Based on the recent NHS Patient Safety notice regarding potential serious risks to patient safety identified with the use of Magentus Software Limited’s Euroking maternity information system, K2 Medical Systems have issued the below responses simply from the perspective of the solutions and software that it provides into the market. 

1. Clinical record inaccuracies as a result of forward copying across a patient record. 

K2 response: This scenario will not happen in the K2 Athena system. Details of relationships, partner, father of the baby, next of kin, etc. are linked at the pregnancy level. Furthermore, the system is able to show the history of the definition of the relationships entered into the system, so if the partner details were to change throughout the pregnancy, then this can be viewed. 

2. Perceived clinical inaccuracies and lack of contemporaneous record keeping as a result of overwritten records. 

K2 response: These scenarios will not happen in the K2 Athena system. System design principles ensure that data integrity for all datasets (many-to-1 and 1-to-1) is maintained throughout the pregnancy journey and beyond. A complete audit trail is maintained that will enable the identification of the nature of the interaction; i.e. new data, modification/edit and deprecation (deletion). 

3. Incorrect safeguarding information as a result of back copying within a pregnancy record. 

K2 response: Safeguarding information is treated with the utmost care within the Athena system. Data that is entered multiple times (many-to-1) in a pregnancy is stored as unique instances and is not copied back through the older instances of the dataset. The system maintains a full audit trail and timeline of data entries, these scenarios will not happen. 

4. Unclear gravidity and parity data. 

K2 response: The K2 Athena system does not automatically update the gravidity and parity after the birth of the babies. The parity and gravidity is maintained at the antenatal values as this is the basis on which care was provided in the antenatal period. These values are used in all reporting, even in delivery and discharge reports, if required. 

K2 System Design

K2 Medical Systems has designed the Athena system to act as a paperless medico-legal record. To achieve this the system is required to have a robust data structure that can maintain the integrity of the information that is entered into the system. 

The system's overriding design principle was to ensure it could be determined what clinical and social information was known, at any given point during the pregnancy. This ensures that the information known when any clinical decisions made could be determined retrospectively. 

The system's data structure links minimal information to the patient record i.e. address, contacts, GP details. etc. Most of which come from the hospital PAS/EPR. The system maintains a history of the updates to these records so it can be determined how the GP, say, changes during the pregnancy. 

All other data is linked to the pregnancy record, with the system maintaining linkages to datasets that will only occur once per pregnancy (1-to-1) datasets, and linkages to datasets that can occur multiple times per pregnancy, (many-to-1) datasets. This enables the system to create and maintain many unique instances of the same dataset to be stored dataset that is linked to the same pregnancy. 

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