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This publication is available at https://www.gov.uk/government/publications/cervical-screening-gynaecological-cytopathology-external-quality-assessment/gynaecological-cytopathology-eqa-background-aims-and-governance
The NHS Cervical Screening Program (CSP) is committed to maintaining its internationally recognized record in innovation, service quality, use and development of evidence and data, education and public information.
Achieving high-quality output in all cancer screening activities is the foundation of all aspects of the plan. Clear professional accountability and governance structures support this concept.
One way the program achieves this goal is through the Gynecological Cytopathology External Quality Assessment (EQA) program.
The requirements of ISO/IEC 17043 promote the program management system defined in the quality manual.
This document provides guidance on:
It is applicable to NHS cervical screening laboratories in England, Wales, Scotland, Northern Ireland and laboratories outside the United Kingdom that have signed an EQA agreement.
At the center of the program is the assessment of the slide set by all staff reporting cervical cytology on behalf of the NHS CSP. It compares individual reports with consensus reports to determine whether the participant’s performance is within an acceptable range.
Each EQA year has 2 rounds (2 slides looping). The EQA year runs from April 1 to March 31.
There are 10 slides in each slide group in each round for performance analysis. The set can include up to 2 additional "special interest" slides. These are for educational purposes and are not included in the calculation of the final evaluation result.
The Quality Assurance Committee for Pathology (QAPC) is a multidisciplinary team responsible for the Royal College of Pathologists (RCPath):
QAPC achieves this goal through a specific subject group that reports to them. In turn, QAPC will work with failed laboratories and must also report persistent nonconformities to the Care Quality Committee (CQC).
Cytopathology NQAAP is responsible for overseeing the operation of histopathology and cytopathology EQA programs. The team oversees the annual activities of each program registered with the college, including investigations of individual pathologists or laboratories for continued unqualified performance.
The team promotes a unified EQA standard across the country. This is very important to ensure that the work of the cytopathology laboratory and its contribution to clinical services have a uniform high standard.
The program aims to provide an acceptable level of reliability and consistency through education, advice, and support for all participants.
The plan is dedicated to:
If you have any questions, please contact the national EQA team at PHE.csp-geqa-admin@nhs.net
Support is provided during normal office hours (9 am to 5 pm).
A dedicated EQA coordinator and management team are responsible for the daily operation of the plan.
The EQA coordinator is also responsible for:
PHE or its successors subcontracted out the role of plan organizer.
The associate plan organizer must:
The agent will provide operational security in the absence of the plan organizer. This includes:
The National Cervical Quality Assurance Officer has national responsibility for EQA as part of his cervical screening responsibilities. This includes:
The national EQA team is composed of staff with clear responsibilities to support the EQA coordinator and responsible for management, IT and data support. The cytology education manager (contracted with PHE Screening or its successor) is responsible for maintaining the national EQA program agreement. In the absence of these staff, the national team will provide appropriate cover.
The EQA Management Committee is responsible to the Joint Action Conference on Cervical Screening (JAM) or its successors. jam:
JAM is responsible to the PHE Screening Strategy and Management Team (SMG) or its successor, and can report any major issues related to the EQA plan.
EQA Online is a secure website that can be accessed via N3 or Health and Social Care Network (HSCN) connections. It provides a secure tool for existing participants to enter the results of their current round and view, download and print their personal reports.
Labs that do not have an N3 or HSCN connection can safely scan and email their EQA response form.
There is an agreement to participate in the EQA program between SQAS, the NHS cervical screening laboratory, and their staff reporting gynecological cytopathology for the NHS CSP.
The agreement also applies to private laboratories and laboratories outside the UK participating in the program. The agreement describes the general terms and conditions of the parties' participation. This requires periodic review.
All staff who report gynecological cytology for the NHS CSP must participate in the program. All employees, whether full-time, part-time, long-term or temporary work, must participate in the program.
Participation in the relevant accredited EQA program is a prerequisite for laboratories to register or maintain UKAS certification under ISO 15189.
The laboratory is responsible for notifying the national EQA team of any changes in service provision and staffing changes that may affect planned arrangements.
Participants are responsible for ensuring that they can only access the latest version of the program documents.
Where possible, the EQA team will make reasonable adjustments to facilitate all potential participants to access the plan. If staff have any special needs that may need to adjust the way they participate in EQA, the laboratory is responsible for notifying the national EQA team.
The program uses only ThinPrep™ liquid-based cytology (LBC) slides for evaluation. Participant documents related to historical SurePath™ assessments (for example, final results reports and participation certificates) are still available upon request.
The laboratory must accept all the terms and conditions described in the EQA agreement to promote employees to register for the program. The laboratory does not need to re-recruit staff every year.
The laboratory is responsible for properly keeping the EQA slides in each round and ensuring their quality for subsequent participants. The laboratory must immediately report the damage or breakage to the EQA coordinator via email. The EQA coordinator advises the laboratory on how to proceed in these situations.
The national EQA team manages all data input and results report management through EQA Online.
According to the preservation and storage of pathology records and specimens in the fifth edition of April 2015, the plan retains all plan documents, electronic and paper documents.
The EQA coordinator provides detailed instructions to the laboratory to ensure that the EQA slides are packaged and labelled correctly and safely and meet Royal Mail requirements. Slide transportation must be delivered by Royal Mail. This method tracks the package during transportation and upon receipt.
The laboratory can use other transportation methods, but it must be approved by the plan management. The laboratory must not use unauthorized methods of transporting slides.
Labs that do not meet the requirements of the agreement may be subject to the plan’s upgrade policy. Deletion from this plan will pose risks to laboratories that maintain ISO 15189 certification.
Students and interns who intend to pursue careers including cervical cytology are eligible to participate in the program for educational purposes if they work in NHS contract laboratories or private laboratories that provide cervical screening services for the NHS.
Performance analysis does not include the scores of students and interns. The laboratory manager must ensure that the group of employees discuss their results with the relevant training officer or supervisor.
Locum employees can participate in the national program and fully comply with all conditions and arrangements, if they work:
Please note that providing a satisfactory report or evidence of participation in EQA does not guarantee that you are eligible to work in a cervical screening laboratory contracted by the NHS or a private laboratory that provides cervical screening services for the NHS.
Staff working in private laboratories that provide cervical screening services for the NHS must fully comply with its conditions and arrangements.
The EQA agreement also describes the conditions for participation of employees working in private laboratories in the UK (not contracted with the NHS) and employees working in cervical screening laboratories outside the UK.
Employees working in private laboratories that provide non-NHS CSP screening may wish to subscribe to the plan. The participation of these people is not mandatory.
Individuals who choose to participate in the program to work in private laboratories must be aware that their answers are not included in the consensus calculation for determining the slide classification. In addition, their total score is not included in the statistical analysis used to determine individual performance.
Results and feedback to these participants were determined by comparison with participants who performed cervical screening for the NHS.
Based on operational capabilities and resources, the program is open to laboratories from outside the UK, provided they meet the specific terms and conditions of the EQA agreement.
Participants working in laboratories outside the UK must be aware that their answers are not included in the consensus calculation that determines the slide classification. In addition, their total score is not included in the statistical analysis used to determine individual performance.
Non-UK laboratories must declare professional accountability channels within their employment organizations and regulatory agencies in accordance with the terms and conditions of the EQA agreement. The plan reports continued unqualified performance to relevant regulatory agencies.
If the screening or report is not currently performed, the individual is not eligible to participate in the EQA program.
After initial registration, the EQA coordinator will direct participants to EQA Online, a secure website that provides general guidance and instructions on how to set up and manage their EQA account.
Participants must use the email address issued by the employer to set up and operate an EQA account. The EQA coordinator will recommend that participants who cannot use N3 or HSCN connections to access EQA Online use the established manual system for alternative arrangements for participation.
EQA Online will prompt participants to confirm that they have read and understood this document.
Participants who are unsure of any EQA Online content or program operation issues must contact the EQA coordinator for guidance.
Participants must be able to complete the EQA during the appearance of the slide in the laboratory.
The EQA coordinator can provide preparations for employees who are unavailable on the agreed EQA date for legitimate reasons (for example, due to pre-arranged annual leave or short-term authorized absences). The EQA coordinator may provide the slides on an alternate date at the end of the round or at another suitable point in the cycle (only one further date is provided). The local management is responsible for ensuring that employees are allocated time to participate in EQA as agreed.
Participants need to understand the consequences of not participating in EQA.
Individuals who are absent on the agreed EQA date or who do not participate without a valid reason will be classified as non-participants without a valid reason. This may result in substandard performance.
If an individual fails to participate in 2 of the 3 rounds without a valid reason, the EQA coordinator will pass the information to:
The legitimate reasons for not participating include:
The EQA coordinator communicates information disclosure responsibilities, responsibilities and procedures to all EQA employees, including those directly employed and contracted by PHE or its successors.
All participant data is confidential. All electronic data are stored in password-protected files or areas that only authorized EQA personnel can access. The paper-based data is stored in a secure, locked cabinet, and only authorized EQA personnel can access it.
Under the conditions of participation in the EQA plan determined by professional institutions through QAPC, the plan is confidential.
Participants may choose to waive confidentiality for the purpose of discussion and mutual assistance. They can also choose to waive confidentiality for regulatory or sanctioning purposes.
The program will not provide the identity of participants to any third party unless specified in the terms and conditions of participation. The EQA coordinator only provides the participant’s name and corresponding code:
Laboratory managers must have appropriate systems to monitor and review continuous employee participation and performance in EQA, and monitor trends in results when appropriate. The plan recommends that the laboratory record it in the departmental evaluation process.
At present, it is extremely unlikely that any government regulatory agency will directly request the results of participants from the program.
If the program receives a third-party request from the regulatory agency to obtain EQA results, the national EQA team will investigate and verify the source and validity of the request. The program will comply with valid and verified requests and notify affected participants of this action in writing within 5 working days.
PHE or its successors are subcontracted with the NHS cervical screening laboratory that provides EQA materials and the staff reviewing the materials. Providing the right materials and qualified personnel to perform the slide review is critical to the success and integrity of the plan.
NHS cervical screening laboratories or those laboratories contracted to provide cervical screening services for the NHS, are accredited or registered by UKAS, and are eligible to provide EQA materials.
The plan considers that employees have the following abilities:
Cervical screening laboratories that have not signed a contract with the NHS (including laboratories outside the UK) should first contact the EQA coordinator to determine their eligibility to submit slide materials or provide staff to conduct slide reviews.
All NHS cervical screening laboratories (or private laboratories that provide cervical screening services for the NHS) and laboratories deemed eligible (private in the UK or outside the UK) must submit slides in accordance with the terms and conditions of the EQA agreement.
During the EQA event, control measures have been taken to minimize the loss or damage of the slides, and the EQA coordinator will monitor this every year. The EQA coordinator records and reports any loss or damage to the stakeholder’s property, making it unsuitable for use in the program. Stakeholder property is physical property, including slides, participant information, and program data.
The total number of slides required for any given round is at least 3 times the number required. This is because as many as two-thirds of the slides may not be suitable for submission due to poor technical quality or lack of consensus on the classification of slides.
The laboratory must maintain records of slides and supporting documents submitted for EQA purposes.
The national EQA team will arrange to return all slides to the submitting laboratory at the end of the EQA year (or earlier).
The national EQA team provides feedback to the submitting laboratory based on the group consensus, and the laboratory needs to consider this information in the review and EQA performance monitoring process.
The EQA coordinator asked to make duplicate slides (repeats) from a single LBC sample from each laboratory. Labs can only submit duplicate slides to the program for inclusion in the EQA round. If the laboratory produces more than one copy from the same sample, the program will treat each copy as a completely separate case for EQA purposes. The laboratory must not assume the same consensus on each replicated slide.
The laboratory must provide good (not necessarily simple) examples of potential uses in EQA.
The slides selected for EQA cover the classifications recognized by the British Cytopathology Association (BAC). This includes:
For further explanation, please refer to the guidelines for laboratories that provide HPV testing and cytology services in the NHS CSP.
It may include slides that contain infection, but it is not required to record these on the response form. Interesting cases may be included to increase the educational value of the program. It does not include rare works, nor does it include slides from unusual or problematic cases of educational value.
If the slide shows:
For advanced (medium) or advanced (severe) slides with CIN2 or CIN3 (exact match is not required), histological confirmation is required.
The submitted slides must reach an internal consensus among staff, including cytology screeners, inspectors, and pathologists or consulting biomedical scientists.
Staff who can choose slides include cytology screeners, inspectors, consultant biomedical scientists, and pathologists. These individuals are qualified and trained to report cervical cytology and are currently reporting cervical cytology on behalf of the NHS CSP. These individuals are also responsible for assessing the suitability and technical quality of the slides for potential use in EQA.
Each slide submitted by the laboratory will provide:
Cytology samples showing low-grade nuclear abnormalities or border changes in squamous cells or endocervical cells may not have been followed up because the individual has returned to routine memories after colposcopy evaluation. In this case, histological confirmation may not be obtained, and slides belonging to these report categories do not require further slides or histology.
Negative or insufficient slides can be included in the EQA plan without the need for a second slide to confirm the classification.
If the laboratory only provides a copy of the report, it must be identified with the corresponding slide number. The laboratory must delete any patient-identifiable information in advance.
The laboratory is responsible for concealing any patient identification information on the slide before submission. The laboratory must obscure the names of patients and submitting laboratories for EQA rounds, but must not remove them from the slides. The laboratory must sufficiently label the slides so that the EQA coordinator can match the slides with the relevant accompanying information.
EQA does not allow dashed templates to be prepared for employees who "catch up" before participating.
The slides submitted by the laboratory will undergo further review before being included in the plan. The EQA coordinator is responsible for organizing the slide review.
The laboratory is responsible for providing qualified and competent personnel to conduct slide review. Cytology screeners, inspectors and pathologists/consultant biomedical scientists conduct the review.
Slide reviewers can report slides that they may have reviewed during the review process. In order to reduce the risk of being identified, the EQA coordinator anonymizes the slides during the review process, and if they are used in the EQA round, they will be anonymous again. The slide sets generated for EQA minimize the number of slides from a single laboratory.
The reviewer agrees to the slide classification consistent with the submitted laboratory opinion, patient history, or histology (for example, a high-grade nuclear abnormality (moderate) cytology report that matches the histological diagnosis of CIN II).
The expert group reached a consensus without knowing the classification of the submitted laboratory in advance. Reviewers evaluate the technical quality of the slides that receive EQA, including staining quality, mounting, and any cracks. The reviewer rejected any technically inadequate slides.
If the expert group's opinion is different from the submitted opinion and will lead to different management of the individual, the EQA coordinator will notify the original laboratory and return the slide immediately. For example, there may be disagreements on whether to report a slide as negative, inadequate, or abnormal. Alternatively, the agreed group opinion may be high-grade (moderate) or worse, and the laboratory may report the slide as a borderline change in squamous cells or endocervical cells, or low-grade nuclear abnormalities.
The medical director of the submitting laboratory is responsible for taking any necessary follow-up actions upon receipt of such notifications.
If participants discover any unexpected clinical findings (eg, sand bodies) during the EQA round, they must first bring the matter to the attention of the EQA coordinator. The EQA coordinator must talk to the plan organizer to confirm the results of the investigation and determine the actions required. The plan organizer must immediately contact the submitting laboratory to agree to take appropriate action. The submission trust is responsible for following up any clinical impact on the individual concerned.
The plan relies on the professional honesty of each participant to ensure that all their staff in the laboratory (excluding valid non-participants) will not discuss the case before completing and submitting their EQA response.
Participants are not allowed to pass on information during the EQA round to allow others to submit their own opinions. The plan defines such behavior as collusion.
At the beginning of each round of EQA, laboratory managers must emphasize the potential consequences of collusion. these are:
Laboratory managers must remain sensitive when dealing with substandard performance and provide support to underperforming employees. Underperforming employees must take advantage of the support provided by management.
These measures are in the interest of all participants and are aimed at avoiding adverse effects on personal performance.
If the individual has evidence or strongly suspects collusion, he must first notify the EQA coordinator. The program organizer must cooperate with relevant laboratories. The laboratory is responsible for investigating allegations at the local level and reporting to the plan organizers. The plan organizer must immediately escalate the proven or admitted collusion. The plan organizer must notify the NQAAP Chairperson of Cytopathology, individual employers, SQAS and relevant regulatory agencies.
Please refer to the procedures for reporting and investigating suspected collusion.
Funding for the program is included in the budget of its successor PHE screening department. Hiring laboratories must pay for the expenses incurred by individuals who need to go to another location to participate in EQA (such as absent personnel or staff).
The EQA program provides free cervical screening services to the NHS CSP for laboratories in England. The program charges fees for providing EQA programs to NHS laboratories outside of England and private laboratories that have not contracted with the NHS.
The EQA coordinator is responsible for the detailed operation plan directly or through their support team. The EQA coordinator provides participants with detailed information about the program, including their rights and responsibilities, before the EQA round. If participants cannot use the system, they can obtain this information through EQA Online or email.
The EQA coordinator is responsible for working with the laboratory to agree on the date when the slide will be received, continued to be transferred, or returned, as well as the deadline and time for submitting a response.
The EQA coordinator is responsible for understanding the location of each slide during the EQA round and recording this information.
The EQA coordinator selects the slides used in the EQA round. The EQA coordinator is responsible for establishing and maintaining a comprehensive slide library record.
The EQA coordinator must cover up any laboratory details that will disclose the source of the slides for the duration of the round. This information is not deleted from the slide, but is covered by a label that only displays the unique identification number of the slide and the device.
The EQA coordinator must check whether the laboratory has removed all dots or marks from the submitted slides.
In each new round, the EQA coordinator must change the order in which they distribute slide sets between laboratories. If repeated microscopy in the EQA round results in deterioration of staining, this will make the distribution of pale slides fairer. The EQA coordinator provides participants with instructions on handling the slides, storing the slides during EQA, and storing them before returning.
If the EQA slides are to be used in the third round, they must be re-evaluated in advance to ensure that their technical quality has not deteriorated. Slides reserved for future use or as an emergency measure must be stored in a suitable light-tight container in a locked drawer or cabinet.
The person in charge of the laboratory must immediately notify the EQA coordinator via email to report any slides damaged, damaged or lost during transportation or during the EQA round. The EQA coordinator will advise the laboratory manager on the next steps.
The nominated QA biomedical scientist must evaluate the slides and inform the EQA coordinator that the laboratory can repair the slides if the damage is not sufficient to disadvantage any participant, or remove the slides from the circulation. The laboratory shall not attempt to repair without the written consent of the submitted laboratory.
The program considers that lost or damaged (irrepairable) slides are non-consensus, and they are not included in the performance calculation. It is not possible to replace a damaged or damaged slide with another slide of the same category, because no 2 slides are the same. In this case, the EQA coordinator will notify the submitting laboratory of the damage.
At the end of the round, the EQA coordinator returns the broken or damaged slides to the submitting laboratory along with the remaining batches. If any slides returned to the EQA coordinator are damaged when received, the QA biomedical scientist will only attempt to repair it with the written consent of the submitting laboratory.
The EQA coordinator is responsible for loading and numbering the slide sets.
The EQA coordinator determines how many slides are needed to complete this round. When possible, at least 45 participants (not including trainees and participants working in a laboratory that only screens private works) will see each slide in a set. The plan has been solicited for comments and confirmed that there is no statistically effective minimum number of participants required for evaluation.
Each slide group contains 10 EQA slides and any additional slides for educational interest. These additional slides are clearly marked and do not form part of the assessment. The EQA coordinator used the following criteria to determine the final composition of the slide group:
The EQA coordinator selects slides from all categories recognized by the British Cytopathology Association (BAC). The slide set must contain a larger proportion of abnormal cases than seen in routine practice.
Each slide set should contain 2 to 6 negative or incomplete slides. The EQA coordinator must change the ratio of negative or insufficient slides to other types of slides in each round.
If the EQA coordinator uses multiple slides for the peer group, each group must include the same number of slides from each category in each round.
The EQA coordinator must use all categories in any EQA year (within two consecutive rounds). This includes:
The EQA coordinator randomly selects slides from the available set. The EQA coordinator tag is assigned to a collection dedicated to pathologists and consultant biomedical scientists.
Participants receive support information and instructions for use at the start of the EQA round and before the presentation of the slide group. The EQA coordinator will guide participants where and how to access relevant information online.
The EQA coordinator will use the manual system to send documents to participants via email before the start of the EQA round.
The manual version of the response form replicates the contents of the EQA Online version.
For manual systems, the EQA coordinator emails the response form to the laboratory contact for distribution to local participants.
In each round, one or more cytology screeners in each laboratory must add their EQA markers to the pathologist’s slide set. These people need to fill out a recommendation form. In addition to completing their own EQA, one or more inspectors must also evaluate each slide that the cytology screener believes may be abnormal and complete a standard referral form.
The laboratory manager or his designated deputy distributes the completed recommendation form to all participants viewing the pathologist’s slides. The laboratory retains the original referral form. There is no need to submit this form as part of the evaluation.
Each slide group is accompanied by slide information. For each slide in the collection, provide the following information:
The categories of slides included for educational interest, as well as any further comments, are attached to the slide group.
The EQA coordinator provides guidance to participants in written or electronic format, or provides a reference to the location of controlled documents. This includes instructions or actions taken regarding:
Participants check the EQA slides under conditions as similar as possible to those used in their daily practice. They will not be evaluated in an exam environment. Participants must compare their own diagnostic opinions with those of their peers. Participants are not allowed to discuss the slides in any way until all participants (excluding valid non-participants) view and record and submit their results.
In each round, there are 2 peer groups: cytology screeners and inspectors, and pathologists and consultant biomedical scientists. If the peer group uses multiple slides, the EQA coordinator will assign a set of slides to each participant. The EQA coordinator ensures that the number of participants in each group is sufficient to make the consensus calculation valid.
The slide category represents the category of slide results found in the daily workload. The nature and number of circulated slides and analysis of the results are key features of the plan.
Generally, the activities performed by non-medical personnel have two clearly identifiable levels: initial screening and examination. Currently, staff who are not medically qualified (except consultant biomedical scientists) will not report abnormal slides. They divided the slides into slides that they reported as negative or inadequate, and slides that they passed on to senior colleagues for further review. The program evaluates non-medical personnel based on their ability to distinguish between negative, inadequate, and abnormal slides. Many laboratories often encourage their inspectors to make classification recommendations. The scoring plan covers all employees to improve the educational effectiveness of the plan.
The individual performing the initial screening (usually a cytology screener and a biomedical scientist) decides whether the slide is negative, insufficient, or potentially abnormal. They submit the abnormal slides to senior staff for more detailed reports. Individuals who regularly undergo primary screening use unscreened and unlabeled slides for EQA.
There is no limit to the maximum time that a cytology screener can view a particular EQA slide. Since the evaluation conditions are similar to those in normal working practice, cytology screeners are expected to be able to screen 10 EQA slides in approximately 2 hours.
The program only evaluates cytology screeners on a set of slides and measures performance based on their ability to distinguish between negative, inadequate, and potentially abnormal slides, as well as any missing nuclear abnormalities. The plan requires cytology screeners to make grading recommendations for abnormal slides, and provide quantitative and qualitative feedback based on these opinions for personal educational purposes. This feedback is not included in the performance analysis.
In addition, cytology screeners can view and report slides used in the EQA program for pathologists and consultant biomedical scientists. The program treats their results as pure education, rather than using them in performance analysis.
The responsibilities of experienced cytology screeners and biomedical scientists vary. Inspectors usually perform some initial screening, quick review and check for abnormal cervical slides. An inspector, such as a cytology screener, reports a set of 10 unlabeled slides.
There may be some inspectors who only view the marked slides without any preliminary screening. The plan allows these people to perform their EQA on the marked slides. They report on all 10 slides in the slide set, not just those that have been marked. Before the inspector performs EQA, the cytology screener in the laboratory must mark the slides in accordance with the usual practice.
The inspector who receives the marked slide will not receive a copy of the cytology screener’s opinion. The program calculates the performance of those who do not perform preliminary screening in the same way as cytology screeners and those who perform preliminary screening.
For personal educational purposes, the inspector will receive quantitative and qualitative feedback on the anomaly classification. The program assessed their ability to distinguish between negative, inadequate and potentially abnormal cervical samples and any missing nuclear abnormalities.
Checkers can view and report slides in the EQA plan for pathologists and/or consultant biomedical scientists. The program treats their results as pure education, rather than using them in performance analysis.
The consultant biomedical scientist checks out the abnormal slides and provides management advice. They can also assume inspection responsibilities and report uninspected slides, effectively acting as their own inspectors. This protocol uses slides screened by cytology screeners and other inspectors, which is in line with laboratory routines.
Although the consultant biomedical scientist acts under the guidance of the consultant pathologist, they are not under his or her direct supervision. From an EQA point of view, it is appropriate to include them with the doctor.
There may be some consulting biomedical scientists to conduct preliminary screening. The plan does not expect these people to participate in EQA as cytology screeners.
The two main activities carried out by most pathologists who routinely report on the NHS cervical cytology screening program are as follows:
The program evaluates the performance of pathologists in providing opinions on slides identified as potentially abnormal and reviewing negative and inadequate slides that have passed preliminary screening. In addition to regular EQA, cytology screeners and inspectors may wish to participate in this type of EQA. The program does not use their answers for performance evaluation, nor does it include them in the final result analysis of the slide set.
For medical staff, the plan uses slides screened by cytology screeners and inspectors in accordance with routine laboratory practices. Different laboratories have different practices, but cytology screeners and inspectors usually mark the slides. If this is normal practice, EQA slides should be marked for evaluation. Pathologists and consultant biomedical scientists should know which slides are referenced by cytology screeners and examiners, but do not know the recommended classification provided by any group.
The response form used by medical staff when reporting slides complies with BAC recommendations, especially their cytopathology laboratory practices. This indicates that pathologists should look at all abnormal materials and a certain percentage of negative materials to ensure that the laboratory maintains accuracy and quality.
Pathologists have experience in screening unlabeled slides (especially re-screening negative slides when abnormalities are subsequently found), and re-screening entire slides when identifying ambiguous cell populations that require comment. The pathologist conducting the EQA assessment examines the entirety of each slide, including the slides that have been marked by the cytology screener and checker.
Choosing a cytological filter that screens slides in the collection of pathologists will label these as in routine practice. They pointed out (with an "R" on the recommendation form), any slides that they thought might be abnormal. The inspector then looks at the slides marked "R" and points out (marked with an "A" on the recommendation sheet) any slides that they believe may be abnormal by the pathologist or consulting biomedical scientist. The checker will also mark the slides as in regular exercises.
Then, pathologists and consultant biomedical scientists only use the reference table to perform EQA on the labeled slide sets (they still don't know the opinion of the cytology screener or inspector on the classification of the slides). Participants examine all EQA slides in the collection, and the pathologist or consultant biomedical scientist examines the entire slide, not just the areas marked as potential abnormalities.
All 10 slides are included in the evaluation. The program assesses the ability of pathologists and consultant biomedical scientists to distinguish between negative, inadequate, and abnormal slides, the grade of each abnormal slide, and any missing nuclear abnormalities.
Pathologists and consultant biomedical scientists may also choose to examine non-medical slides for educational purposes, and these scores are not included in the performance analysis.
Encourage trainee cytology screeners, trainee biomedical scientists and trainee medical personnel who intend to work in the field of cervical cytology to participate in EQA.
The plan has educational value for trainees. The plan evaluates them in the same way as qualified employees among their peers and excludes their results from any consensus calculations or performance analysis of the slide set.
If participants choose to view additional slide groups other than the EQA slide group assigned to them, the results of these additional groups will not be included in the performance analysis and will not be recorded on EQA Online.
All participants of the EQA program register their opinions on the cytological model on the EQA slide in a format consistent with the standard BAC report and standard request form (HMR 101).
For participants who cannot access EQA Online, a paper or electronic response form can be used.
The response form includes the following required fields:
Special interest slides are not part of the evaluation.
The EQA coordinator provides participants with instructions for completing any format forms they use. Participants should note:
Participants are responsible for entering their answers as expected. Participants cannot change their answers after submission. EQA Online will prompt participants to check and confirm their answers before submitting.
The EQA coordinator lets participants who submit responses via paper forms understand the penalties for transcription errors. The EQA coordinator scores the submitted paper forms. There is no opportunity to "modify" the table before marking. Individual participants are responsible for recording their answers correctly.
Participants using EQA Online must upload their results immediately after screening the slides while the slides are still in the lab.
All participants must keep written records of their responses after submission until the final results of the plan are released. This includes participants using EQA Online to record their results. This is to reduce the potential loss of EQA data in the event of an IT system failure.
Once all participants in the laboratory (or one of the peer groups) have viewed the EQA slides and recorded and submitted their results, while the EQA slides are still in the laboratory, the opinions provided by the submitting laboratory will be released to these participants By.
EQA Online provides temporary feedback in the form of submissions for review. The program provides temporary feedback in paper or electronic format for participants who cannot access EQA online. This allows individuals to compare their answers with submissions on EQA slides as early as possible.
Temporary feedback is temporary, and participants must not assume that it must be consistent with their final results. The interim report form clearly states that the results are confidential to individual participants.
The plan bases the final EQA results on consensus opinions that are only available at the end of the round.
The program provides confidential final feedback to each participant at the end of the EQA round. This is in a report (or series of reports) that includes the overall performance score in the plan. No verbal feedback on personal performance is provided.
The National Cervical Quality Assurance Director and the EQA Coordinator jointly authorize the release of reports to individuals after each round is completed. The plan publishes participant reports within 6 months of each round of allocation (the first round shall be no later than September 30, and the second round shall be no later than March 31 as far as possible). Participants must keep records of their performance in the proficiency test, including the survey results of any unsatisfactory results.
Performance results are a useful record for participants, although there are limitations to using these results to determine abilities. Successful performance may represent proof of ability in a particular round, but it may not reflect the individual's continued ability. Likewise, poor performance in a particular round may reflect a random deviation from the participant’s normal abilities.
After verifying and publishing the final result report, all eligible individuals will receive a certificate of participation. All qualified laboratories will also receive a certificate of participation.
The program uses a consensus protocol to conduct a final analysis of the performance of the participants. This scheme is based on the "correct" classification of the slides based on the consensus opinion determined at the end of the round, and is based on the 80% consensus of the results of the participants in each peer group.
In the appropriate peer group that has submitted valid responses for the EQA slide, at least 80% of the participants will agree with their classification of the slide. This type of calculation only considers the EQA responses of participants who participated in the initial screening or issued a report for the CSP. The plan does not include responses from participants working in laboratories, which only conduct private screening from consensus calculations.
If the participant fails to provide a response for the slide, or provides multiple responses for the slide, the program excludes it from the consensus calculation for the slide and scores it according to the guidance.
To simplify data processing and calculations, the EQA coordinator keeps a response record for each EQA slide by participant number (not name).
Automatic electronic calculations of consensus scores are acceptable, provided that these calculations have been reviewed and verified before.
Although the calculation of consensus results in delays in providing final feedback to participants, the difficulties inherent in reaching agreement on cytological classifications mean that this approach is necessary.
If the consensus opinion is significantly different from the opinions submitted to the laboratory and the review team, the EQA coordinator will notify the laboratory and return the slide immediately.
This includes any slides where there is a mismatch between the submitted comments and the consensus opinion, that is, whether the slides are negative, insufficient, or abnormal. It is also applicable to slides that 80% of pathologists agree that there is a high degree of nuclear abnormality (moderate) or more serious, submitted as follows:
The program scores participants based on consensus opinions.
The medical person in charge of the submitted laboratory is responsible for taking any necessary actions after the submitted opinions do not match the consensus opinions.
This scheme uses a consensus protocol on the reactions of all active participants in the peer group to negative, inadequate, and abnormal slides.
In order to calculate the consensus agreement on the distinction between negative, inadequate and abnormal slides, the code on the response form considered abnormal is:
If all participants submitted the same answer to each slide classified as negative, inadequate, or abnormal, the unanimous agreement on the slide is 100%. For the suggested multiple classification slides, the scheme uses the classification calculation consensus protocol with the largest number of responses, as shown below:
Consensus percentage = highest number of participants who gave the same category ÷ total number of participants who answered the slides effectively x 100
Missed nuclear abnormalities were defined as negative or inadequate slides reported by participants, which were consistently classified as nuclear abnormalities.
This is calculated by assessing whether all low-grade nuclear abnormalities or more severe reactions in the group total 80% or more.
This scheme uses a consensus protocol for grading abnormal slides for all valid opinions reported by each peer group on the slides. The plan provides grading consensus for cytology screeners and inspectors, and is only used for educational feedback.
The plan uses only the consensus opinions and scores of the pathologist and the consultant biomedical scientist to grade the EQA response abnormality slides of the pathologist and the consultant biomedical scientist.
If the consensus consistency (calculated in section 6.4) of the abnormal classification of a particular slide is 80% or higher, the program calculates the grading consensus of the slide as follows:
Consensus percentage = the highest number of participants who gave the same score ÷ total number of participants who answered the slides effectively x 100
This scheme allows the merger of adjacent levels to reach 80% consensus. This scheme combines the level with the highest consensus level and the level with the second highest consensus, provided that the two levels in question meet the following groupings:
If merging the boundary changes of different categories still fails to reach an 80% consensus, the program allows merging with the third level (low-level nuclear anomalies). Similarly, this scheme allows adenoma categories to be combined with each other or another adjacent level to reach consensus. The program also allows for the merging of two adenoma formation categories plus one other adjacent level (having the third highest consensus level).
In the unlikely event that the categories on either side of the level with the highest consensus level have the same percentage of consensus, please follow the guidance given in the level consolidation table.
These combinations are for scoring purposes only and may not be compatible with any specific management recommendations.
This solution removes slides that are not reported as negative, inadequate or abnormal with 80% consensus from any performance analysis. This means that participants are only scored based on the remaining slides in the set that have reached consensus. In order to be statistically valid, a consensus must be reached on at least 6 slides in any group.
If a slide has at least 80% consensus on the abnormal classification, but the grading of the slide does not reach 80% consensus (even if adjacent grades are combined), no score is assigned to the grading.
Refer to the table to illustrate the merging of levels when adjacent levels have the same consensus.
The program only scores the slides that are 80% of the participants’ EQA slide group
The program scores the consensus of each slide calculated by participants from laboratories that only conduct private screening work based on the answers of participants working in the NHS CSP.
The basis of the EQA scheme is usually an 80% consensus agreement, which may or may not be correct.
Cytology screeners and checkers are labeled according to their ability to distinguish between negative, inadequate, and abnormal slides (NIA score), as follows:
Slide correctly interpreted as negative or insufficient or abnormal = 2 points.
The incorrect explanation may be because the slide has:
Please refer to the scoring matrix for cytological filters and checkers.
If the cytology screener and the inspector have reached a consensus that the slide shows nuclear abnormalities (80% or more of the participants classify it as low-grade nuclear abnormality or more severe), the plan will record the report slide Participants who are negative or inadequate because they missed a nuclear abnormality. This counts as substandard performance.
In order to increase the educational value of the program, qualitative and quantitative cytology screeners and inspectors will receive feedback on the grading of abnormal slides.
The program scores pathologists and consultant biomedical scientists based on their ability to distinguish between negative, insufficient, and abnormal slides (NIA score).
In addition to the NIA score, the scheme also assigns additional scores to the scoring of consensus abnormal slides:
Correct scoring of the slide = 2 points.
Slide rating within a category on either side = 1 point.
The category of the slide whose score is wider than either side = 0 points.
Participants will not lose their mark because the report slides consistently report that changes in squamous cell boundaries are changes in cervical canal cell boundaries, and vice versa.
See the scoring matrix for pathologists and consultant biomedical scientists.
If the pathologist and consultant biomedical scientist show that the slide shows an 80% consensus that shows a nuclear abnormality (80% or more of the participants classify it as low-grade nuclear abnormality or more severe), the program will record the slide show Participants with negative or inadequate film ratings: Missed nuclear abnormalities. This counts as substandard performance.
If a participant fails to check a box on the response form of a slide, or check multiple boxes on a slide, it will be considered as overcall or undercall, as shown below.
If the participant does not check any boxes, no mark will be given. If the consensus report is a nuclear anomaly, this is counted as a missing nuclear anomaly, and therefore is an unqualified performance.
If the consensus is abnormal, the slide is correctly classified as abnormal (NIA score) and given 2 points, and then the tick box farthest from the consensus level is used for scoring. For example, if the participant checked both low-grade nuclear abnormality and high-grade nuclear abnormality (severe), and agreed that it was invasive squamous cell carcinoma, then the marker would be as if the participant only checked low-grade nuclear abnormality. If the consensus is negative or insufficient, the participant will get zero points.
If the participant checked Negative or Abnormal and Abnormal, no mark will be given. If the consensus is a nuclear anomaly, this is counted as a missing nuclear anomaly, and therefore the performance is substandard.
If one box is marked as unqualified and one is marked as negative, no mark is given. In the case where the consensus is a nuclear anomaly, this is a missing nuclear anomaly, so the performance is substandard.
If a participant gives 2 or more responses to a slide, the consensus calculation does not include those responses for that slide.
To ensure that the scores in the same age group (cytology screeners and inspectors or pathologists and consultant biomedical scientists) are comparable, the total score of each participant is converted to the possibility of the specific slide group used Percentage of scores (in any non-consensus slides have been deleted).
% Score = Participant’s score ÷ Maximum possible score of the slide set x 100
The program generates separate score lists for cytology screeners and examiners, pathologists and consulting biomedical scientists. The program lists the scores by participant code and arranges them in order of percentage scores. The reported score does not include interns or laboratory personnel who did not participate in the NHS CSP.
This scheme expresses the percentage score as two decimal places, rounds the value of the third decimal place down to 4, and rounds up values of 5 or more.
The individual performance assessments of the two groups of participants were different.
For cytology screeners and examiners, the program assesses the individual’s performance in distinguishing between negative, inadequate, and abnormal slides. It also counts any missed nuclear anomalies.
For pathologists and consultant biomedical scientists, the program assesses the individual’s performance in distinguishing between negative, inadequate, and abnormal slides, the cytological pattern grading of abnormal slides, and any missing nuclear abnormalities.
The plan stipulates the unqualified performance as:
You can use the built-in function key (fx) on the toolbar to calculate the bottom 2.5 percentage points in Excel. Percentile functions belong to the category of statistical functions. The "array" of the data is all the percentage scores in the ranking, and the "K" value is the percentile value sought, expressed as a decimal (for example, 0.025). The value obtained is the bottom 2.5 percent of all results. For the purpose of EQA performance evaluation, the program will determine the results below this value as unqualified.
Automatic electronic calculations of a minimum of 2.5 percentage points are acceptable, provided that the plan has previously reviewed and verified these calculations.
You can also manually calculate the score for the 2.5th percentile, as shown in the following example:
The calculation is based on the EQA round and consists of 68 percentage points, ranging from 100% at the upper level to 60% at the lower level. The second-lowest participant (R2) scored 66%; the third-lowest participant (R3) scored 72%.
Where a is an integer representing the result of the score ranking position, b is a score representing the difference ratio of the score at (a) and (a+1), P is the percentile (0.025), and N is the number of participants (68) .
Since a = 2, the score of the second lowest participant is used as the baseline; if the calculation result a = 1, the score of the lowest participant will be used as the baseline, if the result a = 3, the score of the third lowest participant will be used. So on and so forth. When a = 2, the value of b 0.675 is related to the ratio of the difference between the scores of the second-lowest and third-lowest participants (if a = 1, the value of b will be related to the scores of the lowest and second-lowest participants Wait).
Calculate the ratio difference between 2 numbers as follows:
Calculate the required percentile by adding this difference to the score of the second lowest participant (a = 2 in the first part of the calculation), as follows:
Any score below 70.05 is below 2.5 percentage points and is considered unqualified performance.
Due to the nature of the scoring system, in some cases, there may be individuals with a score equal to 2.5 percentage points and no score below that value. In this case, the plan does not consider these people to show substandard performance.
Participants from private (non-NHS contracted) laboratories or overseas laboratories, after calculating other participants, compare their percentage scores with 2.5 percentage points. Therefore, their personal percentage scores are not included in the calculation to determine the 2.5 percentile.
This scheme identifies unqualified performance by arranging the scores of each peer group in the order of each cycle's rank. The program classifies individuals with scores less than 2.5 percentage points as unqualified in the EQA round.
The program identified the missing nuclear abnormalities as negative or inadequate slides reported by the participants, and the slides had the consensus classification of the related nuclear abnormalities group. This is achieved by combining all the effective responses of low-grade nuclear abnormality, high-grade nuclear abnormality (moderate), high-grade nuclear abnormality (severe), invasive squamous cell carcinoma, cervical tube type adenoma and adenoma (non-cervix) .
If a participant scores below the 2.5 percentile and misses a nuclear anomaly, this will be considered a single instance of unqualified performance in the round.
Any participant who does not meet the standards will receive a confidential letter informing them of this and providing support from the plan organizers. Although this does not constitute a continuous disqualification, the program encourages employees to discuss results of this nature with their training officer or line manager.
The program defines continuous substandard performance as 2 of the 3 consecutive rounds of EQA:
After each round, the results will be analyzed based on the participants' latest 3 rounds of EQA results to determine continued substandard performance. The EQA coordinator will record the participant’s previous scores and attach comments to make it easy to identify continued substandard performance.
The program did not classify participants as exhibiting persistent substandard performance in a single round of results. For example, if a participant misses nuclear anomalies two or more times in a round, or misses nuclear anomalies one or more times and is also less than 2.5% in that round, his or her performance is rated as not Qualified, but not as a continuous substandard performance.
NQAAP (Histopathology and Cytopathology) defines when the participant reaches the point of action and the subsequent remedial measures taken.
When the plan recognizes their continued substandard performance, the participant reaches the first point of action.
When the participant reaches the second action point when the performance in 2 out of 3 consecutive rounds is still substandard after reaching the first action point. Continuous substandard performance is determined on a "rolling" basis (using the results of the last 3 consecutive rounds). After the first action point is triggered, a failure to perform in any of the next 2 rounds means that the participant has reached the second action point.
View examples of various combinations of results that can lead to the first and second action points, depending on the individual’s continued substandard performance patterns.
The specific actions taken by the participants when they reach the action point are different for each peer group.
Participants who are determined to be persistently substandard need to develop and implement a remedial action plan. Participants (together with the laboratory manager if necessary) will submit a statement to the plan organizer to confirm and provide evidence that the plan has been implemented and appropriate actions have been taken.
The recommended components of the remedial action plan are:
Non-UK laboratories declare their professional responsibilities within their employment organizations and regulatory agencies in accordance with the terms and conditions of the EQA agreement. The EQA plan reports persistent substandard performance to relevant regulatory agencies.
The plan treats any concerns or negative comments related to any aspect of its operations or management as complaints. Program participants are welcome to express concerns or make suggestions for improvement via email, phone or letter. The national EQA team actively seeks feedback (positive and negative) through the national annual survey and participant forum.
The plan defines the term "complaint" as dissatisfaction or criticism of EQA operations or management. If the communication shows the specified criteria, the plan will treat it as a complaint. The EQA coordinator records all communications, takes action as needed, and uses them to help identify system improvements.
The complaint will first be sent directly to the EQA coordinator phe.csp-admin-geqa@nhs.net. If the complaint is not resolved, the individual concerned can directly complain to the plan organizer. If the problem is still not resolved, participants can submit their complaint to the chairman of the EQA Management Committee. The decision of the management committee is final.
The complaint procedure describes how participants complain about any aspect of the operation or management of the program.
If EQA participants wish to appeal their performance evaluation or results, they must first contact the EQA coordinator via phe.csp-admin-geqa@nhs.net. In the case of escalation, participants can request that their appeal be escalated to the plan organizer.
If the problem is still not resolved, participants can submit their complaint to the chairman of the EQA Management Committee. The decision of the management committee is final.
The appeal process describes how participants can appeal their assessment of their EQA performance.
When opportunities for improvement are identified, or when nonconformities in the process are identified and corrective and/or preventive actions are required, the agreement may change.
All participants must confirm through EQA Online or by submitting a written statement that they have read and accepted the terms of the agreement.
Changes may also occur due to feedback from participants or direct requests from the operations team, steering group, or management committee.
The plan uses change control procedures to determine and manage the priority of all changes. The EQA coordinator informs participants of the agreed plan changes and their effective date.
The participant meeting provides a forum for staff to view comparisons of plan results, discuss the operational aspects of plans, and review any challenging slides and educational cases. Meetings can be held face to face or virtual.
The EQA operations team is responsible for managing the feedback from the participants in the annual meeting and providing summaries in the annual report.
The annual meeting is open to all employees. Encourage the laboratory to send at least one staff member, and then they can pass the information to colleagues.
The EQA operations team is responsible for setting the scope of the audit strategy and preparing the internal audit plan. The EQA Management Committee is responsible for authorizing the review of strategies and plans, and making adjustment recommendations when deemed necessary.
If the audit result shows that the non-conformity has affected the participant's EQA result, the plan organizer is responsible for notifying the participant.
The National Cervical Quality Assurance Officer is responsible for all communications related to UKAS and meets the overall requirements of external evaluations.
The summary of audit activities is included in the annual report.
The program regularly uses short surveys to obtain feedback or opinions from participants on actual or proposed program activities.
Encourage all participants to complete an annual survey to record their satisfaction with EQA services, or use this as an opportunity to provide constructive criticism, comments and suggestions for improvement.
The EQA operations team manages the results of the participant survey and includes a summary in the annual report.
The plan prepares annual reports for the following projects:
The annual report includes a summary of the participants’ results and is widely distributed within the plan and among key stakeholders. The EQA coordinator distributes the annual report at the end of the second quarter of each fiscal year.
Provide procedures for reporting and investigating collusion or any witnessed or strongly suspected behavior, whether intentional or not, these behaviors may compromise the validity of EQA results and thus the integrity of the plan.
This procedure applies to all program participants and EQA employees.
Participants are not allowed to pass on information during the EQA round to allow others to submit their own opinions. The plan defines such behavior as collusion. The plan takes collusion or any act that threatens the integrity of the plan seriously and reports it to the highest authorities.
All individuals are responsible for reporting collusion or any behavior that may undermine the integrity of the plan.
The plan organizer is responsible for responding to reported allegations of collusion. The plan organizer is responsible for cooperating with the individuals involved and the appropriate laboratory manager.
The appropriate laboratory manager is responsible for any local investigations and informs the plan organizer of the results.
If the investigation proves collusion, the person in charge of the appropriate laboratory must submit the matter to the relevant professional regulatory agency and notify the plan organizer.
First, if the individual witnesses or strongly suspects collusion, the EQA coordinator must be notified in writing. The EQA coordinator submits the information to the plan organizer.
This guide provides procedures for handling complaints from any individual who is dissatisfied with any aspect of the operation or management of the plan.
This procedure applies to all participants and EQA employees.
If a complaint is filed, it is the individual's responsibility to follow the procedure. EQA employees are responsible for taking appropriate actions and providing solutions within the specified time frame.
Individuals and EQA staff are responsible for keeping the complaints between the complainant and the plan confidential. The plan will deal with all issues that might treat a complaint as a formal complaint and treat it as confidential.
If individuals wish to lodge a complaint, then they must write to the EQA coordinator.
This guide provides procedures for dealing with participants when they appeal their EQA performance evaluation.
This procedure applies to all participants.
Participants are responsible for promptly appealing the assessment of their EQA performance. EQA employees are responsible for taking appropriate actions and providing solutions within the specified time frame.
If participants wish to appeal their EQA performance assessment, they can write to the EQA coordinator within 28 working days after receiving the final result report.
The EQA coordinator will send a deferred response within 3 working days after receiving the appeal.
The EQA coordinator records the appeal along with a summary of communications and follow-up discussions that may involve other EQA employees (including plan organizers).
The appellant is expected to receive a reply providing a solution within 20 working days.
If the problem is not resolved to the satisfaction of the appellant, the EQA coordinator will submit the problem to the plan organizer. The program organizer will provide a response within 28 working days.
If the problem is still not resolved to the satisfaction of the appellant, the plan organizer will report it to the EQA Management Committee. The decision of the EQA Management Committee is final. The appellant can get a final reply within 28 working days.
Do not include personal or financial information, such as your National Insurance number or credit card details.
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