Select Committee on Health Written Evidence

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 systems?

  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.

  For example:

  The management of diabetes relies heavily on routine measurement of glycated haemoglobin—the 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 commended—patients 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 research?

  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 laboratories.

  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 healthcare R&D.

  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 Data Spine?

  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 of services.

Doris-Ann Williams

Director General, British In Vitro Diagnostics Association

March 2007

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