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: Editor.ACBNews@ACB.org.uk
Associate Editor
Dr Judith Burrows
Department of Clinical Biochemistry
Russell’s Hall Hospital
Dudley DY1 2HQ
Tel: 01384-456111 Fax: 01284-238089
Email: Judith.Burrows@dudleygoh-tr.wmids.nhs.uk
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: richard.spooner.wg@northglasgow.scot.nhs.uk
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
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Department of Clinical Biochemistry
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© 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: info@focus-acb.org 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: editor.acbnews@ACB.org.uk ■
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: andar.gunneberg@swansea-tr.wales.nhs.uk
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
(webmaster@acb.org.uk). ■
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: info@focus-acb.org ■
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: doris-ann@bivda.co.uk
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: ClinChem@ukneqas.org.uk) 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: gill.rumsby@uclh.org
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: ACBNewsAdverts@ACB.org.uk 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