Annually, before submission of a report to the EQA Steering Committee, each SOP is reviewed by the Organiser, signed and dated.
If it is necessary to amend an SOP, or to create a new one, this is done by the Organiser
New SOP's may be implemented without the prior approval of the Steering Committee, but the Organiser must take steps to ensure that approval of the participants is confirmed as soon as possible and the new and old forms of the SOP are submitted to the Steering Committee for approval at its next meeting.
Each SOP is marked with the date of approval by the Steering Committee.
Participants working outside the U.K. may enrol, at a slightly higher fee to cover increased postage and administrative costs; however, if places on the scheme have to be limited due to the limited nature of renal biopsy material, preference will be given to pathologists working in the U.K.
Membership of the scheme is open to pathologists from outside the UK, but the scheme Organiser is at liberty to refuse or rescind membership to pathologists outside the UK if their membership causes disruption to the scheme or if a place is needed for a pathologist within the UK.
When the Organiser is made aware of a pathologists desire to join the scheme, that pathologist will be sent a brief description of the way in which the scheme runs. A copy of that description is attached to this SOP.
Prospective participants are asked to read this description and confirm that they wish to participate on these terms. They are also asked to confirm that they are or soon will be, primarily responsible for reporting renal biopsies.
On receiving this information, the Organiser or EQA secretary will enter the new participant's details into the database, such that the new participant can join the next circulation of EQA material from its start.
New participants will not receive an invoice for participation until the beginning of the next financial year. At this point they may, if they wish, withdraw from the scheme without liability for payment.
At the Organiser's discretion, an appropriate number of letters are sent to participants, selected on the basis of not having contributed case material for the longest period. These letters request the provision of a case for the EQA scheme, in the form of at least seven replicate sets of material. The participant is asked to select a case from within the last 20 renal biopsies which he/she has personally reported. This number is selected in order to allow an interesting and relevant choice of case material, while excluding bizarre cases which would not be representative of the routine workload.
The letter makes it clear to the participant that all relevant clinical information which was available at the time the original report was dictated should be made available to the EQA participants. It is also made clear that the results of any special investigations such as electron microscopy, immunocytochemistry or special stains, should be made available either as replicate slides, replicate photographs or, as a last resort, in the form of a description of the result by the submitting pathologist.
The submitting pathologist is asked to check that the material submitted is of adequate quality. Such a check is not repeated by the Organiser, but if the participants in the scheme subsequently decide that the material was not adequate, then the submitting pathologist will be deemed not to have contributed a case and a further request for an acceptable case will be issued.
On receipt of the case and clinical information, the Organiser will enter the relevant information into the appropriate part of the participant address management database, thereby cancelling the request for a case. The case will be assigned an appropriate circulation letter and case number, and all slides and photographs will be marked with that number. The slides and photographs are then stored in the appropriate filing cabinets until used.
Submission of cases for circulation represents one of the costs of participation. One month before annual invoices are generated (see SOP 15), any participant who has not satisfied a request for a case will be sent a reminder. If the request remains unfulfilled at the time the subscription invoices are generated, a surcharge of £30 will be added to the invoice
In view of the numbers of participants and the limitation of biopsy material, the National Renal Pathology EQA Scheme runs two simultaneous circulations of different cases, each seen by half the participants. When those circulations are complete, the same material is distributed to the other half of the participants.
The circulations are managed using the GENPATH Histopathology EQA Participant Address Database Management System.
Pathologists are organised into small groups or "cells", with a maximum of 6 pathologists in each cell. Within each cell, pathologists are allocated consecutive numbers starting at one to indicate the order in which they receive the slides. The cell letter and order number of each pathologist is recorded in the GENPATH database, in accordance with the instructions in the user manual.
On the morning when a circulation is due to start, the start date, circulation letter, and cells involved are entered into the database in accordance with the instruction manual.
A "circulation initiation" letter is then generated from the database in accordance with the instruction manual.
A sufficient number of slides and photographs is assembled by the Organiser to provide one set for each participant in the first place in each cell.
The circulation initiation and EQA materials are handed to the EQA secretary.
The EQA secretary posts the circulation initiation letters to every participant in the scheme, along with copies of the appropriate response sheets. Immediately prior to posting, the EQA secretary writes the participants numeric code at the bottom of the circulation initiation letter as a reminder to the participant and to facilitate the correct numbering of responses.
The EQA secretary also includes the EQA slides and photographs in the posting to the first participant in each cell.
At appropriate dates, as indicated by the timetable, the EQA secretary also sends reminder letters to participants indicating that they should have received the EQA slides. These letters are generated by the GENPATH application. They indicate that if the slides have not been received, the participant should, in the first instance, contact the person from whom the EQA material should have been received; the name and address of that person is given. If that approach fails, the participant is invited to contact the EQA scheme Organiser.
In the event of the scheme Organiser being made aware of a breakdown of the slide circulation system, the EQA scheme secretary will attempt to trace the missing slides by telephone. If necessary, a spare set of EQA material will be sent out by the EQA scheme Organiser to maintain the circulation, if such a set is available.
This is achieved by a confidential numeric code system generated by the EQA secretary. The secretary has a list of EQA scheme participants in paper form. Against each name the secretary enters a numeric code. This paper represents the only link between the codes and the participant names. It is kept in a locked cabinet and is not made available to the scheme Organiser.
The scheme Organiser therefore communicates to participants when identified by their code number only through the scheme secretary. Any confidential material from the Organiser is passed to the scheme secretary with only the relevant code number exposed, such that the communication is placed in an appropriately addressed envelope by the EQA scheme secretary without the secretary having to read the contents of the communication.
The link between participant names and code numbers may be divulged by the EQA scheme secretary only under two circumstances.
1. In writing to a participant who requests a reminder of his/her code number. Code numbers must not be divulged by telephone.
2. In writing to the Chairman of the Histopathology/Cytopathology Advisory Panel of the Joint Working Group on Quality Assurance, only when justified by SOP 11, in order to investigate appropriately a case of persistent substandard performance in the EQA scheme.
The Organiser enters the participants' diagnoses into the RESPONSE Histopathology EQA database management system, in accordance with the instructions in the user's manual.
Afeter every manipulation of the database, a backup copy of the data file is made on a removable disk, which is normally kept in a separate building from the computer housing the response analysis database. Parent, grandfather, great-grandfather and great-great-grandfather copies are maintained.
The Organiser, as a participant in the scheme, examines the EQA cases and records his own diagnoses on the RESPONSE database before examining the diagnoses of any other participant.
At intervals determined by the Organiser, but starting as soon as is practicable after the initiation of the circulation, the popularity of each diagnosis proffered for each case is calculated by the RESPONSE database. This information is output by the database in the form of a HTML file which is lodged on the World Wide Web at a location with a cryptic URL. The EQA scheme secretary is made aware of this URL and will email it to any participant who requests it, after having first received their diagnoses for that circulation.
When a circulation has been completed (three weeks after the participants at the end of the cells should have received the slides) the RESPONSE application is used to calculate the popularity of each diagnosis proffered on each case. This information is printed out, dated and posted to the participants.
After having recorded his own diagnoses, the Organiser uses the GENPATH application to generate a letter to the pathologists who submitted the cases, requesting their own original diagnoses and any further relevant information which may have become available since the original report was generated. This information is entered into the RESPONSE database in accordance with the user's manual.
1. The general management of the scheme and any way in which the scheme may be extended or improved.
2. The cases which have been circulated since the previous participants' meeting, in order to decide how best they should be used for personal analysis.
At the participants' meeting the Organiser will present a summary of the diagnoses proffered for each case, with some representative photomicrographs. The participants present are asked to decide:
1. Is the case appropriate for personal scoring? Situations where the case may not be appropriate include cases where there was a particularly wide divergence of opinion as to the correct diagnosis from participants; cases where the material circulated was deemed to be inadequate to achieve a specific diagnosis; cases which were originally identified as being rare or unusual and therefore for education purposes only.
2. How should the case be used for personal analysis? This will usually be in accordance with the default procedure of the RESPONSE application, which judges the quality of each individual diagnosis by comparison against the opinion of the entire group. However, it may be necessary to "merge" diagnoses which are not separate entities and it may in some circumstances be necessary to alter the scores in the database in order to achieve a just marking system. The Organiser may suggest how this should best be achieved, and should explain to the participants the consequences of various options, but the decision on how each case should be used must be a democratic one. If dissent cannot be resolved by discussion, the Organiser may request a show of hands to vote on the alternative approaches under discussion.
The Participants' Meeting is also invited to discuss any aspects of scheme management, particularly when changes in how the scheme runs are being contemplated. Participants may also use the meeting to discuss complaints about the scheme which are of a general nature.
If the final favoured diagnosis differs significantly from the diagnosis proffered by the participant who contributed the case, then if the participants' Meeting approves the Organiser will send a letter to the contributor specifically to make this known.
The Participants' Meeting must have at least 10 participants present for the meeting to be considered quorate. If fewer than 10 are present, the meeting may proceed but any decisions will be described in writing to the full membership and a postal ballot will be held. The ballot will ask the members whether the decisions made at the meeting are all acceptable. If a majority of those responding to the ballot do not favour acceptance, personal scoring will be delayed until the cases have been discussed at another participantsâ meeting, at which the above definition of a quorum will again apply.
The data validation systems provided by the RESPONSE application are used, including a visual check of a paper printout to ensure that duplicate entries have not been made. The software is then used to calculate personal scores for each participant.
Personal reports are then printed by the Organiser, and folded by the Organiser so as to leave only the participant code numbers exposed. These are then passed to the EQA secretary who posts them to the appropriate participants, along with any general communication which the Organiser deems necessary to explain how the material has been used.
After the individual scores have been calculated, the Organiser checks the database to test whether any of the participants fulfil the criteria of persistent substandard performance as defined in SOP 11 and modified from time to time by the Histopathology/Cytopathology Advisory Panel.
Annually, towards the end of the financial year, participation certificates are printed and distributed.
The Organiser checks whether any participant whose score falls within this range has also had a score fall within this range in the preceding two circulations. If such a participant is found, the Organiser sends a "Dear Colleague" letter to that participant, pointing out the position, offering appropriate sources of advice and assistance and informing the participant that if the score results in a similar ranking in two out of the next three circulations, the Chairman of the Advisory Panel will have to be asked to investigate. It should also be made clear that for the next three circulations, a failure to participate will be considered equivalent to a score in the bottom 2.5% of the listing.
The participant is asked to confirm that this letter has been received, by reply through the EQA secretary bearing no identifying marks other than the participant's code number. If such a reply is not received within three weeks, the Organiser sends a reminder; if a reply is not received within another three weeks the Organiser informs the Advisory Panel Chairman of the position
This letter is identified by the participant's number only, and is passed to the EQA secretary in a sealed envelope for posting to the relevant participant.
The event of such a letter having been sent is recorded in the RESPONSE database. If such a participant again falls within the bottom 2.5% in two of the next three circulations, the Organiser informs the EQA secretary of this event, and also informs in writing the Chairman of the Advisory Panel. It is anticipated that the Chairman of the Advisory Panel will investigate the matter, initially without knowing the participants name, communicating through the EQA secretary. Subsequently however the Chairman of the Advisory Panel is entitled to be informed of the identity of the relevant participant by the EQA secretary. At no time should the scheme Organiser be informed of the identity of any participant under such investigation.
This EQA scheme does not use the concept of "dangerous diagnoses" as a criterion for defining substandard performance.
The Organiser checks whether any participant whose score falls within this range has also had a score fall within this range in the preceding two circulations. If such a participant is found, the Organiser sends a "Dear Colleague" letter to that participant, pointing out the position, offering appropriate sources of advice and assistance and informing the participant that if the score results in a similar ranking in two out of the next three circulations, the Chairman of the Advisory Panel will have to be asked to investigate. It should also be made clear that for the next three circulations, any non-submission will be considered equivalent to a zero score, and therefore will be in the bottom 2.5% of the listing.
If the Organiser becomes concerned that the performance of a participant gives cause for concern, such that the quality of patient care maybe in doubt, the Organiser is entitled to bring this to the attention of the Advisory Panel Chairman even if the above numeric criteria have not been fulfilled. In this event, the Organiser should, if possible, first present data relating to the participant's performance in an anonymous form at a participants' meeting. That meeting should be invited to decide whether the Panel Chairman should be informed.
The above procedures do not replace or alter in any way the obligation placed by the General Medical Council upon the Organiser, as a Doctor, to take appropriate action to protect patient care if the Organiser believes that patient care is put at risk.
Where a telephone or verbal communication is made, the Organiser or secretary receiving the communication will make a written note summarising the communication and that will be dated and stored in the same file.
Where the communication may be construed as a complaint, the action taken to remedy the complaint will be recorded and dated, clipped to the original communication in the file.
If the Organiser judges the complaint to be justified and of a nature which requires any alteration in the procedures of the scheme, the preferred sequence of events for enacting such changes would be in accordance with SOP 1:
1. Discussion at the participants' meeting
2. Production of a draft revision to the relevant SOP
3. Implementation
4. Notification of the Steering Committee
If the Organiser deems that a change in procedure is too urgent to permit such discussion, a revised SOP may be generated and implemented immediately, for subsequent discussion at the participants' meeting and Steering Committee as laid out in SOP1.
A report is provided annually to the Histopathology EQA Steering committee on the work of the Scheme, with particular emphasis on any changes in how the scheme runs, actual or planned. Specifically, any changes in these SOPs must be communicated to the Steering Committee for approval., as documented in SOP 1.
The report to the Steering Committee includes a summary of the financial accounts of the Scheme.
An annual report is provided to the Advisory Panel. This must include any changes in the assessment procedure and in procedures for managing sub-standard performance, actual or planned, and also the number of participants who triggered action in response to sub-standard performance in the previous year.
Invoices to participants are generated in April, at the beginning of the financial year.
Prior to generating invoices, the GENPATH application will be used to produce a letter to each participant, warning them that subscriptions will soon be due, informing them of the appropriate subscription rate and the address to which the subscriptions will be sent. Corrections from the participants are invited.
The RESPONSE application is used to generate subscriptions in accordance with the instructions in the users manual. Any sums outstanding from a previous financial year are included in the subscriptions, which itemise the fees for each participant, any excess charges for overseas participants and any excess charges for failure to provide a case for circulation in the EQA scheme.
The GENPATH application produces three copies for each participant; an Invoice, a Remittance Advice and a File Copy. The EQA secretary stores the File Copy and posts the other two copies to the appropriate address.
When payments are received, the payment is recorded in the GENPATH application in accordance with the users manual and the file copy is stamped "received". Receipts are not generated unless requested.
If a cheque is received made payable to other than the University of Leicester, the EQA secretary returns the cheque to the sender with a request for a correction and a copy of the file copy of the invoice.
If a cheque is received for other than the invoice amount, the Organiser may decide, at his discretion, to :
1. return the cheque with a request for the appropriate amount.
2. accept the cheque, but record the difference in the database and send a letter to the participant pointing out that this amount will be added/deducted from the subsequent years subscription.
3. accept an incomplete payment as payment in full.
If the slide circulation system has broken down such that participant has been unable to see one or more of the circulations in the year, that participant shall be entitled to submit a reduced fee, reduced in proportion to the proportion of EQA material which has not been made available. This does not apply to participants who miss a circulation because of their own absence.
After a minimum period of six weeks, the Organiser may use the RESPONSE application to send a reminder letter to those participants whose subscription has not been received.
After a minimum of another six weeks, a second reminder letter may be sent. This letter may, at the Organiser's discretion, point out that failure to pay the subscription may result in removal from the EQA scheme.
If a subscription has not been received a minimum of six weeks after the second reminder letter, and if an acceptable explanation for the delay has also not been received, the Organiser may at that point, or at his discretion at any time afterwards, delete that participant from the EQA scheme.
Reinstatement to the scheme after such deletion will be dependent upon payment of the outstanding account, together with a year's subscription in advance.
Subscriptions are paid directly into this account.
The account may be charged for secretarial time (nominally 1 day per week), computing equipment and consumables, photocopying, stationery and postage, fees payable to the Steering Committee and Advisory Panel and any other costs involved in the day-to-day running of the scheme, subject to the approval of the Organiser.
The scheme does not pay overhead costs to the University of Leicester. An informal agreement exists that this is waived; in return, the services of the EQA scheme secretary are available to the University Department of pathology when she is not engaged on EQA scheme work.
The Scheme Secretary is employed by the University of Leicester, and is available for a nominal one day per week for EQA work. The Scheme is charged by the University of Leicester for the cost of this work.
No other staff are employed directly on Scheme work, though the Head of secretarial staff, University Department of Pathology, provides cover for the EQA secretary in her absence.
There is no specific training for work on the EQA scheme; problems are resolved by informal discussion between the Organiser and the Secretary, and the Organiser provides training sessions as required.