Case Study 3

Background and Requirements
The infertility centre at the Woking Nuffield Hospital has been licensed since 1994 and provides IVF treatment including Ovum Donation, Gamete Intra Fallopian Transfer (GIFT) and Intra Uterine Insemination (ICSI) to both private patients and patients referred through the NHS. The centre is part of a private hospital and benefits from all facilities on offer there. It undertakes approximately 500 to 800 IVF cycles a year. In common with many UK facilities, expansion and logistics are not easy because of space restrictions. The Human Tissue Directive 2004/23/EC and associated Technical Directives came into force in the middle of 2006. The Directive requires the monitoring of all stored human tissue samples. An internal review pointed to procedures that needed to be updated concerning alarms sounding in the cryo-store and recommended that all samples stored under cryogenic temperatures be independently monitored and reside in a monitored and alarmed environment. The customer also believed that monitoring all stages in the IVF process would enable them to continuously improve. Planer plc were approached to provide a complete solution to monitor and alarm their equipment and environments, and to provide the facility of being able to review the data after for analysis and audit purposes.

Analysis
Initial observations showed that skilled embryologists were spending time taking daily manual readings on refrigerated equipment; additionally they were on call out in the evenings and weekends and were sometimes needed over holiday periods to ensure equipment was still working to standard. The customer’s needs could be summarised as:

·	a reliable alarm system for sample, equipment and operator safety

·	robust but easy compliance with legislation and good practice

·	relevant information to be channelled to the right people using the appropriate methods

·	a system which could allow data analysis, reporting, easy auditing, interrogation of the data, etc.

·	standard software that required no expensive customisation and had good vendor support

It was felt that a simple alarm system might be a wasted opportunity to improve not just general alarming but the management of equipment, data and people’s time. A primary need was help with compliance on the EU Tissue Directive – requiring all samples stored under cryogenic temperatures to be independently monitored and reside in a monitored and alarmed environment.

Proposed Solution
The solution proposed by Planer was one that allowed the user to automatically monitor all equipment and environments using reliable and independent sensors and one which would alarm via various methods if equipment was not performing as expected. In the Planer system, information could be accessed securely from any browser desktop or indeed anywhere in the world. Alerts – pre alarm conditions defined by the user - could be provided to unlimited users using different methods such as text message, calls to landlines or mobiles, visual and audible alarms , emails to PDA’s and laptops as well as desktops. The solution proposed could:

·	Collect data from e.g. cryogenic vessels, refrigerators, incubators, and oxygen monitors

·	Pass the data in real time to Planer’s management equipment

·	Process the data and inform users of condition and alarms in user defined ways

These alerts and alarms would be able to ‘cascade’ in both their importance and their routing to individuals, depending on the equipment and severity of the problem. The opportunity was taken to integrate safety equipment and monitor Oxygen levels within areas containing liquid nitrogen to provide external sounding alarms.

Project Description
The physical aspects of the project divided into three segments:

·	Installation of sensors and cabling

·	Installation of equipment and software

·	Set-up to user requirements

A simple pre site survey was undertaken and a plan drawn up along with a project timetable, proposed options and various costs. Subsequent to installation by Planer engineers, the system was checked and bedded down over a period of a month or so. With the client’s permission some maintenance can be carried out remotely if and when needed.

Data Warehouse Design
The monitoring and alarm solutions have been designed with expansion in mind. The system installed could house a large amount of data and could cope with many thousands of readings per cycle, automatically backing-up data onto an independent drive. It allowed managers to provide different levels of access for users, as well as being able to create departments so only relevant information need be viewed by employee or department. The system uses IBM Lotus Domino platform, is built to ISO standards and complies with FDA 21 CFR Part 11 and the Medical Device directive. The system was supplied in the form of a pre-installed server (or Network Appliance).

System Reporting
Inherent advantages of the system are fast remote access times and, by using secure Web browsers, the ability to view information anywhere. The flexible structure is such that

·	Non alarm status monitoring can be performed – giving data that can be used for predictive failure

·	Data integrity is preserved robustly – facilities are provided for back-ups.

·	All data is stored in a single database. Graphs can be generated across all the data

The user-friendly GUI (Graphical User Interface) with reporting capability allowed quick and easy access to view readings, create graphs, reports etc. As well as the system allowing for sophisticated reporting, tabulating and graphing of information it also sends reports on readings so that no operation of the software is required to ensure that the invaluable samples are secure. The Assure24seven system also allows for various levels of security – from back up procedures to hardware ‘watchdog’ monitoring.

Time and costs for implementation
The time required to install a system of this complexity is normally around one week. Cabling between devices is normal Ethernet. The whole system is LAN based and the modules can be connected to the existing network to keep costs down.

The advantages of the installed system might be summarised as:

·	Flexibility – sensors can be tailored to different users needs

·	Upgrade path – easy additions and changes can be made later

·	Data analysis allows pre alarm action, as well as compliance and security

·	Automatic logging of all sensors connected to system

·	Different alarms depending on the day, time, sensor, and length of problem

·	Reporting on alarms and conditions

·	Interrogation of information from anywhere in the world

·	Integration with Planer's sample management software KryoTrak in order to view entire location and temperature history for the sample

·	Automatic reports on performance of equipment delivered to your email address

Case Study - Woking Nuffield IVF Unit, Victoria Wing: reporting, alarms and data management