Certification of Death (Scotland) Act 2011 Statutory Guidance

Part 2 – Guidance on the Review Process and Types of Reviews

2.1 Overview

2.1.1 Section 24A of the 1965 Act, as inserted by section 2 of the 2011 Act, sets out that the Registrar General for Scotland must ensure that a random selection of MCCDs are referred for review. Section 8 of the 2011 Act provides that a medical reviewer must review any MCCD referred. The 2011 Act does not set out how many MCCDs should be referred to medical reviewers nor what exactly a review might encompass. This is to ensure that the legislation is sufficiently flexible to allow the system of scrutiny to be reviewed and adjusted over time, if needed. This guidance therefore sets down more detail on how the random sampling of MCCDs will be undertaken and how medical practitioners and reviewers should approach undertaking the reviews under the 2011 Act and the 1965 Act, as amended.

2.1.2 Under the terms of the 2011 Act and the 1965 Act, as amended, the review process commences when a MCCD has been selected for review by the NRS Forward Electronic Register system (FER). The FER system randomly selects a percentage of certificates and forwards them to the Death Certification Review Service (DCRS) for review. A further type of review is possible - an interested person review which is detailed below.

• There are two different processes; one for electronic and another for paper MCCD reviews.
• Electronic MCCDs – Following a death, the certifying doctor enters the deceased’s details into SCI-Gateway^[1] creating a MCCD which is then auto-sent to FER and, if selected for review, is auto-forwarded to DCRS. The outcome of the MCCD review, once completed by a medical reviewer or senior medical reviewer, is then auto-sent and updated in the FER system. When the informant (usually the deceased’s next of kin) subsequently registers the death, the registrar will be informed by the FER system of the outcome of the MCCD review, or if still in progress, the current status.
• Paper MCCDs – Following a death, the certifying doctor completes a paper MCCD and emails this to the registrar. When the registrar puts the details into the FER system, the MCCD may at that point be selected for review and, if so, the system auto-creates a review record in the DCRS system. The outcome of the MCCD review, once completed by a medical reviewer or senior medical reviewer, is then auto-sent and updated in the FER system.
• For both electronic and paper MCCD reviews, the registrar^[2] and the informant^[3] must be notified of the outcome of all reviews.

2.1.3 When a MCCD is selected for review it is likely that the registrar will advise the informant of this at the time that the informant seeks to have the death registered. If the review has already been completed, the registrar may be able to provide the informant with details of the review’s outcome. If the review has still to be completed, the registrar will advise the informant that they will be contacted once the medical reviewer has completed the review. This is expected to be within one to three working days.

2.1.4 The vast majority of reviews will be ‘Level 1’ reviews, which involve a structured consideration of the MCCD, accessing the Emergency Care Summary (ECS) and checking the electronic Key Information Summary (eKIS) where available, in addition to a discussion with the certifying doctor. These reviews are expected to be completed within one working day. A much smaller number of MCCDs will be subject to ‘Level 2’ reviews, which will involve an additional, more detailed review of the clinical information surrounding the death and the MCCD. Although Level 2 reviews are more detailed, the expectation is that these reviews will be completed within three working days.

2.2 Random Sampling

2.2.1 Under 24A of the 1965 Act, Scottish Ministers may give directions to the Registrar General in relation to the referral of certificates for review. This guidance sets out the shared expectation of both the Registrar General and Scottish Ministers’ as to how MCCDs will be selected and referred for review.

2.2.2 When MCCDs are received onto the NRS FER system, a random sample of MCCDs are selected and referred for review.

2.2.3 The purpose of randomisation is to ensure that no-one in the process is able to predict or advise which MCCDs will be selected for review, and therefore it will not be possible for anyone to deal differently with a review case MCCD than they would with any other MCCD. This provides an element of public reassurance regarding the system’s ability to deter any possible malpractice, although the primary function of the Scottish system remains quality improvement and enhancement, which randomisation also serves.

2.2.4 The 1965 Act as amended by the 2011 Act sets out specific instances where a MCCD case may not be referred for review. Whilst this may seem to run counter to the purpose of randomisation, these instances relate mainly to where previous scrutiny has already taken place or alternative scrutiny is already taking place. These specific instances, which must be adhered to, can be found in section 24A(4) of the 1965 Act as amended.

2.2.5 Certificates of Stillbirth (Form 6) are not referred for review and DCRS does not review stillbirth repatriation documentation. There is no change to the role of the COPFS or associated processes. Guidance for medical practitioners on deaths which should be reported to the Procurator Fiscal is available on the COPFS website.

2.3 Reviews - General

2.3.1 As set out in the 2011 Act, reviews will be undertaken by medical reviewers, under the supervision of a senior medical reviewer. Medical reviewers’ assistants provide administrative support to medical reviewers. The senior medical reviewer and medical reviewers must be employed by HIS.

2.3.2 Under section 21 the 2011 Act, Health Boards, Special Health Boards, the Common Services Agency for the Scottish Health Service as constituted under section 10 of the National Health Service (Scotland) Act 1978, and known as Public Services Delivery Scotland, and medical reviewers (including the senior medical reviewer) have a duty to co-operate with one another in order that they can fulfil their respective functions in each of these roles.

2.3.3 The 2011 Act does not make any reference to ‘Level 1’ and ‘Level 2’ reviews, however this tiered approach to reviews is directly aligned with the expectations of Ministers and Parliament and is the model trialled successfully during the 2012-13 test site period. On the basis of this statutory guidance, the senior medical reviewer and medical reviewers therefore undertake the following types of review:

2.4 Level 1 Reviews

2.4.1 A MCCD may be randomly selected for a Level 1 review. The main purpose of Level 1 reviews is to deter poor practice and malpractice, for public reassurance and for quality improvement and quality assurance. Level 1 reviews include the review of the underlying cause of death and other contributory conditions recorded on the MCCD, including the timeline, and will query anything unusual or unexpected.

2.4.2 This will involve checking the MCCD, checking the Emergency Care Summary (ECS) and electronic Key Information Summary (eKIS) (where available), a Community Health Index (CHI) check on the deceased, General Medical Council (GMC) registration check on the certifying doctor and speaking to the certifying doctor (or another doctor or clinical member of the team with knowledge of the case and/or access to the clinical records of the deceased), usually by telephone, to obtain background clinical information. Level 1 reviews should allow for any discrepancies to be picked up and, at the discretion of the medical reviewer, can act as a trigger for a further comprehensive Level 2 review.

2.4.3 It is expected that all Level 1 reviews will be completed within one working day of being selected for review.

2.4.4 Where an MCCD is selected for a Level 1 review the following basic procedure will be followed:

Level 1 Reviews (Process 1)

Death occurs, the MCCD is completed by the certifying doctor.

Step 1

The details are entered into the NRS FER system by the registrar, which triggers a Level 1 review. For eMCCDs, this review is triggered automatically upon submission of the eMCCD by the certifying doctor. Registrar advises the informant that the MCCD has been selected for review and provides the relevant information about what this means.

Where the eMCCD has already been randomly selected and the review is either underway or has been completed, the registrar will provide the information to the informant about the review and its outcome (if available).

In rare instances, this may result in a request for the advance registration procedure (see process 4).

Step 2

The MCCD is sent electronically to the medical reviewer for review, along with any other relevant information. The MCCD number should be written on the reverse side of the form if not present.

Step 3

The DCRS records receipt of the MCCD within its electronic case management system (“eCMS”). It is then allocated to a medical reviewer for review.

Step 4

The medical reviewer receives the MCCD and undertakes the review which includes: a check of the ECS and eKIS (where available), a CHI check on the deceased, GMC registration check on the certifying doctor and a conversation with the certifying doctor.

If the relevant medical practitioner is unavailable or incapacitated, the medical reviewer will speak to another clinical member of the team with knowledge of the case and/or access to the clinical records of the deceased (in the case of junior doctors this should involve a discussion with a senior doctor such as a medical/clinical/educational lead).

Step 4 may result in the case being escalated to a Level 2 review.

Step 5

If the MCCD is in order the medical reviewer will communicate this back to the registrar. The informant is also required to be informed of the outcome of the review. The registrar may also communicate any additional information that may be required from or by the informant (for example, contact details for the medical reviewer if further discussion is needed).

The registration of death then proceeds as normal and the Certificate of Registration of Death (Form 14) is issued to the informant.

Step 6

If the MCCD is not in order then section 10 the 2011 Act applies.

In brief, the medical reviewer and the certifying doctor will explore options including amending (usually by means of an email attached to the original MCCD) or replacing the original MCCD. This will either lead to the amended or replaced MCCD being considered now to be ‘in order’ and registration then able to conclude (see Step 5); or lead to escalation of the case to the senior medical reviewer in the event of an on-going difference of views.

MCCDs, as legal documents, cannot be altered by anyone other than the certifying doctor.

Step 7

If the case is escalated to the senior medical reviewer as not in order then section 11 of the 2011 Act applies^[4]

The senior medical reviewer may review the case again with the certifying doctor and again explore options for the MCCD. This will either lead to the amended or replaced MCCD being considered now to be 'in order' and registration then able to conclude (see Step 5); or if there is still no agreement, and the MCCD remains not in order, then lead the senior medical reviewer to take further steps.

The senior medical reviewer may decide to signify that a review has been conducted and notify the relevant registrar accordingly. As per section 11 of the 2011 Act, the senior medical reviewer may also ‘take such steps as the senior medical reviewer considers appropriate to inform such persons as the senior medical reviewer considers appropriate of the relevant information’. This would include informing the clinical/medical director of the relevant Health Board and the clinical governance processes within the Health Board of any concerns. Discussions about the completion of MCCDs could be included in a doctor’s annual appraisal which contributes to their revalidation with the General Medical Council.

Alternatively, the senior medical reviewer may decide to refer the MCCD to the Procurator Fiscal for investigation into the cause of death of the deceased person^[5].

2.5 Level 2 Reviews

2.5.1 A MCCD may be randomly selected for a Level 2 review. A Level 2 review provides a route, if required, for the more comprehensive examination of a Level 1 review. Level 2 reviews provide an enhanced level of deterrence and public reassurance. A Level 2 review is a thorough review of all relevant medical information and relevant patient clinical records which allows the medical reviewer to come to a view of whether the MCCD is ‘in order’ or ‘not in order’.

2.5.2 The Level 2 Review includes a review of the MCCD and speaking to the certifying doctor (or another doctor or clinical member of the team, with knowledge of the case and/or access to the clinical records of the deceased), usually by telephone, to obtain background clinical information. This will be supplemented, however, with any other relevant health records or conversations with other parties as the medical reviewer sees fit. Specifically, this will include all relevant health records, including the results of any clinical investigations. The case may be discussed with other relevant clinical and health care staff, as required. The medical reviewer may also discuss the case with the family of the deceased or an informal carer, if required, through the most appropriate means such as the telephone, face-to-face, or electronic methods of communication. Other relevant evidence may also be considered, such as viewing the body (this is likely to be necessary only on very rare occasions).

2.5.3 It should be noted that, under section 14 of the 2011 Act, the medical reviewer can ‘require any person who is able, in the opinion of the medical reviewer, to produce relevant documents (including health records), to do so’. This requirement should provide reassurance to certifying doctors in respect of patient confidentiality issues.

2.5.4 Where an MCCD is selected for a Level 2 review the following procedure (which only differs from Level 1 reviews at Step 4) will be followed:

Level 2 Review (Process 2)

Death occurs, the MCCD is completed by the certifying doctor. The details are entered into the NRS FER system which triggers a Level 2 review. For eMCCDs, this review is triggered automatically upon submission of the eMCCD by the certifying doctor.

Step 1

Registrar advises the informant that the MCCD has been selected for review and provides the relevant information about what this means.

Where the eMCCD has already been randomly selected and the review is either underway or has been completed, the registrar will provide the information to the informant about the review and its outcome (if available).

In rare instances, this may result in a request for the advance registration procedure (see process 4).

Step 2

The MCCD is sent electronically to the medical reviewer for review, along with any other relevant information. The MCCD number should be written on the reverse side of the form if not present.

Step 3

DCRS records receipt of the MCCD for review and passes all details to medical reviewer.

Step 4

The medical reviewer receives the MCCD and undertakes a review of the information and details on the MCCD, accesses and reviews any relevant patient medical records either electronically or in hard copy; discusses the case with any other relevant party as well as the required discussion with the certifying doctor.

If the relevant medical practitioner is unavailable or incapacitated, the medical reviewer will speak to another clinical member of the team with knowledge of the case and /or access to the clinical records of the deceased, (in the case of junior doctors this should involve a senior doctor such as a medical/clinical/educational lead).

Step 5

If the MCCD is in order the medical reviewer will communicate this back to the registrar. The informant is also required to be informed of the outcome of the review. The registrar may also communicate any additional information that may be required from or by the informant (for example, contact details for the medical reviewer if further discussion is needed).

The registration of death then proceeds as normal and the Certificate of Registration of Death (Form 14) is issued to the informant.

Step 6

If the MCCD is not in order, section 10 the 2011 Act applies^[6]

In brief, the medical reviewer and the certifying doctor will explore options including amending (usually by means of an email attached to the original MCCD) or replacing the original MCCD. This will either lead to the amended or replaced MCCD being considered to be ‘in order’ (see Step 5) and registration then able to conclude, or lead to escalation of the case to the senior medical reviewer in the event of an on-going difference of opinions.

MCCDs, as legal documents, cannot be altered by anyone other than the certifying doctor.

Step 7

If the case is escalated to the senior medical reviewer as not in order then section 11 of the 2011 Act applies.^[7]

In brief, the senior medical reviewer may review the case again with the certifying doctor and again explore options for the MCCD. This will either lead to the amended or replaced MCCD being considered now to be 'in order' and registration then able to conclude (see Step 5); or if there is still no agreement, and the MCCD remains not in order, then lead the senior medical reviewer to take further steps.

The senior medical reviewer may decide to signify that a review has been conducted and notify the relevant registrar accordingly.

As per section 11 of the 2011 Act, they may also “take such steps as the senior medical reviewer considers appropriate to inform such persons as the senior medical reviewer considers appropriate of the relevant information”. This might include informing the clinical/medical director of the relevant Health Board and the clinical governance processes within the Health Board. Discussions about the completion of MCCDs could be included in a doctor’s annual appraisal which contributes to their revalidation with the General Medical Council.

Alternatively, the senior medical review may decide to refer the MCCD to the Procurator Fiscal for investigation into the cause of death of the deceased person.^[8]

2.5.5 It is expected that all Level 2 reviews will be completed within three working days of being selected for review. In rare circumstances, the medical reviewer or senior medical reviewer may report a death under section 16 of the 2011 Act to the Procurator Fiscal if criminality is suspected.^[9]

2.6 Interested Person Reviews

2.6.1 The main purpose of an interested person review is to provide a further measure of public and professional reassurance, over and above the randomised review selection process. Such reviews must be requested within three years of the date of death and cannot be conducted where the case has already been reported to the Procurator Fiscal for investigation.^[10] For further details of eligibility for an interested person review, refer to section 4 of the 2011 Act.

2.6.2 Requests for an interested person review are expected to be a rare occurrence and should be raised by the interested person directly with DCRS, rather than via registrars. As such, the duty to inform the Registrar General of any such review lies with the medical reviewers.

2.6.3 An interested person review will review the contents of the MCCD and not of the care provided to the deceased prior to their death. Any concerns about the care received should be raised with the team delivering the care prior to death or through the NHS complaints system in the first instance.

2.6.4 It is highly likely, but cannot be automatically assumed, that an interested person review will be a retrospective review where the death has already been registered and the funeral has already taken place. Reasons for requesting such a review may vary, but given they are specifically requested, interested person reviews should be conducted as Level 2 reviews. However, a medical reviewer may reject a request if it is considered vexatious, duplicates (or is substantially the same as) a review already carried out or underway, or where there are other appropriate grounds for doing so.

2.6.5 Section 4 of the 2011 Act includes a definition of who is an ‘interested person’.^[11] Examples of interested persons include qualified informants, health care professionals, funeral directors, and others people specified by Scottish Ministers.

2.6.6 Requests for an interested person review should be made by way of the form (see Annex A). It is expected that interested person reviews will be completed within a maximum of 15 working days.

2.6.7 Once an interested person review request form is received the following process will be followed:

Interested Person Review (Process 3)

Interested Person Review Request Form received.

Step 1

The DCRS records receipt of an interested person review request on the eCMS. The case is allocated to a medical reviewer.

Step 2

The medical reviewer checks the form to ensure that the request meets all eligibility criteria.

More specifically, the medical reviewer is to ensure that the request meets the definition of interested person; that the death did not occur more than three years previously and that the cause of death has not been (or is not being) investigated by the Procurator Fiscal.

The medical reviewer must also check as to whether the death has already been registered, to determine appropriate timescales for review and response.

Step 3

If the request is not eligible, or is considered vexatious, or inappropriate for other reasons, the request is to be refused by the medical reviewer and the DCRS records the outcome of the request. The medical reviewer also provides a response to the applicant (the interested person). The outcome of the review may be that the certificate is in order and no changes are required, it is not in order and amendments are necessary by way of a reissue or the case needs to be reported to the procurator fiscal.

This may include advice to pursue the enquiry (e.g. clinical care) through the clinical team involved or the NHS complaints procedure.

Step 4

If the request is accepted the medical reviewer will notify the Registrar General and undertake a Level 2 review of the MCCD – refer to Process 2.

2.7 Emergency Suspension of Reviews

2.7.1 The above review processes set out the normal series of events, however, under section 24A(7) of the 1965 Act as amended, Scottish Ministers have the power to suspend by order, the referral of certain MCCDs to the medical reviewer during an epidemic, pandemic or if it becomes necessary to do so to prevent the spread of infectious disease or contamination. The certificates which can be suspended are set out in section 24A(1) to (3) of the 1965 Act. Scottish Ministers may alternatively decide to reduce the percentage of MCCDs randomised for review. The impact of an epidemic on bereaved relatives and medical practitioners should always be considered when setting these levels.

2.8 Not Staying Registration (‘Advance Registration’)

Background

2.8.1 As set out elsewhere within this guidance it is expected that reviews of MCCDs will normally take between one to three working days. The system of independent scrutiny should not cause significant delays to the bereaved or to funeral arrangements. Medical reviewers should be mindful at all times of the need to minimise disruption and unnecessary distress to bereaved families, and to complete reviews as quickly as possible.

2.8.2 Whilst the extra time involved in reviewing a certificate prior to completion of registration will not affect the vast majority of funeral arrangements, it is accepted that arrangements should be in place for any rare situations where there is a need and a clear rationale for a funeral to proceed within a specific timescale, and where that timescale may not be met if the standard review procedure is followed.

2.8.3 In cases randomly selected for review (but not in ‘interested person’ reviews), section 6 (which inserts section 24B into the 1965 Act) and section 7 of the 2011 Act provide powers to enable an ‘expedited’ review procedure, or for the review not to delay (stay) registration of the death.^[12] Neither section sets out the criteria for determining which cases should be eligible for the expedited procedure, except to say that it will be for the medical reviewer to ‘determine whether it is appropriate’.^[13]

Key Principles

2.8.4 It is expected that in the vast majority of cases the standard review procedure will be appropriate and a one to three day extension to the registration procedure will not add any significant delay to the funeral arrangements. The request to not delay registration of death should be available in specific circumstances where there is a clear rationale for a funeral to proceed within a quicker timescale.

2.8.5 In practice, at the point of registration, whether in hours or out of hours, and once a MCCD has been selected for review, it will be a matter for the informant to request that the registration is not delayed, if they have any concerns that the review will have an adverse impact by causing a delay to holding the funeral.

2.8.6 If the informant wishes to request that registration of the death is not delayed, the informant will make the request to the district registrar and must complete an advance registration application form. The registrar then contacts DCRS to confirm the status of the review. Section 24B(3) of the 1965 Act requires the inclusion in the application to the medical reviewer of a statement by the informant justifying why the registration of the death should be done as soon as possible and before the MCCD review is complete. This statement should be made on the advance registration application form (see Annex B).

2.8.7 Once a request has been made it is for the medical reviewer, based on the information available in the form, from the MCCD and from any other sources they consider appropriate, to make a decision as to whether or not to allow registration to continue before the review under section 8(1) of the 2011 Act, or any further review under section 11(2), is completed.

2.8.8 The registrar must pass on any request under section 24B of the 1965 Act which they receive to the medical reviewer, because, as set down in legislation, it is for the medical reviewer alone to determine whether the circumstances justify registering the death before any review is complete and whether there are any obvious indications that the MCCD is not ‘in order’.

2.8.9 Section 7 of the 2011 Act permits the medical reviewer to make any enquiries they consider appropriate when deciding whether to register a MCCD before a review is complete. It is expected that the decision whether or not to delay registration should be made within 2 hours of DCRS receiving a correctly completed advance registration application. In effect, this consideration may share some of the characteristics of a Level 1 review, but would be undertaken before any other reviews planned for that day. The medical reviewer must notify the relevant registrar of their determination.

2.8.10 If the medical reviewer agrees to allow the registration to proceed before the review is complete, this will mean that the registrar will complete the registration and issue the Certificate of Registration of Death (Form 14). The body can then be released and the funeral can proceed whilst the formal Level 1 or Level 2 review, as originally randomly selected, continues to take place in the background. In practice this means that further examination of the deceased, if considered necessary at a later stage, such as a post mortem, may not be possible.

Criteria

2.8.11 The Request to Not Stay Registration form (advance registration application form) should be used by informants requesting that registration not be delayed. The form sets out three examples of circumstances where not delaying registration might be appropriate:

i. Not delaying registration for religious or cultural reasons - for example, some religious traditions require burial within 24 hours and some communities have a tradition of burial within three days.

ii. Not delaying registration for compassionate reasons – for example, in the death of a child under 16 years or a neo-natal death where a delay may cause significant additional distress.

iii. Not delaying registration for administrative or practical reasons – for example, where the family does not reside in Scotland and the deceased will be in transit to another part of the UK or international destinations for a funeral.

2.8.12 Informants are required to complete the form to detail the reason for the request in relation to one or more of these three categories, and to provide a short explanatory note. This form will provide the basis for the medical reviewer considering whether or not to delay registration.

2.8.13 It is expected that not delaying registration should happen very rarely and that in the vast majority of cases the standard scrutiny timescales will not cause delays to bereaved families. In circumstances where an eMCCD is transmitted to FER directly, the randomisation and the review may be complete even before the informant makes an appointment to register the death.

2.8.14 The above principles can be summarised in the following process:

Advance Registration (Process 4)

Death occurs, MCCD is completed by certifying doctor

Step 1

The registrar receives the MCCD and the NRS FER system randomly selects it for a Level 1 or Level 2 review.

Step 2

Registrar advises the informant that the MCCD has been selected for review and provides the relevant information about what this means.

Step 3

The informant requests the registration is not delayed on the basis that there is a clear rationale for proceeding with the funeral of the deceased more quickly than the review process will allow.

The registrar contacts DCRS to confirm the status of the review. If advance registration is to proceed, the registrar provides a Request to Not Stay Registration Form (advance registration application form) to be completed by the informant.

Step 4

Registrar will contact DCRS immediately to alert them to the request, and will provide electronic copies of the informant’s complete form and the MCCD.

Registrars must pass on any requests for registration not to be delayed.

Step 5

DCRS records receipt of the MCCD and the advance registration application.

Step 6

Medical reviewer will consider the MCCD and the request form and will make a decision whether or not registration should be delayed. The decision will be based on

• the request fulfilling the eligibility criteria (as below)
• whether the MCCD is substantially in order
• the outcome of any other queries the medical reviewer considers necessary

Step 7a

If not delaying registration is granted the medical reviewer will communicate that back to the registrar as soon as that decision is made.

The outcome of that review should be communicated back to the registrar within 2 hours of the correctly completed advance registration application being received by the DCRS.

The registration of the death will then be completed by the registrar and the Form 14 will be issued to the informant.

• If the case had originally been selected for a Level 1 review, then any remaining elements of the review that still require to be completed will subsequently be undertaken. Any changes required to the MCCD will be notified to the registrar, and to the informant.
• If the case had originally been selected for a Level 2 review, then any remaining elements of the review that still require to be completed will subsequently be undertaken. Any changes required to the MCCD will be notified to the registrar, and to the informant.

If the MCCD is found to be ‘not in order’ after the advanced registration has been granted, DCRS will notify the registrar. The informant is also required to be informed of the outcome of the review.

Step 7b

If not delaying registration is not granted, the medical reviewer will communicate this back to the registrar, with the reasons, and the original review will proceed as normal (see process 1 or process 2 as appropriate)

2.8.15 There is no appeal of the medical reviewers’ decision following consideration of a request to not delay registration.

2.8.16 All requests to not delay registration – whether granted or not granted – will be peer reviewed regularly to ensure consistency and quality.