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Introduction In this issue ... |
• CPA Annual Conference 2004 • The Changing Role of the Haematology Consultant Assessor • Diary Dates |
Vacancy on the CPA
Standards,
Training and Education Group
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The Standards, Training and Education Group
(STEG) are responsible for the production of all CPA training material and they are all spokespersons for the
organisation. In addition the members undertake the document and standards revision annually. |
We have just completed the re-training of all existing assessors to the new standards. There have been 20 two-day training courses and a number of one-day training sessions and of course this has required a massive input from the STEG members. Now this is completed the time commitment over the next few years should be considerably less. STEG members serve for a period of three years. If you are interested in this type of activity and feel that you have the time to commit to this group we would like to hear from you. The person specification and |
application forms can be downloaded from the CPA website at: www.cpa-uk.co.uk We wish to fill this post as soon as possible but we do not want to restrict applicants by having a closing date. There will be other opportunities as STEG members rotate off the committee so we would like to hear from anyone who would like to be considered either now or in the future. Further information can be obtained from Cheryl Blair in Central Office. |
Notice to Assessors and
Applicants,
The Completion of Non-Compliance Clearance
Forms
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In the past, departments with conditional approval were required to write to CPA with evidence that the deficiencies noted had been corrected. Over the years we noticed that applicants were writing to us as each condition had been rectified rather than sending in one submission once all had been corrected. So when we introduced the revised documentation for the new standards we decided to provide a non-compliance clearance form for applicants to complete, one per condition. |
CPA have now processed a number of reports for the new assessments and on a few occasions the non-compliance clearance forms have been attached to the original assessor report. |
CPA ANNUAL CONFERENCE 2004
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The Conference was held on 25 March 2004 at the Royal Institute of British Architects in London. The theme of the Conference was Increasing Burdens in Laboratory Medicine and, as usual, the meeting attracted a capacity audience. The morning session was chaired by Professor Sir Duncan Nichol, Chairman of the CPA Board of Directors, and included four presentations. The first, by Dr Mansel Haeney (CPA Chief Executive), was on the subject of Mandatory Enrolment for Accreditation. The audience was reminded that last July the Department of Health (DH) had announced in Parliament that it had decided that all NHS pathology laboratories in England should enrol with an appropriate accreditation scheme. No timescale had been announced although subsequently the Scottish Health Department had announced a date of 1 April 2004 for Scottish laboratories. The announcement had profound implications for CPA both in terms of the likely effect on workload and the way CPA presents information about the accreditation status of departments. At present only accredited departments are listed on the CPA website; in future all enrolled laboratories will be identified as being either Accredited, holding Conditional Approval, awaiting assessments or being Non Accredited. In response to questions it was acknowledged that the new arrangements posed a considerable challenge for CPA against the background of the new assessment process and a shortage of assessors in some disciplines particularly as at some time in the future assessments may need to be undertaken more frequently than in the present four yearly cycle. The second presentation was by Dr Graham Beastall, a Vice President of the Royal College of Pathologists, who discussed problems with the implementation of the EU In Vitro Medical Devices Directive. This posed particular problems for “in house” assays; still widely used |
in the NHS. The main problem areas relate to the process of CE marking of assays, particularly self certification and to the identification of circumstances in which “in house” assays may be exempt from the regulations. This latter consideration appears to turn on the definition of the legal entity within which the “in house” assay is used (and within which it may therefore be exempt). The Medicines and Healthcare Products Regulatory Agency (MHRA) is presently taking a restrictive view of this interpreting the legal entity as a single NHS Trust. On the other hand the professions take the view that a wider definition, ideally perhaps being the NHS itself as the legal entity, would be more realistic and helpful. Discussions between the various interested parties are continuing against the background of an implementation date of December 2005. |
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The session took the form of a series of short presentations by CPA Professional Advisory Committee members followed by a Panel discussion. Mr Steve Boxall began by reflecting on what has been learned so far from the implementation of the new Standards. He emphasized the importance of preparation for an assessment visit, the differences in the assessment process – particularly the performance of on site audits, the importance of agreeing non-compliances on the spot and the importance of the debrief at the end of the assessment. He felt that the assessment process, although different from before, was probably better; in part because of increased clarity in the Standards and in part because of a better and more timely decision making process. The second presentation by Dr Jim Murray and Mr Brian Warner focused on the changing role of consultant assessors. A précis of the talk appears as a separate article in this issue. In discussion Dr Haeney told of CPA developing proposals for the recruitment of a number of professional assessors to ease the burden on volunteer assessors by having them undertake the bulk of the documentation reviews and some of the audits. Plans were presently being drawn up for consideration by the CPA Board and shareholding organisations. The third presentation was entitled “Professional Input for Immunology – What immunology tests can I do in my lab?”. This was given by Mr Ray Russell and based on a document developed by him and Dr Gavin Spickett at the invitation of the Professional Advisory Committee. This was undertaken in the light of continuing concerns about when professional direction by a Consultant |
Immunologist was required in a laboratory
offering a limited range of immunological tests. A limited list of tests which
may be undertaken in the absence of professional Immunology direction was
described which will be posted on the CPA website as part of a general guidance
document on the organisation and delivery of Immunology services. |
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The
Changing Role of the |
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At the present time CPA are experiencing difficultly in organising assessments to haematology laboratories due to the shortfall of consultant assessor time. Over recent years the number of Consultant Haematology assessors available to CPA has reduced dramatically from 53 in June 2001 to only 15 by March 2004. There are another 15 names on the CPA database but these individuals are not currently assessing for various reasons. |
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The reasons for these changes are probably multi-factorial: |
the ongoing assessment of haematology laboratories? At present all laboratories are assessed by one consultant or clinical scientist of equivalent status, and a senior biomedical scientist. A number of options have been considered to change the assessment process for haematology: • Two biomedical scientists (BMS) only • One BMS and one consultant from another discipline • One BMS and one consultant staff from a combined Haematology/Chemistry Department None of these three options is ideal. Having no consultant assessor is unacceptable, and would probably lead to a loss of credibility of the CPA process with medical staff. Having non-haematologists assess would also create problems, and may simply switch the problem of time commitment to another professional group. The best solution may be to use two BMS assessors for both days, bringing in a consultant assessor for day two. With direction from |
CPA Central Office and the Professional Advisory Committee (PAC) on which standards need assessing, the consultant could be focused to specific areas, while also picking up on anything the BMS assessors had found on day one. This would make much better use of the time of the consultant haematologist reducing their commitment considerably. While consultants are vital for the assessment, they are not required for two days. Of the 48 CPA standards there are probably no more than 9 that require medical input. These include professional direction, needs of the user, reporting and audit processes. The majority of standards describe the laboratory and management process, which can be adequately dealt with by the BMS assessor. The CPA Board continues to debate the issue with other professional organisations, including the British Society for Haematology. Either way something needs to change. We either need more Consultant Haematologists coming forward as assessors or we need to change the assessment process, and we probably need to do it soon! With thanks to Brian Warner (PAC member) |
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DIARY DATES CPA Two-Day Assessor Training Courses |