Guidance

Cervical screening: technical external quality assessment (EQA) scheme

Updated 20 May 2024

This guidance outlines the external quality assessment (EQA) scheme for the preparation and staining of cervical cytology samples. It provides information and guidance on:

• the overall design of the scheme
• interpretation of results
• requirements and responsibilities
• principles and methodology of operation for consistent delivery

Participation is mandatory for the cervical screening laboratories in England who are providing HPV testing and cytology services to the NHS Cervical Screening Programme (NHS CSP).

NHS cervical screening laboratories in England, Wales, Scotland and Northern Ireland take part in the scheme. Laboratories outside the United Kingdom can join subject to meeting the scheme’s terms and conditions. See Chapter 7 of this guidance for more information.

The scheme aims to provide an acceptable degree of reliability and consistency by educating, advising and supporting all participants.

Chapter 1.2 of the gynaecological cytopathology EQA scheme protocol has a description of the aims of both schemes.

1. EQA scheme

There are 4 assessments a year running from 1 April to 31 March. This is consistent with other cellular pathology technical EQA schemes. A quarterly interval allows a laboratory time to modify their processing and staining protocols between assessments.

The slide assessments must take into account the laboratory staining methods and quality of routine preparation.

Since EQA does not fully replicate the routine laboratory situation, a laboratory should not interpret their results or use them in isolation as a means of assessing its competency in preparation and staining.

Please note that:

• the scheme protocol is on GOV.UK
• versions of the files which have been downloaded, printed or electronically transmitted are not controlled documents
• page numbering is not applicable to HTML documents

2. EQA scheme enquiries

For any scheme-related enquiries, please contact the Screening Quality Assurance Service (SQAS) (Midlands and East) at PHE.csp-teqa-admin@nhs.net

Support is available during normal office hours (9am to 5pm).

3. Quality assurance (QA) in pathology

The Quality Assurance in Pathology Committee (QAPC) is a multidisciplinary group accountable to the Royal College of Pathologists for:

• oversight of performance in EQA schemes
• monitoring the EQA performance of clinical laboratories in the UK

The QAPC has discipline specific panels that report to it. It works with failing laboratories and reports persistent substandard performance to the Care Quality Commission (CQC).

3.1 National QA advisory panel (NQAAP) in cellular pathology

The cellular pathology NQAAP oversees:

• the running of EQA schemes in histopathology and cytopathology
• the annual activities of each scheme registered with the college, including the investigation of persistent substandard performance by individual pathologists or laboratories

The panel promotes EQA to make sure the work of cellular pathology laboratories across the country and their contribution to clinical services is of a uniformly high standard.

4. Scheme roles and responsibilities

4.1 EQA facilitator

An EQA facilitator and administrative team are responsible for the day-to-day running of both NHS CSP EQA schemes. Refer to section 2.1 of the gynaecological cytopathology EQA scheme protocol for an outline of their responsibilities.

4.2 Scheme organiser and deputy scheme organiser

NHS England subcontracts the scheme organiser role.

The scheme organiser and the deputy scheme organiser must be one of the following:

• a consultant cytopathologist
• a consultant histopathologist with an interest in cervical cytopathology
• a consultant biomedical scientist with the advanced specialist diploma in cervical cytology
• a biomedical scientist in cervical cytology working in a senior position and regulated through their professional registration body

Refer to the gynaecological cytopathology EQA scheme protocol for further information (Chapter 2, section 2.2).

4.3 National EQA team

The national cervical QA lead has national responsibility for EQA as part of their role for cervical screening including day-to-day support and advice to the EQA operations team.

Refer to the gynaecological cytopathology EQA scheme protocol for further information (Chapter 2, section 2.3).

5. Governance

Governance arrangements are the same for both NHS CSP EQA schemes and managed by the:

• EQA operational group
• EQA steering group
• EQA management board

Further information is in the gynaecological cytopathology EQA scheme protocol (Chapter 3, sections 3.1 to 3.4).

6. Conditions of entry for laboratories

There is an agreement between NHS England and the NHS cervical screening laboratories providing HPV testing and cytology services about taking part in EQA.

The agreement also applies to private laboratories and those from outside the UK. The agreement describes the general terms and conditions for all parties and is subject to periodic review.

6.1 Terms and conditions

Laboratories must take part in relevant accredited EQA schemes to maintain their United Kingdom Accreditation Service (UKAS) accreditation against ISO 15189. The national EQA team is working towards achieving UKAS accreditation for the technical EQA scheme to the international standard ISO/IEC 17043.

The laboratory head of department (lead clinician) must identify at least 2 members of staff (from this point called ‘laboratory leads’) to be the point of contact with the EQA facilitator on scheme-related matters.

The scheme conducts assessments using ThinPrep^TM liquid based cytology (LBC) pooled samples only. The EQA facilitator can provide information relating to historic SurePath^TM assessments on request.

Laboratory leads are responsible for notifying the national EQA team of any changes in service provision that may affect scheme arrangements.

Laboratory leads must contact the EQA facilitator in the first instance if they are unsure about any scheme operational matter.

The national EQA team manages the administration of all data entry and result reports.

The scheme retains all scheme documents, electronic and paper, in accordance with the retention and storage of pathological records and specimens, fifth edition April 2015 .

6.2 Labelling, packaging, and transport of EQA assessment materials

The EQA facilitator gives laboratories detailed instructions to make sure assessment materials are:

• prepared correctly
• safely packaged
• labelled in line with Royal Mail requirements

Laboratories must send vials and slides by Royal Mail Special Delivery. This method tracks packages during transit and upon receipt.

Laboratories must contact the EQA facilitator should they need to use an alternative method of transport.

6.3 Sanctions for non-compliance

Laboratories that do not comply with the EQA agreement may be subject to the scheme’s escalation policy. Removal from the scheme presents a risk to a laboratory maintaining its ISO 15189 accreditation.

7. Eligibility requirements

7.1 Private laboratories under contract to the NHS

Private laboratories that provide HPV testing and cytology services for the NHS must comply fully with the scheme’s conditions and arrangements.

7.2 Private cervical screening laboratories in the UK

Private cervical screening laboratories that provide HPV testing and cytology services may wish to join the scheme even if they are not under contract to the NHS. The scheme reports persistent substandard performance to the relevant regulatory body.

7.3 Cervical screening laboratories outside the UK

The scheme is open to laboratories from outside the UK subject to them meeting the scheme’s terms and conditions, and the scheme’s operational capability and resources.

Non-UK laboratories must declare the pathway for professional accountability within their employing organisation and regulatory body under the terms and conditions of the EQA agreement. The scheme reports persistent substandard performance to the relevant regulatory body.

Non-UK cervical screening laboratories are eligible to participate in slide assessments and will receive advice from the EQA facilitator.

8. Laboratory responsibilities

8.1 Late participation

Cervical screening laboratories must schedule technical EQA into their operational plans.

Laboratories need to make sure they submit slides on time, otherwise:

• they will not be included in the assessment
• the EQA facilitator will record an episode of non-participation and the laboratory may be subject to the conditions of substandard performance

Repeated failure to provide slides on time may lead to a result of substandard performance.

8.2 Non-participation

Laboratories need to be aware of the consequences of non-participation in EQA.

Failure to participate in 2 consecutive assessment cycles without legitimate reasons will lead to a result of substandard performance.

In such circumstances, the EQA facilitator will notify the scheme organiser. The scheme organiser will manage the situation as substandard performance.

A laboratory closure or whole laboratory system conversion are legitimate reasons for non-participation.

8.3 Confidentiality

The EQA facilitator must communicate information disclosure liabilities, responsibilities and procedures to all EQA staff. This includes staff employed directly by, and under contract to, NHS England.

All participant data is confidential. The EQA facilitator must store all electronic data in password-protected files in areas accessible only to authorised EQA scheme staff. They must also store paper-based data in a secure, locked cabinet and make sure only authorised EQA staff have access to it.

The scheme will not disclose the identity of any laboratory to third parties, except under circumstances set out in the terms and conditions.

8.4 Confidentiality when performance triggers action points

The scheme is confidential under the conditions of participation in EQA schemes determined by the professional bodies through the QAPC.

The scheme employs special arrangements when laboratory performance triggers local and national action points.

The scheme will break anonymity when:

• substandard performance requires the involvement of the scheme organiser and, or a QA biomedical scientist
• a complaint or an appeal requires the involvement of the scheme organiser and, or a QA biomedical scientist

The EQA facilitator provides laboratory details and corresponding codes:

• when a laboratory lead has requested a reminder
• when circumstances dictate that the cellular pathology NQAAP chair is notified of a laboratory that has reached the second action point (they may not choose to waive confidentiality in these circumstances)

Laboratory managers must have systems in place to monitor and review ongoing staff participation and performance in EQA, and to monitor trends in results. Laboratories must record this within their management review process.

It is extremely unlikely that any government regulatory authorities will make a direct request to the scheme for participants’ results.

If the scheme receives a third-party request from a regulatory authority requiring technical EQA results, then the national EQA team will investigate and verify the source and validity of the request. They will comply with a valid and verified request and notify the affected participants of this action in writing within 5 working days.

8.5 Professional code of conduct

The EQA management board will lead investigations into behaviour reported to them (suspected or witnessed) that could undermine the value and integrity of the scheme. Investigations will follow the procedure for reporting and investigating alleged collusion as set out in the gynaecological cytopathology EQA scheme protocol (Chapter 13).

Underperforming laboratories or assessors should take up the offer of support available to scheme members.

8.6 Finance

The EQA scheme is free to NHS laboratories in England providing a cervical screening service to the NHS CSP. There is a charge for NHS laboratories outside England and private laboratories not contracted to the NHS.

The scheme funding arrangements are set out in the EQA agreement.

8.7 Sub-contracted services

The success and integrity of the scheme is dependent on:

• cervical screening laboratories providing EQA material
• staff performing the slide assessments

NHS cervical screening laboratories (or those under contract and accredited to ISO 15189) must make sure that qualified and competent staff provide the pooled samples and perform the slide assessments.

8.8 Supplier of pooled samples

The scheme appoints a single laboratory to prepare pooled samples for use in the scheme (from this point called a ‘preparation laboratory’).

The preparation laboratory must provide one pooled sample 4 times a year for each participant laboratory as determined by the EQA facilitator.

The preparation laboratory must follow the procedure for preparing pooled samples, as set out below.

1. Note and retain the required number of in-date samples (including spares in the event of breakage) in accordance with instructions from the EQA facilitator.
2. Use only samples where the prepared slide was well-stained, clean, mature, good quality and reported as negative.
3. Make sure samples selected have a good endocervical component, so that assessors can evaluate the squamous and glandular elements.
4. Retain (if the intention is to recycle) the original vials or obtain the required number of vials for step 7.
5. Use personal protective equipment and observe health and safety precautions.
6. Mix samples together in a clean measuring cylinder or container, which is at least the number of samples required x 20ml in volume.
7. Top up volume to at least the number of samples required x 20ml with PreservCyt^TM and mix gently.
8. Decant 20ml of sample mix into each retained vial.
9. Label each vial appropriately with information provided by the EQA facilitator.
10. Package and send samples quarterly by the due date to laboratories in accordance with instructions from the EQA facilitator.

Suppliers of pooled samples are subject to routine audit by the scheme’s operational staff.

8.9 Technical EQA assessors

Technical EQA assessors must have at least 5 years post qualification experience in screening cervical cytology samples.

Laboratories must make sure assessors can commit to at least 2 assessments per year for a minimum of 2 years (ideally longer). This is to make sure they maintain their competence in the role and to promote continuity and consistency of assessment.

The scheme provides training for technical EQA assessors. The EQA facilitator is responsible for maintaining a pool of trained staff to carry out assessments and provide cover.

8.10 Assessor trainers

The scheme is responsible for providing the initial assessor training and subsequent refresher courses. Assessor trainers must be qualified staff with at least 5 years post qualification experience in reporting cervical cytology samples and experience carrying out assessments.

The training reinforces assessor consistency in applying the assessment criteria, thereby sustaining stakeholder confidence in the scheme.

9. Preparation for EQA

9.1 Operational planning

The EQA facilitator is responsible for detailed operational planning directly and through their support team.

This includes:

• the EQA schedule
• the number of laboratories and staining machines
• a coding system for individual assessors to make sure performance evaluation can be carried out confidentially

The EQA facilitator must contact the preparation laboratory before the start of every financial year to confirm the annual timetable for production and delivery of the pooled samples. They must provide the laboratory lead with detailed information before each assessment cycle.

Laboratory leads must:

• notify the EQA facilitator of the quantity, location, model and serial numbers of all processing and, or staining machines in routine use, and consumables and, or supplier(s)
• notify the EQA facilitator of any changes to equipment, its use and consumables and, or supplier(s) before the start of each assessment cycle
• notify the preparation laboratory when they receive their EQA samples
• make sure slides are prepared on the processor and, or staining machine as determined by the EQA facilitator
• make sure the laboratory labels and dispatches the slides in accordance with instructions provided by the EQA facilitator
• take immediate action if any processor and, or staining machine’s performance is substandard
• deal with any on-going performance issues in accordance with the national protocol
• support staff to attend the annual feedback meeting

Each laboratory must prepare one slide per circulation that is representative of routine throughput. Where a laboratory uses more than one machine as back up, then they should alternate between them.

Laboratories must verify the technical suitability of the slides and make sure they are safe for transportation prior to submission.

10. Production of EQA material

10.1 Stain and dispatch slides

The EQA facilitator will ask the laboratory leads to confirm that their contact details, type, location and number of machines are up-to-date. They will also need to confirm:

• annual assessment dates
• the timetable for the expected receipt of pooled samples
• dates by which they should stain and dispatch their slides

10.2 Control slides for audit

Each assessment includes 3 control slides from the previous EQA round for which the classification was unanimously agreed upon (by all 4 assessors). The scheme uses these slides to support assessor performance management.

10.3 Labelling system for test slides

The EQA facilitator must use a labelling system for assessment materials. To preserve laboratory anonymity, the EQA facilitator will randomly generate an identifier for each and apply it to the slide immediately before an assessment. This will allow them to identify test slides by year, round, laboratory, and specific machine.

10.4 Supporting information

At the start of each round, the EQA facilitator must obtain the following information from laboratories:

• quantity, location, model, serial number of each processor and staining machine(s) in routine use
• coverslip supplier
• slide supplier
• vial supplier (laboratories providing pooled samples only)
• staining schedule
• stain brands
• reagents
• mountant

This information forms part of the assessment and review of assessment results and helps the EQA facilitator to provide feedback to laboratories at the end of the cycle.

10.5 Detection of potentially abnormal material

There may be occasions when an individual detects abnormal cells in a slide prepared by the laboratory before its submission, or in a submitted slide during the assessment. The preparation laboratory uses slides they have reported and cleared for disposal prior to pooling. The scheme will not take action in these circumstances.

10.6 Damaged or broken vials

Laboratories must inform the EQA facilitator immediately if they receive a damaged or broken vial unsuitable for processing. The EQA facilitator will arrange for the preparation laboratory to send a replacement.

10.7 Damaged or broken slides

The EQA facilitator must contact the submitting laboratory to request a replacement slide if they receive one that is broken or damaged and unsuitable for assessment.

10.8 Packaging and transport

All individuals responsible for handling EQA materials must package them appropriately and use Royal Mail special delivery for transporting them. Packaging for vials must be UN3373 compliant.

11. Organising the assessments

The EQA facilitator is responsible for organising the schedule of assessments and notifying the assessors of dates, times, and venues. Assessments can be conducted virtually or face-to-face. Four trained individuals are required for each assessment panel. The EQA facilitator will identify an individual to drive the assessment. A trainee may also attend and participate in the assessment although their scores will not count towards the result.

Assessors should take turns to lead and direct assessments in line with the published protocol and scoring criteria. The EQA facilitator must have contingency plans in terms of the numbers of trained assessors present and back up for unexpected absence on the day.

The EQA Facilitator, or their nominated representative, will attend each assessment to provide logistical support.

Although an assessment is not a screening exercise, the scheme will take care to adopt the principles of time spent on microscopy work as described in national guidance for NHS cervical screening laboratories. The number of slides examined by each panel should not exceed 35 per session.

11.1 Assessment venues

Technical EQA assessments can take place on physical premises or via a virtual platform. There must be access to high quality microscopes, multi-headed discussion microscopes or networked microscope camera display, and photomicrography facilities. There must be internet access and computers or laptops available at physical premises.

12. Preparing for the assessment

The EQA facilitator compiles the slide sets and seeds each assessment with 3 control slides.

The EQA facilitator must label slides so that assessors are unable to distinguish the control slides from the submitted slides. The placement of the control slides must be different in each successive assessment. The assessors must assess the control slides the same way as submitted slides.

The EQA facilitator is responsible for making sure the slides and accompanying documentation are available for assessment sessions.

13. The scoring system

The scoring system is restricted to nuclear staining and cytoplasmic staining.

This scheme uses raw scores but restricts the adequate and good categories to slides that score above a set minimum on both nuclear and cytoplasmic assessment. By setting different minimum scores for nuclear and cytoplasmic assessment, the scheme produces a controlled automatic weighting of the final score. The scheme also accounts for the balance of nuclear and cytoplasmic scores, rejecting slides that score well on one but poorly on the other.

13.1 Scoring for each characteristic

Each slide is rated on 6 characteristics, 3 each for nuclear and cytoplasmic staining. For each characteristic, a score in the range 1 to 5 may be given. Points are deducted to a maximum of 5 for detrimental features, rather than being built up from the minimum of 1 for positive features. This is comparable to other EQA schemes.

A slide may score in the range 3 to 15 on nuclear staining (N) and 3 to 15 on cytoplasmic staining (C), giving a range of total score from 6 to 30.

13.2 Overall slide ratings

Slides will be rated as falling in to one of 4 categories:

• good
• acceptable
• marginal
• unacceptable

A score of 3 on any individual criterion cannot be interpreted as meaning that the slide is ‘average’ on that criterion. A slide that scores straight 3s and has a total score of 18 is not an average score nor is it an acceptable slide. Awarding marks across a range of 1 to 5 against 4 categories means that a score of 3 cannot be average.

Good

To be rated good, a slide must:

• score at least 25 overall, and
• score at least 12 on nuclear staining, and
• score at least 11 on cytoplasmic staining

Note that slides scoring 25 or more will not be classed as good in cases where the imbalance between the nuclear and cytoplasmic components is too great.

Slides with the following component scores will be reduced to acceptable on account of imbalance:

• N15 and C10
• N11 and C14
• N11 and C15
• N10 and C15

Acceptable

Acceptable rated slides must:

• score at least 20 overall, and
• score at least 10 on nuclear staining, and
• score at least 9 on cytoplasmic staining

The scheme will not class slides scoring 20 to 24 as acceptable where the imbalance between the nuclear and cytoplasmic components is too great.

Slides with the following component scores will be reduced to marginal or unacceptable on account of imbalance:

• N9 and C11 or more (marginal)
• N8 or less and C12 or more (unacceptable)
• N12 or more and C8 or less (unacceptable)

Marginal

Marginal rated slides must:

• score at least 18 overall, and
• score at least 9 on nuclear staining
• at least 9 on cytoplasmic staining

Unacceptable

Actions for slides rated as unacceptable are described in section 17.1.

14. Scoring criteria

14.1 Nuclear stain

Differentiation of the haematoxylin

Adequate differentiation is characterised by clear delineation of nuclear components, and lack of residual haematoxylin stain in the cytoplasm of cells.

The score allocated to this criterion indicates the intensity of nuclear staining. The scheme recognises that this depends upon the degree of differentiation, the time in haematoxylin solution, the type of haematoxylin and, or any combination of these factors.

A low score may result from either very dark staining affecting cytoplasmic colour or very pale nuclear staining.

14.2 Clarity of chromatin pattern

Chromatin should appear crisp and distinct. The scheme recognises that a maximum score may only be achievable in a cervical cytology sample with optimal fixation.

14.3 Haematoxylin colour

Haematoxylin colour should be blue to black.

14.4 Cytoplasmic stain

Colour spectrum

The scheme defines colour spectrum as an appropriate range of cytoplasmic colour. The expected colour range will depend on the staining method used.

14.5 Intensity of cyanophilia

This relates directly to the depth of blue or green colour present.

14.6 Intensity of eosino and orangeophilia

This relates directly to the depth of pink or orange colour present. Eosinophilia and orangeophilia are combined because some staining methods may not include an orange component, and orangeophilic cellular material may not always be present in test material. Intensity may vary between preparations

14.7 General (non-scoring) aspects of the slide assessment

There are several factors that can affect the interpretation of the slide. These include:

• preparation: cellularity, holes, patchiness, cell drift
• fixation: cellular distortion
• presentation: marked folding or lifting of the cells, air bubbles, scratches on the coverslip, clarity of mountant

Substandard fixation can result in cellular distortion leading to an unusual staining pattern. The cytoplasm of such cells can take up excessive eosin and the nuclear staining with haematoxylin will be less than optimal.

The elements associated with the presentation of material include uneven staining, incomplete dehydration, and adequacy of mounting such as air bubbles.

The scheme notes all these factors, although they do not influence the overall slide scores.

14.8 Scores for the assessment of nuclear and cytoplasmic staining

Assessors must refer to the scores below when undertaking slide assessments.

Nuclear staining

A – Differentiation

A1: Optimal intensity of nuclear staining in virtually all nuclei

Zero marks deducted

Final score: 5

A2: Optimal intensity of nuclear staining in the majority of nuclei with acceptable staining in the remainder of nuclei

Deduct 1 mark

Final score: 4

A3: Acceptable intensity of nuclear staining without adversely affecting cytoplasmic stains

Deduct 2 marks

Final score: 3

A4: Haematoxylin present but under-represented

Deduct 3 marks

Final score: 2

A5: Nuclei over-stained and affecting cytoplasm

Deduct 3 marks

Final score: 2

A6: Little or no haematoxylin present

Deduct 4 marks

Final score: 1

A7: All nuclei heavily over-stained, with haematoxylin in cytoplasm throughout

Deduct 4 marks

Final score: 1

B – Haematoxylin colour

B1: Blue/Black colour in virtually all nuclei

Zero marks deducted

Final score: 5

B2: Blue/Black colour in the majority of nuclei

Deduct 1 mark

Final score: 4

B3: Purple/Blue colour in the majority of nuclei

Deduct 2 marks

Final score: 3

B4: Pink/Red/Green colour in more than 50% of nuclei

Deduct 3 marks

Final score: 2

B5: Pink/Red/Green colour in virtually all nuclei

Deduct 4 marks

Final score: 1

C – Chromatin

C1: Crisp and distinct pattern in virtually all nuclei

Zero marks deducted

Final score: 5

C2: Crisp and distinct chromatin pattern in the majority of nuclei

Deduct 1 mark

Final score: 4

C3: Chromatin visible, but lacking definition in the minority of nuclei

Deduct 2 marks

Final score: 3

C4: Chromatin visible, but lacking definition in the majority of nuclei

Deduct 3 marks

Final score: 2

C5: Lack of chromatin definition in all of nuclei

Deduct 4 marks

Final score: 1

Cytoplasmic staining

D – Intensity of Cyanophilia

D1: Optimal intensity of cytoplasmic staining throughout the slide

Zero marks deducted

Final score: 5

D2: Good intensity of cytoplasmic staining throughout the slide

Deduct 1 mark

Final score: 4

D3: Acceptable intensity of cytoplasmic staining throughout the slide

Deduct 2 marks

Final score: 3

D4: Inappropriate overall intensity - present, but too pale cyanophilia, or present, but too dark cyanophilia

Deduct 3 marks

Final score: 2

D5: Overtly inappropriate intensity, for example, cyanophilia virtually absent

Deduct 4 marks

Final score: 1

E – Intensity of Eosino/Orangeophilia

E1: Optimal intensity of cytoplasmic staining throughout the slide

Zero marks deducted

Final score: 5

E2: Good intensity of cytoplasmic staining throughout the slide

Deduct 1 mark

Final score: 4

E3: Acceptable intensity of cytoplasmic staining throughout the slide

Deduct 2 marks

Final score: 3

E4: Inappropriate overall intensity - either present, but too pale eosino/orangeo, or present, but too dark eosino/orangeo

Deduct 3 marks

Final score: 2

E5: Overtly inappropriate intensity, for example, eosino/orangeo virtually absent

Deduct 4 marks

Final score: 1

F – Colour spectrum

F1: All colours equally represented, including subtle shades

Zero marks deducted

Final score: 5

F2: All colours equally represented but lack subtle shades

Deduct 1 mark

Final score: 4

F3: All colours present but one or more is under-represented in the minority of the slide

Deduct 2 marks

Final score: 3

F4: One or more colours are grossly under-represented or are absent in the majority of the slide/Must take account of hormonal status, for example, a cyanophilic atrophic cervical cytology sample should not result in a poor score

Deduct 3 marks

Final score: 2

F5: Colour Range/Lack of Spectrum: cytoplasmic staining is one colour only with no shading or variation, or cytoplasmic staining is 2-tone when a monochrome stain is used

Deduct 4 marks

Final score: 1

15. The assessment process

15.1 Stages of the assessment

The assessment is in 2 distinct stages:

• independent examination of cervical cytology samples and subsequent individual scoring to given criteria
• group discussion around multi-headed microscope or networked microscope camera display, and consensus agreement of a rating score for the slide

Assessors use a colour corrector or blue filter on their microscopes.

The lead assessor makes sure the panel reaches agreement in the allocated timeframe.

15.2 Components assessed

Nuclear staining

Haematoxylin staining of individual nuclei must be:

• clearly visible at low power (x 10 objective), and
• blue to black in colour

At high power (x 40 objective), nuclear chromatin must be:

• clearly demonstrated, and
• appear granular, crisp, and distinct

There must be no background staining, apart from cervical mucus, and haematoxylin must not adversely affect the colours of the counterstains.

Counterstains

Superficial squamous cells should stain pink.

Less mature cells should stain blue-green.

Fully keratinised cells should stain orange-yellow or pink depending on the staining method used.

Those colours present should be of equal intensity.

There should be cytoplasmic translucency with a sharp contrast to the nuclear stain.

Polychromasia may be encountered within metaplastic cells where 2 distinct colours are present in the cytoplasm.

15.3 Scoring slides

A minimum of 4 trained assessors must examine each slide, and only their scores used for the slide rating. The EQA facilitator provides a pre-populated spreadsheet for assessors to complete

Assessors must follow the instructions as set out below:

1. Start the assessment with the assumption that 5 marks are allocated to each slide.
2. View, evaluate and score the slides independently (avoiding comparison with any slides assessed previously).
3. Base your judgement on representative areas of the slide.
4. Systematically deduct marks for any perceived deficiencies according to the established criteria outlined in the score sheet for the assessment of nuclear and cytoplasmic staining.
5. Avoid the temptation to ‘give’ a score as this may lead to slides achieving an average score thereby restricting the number reaching the ‘good’ category.
6. Comment separately (using the appropriate field on the assessor score sheet) on the technical aspects of overall slide quality:

• preparation: cellularity, holes, patchiness, cell drift
• fixation: cellular distortion
• presentation: marked folding or lifting of the cells, air bubbles, scratches on the coverslip, clarity of mountant

Detection of these factors will not influence the overall slide scores although the laboratory will receive feedback on these areas.

16. End of the practical assessment

16.1 Group discussion

At the end of the practical assessment, the lead assessor will identify from the individual score sheets any slides that have not achieved a consensus on classification.

The assessors will then convene as a group, review the outliers around a multi-head microscope or networked microscope camera display, and agree an overall rating for each slide to produce a final consensus report. This may involve assessors changing their original score for any of the 6 characteristics of a slide.

The scheme uses original classifications (achieved during the initial part of the assessment) for monitoring individual assessor performance against the classifications of the included control slides.

16.2 Final slide rating

For any slide to be given a final rating of good (rather than acceptable, marginal or unacceptable) at least 3 of the 4 assessors must rate it as good.

For any slide to be given a final rating of acceptable (rather than marginal or unacceptable) at least 3 of the 4 assessors must rate it as acceptable.

16.3 Performance analysis

Nationally collected data is the property of the NHS Cervical Screening Programme.

The EQA facilitator is responsible for acting on a slide rated as substandard.

The EQA facilitator will address and distribute the reports and correspondence generated by the scheme.

At the end of each year, the EQA facilitator will return the submitted slides to the laboratories they came from. Laboratories must be aware that the scheme may retain slides for an additional quarter for the purposes of control slide provision. The EQA facilitator will notify them if this is the case.

The EQA facilitator will monitor assessor performance and provide appropriate feedback.

16.4 Distribution of results

The results package following each assessment will include:

• original submitted slide (unless retained for control purposes)
• image of the best performing slides
• the mean nuclear score, mean cytoplasmic score, the total average score, and the slide classification
• details of the staining methods used by the highest scoring laboratories in that round

16.5 Education and support

Laboratories must review their staining procedures if their performance is within the marginal category.

Laboratories that need help should contact the EQA facilitator in the first instance.

16.6 Certificate of participation

The EQA facilitator will provide a certificate of participation for each laboratory upon completion of 4 assessment cycles in the EQA round.

17. Substandard performance

The scheme manages substandard performance in line with RCPath guidance on the conditions of EQA scheme performance.

The scheme operates the following traffic light system (RAG rating):

• green (no concerns)
• amber (substandard performance)
• red (persistent substandard performance)
• black (unresolved persistent substandard performance)

The scheme’s EQA steering group (in consultation with the EQA management board) have proposed and approved the criteria for poor performance. The cellular pathology NQAAP have ratified it.

Slides with an unacceptable score in one round will fall into the green category of ‘no concerns’ under the traffic light system.

17.1 Action points

Local action point (amber)

The scheme triggers the local action point when the slides submitted for assessment score as unacceptable in 2 out of 3 rounds of the EQA on a rolling basis.

If a laboratory submits a slide for assessment and subsequently the panel cannot assess it for technical reasons, they will score it as unacceptable and trigger the local action point.

The EQA facilitator will inform the scheme organiser when a local action point is triggered. The scheme organiser will notify the lead clinician and initiate appropriate advice. The scheme organiser can seek technical advice from a QA biomedical scientist in determining the appropriate response. The scheme organiser will advise the head of screening QA that the local action point has been triggered.

The laboratory must acknowledge a notification that the local action point has been triggered and provide an explanation. The laboratory must agree a corrective action plan in collaboration with a QA biomedical scientist and submit this to the scheme organiser.

National action point (red)

A laboratory triggers the national action point when they have substandard performance in 3 out of 4 assessments.

The EQA facilitator will inform the scheme organiser that the laboratory has triggered the national action point. The scheme organiser will notify the lead clinician, the head of screening QA and the cellular pathology NQAAP chair (or equivalent outside the UK) within 2 weeks.

The cellular pathology NQAAP chair should agree in writing any corrective action and the timescale and responsibility for carrying it out. Where appropriate, the EQA facilitator will copy the letter to accreditation bodies such as UKAS.

The lead clinician should contact the scheme organiser (or equivalent in Wales, Scotland, and Northern Ireland) for advice with a view to reaching a solution. The scheme organiser can seek technical advice from a QA biomedical scientist to determine the response. All parties must agree how to manage the situation and keep the EQA facilitator informed.

Final action point (black)

If persistent poor performance remains unresolved, the cellular pathology NQAAP chair will submit a report to the chair of the QAPC. This should set out details of the problem, its causes, and reasons why the laboratory has failed to achieve improvement.

The chair of the QAPC will consider the report and, if appropriate, seek specialist advice from a panel of experts from the relevant professional bodies. The chair of the QAPC reserves the right to arrange a site meeting between the panel of experts and the head of the department concerned.

If supportive action fails to resolve the problems, the chair of the QAPC will contact the chief executive (or nearest equivalent within the organisation). The chair will inform the chief executive officer of the problem, the steps taken to rectify it, and the cause of the problem if it has been identified. Such contact will be with the agreement of the panel of experts.

The scheme management will refer laboratories outside the UK to the relevant regulatory body under the terms of the EQA agreement.

18. Communication

18.1 Feedback

The scheme considers any concern or negative comment relating to any aspect of its operation or management to be a complaint.

The EQA facilitator logs all communications and acts on feedback to help identify system improvements.

Refer to the gynaecological cytopathology EQA scheme protocol (Chapter 12, section 12.1).

18.2 Complaints

Complaints go directly to the EQA facilitator PHE.csp-teqa-admin@nhs.net in the first instance. The participant laboratory can contact the scheme organiser if a complaint is not resolved.

If the issue is still unresolved, the participant laboratory can then refer their complaint to the chair of the EQA management board. The EQA management board decision is final.

For information on how to lodge a complaint, refer to the gynaecological cytopathology EQA scheme protocol (Chapter 14).

18.3 Appeals

Laboratories wishing to appeal their performance assessment must contact the EQA facilitator at PHE.csp-teqa-admin@nhs.net in the first instance. The participant laboratory can ask to have their appeal escalated to the scheme organiser.

If the issue is still unresolved, the participant laboratory can then refer their appeal to the chair of the EQA management board. The EQA management board decision is final.

The appeals procedure in the gynaecological cytopathology EQA scheme protocol describes how to lodge an appeal against an evaluation of their EQA performance (Chapter 15).

18.4 Protocol changes

All participant laboratories must submit a declaration to confirm they have read and accept the terms specified in the protocol.

The scheme uses a change control procedure to prioritise and manage all changes. Changes may arise from participant feedback or a direct request from the operational group, steering group, or management board. The EQA facilitator must tell participants of agreed changes to the scheme and the date when they are to come into effect.

18.5 Participants’ annual meeting

The participants’ meetings are a forum for staff to view scheme results comparisons, discuss operational aspects of the scheme and review any challenging slides and educational cases. Meetings can be held either face-to-face or by virtual means.

The EQA operational group manages participant feedback and provides a summary in the annual report. The annual meetings are open to all staff. Laboratories are encouraged to send at least one member of staff who can then cascade information to colleagues.

18.6 Scheme audit

The EQA operational group sets the scope of the audit strategy for both national schemes (gynaecological cytopathology EQA and Technical EQA). The EQA management board authorises the audit strategy and audit programme, and can advise adjustments if necessary.

18.7 Surveys

The scheme uses short surveys to obtain feedback or views from participants on actual or proposed scheme activity.

There is an annual survey that all participants are encouraged to complete. They can register their satisfaction with the EQA service and provide constructive criticism, comments, and improvement suggestions.

The EQA operational group manages findings from the surveys and includes a summary in the annual report.

18.8 Annual report

The scheme produces an annual report for:

• participant laboratories
• members of the EQA management board, steering group, and operational group
• clinical professional groups (laboratories, education and training)
• directors of pathology screening and cytology training centres
• national screening QA service lead
• regional cervical screening QA portfolio leads (for cascade to regional cervical screening QA staff)
• RCPath
• UKAS

The EQA facilitator distributes the annual report widely within the programme by the end of the second quarter of each financial year.