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Introduction |
· CPA Trust Funding · CPA website update · IBMS Congress · Call for peer assessors · Diary Dates |
Introducing the new CPA
Chief Executive
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At the last CPA Board the decision was taken to appoint Paul Stennett as Chief Executive when Dr Ken Scott retires on 12 September 2007. Paul is currently the Chief Executive of UKAS (the United Kingdom Accreditation Service), a post he has held since July 2003. Prior to joining UKAS, he gained a wealth of experience in both the scientific and commercial areas of business. He studied food science at Reading University before working for companies such as Mars and Quaker Oats, eventually becoming European R&D Director and then Marketing Director. When he was appointed Chief Executive of a European R&D organisation, which was based in Germany, Paul was also ideally placed to further broaden his experience in commercial management. Paul has been working closely with Ken Scott and Cheryl Blair to develop the formal partnership
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agreement between CPA and UKAS since 2004. This has involved taking part as a regular observer at both CPA Board meetings and the Professional Advisory Committee. On taking up the post of Chief Executive Paul intends to meet representatives of the major stakeholders in CPA to develop a closer relationship and further understanding of how CPA can continue its necessary work. Additionally, Paul intends to ask CPA’s customers for commentsand feedback in order to clearly assess both CPA’s strengths and areas where there could be opportunities for improvement.
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Both UKAS and CPA will continue to operate as separate business entities, with Paul Stennett reporting to the UKAS Board, chaired by Lord Lindsay, and the CPA Board chaired by Professor Sir Duncan Nichol with respect to CPA activities. Paul Stennett said: “I am delighted to have this opportunity to further the vital work done by UKAS and CPA. Both UKAS and CPA are leaders in their fields, and I believe that by sharing the wealth of expertise that both possess, we will be able to increase still further the recognition of accreditation both at home and abroad.” Ken Scott said: “I am pleased to be handing over to Paul Stennett in September. CPA has a well-established place in the accreditation of medical laboratories in the U.K. and beyond. It is now ready to move on to a new phase of development and Paul, in his new dual role with UKAS, is ideally placed to lead the organisation in the future.” |
Report from the CPA
Regional Conferences 2007
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CPA broke with tradition changing from a one day Conference in London to three regional conferences, one in each of the CPA regions (North, Mid East and Mid West). The programme was designed to provide delegates with information on changes that are required of CPA to align with both the international standard for medical laboratories (ISO 15189:2003) and the standard for assessment bodies (ISO 17011:2004)
Accreditation Cheryl Blair opened each of the morning sessions explaining that towards the end of 2008, CPA will be assessed to ISO 17011:2004 alongside UKAS as part of the UKAS-CPA partnership. Over the next year CPA will be making changes to some procedures and records in order to fully comply with the standard. Cheryl emphasised that to comply with any standard the main objective should be to add value to the organisation, its systems and customers – CPA believe that these proposed changes are adding value to the assessment process. Some highlights: Receipt of documentation: Currently some forty percent of application forms are not received until the final month of the six month schedule. In excess of thirty percent of forms are received after this deadline. In order to meet the rigorous schedule of laboratory assessments it is essential that these forms are returned in a timely manner. In future the application form will be viewed as a part of the contract between CPA and the
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applicant laboratory and a late return may break this contract. ISO 17011:2004 states that the accreditation body must have sufficient information to maintain a laboratory’s accredited status between surveillance and full assessment visits. Currently, the applicant laboratory is required to submit an executive summary of its annual management review (AMR) on an annual basis. However, many of these summaries are not received. From April 2008 the executive summary of the AMR will be used to maintain annual registration and therefore must be submitted on time. Standards: ISO 17011:2004 demands that CPA use appropriate international standards and normative documents. To comply with this clause the Standards Training and Education Group (STEG) have undertaken a “gap analysis” between the CPA standard and ISO 15189:2003. Recommendations for changes to the current CPA standards have been submitted to the Board and more information should be available by September 2007. Use of CPA logo:There have been inconsistencies where laboratories have been granted conditional approval and have used the CPA logo on paperwork. There is no suggestion that conditional approval is seen as accreditation and therefore new rules on the use of the CPA logo by applicant laboratories are now in place. Regional Assessors will check at visits to ensure that there is no confusion on the use and provide advice to applicants. Peer assessor feedback and monitoring: When the new system of assessments began in April 2006, the audit questionnaires were revised to take
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account of the changes. This provided a good opportunity to obtain more structured feedback on the assessors so that in turn CPA could monitor performance and provide more individual feedback. If adverse comments are received then feedback will be given promptly post assessment. Otherwise there will be an annual report to each assessor who has undertaken an assessment in the timeframe.
Regional Assessment Manager’s reportThe local Regional Assessment Manager provided information on changes to the CPA assessments since the introduction of full time assessors. Some highlights: Classification of findings: The median number of non-compliances from each assessment visit remains at 18, the same as in 2005. Fewer of the findings were being classified as observations rather than as non-compliances. This is probably due to the fact that Regional Assessors recognise that observations are about potential future problems where non-compliances are “real-time” findings.
Shortage of peer assessors: Issues around the timetable for CPA visits were discussed, in the main to do with the shortage of peer assessor time. CPA has always accepted that peer assessment is the foundation of the organisation and the best possible
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use of this limited resource has to be considered. It is common knowledge that CPA has problems with the amount of peer assessor time and the availability of peer assessors in specific disciplines. A number of options for peer assessor attendance at visits were put to the conference floor for a show of hands. It was agreed that the results from this poll would be shared with the CPA Board and may be applied as future guidance for standard two-day visits (see advertisement for peer assessors in this newsletter). Report from EQA Assessment ManagerEddie Welsh the Regional EQA Assessment Manager, discussed the CPA standards for EQA schemes in Pathology.
Some highlights: Problems for smaller EQA schemes: Currently there are 40 EQA providers operating some 140 schemes. Most of these schemes are enrolled within the CPA EQA programme. Small providers, particularly in the field of Histology, have difficulties meeting the demands of the quality management system standards and some have withdrawn from accreditation. Eddie suggested a number of possible solutions to help these schemes meet the standards, including association with an accredited medical laboratory’s quality management system. However, it may be that some small schemes may not have the critical mass to achieve EQA accreditation.
Examples of typical non-compliances: Eddie discussed these issues and the actions that could be taken to resolve them. He pointed out that the
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standards for EQA scheme assessment had been revised in line with the standards for the medical laboratory, i.e. there was a requirement for a quality management system to be in place. However, EQA schemes had been assessed to the current standards for a shorter period than the laboratories i.e. since April 2006. It was not surprising, therefore, that the non-compliances were raised in this area (A and H standards). Compliance with the E, F and G standards was excellent with very few findings which showed that the organisation, design and scientific/technical aspects of the schemes were very good. Eddie also demonstrated that the overall number of non-compliances for EQA schemes was slightly lower than those for Medical Laboratories. In conclusion Eddie said that CPA provided a commitment to improvement that should lead to improved customer focus and a better service.
Report from Professional Advisory Committee memberA member of the Professional Advisory Committee attended each session to remind the audience of the role of the PAC in the accreditation process. Some highlights: Decision Making: Post assessment the report is sent back to CPA Office. The Accreditation Managers tidy-up the report, and make an initial decision as to the laboratory’s accreditation status. A draft report is then sent to the appropriate PAC member for agreement. Where a PAC member
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does not agree or the decision is to refer a laboratory, the full report goes to a PAC meeting for a decision.
European Working Time Directive: The PAC has recently experienced problems arising from the interpretation of the European Union Working Time Directive (EUWTD). In future, if there is a perceived non-compliance, CPA will seek assurances from the applicant in the form of a self-declaration of EUWTD compliance. CPA Assessors will ask to see the evidence and where problems are identified the PAC will assess the situation. If there are potential risks the Chief Executive of the organisation will be kept informed.
B1: Professional Direction: The differences between the CPA standard and its alignment with ISO 15189:2003 were discussed. A paper has been submitted to the CPA Board (decision pending), for guidance on rewording of this standard and how it may be objectively assessed (see new standards article in this newsletter).
Increasing peer assessor availability: In autumn 2006 CPA issued a questionnaire to peer assessors providing suggestions for increasing assessor availability. Responses to this showed that a majority of 2:1 felt that payment of assessors would not increase the amount of time available. There had been many positive responses to the proposal of short-term secondment of peer assessors. CPA will be following up these responses to see if this suggestion could provide a solution to the shortage of peer assessors in the future.
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Question & Answer sessionPrior to the conferences CPA had requested that delegates send in questions about the interpretation of CPA standards and non-compliances. The CPA Standards, Training and Education Group had discussed these questions and after lunch, John Wood, STEG Chairman led a session providing the formal CPA response to many of these questions. This session was opened up to the floor and the entire CPA team, providing an opportunity for useful discussion and debate.
Examples of some questions and answers are provided below:
Q. What is the requirement to update staff following document review when using QMS software? A. There is a requirement to update staff whether or not you are using QMS software. The primary reason for a document control system is to know where a document is, who owns it and ensure that it is up to date. The system should ensure that no rogue copies are in circulation. A word of caution was issued that all staff had to buy into a document control system and sometimes this could prove difficult with electronic compared to manual systems, due to familiarity with the system and access.
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Q. How do you control the user manual? A. As an external document, the user manual does not need to be within the document control system. However, you do need to ensure that user manual is not out of date to prevent the risk of providing incorrect information. Many public documents have a review or expiry date, after which the document should not be used. Some organisations use a live, up to date copy on their website stating that the current copy is only valid on the day of download. Q. Temperature of storage facilities - what to do at weekend? A. This requires a risk assessment and the question, how critical, should be asked. In some cases it is necessary to fit an alarm to a refrigeration system. The use of minimum/maximum thermometers can provide retrospective evidence. It is important not to forget room temperature storage. Q. The consultant is single-handed? A. Delegates were referred to the guidelines on single-handed consultants available on the CPA support website. Where consultants are single handed, many trusts draw up a formal service level agreement with a neighbouring trust to ensure that there is continuous consultant availability. Q. Date and time of collection on request form? A. The standard states “the design of the request form shall allow the inclusion of… …date and time of collection”. It is recognised that the laboratory can’t force users to complete this information. Attention is drawn to standard E 2.2 – which states that the applicant should “encourage the proper completion of the request form…”
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Q. Date and time of receipt - why should this be implemented if it increases turnaround time (TAT)? At a recent CPA update meeting it was stated that an audit of time of booking in to the laboratory would suffice in busy laboratories. A. The standard states that the laboratory shall have a procedure to record date and time of receipt. The laboratory should undertake a risk assessment to determine what is an appropriate method for achieving this. In many cases the date and time of first booking is acceptable.
Q. Review EQA of referral laboratories - how do we do this in real world? A. EQA is retrospective. If the referral laboratory is CPA accredited can it be assumed that their EQA performance and turnaround times are acceptable? Again, this is a requirement for a procedure. It may be that all you need is a statement from referral lab to say that their EQA performance is satisfactory.
Q. Should internal audit be independent? A. CPA considers that cross departmental/discipline auditing is a healthy form of audit. According to ISO 9001 (the QMS basis of CPA) staff should not audit their own work.
Delegates provided positive feedback regarding the new format of the regional conferences and CPA are considering a similar format for the future and extending the conference to additional venues. Dr John
Wood
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Revision of CPA Standards 2007
As the joint audit of the CPA UKAS partnership draws nearer, the issue of the CPA standards and their relationship to ISO 15189 has been an important discussion topic for both the CPA Board and its shareholding bodies. It is recognised that for the joint audit to be successful, CPA standards should incorporate all the requirements of the international standard (ISO 15189) and therefore the CPA Standards, Training and Education Group were asked to undertake a full gap analysis. The other main issue to highlight was the wording and interpretation of standards B1 and B2. The resulting revised standards were issued to all shareholding bodies and the Directors for consultation. This process was finalised at the June Board meeting and there was agreement that they could now be circulated. They are dated September 2007, Version 2.0. At present, they are available to download from the CPA website along with a separate document listing the changes made. For other documents the review will proceed as normal to be completed during December and the revised documents including version 2.0 of the Standards will be issued on disc with the January Newsletter.
The timeframe for implementation is as follows:
For further information please do not hesitate to contact CPA Central Office.
Cheryl Blair Executive Manager |
Darren Edwards
Regional Assessor
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Originally born in County Durham, my father’s work brought the family down to the Midlands, where I remained to complete my BSc (Hons) in Microbiology at Wolverhampton. After graduation, I moved around the country following my career. Now settled in Derbyshire with my family, I am delighted to take on my role as Regional Assessor with CPA (UK) Ltd. Although not from the medical profession, I initially developed my laboratory skills as a shift microbiologist within the food industry. A period of fond memories, I can still remember the odd smells in the middle of the night! Laboratory management then allowed me the opportunity to bring accreditation to a multi-discipline laboratory suite. I was extremely fortunate to have a very loyal and dedicated team, and despite our nerves, we gained our certificate on the initial visit. Moving into Quality Management, I adapted my knowledge of laboratory accreditation to the factory floor and
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introduced a number of customer-focused initiatives, including ISO 9001, HACCP (risk management), British Retail Consortium Standards, short-cycle manufacture, lean thinking, and statistical process control, the latter becoming my dissertation to gain a distinction in an MSc in Quality Management and Improvement. I have continued with my CPD, attending courses and gaining qualifications in IRCA lead auditing, and City & Guilds teaching qualifications. I have supported several forums within professional bodies, and have been a keynote speaker within European quality management seminars. Most latterly from a UKAS laboratory accreditation background, my career has allowed development of skills and knowledge across a broad range of business and professions. It is this background that I bring to my role as full time assessor within CPA (UK) Ltd. I am looking forward to meeting the challenges of clinical pathology accreditation, and in meeting all of you.
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Changes to the
membership
In April 2007 several members came to the end of their period as members of the CPA Professional Advisory Committee. We would like to take this opportunity to thank them all for their time, dedication and patience, and most of all, professionalism; it is greatly appreciated. Listed below are those who are leaving us and their new replacements whom we now welcome.
Retiring member New member Specialty
Mr Brian Warner Nomination awaited Haematology Dr Beryl Oppenheim Dr Philip Mannion Microbiology Mr Ray Russell Mr Kevin Green Immunology Mr Steve Boxall Nomination awaited EQA Numerate Vacant Dr Richard Fitzmaurice Histopathology Mr John Turner Mr John Roberts Independent sector Dr Peter Smith Dr Mina Desai Cytology Mr Robin Knight Mr William Chaffe Blood Transfusion Dr Celia Aitken Nomination awaited Virology
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CPA Trust Funding The CPA Trust, a registered charity, was set up in 2004 to support the development of improvements in the quality of medical laboratory services. In addition to funding pilot EQA schemes, the Trustees have agreed to extend funding into other areas that may broadly be described as promoting quality in medical laboratories. Applications are now invited for: · pilot funding for EQA Schemes, such bids being welcome from established providers or newcomers to the field · CPA Trust bursaries, up to a maximum of £6,000 per application. Application forms for both types of funding are available to download from the CPA website www.cpa-uk.co.uk or from CPA (UK) Ltd 45 Rutland Park Botanical Gardens Sheffield S10 2PB
Tel: 0114 251 5800 Fax: 0114 251 5801 e-mail: office@cpa-uk.co.uk
Applications should be returned by Friday 26 October 2007.
CPA TRUST - EQA Pilot Funding and Bursaries
The CPA Trust supported the following bids for the financial year 2006/07.
EQA Pilot Schemes 1. POCT Haemoglobin EQA Scheme Dr A Thomas, Cardiff. £6,000
2. POCT Coagulation EQA Scheme Dr A Thomas, Cardiff. £6,000
3. North West Non Gynaecological Cytology Virtual Microscopy Scheme Dr S Hales, Chester. £4,400
4. Alpha 1 Antitrypsin Phenotyping EQA Scheme Dr W Egner, Sheffield. £4,800
5. EQA Scheme for Morphology Dr J Parker-Williams, London. £800
Bursaries
1. Granulocyte separation and detection of the JAK2 V617F mutation in myeloproliferative disease Dr Joanna Farrugia, Plymouth. £3,000
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IBMS CongressICC Birmingham
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CALL FOR PEER ASSESSORS
Once again we are looking for peer assessors for medical laboratory and EQA assessments. The person specification and application form can be downloaded from the CPA website www.cpa-uk.co.uk We have a training course booked for January and we are prepared to schedule additional training courses if we have sufficient numbers. If you wish to discuss this before applying, please do not hesitate to contact Cheryl Blair at CPA Central Office. We look forward to receiving your applications.
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There is a new addition to the CPA support website: · CPA Guidance on Andrology Testing |
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DIARY DATES
CPA Peer Assessor Training CourseWednesday - Thursday 9-10 January 2008 Beeches Management Centre, Birmingham
Christmas closingThe CPA Office will be closed over the Christmas/New Year period from Tuesday 25 December opening again on Wednesday 2 January 2008.
CPA Regional Conferences / Assessor UpdatesIn order to keep both applicants and peer assessors updated, next year the Regional Conferences will be combined with peer assessor updates. Peer assessors will not be charged for attendance and to facilitate ease of access six dates have been chosen for venues around the UK. The meetings will be held in the weeks commencing 31 March and 7 April 2008. More information will be available shortly.
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