Scotland Deanery Policy on Enhanced Monitoring Authors Quality Workstream Leads A.R.McLellan, D.Bruce & D.Pollock

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Scotland Deanery Policy on Enhanced Monitoring Authors Quality Workstream Leads A.R.McLellan, D.Bruce & D.Pollock Policy approved by MDET 14 th March 2016 Review Date 14 th March 2017 Version 1: 14 th March 2016

Enhanced monitoring is a GMC process that can be initiated by the GMC or by the Deanery, in association with the GMC. The GMC s guide to Enhanced Monitoring is included for reference. Criteria to be fulfilled for escalation by Scotland Deanery to enhanced monitoring: 1. Existence of significant concerns about training or about the training environment despite Deanery QM processes. Examples (but not the only circumstances) of significant concerns include: a. persisting issues such as GMC National Trainee Survey 'triple reds' or 'quadruple reds' linked to any GMC NTS indicator or b. recurrence of red flags for indicators indicating that improvements have not been sustained, c. further deterioration in indicators of quality of training while engaging in Deanery QM processes d. any circumstance where doctors in training are exposed to risk, undermining would be an example. e. Deterioration of quality of training or training environment despite Deanery QM processes. And 2. Where the local context or circumstances suggest that resolution is unlikely without escalation to enhanced monitoring. Or alternatively 3. Where there has been an external scrutiny process eg by HIS or by a College that either explicitly highlights significant concerns about the training environment, or that in the context of known Deanery QM data or information suggests that there are likely to be significant implications for the training environment. Process for escalation (see flowchart): 1. Responsibility for identifying a site where training or the training environment fulfils the above criteria lies with the Lead Dean / Director (LDD) for the specialty Quality Management Group (QMG). 2. The LDD for specialty QMG discusses with the local, regional Postgraduate Dean (PGD) prior to finalizing the decision to escalate to enhanced monitoring (this step is needed to keep the regional PGD aware and to take account of criterion 3 above) 3. Advice can also be sought from the Quality Workstream Leads, from the NES Medical Director or from the Education QA Programme Manager of the GMC Visits and Monitoring Team. 4. When the decision to escalate to enhanced monitoring has been made the specialty Quality Lead (QL) and Quality Improvement Manager (QIM) should prepare a brief report for the specialty LDD to add any further comments and share with the regional PGD (who hereafter will be the point of contact for the GMC and for the affected Health Board, and the Scotland Deanery enhanced monitoring log) with the following: a. the issue / all issues (that necessitate escalation to enhanced monitoring), b. the Board and the site, and which cohorts of trainees (Foundation, GP, Core &/or Higher) are affected and whether there are medical students as well as doctors in training in this department, c. the history including when the issue / issues were first recognised, what QM activity and actions have Version 1: 14 th March 2016

been effected so far, and why enhanced monitoring has been invoked, and d. the name of the regional PGD who will be the point of contact until the issue is resolved. 5. The specialty LDD should produce a succinct press release (to be available for all cases in the event of this scenario generating press interest) with support from the NES comms department & the NES MD. 6. Both the summary and the press release should be emailed to the Quality Workstream Leads including senior QIM (who will update the enhanced monitoring log), and to the regional PGD who will take the lead on this issue through the period of enhanced monitoring and to the NES MD. 7. The regional PGD who will lead on management of the problem through enhanced monitoring will then write a formal letter to confirm that as of the date of the letter, the site & specialty will hereafter be managed and monitored under the GMC's enhanced monitoring process. The summary provided by the LDD will (with editing, if appropriate) be the main substance of the letter. This should be sent to: a. the MD, Chief Executive and the DME for the Health Board responsible for the LEP in question, & copied to b. the LDD originally involved in the decision, c. the APGDs and TPDs for specialty and for the cohorts of trainees covered by the scope of the case (consider higher training, core, GP training and Foundation APGDs and TPDs) and to d. the Quality Workstream leads & e. the Education QA Programme Manager of the GMC Visits and Monitoring Team. 8. The Quality Workstream Leads will liaise with the specialty QMG to agree (when there are more than one of either or both) which QL and which QIM will work with the regional PGD on supporting the associated QM activities going forward. 9. The QL and QIM of the specialty QMG will be responsible, with the regional PGD, for providing updates to the senior QIM who will update the enhanced monitoring log on Alfresco including updating dates of next visits, as these become available 10. When eventually the issues have been addressed, and when the PGD has agreed with the GMC that resolution of the issue/s is evidenced and shown to be sustained - closure of the enhanced monitoring case should be formally communicated by the regional PGD through written communication, to all those listed in section 7. The enhanced monitoring log will be updated to reflect removal of this case. Governance of quality processes relating to enhanced monitoring sites Responsibility for the quality management and quality improvement processes relating to a site (irrespective of specialty or training programme) that has been escalated to the enhanced monitoring process lies with the regional PGD; the regional PGD will also be the point of contact for communications around this site and its issues with the GMC, the Health Board responsible for the site and with Scottish Government Health Department. Administrative support to the regional PGD for the quality management and quality improvement processes relating to a site that has been escalated to the enhanced monitoring will be from the QL/s and QIM/s of the QMG for the specialty / specialties that are within scope of the enhanced monitoring case. Version 1: 14 th March 2016

In all circumstances other than for sites under enhanced monitoring, responsibility for the quality management and quality improvement processes relating to training in any specialty in any site in any region within Scotland Deanery lies with the LDD for that specialty and administrative support is provided by his / her specialty QMG. Tracking and sharing awareness of progress in sites on enhanced monitoring A log of all sites on enhanced monitoring within Scotland Deanery will be maintained and be accessible on Alfresco. This log will include the background to the need for enhanced monitoring, and progress towards resolution will be updated after each visit. Responsibility for the maintenance and integrity of the log lies with the Quality Workstream senior QIM. The Quality Workstream Lead will provide a status report on all enhanced monitoring sites monthly (by end of the first week of each calendar month) for the Scottish Government Health Department; this will be shared with the NES MD. The Quality Workstream senior QIM will provide quarterly updates on the status of all sites on enhanced monitoring to the GMC for publication on their website, as required by the GMC. Version 1: 14 th March 2016

Scotland Deanery Enhanced Monitoring Flowchart Potential role for EM identified by sqmg following QRP or visit or HIS/College review LDD of sqmg Liaison with Regional PGD Liaison with GMC, NES, MD, Workstream Lead as necessary LDD of sqmg confirms that case fulfils Scotland Deanery EM criteria Press Release QL & QIM of sqmg Summary of issues Regional PG Dean Regional PGD Escalates case to EM & writes to Board MD, CE, DME Head of Medical School/s (if medical students also train in affected department) LDD of sqmg Relevant APGD & TPD Workstream leads Education QA Manager GMC Plan future visits Liaison with Senior QIM to maintain log Repeated visits as required to demonstrate sustained resolution of issues, until, with GMC approval, case can be closed Regional PGD confirms closure of EM case and QM-QI processes revert to sqmg & LDD of sqmg

Enhanced monitoring A guide for organisations with quality management responsibilities We use enhanced monitoring to take action on particular issues reported to us by external sources or identified through our own evidence. This document provides information on the enhanced monitoring process for organisations with quality management (QM) responsibility. ENHANCED MONITORING... 1 A GUIDE FOR ORGANISATIONS WITH QUALITY MANAGEMENT RESPONSIBILITIES... 1 Summary of the enhanced monitoring process... 2 Referral to enhanced monitoring... 3 Referrals from organisations with QM responsibility...3 Referral information...3 Referrals from other sources...3 Internal escalation...4 The referral process... 5 Recording and publishing...5 Enhanced monitoring action... 6 We always... 6 We may also... 6 Support for a local visit...6 Ending enhanced monitoring... 7 Publishing enhanced monitoring... 7

Summary of the enhanced monitoring process Medical schools, deaneries and Health Education England (HEE) are responsible for ensuring that our standards for medical education and training are met, and for taking action locally when this is not the case. We receive updates on such concerns through our routine monitoring processes (online deans reporting or medical school annual return). If the situation doesn t improve, then the concern can be referred to our enhanced monitoring process. We can also escalate a concern to our enhanced monitoring process as a result of information from another organisation or individual, or because of what our own evidence tells us (e.g. national training surveys). Concerns that are subject to enhanced monitoring remain the responsibility of the organisation with QM responsibility. The organisation still plans and manages action to drive improvement, but with additional support and oversight from the GMC. This support is proportionate, and ranges from providing GMC representation on a locally-led quality management visit to, in cases where there is systematic and serious failure, a GMC triggered visit or removal of approval for training. Concerns remain in enhanced monitoring until we have evidence that sustainable change has been made. We publish most enhanced monitoring information on our website and share it with system regulators. This diagram gives a high level overview of the process. REFERRAL ACTION Concern about training No further action Agreed action Organisation with QM responsibility submits evidence to GMC Discussion with organisation with QM responsibility Review of evidence Overall approach? Local QM action scheduled reporting to GMC Issue not resolved, further action required Issue resolved, but more evidence required that changes are sustained Cease enhanced monitoring Local QM action with support of GMC, and enhanced monitoring Agreement of next steps, including reporting frequency END OF ENHANCED MONITORING 2

Referral to enhanced monitoring Referrals from organisations with QM responsibility Most of the concerns currently in enhanced monitoring are referred to the process by the organisation with QM responsibility. There are no fixed criteria to determine what should be referred to the process; however the following may be a useful guide: there are persistent and serious patient safety concerns, or educational concerns of such seriousness that the progress of doctors in training may be affected, and progress is not being made despite local QM processes and where progress is unlikely without the enhanced monitoring We are always keen to discuss informally whether enhanced monitoring may be appropriate. Your first contact would normally be the education quality analyst or programme manager from your visits and monitoring team. Referral information When making the initial referral we need the following details: Date you identified the issue The Trust/ Board and the site The curriculum/specialty affected For postgraduate issues, the group of trainees affected (e.g. Foundation, core, and/or Higher) Whether there are both medical students and doctors in training in the department Information about the issue, and how you identified it Details of the action you have taken to date and the action you plan to take next. Referrals from other sources We may decide escalate a concern to enhanced monitoring that has been raised to us by other organisations, such as a system regulator or a medical royal college or faculty, or by an individual. Whatever the route a concern is brought to our attention, we will always check our evidence base (e.g. national trainee survey results, online deans reporting) to see if the 3

concern has already been highlighted and if so, whether appropriate action is being taken. If we are not confident that the concern is already being dealt with appropriately, or it is an unknown concern, we will contact the organisation with QM responsibility to make sure they are aware of the issue and are taking appropriate action. We may want to monitor the resulting action through our routine reporting processes, or we may decide that the concern meets our threshold for escalation to enhanced monitoring. We will always respond to trainees, trainers, patients, or members of the public who report education and training concerns to us. For example, a trainee may contact us directly with complaints about their programme, LEP, deanery, or the quality of their education or training. We normally refer them to local processes, although if they do not obtain adequate resolution and the complaint relates directly to our standards, we may ask them to come back to us with supporting evidence. We will never become involved with complaints about the assessment of individuals (eg complaints about Annual Review of Competence Progression (ARCP) outcomes or exam failures), as it is outside of our remit to contest these types of decisions. We always refer these kinds of complaints back to the organisation that delivers the assessment. However, we do monitor these types of complaints to make sure we can flag areas where there seem to be legitimate trends, which may warrant further investigation. Internal escalation If we hear about serious trainee or patient safety concerns on a visit or in any area of our work we will consider enhanced monitoring. Each case is different and a level of judgement is used to decide whether action is required and if so, whether routine or enhanced monitoring is the most appropriate course of action. Some examples of circumstances when we would consider enhanced monitoring: Negative system regulator inspection Media coverage which might highlight a potential concern Concerning shared intelligence from other areas of the GMC (eg Employer Liaison Service, Regional Liaison Service, Devolved Offices, Patient Safety Intelligence Forum) Trainee or patient safety concerns identified on a routine GMC visit A routine monitoring update where an item is reported/agreed as red in more than one update AND the most recent update does not assure us that improvement will be forthcoming (e.g. there is a lack of engagement with the LEP, the situation 4

seems to have deteriorated OR there has been insufficient progress since the last update) A patient safety or educational environment indicator from the national trainee survey (NTS) has shown a below outlier for three consecutive years (referred to as triple red ) AND the issue is included in the most recent update with little progress. OR the issue does not appear in the most recent update and we require an update prior to the next update. NTS patient safety or undermining and bullying comments AND the update from the organisation with QM responsibility does not assure us that improvements will be forthcoming. The referral process Once we have agreed with the organisation with QM responsibility that an issue will receive enhanced monitoring we will: Check we have all the information we need Confirm the enhanced monitoring in writing to the organisation with the QM responsibility and the LEP Confirm the next steps, including when we expect updates Record the case on our database. Recording and publishing We recorded enhanced monitoring cases on our database. Using the information provided we create a summary, choose appropriate theme/s (eg clinical supervision) and a reporting status. When cases are first recorded, the status is: New, under investigation. The other statuses are: We have received an action plan from the organisation and work has started to resolve the issue. We think the action plan is appropriate. The organisation is working to resolve the issue. We are monitoring progress The organisation has concerns that the action plan to resolve the issue has fallen behind schedule or is likely to fall behind. We and the organisation are monitoring progress. 5

The organisation has told us that changes have taken place which has resolved the issue. We and the organisation are monitoring these changes to see if they are sustainable and to check that the issue will not re-occur. The organisation has told us that the changes are sustainable and the issue has been resolved. We will review the evidence to see if we can stop enhanced monitoring. We are no longer carrying out enhanced monitoring. We don t publish enhanced monitoring that is new, under investigation. More information is given below about publishing and how we stop enhanced monitoring. Enhanced monitoring action The action we take depends on the specifics of the issue, and the local circumstances. We always Write directly to the Trust/Board when we start enhanced monitoring. Require and review real-time updates on progress from the organisation with QM responsibility. Comment on the updates and agree the next steps. We may also Carry out a detailed review of the action plan. Write to the Trust/Board to express our concerns (eg after a visit). Provide GMC representation on a visit organised locally. If there are still concerns over progress, despite local QM efforts and enhanced monitoring support, then we would we consider: a GMC triggered visit withdrawal of approval of training. Support for a local visit Where it will be useful, we can attend a locally arranged visit. The visit is organised by the organisation with QM responsibility. 6

The GMC staff member who attends will normally be from the relevant visits and monitoring team. Depending on the circumstances, an Enhanced Monitoring Associate (EMA) may also attend although this will not be for all visits. Our team of EMAs are experienced clinicians with a background in clinical or medical management and in education, trained to support us with enhanced monitoring. The GMC staff member, and the EMA, if attending, will be part of the visit team, and should receive the agenda and documentation at least a week before the visit. We normally arrange a telephone conference a few days before the visit with the local lead (eg postgraduate dean, or lead visitor) to talk about: the background to the visit the role we will take on the team (will we be observers? or play a more active part?) the result that is hoped for from the visit. After the visit, the organisation with QM responsibility will produce the report according to local processes. We will need to see and comment on a draft report. Ending enhanced monitoring We don t stop enhanced monitoring until we have evidence that the original concern has been addressed and the solution in place is sustainable so that the issue doesn t reoccur. This means that enhanced monitoring will carry on for a period after the concern has been addressed, while we wait to check that the changes that have been made are sustained and until we have enough evidence, for example from the NTS. When we and the organisation with QM responsibility believe that the issues have been resolved and the changes are sustainable, we will assess available evidence. We will then make a decision as to whether the enhanced monitoring item can be closed. If it can be, we write to the organisation with QM responsibility and the LEP to confirm the decision. We can also de-escalate an enhanced monitoring item to routine monitoring if we feel further monitoring is required however at a lower level than the enahnced process. Publishing enhanced monitoring We publish limited information about enhanced monitoring on our website. We don t publish cases that are: new, under investigation. This is because the case may not have been verified. Once a visit has taken place and an action plan is in place then we would expect the case to move onto the next stage, which would be published. 7

not publishable. These are cases that by publishing we risk identifying individuals, e.g. in cases of behaviour, or puts sensitive commercial information into the public domain, e.g. service reconfiguration or closure. We update the information the website every three months. We send organisations with QM responsibility the information we plan to publish for them to check and for checking by the LEPs. The information we publish is used by other healthcare regulators. It is therefore very important that every organisation checks the information before we publish it. 8