Diagnostics Management
- Gavin Start
Version | v1.0 - March 2024 |
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Status | Published |
Important Information
Within this requirements catalogue we use the terms woman, women, and pregnant women. However, we recognise that some transgender men, non-binary people and people with variations in sex characteristics (VSC) or who are intersex may also access maternity services. Maternity services and delivery of care must therefore be appropriate, inclusive, and sensitive to the needs of everyone who accesses maternity services, including those who are trans, non-binary or intersex.
Contents
- 1 M3.01.1 - Obstetric Ultrasound Screening, Diagnosis and Fetal Medicine
- 2 M3.02.1 - Fetal Medicines Procedures and Investigations
- 3 M3.03.1 - Fetal Growth Surveillance
- 4 M3.04.1 - Medical Device Certification for Intrapartum CTG Monitors
- 5 M3.04.2 - Integration with Intrapartum CTG Monitors
- 6 M3.05.1 - Medical Device Certification for Antenatal CTG Monitors
- 7 M3.05.2 - Integration with Antenatal CTG Monitors
- 8 M3.06.1 - Integration with Remote CTG Monitoring Solutions
- 9 M3.07.1 - Updating Ultrasound Scan Findings
- 10 M3.08.1 - Tracking and "Closed-Loop" Failsafe for Maternity Screening
- 11 M3.09.1 - Warning Notifications
- 12 M3.09.2 - Task Management
- 13 M3.10.1 - Production of Electronic Growth Charts
Capability M3.01
The solution must have the functionality to transfer all scan measurements from the scanning system including umbilical artery dopplers, dating/ Nuchal Translucency (NT) scans including biochemistry, anomaly scans, growth scans, Doppler blood flows and any scans from 18 weeks through the interface in the scanning system.
In addition, the solution must have the ability to record and display alerts and prompts for assessments. The solution must also facilitate fetal medicine management, especially the extraction of serial maternal and fetal growth and physiological development data to provide customised risk.
M3.01.1 - Obstetric Ultrasound Screening, Diagnosis and Fetal Medicine |
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DCF Core Capability |
As a Health Care Professional I want the system to display all obstetric and gynaecology ultrasound scan measurements (in discreet numerical format) from third party ultrasound systems So that I can see ultrasound reports within the system without having to access another system for the same information Acceptance CriteriaGiven that a Health Care Professional is permitted to view a woman's record on the system When a woman has undergone an ultrasound scan Then the scan measurements will be transferred from the scanning system on to the woman's record on the system And the Health Care Professional will be able to see all ultrasound reports within the system without having to access another system for the same information And the system will also be able to display alerts and prompt assessments when ultrasound scans demonstrate Fetal Growth Restriction, physical or chromosomal abnormalities And the estimated fetal weight can be plotted on the fetal growth chart to provide customised risk assessment |
Standards Compliance |
STD029 Dictionary of Medicines and Devices |
Capability M3.02
The solution must support the recording of fetal medicine procedures and investigations and link this information to the woman's record.
M3.02.1 - Fetal Medicines Procedures and Investigations |
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DCF Core Capability |
As a Fetal Medicine Consultant I want to be able to record on the system, fetal medicine procedures, investigations and referrals So that I can effectively document procedures and investigations and share these with the woman and other Health Care Professionals Acceptance CriteriaGiven that a Health Care Professional is permitted to add clinical information to a woman's records on the system When the woman has had a fetal medicine procedure and investigations performed Then the Health Care Professional will be able to record on the woman's record the details of the fetal medicine procedures, investigations and referrals And any Health Care Professional permitted to view the woman's record will be able to see fetal medicine records and diagnostic results |
Standards Compliance |
STD029 Dictionary of Medicines and Devices |
Capability M3.03
The solution should allow growth charts (customised or population based), to be generated or imported and shared directly with the woman. This should include Symphysis Fundal Height (SFH) charting and Estimated Fetal Weight (EFW).
M3.03.1 - Fetal Growth Surveillance |
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DCF Core Capability |
As a Health Care Professional I want the system to generate or import customised or population based growth charts including Symphysis Fundal Height (SFH) and Estimated Fetal Weight (EFW) So that I can accurately monitor fetal growth and share this information digitally with the woman Acceptance CriteriaGiven the need to record fetal growth digitally When the woman books with the maternity unit Then the system should generate or import a customised or population growth chart And the Health Care Professional will be able to record on the system the Symphysis Fundal Height (SFH) or Estimated Fetal Weight (EFW) from an ultrasound scan And the Health Care Professional will be able to review the growth chart on the system And the Health Care Professional will be able to share the growth chart from the system with the woman |
Standards Compliance |
STD029 Dictionary of Medicines and Devices |
Capability M3.04
The solution should have the ability to integrate with intrapartum Cardiotocography (CTG) monitors and monitoring solutions. CTG monitoring solutions should be certified as a medical device. Where digital decision support tools are used for CTG interpretation, the solution would also need to be certified as a medical device. The solution must work with the Trust to ensure the storage of all CTG recordings for 25 years (including Dawes Redman CTG analysis or other non-stress test score).
CTG - Cardiotocography
M3.04.1 - Medical Device Certification for Intrapartum CTG Monitors |
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DCF Transformation Capability |
As a health care professional, I want a system to offer digital decision support (or integrate with a third party system) for intrapartum CTG interpretation with the decision support system provided being certified as a medical device, So that compliance with the Medicines and Healthcare Products Regulatory Agency (MHRA) standards is achieved to ensure clinical safety, quality and efficacy of the medical device when offering decision support for intrapartum care Acceptance CriteriaGiven that a system or third party system offers digital decision support for intrapartum CTG interpretation When the system or third party system has been chosen by a Trust Then the system or third party system offering decision support will be certified as a medical device in compliance with the Medicines and Healthcare Products Regulatory Agency (MHRA) standards |
Standards Compliance |
STD029 Dictionary of Medicines and Devices |
M3.04.2 - Integration with Intrapartum CTG Monitors |
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DCF Transformation Capability |
As a Health Care Professional I want the system to integrate with intrapartum Cardiotocography (CTG) monitors directly or via a third party system to display both numerical data and the CTG trace So that I can monitor fetal wellbeing during labour using a single system Acceptance CriteriaGiven that a Health Care Professional is permitted to view a woman's record on the system When an intrapartum CTG trace has been performed Then the CTG trace will be transferred from the CTG monitor to the woman's record on the system or via a third party system And the Health Care Professional will be able to view the numerical data and the CTG trace And the CTG data will be stored for 25 years (including Dawes Redman and other non-stress test scores). Storage and retention can be achieved by the system or via a third party system |
Standards Compliance |
STD029 Dictionary of Medicines and Devices |
Capability M3.05
The solution should have the ability to integrate with antenatal Cardiotocography (CTG) monitors and monitoring solutions. CTG monitoring solutions should be certified as a medical device. Where digital decision support tools are used for CTG interpretation, the solution would also need to be certified as a medical device. The solution must work with the Trust to ensure the storage of all CTG recordings for 25 years (including Dawes Redman CTG analysis or other non-stress test score).
M3.05.1 - Medical Device Certification for Antenatal CTG Monitors |
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DCF Transformation Capability |
As a health care professional, I want a system to offer digital decision support (or integrate with a third party system) for antenatal CTG interpretation with the decision support system provided being certified as a medical device, So that compliance with the Medicines and Healthcare Products Regulatory Agency (MHRA) standards is achieved to ensure clinical safety, quality and efficacy of the medical device when offering decision support for antenatal care Acceptance CriteriaGiven that a system or third party system offers digital decision support for antenatal CTG interpretation When the system or third party system has been chosen by a Trust Then the system or third party system offering decision support will be certified as a medical device in compliance with the Medicines and Healthcare Products Regulatory Agency (MHRA) standards |
Standards Compliance |
STD029 Dictionary of Medicines and Devices |
M3.05.2 - Integration with Antenatal CTG Monitors |
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DCF Transformation Capability |
As a Health Care Professional I want the system to integrate with antenatal CTG monitors directly or via a third party system to display both numerical data and the CTG trace So that I can monitor fetal wellbeing during antenatal using a single system Acceptance CriteriaGiven that a Health Care Professional is permitted to view a woman's record on the system When an antenatal CTG trace has been performed Then the CTG trace will be transferred from the CTG monitor to the woman's record on the system or via a third party system And the Health Care Professional will be able to view the numerical data and the CTG trace And the CTG data will be stored for 25 years (including Dawes Redman and other non-stress test scores). Storage and retention can be achieved by the system or via a third party system |
Standards Compliance |
STD029 Dictionary of Medicines and Devices |
Capability M3.06
The solution should interface with remote Cardiotocography (CTG) monitoring solutions to provide functionality to help monitor or manage activity within the department; e.g. electronic display showing real time updates on care (including CTG traces) taking place at anywhere in the Trust where CTGs are taking place. The solution should also prompt for CTG ‘fresh eyes’ and reviews.
CTG - Cardiotocography
M3.06.1 - Integration with Remote CTG Monitoring Solutions |
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DCF Innovation Capability |
As a Health Care Professional I want the system to interface with remote CTG monitoring solutions So that I can view CTG traces in real-time from a centralised electronic display Acceptance CriteriaGiven that a Health Care Professional requires an overview of all ongoing CTG monitoring When CTG monitoring is in progress, regardless of the location within the maternity unit Then the Health Care Professional will be able to view on the system CTG traces in real-time from a centralised electronic display And the Health Care Professional will also be able to view on the system in real-time updates to care And the system will also prompt the Health Care Professional to provide reviews and CTG ‘fresh eyes’ as needed |
Standards Compliance |
STD029 Dictionary of Medicines and Devices |
Capability M3.07
The solution should allow the scan findings to be updated e.g. a multiple pregnancy to single pregnancy. This should still comply with audit rules outlined elsewhere.
M3.07.1 - Updating Ultrasound Scan Findings |
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DCF Transformation Capability |
As a Health Care Professional I want to be able to update the scan findings on the system So that I can update the woman's record to reflect the current clinical situation e.g. multiple pregnancy to single pregnancy Acceptance CriteriaGiven that a Health Care Professional is permitted to edit a woman’s record on the system When the woman has new ultrasound scan findings Then the Health Care Professional will be able to update on the system the ultrasound scan findings And the system will store a record of changes for the audit trail on the woman's record |
Standards Compliance |
STD029 Dictionary of Medicines and Devices |
Capability M3.08
The solution should support a tracking and “closed-loop” failsafe for maternity screening in line with National Screening Committee requirements. This should include the ability to refer to teams internal and external to the Trust.
M3.08.1 - Tracking and "Closed-Loop" Failsafe for Maternity Screening |
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DCF Transformation Capability |
As a Health Care Professional I want the system to support the tracking and “closed-loop” failsafe for maternity and newborn screening So that the Trust can work in line with National Screening Committee requirements Acceptance CriteriaGiven the need for every woman to be offered timely screening When screening is recorded within the maternity solution Then the maternity solution should support tracking and “closed-loop” failsafe for maternity and newborn screening in line with National Screening Committee requirements And the maternity solution should include the ability to refer to teams internal and external to the Trust |
Capability M3.09
The solution should be certified as a medical device and legally registered with the Medicines and Healthcare Products Regulatory Agency (MHRA) to allow it to produce warning notifications when an entered value is identified as an abnormality e.g. parameters entered are outside expected parameters. The solution should allow users to be able to mark tasks (based on local and National Institute for Health and Care Excellence (NICE) guidance) as complete using simple functionality such as tick boxes, with an option to not complete tasks. Some tasks should be able to be configured to be mandatory, or require a reason to override. The prompts should be based on the stage of the pathway.
MHRA - Medicines and Healthcare Products Regulatory Agency
NICE - National Institute for Health and Care Excellence
M3.09.1 - Warning Notifications |
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DCF Transformation Capability |
As a Health Care Professional I want the system to produce warning notifications when values entered are outside of normal parameters So that I can efficiently manage tasks and access decision support when caring for women Acceptance CriteriaGiven that a Health Care Professional is permitted to edit a woman’s record on the system When the Health Care Professional enters a value outside of normal parameters Then the system will produce a warning notification to indicate that the value entered is outside of normal parameters |
M3.09.2 - Task Management |
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DCF Transformation Capability |
As a Health Care Professional I want the system to have the ability to manage tasks based on local and NICE guidance So that I can efficiently manage tasks and access decision support when caring for women Acceptance CriteriaGiven that the Health Care Professional is permitted to access the system When the Health Care Professional needs to manage maternity tasks on the system Then the Health Care Professional will be able to manage tasks on the system by performing the following:
And the Health Care Professional will be prompted by the system when tasks have not been completed |
Capability M3.10
The solution could produce or link to production of electronic growth charts (customised or population based) for Symphysis Fundal Height (SFH) and/or Estimated Fetal Weight (EFW), that are updated automatically following scan results (EFW) or measurement (SFH). Alert triggers could be available where results are outside normal parameters.
M3.10.1 - Production of Electronic Growth Charts |
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DCF Innovation Capability |
As a Health Care Professional I want the system to seamlessly integrate with customised or population based growth charts for Symphysis Fundal Height (SFH) and Estimated Fetal Weight (EFW) at point of care So that measurements are automatically plotted and alerts triggered to support safe and timely management of care when fetal growth is outside normal parameters Acceptance CriteriaGiven the need to record fetal growth digitally When a measurement has been taken, either Symphysis Fundal Height (SFH) or Estimated Fetal Weight (EFW) from a scan Then the growth chart will be automatically updated on the system And alerts will be triggered on the system if there are any fetal growth abnormalities And the Health Care Professional will be able to share the growth chart from the system with the woman |
Standards Compliance |
STD029 Dictionary of Medicines and Devices |