Manufacturer: Holmusk Europe Ltd, 414 Linen Hall, 162-168 Regent Street, London W1B 5TE, United Kingdom
	Date of manufacture: 11/02/2025
Product Version reference	V6.0.14, V6.0.15, V6.0.16, V7.0.3
	MaST Is compliant with: Medical Devices Regulations 2002 (SI 2002 No 618, as amended)

UK Designated Standards applied:

IEC 62304:2006/AMD 1:2015 BS EN ISO 14971:2019 PD IEC/TR 80002-1:2009 BS EN 1041:2008 BS EN ISO 15223-1:2016 ISO 27001: 2013

Classification:		Class I, Annex IX, 3.3, Rule 12
Device intended use:		MaST is a web-based caseload management tool, designed to be used by Community Mental Health teams to assist in the prioritisation of patients on a healthcare professional’s caseload.
Version	Date	Changes	Author
V1.0	10/03/2024	First in use SaMD Class1a	Zo Payne
V1.1	09/03/2026	Admin Area allows access to multiple instances of MaST from a single website. Admin area enhancements to sorting and filtering users Admin area to enhanced security and support permissions for multiple instances Addition of phased colour on trend graph to indicate when SU not in team in 24 weeks Enhancements to make dashboard widgets more configurable Filter enhancements to In Crisis and GP filters Addition of support email address Enhancements to Caseload emails Non safety related bug fixes	Zo Payne

THESE INSTRUCTIONS FOR USE CAN BE LOCATED ONLINE HERE: https://ifu.mastapp.co.uk/

THESE INSTRUCTIONS FOR USE CAN BE PROVIDED IN PAPER FORMAT ON REQUEST

Intended Use

MaST is a caseload management and predictive risk stratification tool intended to identify and stratify patients, based on risk of using crisis services and user-defined complexity factors, to:

Effectively track and manage team and individual caseloads, the allocation of resources and patient flow through mental health services.

Support clinical decision making and adherence to Trust-defined and National care standards for patients within the NHS mental health services in England.

MaST provides healthcare professionals with clinically relevant insights on patient and cohort risks by running periodically updated feeds of structured data, derived from electronic health records (EHR), through a risk of crisis algorithm. This algorithm assigns mental health service users with a ‘Propensity Score’ and a ‘Complexity Category’ that highlight patients with multiple socioeconomic and health complexity factors who may require crisis services within the next 28 days.

It is important that all MaST users understand how the features and functions work and are aware of safety information associated with its use. Holmusk recommend that all MaST users either complete direct training from Holmusk Clinical Team or complete the Holmusk eLearning module which covers the same key messages.

MaST is intended to support the care of adults accessing a Community Mental Health service.

MaST is intended for use by Healthcare Professionals within a Community Mental Health service:

· Clinical Staff - such as doctors and nurses, who will use the data presented in MaST to support their ability to assess the Resource Needs and allocation of patients, compliance with Trust care standards and the identification of cohorts of patients based on user-defined criteria across their caseload.

· Allied Health Professionals – such as Psychologists, Occupational Therapists and Social Workers who will review the data presented in MaST and filter the data using specific factors to identify cohorts of patients relevant to their professional discipline.

· Team Leads and Managers – who will use the data to support the management of resources across the team caseload and monitor team performance against Trust-defined care standards and anticipation of future capacity demand.

MaST is contraindicated for:

· Use outside of Community Mental Health services.

· Making decisions regarding a patient’s Resource Needs without the input of a suitably qualified health care professional.

· Use of MaST to specifically predict risk of harm to self or risk to others.

· Use by organisations without digital health care records.

o Use where the data items required by the algorithms are not routinely available in the source data as structured fields.

MaST should only be used alongside the application of clinical knowledge and clinical judgement.

Warnings and precautions

· This section outlines important safety information. It highlights potential hazards, limitations, and improper usage scenarios that users should be aware of. Users should carefully review this section to ensure safe and effective use of MaST.

· The healthcare organisation must ensure that the source data is correctly made available to be for import into MaST at the expected time, and users need to be aware that the data shown in MaST is only updated on a periodic basis. Should the user clinically require information, which is up to date, the source system should be consulted directly.

· The healthcare organisation is responsible for maintaining an appropriate relationship with the source system supplier and detect planned changes to the database schema in advance of an upgrade being carried out. Any such changes need to be reported to the Company in good time and that appropriate change management processes are in place to notify Holmusk of modifications that will be made to the source system.

· Healthcare organisations are responsible for the configurations of local firewalls to enable staff to access MaST through their network, and responsible for managing configuration changes relating to single sign on methods and technologies.

· When creating new user accounts and linking healthcare workers to their caseloads it is important to ensure that the linkage is correct. This is particularly the case if there are two users with similar or identical names.

· The healthcare organisation must ensure that team membership is configured correctly in the source system, must test the system to ensure that HCPs are displayed against the correct teams and that users are able to see the caseload that they expect to see.

· Healthcare organisations should ensure that users are aware of what Complexity factors are considered (and therefore what factors are not considered) in formulating the grid.

· Users should understand how the Risk of Crisis versus Complexity grid should be interpreted. Users need to be aware of which factors contribute to the two measures and, importantly, what factors are not included. Users should understand that the grid and algorithm only consider a select number of defined factors. There are many other factors which the clinician will need to consider and therefore the grid should not be solely relied upon to inform clinical decision making.

· Users should understand that the phrase 'Risk of Crisis' refers to the likelihood of them needing to access crisis services (such as a crisis team or inpatient facility). It does not refer to someone's overall assessed level of clinical risk, as this requires clinical judgement.

· Users should understand that only data recorded in the source system belonging to the healthcare organisation will be considered in MaST. Users must therefore consider all sources of available information in making clinical decisions, including information that may not be maintained in the source system and MaST.

· Users should understand that the system will attribute an ‘average’ Risk of Crisis score if there is insufficient information for the algorithm to derive a more accurate score.

· Any recommendation to consider a patient suitable for discharge should be viewed alongside clinical judgement. Users should consult the wider patient record and only initiate the discharge if they are sure that it is clinically indicated.

· Users should not rely solely on the 'Enhanced Care' screen but should consider all Service Users on their caseload and take a view on those which would benefit from their attention, regardless of what is indicated in the system.

· When MaST is required to display the allocated pathway, Healthcare organisations should take care when defining the criteria for the display of care pathway recommendations, to ensure that all required factors are routinely present in the data feeds of service users displayed in MaST.

· Recommendations can be configured in the system which indicate a service user's potential eligibility for treatment by a specific team, or via a particular care pathway, based on factors present in a patient's data. Such recommendations are provided for guidance only and it is assumed that users must consider the service user's full clinical picture when making decisions regarding their care.

· Allocation of service users to specific teams or care pathways remains the responsibility of the user and is in no way automated by the presence of a recommendation lozenge in the service user's record in MaST. Healthcare organisations must ensure that any users who are required to use the system for the allocation of service users to specific teams or care pathways, have the requisite skills and knowledge to safely carry out the role.

· The allocation of a care pathway in the dashboard is only to be used as an indicator that a Service User has been successfully allocated to a care pathway. Therefore, it should subsequently only be used to identify when all necessary activities have been completed in the source systems. Where users are in any doubt regarding the validity of a care pathway or related pathway activity that shows as recorded in the dashboard, they should verify this by consulting the information contained in the relevant source systems. Users should therefore consult alternative sources of information should there be any doubt about whether the action was undertaken. This includes the dates of allocation to a care pathway.

· When using their own FTP server to securely transport the data to the MaST environment, it is the customer’s responsibility to ensure that the server is monitored, configured correctly and remains available.

· MaST is hosted using a high-availability architecture with active monitoring and alerting in place, and so periods of down time are likely to be infrequent and quickly resolved. It is the healthcare organisation's responsibility to ensure that users are notified of planned downtime periods and that appropriate business continuity measures are in place to support clinical decision making.

Considerations for safe operation

This section provides recommendations and guidance on best practices for using MaST safely and effectively. Following these guidelines ensures that MaST performs as expected, remains clinically useful, and provides accurate and reliable outputs to support clinical decision-making

· MaST displays the contacts a patient has had with other teams since discharged from a CMHT, regardless of the team or contact type. It is entirely the user's responsibility to determine whether the displayed contacts are relevant in the context of considering their clinical care.

· MaST is designed to provide information to healthcare organisations to support delivery of care services however healthcare organisations should ensure that they have appropriate business continuity measures in place to manage any periods of downtime and should ensure that appropriate first line support is in place to escalate slow performance and communicate to the manufacturer where the root cause is not related to local issues.

· MaST uses structured data from the source system to reflect a series of complexity factors associated with a patient. Healthcare organisations should consider whether these fields in the source data should be made mandatory for completion to improve data quality and ensure that staff reliably populate those fields in the source system which are used by MaST to establish Complexity factors.

· Healthcare organisations should ensure that user accounts are created or retired on the system by personnel who are appropriately trained and authorised to do so, and in a timely manner so as not to compromise local business processes.

· MaST uses structured data fields to represent information captured in the source system. The healthcare organisation is responsible for ensuring users enter data into the source system in a correct and consistent manner.

· Healthcare organisations should ensure that processes are in place to retire accounts appropriately and that this is only undertaken when a user truly no longer requires access to the system.

· It is the responsibility of the healthcare organisation to manage access to the system via their local Single Sign On methods and technologies.

· Where interventions associated with a care pathway have a completion time-frame attributed to them which is undertaken outside of the timescales mandated by their pathway-specific KPIs, the event will not show as completed in MaST. It is the user's responsibility to ensure that such interventions are repeated, or the dates in the source system are changed where this is appropriate.

· Certain care pathways may require a Service User to be contacted for follow up a specified time after their discharge. It is entirely the user's responsibility to determine whether the displayed contacts are relevant and/or satisfy the service's obligations in line with local KPIs.

· Healthcare organisations must have processes in place to ensure that each Service User in their caseload is correctly allocated to a pathway, where this is required to drive the display of specific KPI information in MaST. If a Service User is identified as having not been correctly allocated to a pathway, this must be rectified in the source system to allow the allocation to display correctly in MaST.

· The content of the timeline in the Service User details screen does not contain every entry made in the source system. Users will be notified of this the scope of event types which are included in the timeline for their particular organisation's implementation of MaST during training.

· If a crisis episode is less than 7 days long, the graph may not accurately represent the period in crisis. This is because data for the graph is collected for a particular day each week rather than every day due to the performance overhead. Users should always check a patient's details in the source system, should this granularity of data be required, and users should be aware that the risk of crisis graph is intended to represent an overview of the patient's current status, rather than a precise day-by-day reflection.

· To ensure that due dates for the completion of Care Standards correspond with organisations requirements, Healthcare organisations should define a local policy to indicate how frequently healthcare professionals and team leaders should review KPIs to determine whether any urgent action needs to be taken.

· To ensure that inpatient and community crisis are accurately captured within MaST, Healthcare organisations must test each of the in-crisis service types to ensure they have been correctly mapped.

· To ensure that MaST correctly displays those patients who are currently in crisis, Healthcare organisation may be required to undertake a data cleansing exercise to close historical crisis episodes, should a considerable number have been left open in the past.

· Healthcare organisation should define a policy to establish how frequently screens such as the 'Discharged from Inpatient' page should be reviewed. Users must then adhere to this policy and actively review their caseload at appropriate times.

· Details of the activities associated with a Service User being allocated to a care pathway should always be recorded in the source system along with an accompanying case note. In this way a user can assure themselves of the activities that have been carried out, should they be in any doubt. The business rules to be followed when using the system to support the allocation of Service Users to care pathways are the responsibility of the healthcare organisation. Subsequently, all care should be given to ensure that users undertaking the role of care pathway allocation are fully trained in the processes they should follow.

Device training materials

Users of the device must be trained in its operation prior to use.

Training materials for the device are provided in electronic form. The eLearning can be accessed here: https://learning.elucidat.com/course/6538e81546361-6554dc6925c87

Incident reporting

Incidents relating to the performance of safety of this device should be reported to: helpdesk@holmusk.co.uk or Holmusk Europe Ltd, 414 Linen Hall, 162-168 Regent Street, London W1B 5TE, United Kingdom