Cervical Screening Programme: histopathology reporting handbook

Question 1

1. Introduction

Accepted Answer

This document replaces the second edition of ‘Histopathology reporting in cervical screening: an integrated approach’ (2012).

The Clinical and Professional Group (CPG) for Laboratories (Laboratory CPG) developed this guidance based on evidence where available, recommended best practice, or expert opinion. This approach is recognised for the development of guidance.

The Laboratory CPG provides professional clinical advice to the NHS Cervical Screening Programme (NHS CSP). Its members are leading professionals in the fields of cervical cytopathology, histopathology and virology.

The Laboratory CPG has consulted extensively with colleagues from the CPGs (Laboratories and Colposcopy), the Royal College of Pathologists (RCPath), the British Association of Gynaecological Pathologists (BAGP) and the British Society for Colposcopy and Cervical Pathology (BSCCP). We will continue to review and revise this guidance as primary high risk human papillomavirus (hrHPV) screening embeds into the programme.

Several histopathology-related incidents in the programme led to the review of the former guidance, and the PHE Screening Quality Assurance Service (SQAS) set up a working group to consider the findings. Evidence obtained from SQAS visits found several important issues, as described below.

Descriptive histopathology reports were issued where no abnormality had been reported. Colposcopy had interpreted these as normal when in fact the biopsy report should have stated inadequate for a variety of reasons.

Histopathology samples originating from the programme were reported by pathologists who routinely examined as few as 6 per year. Based on this information, we have set a target of a minimum of 150 programme cervical histopathology samples reported per year per pathologist. The Laboratory CPG considers this is an achievable target in the smallest of laboratories

A significant number of reports on loop excision specimens were incomplete; they did not contain all the required data set items and many different versions of Systematised Nomenclature of Medicine (SNOMED) codes were used.

Many general histopathology external quality assessment (EQA) schemes do not regularly include cervical biopsies; these are not acceptable for pathologists reporting histopathology samples originating from the programme. The British Association of Gynaecological Pathologists (BAGP) has developed an e-learning module in collaboration with key members of PHE Laboratory CPG. The BAGP website hosts this module.

A specification for histopathology reporting that includes minimum workload numbers, participation in audit or competency assessment does not exist; we have addressed this shortfall (see sections 9, 10 and 11).

Following the review, we developed additional standards to assure the quality of reporting in cervical screening histopathology.

The additional standards cover:

defining the adequacy of cervical biopsies and when they must be called inadequate
monitoring reporting profiles for cervical biopsies and loop excisions
the use of p16 staining
the use of minimum data sets to standardise report content
the introduction of minimum workload figures for pathologists who report programme generated histopathology samples
histopathology input to the colposcopy multidisciplinary team (MDT) meetings
required professional updating in cervical histopathology
clarification of the lead pathologist’s role for cervical histopathology
audit as an integral part of a pathologist’s work
outsourcing and the use of locums
monitoring turnaround times (TATs) for cervical histopathology

Question 2

2. Terminology

Accepted Answer

Use the existing cervical intraepithelial neoplasia (CIN) terminology for the histological reporting of squamous intraepithelial neoplasia. This permits direct correlation with the cytological grades of dyskaryosis. We note that the Lower Anogenital Squamous Terminology (LAST) working group proposed a different system of terminology and grading.

Patient management is based on a 2-tier grading system of low (CIN 1) and high grade (CIN 2 and CIN 3) abnormality. We note that colposcopists may conservatively manage some patients with CIN 2 when confined to the surface epithelium and not involving endocervical crypts or glands, and involving no more than 2 quadrants. The circumstances and pathway for managing these patients is outside the remit of this guidance.

Use cervical glandular intraepithelial neoplasia (CGIN) for the histological reporting of glandular intraepithelial neoplasia (usually classified as low grade or high grade). The World Health Organization (WHO) uses this term synonymously with adenocarcinoma in situ (AIS) which is equivalent to high grade CGIN or endocervical glandular dysplasia (EGD) where the glandular abnormalities fall short of AIS (and could also be termed low grade CGIN).

Use stratified mucin-producing intraepithelial lesion (SMILE) for the histological reporting of intra-epithelial neoplasia showing stratified epithelium with atypical cells containing mucin vacuoles in all layers of the epithelium. The WHO classification for this is a subtype of high grade CGIN/AIS.

The guidance on colposcopy and programme management covers the clinical management of women referred for colposcopy. The primary hrHPV screening implementation guide covers the colposcopy management recommendations.

2.1 Coding of histopathology reports

Classify all cervical carcinomas according to the WHO classification of cervical neoplasms^{[footnote 1]}.

Assign SNOMED topography and morphology codes to all histopathology reports or SNOMED CT (clinical terms). This ensures a retrievable data result for the Screening Quality Assurance Service (SQAS) and cancer registry, and for the production of KC61 and KC65 returns.

Assess the completeness and accuracy of the coding through periodic audits. Please see the lists of SNOMED codes.

Classify all carcinomas as HPV-associated (HPVA) and HPV independent (HPVI) cancers. HPVI precursors of adenocarcinomas are recognised while no HPVI precursors of squamous carcinoma is yet recorded. This distinction is based on p16 staining. In a few cases, HPV RNA ISH may be required. We assume that all laboratories reporting histopathology arising from the cervical screening programme have access to p16 immunohistochemistry.

2.2 Staging of cervical carcinomas

Stage all cervical carcinomas from the available material according to the FIGO system. The Royal College of Pathologists (RCPath) data sets include FIGO staging and they recommend its use.

The programme has implemented the 2018 FIGO staging system (see summary of changes) since 1 January 2020. To ensure the consistency of data collection by the screening programme and cancer registry until then, continue to report the 2009 FIGO staging.

We recommend recording both the 2009 and 2018 FIGO stages within reports. Continue to use 2009 FIGO stage for data returns (cancer outcome and services data set, invasive cervical cancer audit and so on) for all tumours diagnosed before 1 January 2020. Even though the horizontal dimension does not constitute a part of staging, continue to measure the maximum horizontal dimension in all cases.

FIGO 2018 includes information on lymph node status. The Royal College of Pathologists (RCPath) data set recommends that both FIGO and TNM staging are included in the pathology report. Note that the final decision is at the discretion of the pathologist and the preference of their MDT.

Use TNM staging in addition as it gives useful information on lymph node status. Note that it does not form part of the Royal College of Pathologists (RCPath) minimum data set.

Question 3

3. Specimens sent for histological examination

Accepted Answer

The handling and preparation of specimens sent for histological examination is described below.

3.1 Cervical biopsies

These confirm or exclude the presence of cervical pathology. The biopsies received are:

usually fixed in formalin
typically 4mm to 7mm in their greatest dimension
2mm to 4mm thick

You can mount the specimen on paper to provide optimal orientation.

Record the number of fragments, and the maximum size of each fragment.

When taking blocks, you should process all the tissue as received. You can bisect specimens greater than 5mm along their long axis, perpendicular to the mucosal surface. If you do this, record it. For other biopsies, identify the squamocolumnar junction where possible, and slice perpendicularly to this. Again, if you do this, record it.

When processing and or staining you should:

use standard haematoxylin and eosin (H&E)
examine 3 levels initially
examine further levels if there is a suggestion of an abnormality appearing in the initial levels
examine further levels if a high grade abnormality is expected from the cytology and, or colposcopy and is not present on the initial 3 levels

3.2 Cone biopsy and large loop excision of the transformation zone (LLETZ)

Cone and LLETZ (loop) biopsies from women with abnormal (high grade) cytology samples or following a high grade abnormality on punch biopsy can be diagnostic or therapeutic. Large loop diathermy excision is most commonly used.

Performed as an outpatient procedure without a general anaesthetic, it is favoured due to:

reduced levels of bleeding
improved healing
relative preservation of cervical epithelium at the expense of artefact at the resection margins
research indicating reduced incidence of second trimester miscarriage and premature delivery

Electrothermal artefact may impair histological diagnosis and render the assessment of resection margins difficult especially in cases of glandular neoplasia. Cone ‘cold knife’ biopsy is a preferred procedure for assessing glandular lesions of the cervix, especially after a diagnostic biopsy. Cold knife cones are relatively infrequent and LLETZ material can be interpreted, in most cases, for a glandular abnormality if the diathermy artefact is minimal.

You must record:

measurements of the intact central loop or cone biopsy in 3 dimensions (2 side-to-side (lateral), and the greatest depth perpendicular to the ectocervical surface)
measurements of flat or opened loop biopsy in 3 dimensions (noting which dimension is being measured)
number of pieces for multiple loop biopsies, with the smallest and largest measured in the maximum dimension where the sample is small, or in 3 dimensions where it is larger
presence of any surface lesions
presence and completeness of cervical os

When blocking a specimen you must:

block all slices sequentially for intact central loop or cone biopsies
consider using ink where the identification of margins is difficult (for example, inking the ectocervical rim can be useful when orientating individual slices in the presence of a large ectropion)
note that opening or probing an intact loop or cone biopsy may damage the surface epithelium

Slice serially perpendicular to the transverse axis of the external os at 2mm to 3mm intervals when slicing intact central loop or cone biopsies. This is often referred to as ‘bookending’. Slice from one edge to the other. This allows assessment of tumour volume in small lesions and avoids the problems of interpretation that may arise when a loop or cone specimen is sectioned radially, resulting in blocks of variable thickness.

Process opened loop biopsies in sequential transverse slices (and blocks).

Process fragments for example, superficial, deep or ‘top-hat’, or marginal, in designated sequential cassettes (record which block relates to which fragment). Put up to 2 slices of tissue in each cassette in unoriented fragments.

The procedure for blocking a loop is as follows.

Place the surface to be cut face down in the cassette, or if preferred embed the outer (curved) surface of the first and last (edge) slices of the loop, with the outer edge face down for sectioning. The laboratory standard operating procedure (SOP) must identify which approach is used.
Place each subsequent slice in a sequential cassette, with cut faces orientated similarly. This allows for assessment and measurement of invasive lesions if present. (The opposite face can be marked with ink to assist the microtomist.)
Place each slice of tissue in a single cassette. Never put more than 2 pieces of tissue in 1 cassette. This is very important when assessing invasion if present. Block each marginal or edge slice on its cut surface.

The whole loop excision must be submitted in all cases.

When processing or staining use standard haemotoxylin and eosin (H&E). Follow the steps below.

A single full-face section is required from each block.
Further levels may be of value if there are histological features where this may help to clarify the issue, for example where there are pre-invasive features. Another occasion is if there is a need to help correlate with a suggested abnormality based on the cytology report. Invasive tumours may also require further levels to help assess their size and margins.
If the surface epithelium or squamocolumnar junction is missing, or there is a discrepancy between the histological and cytological findings, a single further level is usually adequate.
Histochemistry and immunohistochemistry (IHC) may be required to determine tumour subtype. It may also be required to evaluate difficult high grade CIN or glandular abnormalities such as CGIN.

Question 4

4. Histology report

Accepted Answer

4.1 Report form

The Laboratory CPG recommends using a standard form for reporting cervical histopathology (this can be paper or electronic depending on local IT systems). The form should have fields for content as described in Table 1 below.

4.2 Report content

All reports must include the relevant data set items for loop excisions and cervical biopsies (Table 1).

Table 1 . Data set items for loops and cervical biopsies

Data set items to be included	In loop excision reports	In cervical biopsy reports
	Macro	Macro
Specimen type	Yes	Yes
Number of pieces	Yes	Yes
Dimensions of pieces in 3 planes	Yes	Yes (1 dimension only)
Presence and completeness of cervical os	Yes	-
Description of any lesion, if seen, naked eye	Yes	-
Method of trimming/inking, for example serially sliced in blocks	Yes	-
	Micro	Micro
Number of slices examined	Yes	Number of additional levels examined
Presence or absence of TZ	Yes	Yes
Presence or absence of HPV-related changes	Yes	Yes
Presence or absence of CIN	Yes	Yes
Grades of CIN when present	Yes	Yes
Presence or absence of crypt involvement by CIN	Yes	Yes
Presence or absence of CGIN	Yes	Yes
Presence or absence of SMILE	Yes	Yes
Completeness of excision at ectocervical margin	Yes	-
Completeness of excision at endocervical margin	Yes	-
Completeness of excision at deep lateral margin	Yes	-
Presence or absence of invasion	Yes. If invasion present then use RCPath data set for cervical neoplasia in loop excisions	Yes
Results of p16 or other immuno performed	Yes	Yes
Other histological features if present, for example tuboendometrioid metaplasia, endometriosis, microglandular hyperplasia	Yes	Yes
Correlation with cytology (less than 1 grade difference)	Yes	Yes
Comment if case should be discussed at MDT	Yes	Yes
Diagnosis	Yes	Yes
SNOMED CT/SNOMED code	Yes	Yes

4.3 Report text

In loop excisions or punch biopsies, the microscopy report must specify whether there are any features that impair histological assessment or interpretation – for example fragmentation, crush or diathermy artefact, or epithelial loss.

Make a clear distinction between a specimen that fails to identify the source of the abnormal cells in the cervical cytology sample because it is technically unsatisfactory or damaged, and a biopsy that is technically adequate but does not include or identify the lesion.

Include in the report all pathological lesions and non-neoplastic histological features that may be associated with cytological changes.

In a small biopsy, the text should indicate the worst grade of CIN present, as well as all other grades present. You cannot quantify the amount of CIN of different grades from a biopsy, although it is helpful to know what the predominant pattern is, if any. The colposcopist may find this useful if considering conservative management of women with CIN 2 for example, knowing that the predominant pattern is CIN 1 and that there is only focal CIN 2.

You must not use non-specific text terms such as ‘CIN 1 to 2’ and ‘CIN 2 to 3’. Include the presence or absence of endocervical crypt involvement by CIN, as applicable.

Question 5

5. Reporting cervical biopsies

Accepted Answer

5.1 Adequate

Consider as adequate any biopsy that shows an abnormality irrespective of its size. Do not consider smaller biopsies as adequate for diagnosis if they do not show an abnormality when the tissue obtained is less than 2mm of tissue (removed by cervical biopsy forceps) in keeping with the criteria for adequacy.

An adequate biopsy for histology reporting should be:

more than 2mm in maximum dimension
intact and not so fragmented as to interfere with reliable interpretation
lacking crush artefact
adequately fixed and processed
well oriented
well stained

5.2 Inadequate

In this context, the term ‘inadequate’ means that there is insufficient representative material present to allow for pathological reporting. A biopsy less than 2mm will not be adequate for reporting purposes unless an abnormality is present.

To achieve consistency within histopathology reporting, we recommend that:

a cervical biopsy must not be classified as inadequate if it shows an abnormality
a cervical biopsy taken as a result of cytology showing squamous dyskaryosis must be called inadequate if it does not contain squamous epithelium (you must state this in the report)
a cervical biopsy taken as a result of cytology showing a borderline endocervical abnormality or ?glandular neoplasia (endocervical) must be called inadequate if it does not contain any endocervical tissue and shows no abnormality (you must state this in the report)

5.3 Not representative

Do not call inadequate a cervical biopsy that does not contain transformation zone (TZ) tissue if the sample taker has indicated it is from the ectocervix. If not indicated, then describe it as ‘may not be representative’. If the cervical biopsy has been recorded as ‘directed’ by the biopsy taker or colposcopist, the absence of TZ does not constitute an inadequate sample. TZ tissue will have surface squamous epithelium with either surface columnar tissue or stromal gland crypt, or both.

5.4 No abnormality seen

If TZ sampling is present and no abnormality is seen to account for the reason for the biopsy (whether cytologically or clinically indicated) then repeat biopsy and or further investigation may be indicated, and or discussion with the MDT.

5.5 Non-correlation of biopsy or loop excision with referral cervical sample

We define non-correlation as more than 1 grade difference between the histological diagnosis and cytological diagnosis.

Initially, you should take 3 levels for cervical biopsies. For those cases where this does not identify features that correlate with the referral cervical cytology, a further 3 levels are advocated. For loop excisions you should perform a single full-face section initially and further levels only when required.

If the reason for referral was clinical (for example, post-coital bleeding, suspicious cervix) the biopsies are not considered to be NHS CSP derived. More than 3 levels are unnecessary unless there is a suggestion of an abnormality on initial levels.

If the reason for referral was borderline or low grade dyskaryosis with hrHPV+ve, 3 further levels are only necessary if there is a suggestion of an abnormality appearing in initial levels.

Where local policy recommends more than 3 levels initially on cervical biopsies or more than 1 section on loop excisions, there must be an audit to determine that the additional work adds value.

5.6 Ancillary tests

Further levels or use of ancillary tests such as p16 may be indicated in some cases. If the biopsy still does not correlate with the referral cervical sample or clinical impression then discussion should take place at an MDT meeting.

Review the material and the reason for referral or biopsy.

For a high grade cervical cytology sample and negative or low grade biopsy, consider:

examining more levels
p16 testing
MDT discussion

5.7 High grade CIN extending to margins

The histopathological handling of LLETZ or loop specimens with high grade CIN extending to margins is based on programme and colposcopy management guidance.

All individuals over the age of 50 years who have CIN3 at the deep lateral or endocervical margins

Perform a repeat excision to try and obtain clear margins where satisfactory screening samples and colposcopy cannot be guaranteed.

Individuals under the age of 50 years with HG CIN (CIN2+) on on LLETZ or loop specimens at the deep lateral and, or endocervical canal margin

You do not need to examine extra levels or turn end blocks to assess excisional completion.

Individuals over the age of 50 years with potential deep lateral and, or endocervical canal margin involvement by HG CIN (CIN2+)

You should examine further levels and/or turn end blocks to allow a definitive statement about the adequacy of excision of HG CIN at these margins.

Individuals of any age with evidence of a glandular abnormality or invasive disease

If necessary, you should examine further levels and/or turn end blocks to allow for a definitive comment on the adequacy of excision at these margins.

Question 6

6. Interpretation of p16 immunohistochemistry (IHC) in cervical histopathology reporting

Accepted Answer

p16INK4A (from this point referred to as p16 IHC) is a good surrogate test for the presence of a potentially transforming or hrHPV infection in premalignant and malignant lesions of the cervix. Use immunostaining for p16 as a surrogate for detection of potentially transforming hrHPV infections; its use improves diagnostic agreement in cervical biopsy interpretation.

p16 IHC interpretation is largely based on the guidance issued by the LAST consensus group. The British Association of Gynaecological Pathologists (BAGP) has produced a guide illustrating the use of p16.

The patterns recognised are as follows.

6.1 Normal or reactive expression patterns in squamous epithelium

Normal squamous epithelium generally shows completely absent expression or rare scattered, weakly staining cells. In reactive conditions you will see irregularly scattered, positively stained cells.

6.2 Normal or reactive expression patterns in glandular epithelium

Normal endocervical epithelium, reactive epithelium, tubo-endometrial metaplasia and lower uterine segment endometrial epithelium show patchy staining of epithelial cells.

6.3 Abnormal expression in squamous epithelium

Abnormal expression in squamous epithelial lesions (described as block positive staining) must:

have strong and continuous nuclear or more typically nuclear and cytoplasmic expression in all epithelial cells in the basal and parabasal layers with upward extension
have upward extension involving at least the lower one-third of the epithelial thickness
extend for at least 6 cells across

Reporting terminology
We do not recommend use of the word ‘positive’. Report as ‘abnormal (diffuse/block positive expression) vs negative/normal expression’.

6.4 Abnormal expression in glandular epithelium

Abnormal expression in glandular epithelial lesions is strong and diffuse positive staining in glandular epithelial cells; staining may be nuclear or more commonly nuclear and cytoplasmic.

p16 staining is not a surrogate for grade; up to 50% of cases of low grade squamous intraepithelial lesion (LSIL) (HPV/CIN 1) are p16 positive. Base the grading of squamous intraepithelial lesion (SIL) (cervical intraepithelial neoplasia - CIN) on morphological criteria and not on p16 staining.

Whilst block positive staining is (almost always) seen in high grade CIN, there may be complete absence of staining due to technical reasons. For example, inactivation of the p16 gene through gene deletion or epigenetic silencing. These are rare examples and in such instances it is reasonable to seek the opinion of an experienced colleague.

The interpretation of p16 staining is context dependent. p16 overexpression may be occasionally seen in non-HPV related cervical gastric type adenocarcinomas, as well as occasional (2 to 3 percent) HPV-independent vulval squamous cell carcinomas.

Current evidence does not support any combination of markers to improve performance when compared with the use of p16 alone therefore do not routinely add Ki-67 to p16 IHC.

Research indicates use of p16 in the following situations.

When the H&E morphological differential diagnosis is between pre-cancer (high grade CIN; CIN 2 or CIN 3) and a mimic of this, for example, processes known to be not related to neoplastic risk such as immature squamous metaplasia, atrophy, reparative epithelial changes, tangential cutting).

When considering an H&E morphological interpretation of CIN 2 or above, use p16 IHC to help clarify the situation. Base grading on morphological features and the value of p16 is in exclusion of a high grade lesion in the presence of a negative stain.

As an adjudication tool for cases in which there is a professional disagreement in histological specimen interpretation, with the caveat that the differential diagnosis includes high grade CIN.

As an adjunct to morphological assessment for biopsy specimens interpreted as CIN 1 or lower that are at high risk for missed high grade disease, which is defined as a prior cytological interpretation of high grade dyskaryosis, borderline with hrHPV+ve or borderline in glandular cells. This is only when there is a suspicion of, or difficulty in excluding, a high grade lesion morphologically..

p16 IHC as a routine adjunctive technique in the histological assessment of biopsy specimens is not recommended.

Question 7

7. Histopathology and cytology correlation

Accepted Answer

The cervical biopsy (punch or loop) should explain the cytological findings. Correlate the histology and cytology in every case.

Always regard the cervical cytology findings as the lowest grade of abnormality expected in a biopsy. Include a comment on correlation in every histology report. It is sufficient to state that the histopathology does or does not correlate with the cytology. Systems must be in place to make sure the cytology result is available at the time of biopsy reporting.

7.1 Histological findings higher than expected from the cytology result

This is a normal and recognised feature of cervical screening and may be due to:

undergrading of cytological changes in cervical samples
overgrading of histology changes
unrepresentative cytology

A 1-grade difference in CIN is an acceptable variation.

7.2 Histological findings lower than expected from the cytology result

This may be due to:

poor quality biopsy: loss of surface epithelium or electrothermal artefact may impair histological assessment; deeper levels should be cut in these cases but may be of limited value
unrepresentative biopsy material: the colposcopist may not have selected the most appropriate site to biopsy; not all CIN lesions produce a colposcopic abnormality
overgrading in cytology
undergrading in histopathology
removal during sampling of all of the abnormal cells (in the case of a small pre-invasive lesion) resulting in a genuine negative biopsy
natural disease regression

A 1-grade difference in CIN is an acceptable variation (assuming appropriate levels have been examined).

The cytology service must carry out a cytology review if there is a discrepancy of more than 1 grade. Review of both the cytology and histology may be necessary to either confirm the original diagnosis or determine an explanation for the findings. Feed back to the MDT meeting if a technically satisfactory biopsy does not confirm a significant cytological finding.

7.3 Histological discrepancies and suspected CGIN

The limitations of punch biopsies in diagnosing CGIN are recognised ^{[footnote 2]} ^{[footnote 3]} ^{[footnote 4]} and should not be taken routinely for a glandular abnormality on cytology. Do not misinterpret a cytological prediction of glandular neoplasia, followed by a negative punch biopsy alone, as a cytology overcall.

Always consider the possibility that abnormal cells found on cytology originate from elsewhere in the female genital tract, and investigate if clinically appropriate.

Question 8

8. Multidisciplinary team (MDT) working

Accepted Answer

8.1 Communications with other units

Effective communication between units is an essential component of high quality integrated patient care.

8.2 The MDT process

Describe the entire MDT process in a standard operating procedure (SOP).

Laboratories must have procedures in place to cover the whole MDT process from case selection through to further patient management. Log all cases discussed. Document the outcomes in the patient notes either in writing or by way of an MDT record sheet.

Document the results of reviews of samples for MDT purposes along with the details of who carried out the review.

Take into account HPV status, cytological, histological and colposcopic evidence to make sure there is appropriate patient management. For the majority of women in the screening programme, this leads into relatively straightforward referral and management protocols. The MDT approach to patient management is particularly important where a woman may require referral for treatment of glandular and or invasive disease.

Periodic audits are required to make sure that all relevant cases have been included.

The MDT approach is also very valuable in reviewing women with discrepant cytology/histopathology/colposcopy outcomes as identified elsewhere in programme guidance.

8.3 The role of the MDT meeting

The role of the MDT of specialists is to discuss individual patient cases and determine a consensus management plan. The primary purpose of the colposcopy MDT meeting is to optimise colposcopic management and discuss apparent discrepancies between cytology, histology and colposcopy findings. This is when patient management will also be decided. Professional development of members is also important.

8.4 Main requirements for MDT meetings

The conditions for MDT meetings are listed in colposcopy and programme management guidelines. The conditions make sure that proceedings are valid and meet all programme requirements as follows.

Frequency of meetings

Monthly meetings as a minimum are required (at least 12 per year).

Meeting facilities

Split or multisite working will require the use of video conferencing and digital facilities that are capable of sharing images from all participating histopathology departments. Direct contact through face-to-face meetings is best practice to help maintain and develop professional working relationships.

Meeting configuration

Meeting composition may include:

colposcopists
histologists
cytologists
cervical screening provider lead
nursing staff
laboratory staff
trainees

Trainees may contribute to the meetings and should be encouraged to attend for their educational benefit.

Required minimum attendance

The minimum expected attendance is:

1 person to review and present the cytology (consultant pathologist or consultant biomedical scientist)
1 person to review and present histology (consultant or specialty trainee in cellular pathology if a nominated deputy, or consultant biomedical scientist holding the Advanced Specialist Diploma (ASD) in Histopathology Reporting Gynaecological Pathology)
colposcopy attendance as defined in colposcopy and programme management guidance

A meeting must not go ahead in the absence of the minimum required attendees.

Frequency of attendance

All histologists reporting cervical histology must attend a minimum of 3 colposcopy MDT meetings each year. We consider this best practice to support their full integration into the service and to make sure they understand the function and management decisions taken at the MDTs.

Meeting administration

Each meeting requires:

an identified lead
specific administrative time and support
an attendance register (this must be completed and maintained)

Case selection

Identify MDT cases by histopathology, cytology or colposcopy.

All cases with a 2-grade disagreement between cytology and histopathology must be included when cytology is high-grade dyskaryosis (moderate or severe). Identify these by a searchable field on histology reports.

Cases referred due to moderate dyskaryosis with a CIN1 outcome are discretionary and do not count as a 2-grade discrepancy.

The British Association for Cytopathology (BAC) Code of Practice specifies which cases do not need to be discussed at the MDT.

The following provide further details about case selection:

Produce a history for each case and include:

the reason for discussion
the relevant medical and screening history
any relevant colposcopy or histology
outcomes from the review of relevant previously reported cytology and histology samples

Case review

Identify cases sufficiently in advance to allow collection and review of cytological or histological material, particularly as this can involve material from several hospitals. Such a review may involve undertaking extra work, for example, levels on histological samples.

For all cases, review the cytology and histology prior to the meeting.

The individual who prepares and reviews the pathology element of the meeting must have sufficient time identified in their job plan or working time.

A second individual, different from the original reporter, must perform the histopathology and cytology reviews and if discordant results arise, or potential bias is identified, then a third opinion must be obtained.

Note that the laboratory does not reissue cytology reports as a result of an MDT review.

8.5 Correlation

Individuals who can interpret and report both cytology and histology may undertake the correlation, or a reporting cytologist and a reporting histologist may undertake the correlation together.

Cases for discussion include:

a major discrepancy between cytology and or HPV and histology or colposcopic findings (in practical terms, 2 or more grades of difference)
a cytological glandular abnormality (borderline or ?glandular neoplasia endocervical) not confirmed on histopathology or colposcopy
where clinical management or follow up requires clarification
where a clinically indicated HPV test is required (whilst triage or test of cure is being used)
cases of cervical cancer (if they have not been discussed at another MDT or oncology meeting that includes cervical cytology and cervical screening provider lead (CSPL) representation
examples of educational value
conservative management of CIN 2

There is no need to routinely discuss cases with:

only 1 grade of difference between cytology and histology
high grade CIN where the cytology was low grade but the hrHPV result was positive, in keeping with histological outcome
previous biopsy confirmed CIN and a subsequent negative excisional sample, although a review of the previous biopsy should be undertaken and comment on this included in the excision report
CIN reaching to a margin (incomplete excision) on a LLETZ

All cases of invasive malignancy must be included within the gynaecological cancer MDT.

Do not combine the 2 meetings since their governance, membership and frequency are distinct.

Recording outcomes

Record all outcomes and add to the patient medical record.

Record any revisions to histology results and issue a supplementary report. Feed back any revisions to the original reporting pathologist. There must be an SOP in place which supports this process.

Question 9

9. Laboratory quality standards

Accepted Answer

Laboratories must:

be accredited by or registered for accreditation with the United Kingdom Accreditation Service (UKAS) to ISO 15189: 2012 Medical laboratories’ requirements for quality and competence
be fully compliant with the recommendations laid out in laboratory HPV testing and cytology services and the programme specific operating model for quality assurance in cervical screening programmes
participate in relevant EQA schemes
observe the processes for managing safety incidents in NHS screening programmes

9.1 Maintenance of clinical skill

All pathologists reporting cervical screening histology must report a minimum of 150 histopathology specimens per year (biopsies and or loops originating in the cervical screening programme). We recommend this figure as a minimum to maintain clinical competence and allow statistical comparisons of reporting profiles.

All pathologists reporting cervical screening programme histopathology must undertake continuing professional development (CPD) related to their role in the NHS CSP. This must include morphology and screening programme components to meet the requirements for updating. As part of this, they must complete the cervical histology e-learning module every 2 years to maintain clinical competence. The BAGP website hosts the e-learning module identified here.

The update training must include morphology and screening programme components. The BAGP website hosts the e-learning module for the update training identified here.

9.2 The role of the lead histopathologist

The lead histopathologist for cervical screening histology is a consultant cellular pathologist. They undergo an annual appraisal which makes reference to this specific role.

The lead histopathologist:

must be a consultant cellular pathologist registered on the General Medical Council (GMC) specialist register
has a job plan which takes account of this role and its time commitment
has satisfactory and appropriate participation in the RCPath continuing professional development (CPD) scheme (check this at appraisal)
meets programme standards for reporting cervical histology
participates in histopathology EQA schemes
undertakes the cervical screening histopathology eLearning module
has a nominated deputy
works with the cervical screening provider lead and lead biomedical scientist to make sure the laboratory follows all national guidance related to cervical screening histology
advises on the implementation of new guidance or monitoring of new standards as published by the programme or RCPath when appropriate
attends cervical screening MDT meetings (or where another pathologist attends, makes sure they meet programme standards in cervical histology reporting)
is responsible for making sure the necessary pathology input is made for cases in the national audit of invasive cervical cancer
advises and participates in audits for the local programme relevant to their role
attends trust cervical screening business meetings (or makes sure that a deputy is present) where the performance of the local service will be monitored and trust business issues are discussed
attends the local programme board meetings (multidisciplinary) or makes sure that a deputy is present, where the performance of the local service will be monitored and local programme issues discussed
contributes as necessary to any quality reports given to the local trust cervical screening business meeting, programme board meeting or trust governance meeting
contributes to any annual reports relating to the local service
signs off the cervical histology data returns
is the primary medical contact within the department for cervical screening histology matters
makes sure that an appropriately experienced histopathologist undertakes a review of histological biopsies that are included in MDT meetings and invasive cancer audit

9.3 Outsourcing and locums

Outsourcing cervical histopathology

The histopathology service provider must make sure that:

pathologists undertaking cervical histopathology for the NHS CSP meet the required standards of the cervical screening programme
the requirement is included in a contract or service level agreement

Locums

The histopathology service provider is responsible for enabling locums to:

meet the requirements and standards of the cervical screening programme
meet training and update requirements of the cervical screening programme as identified in this document

The histopathology service provider is responsible for making sure these requirements are included in a contract or service level agreement.

The lead histopathologist is responsible for making sure that locums meet training and update requirements of the cervical screening programme as identified in this document.

Locums must complete the online training once this becomes available, and before reporting cervical screening histopathology. Prior to its release, locums must provide evidence of relevant and current CPD to the lead histopathologist for the service.

9.4 The role of non-consultant grade medical staff

Staff in non-consultant grades can be involved in reporting cervical histology.

These can be:

Staff in non-consultant grades can be involved in the MDT meeting.

Specialist trainees up to stage C may present under supervision.

Specialist trainees in stage D may present unsupervised in line with practice in other cancer MDTs provided that they meet the quality requirements of the cervical screening programme.

Non-career grade doctors may present unsupervised in line with practice in other cancer MDTs provided that they meet the quality requirements of the cervical screening programme.

9.5 The role of non-medical staff

Consultant biomedical scientists who hold the Advanced Specialist Diploma (ASD) in Cervical Cytology may present cytology in the colposcopy MDT meeting.

Consultant biomedical scientists who hold the ASD in Histopathology Reporting Gynaecological Pathology are qualified to report cervical histopathology and can present histopathology in the colposcopy MDT meeting.

9.6 Key assurance and or performance indicators

Audit laboratories on their compliance with RCPath guidance

Question 10

10. Performance monitoring

Accepted Answer

All pathologists and consultant biomedical scientists who report cervical histology for people referred by the screening programme must monitor their performance in this work.

Data items collected for an individual are:

overall number of cervical histopathology samples from a cervical screening programme referral
specimen type (biopsy and or LLETZ) and numbers reported by type
time from cervical histology sample taken to report authorisation (while the RCPath has introduced new key activity indicator (KAI) guidance which relies on local turnaround times (TATs), the NHS CSP will continue to monitor performance against the more specific TATs in the previous RCPath guidance to promote consistency across the programme); NHS CSP standards are:
- cervical histology specimens reported within 7 days of being taken ≥ 80%
- cervical histology specimens reported within 10 days of being taken ≥ 90%
classification or grade of abnormality as numbers and percentages of total cases reported

SQAS analyses 12 months of data (collected quarterly) and determines what standards to apply and identify any outliers.

Analysis is by department and by individual. We recommend a random distribution of workload between pathologists to facilitate interpretation.

Question 11

11. Audit

Accepted Answer

11.1 Audit of histopathology reports

Audit is an integral part of a pathologist’s work. Pathologists must participate in the departmental annual audit programme.

Select cases at random. We do not recommend a specific percentage. The proportion of cases will depend on departmental workload and existing review practices.

Audit histopathology reports against the minimum data set items to check for compliance.

11.2 Audit of colposcopy standards

Use the content of histopathology loop excision reports to monitor colposcopic standards for excisional treatment of cervical lesions.

The specimen should be removed as a single sample in at least 80% of cases. Measure and record the depth of excision in line with programme guidance.

11.3 Audit of invasive cervical cancer

The national audit process is described in ‘Audit of invasive cervical cancers’.

11.4 Maintaining professional performance through audit

The GMC requires its members to monitor and improve the quality of their work.

Evidence of the review of practice and quality improvement activity is required for appraisals and revalidation.

Pathologists can demonstrate review of practice and quality improvement by performing audits of their reports against RCPath minimum data sets for cervical neoplasia and tissue pathways. Audits submitted for evaluation must comply with RCPath guidance.

Biomedical scientists who report cervical pathology are subject to the same monitoring and standards as their medical consultant colleagues.

Question 12

12. Acknowledgements

Accepted Answer

Dr Paul Cross, Dr Karin Denton, Dr Steve Ferryman, Dr Raji Ganesan, Jackie Jamison, colleagues from the Clinical and Professional Groups (Colposcopy and Laboratories), the Royal College of Pathologists, the British Association of Gynaecological Pathologists and the British Society for Colposcopy and Cervical Pathology

Special thanks and gratitude are due to Dr Steve Ferryman for his patience, unstinting support and direction in preparing this guidance.

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Waddell CA, Glandular abnormalities: dilemmas in cytological prediction and clinical management. Cytopathology, 1997, 8: 27-30. ↩
Valente PT, Schantz HD, Schultz M, Cytologic atypia associated with microglandular hyperplasia. Diagnostic Cytopathology, 1994, 10: 326-331. ↩
Lee KR, Manna EA, St John T, Atypical endocervical glandular cells: accuracy of cytologic diagnosis. Diagnostic Cytopathology, 1995, 13: 202-208. ↩

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