Death Certification Test Site Evaluation

1 Background and Context

Introduction

1.1 The Scottish Government established two test sites in Dundee and Dumfries & Galloway in May-June 2012 to pilot a new approach to reviewing death certification. Blake Stevenson Ltd was commissioned in July 2012 to evaluate these test sites. The aim of the evaluation was to assess the test site processes and stakeholder experiences with a view to identifying lessons learned and informing national implementation across Scotland. This report presents the findings from the evaluation.

Context

New legislation

1.2 The Certification of Death (Scotland) Act 2011 makes provision for a new process of independent reviews of Medical Certificates of Cause of Death (MCCDs), whereby registrars will refer a random sample of deaths (excluding deaths which are referred to the Procurator Fiscal) to the newly created post of Medical Reviewer (MR) who will review the quality and accuracy of MCCDs^[1]. Generally, the review must be complete before the death can be fully registered.

1.3 Medical Reviewers can undertake two types of review:

• a basic level 1 review in which the MR reviews the MCCD and holds a conversation with the doctor who certified the death. Original estimates indicated that the level 1 review is expected to take 30 minutes.
• a comprehensive level 2 review which involves the MR reviewing the MCCD and medical records associated with the patient who has died as well as speaking to the certifying doctor. The MR has the power to view the body if necessary and to speak to other involved parties such as other professionals and the family of the deceased for level 2 reviews, which original estimates indicated are expected to take three hours.

1.4 Medical Reviewers are able to escalate a level 1 review to level 2 if they deem it necessary.

1.5 The new legislation was prompted by the findings of the Burial and Cremation Review Group. This Group was set up in 2005 to review existing legislation related to burial and cremation, much of which was over 100 years old, with the aim of updating it to reflect life in the 21^st century. The Review also took into account policy developments in England, particularly the Inquiry into the Harold Shipman case, which highlighted a need to review processes governing death certification.

1.6 The Review recommended that a new system of death certification should be introduced in Scotland. Following consultation on the Review's findings, the Scottish Government developed the new legislation with the aim of:

• introducing a single system of independent, effective scrutiny applicable to deaths that do not require a Procurator Fiscal investigation;
• improving the quality and accuracy of the MCCD form; and
• providing improved public health information and strengthened clinical governance in relation to deaths.

1.7 The Scottish Government recognises that, while the Shipman case was one of the original drivers for reviewing the system of death certification, no death certification system can guarantee that similar cases could not occur. Therefore, the new process in Scotland focuses primarily on the above three aims.

1.8 A new death certification process is also being developed in England and Wales. The Coroners and Justice Act 2009 makes provision for all deaths (that do not require investigation by a Coroner) to be referred to a Medical Examiner for review, before a burial or cremation is authorised. The main aim of this system is to strengthen safeguards for the public, simplify the death certification process and increase the quality of certification and data about causes of death^[2].

1.9 The new process planned in England and Wales is similar to the Scottish process but there are some significant differences: in England and Wales, all deaths will be reviewed and the focus on deterring and detecting malpractice is more pronounced than in the Scottish model, where a sample of deaths will be reviewed with the primary aims of improving the quality and accuracy of MCCDs and public health data about causes of death.

The death certification test sites

1.10 The new process has been tested in two test sites: Dumfries & Galloway and Dundee. Both test sites employed a 0.5 FTE Medical Reviewer (MR) and 0.5 FTE Medical Reviewer Assistant (MRA). The MRs were overseen by the Senior Medical Reviewer (SMR), who is a Senior Medical Officer at the Scottish Government.

1.11 In both areas, the MRs reviewed a sample of deaths referred by local registrars using a random sampling process. The test site in Dundee began in May 2012 and in Dumfries & Galloway in June 2012. The final day for referrals in both areas was 14 February 2013.

1.12 The test sites were required to achieve a target number of reviews: 525 level 1 reviews and 70 level 2 reviews in each test site area.

1.13 Doctors in both areas completed the existing MCCD form as well as a second revised MCCD form for the purposes of the test site.

1.14 MRs in the test sites carried out level 1 and level 2 reviews with the level of each review determined by the random sampling process. MRs could upgrade level 1 reviews to level 2 if they considered it necessary.

1.15 When the MRs finished each review, they completed an MR form and returned it to NHS ISD. NHS ISD then recorded the information on a database with information such as the number of reviews completed, their duration and outcome.

The evaluation

1.16 The aim of the evaluation is to assess the test site processes and stakeholder experiences with a view to identifying lessons learned and informing national implementation across Scotland, which is planned to take place from April 2014. The evaluation focuses on:

• establishing the length of time to complete level 1 and level 2 reviews and reviews upgraded from level 1 to level 2 by the MR;
• the factors that impact on the duration of reviews;
• early identification of any recurring clinical governance and/or training issues;
• stakeholder views on the new system, forms and documentation;
• other issues (rural, urban, faith, stakeholder, MR FTE numbers, public impact and so on) which may arise when implementing the system nationally; and
• implications for national implementation.

Methodology

1.7 Our methodology involved four key elements outlined below:

• interviews with test site stakeholders at the beginning and end of the evaluation;
• interviews with national stakeholders at the end of the evaluation;
• analysis of NHS ISD data; and
• case studies of 18 reviews.

1.18 Each element is described in more detail below.

Interviews with test site stakeholders

1.19 We undertook face-to-face qualitative interviews with all people recruited into statutory roles associated with the test sites at the beginning and end of the evaluation. These stakeholders were:

• the Senior Medical Reviewer;
• the Medical Reviewer (MR) and Medical Reviewer Assistant (MRA) in Dumfries & Galloway; and
• the MR and MRA in Dundee.

1.20 The interviews with these stakeholders at the beginning of the evaluation explored their experience of the test sites so far, their expectations for the test sites and their views of the review process. The interviews at the end of the evaluation explored their experiences and views of the test sites and the review process, how far their expectations had been met and their views of lessons learned through the test sites.

1.21 We also interviewed the Principal Information Analyst with responsibility for the test site data at NHS ISD at the beginning and end of the evaluation to explore data collection and recording issues associated with the test sites.

1.22 A full list of interviewees is in Appendix 1.

Interviews with national stakeholders

1.23 We carried out face-to-face qualitative interviews with eight national stakeholders at the end of the evaluation to discuss their views of the overall impact of the test sites and the implications for national implementation of the test sites and the review process. A list of these stakeholders is in Appendix 1.

Analysis of NHS ISD data

1.24 The Medical Reviewers in both areas sent a form for each review they completed containing information about the review, its duration and outcome. The data from these forms was stored by NHS ISD in a database. NHS ISD sent us monthly updates of data from the database including the number of reviews completed, their duration and their outcome.

Case studies

1.25 We carried out retrospective case studies of 18 reviews (nine in each area) carried out by the MRs. To carry out the case studies, we:

• asked the MRs to select case studies based on the selection criteria in Table 1.1;
• reviewed details of each case as recorded on the reporting form that MRs submitted to NHS ISD;
• gathered details of each case from the MRs; and
• undertook qualitative telephone interviews with the registrars and medical professionals involved in each review^[3].

1.26 We undertook the case studies in two waves: six during wave 1 at the start of the evaluation (three in each test site area) and 12 during wave 2 at the end of the evaluation (six in each test site area).

1.27 Table 1.1 summarises the case studies we completed and the case study review participants we interviewed.

Table 1.1: Case studies

Area	Selection criteria	Interviewees
Wave 1
Dundee	Level 1 review, not in order	MR Registrar Senior member of medical team
Dundee	Level 2 review, not in order	MR Registrar Certifying doctor Senior member of medical team
Dundee	Upgraded review	MR Registrar Certifying doctor Senior member of medical team
Dumfries & Galloway	Level 1 review, not in order	MR Registrar Senior member of medical team
Dumfries & Galloway	Level 2 review, not in order	MR Registrar Certifying doctor Senior member of medical team
Dumfries & Galloway	Upgraded review	MR Registrar Certifying doctor Senior member of medical team
Wave 2
Dundee	Level 1 review which went well	MR Registrar
Dundee	Level 2 review which went well	MR Registrar
Dundee	Level 2 review which went well	MR Registrar Senior member of medical team
Dundee	Level 1 review which was difficult	MR Registrar Senior member of medical team
Dundee	Level 1 review which was difficult	MR Registrar Certifying doctor
Dundee	Level 2 review which was difficult	MR Registrar Certifying doctor
Dumfries & Galloway	Level 1 review which went well	MR Registrar Certifying doctor
Dumfries & Galloway	Level 2 review which went well	MR Registrar Certifying doctor
Dumfries & Galloway	Upgraded review which went well	MR Registrar Certifying doctor
Dumfries & Galloway	Level 1 review which was difficult	MR Registrar Senior member of medical team
Dumfries & Galloway	Level 2 review which was difficult	MR Registrar Senior member of medical team
Dumfries & Galloway	Upgraded review which was difficult	MR Registrar Certifying doctor

1.28 We asked case study interviewees about their involvement in the case study review as well as their overall views of the new review process and its impact on them, their colleagues and the public.

Limitations of the evaluation

1.29 The evaluation has several limitations as noted below.

• The test sites have not operated in 'real time'. Funerals have taken place regardless of whether or not the review is complete but, when the process is implemented nationally, reviews will need to be completed before funerals can be arranged. This is especially notable where particularly time-sensitive cases are concerned, for example deaths in faith groups where the preference is to hold a funeral within 24 hours of a death, or deaths where international repatriation is required. For this reason the information the evaluation has been able to gather regarding the duration of the reviews is particularly important.
• As the test sites did not operate in 'real time', they did not alter the way in which members of the public register deaths or make funeral arrangements. Therefore, gathering the views of the public about the new arrangements was not part of the scope of this evaluation.
• When the process is implemented nationally, people who register a death will have to pay a fee to the registrar to go towards the costs of the review system, but this fee was not charged during the test sites. This issue was therefore not included within the scope of this evaluation.
• In addition, when the process is implemented nationally, Medical Reviewers will have additional powers which they did not have in the test sites. For example, when the process is implemented nationally, MRs will have the power to authorise cremation of repatriated deceased and arrange post mortem examinations under certain circumstances.
• Members of the public were not able to request a review in the test site, but they will be able to when the process is implemented nationally.

The report

1.30 The remainder of the report is set out as follows:

• Chapter 2 presents the quantitative and qualitative evidence from the test sites.
• Chapter 3 sets out the findings.
• Chapter 4 provides conclusions and discusses implications for national implementation.