Whiston Hospital is part of the St Helens and Knowsley NHS Trust. The hospital is a speciality regional burns unit for the North West of England. The three-star rated Trust also has a paediatrics unit and a maternity block.
Challenge
The hospital has a relationship with Episys built up over several years. Prior to working with Episys the company had labelling issues where incorrect expiry dates were being put on labels. The original Episys system eliminated this problem as the hospital could set up expiry dates within the labelling programme.
Three years on, the hospital needed to make some changes to be in line with government guidelines. The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
Whiston passed its MHRA inspection but it recommended that the hospital needed to look at a few areas to improve efficiency and security. These included; who printed the labels, what time they were printed and limit the number of people able to print or modify the labels. It also needed a system that could produce header and footer labels.
The hospital was also keen to improve its worksheet system. For our normal product line that we have on a day-to-day basis, we have a master document. From this document, worksheets are photocopied and issued out when required in the morning, the required labels can then be printed off but it is still possible to print the wrong labels, said Rob Fisher, Aseptic Manager at Whiston Hospital.
Solution
Having previously worked closely with Episys, the company visited the hospital to give a demonstration of its Ultimate technology. This is a fully featured label design and printing solution that will put the hospital in complete control of its label production.
The Ultimate technology met all of the requirements of Whiston Hospital. As well as printing labels, it can limit who can amend the labels and make changes. It will also tell the hospital who prints the labels, how many are printed and give the time of printing.
The hospital is taking two of the Ultimate systems plus the header and footer module and the organisation is also looking at the worksheet module. This will allow the hospital to link the worksheets they produce to the labels required.
At the moment worksheets and labels can be printed off separately and theres still room for error when someone can accidentally print the wrong labels off, added Fisher. The Ultimate system will allow us to get a view of the labels that are being printed on the screen which is not possible with the old system.
The hospital is also licensed for small scale manufacturing of IV products. The MHRA carried out a full and rigorous audit, said Fisher. The inspector spent a day and a half going through the paperwork to make sure everything was in place to allow us to continue to manufacture.
Benefits
With the new worksheet system the hospital will be able to link everything together. The approved worksheet will have an electronic signature which will improve security. The MHRA support this. Its an extra check that things are working and eliminates a possible error path, added Fisher.
The hospital needs a secure audit trail and the Ultimate technology permits this. We can follow the labels from start to finish from where the labels are to made, to when they actually go on the product, to when they are being sent out, said Fisher.
The Ultimate technology has also improved the efficiency of the label printing process. The new system prints out a sample label that allows the hospital to check against its worksheet and that it matches with records. The hospital is also aiming to use the barcoding system as a checking tool to see that the right product has gone together with the right label. By linking systems together it will provide a simple and easy way of double checking information. As well as the Ultimate software, the hospital also buys its labels and ribbons for its thermal printers from Episys and it helped the hospital when different label sizes were required.
The hospital is going to use another part of the Ultimate Labelling System the label approval module. At the moment Id have to go round various people to check that any label we designed is suitable to use. However, this module will allow us to send one email to everyone for their approval and comment, commented Fisher.
The MHRA is also stringent on the validation processes carried out by hospitals. The validation documents that Episys offer allow the hospital to work through to validate that all the processes tie in and are all linked and are all working correctly.
The Future
Going forward, the hospital is looking forward to continue working with Episys. As we go along with the worksheet module I think we will find further areas to develop that we havent thought of yet, said Fisher.
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