UK NEQAS for Cellular Pathology Technique Participant Manual 2016 -17 (Edition 14) Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics www.ukneqascpt.org.uk 2|Page Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Index Page General Information 5 Contact Us 6 Scheme Enquiries 7 Purpose and Scope 8 Benefits to Participants 9 Ethical Considerations 10 Organisation 11 Objectives 12 Assessment and Reports 14 Quality Assessment: Terms and Conditions 15 Responsibilities 16 Participant Responsibilities 17 Confidentiality 18 Information Governance 19 Registration and Subscription 20 Specialist Schemes 22 Assessment Material 26 Slide Submission 28 Assessment Procedure 29 Interpretation 30 Submission Deadlines 32 Repertoire 33 Restricted Repertoires 36 Accessing Online Reports 37 Appeals 41 Performance Monitoring 42 Education and Audit 44 Complaints 46 Associated Documentation 47 3|Page Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics 4|Page Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics General Information This document is designed as an insert for the UK NEQAS for Cellular Pathology Technique (CPT) folder and, together with Run Reports and other material you may be sent, comprises a “User Manual”. Please take the time to study all the sections and to familiarise all of the staff in your laboratory / organisation with the contents of the manual. UK NEQAS for CPT is unique and a world leader in its field. UK NEQAS for CPT is the result of many years of development and evolution in the field of Cellular Pathology Technical External Quality Assessment (EQA) / Proficiency testing. To enable us to provide the best service possible to our participants, this process will continue and changes to this document will be inevitable. Updated versions will be made available and all participants must make sure they have the most recent edition and that all other editions are destroyed. This is a necessary part of the document control procedure of this Scheme and is a requirement of ISO / IEC 17043:2010(E) standards. Electronic copies of this document can be found in PDF format on the UK NEQAS for CPT website at www.ukneqascpt.org.uk Reference ISO / IEC 17043:2010(E) 4.9 Communication with Participants 5|Page Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Contact Us For security and confidentiality reasons, anyone contacting UK NEQAS for CPT, by email, telephone or in writing, must quote their unique participant number. This will enable UK NEQAS for CPT to deal with your queries more efficiently and effectively, and will enable any changes to your participant entry on our office or royal mail systems, to be made. Responses to any queries directed towards UK NEQAS for CPT without a participant number may be seriously delayed as a result. Please see sections on “Confidentiality” and “Scheme Enquiries” for further information. General enquiries [email protected] or contact Lynne Brown on 0191 445 2525 Login or web based issues [email protected] or contact Susan Mulinda / Laura Gamblin on 0191 445 6553 Subscription or workshop enquiries [email protected] or contact Susan Mulinda / Laura Gamblin on 0191 445 6553 Scheme website address: www.ukneqascpt.org.uk Scheme postal address: UK NEQAS for CPT c/o NHS BCS Programme North East Programme Hub Queen Elizabeth Hospital Gateshead NE9 6SX Scheme Organiser – Rob Hughes [email protected] Scheme Manager/ Deputy Scheme Organiser - Chantell Hodgson [email protected] Quality Manager [email protected] 6|Page Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Scheme Enquiries For security and confidentiality reasons, anyone contacting UK NEQAS for CPT, by email, telephone or in writing, must quote their unique participant number, for ALL enquiries. This will enable UK NEQAS for CPT to deal with your queries more efficiently and effectively. For enquiries requiring a change of contact details or information request on a participation number within the CPT scheme, strict guidelines must be followed to ensure that an appropriate person is making this request. Telephone enquiries All registered participants who telephone the UK NEQAS for CPT scheme will be required to give their Participation number before any queries can be dealt with. The person making the enquiry will also be required to give 2 additional pieces of identifying data from the list below, in order for their identity to be verified by a Scheme member of staff. Web user login ID Web user password Email address Hospital address If the caller is not a registered contact on our database, permission MUST BE RECEIVED from a CPT listed contact before participant information can be amended or given. Email enquiries All registered participants who email the UK NEQAS for CPT scheme will be required to give their Participation number before any queries can be dealt with. The person making the enquiry will also be required to give their Web user login ID in order for their identity to be verified by a Scheme member of staff. Their email address can be verified from the email received. If the correspondent is not a registered contact on our database, permission MUST BE RECEIVED from the CPT listed contact before participant information can be amended or given. Written Enquiries All registered participants who write to the UK NEQAS for CPT scheme will be required to give their Participation number before any queries can be dealt with. The person making the enquiry will also be required to give their Web user login ID and email address, in order for their identity to be verified by a Scheme member of staff. If the correspondent is not a registered contact on our database, permission MUST BE RECEIVED from the CPT listed contact before participant information can be amended or given. 7|Page Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Purpose and Scope UK NEQAS for Cellular Pathology Technique (CPT) is an international organization providing a comprehensive range of accredited external quality assessment (EQA) and proficiency testing programmes for all aspects of tissue diagnostics, for both clinical and non clinical laboratories and organisations. UKNEQAS for CPT provides a secure established set of schemes with a first-class reputation and stable participant base that provides EQA and proficiency testing programmes to Cellular Pathology laboratories and organisations internationally. UKNEQAS CPT and its specialist schemes are operating according to ISO/IEC 17043:2010 (E) standards. Tissue diagnostics is an extremely important element in the management of patients and therefore the role of EQA is essential in order to provide assurance that a high standard of testing is achieved for all. Errors with tests can have catastrophic results so it is important for UK NEQAS for CPT to ensure early detection of problems and provide education, help and support to organisations. Currently UK NEQAS for CPT offers 6 assessment cycles / runs per year in the following specialist schemes; General Pathology (Routine Histopathology) Neuropathology Renal Biopsy Muscle Histochemistry Non Gynae Diagnostic Cytology Participants are assessed for the quality of their staining and their staining preparations in Haematoxylin and Eosin stained sections and / or special staining methods, depending on the scheme to which participants are subscribed. Details of each scheme can be found in the Specialist Schemes section. Each test run (cycle) requires participants to submit a maximum of 4 slides from their own laboratory / organisation workload for assessment by UK NEQAS for CPT. All submitted slides are anonymised, so that assessments are carried out blind and all material is returned following assessment. Complete participant confidentiality is maintained throughout all of our processes. All of our slides are assessed by peer assessors, experts in the field of Cellular Pathology. All of our peer assessors operate as Specialist Biomedical Scientists as a minimum. Each assessor undergoes training prior to appointment, and competency is assessed prior to and during each assessment session. Results are available on line and our results package shows accumulated historical activity that highlights improvement or decreases in quality. This includes an annual report which is available at the end of each annual subscription. Each slide assessed has a separate feedback sheet detailing scoring based on appropriate score and any additional feedback or comments which may be of value to participants to maintain, review and / or improve their quality standards. Best methods and image gallery are also available to participants on the UK NEQAS for CPT website at www.ukneqascpt.org.uk 8|Page Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Benefits to Participants UK NEQAS for CPT is a member of the UK NEQAS organisation which provides external quality assessment programmes throughout pathology. Participation in the UK NEQAS for CPT Scheme provides a number of benefits, including: 6 assessment runs per year Specific schemes catering for the specialised needs of the participant Assessment of 4 stains per run (stains will differ depending on the scheme) Individual reports following each assessment, showing a detailed summary of the scoring against designated criteria Improved feedback in the form of definitions for each criteria and constructive comments from the assessors Frequency charts illustrating the distribution of participant scores for each run End of year Participation Certificate with annual performance records Annual reports at the end of each annual subscription following 6 consecutive run assessments, showing a detailed summary of the scoring and a league table of Participant Performance Access to Scheme IT and admin support Technical advice and expertise Annual Scientific meetings and seminars Specialist educational workshops Fully interactive website, including; On-line library of colour images showing optimal and sub-optimal staining On-line library of best methods News and events section Other articles and reviews from UK NEQAS for CPT CPT Newsletter 3 times a year UK NEQAS for CPT is operating according to ISO/IEC 17043:2010 (E) Standards for External Quality Assessment. 9|Page Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Ethical Considerations UK NEQAS for CPT is governed principally by the guidelines and standards issued by the Human Tissue Act, Nuffield Council on Bioethics, ISO/IEC 17043:2010 (E) standards and RCPath / IBMS, on the supply of human tissue. In particular: Material commissioned for special stain slides is “left over from investigations” No more tissue was removed from the patient in excess of that required for ordinary clinical care and the EQA / proficiency testing use of the tissue does not compromise routine diagnostic assessment Such tissue is used for the purpose of education and the audit of quality of care through “implementation of quality control and assurance programmes” All tissue samples are anonymised UK NEQAS for CPT operates on a not-for-profit basis Where transactions between UK NEQAS for CPT and suppliers of tissue do take place, “reasonable handling charges” only are involved and the tissue itself is neither bought nor sold The preparation and distribution of tissue is carried out in accordance with current Health and Safety legislation. The first 4 points constitute an exemption from the need to seek advice from Local Research Ethics Committees. The provision of material for UK NEQAS for CPT EQA / proficiency testing is subcontracted to external laboratories / organisations. All laboratories / organisations providing tissue for UK NEQAS for CPT must be ISO accredited or equivalent, and provide written declaration confirming that they are operating to the above guidelines. Provided tissue is validated, following strict guidelines, at source and again by UK NEQAS for CPT, prior to distribution. Should any distributed tissue be found to be compromised, material will be recalled and the associated run suspended. 10 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Organisation UK NEQAS UK NEQAS for CPT is a member of the UK NEQAS confederation of EQA / Proficiency Testing schemes. UK NEQAS Steering Committee for Cellular Pathology Techniques This committee provides support to all UK NEQAS cellular pathology schemes offering technical EQA / proficiency testing in cellular Pathology. Whilst UK NEQAS for CPT has responsibility for the operational domain of its schemes, the UK NEQAS for Cellular Pathology Techniques Steering Committee exists in an advisory / supporting capacity. The role of the UK NEQAS for Cellular Pathology Steering Committee does not extend to performance issues except where this involves the design and operation of the performance monitoring mechanism itself. JWG and NQAAP The Joint Working Group on Quality Assurance (JWG) oversees the National Quality Assurance Advisory Panels (NQAAP), which in turn are the reference points for organisers on matters of participant performance. In 2009 the Royal College of Pathologists agreed that the JWG would be incorporated into the College structures, formally as a section of the Professional Standards Units (see Performance Monitoring). UK NEQAS for CPT Structure In order to maximise the efficiency and quality of UK NEQAS for CPT, the roles of organiser and manager have been separated. The Scheme Organiser is appointed jointly by UK NEQAS and UK NEQAS for CPT legal entity, LabXCell. One of the Scheme Organiser duties is to appoint the Scheme Manager and this appointment is made in accordance with the financial rules of the legal entity which is LabXCell Ltd. So as to maintain a high standard, UK NEQAS for CPT and its personnel will be active in the following areas; Promoting local participation in UK NEQAS for CPT Providing assistance, when requested, to participants Gathering opinion from participants and informing the Scheme Manager / Organiser Involvement in the Complaints Procedure. Providing up to date information via UK NEQAS for CPT website and CPT Newsletter Provide participant meetings and seminars Provide educational workshops for general and specialist cellular pathology 11 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Objectives UK NEQAS for CPT aims to: Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Provide regular, impartial and confidential assessments of a range of technical procedures performed by participating organisations Provide data to assist participating laboratories / organisations audit their performance Contribute to the improvement of procedures used within participating organisations Contribute to the continuing professional development of staff within participating Organisations Assist participating organisations in meeting accreditation standards relating to EQA / proficiency testing Ensure early detection of problems and provide education, help and support to organisations UK NEQAS for CPT is open to all clinical laboratories / organisations and non-clinical laboratories / organisations worldwide. Tissue diagnostics is an extremely important element in the management of patients and therefore the role of external quality assessment is essential in order to provide assurance that a high standard of testing is achieved for all. Errors with tests can have catastrophic results so it is important for UK NEQAS for CPT to ensure early detection of problems and provide education, help and support to organisations. Education is important to provide useful information that allow for quality improvement in Cellular Pathology Techniques. UK NEQAS for CPT provides a large educational component including; an educational website, best methods and image galleries, annual participant feedback meetings, scientific meetings and seminars, educational workshops and newsletters. 12 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics ISO Laboratory Accreditation ISO 15189 standards, 5.6.3 Interlaboratory comparisons, provides guidelines directly related to EQA / proficiency testing: The laboratory / organisation shall participate in an interlaboratory comparison programme(s) (such as an external quality assessment programme or proficiency testing programme) appropriate to the examination and interpretations of examination results. The laboratory / organisation shall monitor the results of the interlaboratory comparison programme(s) and participate in the implementation of corrective actions when predetermined performance criteria are not fulfilled. The laboratory / organisation shall establish a documented procedure for interlaboratory comparison participation that includes defined responsibilities and instructions for participation, and any performance criteria that differ from the criteria used in the interlaboratory comparison programme. The performance in interlaboratory comparisons shall be reviewed and discussed with relevant staff. When predetermined performance criteria are not fulfilled (i.e. nonconformities are present), staff shall participate in the implementation and recording of corrective action. The effectiveness of corrective action shall be monitored. Interlaboratory comparison programme(s) chosen by the laboratory / organisation shall, as far as possible, provide clinically relevant challenges that mimic patient samples and have the effect of checking the entire examination process, including pre-examination procedures, and post-examination procedures, where possible. EQA / Proficiency Testing Accountability The standards above use the terms “approved EQA schemes”, “inter-laboratory comparison programmes” and “external quality assessment programme or proficiency testing programme”. These terms are defined as those that are accredited according to ISO/IEC 17043:2010(E) standards. UK NEQAS for CPT is operating according to ISO/IEC 17043:2010(E) Standards for External Quality Assessment. Further details can be found on our website www.ukneqascpt.org.uk 13 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Assessment and Reports Assessment For each assessment run, participants are sent slide mailers with a delivery letter detailing instructions for slide submission and other important information. Participants are asked to submit up to 4 slides in total for assessment (see Specialist Schemes). Participants are asked not to submit multiple slides for selection by UK NEQAS for CPT. The submitted slides are masked for anonymity using removable labels. The slides bearing each participant’s unique laboratory / organisation code number are then assessed by a pair of experts in the field of Cellular Pathology Techniques. The assessment team consists of biomedical scientists, clinical scientists, and consultant pathologists, with extensive knowledge and experience in the field of cellular pathology. This includes specialist assessors for each of the specialist schemes. Anonymisation of participants’ slides, and the assessment of slides using assessor pairs, prevents any conflict of interest or collusion by UK NEQAS for CPT assessors. Participant Report Following each assessment, participants are emailed notification of availability of reports. These are available on-line, and can be viewed and / or downloaded from the UK NEQAS for CPT website www.ukneqascpt.org.uk (See Accessing On-line Reports). Individual reports following each assessment include; the individual assessors’ scores out of 5, and a total score out of 10 a detailed summary of the scoring against designated criteria, including detailed explanations of each criteria allocated against that submission constructive comments from the assessors, to help participants improve their methodology / technique. frequency charts of submitted slide scores, illustrating the distribution of participant scores for each run and the mean participant score for the submitted slides for the assessment run, as well as a summary of your scores from the last 5 runs After each assessment, ‘Best Methods’ and images are uploaded to the website from anonymised participant data. Annual Report Annual reports are available on line, at the end of each annual subscription following 6 consecutive run assessments. A personalised report shows a detailed summary of scores, including frequency charts and graphs against national scores, and a league table of Participant Performance. Use of UK NEQAS for CPT Reports Participant performance data and evidence of appropriate EQA / proficiency testing participation may be used for accreditation purposes and as supporting evidence for such as organisational KPI’s. However, UK NEQAS for CPT reports / performance data must not be used in a promotional manner, which is outside the scope and ethos of UK NEQAS for CPT activity, and may be to the business detriment of other services. The UK NEQAS for CPT Scheme Manager and Scheme Organiser will investigate any claims of data misuse. Any participant suspected to be in breach of the above will be suspended from UK NEQAS for CPT pending investigation, and the centre will be asked to remove / retract any promotional information with immediate effect. Subscription to the UK NEQAS for CPT scheme may be cancelled as a result. 14 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Quality Assessment: Terms and Conditions Terms and Conditions of Participation By submitting an annual subscription / registration form the participant agrees to follow the guidelines in this manual and in particular to: Ensure the prompt payment of any fees due Ensure that material returned through the post is packaged safely Ensure that the rules covering selection of file material are followed Ensure that distributed EQA samples are treated in the same way as clinical samples Participate fully in UK NEQAS for CPT (see also Restricted repertoires). Additional information for the above can be found within this manual, the associated scheme Staining Criteria Handbook and on the website www.ukneqascpt.org.uk Outline of Service Provided UK NEQAS for CPT will complete 6 circulations per annum and, on each of these; 2 H&E preparations and 2 special stains will be assessed for the general and neuropathology scheme (4 slides in total). for other schemes within UK NEQAS for CPT, preparations to be assessed will vary but will also consist of 4 slides in total (see Specialist Schemes and Scheme Schedule available on the website). UK NEQAS for CPT provides all participants with the opportunity of attending an Annual Participant Feedback Meeting. Presentations from these meetings will be available on the UK NEQAS for CPT website www.ukneqascpt.org.uk Participation in Assessment Submission of in house material One of the purposes of selecting in house / archival material is to assess all the stages of slide preparation, from fixation through to cover slipping, on material produced as part of the routine workload. As such participants will be asked to submit the first tissue section / cellular preparation from the first case received by the department/ organisation on a given date (see Assessment Material). Participants must not submit recut, re-prep or remounted slides or special stains, or select a “best example” for submission. Submission of UK NEQAS for CPT material When participating in the UK NEQAS for CPT schemes it is important that you treat the assessment material provided by UK NEQAS for CPT in exactly the same way as your patient test material. Our Scheme is designed to assess how you test patient material as part of your routine daily procedures (see Assessment Material). Participants must use their routine special stains procedure for submission to UK NEQAS for CPT. Submission of material for Appeal Material submitted as part of the appeal process should be the original section which was submitted for assessment in the first instance. A new slide must not be submitted (see Appeals). Treating your assessment material in the same way as you would your patient test material ensures that assessments are a reliable measure of the quality of your patient testing. Any participant suspected to be in breach of the above Terms and Conditions will be suspended from UK NEQAS for CPT pending investigation. Subscription to the UK NEQAS for CPT scheme may be cancelled as a result. 15 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Responsibilities Scheme Organiser Rob Hughes UK NEQAS for CPT Scheme Organiser, c/o The Pathology Centre, Queen Elizabeth Hospital, Sheriff Hill, Gateshead, Tyne and Wear NE9 6SX Email : [email protected] Scheme Manager / Deputy Scheme Organiser Chantell Hodgson UK NEQAS for CPT, The Pathology Centre, Queen Elizabeth Hospital, Sheriff Hill, Gateshead, Tyne and Wear NE9 6SX Tel : +44 (0)191 445 5566 email : [email protected] Quality Manger To be confirmed email: [email protected] Tissue Procurement Coordinator Iain MacMillan email: [email protected] Training Officer Chantell Hodgson email: [email protected] Run Queries Lynne Brown Tel: +44 (0)191 445 2525 Administration / IT Support Susan Mulinda Laura Gamblin Tel: +44 (0)191 445 6553 Tel: +44 (0)191 445 6553 Renal Co-ordinator Jane Pizer email: [email protected] Neuropathology / Muscle Co-ordinator Richard Mathias email: [email protected] Non Gynae Cytology Co-ordinator Dr Paul Cross email: [email protected] 16 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Participant Responsibilities Participant Responsibilities Participants must; Inform and update UK NEQAS for CPT of any change of personnel or contact details. Without a valid / up to date email address and contact details, participants may not receive essential scheme information Ensure slides are securely packaged to prevent breakages, which may prevent assessment Return Slides in the bar code labelled slide boxes to enable identification on receipt. Continuous abuse of this may result in slides not be accepted / returned without assessment Ensure slides are clearly labelled, regarding specimen type and staining details, as appropriate Adhere to submission deadlines. Late submissions will be logged and monitored by UK NEQAS for CPT Ensure prompt payment of subscription fees, your account will be suspended if payment is not received Update their own repertoire (see Repertoire). Invalid repertoires may lead to a nonsubmission (0 score) and possible poor performance issues Declare restricted repertoires - non declaration of this may lead to a non-submission (0 score) and possible poor performance issues Adhere to staining requirements (for both the UK NEQAS for CPT supplied sections and in-house slides) Adhere to specific requirements for specialist schemes, as instructed Access online assessment reports and associated documentation Handle and interpret own results Respect the confidentiality of EQA when corresponding with other centres Respond timely to requests issued by UK NEQAS for CPT, including submission of annual subscriptions and poor performance issues. Delays in response may result in avoidable communication issues and / or your account being suspended Always quote your unique participants’ number whenever contacting UK NEQAS for CPT 17 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Confidentiality Participation in UK NEQAS for CPT is governed principally by the confidentiality and Information Governance guidelines and standards issued by ISO / IEC 17043:2010(E) and the Joint Working Group (JWG) on Quality Assurance. The following guidelines apply in accordance with UK NEQAS for CPT policies and procedures: 1. “The EQA code number and name of the laboratory and the assessment of individual laboratory performance are confidential to the participant and will not be released by Scheme Organisers without the written permission of the Head of the laboratory to any third party other than the Chairman and members of the appropriate NQAAP and the Chairman and members of the JWG”. The confidentiality of a participant’ performance results are maintained by UK NEQAS for CPT at all times. However to ensure patient safety, UK NEQAS for CPT is obliged to inform regulatory bodies of UK clinical laboratories / organisations that are persistent poor performer (red - see Performance Monitoring). If a UK clinical laboratory / organisation is identified as a persistent poor performer (red), or has unresolved poor performance issues, the Scheme Organiser / Manager will notify the Chairman of the appropriate NQAAP together with a resume of remedial action taken or proposed, by the participant. 2. “The identity of a participant (name of laboratory and Head of Department) and the tests and EQA schemes for which that laboratory is registered (but not details of performance) may also be released by the Scheme Organiser on request to the Health Authority, Hospital Trust/Private Company in which the laboratory is situated after a written request has been received”. The identity of a persistently poor performing laboratory (red) will be made available to members of the NQAAP and JWG. In instances of persistent poor performance the code number and the name of laboratory / organisation will be released. Participants will be informed in advance in all such instances. 3. “A NQAAP may, with the written permission of the Head of a laboratory, correspond with the Authority responsible for the laboratory, about deficiencies in staff or equipment which, in the opinion of the NQAAP members, prevent the laboratory from maintaining a satisfactory standard”. Where a third party enquires regarding an organisations participation in, or the use of an individual participants’ / organisations data, information will only be disclosed with the express permission of the participant. During assessment sessions, or for the use of data for educational purposes, a participants’ identity is not disclosed. 18 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Information Governance Information Governance requires EQA / Proficiency testing providers to handle ALL organisational information in a confidential manner, according to legal and best practice standards. In line with Information Governance, UK NEQAS for CPT has a responsibility to keep participant information safe, secure and confidential. Information Governance is the responsibility of both UK NEQAS for CPT and the Participant. Organisational information should only be shared with others who are authorised to see it and need to know it in order to carry out their role. As such, UK NEQAS for CPT should be informed immediately of any amendments to “key personnel” at a registered centre, so that their login privileges can be removed and new login ID and password details issued. “Key personnel” are the 3 main points of contact within a centre; Main Contact This is designated as the Clinical Lead within a department, or the Consultant Pathologist departmental head. Technical Head The technical lead with managerial responsibility for the registered department. This may also be the Laboratory / organisation Manager. Day to Day The individual within a department who has section or day to day responsibility for the laboratory / organisation workings. Additional personnel can also be added to a participant record as “Quality Manager” or “Web Member”, to enable other members of staff to receive UK NEQAS for CPT communications. Run Distributions and Poor Performance Notifications Both the main contact and technical head are informed in writing of any poor performance issues (see Performance Monitoring). If a response is not received in the designated time, the technical head and day to day contact will be issued a reminder. UK NEQAS for CPT accept no responsibility for any non-notification of slide / run distribution or performance issues where incorrect or old participant details are supplied. Any user changing their email address should notify UK NEQAS for CPT immediately. 19 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Registration and Subscription Registration Initial registration can be done via the website by completing the on - line Registration Form at www.ukneqascpt.org.uk This can be accessed under Members Area by selecting Registration or by using the Register icon to the left of the screen. You can also register by emailing [email protected] Once your details are registered you will be contacted directly by UK NEQAS for CPT who will require the email and contact details for the 3 main points of contact (see Confidentiality / Information Governance). The relevant contacts will be sent their own unique login ID and password details. Following registration an invoice will be issued for your participation fees. Payment options are flexible depending on the institution. Once registered, each department is responsible for reviewing and maintaining its repertoire, contact and address details online (see Participant Responsibilities). UK NEQAS for CPT must be informed of any ID changes immediately, especially with regard to email addresses, as this may result in miscommunication or assessment runs being issued to the wrong individual and / or address. Detailed descriptions of the schemes we offer can be found at www.ukneqascpt.org.uk in the Registration menu under Scheme Information, or Specialist Schemes in this booklet. Further information and guidance, can be obtained from the Scheme Manager. Annual Subscription Annual subscription is April to March but we accept subscriptions at any time during the year, as part of the registration process above. An Annual Subscription reminder letter is issued with the latest edition of the Participant Manual to the Day to Day contact at the end of January each year. Details of how to subscribe are included in the annual subscription reminder letter. Annual subscription is completed on line at www.ukneqascpt.org.uk. Annual subscription is open from Ist February to 1st March each year. 20 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Annual subscription MUST be completed and submitted on-line by following the link on the UK NEQAS for CPT website, www.ukneqascpt.org.uk to ensure there is no cessation of your EQA / proficiency testing participation. Completion of the online form will be required for each of the schemes separately. On line annual subscription will include confirmation of the following details; UK NEQAS CPT scheme you wish to subscribe to Main contact / clinical head of department Technical head of department Day to day contact Quality manager / website member (where applicable) Finance / Supplies contact* Trust / Organisation where an Order Number or Purchase Order Number will originate from and invoice payments will be made from* A purchase order number for your annual subscription must be submitted at the time of resubscription * The finance / supplies and Trust / Organisation contact details must be completed for invoicing purposes. UK NEQAS for CPT must be informed if you wish to cease participation. Billing UK NEQAS for CPT will invoice participants for the annual subscription, which is due within 60 days of receipt. Heads of department are asked to ensure prompt payment of subscriptions, before August. Late payment of annual subscriptions could result in suspension of your laboratory / organisation from UK NEQAS for CPT. If you are a CPA / UKAS accredited laboratory / organisation and you are suspended from UK NEQAS for CPT you are obliged to notify CPA / UKAS of this fact. Fees UK NEQAS for CPT seeks to keep the subscriptions charged to participants down to a minimum but it should be stated that we always try to improve the service provided. Wherever possible, such improvement will be implemented without any increase in fees. Participants should be aware, however, that UK NEQAS schemes receive no financial support for the running of UK NEQAS for CPT, other than that generated from participants’ subscription fees. UK NEQAS for CPT are required to recover all of their operating costs through participant subscription on a strictly non-profit-making basis. Fees are set to cover the costs of running UK NEQAS for CPT. Thus the level of subscription is under continual review. Certificate of Participation UK NEQAS for CPT will issue a Certificate of Registration each autumn to those departments who have completed the billing process. UK NEQAS for CPT currently attracts members from over 30 different countries and welcomes participation from UK and non-UK based laboratories / organisations. 21 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Specialist Schemes UK NEQAS for CPT offers bi-monthly distributions in the following schemes; General Pathology Neuropathology Renal Biopsy Pathology Muscle Histochemistry Non Gynae Diagnostic Cytology For each scheme UK NEQAS for CPT must encompass the wide variety of techniques and methodologies, and be able to either review material from the laboratory / organisation or distribute sufficient quantity of material for laboratories / organisations to stain. Details for each of the specialist schemes are detailed below. A more detailed explanation of the scoring criteria used in assessment and interpretation can be found in the scheme specific Staining Criteria Handbooks which are available in the “Introduction” dropdown menu under “Assessment Criteria and Scoring Guidelines”, on the UK NEQAS for CPT website www.ukneqascpt.org.uk (also see Interpretation - Staining Criteria Handbooks). General Pathology (Routine Histopathology) This scheme involves 6 distributions over a 12 month period and is available to both public and private institutions within the UK and overseas. This scheme assesses 2 archival surgical Haematoxylin and Eosin (H&E) stained sections, and 2 special stained sections. The 2 special stained sections, marked as A and B, are designated on the accompanying delivery letter issued with each run. These are in accordance with the UK NEQAS for CPT Schedule which can be found on the Members Area of the UK NEQAS for CPT website www.ukneqascpt.org.uk Two pairs of unstained sections are provided to each participant for staining by the special stain methods directed, with one of each to be submitted for assessment. A method is not specified, and the laboratory / organisation is free to use any suitable technique to demonstrate the target. The scheme currently has a team of over 50 peer assessors all of whom have extensive experience and expertise in the field of Cellular Pathology. EVG (General Pathology) Retic (General Pathology) 22 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Neuropathology This scheme is aimed at laboratories / organisations performing a neuropathology service, as part of routine Cellular Pathology, or a stand alone unit. As with the general pathology scheme, it is available to public and private institutions in the UK and overseas. It operates in the same way as the general scheme, 6 runs per annum; 2 archival H&E stained sections and 2 special stained sections performed on sections supplied by UK NEQAS for CPT. The special stains are divided into groups A & B; A is the same as the general scheme, B comprises specialist neuropathological methods. Specialist methods assessed include; swollen axons, myelin, glial fibres, senile plaques, neurofibrillary tangles, and Nissl. NB. A method is not specified, and laboratory / organisation is free to use any suitable technique to demonstrate the target. The scheme has been running since 1991 with a team of specialist assessors able to draw upon allencompassing experience working in the UK and Ireland neuropathology centres. Myelin (Neuropathology) Nissl substance (Neuropathology) Renal Biopsy Pathology This scheme is intended for use by clinical laboratories / organisations which may be either specialist departments or sections within general laboratories / organisations. It is available to both public and private institutions within the UK and overseas. This scheme has been running since April 2006 and employs a team of specialist renal biopsy assessors all of whom have many years’ experience working in some of the biggest renal biopsy centres in the UK and Ireland. The renal pathology scheme assesses surgical renal biopsies using 4 routine renal staining methods. Specialist methods assessed include; H&E, Methenamine silver, Periodic acid-Schiff and EVG. 23 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Like the general and neuropathology schemes, the renal scheme works on a retrospective basis. Participants are asked to submit diagnostic slides from their archive containing material from a suitable native renal biopsy which has been recently processed in the laboratory / organisation. A suitable biopsy must include renal cortex to ensure demonstration of glomerular basement membranes can be assessed. Methenamine Silver (Renal Pathology) PAS (Renal Pathology) Muscle Histochemistry This scheme is designed for clinical laboratories / organisations which may be either specialised departments or sections within general laboratories / organisations / organisations. As with the other schemes it is available to both public and private institutions within the UK and overseas. This scheme has been running since April 2008 and assesses archived material using 4 routine muscle staining methods, using a team of specialist assessors all of whom have wide-ranging experience working in specialist muscle biopsy centres in the UK and Ireland. Specialist methods assessed include; H&E, NADH, Cytochrome Oxidase and Gomori Trichrome. NADH (Muscle Histochemistry) Cytochrome Oxidase (Muscle Histochemistry) 24 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Non Gynaecological Diagnostic Cytology In the field of non-gynaecological cytology there are many sites for samples to be obtained from eg. urine, sputum, pleural fluid, ascitic fluid, FNA etc. The two main staining preparations are Romanowsky and Papanicolaou based, although some places may use H&E or potentially even other stains. In addition there are several possible preparation techniques e.g. direct smears, cytospins, liquid based methodologies, in particular. This scheme assesses 2 archival stained preparations, from 2 distinct cytology specimens, which are designated on the accompanying delivery letter issued with each run. A preparation technique is not specified, and laboratory / organisation is free to use any suitable technique to adequately demonstrate the staining method. This scheme does not assess H&E stained preparations. UK NEQAS for CPT follows RCPath guidance which explicitly states that H&E should not be used for cytology preparations. The BSCC does not specifically exclude H&E as a cytology stain, but equally does not advocate its use. If the guidance changes, then H&E may be included as part of the repertoire for this scheme. The scheme currently has a large team of assessors all of whom have many years’ experience and expertise in the field of Non Gynaecological Diagnostic Cytology. Papanicolaou (Non Gynae Diagnostic Cytology) Romanowsky (Non Gynae Diagnostic Cytology) Assessment Team Scheme assessors who assess and evaluate preparations and stains on behalf of UK NEQAS for CPT are appropriately trained and experienced, to offer a consistent expert approach to interpretation and scoring. Their competency is assessed annually and at each assessment session. Training days are held for new assessors, and new assessment team members adhere to strict Scheme guidelines before they are deemed competent. CPT Peer Assessor profiles are available on the UK NEQAS for CPT website www.ukneqascpt.org.uk, under Introduction. 25 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Assessment Material Distributed Material For the assessment of general pathology and neuropathology scheme special stains, participants receive two unstained paraffin sections per method and will be expected to return one of these per method for marking. The distributed slides are mailed out in a bar code labelled slide mailer. The bar coded label is unique to your participation number and laboratory / organisation and will identify slides returned for assessment. General pathology and neuropathology scheme H&E’s will be assessed on selected in house / archival material, as with the other schemes which also assess archival material (see Selected Material below). Selected Material One of the purposes of selecting in house / archival material is to assess all the stages of slide preparation, from fixation through to cover slipping, on material produced as part of the routine workload (see Quality Assessment: Terms and Conditions). General Pathology and Neuropathology Participants Participants will be asked to submit the first H&E section from the first case received by your department on a given date. The work patterns in some departments / organisations may mean that the first specimen is always of a particular, perhaps unrepresentative type. Substitution of a later case is permissible provided this is chosen in accordance with a written departmental operating procedure. Please use your professional judgement. Renal Scheme Participants Participants are asked to submit diagnostic slides from their archive containing material from a suitable native renal biopsy which has been recently processed in the laboratory / organisation, stained with H&E, Methenamine Silver, PAS and EVG. NB A suitable biopsy must include renal cortex to ensure demonstration of glomerular basement membranes can be assessed. Muscle Histochemistry Scheme Participants Participants are asked to submit diagnostic slides from their archive stained with H&E, NADH, Gomori and Cytochrome Oxidase. Non Gynaecological Diagnostic Cytology Participants Participants will be asked to submit the first cellular preparation from the first case received by your department on a given date. The work patterns in some departments / organisations may mean that the first specimen is always of a particular, perhaps unrepresentative type. Substitution of a later case is permissible provided this is chosen in accordance with a written departmental operating procedure. Please use your professional judgement. Recall of Material Provided tissue is validated, following strict guidelines, at source and again by UK NEQAS for CPT, prior to distribution. Should any distributed tissue be found to be compromised, material will be recalled and the associated run suspended. All Participants Participants must not submit re-cut or re-mounted file material. The Schemes are intended to be educational in nature, so if problems are identified this will enable the participant laboratory / organisation to improve quality of their patient testing. 26 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics You may substitute the first suitable slide after that requested if: the slide is not an H&E (General pathology and neuropathology schemes only) the slide has not been prepared from a paraffin block (excluding non gynae diagnostic cytology scheme) the slide requested consists of minimal or acellular material (see scheme specific Staining Criteria Handbooks for definitions and guidance) the slide was referred into the department from an outside laboratory / organisation the slide is required for another purpose or is still involved in the diagnostic process Some departments (for example some neuropathology departments) have extended fixation and processing times and these may submit from the first case reported on the given date. Where tissue has been involved in some other process prior to routine embedding, such as frozen sectioning or decalcification, slides should still be submitted and an appropriate comment made on the delivery letter. Generally, the first slide in a multi-slide case is requested. If the nature of the first slide is such that the participant is unreasonably disadvantaged (e.g. unsuitable material for effective assessment by UK NEQAS for CPT based on the scheme specific Staining Criteria Handbooks definitions and guidance) then a later slide from the same case may be substituted. Where more than one slide is available, the participant is expected to submit the first except where this would render assessment difficult (e.g. deliberately superficial levels i.e. unsuitable material for effective assessment), in which case a later slide may be substituted. Provision is made on the delivery letter to provide the assessors with any relevant information and participants are urged to use this facility. This information is available on the assessment screen during assessment sessions. All participants are strongly recommended to draw up a written procedure covering the selection of material for EQA and to record instances of departure from any instructions given by UK NEQAS for CPT. Labelling It is important that you do not remove or obscure your original H&E slide labels. A removable label to anonymise the slide during assessment will cover these. Documentation / Best Method Requests Circulations may include a request for details of methods and /or reagents used. This enables us to provide useful feedback to other participants. This documentation is not assessed in any way and will always be anonymised. This aspect of the service relies on the co-operation of all participants. Postage and Packaging UK NEQAS for CPT is very conscious that associated personnel have a duty of care over your file material. With this in mind, we use high quality packaging, to satisfy Post Office regulations, to be environmentally friendly and to speed handling. Optional Courier service Our slides are now sent Royal Mail tracked First Class Recorded Delivery, UK and Overseas International as part of the annual subscription fee. However if you would prefer your slide shipments to be sent via courier we can offer this service at an additional one off annual cost. All participants are strongly recommended to log receipt and dispatch of all EQA materials. 27 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Slide Submission Slides Submitted for Assessment PLEASE submit slides in the slide mailer with the allocated run participant barcode label attached, which you receive with each run. PLEASE DO NOT remove the bar coded label from the plastic slide mailer, this is a UNIQUE participant ID barcode identifier and is used by UK NEQAS for CPT to log receipt of your EQA material. Without this, slides are very difficult to track and allocate to the appropriate participant. If submission without this barcode persists this may result in your submission being returned to sender and logged against your record as a non submission. When using plastic slide mailers, please take particular care to pad the top space and to seal the container with adhesive tape. The most likely cause of breakage, and the greatest risk presented, is from unsealed slide mailers. Slides submitted which arrive damaged or broken may be due to; slides received loose in the envelope - please ensure the plastic slide mailer is used for transit purposes and that the end is taped to prevent opening during transit. slides stuck inside the slide mailer – please ensure that the slides are dry before inserting them into the slide mailer for submission. Postage envelopes which arrive open and the slides missing may be due to; Not sealing envelopes Not closing and taping slide mailers Please note: Slides / slide mailers should not be submitted wrapped in tape and bubble wrap, this significantly slows down the receipt of slide process. PLEASE DO NOT staple the EQA envelope for its return. When envelopes are stapled the delivery letter is inevitably stapled along with the envelope, which damages the delivery letter for its use at the point of submission. Numerous staples in the end of the envelope also poses a sharps risk to administrative staff! UK NEQAS for CPT allows 4 slides ONLY for each scheme, to be submitted for assessment. PLEASE DO NOT send multiple slides for assessment, unless you have contacted the Scheme Manager to agree this. A maximum of 4 slides should be submitted as requested per the delivery letter. Please do not send additional slides for “selection” by Scheme personnel. Participants are reminded that they are liable for the cost of return postage. Packages received marked “postage due” cannot be accepted. Participants are recommended to send slide submissions tracked in the event that slides do not arrive. Return postal address labels are provided by UK NEQAS for CPT in each package for use when returning your slides. • 28 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Assessment Procedure General and Neuropathology Schemes For each assessment run, participants are sent formalin-fixed paraffin processed tissue sections with a delivery letter detailing instructions and other important information. Participants generally are asked to demonstrate 2 different special stains on slides provided and submit those along with 2 archival H&E sections for assessment. Renal Biopsy Pathology Like the general and neuropathology schemes, the renal scheme works on a retrospective basis. For each assessment run, a delivery letter detailing instructions and other important information is sent to participants, requesting they submit material from a suitable native renal biopsy which has been recently processed in the laboratory / organisation. A suitable biopsy must include renal cortex to ensure demonstration of glomerular basement membranes can be assessed. This scheme assesses surgical renal biopsies using 4 routine renal staining methods – H&E, Methenamine silver, Periodic acid-Schiff and EVG. Muscle Histochemistry The muscle scheme assesses archived material using 4 routine muscle staining methods – H&E, NADH, Cytochrome Oxidase and Gomori Trichrome. For each assessment run, participants are sent a delivery letter detailing instructions and other important information. Participants are asked to submit archival slides for assessment from a specified date. Non Gynae Diagnostic Cytology Like the muscle scheme, the non gynae cytology scheme assesses archived material. For each assessment run, participants are sent a delivery letter detailing instructions and other important information, such as the specimen type and staining method being assessed for that run. Participants are asked to submit archival slides for assessment from a specified date, using 2 staining methods, on 2 specimen types. The Non Gynae Diagnostic Cytology scheme does not assess H&E stained preparations. UK NEQAS for CPT follows RCPath guidance which explicitly states that H&E should not be used for cytology preparations. The BSCC does not specifically exclude H&E as a cytology stain, but equally does not advocate its use. If the guidance changes, then H&E may be included as part of the repertoire for this scheme. UK NEQAS for CPT allows 4 slides ONLY for each scheme, to be submitted for assessment. PLEASE DO NOT send multiple slides for assessment, unless you have contacted the Scheme Manager to agree this. A maximum of 4 slides should be submitted as requested per the delivery letter. Please do not send additional slides for “selection” by Scheme personnel. All submitted slides are masked for anonymity using removable labels. The labels are generated using the bar coded label on the plastic slide mailer used for slide dispatch and return. The slides bearing unique slide number identifiers are then assessed by a pair of experts in the field of Cellular Pathology Techniques, consisting of experienced biomedical /clinical scientists, and consultant histopathologists, which includes specialist assessors for each of the specialist schemes (see Assessment and Reports). 29 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Interpretation The assessment of submissions is designed to be as fair and consistent as possible. Scoring Guidelines Each pair of assessors complete an assessment form and data from these forms are converted into a mark out of 5, from each assessor. The mark out of 5 from each assessor is based on the criteria for a given method. Guide lines for individual assessors mark (out of 5) where 0 – non submission, 1- Fail, 2 - Borderline Fail, 3 - Pass, 4 – Good, 5 - Excellent 0 – non submission 1 – Fail - No staining demonstrated based on the method employed and the expected staining results. 2 – Borderline Fail - unsatisfactory demonstration based on the method employed, with expected staining results being inappropriate. 3 – Pass - appropriate demonstration based on the method employed and the expected staining results, although improvements need to be made in the staining. 4 – Good – good appropriate demonstration based on the method employed and the expected staining results. 5 – Excellent – excellent demonstration based on the method employed and the expected staining results. Each assessor submits their mark out of 5 based on the criteria for a given method, giving a total score for the submitted slide out of 10. Guide lines for total score (out of 10) Score <5 - A score of less than 5 / 10 is given for poor staining, where the participant has failed to clearly demonstrate the expected results. Score 5/6 – a score of 5 or 6 / 10 is a pass. Whilst the staining appropriately demonstrates the expected staining results, staining is suboptimal and improvements are still required overall. Score 7/8 – a score of 7 or 8 / 10 shows good appropriate demonstration of the expected results, and an acceptable level of quality. Score 9/10 – a score of 9 or 10 / 10 shows excellent appropriate demonstration of the expected results, and a high level of quality. NB. Any slides which score a mark of 2 or below are passed to a secondary assessor for further assessment before a final score is issued. If there is a discrepancy of 2 between the assessing pair e.g. 3 & 5, the slide will be passed for secondary assessing. If there is a discrepancy of pass / fail between the assessing pair, the slide will be passed for secondary assessing. 30 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics A more detailed explanation of the scoring criteria and its interpretation can be found in the scheme specific Staining Criteria Handbooks (see below). Staining Criteria Handbooks UK NEQAS for CPT have developed assessment criteria and associated definitions to help participants interpret their scores and provide feedback from assessment sessions. Each scheme has a separate Staining Criteria Handbook which contains a list of scheme specific staining criteria, definitions and guidance, as well as model descriptions and a more detailed explanation of the scoring criteria and its interpretation. Copies of these criteria are available in the Members Area under Document Library on the UK NEQAS for CPT website and in the Introduction dropdown menu under Assessment Criteria and Scoring Guidelines at www.ukneqascpt.org.uk (also see Specialist Schemes). This format is very similar to that used by the assessors themselves. UK NEQAS for CPT assessment is carried out as a group session held at the Pathology Centre QEH Gateshead, with assessor training and monitoring provided at each session. Assessment sets comprise a random selection of H&E and special stained slides, with separate sets for scheme specialities. Results Following assessment, results and assessment sheet feedback are uploaded to the website. Participants are sent an email to inform them when the results are available, and participants access their results online. Laboratories / organisations are only able to access their own results (see Assessment and Reports). Results include; individual scores for each slide, with assessors’ scores out of 5, and a total score out of 10 a detailed summary of the scoring against designated criteria, including detailed explanations of each criteria allocated against that submission constructive comments from the assessors, to help participants improve their individual score frequency charts of submitted slide scores, illustrating the distribution of participant scores for each run and the mean participant score for the submitted slides for the assessment run, as well as a summary of your scores from the last 5 runs Non submissions which receive a score of zero are shown on the histogram but these scores are not included in the mean participant score for the submitted slides for each assessment run. The original submission material is returned by to the participant, along with the material and information for the next run. Annual Report Annual reports are available on line, at the end of each annual subscription following 6 consecutive run assessments. A personalised report shows a detailed summary of scores, including frequency charts and graphs against national scores, and a league table of Participant Performance. Appeals procedure Participants who are not satisfied with any scores received at an assessment can re-submit the slides to be re-assessed (See Appeals). 31 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Submission Deadlines Closing Date for Submission Submitting material on time enables UK NEQAS for CPT to evaluate your slides and communicate your results in a timely manner. To give you ample time for submission, the closing / return date for submission is never less than four weeks after the date on which the results of the previous circulation are issued (see NEQMANFO030 Scheme Schedule, which can be found under the Document Library in the Members Area of the UK NEQAS for CPT website). We encourage early submission – our system records when your material was submitted and calculates the turn-around time in days before the submission deadline. We discourage late submission – the system does not accept material submitted after the submission deadline. We appreciate delays may occur due to mail, courier and other postal issues which may be beyond the control of UK NEQAS for CPT and its participants. Any delays encountered by UK NEQAS for CPT in distributing assessment material will be communicated to participants via email. Late Submission Procedure The timing of each circulation is determined by its Closing Date for Submission. The Closing Date for Submission is clearly stated on the run Delivery letter. This form also advises that submissions cannot be accepted after this date. In reality, there is a short period between the closing date and the date on which slides are assessed. Submissions received during this period may be accepted at the discretion of the Scheme Manager, if contact has been made by the participant stating a genuine reason for the late submission of material. Submissions received after the date on which slides are being assessed will be returned to the participant with an explanation. Such submissions will be considered non-submissions for performance monitoring. We do not encourage late submission of material and late submissions will be dealt with on a case by case basis by the Scheme Manager. Late submissions are regularly audited, and any frequent abusers are notified. 32 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Repertoire Online Repertoire A participant’s repertoire is declared and confirmed at annual subscription. Participants are however able to amended this during the course of the year, via the Repertoire tab found in the Member’s Area on UK NEQAS for CPT website www.ukneqascpt.org.uk Participants are responsible for updating and maintaining their own on line repertoire, as part of participant responsibilities as a member of UK NEQAS for CPT. A non-submission is a score of zero. This is not an indication of a fail (scoring guideline are defined in the Staining Criteria Handbooks for each Scheme). The overriding principle is that when UK NEQAS for CPT requests a slide that is not part of a participant’s repertoire (i.e. not supported by a standard operating procedure), the non-submission, or a low mark, will not count against them for the purposes of performance monitoring. Logging on to the Website Opening www.ukneqascpt.org.uk will take you directly to the Home Page. From this page you can amend your repertoire by logging in to the members’ area; Repertoire via Members Area From the Members Area tab at the top of the screen click on Members Login, and enter your login details, which will have been issued to the email address you supplied when registering for the Scheme. The login details consist of: Lab Number - 4 digit laboratory / organisation participation code that appears on all documents issued to you from UK NEQAS CPT e.g. 4633. Identity - 4 digit random ID number, which is unique to the individual e.g. 7896 Password - an alphanumeric series of at least six characters unique to the individual Following entry of the appropriate data please select Login. 33 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Please Note: ID’s and passwords are generated for the contact personnel who are registered with UK NEQAS for CPT (see Information Governance). From the Members Area dropdown menu select Repertoire. This will take you directly to the Scheme screen to enable you to select the scheme you wish to view / amend your repertoire for. 34 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Selecting a Scheme Use the drop down box to select a scheme. Select the relevant scheme you wish to view / amend. Amending your repertoire From this screen you will be able to “tick” or “un-tick” in the allocated boxes which staining methods you wish to be subscribed for. Once your repertoire is correct, click the Save Repertoire button, at the bottom of the screen. Any amendments are immediately sent to our EQA Programme Management Office system, and are linked directly to your record, making any amendments to your repertoire where necessary. Please Note: If you as a participant, amend your repertoire on-line this will be reflected in the next run regarding any potential non submissions or performance monitoring. This will not be reflected in any run which has already been issued to participants and is awaiting assessment. 35 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Restricted Repertoires Informing us if your participant repertoire is restricted means when UK NEQAS for CPT requests a special stain that is not part of a participant’s repertoire (i.e. not supported by a standard operating procedure), the non-submission, or a low mark, will not count against them for the purposes of performance monitoring. However, in order to avoid missing instances of continuing substandard performance, the most common special stains are requested regularly. For the routine pathology scheme this is achieved by grouping the more common stains together as List A and the less common ones as List B. Each circulation will request one stain from List A and one from List B or other list dependant on the scheme you participate in. A copy of the stains in each list will be found at the back of each scheme specific Staining Criteria Handbook. Copies of these are available in the Members Area under Document Library and /or in the Introduction dropdown menu under Assessment Criteria and Scoring Guidelines on the UK NEQAS for CPT website. In order for them to benefit fully from participation, laboratories / organisations are encouraged to attempt the stains requested even if they are not in their repertoire. The participant’s repertoire is declared and confirmed at annual subscription, but may be amended during the course of the year, via the Repertoire tab found in the Member’s Area on the UK NEQAS for CPT website www.ukneqascpt.org.uk (see Repertoire). Participants who fail to submit a stain that is part of their declared repertoire will automatically be awarded a mark of zero, and as such will be considered non-submissions for performance monitoring. It is fair to assume that accreditation inspectors will expect a laboratory / organisation’s EQA repertoire to match that declared in its accreditation application. Where it is the laboratory / organisation’s policy to refer special stains to another department or laboratory / organisation, these stains should be included in the declared repertoire and the EQA material referred to the relevant third party as if it were diagnostic material. UK NEQAS for CPT requires no details of the commissioning arrangement. Once registered, each department is responsible for reviewing and maintaining its repertoire, online (see Participant Responsibilities and Repertoire). Participants are reminded that it is their responsibility to; Update their own repertoire. Invalid repertoires will lead to a non-submission (0 score) and possible poor performance issues Declare restricted repertoires, non declaration of this will lead to a non-submission (0 score) and possible poor performance issues 36 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Accessing Online Reports Online Reports When results have been issued following slide assessment, an email notification will be sent to all registered participants. Individual participant reports will then be available to view and / or download at www.ukneqascpt.org.uk Logging on to the Website Opening www.ukneqascpt.org.uk will take you directly to the Home Page. From this page you can access your results in 2 ways; 1. Access from Members Area From the Members Area tab at the top of the screen click on Members Login, and enter your login details, which will have been issued to the email address you supplied when registering with UK NEQAS for CPT. The login details consist of: Lab Number - 4 digit laboratory / organisation participation code that appears on all documents issued to you from UK NEQAS CPT e.g. 4633. Identity - 4 digit random ID number, which is unique to the individual e.g. 7896 Password - an alphanumeric series of at least six characters unique to the individual Following entry of the appropriate data please select Login. 37 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics In the left hand Margin of the homepage click on the Results button. This will take you directly to the Scheme screen to enable you to select the scheme you wish to view results for. 2. Access from the Results button In the left hand margin of the homepage click on the Results button (as shown above) and enter your login details consisting of; Lab Number, Identity and Password . This will take you directly to the Scheme screen to enable you to select the scheme you wish to view results for. 38 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Please Note: ID’s and passwords are generated for the contact personnel who are registered for UK NEQAS for CPT (see Information Governance). If you request to change a contact, UK NEQAS for CPT will automatically generate a new password. Please do not disclose your login ID and password to non-staff members. No responsibility can be taken by UK NEQAS for CPT for any misuse of the system, or breach of confidentiality, where this may have happened. Selecting a Scheme Use the drop down box to select a scheme. All of the schemes a participant is registered for will be displayed. Highlighting the relevant scheme will result in the display changing to show all the relevant distributions / runs issued in that scheme. All of the distributions a participant has registered for in that scheme will be displayed. Selecting a Run Highlight the distribution of choice to select a run. Double clicking on the highlighted run will automatically open a separate screen showing your run report as shown overleaf. This will appear as a PDF which you will be able to download or print. 39 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Run Reports Individual reports following each assessment show a frequency charts of submitted slide scores, illustrating the distribution of participant scores for each run and the mean participant score for the submitted slides for the assessment run, as well as a summary of your scores from the last 5 runs, the individual assessors’ scores out of 5, and a total score out of 10, a detailed summary of the scoring against designated criteria, including detailed explanations of each criteria allocated against that submission and constructive comments from the assessors. Annual Reports Annual reports are available on line, at the end of each annual subscription following 6 consecutive run assessments. A personalised report shows a detailed summary of scores, including frequency charts and graphs against national scores, and a league table of Participant Performance. The authorisation of any report is the responsibility of UK NEQAS for CPT management. Following each distribution (run report) or at the end of each annual subscription (annual report), participant reports are generated, reviewed and authorised by the Scheme Manager, or in their absence, their deputy. The reports are uploaded to the UK NEQAS for CPT website for participants to access. 40 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Appeals Appeals Procedure Participants who are not satisfied with any scores received at an assessment can re-submit the slides to be re-assessed. This will be done at the next assessment session after receipt of the slides. Submission of Material for Appeal The appeals procedure has been designed to maintain confidentiality. An appeals form can be found as NEQMANFO006 in the Members Area, of the UK NEQAS for CPT website www.ukneqascpt.org.uk or downloaded from the Members Area under How to Appeal. Any appeal should be sent for the attention of the Scheme Manager, along with; Resubmission of the original slide Appeals Form with page 1 completed A copy of the original report for that slide. All 3 should be submitted before the deadline of the next run. The address to return material to is given on the Appeals form. Please note: one form should be completed for each slide submitted. Your material will be returned to you if the correct paperwork is not enclosed. Falsification of Appeal Material Material submitted as part of the appeal process should be the original section, in the original state, in which the slide was submitted for assessment in the first instance. A new slide must not be submitted. Any participant suspected to be in breach of the above or suspected of collusion and falsification, will be suspended from UK NEQAS for CPT pending investigation. Subscription to the UK NEQAS for CPT scheme may be cancelled as a result. (see Quality Assessment: Terms and Conditions). Assessment of Appeals Your returned slide and paperwork will be redirected by the Scheme Manager for inclusion in the next assessment session. Assessment of appeals is carried out according to routine assessment protocol, by 2 expert CPT assessors, which includes specialist assessors for each of the specialist schemes (see Assessment and Reports). Assessment of appeal slides will be carried out by an independent set of assessors from the original submission, to eliminate any potential bias within the procedure. Appeal Feedback Once assessed, the slide and any paperwork will be returned to you via the Scheme Manager. The amended report will then be available to view on the UK NEQAS for CPT website www.ukneqascpt.org.uk At the Scheme Manager’s discretion, the appeals material may be sent to the appropriate assessor before being returned to the participant. Any scoring amendments are fed back to the original assessor pairs for auditing and training purposes. 41 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Performance Monitoring UK NEQAS for CPT Obligations UK NEQAS for CPT as an EQA / proficiency testing provider, is required to monitor the performance of all of its participants in UK clinical laboratories / organisations. This requirement does not apply to non-clinical or overseas laboratories / organisations, however, UK NEQAS for CPT will inform those laboratories / organisations who do fall in to performance monitoring, and offer assistance in the required area of expertise. In 2010, NQAAP made it mandatory for EQA schemes to use a ‘traffic light’ system for the grading of all its UK participants; Amber rating: issues with poor performance - managed locally by UK NEQAS for CPT Red rating: persistent poor performer / unresolved poor performance issues – referred nationally to NQAAP. Black rating: cases that cannot be managed by the Organiser / NQAAP and that have to be referred to the JWG NQAAP states that submission rates should be 100% for all UK clinical laboratories / organisations. If a laboratory / organisation do not submit for a run, then the EQA provider should be given / sent a valid explanation or reason why, e.g. not clinically tested or testing being outsourced (see Repertoire and Restricted Repertoires). Retrospective explanations following the production of results, and subsequent poor performance reports, may not be acceptable. Performance Monitoring Mechanism Substandard / poor performance in either can trigger local or national support. Good performance in one scheme cannot be offset against substandard performance in the other. Performance is reviewed after each circulation when the most recent five runs are analysed. Poor performance is defined as a “low mark” which is a mark of 2/5 (4/10) or lower, including nonsubmission of methods in declared repertoire. N.B. Non-submission of slides will result in a score of zero (0), and will be included in poor performance monitoring, unless the lab has informed UK NEQAS for CPT of a valid reason for non-submission. Poor performance will result in a letter being issued by UK NEQAS for CPT offering advice and assistance. A route cause analysis form (Poor Performance Monitoring Action form) is also included which MUST be completed by the participant and returned with their response to the corresponding letter. If no response has been received from the laboratory / organisation by the due date (one month from the date letter is sent) the Scheme Manager will inform NQAAP. Confidentiality The mechanism complies with the guidelines laid down by JWG for confidentiality (see Confidentiality). A “traffic light” system of notification is used; AMBER: RED: BLACK: When a participant accumulates 3 low marks within the review period (last 5 runs) When a participant accumulates 5 low marks within the review period (last 5 runs) Defined by NQAAP for participants with unresolved performance issues 42 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Amber Notification (all participants) This will result in a letter being sent by the Scheme Manager to the CHD and THOD summarising performance and offering advice and assistance through the UK NEQAS for CPT Scheme. To maintain laboratory / organisation confidentiality an anonymised version of the same letter is available in the UK NEQAS for CPT central office for the Scheme Organiser. This letter will request that the laboratory / organisation in question inform the UK NEQAS for CPT Scheme of any actions they have taken within their Quality Management System in response to these low marks, by the due date given on the letter. A Route Cause Analysis form is included which MUST be completed by the participant and returned with their response to the corresponding letter. If no response has been received from the laboratory / organisation by the due date (one month from the date the letter is sent), the Scheme Manager will inform NQAAP. In contacting the UK NEQAS for CPT Scheme, it is the laboratory / organisation, and not UK NEQAS for CPT, which is extending confidentiality and any further extension required for assistance to be provided will be agreed between the Scheme Manager / Organiser and the laboratory / organisation. Any written correspondence between the Scheme Manager / Organiser and the laboratory / organisation will be held in strict confidence between them, but must be available should the need for notification to NQAAP arise. Red Notification (UK clinical labs) This will result in a letter being sent by the Scheme Manager to the CHD and THOD summarising performance and offering advice and assistance through the UK NEQAS for CPT Scheme. The Scheme Manager will also make a letter available to the Scheme Organiser informing him of the laboratory / organisation code number. This letter will request that the Laboratory / organisation in question inform the UK NEQAS for CPT Scheme of any actions they have taken within their Quality Management System in response to these low marks, by the due date given on the letter. A Root Cause Analysis form is included which MUST be completed by the participant and returned with their response to the corresponding letter. If no response has been received from the laboratory / organisation by the due date (one month from the date the letter is sent), the Scheme Manager will inform NQAAP. Following consultation with the laboratory / organisation, the Scheme Manager will also prepare a report to NQAAP detailing the nature of the problem and any action taken. It is our understanding that NQAAP’s remit covers UK healthcare labs only. If NQAAP wish to contact the laboratory / organisation they will request the contact details from the Scheme Manager (see Confidentiality). Black Notification (UK clinical labs) If the actions of NQAAP do not resolve the poor performance issues, then NQAAP will refer the participants to the Joint Working Group (JWG). 43 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Education and Audit UK NEQAS for CPT includes as large an educational component as is possible given resource and confidentiality restraints. One of the main aims is to provide useful information that allow for quality improvement in Cellular Pathology Techniques. The UK NEQAS for CPT website can be found at www.ukneqascpt.org.uk Methodology and Reagent Data Participants may be asked to provide their validated method and reagent data relating to specific stains submitted. This best method data will then be posted in the Members Area of the UK NEQAS for CPT website under the Best Methods section. Images are uploaded in to the Image Gallery, also in the Members Area of the website, following each assessment run. These images are designed to demonstrate the scoring system and criteria employed for each of the methods assessed by UK NEQAS for CPT. Images are available for all schemes, showing “good”, “bad” and “indifferent” examples. Results, annual reports and other documents issued are designed to assist participants with internal audit, particularly through regular departmental EQA review meetings. Results are presented on line in graph and tabulated forms (see Assessment and Reports). Participants are strongly recommended to maintain a record of results and that this record should be “reviewed and communicated to staff and the decisions taken recorded, monitored and acted upon.” Participant Input UK NEQAS for CPT hold an annual Participant Feedback Meeting for all participants. In addition to a scientific programme, participants can discuss cellular pathology and EQA related topics with other participants, UK NEQAS for CPT assessors, and CPT personnel. This meeting will also provide participants with an opportunity to feedback to UK NEQAS for CPT, suggest improvements or voice misgivings about UK NEQAS for CPT. However, please note, that this does not form part of the complaints procedure. Additional scientific meetings and seminars hosted or associated with UK NEQAS for CPT will also be held when appropriate. Participants will be invited to such events through UK NEQAS for CPT emails to all registered points of contact (see Information Governance) Details of any of the above meetings will be circulated to all participants by email as soon as they are confirmed and are shown in the News / Events section of the UK NEQAS for CPT website. A Participants Survey is issued at the beginning of each year to allow participant feedback on various aspects of UK NEQAS for CPT. Results from this are available in the Members Area of the website and will be fed back at the annual Participant Feedback Meeting. 44 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics General Education Our aim for UK NEQAS for CPT remains educational. As an EQA / proficiency testing scheme we are more than happy to be approached for “expert advice” with any issues you may have, including stains you are struggling with or new technology or techniques you may want us to “assess”/ evaluate before you introduce them in to routine use. We are happy to provide advice and help during normal working hours by email or telephone. Workshops UK NEQAS for CPT are continuing with our commitment to education and hold both beginners / refresher one day and specialist staining workshops in the following subjects; Cellular Pathology staining and demonstration techniques Muscle / Neuropathology and Electron Microscopy Non Gynae Diagnostic Cytology Basic and Intermediate Immunocytochemistry Practical one day workshops are held in conjunction with the University of Northumbria, Newcastle, The Pathology Centre, Queen Elizabeth Hospital Gateshead, and the Walton Centre, Liverpool, UK, and are offered regularly throughout the year. UK NEQAS for CPT are currently able to get sponsorship for these events to minimise the cost to participants. The workshops are design to supplement the in-house experience and training for qualified BMS and support staff. Details of workshops will be circulated to all participants by email as soon as they are confirmed and are shown in the News / Events section of the UK NEQAS for CPT website www.ukneqascpt.org.uk under Educational Workshops. Website The UK NEQAS for CPT Members Area of the UK NEQAS for CPT website provides participants with information regarding the UK NEQAS for CPT scheme, including; Best Methods Library Image Gallery Articles and Publications Members Discussion Forum Facility to update laboratory / organisation / contact details and repertoire Participants are encouraged to access the site and to take advantage of the facilities on offer. Newsletter A UK NEQAS for CPT Newsletter is produced 3 times a year detailing updates, changes and developments within UK NEQAS for CPT. As well as best methods the newsletter includes advances in the world of Cellular Pathology and articles and insight from participants and CPT personnel. Bi-Annual Report UK NEQAS for CPT undertake an Annual Management Review from which a Bi-Annual Report of its activities is presented to the Board of the Legal Entity, LabXCell. Updates are available Spring and Autumn to all participants on the UK NEQAS for CPT website www.ukneqascpt.org.uk UK NEQAS for CPT is always willing to improve the services provided and welcomes any suggestions, which should be directed to the Scheme Manager. 45 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Complaints UK NEQAS for CPT attempts to provide a fair and effective EQA service to its participants and is required to have a formal complaints procedure. A Complaints Policy (NEQMANPO004), outlining the complaints procedure, can be found under the Document Library in the Members Area of the UK NEQAS for CPT website www.ukneqascpt.org.uk. All complaints regarding any aspect of the service provided by UK NEQAS for CPT should be directed to the Quality Manager. The Quality Manager will then make sure that all complaints are passed to the relevant person within UK NEQAS for CPT for investigation. Follow up to complaints will be done so on an individual basis, and the resulting outcome fed back to the individual participant where appropriate. At all times during the complaints procedure, participant confidentiality will be maintained. Participants are requested to assist in this respect. Any complaints should be directed to the Quality Manager; Email: [email protected] If the matter cannot be resolved at this level, the Quality Manager / Scheme Manager will advise the participant to refer the complaint to either: a) the chairperson of the UK NEQAS Steering Committee for Techniques in Cellular Pathology, if the complaint concerns operational aspects of UK NEQAS for CPT, or b) the chairperson of the National Quality Assurance Advisory Panel for Histopathology and Cytopathology if the complaint concerns performance. The chairperson of these two committees may choose to refer the matter to the UK NEQAS Executive or the Joint Working Group on Quality Assurance respectively. 46 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics Associated Documentation All documents relating to participation in the UK NEQAS for CPT schemes are available in the member’s area of the UK NEQAS for CPT Website www.ukneqascpt.org.uk NEQMANMA003 – Special Stain Criteria Handbook Non Gynaecological Diagnostic Cytology NEQMANMA004 – Special Stain Criteria Handbook General Pathology and Neuropathology NEQMANMA005 – Special Stain Criteria Handbook Muscle Histochemistry NEQMANMA006 – Special Stain Criteria Handbook Renal Biopsy Pathology NEQMANFO006 – Appeals Form NEQMANFO050 – Complaints Form Appeals Procedure Late Submission Procedure UK NEQAS for CPT Online Log-in Guide Quality Manual Quality Policy Use of Reports Policy 47 | P a g e Providing worldwide external quality assessment and proficiency testing for all aspects of tissue diagnostics
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