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Introduction |
· CPA Trust - EQA Pilot Funding and Bursaries · Out of date antibodies in histology laboratories · Internal quality assurance in microbiology laboratories · Diary Dates |
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Regional Assessor vacanciesSalary: £38,828 - £45,530
Location: We have posts available and applications are invited from all geographical areas. Please note: the regional boundaries change from time to time and flexibility in travel is essential.
Position Type: Permanent – full time
Timescale: The closing date for application is 8 August 2008 Short-listing will be 18 August 2008 Invitations to attend interview will be posted on 20 August 2008 Interviews will be held in London on 8 September 2008
Details: Regional assessors work with the professional peer assessors, forming the assessment team that recommends the status of a medical laboratory to CPA. These roles were established in April 2006 and provide tremendous scope for individuals interested in quality management and medical laboratory standards. The jobholders work from home and therefore a significant amount of travel is included on a regular basis. A current driving licence is essential. The post of Regional Assessor may suit someone who has a medical laboratory background and an interest in the concept of quality management. You will have good communication skills, a high degree of flexibility and excellent time-management skills. If you think that you could fit into our team the application pack is available from Central Office.
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Recruiting retired peer assessors
By now you will realise that we continue to have a shortage of peer assessors, particularly in some specialties. We particularly value the contribution made by retired members of the professions who continue as assessors, and would make the following observation. Whether or not you have been an assessor in the past, you may be considering the possibility of undertaking some CPA assessments in retirement, it is worth planning ahead. Please apply to be an assessor or to be re-trained well in advance of retirement. Your application can be considered and you can be placed on a training course; these only run once or twice a year. That would enable you to commence assessments promptly upon retirement. Please note that those who are currently active assessors can continue into retirement without these formalities and / or re-training. In general, we retain assessors for two years in retirement without any additional documentation. Beyond that time we require evidence of continuing involvement with your profession’s CPD scheme, as well as registration with your professional body. Please contact CPA office if you think you may be interested in commencing as a peer assessor in retirement.
John Goepel, PAC Chairman
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CPA Regional Conferences 2008
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The meeting was opened and delegates were welcomed by the Professional Advisory Committee Chairman Dr John Goepel. CPA report As has now become tradition, the 2008 CPA assessor update was kicked off by CPA Executive Manager Cheryl Blair. Cheryl outlined the main objectives of conferences, which was to firstly keep applicants informed of any changes made to the process and, secondly to update peer assessors, especially on changes to standards,
Standards revision Cheryl described that there were two reasons why CPA had revised the standards; firstly that a gap analysis had been performed between the original CPA standards and the original ISO 15189:2003 standards, and secondly the revised ISO 15189:2007 had just been published. At this point, it was emphasised that CPA was not in the habit of changing standards without good cause. The new CPA standards were published in September 2007, first assessments being performed against them from April 2008. It was highlighted that a year would be allowed for laboratories to become compliant and anything found before September 2008 would be raised but would not affect the site’s CPA status until the lead-in year was completed. For sometime there had been no specific point of care testing (POCT) standard. A new international standard was available and CPA now had a POCT appendix to the existing standards. This addition was intended for use in hospitals, not for those on the “high street”. The CPA shareholders were currently consulting on the draft prior to its implementation. Peer assessor resource CPA’s most precious and limited resource is that of the peer assessor. Numbers are now at their lowest level ever, a situation Cheryl views as being critical. Two questionnaires had been issued to peer assessors during 2007. Major questions raised were “whether more time would be available if some form of payment was made to the assessor or the Trust?” “whether assessors could be seconded for a number of days?” The positive aspects of this approach were seen as greater control over assessments, a better overall service,
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providing peer assessors on some surveillance visits, and more consistency. The subsequent downside was mainly the increase in registration cost, and the concern about the longevity of the scheme with new assessors being difficult to recruit. A possible solution to increasing time available was to ask for the peer assessors’ availability first, rather than arranging dates and slotting in the assessors afterwards. Essentially, with appropriate notice, telling the site when the assessment would take place. The Chairman took views from the floor and in the main it was accepted that it might be essential to change the process. Turnaround times Data was presented showing turnaround times for “reports”, “application forms”, and “annual registration forms”. All of these were showing significant improvement, especially with reports where over 91% were now returned in less than 3 months, as opposed to 2005 when only 50% met that target. Other issues CPA was working on:- Conditional approval It was highlighted that “Conditional approval” is not accreditation, but users sometimes consider this status as such. Conditionally approved sites may have a number of non compliances that need clearing, so they can often be some way from being accredited. In an attempt to encourage sites to clear conditions quicker, expiry dates have now been removed. There will be a risk assessment to decide whether or not a clearance visit will be required. At present less than 50% of laboratories are currently accredited. It was suggested that if the status of conditional approval did not exist then the process may have to be more black and white. It is possible that there could then be an increase in the number of accredited laboratories. Scopes The use of service scopes should be in place by the end of the year with certificates highlighting what “scopes” a particular laboratory was accredited for. CPA is working closely with UKAS on this issue in order to provide a consistent approach. Decision making CPA is currently working hard to reduce the time taken for a decision to be made about a site’s
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status. In future regional assessors could be in a position to make an initial recommendation. Cheryl concluded her talk, thanking again the peer assessors for their time and effort and highlighting that one of CPA’s key aims for next year was to continue to improve customer satisfaction. The revised standards part one and two Without any question the “short straw” at this years conference was the presentation made by the Regional Assessment Managers. In a session before and after lunch (even harder!) the changes to the standards were presented. At the conference in Birmingham, Phil Shread did a sterling job, stepping through each standard describing what had changed, why it had been changed, and in some cases what the change meant. Despite this work it would be impossible to do justice to the presentation here. For detail, visit the CPA website, for both the presentation and the new standards themselves. However, just a few general points. It was highlighted that most changes were straightforward; however some are more complex and have generated much discussion in the standards revision group. Clearly questions have already been raised about the new standards as many assessors and quality managers have asked for clarification about them. The importance of communication with the regional assessors was emphasised. Phil brought to the attention of the meeting that many standard changes were designed to ensure that the user requirements were met. It was noted that the “user” appears a number of times in the revision. Maybe its not only CPA that will be considering a greater “customer focus” in the future! Myth Busters Dr John Wood chairman of the CPA Standards, Training and Education Group (STEG) opened his presentation with the comment that most feedback from previous conferences and updates had suggested there was a need for more presentations on the standards. This had been taken into consideration, hence 2008 had been organised in such a way. John described that he felt there were three sources
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of “Myths” about CPA standards: · Some quality managers misinterpret the standards · Assessors judge standards against what they do in their own environments · Some sites try to use CPA as a tool for additional resource John described 19 myths that he wanted to bust, all of these can be found in his presentation on the website. But to bust a few of the common ones:- A laboratory manager can’t be the quality manager. Yes, they can, but do they really have time to do this, and at times they may have a conflict of interest. If this situation does exist a risk assessment should be performed. The quality manager has to be a member of laboratory staff. No they don’t, they just need to ensure the quality management system functions correctly. My lab is conditionally accredited. No such thing. The status of conditional approval indicates a number of non compliances that need to be cleared before accreditation is attained. Accredited means accredited. Portable appliance testing (PAT) needs to be carried out annually. Not at all. If you visit the HSE website, they state that most electrical equipment, especially office types, can be visually checked for obvious signs of damage. I have to review all documents every 12 months. This is not the case. The standards describe regular review, only the quality policy is required to have an annual review. Sites may consider risk assessments to help support their decision to review less frequently. Remember review does not mean rewrite, it can often be just signed off, with no changes. All samples must be labelled with the patient’s name and date of birth. Not true, sites must have a labelling policy with an unequivocal identifier. CPA assessors are infallible. Sadly not. The current assessment process allows interaction and mutual agreement of the findings. Sites should challenge at the time if they disagree with a finding.
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Names of referral labs have to appear on reports. Not necessarily, you need to identify on a report that the work was performed in a referral laboratory. They can be identified via a code. All documents must be signedNot true, only the quality policy is defined as being signed. We don’t have sufficient toiletsThat maybe true, but there are legal requirements under the “Workplace regulations 1992” to check against. CPA keep adding new standards to make life difficult Hopefully you know now from the previous presentations this is not the case. CPA standards are based on internationally agreed standards, which are themselves regularly reviewed. CPA statistics John Wood returned after lunch to present some recent statistics on the accreditation process. To be enrolled in an accreditation scheme is a requirement, being accredited is currently not a requirement. John reported that around 1400 sites were in the CPA system and currently 53% are accredited 37% have conditions 6% are awaiting assessment 4% are non-accredited. Of the non-accredited laboratories only 9% were actually referred. When considering the distribution of non compliances amongst the standards, there was a higher percentage against the quality management standards A, and the evaluation and QA standards H. Interestingly the number of observations had reduced in recent years. This was thought to be due to the presence of the regional assessors, who were able to help correctly categorise findings. The final statistic John presented was the number of non compliances found per visit, which had a mean of 21, the highest 65. Finding the evidence John’s last slide led nicely into the presentation given by the Regional Assessor. In Birmingham it was Julie Rogers describing the common standards where findings were attributed. Julie presented a couple of league tables, the first charting the top ten findings
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recorded for 2007 and the second the trends from 2004-2007. The audience found out that the most common finding for 2007 by some way was against standard A8.1, which describes document control. In second place came standard C5.1 which relates to health and safety. Not surprisingly the most critical non compliances were recorded against this standard. Interestingly only one of the analytical standards (E F and G), appear in the top 10. Standard F2.1, which relates to documentation of procedures. It was noted that there had been a reduction in findings to F2.1, maybe demonstrating that there is a perception that CPA and SOPs are synonymous. Other reductions include D1.2, C5.3 B2.1 and H2.1, I leave you to look up the standards for yourself ! None of the top 10 findings had in fact recorded an increase since 2004. So, this is further evidence of continually improving quality in our medical laboratory services.
Questions and answers The day was rounded up by Cheryl Blair with a question and answer session. One point raised to both assessors and applicants was that CPA is not able to offer consultancy. There are a number of ways that standards can be met and it is not for CPA to be prescriptive. Applicants must decide which process is best for them and it is for assessors to judge if that process meets the standards. The most contentious issue raised related to the use of out of date antisera. Cheryl headed off any heated discussion on this issue by stating that the question had been returned to the PAC for debate. Their response can be viewed in this newsletter. The full list of Q&A is available on the CPA website. The Conference was closed by John Goepel. Thanks to Brian Warner for this write-up.
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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 scope of the Trust’s activities extends 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 Central Office. Closing date for applications is Friday 31 October 2008. |
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CPA TRUST - EQA PILOT FUNDING AND BURSARIES
The CPA Trust supported the following bids for the financial year 2007/08. EQA Pilot Funding Approved 2007/2008
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Molecular EQA for
Preimplantation Genetic Diagnosis for Monogenic Disorders
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Antibiotic Assays · UK NEQAS for Cellular Pathology Technique (Osteoarticular Histology Option) Mr David Evans, Newcastle-upon-Tyne - £2350
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Activated Clotting Time (ACT) ·
Human Embryo Morphology
Bursaries Approved 2007/2008
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Validation of CytoChip (BlueGnome Cambridge)
comparative genomic hybridization arrays for the identification of genomic
imbalance in patients referred to a Regional Genetics Centre with undiagnosed
learning difficultes and dysmorphic features.
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Evaluation of the use of MLPA technology for
assessing genetic imbalance in tissues obtained from pregnancy loss
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The rapid detection of extended spectrum B-lactamase
producing Escherichia coli and Klebsiella pneumoniae in blood cultures
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Computer aided diagnosis of large loop
excision of transformation zone (LLETZ) specimens
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Immunohistology laboratories are well-known for their frugal approach to the use of antibodies. This has led many laboratories to continue to use antibodies beyond the manufacturer’s expiry date. Not surprisingly, when this has been discovered during an assessment a non-compliance has been noted. During further discussion of this matter on the PAC and in dialogue with some laboratories a way forward has been agreed. In outline, this relies on the laboratory establishing that the reagent still works, establishing a new expiry date and agreeing with hospital management to accept the risk. There are further restrictions on this use of antibodies beyond their manufacturer’s expiry date.
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Those reagents that are used in a quantitative manner to establish specific drug treatment, for example oestrogen receptor, are specifically excluded. In response to the question about why this relaxation of expiry date only applies to histology, the answer is the context in which they are used. Immunohistology uses all the available morphology, and does not rely on an antibody reaction alone in its interpretation. In addition, antibodies are almost universally used in panels, enabling detection of outlying results. The consultant pathologist remains responsible for their report, including the credibility of any immunohistology contributing to it. John Goepel, PAC Chairman |
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Internal quality assurance in microbiology laboratories
The topic of internal quality assurance (IQA) in microbiology laboratories was discussed earlier this year on the Professional Advisory Committee. The outcome of that discussion has been widely misunderstood. IQA in microbiology laboratories is the process whereby a test sample is resubmitted to examination: the results of these two examinations are then compared, and any discrepancies considered carefully. We had received a report in which the assessor had raised a non-compliance because the laboratory visited was not putting through the assessor’s expected percentage of cases for IQA. However, of itself this does not contravene Standard F3.2 which states more broadly that “there shall be procedures for internal quality control of all examinations which verify that the intended quality is achieved”. This Standard does not state exactly what “procedures for internal quality control” have to be done, and in the context of this discussion, does not state what percentage of cases should be re-tested. Thus every laboratory must have adequate internal quality control, and IQA may become part of the quality control done by the laboratory, but the laboratory and not CPA decide what is appropriate. At an assessment visit CPA would discover if the laboratory fulfilled its requirement to “verify that the intended quality is achieved”, including the reasons why particular activities such as IQA were or were not undertaken. CPA has emphatically not stated that IQA is no longer required.
John Goepel, PAC Chairman
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DIARY DATES
CPA EQA Participants Meeting & EQA Peer Assessor Updates 2008Monday 15 September 2008 Austin Court, Birmingham
CPA Peer Assessor Training CourseWednesday-Thursday, 1-2 October 2008 Beeches Management Centre, Birmingham
Christmas closingThe CPA Office will be closed on the following dates:
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