6 Clinical Risk Evaluation and Clinical Risk Control (page 35 of 18) in Clinical Safety Case Report (chapter 3 of 5) within Core Information Standard: Reports

6.1 Patient safety risk assessment approach

The patient safety risk assessment approach was as follows:

• What could go wrong, and how often? (hazard and likelihood) [See Appendix A for risk matrix]
• Possible main causes
• Most likely consequences / potential clinical impact (i.e., for patient safety)
• Mitigations (and recommendations to improve patient safety) leading to a reduced residual risk
• Clarification regarding actions required and risk transferred to implementers.

6.2 Hazard log composition

The Hazard log is contained in an Excel Spreadsheet and contains the following sections:

• Hazard number
• Hazard name
• Hazard description
• Potential clinical impact
• Possible causes
• Existing controls
• Unmodified risk rating including likelihood and consequence
• Proposed mitigations (In design, testing, training or business process controls)
• Modified risk ratings (taking into account proposed mitigations)
• Summary of actions / notes
• Owner of the residual risk
• Hazard status

6.3 Risk assessment methodology

Risk assessment was undertaken using the risk matrix and scoring tool shown in Appendix A. Note that consequences were interpreted in terms of impact on outcomes including the person’s experience of care.

When assessing the risk severity and likelihood, the highest combined value was used. However, where that can be arrived at by different values for severity and likelihood, such as major but very low versus considerable and low, generally the lower severity has been used. It is recognized that very occasionally the absence of information in the record might lead to death of a patient, but that the likelihood is very low indeed, especially given that this record is additional to existing systems.

6.4 Hazard workshops and clinical safety case meetings

Potential clinical safety risks were identified throughout the development of the CIS and the updates conducted as part of the Digital Social Care Information project. These risks were specifically explored at several advisory group meetings.

6.4.1 Original consultation:

A hazard workshop was convened to explore all the risks to patient safety and develop the original CIS hazard log. Details of these meetings are described below:

Clinical safety case Meeting

| Date | 22.05.2019 | Time | 9:30 – 10:30 | |---|---|---|---| | Location | Meeting by teleconference |

Attendees:

| Name | Role | |---|---| | Chair | John Robinson | Clinical Safety Officer (CSO) / GP Clinical informatician | | | Laura Fulcher | PRSB Patient Advisor and Assurance Committee member | | | Maggie Lay | Integrated Care Lead/CSO/ CNIO/ Community nurse | | | Matt Butler | Clinical informatician/Mental health nurse | | | Prof Iain Carpenter | Clinical informatician/CSO/Consultant Geriatrician | | | Annette Gilmore | Clinical informatician/ Acute nurse |

Potential clinical safety risks and hazards were explored at the LCR project Expert review group meetings on the following dates: 1^st May 2019; 9am to 1.30pm and 16 May 2019; 9am to 12.30pm

Expert review group (attendees)

| Expert Group Role | Name | |---|---| | Consultant Psychiatrist & CCIO & clinical informatician | James Reed | | Emergency care physician | Tony Shannon | | Geriatrician & clinical informatician | Iain Carpenter | | GP & clinical informatician | Ian McNicoll | | GP & clinical informatician | Nick Booth | | General Practitioner & clinical informatician | John Robinson | | General Practitioner & clinical informatician | Phil Koczan | | Mental Health Nurse & clinical informatician | Matt Butler | | North Yorkshire county council, LCR (social care) | Neil Bartram | | Physiotherapist (AHP) | Euan McComiskie | | Renal physician, CCIO & clinical informatician | Afzal Chaudhry | | Surgeon & CCIO | Dermott O’ Riordan |

6.4.2 **Digital Social Care Information consultation:**

A hazard workshop (two sessions) was convened to explore all the risks to patient safety and develop updated CIS hazard log. Details of these meetings are described below:

Hazard Workshop 2

| Date | 08.07.2020 | Time | 12:00 – 13:30 | |---|---|---|---| | Location | Conducted via teleconference call following COVID-19 pandemic | | |

Attendees:

| | Name | Role | |---|---|---| |Chair| Dr John Robinson | PRSB Clinical Advisor for Digital Social Care Information Project, PRSB Clinical Safety Officer, Retired General Practitioner and Clinical Informatician | | | Annette Gilmore | Clinical informatician (PRSB) / Acute care nurse | | | Beverley Latania | PRSB Social Care Advisor for Digital Social Care Information Project, Head of Mental Health Social Work – Islington Council | | | Helene Feger | PRSB, Director of Strategy, Communications and Engagement | | | James Critchlow | Associate Medical Researcher (PRSB) | | | Katie Thorn | PRSB Social Care Advisor for Digital Social Care Information Project, Digital Engagement Manager – Registered Nursing Home Association, Project Lead – Digital Social Care | | | Martin Orton | PRSB, Director of Delivery & Development | | | Samantha Goncalves | PRSB Citizen Lead for Digital Social Care Information Project | | | Sarah Jackson | PRSB Project Manager |

Hazard Workshop 3

| Date | 15.07.2020 | Time | 12:00 – 13:00 | |---|---|---|---| | Location | Conducted via teleconference call following COVID-19 pandemic | | |

Attendees:

| Name | Role | |---|---| |Chair| Dr John Robinson | PRSB Clinical Advisor for Digital Social Care Information Project, PRSB Clinical Safety Officer, Retired General Practitioner and Clinical Informatician | | | Professor Adam Gordon | PRSB Clinical Advisor, Clinical Associate Professor of Medicine of Older People – University of Nottingham, Consultant Geriatrician – Derby Teaching Hospitals NHS Trust, Vice President for Academic Affairs – British Geriatric Society | | | Annette Gilmore | Clinical informatician (PRSB) / Acute care nurse | | | Beverley Latania | PRSB Social Care Advisor for Digital Social Care Information Project, Head of Mental Health Social Work – Islington Council | | | Helene Feger | PRSB, Director of Strategy, Communications and Engagement | | | James Critchlow | Associate Medical Researcher (PRSB) | | | Katie Thorn | PRSB Social Care Advisor for Digital Social Care Information Project, Digital Engagement Manager – Registered Nursing Home Association, Project Lead – Digital Social Care | | | Martin Orton | PRSB, Director of Delivery & Development | | | Samantha Goncalves | PRSB Citizen Lead for Digital Social Care Information Project| | | Sarah Jackson | PRSB Project Manager |

Clinical Safety Meeting

| Date | 19.08.2020 | Time | 12:00 – 13:00 | |---|---|---|---| | Location | Conducted via teleconference call following COVID-19 pandemic | | |

Attendees:

| Name | Role | |---|---| | Dr John Robinson | PRSB Clinical Advisor for Digital Social Care Information Project, PRSB Clinical Safety Officer, Retired General Practitioner and Clinical Informatician | | Professor Adam Gordon | PRSB Clinical Advisor, Clinical Associate Professor of Medicine of Older People – University of Nottingham, Consultant Geriatrician – Derby Teaching Hospitals NHS Trust, Vice President for Academic Affairs – British Geriatric Society | | Beverley Latania | PRSB Social Care Advisor for Digital Social Care Information Project, Head of Mental Health Social Work – Islington Council | | Helene Feger | PRSB, Director of Strategy, Communications and Engagement | | James Critchlow | Associate Medical Researcher (PRSB) | | Katie Thorn | PRSB Social Care Advisor for Digital Social Care Information Project, Digital Engagement Manager – Registered Nursing Home Association, Project Lead – Digital Social Care | | Martin Orton | PRSB, Director of Delivery & Development | | Samantha Goncalves | PRSB Citizen Lead for Digital Social Care Information Project | | Sarah Jackson | PRSB Project Manager |