PUBLISHED IN THE BIOMEDICAL SCIENTIST AUGUST 2011

Changing information needs and laboratory information management systems

The need to comply with Acts of Parliament and the demands of other requirements can have an important impact on data storage and management, as Carol Cresswell explains.

National Health Service laboratories are coming under increasing pressure to store additional data in their laboratory information management systems (LIMS) to demonstrate adherence to certain processes and procedures. This pressure is predominantly due to the development of new legislation such as the Human Tissue Act, the EU Blood Traceability Directive 2002/98/EC and also the growing concerns of patients and relatives about the patient information stored by NHS computer systems.

TISSUE AND BLOOD

The Human Tissue Act 2004 came into effect on 1 April 2005 and its statutory functions began on 1 April 2006. The requirements outlined in the Act are regulated by the Human Tissue Authority. The Act makes consent the fundamental principle underpinning the lawful storage and use of body parts, organs and tissue from the living or the deceased for specified health-related purposes and public display. It also covers the removal of such material from the deceased and has fundamentally changed the way in which laboratories in the UK and Wales store information (there is separate legislation in Scotland – the Human Tissue (Scotland) Act 2006).

The Human Tissue Act 1961 was reviewed and replaced as a consequence of high-profile cases such as the one that came to light at the Royal Liverpool Children’s Hospital(Alder Hey), in which organs of children had been retained by the hospital without consent.

Under the Act, the following activities are illegal:

·         removing tissue from the deceased

·         storing or using human tissue without consent (except for medical diagnosis)

·         taking and testing DNA without consent

·         organ trafficking

·         storing tissue or organs for a purpose not stated.

The 2004 Act can be compared to the Blood Traceability Directive in terms of the information that needs to be gathered by the laboratory. Both mandate that the ultimate status and location of blood or tissue be recorded without ambiguity, but the Human Tissue Act currently does not inflict the same penalties on the laboratories for noncompliance as does the Blood Traceability Directive.

The Blood Traceability Directive was incorporated into UK law through the Blood Safety and Quality Regulations 2005. Since November of that year, all UK hospitals and blood banks have been mandated to establish a fully auditable system for the traceability of blood, from donor to recipient. Compliance with the regulations is compulsory and monitored by the Medicines and Healthcare products Regulatory Agency (MHRA). Noncompliance is a criminal offence and could result in a prison sentence for trust chief executives. Many hospitals, however, have not found it easy to meet all the requirements, and smaller hospital in particular have found it difficult to finance the new technology needed to meet the legal requirements.

In terms of the Blood Traceability Directive, hospital laboratories are mandated to follow certain processes and procedures, and modern LIMS need to be designed in such a way that it is easy to evidence adherence to the directive. In terms of the Human Tissue Act, however, there is no equivalent EU directive, and therefore less of an imperative to code this functionality into the laboratory information systems.

Without the pressure of an EU directive and other legislative consequences, laboratories have, up to now, been adhering to the Human Tissue Act as best they can, either by means of a manual process or through use of existing, unused free-text fields in their LIMS to capture this information (most

LIMS currently do not have the dedicated functionality to address this). However, as legislation is changing, laboratories need to show evidence of adherence to the Act, and suppliers need to address this by developing their systems to contain specific functionality for the capture of these data.

Under the Act, an individual who has undergone surgery or a relative of a deceased person is at liberty to ask for all tissue samples taken from the body to be returned to them, and therefore laboratories need to be prepared for this eventuality.

MORTUARY SUPPORT

It is not only legislation that necessitates the collection of new information. The degree of cooperation and interactive working now required between the laboratory and mortuary is becoming increasingly complex, and the fundamental requirements regarding information captured in the mortuary are also changing. There are often incidences where a body is awaiting a post-mortem examination but a relative asks for valuable items to be returned to the family. Currently, such information is being gathering by staff by whatever means possible (eg paper registers or use of a free-text area in the LIMS). Ideally, systems need to be developed in such a way that they have the ability to record when and to whom specific items have been returned, and by which member of staff. This also requires a means of itemising the valuable items, and whether or not they have been released before the body.

It is also necessary to be able to track the location of bodies in storage and have a chain of- custody record for transfer where autopsy services are centralised on one location in multisite trusts. Sometimes, a body may need to undergo a series of autopsies; for example, as part of a criminal investigation in to a suspicious death. Therefore, mortuary systems need to be able to track the different stages of the post-mortem process. The LIMS must be able to capture the journey a body may take once it enters the mortuary, and the integration of that process with the laboratory function.

FLEXIBILITY REQUIRED

There are also increasing demands for statistical information from LIMS both for laboratory and mortuary services. It is therefore important that data entered on the LIMS can be extracted in a useable format to provide the required information. Modern laboratories need more flexible systems that can be adapted easily to meet changing needs and which are developed with consideration of the requirements of new legislation, thus making it easier for the laboratory to capture and extract the information it requires.

Carol Cresswell is IT manager and chief biomedical scientist in the Department of Cellular Pathology, Royal Victoria Infirmary, Newcastle upon Tyne. With colleagues, she is currently working with iSOFT, one of the largest suppliers of LIMS in the UK, to develop the required functionality outlined in this article.

 

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