We assist organisations to thoroughly investigate and respond to complex complaints received from patients or service users covering a wide range of issues from concerns about an individual’s care and treatment, the conduct and/or capability of healthcare professionals, through to alleged service failures.
Where relevant, we work in accordance with the NHS Complaints Standards, and liaise directly with patients and their families, with commissioners and the Parliamentary Health Service Ombudsman.
A well-executed and independent investigation in response to a whistle-blower disclosure can identify patient safety and service failure concerns, assist organisations to take swift action to address systemic deficiencies or concerns regarding a healthcare professional’s conduct and/or capability, and supports an open and transparent culture where individuals feel empowered and able to raise concerns.
A ‘Patient Safety’ incident is ‘any unintended or unexpected incident which could have, or did, lead to harm for one or more patients receiving healthcare’ (NHS England).
The core purpose of a Patient Safety Incident Investigation is to learn from mistakes and to take action to keep patients safe.
A Patient Safety Incident Investigation led by an external and independent investigator can provide valuable oversight and assessment of how an organisation’s practices and systems may have contributed to a Patient Safety Incident and what improvement actions can be taken to ensure high quality and safe patient care.
MHPS and UPSW are national frameworks which govern the approach and management of conduct and capability concerns about doctors and dentists in the NHS. The outcomes from a MHPS/UPSW investigation are wide-ranging and can include disciplinary action being taken by the Trust/Health Board and referrals being made to a practitioner’s regulator.
We are experienced and independent MHPS/UPSW case investigators, who undertake complex and challenging investigations, which often involve senior and Board level members of staff in England and Wales.
When concerns are raised about a director (or individuals performing functions equivalent to the functions of a board director) in a health or social care organisation, a provider must carry out a thorough investigation to enable it to reach a decision as to whether the director or equivalent continues to meet the CQC’s Fit and Proper Person requirements/NHS England’s Fit and Proper Person Test (FPPT) Framework for board members.
We work in partnership with organisations to carry out external, objective and independent FPPT investigations, often into complex and high-profile concerns such as allegations of serious misconduct or mismanagement in delivering CQC-regulated activity. We also support organisations to rectify and address any compliance issues which may have been identified regarding FPPT processes and procedures.
We assist organisations to investigate and respond to data breaches. We help clients to navigate reporting requirements, communication with the Information Commissioner’s Office, and if necessary, the data subject(s) concerned.
We work closely with organisations to produce thematic reviews in order to identify trends and areas of risk. This data is then used to produce recommendations to ensure compliance with UK data protection legislation and associated guidance.
We provide expert regulatory analysis of information governance practices including review of policies and procedures, and data protection training and guidance for staff.
Working closely with organisations, we identify potential areas of non-compliance with data protection legislation in order to develop practical recommendations to reduce risk and improve efficiency.
We can assist with management of requests made under the UK GDPR/ DPA 2018; the Freedom of Information Act 2000; and Access to Health Records Act 1990, and review of systems in place for managing these requests.
We work with organisations supporting the establishment and development of good clinical governance across the wider organisation to ensure visibility from ‘ward to board.’ Our methodology for data gathering includes interviews, document review and analysis, listening groups and surveys.
Our reviews include consideration of Board awareness of quality and safety issues, effectiveness of quality and safety committees and sub-groups, effectiveness of quality and safety reporting structures within the organisation, and compliance with the regulatory framework and internal procedures and policies.
We will work closely with you in relation to the outcomes of the review, and support the implementation of any recommendations.
NHS England define a positive safety culture as one where the environment is collaboratively crafted, created, and nurtured so that everybody (individual staff, teams, patients, service users, families, and carers) can flourish to ensure brilliant, safe care by:
A review of the patient safety culture within your organisation will provide an in-depth assessment of all of these areas.
The review will be tailored to your specific organisational needs and can focus on areas such as staff confidence in raising patient safety concerns, a temperature check on the use of the Trust’s Freedom to Speak Up Guardian, and an objective assessment of the level of psychological safety within a particular team or department. The review would also examine relevant data to explore whether a learning culture (from incidents, complaints and claims) exists, and whether robust governance systems are in place to embed this learning.
Our governance and assurance experts will also identify any regulatory risks, compliance gaps, and governance shortfalls from the review findings, and help craft solutions to deliver Board assurance.
Whether a health or social care organisation is ‘Well-led’ is now the key focus of CQC inspections as it’s generally accepted that if an organisation has the right leadership and culture in place, good outcomes in the other domains i.e. Safe, Effective, Responsive and Caring, are likely to follow. The CQC define ‘Well-led’ as ʻBy well-led, we mean that the leadership, management and governance of the organisation assures the delivery of high quality, person-centred care, supports learning and innovation, and promotes an open and fair culture.ʼ
Demonstrating to the CQC that your organisation is ‘Well-led’ will increase the CQCʼs confidence in you as provider (and thereby reduce the frequency of the CQCʼs scrutiny) and is the route to obtaining ʻGoodʼ and ʻOutstandingʼ inspection ratings. The key to maximising an organisationʼs chances of obtaining a positive rating in the ‘Well-led’ domain is to ensure that relevant team members who are likely to be interviewed by the CQC are thoroughly prepared and knowledgeable regarding the issues facing the organisation.
We can assist with this by:-
We have significant experience in undertaking and project managing comprehensive regulatory due diligence exercises on mergers, acquisitions and sales of health and social care businesses, and producing regulatory due diligence reports highlighting key areas of health or social care regulatory risk for UK and international clients.
We can offer a stand-alone regulatory due diligence service or work alongside your corporate legal team to input our specific health and social care regulatory expertise into the wider due diligence exercise. We can also support UK and overseas public and private health and social care organisations, on the regulatory implications of acquiring or selling health or social care businesses in the UK.
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