GP Post Event Message - Mental Health

111 Referral Business Rules

111 Referral Final Report

111 Referral Hazard Log

111 Referral to Dentistry Data Set

111 to Emergency Department Example

111 Referral to Emergency Department 

111 Referral to GP

111 Referral Simplified (json)

111 Referral to Emergency Department - Post Event Message

111 Post Event Message Reformatted (json)

111 Referral Standard - Clinical Safety Case

PRSB General Implementation Guidance Version 1.4

111 Referral to Dentistry - Post Event Message

111 Referral to Pharmacy - Post Event Message

111 Referral to Pharmacy

111 Referral to Dentistry

111 Referral to Mental Health

This standard supports the Booking and Referral Standard programme (BaRS). The standard defines the information that should be shared from 111 or 999 services when a person is referred onto another service.

<span>PRSB was commissioned by NHS England to produce the 111 Referral Standard as part of the Booking and Referral Standard programme (BaRS). The 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.</span>
<span>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.</span>
<span>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&amp;E departments by referring people to the most appropriate service.</span>
<span>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.</span>
<span>Scope
The standard applies to:</span>
<ul>
<li>All 111 and 999 service referrals to wherever the person goes next.</li>
<li>Referrals through 111 online, call handler or clinical assessment services and 999 services, and is not specific to any triage system.</li>
<li>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.</li>
<li>All age groups including children.</li>
</ul>
<span>The standard does not apply to transfers between 111 services (e.g. across a country border) or between 111 and 999 services.</span>
<span>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).</span>
<span>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.</span>
<span>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.</span>


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

### Reviewers

<table>
<thead>
<tr>
<th>Reviewer name</th>
<th>Title / Responsibility</th>
<th>Date</th>
<th>Version</th>
</tr>
</thead>
<tbody>
<tr>
<td>Martin Orton</td>
<td>PRSB Project Manager</td>
<td>11.03.2022</td>
<td>0.2</td>
</tr>
<tr>
<td>James Ray</td>
<td>Clinical Lead (ED)</td>
<td>16.02.2022</td>
<td>0.5</td>
</tr>
<tr>
<td>Alison Allam</td>
<td>Patient Lead</td>
<td>16.02.2022</td>
<td>0.5</td>
</tr>
<tr>
<td>Eve Wijayanayagam</td>
<td>Clinical Lead (GP)</td>
<td>16.02.2022</td>
<td>0.5</td>
</tr>
</tbody>
</table>

### Approved by

<table>
<thead>
<tr>
<th>Name</th>
<th>Date</th>
<th>Version</th>
</tr>
</thead>
<tbody>
<tr>
<td>PRSB Assurance Committee</td>
<td>21.03.2022</td>
<td>0.6</td>
</tr>
<tr>
<td>Booking and Referral Standard (BaRS) Product Board</td>
<td>04.04.2022</td>
<td>0.6</td>
</tr>
</tbody>
</table>

### Glossary of Terms

<table>
<thead>
<tr>
<th>Term / Abbreviation</th>
<th>What it stands for</th>
</tr>
</thead>
<tbody>
<tr>
<td><strong>The PRSB</strong></td>
<td><strong>The Professional Records Standard Body</strong> 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.</td>
</tr>
<tr>
<td><strong>The PRSB CTOP</strong></td>
<td><strong>PRSB clinical and technical operations panel</strong></td>
</tr>
<tr>
<td><strong>NHS E &amp; I</strong></td>
<td><strong>NHS England &amp; Improvement</strong> - 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.</td>
</tr>
  <tr>
    <td><strong>NHS D</strong></td>
    <td><strong>NHS Digital</strong> – 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<br>NHS X and NHS D have integrated with the Transformation Directorate at NHS England.</td>
  </tr>
  <tr>
    <td><strong>NHS X</strong></td>
    <td><strong>NHS X</strong> – 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.</td>
  </tr>
  <tr>
    <td><strong>NHS 111</strong></td>
    <td><strong>NHS 111</strong> - 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.<br>To get help from NHS 111, you can:<ul><li>Go online to 111.nhs.uk (for assessment of people aged 5 and over only).</li><li>Call 111 for free from a landline or mobile phone.</li></ul></td>
  </tr>
  <tr>
    <td><strong>NHS 24</strong></td>
    <td><strong>NHS 24 – Scotland 111 service</strong> - provides urgent care and advice when your general practice, pharmacy or dental practice is closed</td>
  </tr>
  <tr>
    <td><strong>111 Online</strong></td>
    <td><strong>111 Online</strong> - is a fast and convenient alternative to the 111-phone service and provides an option for people who want to access 111 digitally.<br>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</td>
  </tr>
  <tr>
    <td><strong>111 CAS</strong></td>
    <td><strong>111 Clinical Assessment Service</strong> - 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&amp;E.</td>
  </tr>
  <tr>
    <td><strong>COVID 19</strong></td>
    <td><strong>COVID-19</strong> is a new form of coronavirus known as SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). It was first reported in December 2019</td>
  </tr>
  <tr>
    <td><strong>PEM For Information</strong></td>
    <td><strong>Post Event Message</strong> – A message that is sent back to the registered general practice informing them of the encounter with 111</td>
  </tr>
  <tr>
    <td><strong>PEM For Action</strong></td>
    <td><strong>Post Event Message</strong> – 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.</td>
  </tr>
  <tr>
    <td><strong>Repeat Caller</strong></td>
    <td>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).</td>
  </tr>
  <tr>
    <td><strong>Royal Colleges</strong></td>
    <td>The organisations that provide oversight and governance to the medical professions and provide endorsement to PRSB standards</td>
  </tr>
  <tr>
    <td><strong>BDA</strong></td>
    <td>British Dental Association</td>
  </tr>
  <tr>
    <td><strong>OCDO</strong></td>
    <td><strong>Office of the Chief Dental Officer</strong></td>
  </tr>
  <tr>
    <td><strong>RPS</strong></td>
    <td><strong>Royal Pharmaceutical Society</strong></td>
  </tr>
  <tr>
    <td><strong>BPS</strong></td>
    <td><strong>British Psychological Society</strong></td>
  </tr>
  <tr>
    <td><strong>NHS BaRS</strong></td>
    <td><strong>Booking and Referrals Standard</strong> - 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.</td>
  </tr>
  <tr>
    <td><strong>AACE</strong></td>
    <td><strong>Association of Ambulance Chief Executives - includes:</strong>
      <ul>
        <li>The National Ambulance Service Medical Directors (NASMeD)</li>
        <li>National Ambulance Service Directors of Operations (NDOG)</li>
        <li>National Digital Leaders Group (NDLG)</li>
      </ul>
    </td>
  </tr>
  <tr>
    <td><strong>CDSS</strong></td>
    <td><strong>Clinical Decision Support Systems</strong></td>
  </tr>
  <tr>
    <td><strong>NHS Pathways</strong></td>
    <td><strong>NHS Pathways</strong> - NHS owned algorithmic clinical assessment tool</td>
  </tr>
  <tr>
    <td><strong>NHS Pathways Outcome codes SG, SD &amp; DX Codes</strong></td>
    <td><strong>SG – Symptom Group – Presenting Need / Issue</strong><br>
      <strong>SD – Symptom Discriminator – Severity, Clinical need</strong><br>
      <strong>DX – Disposition Code – Urgency</strong></td>
  </tr>
  <tr>
    <td><strong>AMPDS</strong></td>
    <td><strong>Advanced Medical Priority Dispatch System (AMPDS)</strong> is a unified system used to dispatch appropriate aid to medical emergencies including systematized caller interrogation and pre-arrival instructions</td>
  </tr>
  <tr>
    <td><strong>DOS</strong></td>
    <td><strong>The Directory of Services (DoS)</strong> 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.</td>
  </tr>
  <tr>
    <td><strong>PODAC Program</strong></td>
    <td><strong>Pharmacy, Optometry, Dentistry, Ambulance and Community</strong> - national Digital PODAC programme to improve digitisation and productivity using digital technology across PODAC sectors.</td>
  </tr>
  <tr>
    <td><strong>ECDS</strong></td>
    <td><strong>The Emergency Care Data Set (ECDS)</strong> is the national data set for urgent and emergency care. It replaced Accident and Emergency Commissioning Data Set</td>
  </tr>
  <tr>
    <td><strong>ED</strong></td>
    <td><strong>Emergency Department</strong> (also known as A&amp;E)</td>
  </tr>
  <tr>
    <td><strong>111 – ED Pilot</strong></td>
    <td>A First of Type use case using the 111 Referral standard</td>
  </tr>
  <tr>
    <td><strong>FoT</strong></td>
    <td><strong>First of Type</strong></td>
  </tr>
  <tr>
    <td><strong>ITK Message</strong></td>
    <td><strong>Interoperability Toolkit</strong> - provides specifications for electronic messaging between systems, supported by an accreditation for suppliers who build solutions that adhere to these specifications.</td>
  </tr>
  <tr>
    <td><strong>SNOMED CT</strong></td>
    <td><strong>Systematized Nomenclature of Medicine Clinical Terms</strong> 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.</td>
  </tr>
  <tr>
    <td><strong>Fast Healthcare Interoperability Resources (FHIR)</strong></td>
    <td><strong>FHIR</strong> is a Health Level Seven International (HL7®) <strong>standard</strong> for exchanging healthcare information electronically. ... <strong>FHIR</strong> combines the best features of previous <strong>standards</strong> into a common specification, while being flexible enough to meet needs of a wide variety of use cases within the healthcare ecosystem.</td>
  </tr>
  <tr>
    <td><strong>IUC Specification</strong></td>
    <td><strong>Integrated Urgent Care Service Specification</strong></td>
  </tr>
  <tr>
    <td><strong>Use Case</strong></td>
    <td>A methodology used in system analysis to identify, clarify, and organise system requirements</td>
  </tr>
  <tr>
    <td><strong>NHS appointment booking standard</strong></td>
    <td>The NHS appointment <strong>booking standard</strong> is an open <strong>standard</strong> supporting <strong>booking</strong> across many <strong>care</strong> settings. It utilises the <strong>Care Connect FHIR</strong> messaging <strong>standard</strong> and is being published in the form of a website</td>
  </tr>
  <tr>
    <td><strong>API</strong></td>
    <td><strong>Application Programming Interface</strong>, 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.</td>
  </tr>
  <tr>
    <td><strong>Clinical Document Architecture (CDA)</strong></td>
    <td>The <strong>HL7 Version 3 Clinical Document Architecture (CDA®)</strong> is a document markup standard that specifies the structure and semantics of "clinical documents" for the purpose of exchange between healthcare providers and people.</td>
  </tr>
</tbody></table>

### 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

## 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&amp;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.

### 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.

### 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 &amp; 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.

### 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.

<table>
<thead>
<tr>
<th>Section Name</th>
<th>Conformance - Mandatory, Required, Optional</th>
<th>Description</th>
</tr>
</thead>
<tbody>
<tr>
<td>Person demographics</td>
<td>Mandatory</td>
<td>The person's details and contact information.</td>
</tr>
<tr>
<td>Caller Details</td>
<td>Required</td>
<td>Name of caller, relationship, telephone number and preferred contact method. For use where the caller isn't the person needing care or advice,</td>
</tr>
<tr>
<td>GP practice details</td>
<td>Required</td>
<td>Details of the person's GP practice.</td>
</tr>
<tr>
<td>Dental Practice details</td>
<td>Required</td>
<td>Details of the person's usual dental practice.</td>
</tr>
<tr>
<td>Individual requirements</td>
<td>Required</td>
<td>Note that the Individual requirements section includes reasonable adjustment and specific elements for accessible information requirements to support communication.</td>
</tr>
<tr>
<td>Safeguarding</td>
<td>Required</td>
<td>Any safeguarding concerns identified</td>
</tr>
<tr>
<td>Risks</td>
<td>Required</td>
<td>Any risks identified, includes risks to self or to others</td>
</tr>
<tr>
<td>Consent for information sharing</td>
<td>Required</td>
<td>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.</td>
</tr>
<tr>
<td>Referral details</td>
<td>Mandatory</td>
<td>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.</td>
</tr>
<tr>
<td>Presenting Complaints or issues</td>
<td>Mandatory</td>
<td>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.</td>
</tr>
<tr>
<td>Problem</td>
<td>Required</td>
<td>Provides either a diagnosis or the chief clinical concern. These are only likely to be available where there has been a clinical assessment.</td>
</tr>
<tr>
<td>Clinical Summary</td>
<td>Required</td>
<td>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.</td>
</tr>
<tr>
<td>Social Context</td>
<td>Required</td>
<td>The social setting in which the person lives, such as their household (e.g. lives alone), occupational history, and lifestyle factors.</td>
</tr>
<tr>
<td>Allergies and adverse reactions</td>
<td>Required</td>
<td>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).</td>
</tr>
<tr>
<td>Medications and medical devices</td>
<td>Required</td>
<td>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.</td>
</tr>
<tr>
<td>Plan and requested actions</td>
<td>Required</td>
<td>The details of any actions or plans for the person (or carer) or the receiving professional.</td>
</tr>
<tr>
<td>Person and carer concerns expectations and wishes</td>
<td>Required</td>
<td>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.</td>
</tr>
</tbody>
</table>

### 1.4 Recommendations

The following recommendations are made to support implementation, adoption and achieving the full benefits of the engagement and the standard:

1. 111 services should work towards using SNOMED CT for coding the outputs. SNOMED CT is the NHS’s chosen standard for clinical terminology, and there are many advantages to using coded data at both the sending and receiving ends of the referral. The use of SNOMED CT is increasing across the NHS, is specified and used in the developing UK Core FHIR specifications and standards, for other transfers of care standards and used extensively in emergency departments and urgent care driven in part by the use of the emergency care dataset (ECDS) which uses SNOMED CT.
2. Consider if 111 call handlers in England are able to provide a summary for onward referrals as happens with NHS24 in Scotland.
3. Implementation of the general practice PEM should be combined with the implementing the 111 referral to general practices. Consider the workflow and handling in the general practice system to ensure the PEM is distinguished from the referral and both are handled in appropriate ways.
4. Consideration should be given to format and layout of the PEM to ensure it meets the requirements of 111 services and general practice services.
5. The current 111 report or ITK message could be edited to remove the negative responses to the pathways clinical triage, and instead clearly show the resulting disposition (symptom group and symptom discriminator) codes and urgency (DX codes). This would make the current 111 report useful and useable to both receivers of 111 referrals and to general practices receiving the “For Information” 111 report (or PEM).
6. In parallel with the recommendation 5 above, engagement with both general practice system suppliers and general practices could explain the difference between the current 111 report “For Action” (or 111 referral) from the 111 report “For Information” (or PEM) so they can be easily distinguished and handled in the appropriate ways. This could change the use of these current messages to be useful and effective, rather than difficult or ignored.
7. Revise the general practice PEM ‘never send list’ based on feedback from our GP consultation and further engagement with GPs. There are a number of never send conditions where the feedback indicated that GPs would like to receive the PEM.
8. Consider the existing service data sets; ECDS, Ambulance, Integrated Urgent Care when 111 moves to using SNOMED CT, to ensure the codes selected at 111 call handler and/or CAS level will be received and align with these already defined data sets.
9. Pilot and test the BaRS including the 111 referral standard in the other destination areas beyond 111 to ED, as is being planned in the BaRS programme.
10. Primary care systems should be able to handle qualifiers (e.g. a suspected diagnosis) so these functions in SNOMED CT can be used safely all across health and care. This is recognised as being beyond the 111 Referral standard and BaRS, but needs to be addressed, particularly as general practice systems move to being able to receive structured coded messages.

### 1.5 Conclusion

In conclusion,

* The 111 referral standard has been developed through UK wide consultation and consensus.
* The BaRS team are currently piloting the draft standard for 111 to ED as a First of Type. Learning from this implementation will be used to update the standard and inform further pathways going forward.
* The general practice PEM is a subset of the 111 Referral standard as agreed as part of the consultation.

This Final report is the accumulation of the work carried out to produce the 111 Referral standard and describes the activities undertaken. Following approval of the standard and this final report by the BaRS product board and the PRSB assurance committee, endorsement will be sought from the relevant professional bodies and other key stakeholders.

Once the standard is endorsed and the initial 111 to ED pilot completed, PRSB will support the BaRS programme with approval of an Information Standards Notice (ISN) to give the standard a formal and legal basis.

### 2.1 Background and Context

The need for effective referral information for a person referred on from 111 services was identified as 111 services become more frequently used. In 2018, PRSB, commissioned by NHS England produced a report on urgent care information flows which set out the high-level requirements for a referral from a 111 clinical assessment service (CAS).

For several years, there has been focus on improving urgent and emergency services, primarily getting individuals to the most appropriate service for their needs., The COVID-19 pandemic raised the profile of this requirement. Revised schemes have been introduced over the past 2 years including bookings from 111 direct into Emergency Department (ED) systems listing arrival time slots so ED can manage arrival flows.

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 Pathways 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 PEM – for information.

A newer interoperability standard known as FHIR (Fast Healthcare Interoperability Resource) is now being adopted by many clinical IT systems which offers potential for an improved message sharing capability including urgent and emergency care systems and across the UK.

A need was identified for a new 111 referral standard, which can be implemented in FHIR and can provide clear and concise referral information to all receiving organisations (including ED, pharmacy, dentistry, optometry, mental health, community, and general practices). PRSB have been tasked with standardising the information captured and shared in the 111 report following a person encounter with the 111 service. The new 111 referral standard was commissioned by NHSX as part of the NHS Booking and Referral standard (BaRS ) programme. The long-term aim is for this standard to be part of a future standard or set of standards for referrals from any source to any destination.

NHS Digital’s Booking and Referrals Service (BaRS) are carrying out a First of Type (FoT) pilot for the 111 to ED referral and developing the FiHR messaging to support the draft PRSB 111 referral standard.

PRSB have produced the 111 referral standard following a UK wide full consultation.

### 2.2 Previous stages of work contributing to the standard

#### 2.2.1 2018 High level information requirements

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.

The report and requirements are referenced in Appendix 1

#### 2.2.2 2021 Discovery work

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

#### 2.2.3 2021 1st Draft Information Model

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.

## 3 Methodology and Consultation Approach

#### 3.1.1 Aims
To enable the flow of clear, succinct, and effective information for persons being referred on from 111 or 999 services to support the receiving organisations and clinicians in providing safer and more effective care.

The standard should be consistent with existing PRSB and other relevant standards and aim to be part of a future standard or set of standards for referrals from any source to any destination.

#### 3.1.2 Objectives
* Develop a standard for all 111 and 999 service referrals to wherever the person goes next, replacing the current 111 report with clear, succinct, and effective information to inform the receiver.
* The standard will work for 111 online, call handler or clinical assessment services and 999 services, and be achievable with the current pathways triage system used in England and all the UK nations.
* Facilitate and incorporate improvements from the 111 to emergency department pilot running in parallel through NHS Digital.

The critical success factors are:
* A standard endorsed and supported by the relevant professional bodies and organisations
* A standard which is part of a full implementable package
* A standard proven through pilot use in one area (111 to ED) and verified through consultation to be suitable for all 111 referrals
* Clinicians, providers, and system suppliers who have been engaged and are aware and keen to implement or adopt the standard.

#### 3.2.1 Benefits to the person contacting 111
An information standard for 111 referrals should support the person as follows:
* Individuals using the 111 services should trust that the information given to 111 will be passed on clearly and concisely to their next point of care so they do not need to repeat their story
* Individuals should be confident that their next point of care is correctly informed of their situation with a clear reason for referral so they can be referred to the correct services
* general practice should be notified of the 111 contacts (noted on the person’s record) so there is consistency of care

#### 3.2.2 Benefits to clinicians/professionals
For clinicians and other health and care professionals, an information standard would help ensure they can access all the information they need, supporting:
* Clear, easy to use information shared with the clinician so they can provide efficient, effective and safe treatment of the person
* Relevant information sharing – showing a clear reason for referral to allow a safe transfer or care
* Highlight chief complaint and clinical concerns to improve quality and allow improved feedback (where referrals are perceived as inappropriate for the setting referred to)
* Ensure the person’s general practice is informed of the person contact and referral through 111 services

### 3.3 Scope

A key principle used for the standard is that it should pass on the new information gathered in the 111 service, but not pass on 3rd party information which the receiving services for the referral could get directly themselves, e.g. risks identified by the 111 service, not risks available from the general practice or shared care record.

#### 3.31 In scope

Included in scope:

*   111 or 999 service referrals to all services
*   Contact through 111 online, call handler and clinician assessment services
*   The 111 post event message (PEM) to inform the general practice of the contact and, where there is one, the referral
*   All age groups including children
*   All UK nations
*   Support to the 111 to emergency department (ED) pilot being managed by NHS Digital, and to revise the standard as appropriate with the pilot feedback

#### 3.3.2 Exclusions from scope

Out of scope:

*   111 to 999 or 111 to another 111 service (e.g. across a country border) – The consultation however, included all nations.
*   999 to 111 referral or transfer. This is more complex and includes clinical validation of 999 triage and needs different data to the other 111 and 999 referrals included in scope.
*   Referral from other sources to ED or other urgent care destinations. The overall vision is for a standard or set of consistent standards for referral from any source to any destination, which will be approached in stages with this being a key stage and aligning with other existing PRSB standards
*   Specific work around any differences for Scotland, Wales or Northern Ireland, which would require separate funding from those countries.

### 3.4 Project Governance and Resources

The project reported into the already existing Booking and Referral standard (BaRS) product board.

The methodology and products were approved through the PRSB assurance committee.

The project team included two clinical leads (a GP and an ED consultant) plus a patient/person lead, all of whom continued from the previous 2021 work to ensure continuity.

### 3.5 Development and Consultation Approach

The development and consultation approach followed the proven and trusted PRSB methodology, although the work was spread over several years and phases (commissions).

Research and evidence gathering, initial shaping of the information requirements and developing of those information requirements through a multi-disciplinary workshop was conducted in the 2018 requirements work.

The 2021 discovery work validated the 2018 work and concluded it could apply to 111 services through a call handler or 111 online as well as through a clinical assessment service.

The 2022 (Phase 3) work approach included:

*   Wide consultation through a survey for users of services, senders of referrals 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 delayed to May/June 2022 to gather and analyse feedback from the 111 to ED pilots and update the standard as appropriate.

### 4.1 111 Referral wide consultation

The PRSB develops standards for use across the UK. As part of the consultation for the 111 Standard all UK nations were included in any stakeholder communications and encouraged to take part in the consultation. Specific conversations were held with both Scotland and Wales (NI didn’t respond) during the 2021 discovery work to raise awareness and understand key differences.

#### 4.1.1 Survey – 10 November 2021 – 12 December 2021

In November and December 2021, the project team launched a survey to a large stakeholder group which was closed on 12 December 2021. The Full 111 Referral Survey report is referenced in Appendix 3

Overall respondent information:

*   416 responses were collected
*   35% respondents were receiving services (n=136)
*   25% respondents were potential users of 111 services (n=94)
*   18% respondents were 111 service providers (n=69)
*   17% respondents classified themselves as ‘other’ (n=61)
*   4% respondents were 999 service providers (n=13)

#### 4.1.2 General feedback on the items within the information standard:

*   Key demographic information about the individual was considered to be the most important part of the referral e.g. name, address, NHS number
*   Information about urgency and complaint also considered very important along with a summary of the need/support required
*   Some demographic information was seen as the least important including ethnicity, immigration status and overseas visitor status
*   Users of 111 services found the level of urgency and summary of needs most important with most demographics such as pronouns, religion, ethnicity, and gender are the least important

72% respondents did not think any other information should be shared as part of a 111 referral. Of those that thought additional information should be added, examples included COVID-19 status, medical history (including mental health), life-style factors (like alcohol use), risk to others and end of life preferences.

The information that some respondents suggested should be included in the 111 referral standard was information that could already be accessed using other methods. The principle of the 111 referral standard was that it did not share information that was already recorded elsewhere in the system e.g. general practice electronic record, Special Patient Notes (SPN’s), and shared care record, but captured ‘new’ information relevant to the persons current complaint or issue.

#### 4.1.3 Concerns about the standard

60 comments were received noting concerns about the standard (16% all respondents) with the majority referring to the layout and format of the existing PEM, but there were also concerns about information relevance:

*   “[The length of the standard is] potentially overwhelming and of little relevance to a fit healthy individual with an isolated non-lethal acute injury”
*   “[There is the] potential to include too much [information] burying important information in a mass of irrelevant information”
*   “[Sometimes] clinicians get referrals and ask ‘why am I being sent this…they could have been seen by their general practice etc” and this erodes trust in the pathways system”

#### 4.1.4 Mitigating concerns raised during consultation

The concerns raised during consultation can be mitigated via:

1. Implementation guidance – which will reference that information captured is ‘mandatory’, ‘required’ or ‘optional’. Very little information in the standard is ‘mandatory’, where it is ‘required’ or ‘optional’, it is captured where it is relevant to the individual.
2. Training – implementation of the standard via systems and technology will require some training. This training can reference how the information standard is used in practice i.e. not all information will be relevant.
3. System set-up – ensure that feedback on the layout and format of the PEM is feedback to NHSE and system suppliers who can develop the format based on said feedback
4. The use of the SNOMED CT : - ^1127581000000103 |Health issues simple reference set| when recording the chief clinical concern, has raised an issue over the ability of Primary Care systems to use and record the qualifier associated with a suspected diagnosis e.g. UTI with a qualifier of ‘suspected’. The primary care clinical systems may only bring through the diagnosis of a UTI without the qualifier, causing an incorrect confirmed diagnosis to be recorded. This is mitigated in the hazard log and implementation guidance which make clear that diagnosis qualifiers should not be used in coded form until such time as primary care systems can handle them correctly.

As 111 Pathways (used in England 111 triage systems) is not yet SNOMED compliant, the symptom Group code (SG code) and Symptom Discriminator (SD) code descriptions (terms) will replace Chief Complaint and Chief Clinical Concern when identified by the CAS. The clinician can enter suspected diagnosis in free text.

### 4.2 Survey follow-up sessions

The survey reached a wide variety of stakeholders however, analysis of the survey highlighted a number of areas with a low number of responses, including some potential endorsers of the standard. Follow up sessions with those low responding groups were held on the following dates:

*   Royal College of Psychiatrists (RCPsych) – 17 January 2022
*   British Psychological Society (BPS) – 26 January 2022
*   Office of the Chief Dental Officer (OCDO) – 18 January 2022
*   British Dental Association (BDA) – 10 February 2022
*   Royal Pharmaceutical Society (RPS) – 19 January 2022
*   College of Optometrists – 31 January 2022

#### 4.2.1 Key points from these sessions included:

**Mental Health Focus Groups (RC Psych &amp; BPS)**

The Royal College Psychiatry raised a concern over the ability to record and share **all** medications a person may be taking when using the standard. Their concern was regarding medications that may be being prescribed by mental health trusts (e.g. clozapine / depot antipsychotics), but may not be recorded within the general practice record. The RCPsych suggested the inclusion of any ‘over the counter’ and ‘medications’ bought online that the person maybe taking. Some medications bought online or over the counter relate to contraindications with a person’s prescribed drugs and risks of overdose for mental health presentations.

The implementation guidance was updated to include the recommendations for the capturing of medications known be taken but not recorded in the general practice record.

**Dentistry Focus Groups (BDA &amp; OCDO)**

The BDA policy team responded to the survey and engaged with the additional focus groups.

Dentists do not yet have access to shared care records, but increasingly it is noted that dentists require specific information about a person referred from 111. Individual requirements and in particular; obesity/bariatric (fit in dentist chair), anxiety, other mental health conditions, impairments would be helpful before treating a person.

The OCDO who are working closely with the PODAC programme (which includes the 111 referral) have highlighted that when a person calls 111 with an oral health issue the call is transferred to a 111 dental call handler. To ensure the person’s own dentist is updated with any treatment or advice from the 111 service it has been suggested that the 111 referral standard should include a section to capture the person’s registered / usual dentist (if they have one).

The standard was updated to include a new section for Dental Practice (based on the existing GP Practice section.

**Community Pharmacy Focus Group (RPS)**

Many pharmacies now have access to the Summary Care Record or GP Connect record viewer so are able to view some general practice information to support the direct care of an individual. As part of the discussion with RPS it was noted that ‘new’ Risks were not in the 111 Referral standard. This was taken back to the project team as an omission and ‘risks’ were added in to the Standard. Risks, currently can be added as free text or when SNOMED compatible, the standard will look to the SNOMED coding to capture any ‘new’ risks identified. To ensure there is no ambiguity as to whether there are risks or not, the standard mandates that the risk element requires a response so the 111 call handler or CAS clinician needs to state if there are ‘no known risks’

**Optometry Focus Group (College of Optometrists)**

Many optometry practices in England are, and increasingly, offering urgent/emergency eye care services. These are commissioned locally but not consistently as yet across England. Local NHS111 Teams should be aware of these urgent/emergency commissioned services in optometry practices and the mechanisms to communicate with them, the provision of which will vary locally including how they receive referrals. The 111 Referral standard would support the digital communication between 111 and optometry. This is expected to be delivered by the PODAC program.

### 4.3 999 Services Validation

PRSB carried out a validation exercise to confirm that the 999 services could provide the essential information to populate the 111 referral standard. This was done on the basis that the referral must contain a minimum set of information regarding:

*   the person with the concern / issue - the person demographics
*   referral details – where from and to, and urgency
*   presenting complaints
*   chief complaint

The validation compared the 999 data model (used for transferring information from 999 to 111 CAS services for clinical validation) with the 111 referral standard which showed that the essential elements could be populated by the 999 service.

The validation work concluded that the draft 111 referral standard information could be extracted from the 999 services to provide a referral to non-ambulance related destinations and therefore be included in scope of the 111 referral standard.

The BaRS 999 to CAS Data Model for endorsement is shown in Appendix 4.

### 4.4 General Practice PEM Consultation

#### 4.4.1 GP interviews re 111 Post Event Message – June 2021

The GP interviews asked GPs to feedback on the content and format of the Post Event Messages (PEMs) currently received in the General Practices systems from 111. The GP interviews were carried out via Teams during June 2021 using a prompting questionnaire.

**Interviewees:**

1/6/2021 Dr Andrew Sharpe, Surrey Heartlands GP and Shared Care Record CCIO
2/6/2021 Dr Ayesha Azhar, GP at NHS NENE CCG
3/6/2021 Kieran Sharrock, Lincolnshire Partnership NHS Foundation Trust

The main interview findings were that the PEM:

*   Contains too much unnecessary information e.g., the negative responses that the NHS pathway algorithm capture are returned in the PEM
*   The general practice Referral and the general practice PEM from 111 are not easily distinguishable by the receiving general practice
*   Differences in the understanding of what actions need to be undertaken on receipt of a PEM ‘for information’ or ‘for action’.
*   The rendering of the PEM document in the general practice Clinical System is reliant on the local receiving system configuration, not the 111 sending systems.
*   General practice PEM Actions be sent back as part of the coded messaging back to general practice clinical system via general practice Workflow.

Following the GP interviews carried out in June 2021 the PEM element of the 111 Standard project was taken back by NHS Digital to be delivered by the NHS Digital PEM’s team.

#### 4.4.2 Joint GP IT Committee Meetings

PRSB attended two Joint GP IT Committee meetings:

**9th June 2021** – to update the committee on the 111 referral standard feedback from recent GP interviews regarding the general practice PEM and gather further insight regarding the PEM from the GP IT Committee members.

**Outcomes**

*   The JGPIT committee are in full support of the PEM work and requested to be involved in the development of the general practice PEM.
*   They agreed with the findings from the GP interviews, particularly regarding the location of the clinical information in the existing 111 reports. The important information not being easy to locate and could lead to increased clinical risk.
* Concerns were raised about the possible financial implications if making rigid changes to the PEM in England, without consulting the rest of the UK. As changes may need to be made to Scottish supplier systems and this would have a cost attached.

**26th January 2022** – to provide an update on the 111 Referral standard survey. Gather views on the content and structure of the PEM, when it shouldn’t be sent to the practice, and discuss the existing workflows in practices on receipt of the PEM to help inform the agenda and questions for the GP focus group sessions.

**Outcomes**

Discussions regarding the status of the 111 standard and the PEM. A Mentimeter interactive questionnaire was undertaken (see table 1 below). JGPIT members raised a concern regarding the requirement to read a PEM for information. Some GP’s file the PEM in the patient record without reading / coding. A discussion was had as to whether the GP contract required GP’s to read all PEMs for information. Further discussions with the NHS Policy team confirmed that the contract does not state what a GP should do on receipt of a PEM. It is for the clinician to assess the contents and decide what is appropriate to capture and code on the individuals general practice record.

Joint GPIT Committee meeting Mentimeter outputs are shown in Appendix 5

#### 4.4.3 GP focus groups – February 2022

PRSB carried out some initial GP interviews in early 2021 and NHS Digital’s PEM team carried out further discovery work during 2021 with GPs in England gathering feedback on the content and structure of the existing PEM and the processes within general practices on receipt of a PEM. NHS Digital’s PEM report is shown in Appendix 6

The Post Event Message (PEM), received by the general practice following a person's encounter with 111, was brought back into the scope of the PRSB commissioned work in late 2021. PRSB utilised the NHS Digital’s PEM report to support the additional GP focus groups and attended the Joint GPIT committee meeting in Feb 2022 to gather further insight and confirm the information required to flow back to the general practice in the PEM for information.

Two GP focus groups were held with attendees from three of the four nations. The 1st focus group was attended by 12 external delegates, 6 of which were GPs, the 2nd group had 16 attendees with 9 of them GP’s. Each group was taken through the 111 Referral standard and asked which items from the information standard would improve the content of the PEM for information. Mentimeter was used to gather some of the information, from the GP Focus groups.

The Mentimeter outputs are shown in Appendix 7

Key findings included:

*   111 reports are currently received into general practice via ITK Messaging direct into their clinical systems or via email into the document management system.
*   111 Reports can be either ‘For action’ or ‘For information’.
*   Local system configuration is required to render the ‘For information’ or ‘For action’ in the document header The current 111 reports received by general practices, are not always clearly distinguishable as either ‘For action’ or ‘For information’.
* This is translated from the sending system and rendered by the receiving system, but this is not consistent across the country. Hence the confusion over ‘For action’ or ‘For information’ within general practices.
* Some suppliers convert the XML coding applied at the provider end for either ‘For action’ or ‘For Information’ into human readable format so that it is displayed when rendered as a PEM in the receiving system. This is not visible to all recipients as relies on local system configuration.
* Local systems determine how the referral and PEM are rendered in a receiving organisation.
* A PEM for information (i.e. not a referral PEM) is processed differently in individual practices across the UK. Some PEMs are directly filed in the person’s general practice record and not read by the GP.
* Generally, the 111 encounter itself is coded to a person’s GP.
* Information within the PEM ‘For information’ is rarely coded into the general practice person record.
* Excluding demographic type data, the key information that should be included in the 111 PEM is as follows:
    * general practice details
    * Individual requirements
    * Safeguarding and risks
    * Referral details (where from, where to and urgency)
    * Plan and requested actions for both the general practice and the person
    * Presenting complaints or issues
    * Chief Complaint
    * Chief Clinical Concern
    * Diagnosis
    * Allergies and allergies (new)
    * Medications and medical devices (new)
    * Clinical summary (following CAS)

* There is an NHS England predefined ‘Never send list’ where a 111 PEM is not sent to the general practice. Discussions with GP’s highlighted that the never send list included some 111 reports that they felt should come to the general practice and as part of the Mentimeter questions GP’s identified when they would not want to receive a PEM. These are shown in the Mentimeter outputs, but are essentially calls which are about finding services or information rather than seeking help on a problem.

#### 4.4.4 Variance in 111 systems and general practice processes across the UK

**England**
*   NHS 111 use NHS Pathways clinical assessment tool
*   Pathways is not SNOMED compliant
*   111 can book direct into general practice appointments and ED appointments
*   111 send a 111 report to General Practice which can be for action or for information

**Scotland**
*   NHS24 cannot book direct into general practice appointments.
*   Persons are advised to contact their general practice and a PEM is sent to the practice.
*   The PEM in Scotland is received into the general practice system via Docman and work flowed as a PDF.
*	The format requires improvement pending moving to coded structured data.
*	Actions for the general practice need to be clearly stated at the top of the document, currently this is hard to find, usually at the bottom of the document.
*	The 111 Referral standard would improve the format and content of the PEM.

**Wales**
*	111 Wales is undergoing a large 111 programme including the procurement of a new 111 system – Solus.
*	The PEM informing the general practice of a contact with 111 includes the reason for the call and the duration of any symptoms.
*	A clinical assessor will not be able to make a referral.
*	The outcome is for the person: ‘Advised to contact general practice’.
*	Referrals are made only via the Clinical Support Hubs (CAS in England)
*	111 Wales are not able to book direct into general practice appointments so 111 referrals are always for the daytime GP to action as they feel fit, but highlighted by specific informational outcomes.

**Northern Ireland**
There was no feedback from the consultation that could be linked back to any individual roles, services or organisations from Northern Ireland.

*	Health and Care Northern Ireland provide 111 type services via 5 separate GP OOH’s service

## 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.**

<table>
<thead>
<tr>
<th>Section Name</th>
<th>Conformance - Mandatory, Required, Optional</th>
<th>Description</th>
</tr>
</thead>
<tbody>
<tr>
<td>Person demographics</td>
<td>Mandatory</td>
<td>The person's details and contact information.</td>
</tr>
<tr>
<td>Caller Details</td>
<td>Required</td>
<td>Name of caller, relationship, telephone number and preferred contact method. For use where the caller isn't the person needing care or advice,</td>
</tr>
<tr>
<td>GP practice details</td>
<td>Required</td>
<td>Details of the person's GP practice.</td>
</tr>
<tr>
<td>Dental Practice details</td>
<td>Required</td>
<td>Details of the person's usual dental practice.</td>
</tr>
<tr>
<td>Individual requirements</td>
<td>Required</td>
<td>Note that the Individual requirements section includes reasonable adjustment and specific elements for accessible information requirements to support communication.</td>
</tr>
<tr>
<td>Safeguarding</td>
<td>Required</td>
<td>Any safeguarding concerns identified</td>
</tr>
<tr>
<td>Risks</td>
<td>Required</td>
<td>Any risks identified, includes risks to self or to others</td>
</tr>
<tr>
<td>Consent for information sharing</td>
<td>Required</td>
<td>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.</td>
</tr>
<tr>
<td>Referral details</td>
<td>Mandatory</td>
<td>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.</td>
</tr>
<tr>
<td>Presenting Complaints or issues</td>
<td>Mandatory</td>
<td>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.</td>
</tr>
<tr>
<td>Problem</td>
<td>Required</td>
<td>Provides either a diagnosis or the chief clinical concern. These are only likely to be available where there has been a clinical assessment.</td>
</tr>
<tr>
<td>Clinical Summary</td>
<td>Required</td>
<td>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.</td>
</tr>
<tr>
<td>Social Context</td>
<td>Required</td>
<td>The social setting in which the person lives, such as their household (e.g. lives alone), occupational history, and lifestyle factors.</td>
</tr>
<tr>
<td>Allergies and adverse reactions</td>
<td>Required</td>
<td>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).</td>
</tr>
<tr>
<td>Medications and medical devices</td>
<td>Required</td>
<td>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.</td>
</tr>
<tr>
<td>Plan and requested actions</td>
<td>Required</td>
<td>The details of any actions or plans for the person (or carer) or the receiving professional.</td>
</tr>
<tr>
<td>Person and carer concerns expectations and wishes</td>
<td>Required</td>
<td>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.</td>
</tr>
</tbody>
</table>

### 5.1 Information Standard

The information model was developed in PRSB’s Art-Décor information modelling tool. Wherever possible it uses existing components from PRSB standards to ensure consistency between standards and facilitate reuse, including items such as technical (FHIR) specifications. The new elements added for this standard are:

* Caller Details section – to provide details of the caller where it is not the person seeking care themselves.
* Referral Details
    * Person input to service selection – indicating if and what input a person had to their referral service selection
    * Person Referral Reference – a marker for a future reference the person could use on arrival at the referral destination
    * Journey ID – a marker for a future ID to track multiple referrals
* Presenting complaints
    * Repeat caller – to indicate the person has called more than twice in 96 hours
* Dental Practice – To provide details of a person’s usual dental practice.

The information model will be published on the PRSB website and made available in machine readable form for use by system suppliers and technical message developers.

The information model includes implementation guidance at a section and element level, and a business rules document will be published alongside the standard.

**111 Referral standard – Full version is referenced in Appendix 8**

## 6 Clinical Safety Case

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 essential structures of a CSMS have been implemented in this project through the consultation with healthcare professionals, persons, informaticians and system suppliers, during the development of the standard.

For this standard PRSB has produced a Clinical Safety Case and hazard log. These will be approved through the NHS Digital CSG and published on the PRSB website with the standard. Updates to the clinical safety case are the responsibility of PRSB.

The consultation process for the clinical safety case is described in the Clinical Safety Case Report. During the consultations, hazards were identified, reviewed and mitigations / actions considered. Nevertheless, some risks are inherent in the standards, but most have been either:
* mitigated during the development of the standards (including the clinical safety case)
or
* the residual risk has been transferred (with guidance) to the implementers

**The Clinical Safety Case and Hazard Log are referenced in Appendix 9**

## 7 Recommendations

The following recommendations are made to support implementation, adoption and the achieving the full benefits of the engagement and the standard:

1. 111 services should work towards using SNOMED CT for coding the outputs.
SNOMED CT is the NHS’s chosen standard for clinical terminology, and there are many advantages to using coded data at both the sending and receiving ends of the referral. The use of SNOMED CT is increasing across the NHS, is specified and used in the developing UK Core FHIR specifications and standards, for other transfers of care standards and used extensively in emergency departments and urgent care driven in part by the use of the emergency care dataset (ECDS) which uses SNOMED CT.

2. Consider if 111 call handlers in England are able to provide a summary for onward referrals as happens with NHS24 in Scotland.

3. Implementation of the general practice PEM should be combined with the implementing the 111 referral to general practices. Consider the workflow and handling in the general practice system to ensure the PEM is distinguished from the referral and both are handled in appropriate ways.

4. Consideration should be given to format and layout of the PEM to ensure it meets the requirements of 111 services and general practice services.

5. The current 111 report or ITK message could be edited to remove the negative responses to the pathways clinical triage, and instead clearly show the resulting disposition (symptom group and symptom discriminator) codes and urgency (DX codes). This would make the current 111 report useful and useable to both receivers of 111 referrals and to general practices receiving the “For Information” 111 report (or PEM).

6. In parallel with the recommendation 5 above, engagement with both general practice system suppliers and general practices could explain the difference between the current 111 report “For Action” (or 111 referral) from the 111 report “For Information” (or PEM) so they can be easily distinguished and handled in the appropriate ways. This could change the use of these current messages to be useful and effective, rather than difficult or ignored.

7. Revise the general practice PEM ‘never send list’ based on feedback from our GP consultation and further engagement with GPs. There are a number of never send conditions where the feedback indicated that GPs would like to receive the PEM.

8. Consider the existing service data sets; ECDS, Ambulance, Integrated Urgent Care when 111 moves to using SNOMED CT, to ensure the codes selected at 111 call handler and /or CAS level will be received and align with these already defined data sets.

9. Pilot and test the BaRS including the 111 referral standard in the other destination areas beyond 111 to ED, as is being planned in the BaRS programme.

10. Primary care systems should be able to handle qualifiers (e.g. a suspected diagnosis) so these functions in SNOMED CT can be used safely all across health and care. This is recognised as being beyond the 111 Referral standard and BaRS, but needs to be addressed, particularly as general practice systems move to being able to receive structured coded messages.

## 8 Conclusion

In conclusion,
*   The 111 referral standard has been developed through UK wide consultation and consensus.
*   The BaRS team are currently piloting the draft standard for 111 to ED as a First of Type. Learning from this implementation will be used to update the standard and inform further pathways going forward.
*   The general practice PEM is a subset of the 111 Referral standard as agreed as part of the consultation.

This Final report is the accumulation of the work carried out to produce the 111 Referral standard and describes the activities undertaken. Following approval of the standard and this final report by the BaRS product board and the PRSB assurance committee, endorsement will be sought from the relevant professional bodies and other key stakeholders.

Once the standard is endorsed and the initial 111 to ED pilot completed, PRSB will support the BaRS programme with approval of an Information Standards Notice (ISN) to give the standard a formal and legal basis.

### 9.1 Appendix 1 – Urgent care information flows report (2018)
Urgent care information flows – PRSB (theprsb.org)

### 9.2 Appendix 2 – PRSB discovery report
The discovery report from the 2021 work will be available on the 111 Referral Standard webpage.

### 9.3 Appendix 3 – PRSB 111 Referral Survey report
The survey report will be available on the 111 Referral Standard webpage.

### 9.4 Appendix 4 - BaRS 999 to CAS Data Model validation

<table>
    <tbody><tr>
        <td style="vertical-align:top;">
            <strong>Business Element</strong><br>
            <strong>Patient demographics</strong><br>
            Patient name<br>
            Patient NHS Number<br>
            Patient identifier (Local)<br>
            NHS number verification status<br>
            Patient telecom<br>
            Patient gender<br>
            Sex assigned at birth<br>
            Patient date of birth<br>
            Patient age group<br>
            Patient Address<br>
            Patient Ethnicity<br>
            Patient communication preferences<br>
            Patient’s Registered General Practice (GP)<br>
            Overseas visitor status<br>
            Emergency contact<br>
            <strong>Social context</strong><br>
            Household composition<br>
            Social circumstances<br>
            Accomodation status<br>
            <strong>Third party caller</strong><br>
            Third party caller relationship<br>
            Third party caller name<br>
            Third party caller telecom<br>
            Third party caller gender<br>
            Third party caller communication preferences<br>
            <strong>Service provider information</strong><br>
            Sending service name<br>
            Sending service ID<br>
            Receiving service name<br>
            Receiving service ID<br>
            <strong>Practitioner details</strong><br>
            Organisation<br>
            Practitioner name<br>
            Practitioner Role<br>
            Practitioner specialty<br>
            Practitioner contact details
        </td>
        <td style="vertical-align:top;">
            <strong>Timing data</strong><br>
            999 Call connect date/time<br>
            999 Disposition date/time<br>
            Validation breach date/time<br>
            Call back breach time<br>
            CAS Disposition date/time<br>
            <strong>Case identification data</strong><br>
            JourneyID<br>
            999 CAD Case number<br>
            CAS Case Number<br>
            <strong>Incident location</strong><br>
            Incident location<br>
            Incident Location ID (Property)<br>
            Incident Location ID (Property)<br>
            Incident Location Latitude<br>
            Incident Location Longitude<br>
            Incident Location Altitude<br>
            Incident Location Eastings<br>
            Incident Location Northings<br>
            Incident Location What3Words<br>
            Incident location type<br>
            Incident location supplementary information<br>
            <strong>999 Triage Information</strong><br>
            Pathways SG code/description<br>
            Pathways SD code/description<br>
            Pathways Dx code/description<br>
            Pathways Pathway Template code/description<br>
            AMPDS Dispatch Code/description<br>
            ARP Code/description<br>
            Clinical summary<br>
            Patient expectations<br>
            <strong>CAS Triage/Assessment Information</strong><br>
            Pathways SG code/description<br>
            Pathways SD code/description<br>
            Pathways Dx code/description<br>
            Pathways Pathway Template code/description<br>
            AMPDS Dispatch Code/description<br>
            ARP Code/description<br>
            Presenting complaint<br>
            Chief concern<br>
            Acuity<br>
            Next activity<br>
            Clinical summary<br>
            Patient expectations
        </td>
        <td style="vertical-align:top;">
            New Allergy information<br>
            New medication information<br>
            <strong>Action for receiving service</strong><br>
            Action for receiving service<br>
            <strong>Scene Safety</strong><br>
            Scene safe?<br>
            Hazards present<br>
            <strong>Safeguarding</strong><br>
            Safeguarding concern date identified<br>
            Safeguarding Coded value<br>
            Safeguarding free text<br>
            <strong>Resonable adjustments</strong><br>
            Reasonable adjustment Date<br>
            Reasonable adjustment Coded value<br>
            Reasonable adjustment Free text<br>
            <strong>ResPECT Plan</strong><br>
            ResPECT date<br>
            ResPECT Coded value<br>
            ResPECT Free text<br>
            <strong>Consent</strong><br>
            Consent date<br>
            Consent Coded value<br>
            Consent free text
        </td>
    </tr>
</tbody></table>

### 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.

### 9.6 Appendix 6 – Joint GPIT Committee Mentimeter outputs

<table>
<thead>
<tr>
<th>Q1</th>
<th>Currently, how easy is it, in the clinical system document workflow, to distinguish a ‘PEM for Information’ from a ‘PEM for Action’?</th>
<th>Easy – 0<br>Somewhat easy – 1<br>Quite difficult - 4<br>Impossible - 1</th>
</tr>
</thead>
<tbody>
<tr>
<td>Q2</td>
<td>Is a 111 Encounter where a PEM for information is produced coded into the patient record?</td>
<td>Yes, always - 0<br>Sometimes - 4<br>Never - 2</td>
</tr>
<tr>
<td>Q3</td>
<td>What things could or should trigger alerts or actions in the workflow ?</td>
<td>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)<br>The patient or carer needs be given clear written information to satiety net if action not met<br>Real safeguarding issues should be referred<br>Specific action should be a referral<br>No alerts should be for action in less than a week</td>
</tr>
<tr>
<td>Q4</td>
<td>Are prescriptions given by 111 If included in a PEM for information coded into the patient record?</td>
<td>Yes always - 0<br>Sometimes - 3<br>Never - 0</td>
</tr>
<tr>
<td>Q5</td>
<td>Excluding demographics what order should the New 111 Information Standard appear on the 111 PEM for Information?</td>
<td><strong>Respondent 1</strong><br>presenting complaint<br>Differential diagnosis<br>Management plan</td>
<td><strong>Respondent 2</strong><br>Action needed,<br>diagnosis,<br>history of complaint,<br>examination,<br>investigation,<br>treatment</td>
<td><strong>Respondent 3</strong><br>Presenting Symptoms<br>Differential diagnosis<br>Management plan<br>Action to be taken by general practice</td>
</tr>
</tbody>
</table>

### 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?

&lt;img&gt;
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
&lt;/img&gt;

Excluding the expected demographic type data, what information from the 111 Information Standard should be included in the 111 PEM?

<table>
<tbody><tr>
<td>1st</td>
<td style="background-color: blue;">Clinical summary (following CAS)</td>
</tr>
<tr>
<td>2nd</td>
<td style="background-color: pink;">Plan and requested actions (for both the GP and for person)</td>
</tr>
<tr>
<td>3rd</td>
<td style="background-color: red;">Presenting complaints or issues (includes repeat caller flag)</td>
</tr>
<tr>
<td>4th</td>
<td style="background-color: yellow;">Safeguarding &amp; Risks</td>
</tr>
<tr>
<td>5th</td>
<td style="background-color: green;">Suspected diagnosis</td>
</tr>
<tr>
<td>6th</td>
<td style="background-color: lightblue;">Medications (person reported, e.g. OTC, online)</td>
</tr>
<tr>
<td>7th</td>
<td style="background-color: brown;">Individual requirements (reasonable adjustments etc.)</td>
</tr>
<tr>
<td>8th</td>
<td style="background-color: blue;">Allergies (person reported)</td>
</tr>
<tr>
<td>9th</td>
<td style="background-color: pink;">Confirmed diagnosis</td>
</tr>
</tbody></table>

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.

### 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.

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

Final Report

Guidance For All Prsb Standards August 2023

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

### Reviewers

<table>
<thead>
<tr>
<th>Reviewer name</th>
<th>Title / Responsibility</th>
<th>Date</th>
<th>Version</th>
</tr>
</thead>
<tbody>
<tr>
<td>Sandip Kaur</td>
<td>Architect</td>
<td>Sep-2021</td>
<td>0.1</td>
</tr>
<tr>
<td>Charlie McCay</td>
<td>Technical Adviser</td>
<td>Sep-2021</td>
<td>0.1</td>
</tr>
<tr>
<td>Lorraine Foley</td>
<td>CEO</td>
<td>Sep-2021</td>
<td>0.1</td>
</tr>
<tr>
<td>Annette Gilmore</td>
<td>PRSB conformance lead analyst</td>
<td>Sep-2021</td>
<td>0.1</td>
</tr>
</tbody>
</table>

### Approved by

<table>
<thead>
<tr>
<th>Name</th>
<th>Date</th>
<th>Version</th>
</tr>
</thead>
<tbody>
<tr>
<td>PRSB Task and Finish Group</td>
<td>May-2022</td>
<td>1.1</td>
</tr>
</tbody>
</table>

### Glossary of Terms

<table>
<thead>
<tr>
<th>Term / Abbreviation</th>
<th>What it stands for</th>
</tr>
</thead>
<tbody>
<tr>
<td>dm+d</td>
<td>Dictionary of medicines and devices</td>
</tr>
<tr>
<td>EPR</td>
<td>Electronic Patient Record</td>
</tr>
<tr>
<td>FHIR</td>
<td>Fast Healthcare Interoperability Resources</td>
</tr>
<tr>
<td>GP</td>
<td>General Practitioner</td>
</tr>
<tr>
<td>HL7</td>
<td>Health Level 7</td>
</tr>
<tr>
<td>Metadata</td>
<td>A set of data that describes and gives information about other data</td>
</tr>
<tr>
<td>NICE</td>
<td>The National Institute for Health and Care Excellence</td>
</tr>
<tr>
<td>NHS</td>
<td>National Health Service</td>
</tr>
<tr>
<td>NHSDD</td>
<td>NHS Data Dictionary</td>
</tr>
<tr>
<td>NHSE/ NHSEI</td>
<td>NHS England/ now NHS England Improvement</td>
</tr>
<tr>
<td>NRLS</td>
<td>National Record Locator Service</td>
</tr>
<tr>
<td>ODS</td>
<td>Organisation Data Service</td>
</tr>
<tr>
<td>PDS</td>
<td>Personal Demographic Service</td>
</tr>
<tr>
<td>PRSB</td>
<td>Professional Record Standards Body</td>
</tr>
<tr>
<td>DAPB / DCB / SCCI</td>
<td>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</td>
</tr>
<tr>
<td>SNOMED-CT</td>
<td>Systematized Nomenclature of Medicine - Clinical Terms</td>
</tr>
</tbody>
</table>

### 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.

### 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.

### 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.

<table>
<thead>
<tr>
<th>Information Components</th>
<th>Model Description</th>
</tr>
</thead>
<tbody>
<tr>
<td>Section</td>
<td>A section groups together all the information related to a specific topic e.g. ‘Medications and medical devices’ and ‘Person demographics’.</td>
</tr>
<tr>
<td></td>
<td>It is the highest level to logically group data elements that may be independent or related. For example:</td>
</tr>
<tr>
<td></td>
<td>- ‘Legal information’ includes a set of independent elements or information items, grouped in a logical section.</td>
</tr>
<tr>
<td></td>
<td>- ‘Medications and medical devices’ includes sets of related elements with dependencies between the elements.</td>
</tr>
<tr>
<td>Record entry</td>
<td>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.</td></tr>
<tr><td>Cluster</td>
<td>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.</td></tr>
<tr><td>Element</td>
<td>The data item.

An element can appear in one or more sections e.g. name, date. </td></tr>
</tbody>
</table>

<table>
<thead>
<tr>
<th>Information model rules and instructions</th>
<th>Explanations</th>
</tr>
</thead>
<tbody>
<tr><td>Description</td>
<td>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.</td></tr>
<tr><td>Cardinality</td>
<td>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…… *.</td></tr>
<tr><td>Conformance</td>
<td>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.</td></tr>
<tr><td>Valuesets</td>
<td>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.</td></tr>
</tbody>
</table>
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.

<table>
  <tbody><tr>
    <td>Section</td>
    <td>Record entry</td>
    <td>Description</td>
    <td>Conformance</td>
    <td>Cardinality</td>
  </tr>
  <tr>
    <td>Risks</td>
    <td>Allergies and adverse reactions</td>
    <td>Details of any risks related to the person.</td>
    <td>R</td>
    <td>0 ... 1</td>
    <td></td>
  </tr>
  <tr>
    <td>Allergies and adverse reactions record entry</td>
    <td>Allergies and adverse reactions</td>
    <td>This is a allergies and adverse reactions record entry. There may be 1 to many record entries under this section.</td>
    <td>M</td>
    <td>1 ... 1</td>
    <td></td>
  </tr>
  <tr>
    <td></td>
    <td>Each record entry is made up of a number of elements or data items.</td>
    <td></td>
    <td>M</td>
    <td>1 ... *</td>
    <td></td>
  </tr>
  <tr>
    <td>Causative agent</td>
    <td>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"</td>
    <td></td>
    <td>M</td>
    <td>1 ... 1</td>
    <td></td>
  </tr>
  <tr>
    <td>Coded value</td>
    <td>The coded value for causative agent</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td></td>
  </tr>
  <tr>
    <td>Free text</td>
    <td>Free text field to be used if no code is available</td>
    <td></td>
    <td>R</td>
    <td>1 ... 1</td>
    <td>Valueset</td>
  </tr>
  <tr>
    <td>Reaction details cluster</td>
    <td>Details of the reaction.</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td>Free text</td>
  </tr>
  <tr>
    <td>Date</td>
    <td>The date that the reaction was identified.</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td>Date and time</td>
  </tr>
  <tr>
    <td>Location</td>
    <td>Details of where the allergy was identified.</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td></td>
  </tr>
  <tr>
    <td>Coded value</td>
    <td>The coded value for location.</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td>NHS data dictionary : - Organisation data service</td>
  </tr>
  <tr>
    <td>Free text</td>
    <td>Free text field to be used if no code is available</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td>Free text</td>
  </tr>
  <tr>
    <td>Substance</td>
    <td>The substance, or a class of substances, that is considered to be responsible for the adverse reaction.</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td></td>
  </tr>
  <tr>
    <td>Description of reaction</td>
    <td>A description of the manifestation of the allergic or adverse reaction experienced by the person. For example, skin rash.</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td></td>
  </tr>
  <tr>
    <td>Severity</td>
    <td>A description of the severity of the reaction.</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td></td>
  </tr>
  <tr>
    <td>Certainty</td>
    <td>A description of the certainty that the stated causative agent caused the allergic or adverse reaction.</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td></td>
  </tr>
  <tr>
    <td>Comment</td>
    <td>Any additional comment or clarification about the adverse reaction.</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td>Free text</td>
  </tr>
  <tr>
    <td>Type of reaction</td>
    <td>The type of reaction experienced by the person (allergic, adverse, intolerance)</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td>FHIR value set :- Allergy, Intolerance, Not known</td>
  </tr>
  <tr>
    <td>Evidence</td>
    <td>Results of investigations that confirmed the certainty of the diagnosis. Examples might include results of skin prick allergy tests</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td>Free text</td>
  </tr>
  <tr>
    <td>Date first experienced</td>
    <td>When the reaction was first experienced. May be a date or partial date (e.g. year) or text (e.g. during childhood)</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td>Date and time</td>
  </tr>
  <tr>
    <td>Probability of recurrence</td>
    <td>Probability of the reaction (allergic, adverse, intolerant) occurring.</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td>Free text</td>
  </tr>
  <tr>
    <td>Performing professional</td>
    <td>The professional who identified the reaction.</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td></td>
  </tr>
  <tr>
    <td>Person completing record</td>
    <td>Details of the person completing the record.</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td></td>
  </tr>
  <tr>
    <td>Medications and medical devices</td>
    <td>Medications and medical devices</td>
    <td></td>
    <td>R</td>
    <td>0 ... 1</td>
    <td></td>
  </tr>
</tbody></table>

### 2.2 Version Numbering

PRSB standards published with the detailed implementation guidance in the information model use a 3-segment version number, e.g., V3.01.02, while older standards published before the detailed implementation guidance was put into the information model retain the previous 2-segment version number, e.g., V2.02 until their next maintenance release or revision.

2-segment version numbers take the form of major version.minor version, e.g., V2.02 where the information model is major version 2 and minor version 01.

3-segment version numbers use the format Va.bb.cc where:

*   **a** - is the major version number of the information model, incremented on significant revisions or enhancement of the information model
*   **bb** – is the minor version number of the information model, incremented on minor updates such as changes or issue resolutions
*   **cc** – is the implementation guidance version number, incremented whenever the implementation guidance is updated, which can be with or independent from an information model update. At a major revision of the information model this will restart at version 01.

### 2.3 Dependencies

The implementation of PRSB information standards is often dependent on the following:

*   The national and local Information Governance frameworks which will determine information access and sharing controls and legitimate relationships between health and care provider organisations.
*   Technical messaging standards e.g., FHIR profiles (to support the transfer of information between systems).
*   The availability of other sources to access some of the person’s care information such as the national record locator service (NRLS), GP records and shared care records.

### 2.4 Risk Mitigation

We recommend system suppliers and local implementers apply further risk mitigations when implementing PRSB standards by addressing the risks that have been flagged in the clinical safety case report and hazard log for each standard. Suppliers and implementors should aim to reduce the risk scores to 2, or better, when carrying out clinical risk assessments and developing safety cases for their implementations with respect to DCB0129 and DCB0160.

### 2.5 Information Governance

Sound principles of information governance and respecting the privacy of people and their information is paramount. NHS England has published a national Information Governance framework which needs to be considered when planning implementation.

Local agreements should be drawn up between organisations to define information requirements for communication.

### 2.6 Data Quality

Data quality and accuracy of coded data entry should be managed in local ‘source’ systems to ensure that information shared with people and professionals through other systems is dependent on the source data quality.

### 2.7 Context of the information

It is vital for use of the data that all contextual information is maintained and should not be lost on exchange or import of information. For example, if a frailty assessment was undertaken at the care home 2 days before the individual was admitted to hospital it is important that the full context of the information is known (where and when the assessment was done and by whom).

The principle, for PRSB standards, is that for clinical safety and efficacy of communications, the following key contextual data should be shared where specified by the “information type” of the data item in any PRSB standard.:

*   **Performing Professional** – is the person who performed the activity for example conducted the procedure, assessment etc. It has various attributes that are expected to be completed, name, role, specialty, organisation of the professional. If the professional is not known but the organisation and specialty are known they should be included as contextual information. In some situations, the action or event may be performed by the patient or a device. In these situations, a Performing Person or Performing Device may be recorded. Alternatively a more generic “Performer” may be specified with the same content model as “Performing Professional”.

*   **Location** – the place in which the activity took place e.g., observations were made.
*   **Date** - the date on which the activity took place e.g., the assessment was performed. In some instances, this would be start and end dates.
*   **Author** - is the person, device or application that recorded the information and has various attributes; name, role, speciality and organisation and the date the record was completed. This is expected to be automated and linked to audit trail (see section 2.8).

Note that although both ‘Performing professional’ and ‘Author' contain the element ‘speciality’ it is recognised that this only applies to some professionals so only needs to be included where relevant.

The principle applied in the information model is that where it is important (from a professional perspective) to know who undertook the activity and who recorded the activity, an information type of “Event.Record” or “Record” will be included in the model. For every item of information shared it is important that an audit trail is recorded (even if not explicitly stated in the information model). This is set out below.
The provenance information model is published on the PRSB website [Provenance data – PRSB (theprsb.org)](http://www.theprsb.org)

### 2.8 Time stamp and audit trail

It is important that an audit trail is recorded for every item of information recorded or shared (even if not explicitly stated in the information model).

Each record entry will need to be time stamped from the source system with date and time recorded and the identity of the person making the record. This needs to be viewable in the records themselves where appropriate and via a full audit trail which may be viewable by the end user to enhance transparency.

### 2.9 Links to other records and documents

The person may have multiple detailed records or documents held on local systems, e.g. there may be a mental health record for a person at a particular trust or shared care records such as an end of life care plan. PRSB record standards do not define all these possible links. It is expected that the local areas will define the requirements for accessing other records or documents, and where applicable and provide access through the shared care record for authorised professionals.

### 2.10 Use of terms

The term ‘role’ has been consistently used rather than ‘designation’ throughout PRSB standards to apply to the role the professional had in an activity. It is the term used in the NHS data dictionary.

The term ‘organisational role’ means the role the professional has in their employer organisation.

Some clusters such as referrer details have elements for one or more of specialty, team, service and department. This is to allow for all situations across health and care where different terms are required. Where possible specialty and service should be used and coded as detailed in the value set for the element.

### 2.11 Coding

The *Personalised Health and Care 2020 framework for action* (https://www.gov.uk/government/publications/personalised-health-and-care-2020) recommends the use of SNOMED CT and the dictionary of medicines and devices (dm+d). Local decisions need to be made about when these codes are to be used, depending on local system functionality and plans. The current ambition is for SNOMED CT and dm+d to be the primary clinical coding schemes in use in the NHS.

### 2.12 Accessibility

The design of user interfaces for health and care record systems should follow guidance for specific PRSB standards and should comply with the NHS England Accessible Information Standard (https://www.england.nhs.uk/ourwork/accessiblinfo/). This sets out the rules for accessible patient information in patient literature and clinical systems.

Guidance For All Prsb Standards

Clinical Safety Case Report Published September 2022

## Document Management
<table>
    <tbody><tr>
        <td>Document filename:</td>
        <td>Clinical Safety Case Report – 111 Referral Standard</td>
    </tr>
    <tr>
        <td>Directorate / Programme</td>
        <td>Project</td>
        <td>111 Referral Standard</td>
    </tr>
    <tr>
        <td>Document Reference</td>
        <td></td>
        <td></td>
    </tr>
    <tr>
        <td>Director</td>
        <td>Status</td>
        <td>Draft</td>
    </tr>
    <tr>
        <td>Owner</td>
        <td>Version</td>
        <td>V1.0</td>
    </tr>
    <tr>
        <td>Authors</td>
        <td>Sharon Hanley</td>
        <td>Version issue date</td>
        <td>21/09/2022</td>
    </tr>
</tbody></table>

### Revision History

<table>
<thead>
<tr>
<th>Version</th>
<th>Date</th>
<th>Summary of Changes</th>
</tr>
</thead>
<tbody>
<tr>
<td>V0.1</td>
<td>8/12/21</td>
<td>First draft</td>
</tr>
<tr>
<td>V0.2</td>
<td>28/2/22</td>
<td>Second draft</td>
</tr>
<tr>
<td>V0.3</td>
<td>13/5/22</td>
<td>Third revision</td>
</tr>
<tr>
<td>V0.4</td>
<td>6/7/22</td>
<td>Further revision after NHSD CSG review</td>
</tr>
<tr>
<td>V0.5</td>
<td>8/8/22</td>
<td>Revised for updated hazard log</td>
</tr>
<tr>
<td>V1.0</td>
<td>21/9/22</td>
<td>Version 1 following NHSD CSG approval</td>
</tr>
</tbody>
</table>

### Reviewers

This document must be reviewed by the following people:

<table>
<thead>
<tr>
<th>Reviewer name</th>
<th>Title / Responsibility</th>
<th>Date</th>
<th>Version</th>
</tr>
</thead>
<tbody>
<tr>
<td>James Ray</td>
<td>Clinical Lead (UEC)</td>
<td>20/5/2022</td>
<td>0.3</td>
</tr>
<tr>
<td>Eve Wijayanayagam</td>
<td>Clinical Lead (GP)</td>
<td>20/5/2022</td>
<td>0.3</td>
</tr>
<tr>
<td>Lee Montgomery</td>
<td>Clinical Safety Officer</td>
<td>20/5/2022</td>
<td>0.3</td>
</tr>
</tbody>
</table>

### Approved by

This document must be approved by the following people:

<table>
<thead>
<tr>
<th>Name</th>
<th>Title</th>
<th>Date</th>
<th>Version</th>
</tr>
</thead>
<tbody>
<tr>
<td>James Ray</td>
<td>Clinical Lead (UEC)</td>
<td>20/5/2022</td>
<td>0.3</td>
</tr>
<tr>
<td>Lee Montgomery</td>
<td>Clinical Safety Officer</td>
<td>16/5/2022</td>
<td>0.3</td>
</tr>
<tr>
<td>NHS Digital Clinical Safety Group</td>
<td>Clinical Safety Officers and Engineers</td>
<td></td>
<td>0.3</td>
</tr>
</tbody>
</table>

### Related Documents

These documents provide additional information and are specifically referenced within this document.

<table>
<thead>
<tr>
<th>Ref</th>
<th>Doc Reference Number</th>
<th>Title</th>
<th>Version</th>
<th>Status</th>
</tr>
</thead>
<tbody>
<tr>
<td>1</td>
<td>DCB 0129</td>
<td>Clinical Risk Management: its Application in the Manufacture of Health IT Systems - Specification</td>
<td>4.2</td>
<td>Approved</td>
</tr>
<tr>
<td>2</td>
<td>DCB 0160</td>
<td>Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems - Specification</td>
<td>3.2</td>
<td>Approved</td>
</tr>
<tr>
<td>3</td>
<td>Appendix 2</td>
<td>111 Information Standard</td>
<td>2.0</td>
<td>Approved</td>
</tr>
<tr>
<td>4</td>
<td>Appendix 3</td>
<td>Developing an information standard for 111 - Final Report</td>
<td>1.0</td>
<td>Approved</td>
</tr>
<tr>
<td>5</td>
<td>Appendix 4</td>
<td>111 Survey Report</td>
<td>1.3</td>
<td>Approved</td>
</tr>
<tr>
<td>6</td>
<td>Appendix 5</td>
<td>General implementation guidance for ALL PRSB standards (Detailed guidance, specific to the sections and elements of the standard, are included in the standard)</td>
<td>1.0</td>
<td>Approved</td>
</tr>
<tr>
<td>7</td>
<td>Appendix 6</td>
<td>Link to the PRSB 111 Information Standard web page</td>
<td></td>
<td>Live</td>
</tr>
</tbody>
</table>

## 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 &amp; Emergency Care, GP’s, allied health professions, health informatics professionals NHS E&amp;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.

## 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&amp;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&amp;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 &amp; 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.

## 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.

## 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&amp;I Bookings &amp; Referrals service team
*   NHS Digital clinical safety group
*   Digital Health &amp; 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.

## 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.

<table>
<thead>
<tr>
<th>Initial</th>
<th>Residual</th>
<th>Risk rating</th>
<th>Definition</th>
</tr>
</thead>
<tbody>
<tr>
<td>0</td>
<td>0</td>
<td style="background-color: orange;">5</td>
<td>Unacceptable level of risk.</td>
</tr>
<tr>
<td>1</td>
<td>0</td>
<td style="background-color: pink;">4</td>
<td>Mandatory elimination or control to reduce risk to an acceptable level</td>
</tr>
<tr>
<td>3</td>
<td>1</td>
<td style="background-color: lightgoldenrodyellow;">3</td>
<td>Undesirable level of risk<br>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.</td>
</tr>
<tr>
<td>4</td>
<td>5</td>
<td style="background-color: yellow;">2</td>
<td>Acceptable where cost of further reduction outweighs benefits gained.</td>
</tr>
<tr>
<td>0</td>
<td>2</td>
<td style="background-color: lightgreen;">1</td>
<td>Acceptable, no further action required</td>
</tr>
</tbody>
</table>

**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.

## 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 &amp; Improvement, NHS X and NHS Digital Leads.

<table>
  <tbody><tr>
    <td colspan="3" style="background-color: #ADD8E6;">Hazard Workshop 1</td>
  </tr>
  <tr>
    <td>Date</td>
    <td>Attendees</td>
    <td>Role</td>
  </tr>
  <tr>
    <td rowspan="4">23th Nov 2021</td>
    <td>Dr James Ray</td>
    <td>111 Referral Clinical Lead &amp; Emergency Medicine Consultant</td>
  </tr>
  <tr>
    <td>Lee Montgomery</td>
    <td>Clinical Informatics Manager &amp; Clinical Safety Officer<br>NHS Bookings &amp; Referrals</td>
  </tr>
  <tr>
    <td>Eve Wijayanayagam</td>
    <td>Clinical Lead – Integrated Urgent care, Home Visiting and Appt +</td>
  </tr>
  <tr>
    <td>Sharon Hanley</td>
    <td>PRSB Business Analyst / IT Consultant</td>
  </tr>
</tbody></table>

<table>
  <tbody><tr>
    <td colspan="3" style="background-color: #ADD8E6;">Hazard Workshop 2</td>
  </tr>
  <tr>
    <td>Date</td>
    <td>Attendees</td>
    <td>Role</td>
  </tr>
  <tr>
    <td rowspan="2">3 Dec 2021</td>
    <td>Alison Allam</td>
    <td>Patient with lived experience</td>
  </tr>
  <tr>
    <td>Sharon Hanley</td>
    <td>PRSB Business Analyst / IT Consultant</td>
  </tr>
</tbody></table>

<table>
  <tbody><tr>
    <td colspan="3" style="background-color: #ADD8E6;">Hazard Workshop 3</td>
  </tr>
  <tr>
    <td>Date</td>
    <td>Attendees</td>
    <td>Role</td>
  </tr>
  <tr>
    <td rowspan="4">28th Feb 2022</td>
    <td>Dr James Ray</td>
    <td>111 Referral Clinical Lead &amp; Emergency Medicine Consultant</td>
  </tr>
  <tr>
    <td>Lee Montgomery</td>
    <td>Clinical Informatics Manager &amp; Clinical Safety Officer<br>NHS Bookings &amp; Referrals</td>
  </tr>
  <tr>
    <td>Dr Eve Wijayanayagam</td>
    <td>Clinical Lead – Integrated Urgent care, Home Visiting and Appt +</td>
  </tr>
  <tr>
    <td>Sharon Hanley</td>
    <td>PRSB Business Analyst / IT Consultant</td>
  </tr>
</tbody></table>

### 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.

<table>
<thead>
<tr>
<th>Hazard Id:</th>
<th>1</th>
</tr>
</thead>
<tbody>
<tr>
<td>Initial risk ranking</td>
<td>3</td>
</tr>
<tr>
<td>Hazard Name</td>
<td>Missing data (blank fields), incorrect, or corrupt data.</td>
</tr>
<tr>
<td>Hazard Description:</td>
<td>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.</td>
</tr>
<tr>
<td>Hazard Causes:</td>
<td>1) Incorrect data entered in source system unable to be mapped into the receiving system.<br>
2) Information model in source system is misinterpreted/not understood by?<br>
3) Logical data model is wrong leading to incorrect or missing data attributes.<br>
4) Data processing and de-duplication loses important data item.<br>
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.<br>
6) Consequence of different professional groups with different roles and emphasis in creating electronic health and care records.<br>
7) Semantics and language difference between the different professions.</td>
</tr>
<tr>
<td>Potential patient safety impact description</td>
<td>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.</td>
</tr>
<tr>
<td>Dependencies &amp; assumptions</td>
<td>1. Suppliers implement the standard in accordance with the PRSB guidance provided.<br>
2. Supplier systems are able to configure their system to support recommended conformance.</td>
    </tr><tr>
        <td>Mitigation:</td>
        <td><strong>Existing controls / Mitigation</strong><br>
        Assurance/compliance processes already published for system suppliers / implementers.<br>
        <strong>Design Mitigations</strong><br>
        Providing system suppliers with implementation guidance explaining confirmation on data item conformance - 'Mandatory (&amp; Must haves), Required and optional<br>
        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]</td>
    </tr>
    <tr style="background-color: yellow;">
        <td><strong>Residual risk:</strong></td>
        <td>2</td>
    </tr>
</tbody></table>

<table>
    <tbody><tr>
        <td><strong>Hazard Id:</strong></td>
        <td>2</td>
    </tr>
    <tr>
        <td><strong>Initial risk ranking</strong></td>
        <td>3</td>
    </tr>
    <tr>
        <td><strong>Hazard Name</strong></td>
        <td>Incorrect mapping / transcription of data items from source systems (including paper/excel) into receiving system.</td>
    </tr>
    <tr>
        <td><strong>Hazard Description:</strong></td>
        <td>Suppliers map incorrect codes or data.<br>
        Incorrect transcription of written terminology</td>
    </tr>
    <tr>
        <td><strong>Hazard Causes:</strong></td>
        <td>1) Recommended coding not available in supplier system.</td>
    </tr>
    <tr>
        <td><strong>Potential patient safety impact description</strong></td>
        <td>Incorrect treatment or advice given by the HCP which could lead to an absence or delay to care, which could result in patient harm.</td>
    </tr>
    <tr>
        <td><strong>Dependencies &amp; assumptions</strong></td>
        <td>1. Supplier systems can implement the 111-standard using the recommended coding via HL7 and/or FiHR for input and extract.</td>
    </tr>
    <tr>
        <td><strong>Mitigation:</strong></td>
        <td><strong>Existing controls / mitigations</strong><br>
        Assurance / compliance processes already in place for system suppliers / implementers.<br>
        <strong>Design mitigations</strong><br>
        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</td>
    </tr>
    <tr style="background-color: yellow;">
        <td><strong>Residual risk:</strong></td>
        <td>2</td>
    </tr>
    <tr>
        <td><strong>Hazard Id:</strong></td>
        <td>4</td>
    </tr>
<tr>
<td>Initial risk ranking</td>
<td>3</td>
</tr>

</tbody><tbody>
<tr>
<td>Hazard Name</td>
<td>Known, existing information e.g. medications and allergies may not be available to receiving service</td>
</tr>
<tr>
<td>Hazard Description:</td>
<td>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.</td>
</tr>
<tr>
<td>Hazard Causes:</td>
<td>1) Medication, allergies and risk Information captured in the 111 standard is 'New' patient reported information only.<br>2) Not all services have access to Summary Care Record so are unable to view existing GP information<br>3) shared care records are not available to all health and care settings,</td>
</tr>
<tr>
<td>Potential patient safety impact description</td>
<td>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</td>
</tr>
<tr>
<td>Dependencies &amp; assumptions</td>
<td>1. Majority of services have access to existing health and care records<br>2. The NHS E road map for access to Health &amp; care records includes dentistry, ophthalmology and pharmacy etc.</td>
</tr>
<tr>
<td>Mitigation:</td>
<td><strong>Existing controls / implementers</strong><br>Many services are able to access a person's core information (medications, allergies and adverse reactions) via the SCR)<br>Most of the time the individual or advocate will be able to provide the information via memory or patient access to GP records..<br><strong>Design mitigation</strong><br>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)<br>Clinical suppliers should consider including a warning that the 'medication, allergies and adverse reactions and risks in the 111 referral are patient reported only'</td>
</tr>
<tr>
<td><strong>Residual risk:</strong></td>
<td><strong>2</strong></td>
</tr>
</tbody>
</table>


<table>
    <tbody><tr>
        <td>Hazard Id:</td>
        <td>5</td>
    </tr>
    <tr>
        <td>Initial risk ranking</td>
        <td>3</td>
    </tr>
    <tr>
        <td>Hazard Name</td>
        <td>Unconfirmed diagnoses recorded into GP record as a problem</td>
    </tr>
    <tr>
        <td>Hazard Description:</td>
        <td>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.</td>
    </tr>
    <tr>
        <td>Hazard Causes:</td>
        <td>1) GP systems cannot easily record a diagnosis with a qualifier and may incorrectly add a diagnosis code to the patient record</td>
    </tr>
    <tr>
        <td>Potential patient safety impact description</td>
        <td>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</td>
    </tr>
    <tr>
        <td>Dependencies &amp; assumptions</td>
        <td>1. Suppliers can disable the recording of diagnoses with a 'suspected' qualifier<br>2. Suppliers can capture the Chief clinical concern using SNOMED findings data set (suspected diagnosis)</td>
    </tr>
    <tr>
        <td>Mitigation:</td>
        <td><strong>Existing controls/mitigations</strong><br>Systems receiving ITK messaging can manually code information into the care record from the 111 / discharge report and search for suspected diagnoses code.<br><strong>Design mitigation</strong><br>Systems should map Chief clinical concern to SNOMED findings (suspected diagnosis) and Diagnoses to diagnoses codes that do not require a qualifier.</td>
    </tr>
    <tr>
        <td>Residual risk:</td>
        <td style="background-color: yellow;">2</td>
    </tr>
</tbody></table>

<table>
    <tbody><tr>
        <td>Hazard Id:</td>
        <td>6</td>
    </tr>
    <tr>
        <td>Initial risk ranking</td>
        <td>4</td>
    </tr>
    <tr>
        <td>Hazard Name</td>
        <td>Disclosure of Gender reassignment without the individual’s consent/knowledge</td>
    </tr>
    <tr>
        <td>Hazard Description:</td>
        <td>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)</td>
    </tr>
	<tr>
        <td>Hazard Causes:</td>
        <td>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</td>
    </tr>
	<tr>
        <td>Potential patient safety impact description</td>
        <td>Disclosure of a person’s gender reassignment without their consent could impact the individual psychologically and may lead to harm of the individual</td>
    </tr>
	<tr>
        <td>Dependencies &amp; assumptions</td>
        <td>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</td>
    </tr>
	<tr>
        <td>Mitigation:</td>
        <td>**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.</td>
    </tr>
	<tr>
        <td>Residual risk:</td>
        <td style="background-color: yellow;">2</td>
    </tr>
</tbody></table>

<table>
    <tbody><tr>
        <td>Hazard Id:</td>
        <td>8</td>
    </tr>
    <tr>
        <td>Initial risk ranking</td>
        <td>2</td>
    </tr>
    <tr>
        <td>Hazard Name</td>
        <td>Incorrect entry of diagnosis code in the persons GP
electronic record</td>
    </tr>
    <tr>
        <td>Hazard Description:</td>
        <td>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</td>
    </tr>
	<tr>
        <td>Hazard Causes:</td>
        <td>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</td>
    </tr>
	<tr>
        <td>Potential patient safety impact description</td>
        <td>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.</td>
    </tr>
	<tr>
        <td>Dependencies &amp; assumptions</td>
        <td>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</td>
    </tr>
	<tr>
        <td>Mitigation:</td>
        <td>**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</td>
    </tr>
	<tr>
        <td>Residual risk:</td>
        <td style="background-color: yellow;">2</td>
    </tr>
</tbody></table>

### The hazard log

The 111 information standard hazard log is embedded below

<p>The incorrect diagnosis will appear in any reports requiring their diagnosis to be extracted from the clinical record.</p><p>Patient may not be prescribed a medication due to possible contraindications with a diagnosis in their record.</p>

<table>
  <thead>
    <tr>
      <th>Hazard Number</th>
      <th>Hazard Name</th>
      <th>Hazard Description</th>
      <th>Hazard Causes</th>
      <th>EFFECT - Patient Safety Impact Description</th>
      <th>Initial Risk - Likelihood</th>
      <th>Initial Risk - Consequence</th>
      <th>Initial Risk - Acceptability</th>
      <th>Dependencies and Assumptions</th>
      <th>Existing Controls / Mitigations</th>
      <th>Residual Risk - Likelihood</th>
      <th>Residual Risk - Consequence</th>
      <th>Residual Risk - Acceptability</th>
      <th>Summary of Actions</th>
      <th>Additional Comments</th>
    </tr>
  </thead>
  <tbody>
    <tr><td>1</td><td>Missing data (blank fields) , Incorrect, corrupt data</td><td>Data items left blank or corrupted in transmission.</td><td>Incorrect data entry, mapping errors, or system failure.</td><td>Inappropriate care, delay to care, or patient harm.</td><td>Medium</td><td>Considerable</td><td>3</td><td>Standardized implementation by suppliers.</td><td>Assurance processes in place.</td><td>Low</td><td>Considerable</td><td>2</td><td>Implementation guidance to explain conformance.</td><td>Hazard transferred to suppliers.</td></tr>
    <tr><td>2</td><td>Incorrect mapping / transcription</td><td>Suppliers map incorrect codes or data.</td><td>Recommended coding not available in system.</td><td>Incorrect treatment or advice given by clinician.</td><td>Medium</td><td>Considerable</td><td>3</td><td>HL7/FHIR implementation by suppliers.</td><td>Standardized data dictionary.</td><td>Medium</td><td>Significant</td><td>2</td><td>Guidance on reference sets and messaging.</td><td>Hazard transferred to suppliers.</td></tr>
    <tr><td>3</td><td>Unstructured data not easily accessible</td><td>Data exists in free text form (unstructured).</td><td>Supplier ability to send/render free text.</td><td>Information may be missed leading to delays in care.</td><td>Medium</td><td>Minor</td><td>2</td><td>System can handle/render free text.</td><td>Standard ITK messaging used.</td><td>Low</td><td>Minor</td><td>1</td><td>Default to data sets; use free text as backup.</td><td>Hazard transferred to suppliers.</td></tr>
    <tr><td>4</td><td>Existing info (meds/allergies) not included</td><td>111 standard only captures 'new' info.</td><td>Presumption that SCR/GP Connect is available.</td><td>Clinician unaware of existing meds/allergies.</td><td>Medium</td><td>Major</td><td>3</td><td>Access to SCR/Shared care records.</td><td>Access to SCR is common.</td><td>Low</td><td>Major</td><td>2</td><td>Include warning boxes about 'new' info only.</td><td>Hazard transferred to suppliers.</td></tr>
    <tr><td>5</td><td>Unconfirmed diagnoses recorded as problem</td><td>Diagnoses with 'suspected' qualifier recorded as confirmed.</td><td>GP systems unable to recognize qualifiers.</td><td>Incorrect updates to patient records.</td><td>Medium</td><td>Significant</td><td>2</td><td>Suppliers can disable suspected qualifiers.</td><td>Manual coding from ITK messages.</td><td>Low</td><td>Significant</td><td>2</td><td>Explain mapping of chief clinical concern.</td><td>Hazard transferred to suppliers.</td></tr>
    <tr><td>6</td><td>Disclosure of Gender reassignment</td><td>Sharing sex and gender where they don't match.</td><td>Breach of GDPR Article 9.</td><td>Psychological impact on individual.</td><td>Medium</td><td>Considerable</td><td>4</td><td>Patient consent gained for recording.</td><td>Both fields are 'required', not 'mandatory'.</td><td>Low</td><td>Considerable</td><td>2</td><td>Explain impact and prompt for consent.</td><td>Hazard transferred to suppliers/orgs.</td></tr>
    <tr><td>7</td><td>Individuals not matched on SPINE</td><td>Patients not registered with a GP cannot be matched.</td><td>111 uses GP registered on SPINE for referrals.</td><td>Referral to GP cannot be sent.</td><td>Medium</td><td>Minor</td><td>2</td><td>Existing processes for unregistered patients.</td><td>Handler advises patient to register.</td><td>Medium</td><td>Minor</td><td>2</td><td>N/A</td><td>Hazard transferred to health org.</td></tr>
    <tr><td>8</td><td>Incorrect entry of diagnosis code</td><td>SNOMED qualifiers (e.g. Suspected) not ingested.</td><td>GP systems unable to display qualifiers.</td><td>Incorrect diagnosis appears in reports.</td><td>High</td><td>Significant</td><td>3</td><td>Suppliers working on solutions for qualifiers.</td><td>Pathways does not yet use SNOMED.</td><td>Low</td><td>Significant</td><td>2</td><td>Review when Pathways introduces SNOMED.</td><td>Hazard transferred to NHS E&amp;I.</td></tr>
  </tbody>
</table>

<p>This Hazard log will need to be reviewed when Pathways introduced Snomed CT and the 111 referral standard is impacted.</p>
<p>Full testing will need to be performed by suppliers when pathways moves to Snomed</p>
    
<p>Hazard transferred to NHS E&amp;I With regards to wider management of development of sending and receiving of structured data and SNOMED coded data.</p>
<p>In the short term GP Suppliers to ensure qualifiers are shared and surfaced in sstems appropriately.</p>

**Please note:** The mitigations we have taken to address clinical safety risks are largely in relation to the transmission of data between software suppliers systems. Further mitigations will be required when the headings are implemented in electronic health record 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 sites during the implementation.

## 7 Test Issues

As this Clinical Safety Case report pertains to an information standard rather than a clinical IT system, live testing was not undertaken.

The 111 to ED pilot First of Type will inform PRSB of any issues / feedback.

## 8 Summary Safety Statement

The clinical safety statement is based on the safety argument below, based on two of the following criteria:

1. Demonstration of adherence to a fit for purpose clinical safety process:
   The Clinical Safety process described in Section 4 has been carried out and is consistent with the NHS Digital’s Clinical Safety Management System (CSMS) and DCB 0129 outlined in reference 2.

2. The mitigation is deemed to be appropriate and commensurate with the scale of risk.
   Risk is deemed to be acceptable in most cases and tolerable in others.

All risks identified within the hazard log have been managed via their associated controls to either an ‘Acceptable’ or ‘Tolerable’ level, in line with the identified risk tolerance levels.

As previously stated, this clinical safety report is not directly related to software development or deployment. It has been designed to look at the clinical safety hazards and mitigate the risks in the creation and production of the social prescribing information standard itself. Suppliers developing software to implement these standards, will therefore need to undertake their own DCB0129 Clinical Safety Case and healthcare organisations involved in the deployment of such software will still be expected to apply DCB0160. From this perspective the Clinical Safety Officer considers the 111-information standard v0.4 safe to deploy.

## 9 Quality Assurance and Document Approval

All PRSB standards and associated documents undergo a formal internal assurance process and full approval by the both the PRSB assurance committee and BaRS product board before any standard is released for public use.

## 10 Configuration Control / Management

Future governance of the development and maintenance of the 111 Referral Standard is the responsibility of the PRSB.

All reviews and changes are fully documented and recorded via the version control processes within the software hosting the 111 Referral standard.

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

### 11.2 Clinical safety hazard log risk matrix &amp; scoring tool

**Table 1**

<table>
<thead>
<tr>
<th>Likelihood Category</th>
<th>Interpretation</th>
</tr>
</thead>
<tbody>
<tr>
<td>Very high</td>
<td>Certain or almost certain; highly likely to occur</td>
</tr>
<tr>
<td>High</td>
<td>Not certain but very possible; reasonably expected to occur in most cases</td>
</tr>
<tr>
<td>Medium</td>
<td>Possible</td>
</tr>
<tr>
<td>Low</td>
<td>Could occur but in the great majority of occasions will not</td>
</tr>
<tr>
<td>Very low</td>
<td>Negligible or nearly negligible possibility of occurring</td>
</tr>
</tbody>
</table>

**Table 2**

<table>
<thead>
<tr>
<th>Severity Classification</th>
<th>Interpretation</th>
<th>No. of Patients Affected</th>
</tr>
</thead>
<tbody>
<tr>
<td rowspan="2">Catastrophic</td>
<td>Death</td>
<td>Multiple</td>
</tr>
<tr>
<td>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</td>
<td>Multiple</td>
</tr>
<tr>
<td rowspan="4">Major</td>
<td>Death</td>
<td>Single</td>
</tr>
<tr>
<td>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</td>
<td>Single</td>
</tr>
<tr>
<td>Severe injury or severe incapacity from which recovery is expected in the short term</td>
<td>Multiple</td>
</tr>
<tr>
<td>Severe psychological trauma</td>
<td>Multiple</td>
</tr>
<tr>
<td rowspan="4">Considerable</td>
<td>Severe injury or severe incapacity from which recovery is expected in the short term</td>
<td>Single</td>
</tr>
<tr>
<td>Severe psychological trauma</td>
<td>Single</td>
</tr>
<tr>
<td>Minor injury or injuries from which recovery is not expected in the short term.</td>
<td>Multiple</td>
</tr>
<tr>
<td>Significant psychological trauma</td>
<td>Multiple</td>
</tr>
<tr>
<td rowspan="4">Significant</td>
<td>Minor injury or injuries from which recovery is not expected in the short term</td>
<td>Single</td>
</tr>
<tr>
<td>Significant psychological trauma</td>
<td>Single</td>
</tr>
<tr>
<td>Minor injury from which recovery is expected in the short term</td>
<td>Multiple</td>
</tr>
<tr>
<td>Minor psychological upset; inconvenience</td>
<td>Multiple</td>
</tr>
<tr>
<td>Minor</td>
<td>Minor injury from which recovery is expected in the short term; minor psychological upset; inconvenience; any negligible severity</td>
<td>Single</td>
</tr>
<tr>
<th>Likelihood Category</th>
<th>Interpretation</th>
</tr>

</tbody><tbody>
<tr>
<td>Very high</td>
<td>Certain or almost certain; highly likely to occur</td>
</tr>
<tr>
<td>High</td>
<td>Not certain but very possible; reasonably expected to occur in the majority of cases</td>
</tr>
<tr>
<td>Medium</td>
<td>Possible</td>
</tr>
<tr>
<td>Low</td>
<td>Could occur but in the great majority of occasions will not</td>
</tr>
<tr>
<td>Very low</td>
<td>Negligible or nearly negligible possibility of occurring</td>
</tr>
</tbody>
</table>

<table>
<thead>
<tr>
<th></th>
<th>Risk Acceptability</th>
<th></th>
<th></th>
<th></th>
</tr>
</thead>
<tbody>
<tr>
<td>5</td>
<td>Unacceptable level of risk</td>
<td></td>
<td></td>
<td></td>
</tr>
<tr>
<td>4</td>
<td>Mandatory elimination of hazard or addition of control measure to reduce risk to an acceptable level</td>
<td></td>
<td></td>
<td></td>
</tr>
<tr>
<td>3</td>
<td>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</td>
<td></td>
<td></td>
<td></td>
</tr>
<tr>
<td>2</td>
<td>Acceptable where cost of further reduction outweighs benefits gained or where further risk reduction is impractical</td>
<td></td>
<td></td>
<td></td>
</tr>
<tr>
<td>1</td>
<td>Acceptable, no further action required</td>
<td></td>
<td></td>
<td></td>
</tr>
</tbody>
</table>

### 11.3 Information Standard [Ref 3]

Example screen shot of 111 Standard via PRSB Viewer. To see full interactive standard click on link below:

PRSB 111 standard viewer

Table showing the 111 Referral Information Standard.&lt;/img&gt;

### 11.4 Developing an Information Standard – Final Report [Ref 4]

https://theprsb.org/standards/111referralstandard/
Navigate to ‘Supporting Documentation’

### 11.5 Survey Report [Ref 5]

https://theprsb.org/standards/111referralstandard/
Navigate to ‘Supporting Documentation’

### 11.6 General Implementation guidance for All PRSB standards [Ref 6]

https://theprsb.org/standards/111referralstandard/
Navigate to ‘Supporting Documentation’

### 11.7 Link to the PRSB 111 Standard web page [Ref 7]

https://theprsb.org/standards/111referralstandard/
Navigate to ‘111 referral standard’

The PRSB 111 Referral Standard Clinical Safety Case

Clinical Safety Case Report

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).

111-referral-standard

All data items in the standard should be supported including optional items

The contextual information (performing professional, location, date, person completing the record) should be sent where it applies

The local system should retain an audit trail of the provenance of all contributions

The system should support the implementation of an information governance/privacy model

The system should be able to link to the Patient Demographic Service (PDS) for demographic information and information about the GP practice (Both stored in the PDS)

The system should be able to protect the gender identity of transgender persons. The person's Sex (phenotypic) &amp; Gender (self reported) must be displayed in a way that does not inadvertently reveal protected information. This applies to both sending and receiving ends of the referral.

The systems should be able to interface with the Organisation Data Service (ODS) to retrieve site codes

The sending system should automatically populate fields such as referrer details using the login and service details.

The sending system should auto-populate as many fields as possible from the 111 or 999 service record systems, leaving the minimum to be completed by the user.

The medication section should support FIHR messaging as set-out in the NHS Digital implementation guidance, referenced in the information model

GP receiving systems must distinguish between a referral and PEM message and handle and manage the messages accordingly

One of either the person's phone number or the callers details must be present in the referral, unless the person does not have a phone number

111 Referral Standard: Final Report

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