Focus Debates Fun in Japan QC Pilot for Kidney Function Tests
Transcription
Focus Debates Fun in Japan QC Pilot for Kidney Function Tests
ACB News The Association of Clinical Biochemists • Issue 479 • 20th March 2003 Focus Debates Fun in Japan QC Pilot for Kidney Function Tests Remember . . . Focus 2003 Late Booking Fee Applies After 1st April About ACB News The monthly magazine for Clinical Science The Editor is responsible for the final content. Views expressed are not necessarily those of the ACB. Editor Dr Jonathan Berg Department of Clinical Biochemistry City Hospital Dudley Road Birmingham B18 7QH Tel: 07973-379050/0121-507-5353 Fax: 0121-765-4224 Email: [email protected] Associate Editor Dr Judith Burrows Department of Clinical Biochemistry Russell’s Hall Hospital Dudley DY1 2HQ Tel: 01384-456111 Fax: 01284-238089 Email: [email protected] Associate Editor Miss Sophie Barnes Department of Chemical Pathology St Georges Hospital, Blackshaw Road London SW17 0QT Tel: 020-8725-5862 Fax: 020-8682-0744 Focus Handbook Editor Dr Richard Spooner Department of Biochemistry Gartnavel General Hospital Glasgow G12 0YN Tel: 0141-211-3470/3353 Fax: 0141-211-3455 Email: [email protected] ACB News Number 479 • March 2003 General News 4 Disposable Laboratory Tips 8 MRCPath Short Questions 9 IT Links 10 Focus 2003 12 Federation of Clinical Scientists 16 Meeting Reports 20 Current Topics 27 Accreditation News 29 Corporate News 31 Letters 32 Situations Vacant 33 Situations Vacant Advertising Please contact the ACB Office: Tel: 0207-403-8001 Fax: 0207-403-8006 Email: [email protected] Display Advertising & Inserts PRC Associates The Annexe, Fitznells Manor Chessington Road Ewell Village Surrey KT17 1TF Tel: 0208-786-7376 Fax: 0208-786-7262 Email: [email protected] ACB Administrative Office Association of Clinical Biochemists 130-132 Tooley Street London SE1 2TU Tel: 0207-403-8001 Fax: 0207-403-8006 Email: [email protected] ACB Chairman Mr Mike Hallworth Department of Clinical Biochemistry Royal Shrewsbury Hospital Mytton Oak Road Shrewsbury SY3 8XQ Tel: 01743-261157 Fax: 01743-261159 Email: [email protected] ACB Home Page http://www.acb.org.uk Printed by Piggott Printers Ltd, Cambridge ISSN 0141 8912 © Association of Clinical Biochemists 2003 Front cover: Clare Jeffray and Loretta Ford get a lesson on colorimetry from Tom Whitehead ƒ ocus2003 MICC • MANCHESTER • 13-15 MAY The Association of Clinical Biochemists National Meeting MICC, Manchester Tel: 01223 404830 Fax: 01223 404841 Email: [email protected] Web: www.focus-acb.org March 2003 • ACB News Issue 479 • 3 General News General News General News General News General News Older Members in Manchester . . . A Grade A and Grade B trainee visit Tom Whitehead to ask “What is the 50th Anniversary Celebration in Manchester all about Prof!” By Loretta Ford & Clare Jeffray City Hospital, Birmingham Coinciding with the Focus meeting in Manchester this year, the Association is holding its 50th Anniversary celebrations. There will be a special symposium and many retired members will be attending the conference banquet. To find out more, ACB News sent a couple of junior members along to meet Professor Tom Whitehead in Leamington Spa. Our two intrepid investigators were Clare Jeffray, Grade A Trainee on the West Midlands Scheme and Loretta Ford, Grade B Clinical Scientist. They found Professor Whitehead on form. He had just finished a substantial paper, submitted to a learned Medical Journal entitled “Transition metals maybe present in the air environment in far higher concentrations than is indicated by official measurements of atmospheric pollution”. This single-author paper has included much research conducted on the patio of Tom’s Leamington Spa home and the construction of a special instrument to measure pollution (designed and built by Roger Bunce at the Wolfson Research Laboratories). This is far from the only work on pollution with a patent for detecting pollution in water having been commercialised jointly by Randox and Severn Trent in recent years. would see 20 such tests done for the 120 bed Warwick Hospital. Over lunch, Professor Whitehead looked back over some of the clinical science he had been involved with. We discussed the establishment of external quality assesment in the UK and the importance of feedback in a reasonable time. Other work that Professor Whitehead’s Department in Birmingham was involved with included a clinical chemistry analyser, which became the Coulter Dacos, the development of immunoassay systems based on chemiluminescence and the development of the Telepath Computer System. Professor Whitehead’s Wolfson Research Department was also heavily involved with the World Health Organisation. The 50th Anniversary celebrations have been a lot of work for Tom and his team. It is hoped as many retired members as possible will attend to make the symposium and the Gala Dinner a truly memorable meeting. ■ Twenty Tests a Day! Professor Whitehead explained that the seminar on the Wednesday afternoon of Focus should be really good fun and brings together pioneers in the Association followed by people who are present day activists in the same areas. There will also be a display throughout the conference of laboratory artifacts, which were in use 50 years ago. One of these, the EEL portable colorimeter was demonstrated on the patio! In 1953 this was the main analyser in Professor Whitehead’s laboratory at Warwick Hospital. It produced results for analytes such as urea, glucose and protein and commonly a busy day Tom with the EEL portable colorimeter Don’t forget to register for Focus 2003 before 1st April to avoid the late booking fee! 4 • ACB News Issue 479 • March 2003 General News General News General News General News General News Letters and Corporate Members ACB Administrative Assistant Required Please note that ACB News values all forms of contributions including letters to the editor. This month we have also reintroduced the Corporate Members’ column. If you want to submit an item for the column please do so by email to the Editor. We are looking for innovative and unusual information from commerce, not every new kit brought to market. ■ Applicants are invited for a temporary 1-year full-time post of Administrative Assistant in the ACB Office (part time or job share considered). Applicants should have an outgoing personality, be familiar with Microsoft Office and be willing to learn a variety of office and administrative skills. The functions of the Office are varied and include dealing with Members’ queries, organising small meetings and processing training course and publications orders. The Office is a friendly and hardworking environment to work in and will provide an opportunity to develop skills for those undertaking a gap year in their studies or considering an office/business career. For further information and an application form contact Graham Groom at the ACB Office, 130-132 Tooley Street, London SE1 2TU. Tel: 020 7403 8001 ■ Dr Gaston Pawan We are sad to report the death of one of our founder members, Dr G L S Pawan, who died in February. ■ Job Share Consultant Available Principal clinical scientist, PhD, FRCPath, is currently looking for a person in a similar position to job share with at a Consultant Level (south of England). If you are interested please email the editor, who will forward your details on. Email: [email protected] ■ ACB Wales Region Spring 2003 Meeting Morriston Hospital, Swansea 21st May 2003 9.30-10.00 10.00-10.40 10.40-11.20 11.20-11.40 11.40-12.20 12.20-13.00 13.00-14.00 14.00-14.45 14.45-16.00 16.00-16.15 16.15 Registration and Coffee Obesity: A Public Health Perspective Professor Rhys Williams, Professor of Clinical Epidemiology, Swansea Clinical School Surgical Management of Obesity Mr Zahir Soonawalla, Consultant Surgeon Coffee Medical Management of Obesity Dr Cyril Weinkove, Consultant Chemical Pathologist, Manchester Future Applications on Latest Findings in Obesity Research Dr Vivion Crowley, Wellcome Trust Research Training Fellow, Addenbrooke’s Hospital, Cambridge Lunch Fat Females and Fertility: Reflections on the Metabolic Consequences of Obesity Dr Andrew Krentz, Lead Consultant in Diabetes & Endocrinology, Southampton General Hospital All Wales Clinical Biochemistry Audit Group Meeting Coffee ACB Wales Region Annual General Meeting Further information can be obtained by ringing Dr Andar Gunneberg on Tel: 01792-842-196 or writing to Department of Chemical Pathology, Morriston Hospital, Swansea SA6 6NL. Email: [email protected] 6 • ACB News Issue 479 • March 2003 Disposable Laboratory Tips Disposable Laboratory Tips Disposable 8 • ACB News Issue 479 • March 2003 Questions MRCPath Short Questions MRCPath Short Questions Deacon’s Challenge No. 24 Answer In a random sample of 100 pathology request cards, 36 were found to have an error associated with either their name or date of birth. What is the probability that more than 42% of pathology request cards have such errors? MRCPath, May 2002 Examination of each request card has only two possible results – error or no error. This is an example of the binomial distribution. For a sample of 100 cards the possible total errors (a) are 0,1,2,3...100. The proportion of cards found with an error (a/n) will depend on the probability of an error occurring (p) i.e. a=np. If p is not known, then provided the number of cards examined (n) is reasonably large (>30) and p is not too close to zero or 1 then a/n approximates to p. The estimate a/n of the unknown probability, p, together with its standard error is given by: a n ± Estimate of p = a n a/n (1 - a/n) n = 36 = 100 0.36 Standard error of p = √ (0.36 x 0.64/100) = √ 0.00230 = 0.048 To find the probability of finding 42% errors (a/n = 42/100 = 0.42 ) calculate the z value in the usual way: z = (a/n) - p = Standard error 0.42 - 0.36 = 0.06 = 1.25 0.048 0.048 From tables of z, the probability of obtaining a z value greater (i.e. use one-tailed) than 1.25 (i.e. finding more than 42% cards with errors) is 0.11. ■ Question No. 25 A centrifugal analyser is designed so that the light travels on a longitudinal path through the rotating cuvette (which has a constant cross-section C cm 2 ) rather than perpendicularly through the sides of the cuvette as is more usual. A solution of a light absorbing compound Y, volume d µL at a concentration of y mmol/L, is diluted with a volume D µL of an optically clear reagent. Using the Beer-Lambert equation, prove that the absorbance of light through the diluted solution of Y is independent of the volume of diluent (D) when absorbance is measured longitudinally in this system. MRCPath, November 2002 March 2003 • ACB News Issue 479 • 9 IT Links IT Links IT Links IT LInks IT LInks IT Links IT Links IT Links Website of the Month: Clinical Molecular Genetics Society By Malcolm Gray, St Bartholomews http://www.cmgs.org ave your clinicians ever asked you for a genetic test you’ve never heard of? Well, it is a common enough occurrence in most laboratories where the requesting clinician usually expects us to already know about the test and where to send the samples. Rarely do they have the information themselves! The result of this is to either send samples to your local DNA lab, who will send them on again if they don’t do the analysis themselves, or to spend large amounts of time finding telephone numbers and contacting labs yourself. Fortunately, there is a website similar to Assay Finder which can be searched (i.e. by disease name) for genetic tests. I recently had a request for diagnosis of Marfan’s disease. Looking at the Test Search function, the search gave several laboratories, which do this, together with their contact details. I would heartily recommend all laboratories add this to their Favourites List as it saves a large amount of time. H • Don’t forget links to all past and present ‘Websites of the Month’ are available from the ACB website (www.acb.org.uk). If you wish to suggest a site for the ‘Website of the Month’, please submit a short review (150-200 words) to Ian Godber at Wishaw General Hospital ([email protected]). ■ 10 • ACB News Issue 479 • March 2003 Focus 2003 Focus 2003 Focus 2003 Focus 2003 Focus 2003 Focus Diagnostics Information Pack . . . Study Material Required Mr Gilbert Wieringa, Chair, Focus 2003 & Dr Julian Barth, Scientific Programme s part of the Focus theme of promoting the role of diagnostics in healthcare we will be producing a diagnostics information pack which will be sent to the national and regional media and which selected ambassadors for diagnostics will also use during and after Focus 2003 when meeting key stakeholders. It will include background information on the role of laboratory diagnostics in healthcare, data on the under investment in UK diagnostics and case studies to illustrate the use of diagnostics. The wish is to use eye-catching, media-friendly case studies that spark greater interest and awareness of diagnostics. We are interested in receiving case studies, statistics and visuals that describe scenarios in which a change in healthcare outcome is attributable to the use of diagnostics. Examples of poor practice are also of interest if they highlight a theme. Suggestions for categories include: A • Introduction of a new test • Introduction of new technology • Changes in practice • Individual patient care cases We would welcome material that incorporates topical themes. Examples could be near patient testing, cost savings, pathology modernization and studies which can cross-reference to national planning e.g. NICE guidelines, Cancer Plan, Primary Care Trusts. All case studies will be attributable to the supplier. They need not be restricted to clinical biochemistry and examples of good practice in other laboratory disciplines would be entirely appropriate. Any discussion on case compilation with either one of us is welcomed but please supply case studies to us by April 17th 2003. ACB, BIVDA and Citigate Communications will make the final decision on the contents of the information pack. Any editorial changes to case studies will be agreed in liaison with the authors. Please submit information to: Mrs Nikki Beeson, Conference Co-ordinator, Focus 2003, PO Box 409, Cambridge CB1 4QD. Email: [email protected] ■ 12 • ACB News Issue 479 • March 2003 2003 Focus 2003 Focus 2003 Focus 2003 Focus 2003 Focus 2003 Promoting the Role of Diagnostics in Healthcare By Gilbert Wieringa, Focus 2003 Chairman Central to this year’s Focus will be two lunchtime debates to which extensive media participation has been invited. Both debates are geared towards raising awareness of diagnostics. Tuesday 13th May at 12.45 “This house believes diagnostics should be available on the high street” Should this be better regulated? Are the ethical issues of relevance to our practice in and around the laboratory? Should the advent of high street genetic testing be welcomed? Where does the involvement of laboratory medicine begin and end in these advances? The membership’s input to these debates will be strongly welcomed. Consider the issues, grab the chairman’s attention and make your case! Professor John Harris has made a special study of the ethical issues relating to genetics and to human reproduction. He is the author of one of the first book-length studies on the ethics of genetics (Wonderwoman & Superman) and is the author or editor of 14 other books and over 150 papers. He has been prominent in national debates on genetic manipulation, gene therapy, genetic testing and screening, the use of human tissue and the human tissue archive, privacy and confidentiality issues, embryo stem-cell research and therapy and human cloning. He was a member of the Ethics Committee of the British Medical Association from 1991 to 1997, and again from 1999, and was one of the Founder Directors of the International Association of Bioethics. In 2001 Prof Harris was elected a fellow of the Academy of Medical Science and is the first philosopher to be honoured in this way. Professor Harris is also a member of the Human Genetics Commission. Dr Ian Gibson was born in Scotland and educated at Dumfries Academy, where he was awarded a BSc and a PhD. After working at the University of Edinburgh and Indiana, he joined the University of East Anglia. At the UEA Dr. Gibson was Dean of the School of Biological Sciences and served as head of a 10 strong research team investigating various forms of cancer. In 1997, and again in 2001 he was elected as Member of Parliament for Norwich North. He specialises in science and health issues and chairs the All Party Parliamentary Group on Cancer, the House of Commons Select Committee on Science and Technology and the Parliamentary and Scientific Committee. He also co-manages the Parliamentary football team. March 2003 • ACB News Issue 479 • 13 Focus 2003 Focus 2003 Focus 2003 Focus 2003 Focus 2003 Focus Dr Thomas Stuttaford (OBE) is an influential medical writer has been a columnist for The Times since 1990 and formally contributed to Elle magazine and Options Magazine. Dr Stuttaford is author of a number of books including: A Birth Control Plan for Britain‚ (1972) and the Wise Drinker’s Guide‚ (1997), and he is also the author of chapters in Drinking to Your Health (1989), Which Wine Guide (1991), In Your Right Mind (1999). Wednesday 14th May at 1245 “This house believes clinical diagnostics should be rationed” Should there be rationing? The taxpayer will demand maximum value for money for the increase in national insurance in April 2003. Should an increased allocation be going to diagnostic services? How can this be justified? How do we justify a possible case for diagnostics not to be rationed? Where does individual responsibility lie in ensuring maximum value for money? The issues in this debate potentially impinge on many topical issues. Please consider them beforehand. Mike Hallworth MA MSc MCB FRCPath is Consultant Clinical Biochemist at the Royal Shrewsbury Hospital, Shrewsbury, Shropshire. He trained in chemistry at the University of Oxford and in clinical biochemistry in Leeds, Manchester and Cambridge. He is the current chairman of the Association of Clinical Biochemists, a professional body for doctors and scientists in clinical biochemistry and has held this post since May 2000. Mike's scientific interests are in drug monitoring - measuring the concentrations and effects of drugs in the body to guide and improve treatment. He also chairs an ACB working group which is developing a web-site designed to explain diagnostic tests to patients and their relatives. Dr Ian Banks BSc. BAO. BCh. MB. MSc. PhD. is a part time GP/casualty officer and medical journalist. While working part-time as a family doctor and casualty officer in Belfast, he also represents GPs for the British Medical Association (BMA) and is a member of Council for the UK. Being a trustee for the Doctor Patient Partnership and a member of the Consumer Health Information Centre fits with his role as the official spokesman on men’s health issues for the BMA, president of the European, England & Wales and Ireland Men’s Health Forum and for six years the medical editor for The Men’s Health Magazine (Rodale). The BBC book ‘The Trouble with Men’ was written by Dr Banks in 1996 to accompany the television series of the same name. It was followed by Men’s Health, The Good Patient Guide, The Children's Health Guide, Get Fit with Brittas, Men’s Health in General Practice, Ask About Sex and the 50th NHS Anniversary book from the NHSE/HEA The Home Medicine Guide. He is also the author of the NHS Direct Healthcare Guide and Website. Dr Banks is the editor of the Men's Health Journal and the UEMO Clinical Journal. His latest books are “The Dad’s Survival guide” and the Haynes "Man Workshop Manual". He is currently working on the Haynes "Baby Workshop Manual". Home is a small GM free farm in Northern Ireland. 14 • ACB News Issue 479 • March 2003 2003 Focus 2003 Focus 2003 Focus 2003 Focus 2003 Focus 2003 Professor Vincent Marks became consultant chemical pathologist and Group Pathologist in Epsom in 1962 before translocated in Guildford as the first professor of Clinical Biochemistry at the newly established University of Surrey in 1970 and consultant chemical pathologist at nearby Royal Surrey County Hospital. He retired from the NHS and his chair of Clinical Biochemistry in 1995 but stayed on at the University as Dean of Medicine in order to establish a Postgraduate Medical School. Professor Marks is a Fellow of the Royal College of Physicians and of Pathologist. He was vice-president of the Royal College of Pathologists during 1989-91 whilst President of the Association of Clinical Biochemists. In addition to his academic, clinical and educational activities Professor Marks has played an innovative role in the diagnostics industry. In 1974, he and his colleagues developed the first immunoassay for cannabis in body fluids and subsequently for many other drugs and hormones that are still of clinical and forensic interest. In 1976, he established Guildhay Ltd, with which he is no longer associated, to market and distribute the antisera and immuno-diagnostic reagents that he and his colleagues had developed at Surrey to further their own research and clinical interests. In 1985, he and Professor Roland Clift, backed by a grant from the Wolfson Foundation, established ClifMar Associates Limited to exploit and licence their biotechnological expertise in antibody production and purification. They both continue to have an interest in the company which at seventeen is amongst the oldest biotech companies in the UK. Professor Marks was one of the pioneers of immunoassay and of the use of enzymes as diagnostic reagents. Together with Professor Sir George Alberti he organised the world’s first conference on Point of Care Testing in Guildford in 1983 and with Professor Alan Richens the first international conference on Therapeutic Drug Monitoring in 1980. He is known internationally for his research on hypoglycaemia and has appeared as an expert witness in several notorious cases in which it has featured significantly. Clement Fitzgerald is currently Sales and Marketing Director for Randox Laboratories and has 22 years experience in clinical and veterinary diagnostic markets. Clement built Randox into one of the UK’s top diagnostic companies and a world player with four Queens Awards for export to date. His key areas of interest are in clinical chemistry, infectious diseases and environmental/food diagnostics. Formally, Randox focused on consumables and it is now also firmly committed to hardware development and information systems. Although Randox Laboratories is a global organisation, Clement has a particularly strong market knowledge of Europe and North America. Extensive travel and prolonged periods overseas have helped him to be more ‘gymnastic’ in solution finding. However, no less blunt in addressing the core issues. His special interests include: litigation employment, recruitment and training, European IVD directive (cost of implementing), open market trading for all sizes of companies in the NHS, diagnostic research: predictive and preventative diagnoses, medical errors, research applications, and a better NHS with real patient focus. ■ March 2003 • ACB News Issue 479 • 15 Federation of Clinical Scientists Federation of Clinical Scientists Part Timers Rights Explained By Clare Kitchen, Federation of Clinical Scientists his third briefing paper from the Alliance for health care professionals gives an overview of new legislation and how it affects part-timers. The information is in four parts. The complete document can be found on the Alliance web site at www.alliance.uk.com. The following is a summary of the salient points. T Section 1: Why Part Time Workers Are Important Over a third of members of Alliance organisations employed in the NHS are working part-time. In 1988 the CSP Council agreed a policy of equal opportunity for part-time workers. Members may wish to work part-time for a variety of reasons to achieve a greater balance between their working and private lives. Part-time workers should be afforded the same opportunities as their full-time counterparts in terms of in service continuing professional development, work allocation, promotion, and training opportunities. Section 2: Part Time Workers (Prevention of Less Favourable Treatment) Regulations 2000 On 1st July 2000, the Part-Time Workers (Prevention of Less Favourable Treatment) Regulations 2000 came into force in the UK. Anybody working less than the standard hours for their group would meet the definition of a part-timer. Part-time workers have the right to no less favourable treatment than full-timers. They are directly comparable with other workers with the same contract doing basically the same work with a similar level of qualifications and skills and experience in the same or similar establishment, (this may require clarification). Employers must ensure that terms and conditions, as well as pay, are available on a pro-rata basis for part-timers i.e. in proportion to the number of hours that they work compared to a full-timer. The only exception to this is overtime pay, since a part-timer must work the same number of hours as a full-timer before they become entitled to receive enhanced overtime rates. Section 3: NHS Support for Part-Timers There is a strong emphasis on the promotion of part-time and other flexible working practices to help to reduce the severe recruitment and retention problems which the service has been experiencing for so many years. Section 4: A Useful Tick List to Ensure Part-Timers are not Losing Out • Job sharers: a job sharer counts as a part-time worker. • Annual leave: is annual leave available on a proper pro rata basis for part-timers? • Bank and public holidays: are part-timers entitled to a pro rata allowance for bank holidays. 16 • ACB News Issue 479 • March 2003 Federation of Clinical Scientists Federation of Clinical Scientists • Overtime: there is no legal right to be paid at a premium rate for working more than contractual hours. • Pension Scheme: should allow equal access to part-timers as the NHS Scheme does. • Training and study leave: employers must not exclude individuals just because they work part-time and that training should be scheduled, so far as possible, so that all staff including part-timers can attend. • Trade union activities: facilities agreements should not discriminate against part timers particularly in terms of time spent on training courses. If the time spent on a course is longer than contractual hours these should be payed for. • Maternity rights: the rights to pay and leave should be the same for full and part timers • Right to return part-time after maternity leave: in the NHS there exists both case law and other arguments that can be used to help full-timers return on a part time basis to the same job regardless of their grade or supervisory responsibilities. • Sick pay: part-timers should have equal access to any occupational sick pay schemes. • Service qualifications: One year of a part-time worker’s service is equivalent to a year’s service of a full-time worker for increments , promotion, leave etc... • Breaks: Any worker who works more than six hours in a day has the right to a break of at least 20 minutes away from their workstation. • Opportunities to work part-time: are available to all staff groups. Department of Health Publications “The Vital Connection: An Equalities Framework for the NHS” April 2000 http://www.doh.gov.uk/nhsequality/nhsequalitiesframework.htm Improving Working Lives Standard http://www.doh.gov.uk/iwl “Looking Beyond Labels” http://www.doh.gov.uk/nhsequality.htm ■ Annual General Meetings Monday 12th May 2003 Palatine, MICC, Manchester The fiftieth Annual General Meeting of the Association of Clinical Biochemists will take place in the Palatine at the Manchester International Conference Centre, Manchester. The Federation of Clinical Scientists’ Annual General Meeting will commence at 17.15 and the Association of Clinical Biochemists’ Annual General Meeting will commence at 18.00. March 2003 • ACB News Issue 479 • 17 Meeting Reports Meeting Reports Meeting Reports Meeting Reports Science, Sushi and Sore Knees in Japan Reported by Catherine Davies, Royal Gwent Hospital, Newport and Pat Twoomey, Edinburgh Royal Infirmary he meeting began with a very regal opening ceremony attended by members of the Japanese Monarchy and with congratulatory addresses from the Governor of Kyoto and the Prime Minister of Japan. Following a greeting from Mathias Muller, President of the IFCC, the 2002 IFCC Awards were presented including the award of the IFCC/Bayer Distinguished Clinical Chemist award to Professor Nick Hales. The opening lecture was given by Professor Leo Eskai, a Nobel physics laureate famed for the invention of the Eskai diode. Following the ceremony the welcome party began and despite the torrential rain, which turned the promised firework spectacle into something of a washout, spirits were high with the promise of an exciting week ahead. One of the problems when attending such a large meeting with so many respected international speakers is that it can be difficult to decide which talks to attend. Highlights from the scientific programme included: T • ‘Standardisation of glycohemoglobin’ by A. Mosca from Italy – a good overview of the work completed to date by the IFCC HbA1c standardisation subcommittee. Interestingly, the difference between DCCT-aligned and IFCC standardised HbA1c changes with glycaemic control so that the application of a simple factor to each DCCT-aligned value (say minus 1.5% absolute) is an oversimplification. When linear regression between the mean blood glucose and the IFCC standardised HbA1c is performed, the intercept is not statistically different from zero unlike with the DCCT-aligned method, yet another reason for changing to the IFCC standardised value. • ‘The role of the clinical laboratory in primary and secondary prevention, risk stratification, and diagnosis of cardiovascular disease’ by Professor ML McQueen, Canada. Another good general overview. Points that were emphasised included the fact that CRP is a long way from use in primary prevention risk stratification due to standardisation issues and total variation and that much more sensitive troponin assays are required and that the whole process of confirming the clinical utility of such assays when they are eventually available will have to be carried out. • ‘Atherosclerosis and high-sensitivity CRP’ by N. Rifai, USA. Without doubt, CRP seems to be a potential marker for CHD risk assessment in epidemiological studies. However, as clinicians treat individuals, such epidemiological data may not be as applicable as anticipated. Another issue that was not mentioned was if CRP adds 20 • ACB News Issue 479 • March 2003 The beautiful city of Kyoto in Japan was the location for the 18th International Congress of Clinical Chemistry meeting Meeting Reports Meeting Reports Meeting Reports Meeting Reports to the sensitivity of the current versions of the Framingham equation, and if so, is this extra sensitivity worth the extra cost and imprecision? However, it is good to hear that progress is being made on CRP standardisation • ‘The clinical burden of obesity and benefits of management’ by Professor Mike Lean from Glasgow was an excellent overview of this important area. The three 2 hour educational courses on biostatistics (‘Variance analyses and quality specifications’, ‘Method comparison’, and ‘Diagnostic test evaluation and clinical decision-making’) were intensive but well worth attending as shown by the number of people who stayed late each evening. Each course had its own course book containing all the slides. It was obvious that the organisers of these 3 sessions put a lot of time and effort in to this set of courses and they should be praised for this. Perhaps future meetings should include such stand-alone educational courses? Popular ACB Stand Breaks in the scientific symposia gave delegates the opportunity to visit the huge trade exhibition. The ACB stand proved to be a popular site and was inundated with delegates who had obviously heard about the new ACB Blockbuster that was being premiered. Starring our very own Stephen Halloran and David Burnett, the short film addressing current issues surrounding accreditation in Laboratory Medicine sparked much interest and did wonders for book sales! Everybody say Cheese! March 2003 • ACB News Issue 479 • 21 Meeting Reports Meeting Reports Meeting Reports Meeting Reports A convenient gap in the conference proceedings allowed us to experience the Jidai Festival, a procession celebrating the culture of Kyoto. More than 3000 residents of the city dressed in traditional costumes from the last 1200 years paraded through the streets of the city to produce a spectacular display. A little time was also found to visit some of the many famous landmarks in Kyoto including the Kinkakuji Temple, a beautiful building constructed from gold. We also had plenty of opportunity to sample the beautiful Japanese cuisine accompanied by the traditional Sake. However, despite the copious quantities of Sake that were consumed, those biochemists who had neglected to take their Cod Liver Oil supplements found the traditional Japanese seating arrangements to be a little hard on the knees! The conference was superbly organised. The excellent scientific programme combined with the opportunities to explore the Japanese culture provided an incredible experience for all delegates. Many thanks to fellow ACB members who made the trip so enjoyable. ■ The Kinkakuji Temple 22 • ACB News Issue 479 • March 2003 Meeting Reports Meeting Reports Meeting Reports Meeting Reports Irrashaimase! Reported by Richard Taylor rrashaimase! Welcome! And indeed we were made to feel very welcome at the 18th International Congress of Clinical Chemistry and Laboratory Medicine in the beautiful and historic city of Kyoto. It commemorated the 50th anniversary of the IFCC and was the first Congress to be held in Asia. The Japanese Society of Clinical Chemistry were our gracious hosts at the Kyoto International Conference Hall in October. We were treated to a rich scientific programme, a plethora of posters, round-table discussions and extensive trade exhibitions. The city itself was the capital of Japan for over a thousand years until a sudden move to Tokyo in 1867. Kyoto’s countless enduring cultural treasures were an attraction for all delegates, creating continuing time management challenges throughout the week. A particular attraction was the Festival of Ages, in which over 3000 people in traditional costumes of the last thousand years process through the city’s streets. In the present day the Kyoto area is home to several high-tech Japanese multinationals. Academic tours combined culture with visits to worldleading laboratories or factories. The spirit of excellence extended to the conference banquet. Shortly after an elegant performance of traditional Japanese music we were addressed by Dr Tanaka, a 2002 Joint Nobel Laureate in Chemistry. Whilst working for Shimadzu he and his team devised matrix assisted laser desorption ionisation time of flight mass spectrometry (MALDI-TOF), a technique with direct benefits for Clinical Chemistry. See www.nobel.se/chemistry/laureates/2002/ index.html. The flavour of just some of the conference scientific sessions are outlined below. In a plenary lecture sketching out possible future directions for laboratory medicine Dr Nakamura, Director of the Human genome Centre, University of Tokyo, described progress in applying human genome analysis to personalised medicine. Work on polymorphic DNA markers including variable number of tandem repeats (VNTR) has been used to create genetic linkage maps for genetic diseases using single nucleotide polymorphisms (SNPs). They are the most common form of DNA sequence variation and are useful polymorphic markers for investigating genes susceptible to diseases or those related to drug responsiveness. A small subset of SNPs directly influences the quality and/or quantity of the gene product, and increases the risk of certain diseases and drug side effect. Through discovery of a large number of SNPs, the aim is to identify disease-related genes and also to establish a diagnostic method to avoid drug side-effects. See http://snp.ims.u-tokyo.ac.jp/ A symposium on recent progress in diabetes described developments in the standardisation of glycated haemoglobin. Prof Mosca (Italy) explained that the DCCT-linked calibrant, based on a non-specific ion exchange method, can now be superseded by the IFCC standard (Little RR, Clin Chem 2001; 47: 1985-92; Jeppsson J O et al, Clin Chem Lab Med 2002; 40: 78-89). Haemoglobin is cleaved into peptides by the I March 2003 • ACB News Issue 479 • 23 Meeting Reports Meeting Reports Meeting Reports Meeting Reports enzyme endoproteinase Glu-C, and in a second step the glycated and non-glycated N-terminal hexapeptides of the beta-chain obtained are separated and quantified by HPLC and electrospray ionisation mass spectrometry or using HPLC and capillary electrophoresis with UVdetection. These approaches give identical results. An international inter-laboratory referencing study is in progress and the material will be introduced as a new standard in Europe in 2003. The intercept of approximately 2 % in the relationship between DCCT-calibrated HbA1c and glucose is effectively eliminated if the value of the more specific IFCC HbA1c calibrant is used (Rohlfing CL, Diabetes Care 2002; 25: 2758). Good agreement should be achievable for ion exchange and affinity methods. Immunoassay methods show poorer between-laboratory precision but good calibration may be achievable with further work on standardisation and EQA. A satellite meeting immediately after the Congress has taken this further. The Evidence Laboratory A symposium on evidence-based laboratory medicine emphasised the need for greater evidence for both point of care and laboratory tests. Dr Sandberg (Norway) explained that the STARD initiative is investigating how primary studies should be done. See www.clinchem.org/ (January 2003 edition) and www.consort-statement.org/. Dr Horvath (Hungary) explained how to perform a primary study on diagnostic accuracy (Steurer J, BMJ 2002; 324: 824-6). See Bandolier extra 02/02 pp1-9 on how to assess the quality of a study. This has been summarised in Lijmer J G et al JAMA 99; 282: 1061-6. See also www.clinchem.org/cgi/reprint/46/7/893 on how to do studies in a meaningful way. Dr Oosterhuis (Netherlands) gave good examples of systematic reviews. For how to assess evidence see Altman & Bruns, Clin Chem 2000; 46: 893-5 and Oosterhuis on the Clin Chem Lab Med website www.ckchl-mb.nl/ifcc/. Dr Kawai (Japan) explained that practice guidelines for clinicians’ appropriate use of the laboratory should be drawn up in collaboration with a small group of key physicians, with agreement based on expert clinical opinion. The group should then proceed to broad implementation without further extensive consultation. Education of users and open communication are important. See Lundberg GD JAMA. 1998; 280: 2036. Examples of changed practice from the application of POCT are Nichols JH et al Clin Chem. 2000; 46: 543-50; Cagliero E et al Diabetes Care 1999; 22:17859. Also see Irwig L et al BMJ 2002;324:669-671. Bossuyt et al Lancet 2000; 25;356(9244):1844-7 describes the problems associated with randomised comparisons of medical tests. We were left with the impression that there is much work to be done to improve the clinical value of the tests we offer. To be effective this must involve close collaboration with our clinical users at all stages of the process. A symposium on evidence based medicine and the global campaign on diabetes mellitus was opened by Gary John who reviewed the criteria for diagnosis and monitoring. In summary the 1999 WHO definition results in diagnostic equivalence between fasting plasma glucose and the 2 hour value of 11.1 mmol/L. The role of the OGTT is clari24 • ACB News Issue 479 • March 2003 Meeting Reports Meeting Reports Meeting Reports Meeting Reports fied. HbA1c is not recommended for diagnosis. See Diabetic Medicine 99; 16:716-30 for guidance on Type 2 diabetes and also Lamb & Day Ann Clin Biochem 2000; 37: 588-92. The change in criteria increases the number of diagnoses of DM, as demonstrated in some posters from Denmark. Prof Sandberg (Norway) presented the evidence for the benefit of self blood glucose monitoring (smbg). Increased strip use has been shown to be associated with lower HbA1c (Evans JM et al BMJ 99; 319:83-6 and Karter et al Am J Med 2001; 111: 1-9). Self monitoring at least three times daily is recommended in Type 1 DM (Diabetes Care 2002; 25: supp 1 S97-9). In Type 2 DM there is no evidence for improvement in management. RCTs are required. Many factors must be addressed if benefits of smbg are to be achieved. These include analytical performance of meters, cost/reimbursement/affordability for patients, guidelines for action resulting in improved self medication, access to and communication with professional support. The diagnostics industry, the laboratory, diabetes specialists and primary care must all play their part. Dr Steffes (USA) reviewed the value of glycated haemoglobin as a primary indicator of the complications of DM. Six years after the end of the DCCT the HbA1c of the groups have converged but the conventional group have increased microalbuminuria and blood pressure (ADA 2001 abstract – Diabetes 50, A63, 2001). The ADA recommends at least twice yearly measurement, four times if control is poor. In the EPIC-Norfolk study the male cohort has increased macrovascular risk even with HbA1c within the reference range (Khaw KT et al BMJ 2001; 322: 1-6). Stephen Halloran got a shock when he discovered what the tea-leaves had in store for him! March 2003 • ACB News Issue 479 • 25 Meeting Reports Meeting Reports Meeting Reports Meeting Reports In a neonatal testing symposium Dr Lockitch (Canada) reviewed the challenges of testing neonates. These include naming and identifying the appropriate neonate, the apparently ever smaller neonates being treated, small sample volume and its proportion of the neonatal blood volume, labelling; time to results, analysis on the unit or in the laboratory; interpretation – what is ‘normal’? Some of the analytical challenges with small specimens may be met by tandem MS or other MS techniques. In a session on Point of Care Testing in Clinical Chemistry Dr Lewenstam (Finland) described progress with the development of biosensors using conducting polymers in all solid-state ISEs (Bobacka J et al, Anal Chem 99; 71: 4932). These developments could revolutionise sensors for POCT. Sensors with direct ion-electron conduction have been developed. Multifunctional conjugated polymers can be created, including antibodies and DNA. Prof Price (UK) discussed outcomes in POCT in primary care. The 1997 Health Technology Assessment suggested little evidence for benefit but the chosen outcomes in many studies may have given an incomplete picture. For example, a study of urine testing did not show benefits for improved detection of positive cases, but real benefits may lie in its usefulness for ruling out, so reducing routine laboratory workload and costs. The benefits are always outside the testing environment and budgetary compartmentalisation can make costing difficult to assess. Other studies discussed were Gillam S et al. J Eval Clin Prac 1998; 4: 165-9 – costs and workload increased but the primary care practices profile image improved and patient satisfaction increased. In a study of CRP in primary care, lab tests and follow up consultations were reduced (Dahler-Eriksen BS et al Clin Chem 1999; 45: 478-85). A paper investigating the benefit from smbg in Type 2 diabetes was also discussed. Using HbA1c as a surrogate marker for complications little benefit was apparent but the potential effect of improved education was not investigated (Coster S et al Diabet Med 2000; 17: 755-61). Similarly, studies of the benefit of POCT HbA1c testing have shown that referral and treatment in primary care must be optimised for any benefits to be seen (Griffin S BMJ 1998; 317: 390-6; Cagliero E et al Diabetes Care1999; 22: 1785-9). Laboratory support will be required, covering education and accreditation. Clinical and economic benefits should be demonstrable for patients, health professions and society. Outside the scientific sessions in conversations with clinical laboratory workers from other countries we could discuss the similarities and differences in other healthcare. These conversations give us an opportunity to consider the strengths and weaknesses of our own service, a useful thing in the light of Pathology Modernisation. Beyond the conference itself we only had time to scratch the surface of life in Kyoto. So many apparently familiar everyday things were different on closer inspection. The taxi drivers wear peaked caps and white gloves and the pedestrian crossings play tunes as you cross. Those of us who visited Kyoto have come home with plenty of memories and lots to think about. I hope it’s not another fifty years before Japan hosts another ICCC conference. ■ 26 • ACB News Issue 479 • March 2003 Topics Current Topics Current Topics Current Topics Current Topics NICE Try to a New Approach By Professor Chris Price n 2002 the Department of Health and Welsh Assembly Government undertook a consultation exercise on the process of topic selection for consideration by the National Institute for Clinical Excellence (NICE). The outcome of this consultation in the form of new arrangements was published at the end of the year and a presentation on the new arrangements was made to interested parties on January 30th. The aim of the new arrangements for topic selection and timing of guidance on new technology is to enable wider consultation on topics to more accurately reflect stakeholders, with greater involvement of patient groups and industry as well as health professionals, managers and policy makers. The new arrangements will also bring greater coordination between the activities of NICE and the National Coordinating Centre for Health Technology Assessment (NCCHTA). Topic selection arises from a combination of speciality mapping and horizon scanning for new technologies as well as a regular call for proposals that goes out to a wide range of stakeholders. The aim is that this latter route will be more widely available through a web based system on the NICE website. It will also bring together the proposals for appraisal of new technology and the creation of guidelines. The proposals will be reviewed twice a year which will be followed by a screening process to ensure completeness of the proposal, clarity of relevance, degree of overlap with current projects and then a briefing note will be commissioned. Some prioritisation will take place at this point. There will then be a peer review of the briefing note by expert advisors after which the topics will be considered by a new Advisory Committee for Topic Selection (ACTS) against defined selection criteria. A Joint Planning Group will then consider the recommended topics against NICE’s capacity and technical feasability, at which point the proposed topics will be considered by the relevant Ministers. There will then be a further period of consultation with stakeholders and at the end of this process a decision will be made to refer the topics selected to NICE for inclusion in its work programme. One additional advantage of the web based approach to consultation is that there will be a database of all of the proposals on the NICE website so that individuals can review their ideas with current suggestions and work in progress. I Laboratory Medicine, Diagnostics and NICE Anyone who keeps up to date with the activities of NICE and the NCCHTA will know that ‘laboratory diagnostics’ has not figured highly in the programmes of either of these organisations to date. There may be several March 2003 • ACB News Issue 479 • 27 Current Topics Current Topics Current Topics Current Topics Current reasons for this, including the fact that they are not perceived as ‘expensive’ or that they may not be perceived as contributing to the patient outcome (!). Certainly the language used in several of the NICE documents talks about ‘understanding the therapeutic area’. It is also clear that, somewhat perversely, diagnostics technology may be at a disadvantage because it does not require a considerable body of evidence on clinical effectiveness to be available in order to be registered for use, and consequently any review at the stage of prioritisation may conclude that there is no evidence on which to establish a review! However, the new arrangements may offer a real opportunity for diagnostics to achieve a higher profile in NICE’s work programme, and this may be through the closer juxtapositioning of technology appraisal and guideline formulation. Thus when the appraisal of a new intervention is proposed, or a guideline sought then consideration can be given to the contribution made by the relevant diagnostic test or device. Clearly most diagnostic tests are concerned with either establishing the need for a therapeutic intervention, or assessing the efficacy of, or compliance with, that intervention. A quick review of the current topics proposed to NICE (which runs to 37 pages in its paper version!!) shows that there are over 20 proposals in which it would be appropriate to consider a parallel review of the role that a diagnostic test would play in either selection or monitoring of the intervention. The professional bodies associated with laboratory medicine and the British In Vitro Diagnostics Manufacturers Association are both on the consultation list although there is unlikely to be any formal representation on ACTS but specific expertise will be sought when relevant diagnostics related topics are on the agenda. The Future Clearly there is now an opportunity for wider consultation on the NICE programme with more transparent mechanisms for both proposing topics as well as monitoring of work under consideration. The closer links between technology appraisal and clinical guideline production will undoubtedly offer the opportunity to explore the role of diagnostics and laboratory medicine in the diagnosis and management of disease. This will undoubtedly help to stimulate the search for more evidence on the effectiveness of diagnostic tests and devices, as well as helping to demonstrate the role and value of diagnostics in clinical practice. Regular review of the NICE website should definitely (if it wasn’t already) be on the list of action items for all laboratory professionals. The meeting was attended by Doris-Ann Williams, Director General of the British In Vitro Diagnostics Manufacturers Association and Professor Chris Price. Further information concerning the background to this report, and the activities of NICE, can be obtained from the website: http://www.nice.org.uk ■ 28 • ACB News Issue 479 • March 2003 Chris Price gets to grips with local customs in the Kyota meeting Ac c re d i t a t i o n N ew s Ac c re d i t a t i o n N ew s Ac c re d i t a t i o n N ew s More than a Designer Label An Interview by Stephen Halloran David, congratulations on completing your second book on accreditation, which you have called ‘A Practical Guide to Accreditation in Laboratory Medicine’. Your first book entitled, ‘Understanding Accreditation in Laboratory Medicine’, was published in 1996, what made you decide to write a further book? The original plan was to simply revise the original book and I did actually start on that for about a week, but since my first book was published I have been working with colleagues, particularly in the Republic of Ireland, facilitating their preparations for accreditation. I worked in a whole range of laboratories, from small multidisciplinary laboratories to those in large teaching hospitals, working across all disciplines. What I realised from that experience was what people needed was a practical guide to preparing a laboratory for accreditation. Having decided that, I faced writing a very different type of book and I have tried to achieve this by taking the fictional device of the Pathology Laboratory at St Elsewhere’s Hospital started in my first book and developing it further. This has enabled me to illustrate key areas of activity at St Elsewhere’s Pathology Laboratory by showing its Quality Policy pages from its Quality Manual; showing how the staff went about analysing in detail, key areas of pre-examination, examination and post-examination activity and detailing the documentation they needed to create. People find it difficult knowing where to start when writing procedures, particularly what headings you need. I have provided contents pages of major procedures to give an idea of how to start. Finally, there are the forms which you would use in conjunction with procedures to record the activity that results from implementing the procedures. So, for example, if you were writing a procedure for personnel management, you need a staff induction form. Throughout the book there are examples of the forms used for recording information; there is, for example, a partly completed staff training form, to give people an idea not only of design, but how it can be used to provide a record for the laboratory and for an external assessor. I hope in this way I have provided practical material, not so that people will use it unchanged, but that it will trigger them into knowing how to begin. Stephen Halloran, Chairman of the Publications Committee interviews David Burnett about his second book on accreditation It is said that ‘a year is a long time in politics’ and I presume that would also apply to accreditation; so over the last six years what would you see as the major developments in this important field? There are really three. Firstly, the purchasers of medical laboratory services, those who provide them and those who use them, have become increasingly aware of the importance of accreditation as a means of knowing the standard of services being provided. Secondly, during that time there have been developments in International Standards, published by the International Standards Organisation, (ISO) that are of great importance to medical laboratories and finally, National Accreditation Bodies throughout the world have become much more conscious of the importance of being involved in the accreditation of medical laboratories. So those are really the three distinct areas of development. March 2003 • ACB News Issue 479 • 29 Ac c re d i t a t i o n N ew s Ac c re d i t a t i o n N ew s Ac c re d i t a t i o n N ew s Of the ISO Standards which you refer to in your book which would you consider to be the most important? Well clearly there are three. For the first time, this year, we hope to see the publication of the first ever ISO Standard for medical laboratories, ISO 15189, that provides requirements for quality and competence in medical laboratories. In that standard there are two further standards referenced, one is ISO 9001, which gives the requirements for quality systems, a standard well known to people inside and outside the laboratory. The third standard is the generic standard for testing and calibration laboratories, ISO 17025, published in 1999. At the moment, this latter standard is used by accreditation bodies throughout the world to accredit testing and calibration laboratories whatever work they undertake.The major step forward is to have an international standard, ISO 15189, that sets out specific requirements for quality systems and competence in medical laboratories. I notice in the book you have created a second fictional concept of an ‘Ideal Standard’. Why did you do that? I have been very fortunate to be working as an external consultant to Clinical Pathology Accreditation (CPA) in the UK over the last few years and was asked to chair their Standards Revision Committee. The committee began that work by looking at all the material available and decided to use the three standards I have mentioned, and the ‘Essential Criteria’ developed by the EC4 Working Group on Accreditation, as source documents for the new CPA standards. They were published in 2001 and essentially integrated the ISO standards and the ‘Essential Criteria’. From this work I developed the ‘Ideal Standard’ in my book. It sounds a bit presumptuous to call it the ‘Ideal Standard’, but in the book it is represented by clauses and sub clauses that are referenced throughout the book and give logical structure to Chapters 4-11 which are the practical part of the book. In Appendix 1 there is a table which I suggest readers should photocopy and have alongside them while they use the book. This table cross references the ‘Ideal Standard’ with the three main ISO Standards, ISO 9001, ISO 17025, ISO 15189 and to the CPA Standards, so whatever standard you choose to prepare your laboratory for, you can look up the relevant clause or subclause of the ‘Ideal Standard’ and find the part of the book which will help you interpret the standard and put it into practice. Well David, the book is now published, a tremendous amount of work has gone into it. How would you like to see your book used in the modern clinical laboratory? Firstly, I would to see laboratories use it to review the way they do things and most of all I hope it will help them to prepare for accreditation with the minimum amount of effort. Secondly, I have enjoyed working with people from all disciplines and we have a lot to learn from each other. I hope it encourages people work across disciplines and to share their individual expertise. To facilitate this I have provided examples in the book from all different disciplines. Laboratories all over the world face increasing workloads and have inadequate staffing, but the service they provide is at the core of modern medicine and it is very important that preparation for accreditation should not be seen as an extra burden. Accreditation is not about getting a designer label, it is about understanding the standards, taking the spirit of them and creating new and innovative ways of meeting them. David, your last book was widely acknowledged and was commended in both the BMA Medical Book Competition and by the Society of Authors, Medical Book Awards. We wish you similar success with your new book and look forward to it gaining international recognition as the premier guide to laboratory accreditation. Thank you, I would like to thank the ACB Venture Publications Team for their support and all the people in many corners of the world who have given me so much encouragement to complete this project and I like to think of the book as repaying, in small measure, that encouragement. ■ 30 • ACB News Issue 479 • March 2003 Corporate News Corporate News Corporate News Corporate News New OCTEIA™ Pro-OpioMelanoCortin Assay A non-isotopic assay for ACTH precursors in human plasma ProOpioMelanoCortin (POMC) has long been a molecule of fascination, being the prime precursor to a multiplicity of biologically-active peptides such as ACTH, ß-Lipotrophin (ß-LPH), ß-endorphin, a-MSH and more. It is also a very ancient molecule, being found in most vertebrates studied, including those 'living fossils', the lungfish. The new OCTEIA POMC ELISA actually measures 'ACTH precursors' (i.e. reads both POMC and proACTH equally) in plasma samples, and provides a tool to researchers investigating pituitary function and the HPA axis. The relative proportions of precursors to ACTH is of interest in the aetiology of Cushing's syndrome and in precursor processing in tumours of different types and origins. There are potential roles in satiety v obesity and hyperpigmentation and there is much research potential for the kit. Together with high throughput and a rapid turnaround time, IDS has made it possible to accurately and precisely measure POMC in a simple assay which can be easily assimilated into routine laboratory testing. The kit is available in 96 well format to accommodate the needs of both clinical and research laboratories. For further information contact IDS Customer Care on Tel: 0191-519-0660 or visit our website: www.idsltd.com ■ Radiometer Goes WWW with Blood Gas Radiometer has launched a website to focus exclusively on blood gas analysis. www.bloodgas.org provides practical information for healthcare professionals on key issues surrounding blood gas and critical care testing. The content of bloodgas.org is divided into four information tracks: Technology, Quality assurance, Point-of-care testing, and other topics. Registration to the new website is free of charge and enables users to gain complete access to all publications on www.bloodgas.org In addition, all registered users can receive a customized subscription to the newsletter ‘bloodgas.today’ detailing issues of particular interest to them. ■ BIVDA Position on Self-Testing Kits [After a misleading press article in the area of self-testing with in vitro diagnostic devices BIVDA recently made the following statement.] The self testing market is huge in the USA and Japan and is increasing in Europe where it now represents approximately 20% of the total diagnostics market. This growth has been much slower in the UK but the variety of tests available is rising. This matches the public’s interest in health issues, with criticism of UK healthcare in the media virtually every day. The government is encouraging people to take more responsibility for their own health. Diagnostics have long been an under recognised part of health care and is both underfunded and poorly utilised. Regarding self testing BIVDA would like to make the following comments: • New regulations coming into force at the end of 2003 requiring CE marking on packaging will prevent the sale of poor quality or unsafe tests. However the public do need to be made aware of the CE mark in the same way they were informed about the same requirement on toys and electrical goods to indicate safety and quality of the products. • Most of the self tests used are for screening for absence of disease and confirm ‘wellness’. They are in no way diagnostic. Any tests indicating a positive result should be discussed with a doctor or health professional. • The whole issue of self-testing is not black and white – but it has been used effectively for years to diagnose pregnancy. • Instruction leaflets must be read carefully – interfering substances or conditions can affect the result. • All diagnostic tests, whether performed by a laboratory, health professional or the patient, are done as part of the diagnostic procedure and are rarely performed alone – they are indications of disease in the same way that physical symptoms are. Manufacturers state that results should be discussed with a doctor or health professional. For further information please contact: Doris-Ann Williams, Director General, BIVDA, 1 Queen Anne’s Gate, London SW1H 9BT. Tel: 0207-957-4633. Fax: 0207-957-4644. Email: [email protected] Website: www.bivda.co.uk ■ March 2003 • ACB News Issue 479 • 31 Letters Letters Letters Letters Letters Letters Letters Letters ? Letters Readers speak out Pilot UK NEQAS for Kidney Function Investigations We are pleased to invite readers to participate in a pilot scheme for kidney function tests, which will provide participants with objective information on how their results compare with others. It is also intended to increase awareness of new demands on laboratories for early and sensitive detection of kidney disease through improved reporting of GFR and using cystatin C and iohexol clearance. The assessment of glomerular filtration rate (GFR) by means of creatinine clearance is recognised to be suboptimal due to practical, analytical and clinical limitations. Reliable 24 h urine collection presents practical problems, and both serum and urinary creatinine assays are subject to potential interferences. Though serum creatinine on its own is an insensitive marker of glomerular damage, there are formulae for calculating GFR based on serum creatinine which have improved sensitivity. The UK Renal Registry recommend that GFR be calculated using the Cockcroft and Gault formula, based on the measurement of serum creatinine. New markers of glomerular function, primarily cystatin C and iohexol clearance, are now also coming into use, not only into research settings but also into routine clinical practice. Reliable assessment of renal function requires the wider use of such investigations to support dialysis and transplant units, and to support new National Service Frameworks. Comparability of results is essential to equity of patient management and to pooling of data nationally for outcome audit activities, e.g. those carried out by the Renal Registry. Demonstration of comparability requires EQA, and we anticipate that this will be recommended in the renal National Service Framework which is in development. EQA is essential to confirm that comparability can be attained nationally, to assist participant laboratories in maintaining performance, and to facilitate and support the wider use of new markers. Distributions in the scheme will be two-monthly, 32 • ACB News Issue 479 • March 2003 starting in May/June 2003. Laboratories may register for creatinine and cystatin C (3 serum specimens per distribution) and/or for iohexol plasma clearance (4 serum specimens per distribution). Participants will be expected to: • assay for serum cystatin C • assay creatinine then calculate the GFR from the creatinine using a formula, e.g. Cockcroft and Gault, using the height, weight, sex, age and race supplied. A clinical comment on the results will be requested • assay for iohexol and report the clearance. Each distribution will include a basal specimen with no iohexol, and 3 timed specimens after administration of iohexol. All data will be processed using overall or methodrelated consensus means as target values, with reports in UK NEQAS house style and performance assessment using 'the ABC of EQA' scoring system As this scheme is part-funded by CPA from their pilot EQAS programme there will be no charge to laboratories providing a clinical service in the UK. Laboratories carrying out Cystatin C and/or iohexol assays are requested to contact UK NEQAS, (P O Box 3909, Birmingham B15 2UE. Fax: 0121414 -179. Email: [email protected]) as soon as possible for a registration package, giving their UK NEQAS laboratory code. We hope members will find this new service of value, and should be pleased to receive any comments. Dr David Bullock UK NEQAS Birmingham P O Box 3909 Queen Elizabeth Medical Centre Birmingham B15 2UE Dr Jeffrey Barron Department of Chemical Pathology St Helier Hospital Carshalton SM5 1AA Vacant Situations Vacant Situations Vacant Situations Vacant University of London MSc Clinical Biochemistry Applications are invited for this two year, part-time intercollegiate course beginning in September 2003 Candidates should have a first or second class honours degree in chemistry, biochemistry or a related subject, or hold a medical qualification registrable in the United Kingdom. Candidates without these qualifications may be considered providing they have relevant work experience. Students will usually be expected to have at least one year’s experience in clinical chemistry, but well qualified candidates working in a clinical chemistry laboratory for less than one year will be considered. Candidates must hold posts in suitable laboratories for the duration of the course and must be in a position to attend lectures and seminars at a London medical school on Wednesday afternoons (2pm-7pm) during the university terms. Students will be registered as internal students of the University of London. The degree is awarded on the basis of examinations held at the end of the course, a project and assessment of the practical work set throughout the course. The course provides an excellent grounding for those individuals wishing to progress to the MRCPath in Chemical Pathology. For further details and application forms write to: Dr Gill Rumsby, Department of Chemical Pathology, UCL Hospitals, Windeyer Building, Cleveland St, London W1T 4JF. Tel: 020-7679-9229; Fax: 020-7679-9496; email: [email protected] Closing date for receipt of applications will be 1st June 2003. March 2003 • ACB News Issue 479 • 33 Situations Vacant Situations Vacant Situations Vacant Situations To advertise your vacancy contact: ACB Administrative Office, 130-132 Tooley Street, London SE1 2TU Tel: 0207-403-8001 Fax: 0207-403-8006 Email: [email protected] Deadline: 26th of the month prior to the month of publication Training Posts: When applying for such posts you should ensure that appropriate supervision and training support will be available to enable you to proceed towards state registration and the MRCPath examinations. For advice, contact your Regional Tutor. The editor reserves the right to amend or reject advertisements deemed unacceptable to the Association. Advertising rates are available on request 34 • ACB News Issue 479 • March 2003
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