Evidence submitted by the British In Vitro
Diagnostics Association (EPR 33)
The British In Vitro Diagnostics Association
(BIVDA) represents manufacturers and suppliers of in vitro
diagnostic products operating within the UK. Our membership represents
more than 95% of the industry sector which had annual sales in
2005 of £447 million. Our products are the tests which diagnose
and rule out disease or physiological conditions, monitor therapy,
screen for disease and are also used to ensure the safety of the
blood supply. They range from simple self-test kits such as for
pregnancy to the most sophisticated molecular technologies and
fully automated laboratory systems. We are delighted to respond
to this inquiry, and state our thoughts on the subject areas outlined
by the Committee.
What patient information will need to be held
on the new local and national electronic record systems, and will
patients be able to prevent their personal data being placed on
The in vitro diagnostic sector provides
an essential, yet often underestimated role in the delivery of
NHS care. Of all patient data collected for diagnosis, an estimated
70% comes from diagnostic tests.
The management of diabetes relies heavily on
routine measurement of glycated haemoglobinthe results
are use to determine how well the patient is maintaining their
blood sugar levels day to day which is crucial to prevent, or
at least delay, onset of the serious side effects of this condition.
The routine test results need to be easily accessible by all healthcare
practitioners involved in the patient's care.
Similarly there are tests used to monitor therapy
and progress in heart disease such as testing for the levels of
the drug Digoxin or using naturietic peptides to monitor patients
suffering heart failure.
And there are a battery of essential tests which
monitor the treatment of cancers or which can indicate early recurrence
such as prostate specific antigen (PSA) or alpha feto protein
(AFP). Equally c-reactive peptide is a useful marker of infection
which can help determine if an oncology patient needs to be re-admitted
to hospital during chemotherapy.
These are just a very few examples of some tests
used to monitor some of the more common long tem conditions.
It is clearly crucial that the results of these
tests are included on the patient record if the EPR is to perform
the functions of assisting early detection, prevention and monitoring.
Furthermore, all health professionals involved in patient care
have access to this data, to enable decisions and interventions
to be made as early as possible.
Who will have access to locally and nationally
held information and under what circumstances?
In order to address the capacity constraints
on the NHS, there has been a marked increase in the level of point
of care testing. This is to be commendedpatients are able
to be tested much earlier, as health professionals such as community
pharmacists are now able to conduct tests that may previously
have required a hospital out-patient appointment.
The role of the EPR must therefore take account
of these changes in testing location. Community pharmacists and
other professionals who have been brought into the diagnosis process
through point of care testing must be able to input results into
the EPR as well as accessing records.
Failing to take this into account will significantly
undermine the advances made under point of care testing.
Will patient confidentiality be adequately protected?
The issue of patient confidentiality is central
to the EPR debate. BIVDA fully support the argument that the necessary
safeguards must be in place in order for patients to feel reassured
about their privacy.
It must be noted, however, that safeguards to
ensure patient confidentiality should not be at such a level so
as to restrict disease management.
Access to results from IVD tests are crucial
to a wide range of management processes, such as detecting infections,
ensuring a match for blood or organ transplantation, and screening
populations at risk for symptom-less diseases.
A sophisticated process of check points must
be developed to ensure that access to test results is permitted
at the necessary level to ensure such disease management techniques
are uninhibited, without compromising patient confidentiality.
How data held on the new systems will (and should)
be used for purposes other than the delivery of care eg clinical
The UK has a strong diagnostic sector which
can take credit for the development and introduction of a number
of cutting edge tests and technologies over recent years. The
industry itself is relatively young having grown significantly
in the last forty years. Prior to this all tests were discovered
and developed in the UK by the professionals working in the pathology
Much of this innovation often comes from within
the NHS, with essential research based on data obtained from NHS
sources. In order to continue the UK's record in the development
of new diagnostic services for the benefit of NHS patients, clinical
research must be made available to the appropriate engines of
The EPR provides a simpler and more effective
means to collecting patient data. Such data must continue to be
shared with the research sector to ensure the continuation of
new product development, whilst adhering to all the sufficient
checks to guarantee patient confidentiality.
What are your views on the current progress on
the development of the NHS Care Records Service and the National
BIVDA is concerned at the scope of these two
initiatives. The connectivity of laboratories to the NHS system
is not included in the specifications, despite clear evidence
to demonstrate that the lack of a joined up approach between laboratories
and primary care practitioners is restricting the effectiveness
Director General, British In Vitro Diagnostics