Owner: Carl Evans

Owner: Carl Evans

Author: Mary Riches

Publication date: 26.03.12

Version: v0.7

Review date:

Link to online version:

CAF Guidance: Clinical Safety

Background

Software hazard assessment is best practice in any industry with a safety dimension (nuclear, aviation, chemicals etc.). ‘Clinical safety’ is the approach taken by NHS Connecting for Health (NHS CFH) to ensure that IT systems linked to NHS CFH spine services, such as the Personal Demographics Service (PDS), are designed and implemented safely. The term ‘clinical safety’ is equivalent to ‘patient safety’ or ‘service user safety’. However, the concepts are also applicable to a social care system linking to a local NHS system, as similar risks would apply.

In 2009, the Information Standards Board released two standards which govern the manufacture and deployment of health IT systems:

·  ISB 0129 (DSCN 14/2009)-Application of Patient Safety Risk Management to the Manufacture of Health Software

·  ISB 0160 (DSCN 18/2009)-Application of Patient Safety Risk Management to the Deployment and Use of Health Software.

These two standards build upon the established NHS CFH safety approach, discussed below, and cover all health IT systems that could have an impact on clinical care, not just NHS CFH applications.

Purpose

This guidance document provides an overview of the clinical safety approach required from organisations (health, social care, voluntary and independent sectors) planning to use IT systems to share information about the individuals they support. It outlines the benefits, resources required and some potential challenges.

Audience

Partnerships looking to link up health and social care information systems, in particular: adult social care practitioners and managers, health practitioners and managers, IT managers, social care IT system suppliers and NHS IT system suppliers.

Benefits

Ø  IT Systems are as safe as they possibly can be and all known risks have been mitigated and do not introduce additional risks to care (Organisational benefit - reduced complaints)

Ø  Practitioners and service users have confidence in systems and how they are used (Workforce benefit –increased use of IT by practitioners)

Ø  Policies and procedures are in place to address clinical safety and any safety risks identified are seen to be properly managed and mitigated (Organisational benefit – improved safety)

Approach

The NHS CFH Clinical Safety Team assures clinical safety as part of the Common Assurance Process (CAP) through a series of defined activities. (CAP is required only when first-of-type systems are being linked to NHS CFH services). However it is good practice to consider clinical safety risks in any health IT systems developments, including linkage to social care systems, and the principles and processes associated with clinical safety are equally applicable to local integration. In this context, clinical safety practices are being disseminated and their use encouraged by NHS CFH in health and social care. Good practice is sustained by including clinical safety in the job description of one or more key practitioners in an organisation, thereby ensuring that risks are identified and managed systematically and consistently for upgrades and new releases as well as major projects.

The NHS CFH Clinical Safety Team provides knowledge and skills through a set of guidance documents and through the provision of training for those involved with IT solutions. At the time of writing, the training provision is under review but currently follows the arrangements outlined below.

2-day training programmes take place several times a year, covering either ‘Safer Design’ aimed particularly at system suppliers or ‘Safer Implementation’ aimed at those delivering IT solutions. Health or social care practitioners who attend one of these 2-day courses (and complete a refresher course every 12-18 months) and are professionally registered practitioners e.g. nurse, social worker, OT, doctor, are recognised as ‘accredited clinicians’ in the NHS or ‘safety leads’ in social care. Each health or social care organisation in a partnership will need an accredited clinician/safety lead to sign off system safety related to practice on behalf of that organisation as part of the CAP or a local integration project. System suppliers should also have an accredited clinician/safety lead within their team to assure safety of the system for CAP or for local integration.

Timescales

For first-of-type deployments, timescales are dictated by the CAP. Local deployment timescales are determined by local plans.

Resources required

Local project teams will need to include a member(s) whose role includes the clinical safety activities.

A registered and experienced practitioner, registered with an appropriate professional regulatory body, in each social care or health organisation who can become an accredited clinician/safety lead by attending the 2-day training (and subsequent refresher courses) and commit to active participation in the local project. This will be an on-going resource requirement as the safety of systems must be reviewed especially when changes are made to it e.g. upgrades or adding of new components.

Risks and issues

Clinical safety requirements may, on first reading, appear onerous and deter health and social care partnerships from implementing these processes and from linking to NHS CFH services.

Suppliers may not have registered health or social care professionals in their workforce.

Identifying and freeing up practitioners to attend training and contribute to the project locally may prove challenging.

Top tips / lessons learned

Ø  Clinical safety is not as onerous as it might at first appear.

Ø  Local Authorities and the NHS are used to assessing risks associated with implementing IT systems, but clinical safety is an aspect of IT developments that social care may not have considered before.

Ø  In relation to accessing the Personal Demographics Service, clinical safety risks relate mainly to mis-identification of an individual and software which minimises the risk of this occurring (e.g. requiring a minimum data set to search for a client record) and training of staff in good data quality practices will mitigate these risks.

Ø  Another risk in relation to data sharing, identified in the East Cheshire CAF Demonstrator, was social care recording medication that a patient is on incorrectly in an assessment record. Mitigations include the IT system identifying clearly the context and source of this information, excluding it from any formal medication records and training staff in how to record and interpret it.

Connections / contacts / support

CAF Demonstrator Sites (in association with their suppliers) that are completing the clinical safety activities required by the CAP include Barnsley, Camden, Cheshire East, Rochdale, Southampton, Shropshire and Stockport.

Links to sources of detailed information

Ø  CFH Clinical Safety Team website and email:

http://www.connectingforhealth.nhs.uk/systemsandservices/clinsafety

Ø  Sample job description and person specification for clinical safety lead:

Clinical Safety JD anonymised

Clinical Safety Person Spec anonymised

The above documents can be found in the Common Assurance Process Lessons Learnt folder on the Common Assessment Framework for Adults Learning Network

Ø  CAP website:

http://www.connectingforhealth.nhs.uk/industry/compliance/cap

Ø  NHS CFH Clinical Safety SharePoint site (user name and password required) https://www.portal.nss.cfh.nhs.uk/sites/clinicalsafety/default.aspx

Glossary

Term / Definition
NHS Connecting for Health (NHS CFH) / NHS Connecting for Health (NHS CFH) is part of the Department of Health Informatics Directorate.
Its role is to maintain and develop the NHS national IT infrastructure. This infrastructure includes a number of national services and a range of national applications.
Common Assurance Process (CAP) / To ensure that systems work correctly and safely with the NHS computer systems and services, NHS Connecting for Health (NHS CFH) operates a robust assurance regime known as the 'Common Assurance Process', or CAP. Any system and supplier connecting to the Spine (outside of a CFH Local Service Provider contract) must follow a form of CAP.
Personal Demographics Service (PDS) / The Personal Demographics Service (PDS) is the national electronic database of NHS patient demographic details such as name, address, date of birth and NHS Number.
Professional Regulatory Body / These are the bodies that regulate professional workers in health and social care and ensure high standards of care to patients and clients. Examples include The Nursing and Midwifery Council, The General Social Care Council, The Health Professions Council, The General Medical Council.