SOPs for the Yorkshire General Histopathology EQA Scheme

Yorkshire General Histopathology External
Quality Assessment Scheme
Standard Operating Procedures
Original Produced March 2007
Version 8 last reviewed: 01/08/2013
Document maintained by:
Mandy Winterbottom
Senior Audit Officer/ Quality Manager
Public Health England
Health and Wellbeing Directorate
Quality Assurance Reference Centre
Ground Floor, Raynham House
2 Capitol Close, Capitol Park West
Leeds LS27 0WH
Tel: 0113 2466300
Fax: 0113 2466320
Email: mandy.winterbottom@nhs.net

STANDARD OPERATING PROCEDURES
CONTENTS
Standard Operating Procedure 1: Identification of Participants ..................... 4
Standard Operating Procedure 2: Movers and Locums ................................. 5
Standard Operating Procedure 3: Enrolment of Participants ......................... 6
Standard Operating Procedure 4: Allocation of Code Numbers ..................... 7
Standard Operating Procedure 5: Identification of Laboratories for Slide
Submission .................................................................................................... 8
Standard Operating Procedure 6: Slide Request ........................................... 9
Standard Operating Procedure 7: Dealing with Submitted Broken Slides ... 10
Standard Operating Procedure 8: Organisation of the Slide Review Meeting
..................................................................................................................... 11
Standard Operating Procedure 9: Compilation and Labelling of the Slide
Sets ............................................................................................................. 12
Standard Operating Procedure 10: Producing the Documentation .............. 13
Standard Operating Procedure 11: Setting the Dates of the Circulation ...... 14
Standard Operating Procedure 12: Informing the Participants..................... 15
Standard Operating Procedure 13: Starting the Circulation ......................... 16
Standard Operating Procedure 14: Monitoring the Slide Set Locations ....... 17
Standard Operating Procedure 15: Slides Broken During the Round .......... 18
Standard Operating Procedure 16: Return of Responses ........................... 19
Standard Operating Procedure 17: Late Participation ................................. 20
Standard Operating Procedure 18: Non-Participation .................................. 21
Standard Operating Procedure 19: Entering the Participants Responses ... 22
Standard Operating Procedure 20: Initial Case Analysis Results ................ 23
Standard Operating Procedure 21: Participants Meeting ............................. 24
Standard Operating Procedure 22: Final Feedback to Participants ............. 26
Standard Operating Procedure 23: Bottom 2.5th Percentile Calculation ..... 27
Standard Operating Procedure 24: Persistent Substandard Performance .. 28
Standard Operating Procedure 25: Regional Report ................................... 29
Standard Operating Procedure 26: Storage & Return of Slides ................... 30
Standard Operating Procedure 27: Record Keeping ................................... 31
Standard Operating Procedure 28: Back Up of Computerised Files ............ 32
Standard Operating Procedure 29: Validation ............................................. 33
Standard Operating Procedure 30: Disposal of Records ............................. 34
Standard Operating Procedure 31: Cover for Facilitator Leave ................... 35
Standard Operating Procedure 32: Complaints and Revision...................... 36
Standard Operating Procedure 33: Preparation of Standard Operating
Procedures .................................................................................................. 37
Standard Operating Procedure 34: Data Entry ............................................ 38
Standard Operating Procedure 35: Data Retrieval ...................................... 39
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 2 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 36: Scheme Audit and Monitoring Exercises
..................................................................................................................... 40
Standard Operating Procedure 37: Confidentiality and Data Safety ............ 41
Standard Operating Procedure 38: Document Control ................................ 42
Standard Operating Procedure 39: Audit of the Quality Management System
..................................................................................................................... 44
Standard Operating Procedure 40: Quality Improvement ............................ 45
Standard Operating Procedure 41: Committee Meetings/ Annual
Management Review ................................................................................... 46
Standard Operating Procedure 42: Other Non-Conformities Identified (not via
Audits).......................................................................................................... 47
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 3 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 1:
Identification of Participants
(CPA Standards: E3, E5)
The scheme is available to those histopathologists who report general surgical
pathology cases within laboratories derived largely from the old Yorkshire
Regional Health Authority area with additional participants from South Yorkshire,
Durham, North Tees and Newcastle. This includes consultants, staff grade and
associate specialists who have the authority to report independently on material
which is part of the scheme. Specialist trainees are encouraged to see the cases
and submit written responses.
At the start of each round the EQA Scheme Secretary emails the lead contact
within each laboratory with a copy of the participants list from the previous
circulation. The lead is asked to check for accuracy and highlight any participants
who wish to join or leave the scheme.
Once all the amendments are received the Scheme Secretary creates the
participants list for the circulation. Any notable changes such as a participant
leaving or a trainee qualifying are recorded against the participant in the ‘Record
of Responses.xls’ Excel document.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 4 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 2: Movers and
Locums
(CPA Standards: E3, E5)
Participants who have moved laboratories retain their individual code. The
Scheme Secretary records these changes on the ‘Record of Responses.xls’
Excel document. If an individual joins the region (as a permanent or locum staff
member) the Scheme Secretary ascertains if they have previously been a
participant. If this is the case the participant will be allocated their original code
to allow follow-up where necessary.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 5 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 3: Enrolment
of Participants
(CPA Standards: E3, E5)
A copy of the Participants Manual is sent to all new participants with a
participation form. This participation form must be completed and returned to the
Scheme Secretary prior to the allocation of a unique code. All participation forms
are scanned and saved on the EQA drive.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 6 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 4: Allocation
of Code Numbers
(CPA Standards: E4)
Once a participant has agreed to the scheme they will be allocated a unique
participation code, which is known only by the participant and the Scheme
Secretary.
The code allocated should be a three number code; for Consultant Pathologists it
will be the next number in the sequence (for example if the last person to join the
scheme was participant 192, then the next code would be 193). When adding
trainees then the code should start 9—(e.g. 901, 902).
When the new participant has been allocated a code they are entered onto the
Name list, Code list and the current circulation list in the ‘Record of
Responses.xls’ spreadsheet.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 7 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 5:
Identification of Laboratories for Slide
Submission
(CPA Standards: D3, E3, E6, F1)
Cases for the EQA are collected on a rotation system. The rota consists of
laboratories grouped together based on numbers of participants. Requests for
submission of cases are made every 12 months from the relevant laboratories on
the rota, as detailed in the ‘Slide Submission Rota.doc’ word document. Each
participant is required to submit a minimum of two cases during their laboratory’s
scheduled turn on the rota in order to maintain the slide bank with an adequate
number of cases for annual review and selection.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 8 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 6: Slide
Request
(CPA Standards: A4, A9, A10, D3, F1)
The Scheme Secretary will request cases on a yearly basis from participants in
the relevant laboratories identified in the ‘Slide Submission Rota.doc’ word
document who are eligible to submit cases. The ‘Slide Request Letter’ requesting
that they submit a minimum of two cases (12 H&E stained slides from one block
of each case) along with the ‘EQA clinical info template’ form and the ‘EQA
diagnosis template’ is emailed to the participants.
They are asked to submit cases which are appropriate to a general
histopathology scheme. These should cover all the main organ systems and
specialities likely to be seen by a general histopathologist in a district general
hospital as part of the routine workload. Specialised neuropathology, paediatric
pathology, orthopaedic pathology, ophthalmic pathology, dental pathology, and
renal biopsy pathology would normally be excluded. Post mortem cases are not
accepted.
For each case the participant is asked to provide the following:
Case provided by
Specimen
Your case number
Macroscopic Description
Clinical Information (including special stains etc.)
Age
Sex
Your diagnosis
The participants are informed that slides and accompanying information sent to
the QARC should not have visible patient identifiers. The cases will be relabelled
as necessary during the circulations to ensure there are no details which could
disclose the origin of the case.
For all slides the submitted information is recorded in the ‘Slide Selection’ Excel
document, to allow them to be located at any time. This information should be
kept according to SOP 38: Document Control. The cases details forms and
diagnosis information should be kept separately.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 9 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 7: Dealing
with Submitted Broken Slides
(CPA Standards: A4, A10, C4, D3, F1)
If a slide is broken in transport the EQA Scheme Secretary contacts the
participant to arrange return of the slide. Depending on the level of damage the
slide may be returned by hand.
The EQA Scheme Secretary records details of any cases which have been
returned with an explanation in the database and the ‘Slide Selection’ Excel
document.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 10 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 8:
Organisation of the Slide Review Meeting
(CPA Standards: A4, F1)
Upon receipt of slides, the EQA Scheme Secretary checks over all slides
submitted for each case to ensure that there is a similar amount of material in
each slide. The Secretary arranges a date suitable for all members of the
Scheme Organising Committee to attend (Prior to the slide review an Organising
Committee meeting is usually held).
The Committee members assess all submitted cases for suitability including
whether adequate clinical information, immunocytochemistry and special stains
have been provided.
The Scheme Secretary records the opinions of the Organising Committee
including those cases which should appear in different circulations. During the
slide review the Committee may select a number of cases to be included as
Educational Cases against which the participant will not be scored. The Scheme
Organiser then conducts a microscopic check on all slides for the cases deemed
suitable for the EQA and records this on the ‘EQA Clinical Information’ form for
each case.
Following the review the Scheme Secretary updates the ‘Slide Selection’ Excel
document.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 11 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 9:
Compilation and Labelling of the Slide Sets
(CPA Standards: A4, A10, C4, D3, E3, E4, F1, F2)
At the beginning of each circulation, the Scheme Secretary selects 10 cases from
the cases deemed suitable by the Committee. It is the responsibility of the
Secretary to assemble the slide sets and to ensure that the diagnoses are not in
duplicate.
The cases to be included in the circulation are marked with a circulation letter
and a unique circulation number. The letter allocated to the circulation is the next
in the alphabet (e.g. the last circulation was H so the next sets will be I). Each
case is given a three digit number; the first number is specific to the circulation
with the next two relating to the case number, 00 to 09. The circulation number
increases by one from the previous circulation e.g. for circulation H the cases
were 700 to 709 so circulation I will be 800 to 809. For each case, the case
details including the diagnosis need to be entered into the Omnis7 Genpath
library.
When the Scheme Organiser has checked and approved the cases the Scheme
Secretary re-labels the slides with the new three digit number, and makes up
twelve slide sets. Each slide set should contain one slide from each case (ten
slides in each set). Slide sets are then numbered from set 1 to set 12. The
laboratories are allocated a slide set, which allows the identification of any
problems with sets if necessary.
As cases consist of permanent non-degradable slides (stored in appropriate
boxes within a lockable cabinet) unused appropriate cases can be used during
circulations held within two years of submission.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 12 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 10: Producing
the Documentation
(CPA Standards: A4, A9, F2)
The response forms are produced by the Scheme Secretary using the ‘Response
Sheet Template’ Excel document. The response forms are then sent via email to
the Scheme Organiser for checking.
The Scheme Secretary records the case circulation number on the original
submitted cases details and diagnosis forms. These are held in a lockable
cabinet accessible only by the Scheme Secretary.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 13 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 11: Setting
the Dates of the Circulation
(CPA Standards: E4)
The Yorkshire General Histopathology EQA scheme holds two circulations per
year. These are in Spring and Autumn. Prior to the circulation the EQA Scheme
Secretary identifies periods which should be avoided such as school holiday
periods. The circulations take place over a five week period (usually
February/March and September/October). Once the period has been identified
the EQA Scheme Secretary will inform the Scheme Organising Committee via
email and if appropriate, discuss at the Committee meeting.
There are 12 sets which can be circulated to the laboratories within the scheme.
Those laboratories with larger numbers of participants will receive a set for the
entire four weeks. A number of sets will be sent to laboratories for part of the
circulation with instructions to forward on to the next laboratory on a set date.
A calendar is prepared for each circulation (using the ‘Circulation Schedule
Template’ Word document) which states, by slide set, the date the slides are
available in each laboratory.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 14 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 12: Informing
the Participants
(CPA Standards: E4)
Prior to the circulation the EQA Scheme Secretary sends the ‘Starting the
circulation - Prestart Letter’ to all participants to notify them of the dates the slides
will be available in their laboratory; this should occur a minimum of one month
prior to the start of the round. In this letter the Secretary asks the participant to
contact them if they do not wish to participate or with any reasons for nonparticipation.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 15 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 13: Starting
the Circulation
(CPA Standards: E4, F2)
The week prior to the start of the circulation the EQA Scheme Secretary sends all
participants their response forms electronically via email with the calendar.
Also in the week prior to the circulation the Secretary prepares the ‘Starting the
circulation - Lab Coordinator Letters’ for each laboratory. There are two letters
sent at this point. The first is to those laboratories where the slides are due on the
first day of the circulation. The letter contains a slide set and details (including an
envelope label) of where and when the slides are to be sent to the next location.
The second letter goes to those laboratories who receive slides part way through
the circulation. This states the date the slides will arrive and details if applicable
(including an envelope label) of where and when the slides are to be sent to the
next location.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 16 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 14:
Monitoring the Slide Set Locations
(CPA Standards: A4, A9, A10, D3, E4, F1)
The Scheme Secretary contacts via email the lead contact in the laboratory on
the date the slides are due to arrive to confirm receipt. If the slides have not
arrived the Scheme Secretary contacts the previous laboratory to check that they
have forwarded the slides.
A spare set of slides for each circulation is retained at the Quality Assurance
Reference Centre for future reference. These are stored in a slide bank in a
locked, cool room.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 17 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 15: Slides
Broken During the Round
(CPA Standards: A10, D3, E4, F1)
If slides are damaged or broken beyond repair in a round then the slide set will
be removed from the circulation and those who have not completed responses
will be given another set.
Broken slides will be passed to the Scheme Organiser for secure disposal.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 18 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 16: Return of
Responses
(CPA Standards: A9, E4, F3)
The participants are encouraged to return their responses at the earliest
opportunity, via email to the Scheme Secretary. When the Secretary receives the
response the unique identifiable code and the ‘record of responses.xls’, are used
to identify the individual. The Scheme Secretary then records that the responses
have been received on the ‘record of responses.xls’ Excel spreadsheet. The
response forms are then filed electronically by code on the EQA drive.
Two weeks after the end of the circulation the Scheme Secretary writes to those
participants who have not submitted response forms requesting that these are
sent within two weeks. A note is made on the ‘record of responses.xls’ of the date
the reminders were sent.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 19 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 17: Late
Participation
(CPA Standards: E5, F3)
Response forms received after the initial results have been produced, but prior to
their circulation are entered in to the system, but not included in the scoring for
discussion at the meeting. Those response forms received after the initial results
have been circulated will not be entered and the participant will be recorded as
not participating. These will be retained with an explanation being recorded on
the‘record of responses.xls’ Excel spreadsheet.
If a participant chooses to submit additional/amended results these will not be
accepted for scoring, but will be retained with the original response sheets.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 20 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 18: Non-
Participation
(CPA Standards: E5, F3)
Acceptable reasons for staff not participating are long term ill health and
maternity leave. When considering instances of ill health, each case should be
looked at individually and decisions based on common sense. For example, if an
individual has a serious illness then non-participation is acceptable; however, if a
participant is only ever absent on/around the circulation dates then this is not
acceptable.
Failure to participate in two out of three rounds will be reported by the Scheme
Secretary to the Scheme Organising Committee. They will then write to the
participant to ask if they wish to continue participating.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 21 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 19: Entering
the Participants Responses
(CPA Standards: F3, F4)
Following the initiation of the circulation the Scheme Secretary copies the
relevant CLINICAL.DAT file onto the Scheme Organiser’s version of the Omnis7
database.
When the Scheme Organiser has returned their responses he/she can begin to
enter the results into the Omnis7 database. The Scheme Secretary provides the
Scheme Organiser with the received responses in a non-identifiable manner for
data entry.
When all results have been entered and the amalgamations decided at the
participants meeting have been conducted a copy of the consultants file is
created into which the trainee results are entered. This allows the trainees to
compare their results to consultants without them being included in the final
scoring.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 22 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 20: Initial
Case Analysis Results
(CPA Standards: E4, F4, F5)
Following the entering of the responses the Scheme Secretary prints the Initial
Case Analysis results from Omnis7. These are circulated to all participants the
week prior to the participants meeting via email.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 23 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 21:
Participants Meeting
(CPA Standards: A2, E5, F4, G1, G2, H1)
A participants meeting is held at the end of each round in conjunction with the
Yorkshire Histopathologists Business Meeting. At the earliest possible
opportunity the Scheme Secretary should write to the participants with the date of
this meeting. The intention of the meeting is to allow participants to discuss:
1. The general management of the scheme and any way in which the
scheme may be extended, improved and audited.
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.
The submitting pathologists are asked to present the educational cases at the
participants meeting; this is expected to be a short explanation for the diagnosis
given, including photographs of the relevant areas within the slide. The Scheme
Secretary should ensure that the required equipment is available at the meeting.
The Scheme Secretary writes to the participants providing a copy of the initial
case analysis and asking them to confirm attendance. For the participants
meeting to be valid the quorum (~ 30%) must be met. An attendance register
should be completed, and minutes of the meeting are produced and sent to all
participants.
Participants present at the meeting are asked to decide:
1. Whether each case is appropriate for the scheme.
2. How/If the responses should be amalgamated for the final results.
Following the meeting the Scheme Secretary will record on the ‘Attendance at
Part Meeting Audit.xls’ those who attended. The spread sheet calculates those
participants who have not attended a meeting within the previous three
circulations, which is recommended as good practice.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 24 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Any feedback from CPA or the Royal College of Pathologists is communicated to
the group at the participants meeting. If a complaint or suggestion for altering the
scheme is made at the meeting, it is taken to the next Scheme Organising
Committee for discussion.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 25 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 22: Final
Feedback to Participants
(CPA Standards: F5)
Following the decisions made at the Participants Meeting, the Scheme Secretary
performs the amalgamations agreed and produces the final results for all
participants.
The Scheme Secretary then produces the final result packs which include:
Individual Results
Certificate of Participation
Minutes of the Participant Meeting
These are circulated within one month of the participant meeting.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 26 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 23: Bottom
2.5th Percentile Calculation
(CPA Standards: E4, E5, F4)
The Omnis7 database calculates those participants who have scored below the
2.5 percentile. These are then recorded on the ‘Poor Performer & Non-part.xls’
spread sheet.
Due to the nature of the scoring system, on some occasions there may be a
number of individuals whose scores equal the 2.5 percentile point, with no score
falling below the value. In these cases no participants can be identified as
substandard performers.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 27 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 24: Persistent
Substandard Performance
(CPA Standards: E2, E4, E5, F4)
Persistent substandard performance is identified when a participant scores below
the 2.5 percentile mark twice within three circulations. Following the identification
of those falling below the 2.5 percentile mark the Scheme Secretary checks if any
of these individuals have scored below this mark in either of the two preceding
circulations.
If a persistent substandard performer is identified, the Scheme Organiser sends a
“Dear Colleague” letter to the participant, through the Scheme Secretary to
maintain anonymity. This includes a copy of their results for the circulations
where they scored below the 2.5 percentile mark. The intention of the letter is to
offer appropriate advice and assistance and to inform the participant that if the
score results in a similar ranking in two out of the next three circulations, the
Chairman of the NQAAP 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 to be a score of zero. This letter should be sent within one month
following the distribution of the final results.
The participant is asked to confirm that this letter has been received, by reply
through the Scheme Secretary, bearing no identifying marks other than the
participant’s code number. If this is not received within three weeks, the Scheme
Organiser sends a reminder; if a reply is not received within another three weeks
they are then required to inform the NQAAP Chairman of the position. This letter
is identified by the participant’s number managed through the Scheme Secretary.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 28 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 25: Regional
Report
(CPA Standards: A2, A5)
The Scheme Secretary compiles an annual report containing relevant information
relating to the year period. These include; the circulations, changes to staffing,
CPA applications and internal audits. The report is produced by calendar year
and is made available to the scheme participants through the Virtual Pathology
website.
A separate report is produced for the Royal College of Pathologists in
accordance with the template circulated each year.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 29 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 26: Storage &
Return of Slides
(CPA Standards: A4, A9, A10, D3)
At the end of each circulation, the slide sets are retained indefinitely by the last
laboratory to receive them for educational purposes. The schedule is organised
so that the teaching hospitals are usually last in the circulation for this reason.
One slide set is retained by the QA Reference Centre for audit purposes. These
are stored in solid slide containers in a secure locked room with restricted fob
access. Cases are filed in slide sets by circulation.
If a participant requests a case to be returned the Scheme Secretary is obliged to
do so. The facilitator must record details of the date the case was returned and
the reason for doing so. If the case is part of a set it should be removed from
scoring and counted as not being suitable for EQA.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 30 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 27: Record
Keeping
(CPA Standards: A4, A9, D2)
It is the Scheme Secretary’s responsibility to keep accurate records and
documentation. All written communication should be kept according to SOP 38:
Document Control. All documentation is stored electronically or in a locked
cabinet which is only accessible by the Scheme Secretary.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 31 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 28: Back Up
of Computerised Files
(CPA Standards: A4, A9, D2)
All computerised files are stored on the Quality Assurance Reference Centre
server on the relevant secured shared drive. The server is fully backed up weekly
locally and to another site with incremental local back up nightly.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 32 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 29: Validation
(CPA Standards: A4, A9, D2, E4, F4)
The Scheme Secretary performs the validation audit on ten percent of the
entered results prior to circulating the final results. This audit is retained for a
period of ten years, and is accessible when required.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 33 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 30: Disposal
of Records
(CPA Standards: A4, A9, D2)
All records must be kept for a minimum of ten years. Due to the confidentiality
associated with the scheme all records which are to be disposed of must be
treated in the required manner. Paper documents must be shredded in house by
the Scheme Secretary.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 34 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 31: Cover for
Scheme Secretary Leave
(CPA Standards: B2)
If the Scheme Secretary is on short term sickness leave during the EQA round
then a nominated person (usually the Quality Manager or another EQA staff
member) will take on responsibility for ensuring that the slides have been
circulated as appropriate.
If a Scheme Secretary is not in work for a long period (for example if they are on
long term sick or maternity leave), a replacement is put in post. Preferably this is
someone working within the Quality Assurance Reference Centre who has an
understanding of the Yorkshire General Histopathology EQA scheme. This
individual will work closely with the Quality Manager to ensure that the scheme is
run to the standard operating procedures. The acting Scheme Secretary will have
access to the participant name – code list.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 35 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 32:
Complaints and Revision
(CPA Standards: A2, A11, E2, G2, H1, H2, H5)
The procedure for complaints is documented in the Participant Manual, which all
participants have access to.
Following the participants’ meeting there may be some suggested changes to the
organisation/running of the scheme. Proposals for amendments to the Standard
Operating Procedures are submitted to the Scheme Organising Committee for
discussion. The Scheme Organising Committee will make the decision on any
changes to the scheme.
If a participant wishes to make a complaint they can either contact the Scheme
Secretary or Scheme Organiser. The action taken to remedy the complaint will be
recorded and dated, and appended to the original communication in the file. All
written or verbal communications from participants to the Scheme Organiser or
the Scheme Secretary will be stored according to SOP 38: Document Control.
If the Scheme 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:
1. Discussion at the participants’ meeting
2. Production of a draft revision to the relevant SOP
3. Implementation pending approval by the Scheme Organising
Committee
4. Notification of the revisions to the Royal College of Pathologist
Steering Committee
If the organiser deems that a change in procedure is too urgent to warrant such
discussion, a revised SOP may be generated and implemented immediately, for
subsequent discussion at the participants’ meeting and Scheme Organising
Committee.
In the event of the complaint being handled locally to the dissatisfaction of a
participant, the participant can complain direct to the Chairman of the Steering
Committee for EQA in Histopathology and Cytopathology.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 36 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 33:
Preparation of Standard Operating
Procedures
(CPA Standards: A2, E2, G1, G2)
The Scheme Organising Committee is responsible for producing the Scheme
Standard Operating Procedures. They take responsibility for introducing and
communicating any amendments to scheme participants. The Standard
Operating Procedures are controlled documents and a copy is held centrally at
the Quality Assurance Reference Centre. The participants will be issued with an
amended Participant Manual when necessary.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 37 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 34: Data Entry
(CPA Standards: A9, D2, F3, F4)
Data entry and data validation is the responsibility of both the Scheme Secretary
and the Scheme Organiser. They must allocate enough time to enter case data
and responses accurately. Validation of the data is important and must be
performed prior to sending results (SOP 29).
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 38 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 35: Data
Retrieval
(CPA Standards: A9, D2, F4)
The Omnis7 database is used to retrieve data when required. This data is only
accessible by the regional EQA Scheme Secretary (with limited access for the
Scheme Organiser) using confidential passwords. The Scheme Secretary may
produce data if requested; this will depend on the individual who has made the
request and the information being requested. It is the responsibility of the
Scheme Secretary to decide what information cannot be disclosed. In cases
where he/she is unsure they should seek advice from the Scheme Organising
Committee.
All copies of response forms are held in unique code number order by circulation
on the EQA drive.
If required the data can be retrieved from the weekly back-up of the server as per
SOP 28: Back Up of Computerised Files.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 39 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 36: Scheme
Audit and Monitoring Exercises
(CPA Standards: A2, H1, H3, H4, H5)
The Scheme Secretary will ensure that the scheme participates in any audits
requested by the Scheme Organising committee. These currently include:
1. Database validation exercise: the Scheme Secretary checks 10% of the
entered results for errors. Details of this are retained for future reference.
2. Participant Satisfaction Questionnaires: the Quality Manager circulates a
satisfaction questionnaire every year to ascertain any issues the participants
may have. This questionnaire is sent to all participants.
3. Audit of Attendance at Participants Meetings: the Scheme Secretary
records attendance on the regional spreadsheet which highlights those who
have not attended the three most recent meetings.
4. Audit of the Quality management System: the Quality Manager is
responsible for regularly auditing the Quality Management System in line with
the recommendations of SOP 39. The results of this audit are recorded on
the relevant Audit of QMS spreadsheet. This audit is performed yearly by the
Quality Manager.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 40 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 37:
Confidentiality and Data Safety
(CPA Standards: A9, D2, F3, F4, G1)
The IT Manager is responsible for ensuring that the network is secure and the
EQA drives are only accessible by the required EQA staff. They will ensure that
incremental back-ups of the network take place, and will complete regular
investigations of the audit log. All of the audit logs are archived for future
reference. Access to the EQA drives will only be granted following completion of
a network authorisation form, which must be authorised by the Quality Manager
and current Scheme Secretary. All members of the Quality Assurance Reference
Centre have completed training in Information Governance.
Throughout the running of the scheme all correspondence and documentation is
based on participant code numbers; the corresponding participant names are
only known by the Scheme Secretary. On occasions the Scheme Secretary may
have a member of the Quality Assurance Reference Centre or other sources
requesting details of a participant’s code or results. The Secretary must not
divulge this information, if the person continues with their enquiry the Scheme
Secretary will refer them to the Scheme Organiser.
The Scheme Secretary will be required to divulge the links between the code and
name in the following circumstances:
In writing to a participant who requests a reminder of his/her code number,
this cannot be done by telephone.
In writing to the Chairman of the Histopathology / Cytopathology National
Advisory Panel of the Joint Working Group on Quality Assurance, in order to
investigate appropriately a case of persistent substandard performance.
When persistent substandard performance is identified the Scheme Organiser is
not told the identity of the participant. Any correspondence between the Scheme
Organiser and the participant only contains the participant code and should be
placed in a sealed envelope with only the code visible for the Scheme Secretary
to put in an appropriately labelled envelope.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 41 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 38: Document
Control
(CPA Standards: A4, A8, A9)
The Yorkshire General Histopathology Scheme has a number of documents
which have been produced in order to aid with the running of the scheme.
Standard operating procedures are a controlled document with the hard copy
being available at the Quality Assurance Reference Centre. In addition, the
participants are provided with a participants’ manual which documents how the
scheme is run and the current version is made available on the Virtual Pathology
website. All controlled documents are recorded in the ‘Document control’ Access
database which details the information above along with the location of any hard
copies. Any external documents which the scheme references are also recorded
in the ‘Document control’ Access database and reviewed on an annual basis to
confirm they are still current. Members of staff working to controlled documents
are required to sign a documents control log to confirm they have read and
understood the procedure.
The Quality Manager is responsible for authorising all controlled documents. Any
major changes to the standard operating procedures or the participants’ manual
are discussed at the organising committee meeting before they are authorised by
the Quality Manager. All controlled documentation must have the following
information recorded in the header, footer or front page; file name, version
number, date created, date of last revision, review date, number of pages, author
and authorisation signature. Once a document has been authorised it is recorded
in the ‘Document control’ Access database.
All documents are reviewed annually by the Quality Manager as part of the
review of the Quality Management System. When a new version of a document is
created, the electronic copy of old version is moved to an archive folder and the
hard copy is archived in the EQA cupboard. The document control database is
updated to reflect the archived document’s new location and that it is no longer
current.
Document Type
Minimum Retention
Time / Years
Protocols and standard operating procedures 30
Participant list 10
Agreements to terms of the EQA scheme 10
Filename: yorkshire histo
eqa sops v8
Version No: 8.0 Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 42 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Documents relating to the production of circulation
10
sets
Standard scheme letters 10
Response forms 10
Database containing responses and statistical
10
analysis
Evidence of participation from movers/locum staff 10
Dates and time taken for interim/final feedback 3
Annual reports/minutes of meetings 10
Audit documentation 10
Participant questionnaires
Master copies/annual summary of responses
Completed returned copies
10
3
Correspondence/telephone conversations and all
10
complaints
Accounts 10
Once a hard copy document has exceeded its retention period, it is securely
shredded in house and the document control database is updated.
The Quality Assurance Reference Centre staff work to the current versions of the
Public Health England policies, which are held electronically on the PHE intranet
site.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 43 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 39: Audit of
the Quality Management System
(CPA Standards: A4, H1, H3, H5)
The Quality Manager is responsible for undertaking the annual audit of the quality
management system.
The purpose of the audit is to:
a) determine compliance of the quality management system with CPA
requirements
b) determine the effectiveness of the implemented quality management
system for the purposes of meeting specified quality objectives
c) ensure that corrective actions agreed upon as a result of the previous audit
have been completed effectively
The audit of the quality management system will be undertaken as follows:
a) Review of the quality management system
b) Review of previous non-compliances, reasons/ contributing factors and
actions taken
c) Conduct document review
d) Conduct on-site audit activities
e) Completion of Quality Management System spreadsheet referencing the
findings of the review of each document/standard
f) Raise critical non compliances to Scheme Organiser with immediate effect
g) Prepare, approve and distribute the audit report
h) Monitor the work undertaken to address non-compliance
The report on the audit of the Quality Management System will be provided on an
annual basis to the Scheme Organising Committee.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 44 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 40: Quality
Improvement
(CPA Standards: A2, H1, H5)
All members of the EQA team are required to ensure a process of continual
quality improvement through the undertaking of internal quality assurance. The
Quality Manager will develop a plan for undertaking the audits indicated in SOPs
36 and 39 with the support of the Scheme Organising Committee. The audit plan
will include details of the audits to be undertaken and relevant timescales.
On completion of each audit the Quality Manager will provide a summary and
action plan of the findings including non-conformities identified, reasons/
contributing factors for the non-conformity, action required, responsible individual
and timescales. The Quality Manager will also identify areas where noncompliance
may occur if preventative action is not taken. These will be provided
to the members of the EQA Scheme Organising Committee for approval. The
Quality Manager will monitor the progress of the action plan and provide
feedback to the EQA Scheme Organising Committee.
All outcomes of the quality improvement programme will be summarised to the
staff members for educational purposes as part of the EQA team meetings.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 45 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 41:
Committee Meetings/ Annual Management
Review
(CPA Standards: A1.6, A11)
The scheme organising committee consists of several members who are
participants in the regional scheme, together with relevant operational staff
(Scheme Organiser, Scheme Secretary and Quality Manager).
The Terms of Reference for the group are reviewed annually by the Quality
Manager.
The committee meets twice per year, with one meeting (usually held in February
or March) being treated as the Annual Management Review (AMR).
Standing agenda items for the meetings include the following:
Review of previous quality objectives for the scheme
Setting future quality objectives for the scheme
Review of Quality Policy
Outcomes from internal audits
Feedback from the audit of the Quality Management System (QMS)
Any non-conformities identified as part of the QMS (together with any
reasons for non-compliance, action required, responsible individual and
timescales for actions)
Any non-conformities identified as part of internal audits of the scheme
(together with any reasons for non-compliance, action required,
responsible individual and timescales for actions)
Any non-conformities identified through any other means (together with
planned action, reasons for non-compliance and timescales for actions)
An action plan is produced and circulated to members following each meeting,
which includes timescales for each action and who is responsible for completing
them.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 46 of 47 Author: Leeds
Office MW
Authorised By:

STANDARD OPERATING PROCEDURES
Standard Operating Procedure 42: Other
Non-Conformities Identified (not via Audits)
(CPA Standards: H1.1d)
There may be occasions where non-conformities to CPA standards are identified
through a means other than audit.
For complaints, the procedure will be followed as per SOP32 – Complaints and
Revision.
Where an issue arises, which requires further investigation, this will be managed
by the relevant individual, usually the Quality Manager. The issue may be
reported as an incident, in which case the usual QARC incident guidance will be
followed; an “Initial Assessment form” will be completed and forwarded to the QA
Coordinator, who will respond with recommendations on how the incident should
be managed and by whom. If required, a root cause analysis will be carried out to
determine any contributing factors to the incident.
As with other Non-conformities, any findings will be communicated to the scheme
Organising Committee, together with action taken and the relevant documents
(SOPs/ SQMs/ Participants’ Manual) will be added to or amended as necessary.
Any investigation and findings will be fully documented and any learning from
such an investigation will be shared with the relevant staff, including the scheme
Organising Committee and relevant QA Reference Centre staff.
Where the outcomes could have an impact/ benefit to other EQA schemes run by
QARC, the Quality Manager will ensure that these are shared with the key
individuals for those schemes.
Filename: yorkshire histo
eqa sops v8
Version No: 8.0
Date Created:
01/08/2013
Last Revised On:
01/08/2013
Review Date: 08/14 Page 47 of 47 Author: Leeds
Office MW
Authorised By: