NHSE SD > 111 Referral Standard @ 286829

Version: 1.0.16 | Published: 19 Feb 2026 | Updated: 4 days ago

111 Referral Standard

Dataset

CONTACT

Summary

Publication Version:

1.0.0

Type:

Information standards

Applies To:

All 111 and 999 service referrals to wherever the person goes next.
Referrals through 111 online, call handler or clinical assessment services and 999 services.

Topics:

Care records
Continuity of care
Health
Interoperability
Key care information
Messaging
Referrals

Care Settings:

Ambulance (Urgent and Emergency Care)
Dentistry
GP / Primary care
Mental health
Pharmacy
Urgent and Emergency Care

Contact Point

Contact Point:

england.standards.assurance@nhs.net

Documentation

Associated Media:

111 Referral Standard: GP Post Event Message - Mental Health

111 Referral Standard: Business Rules (EXCEL)

111 Referral Standard: Final Report

111 Referral Standard: Hazard Log (EXCEL)

111 Referral Standard: Dentistry Data Set (EXCEL)

111 Referral Standard: Emergency Department Example (EXCEL)

111 Referral Standard: Emergency Department Example

111 Referral Standard: GP Example

111 Referral Standard: Simplified (JSON)

111 Referral Standard: Emergency Department - Post Event Message

111 Referral Standard: Post Event Message Reformatted (json)

111 Referral Standard: Clinical Safety Case

General Implementation Guidance Version 1.4

111 Referral Standard: Dentistry - Post Event Message Example

111 Referral Standard: Pharmacy - Post Event Message Example

111 Referral Standard: Pharmacy Example

111 Referral Standard: Dentistry Example

111 Referral Standard: Mental Health Example

111 Referral Standard: Post Event Message Reformatted (Excel)

111 Referral Standard (Excel)

Description:

This standard defines the information that should be shared from 111 or 999 services when a person is referred onto another service. It also defines the information for a post event message (PEM) to inform a person’s GP of their contact with 111 services.

This is subset of the 111 referral to give GPs an effective summary, and is sent after all contacts with a few exceptions, including if the referral is to the GP, or the call was just to seek information. GPs should not confuse this PEM, which is just for their information, with a 111 referral to GP, which they must action. These will replace the current referral messages which are poorly regarded and little used.

Across the UK, 111 services are becoming the first point of contact for urgent care and are essential in ensuring that people are referred to the most appropriate service safely and efficiently. In England the NHS Long Term Plan sets out to ensure patients get the care they need, fast and to relieve pressure on A&E departments by referring people to the most appropriate service.

This standard was created to support clear and concise information flows between the 111 referrer and the receiving services and professionals or clinicians to support safe and effective care.

Scope

The standard applies to:

All 111 and 999 service referrals to wherever the person goes next.
Referrals through 111 online, call handler or clinical assessment services and 999 services, and is not specific to any triage system.
The standard is UK-wide and developed in consultation with a wide range of professionals from all four nations, including from 111 services, receiving services, IT suppliers and people who use services.
All age groups including children.

The standard does not apply to transfers between 111 services (e.g. across a country border) or between 111 and 999 services.

How it works

The standard defines the full set information which should be sent in a 111 referral, however some of the information will only be appropriate when the referral is from a clinician or the clinical assessment service (e.g., the chief clinical concern or the diagnosis).

These occurrences are noted in the implementation guidance and supported by the conformance (mandatory, required or optional) for each data item, where required means the information should be sent where it is available, recognising that this information may not be available where its not relevant to the individual case or not gathered during calls or online contact.

Much of the referral information should be generated from the system with the information recorded during the contact, with only information like the clinical summary (where used) having to be added by the referring person.

Is Part Of:

Developed to support the Booking and Referral Standard programme (BaRS)

Name:

Booking and Referral Standard Website

Abstract:

Final Report V1.1 April 2023

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## Document Management

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### Revision History

Version	Date	Summary of Changes
0.1	16.02.2022	Initial report
0.2	21.2.2022	After initial review
0.3	11.03.2022	Further team review
0.4	16.03.2022	New version to clear comments and track changes
0.5	16.03.2022	Headings reformatted
0.6	17.03.2022	Updates after full team review
0.7	31.03.2022	Updates following BaRS and assurance committee review
1.0	11.04.2022	First release after BaRS and assurance committee approval
1.1	11.04.2023	Updated to change GP to general practice for clarity

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### Reviewers

Reviewer name	Title / Responsibility	Date	Version
Martin Orton	PRSB Project Manager	11.03.2022	0.2
James Ray	Clinical Lead (ED)	16.02.2022	0.5
Alison Allam	Patient Lead	16.02.2022	0.5
Eve Wijayanayagam	Clinical Lead (GP)	16.02.2022	0.5

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### Approved by

Name	Date	Version
PRSB Assurance Committee	21.03.2022	0.6
Booking and Referral Standard (BaRS) Product Board	04.04.2022	0.6

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### Glossary of Terms

Term / Abbreviation	What it stands for
The PRSB	The Professional Records Standard Body are a unique collaboration of groups representing those who receive and provide health and social care across the UK, as well as those providing the IT systems that support care.
The PRSB CTOP	PRSB clinical and technical operations panel
NHS E & I	NHS England & Improvement - NHS England and NHS Improvement have worked together as a single organisation since 1 April 2019, to help improve care for persons and provide leadership and support to the wider NHS.
NHS D	NHS Digital – Formally the Health and Social Care Information Centre (HSCIC) was formed in 2013 as the primary delivery organisation taking charge of information, data and IT systems for commissioners and clinicians in health and social care across England NHS X and NHS D have integrated with the Transformation Directorate at NHS England.
NHS X	NHS X – Lead the digital transformation arm of the NHS setting standards and policy, supporting the digitisation of health and care organisations 2019 – 2022. After three years leading the digital transformation of health and social care as NHS X, NHS X and NHS D have integrated with the Transformation Directorate at NHS England.
NHS 111	NHS 111 - is an NHS service which makes it easier and quicker for persons to get the right advice or treatment they need, be that for their physical or mental health. 24 hours a day, 7 days a week. To get help from NHS 111, you can: Go online to 111.nhs.uk (for assessment of people aged 5 and over only). Call 111 for free from a landline or mobile phone.
NHS 24	NHS 24 – Scotland 111 service - provides urgent care and advice when your general practice, pharmacy or dental practice is closed
111 Online	111 Online - is a fast and convenient alternative to the 111-phone service and provides an option for people who want to access 111 digitally. It is one of several digital NHS services that are empowering people to manage their own health and care. Where enabled 111 offers the ability for the person to book direct into ED
111 CAS	111 Clinical Assessment Service - Through a single Clinical Assessment Service (CAS), healthcare professionals working outside of a hospital setting, staff within care homes, paramedics and other community-based clinicians will be able to make the best possible decision about how to support people closer to home, potentially avoiding unnecessary trips to A&E.
COVID 19	COVID-19 is a new form of coronavirus known as SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). It was first reported in December 2019
PEM For Information	Post Event Message – A message that is sent back to the registered general practice informing them of the encounter with 111
PEM For Action	Post Event Message – A general practice Referral message from 111 which is sent to the general practice when action is required from the general practice. This is the current name and applies to the currently flowing ITK messages. In future this will be called a 111 referral. 111 sends a referral (PEM for action currently) when booking direct in to general practice appointments in England.
Repeat Caller	Identifies repeat caller that calls the 111 service on multiple occasions over a short period of time (in response to the section 28 of the coroners ruling in the Penny Campbell case).
Royal Colleges	The organisations that provide oversight and governance to the medical professions and provide endorsement to PRSB standards
BDA	British Dental Association
OCDO	Office of the Chief Dental Officer
RPS	Royal Pharmaceutical Society
BPS	British Psychological Society
NHS BaRS	Booking and Referrals Standard - The Booking and Referral standard is an interoperability standard for healthcare IT systems that enables booking and referral information to be sent between NHS service providers quickly, safely and in a format that is useful to clinicians. It will eventually be available in all care settings.
AACE	Association of Ambulance Chief Executives - includes: The National Ambulance Service Medical Directors (NASMeD) National Ambulance Service Directors of Operations (NDOG) National Digital Leaders Group (NDLG)
CDSS	Clinical Decision Support Systems
NHS Pathways	NHS Pathways - NHS owned algorithmic clinical assessment tool
NHS Pathways Outcome codes SG, SD & DX Codes	SG – Symptom Group – Presenting Need / Issue SD – Symptom Discriminator – Severity, Clinical need DX – Disposition Code – Urgency
AMPDS	Advanced Medical Priority Dispatch System (AMPDS) is a unified system used to dispatch appropriate aid to medical emergencies including systematized caller interrogation and pre-arrival instructions
DOS	The Directory of Services (DoS) is a central directory that is integrated with NHS Pathways and is automatically accessed if the patient does not require an ambulance or by any attending clinician in the urgent and emergency care services.
PODAC Program	Pharmacy, Optometry, Dentistry, Ambulance and Community - national Digital PODAC programme to improve digitisation and productivity using digital technology across PODAC sectors.
ECDS	The Emergency Care Data Set (ECDS) is the national data set for urgent and emergency care. It replaced Accident and Emergency Commissioning Data Set
ED	Emergency Department (also known as A&E)
111 – ED Pilot	A First of Type use case using the 111 Referral standard
FoT	First of Type
ITK Message	Interoperability Toolkit - provides specifications for electronic messaging between systems, supported by an accreditation for suppliers who build solutions that adhere to these specifications.
SNOMED CT	Systematized Nomenclature of Medicine Clinical Terms is a structured clinical vocabulary for use in an electronic health record. It is the most comprehensive and precise clinical health terminology product in the world.
Fast Healthcare Interoperability Resources (FHIR)	FHIR is a Health Level Seven International (HL7®) standard for exchanging healthcare information electronically. ... FHIR combines the best features of previous standards into a common specification, while being flexible enough to meet needs of a wide variety of use cases within the healthcare ecosystem.
IUC Specification	Integrated Urgent Care Service Specification
Use Case	A methodology used in system analysis to identify, clarify, and organise system requirements
NHS appointment booking standard	The NHS appointment booking standard is an open standard supporting booking across many care settings. It utilises the Care Connect FHIR messaging standard and is being published in the form of a website
API	Application Programming Interface, which is a software intermediary that allows two applications to talk to each other. Each time you use an app like Facebook, send an instant message, or check the weather on your phone, you're using an API.
Clinical Document Architecture (CDA)	The HL7 Version 3 Clinical Document Architecture (CDA®) is a document markup standard that specifies the structure and semantics of "clinical documents" for the purpose of exchange between healthcare providers and people.

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### Planned Review Date and Route for User Feedback The next maintenance review of this document is planned for a 3 year period, subject to agreement with NHS X as the commissioning body. Please direct any comments or enquiries related to the project report and implementation of the standard to support@theprsb.org

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## 1 Executive Summary It is well known that the NHS services across the UK are under real pressure with demand outstripping supply. The pressure has recently been exacerbated by the pandemic but also exacerbated by patients not being seen in the services appropriate for their needs. Across the UK, 111 services are becoming the first point of contact for urgent care with the aim to direct patients to the most appropriate service for their needs. England’s NHS Long Term Plan sets out to ensure patients get the care they need, fast, and to relieve pressure on A&Es through referring patients to the most appropriate service, which could include urgent treatment centres, same day access services, general practice primary care based services, or other services such as community, mental health, community pharmacy, dentistry or optometry. In some cases the 111 services would have the ability to book slots or appointments with the receiving service. Currently in England, a 111 report can flow to the receiving organisation using an Interoperability Tool Kit (ITK) message. This report is based on the summary of decision points from the triage algorithm and reads poorly by clinicians on the receiving end – it lacks clinical value by not using a language that clinicians are trained to use. The same ITK message is used to inform the person’s general practice of the 111 encounters, this is known as a post event message (PEM) or 111 report for information. The NHS bookings and referral standard programme (BaRS) is working to develop both a booking and referral standard for 111 referrals to support the needs and policy, and which can be implemented using FHIR (Fast Healthcare Interoperability Resources) technology which is the current NHS standard and being widely adopted across health and care. The PRSB is providing the 111 referral content standard. PRSB have developed the 111 referral standard to provide clear, concise and effective information for the 111 referral along with a post event message (PEM), a subset of the referral, to inform the person’s general practice. The standard will provide clear, easy to use information that can be shared with the receiving clinician or professional so they can provide appropriate, efficient, effective, and safe treatment to the person. It allows for the sharing of the clear reason for the referral to allow a safe transfer of care. The presenting need (as identified by the person), the chief complaint (identified either through the triage process or by a clinician) and the chief clinical concern or a diagnosis where there has been assessment by a clinician. The standard will give people confidence that information they provide is passed on to next stage in their journey so they don’t have to repeat it all each time.

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### 1.1 Development methodology The 111 Referral standard has been developed over a four-year period through several commissions and phases, as summarised below, and in accordance with the proven, established, and trusted PRSB methodology involving UK wide consultation. In 2018 PRSB were commissioned by NHSE to set out the high-level information requirements for a 111 clinical assessment service. The work included research and evidence gathering of existing guidance, current practice (examples of current records and communications, output from clinical decision support systems), and relevant related projects and standards. Draft requirements were developed from this and then refined through a multi-disciplinary workshop with health and care professionals, patients and system suppliers. Urgent care workflow report and requirements are referenced in Appendix 1 In 2021, PRSB conducted discovery work to validate the previous high-level requirements from 2018 and recommend the work needed to develop a 111 referral standard. This work: * Validated the 2018 requirements with the addition of a few data items * Concluded that the proposed standard could work for 111 referrals from call handlers and 111 online, although some information would only be available where there was contact with a clinician. * Concluded that a general practice post event message (PEM) should be developed alongside the 111 referral standard as it is expected to be subset of the referral information and consultation will involve many of the same stakeholders. The discovery phase report is referenced in Appendix 2 In August 2021 a short commission delivered a draft information model from the outputs of the discovery work to support pilots for BaRS for 111 to emergency departments (ED). The 111 referral information model V0.2 was provided for this purpose, validated by the same project team from the discovery work, working with NHS Digital and NHSX and using existing PRSB standards components wherever possible for consistency with other standards and FHIR profiles. Starting in October 2021 PRSB completed the development through; * Wide consultation through a survey for users of services, senders and receivers of 111 referrals to gain consensus and support for the standard and test it across the many different destination communities including with IT providers and system suppliers. This was followed up with specific engagement with areas with lower numbers of survey responses (dentistry, optometry, mental health and community pharmacy) to verify the draft 111 referral standard was suitable for those areas. * Verifying that 999 services could provide the essential information of a 111 referral and therefore be included into scope of the standard. * Engagement with GPs through interviews and focus groups to define the general practice PEM. * Further work is delayed to May/June 2022 to gather and analyse feedback from the 111 to ED pilots and update the standard as appropriate.

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### 1.2 Summary of findings * The survey responses and discussions with individual sector focus groups confirmed that the UK wide 111 Referral standard will provide the information required for a clear and informative 111 Referral to any organisation or services the person may go to next following an encounter with 111. * There is variance across the UK with the Clinical Decision Support Systems (CDSS) used by the 111 services, resulting in differences in the content, structure and workflow of the 111 reports. All UK Countries are keen to standardise the information and information flows. * All aspects of the 111 Referral consultation, involving general practice, (the survey, GP focus groups & interviews) reported that the existing 111 reports were difficult to read due to the inclusion of the NHS Pathways negative responses and the overall format pushing the important information to the bottom of the 111 report. Discussions with the JGP IT Committee and other GPs representatives confirmed that a subset of the 111 Referral could be used to create a much improved general practice PEM. There is widespread support for the general practice PEM to be updated as soon as possible. * The comparison of the 999 data set with the 111 Referral standard confirmed that the 999 services data set can be used to populate the 111 Referral standard. This will support the sending of referrals that do not require the 999 services to 111, but where the 999 service refers directly to other services in the same way as 111 services. * There are technical developments underway to improve interoperability and information flows across the wider health and care system. These being the implementation of SNOMED by the Clinical Decision Support supplier systems and the ability of sending and receiving systems to send and receive messages via FIHR messaging, the 111 referral standard has been developed with the future in mind but will need updating alongside the system technical developments as required.

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### 1.3 111 Referral Standard The table below provides a high-level view of the standard. The blue shaded sections are the sections included in the general practice post event message (PEM). The full standard is referenced in Appendix 8.

Section Name	Conformance - Mandatory, Required, Optional	Description
Person demographics	Mandatory	The person's details and contact information.
Caller Details	Required	Name of caller, relationship, telephone number and preferred contact method. For use where the caller isn't the person needing care or advice,
GP practice details	Required	Details of the person's GP practice.
Dental Practice details	Required	Details of the person's usual dental practice.
Individual requirements	Required	Note that the Individual requirements section includes reasonable adjustment and specific elements for accessible information requirements to support communication.
Safeguarding	Required	Any safeguarding concerns identified
Risks	Required	Any risks identified, includes risks to self or to others
Consent for information sharing	Required	This is a record of consent for information sharing under the common law duty of confidentiality. Where consent has not been obtained or sought, the reason why should be provided. Include best interests decision where person lacks capacity.
Referral details	Mandatory	Details of the referral; from where and to where and any person input into the selection. Also urgency of referral, which where the Pathways triage is used is derived from the DX code resulting from the triage process.
Presenting Complaints or issues	Mandatory	Presenting complaints or issues and the Chief Compliant which is manadatory. Where the Pathways triage is used the Chief Complaint is derived from the symptom group (SD) or symptom discriminator (SG) code resulting from the triage process.
Problem	Required	Provides either a diagnosis or the chief clinical concern. These are only likely to be available where there has been a clinical assessment.
Clinical Summary	Required	A summary of the person's contact such as reason for attendance, chief clinical concern or diagnosis and actions taken or required. Only likely to be available where there has been a clinical assessment.
Social Context	Required	The social setting in which the person lives, such as their household (e.g. lives alone), occupational history, and lifestyle factors.
Allergies and adverse reactions	Required	This is for person reported allergies or adverse reactions which may not be on the persons electronic health record. It is NOT to transfer the person's recorded allergies which the receiver can look up (e.g. via SCR, GP Record or shared care record).
Medications and medical devices	Required	This is for person reported medications and medical devices which may not be on the person's electronic health record. It is NOT to transfer the person's prescribed medications which the receiver can look up (e.g. via SCR, GP Record or shared care record). The full section has been kept for consistency even if only some of the elements are needed for this use case. This is important for example if the person is taking over the counter medications (e.g St John's Wort) bought online or other medications which are not on the person's record such as mental health medications.
Plan and requested actions	Required	The details of any actions or plans for the person (or carer) or the receiving professional.
Person and carer concerns expectations and wishes	Required	Description of the concerns, wishes or goals of the person in relation to their care, as expressed by the person, their representative or carer. Record who has expressed these (patient or carer/ representative on behalf of the patient).Where the person lacks capacity this may include their representative's concerns, expectations or wishes.

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## 5 The 111 Referral Information Standard The 111 information Standard is developed in an information modelling tool called Art Décor. The export of the full 111 Referral standard from Art Décor is very long and can appear complicated to an untrained eye. The table below provides a high-level view of the standard. The blue shaded sections are the sections included in the general practice post event message (PEM). **The full standard is referenced in Appendix 8.**

Section Name	Conformance - Mandatory, Required, Optional	Description
Person demographics	Mandatory	The person's details and contact information.
Caller Details	Required	Name of caller, relationship, telephone number and preferred contact method. For use where the caller isn't the person needing care or advice,
GP practice details	Required	Details of the person's GP practice.
Dental Practice details	Required	Details of the person's usual dental practice.
Individual requirements	Required	Note that the Individual requirements section includes reasonable adjustment and specific elements for accessible information requirements to support communication.
Safeguarding	Required	Any safeguarding concerns identified
Risks	Required	Any risks identified, includes risks to self or to others
Consent for information sharing	Required	This is a record of consent for information sharing under the common law duty of confidentiality. Where consent has not been obtained or sought, the reason why should be provided. Include best interests decision where person lacks capacity.
Referral details	Mandatory	Details of the referral; from where and to where and any person input into the selection. Also urgency of referral, which where the Pathways triage is used is derived from the DX code resulting from the triage process.
Presenting Complaints or issues	Mandatory	Presenting complaints or issues and the Chief Compliant which is manadatory. Where the Pathways triage is used the Chief Complaint is derived from the symptom group (SD) or symptom discriminator (SG) code resulting from the triage process.
Problem	Required	Provides either a diagnosis or the chief clinical concern. These are only likely to be available where there has been a clinical assessment.
Clinical Summary	Required	A summary of the person's contact such as reason for attendance, chief clinical concern or diagnosis and actions taken or required. Only likely to be available where there has been a clinical assessment.
Social Context	Required	The social setting in which the person lives, such as their household (e.g. lives alone), occupational history, and lifestyle factors.
Allergies and adverse reactions	Required	This is for person reported allergies or adverse reactions which may not be on the persons electronic health record. It is NOT to transfer the person's recorded allergies which the receiver can look up (e.g. via SCR, GP Record or shared care record).
Medications and medical devices	Required	This is for person reported medications and medical devices which may not be on the person's electronic health record. It is NOT to transfer the person's prescribed medications which the receiver can look up (e.g. via SCR, GP Record or shared care record). The full section has been kept for consistency even if only some of the elements are needed for this use case. This is important for example if the person is taking over the counter medications (e.g St John's Wort) bought online or other medications which are not on the person's record such as mental health medications.
Plan and requested actions	Required	The details of any actions or plans for the person (or carer) or the receiving professional.
Person and carer concerns expectations and wishes	Required	Description of the concerns, wishes or goals of the person in relation to their care, as expressed by the person, their representative or carer. Record who has expressed these (patient or carer/ representative on behalf of the patient).Where the person lacks capacity this may include their representative's concerns, expectations or wishes.

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### 9.5 Appendix 5 – NHS Digital PEM’s Report This is not a published report. Please contact PRSB (support@theprsb.org) to request a copy.

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### 9.6 Appendix 6 – Joint GPIT Committee Mentimeter outputs

Q1	Currently, how easy is it, in the clinical system document workflow, to distinguish a ‘PEM for Information’ from a ‘PEM for Action’?	Easy – 0 Somewhat easy – 1 Quite difficult - 4 Impossible - 1
Q2	Is a 111 Encounter where a PEM for information is produced coded into the patient record?	Yes, always - 0 Sometimes - 4 Never - 2
Q3	What things could or should trigger alerts or actions in the workflow ?	Need to ensure that we don’t create a gap between the expectations of the patient or 111 services and the general practices obligations. A standardised free-text box for clinician only assessment to highlight specific action or alert to registered general practice. Safeguarding referral, clinician-to-clinician concern, need for urgent ref (USC referral criteria met) The patient or carer needs be given clear written information to satiety net if action not met Real safeguarding issues should be referred Specific action should be a referral No alerts should be for action in less than a week
Q4	Are prescriptions given by 111 If included in a PEM for information coded into the patient record?	Yes always - 0 Sometimes - 3 Never - 0
Q5	Excluding demographics what order should the New 111 Information Standard appear on the 111 PEM for Information?	Respondent 1 presenting complaint Differential diagnosis Management plan	Respondent 2 Action needed, diagnosis, history of complaint, examination, investigation, treatment	Respondent 3 Presenting Symptoms Differential diagnosis Management plan Action to be taken by general practice

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### 9.7 Appendix 7 – GP Focus Group outcomes (Menti slides) What, if anything is coded in to the patients GP Record from a PEM for information? <img> A bar chart showing responses to the question "What, if anything is coded in to the patients GP Record from a PEM for information?" - Nothing coded. The document is filed to the patients record: 1 - The 111 encounter is coded to the record and the document filed to the patient record: 5 - The 111 encounter and any useful additional information is coded and the document filed: 2 </img> Excluding the expected demographic type data, what information from the 111 Information Standard should be included in the 111 PEM?

1st	Clinical summary (following CAS)
2nd	Plan and requested actions (for both the GP and for person)
3rd	Presenting complaints or issues (includes repeat caller flag)
4th	Safeguarding & Risks
5th	Suspected diagnosis
6th	Medications (person reported, e.g. OTC, online)
7th	Individual requirements (reasonable adjustments etc.)
8th	Allergies (person reported)
9th	Confirmed diagnosis

PEM's are not always sent back to the GP e.g. if a person does not consent to share. Are there other times when you would NOT want to receive a PEM? non-relevant contact quick dos look ups health information dental if a duplicate call The dental entry was later withdrawn (by the GP who submitted it) following discussion in the group.

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### 9.8 Appendix 8 – PRSB 111 Referral standard - Full version The full 111 Referral Standard will be available in the PRSB viewer via the 111 Referral Standard webpage. It will also be available on request in XML, JSON or Excel form as extracts from the PRSB modelling tool.

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### 9.9 Appendix 9 – PRSB 111 Referral standard Clinical Safety case & Hazard Log The safety case and hazard log will be available on the 111 Referral Standard webpage.

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Document 2

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Guidance For All Prsb Standards August 2023

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## Document Management

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### Revision History

Version	Date	Summary of Changes
0.1	25-08-21	First draft as general "Guidance for all PRSB standards"
1.0	02.02.2022	First version after incorporating reviewer comments
1.1	25/05/2022	Updated for changes to how provenance data is held in PRSB information models
1.2	31/01/2023	Minor updates
1.3	27/03/2023	Minor update to Section 1.1
1.4	15/08/2023	Update to include new version numbering scheme

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### Reviewers

Reviewer name	Title / Responsibility	Date	Version
Sandip Kaur	Architect	Sep-2021	0.1
Charlie McCay	Technical Adviser	Sep-2021	0.1
Lorraine Foley	CEO	Sep-2021	0.1
Annette Gilmore	PRSB conformance lead analyst	Sep-2021	0.1

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### Approved by

Name	Date	Version
PRSB Task and Finish Group	May-2022	1.1

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### Glossary of Terms

Term / Abbreviation	What it stands for
dm+d	Dictionary of medicines and devices
EPR	Electronic Patient Record
FHIR	Fast Healthcare Interoperability Resources
GP	General Practitioner
HL7	Health Level 7
Metadata	A set of data that describes and gives information about other data
NICE	The National Institute for Health and Care Excellence
NHS	National Health Service
NHSDD	NHS Data Dictionary
NHSE/ NHSEI	NHS England/ now NHS England Improvement
NRLS	National Record Locator Service
ODS	Organisation Data Service
PDS	Personal Demographic Service
PRSB	Professional Record Standards Body
DAPB / DCB / SCCI	Data Alliance Partnership Board, formerly Data Co-ordination Board and Standardisation Committee for Care Information. Acts on behalf of SoS health to approve health and care data and information standards
SNOMED-CT	Systematized Nomenclature of Medicine - Clinical Terms

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## 1 Introduction

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### 1.1 Purpose of this document This document provides general guidance to support the implementation and use of all PRSB standards. Specific implementation guidance for specific standards at section and element level is available as part of the information model for that standard. In addition, each standard will have a safety case and hazard log developed and approved in accordance with the DCB0129: Clinical Risk Management standard. This guidance should be used in conjunction with section 0 Risk Mitigation.

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### 1.2 Audience This guidance is intended for anyone implementing and using PRSB standards. This will include health and social care professionals, IT system suppliers, developers, and implementors.

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## 2 General Guidance

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### 2.1 Structure of the PRSB standards explained An information standard is organised into sections made up of several data (information) elements, with record entries and clusters (subsections) to support repeated sets of information and grouping of related items. The set of rules and instructions governing the type of information expected within a section, cluster, record entry and element and how it is communicated is defined in the information model under the titles of Description, Cardinality, Conformance and Valuesets. The PRSB information model structure and rules are explained in Table 1 and the annotated example below.

Information Components	Model Description
Section	A section groups together all the information related to a specific topic e.g. ‘Medications and medical devices’ and ‘Person demographics’.
	It is the highest level to logically group data elements that may be independent or related. For example:
	- ‘Legal information’ includes a set of independent elements or information items, grouped in a logical section.
	- ‘Medications and medical devices’ includes sets of related elements with dependencies between the elements.
Record entry	A record entry within a section is typically used where a set of information is repeated for a particular item, and there can be multiple items. For example, for each medication there is a set of information associated with that medication. Other examples are allergies or adverse reactions and procedures. A record entry has contextual information associated with it. The data model for the context information is determined by the information type of the record entry. There are two information types used: “Record” and “Event.Record”. For “Record” entries, the provenance data includes the person recording the data, and the time it was recorded. For “Event.Record” entries, details of the performer of the event, the location, and the time the event happened are also included in the provenance data.
Cluster	This is a set of elements put together as a group and which relate to each other; e.g. medication course details cluster which is the set of elements describing the course of the medication.
Element	The data item. An element can appear in one or more sections e.g. name, date.

Information model rules and instructions	Explanations
Description	This is the description of the section, record entry, cluster or element. For an element, it describes the information that the element should contain in as plain English as possible.
Cardinality	Each section, record entry, cluster and element will have a statement of cardinality. This clarifies how many entries can be made i.e. zero, one or many entries. The number of records expected and allowed are displayed as: 0…….* = zero to many record entries are allowed 0…….1 = zero to one record entry is allowed 1…….1 = one record is expected 1…….* = one to many records are expected For example, the ‘Medications and medical devices’ section may have zero to many medication item records in it and is displayed as 0…… *.
Conformance	Conformance defines what information is ‘mandatory’, ‘required’ or ‘optional’ and applies to sections, record entries, clusters and elements. The IT system must be developed to handle all the information elements that are defined in the Standard but not all the information is required for every individual record or information transfer. The following set of rules apply to enable implementers to cater for the end users (senders and receivers) requirements: \| *Mandatory – the information must be included *Required – if it exists, the information must be included *Optional – a local decision is made as to whether the information is included These rules apply at all levels and give the flexibility to allow local clinical or professional decisions on some information that is included, while being clear on what is important information to include. For example, a person subject to a referral may have many assessments, but not all of these will be relevant to the referral. The conformance can be used to allow just relevant assessments to be included. Assessment Section – Required – i.e. its important information you must include if you have it. Record entry level – Optional – allows a local decision on what assessments are included, so only relevant ones are included based on clinical or professional needs. Assessment elements – Conformance set on the normal basis of which elements for an assessment are mandatory, required or optional. NB: It is permitted to upgrade a conformance rule but not to downgrade one. For instance, a section that is classed as optional in the standard can be upgraded to required or mandatory in local implementations. However, one that is classed mandatory or required cannot be downgraded to required or optional.
Valuesets	Valuesets describe precisely how the information is recorded in the system and communicated between systems. This is required for interoperability (for information to flow between one IT system and another). The information can be text, multi-media or in a coded format. If coded it can be constrained to SNOMED CT and specific SNOMED CT reference sets, NHS Data Dictionary values or other code sets.

Table 1: PRSB information standard data structure In the annotated example shown below for Allergies: * The standard has a section for ‘Allergies and adverse reactions’, it’s conformance is ‘mandatory’ and the cardinality is ‘1 only’ (or 1…1) i.e. there must be just one allergies section * It has a record entry to allow for multiple allergies, which is also ‘mandatory’ so with a cardinality of 1 to many (or 1…*). The record entry contains a set of elements, i.e. the set of information for each allergy and there must be at least 1 record entry. * The record entry also includes a cluster (reaction details cluster), which groups the reaction details together. * Each element has a description, conformance, cardinality and valueset. e.g. Causative agent, which is mandatory with a cardinality of 1 only (or 1…1) and a valueset with two options, coded value with a constrained set of SNOMED codes (including an option for “No known allergy”) or free text if coded values are not available. Other elements are required in this example. i.e. the set of information for each allergy or adverse reaction must have a causative agent, and where available should have the other information such as reaction details, substance, severity etc.

Section	Record entry	Description	Conformance	Cardinality
Risks	Allergies and adverse reactions	Details of any risks related to the person.	R	0 ... 1
Allergies and adverse reactions record entry	Allergies and adverse reactions	This is a allergies and adverse reactions record entry. There may be 1 to many record entries under this section.	M	1 ... 1
	Each record entry is made up of a number of elements or data items.		M	1 ... *
Causative agent	The agent such as food, drug or substances that has caused or may cause an allergy, intolerance or adverse reaction in this person Or "No known drug allergies or adverse reactions" Or "Information not available"		M	1 ... 1
Coded value	The coded value for causative agent		R	0 ... 1
Free text	Free text field to be used if no code is available		R	1 ... 1	Valueset
Reaction details cluster	Details of the reaction.		R	0 ... 1	Free text
Date	The date that the reaction was identified.		R	0 ... 1	Date and time
Location	Details of where the allergy was identified.		R	0 ... 1
Coded value	The coded value for location.		R	0 ... 1	NHS data dictionary : - Organisation data service
Free text	Free text field to be used if no code is available		R	0 ... 1	Free text
Substance	The substance, or a class of substances, that is considered to be responsible for the adverse reaction.		R	0 ... 1
Description of reaction	A description of the manifestation of the allergic or adverse reaction experienced by the person. For example, skin rash.		R	0 ... 1
Severity	A description of the severity of the reaction.		R	0 ... 1
Certainty	A description of the certainty that the stated causative agent caused the allergic or adverse reaction.		R	0 ... 1
Comment	Any additional comment or clarification about the adverse reaction.		R	0 ... 1	Free text
Type of reaction	The type of reaction experienced by the person (allergic, adverse, intolerance)		R	0 ... 1	FHIR value set :- Allergy, Intolerance, Not known
Evidence	Results of investigations that confirmed the certainty of the diagnosis. Examples might include results of skin prick allergy tests		R	0 ... 1	Free text
Date first experienced	When the reaction was first experienced. May be a date or partial date (e.g. year) or text (e.g. during childhood)		R	0 ... 1	Date and time
Probability of recurrence	Probability of the reaction (allergic, adverse, intolerant) occurring.		R	0 ... 1	Free text
Performing professional	The professional who identified the reaction.		R	0 ... 1
Person completing record	Details of the person completing the record.		R	0 ... 1
Medications and medical devices	Medications and medical devices		R	0 ... 1

Description:

## 1 Executive summary and safety statement This document provides a clinical safety case for the 111standard project. The project has delivered information models, developed within the Art Décor open source tool suite (Art Decor supports the creation and maintenance of HL7 templates, value sets and data sets) and implementation guidance which will be used by IT suppliers and healthcare organisations to develop technical standards for structuring, coding and sharing 111 information, with a view The PRSB 111 Referral Standard Clinical Safety Case to incorporating it into standard clinical IT contracts to facilitate improved access to health and care services via interoperability. A total of 8 potential hazards were identified and mitigated. Of these 1 was scored at level 4 and 4 at level 3, these required additional controls to reduce risk to an acceptable level on the Risk Matrix (see table 1 below). After additional controls were put in place all hazards 3 and above were reduced to 2. The remaining 3 hazards were reduced to level 1 and 2 which were either acceptable where cost of further reduction outweighs the benefit, or no further action is required. The mitigated hazards include information that should be addressed by implementers. All hazards were identified through the consultation steps carried out to develop these standards. The consultations consisted of a multidisciplinary workshop, online survey, review of draft information models and implementation guidance (by clinical informaticians and system suppliers) and an expert user group meeting. These workshops, surveys and communications included patient representatives as well as professionals from Royal College of Emergency Medicine, Urgent & Emergency Care, GP’s, allied health professions, health informatics professionals NHS E&I and IT vendors. At each step of the consultation hazards were identified, reviewed and mitigations/actions considered. Nevertheless, some risk is inherent in the standards, but most has been: (A) mitigated by the development of the standards (B) or the residual risk has been transferred (with guidance) to the implementers. Certain hazards were deemed system implementation matters. The hazard log (embedded within this document see section ‘Clinical risk management System’) provides guidance for system developers and implementers. It is important that this guidance in relation to these hazards becomes a requirement for implementation. N.B: This clinical safety report is necessarily limited in its scope because it is neither directly related to software development nor to deployment. Suppliers developing software to implement these standards will therefore still be expected fully to apply DCB0129. Organisations involved in the deployment of such software will still be expected fully to apply DCB0160. This clinical safety case report is, however, a useful reference guide for any such projects. The report has been overseen by the Clinical Safety Officer (CSO) for the project.

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## 2 Introduction This Clinical Safety Case Report documents the scope, functionality and clinical risk management activities for a new standard for 111 Referrals and the GP Post Event Message for Information. It is intended to support vendors and developers as well as healthcare organisations implementing the standard in clinical IT systems. The Standard v0.4 [Ref 3] has been co-produced with a wide range of stakeholders; NHS E&I Transformation directorate, Royal College of General practitioners, Urgent and Emergency Care Clinicians, citizens, healthcare professionals, and suppliers to ensure that the standard meets their needs. **The following approach was taken to develop the project deliverables** * 2 multidisciplinary consultation workshops and 2 GP Focus Groups (Feb 2022) were held with key stakeholders, including front line health and care professionals, health informaticians. The first workshops in 2018 discussed and reviewed the integrated urgent care information sharing requirements. A further workshop in March 2021 validated the findings of the initial workshop to gather agreement for the continuation of the draft 111 standard. The GP focus groups focused on the GP Post Event Message (PEM). * Close working with the NHS E&I Booking and Referrals (BaRs) programme to support the 111 to ED pilot for the 111 standard. PRSB attended the BaRs programme board to ensure any hazards were identified and mitigated during the development of the standard. * A wider consultation on the 111 standard was carried out via an online survey during Nov – Dec 2021. The survey was aimed at frontline care professionals, who either receive or send 111 referrals, people, who work in the 111 services and those who are users of the 111 service. The findings and outcomes of the survey can be found in Appendix 5. * Outstanding issues were consulted on by the 111 standard project group and the BaRS Programme Board. The outputs from these meetings informed the final drafts of the 111 standard. * Final drafts of the standard and supporting documentation were disseminated to the 111 project board of their official sign off in March 2022 **In scope** 1. The scope of the 111 standard applies to: * All 111 and 999 service referrals to wherever the person goes next. * The GP Post Event Message * Referrals through 111 online, call handler or clinical assessment services and 999 services, and is not specific to any triage system. * To support NHS Digital with the pilot use case 111 to ED * The standard is UK-wide and developed in consultation with a wide range of professionals from all four nations, including from 111 services, receiving services, IT suppliers and people who use services. * All age groups including children. To support the full information journey from 111 receiving the call or online request to referral to an onward service and / or the post event message back to the GP, the standard has been split into 2 sections. i. The 111 Referral **Below are the high-level data items for the ‘111 Referral information standard’** * Patient Demographics * GP Practice detail * Dental practice detail * Consent * Safeguarding * Individual Requirements (Reasonable Adjustments) * Referral Details * Caller details * Presenting Complaints and issues * Problem List * Clinical Summary * Social Context * Risk * Allergies and Adverse reactions * Medications and medical devices * Plan and requested actions * Person and carer concerns expectations & wishes For a system supplier view and human readable view of a 111 Referral to ED see Appendix 7 and navigate to the Examples section of the PRSB 111 standards webpage. ii. The Post Event Message (back to registered GP) **Below are the high-level data items for the ‘111 PEM information standard’** * Patient Demographics * GP Practice detail * Safeguarding * Individual Requirements (Reasonable Adjustments) * Referral Details * Presenting Complaints and issues * Problem List * Clinical Summary * Risk * Allergies and Adverse reactions * Medications and medical devices * Plan and requested actions For system supplier view and human readable view of the 111 ED PEM example see Appendix 7 and navigate to the Examples section of the PRSB 111 standards webpage. **Out of scope** The standard does not apply to transfers between 111 services (e.g. across a country border) or between 111 and 999 services and these are therefore out of scope. As is the actual implementation of the 111 standard in to organisations and IT systems.

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## 3 System Definition / Overview As this Clinical Safety Case report pertains to an information standard rather than a clinical IT system, the systems definition cannot be provided. Multiple systems suppliers will be asked to implement the 111 Referral Standard and will undertake their own DCB0129 Clinical Safety Case for their individual system. The Standard will impact all users on the 111 telephone and online service once implemented across the UK.

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## 4 Clinical Risk Management System The NHS Digital Clinical Safety Group (CSG) operates a full Clinical Safety Management System (CSMS) that encompasses integration with Health Organisations and professional bodies. The CSMS considers the integration with the Information Standards Board and the process in which professional standards are developed in the CSMS framework. The Clinical Safety Management System has been applied throughout all phases of the PRSB 111 standard. This Clinical Safety Case has been developed in accordance with the requirements of DCB0129 Clinical Risk Management: its Application in the Manufacture of Health IT Systems – Specification [Ref1] and DCB0160 Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems - Specification [Ref. 2]. The essential structures of a CSMS have been implemented in this project by engagements with the following organisations: * Royal College of Physicians * Royal College of General Practitioners * Royal College of Nursing * 111 Information Standard project board * 111 expert user group * Joint GP IT Committee * NHS E&I Bookings & Referrals service team * NHS Digital clinical safety group * Digital Health & Care Wales * RCP Patient and Carer Network The first step to preventing harm to patients through the use of these standards is to ensure a good development process that results in systems which are fit for purpose. Activities that have been carried out to clarify and address this include: * A Hazard Workshop carried out with input from stakeholders and potential users of any such system facilitated by the Clinical Safety Officer * Production of a hazard log for the project further revised through consultation with stakeholders * Review of the hazard log following online consultation on the headings and any safety risks associated with any of the headings * Review of mitigation of risks as part of the development of the standard headings This hazard log comprises: * Hazard name and description * Potential causes * Potential patient safety impact * Initial hazard rating including likelihood and consequence * Dependencies and assumptions * Proposed mitigation * Revised hazard ratings Risks were scored using the risk matrix and scoring tools shown in Tables 1 - 4 Appendix 2. A summary of hazards identified, including those deemed implementation issues is included in the following section. The suggested mitigations aim to address clinical safety in relation to the design of the structure and description of the content of the standard. Further mitigations will be required when the standard is implemented in clinical / IT systems. We have flagged some risks relating to implementation in this report but expect that further mitigations will be identified as clinical risk assessments and safety cases are developed by vendors and healthcare organisations during implementation.

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## 5 Clinical Risk Analysis A total of 8 hazards and their mitigations were identified via consultation and the hazard workshops, which are summarised in the table below.

Initial	Residual	Risk rating	Definition
0	0	5	Unacceptable level of risk.
1	0	4	Mandatory elimination or control to reduce risk to an acceptable level
3	1	3	Undesirable level of risk Attempts should be made to eliminate or control to reduce risk to an acceptable level. Shall only be acceptable when further risk reduction is impractical.
4	5	2	Acceptable where cost of further reduction outweighs benefits gained.
0	2	1	Acceptable, no further action required

**Table 1 : Summary of 111 standard hazard risk scores** These mitigated hazards should be considered and addressed in local implementations of the 111 Referral Standard.

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## 6 Clinical Risk Evaluation Hazards were identified using the SWIFT (Structured ‘What If’ Technique) method of hazard identification during the hazard workshops. This entailed description of potential hazard, patient safety consequences, explanation of hazard causes, identification of existing controls, an estimation/rating of clinical risk and suggested further mitigations. Potential clinical safety risks and hazards were also explored at regular programme and project team meetings that included NHS England & Improvement, NHS X and NHS Digital Leads.

Hazard Workshop 1
Date	Attendees	Role
23th Nov 2021	Dr James Ray	111 Referral Clinical Lead & Emergency Medicine Consultant
	Lee Montgomery	Clinical Informatics Manager & Clinical Safety Officer NHS Bookings & Referrals
	Eve Wijayanayagam	Clinical Lead – Integrated Urgent care, Home Visiting and Appt +
	Sharon Hanley	PRSB Business Analyst / IT Consultant

Hazard Workshop 2
Date	Attendees	Role
3 Dec 2021	Alison Allam	Patient with lived experience
3 Dec 2021	Sharon Hanley	PRSB Business Analyst / IT Consultant

Hazard Workshop 3
Date	Attendees	Role
28th Feb 2022	Dr James Ray	111 Referral Clinical Lead & Emergency Medicine Consultant
	Lee Montgomery	Clinical Informatics Manager & Clinical Safety Officer NHS Bookings & Referrals
	Dr Eve Wijayanayagam	Clinical Lead – Integrated Urgent care, Home Visiting and Appt +
	Sharon Hanley	PRSB Business Analyst / IT Consultant

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### Clinical Risk Control Of the 8 hazards originally identified, 1 was scored at level 4, 5 at level 3 and 2 at level 2 all of which required additional controls to reduce risk to an acceptable level. After the additional controls and mitigations were evaluated and verified during the hazard workshops the residual hazards are: * 6 hazards were reduced to level 2 - Acceptable where cost of further reduction outweighs benefits gained. * The remaining 2 hazards 1 remained at level 2 and the other reduced to level 1 - acceptable, no further action is required. There are 6 hazards with a residual risk of 2, which is Undesirable level of risk, attempts should be made to eliminate or control to reduce risk to an acceptable level. Below is a summary of each of the hazards that were initially give a risk raking of 3 and above.

Hazard Id:	1
Initial risk ranking	3
Hazard Name	Missing data (blank fields), incorrect, or corrupt data.
Hazard Description:	Data items that are either not completed, completed incorrectly, or corrupted in message transmission which result in blank fields in the sending and /or receiving system.
Hazard Causes:	1) Incorrect data entered in source system unable to be mapped into the receiving system. 2) Information model in source system is misinterpreted/not understood by? 3) Logical data model is wrong leading to incorrect or missing data attributes. 4) Data processing and de-duplication loses important data item. 5) Headings have similar meanings, so users are unsure where to find the information they need e.g. About Me, Individual Requirements and Social Context. 6) Consequence of different professional groups with different roles and emphasis in creating electronic health and care records. 7) Semantics and language difference between the different professions.
Potential patient safety impact description	Healthcare provider delivers inappropriate care based on absent / incorrect information which could lead to an absence or delay to care, which could result in patient harm.
Dependencies & assumptions	1. Suppliers implement the standard in accordance with the PRSB guidance provided. 2. Supplier systems are able to configure their system to support recommended conformance.
Mitigation:	Existing controls / Mitigation Assurance/compliance processes already published for system suppliers / implementers. Design Mitigations Providing system suppliers with implementation guidance explaining confirmation on data item conformance - 'Mandatory (& Must haves), Required and optional Data standard has been designed to ensure conformance criteria is clear as described on page 6 of the General implementation guidance for ALL PRSB standards [Ref 7]
Residual risk:	2

Hazard Id:	2
Initial risk ranking	3
Hazard Name	Incorrect mapping / transcription of data items from source systems (including paper/excel) into receiving system.
Hazard Description:	Suppliers map incorrect codes or data. Incorrect transcription of written terminology
Hazard Causes:	1) Recommended coding not available in supplier system.
Potential patient safety impact description	Incorrect treatment or advice given by the HCP which could lead to an absence or delay to care, which could result in patient harm.
Dependencies & assumptions	1. Supplier systems can implement the 111-standard using the recommended coding via HL7 and/or FiHR for input and extract.
Mitigation:	Existing controls / mitigations Assurance / compliance processes already in place for system suppliers / implementers. Design mitigations The information standard has been developed with specific headings which link to SNOMED codes, NHS Data Dictionary, Reference sets where appropriate, including conformance and compliance requirements
Residual risk:	2
Hazard Id:	4
Initial risk ranking	3
Hazard Name	Known, existing information e.g. medications and allergies may not be available to receiving service
Hazard Description:	The 111 standard captures and passes to receivers 'new' information only. There is a presumption that existing / known information e.g. medications, allergies, risks will be available via Summary Care Record, GP Connect, shared care records etc.
Hazard Causes:	1) Medication, allergies and risk Information captured in the 111 standard is 'New' patient reported information only. 2) Not all services have access to Summary Care Record so are unable to view existing GP information 3) shared care records are not available to all health and care settings,
Potential patient safety impact description	Information already recorded in existing clinical systems is not shared as part of the 111 standard. Not being aware of this information may result in inappropriate advice or care being given to the patient resulting in harm to the patient
Dependencies & assumptions	1. Majority of services have access to existing health and care records 2. The NHS E road map for access to Health & care records includes dentistry, ophthalmology and pharmacy etc.
Mitigation:	Existing controls / implementers Many services are able to access a person's core information (medications, allergies and adverse reactions) via the SCR) Most of the time the individual or advocate will be able to provide the information via memory or patient access to GP records.. Design mitigation The standard includes a field for the 111 call handler / CAS clinician to include a link to where other information about the patient can be accessed (Local shared care record) Clinical suppliers should consider including a warning that the 'medication, allergies and adverse reactions and risks in the 111 referral are patient reported only'
Residual risk:	2

Hazard Id:	5
Initial risk ranking	3
Hazard Name	Unconfirmed diagnoses recorded into GP record as a problem
Hazard Description:	The 111 standard allows for the recording of presenting complaint, chief complaint, chief clinical concern and diagnoses. Care must be taken when recording diagnoses with a qualifier e.g. suspected as GP systems do not always recognise the qualifier.
Hazard Causes:	1) GP systems cannot easily record a diagnosis with a qualifier and may incorrectly add a diagnosis code to the patient record
Potential patient safety impact description	Patient's records will be incorrectly updated and may cause issues for the patient with regards to contraindicated care/medicines and obtaining a mortgage / life insurance
Dependencies & assumptions	1. Suppliers can disable the recording of diagnoses with a 'suspected' qualifier 2. Suppliers can capture the Chief clinical concern using SNOMED findings data set (suspected diagnosis)
Mitigation:	Existing controls/mitigations Systems receiving ITK messaging can manually code information into the care record from the 111 / discharge report and search for suspected diagnoses code. Design mitigation Systems should map Chief clinical concern to SNOMED findings (suspected diagnosis) and Diagnoses to diagnoses codes that do not require a qualifier.
Residual risk:	2

Hazard Id:	6
Initial risk ranking	4
Hazard Name	Disclosure of Gender reassignment without the individual’s consent/knowledge
Hazard Description:	Sharing both 'sex' and 'gender' where the gender does not match the ‘sex’ phenotype recorded at birth for example within a referral letter, discharge summary or electronic shared care record, (without the individual’s consent) could lead to inappropriate sharing of sensitive personal data. (In breach of GDPR Article 9)
Hazard Causes:	The two data items 'Sex' and 'gender' recorded as part of the 111 Standard, where they do not match, could indicated gender reassignment. Disclosure of a person's gender reassignment without the consent of the individual is prohibited under GDPR Article 9
Potential patient safety impact description	Disclosure of a person’s gender reassignment without their consent could impact the individual psychologically and may lead to harm of the individual
Dependencies & assumptions	Conversation will be had with individuals about the recording of 'sex' and 'gender' either to gain their consent or to agree not to record specific information. System suppliers will be able to configure their system to prevent sex and gender being recorded together without gaining the individuals consent
Mitigation:	Existing controls/ Mitigations Not known Design Both Sex and gender are 'required' fields NOT 'mandatory'. these fields can be left blank. System suppliers to follow business rule to ensure a person's protected characteristics are not disclosed without the individual's consent.
Residual risk:	2

Hazard Id:	8
Initial risk ranking	2
Hazard Name	Incorrect entry of diagnosis code in the persons GP electronic record
Hazard Description:	The SNOMED Ref set is a very large ref set which includes diagnosis codes with qualifiers i.e. . If a clinician was to select UTI with a qualifier of 'Suspected' . The UTI would be recorded in the patient record but the qualifier would not. Resulting in an unconfirmed diagnosis being added to the record
Hazard Causes:	GP systems unable to ingest and display 'qualifiers' linked to diagnosis SNOMED codes in the GP electronic record. Use of the SNOMED ref Set for Chief Clinical Concern may cause incorrect coding of diagnoses
Potential patient safety impact description	The incorrect diagnosis will appear in any reports requiring their diagnosis to be extracted from the clinical record. Patient may not be prescribed a medication due to possible contraindications with a diagnosis in their record.
Dependencies & assumptions	1. Primary care clinical system suppliers are working on a solution for displaying the 'qualifiers' attached to a diagnosis SNOMED code 2. The SNOMED ref set will be available to the clinician to select from in the 111 Standard for referrals and PEM for information
Mitigation:	Existing controls / mitigations Pathways does not yet use Snomed CT therefore the Ref set is not yet available to the clinician to select a diagnosis with a qualifier. Design mitigation The clinician can enter free text which will be transferred as part of the 111 Standard. The pathways SG and SD codes will be pulled through from Pathways.. **Technical Assurance To be confirmed as part of supplier testing
Residual risk:	2

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### The hazard log The 111 information standard hazard log is embedded below

The incorrect diagnosis will appear in any reports requiring their diagnosis to be extracted from the clinical record.

Patient may not be prescribed a medication due to possible contraindications with a diagnosis in their record.

high significant

Hazard Number	Hazard Name	Hazard Description	Hazard Causes
Generic Hazards
1	Missing data (blank fields), Incorrect, corrupt data	Data items that are not completed or completed incorrectly are left blank. Data items that are either not completed, completed incorrectly, or corrupted in message transmission which result in blank fields in the sending and /or receiving system's in the sending and /or receiving system	1) Incorrect data entered in source system unable to be mapped into the receiving system. 2) Information model in source system is misinterpreted/not understood by? 3) Logical data model is wrong leading to incorrect or missing data attributes. 4) Data processing and de-duplication loses important data item. 5) Headings have similar meanings so users are unsure where to find the information they need e.g. Individual Requirements and Social Context; 6) Consequence of different professional groups with different roles and emphasis in creating electronic health and care records; 7) Semantics and language difference between the different professions;
Incorrect mapping / transcription of data items from source systems (including paper /excel) into receiving system.	Suppliers map incorrect codes or data. Incorrect transcription of written terminology.	1) Recommended coding not available in supplier system.
2	Unstructured data not easily accessible for review	Data can exist in both structured and unstructured form (free text). The later making the data more difficult to transfer for review.	1) Ability of supplier to send free text as part of referral and post event message 2)Rendering of information by receiving system in to pdf / word document
4	Known , existing recorded information e.g. medications, allergies and risks are not included in the 111 standard	The 111 standard captures and passes to receivers 'new' information only. There is a presumption that existing / known information e.g. medications, allergies, risks will be available via Summary Care Record, GP Connect, shared care records etc.	1) Medication, allergies and risk Information captured in the 111 standard is 'New' patient reported information only. 2)Not all services have access to Summary Care Record so are unable to view existing GP information 3) shared care records are not available to all health and care settings,
Unconfirmed diagnoses recorded into GP record as a problem	The 111 standard allows for the recording of presenting complaint, chief complaint, chief clinical concern and diagnoses. Care must be taken when recording diagnoses with a qualifier e.g. suspected as GP systems do not always recognise the qualifier.	1) GP systems can not easily record a diagnoses with a qualifier and may incorrectly add a diagnoses code to the patient record
6	Disclosure of Gender reassignment without the individuals consent / knowledge	Sharing / displaying both 'sex' and 'gender' (where the gender does not match the 'sex' phenotype recorded at birth) within a referral letter, discharge summary or electronic shared care record, without the individual's consent could lead to inappropriate sharing of sensitive personal data. (In breach of GDPR Article 9)	The two data items 'Sex' and 'gender' recorded as part of the Social Prescribing Standard, where they do not match, could indicated gender reassignment. Disclosure of a person's gender reassignment without the consent of the individual is prohibited under GDPR Article 9
7	The 111 Referral standard will not fully support individuals contacting 111 who are not matched on the SPINE	Patients who contact 111 who are not registered with a GP and cannot be SPINE matched the 111 onward referral to the GP is unable to be sent	The 111 Referral Standard uses the registered GP recorded on the SPINE for an individual registered to a GP Practice. This is used to send the onward referral and PEM for information
Incorrect entry of diagnosis code in the persons GP electronic record	The Snomed Ref set is a very large ref set which includes diagnosis codes with qualifiers i.e.. If a clinician was to select UTI with a qualifier of 'Suspected'. The UTI would be recorded in the patient record but the qualifier would not. Resulting in an unconfirmed diagnosis being added to the record	GP systems unable to ingest and display 'qualifiers' linked to diagnosis SNOMED codes in the GP electronic record. Use of the Snomed ref Set for Chief Clinical Concern may cause incorrect coding of diagnoses
Healthcare provider delivers inappropriate care based on absent / incorrect information which could lead to an absence or delay to care, which could result in patient harm.	Medium	Considerable
Incorrect treatment or advice given by the HCP which could lead to an absence or delay to care, which could result in patient harm.	Medium	Considerable
Information transferred as part of referral or PEM may not be easily located or missed leading to clinicians treating patients without full information resulting in delays / issues in patient care	Medium	Minor
Medication, allergy and risk information already recorded in existing clinical systems is not shared as part of the 111 standard. Not being aware of this information may result in inappropriate advice or care being given to the patient resulting in harm to the patient	Medium	Major
Patients records will be incorrectly updated and may cause issues for the patient with regards to contraindicated care/medicines and obtaining a mortgage / life insurance	Medium	Significant
Disclosure of a person's gender reassignment without their consent could impact the individual psychologically and may lead to harm of the individual	Medium	Considerable
The patient will not be able to receive the next stage of care should the outcome be an action for the GP. The patient will be responsible for ensuring they access the appropriate care.	Medium	Minor
Risk Acceptability	Dependencies and Assumptions	Existing Controls / Mitigations

	1. Suppliers implement the standard in accordance with the PRSB guidance provided. 2. Supplier systems are able to configure their system as specified to (?) to support recommended conformance.	Assurance/ compliance processes already published for system suppliers / implementers.
3
3	1. Supplier systems can implement the 111 standard using the recommended coding via HL7 and/or FiHR for input and extract.	Assurance / compliance processes already in place for system suppliers / implementers.
2	1. Supplier systems can handle free text 2. Supplier systems render information in an easy to navigate format	Suppliers already utilise Standard ITK messaging in place Receivers rendered information is able to be configured locally
3	1. Majority of services have access to existing health and care records	Many services are able to access a persons core information (medications, Allergies and adverse reactions) via the SCR
2. The NHS E road map for access to Health & care records includes dentistry, ophthalmology and pharmacy etc.	Most of the time the individual or advocate will be able to provide the information via memory or patient access to GP records.

2	1. Suppliers can disable the recording of diagnoses with a 'suspected' qualifier 2. Suppliers can capture the Chief clinical concern using SNOMED findings data set (suspected diagnosis)	Systems receiving ITK messaging can manually code information into the care record from the 111 / discharge report and search for suspected diagnoses code.
4	Conversation will be had with individuals about the recording of 'sex' and 'gender' either to gain their consent or to agree not to record specific information	Not known
System suppliers will be able to configure their system to prevent sex and gender being recorded together without gaining the individuals consent
1. There are existing processes in place for unregistered patients who call 111. 2. A referral to the GP is not urgent or life threatening and if the clinician knows the person does not have a registered GP they could refer to a more appropriate service	The 111 call handler can see if the person does not have a registered GP and can advise them to register as soon as possible.
1. Primary care clinical system suppliers are working on a solution for displaying the 'qualifiers' attached to a diagnosis Snomed code	Pathways does not yet use Snomed CT therefore the Ref set is not yet available to the clinician to select a diagnosis with a qualifier .
2. The Snomed ref set will be available to the clinician to select from in the 111 Standard for referrals and PEM for information
3
Additional Controls / Mitigations
Design	Technical Assurance	Training
Providing system suppliers with implementation guidance explaining confirmation on data item conformance - 'Mandatory (& Must haves) , Required and optional	N/A	N/A
Data standard has been designed to ensure conformance criteria is clear
The information standard has been developed with specific headings which link to SNOMED codes, NHS Data Dictionary, Reference sets where appropriate, including conformance and compliance requirements	N/A	N/A
The information standard has data/ref sets where available Free text fields are clearly identified in the Standard.	N/A	N/A
The standard includes a field for the 111 call handler / CAS clinician to include a link to where other information about the patient can be accessed (Local shared care record)	N/A	N/A
Clinical suppliers should include a warning box informing the receiver that the 'medication, allergies and risks' in the 111 referral is 'new' patient reported information only and the users is advised to view the SCR, GP Connect record or shared care record if available.
Systems should map Chief clinical concern to SNOMED findings (suspected diagnosis) and Diagnoses to diagnoses codes that do not require a qualifier.	N/A	N/A
Both Sex and gender are 'required' fields NOT 'mandatory'. these fields can be left blank	N/A	N/A
System suppliers to follow business rule to ensure a persons protected characteristics are not disclosed without the individuals consent
The clinician can enter free text which will be transferred as part of the 111 Standard.	To be conformed as part of supplier testing
The pathways SG and SD codes will be pulled through from Pathways.
Business Processes	Residual Hazard Risk Rating
Likelihood	Consequence
	low	Considerable
	Medium	Significant
	low	Minor
Risk Acceptability	Summary of Actions/Additional Comments	Additional Comments

2	PRSB Implementation guidance to clearly explain Conformance	Hazard transferred to system suppliers
2	Implementation guidance to clearly explain agreed data sets / reference sets, and FIHR messaging	Hazard transferred to system suppliers
1	PRSB standard to use data / ref sets as a default and free text only where there is no ref set.	Hazard transferred to system suppliers
2	Feedback to NHS E the importance of enabling all health & care settings with access to Health records	Hazard transferred to system suppliers
Implementation Guidance to clearly explain requirement of mapping to appropriate suspected diagnosis / finding code set to chief clinical concern	Hazard transferred to system suppliers
Implementation guidance to clearly explain impact of recording sex and gender together. With recommendation to prompt for patient consent if entered. 2	Hazard transferred to system suppliers and health organisation implementing the standard to ensure staff are explaining information governance to patients correctly and understand GDPR
2	Hazard transferred to health organisation managing the unregistered patient. Awareness of local processes for referring unregistered patients.
This Hazard log will need to be reviewed when Pathways introduced Snomed CT and the 111 referral standard is impacted. Full testing will need to be performed by suppliers when pathways moves to Snomed	Hazard transferred to NHS E&I With regards to wider management of development of sending and receiving of structured data and SNOMED coded data. In the short term GP Suppliers to ensure qualifiers are shared and surfaced in sstems appropriately.

### 11.1 Expert Group

Organisation	Title/Role
	Project Patient Lead
Royal College of Emergency Medicine	Vice President
NHS England/ Improvement	National Clinical Advisor 111 First, Hospitals Programme and Emergency Medicine Consultant
NHS England/ Improvement	Consultant in Emergency Medicine and Clinical Lead, Emergency Care Data Set
Same Day Emergency Care, NHS England and Improvement	EM Consultant and National Clinical Lead for Same Day Emergency Care
NHS Digital	Clinical Development Lead - Urgent and Emergency Care
Royal College of General Practitioners	National lead GP for urgent and emergency care
Mulberry Surgery	Project GP lead
NHSE / Wake Green Surgery	GP, Acting Chief Officer - Integrated Urgent & Emergency Care West Midlands, National Clinical Lead for Urgent and Emergency Care
PRSB	Clinical Director for health and care
South Central Ambulance Service NHS foundation Trust	Locality Manager (Business Change) - Integrated Urgent Care & NHS 111 Services (Adastra)
Integrated Care 24 Clinical Systems	Head of Systems and development
North West Ambulance Service NHS Trust	Transformation delivery manager
Dorset Healthcare University NHS Trust	Head of applications development and support (TPP)
North West Ambulance Service NHS Trust	Clinical Records & Electronic Care Systems Manager
Yorkshire Ambulance Service NHS Trust	CRM
South Central Ambulance Service NHS foundation Trust	Locality Manager (Business Change) - Integrated Urgent Care & NHS 111 Services
NHSX	Deputy Director, Digital Urgent and Emergency Care
NHS Digital	Senior product Manager
NHS Digital	111 online product lead
NHS Digital	Product and delivery management graduate (111 online)
NHS Digital	Business Analyst Manager/ Lead Business Analyst (Bookings and Referrals)
PRSB	Senior product Manager
PRSB – Hanley Consulting	Project Analyst
PRSB – Hanley Consulting	Analyst

New Chapter:

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Description:

### 11.2 Clinical safety hazard log risk matrix & scoring tool **Table 1**

Likelihood Category	Interpretation
Very high	Certain or almost certain; highly likely to occur
High	Not certain but very possible; reasonably expected to occur in most cases
Medium	Possible
Low	Could occur but in the great majority of occasions will not
Very low	Negligible or nearly negligible possibility of occurring

**Table 2**

Severity Classification	Interpretation	No. of Patients Affected
Catastrophic	Death	Multiple
Catastrophic	Permanent life-changing incapacity and any condition for which the prognosis is death or permanent life-changing incapacity; severe injury or severe incapacity from which recovery is not expected in the short term	Multiple
Major	Death	Single
	Permanent life-changing incapacity and any condition for which the prognosis is death or permanent life-changing incapacity; severe injury or severe incapacity from which recovery is not expected in the short term	Single
	Severe injury or severe incapacity from which recovery is expected in the short term	Multiple
	Severe psychological trauma	Multiple
Considerable	Severe injury or severe incapacity from which recovery is expected in the short term	Single
	Severe psychological trauma	Single
	Minor injury or injuries from which recovery is not expected in the short term.	Multiple
	Significant psychological trauma	Multiple
Significant	Minor injury or injuries from which recovery is not expected in the short term	Single
	Significant psychological trauma	Single
	Minor injury from which recovery is expected in the short term	Multiple
	Minor psychological upset; inconvenience	Multiple
Minor	Minor injury from which recovery is expected in the short term; minor psychological upset; inconvenience; any negligible severity	Single
Likelihood Category	Interpretation
Very high	Certain or almost certain; highly likely to occur
High	Not certain but very possible; reasonably expected to occur in the majority of cases
Medium	Possible
Low	Could occur but in the great majority of occasions will not
Very low	Negligible or nearly negligible possibility of occurring

	Risk Acceptability
5	Unacceptable level of risk
4	Mandatory elimination of hazard or addition of control measure to reduce risk to an acceptable level
3	Undesirable level of risk. Attempts should be made to eliminate the hazard or implement control measures to reduce risk to an acceptable level. Shall only be acceptable when further risk reduction is impractical
2	Acceptable where cost of further reduction outweighs benefits gained or where further risk reduction is impractical
1	Acceptable, no further action required

Scope:

NHS Services

Licenced ID:

Open Government Licence v3.0 (OGL 3.0) https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/

Licenced Title:

This standard is owned by NHS England and is made available for reuse or amendment under the Open Government Licence v3.0 (OGL 3.0).

Mandated:

Status:

active

Origin

Name:

NHSE-SD Data Catalogue

URL:

https://sd-asc-ui-sd.metadata.works

Link:

https://sd-asc-ui-sd.metadata.works/browser/dataset/286829/0