography in the histopathology laboratory helps to ensure that the correct blocks of tissue are selected for examination.

Histopathologists must have ready access to digital specimen x-ray facilities or services and should be able to view these images in the Department.

If x-ray facilities are located in the pathology laboratory, the quality of equipment must be reviewed and maintained, and their safety and performance monitored by appropriately expert (radiation protection and physics) advisors. This will form part of breast screening quality assurance reviews.

It may be helpful in difficult cases to have radiological expert opinion for review of specimen slice x-rays and this should be available.

Written laboratory protocols should be in place for x-raying breast specimens and derivative slices and for using and monitoring the associated equipment.

2.6 Quality assurance aspects of computers and monitors

All breast pathologists require adequate IT support, including personal computers (PCs) and monitors.

Monitors should be of appropriately high quality to view digital x-ray images, web-based EQA and educational material, as well as digital pathology slides if pathologists are using digital pathology to report screening cases for guidelines see Digital histopathology in NHS cancer screening programmes.

Guidance on computer and monitor minimum specification, for example for the breast pathology EQA scheme, is available on the NCCBP website.

2.7 Quality assurance of histological examination

Details for standardisation of assessment of pathological prognostic factors and minimum dataset items are described in Dataset for histopathological reporting of breast disease in surgical excision specimens of breast cancer (2024). Pathologists must be familiar with these guidelines and adhere to their recommendations for handling and reporting.

Recording histological features of invasive carcinomas that are of prognostic and predictive significance affects patient management. Accurate pre-operative assessment of grade and receptor status makes sure that the correct patients receive neoadjuvant therapy and access to appropriate clinical trials.

Assessment of histological features also allows comparison of cancers detected by screening and those presenting symptomatically, either as interval cancers or in unscreened women.

Pathologists are required to participate in the national breast pathology EQA scheme (see section 4.1 and appendix 1) and to be familiar, and practise in accordance, with the NHSBSP and RCPath guidelines on reporting breast specimens both non-operative and surgical specimens.

2.8 Laboratory Quality Assurance

Minor variations in processing and staining methods from laboratory to laboratory do not significantly alter pathological interpretation. All laboratories involved in breast cancer screening must participate in general histology technical schemes and the national immunocytochemistry EQA scheme, if appropriate for the service they provide. Action must be taken if results of such schemes are sub-optimal.

For laboratories providing therapeutic predictive testing of patient samples, such as hormone receptor and human epidermal growth factor receptor 2 (HER2) assays, participation in a recognised EQA scheme is mandatory. Action must be taken if results of such schemes are sub-optimal.

Laboratories should ensure they are carrying out the minimum number of assays per year for oestrogen receptor (ER) (ideally 300 cases) and HER2 (250 cases for immunohistochemistry and 100 cases for in situ hybridisation), if they provide these services, as per RCPath guidance.

Regular and ongoing audit of ER and HER2 positivity rates should also be undertaken by the laboratory, as per RCPath recommendations.

Audit of assay turnaround times is also important, as these are critical to the patient pathway and to facilitate patient management.

Question 3

3. Achieving the pathology quality assurance objectives

Accepted Answer

3.1 External quality assurance - the UK National Breast Pathology Interpretive External Quality Assurance (EQA) scheme

Participation in the UK National Breast Pathology Interpretive EQA scheme is mandatory for consultant pathologists working in the NHS BSP who provide a breast screening pathology service. It forms part of the contractual agreement for this service.

Participation is also recommended for all consultant pathologists who report breast specimens in the symptomatic service.

The scheme provides participants with a diagnostic assessment and personal performance appraisal. It also provides educational cases, with a view to encouraging the development of further expertise.

Evidence of participation in the UK National Breast Interpretive EQA scheme is provided in the form of a Certificate of Participation. Submission of these certificates as proof of participation is required for all pathologists reporting breast screening cases as part of the evidence appended to the pathology questionnaire for any QA visits and provides evidence for consultant’s annual appraisal.

Outline details of the scheme are provided in Section 6 of the guidance, below. Further scheme details, including documentation relating to the management and operation of the scheme can be accessed via the NCCBP website.

3.2 Education and training

Consultants taking on breast screening responsibilities should attend an appropriate breast pathology course within 6 months of appointment (or have attended one in the previous 6 months).

It is essential that pathologists gain an awareness of the roles of the other members of the multidisciplinary team (MDT) and of the problems which other specialities may encounter. This may be provided by attendance at a conference or course with a multidisciplinary component.

Pathologists must keep up to date and participate in the Royal College of Pathologists’ continuing professional development (CPD) scheme. CPD activity should include regular, relevant, breast pathology-associated content (at least 8 hours related to breast pathology per year or 24 points in 3 years). This CPD activity should be reviewed as part of annual appraisal and at any QA visits.

Update and refresher courses are provided by a number of education centres to support ongoing breast pathology education. Where more individual tuition is needed, secondments to training centres can be arranged through the NCCBP.

3.3 Local delivery of breast pathology quality

Laboratories involved in diagnosing screen-detected breast pathology (and also those diagnosing symptomatic disease) should be accredited by the UK Accreditation Service (UKAS) to ISO standards.

All breast pathologists should provide a service that meets the quality standards in the following guidance:

Dataset for histopathological reporting of breast disease in surgical excision specimens of breast cancer (2024)
Guidelines for non-operative diagnostic procedures and reporting in breast cancer screening

All breast screening histological (or cytological) specimens must be reported by a consultant pathologist or a trainee under consultant supervision. The name of the reporting pathologist should be clearly identified within the synoptic report to facilitate data collection for the screening programme.

Pathology turnaround time targets relevant to the local breast service should be audited and met wherever possible, but these must not impact on the quality of pathological processing and reporting. Local targets should help ensure that the faster diagnosis standard is met.

Provisional/preliminary and verbal reports should not be routine practice as stated in NHS BSP guidance on Issuing provisional or verbal pathology reports.

3.4 Multidisciplinary Team Meetings (MDTMs)

Attendance at routine multidisciplinary case management meetings by a pathologist providing a service to the breast screening unit is mandatory.

This need not be the sole responsibility of the lead breast pathologist.

Pre-MDT meeting case review practice is variable and should be adapted to local circumstances. There is no mandatory requirement for pathology slide review prior to MDTMs, but this is regarded as good practice.

The local MDT pathologist is best placed to select cases they feel may benefit from slide review, based on knowledge of the service’s breast screening data (for example, B3 rates), experience of colleagues (for example, new consultants or locum staff) and other local circumstances.

3.5 Local resource implications

The provision of high-quality pathology services depends on appropriate resourcing. This includes adequate staffing levels and funding to meet capital equipment and running costs.

The RCPath has produced Guidelines on staffing and workload for histopathology and cytology departments. Individual pathologist’s workload should be reviewed in line with these at annual job planning and appraisal meetings.

Pathologists should have protected time in their job plan to support CPD, audit and MDT meetings, as set out in the RCPath guidelines.

High-quality histology and cytology services rely on adequate administrative and secretarial support.

Breast screening pathology also makes particular demands on laboratory resources. For example, it may require a large number of blocks, specimen (and specimen slice) radiography and examination of extra levels, for example, to identify microcalcification in vacuum-assisted cores and surgical resection specimens. Adequate laboratory staffing and facilities are therefore required.

High-quality specimen radiography equipment is vital for all laboratories handling breast specimens. Resources should be allocated for its maintenance and timely replacement, and it should be subject to a physics quality control programme.

Access to suitable facilities, including projection of microscopic images (slides or digital), is beneficial for multidisciplinary team meetings.

3.6 Sources of information

Sources of information and educational resources for breast pathologists include:

National discussion of slides circulated in the UK National Breast Pathology Interpretive External Quality Assurance (EQA) scheme provided through virtual meetings from scheme organisers;
Feedback from the NCCBP committee meetings
Review of breast screening incidents relating to pathology via SQAS
National pathology Data Review (audit of non-operative statistics) presented annually

3.7 Research and development

Research is a vital component of pathology in breast cancer screening, which provides opportunities to study the early stages of human breast cancer. All breast pathologists are encouraged to facilitate research in the breast screening programme and to support clinical colleagues. Local and national clinical trials recruitment depends on access to high quality pathological data.

The Research Sub-group of the NCCBP actively identifies areas of research and development and provides publications, updates and national guidance in new and emerging areas.

3.8 Second opinions and transfer of specimens between Hospitals

Seeking second opinions on difficult cases is good practice and a useful educational exercise. This may be in the form of showing difficult cases, such as examples of atypical epithelial proliferations, to colleagues within the department as part of routine reporting practice, or as sending rare or more challenging cases for external expert second opinion. When cases have been shown to colleagues for second opinion this needs to be documented within the pathology LIMS system.

Each Department should have standard operating procedures (SOPs) for specimen transfer when sending cases away for second opinion or for other reasons such as external testing or clinical trials but UK breast screening guidance for transport can also be found in the document “Guidance for transfer of breast specimens between laboratories” and the RCPath guidance “Guidance on inter-departmental dispatch of cellular pathology material for referral and clinical trials.”.

Question 4

4. Roles and responsibilities

Accepted Answer

Biomedical scientists should not independently report specimens from the NHS BSP. These guidelines are applicable to pathologists providing a breast screening pathology service and to those working in outsourced and/or private (third party) providers providing pathology reporting services to the NHS Breast Screening Programme. To optimise consistency, the NCCBP recommend that these standards are also adopted by pathologists in the specialist breast symptomatic service.

4.1 Breast screening pathologist

The recommended minimum standards for all pathologists providing a service to the NHSBSP are that the pathologist:

Must fulfil the requirements of participation in the UK National Breast Pathology Interpretive EQA scheme;
Must report a minimum of 50 primary breast cancer resection specimens each year*;
Must have protected time in their job plan to support CPD, audit and MDT team meetings, as set out in the RCPath guidelines
Should attend an appropriate breast pathology course or conference within 6 months of appointment (or have attended one in the previous 6 months);
Must participate in relevant CPD for each round (the recommendation is at least 8 hours related to breast pathology per annum);
Should participate in relevant and regular departmental audit;
Should be a member of a specialist breast service MDT and participate regularly in clinical multidisciplinary team meetings;
Must participate in NHSBSP QA visits and reviews.

*Such a workload will involve handling additional specimens, including non-cancer and cancer-related non-operative and diagnostic specimens and those relating to follow-up and subsequent treatment episodes. If they report limited numbers of non-operative specimens per year, they should consider whether they are receiving sufficient exposure to maintain expertise and to report breast screening non-operative pathology samples. The RCPath has produced Guidelines on staffing and workload for histopathology and cytology departments. Individual pathologist’s workload should be reviewed in line with these at annual job planning and appraisal meetings.

4.2 Locum Consultants/Specialty Doctors/Post-FRCPath (Fellowship of Royal College of Pathologists) Specialty Registrars (StRs)

Pathologists who are not on the specialist register may only independently report breast screening cases with the agreement of the local Trust management, Head of Department and Director of Breast Screening and must meet the following criteria:

They must comply with all requirements of a breast screening pathologist (see above)
Independent reporting can only commence following a period of adequate supervision (see below).
The period of supervision must include “double reporting” with rigorous documentation of the results. This must then lead to a sign-off by the Lead breast pathologist and the Head of Department prior to independent reporting.
Supervision must also include MDT meetings with similar sign-off from Lead breast pathologist and Head of Deparment
The sign-off (both reporting and MDTs) would usually include review of results and reflective notes.
Regular review of performance should be done until such time that the doctor is on the Specialist Register

4.3 Lead breast pathologist

Each laboratory is required to have a nominated lead pathologist with responsibility for breast screening pathology.

The lead breast pathologist requires adequate time in their job plan to perform this role.
The lead role is not considered a shared responsibility and would usually be held by a single individual.
A nominated individual should be chosen to deputise during periods when the lead is on leave.

The roles and responsibilities of the lead pathologist are to:

comply with all other requirement of a breast screening pathologist (see Section 4.1)
Ensure multidisciplinary case discussion meetings are attended by at least one pathologist of consultant level
Review breast pathology data for the service
Act as nominated point of contact for SQAS
Provide evidence for QA visits and reviews
Advise the director of breast screening regarding pathology related issues.

4.4 Screening Professional Clinical Advisors

Screening Professional Clinical Advisors (SPCAs) are appointed nationally by NHS England (NHSE). Their roles and responsibilities are to:

be involved with developing and/or implementing screening policy or guidance
comment on guidance or standards and in relation to the delivery plan for the NHS BSP
provide ad-hoc advice on issues and incidents notified locally to SQAS by screening providers or nationally by the breast SQAS team
participate in QA visits and review activity

4.5 National Co-ordinating Committee for Breast Pathology (NCCBP)

The NCCBP is responsible for coordinating QA procedures and guidance, in particular reviewing and recommending standards. It also provides guidelines and advice on pathological examination of breast tissues to achieve a high level of accuracy and consistency in reporting breast lesions.

The group comprises:

the Screening Professional Clinical Advisors (SPCAs) to the Breast Screening Programme in England
representatives of NHSE
the RCPath Specialty Advisor in Breast Pathology
president of the Association of Breast Pathology (ABP)
co-opted pathologists with specialist expertise in breast pathology including representatives from Scotland, Wales, Northern Ireland and the Republic of Ireland
representatives of equivalent surgical and radiological clinical professional groups
members of the EQA scheme secretariat and management are in attendance
Information on the Terms of Reference of the committee and current membership and contact details can be found on the NCCBP website.

The functions of the group are to:

advise NHSE, RCPath and other medical organisations on breast pathology related issues
advise NHSE on aspects of programme pathway delivery and support the programme by providing professional advice as required, for example in the support of incident management
monitor and have oversight of the performance of pathology services in the breast screening programme, including the Annual National Pathology Data Review
provide support and information for SPCAs and thus to breast pathologists nationally
identify educational needs of pathologists and organises training, including national courses
monitor the adequacy of data provided by pathologists
promote the timely uptake of quality issues and standards;
continually review the pathology information system for the breast screening programme;
acts as the Steering Committee for the UK National Breast Pathology Interpretive External Quality Assurance (EQA) scheme
establish and maintain close working relationships with other breast pathology associations, to ensure standardisation of advice and to avoid duplication of effort and responsibilities;
support the exchange of information and quality issues with other professional groups
support the exchange of information and pathological material between pathologists and the wider research community.

Question 5

5. Quality assurance visits and reviews

Accepted Answer

The QA process for the breast screening programme is now operated and managed through a national model within NHSE. This includes determining which services will be prioritised to have a QA visit or review. These interventions will still be supported by the SPCAs for the various disciplines as required, including pathology where applicable.

Visit schedules will be decided by assessment against an agreed set of criteria each year to align SQAS resource according to services’ needs see BSP SOM for more details Breast screening: programme specific operating model - GOV.UK.

Services will be informed of scheduled visits or reviews to give adequate preparation time. The QA visit is primarily a means of providing support and facilitating improvement rather than an inquisitorial process. Only if a significant issue is identified will immediate action be recommended. Their outcomes are currently reported to the host Trust and the screening commissioners. Appropriate guidance regarding remedial actions and required changes and actions are advised when facilities, resources, protocols or performance is assessed as sub-optimal.

5.1 Objectives of the QA visit

The QA visit is to:

assess whether the pathology service provided to the local breast screening is performing in accordance with national guidelines and standards.
identify areas of underperformance and to make recommendations as to where improvements should be made.
determine or resolve multidisciplinary working issues.

5.2 Process of the QA visit

The visiting pathology SPCA meets with the local pathologist(s) and determines if the performance, organization and resourcing of the service meets national pathology guidelines and standards and quality standards in breast pathology. This is done through:

review of a completed detailed QA questionnaire
discussion
observation
examination of data, slides and reports

The QA visit aims to support the local service to achieve improvements in performance through identification of any areas of deficiency. Should problems be identified, the QA team will suggest mechanisms to support the local pathologists and the screening service to achieve the necessary standards.

5.3 Data Required for QA visit

The following data/information is required and provided to the visiting Pathology SPCA by the SQAS before the QA visit. The data/information includes:

pathology questionnaire(s), completed by the relevant lead breast pathologist(s), in conjunction with colleagues reporting breast pathology specimens, with relevant supplementary documents for all units providing a service to the screening service (see below) (for example, all pathologists’ breast EQA certificates, relevant National External Quality Assessment Service (NEQAS) data, Departmental SOPs and details of attendance at appropriate breast pathology meetings and MDT attendance
needle core biopsy (BQA) from the KC62 cohort return for the previous three years - this information should be provided for the Unit as a whole and also for individual pathologists
a breakdown of the histological characteristics of benign and malignant lesions (HQA data) for the previous three years
service data from the annual national pathology data review process
details of outstanding pathology recommendations from the previous QA intervention (visit or review)
any requested policies, patient information and audits where relevant
completed live MDT review proforma

5.4 Peer review of slides and reports

From Breast screening: programme specific operating model - GOV.UK

The purpose of the review is to:

understand and review internal processes
ascertain if sampling/levels meet national guidelines
review the quality of documentation/completion of RCPath/NHSBSP minimum datasets
observe if there is effective use of the MDT process
create a forum to have a full discussion of cases/representative issues
highlight specific areas of good practice

The review does not intend to ‘check’ the accuracy of the diagnosis. If concerns are identified a separate process common to all screening programmes and disciplines should be followed.

The slides (glass slides or digital format, as appropriate and technically feasible) from at least 5 cases should be reviewed for each reporting pathologist and include a selection of:

pre-operative specimens
surgical cases
open diagnostic biopsies
all true false positive cases and those cases where the core biopsy has removed the invasive malignancy and/or all of a DCIS lesion

However, the total number of slides and nature of the cases reviewed will depend on the number of histopathologists within a Unit that are reporting breast screening specimens and data review, and is at the discretion of the pathology SPCA. For all cases selected, the department being visited should provide all sections and matched histology reports.

The pathology SPCA will also undertake a review of 10 anonymised reports per pathologist, including:

5 core/vacuum-assisted biopsies
5 surgical excision specimens (including examples of carcinomas)

5.5 MDT review

An SPCA (which may be a pathologist, radiologist or surgeon) will observe a live breast MDT (where required) to enable comment on the adequacy of facilities, clarity of inter-professional communication, arrangements for pathology case review and approaches to discrepancies in diagnosis.

5.6 QA report

The report follows the NHS BSP template and will include comment on aspects of:

Organization & leadership
Workload, staffing and laboratory accreditation
Communication
Laboratory processes
Pathology reporting and data collection
Training and CPD
Quality assurance and audit
Slide and report review
MDT Meetings

Recommendations will include anticipated timescales with evidence required, and be categorized with the following priorities:

Immediate
Urgent
High
Standard

Recommendations to meet a defined standard and to achieve a quality service will be included in a performance managed Action Plan.

5.7 QA process for breast pathology services for varying laboratory configurations

Whilst a single QA visit process has been developed for England which includes standardised pre-visit activities, questionnaires and rationales for evidence requested, it is clear that there is increasing variability in configuration of delivery of pathology services for the breast screening programme.

Some screening units are served by more than one laboratory, whilst other cellular pathology departments may provide a service to more than one screening unit. Frequently, even if non-operative specimens are reported in a ‘main’ laboratory serving the screening unit, subsequent surgical samples may be processed and reported in another.

The following information outlines how the standardized QA visit process applies to these settings. This ensures QA is maintained without excess duplication of activity for the SQAS, SPCAs and the laboratories involved.

Models of delivery of service include:

(1) One screening unit and one pathology laboratory (on same or another site)

(2) One screening unit and one ‘main’ histology laboratory, but some specimens (often surgical samples) are received in other pathology laboratories

(3) One screening unit and multiple pathology laboratories

(4) Several screening units served by one pathology laboratory

(5) Complex situations may arise, for example, one screening unit submits specimens to multiple laboratories, but these also receive samples from other screening units.

As a principle, when a QA visit is being undertaken for any one screening centre, all pathology laboratories providing the service to that unit should be included in the QA review, whether that is one single (‘main’) cellular pathology department, or multiple histology departments.

5.8 QA visit to a screening unit serviced by more than one pathology laboratory

Of note, significant differences between results (e.g. audit data) from laboratories serving one screening unit are likely to be related to that cellular pathology department, and not radiological aspects of the programme. It is therefore important that all laboratories are included in the QA process to maintain consistency of a high quality service (technical and medical) and ensure standardisation of application of both diagnostic criteria and terminology.

When multiple laboratories serve one screening unit, attention should also be paid to adequacy and timeliness of transport and fixation of specimens.

For pathology QA visits in this setting (i.e. as per models 1, 2, 3 and 5):

A pathology questionnaire should be completed for all laboratories.
Slide and pathology report review should be undertaken for all laboratories, ensuring samples from all reporting pathologists from each centre are included.
Audit data by pathologist should be reviewed; great care should be taken in evaluation of data from those reporting only small numbers of cases, whilst conversely noting the guidelines set for numbers of resections (50 cases per annum) for specialist breast pathologists.
All reporting pathologists should have undertaken adequate CPD and provide evidence of participation in the breast EQA scheme and regional pathology meetings, as detailed in the visit questionnaire.
At a minimum, the Lead Breast Pathologist for each laboratory should be interviewed as part of the QA visit process.
Multiple breast MDTMs will be in place; the format of these will vary according to local protocol, which may be complicated. It may not be feasible for the pathology SPCA to be present at an MDTM for every combination of screening unit/laboratory service, but one of the visiting QA team should assess staff interactions as well as adequacy of facilities, which may include video-links.

5.9 QA visit to a screening unit serviced by one pathology laboratory, which has been visited by the QA team within the previous year

Given the increasing complexity of breast screening pathology provision, a pragmatic approach to QA visits is sensible. For example, if one laboratory provides a service to more than one screening unit (e.g. models 4 and 5, above) it is possible that the pathology department has been visited by the Breast QA team within the previous cycle.

In this setting (if QA visit to that laboratory has been undertaken within the previous year), in order not to duplicate assessment and cause unnecessary work for the laboratory being visited and for the SPCA, particularly if no significant issues were recorded, pathology QA should include:

Review of the previous QA visit pathology questionnaire with confirmation of ongoing EQA and CPD by the reporting pathologists and confirmation of an absence of change in facilities, staffing and management. This is considered adequate if completed and satisfactory (without any outstanding issues) within the previous year. Re-review, for example of laboratory protocols (SOPs) and technical audit results etc are not required.
Adequacy of pathology sampling and reporting, e.g. as per minimum datasets will have been evaluated previously. However, as the laboratory is also receiving specimens from the Screening Unit now under review, there may be issues of specimen transport and fixation and case review of representative cases is good practice. In this setting concentration on such specimens as may be most severely affected by delayed transport and fixation (such as mastectomies) should be considered.
Audit data for the screening unit under review should be assessed. It may prove useful to compare this with data for the previously reviewed screening unit, as well as national data, if issues are identified.
The visiting pathology SPCA should meet with, ideally all, the pathologists reporting breast specimens to determine if there are any issues relating to the screening unit presently under review, for example regarding specimen fixation and transport, attendance and logistics of MDTMs (including videoconferencing, if used) and personnel.

Question 6

6. Overview of the UK National Breast Pathology Interpretive External Quality Assurance (EQA) scheme (BQAS)

Accepted Answer

The National Breast Pathology EQA scheme was initiated in 1990, primarily to investigate the level of consistency that pathologists involved in the breast screening programme could achieve in reporting breast lesions. The scheme used data gathered to devise improvement initiatives. The success of these could be evaluated in further rounds of the scheme. Subsequently the scheme was opened to non-screening pathologists and adapted to be used for individual assessment and collective performance review.

The Scheme is hosted by Nottingham University Hospitals NHS Trust and overseen by the NCCBP.

The scheme circulates 2 assessments per year, each consisting of 14 cases including 13 mandatory cases and 1 educational case.

To participate, individuals are required to register with the scheme. Upon registration a user name and password are issued to enable access to the tools and materials available.

The scheme provides guidance for participants about the computer hardware, browser and network specifications required to optimise participation in the breast EQA scheme. Scheme guidance on IT technical requirements is published on the Website or can be obtained via direct enquiry using the contact details provided.

Additional information on the scheme is contained in the scheme management documentation and in the participants’ manual which is available either on request or on the EQA Scheme website http://www.nccbp.com

All UK National Breast Pathology Interpretive EQA scheme enquiries should be directed to:

Email: contact@nccbp.com

Patricia Islip – Scheme Lead Administrator

0115 9691169 ext. 55419

Email: pislip@nhs.net

BQAS - National Breast Pathology Interpretive EQA Scheme

Nottingham University Hospitals NHS Trust

Department of Cellular Pathology

City Hospital Campus

Hucknall Road

Nottingham

NG5 1PB

Cookies on GOV.UK

Applies to England

Revisions to previous guidance