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Thyroid Fine Needle Aspiration
(FNA) Cytology:

Implementation of a standardised and
reproducible terminology system

Provided by: Portsmouth Acute Hospitals NHS Trust on behalf of
The Royal College of Pathologists Working Group on Thyroid FNA
Cytology

Publication type: Quality and productivity example

QIPP Evidence provides users with practical case studies that address the quality
and productivity challenge in health and social care. All examples submitted are
evaluated by NICE. This evaluation is based on the degree to which the initiative
meets the QIPP criteria of savings, quality, evidence and implementability; each
criterion is given a score which are then combined to give an overall score. The
overall score is used to identify the best examples, which are then shown on NHS
Evidence as ‘recommended’ or ‘highly recommended’.

Our assessment of the degree to which this particular case study meets the criteria is
represented in the evidence summary graphic below.

Evidence summary

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Details of initiative

Purpose

To improve the quality of terminology and the reporting of thyroid
cytology diagnoses and thus improve the service quality for
patients.
This initiative demonstrates the effectiveness and clinical
usefulness of The Royal College of Pathologists

’ (RCPath)

guidance on the reporting of thyroid cytology specimens, an
evidence-based terminology and reporting guideline for
preoperative diagnosis of thyroid lesions.

Description
(including scope)

Fine Needle Aspiration (FNA) is a technique used to improve the
clinical management of thyroid lesions. Previously there was no
standard approach to reporting thyroid FNA, and in some
instances unnecessary surgery was performed. By using a
standardised approach, such unnecessary surgery should be
reduced.

The introduction of a standardised and reproducible terminology
system for diagnosis of a particular condition should reduce the
need for unnecessary investigations and operations. It will reduce
patient morbidity and thus save on NHS treatment costs. The
RCPath working party produced an evidence-based guideline for
the reporting of thyroid cytology specimens in November 2009.
The guideline was based onThe Bethesda System for Reporting
of Thyroid Cytology (TBSRTC). Because this is national RCPath
guidance this reporting system will be implemeted by most if not
all pathology providers within the UK, including all NHS trusts that
provide pathology services such as Portsmouth Acute Hospitals
NHS Trust.

In the UK, any FNA where malignancy is considered a possibility
must be reviewed and the treatment agreed in a site specific
thyroid or head and neck cancer multidisciplinary team meeting
(MDT). The TBSRTC does not require a review of the diagnosis
in an MDT so, in this respect, the RCPath classification is slightly
different to TBSRTC. For futher explanation of the two systems
see Appendix 1.

There has been a lack of national and international consensus
about how to use the results of thyroid FNA cytology to guide
clinical management. Thyroid nodules occur in around 1 in 20 of
the population. Most are benign, but a minority are cancerous.
FNA cytology is the mainstay of preoperative diagnosis of thyroid
lesions and it saves unnecessary surgery.

Topic

Right care and clinical rationalisation.

Other information

With current practice, 50% of excised nodules are found to be

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malignant (Yassa et al 2007) compared with 14% before the
advent of FNA (Hamberger, 1982). Despite this there has been
no overall international agreement on diagnostic terminology, or
how to use thyroid FNA results in the clinical MDT setting.

The use of RCPath guidance is automatically mandated in
Cancer Networks by NHS Cancer Peer Review/COG Guidance.
An interobserver reproducibility study to demonstrate the
diagnostic effectiveness of the RCPath classification (Kocjan et al
2011) confirmed that it is reproducible and thus clinically useful.

Six members of The Royal College of Pathologists Committee
independently examined 200 representative thyroid FNAs,
representing a range of diagnostic thyroid lesions. The results -
expressed as non-parametric kappa statistics - showed that most
of the diagnostic categories were moderately reproducible, with
kappa scores of 0.6 or above.

Gate 1: Savings delivered/anticipated

Amount of savings
delivered/anticipated

Difficult to precisely quantify as the amount of cost savings would
depend to some extent on the operative policy of each head and
neck/thyroid MDT. As yet, no complete savings data are
available.

Type of saving

All savings at this stage relate to improved productivity.

Any costs required to
achieve the savings

Minimal costs required to implement this terminology within any
single organisation.

Programme budget

Cancers and tumours.

Details supporting
Gate 1

Introduction of a standardised and reproducible terminology
system for diagnosis of a particular condition will reduce the need
for unnecessary investigations and operations thereby reducing
patient morbidity and thus save on NHS treatment costs.

With current thyroid FNA practice, more than 50% of resected
nodules are found to be malignant. Therefore, it is not just the
volume of surgery that is expected to decrease; surgical
management can be targeted towards patients with neoplasms
rather than benign disease.

For example, most patients with a THY 5 diagnosis after MDT
review and discussion will be able to proceed to definitive surgery
(total thyroidectomy) rather than a two stage procedure
(lobectomy followed by completion thyroidectomy) in the majority
of cases.

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Gate 2: Quality outcomes

Impact on clinical
quality

Introduction of a standardised and reproducible terminology
system for FNA Cytology will improve quality by:
i) Improving the comparability of diagnostic results between
centres to enable audit and quality control.
ii) Improving the practice of the technique by allowing guidelines
to be set for inadequate rates, false positive and false negative
diagnoses based on national data collection which can then be
audited.

Impact on patient
safety

Standardisation of terminology is expected to improve patient
safety and reduce risk to patients as any positive result will be
identified and acted upon quickly.

Impact on patient and
carer experience

Not anticipated to have any impact on patient and carer
experience. However, as the reporting of results will be
standardised across the UK, patient and service user confidence
in the technique will be increased..

Supporting evidence

The initiative will identify some areas where further research is
needed.

The initiative could have an impact on clinical outcomes as
patients will be treated more appropriately. Prior to the routine
use of thyroid FNAC, only 14% of surgically-resected thyroid
nodules were found to be malignant. With current thyroid FNA
practice, more than 50% of resected nodules are found to be
malignant. Therefore, it is not just the volume of surgery that is
expected to decrease; surgical management can be targeted
towards patients with neoplasms rather than benign disease.

The new terminology will aid better communication between the
clinician and patient. Each diagnostic category in the new
terminology is associated with a certain cancer risk. Clinicians
and patients will have greater certainty of the risk of malignancy
for a given thyroid lesion and cytological diagnosis.

Gate 3: Evidence of effectiveness

Evidence base for
initiative

Change arises from published research evidence such as
systematic review or guidance (see contacts and resources
section). The evidence base is the extensive review of the
literature and a web-based discussion forum which was
undertaken by the Bethesda working group in 2007.

Evidence of
deliverable from
implementation

Portsmouth Acute Hospitals NHS Trust have implemented this
guidance, as have most if not all other NHS acute trusts in the UK
which provide pathology services.

Where implemented

NHS England, Scotland, Wales and Northern Ireland.

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Degree to which the
actual benefits
matched
assumptions

Same as expected.

If initiative has been
replicated how
frequently/widely has
it been replicated

It is likely that many other countries in Europe will also adopt a
similar system for thyroid FNA terminology.

Supporting evidence
for Gate 3

As the guidance was only published in November 2009, it is too
early to assess the formal results. The monitoring of compliance
with the use of the new RCPath terminology system will be via
laboratory accreditation inspections or similar and by annual
cancer peer review self assessment of cancer units, cancer
centres and cancer networks and by on site inspections. As
expected, all pathologists started to use the new RCPath
terminology immediately after its publication (December 2009).

Gate 4: Details of implementation

Implementation
details

Through published national guidance from The Royal
College of Pathologists to Cancer Networks.

Time taken to
implement

Can be achieved quickly: 0-3 months. Implementation of a
standardised terminology sytem can be addressed via
documentation and training.

Ease of
implementation

Implementation of this naming system affects one
department.

Level of support and
commitment

Whilst implementation of this naming system affects one
department or team, a number of stakeholders throughout the
wider SHA will require a working knowledge of this terminology.

Barriers to
implemenation

None

Risks

None

Supporting evidence
for Gate 4

This is the first published attempt to establish the interobserver
reproducibility of thyroid FNA using kappa statistics that has ever
been undertaken with more than two observers across the full
range of thyroid diagnostic lesions.

Further evidence

Dependencies

None yet identified.

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Contacts and resources

Contacts and
resources

If you require any further information please email:

[e-mail]

and we will forward your enquiry and

contact details to the provider of this case study. Please quote
QIPP reference 10/0083 in your email.

Dr David Poller, Portsmouth Acute Hospitals NHS Trust, on
behalf of The Royal College of Pathologists Working Group on
Thyroid FNA Cytology; Dr A Chandra, Dr P Cross, Dr T Giles, Dr
S J Johnson, Dr G Kocjan, Dr D Poller, Prof T Stephenson.

Ali SZ, Cibas ES. The Bethesda System for Reporting Thyroid
Cytopathology. Defintions, Criteria and Explanatory Notes.
Springer, London 2010

Baloch ZW, LiVolsi VA, Asa SL, Rosai J, Merino MJ, Randolph G,
Vielh P, DeMay RM, Sidawy MK and Frable WJ. Diagnostic
Terminology and morphologic criteria for cytologic diagnosis of
thyroid lesions: a synopsis of the National Cancer Institute
Thyroid Fine Needle Aspiration State of the Science Conference.
Diagnostic Cytopathology 2008;36:425-37

Hamberger B, Gharib H, Melton LJ et al Fine needle aspiration of
thyroid nodules. Impact on thyroid practice and cost of care Am J
Med 1982;73: 381-4

Kocjan G, Chandra A, Cross PA, Giles T, Johnson SJ,
Stephenson TJ, Roughton M, Poller DN, The interobserver
reproducibility of thyroid fine needle aspiration using the UK Royal
College of Pathologists Classification system. Am J Clin Pathol
2011;135:852-9.

Yassa L, Cibas ES, Benson CB et al., Long term assessment of a
multidisciplinary approach to thyroid nodule diagnostic evaluation,
Cancer 2007;111:508-16.

ID: 10/0083
Published: June 2011
Review due: June 2012

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Appendix 1: Comparison Table of The Royal College of Pathologists’ Thyroid FNA

Classification and The Bethesda System for Reporting Thyroid Cytopathology

RCPath

Bethesda

Non-diagnostic for cytological diagnosis (Thy1)

I. Non-diagnostic or unsatisfactory

Virtually acellular specimen

Other (obscuring blood, clotting artefact, etc.)

Non-diagnostic for cytological diagnosis

—Cystic

lesion (Thy1c)

Cyst fluid only

Non-neoplastic (Thy2)

II. Benign

Consistent with a benign follicular nodule (includes adenomatoid nodule,

colloid nodule, etc)

Consistent with lymphocytic (Hashimoto) thyroiditis in the proper clinical

context

Consistent with granulomatous (subacute) thyroiditis

Non-neoplastic, cystic lesion (Thy2c)

Neoplasm possible

—atypia/non-diagnostic(Thy3a)

III. Atypia of undetermined significance or follicular lesion of undetermined

significance

Neoplasm possible, suggesting follicular neoplasm

(Thy3f)

IV. Follicular neoplasm or suspicious for a follicular neoplasm

Specify if Hürthle cell (oncocytic) type

Suspicious of malignancy (Thy4)

V. Suspicious for malignancy

Suspicious for papillary carcinoma

Suspicious for medullary carcinoma

Suspicious for metastatic carcinoma

Suspicious for lymphoma

Other

Malignant (Thy5)

VI. Malignant

Papillary thyroid carcinoma

Poorly differentiated carcinoma

Medullary thyroid carcinoma

Undifferentiated (anaplastic) carcinoma

Squamous cell carcinoma

Carcinoma with mixed features (specify)

Metastatic carcinoma

Non-Hodgkin lymphoma