Health: Pathology

House of Lords written question – answered at on 13 December 2012.

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Photo of Baroness Masham of Ilton Baroness Masham of Ilton Crossbench

To ask Her Majesty's Government what assessment they have made of the use of in-house pathology tests in the National Health Service.

To ask Her Majesty's Government for which disease areas and health conditions in-house pathology tests have been developed in the National Health Service.

To ask Her Majesty's Government whether errors or accidents related to the use of in-house pathology testing in the National Health Service are required to be reported to an appropriate regulatory body.

Photo of Earl Howe Earl Howe The Parliamentary Under-Secretary of State for Health

The department does not formally collect any information on in-house tests utilised for specific disease areas within National Health Service pathology services. The decision to use in-house methods is a matter for local NHS determination, based on local need and the availability of suitable alternatives.

By far the largest services in terms of volume and range of tests are clinical biochemistry and haematology which are often combined into core blood service departments and account for approximately 80% of the total pathology workload. The bulk of this work is routine high throughput testing from primary care (general practitioners) and hospital inpatient and outpatients. It is processed on commercial modular and high throughput analysers 24 hours a day. The number of in-house methods will be very small and in most labs will be zero.

There are some in-house methods in specialist areas which use technology such as tandem mass spectrometry. These technologies do not usually come with commercial kits so laboratories devise their own methods. We understand that clinical areas where these methods are used include toxicology, paediatric biochemistry, vitamin D analysis, and special endocrinology.

There are some in-house methods in microbiology and immunology, but most are commercially derived.

Legislation covering the manufacture and marketing of in vitro diagnostic medical devices (IVDs) includes an exemption for IVDs manufactured and used in-house by health institutions to comply with the requirements of the legislation. Unlike for commercial IVDs, there is no requirement for adverse incidents-where failure of an IVD leads to a risk to patients-concerning IVDs manufactured in-house by health institutions to be reported to the Medicines and Healthcare products Regulatory Agency. However, any adverse clinical incident resulting from an analytical or technological error whether in-house or commercial, should be notified through the incident reporting mechanisms, for example, serious untoward incidents.

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