The National Institute for Biological Standards and Control (NIBSC) has for several years been involved in moving the recording of sample information from traditional paper-based and individual electronic systems, to a single cohesive and accessible electronic system. The aim is to access all information on all stored samples easily from anywhere within the Institute.
We discussed with Pam Pipkin, Scientific Support Manager at NIBSC, how they have implemented this throughout the Institute.

NIBSC is the leading World Health Organisation (WHO) international standards laboratory and responsible for both creating and preserving reference materials and 95% of the world’s international standards for biological medicines.

It has been producing biological products since the 1950s and has a massive archive totaling approximately two million samples. These include clotting agents, such as thrombin and Factor VIII, more than 100 hormones, reference allergens such as bee venom, ragweed and birch pollen, biotherapeutics such as interferon and TNF alpha used for rheumatoid arthritis, reagents used in work on HIV/Aids, resources for work on CJD and also bacterial and viral vaccines, many of which are live.

Historically, recording of information about samples at the Institute was the domain of the scientist in charge of each area. Methods ranged from memorising the information or writing it down, to more advanced spreadsheets and databases. This somewhat disjointed approach made central analysis, i.e. keeping track of the numbers of samples, their location and that of the information relating to them, virtually impossible. This inevitably resulted in time wasted tracking down certain samples and the corresponding documentation. And, sometimes problems arose when individual scientists left the Institute if they failed to leave clear and accessible information about the material they had stored.

The building of the NIBSC Cryogenic Storage Unit (CSU) provided the perfect opportunity to sort through the material being stored. An inventory control system was clearly required and the hunt was on for a single cohesive electronic system that would be responsible for tracking and recording information on all of the samples in the CSU and subsequently for the majority of cold storage throughout the Institute.

Before the search for a system began, meetings were held amongst key personnel to draw up a list of requirements. The system had to be user friendly to the people in the laboratories, but also have the functionality required by management to control and audit samples. It also needed to easily show what samples were being held where and what information was available about them.

The first decision was whether to build a system or purchase an off-the-shelf product. The general feeling was that if there was an existing product flexible enough to accommodate their requirements then it would be better to buy an off-the-shelf system. However, the software had to fulfil all their present requirements and have the facility to be custom programmed to cover any unforeseen eventualities. The company supplying the solution needed to be able to demonstrate that it could provide superior long term support and quality training on an ‘as needed’ basis and meet both the current and future needs of the Institute.

To further ensure that the Institute purchased a product that was fully supported into the future, negotiations also included a risk analysis of what would happen in this eventuality. This revolved around an escrow agreement that ensured the source code would become available to them in such a situation allowing them to further develop the system if needed.

A major requirement was to be able to put samples from all departments on the system but restrict who could view all the data. This prevented the possibility of samples being seen or tampered with but allowed the management to see the full range of samples held by the Institute.

The software also had to be able to show if space was available for new samples and, if so, where the spaces were. Traditionally, with every scientist personally recording information on their systems, the only way to know what space was available in a particular freezer or vessel was by physically checking, wasting time.

During the market search, the possibilities and advantages of bar coding became apparent, and this was added to the specification. Also a system that facilitated the scanning and linking of documents became first a ‘wish’ and then a ‘must’ for the software system.

After searching the marketplace, the Institute found three alternatives that provided the functionality of being able to graphically show the storage area. One would permit the creation of new vessels of any shape and size by the users, one allowed only for rectangular containers and the other required a payment to the developers for each different vessel configuration.

It became apparent that there was only one system that met most of the Institute’s specifications and where it did not meet the requirements set down by the Institute these were implemented by the developers.

The product chosen was ItemTracker, distributed in the UK by Cryosafe. Initially the software was trialled in a few projects and one of these was the ‘EU Batch Release Archive’. This is an archive required by the Department of Health consisting of all biological products released by NIBSC for use in the community, and the associated protocols, results etc, known as the ‘document bundle’. NIBSC decided to standardise storage and set up -80ºC freezers containing aliquots of products, linking them by barcodes to their document bundles. ItemTracker was the ideal software package for this project.

After the evaluation it was decided to purchase the package. It was then used in other departments for other projects, before it was rolled out across the entire Institute. And, to help them achieve one of the main aims of the project - a single cohesive repository for recording all information about samples held at the Institute - all people involved in cold storage would be required to use the system to record their information.

As with any new system, there were the early adopters who embraced the idea and there were also those who were less enthusiastic about changing to a computerised system. However, after seeing the benefits gained by those who used the system, they also started to use it.

Initially one person was responsible for administrating the system and performing such tasks as setting up users, user groups and sample types. With the software rolled out Institute-wide, there was a need for group administrators that would be responsible for users in their own specific areas.

As such, part of the rollout involved deciding who the group administrators and main users would be. Training courses were then established for both of these groups to enable them to quickly get up to speed with what they needed to know.

With some scientists being less familiar with the use of computers in the laboratory, there were some concerns about the amount of training that would be required. However, due to the design of the product, they found most people were easily able to perform the tasks that they wished to achieve.

Another concern from both users and management was that users might have the ability to make mistakes that could negatively impact the entire system or other users. ItemTracker allows group administrators to limit the functionality and rights of individual users or user groups.

The rollout is continuing successfully with different departments making use of the different features of the software. Many departments have found ItemTracker’s ability to import and export to and from spreadsheets and simple databases invaluable. While others are making use of the bar-coding functionality to keep track of both samples and documents. All appreciate the fact that they can see from their computer where their samples are and the available free space.

The system’s flexibility allows the Institute to perform many tasks. This includes adding a new type of material to be tracked, or adding a new field to record other information, or even the addition of a completely new vessel.

The life sciences arena is governed by an ever-increasing amount of legislation, including the Human Tissue Bill, which was introduced in Parliament in December 2003. The extent this bill will impact the NIBSC is not yet clear, but the legislation will at least require the Institute to know the amount of all human material, such as blood products, stored and where to find it. Also, Good Laboratory and Manufacturing Practice (GLP/GMP) and the other quality systems to which the Institute adheres, dictate that samples should be accounted for and history traced for audit purposes.

ItemTracker enables samples to be tracked from the date of receipt right through to ultimate disposal after completion of the work. It also permits the scanning of any number of documents, such as approval forms and connects them to their related samples. Once a sample is entered onto the system it is never actually removed, even if they are used up and marked as deleted. This means a record of every sample’s existence will always be stored and a full audit trail exists.

In conclusion, Pam Pipkin said, “We are happy with the way the project is rolling out. Despite initial concerns of not being able to find suitable software or buying a system that did not meet all of the Institute’s requirements, including the support from the suppliers, ItemTracker has been everything we could hope for.”

By Caroline King